Lexicon Pharmaceuticals, Inc 10-K for FY2024
Lexicon Pharmaceuticals, Inc. (LXRX)
10-K
2025-03-07
For: 2024-12-31
View Original
Added on
April 05, 2026
About this 10-K
Lexicon Pharmaceuticals, Inc filed this 10-K on March 7, 2025, covering the fiscal year ended December 31, 2024 (FY2024).
Headline figures
Fiscal year ended December 31, 2024, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $31.08M
- up 2481.5% from $1.2M a year earlier
- Net loss
- $200.4M
- compared with a net loss of $177.12M a year earlier
- Diluted EPS
- -$0.63
- compared with -$0.80 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
| (Mark One) | ||||||||
| ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | ||||||||
| For the Fiscal Year Ended | ||||||||
or
| | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | ||||
| For the Transition Period from _____________ to _____________ | |||||
Commission File Number: 000-30111
(Exact Name of Registrant as Specified in its Charter)
| (State or Other Jurisdiction of Incorporation or Organization) | (I.R.S. Employer Identification Number) | |||||||||||||
| (Address of Principal Executive Offices and Zip Code) | (Registrant’s Telephone Number, Including Area Code) | |||||||||||||||||||
Securities registered pursuant to Section 12(b) of the Act:
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Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act of 1933. Yes ☐ No ☑
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934. Yes ☐ No ☑
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days. Yes ☑ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☑ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Securities Exchange Act of 1934. (check one): Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☑ Smaller reporting company ☑ Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Securities Exchange Act of 1934. ☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐
If securities are registered pursuant to Section 12(b) of the Securities Exchange Act of 1934, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Securities Exchange Act of 1934). Yes ☐ No ☑
The aggregate market value of voting stock held by non-affiliates of the registrant as of the last day of the registrant’s most recently completed second quarter was approximately $297.1 million, based on the closing price of the common stock on the Nasdaq Global Select Market on June 30, 2024 of $1.68 per share. For purposes of the preceding sentence only, our directors, executive officers and controlling stockholders are assumed to be affiliates. As of February 28, 2025, 361,492,295 shares of common stock were outstanding.
Documents Incorporated by Reference
Certain sections of the registrant’s definitive proxy statement relating to the registrant’s 2025 annual meeting of stockholders, which proxy statement will be filed under the Securities Exchange Act of 1934 within 120 days of the end of the registrant’s fiscal year ended December 31, 2024, are incorporated by reference into Part III of this annual report on Form 10-K.
Lexicon Pharmaceuticals, Inc.
Table of Contents
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The Lexicon name and logo and INPEFA® are registered trademarks of Lexicon Pharmaceuticals, Inc. ZYNQUISTA™ is a trademark of Lexicon Pharmaceuticals, Inc.
_____________________________________________________
In this annual report on Form 10-K, “Lexicon Pharmaceuticals,” “Lexicon,” “the Company,” “we,” “us” and “our” refer to Lexicon Pharmaceuticals, Inc. and its subsidiaries.
_____________________________________________________
Factors Affecting Forward-Looking Statements
This annual report on Form 10-K contains forward-looking statements. These statements relate to future events or our future financial performance. We have attempted to identify forward-looking statements by terminology including “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “should” or “will” or the negative of these terms or other comparable terminology. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks outlined under “Item 1A. Risk Factors,” that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements.
Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. We are not under any duty to update any of the
forward-looking statements after the date of this annual report on Form 10-K to conform these statements to actual results, unless required by law.
PART I
Item 1. Business
Overview
We are a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. We are devoting most of our resources to the research and development of our most advanced drug candidates and the commercialization of our approved drug, INPEFA® (sotagliflozin):
•We are developing pilavapadin (LX9211), an orally-delivered small molecule drug candidate, as a treatment for neuropathic pain. We have completed three Phase 2 clinical trials evaluating the safety and tolerability of pilavapadin and its effects on DPNP and neuropathic pain. We have reported top-line results from our Phase 2b clinical trial of pilavapadin in diabetic peripheral neuropathic pain, or DPNP, which demonstrated clear evidence of effect at the 10 mg dose and have received Fast Track designation from the U.S. Food and Drug Administration, or FDA, for development of pilavapadin in that indication. We have also reported positive results from a Phase 2a clinical trial of pilavapadin in DPNP and results from a separate Phase 2a clinical trial of pilavapadin in post-herpetic neuralgia which also demonstrated evidence of effect.
•We are developing LX9851, an orally-delivered small molecule drug candidate, as a treatment for obesity and associated cardiometabolic disorders and are conducting preclinical development of LX9851 in preparation for filing an investigational new drug application, or IND, with the FDA.
•We are commercializing INPEFA (sotagliflozin), an orally-delivered small molecule drug, in the United States to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, or CKD, and other cardiovascular risk factors.
We are also developing sotagliflozin as a treatment for hypertrophic cardiomyopathy, or HCM, and are conducting a Phase 3 clinical trial of sotagliflozin in that indication.
We are separately pursuing regulatory approval of ZYNQUISTA™ (sotagliflozin) as a treatment for type 1 diabetes. The FDA issued a complete response letter regarding our New Drug Application, or NDA, for sotagliflozin in type 1 diabetes in March 2019 and an additional complete response letter in December 2024 regarding our NDA for sotagliflozin as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and CKD. At our request, the FDA has issued a public Notice of Opportunity for Hearing, or NOOH, on whether there are grounds for denying approval of our NDA and those proceedings are ongoing.
•We are conducting preclinical research and development of compounds from a number of additional drug programs originating from our internal drug discovery efforts.
Pilavapadin originated from our collaborative neuroscience drug discovery efforts with Bristol-Myers Squibb and LX9851, sotagliflozin and compounds from a number of additional drug programs originated from our own internal drug discovery efforts. Our efforts were driven by a systematic, target biology-driven approach in which we used gene knockout technologies and an integrated platform of advanced medical technologies to systematically study the physiological and behavioral functions of almost 5,000 genes in mice and assessed the utility of the proteins encoded by the corresponding human genes as potential drug targets. We have identified and validated in living animals, or in vivo, more than 100 targets with promising profiles for drug discovery.
We have worked both independently and through collaborations and strategic alliances with third parties to capitalize on our drug target discoveries and research and development programs. We seek to retain exclusive or co-exclusive rights to the benefits of certain research and development programs by developing and commercializing drug candidates from those programs internally, particularly in the United States for indications treated by specialist physicians. We seek to collaborate with other pharmaceutical and biotechnology companies with respect to the research, development and commercialization of certain of our drug candidates, particularly with respect to commercialization in territories outside the United States or commercialization in the United States for indications treated by primary care physicians, or when the collaboration may otherwise provide us with access to expertise and resources that we do not possess internally or are complementary to our own.
We were incorporated in Delaware in July 1995, commenced operations in September 1995 and were listed on The Nasdaq Global Select Market in April 2000. Our corporate headquarters are located at 2445 Technology Forest Blvd., 11th Floor, The Woodlands, Texas 77381, and our telephone number is (281) 863-3000.
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Our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 are made available free of charge on our corporate website located at www.lexpharma.com as soon as reasonably practicable after the filing of those reports with the Securities and Exchange Commission, or the SEC. Information found on our website should not be considered part of this annual report on Form 10-K. Alternatively, you may access these reports on the SEC’s website at www.sec.gov.
Drugs and Drug Candidates
We are devoting most of our resources to the research and development of pilavapadin, LX9851 and sotagliflozin and the commercialization of INPEFA. We have also advanced a number of additional compounds into various stages of preclinical research and development.
Pilavapadin (LX9211)
Pilavapadin is an orally-delivered small molecule compound that we are developing as a treatment for neuropathic pain. We have received Fast Track designation from the FDA for development of pilavapadin in DPNP. Our scientists identified the target of pilavapadin, adapter-associated kinase 1, or AAK1, in our target discovery efforts based on their discovery that mice lacking AAK1 exhibited increased resistance to induced neuropathic pain in preclinical models. Pilavapadin and another development candidate were discovered by scientists working within our drug discovery alliance with Bristol-Myers Squibb from which we hold exclusive development and commercialization rights. Preclinical studies of pilavapadin demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain without affecting opiate pathways.
We have completed three Phase 2 clinical trials evaluating the safety and tolerability of pilavapadin and its effects on DPNP and neuropathic pain.
Our PROGRESS Phase 2b clinical trial enrolled 496 patients with type 1 or type 2 diabetes and experiencing moderate to severe DPNP in a randomized, double-blind, placebo-controlled study evaluating three treatment groups receiving once daily pilavapadin doses of 10mg, 20mg or 20mg for seven days followed by 10mg thereafter. The effects of pilavapadin were assessed over a 16-week evaluation period, which included a screening period of two weeks and a blinded evaluation period of 14 weeks. The primary efficacy endpoint under evaluation in the study was the reduction in an average daily pain score, or ADPS, from baseline to Week 8 as compared to placebo, with secondary endpoints including reduction in burning pain and reduction in pain interference on sleep at 8 weeks. Certain patient-reported outcome measures were also assessed. Topline data from the study showed a reduction in ADPS from baseline to week 8 with the 10 mg, 20 mg/10 mg and 20 mg dose arms achieving reductions of 1.74, 1.70 and 1.38 respectively, compared to 1.31 in the placebo arm. The study’s statistical analysis plan was designed to detect a dose-response signal based on a prespecified model that assumed separation of all treatment arms from placebo when measuring the primary endpoint. As a result of the lack of separation in ADPS reduction between the 20 mg dose arm and placebo, the study results did not reach statistical significance on the primary endpoint (p=0.11). However, the 10 mg dose arm demonstrated clear evidence of effect by achieving early and clinically meaningful separation from placebo on ADPS that was maintained throughout the study duration. Adverse events were more frequent in the pilavapadin treatment arms, but were significantly improved from the RELIEF-DPN-1 study across all doses. Nearly all adverse events were reported as mild or moderate. Adverse events were most prominent at the 20 mg dose and pilavapadin was generally well-tolerated at the 10 mg dose. Dizziness and nausea were the most commonly reported adverse events and the most frequently associated with patient discontinuations from the study, which occurred most predominantly in the 20 mg dose. No drug related serious adverse events or deaths were reported in the study.
Our RELIEF-DPN-1 Phase 2 clinical trial enrolled 319 patients experiencing DPNP in a randomized, double-blind, placebo-controlled study of pilavapadin evaluating three treatment groups receiving an initial loading dose of 100mg or 200mg of pilavapadin or placebo, followed by once daily doses of 10mg or 20mg of pilavapadin or placebo, respectively. The effects of pilavapadin were assessed over an 11-week evaluation period, which included a 5-week placebo run-off period following the initial 6-week treatment period. The primary efficacy endpoint under evaluation in the study was the change from baseline to week 6 in average daily pain score, or ADPS, based on the 11-point numerical rating scale in patients treated with pilavapadin compared with placebo. Data from the study showed a statistically significant reduction from baseline to week 6 in ADPS of 1.39 points in the low dose arm, compared to 0.72 in the placebo arm (p=0.007 versus placebo), meeting the study’s primary endpoint. The high dose arm demonstrated a reduction from baseline to week 6 in ADPS of 1.27 points (p=0.030 versus placebo), narrowly missing statistical significance. Consistent and statistically significant benefits in burning pain, pain interference with sleep and other measures of particular importance in DPNP were also observed in both pilavapadin treatment arms as compared to placebo during the initial 6-week treatment period. During the blinded 5-week placebo run-off period, there was a gradual tapering of efficacy in both treatment arms with no evidence of rebound pain or withdrawal symptoms.
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Adverse events were more frequent in the pilavapadin treatment arms and at the higher dose during the initial 6-week treatment period, with the most common being dizziness, headache and nausea and nearly all being reported as mild or moderate. There were no observed differences in drug-related treatment-emergent adverse events between the treatment and placebo arms during the run-off period, and no drug-related serious adverse events or deaths were reported in the study.
Our RELIEF-PHN-1 Phase 2 clinical trial enrolled 79 patients experiencing post-herpetic neuralgia, or PHN, in a randomized, double-blind, placebo-controlled study of pilavapadin evaluating two treatment groups receiving an initial loading dose of 200mg of pilavapadin or placebo, followed by once daily doses of 20mg of pilavapadin or placebo, respectively. The effects of pilavapadinwere assessed over an 11-week evaluation period, which included a 5-week placebo run-off period following the initial 6-week treatment period. The primary efficacy endpoint under evaluation in the study was the change from baseline to week 6 in ADPS based on the 11-point numerical rating scale in patients treated with pilavapadin compared with placebo. Topline data from the study showed a reduction from baseline to week 6 in ADPS of 2.42 points in the pilavapadin arm, compared to a reduction of 1.62 points in the placebo arm (p=0.120 versus placebo), missing statistical significance in the study’s primary endpoint but demonstrating evidence of effect. Separation of pilavapadin from placebo on ADPS was observed at week 1 and maintained consistently thereafter, with an average placebo-adjusted reduction over the 6-week treatment period of 0.80 points (p=0.031 versus placebo). Adverse events were consistent with those observed in our RELIEF-DPN-1 clinical trial, with dizziness as the most commonly reported and the most frequently associated with patient dropouts from the study. No drug-related serious adverse events or deaths were reported in the study.
LX9851
We are developing LX9851, an orally-delivered small molecule drug candidate, for the treatment of obesity and as a tool for weight management. We are conducting IND-enabling studies of the compound and its associated back-up molecules in preparation for filing an IND. Our scientists identified the target of LX9851 in our target discovery efforts based on their discovery that mice lacking such target exhibited favorable phenotypes across multiple measures of metabolic syndrome in preclinical models, including resistance to diet-induced obesity and improved body composition.
Sotagliflozin
Sotagliflozin is an orally-delivered small molecule compound that we are commercializing for heart failure and developing for HCM and type 1 diabetes. Our scientists identified the targets of sotagliflozin, sodium-glucose cotransporter type 1, or SGLT1, and sodium-glucose cotransporter type 2, or SGLT2, in our target discovery efforts based on their discovery that mice lacking SGLT1, SGLT2 or both exhibited favorable phenotypes across multiple measures of metabolism and glucose control in preclinical models. Preclinical studies of sotagliflozin demonstrated that compounds inhibiting both targets had a favorable preclinical profile relative to compounds selective for SGLT2.
We use “INPEFA” when referring to our FDA-approved drug, “sotagliflozin” when referring to our development for HCM and “ZYNQUISTA” when referring to our development for type 1 diabetes.
Heart Failure
We commercially launched INPEFA, a once-daily oral tablet, following regulatory approval in the United States in May 2023 to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or type 2 diabetes, CKD, and other cardiovascular risk factors.
In November 2024, we restructured and significantly reduced our commercial operations for INPEFA, but we continue to manufacture and make INPEFA available to patients and prescribers. We do not maintain a sales force for INPEFA. Our internal medical affairs function maintains responsibility for responding to external inquiries regarding the appropriate use of INPEFA with regularly updated and well-substantiated scientific and medical information. We principally sell INPEFA to a limited number of major wholesalers, as well as selected regional wholesalers, most of whom in turn resell INPEFA to retail pharmacies, hospitals, government agencies and other institutions for subsequent resale to patients and healthcare providers.
Hypertrophic Cardiomyopathy
We are conducting a Phase 3 clinical trial, SONATA HCM, evaluating the efficacy and safety of sotagliflozin and its effects on HCM. The trial is expected to enroll approximately 500 patients experiencing obstructive or non-obstructive HCM in a randomized, double-blind, placebo-controlled study of a 400mg once daily dose of sotagliflozin over a 26-week treatment period. Doses for patients not tolerating treatment may be reduced to 200mg beginning at week 4. The primary efficacy endpoint under evaluation will be change from baseline in the patient-reported Kansas City Cardiomyopathy Questionnaire, or
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KCCQ, clinical summary score at 26 weeks, with secondary endpoints including change in KCCQ total symptom score and New York Heart Association class improvement at 26 weeks.
Type 1 Diabetes
The FDA issued a complete response letter in March 2019 regarding our NDA for ZYNQUISTA in type 1 diabetes and confirmed that position in denying two appeals of the complete response letter in November 2019 and March 2020. The FDA issued an additional complete response letter in December 2024 regarding our NDA for ZYNQUISTA as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and CKD. At our request, the FDA has issued a public NOOH on whether there are grounds for denying approval of our NDA and those proceedings are ongoing.
Additional Research and Development Programs
We are conducting preclinical research and development of compounds from a number of additional drug programs originating from our internal drug discovery efforts. Those efforts were driven by a systematic, target biology-driven approach in which we used gene knockout technologies and an integrated platform of advanced medical technologies to systematically study the physiological and behavioral functions of almost 5,000 genes in mice and assessed the utility of the proteins encoded by the corresponding human genes as potential drug targets. We have identified and validated in living animals, or in vivo, more than 100 targets with promising profiles for drug discovery.
Collaborations and Strategic Alliances
We have worked both independently and through collaborations and strategic alliances with third parties to capitalize on our drug target discoveries and research and development programs. Consistent with this approach, we seek to retain exclusive rights to the benefits of certain research and development programs by developing and commercializing drug candidates from those programs internally, particularly in the United States for indications treated by specialist physicians. We seek to collaborate with other pharmaceutical and biotechnology companies with respect to the research, development and commercialization of certain of our drug candidates, particularly with respect to commercialization in territories outside the United States or commercialization in the United States for indications treated by primary care physicians, or when the collaboration may provide us with access to expertise and resources that we do not possess internally or are complementary to our own. We also seek to collaborate with other pharmaceutical and biotechnology companies, research institutes and academic institutions to capitalize on our drug target discoveries.
Viatris
We entered into an exclusive license agreement with Viatris Inc. in October 2024 under which we granted Viatris an exclusive, royalty-bearing right and license to develop and commercialize sotagliflozin in the licensed territory. We received a $25 million upfront payment under the agreement and are eligible to receive up to an aggregate of $12 million upon the achievement of specified regulatory milestones, up to an aggregate of $185 million upon the achievement of specified sales milestones and tiered royalties ranging from low double-digit to upper-teens percentages of annual net sales of sotagliflozin in the licensed territory.
Viatris is responsible for all regulatory and commercialization activities for sotagliflozin in the licensed territory as well as conducting any additional clinical trials required to obtain such regulatory approvals. We and Viatris have agreed to enter into a manufacturing and supply agreement pursuant to which we will supply Viatris’ development and commercial requirements of sotagliflozin and Viatris will pay an agreed upon transfer price for such supply.
Bristol-Myers Squibb
We established a drug discovery alliance with Bristol-Myers Squibb Company in December 2003 to discover, develop and commercialize small molecule drugs in the neuroscience field. Bristol-Myers Squibb extended the target discovery term of the alliance in May 2006. We initiated the alliance with a number of neuroscience drug discovery programs at various stages of development and used our gene knockout technologies to identify additional drug targets with promise in the neuroscience field. For those targets that were selected for the alliance, we and Bristol-Myers Squibb worked together, on an exclusive basis, to identify, characterize and carry out the preclinical development of small molecule drugs. Bristol-Myers Squibb has the first option to assume full responsibility for clinical development and commercialization of any drugs resulting from the alliance which enter clinical trials, other than pilavapadin and additional compounds acting through AAK1, for which we hold exclusive development and commercialization rights under the alliance. We received $86 million in upfront payments and research funding under the agreement during the target discovery portion of the alliance, which expired in October 2009. In addition, we are entitled to receive clinical and regulatory milestone payments ranging, depending on the timing and extent of our efforts in
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the alliance, up to $76 million for each drug developed by Bristol-Myers Squibb under the alliance. We will also earn royalties on sales of drugs commercialized by Bristol-Myers Squibb under the alliance.
Pilavapadin and another development compound acting through AAK1 were discovered by scientists working within our alliance with Bristol-Myers Squibb. We have agreed to pay Bristol-Myers Squibb up to $34.5 million in clinical and regulatory milestones for the first indication and up to $16 million in clinical and regulatory milestones for each of the second and third indications, if applicable. We have also agreed to pay single digit royalties on worldwide net sales and up to $40 million in commercial milestones.
Other Collaborations
We have established collaborations with a number of pharmaceutical and biotechnology companies, research institutes and academic institutions under which we have received fees in exchange for generating knockout mice for genes requested by the collaborator, providing phenotypic data with respect to such knockout mice or otherwise granting access to some of our technologies and discoveries. In some cases, we remain eligible to receive milestone or royalty payments on the sale of mice and phenotypic data or on products that our collaborators discover or develop using our technology.
Manufacturing and Product Supply
We do not own or operate manufacturing or distribution facilities or resources for commercial production and distribution of INPEFA or clinical production and distribution of pilavapadin, LX9851, sotagliflozin or our other drug candidates. Instead, we have multiple contractual agreements in place with third-party contract manufacturing organizations, or CMOs, who, on our behalf, manufacture commercial supplies of INPEFA and clinical supplies of our drug candidates, and will continue to do so for the foreseeable future. We have selected well-established and reputable global CMOs for our active pharmaceutical ingredient, or API, and drug product manufacturing that have good regulatory standing, large manufacturing capacities, and multiple manufacturing sites within their business footprint. We employ highly skilled personnel with both technical and manufacturing experience to diligently manage the activities at our CMOs. Our quality department audits these suppliers on a periodic basis. Our commercial suppliers are subject to routine inspection by regulatory agencies. We work closely with our third-party manufacturers to ensure compliance with current good manufacturing practices, or cGMP, and other stringent regulatory requirements enforced by the FDA and foreign regulatory agencies in other territories, as applicable.
Raw materials that are used to manufacture our API are sourced from multiple third-party suppliers in Asia and Europe. Third-party API contract manufacturers in Asia and Europe stock sufficient quantities of these materials to ensure they can manufacture quantities of API sufficient to meet our commercial and clinical requirements. We store API at third-party facilities in North America and Asia, and provide appropriate amounts to third-party drug product contract manufacturers in North America and Asia who then manufacture, package and label our specified quantities of finished commercial goods for INPEFA and clinical goods for our drug candidates. Our third-party contract manufacturers also need to obtain materials such as excipients, components and reagents to manufacture our API and finished drug products. Within our supply chain, we have established safety stock amounts for both our API and drug products, and store those quantities in multiple locations. The quantities that we store are based on our business needs and take into account scenarios for demand, production lead times, potential supply interruptions and shelf life for our API and drug products. We believe that our current manufacturing network has the appropriate capacity to produce sufficient commercial quantities of INPEFA and clinical quantities of pilavapadin, LX9851, sotagliflozin and our other drug candidates.
For business continuity reasons, we are establishing a backup supplier for the API necessary to manufacture commercial supplies of INPEFA. We rely on a sole source third party drug product contract manufacturer in North America to manufacture, package and label finished drug product for commercial distribution of INPEFA, and have identified a backup supplier for our commercial INPEFA drug product. We also rely on a single third party logistics provider, with two distribution locations, to provide shipping and warehousing services for our commercial supply of INPEFA.
Competition
The biotechnology and pharmaceutical industries are highly competitive and characterized by rapid technological change. We face significant competition in each of the aspects of our business from other pharmaceutical and biotechnology companies, as well as academic research institutions, clinical reference laboratories and governmental agencies that are pursuing research or development activities similar to ours. Many of our competitors have substantially greater research, development and commercialization capabilities and financial, scientific, marketing and human resources than we do. As a result, our competitors have and may in the future succeed in developing products earlier than we do and obtaining approvals from the FDA or other regulatory agencies for those products more rapidly than we do. In addition, our competitors may develop products that are more effective than those we develop or commercialize products more effectively and profitably than we do. Similarly, our collaborators face similar competition from other competitors who may succeed in developing products
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more quickly, developing products that are more effective than those developed by our collaborators or commercialize products more effectively and profitably than our collaborators.
The competition for our drugs and drug candidates includes both marketed products and drug candidates that are being developed by others, including pharmaceutical products that are currently in a more advanced stage of commercialization or clinical development than are our own drugs and drug candidates. These competitive marketed products and drug candidates include compounds that employ different mechanisms of action in addressing diseases and conditions for which we are developing our own drug candidates and, in some cases such as INPEFA, that employ the same or similar mechanisms of action.
We believe that our ability to successfully compete with these competitive products currently on the market and potentially competitive drug candidates will depend on, among other things:
•the efficacy, safety and reliability of our products;
•our ability, and the ability of our collaborators, to complete preclinical and clinical development and obtain regulatory approvals for our drug candidates;
•the timing and scope of regulatory approvals of our products;
•our ability, and the ability of our collaborators, to obtain product acceptance by physicians and other health care providers and secure coverage and adequate reimbursement for product use in approved indications;
•our ability, and the ability of our collaborators, to manufacture and sell commercial quantities of our products;
•the skills of our employees and our ability to recruit and retain skilled employees;
•protection of our intellectual property; and
•the availability of substantial capital resources to fund commercialization and development activities.
We expect that our principal competition for pilavapadin for the treatment of DPNP would include duloxetine and pregabalin, which are currently marketed for the treatment of DPNP by Eli Lilly and Pfizer, respectively, and are also available as generics. We may also experience competition from suzetrigine, which is currently being developed for DPNP by Vertex. We also expect that we would experience competition from gabapentin, which is available as a generic and is frequently prescribed off-label for the treatment of DPNP.
We expect that our principal competition for LX9851 would include drugs approved for weight loss, including GLP-1 analogs and similar drugs.
Our principal competition for INPEFA for the treatment of heart failure includes dapagliflozin and empagliflozin, currently marketed for the treatment of heart failure by AstraZeneca and through an alliance between Boehringer Ingelheim and Eli Lilly, respectively. Such competition also includes, to some extent, other classes of drugs used in the treatment of heart failure, such as the combination drug sacubitril/valsartan, currently marketed for the treatment of heart failure by Novartis, and vericiguat, currently marketed for the treatment of heart failure by Merck.
We expect that our principal competition for sotagliflozin in the treatment of hypertrophic cardiomyopathy would include generic beta blockers and calcium channel blockers and cardiac myosin inhibitors, such as mavacamten marketed by Bristol Myers Squibb and aficamten in development by Cytokinetics.
We expect that our principal competition for sotagliflozin in the treatment of type 1 diabetes would include established insulin therapies, and potentially, to some extent, selective SGLT2 inhibitors currently being prescribed off-label. Such selective SGLT2 inhibitors include dapagliflozin, empagliflozin and canagliflozin, currently marketed for the treatment of type 2 diabetes by AstraZeneca, through an alliance between Boehringer Ingelheim and Eli Lilly, and by Janssen (a subsidiary of Johnson & Johnson), respectively.
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Government Regulation
Regulation in the United States
The development, manufacture and sale of pharmaceutical products are subject to extensive regulation by United States governmental authorities, including federal, state and local authorities. In the United States, new drugs are subject to regulation under the Federal Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or the FDC Act. The FDA and comparable governmental authorities regulate, among other things, research and development activities and the testing, manufacture, quality control, safety, efficacy, record keeping, reporting, labeling, storage, approval, advertising, promotion, sale, distribution, export and import of pharmaceutical products.
The standard process required by the FDA before a drug candidate may be marketed in the United States generally includes the following:
•preclinical laboratory and animal tests performed under current good laboratory practices, or cGLP;
•submission of an Investigational New Drug application, or IND, which must become effective before human clinical trials may commence;
•adequate and well-controlled human clinical trials to establish the safety and efficacy of the drug candidate for its intended use;
•submission of an NDA, for approval of commercial marketing and sale, or of an NDA supplement, or sNDA, for approval of a new indication if the product is already approved for another indication;
•pre-approval inspection of manufacturing facilities and selected clinical investigators for their compliance with cGMP and current good clinical practices, or cGCP;
•if the FDA convenes an advisory committee, satisfactory completion of the advisory committee review; and
•FDA approval of the NDA or sNDA.
This process for the testing and approval of drug candidates requires substantial time, effort and financial resources. Preclinical development of a drug candidate can take from one to several years to complete, with no guarantee that an IND based on those studies will become effective to even permit clinical testing to begin. Before commencing the first clinical trial of a drug candidate in the United States, we must submit an IND to the FDA. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises concerns or questions about the conduct of the clinical trial. In such a case, we and the FDA must resolve any outstanding concerns before the clinical trial may begin. Submission of an IND may not result in FDA authorization to commence a clinical trial. A separate submission to the existing IND must be made for each successive clinical trial conducted during product development, and the FDA must grant permission for each clinical trial to start and continue. Further, an independent institutional review board for each medical center proposing to participate in the clinical trial must review and approve the plan for any clinical trial before it commences at that center. Regulatory authorities or an institutional review board or we may suspend a clinical trial at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk.
For purposes of NDA approval, human clinical trials are typically conducted in three sequential phases that may overlap.
•Phase 1 clinical trials are conducted in a limited number of healthy human volunteers or, in some cases, patients, to evaluate the safety, dosage tolerance, absorption, metabolism, distribution and excretion of the drug candidate;
•Phase 2 clinical trials are conducted in groups of patients afflicted with a specified disease or condition to obtain preliminary data regarding efficacy as well as to further evaluate safety and optimize dosing of the drug candidate. Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical trials; and
•Phase 3 clinical trials are conducted in larger patient populations at multiple clinical trial sites to obtain statistically significant evidence of the efficacy of the drug candidate for its intended use and to further test for safety in an expanded patient population.
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In addition, the FDA may require, or companies may pursue, additional clinical trials after a product is approved. These so-called Phase 4 studies may be made a condition to be satisfied after a drug receives approval. Failure to satisfy such post-marketing commitments can result in FDA enforcement action, up and to including withdrawal of NDA approval. The results of Phase 4 studies can confirm the effectiveness of a drug candidate and can provide important safety information to augment the FDA’s adverse drug reaction reporting system.
After completion of clinical trials, FDA approval of an NDA must be obtained before a new drug may be marketed in the United States. The submission of an NDA requires payment of a substantial user fee to the FDA. An NDA must contain, among other things, information on chemistry, manufacturing controls and potency and purity, non-clinical pharmacology and toxicology, human pharmacokinetics and bioavailability and clinical data. There can be no assurance that the FDA will accept an NDA for filing and, even if accepted for filing, that approval will be granted. The FDA may convene an advisory committee to provide clinical insight on NDA review questions. Although the FDA is not required to follow the recommendations of an advisory committee, the agency typically does so. Among other things, the FDA reviews an NDA to determine whether a product is safe and effective for its intended use and whether the facility in which it is manufactured, processed, packed, or held meets standards designed to assure the product’s continued safety, purity and potency. The FDA may deny approval of an NDA by way of a complete response letter if the applicable regulatory criteria are not satisfied, or it may require additional clinical data or an additional pivotal Phase 3 clinical trial. Even if such data are submitted, the FDA may ultimately decide that the NDA does not satisfy the criteria for approval. An NDA may be approved with significant restrictions on its labeling, marketing and distribution under a Risk Evaluation and Mitigation Strategy or otherwise that could restrict the commercial applications of a product or impose costly procedures in connection with the commercialization or use of the product. Once issued, the FDA may withdraw product approval if ongoing regulatory standards are not met or if safety problems occur after the product reaches the market. In addition, the FDA may require testing and surveillance programs to monitor the effect of approved products which have been commercialized, and the FDA has the power to prevent or limit further marketing of a product based on the results of these post-marketing programs.
In addition to obtaining FDA approval for each product, each drug manufacturing establishment must be inspected and approved by the FDA. All manufacturing establishments are subject to inspections by the FDA and by other federal, state and local agencies and must comply with cGMP requirements. Non-compliance with these requirements can result in, among other things, total or partial suspension of production, failure of the government to grant approval for marketing and withdrawal, suspension or revocation of marketing approvals.
Satisfaction of FDA requirements or similar requirements of state, local and foreign regulatory agencies typically takes many years, with the actual time required varying substantially based on, among other things, the nature, novelty and complexity of the drug candidate and of the disease or condition. Government regulation may delay or prevent marketing of drug candidates or new diseases for a considerable period of time and impose costly procedures upon our activities. The FDA or any other regulatory agency may not grant approvals for new indications for our product candidates on a timely basis, if at all. Success in earlier-stage clinical trials does not ensure success in later-stage clinical trials. Targets and pathways identified in vitro may be determined to be less relevant in clinical studies and results in animal model studies may not be predictive of human clinical results. Furthermore, data obtained from clinical activities is not always conclusive and may be susceptible to varying interpretations, which could delay, limit or prevent regulatory approval. Even if a drug candidate receives regulatory approval, the approval may be significantly limited to specific disease states, patient populations and dosages. Further, even after regulatory approval is obtained, later discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the market.
Once the FDA approves a product, a manufacturer must provide certain updated safety and efficacy information. Product changes as well as certain changes in a manufacturing process or facility would necessitate additional FDA review and approval. Other post-approval changes may also necessitate further FDA review and approval. Additionally, a manufacturer must meet other requirements including those related to adverse event reporting and record keeping.
Products manufactured or distributed by us pursuant to FDA approvals are subject to continuing regulation by the FDA, including record-keeping requirements and reporting of adverse experiences with the drug. Drug manufacturers and their subcontractors are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP, which impose certain procedural and documentation requirements upon us and our third-party manufacturers.
The FDA closely regulates the marketing and promotion of drugs, including restricting the promotion of uses for which a drug is not approved by the agency. Not only must a company have appropriate substantiation to support claims made about a drug, under the FDA’s current interpretation of relevant laws, a company can make only those claims relating to safety and efficacy that are for indications for which the FDA has approved the drug and are otherwise consistent with the FDA-
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approved label for the drug. Failure to comply with these requirements can result in adverse publicity, warning letters, corrective advertising and potential civil and criminal penalties. Physicians may, in their independent medical judgment, prescribe legally available drugs for uses that are not described in the product’s labeling and that differ from those tested by us and approved by the FDA. Such off-label uses are common across medical specialties. Physicians may believe that such off-label uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA does, however, restrict manufacturers’ communications on the subject of off-label use. Additionally, a significant number of pharmaceutical companies have been the target of inquiries and investigations by various United States federal and state regulatory, investigative, prosecutorial and administrative entities in connection with the promotion of products for off-label uses and other sales practices. These investigations have alleged violations of various United States federal and state laws and regulations, including claims asserting antitrust violations, violations of the FDC Act, false claims laws, the Prescription Drug Marketing Act, anti-kickback laws, and other alleged violations in connection with the promotion of products for unapproved uses, pricing and Medicare and/or Medicaid reimbursement.
The United States Orphan Drug Act is intended to incentivize the development of products for rare diseases or conditions that affect fewer than 200,000 people in the United States. If a drug is being developed for a rare disease or condition, to be eligible for designation as an orphan drug, the FDA must not have previously approved a drug considered the “same drug” for the same orphan indication. If the FDA has previously approved another same drug for the same indication, the sponsor of the subsequent drug would be required to provide a plausible hypotheses of clinical superiority over the previously approved drug to obtain an orphan designation. Upon FDA receipt of orphan drug designation, the sponsor is eligible for tax credits of up to 25% for qualified clinical trial expenses, the ability to apply for annual grant funding and waiver of PDUFA application fee. In addition, upon marketing approval, an orphan-designated drug could be eligible for seven years of market exclusivity for the approved orphan-designated indication. Such orphan drug exclusivity, if awarded, would only block the approval of any drug considered the same drug for the same orphan indication. Moreover, a subsequent same drug could break a previously approved drug’s orphan exclusivity through a demonstration of clinical superiority over the previously approved drug.
The FDA has various programs, including Fast Track, priority review and accelerated approval, which are intended to expedite or simplify the process for developing and reviewing promising drugs, or to provide for the approval of a drug on the basis of a surrogate endpoint. Generally, drugs that are eligible for these programs are those for serious or life-threatening conditions, those with the potential to address unmet medical needs and those that offer meaningful benefits over existing treatments. For example, Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious or life-threatening diseases or conditions and fill unmet medical needs. Priority review is designed to give drugs that treat serious conditions and offer major advances in treatment or provide a treatment where no adequate therapy exists an initial review within six months of NDA filing as compared to a standard review time of 10 months from NDA filing. Certain other types of drug applications are also eligible for priority review. Although Fast Track and priority review do not affect the standards for approval, the FDA will attempt to facilitate early and frequent meetings with a sponsor of a Fast Track-designated drug and expedite review of the application for a drug designated for priority review. Accelerated approval provides for an earlier approval for a new drug that is intended to treat a serious or life-threatening disease or condition and that fills an unmet medical need based on a surrogate endpoint. As a condition of approval, the FDA may require that a sponsor of a product candidate receiving accelerated approval perform post-marketing clinical trials to confirm the clinically meaningful outcome as predicted by the surrogate marker trial. In addition to the Fast Track, accelerated approval and priority review programs, the FDA also designates Breakthrough Therapy status to drugs that are intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. Drugs designated as breakthrough therapies are also eligible for accelerated approval. The FDA will seek to ensure the sponsor of a breakthrough therapy product candidate receives intensive guidance on an efficient drug development program, intensive involvement of senior managers and experienced staff on a proactive, collaborative and cross-disciplinary review and rolling review.
Additional programs intended to expedite the development of drug products were included in the 21st Century Cures Act, or the Cures Act. The Cures Act includes various provisions to accelerate the development and delivery of new treatments, such as those intended to expand the types of evidence manufacturers may bring to the FDA to support drug approval, to encourage patient-centered drug development, to liberalize the communication of healthcare economic information to payers, and to create greater transparency with regard to manufacturer expanded access programs. Central to the Cures Act are provisions that enhance and accelerate the FDA’s processes for reviewing and approving new drugs and supplements to approved NDAs, including provisions that:
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•require the FDA to establish a program to evaluate the potential use of real world evidence to help support the approval of a new indication for an approved drug and to help support or satisfy post-approval study requirements;
•provide that the FDA may rely upon qualified data summaries to support the approval of a supplemental application with respect to a qualified indication for an already approved drug;
•require the FDA to issue guidance for purposes of assisting sponsors in incorporating complex adaptive and other novel trial designs into proposed clinical protocols and applications for new drugs; and
•require the FDA to establish a process for the qualification of drug development tools for use in supporting or obtaining FDA approval for or investigational use of a drug.
The Cures Act amends Section 114 of the Food and Drug Administration Modernization Act of 1997 to help clarify and facilitate the dissemination of healthcare economic information, including by broadening the definition of healthcare economic information, expressly extending the dissemination of healthcare economic information to payors, and clarifying that healthcare economic information must only relate to an FDA-approved indication rather than directly relate to the indication.
Regulation Outside of the United States
In addition to regulations in the United States, we are subject to the regulations of other countries governing clinical trials and the manufacturing, commercial sales and distribution of our products outside of the United States. Whether or not we obtain FDA approval for a product, we must obtain approval by the comparable regulatory authorities of countries outside of the United States before we can commence clinical trials in such countries and approval of the regulators of such countries or economic areas, such as the European Union, before we may market products in those countries or areas. The approval process and requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from place to place, and the time may be longer or shorter than that required for FDA approval.
Under European Union regulatory systems, a company may submit marketing authorization applications, or MAAs, either under a centralized or decentralized procedure. Under the centralized procedure, MAAs are submitted to the European Medicines Agency, or EMA, whose Committee for Medicinal Products for Human Use reviews the application and issues an opinion on it. The opinion is considered by the European Commission which is responsible for deciding applications. If the application is approved, the European Commission grants a single marketing authorization that is valid for all European Union member states as well as Iceland, Liechtenstein and Norway, or the EEA. The national authorization procedures, the decentralized and mutual recognition procedures, as well as national applications, are available for products for which the centralized procedure is not compulsory. The mutual recognition procedure provides for the European Union member states selected by the applicant to mutually recognize a national marketing authorization that has already been granted by the competent authority of another member state, referred to as the Reference Member State, or RMS. The decentralized procedure is used when the product in question has yet to be granted a marketing authorization in any member state. Under this procedure the applicant can select the member state that will act as the RMS. In both the mutual recognition and decentralized procedures, the RMS reviews the application and submits its assessment of the application to the member states where marketing authorizations are being sought, referred to as Concerned Member States or CMS. Within 90 days of receiving the application and assessment report, each CMS must decide whether to recognize the RMS assessment. If a member state does not agree with the assessment and the disputed points cannot be resolved, the matter is eventually referred to the European Commission, whose decision is binding on all member states. If the application is successful, national marketing authorizations will be granted by the competent authorities in each of the member states chosen by the applicant.
Conditional marketing authorizations may be granted for a limited number of medicinal products for human use referenced in European Union law applicable to conditional marketing authorizations where the clinical dataset is not comprehensive, if the risk-benefit balance of the product is positive, it is likely that the applicant will be in a position to provide the required comprehensive clinical trial data, unmet medical needs will be fulfilled and the benefit to public health of the immediate availability on the market of the medicinal product outweighs the risk inherent in the fact that additional data are still required. Specific obligations, such as the completion of ongoing or new studies and obligations relating to the collection of pharmacovigilance data, may be amongst the conditions stipulated in the marketing authorization.
As in the United States, we may apply for designation of a product as an Orphan drug for the treatment of a specific indication in the European Union before the application for marketing authorization is made. In the European Union, orphan designation is available for products in development which are either intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions affecting not more than 5 in 10,000 persons in the European Union, or intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition
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in the community and when, without incentives, it is unlikely that sales of the drug in the European Union would be sufficient to justify the necessary investment in developing the medicinal product. Additionally, the sponsor of an application for orphan drug designation must establish that there exists no satisfactory authorized method of diagnosis, prevention, or treatment of the condition or even if such treatment exists, the product will be of significant benefit to those affected by that condition.
Orphan drugs in the European Union enjoy economic and marketing benefits, including up to ten years of market exclusivity for the approved indication unless another applicant can show that its product is safer, more effective or otherwise clinically superior to the orphan-designated product. The period of market exclusivity may be reduced to six years if at the end of the fifth year it is established that the criteria for orphan designation are no longer met, including where it is shown that the product is sufficiently profitable not to justify maintenance of market exclusivity.
Healthcare Regulation
Federal and state healthcare laws, including fraud and abuse and health information privacy and security laws, also apply to our business. If we fail to comply with those laws, we could face substantial penalties and our business, results of operations, financial condition and prospects could be adversely affected. The laws that may affect our ability to operate include, but are not limited to: the federal Anti-Kickback Statute, which prohibits. among other things, soliciting, receiving, offering or paying remuneration, directly or indirectly, to induce, or in return for, the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs; and federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent. Additionally, we are subject to state law equivalents of each of the above federal laws, which may be broader in scope and apply regardless of whether the payer is a federal healthcare program, and many of which differ from each other in significant ways and may not have the same effect, further complicate compliance efforts.
Numerous federal and state laws, including state security breach notification laws, state health information privacy laws and federal and state consumer protection laws, govern the collection, use and disclosure of personal information. Other countries also have, or are developing, laws governing the collection, use and transmission of personal information. In addition, most healthcare providers who are expected to prescribe our products and from whom we obtain patient health information, are subject to privacy and security requirements under the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology and Clinical Health Act, or HIPAA. Although we are not directly subject to HIPAA, we could be subject to criminal penalties if we knowingly obtain individually identifiable health information from a HIPAA-covered entity, including healthcare providers, in a manner that is not authorized or permitted by HIPAA. The legislative and regulatory landscape for privacy and data protection continues to evolve, and there has been an increasing amount of focus on privacy and data protection issues with the potential to affect our business, including recently enacted laws in a majority of states requiring security breach notification. These laws could create liability for us or increase our cost of doing business. International laws, such as the EU Data Privacy Directive and Swiss Federal Act on Data Protection, regulate the processing of personal data within the European Union and between countries in the European Union and countries outside of the European Union, including the United States. Failure to provide adequate privacy protections and maintain compliance with safe harbor mechanisms could jeopardize business transactions across borders and result in significant penalties.
In addition, the Physician Payments Sunshine Act, enacted as part of the Patient Protection and Affordable Care Act of 2010, or the ACA, created a federal requirement under the federal Open Payments program, that requires certain manufacturers to track and report to the Centers for Medicare and Medicaid Services, or CMS, annually certain payments and other transfers of value provided to physicians and certain advanced non-physician health care practitioners and teaching hospitals made in the previous calendar year, as well as ownership and investment interests held by physicians and their immediate family members. In addition, there are also an increasing number of state laws that require manufacturers to make reports to states on pricing and marketing information. These laws may affect our sales, marketing, and other promotional activities by imposing administrative and compliance burdens on us. In addition, given the lack of clarity with respect to these laws and their implementation, our reporting actions could be subject to the penalty provisions of the pertinent state and federal authorities.
For those marketed products which are covered in the United States by the Medicaid program, we have various obligations, including government price reporting and rebate requirements, which generally require products be offered at substantial rebates/discounts to Medicaid and certain purchasers. We are also required to discount such products to authorized users of the Federal Supply Schedule of the General Services Administration, under which additional laws and requirements apply. These programs require submission of pricing data and calculation of discounts and rebates pursuant to complex statutory formulas, as well as the entry into government procurement contracts governed by the Federal Acquisition Regulations, and the guidance governing such calculations is not always clear. Compliance with such requirements can require
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significant investment in personnel, systems and resources, but failure to properly calculate our prices, or offer required discounts or rebates could subject us to substantial penalties.
Healthcare Reform
In the United States and some foreign jurisdictions, there have been, and continue to be, several legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of pharmaceutical products, restrict or regulate post-approval activities, and affect the ability to profitably sell pharmaceutical products that obtain marketing approval. The FDA’s and other regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of drug candidates. Moreover, among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access.
For example, the ACA has had a significant impact on the health care industry in the United States. The ACA was designed to expand coverage for the uninsured while at the same time contain overall healthcare costs. With regard to biopharmaceutical products, the ACA, among other things, addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected, increased the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extended the rebate program to individuals enrolled in Medicaid managed care organizations, established annual fees on manufacturers of certain branded prescription drugs, and created a new Medicare Part D coverage gap discount program. Additionally, the Creating and Restoring Equal Access to Equivalent Samples Act of 2019, or the CREATES Act, aimed to address the concern articulated by both the FDA and others in the industry that some brand manufacturers have improperly restricted the distribution of their products, including by invoking the existence of a risk evaluation and mitigation strategies, or REMS, program for certain products, to deny generic product developers access to samples of brand products. Because generic product developers need samples to conduct certain comparative testing required by the FDA, some have attributed the inability to timely obtain samples as a cause of delay in the entry of generic products. To remedy this concern, the CREATES Act established a private cause of action that permits a generic product developer to sue the brand manufacturer to compel it to furnish the necessary samples on “commercially reasonable, market-based terms.” Whether and how generic product developments will use this new pathway, as well as the likely outcome of any legal challenges to provisions of the CREATES Act, remain highly uncertain and its potential effects on future competition are unknown.
Since its enactment, there have been executive, judicial and Congressional challenges to certain aspects of the ACA and we expect there will be additional challenges and amendments to the ACA in the future. Members of the United States Congress have indicated that they may continue to seek to modify, repeal or otherwise invalidate all, or certain provisions of, the ACA. For example, the Tax Cuts and Jobs Act, among other things, removed penalties for not complying with the ACA’s individual mandate to carry health insurance, commonly referred to as the “individual mandate.” It is unclear how this and other efforts to repeal and replace the ACA will impact the implementation of the ACA, the pharmaceutical industry more generally, and our business.
In addition, the Inflation Reduction Act of 2022, or the Inflation Reduction Act, imposed significant changes to how drugs are covered and paid for under the Medicare program, including the creation of financial penalties for drugs whose prices rise faster than the rate of inflation, redesign of the Medicare Part D program to require manufacturers to bear more of the liability for certain drug benefits, and government price-setting for certain Medicare Part D drugs, starting in 2026, and Medicare Part B drugs starting in 2028. The long-term implications of the Inflation Reduction Act remain uncertain and subject to various factors, including the manner in which the Department of Health and Human Services, or DHHS, decides to implement the statute. Many experts and analysts, both within the industry and outside, have predicted that the law will harm innovation in the pharmaceutical industry and result in fewer new treatments being developed and approved over time.
As another example, the 2021 Consolidated Appropriations Act incorporated extensive healthcare provisions and amendments to existing laws, including a requirement that all manufacturers of drugs and biological products covered under Medicare Part B report the product’s average sales price to the DHHS, subject to enforcement via civil money penalties.
Moreover, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products. DHHS has solicited feedback on some of various measures intended to lower drug prices and reduce the out of pocket costs of drugs and implemented others under its existing authority. Congress and the executive branch have each indicated that it will
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continue to seek new legislative and/or administrative measures to control drug costs, making this area subject to ongoing uncertainty.
Individual states in the United States have also increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. In December 2020, the United States Supreme Court held unanimously that federal law does not preempt the states’ ability to regulate pharmaceutical benefit managers and other members of the health care and pharmaceutical supply chain, an important decision that may lead to further and more aggressive efforts by states in this area.
We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad. We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services.
Environmental and Worker Safety Matters
In addition to the foregoing, our business is subject to regulation under various state and federal environmental and worker safety laws, including the Occupational Safety and Health Act, the Resource Conservation and Recovery Act, the Comprehensive Environmental Response, Compensation and Liability Act and the Toxic Substances Control Act, each as amended from time to time. These and other laws and their implementing regulations govern our manufacture, use, storage, handling, transport and disposal of various biological, chemical, radioactive and other hazardous substances used in our operations and the wastes generated by those activities. We cannot eliminate the risk of accidental contamination or discharge and any resultant injury from these substances. We may face liability for any injury or contamination that results from our use or the use by third parties of those substances, and such liability may exceed our insurance coverage and our total assets. Historically, our environmental and worker safety compliance costs have not had a material adverse effect on our results of operations, but there can be no assurance that such costs will not be material in the future or that such future compliance will not have a material adverse effect on our business and operational results. The trend in environmental and occupational health and safety laws and regulations is to typically place more restrictions and limitations on activities that may adversely affect the environment or expose workers to injury. If existing regulatory requirements or enforcement policies change or new regulatory or enforcement initiatives are developed and implemented in the future, we may be required to make significant, unanticipated capital and operating expenditures.
Patents and Proprietary Rights
We can protect our proprietary rights from unauthorized use by third parties only to the extent that those rights are claimed by valid and enforceable patents or are effectively maintained as trade secrets. Accordingly, patents and other proprietary rights are an essential element of our business. We own or exclusively license patents and patent applications throughout the world that claim our drugs and drug candidates, including:
•issued patents and pending patent applications in Europe, the United States, and other countries throughout the world, including Australia, Brazil, Canada, China, Europe, India, Israel, Japan, Mexico, New Zealand, South Africa, and South Korea, that claim pilavapadin, crystalline forms of pilavapadin, pharmaceutical compositions comprising pilavapadin, and methods of its manufacture and use;
•pending United States and Patent Cooperation Treaty (PCT) patent applications that claim LX9851, pharmaceutical compositions comprising it, and methods of its manufacture and use; and
•issued patents and pending patent applications in Europe, the United States, and other countries throughout the world, including Australia, Argentina, Brazil, Canada, China, Europe, India, Israel, Japan, Mexico, New Zealand, South Africa, and South Korea, that claim sotagliflozin, crystalline forms of sotagliflozin, pharmaceutical compositions comprising sotagliflozin, and methods of its manufacture and use.
The normal life of a patent depends primarily on when it was filed. Patents granted in PCT member states typically expire 20 years after their earliest filing date. The actual protection afforded by a patent, which can vary from country to country, depends on the type of patent, the scope of its coverage and the availability of legal remedies in the country. We have filed patent applications and hold issued patents covering each of our drugs and drug candidates. None of our United States patents that claim pilavapadin has a normal expiration date earlier than 2035. The earliest normal expiration date for any patent that issues from our applications claiming LX9851 is February 15, 2045. The earliest normal expiration date of our United States patents that claim sotagliflozin is 2028. However, we have applied for an extension of patent term based on the FDA’s
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approval of the drug and expect that upon acceptance of that application, an additional five years will be added to the term of a patent that claims sotagiflozin, pushing its expiration date out to 2033.
All of our employees, consultants and advisors are required to execute a proprietary information agreement upon the commencement of employment or consultation. In general, the agreement provides that all inventions conceived by the employee or consultant, and all confidential information developed or made known to the individual during the term of the agreement, shall be our exclusive property and shall be kept confidential, with disclosure to third parties allowed only in specified circumstances. We cannot assure you, however, that these agreements will provide useful protection of our proprietary information in the event of unauthorized use or disclosure of such information.
Our patent and intellectual property rights are subject to certain rights and uncertainties. See “Risks Related to Our Intellectual Property” under “Item 1A. Risk Factors.”
Executive Officers
Our executive officers and their ages and positions are listed below.
| Name | Age | Position with the Company | ||||||
| Michael S. Exton, Ph.D. | 55 | Chief Executive Officer and Director | ||||||
| Scott M. Coiante | 58 | Senior Vice President and Chief Financial Officer | ||||||
| Brian T. Corrigan | 41 | Senior Vice President, Regulatory and Quality Assurance | ||||||
| Brian T. Crum | 52 | Senior Vice President and General Counsel | ||||||
| Lisa M. DeFrancesco | 46 | Senior Vice President, Investor Relations and Corporate Communications | ||||||
| Craig B. Granowitz, M.D., Ph.D. | 60 | Senior Vice President and Chief Medical Officer | ||||||
| Alan J. Main, Ph.D. | 71 | Executive Vice President, Innovation and Chemical Sciences | ||||||
| Wendy E. McDermott | 54 | Senior Vice President, Human Resources | ||||||
| Kristen L. Alexander | 57 | Vice President, Finance and Accounting | ||||||
Michael S. Exton, Ph.D. has been our chief executive officer and a director since July 2024. Dr. Exton previously served for fourteen years in a series of senior leadership positions at Novartis, most recently as cardiometabolism therapeutic head from August 2022 to June 2024. In such role, Dr. Exton led the global cross functional commercial therapeutic areas of cardiovascular and metabolic disease, with key responsibilities in discovery, development, commercial launch preparation, business development, investor relations and media engagement. Dr. Exton’s previous positions with Novartis included vice president and global head, cardiovascular renal and metabolism franchise from November 2021 to August 2022 and vice president and head, cardiovascular renal and metabolism franchise of Novartis USA from January 2018 to August 2022. Prior to joining Novartis, Dr. Exton was director of business development with Invida Pty Ltd and spent seven years with Eli Lilly Australia, where he held a variety of research, business development and sales positions. Dr. Exton holds a B.Sc. and a Ph.D. in neuroscience from the University of Newcastle and a Ph.D. in immunology from the University of Essen, Germany.
Scott M. Coiante has been our chief financial officer since January 2025. Mr. Coiante previously served for ten years in senior leadership positions at Agile Therapeutics, Inc., most recently as senior vice president, chief financial officer from 2011 to 2019 and from August 2023 to August 2024. Mr. Coiante also served as senior vice president, chief financial officer at Aprea Therapeutics, Inc. from 2019 to March 2023 and in a series of senior financial and accounting positions with Medarex, Inc. and Ernst & Young LLP prior to joining Agile Therapeutics. Mr. Coiante is a certified public accountant and received his B.S. from Villanova University.
Brian T. Corrigan has been our senior vice president, regulatory affairs and quality assurance since August 2024. Mr. Corrigan previously served as executive vice president, regulatory policy at Greenleaf Health, Inc. since 2014. Prior to joining Greenleaf Health, Mr. Corrigan held a variety of senior government affairs and public policy positions with Vertex Pharmaceuticals, Inc. and Astellas Pharma US, Inc. Mr. Corrigan received his B.A. from Boston College and J.D. from George Mason University School of Law.
Brian T. Crum has been our senior vice president and general counsel since October 2021 and previously served in a series of legal leadership positions since joining our company in 2001. Mr. Crum was previously a corporate securities attorney with the law firms of Brobeck, Phleger & Harrison LLP and Andrews & Kurth L.L.P., where he represented companies in the energy and information technology industries. Mr. Crum received his B.B.A. and J.D. from the University of Texas.
Lisa M. DeFrancesco has been our senior vice president, investor relations and corporate communications since February 2025 and previously served as our vice president, investor relations and corporate communications since November
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2023. Ms. DeFrancesco previously served as senior vice president, investor relations and corporate affairs for Amarin Corporation plc from 2022 to August 2023. Prior to joining Amarin, Ms. DeFrancesco held various leadership roles in investor relations and corporate affairs at Intercept Pharmaceuticals, Inc. from 2019 to 2022 and at Melinta Therapeutics LLC, Allergan plc and other companies in the telecommunications, real estate and health insurance industries. Ms. DeFrancesco received her B.S. from Seton Hall University.
Craig B. Granowitz, M.D., Ph.D. has been our senior vice president and chief medical officer since August 2021. Dr. Granowitz previously served as chief medical officer of Amarin Corporation plc since 2016. Prior to joining Amarin, Dr. Granowitz served as senior vice president and head of global medical affairs, global human health of Merck & Co., Inc. and in a variety of medical and commercial management positions for Schering-Plough Corporation. Dr. Granowitz received his B.A. from Dartmouth College and his M.D. and Ph.D. from Columbia University.
Alan J. Main, Ph.D. has been our executive vice president of innovation and chemical sciences since September 2020 and previously served in a series of manufacturing and scientific leadership positions since joining our company in 2001. Dr. Main was president and chief executive officer of Coelacanth Corporation, a leader in using proprietary chemistry technologies to rapidly discover new chemical entities for drug development, until our acquisition of Coelacanth in 2001. Dr. Main was formerly senior vice president, U.S. Research at Novartis Pharmaceuticals Corporation, where he worked for 20 years before joining Coelacanth. Dr. Main holds a B.S. from the University of Aberdeen, Scotland and a Ph.D. in organic chemistry from the University of Liverpool, England and completed postdoctoral studies at the Woodward Research Institute.
Wendy E. McDermott has been our senior vice president, human resources since August 2024 and previously served as our vice president, human resources since January 2022. Ms. McDermott previously served as chief people officer of Rafael Pharmaceuticals, Inc. since 2019, vice president, human resources of Sanofi from 2017 to 2019 and in a variety of human resources positions with Sanofi, Schering-Plough Corporation and other companies in the tobacco, media and talent and event management industries. Ms. McDermott received her B.A. from State University of New York at Plattsburgh.
Kristen L. Alexander has been our vice president of finance and accounting and principal accounting officer since September 2021 and previously served as controller since joining our company in 2017. Ms. Alexander previously served as controller of Johnson Specialty Tools, LLC and in a variety of finance and accounting management positions for Trican Well Services, L.P., Nabors Industries Ltd. and Ernst & Young, LLP. Ms. Alexander is a certified public accountant and received her B.B.A. from the University of Oklahoma.
Significant Shareholders
We have valuable relationships with Invus, L.P. and its affiliates, which we collectively refer to as Invus. Invus currently owns approximately 50% of the outstanding shares of our common stock.
Human Capital Resources
As of February 28, 2025, we employed 103 persons, of whom 19 hold M.D. or Ph.D. degrees and another 33 hold other advanced degrees. All of our employees are located in the United States. None of our employees are represented by a labor union and we believe that our relationship with our employees is good. Historically, we have had a relatively low turnover of employees.
Our company culture is supported by our five core values: innovation, transparency, ownership, respect and integrity. We value a diverse workforce and proudly reflect a company culture developed with a variety of ethnic backgrounds, nationalities, races, religions, military service, sexual preferences and abilities. We are committed to promoting and maintaining an inclusive, high-performing environment where all team members embrace and leverage each other’s talents and backgrounds and nourish innovative thinking in order to achieve their full potential and contribute to our success.
Our most valued resource is the collective talent and time that our employees dedicate to support and advance our mission. Accordingly, we offer our employees a comprehensive compensation and benefits package that is competitive within the industry and make investing in the growth and development of our employees an important priority. Employee development is advanced through talent management, promotions, mentoring, stretch assignments, internships, formal training, speaker series, conferences, continuing education and educational reimbursement.
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Research and Development Expenses
In 2024, 2023 and 2022, respectively, we incurred expenses of $84.5 million, $58.9 million and $52.8 million in company-sponsored as well as collaborative research and development activities, including $5.8 million, $5.1 million and $4.3 million of stock-based compensation expense in 2024, 2023 and 2022, respectively.
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Item 1A. Risk Factors
The following risks and uncertainties are important factors that could cause actual results or events to differ materially from those indicated by forward-looking statements. The factors described below are not the only ones we face and additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations.
Risk Factor Summary
Below is a summary of the material risks to our business, operations and the investment in our common stock. This summary does not include all of the risks we face and you should carefully review and consider the full discussion of our risk factors below, together with the other information in this annual report on Form 10-K.
Risks Related to Our Business and Industry
•We depend heavily on our ability to successfully complete the ongoing research and development of our drug programs. If we fail to successfully complete and gain positive results from such research and development efforts, our business will suffer and our stock price will likely decline.
•Clinical testing of our drug candidates in humans is an inherently risky and time-consuming process that may fail to demonstrate safety and efficacy, which could result in the delay, limitation or prevention of regulatory approval.
•Our drug candidates are subject to a lengthy and uncertain regulatory process that may not result in the necessary regulatory approvals, which could adversely affect our and our collaborators’ ability to commercialize products.
•We are subject to certain healthcare laws, regulation and enforcement; our failure to comply with those laws could have a material adverse effect on our results of operations and financial condition.
•Our competitors may develop products that impair the value of any products that we or our collaborators may develop.
Risks Related to Our Capital Requirements and Financial Results
•We will need additional capital in the future and, if it is unavailable, we will be forced to delay, reduce or eliminate our research and development programs.
•We may not have sufficient capital to support Phase 3 development of pilavapadin in DPNP and do not have sufficient capital to support Phase 3 development of pilavapadin in neuropathic pain broadly. If we are unable to establish a strategic collaboration or other arrangement for that purpose, our capital needs will be substantially higher and we may be unable to obtain financing sufficient to fund Phase 3 development of pilavapadin on acceptable terms, or at all, and may be required to forego or reduce the scope of any such Phase 3 development program.
•We have a history of net losses, and we expect to continue to incur net losses and may not achieve or maintain profitability.
Risks Related to Our Relationships with Third Parties
•We depend on our ability to establish collaborations or other arrangements with pharmaceutical and biotechnology companies for the development and commercialization of our drug candidates. If we are unable to establish such collaborations or arrangements, or if pharmaceutical products are not successfully and timely developed and commercialized under such collaborations or arrangements, our opportunities to generate revenues from milestones and royalties or our other drug candidates will be greatly reduced.
Risks Related to Our Intellectual Property
•If we are unable to adequately protect our intellectual property, third parties may be able to use our products and technologies, which could adversely affect our ability to compete in the market.
Risks Related to Our Employees and Facilities
•The loss of key personnel or the inability to attract and retain additional personnel could impair our ability to operate and expand our operations.
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Risks Related to Environmental and Product Liability
•Our business has a substantial risk of product liability and we face potential product liability exposure far in excess of our limited insurance coverage.
Risks Related to Our Common Stock
•Invus, L.P. and its affiliates own a substantial interest in our outstanding common stock and may have interests which conflict with those of our other stockholders.
•Invus has additional rights under its stockholders’ agreement relating to the membership of our board of directors and under our certificate of incorporation relating to preemptive and consent rights, which provide Invus with substantial influence over significant corporate matters.
Risks Related to Our Business and Industry
We depend heavily on our ability to successfully complete the ongoing research and development of our drug programs. If we fail to successfully complete and gain positive results from such research and development efforts, our business will suffer and our stock price will likely decline.
We are developing pilavapadin for neuropathic pain, LX9851 for obesity and cardiometabolic disorders and sotagliflozin for HCM and conducting research and development of compounds from a number of additional drug programs. We cannot offer any assurances or predict with any certainty that our ongoing research and development efforts, including our IND-enabling studies for LX9851 and SONATA-HCM Phase 3 clinical trial of sotagliflozin in HCM, will be successfully completed, generate positive data or demonstrate competitive clinical or commercial profiles, in any case on our expected timelines. Should we fail to obtain positive results from any ongoing research and development efforts, or if any such efforts are not completed on our expected timelines, the likelihood of gaining regulatory approval for the impacted drug program would be reduced, our opportunity to establish a strategic collaboration or other arrangement for the further research, development and commercialization of the impacted drug program would be negatively affected, our business and financial condition could be materially harmed and we may be more heavily dependent on the success of our other drug programs.
Clinical testing of our drug candidates in humans is an inherently risky and time-consuming process that may fail to demonstrate safety and efficacy, which could result in the delay, limitation or prevention of regulatory approval.
In order to obtain regulatory approvals for the commercial sale of any products that we or our collaborators may develop, we or our collaborators are required to complete extensive clinical trials in humans to demonstrate the safety and efficacy of our drug candidates. We or our collaborators may not be able to obtain authority from the FDA, or other equivalent foreign regulatory agencies, to initiate or complete any clinical trials. In addition, we have limited internal resources for making regulatory filings and interacting with regulatory authorities.
Clinical trials are inherently risky and the results from preclinical testing of a drug candidate that is under development may not be predictive of results that will be obtained in human clinical trials. In addition, the results of early human clinical trials may not be predictive of results that will be obtained in larger-scale, advanced stage clinical trials. A number of companies in the pharmaceutical industry have suffered significant setbacks in advanced clinical trials, even after achieving positive results in earlier trials. Negative or inconclusive results from a preclinical study or a clinical trial could cause us, our collaborators or the FDA or other equivalent foreign regulatory agencies to terminate a preclinical study or clinical trial or require that we or our collaborators repeat or modify it. Furthermore, we, one of our collaborators or a regulatory agency with jurisdiction over the trials may suspend clinical trials at any time if the subjects or patients participating in such trials are being exposed to unacceptable health risks or for other reasons.
Any preclinical or clinical test may fail to produce results satisfactory to the FDA or foreign regulatory authorities. Preclinical and clinical data can be interpreted in different ways, which could delay, limit or prevent regulatory approval. The FDA or institutional review boards at the medical institutions and healthcare facilities where we or our collaborators sponsor clinical trials may suspend any trial indefinitely if they find deficiencies in the conduct of these trials. Clinical trials must be conducted in accordance with the FDA’s cGCP requirements. The FDA and these institutional review boards have authority to oversee our and our collaborators’ clinical trials, and the FDA may require large numbers of subjects or patients. In addition, we or our collaborators must manufacture, or contract for the manufacture of, the drug candidates that we use in our clinical trials under the FDA’s cGMP requirements.
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The rate of completion of clinical trials is dependent, in part, upon the rate of enrollment of patients. Patient accrual is a function of many factors, including the size of the patient population, the proximity of patients to clinical sites, the eligibility criteria for the study, the nature of the study, the existence of competitive clinical trials and the availability of alternative treatments. Delays in planned patient enrollment may result in increased costs and prolonged clinical development, which in turn could allow our competitors to bring products to market before we do and impair our ability to commercialize our products or potential products.
We or our collaborators may not be able to successfully complete any clinical trial of a drug candidate within any specified time period. In some cases, we or our collaborators may not be able to complete the trial at all. Moreover, clinical trials may not show our drug candidates to be both safe and effective. Thus, the FDA and other regulatory authorities may not approve any drug candidates that we develop for any indication or may limit the approved indications or impose other conditions.
Our drug candidates are subject to a lengthy and uncertain regulatory process that may not result in the necessary regulatory approvals, which could adversely affect our and our collaborators’ ability to commercialize products.
Our drug candidates, as well as the activities associated with their research, development and commercialization, are subject to extensive regulation by the FDA and other regulatory agencies in the United States and by comparable authorities in other countries. Failure to obtain regulatory approval for any drug candidate would prevent us from commercializing that drug candidate. The process of obtaining regulatory approvals is expensive, and often takes many years, if approval is obtained at all, and can vary substantially based upon the type, complexity and novelty of the drug candidates involved. Before a new drug application can be filed with the FDA, the drug candidate must undergo extensive clinical trials, which can take many years and may require substantial expenditures. Any clinical trial may fail to produce results satisfactory to the FDA. For example, the FDA could determine that the design of a clinical trial is inadequate to produce reliable results. Furthermore, prior to approving a new drug, the FDA typically requires that the efficacy of the drug be demonstrated in two double-blind, controlled studies. The regulatory process also requires preclinical testing, and data obtained from preclinical and clinical activities are susceptible to varying interpretations, which could delay, limit or prevent regulatory approval. In addition, delays or rejections may be encountered based upon changes in regulatory policy for product approval during the period of product development and regulatory agency review. Changes in regulatory approval policy, regulations or statutes or the process for regulatory review during the development or approval periods of our drug candidates may cause delays in the approval or rejection of an application. Even if the FDA or a comparable authority in another country approves a drug candidate, the approval may impose significant restrictions on the indicated uses, conditions for use, labeling, advertising, promotion, marketing and/or production of such product and may impose ongoing requirements for post-approval studies, including additional research and development and clinical trials. These agencies also may impose various civil or criminal sanctions for failure to comply with regulatory requirements, including withdrawal of product approval.
The commercial success of any products that we or our collaborators may develop will depend upon the degree of market acceptance among physicians, patients, health care payers and the medical community.
Our or our collaborators’ ability to commercialize any products that we or they may develop will be highly dependent upon the extent to which such products gain market acceptance among physicians, patients, health care payers, such as commercial health insurers, Medicare and Medicaid, and the medical community. If such products do not achieve an adequate level of acceptance, we may not generate adequate product revenues and we may not become profitable. The degree of market acceptance of such products will depend upon a number of factors, including:
•the effectiveness, or perceived effectiveness, of our products in comparison to competing products;
•the existence of any significant side effects, as well as their severity in comparison to any competing products;
•potential advantages or disadvantages in relation to alternative treatments;
•current and future indications for which our products may be approved;
•the ability to offer our products for sale at competitive prices;
•relative convenience and ease of administration;
•the strength of marketing and distribution support; and
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•sufficient third-party coverage or reimbursement.
If we are unable to establish an effective sales force, marketing infrastructure and distribution capabilities, we will not be able to successfully commercialize any products that we or our collaborators may develop.
In order to successfully commercialize any product that we or our collaborators may develop, we or they must establish or maintain an effective commercialization infrastructure supporting such product, including sales force, marketing organization and distribution capabilities. We no longer maintain a significant commercial infrastructure following our restructuring and reduction of commercial operations for INPEFA and would need to reestablish sales capabilities in order to effectively commercialize any future products. Factors that may hinder efforts to effectively reestablish, manage and maintain such infrastructure for products that we or our collaborators may develop include:
•inability to recruit, retain and effectively manage adequate numbers of effective sales and marketing personnel;
•inability to maintain relationships with third-party logistics providers, pharmacies, third-party manufacturers and other third parties instrumental in the commercial manufacture and distribution of such products;
•inability to establish or implement internal controls and procedures required in connection with sales of such products;
•inability of sales personnel to obtain access to or convince adequate numbers of physicians to prescribe such products; and
•potential lack of complementary products to be offered by sales personnel, which may put us or our collaborators at a competitive disadvantage relative to companies with more extensive product lines.
If we or our collaborators are unable to sustain our or their sales force, marketing infrastructure and distribution capability for such products, we may not be able to generate any product revenue, may generate increased expenses and may never become profitable.
We or our collaborators will need to expend significant time and resources to train our sales forces to be credible, persuasive and compliant in discussing such products with the physicians treating the patients indicated under the label. We or our collaborators will also need to continue to train our sales forces to ensure that a consistent and appropriate message about such products is being delivered to potential customers. If we or our collaborators are unable to effectively train our sales forces and equip them with effective materials, including medical and sales literature to help them inform and educate potential customers about the benefits and risks of such products and their proper administration, our and their ability to successfully commercialize such products could be diminished, which could have a material adverse effect on our financial condition, stock price and operations.
If we are unable to establish adequate coverage and reimbursement from third-party payers for any products that we or our collaborators may develop, our revenues and prospects for profitability will suffer.
Our ability to successfully commercialize any products that we or our collaborators may develop is highly dependent on the extent to which coverage and reimbursement for such products are available from third-party payers, including governmental payers, such as Medicare and Medicaid, and private health insurers, including managed care organizations and group purchasing organizations. Many patients are not capable of paying themselves for the products that we or our collaborators may develop, and rely on third-party payers to pay for, or subsidize, their medical needs. If third-party payers do not provide coverage or reimbursement for such products, our revenues and prospects for profitability will suffer. In addition, even if third-party payers provide some coverage or reimbursement for such products, the availability of such coverage or reimbursement for prescription drugs under private health insurance and managed care plans often varies based on the type of contract or plan purchased.
In addition, in some foreign countries, particularly the countries in the European Union, the pricing of prescription pharmaceuticals is subject to governmental control. In these countries, price negotiations with governmental authorities can take six to 12 months or longer after the receipt of regulatory marketing approval for a product. To obtain reimbursement and/or pricing approval in some countries, we or our collaborators may be required to conduct a clinical trial that compares the cost effectiveness of our drug candidates or products to other available therapies. The conduct of such a clinical trial could be expensive and result in delays in the commercialization of our drug candidates. Third-party payers are challenging the prices charged for medical products and services, and many third-party payers limit reimbursement for newly approved health care products. In particular, third-party payers may limit the indications for which they will reimburse patients who use any
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products that we or our collaborators may develop. Cost-control initiatives could decrease prices we or our collaborators might establish for products that may be developed, which would result in lower product revenues to us.
We may not be able to manufacture products that we or our collaborators may develop in commercial quantities, which would impair our ability to commercialize such products.
Our drug candidates other than INPEFA have been manufactured in relatively small quantities for preclinical and clinical trials. If any of these drug candidates are approved by the FDA or other regulatory agencies for commercial sale, we or our collaborators will need to manufacture them in larger quantities. We may not be able to successfully increase the manufacturing capacity, whether in collaboration with third-party manufacturers or on our own, for any approved product in a timely or economic manner, or at all. Significant scale-up of manufacturing may require additional validation studies, which the FDA must review and approve. If we or our collaborators are unable to successfully increase the manufacturing capacity for any such product, the regulatory approval or commercial launch of that product may be delayed or there may be a shortage in supply. Pharmaceutical products typically require precise, high-quality manufacturing. The failure to achieve and maintain these high manufacturing standards, including the incidence of manufacturing errors, could result in patient injury or death, product recalls or withdrawals, delays or failures in product testing or delivery, cost overruns or other problems that could seriously hurt our business.
We and our collaborators are subject to extensive and rigorous ongoing regulation relating to any products that we or our collaborators may develop.
We and our collaborators are subject to extensive and rigorous ongoing domestic and foreign government regulation of, among other things, the research, development, testing, manufacture, labeling, promotion, advertising, distribution and marketing of any products which receive regulatory approvals from the FDA or foreign regulatory authorities. The failure to comply with these requirements or the identification of safety problems during commercial marketing could lead to the need for product marketing restrictions, product withdrawal or recall or other voluntary or regulatory action, which could delay further marketing until the product is brought into compliance. The failure to comply with these requirements may also subject us or our collaborators to stringent penalties.
We are subject to certain healthcare laws, regulation and enforcement; our failure to comply with those laws could have a material adverse effect on our results of operations and financial condition.
We are subject to certain healthcare laws and regulations and enforcement by the federal government and the states in which we conduct our business. The laws that may affect our ability to operate include, without limitation:
•the federal Anti-Kickback Statute, which constrains our marketing practices, educational programs, pricing policies, relationships with healthcare providers or other entities, and other business activities, by prohibiting, among other things, persons and entities from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;
•federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent;
•federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;
•state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts;
•the Foreign Corrupt Practices Act, a United States law which regulates certain financial relationships with foreign government officials (which could include, for example, certain medical professionals);
•federal and state consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers;
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•state and federal government price reporting laws that require us to calculate and report complex pricing metrics to government programs, where such reported price may be used in the calculation of reimbursement and/or discounts on our marketed drugs (participation in these programs and compliance with the applicable requirements may subject us to potentially significant discounts on our products, increased infrastructure costs, and potentially limit our ability to offer certain marketplace discounts); and
•state and federal expenditure tracking and reporting laws, which generally require certain types of expenditures in the United States to be tracked and reported. For example, the Physician Payments Sunshine Act, among other things, imposes reporting requirements on certain manufacturers to annually report to CMS information related to payments and other transfers of value to physicians and certain advanced non-physician health care practitioners and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members. Compliance with such requirements may require investment in infrastructure to ensure that tracking is performed properly, and some of these laws result in the public disclosure of various types of payments and relationships, which could potentially have a negative effect on our business and/or increase enforcement scrutiny of our activities.
In addition, certain marketing practices, including off-label promotion, may also violate certain federal and state health regulatory fraud and abuse laws as well as false claims laws, including the civil False Claims Act. Suits filed under the civil False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of the government and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines or settlement. The filing of qui tam actions has caused a number of pharmaceutical, medical device and other healthcare companies to defend a civil False Claims Act action. When an entity is determined to have violated the civil False Claims Act, it may be required to pay up to three times the actual damages sustained by the government, plus civil penalties for each separate false claim.
If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we, or our officers or employees, may be subject to penalties, including administrative civil and criminal penalties, damages, fines, withdrawal of regulatory approval, the curtailment or restructuring of our operations, the exclusion from participation in Medicare, Medicaid and other federal and state healthcare programs, individual imprisonment, contractual damages, reputational harm, diminished profits and future earnings, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, any of which could adversely affect our ability to sell our products or operate our business and also adversely affect our financial results. Defending against any such actions can be costly, time-consuming and may require significant financial and personnel resources. Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired.
Numerous federal and state laws, including state security breach notification laws, state health information privacy laws and federal and state consumer protection laws, govern the collection, use and disclosure of personal information. Other countries also have, or are developing, laws governing the collection, use and transmission of personal information. In addition, most healthcare providers who may be expected to prescribe our products and from whom we may obtain patient health information are subject to privacy and security requirements under the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA. Although we are not directly subject to HIPAA, we could be subject to criminal penalties if we knowingly obtain individually identifiable health information from a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA. The legislative and regulatory landscape for privacy and data protection continues to evolve, and there has been an increasing amount of focus on privacy and data protection issues with the potential to affect our business, including recently enacted laws in a majority of states requiring security breach notification. These laws could create liability for us or increase our cost of doing business. International laws, such as the EU Data Privacy Directive and Swiss Federal Act on Data Protection, regulate the processing of personal data within Europe and between European countries and the United States. Failure to provide adequate privacy protections and maintain compliance with safe harbor mechanisms could jeopardize business transactions across borders and result in significant penalties.
Current healthcare laws and regulations and future legislative or regulatory reforms to the healthcare system may negatively affect our revenues and prospects for profitability.
In the United States and some foreign countries, there have been, and continue to be, several legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of pharmaceutical products, restrict or regulate post-approval activities, and affect the ability to profitably sell pharmaceutical products that obtain marketing approval. The FDA’s and other regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of drug candidates. If we are
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slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we otherwise may have obtained and we may not achieve or sustain profitability. Moreover, complying with any new legislation or regulatory changes could be time-intensive and expensive, resulting in a material adverse effect on our business.
For example, the Inflation Reduction Act imposed significant changes to how drugs are covered and paid for under the Medicare program, including the creation of financial penalties for drugs whose prices rise faster than the rate of inflation, redesign of the Medicare Part D program to require manufacturers to bear more of the liability for certain drug benefits, and government price-setting for certain Medicare Part D drugs, starting in 2026, and Medicare Part B drugs starting in 2028. The long-term implications of the Inflation Reduction Act remain uncertain and subject to various factors, including the manner in which the DHHS decides to implement the statute.
A primary trend in the United States and some foreign countries is toward reform and cost containment in the health care industry. The United States and some foreign jurisdictions are considering or have enacted a number of legislative and regulatory proposals, such as the Inflation Reduction Act, that may have the effect of reducing the prices that we are able to charge for products we or our collaborators may develop. Healthcare reform measures which may be adopted in the future in the United States and foreign jurisdictions may result in more rigorous coverage criteria and significant downward pressure on the prices drug manufacturers may charge. As a result, our revenues and prospects for profitability could be significantly harmed.
As a result of the overall trend towards cost-effectiveness criteria and managed healthcare in the United States, third-party payers are increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement of new drugs. They may use tiered reimbursement and may adversely affect demand for products we or our collaborators may develop by placing them in an expensive tier. They may also refuse to provide any coverage of uses of approved products for medical indications other than those for which the FDA has granted market approvals. As a result, significant uncertainty exists as to whether and how much third-party payers will reimburse for newly approved drugs, which in turn will put pressure on the pricing of drugs. Further, we do not have experience in ensuring approval by applicable third-party payers outside of the United States for coverage and reimbursement of pharmaceutical products. We also anticipate pricing pressures in connection with the sale of products we or our collaborators may develop due to the increasing influence of health maintenance organizations and additional legislative proposals.
Our competitors may develop products that impair the value of any products that we or our collaborators may develop.
The pharmaceutical and biotechnology industries are highly diversified and are characterized by rapid technological change. We and our collaborators face, and will continue to face, intense competition from biotechnology and pharmaceutical companies, as well as academic research institutions, clinical reference laboratories and government agencies that are pursuing research and development activities similar to ours. In addition, significant delays in the development of our drug candidates could allow our competitors to bring products to market before us, which would impair our or our collaborators’ ability to commercialize our drug candidates. Any products that we or our collaborators develop will compete in highly competitive markets. Further, our competitors may be more effective at using their technologies to develop commercial products. Many of the organizations competing with us have greater capital resources, larger research and development staff and facilities, more experience in obtaining regulatory approvals and more extensive product manufacturing and marketing capabilities. As a result, our competitors may be able to more easily develop and commercialize products that would render any products that we or our collaborators develop obsolete and noncompetitive. In addition, there may also be drug candidates of which we are not aware at an earlier stage of development that may compete with our drugs and drug candidates.
The outbreak of the novel coronavirus, or COVID-19, had an adverse impact on our business operations and clinical trials and another novel coronavirus could adversely affect our business in the future.
Our business was disrupted and adversely affected by the COVID-19 pandemic. The emergence of any new, more virulent SARS-CoV-2 variants could negatively affect the health and availability of our workforce and cause new disruptions to our business operations. Any such disruptions could negatively impact productivity and delay our ongoing commercialization of INPEFA and research and development efforts with respect to our drug candidates.
The emergence of new, more infectious and virulent variants may also negatively impact future clinical trials by impeding our ability to effectively recruit and retain patients, principal investigators and site staff due to concerns for patient safety and prioritization of healthcare resources. In addition, significant disruption in the operations of third party manufacturers and research and development organizations upon whom we rely may occur and, as a result, our business operations could be
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severely impacted. These and similar, and perhaps more severe, disruptions in our operations due to the emergence of a novel coronavirus could negatively impact our business, operating results and financial condition.
The pandemic also resulted in the disruption of global financial markets and supply chains. Any disruption could make it more difficult for us to access capital, which could in the future negatively affect our liquidity, and effectively manage the clinical and commercial supply of our products. In addition, a recession or market correction resulting from the spread of a novel coronavirus could materially affect our business and the value of our common stock. The ultimate impact of a health pandemic or epidemic is highly uncertain and subject to change. These effects could have a material impact on our operations.
Changes in government trade policies could disrupt our supply chain or increase the costs of our clinical and commercial supply, negatively impacting our ability to conduct our clinical and commercial operations, price our commercial product competitively and conduct clinical development in a cost effective manner.
We rely on third party drug product contract manufacturers in Canada and China who then manufacture, package and label finished commercial supply of INPEFA and clinical supply of our drug candidates. Recent changes in U.S. foreign trade policies, including changes to trade regulations, proposed tariffs or other import or export restrictions with countries such as Canada, Mexico and China, could disrupt our supply chains and jeopardize the commercial availability of INPEFA and our conduct of planned clinical development activities for our drug candidates. Such trade dynamics could also increase our costs for raw materials or products that we source internationally, which would negatively impact our business margins and financial results.
We cannot predict what other changes to trade policy, if any, will be made by the current or a future administration or Congress, including whether existing tariff policies will be maintained or modified.
Risks Related to Our Capital Requirements and Financial Results
We will need additional capital in the future and, if it is unavailable, we will be forced to delay, reduce or eliminate our research and development programs. If additional capital is not available on reasonable terms, we will be forced to obtain funds, if at all, by entering into financing agreements on unattractive terms.
As of December 31, 2024, we had $238.0 million in cash, cash equivalents and short-term investments. We anticipate that our existing capital resources and revenues will enable us to fund our currently planned operations for at least the next 12 months from the date of this report. However, we caution you that we may generate less cash and revenues or incur expenses more rapidly than we currently anticipate. Our currently planned operations for the next twelve months include the continued research and development of pilavapadin, LX9851, sotagliflozin and our other drug candidates and the continued limited commercialization of INPEFA for the treatment of heart failure.
Although difficult to accurately predict, the amount of our future capital requirements will be substantial and will depend on many factors, including:
•the timing, progress and results of our research and development efforts for pilavapadin, LX9851, sotagliflozin and our other drug candidates and our ability to obtain necessary regulatory approvals based on clinical trials of those drug candidates;
•our success in establishing new collaborations and licenses;
•the amount and timing of our research, development and commercialization expenditures;
•the effect of competing programs and products, and of technological and market developments; and
•the filing, maintenance, prosecution, defense and enforcement of patent claims and other intellectual property rights.
If our capital resources are insufficient to meet future capital requirements, we will need to raise additional funds to continue our currently planned operations. Our ability to raise additional capital is dependent on a number of factors, including the market demand for our securities, which itself is subject to a number of pharmaceutical development and business risks and uncertainties, as well as uncertainty that we would be able to raise such additional capital at a price or on terms that are favorable to us. If we raise additional capital by issuing equity securities, our then-existing stockholders will experience dilution and the terms of any new equity securities may have preferences over our common stock. The affirmative and restrictive covenants and the pledge of all of our assets as collateral under our existing term loans with Oxford Finance LLC, or the Oxford Term Loans, restrict our ability to raise additional capital by issuing debt securities. We cannot be certain that additional financing, whether debt or equity, will be available in amounts or on terms acceptable to us, if at all. We may be unable to raise sufficient additional capital on reasonable terms, and if so, we will be forced to delay, reduce or eliminate our
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clinical development programs or commercialization efforts or obtain funds, if at all, by entering into financing agreements on unattractive terms.
We may not have sufficient capital to support Phase 3 development of pilavapadin in DPNP and do not have sufficient capital to support Phase 3 development of pilavapadin in neuropathic pain broadly. If we are unable to establish a strategic collaboration or other arrangement for that purpose, our capital needs will be substantially higher and we may be unable to obtain financing sufficient to fund Phase 3 development of pilavapadin on acceptable terms, or at all, and may be required to forego or reduce the scope of any such Phase 3 development program.
Our existing resources may be insufficient to support Phase 3 development of pilavapadin in DPNP and will be insufficient to support Phase 3 development of pilavapadin in neuropathic pain broadly. Although we seek to collaborate with another pharmaceutical or biotechnology company or strategic partner under terms which would enable reliance on their resources, in whole or in part, and provide additional funding for such Phase 3 development program, we may be unable to successfully enter into any such collaboration or other arrangement on reasonable terms, or at all. In such event, our capital needs will be substantially higher and we will be reliant on obtaining financing in support of any such Phase 3 development program from alternative sources. We cannot be certain that such financing will be available in amounts or on terms acceptable to us, if at all. If we are unable to secure such financing, we may be required to forego or reduce the scope of any such Phase 3 development program.
We have a history of net losses, and we expect to continue to incur net losses and may not achieve or maintain profitability.
We have incurred aggregate net losses since our inception, including an aggregate net loss of approximately $479.5 million for the three-year period ended December 31, 2024. As of December 31, 2024, we had an accumulated deficit of approximately $2.0 billion. Because of the numerous risks and uncertainties associated with successfully developing and commercializing drug products, we are unable to predict the extent of any future losses or whether or when we will become profitable, if at all. The size of our net losses will depend, in part, on the rate of decline or growth in our revenues and on the amount of our expenses. We expect to continue to incur significant expenses over the next several years including the continued research and development of pilavapadin, LX9851, sotagliflozin and our other drug candidates.
We have derived a substantial portion of our revenues from strategic collaborations and other research and development collaborations and technology licenses. Future revenues from our existing collaborations are uncertain because they depend, to a large degree, on the achievement of milestones and payment of royalties we earn from any products developed or commercialized under the collaborations. Our ability to secure future revenue-generating agreements will depend upon our ability to address the needs of our potential future collaborators and licensees, and to negotiate agreements that we believe are in our long-term best interests. We may determine that our interests are better served by retaining rights to our discoveries and advancing our therapeutic programs to a later stage, which could limit our near-term revenues and increase expenses. Because of these and other factors, our operating results have fluctuated in the past and are likely to do so in the future, and we do not believe that period-to-period comparisons of our operating results are a good indication of our future performance.
We have spent and expect to continue spending significant amounts to fund our continued research and development of pilavapadin, LX9851, sotagliflozin and our other drug candidates. As a result, we will need to generate substantial additional revenues to achieve profitability in future periods. Even if we do achieve profitability in future periods, we may not be able to sustain or increase such profitability on a quarterly or annual basis.
Our operating results have fluctuated and likely will continue to fluctuate, and we believe that period-to-period comparisons of our operating results are not a good indication of our future performance.
Our operating results have fluctuated in the past and are likely to fluctuate in the future. A number of factors, many of which we cannot control, could subject our operating results to volatility, including:
•the success of our ongoing research and development efforts and our ability to obtain regulatory approval of our drug candidates as a result of such efforts;
•the timing and amount of expenses incurred with respect to our research, development and commercialization efforts;
•our success in establishing new collaborations and technology licenses and the timing and financial terms of such arrangements;
•the timing and willingness of our collaborators to commercialize pharmaceutical products that would result in milestone payments and royalties;
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•disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our products and technologies; and
•general and industry-specific economic conditions, which may affect our and our collaborators’ research and development expenditures.
Because of these and other factors, including the risks and uncertainties described in this section, our operating results have fluctuated in the past and are likely to do so in the future. Due to the likelihood of fluctuations in our revenues and expenses, we believe that period-to-period comparisons of our operating results are not a good indication of our future performance.
We have substantial indebtedness that may limit cash flow available to invest in the ongoing needs of our business.
As of December 31, 2024, we have incurred approximately $100.3 million of indebtedness. Although the affirmative and restrictive covenants and the pledge of substantially all of our assets as collateral under the Oxford Term Loans restrict our ability to obtain additional debt financing, we could in the future incur additional indebtedness beyond such amount. Our substantial debt combined with our other financial obligations and contractual commitments could have significant adverse consequences, including:
•requiring us to dedicate a substantial portion of cash flow from operations to the payment of interest on, and principal of, our debt, which will reduce the amounts available to fund working capital, capital expenditures, product commercialization and development efforts and other general corporate purposes;
•increasing our vulnerability to adverse changes in general economic, industry and market conditions;
•limiting our flexibility in planning for, or reacting to, changes in our business and the industry in which we compete; and
•placing us at a competitive disadvantage compared to our competitors that have less debt or better debt servicing options.
We intend to satisfy our current and future debt service obligations with our existing cash and cash equivalents and marketable securities and funds from external sources. However, we may not have sufficient funds or may be unable to arrange for additional financing to pay the amounts due under our existing debt. Funds from external sources may not be available on acceptable terms, if at all. In addition, a failure to comply with the covenants under our existing debt instruments could result in an event of default under those instruments. In the event of an acceleration of amounts due under our debt instruments as a result of an event of default, including upon the occurrence of an event that would reasonably be expected to have a material adverse effect on our business, operations, properties, assets or condition or a failure to pay any amount due, we may not have sufficient funds or may be unable to arrange for additional financing to repay our indebtedness or to make any accelerated payments, and the lenders could seek to enforce their security interests in the collateral securing such indebtedness.
If we do not effectively manage our affirmative and restrictive covenants under the Oxford Term Loans, our financial condition and results of operations could be adversely affected.
Our obligations under the Oxford Term Loans are secured by a first lien security interest in substantially all of our assets. In addition, the Oxford Term Loans require that we comply with certain affirmative and restrictive covenants, including financial covenants relating to net sales of INPEFA and minimum cash balance requirements and additional covenants restricting dispositions, fundamental changes in our business, mergers or acquisitions, indebtedness, encumbrances, distributions, investments, transactions with affiliates and subordinated debt, any of which could restrict our business and operations, particularly our ability to respond to changes in our business or to take specified actions to take advantage of certain business opportunities that may be presented to us. Our failure to comply with any of these covenants could result in a default under the Oxford Term Loans, which could permit the lenders to declare all or part of any outstanding borrowings to be immediately due and payable. If we are unable to repay those amounts, the lenders could enforce the security interest granted to them to secure that debt, which would seriously harm our business.
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Risks Related to Our Relationships with Third Parties
We depend on our ability to establish collaborations or other arrangements with pharmaceutical and biotechnology companies for the development and commercialization of our drug candidates. If we are unable to establish such collaborations or arrangements, or if pharmaceutical products are not successfully and timely developed and commercialized under such collaborations or arrangements, our opportunities to generate revenues from milestones and royalties or our other drug candidates will be greatly reduced.
We have derived a substantial majority of our revenues to date from collaborative arrangements with other pharmaceutical and biotechnology companies for the research, development and commercialization of our drug candidates and other research and development collaborations and technology licenses. For example, we have entered into an exclusive license agreement with Viatris for the development and commercialization of sotagliflozin in all markets outside of the United States and Europe. Future revenues from our existing and future collaborations depend upon the achievement of milestones and payment of royalties we earn from any future products developed under those arrangements. If our relationship terminates with any collaborator, our reputation in the business and scientific community may suffer and revenues will be negatively impacted to the extent such losses are not offset by additional collaborations or strategic alliances. If milestones are not achieved or our collaborators are unable to successfully develop and commercialize products from which milestones and royalties are payable, we will not earn the revenues contemplated by those arrangements.
We have limited or no control over the resources that any third party may devote to the development and commercialization of products under our collaborations. Any of our present or future collaborators may not perform their obligations as expected. Our collaborators may breach or terminate their agreements with us or otherwise fail to conduct research, development or commercialization activities successfully or in a timely manner. Further, our collaborators may elect not to develop pharmaceutical products arising out of our arrangements or may not devote sufficient resources to the development, regulatory approval, manufacture, marketing or sale of these products. If any of these events occurs, we may not receive revenue or otherwise realize anticipated benefits from such collaborations, our product development efforts may be delayed and our business, operating results and financial condition could be adversely affected.
Conflicts with our collaborators could jeopardize the success of our collaborative agreements and harm our product development efforts.
We may pursue opportunities in specific disease and therapeutic modality fields that could result in conflicts with our collaborators, if any of our collaborators takes the position that our internal activities overlap with those activities that are exclusive to our collaboration. Moreover, disagreements could arise with our collaborators over rights to our intellectual property or our rights to share in any of the future revenues of compounds or therapeutic approaches developed by our collaborators. Any conflict with or among our collaborators could result in the termination of our collaborative agreements, delay collaborative research or development activities, impair our ability to renew or obtain future collaborative agreements or lead to costly and time consuming litigation. Conflicts with our collaborators could also have a negative impact on our relationship with existing collaborators, materially impairing our business and revenues. Some of our collaborators are also potential competitors or may become competitors in the future. Our collaborators could develop competing products, preclude us from entering into collaborations with their competitors or terminate their agreements with us prematurely. Any of these events could harm our product development efforts.
We rely on third parties to carry out our preclinical studies and clinical trials, which may harm or delay our research and development efforts.
We rely on clinical research organizations and other third-party contractors to carry out many of our drug development activities, including the performance of preclinical laboratory and animal tests under the FDA’s current Good Laboratory Practices regulations and the conduct of clinical trials of our drug candidates in accordance with protocols we establish. If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, our drug development activities may be delayed, suspended or terminated. Such a failure by these third parties could significantly impair our ability to develop and commercialize the affected drug candidates.
We lack the capability to manufacture commercial supplies of INPEFA and any other products which gain regulatory approval and other materials for our research and development activities relating to our drug candidates. Our reliance on third parties to manufacture our drugs and drug candidates may harm or delay our research, development and commercialization efforts.
We currently do not have the manufacturing capabilities or experience necessary to produce commercial supplies of INPEFA and any other products which gain regulatory approval and other materials for our research and development activities relating to our drug candidates and intend in the future to continue to rely on collaborators and third-party contractors to
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produce such materials. We will rely on selected manufacturers to deliver materials on a timely basis and to comply with applicable regulatory requirements, including the cGMP regulations of the FDA, which relate to manufacturing and quality control activities. These manufacturers may not be able to produce material on a timely basis or manufacture material at the quality level or in the quantity required to meet our development and commercialization timelines and applicable regulatory requirements. In addition, there are a limited number of manufacturers that operate under the FDA’s cGMP regulations and that are capable of producing such materials, and we may experience difficulty finding manufacturers with adequate capacity for our needs. If we are unable to contract for the production of sufficient quantity and quality of materials on acceptable terms, our product development or commercialization efforts may be delayed. Moreover, noncompliance with the FDA’s cGMP regulations can result in, among other things, fines, injunctions, civil and criminal penalties, product recalls or seizures, suspension of production, failure to obtain marketing approval and withdrawal, suspension or revocation of marketing approvals.
Risks Related to Our Intellectual Property
If we are unable to adequately protect our intellectual property, third parties may be able to use our products and technologies, which could adversely affect our ability to compete in the market.
Our commercial success will depend in part upon our ability to obtain patents and maintain adequate protection of the intellectual property related to our products and technologies. The patent positions of biotechnology and pharmaceutical companies, including our patent position, are generally uncertain and involve complex legal and factual questions. We will be able to protect our intellectual property rights from unauthorized use by third parties only to the extent that our products and technologies are covered by valid and enforceable patents or other intellectual property rights, or are effectively maintained as trade secrets or otherwise protected from disclosure by non-disclosure agreements. We will continue to apply for patents covering our products and technologies as, where and when we deem appropriate. However, pending patent applications do not provide protection against competitors because they are not enforceable until they issue as patents. Further, the disclosures contained in our current and future patent applications may not be sufficient to meet statutory requirements for patentability and our applications may fail to result in issued patents. Once issued, patents still may not provide commercially meaningful protection. Our existing patents and any future patents we obtain may not be sufficiently broad to prevent others from developing competing products and technologies. Furthermore, others may independently develop similar or alternative products or technologies or design around our patents. If anyone infringes upon our or our collaborators’ patent rights, enforcing these rights may be difficult, costly and time-consuming and, as a result, it may not be cost-effective or otherwise expedient to pursue litigation to enforce those patent rights. Further, as we customarily assess whether to apply for new patents based on our ongoing research and development activities, this assessment and the filing for additional patent protection may require significant expenditures and therefore may not be commercially practicable.
Our patents and other intellectual property rights may be challenged by third parties and may be invalidated, cancelled or held unenforceable under U.S. or foreign laws, or they may be infringed or misappropriated by third parties. As a result, we may be involved in the defense and enforcement of our patent or other intellectual property rights in a court of law, U.S. Patent and Trademark Office inter partes review or reexamination proceeding, foreign opposition proceeding or related legal and administrative proceeding in the United States and elsewhere. The costs of defending our patents or enforcing our other intellectual property rights, such as trademarks and trade secrets, in post-issuance administrative proceedings and litigation may be substantial and the outcome can be uncertain. An adverse outcome may allow third parties to use our intellectual property without a license and negatively impact our business.
In addition, because patent applications can take many years to issue, third parties may have pending applications, unknown to us, which may later result in issued patents that cover the production, manufacture, commercialization or use of our products and drug candidates. If any such patents are issued to other entities, we may be unable to obtain patent protection for the same or similar discoveries that we make relating to our products and drug candidates. Moreover, we may be blocked from using our drug targets or drug candidates or developing or commercializing our products and other drug candidates, or may be required to obtain a license from a third party that may not be available on reasonable terms, if at all. Further, others may discover uses for our products and technology other than those covered in or claimed by our issued or pending patents, such as other uses for our drug targets and drug candidates, and these other uses may be separately patentable. Even if we have a patent claim on a particular technology or product, the holder of a patent covering the use of a similar technology or product could exclude us from selling a product that is based on the same use of that product.
The laws of some foreign countries do not protect intellectual property rights to the same extent as the laws of the United States, and many companies have encountered significant problems in protecting and defending such rights in foreign jurisdictions. Many countries, including certain countries in Europe, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties (for example, if the patent owner has failed to “work” the invention in that country or the third party has patented improvements). In addition, many countries limit the enforceability of patents
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against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of the patent. Compulsory licensing of life-saving drugs is also becoming increasingly popular in developing countries either through direct legislation or international initiatives. Such compulsory licenses could be extended to include some of our products and drug candidates, which could limit our potential revenue opportunities. Moreover, the legal systems of certain countries, particularly certain developing countries, do not favor the aggressive enforcement of patent and other intellectual property protection, which makes it difficult to stop infringement and misappropriation.
We rely on trade secret protection for some of our confidential and proprietary information. We have taken security measures to protect our proprietary information and trade secrets, but these measures may not provide adequate protection. While we seek to protect our proprietary information by entering into confidentiality agreements with employees, collaborators and consultants, we cannot assure you that our proprietary information will not be disclosed, or that we can meaningfully protect our trade secrets. In addition, our competitors may independently develop or duplicate substantially equivalent proprietary information or may otherwise gain access to or misappropriate our trade secrets. For example, publicly available information, such as information in issued patents, published patent applications and scientific literature, can be used by third parties to independently develop technology and we cannot provide assurance that any such independently developed technology will not be equivalent or superior to our proprietary technology.
We rely on registered trademarks to protect our investment in our brand and goodwill. However, competitors may challenge the validity of those trademarks and other brand names in which we have invested or may invest. Such challenges can be expensive and may adversely affect our ability to maintain the goodwill gained in connection with a particular trademark.
We may be involved in patent litigation and other disputes regarding intellectual property rights and may require licenses from third parties for our planned research, development and commercialization activities. We may not prevail in any such litigation or other dispute or be able to obtain required licenses.
Our products and those of our collaborators, as well as our research and development efforts, may give rise to claims that they infringe or misappropriate the patents or other intellectual property rights of others. We are aware that other companies and institutions are developing products that act on the same drug targets upon which some of our drug candidates act, have conducted research on many of the same targets that we have identified and have filed patent applications potentially covering drugs that act on those targets. In some cases, patents have issued, and may issue in the future, from those applications. In addition, many companies and institutions have patent portfolios directed to commonly used techniques, methods and means of developing, producing and manufacturing pharmaceutical products. These or other companies or institutions could bring legal actions against us or our collaborators for damages or to stop us or our collaborators from engaging in certain research and development activities or from manufacturing and marketing therapeutic products that allegedly infringe their patent rights. If any of these actions are successful, in addition to our potential liability for damages, these entities may require us or our collaborators to obtain a license in order to continue engaging in the infringing activities or to manufacture or market the infringing therapeutic products or may force us to terminate such activities or manufacturing and marketing efforts.
We may deem it advisable to pursue litigation or other dispute resolution proceedings against others to enforce our patents and intellectual property rights and may be the subject of litigation brought by third parties to enforce their patent and intellectual property rights. In addition, we may become involved in litigation or other dispute resolution proceedings based on intellectual property indemnification undertakings that we have given to certain of our collaborators. Patent and other intellectual property litigation is expensive and requires substantial amounts of management attention. The eventual outcome of any such litigation or dispute resolution proceedings is uncertain and involves substantial risks. If we are sued for infringement or misappropriation and lose, we could be required to pay substantial damages and/or be enjoined from using or selling the allegedly infringing or misappropriation products or technology. The results or costs of any such litigation or dispute resolution proceedings may have an adverse effect on our business, operating results and financial condition.
We believe that there will continue to be significant litigation in our industry regarding patent and other intellectual property rights. We have expended and many of our competitors have expended and are continuing to expend significant amounts of time, money and management resources on intellectual property litigation. If we become involved in future intellectual property litigation, it could consume a substantial portion of our resources and could negatively affect our results of operations.
Data breaches and cyber-attacks could compromise our intellectual property or other sensitive information and cause significant damage to our business, reputational harm and financial loss.
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In the ordinary course of our business, we collect, maintain and transmit sensitive data on our networks and systems, including our intellectual property and proprietary or confidential business information (such as research data and personal information) and confidential information with respect to our customers, clinical trial patients and our business partners. We have outsourced significant elements of our information technology infrastructure and, as a result, third parties may or could have access to our confidential information and personal data. The secure maintenance of this information is critical to our business and reputation. Companies have been increasingly subject to a wide variety of security incidents, cyber-attacks and other attempts to gain unauthorized access and unintentional breaches. These threats can come from a variety of sources, ranging in sophistication from an individual hacker to a state-sponsored attack and motive (including corporate espionage). Cyber threats may be generic, or they may be custom-crafted against our information systems. Our network and storage applications and those of our vendors may be subject to unauthorized access by hackers or information security breaches due to operator error, malfeasance or other system disruptions. It is often difficult to anticipate or immediately detect such incidents and the damage caused by such incidents, particularly for cyber incidents such as advanced persistent threats. These data breaches and any unauthorized access or disclosure of our information or intellectual property could compromise our intellectual property and expose sensitive business information. A data security breach could also lead to public exposure of personal information of our clinical trial patients, customers and others. Cyber-attacks and information security breaches could cause us to incur significant remediation costs, result in product development delays, disrupt key business operations and divert attention of management and key information technology resources. Our network security and data recovery measures and those of our vendors may not be able to detect or prevent every attempted breach and may not permit us to respond effectively to every breach. These incidents could also subject us to liability, expose us to significant expense and cause significant harm to our reputation and business. Reputational harm resulting from a significant cyber incident may cause unquantifiable damage to our established goodwill. Moreover, as cyber incidents continue to evolve, we will likely be required to expend additional resources to enhance our security posture and cybersecurity defenses or to investigate and remediate any vulnerability to or consequences of cyber incidents. Our insurance coverage may not be sufficient to prevent or recover from cyberattacks, including coverage of applicable resulting losses arising from the incident.
Each foreign jurisdiction and U.S. state in which we operate may have laws governing how we must respond to a cyber incident that results in the unauthorized access, disclosure, or loss of personal information. Additionally, new laws and regulations governing data privacy and unauthorized disclosure of confidential information, including recent California legislation providing for a private right of action, pose increasingly complex compliance challenges and could potentially elevate our costs over time. As legislation continues to develop and cyber incidents continue to evolve, we will likely be required to expend significant resources to continue to modify or enhance our protective measures to comply with such legislation and to detect, investigate and remediate vulnerabilities to cyber incidents. Any failure by us to comply with such laws and regulations could result in reputational harm, loss of goodwill, penalties, liabilities and/or mandated changes in our business practices.
We may be subject to damages resulting from claims that we, our employees or independent contractors have wrongfully used or disclosed alleged trade secrets of their former employers.
Many of our employees and independent contractors were previously employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors. We may be subject to claims that these employees, independent contractors or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers. Litigation or other dispute resolution proceedings may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation or other dispute resolution proceedings could result in substantial costs and divert management’s attention. If we fail in defending such claims, in addition to paying money claims, we may lose valuable intellectual property rights or personnel. A loss of key research personnel and/or their work product could hamper or prevent our ability to commercialize certain drug candidates, which could severely harm our business.
Risks Related to Our Employees and Facilities
If we are unable to manage our business, financial condition, results of operations and prospects may be adversely affected.
In the past we have experienced and may continue to experience substantial growth in the number of our employees and in the scope of our operations. If we experience it again, it will likely place significant demands on our management, operational and financial resources, and our current and planned personnel, systems, procedures and controls may not be adequate to support our growth. To effectively manage our growth, we must continue to improve existing, and implement new, operational and financial systems, procedures and controls and must expand, train and manage our growing employee base, and there can be no assurance that we will effectively manage our growth without experiencing operating inefficiencies or control deficiencies. We have increased our commercial, medical, clinical, and other personnel, and recruiting and retaining qualified
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individuals is difficult. If we are unable to manage our growth effectively, or are unsuccessful in recruiting or retaining qualified personnel when advisable, our business, financial condition, results of operations and prospects may be adversely affected.
The loss of key personnel or the inability to attract and retain additional personnel could impair our ability to operate and expand our operations.
We are highly dependent upon the principal members of our management, as well as medical and clinical staff, the loss of whose services might adversely impact the achievement of our objectives. Retaining and, where advisable, recruiting qualified personnel will be critical to the advancement of our research and development efforts for pilavapadin, LX9851, sotagliflozin and our other drug candidates. Competition is intense for experienced personnel, and we may be unable to retain or recruit such personnel with the expertise or experience necessary to allow us to successfully develop and commercialize our products. Further, all of our employees are employed “at will” and, therefore, may leave our employment at any time.
Our facilities are located near coastal zones, and the occurrence of a hurricane or other disaster could damage our facilities and equipment, which could harm our operations.
Our facilities are located in The Woodlands, Texas and Bridgewater, New Jersey, and therefore our facilities are vulnerable to damage from hurricanes. We are also vulnerable to damage from other types of disasters, including fire, floods, power loss, communications failures, terrorism and similar events and any insurance we may maintain may not be adequate to cover our losses. If any disaster were to occur, our ability to operate our business at our facilities could be seriously, or potentially completely, impaired.
Risks Related to Environmental and Product Liability
We have used hazardous chemicals and radioactive and biological substances in our business. Any claims relating to improper handling, storage or disposal of these substances could be time consuming and costly.
Our research and development processes have historically involved the controlled use of hazardous substances, including chemicals and radioactive and biological materials, and our operations have produced hazardous waste products. See “Part I, Item 1. Business – Government Regulation – Environmental and Worker Safety Matters” for more discussion on these and other environmental matters. Compliance with environmental laws and regulations may be expensive, and current or future environmental regulations may impair our research, development and production efforts.
In addition, our collaborators may use hazardous materials in connection with our collaborative efforts. In the event of a lawsuit or investigation, we could be held responsible for any injury caused to persons or property by exposure to, or release of, these hazardous materials used by these parties. Further, we may be required to indemnify our collaborators against all damages and other liabilities arising out of our development activities or products produced in connection with these collaborations.
Our business has a substantial risk of product liability and we face potential product liability exposure far in excess of our limited insurance coverage.
We may be held liable if INPEFA or any other product that we or our collaborators develop or commercialize, or any other product that is made with the use or incorporation of any of our technologies, causes injury or is found otherwise unsuitable during product testing, manufacturing, marketing or sale. Regardless of merit or eventual outcome, product liability claims could result in decreased demand for INPEFA or our other products and product candidates, injury to our reputation, withdrawal of patients from our clinical trials, product recall, substantial monetary awards to third parties and the inability to commercialize any products that we may develop. These claims might be made directly by consumers, health care providers, pharmaceutical companies or others selling or testing our products. We have obtained limited product liability insurance coverage for our commercialization of INPEFA and clinical trials of our drug candidates. However, our insurance may not reimburse us or may not be sufficient to reimburse us for expenses or losses we may suffer. Moreover, if insurance coverage becomes more expensive, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses due to liability. On occasion, juries have awarded large judgments in class action lawsuits for claims based on drugs that had unanticipated side effects. In addition, the pharmaceutical and biotechnology industries, in general, have been subject to significant medical malpractice litigation. A successful product liability claim or series of claims brought against us could harm our reputation and business.
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Risks Related to Our Common Stock
Invus, L.P. and its affiliates own a substantial interest in our outstanding common stock and may have interests which conflict with those of our other stockholders.
Invus, L.P. and its affiliates, which we collectively refer to as Invus, currently own approximately 50% of the outstanding shares of our common stock and are thereby able to exert substantial control over the election and removal of our directors and determination of our corporate and management policies, including potential mergers or acquisitions, asset sales, the amendment of our articles of incorporation or bylaws and other significant corporate transactions. This concentration of ownership may delay or deter possible changes in control of our company, which may reduce the value of an investment in our common stock. The interests of Invus and its affiliates may not be aligned with the interests of other holders of our common stock.
Invus has additional rights under its stockholders’ agreement relating to the membership of our board of directors and under our certificate of incorporation relating to preemptive and consent rights, which provide Invus with substantial influence over significant corporate matters.
Under its stockholders’ agreement, Invus has the right to designate a number of directors equal to the percentage of all the outstanding shares of our common stock owned by Invus and its affiliates, rounded up to the nearest whole number of directors. Invus has designated three of the eight current members of our board of directors. While Invus has not presently exercised its director designation rights in full, it may exercise them at any time in the future in its sole discretion. To facilitate the exercise of such rights, we have agreed, upon written request from Invus, to take all necessary steps in accordance with our obligations under the stockholders’ agreement to (a) increase the number of directors to the number specified by Invus (which number shall be no greater than reasonably necessary for the exercise of Invus’ director designation rights under the stockholders’ agreement) and (b) cause the appointment to the newly created directorships of directors so designated by Invus pursuant to its rights under the stockholders’ agreement. Invus also has the right to require proportionate representation of Invus-appointed directors on the audit, compensation and corporate governance committees of our board of directors, subject to certain restrictions. Invus-designated directors currently serve as one of the three members of each of the compensation committee and the corporate governance committee of our board of directors, and no Invus-designated directors currently serve on the audit committee of our board of directors.
Our certificate of incorporation also grants holders of 20% or more of our issued and outstanding common stock customary preemptive rights and consent rights prior to us taking any of the following actions: (a) creating or issuing any new class or series of shares of capital stock (or securities convertible into or exercisable for shares of capital stock) having rights, preferences or privileges senior to or on parity with the common stock, (b) subject to certain exceptions, repurchasing, retiring, redeeming or otherwise acquiring any equity securities (or securities convertible into or exchangeable for equity securities) or any subsidiary and (c) adopting, or proposing to adopt, or maintaining any shareholders’ rights plan, “poison pill” or other similar plan or agreement, unless such stockholder is exempt from such plan or agreement. Invus currently has such preemptive and consent rights as a result of its ownership position in our issued and outstanding common stock.
Each of these rights provide Invus with substantial influence over significant corporate matters and Invus’ interest in those matters may not be aligned with the interests of other holders of our common stock.
Our stock price may be extremely volatile.
The trading price of our common stock has been highly volatile, and we believe the trading price of our common stock will remain highly volatile and may fluctuate substantially due to factors such as the following, many of which we cannot control:
•actions taken by regulatory agencies with respect to pilavapadin, LX9851, sotagliflozin and our other drug candidates;
•results or delays in our or our collaborators’ clinical trials;
•the announcement of FDA approval or non-approval, or delays in the FDA review process, of our or our collaborators’ drug candidates or those of our competitors or actions taken by regulatory agencies with respect to our, our collaborators’ or our competitors’ clinical trials;
•the announcement of new products by our competitors;
•quarterly variations in our or our competitors’ results of operations;
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•developments in our relationships with our collaborators, including conflicts, litigation or the termination or modification of our agreements;
•the announcement of an in-licensed drug candidate or strategic acquisition;
•litigation, including intellectual property infringement and misappropriation, and product liability lawsuits, involving us;
•failure to achieve operating results projected by securities analysts;
•changes in earnings estimates or recommendations by securities analysts;
•the satisfaction of outstanding debt obligations or entry into new financing arrangements;
•developments in the biotechnology or pharmaceutical industry;
•sales of large blocks of our common stock or sales of our common stock by our executive officers, directors and significant stockholders;
•departures of key personnel or board members;
•FDA or international regulatory actions;
•third-party coverage and reimbursement policies;
•disposition of any of our drug programs or other technologies; and
•other factors, including general market, economic and political conditions and other factors unrelated to our operating performance or the operating performance of our competitors.
These factors may materially adversely affect the market price of our common stock. In addition, the stock markets in general, and the markets for biotechnology and pharmaceutical stocks in particular, have historically experienced significant volatility that has often been unrelated or disproportionate to the operating performance of particular companies. For example, negative publicity regarding drug pricing and price increases by pharmaceutical companies has negatively impacted, and may continue to negatively impact, the markets for biotechnology and pharmaceutical stocks. Likewise, the broader financial markets could experience significant volatility that could also negatively impact the markets for biotechnology and pharmaceutical stocks. These broad market fluctuations have adversely affected and may in the future adversely affect the trading price of our common stock. Excessive volatility may continue for an extended period of time.
In the past, following periods of volatility in the market price of a company’s securities, securities class action litigation has often been instituted. A securities class action suit against us could result in substantial costs and divert management’s attention and resources, which could have a material and adverse effect on our business.
Future issuances or sales of our common stock, or the perception that such issuances or sales may occur, may depress our stock price.
A substantial number of shares of our common stock is reserved for issuance upon the exercise of stock options and vesting of restricted stock units. If we or our stockholders issue or sell substantial amounts of our common stock (including shares issued upon the exercise of stock options or vesting of restricted stock units) in the public market, or if the market perceives that such sales may occur, the market price of our common stock could fall and it may become more difficult for us to sell equity or equity-related securities in the future at a time and price that we deem appropriate. In addition, any such issuance or sale of our common stock will dilute the ownership interests of existing stockholders and may cause the market price of our common stock to decline.
If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.
The trading market for our common stock will depend in part on the research and reports that securities or industry analysts publish about us or our business. If one or more of the analysts who cover us downgrade our stock or publish inaccurate or unfavorable research about our business, our stock price would likely decline. If one or more of these analysts
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cease coverage of our company or fail to publish reports on us regularly, demand for our common stock could decrease, which might cause our stock price and trading volume to decline.
If we are unable to meet Nasdaq continued listing requirements, including minimum trading price, Nasdaq may take action to delist our common stock.
Our common stock trades on The Nasdaq Global Select Market, which has qualitative and quantitative listing criteria, including a requirement to maintain a minimum bid price of $1 per share. On January 3, 2025, we received a letter from Nasdaq’s listing qualifications staff indicating that we no longer meet such minimum bid price requirement. In accordance with Nasdaq rules, we have been provided a period of 180 calendar days, or until July 2, 2025, in which to regain compliance by ensuring the closing bid price of our common stock is at least $1 per share for a minimum of ten consecutive business days during such 180-day period. In the event that we do not regain compliance within such 180-day period, we may be eligible to seek an additional compliance period of 180 calendar days if we meet the continued listing requirement for market value of publicly held shares and all other Nasdaq initial listing standards, with the exception of the bid price requirement, and provide written notice to Nasdaq of our intent to cure the deficiency during this second compliance period, by effecting a reverse stock split, if necessary. However, if it appears to the Nasdaq staff that we will not be able to cure the deficiency, or if we are otherwise not eligible, Nasdaq will provide us notice that our common stock will be subject to delisting.
Although we are monitoring the closing bid price of our common stock and considering our available options in the event that the closing bid price of our common stock remains below $1 per share, there can be no assurance that we will be able to regain compliance with the minimum bid price requirement or otherwise maintain compliance with the other Nasdaq listing requirements. A delisting of our common stock would likely negatively impact us and our shareholders by reducing the liquidity and market price of our common stock and potentially reducing the number of investors willing to hold or acquire our common stock.
Item 1B. Unresolved Staff Comments
None.
Item 1C. Cybersecurity
Cybersecurity represents an important component of our overall approach to enterprise risk management. Our cybersecurity policies, standards, processes and practices are fully integrated into our enterprise risk management program and are based on recognized frameworks established by the National Institute of Standards and Technology, the International Organization for Standardization and other applicable industry standards. In general, we seek to address cybersecurity risks through a comprehensive, cross-functional approach that is focused on preserving confidentiality, security and availability of the information that we collect and store by identifying, preventing and mitigating cybersecurity threats and effectively responding to cybersecurity threats when they occur.
Our cybersecurity program is focused on the following key areas:
•Technical Safeguards. We deploy technical safeguards that are designed to protect our information systems from cybersecurity threats, including firewalls, intrusion prevention and detection systems, an endpoint protection platform system, anti-malware functionality, email filtering, url filtering and access controls, which are evaluated and improved through vulnerability assessments and cybersecurity threat intelligence.
•Education and Awareness. We provide regular, mandatory training for personnel regarding cybersecurity threats, as well as periodic decoy and honeypot testing, as a means to equip our personnel with effective tools to address cybersecurity threats, and to communicate our evolving information security policies, standards, processes and practices.
•Assessments of Third Party Service Providers. We regularly evaluate the cybersecurity policies, standards, processes and practices of our key third party service providers in order to effectively identify and address any vulnerabilities or other risks.
•Incident Response and Recovery Planning. We have established and maintain comprehensive incident response and recovery plans that fully address our response to a cybersecurity incident, and such plans are tested and evaluated on a regular basis.
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•Collaborative Approach. We have implemented a comprehensive, cross-functional approach to identifying, preventing and mitigating cybersecurity threats and incidents, while also implementing controls and procedures that provide for the prompt escalation of certain cybersecurity incidents so that decisions regarding the public disclosure and reporting of such incidents can be made by management in a timely manner.
We engage in the periodic assessment and testing of our policies, standards, processes and practices that are designed to address cybersecurity threats and incidents. These efforts include a wide range of activities, including audits, assessments, tabletop exercises, threat modeling, vulnerability testing and other exercises focused on evaluating the effectiveness of our cybersecurity measures and planning. We regularly engage third parties to perform assessments on our cybersecurity measures , including information security maturity assessments, audits and independent reviews of our information security control environment and operating effectiveness. The results of such assessments, audits and reviews are reported to our executive management and board of directors, and we adjust our cybersecurity policies, standards, processes and practices as necessary based on the information provided by these assessments, audits and reviews.
Our executive management and board of directors oversee our enterprise risk management process, including the management of risks arising from cybersecurity threats. Our executive management and board of directors each receive regular presentations and reports on cybersecurity risks, which address a wide range of topics including recent developments, evolving standards, vulnerability assessments, third party and independent reviews, the threat environment, technological trends and information security considerations arising with respect to our peers and third parties. Our executive management and board of directors also receive prompt and timely information regarding any cybersecurity incident that meets established reporting thresholds, as well as ongoing updates regarding any such incident until it has been addressed.
Item 2. Properties
In February 2021, we leased a 25,000 square-foot office space in The Woodlands, Texas. The term of the sublease extends from March 2021 through August 2025, and provides for escalating yearly base rent payments which are $557,000 for 2025, the final year of the lease. In July 2024, we entered into a new lease agreement for our existing office space in The Woodlands, Texas. The term of the lease begins September 2025, extends through January 2031 and provides for escalating yearly base rent payments starting at $774,000 and increasing to $875,000 in the final year of the lease.
In July 2022, our subsidiary, Lexicon Pharmaceuticals (New Jersey), Inc. leased a 22,000 square-foot office space in Bridgewater, New Jersey. The term of the lease extends through January 2034 and provides for escalating yearly base rent payments starting at $820,000 and increasing to $986,000 in the final year of the lease.
We believe that our facilities are well-maintained, in good operating condition and acceptable for our current operations.
Item 3. Legal Proceedings
We are from time to time party to claims and legal proceedings that arise in the normal course of our business and that we believe will not have, individually or in the aggregate, a material adverse effect on our results of operations, financial condition or liquidity. We are currently not aware of any material legal proceedings affecting our company.
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Item 4. Mine Safety Disclosures
Not applicable.
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PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Our common stock is quoted on The Nasdaq Global Select Market under the symbol “LXRX.” As of February 28, 2025, there were approximately 273 holders of record of our common stock.
We have never paid cash dividends on our common stock. We anticipate that we will retain all of our future earnings, if any, for use in the expansion and operation of our business and do not anticipate paying cash dividends in the foreseeable future.
Performance Graph
The following performance graph compares the performance of our common stock to the Nasdaq Composite Index and the Nasdaq Biotechnology Index for the period beginning December 31, 2019 and ending December 31, 2024. The graph assumes that the value of the investment in our common stock and each index was $100 at December 31, 2019, and that all dividends were reinvested. The stock performance shown on the graph below represents historical performance and is not necessarily indicative of future stock price performance.
| December 31, | |||||||||||||||||||||||||||||||||||
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | ||||||||||||||||||||||||||||||
| Lexicon Pharmaceuticals, Inc. | 100 | 82 | 95 | 46 | 37 | 18 | |||||||||||||||||||||||||||||
| Nasdaq Composite Index | 100 | 144 | 174 | 117 | 167 | 215 | |||||||||||||||||||||||||||||
| Nasdaq Biotechnology Index | 100 | 126 | 125 | 111 | 115 | 114 | |||||||||||||||||||||||||||||
The foregoing stock price performance comparisons shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference by any general statement incorporating by reference this annual report on Form 10-K into any filing under the Securities Act of 1933 or under the Securities Exchange Act of 1934, except to the extent that we specifically incorporate such comparisons by reference.
Item 6. [Reserved]
Not applicable.
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Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis should be read with our financial statements and notes included elsewhere in this annual report on Form 10-K.
Overview
We are a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. We are devoting most of our resources to the research and development of our most advanced drug candidates and the commercialization of our approved drug, INPEFA® (sotagliflozin):
•We are developing pilavapadin (LX9211), an orally-delivered small molecule drug candidate, as a treatment for neuropathic pain. We have completed three Phase 2 clinical trials evaluating the safety and tolerability of pilavapadin and its effects on DPNP and neuropathic pain. We have reported top-line results from our Phase 2b clinical trial of pilavapadin in diabetic peripheral neuropathic pain, or DPNP, which demonstrated clear evidence of effect at the 10 mg dose and have received Fast Track designation from the U.S. Food and Drug Administration, or FDA, for development of pilavapadin in that indication. We have also reported positive results from a Phase 2a clinical trial of pilavapadin in DPNP and results from a separate Phase 2a clinical trial of pilavapadin in post-herpetic neuralgia which also demonstrated evidence of effect.
•We are developing LX9851, an orally-delivered small molecule drug candidate, as a treatment for obesity and associated cardiometabolic disorders and are conducting preclinical development of LX9851 in preparation for filing an investigational new drug application, or IND.
•We are commercializing INPEFA (sotagliflozin), an orally-delivered small molecule drug, in the United States to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, or CKD, and other cardiovascular risk factors.
We are also developing sotagliflozin as a treatment for hypertrophic cardiomyopathy, or HCM, and are conducting a Phase 3 clinical trial of sotagliflozin in that indication.
We are separately pursuing regulatory approval of ZYNQUISTA™ (sotagliflozin) as a treatment for type 1 diabetes. The FDA issued a complete response letter regarding our New Drug Application, or NDA, for sotagliflozin in type 1 diabetes in March 2019 and an additional complete response letter in December 2024 regarding our NDA for sotagliflozin as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and CKD. At our request, the FDA has issued a public NOOH on whether there are grounds for denying approval of our NDA and those proceedings are ongoing.
•We are conducting preclinical research and development of compounds from a number of additional drug programs originating from our internal drug discovery efforts.
Pilavapadin originated from our collaborative neuroscience drug discovery efforts with Bristol-Myers Squibb and LX9851, sotagliflozin and compounds from a number of additional drug programs originated from our own internal drug discovery efforts. Our efforts were driven by a systematic, target biology-driven approach in which we used gene knockout technologies and an integrated platform of advanced medical technologies to systematically study the physiological and behavioral functions of almost 5,000 genes in mice and assessed the utility of the proteins encoded by the corresponding human genes as potential drug targets. We have identified and validated in living animals, or in vivo, more than 100 targets with promising profiles for drug discovery.
We have worked both independently and through collaborations and strategic alliances with third parties to capitalize on our drug target discoveries and research and development programs. We seek to retain exclusive or co-exclusive rights to the benefits of certain research and development programs by developing and commercializing drug candidates from those programs internally, particularly in the United States for indications treated by specialist physicians. We seek to collaborate with other pharmaceutical and biotechnology companies with respect to the research, development and commercialization of certain of our drug candidates, particularly with respect to commercialization in territories outside the United States or commercialization in the United States for indications treated by primary care physicians, or when the collaboration may otherwise provide us with access to expertise and resources that we do not possess internally or are complementary to our own.
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We have derived substantially all of our revenues from strategic collaborations and other research and development collaborations and technology licenses, as well as from commercial sales of our approved drug products. To date, we have generated a substantial portion of our revenues from a limited number of sources.
Our operating results and, in particular, our ability to generate additional revenues are dependent on many factors, including the success of our ongoing research and development efforts and the ability to obtain necessary regulatory approvals of the drug candidates which are the subject of such efforts; our success in establishing new collaborations and licenses and our receipt of milestones, royalties and other payments under such arrangements; and general and industry-specific economic conditions which may affect research, development and commercialization expenditures.
Our ability to secure future revenue-generating agreements will depend upon our ability to address the needs of our potential future collaborators and licensees, and to negotiate agreements that we believe are in our long-term best interests. We may determine, as we have with INPEFA in heart failure in the United States, that our interests are better served by retaining rights to our discoveries and advancing our therapeutic programs to a later stage, which could limit our near-term revenues and increase expenses. Because of these and other factors, our operating results have fluctuated in the past and are likely to do so in the future, and we do not believe that period-to-period comparisons of our operating results are a good indication of our future performance.
Since our inception, we have incurred significant losses and, as of December 31, 2024, we had an accumulated deficit of approximately $2.0 billion. Our losses have resulted principally from costs incurred in research and development, selling, general and administrative costs associated with our operations, and non-cash stock-based compensation expenses associated with stock options and restricted stock units granted to employees and consultants. Research and development expenses consist primarily of salaries and related personnel costs, external research costs related to our nonclinical and clinical efforts, material costs, facility costs, depreciation on property and equipment, and other expenses related to our drug discovery and development programs. Selling, general and administrative expenses consist primarily of salaries and related expenses for executive, sales and marketing, and administrative personnel, professional fees and other corporate expenses, including information technology, facilities costs and general legal activities. We expect to continue to incur significant research and development costs in connection with the continuing research and development of our drug candidates. As a result, we will need to generate significantly higher revenues to achieve profitability.
Critical Accounting Policies
Our Consolidated Financial Statements included in this Annual Report on Form 10-K have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP, which require that we make numerous estimates and assumptions. Actual results could differ from those estimates and assumptions, thus impacting our reported results of operations and financial position. The critical accounting policies and estimates described in this section are those that are most important to the depiction of our financial condition and results of operations and the application of which requires our most subjective judgments in making estimates about the effect of matters that are inherently uncertain. We describe our significant accounting policies more fully in Note 2, “Summary of Significant Accounting Policies,” to the Consolidated Financial Statements included in this Annual Report on Form 10-K.
Research and Development Expenses
Research and development expenses consist of costs incurred for research and development activities solely sponsored by us as well as collaborative research and development activities. These costs include direct and research-related overhead expenses and are expensed as incurred. Technology license fees for technologies that are utilized in research and development and have no alternative future use are expensed when incurred.
We are presently devoting most of our resources to the continued research and development of pilavapadin, LX9851, sotagliflozin and our other drug candidates.
Pilavapadin originated from our collaborative neuroscience drug discovery efforts with Bristol-Myers Squibb and LX9851, sotagliflozin and compounds from a number of additional drug programs originated from our own internal drug discovery efforts. Those efforts were driven by a systematic, target biology-driven approach in which we used gene knockout technologies and an integrated platform of advanced medical technologies to systematically study the physiological and behavioral functions of almost 5,000 genes in mice and assessed the utility of the proteins encoded by the corresponding human genes as potential drug targets. We have identified and validated in living animals, or in vivo, more than 100 targets with promising profiles for drug discovery.
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The drug development process takes many years to complete. The cost and length of time varies due to many factors including the type, complexity and intended use of the drug candidate. We estimate that drug development activities are typically completed over the following periods:
| Phase | Estimated Completion Period | |||||||
| Preclinical development | 1-2 years | |||||||
| Phase 1 clinical trials | 1-2 years | |||||||
| Phase 2 clinical trials | 1-2 years | |||||||
| Phase 3 clinical trials | 2-4 years | |||||||
We expect research and development costs to remain substantial in the future as we continue to fund our research and development efforts and advance new drug candidates into clinical development. Due to the variability in the length of time necessary for drug development, the uncertainties related to the cost of these activities and ultimate ability to obtain regulatory approval for commercialization, accurate and meaningful estimates of the ultimate costs to bring our drug candidates to market are not available.
We record significant accrued liabilities related to unbilled expenses for products or services that we have received from service providers, specifically related to ongoing preclinical studies and clinical trials. These costs primarily relate to clinical study management, monitoring, laboratory and analysis costs, drug supplies, toxicology studies and investigator grants. We may have multiple drug candidates in concurrent preclinical studies and clinical trials at clinical sites throughout the world. In order to ensure that we have adequately provided for ongoing preclinical and clinical development costs during the period in which we incur such costs, we maintain accruals to cover these expenses. Substantial portions of our preclinical studies and clinical trials are performed by third party laboratories, medical centers, contract research organizations and other vendors. For preclinical studies, we accrue expenses based upon estimated percentage of work completed and the contract milestones remaining. For clinical studies, expenses are accrued based upon milestones and the number of patients enrolled over the duration of the study. We monitor patient enrollment, the progress of clinical studies and related activities to the extent possible through internal reviews of data reported to us by the vendors and clinical site visits. Our estimates depend on the timeliness and accuracy of the data provided by our vendors regarding the status of each program and total program spending. We periodically evaluate the estimates to determine if adjustments are necessary or appropriate based on information we receive. Although we use consistent milestones or subject or patient enrollment to drive expense recognition, the assessment of these costs is a subjective process that requires judgment. Upon settlement, these costs may differ materially from the amounts accrued in our consolidated financial statements.
The financial terms of these agreements are subject to negotiation and vary from contract to contract. In accruing the relevant costs, we estimated the time period over which services were to be performed and the level of effort required to complete or wind down each study. Upon completion and settlement, these costs may differ materially from the amounts accrued in our consolidated financial statements.
We record our research and development costs by type or category, rather than by project. Significant categories of costs include personnel, facilities and equipment costs and third-party and other services. In addition, a significant portion of our research and development expenses is not tracked by project as it benefits multiple projects. Consequently, fully-loaded research and development cost summaries by project are not available.
Recent Accounting Pronouncements Issued But Not Yet Adopted
See Note 2, Summary of Significant Accounting Policies, of the Notes to Consolidated Financial Statements, for a discussion of the impact of new accounting standards issued but not yet adopted on our consolidated financial statements.
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Results of Operations
The following discussion and analysis should be read with “Results of Operations” and our financial statements and notes included in our annual report on Form 10-K for the year ended December 31, 2023.
Revenues
Revenues for the year ended December 31, 2024 were approximately $31.1 million and primarily consisted of the upfront payment of $25.0 million received from the Viatris licensing agreement and net product revenues of $6.0 million recognized from sales of INPEFA.
Cost of Sales
Cost of sales for the years ended December 31, 2024 and 2023 consist of third-party manufacturing costs and freight associated with sales of INPEFA. Prior to receiving regulatory approval of INPEFA on May 26, 2023, we had completed or begun the manufacturing of certain INPEFA raw materials. These raw materials were either received at “zero-cost” to us in conjunction with a terminated agreement in 2019 or recorded as research and development expense. Based on our expectations for future manufacturing costs, we estimate these amounts totaled approximately $39.0 million. We began capitalizing inventory manufactured subsequent to regulatory approval of INPEFA as the related costs were expected to be recoverable through the commercialization of the product. At December 31, 2024, substantially all of the “zero-cost” INPEFA raw materials remains available to us. However, the time period over which this inventory is consumed will depend on a number of factors that may include the amount of future INPEFA sales, use of this inventory to satisfy the manufacturing and supply agreement we have agreed to enter into with Viatris (see Note 7) or in clinical development or other research activities, production lead times, and/or the ability to utilize inventory prior to its expiration date. Any future sales of INPEFA will utilize this “zero-cost” inventory and will result in a lower average per unit cost of materials during that period. We estimate our cost of goods sold as a percentage of net product revenue will be less than 10% subsequent to the utilization of all of the remaining “zero-cost” inventory.
Research and Development Expenses
Research and development expenses and dollar and percentage changes as compared to the prior year are as follows (dollar amounts are presented in millions):
| Year Ended December 31, | |||||||||||||||||
| 2024 | 2023 | 2022 | |||||||||||||||
| Total research and development expense | $ | 84.5 | $ | 58.9 | $ | 52.8 | |||||||||||
| Dollar increase | $ | 25.6 | $ | 6.1 | |||||||||||||
| Percentage increase | 43 | % | 12 | % | |||||||||||||
Research and development expenses consist primarily of third-party services principally related to preclinical and clinical development activities, salaries and other personnel-related expenses, facility and equipment costs, stock-based compensation expense and other costs each of which are described below.
Years Ended December 31, 2024 and 2023
•Third-party services – Third-party services relate principally to our clinical trial and related development activities, such as preclinical and clinical studies and contract manufacturing. Overall, third-party services increased 64% in 2024 to $56.7 million, primarily driven by higher clinical external research expense associated with our current drug candidates and higher consulting fees related to the resubmission of the NDA for ZYNQUISTA.
•Personnel – Personnel costs increased 16% in 2024 to $16.7 million from $14.3 million in 2023. Salaries (including severance), bonuses, employee benefits, payroll taxes, recruiting and relocation costs are included in personnel costs.
•Stock-based compensation – Stock-based compensation expense increased 14% in 2024 to $5.8 million as compared to 2023.
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•Facilities, equipment, and other – Facilities, equipment, and other costs relate primarily to rent, insurance, travel and training, and software licensing costs. Facilities, equipment, and other costs were $5.3 million and $4.9 million in 2024 and 2023, respectively.
Selling, General and Administrative Expenses
Selling, general and administrative expenses and dollar and percentage changes as compared to the prior year are as follows (dollar amounts are presented in millions):
| Year Ended December 31, | |||||||||||||||||
| 2024 | 2023 | 2022 | |||||||||||||||
| Total selling, general and administrative expense | $ | 143.1 | $ | 114.0 | $ | 48.1 | |||||||||||
| Dollar increase | $ | 29.1 | $ | 65.9 | |||||||||||||
| Percentage increase | 26 | % | 137 | % | |||||||||||||
Selling, general and administrative expenses consist primarily of personnel costs to support the commercialization of INPEFA and support of our research and development activities, professional and consulting fees, stock-based compensation expense, and facilities, equipment, and other costs each of which are described further below.
Years Ended December 31, 2024 and 2023
•Personnel – Personnel costs increased 28% in 2024 to $68.1 million as compared to the corresponding period in 2023. Salaries (including severance), bonuses, employee benefits, payroll taxes, recruiting and relocation costs are included in personnel costs. The increase is driven by higher employee salaries and benefit costs, including severance of $11.2 million incurred in late 2024 related to the significant reduction in our commercial field force.
•Professional and consulting fees – Professional and consulting fees increased 36% in 2024 to $52.7 million, primarily due to higher marketing expenses in 2024 and professional fees incurred for ZYNQUISTA prior to receipt of the complete response letter in December 2024 by the FDA.
•Stock-based compensation – Stock-based compensation expense decreased 17% in 2024 to $7.7 million as compared to 2023 reflecting forfeitures of unvested awards due to decreased headcount, primarily reflecting the reduction in the field force in late 2024.
•Facilities, equipment, and other – Facilities, equipment, and other costs were $14.6 million and $13.1 million in 2024 and 2023, respectively. The increase was primarily due to travel in conjunction with the commercialization of INPEFA.
Interest and Other Expense
Interest and Other Expense. Interest and other expense increased to $15.6 million in 2024 from $13.1 million in 2023, reflecting the additional $50 million borrowed under the Oxford Term Loans in June 2023.
Interest Income and Other, Net
Interest Income and Other, Net. Interest income and other, net increased to $12.3 million in 2024 from $7.7 million in 2023 reflecting an increase in cash and investments.
Net Loss and Net Loss per Common Share
Net loss was $200.4 million, or $0.63 net loss per share, in 2024, as compared to a net loss of $177.1 million, or $0.80 net loss per share, in 2023.
Liquidity and Capital Resources
We have financed our operations from inception primarily through sales of common and preferred stock, contract and milestone payments we received under our collaborations and strategic licenses, target validation, database subscription and
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technology license agreements, government grants and contracts, and financing under debt, lease and other project financing arrangements, as well as from commercial sales of our approved drug products.
In March 2022, we entered into a loan and security agreement (as subsequently amended) with Oxford Finance LLC that provides up to $150 million in borrowing capacity, available in five tranches, under which $100 million has been funded under the first three tranches. The fourth $25 million tranche is available for draw at our option upon the achievement of specified INPEFA net sales and until April 25, 2025. The fifth $25 million tranche is available for draw at our option, subject to Oxford’s consent, at any time prior to the expiration of the 60-month interest-only payment period with an amortization date of May 1, 2027. Payments of $34.8 million, $52.2 million, and $20.0 million, including debt principal and final exit fee payments, will be due during the fiscal years ended December 31, 2027, December 31, 2028 and December 31, 2029, respectively, with respect to all borrowed loan tranches as of December 31, 2024.
The loan and security agreement includes a financial covenant relating to net product revenue, which will be effective as of the quarter ending June 30, 2026, and a separate financial covenant which requires us to maintain a minimum unrestricted cash and investments balance of 50% of the outstanding principal amount through June 30, 2026, tested monthly as of the last day of each month. In addition, we are separately required to maintain a quarterly minimum unrestricted cash and investments balance of $10 million until the achievement of specified INPEFA net sales (which will be satisfied by meeting the monthly minimum unrestricted cash and investments covenant noted above). Upon funding of the fourth tranche, the quarterly minimum unrestricted cash and investments balance requirement will increase to $25 million. For additional information, please refer to Note 9 of the Notes to Consolidated Financial Statements.
In December 2023, we entered into an Open Market Sale AgreementSM with Jefferies LLC pursuant to which we may offer and sell shares of our common stock having an aggregate sales price of up to $75 million from time to time through Jefferies as sales agent. As of December 31, 2024, the full amount is still available for issuance under the agreement.
On March 11, 2024, we entered into an agreement with certain accredited investors pursuant to which we agreed to sell 2,304,147 shares of our Series A Convertible Preferred Stock, at a price of $108.50 per share. We received net proceeds of approximately $241.3 million, after deducting placement agent fees and offering expenses from the private placement offering. On May 10, 2024, each share of preferred stock was converted into 50 shares of our common stock, or an aggregate of 115,207,350 shares. For additional information on the private placement offering, please refer to Note 13 of the Notes to Consolidated Financial Statements.
On October 16, 2024, we entered into an exclusive license agreement with Viatris for the development and commercialization of sotagliflozin in all markets outside of the United States and Europe pursuant to which we received an upfront payment of $25 million. For additional information on the exclusive license agreement, please refer to Note 7 of the Notes to Consolidated Financial Statements.
As of December 31, 2024, we had $238.0 million in cash, cash equivalents and short-term investments. As of December 31, 2023, we had $170.0 million in cash, cash equivalents and short-term investments. We used cash of $178.8 million in our operations in 2024 largely reflective of the net loss for the year of $200.4 million (including non-cash charges of $7.4 million) and changes in working capital. Investing activities used cash of $15.4 million in 2024, primarily due to net purchases of investments. Financing activities provided cash of $238.3 million, primarily from the issuance and sale of 2,304,147 shares of our Series A Convertible Preferred Stock in a private placement in March 2024 at a price of $108.50 per share. The preferred shares were converted into an aggregate of 115,207,350 common shares in May 2024.
Other commitments. Upon the regulatory approval of sotagliflozin for the treatment of type 1 diabetes in a major market, we will be required to make certain royalty payments, totaling $4.5 million, in three equal annual installments of $1.5 million. Under our drug discovery alliance with Bristol-Myers Squibb, we will be required to make a milestone payment of $5 million upon dosing of the first patient in a Phase 3 clinical trial of pilavapadin.
For a further discussion of our commitments and contingencies see Note 10 of the Notes to Consolidated Financial Statements.
Our future capital requirements will be substantial and will depend on many factors, including the success of our ongoing research and development efforts and the ability to obtain necessary regulatory approvals of the drug candidates which are the subject of such efforts; our success in establishing new collaborations and licenses and our receipt of milestones, royalties and other payments under such arrangements; the amount and timing of our research, development and commercialization expenditures; the resources we devote to commercializing, developing and supporting our products and other factors. Our capital requirements will also be affected by any expenditures we make in connection with license agreements and acquisitions of and investments in complementary technologies and businesses.
43
We expect to continue to devote substantial capital resources to the research and development of our drug candidates and for other general corporate activities. We believe that our current unrestricted cash and investment balances and cash and revenues we expect to derive from strategic and other collaborations and other sources will be sufficient to fund our currently planned operations for at least the next 12 months from the date of this report. In future periods, if cash on hand or generated by operations is insufficient to satisfy our liquidity requirements, we will need to obtain additional liquidity through future strategic and other collaborations or sell additional equity or debt securities or obtain additional credit arrangements. If we are unable to obtain adequate financing when needed, we may have to delay or reduce the scope of our commercialization efforts or one or more of our clinical trials and other research and development programs. Additional financing may not be available on terms acceptable to us or at all. The sale of additional equity or convertible debt securities may result in additional dilution to our stockholders.
From time to time, our board of directors may authorize us to repurchase shares of our common stock. If and when our board of directors should determine to authorize any such action, it would be on terms and under market conditions that our board of directors determines are in the best interest of us and our stockholders. Any such actions could deplete significant amounts of our cash resources and/or result in additional dilution to our stockholders.
Disclosure about Market Risk
We are exposed to limited market and credit risk on our cash equivalents which have maturities of three months or less at the time of purchase. We had approximately $238.0 million in cash and cash equivalents and short-term investments as of December 31, 2024. We maintain a short-term investment portfolio which consists of U.S. Treasury bills and corporate debt securities that mature three to 12 months from the time of purchase, which we believe are subject to limited market and credit risk. We currently do not hedge interest rate exposure or hold any derivative financial instruments in our investment portfolio.
We are subject to interest rate sensitivity on our outstanding Oxford Term Loans which bear interest at a floating rate equal to the 1-month CME Term SOFR rate. Interest on the Oxford Term Loans is payable in cash monthly and the term loans are fully matured by March 2029, unless earlier repaid in accordance with their terms.
We have operated primarily in the United States and substantially all sales to date have been made in U.S. dollars. Accordingly, we have not had any material exposure to foreign currency rate fluctuations.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
See “Disclosure about Market Risk” under “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” for quantitative and qualitative disclosures about market risk.
Item 8. Financial Statements and Supplementary Data
The financial statements required by this Item are incorporated under Item 15 in Part IV of this report.
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
None.
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our principal executive officer and principal financial officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934) as of the end of the period covered by this report. Based on that evaluation, our principal executive officer and principal financial officer have concluded that our disclosure controls and procedures were effective as of December 31, 2024 to ensure that the information required to be disclosed by us in the reports we file under the Securities Exchange Act is gathered, analyzed and disclosed with adequate timeliness, accuracy and completeness.
Management’s Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act).
44
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2024. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework (2013 Framework).
Based on such assessment using those criteria, management concluded that, as of December 31, 2024, our internal control over financial reporting was effective.
Changes in Internal Control Over Financial Reporting
Subsequent to our evaluation described above, there were no significant changes in internal controls or other factors during the fiscal quarter ended December 31, 2024 that could significantly affect internal controls, including any corrective actions with regard to significant deficiencies and material weaknesses.
Item 9B. Other Information
Insider Trading Arrangements
During the three months ended December 31, 2024, none of our directors or executive officers adopted or terminated
Management Severance Plan
On March 4, 2025, we adopted a Management Severance Plan, which will provide severance payments and benefits to eligible employees in connection with certain terminations of employment. The plan was approved by our compensation committee and has an effective date of March 4, 2025.
Under the plan, in the event that a participating executive officer’s employment is terminated by us without cause (as defined in the plan) or resigns for good reason (as defined in the plan), if the participating executive officer signs a release of all claims, then the participating executive officer would be entitled to lump sum payments equal to (a) 12 months of current base salary, (b) pro-rated amount of current target cash bonus (only if such termination occurs between September 1 and December 31) and (c) an amount approximating 12 months of COBRA premiums for continued coverage under our group health plans, less the employee contribution amount that our similarly situated employees pay for such coverage (only if the participating executive officer is enrolled in our group health plans and elects to continue such coverage).
In the event that the separation described in the preceding paragraph occurs within the 24-month period following a change in control, if the participating executive officer signs a release of all claims, then the participating executive officer would be entitled to lump sum payments equal to (a) 12 months of current base salary (or 18 months of current base salary in the case of our chief executive officer), (b) current target cash bonus and (c) an amount approximating 12 months of COBRA premiums for continued coverage under our group health plans (or 18 months in the case of our chief executive officer), less the employee contribution amount that our similarly situated employees pay for such coverage (only if the participating executive officer is enrolled in our group health plans and elects to continue such coverage).
For purposes of the plan, a change in control shall have occurred upon any of the following events: (a) any person (other than Invus, L.P. and its affiliates) becomes the beneficial owner of securities representing 35% or more of the combined voting power of our securities, (b) the consummation of a reorganization, merger or consolidation pursuant to which our stockholders immediately prior to such reorganization, merger or consolidation do not, immediately thereafter, own or control more than 50% of the combined voting power of the surviving entity’s outstanding voting securities in substantially the same proportions as prior to such reorganization, merger or consolidation, (c) our liquidation or dissolution or the sale of all or substantially all of our assets, (d) following the election or removal of directors, a majority of our board of directors consists of individuals who were not members of our board of directors two years before such election or removal or (e) any other corporate event deemed to be a change in control by the plan administrator.
45
The terms of the plan will supersede all potential severance payments and benefits contained within participating executive officers’ individual offer letters and employment agreements.
The foregoing description of the plan does not purport to be complete and is qualified in its entirety by reference to the plan, a copy of which is attached as an exhibit to this annual report on Form 10-K and the terms of which are incorporated herein by reference.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
None.
46
PART III
Item 10. Directors, Executive Officers and Corporate Governance
The information required by this Item is hereby incorporated by reference from (a) the information appearing under the captions “Election of Directors,” “Stock Ownership of Certain Beneficial Owners and Management,” “Corporate Governance” and “Executive and Director Compensation” in our definitive proxy statement which involves the election of directors and is to be filed with the SEC pursuant to the Securities Exchange Act of 1934 within 120 days of the end of our fiscal year on December 31, 2024 and (b) the information appearing under Item 1 in Part I of this report.
Item 11. Executive Compensation
The information required by this Item is hereby incorporated by reference from the information appearing under the captions “Corporate Governance” and “Executive and Director Compensation” in our definitive proxy statement which involves the election of directors and is to be filed with the Commission pursuant to the Securities Exchange Act of 1934 within 120 days of the end of our fiscal year on December 31, 2024. Notwithstanding the foregoing, in accordance with the instructions to Item 407(e)(5) of Regulation S-K, the information contained in our proxy statement under the sub-heading “Compensation Committee Report” shall not be deemed to be filed as part of or incorporated by reference into this annual report on Form 10-K.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The information required by this Item is hereby incorporated by reference from the information appearing under the captions “Stock Ownership of Certain Beneficial Owners and Management” and “Equity Compensation Plan Information” in our definitive proxy statement which involves the election of directors and is to be filed with the Commission pursuant to the Securities Exchange Act of 1934 within 120 days of the end of our fiscal year on December 31, 2024.
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required by this Item is hereby incorporated by reference from the information appearing under the captions “Corporate Governance” and “Transactions with Related Persons” in our definitive proxy statement which involves the election of directors and is to be filed with the Commission pursuant to the Securities Exchange Act of 1934 within 120 days of the end of our fiscal year on December 31, 2024.
Item 14. Principal Accountant Fees and Services
The information required by this Item as to the fees we pay our principal accountant is hereby incorporated by reference from the information appearing under the caption “Ratification and Approval of Independent Auditors” in our definitive proxy statement which involves the election of directors and is to be filed with the Commission pursuant to the Securities Exchange Act of 1934 within 120 days of the end of our fiscal year on December 31, 2024.
47
PART IV
Item 15. Exhibit and Financial Statement Schedules
(a)Documents filed as a part of this report:
1.Consolidated Financial Statements
| Page | |||||
Report of Independent Registered Public Accounting Firm (PCAOB ID: | |||||
2.Financial Statement Schedules
All other financial statement schedules are omitted because they are not applicable or not required, or because the required information is included in the financial statements or notes thereto.
3.Exhibits
| Exhibit No. | Description | |||||||
| 1.1 | — | Open Market Sale Agreement℠, dated December 29, 2023, with Jefferies LLC (filed as Exhibit 1.1 to the Company's Current Report on Form 8-K dated December 29, 2023 and incorporated by reference herein). | ||||||
| 3.1 | — | Sixth Amended and Restated Certificate of Incorporation (filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K dated May 10, 2024 and incorporated by reference herein). | ||||||
| 3.2 | — | Second Amended and Restated Bylaws (filed as Exhibit 3.2 to the Company’s Current Report on Form 8‑K dated April 26, 2012 and incorporated by reference herein). | ||||||
| 4.1 | — | Securities Purchase Agreement, dated June 17, 2007, with Invus, L.P. (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K dated June 17, 2007 and incorporated by reference herein). | ||||||
| 4.2 | — | Amendment, dated October 7, 2009, to Securities Purchase Agreement, dated June 17, 2007, with Invus, L.P. (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K dated October 7, 2009 and incorporated by reference herein). | ||||||
| 4.3 | — | Registration Rights Agreement, dated June 17, 2007, with Invus, L.P. (filed as Exhibit 10.3 to the Company’s Current Report on Form 8-K dated June 17, 2007 and incorporated by reference herein). | ||||||
| 4.4 | — | Stockholders’ Agreement, dated June 17, 2007, with Invus, L.P. (filed as Exhibit 10.4 to the Company’s Current Report on Form 8-K dated June 17, 2007 and incorporated by reference herein). | ||||||
| 4.5 | — | Supplement to Transaction Agreements, dated March 15, 2010, with Invus, L.P. and Invus C.V. (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K dated March 15, 2010 and incorporated by reference herein). | ||||||
| 4.6 | — | Supplement No. 2 to Transaction Agreements, dated February 23, 2012, with Invus, L.P. and Invus C.V. (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K dated February 23, 2012 and incorporated by reference herein). | ||||||
| 4.7 | — | Supplement No. 3 to the Transaction Agreements, dated December 16, 2020, with Invus, L.P. and Invus C.V. (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K dated December 16, 2020 and incorporated by reference herein). | ||||||
| 4.8 | — | Description of Common Stock (filed as Exhibit 4.8 to the Company’s Annual Report on Form 10-K for the period ended December 31, 2021 and incorporated by reference herein). | ||||||
| *†10.1 | — | Management Severance Plan, dated March 4, 2025 | ||||||
| 10.2 | — | Offer Letter, dated July 3, 2024, with Michael S. Exton, Ph.D. (filed as Exhibit 10.1 to the Company’s Current Report on Form 8‑K dated July 3, 2024 and incorporated by reference herein). | ||||||
| 10.3 | — | Offer Letter, dated July 27, 2021, with Craig B. Granowitz, M.D., Ph.D. (filed as Exhibit 10.3 to the Company’s Annual Report on Form 10-K for the period ended December 31, 2021 and incorporated by reference herein). | ||||||
| 10.4 | — | Employment Agreement, dated July 12, 2001, with Alan J. Main, Ph.D. (filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2001 and incorporated by reference herein). | ||||||
48
| 10.5 | — | Separation Agreement, dated September 13, 2024, with Jeffrey L. Wade (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K dated September 13, 2024 and incorporated by reference herein). | ||||||
| 10.6 | — | Consulting Agreement, dated September 13, 2024, with Jeffrey L. Wade (filed as Exhibit 10.2 to the Company’s Current Report on Form 8-K dated September 13, 2024 and incorporated by reference herein). | ||||||
| 10.7 | — | Form of Indemnification Agreement with Officers and Directors (filed as Exhibit 10.6 to the Company’s Registration Statement on Form S-1 (Registration No. 333-96469) and incorporated by reference herein). | ||||||
| 10.8 | — | Summary of Non-Employee Director Compensation (filed as Exhibit 10.6 to the Company’s Annual Report on Form 10-K for the period ended December 31, 2023 and incorporated by reference herein). | ||||||
| 10.9 | — | 2017 Equity Incentive Plan, as amended (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K dated April 27, 2023 and incorporated by reference herein). | ||||||
| 10.10 | — | 2017 Non-Employee Directors’ Equity Incentive Plan, as amended (filed as Exhibit 10.2 to the Company's Current Report on Form 8-K dated April 27, 2023 and incorporated by reference herein). | ||||||
| *10.11 | — | Form of Stock Option Agreement with Officers under the 2017 Equity Incentive Plan | ||||||
| *10.12 | — | Form of Restricted Stock Unit Agreement with Officers under the 2017 Equity Incentive Plan | ||||||
| 10.13 | — | Form of Notice of Stock Option Grant to Directors under the 2017 Non-Employee Directors’ Equity Incentive Plan (filed as Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2019 and incorporated by reference herein). | ||||||
| 10.14 | — | Form of Notice of Restricted Stock Unit Grant to Directors under the 2017 Non-Employee Directors’ Equity Incentive Plan (filed as Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2019 and incorporated by reference herein). | ||||||
| *†10.15 | — | Exclusive License Agreement, dated October 16, 2024, with Viatris Inc. | ||||||
| 10.16 | — | Collaboration and License Agreement, dated December 17, 2003, with Bristol-Myers Squibb Company (filed as Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2015 and incorporated by reference herein). | ||||||
| 10.17 | — | First Amendment, dated May 30, 2006, to Collaboration and License Agreement, dated December 17, 2003, with Bristol-Myers Squibb Company (filed as Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2015 and incorporated by reference herein). | ||||||
| †10.18 | — | Second Amendment, dated November 2, 2016, to Collaboration and License Agreement, dated December 17, 2003, with Bristol-Myers Squibb Company (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K dated November 2, 2016 and incorporated by reference herein). | ||||||
| 10.19 | — | Sublease Agreement, dated February 8, 2021, with Repsol Oil & Gas USA, LLC (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K dated February 8, 2021 and incorporated by reference herein). | ||||||
| 10.20 | — | Office Lease dated July 30, 2024, with RFL NO.4 Limited Partnership (filed as Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2024 and incorporated by reference herein). | ||||||
| †10.21 | — | Loan and Security Agreement, dated March 17, 2022, with Oxford Finance, LLC and the lenders listed therein (filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2022 and incorporated by reference herein). | ||||||
| †10.22 | — | First Amendment to Loan and Security Agreement, dated August 29, 2022, with Oxford Finance, LLC and the lenders listed therein (filed as Exhibit 10.1 to the Company's Current Report on Form 8-K dated August 29, 2022 and incorporated by reference herein). | ||||||
| †10.23 | — | Second Amendment to Loan and Security Agreement, dated May 1, 2023, with Oxford Finance, LLC and the lenders listed therein (filed as Exhibit 10.1 to the Company's Current Report on Form 8-K dated May 1, 2023 and incorporated by reference herein). | ||||||
| †10.24 | — | Third Amendment to Loan and Security Agreement, dated June 23, 2023, with Oxford Finance, LLC and the lenders listed therein (filed as Exhibit 10.1 to the Company's Current Report on Form 8-K dated June 23, 2023 and incorporated by reference herein). | ||||||
| †10.25 | — | Fourth Amendment to Loan and Security Agreement, dated December 29, 2023, with Oxford Finance, LLC and the lenders listed therein (filed as Exhibit 10.1 to the Company's Current Report on Form 8-K dated December 29, 2023 and incorporated by reference herein). | ||||||
| †10.26 | — | Fifth Amendment to Loan and Security Agreement, dated March 6, 2024, with Oxford Finance, LLC and the lenders listed therein (filed as Exhibit 10.2 to the Company's Current Report on Form 8-K dated March 6, 2024 and incorporated by reference herein). | ||||||
49
| †10.27 | — | Sixth Amendment to Loan and Security Agreement, dated June 28, 2024 with with Oxford Finance, LLC and the lenders listed therein (filed as Exhibit 10.1 to the Company's Current Report on Form 8-K dated June 28, 2024 and incorporated by reference herein) | ||||||
| 10.28 | — | Preferred Stock Purchase Agreement, dated March 11, 2024, with the purchasers party thereto (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K dated March 6, 2024 and incorporated by reference herein). | ||||||
| *19.1 | — | |||||||
| 21.1 | — | Subsidiaries (filed as Exhibit 21.1 to the Company’s Annual Report on Form 10-K for the period ended December 31, 2021 and incorporated by reference herein). | ||||||
| *23.1 | — | |||||||
| *24.1 | — | Power of Attorney (contained in signature page). | ||||||
| *31.1 | — | |||||||
| *31.2 | — | |||||||
| *32.1 | — | |||||||
| 97.1 | — | Incentive-Based Compensation Clawback Policy (filed as Exhibit 97.1 to the Company’s Annual Report on Form 10-K for the period ended December 31, 2023 and incorporated by reference herein). | ||||||
| *101.INS | — | XBRL Instance Document. | ||||||
| *101.SCH | — | XBRL Taxonomy Extension Schema Document. | ||||||
| *101.CAL | — | XBRL Taxonomy Extension Calculation Linkbase Document. | ||||||
| *101.DEF | — | XBRL Taxonomy Extension Definition Linkbase Document. | ||||||
| *101.LAB | — | XBRL Taxonomy Extension Label Linkbase Document. | ||||||
| *101.PRE | — | XBRL Taxonomy Extension Presentation Linkbase Document. | ||||||
______________
| * | Filed herewith. | ||||
| † | Certain information (indicated by “[**]”) has been excluded from this exhibit because it is both not material and would likely cause competitive harm to the Company if publicly disclosed. | ||||
Item 16. Form 10-K Summary
Not applicable.
50
Signatures
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| Lexicon Pharmaceuticals, Inc. | |||||||||||
| Date: | March 7, 2025 | By: | /s/ MICHAEL S. EXTON | ||||||||
| Michael S. Exton, Ph.D. | |||||||||||
| Chief Executive Officer | |||||||||||
| Date: | March 7, 2025 | By: | /s/ SCOTT M. COIANTE | ||||||||
| Scott M. Coiante | |||||||||||
| Senior Vice President and Chief Financial Officer | |||||||||||
Power of Attorney
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Michael S. Exton, Ph.D. and Scott M. Coiante, or either of them, each with the power of substitution, his or her attorney-in-fact, to sign any amendments to this Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, here ratifying and confirming all that each of said attorneys-in-fact, or his or her substitute or substitutes, may do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
| Signature | Title | Date | |||||||||
| /s/ MICHAEL S. EXTON | Chief Executive Officer and Director (Principal Executive Officer) | March 7, 2025 | |||||||||
| Michael S. Exton, Ph.D. | |||||||||||
| /s/ SCOTT M. COIANTE | Senior Vice President and Chief Financial Officer (Principal Financial Officer) | March 7, 2025 | |||||||||
| Scott M. Coiante | |||||||||||
| /s/ KRISTEN L. ALEXANDER | Vice President, Finance and Accounting (Principal Accounting Officer) | March 7, 2025 | |||||||||
| Kristen L. Alexander | |||||||||||
| /s/ RAYMOND DEBBANE | Chairman of the Board of Directors | March 7, 2025 | |||||||||
| Raymond Debbane | |||||||||||
| /s/ PHILIPPE J. AMOUYAL | Director | March 7, 2025 | |||||||||
| Philippe J. Amouyal | |||||||||||
| /s/ SAMUEL L. BARKER | Director | March 7, 2025 | |||||||||
| Samuel L. Barker, Ph.D. | |||||||||||
| /s/ IVAN H. CHEUNG | Director | March 7, 2025 | |||||||||
| Ivan H. Cheung | |||||||||||
| /s/ CHRISTOPHER J. SOBECKI | Director | March 7, 2025 | |||||||||
| Christopher J. Sobecki | |||||||||||
| /s/ DIANE E. SULLIVAN | Director | March 7, 2025 | |||||||||
| Diane E. Sullivan | |||||||||||
| /s/ JUDITH L. SWAIN | Director | March 7, 2025 | |||||||||
| Judith L. Swain, M.D. | |||||||||||
51
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Stockholders and the Board of Directors of Lexicon Pharmaceuticals, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Lexicon Pharmaceuticals, Inc. (the Company) as of December 31, 2024 and 2023, the related consolidated statements of comprehensive loss, stockholders' equity and cash flows for each of the three years in the period ended December 31, 2024, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2024, in conformity with U.S. generally accepted accounting principles.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
F-1
| Accrued research and development expenses | |||||
| Description of the Matter | As described in Note 2 and Note 5 to the consolidated financial statements, the Company records accruals for estimated costs of research and development activities that include contract services for clinical trials. Clinical trial expenses are accrued based upon milestones and the number of patients enrolled over the duration of the study. The accrual for these third-party clinical trial research and development expenses includes estimates of services completed. Auditing management’s accounting for accrued third-party clinical trial research and development expenses is especially challenging because of the judgment applied by management to determine the estimate of services completed related to the activities under the Company’s research and development agreements. | ||||
| How We Addressed the Matter in Our Audit | Our audit procedures included, among others, testing the accuracy and completeness of the underlying inputs used in management’s analysis to determine costs incurred. We compared recorded expenses to budgeted amounts per executed vendor contracts, actual amounts incurred at the end of each study milestone, and to expenses incurred in prior periods and obtained an understanding of the reasons for significant changes. We inspected the terms and conditions of vendor contracts, change orders and trial budgets, and clerically tested the cost models to track progress against trial budgets. We evaluated estimated services incurred by third parties by understanding the terms and timeline of significant projects, evaluating management’s estimate of work performed and costs incurred by meeting with members of the Company’s clinical operations team, and obtaining external confirmation of key inputs to the clinical trial expense calculation, such as total approved trial budgets and amounts invoiced, and number and timing of patients enrolled in clinical studies. Further, we inspected invoices received from third parties during the year as well as after the balance sheet date and performed a lookback analysis to evaluate the completeness of accrued research and development expenses. | ||||
/s/ Ernst & Young LLP
We have served as the Company’s auditor since 2002.
March 7, 2025
F-2
Lexicon Pharmaceuticals, Inc.
Consolidated Balance Sheets
(In thousands, except par value and share amounts)
| As of December 31, | |||||||||||
| 2024 | 2023 | ||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | $ | |||||||||
| Short-term investments | |||||||||||
| Accounts receivable, net | |||||||||||
| Inventory | |||||||||||
| Prepaid expenses and other current assets | |||||||||||
| Total current assets | |||||||||||
Property and equipment, net of accumulated depreciation and amortization of $ | |||||||||||
| Goodwill | |||||||||||
| Operating lease right-of-use-assets | |||||||||||
| Other assets | |||||||||||
| Total assets | $ | $ | |||||||||
| Liabilities and Stockholders’ Equity | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | $ | |||||||||
| Accrued liabilities | |||||||||||
| Total current liabilities | |||||||||||
| Long-term debt, net | |||||||||||
| Other long-term liabilities | |||||||||||
| Total liabilities | |||||||||||
| Commitments and contingencies (Note 10) | |||||||||||
| Stockholders' Equity: | |||||||||||
Preferred stock, $ | |||||||||||
Series A Convertible preferred stock; | |||||||||||
Common stock, $ | |||||||||||
| Additional paid-in capital | |||||||||||
| Accumulated deficit | ( | ( | |||||||||
| Accumulated other comprehensive income | |||||||||||
Treasury stock, at cost, | ( | ( | |||||||||
| Total stockholders' equity | |||||||||||
| Total liabilities and stockholders’ equity | $ | $ | |||||||||
The accompanying notes are an integral part of these consolidated financial statements.
F-3
Lexicon Pharmaceuticals, Inc.
Consolidated Statements of Comprehensive Loss
(In thousands, except per share amounts)
| Year Ended December 31, | |||||||||||||||||
| 2024 | 2023 | 2022 | |||||||||||||||
| Revenues: | |||||||||||||||||
| Net product revenue | $ | $ | $ | ||||||||||||||
| Licensing revenue | |||||||||||||||||
| Royalties and other revenue | |||||||||||||||||
| Total revenues | |||||||||||||||||
| Operating expenses: | |||||||||||||||||
| Cost of sales | |||||||||||||||||
Research and development, including stock-based compensation of $ | |||||||||||||||||
Selling, general and administrative, including stock-based compensation of $ | |||||||||||||||||
| Total operating expenses | |||||||||||||||||
| Loss from operations | ( | ( | ( | ||||||||||||||
| Interest and other expense | ( | ( | ( | ||||||||||||||
| Interest income and other, net | |||||||||||||||||
| Net loss | $ | ( | $ | ( | $ | ( | |||||||||||
| Net loss per common share, basic and diluted | $ | ( | $ | ( | $ | ( | |||||||||||
| Weighted average common shares outstanding, basic and diluted | |||||||||||||||||
| Other comprehensive loss: | |||||||||||||||||
| Unrealized gain (loss) on investments | ( | ||||||||||||||||
| Comprehensive loss | $ | ( | $ | ( | $ | ( | |||||||||||
The accompanying notes are an integral part of these consolidated financial statements.
F-4
Lexicon Pharmaceuticals, Inc.
Consolidated Statements of Stockholders’ Equity
(In thousands)
| Accumulated | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Additional | Other | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Common Stock | Preferred Stock | Paid-In | Accumulated | Comprehensive | Treasury | ||||||||||||||||||||||||||||||||||||||||||||||||
| Shares | Par Value | Shares | Par Value | Capital | Deficit | Income (Loss) | Stock | Total | |||||||||||||||||||||||||||||||||||||||||||||
| Balance at December 31, 2021 | $ | $ | $ | $ | ( | $ | ( | $ | ( | $ | |||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of common stock under Equity Incentive Plans | — | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||
| Issuance of common stock, net of issuance fees | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of equity-classified warrants | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of treasury stock | — | — | — | — | ( | — | — | ||||||||||||||||||||||||||||||||||||||||||||||
| Repurchase of common stock | — | — | — | — | — | — | — | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||
| Net loss | — | — | — | — | — | ( | — | — | ( | ||||||||||||||||||||||||||||||||||||||||||||
| Unrealized loss on investments | — | — | — | — | — | — | ( | — | ( | ||||||||||||||||||||||||||||||||||||||||||||
| Balance at December 31, 2022 | $ | $ | $ | $ | ( | $ | ( | $ | ( | $ | |||||||||||||||||||||||||||||||||||||||||||
| Issuance of equity-classified warrants | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of common stock, net of fees | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of common stock under Equity Incentive Plans | — | — | ( | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||
| Repurchase of common stock | — | — | — | — | — | — | — | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||
| Net loss | — | — | — | — | — | ( | — | — | ( | ||||||||||||||||||||||||||||||||||||||||||||
| Unrealized gain on investments | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||
| Balance at December 31, 2023 | $ | $ | $ | $ | ( | $ | $ | ( | $ | ||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of preferred stock, net of fees | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of common stock under Equity Incentive Plans | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||
| Repurchase of common stock | — | — | — | — | — | — | — | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||
| Conversion of preferred stock to common stock | ( | ( | ( | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||
| Net loss | — | — | — | — | — | ( | — | — | ( | ||||||||||||||||||||||||||||||||||||||||||||
| Unrealized gain on investments | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||
| Balance at December 31, 2024 | $ | $ | $ | $ | ( | $ | $ | ( | $ | ||||||||||||||||||||||||||||||||||||||||||||
The accompanying notes are an integral part of these consolidated financial statements.
F-5
Lexicon Pharmaceuticals, Inc.
Consolidated Statements of Cash Flows
(In thousands)
| Year Ended December 31, | |||||||||||||||||
| 2024 | 2023 | 2022 | |||||||||||||||
| Cash flows from operating activities: | |||||||||||||||||
| Net loss | $ | ( | $ | ( | $ | ( | |||||||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||||||||
| Depreciation and amortization | |||||||||||||||||
| Stock-based compensation | |||||||||||||||||
| Amortization of debt-related costs | |||||||||||||||||
| Loss on disposal of property and equipment | |||||||||||||||||
| Accretion of marketable securities purchased at a discount | ( | ( | |||||||||||||||
| Other non-cash adjustments | |||||||||||||||||
| Changes in operating assets and liabilities: | |||||||||||||||||
| Increase in accounts receivable | ( | ( | ( | ||||||||||||||
| Decrease (increase) in inventories | ( | ||||||||||||||||
| Decrease (increase) in prepaid expenses and other current assets | ( | ( | |||||||||||||||
| Decrease in other long-term assets | |||||||||||||||||
| Increase in accounts payable and other liabilities | |||||||||||||||||
| Net cash used in operating activities | ( | ( | ( | ||||||||||||||
| Cash flows from investing activities: | |||||||||||||||||
| Purchases of property and equipment | ( | ( | ( | ||||||||||||||
| Purchases of investments | ( | ( | ( | ||||||||||||||
| Maturities of investments | |||||||||||||||||
| Net cash used in investing activities | ( | ( | ( | ||||||||||||||
| Cash flows from financing activities: | |||||||||||||||||
| Proceeds from issuance of common stock, net of fees | |||||||||||||||||
| Proceeds from issuance of common stock for equity incentive plans | |||||||||||||||||
| Proceeds from issuance of preferred stock, net of fees | |||||||||||||||||
| Repurchase of common stock | ( | ( | ( | ||||||||||||||
| Proceeds from debt borrowings, net of fees | |||||||||||||||||
| Other debt financing fees | ( | ||||||||||||||||
| Net cash provided by financing activities | |||||||||||||||||
| Net increase (decrease) in cash and cash equivalents | ( | ( | |||||||||||||||
| Cash and cash equivalents at beginning of year | |||||||||||||||||
| Cash and cash equivalents at end of year | $ | $ | $ | ||||||||||||||
| Supplemental disclosure of cash flow information: | |||||||||||||||||
| Cash paid for interest | $ | $ | $ | ||||||||||||||
| Supplemental disclosure of noncash investing and financing activities: | |||||||||||||||||
| Right-of-use assets obtained in exchange for operating lease liability | $ | $ | $ | ||||||||||||||
| Issuance of equity-classified warrants | $ | $ | $ | ||||||||||||||
| Issuance of treasury stock | $ | $ | $ | ||||||||||||||
| Accrual of deferred financing costs | $ | $ | $ | ||||||||||||||
| Conversion of preferred stock to common stock | $ | $ | $ | ||||||||||||||
The accompanying notes are an integral part of these consolidated financial statements.
F-6
Lexicon Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
1. Organization and Operations
Lexicon Pharmaceuticals, Inc. (“Lexicon” or the “Company”) is a Delaware corporation incorporated on July 7, 1995. Lexicon was organized to discover the functions and pharmaceutical utility of genes and use those gene function discoveries in the discovery and development of pharmaceutical products for the treatment of human disease.
Lexicon has financed its operations from inception primarily through sales of common and preferred stock, contract and milestone payments to it under strategic collaborations and other research and development collaborations, target validation, database subscription and technology license agreements, product sales, government grants and contracts and financing under debt and lease arrangements. The Company’s future success is dependent upon many factors, including, but not limited to, its ongoing research and development efforts and its ability to obtain necessary regulatory approvals of the drug candidates which are the subject of such efforts; its success in establishing new collaborations and licenses and its receipt of milestones, royalties and other payments under such arrangements; the amount and timing of research, development and commercialization expenditures; the resources devoted to developing and supporting its products; general and industry-specific economic conditions which may affect research, development and commercialization expenditures; and its ability to obtain and enforce patents and other proprietary rights in its discoveries, comply with federal and state regulations, and maintain sufficient capital to fund its activities. As a result of the aforementioned factors and the related uncertainties, there can be no assurance of the Company’s future success.
2. Summary of Significant Accounting Policies
Use of Estimates. The preparation of financial statements in conformity with U. S. generally accepted accounting principles (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the period. Actual results could differ from those estimates.
Segment Information. Lexicon operates as one business segment, which primarily focuses on the discovery, development and commercialization of pharmaceutical products for the treatment of human disease. Substantially all of the Company’s revenues have been derived from drug discovery alliances, target validation collaborations for the development and, in some cases, analysis of the physiological effects of genes altered in knockout mice, technology licenses, subscriptions to its databases, product sales, government grants and contracts and compound library sales, as well as from commercial sales of its approved drug products. For additional segment disclosures, see Note 14.
Cash, Cash Equivalents and Short-Term Investments. Lexicon considers all highly-liquid investments with original maturities of three months or less to be cash equivalents. As of December 31, 2024 and 2023, short-term investments consist primarily of U.S. treasury bills as well as certain corporate and other debt securities. The Company’s short-term investments are available for use in current operations regardless of the stated maturity date of the security. These short-term investments are classified as available-for-sale securities as the Company has not historically or does not intend to sell any of its available-for-sale securities prior to their maturity dates.
F-7
Property and Equipment. Property and equipment that is held and used is carried at cost and depreciated using the straight-line method over the estimated useful life of the assets, which ranges from to 40 years. Maintenance, repairs and minor replacements are charged to expense as incurred. Leasehold improvements are amortized over the shorter of the estimated useful life or the remaining lease term. Significant renewals and betterments are capitalized.
Impairment of Long-Lived Assets. Long-lived assets and right-of-use assets for leases are reviewed for impairment when events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Recoverability of assets to be held and used is measured by comparison of the carrying amount of an asset to future net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount that the carrying amount of the assets exceeds the fair value of the assets. Assets to be disposed of are reported at the lower of the carrying amount or fair value less costs to sell. There were no impairments of long-lived assets, in 2024, 2023, or 2022.
Inventory: Inventory is comprised of INPEFA, the Company’s approved product that it is commercializing in the United States. Inventories are determined at the lower of cost or market value, with cost determined under the specific identification method.
Revenue Recognition. The Company performs the following five steps in determining the amount of revenue to recognize as it fulfills its performance obligations under each of its agreements: (a) identify the contract(s) with a customer; (b) identify the performance obligation in the contract; (c) determine the transaction price; (d) allocate the transaction price to the performance obligation in the contract, and (e) recognize revenue when (or as) the Company satisfies the performance obligation. The Company applies this five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. The Company develops assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract.
Product Revenues
F-8
Product revenues consist of U.S. sales of INPEFA, which Lexicon began shipping to its customers in the U.S. in June 2023. These customers primarily include wholesalers and limited retail pharmacies. The Company is continuing to contract with certain managed care programs or pharmacy benefit managers (“PBMs”) and has legislatively mandated contracts with the federal and state governments under which rebates are provided based on product utilization. Product revenues are recognized when control is transferred to the customer upon delivery.
The Company recognizes product revenue net of applicable estimates of reserves for variable consideration using the expected value method. These estimates consider relevant factors such as current contractual and statutory requirements, industry data and forecasted customer buying and payment patterns. Net product revenue includes variable consideration only to the extent that it is probable that a significant reversal in revenue recognized will not occur in a future period. As necessary, these estimates will be adjusted in the period that such variances to actuals become known. Listed below is a further discussion of these reserves and sales return allowances:
Customer Credits. The Company’s customers are offered various forms of consideration, including allowances, service fees and prompt payment discounts. The Company records allowances, deducts the full amount of prompt payment discounts, and deducts service fees from total product sales when revenues are earned and recognized.
Rebates. Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program reflecting amounts owed after final dispensing of the product to participants. The Company’s estimates for rebates is based on statutory discount rates, third party market research data and data from sales to its customers. As rebates are generally invoiced and paid in arrears, the Company accrues an estimate of rebates based on the current quarter’s activity, plus any known unpaid prior quarter rebates.
Chargebacks. Chargebacks are discounts that occur when contracted healthcare providers purchase directly from a wholesaler. Generally, the contracted healthcare providers purchase INPEFA at a discounted price. The wholesaler, in turn, charges back to Lexicon the difference between the price paid by the wholesaler and the discounted price that the wholesaler’s customer pays for that product.
Medicare Part D Coverage Gap. The Medicare Part D prescription drug benefit mandates manufacturers to fund a portion of the Medicare Part D insurance coverage gap for prescription drugs sold to eligible patients. The Company’s estimates for the expected Medicare Part D coverage gap are based on sales data received from a third party and projections based on historical data. As funding of the coverage gap is generally invoiced and paid in arrears, the Company accrues an estimate based on the current quarter’s activity, plus any known unpaid prior quarter estimates.
Co-payment assistance. Patients with commercial insurance who meet certain eligibility requirements are eligible to receive co-payment assistance. The Company accrues a liability for co-payment assistance based on actual program participation and estimates of program redemption using data provided by third-party administrators.
Collaboration and Licensing Agreements
Revenues under collaborative agreements may include both license revenue and contract research revenue. At contract inception, the Company evaluates whether development milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal will not occur, the associated development milestone value is included in the transaction price. Development milestones that are not within the control of the Company or the licensee, including those requiring regulatory approval, are not considered probable of being achieved until those approvals are received. The transaction price is allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue when (or as) the performance obligation is satisfied. At the end of each reporting period, the Company re-evaluates the probability of achievement of the development milestones and any related constraint, and if necessary, adjusts its estimates of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect such revenues in the period of adjustment.
For agreements in which a license to the Company’s intellectual property is determined to be distinct from other performance obligations identified in the agreement, the Company recognizes revenue when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For agreements that include sales-based royalties, including milestones based on a level of sales, the license is deemed to be the predominant item to which the royalties relate and the
F-9
Company recognizes revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). The Company may receive payments from its licensees based on billing schedules established in each contract. Upfront payments and fees are recorded as deferred revenue upon receipt or when due, and may require deferral of revenue recognition to a future period until the Company performs its obligations under these agreements. Amounts are recorded as accounts receivable when revenue has been recognized and the Company’s right to consideration is unconditional.
Stock-Based Compensation. Compensation expense related to stock options and restricted stock units (“RSUs”) is determined based on the fair value of the award on the date of the grant and is recognized on a straight-line basis over the vesting period in which an employee is required to provide service. Forfeitures of share-based payment awards are recognized in the period in which they occur. Compensation expense is recorded in research and development expense and selling, general, and administrative expense as noted on the Company’s consolidated statements of comprehensive loss.
Net Loss per Common Share. Net loss per common share is computed using the weighted average number of shares of common stock outstanding. Shares associated with warrants, stock options and restricted stock units that could potentially dilute earnings per share in the future are not included in the computation of diluted earnings per share when the company has a net loss because they are antidilutive.
Recent Accounting Pronouncements Issued But Not Yet Adopted. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740) – Improvements to Income Tax Disclosures, which is effective prospectively for annual periods beginning after December 15, 2024. Early adoption is permitted. The Company does not expect this accounting pronouncement to have a material impact on the financial statements.
F-10
3. Cash, Cash Equivalents and Investments
The fair value of cash and cash equivalents and investments held at December 31, 2024 and 2023 are as follows:
| As of December 31, 2024 | |||||||||||||||||||||||
| Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | ||||||||||||||||||||
| (in thousands) | |||||||||||||||||||||||
| Cash and cash equivalents | $ | $ | $ | $ | |||||||||||||||||||
| Securities maturing within one year: | |||||||||||||||||||||||
| U.S. treasury securities | |||||||||||||||||||||||
| Corporate debt securities | ( | ||||||||||||||||||||||
| Total short-term investments | $ | $ | $ | ( | $ | ||||||||||||||||||
| Total cash and cash equivalents and short-term investments | $ | $ | $ | ( | $ | ||||||||||||||||||
| As of December 31, 2023 | |||||||||||||||||||||||
| Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | ||||||||||||||||||||
| (in thousands) | |||||||||||||||||||||||
| Cash and cash equivalents | $ | $ | $ | $ | |||||||||||||||||||
| Securities maturing within one year: | |||||||||||||||||||||||
| U.S. treasury securities | ( | ||||||||||||||||||||||
| Corporate debt securities | |||||||||||||||||||||||
| Total short-term investments | $ | $ | $ | ( | $ | ||||||||||||||||||
| Total cash and cash equivalents and short-term investments | $ | $ | $ | ( | $ | ||||||||||||||||||
4. Fair Value Measurements
The Company uses various inputs in determining the fair value of its investments and measures these assets on a recurring basis. Assets and liabilities recorded at fair value in the consolidated balance sheets are categorized by the level of objectivity associated with the inputs used to measure their fair value. The following levels are directly related to the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities:
•Level 1 – quoted prices in active markets for identical assets, which include U.S. treasury securities
•Level 2 – other significant observable inputs (including quoted prices for similar investments, market corroborated inputs, etc.), which include corporate debt securities
•Level 3 – significant unobservable inputs
The inputs or methodology used for valuing securities are not necessarily an indication of the credit risk associated with investing in those securities. The following tables provide the fair value measurements of applicable Company assets that are measured at fair value on a recurring basis according to the fair value levels defined above as of December 31, 2024 and 2023. There were no transfers between Level 1 and Level 2 during the periods presented.
F-11
F-12
| Assets at Fair Value | |||||||||||||||||||||||
| As of December 31, 2024 | |||||||||||||||||||||||
| Level 1 | Level 2 | Level 3 | Total | ||||||||||||||||||||
| (in thousands) | |||||||||||||||||||||||
| Cash and cash equivalents | $ | $ | $ | $ | |||||||||||||||||||
| Short-term investments | |||||||||||||||||||||||
| Total cash and cash equivalents and short-term investments | $ | $ | $ | $ | |||||||||||||||||||
| Assets at Fair Value | |||||||||||||||||||||||
| As of December 31, 2023 | |||||||||||||||||||||||
| Level 1 | Level 2 | Level 3 | Total | ||||||||||||||||||||
| (in thousands) | |||||||||||||||||||||||
| Cash and cash equivalents | $ | $ | $ | $ | |||||||||||||||||||
| Short-term investments | |||||||||||||||||||||||
| Total cash and cash equivalents and short-term investments | $ | $ | $ | $ | |||||||||||||||||||
5. Supplemental Financial Information
The following tables show the Company’s additional balance sheet information as of December 31, 2024 and 2023:
| As of December 31, | ||||||||||||||
| 2024 | 2023 | |||||||||||||
| (in thousands) | ||||||||||||||
| Inventories: | ||||||||||||||
| Raw materials | $ | $ | ||||||||||||
| Work-in-progress | ||||||||||||||
| Finished goods | ||||||||||||||
| Inventory | $ | $ | ||||||||||||
| As of December 31, | ||||||||||||||
| 2024 | 2023 | |||||||||||||
| (in thousands) | ||||||||||||||
| Accrued Liabilities: | ||||||||||||||
| Accrued research and development services | $ | $ | ||||||||||||
| Accrued compensation and benefits | ||||||||||||||
| Other | ||||||||||||||
| Accrued liabilities | $ | $ | ||||||||||||
During the years ended December 31, 2024 and 2022 the Company incurred $1.1 million and $0.3 million, respectively, of severance expense reflected in research and development expenses. During the years ended December 31, 2024
F-13
F-14
6. Property and Equipment
Property and equipment at December 31, 2024 and 2023 are as follows:
| Estimated Useful Lives | As of December 31, | ||||||||||||||||||||||
| In Years | 2024 | 2023 | |||||||||||||||||||||
| (in thousands) | |||||||||||||||||||||||
| Computers and software | $ | $ | |||||||||||||||||||||
| Furniture and fixtures | |||||||||||||||||||||||
| Leasehold improvements | |||||||||||||||||||||||
| Total property and equipment | |||||||||||||||||||||||
| Less: Accumulated depreciation and amortization | ( | ( | |||||||||||||||||||||
| Net property and equipment | $ | $ | |||||||||||||||||||||
7. Collaboration and Licensing Arrangement
On October 16, 2024, Lexicon entered into an exclusive license agreement (the “License Agreement”) with Viatris Inc. (“Viatris”) for the development and commercialization of sotagliflozin in all markets outside of the United States and Europe (the “Licensed Territory”). Under the License Agreement, Lexicon granted Viatris an exclusive, royalty-bearing right and license under its patent rights and know-how to develop and commercialize sotagliflozin in the Licensed Territory. Viatris is responsible for all regulatory and commercialization activities for sotagliflozin in the Licensed Territory as well as conducting any additional clinical trials required to obtain such regulatory approvals. Lexicon and Viatris have agreed to enter into a manufacturing and supply agreement pursuant to which Lexicon will supply the development and commercial requirements of sotagliflozin of Viatris, and Viatris will pay an agreed upon transfer price for such supply.
Under the License Agreement, Lexicon received an upfront payment of $25.0 million and is also eligible to receive (a) up to an aggregate of $12.0 million upon the achievement of specified regulatory milestones, (b) up to an aggregate of $185.0 million upon the achievement of specified sales milestones and (c) tiered royalties ranging from low double-digit to upper-teens percentages of annual net sales of sotagliflozin in the Licensed Territory.
In accordance with ASC 606, Revenue from Contracts with Customers, the Company recognized the upfront cash payment of $25.0 million as licensing revenue for the year ended December 31, 2024 at the outset of the License Agreement, based on the satisfaction of its performance obligation upon delivery of an exclusive right and license under its patent rights and know-how to develop and commercialize sotagliflozin in the Licensed Territory. Any future milestone or royalty payments that the Company would be eligible to receive were excluded from the upfront payment, as all milestone or royalty amounts were fully constrained based on the probability of achievement. Any future milestone payments or royalties the Company is entitled to receive upon achievement of future sales of the licensed products by Viatris will be recognized when the related sales occur.
Pursuant to ASC 606, the Company identified the exclusive right and license under its patent rights and know-how to develop and commercialize sotagliflozin in the Licensed Territory as one distinct performance obligation. The Company further evaluated its stated intent in the Licensing Agreement to enter into a separate manufacturing and supply agreement related to supply of the licensed products to Viatris. The Company concluded for accounting purposes that there was no separate material right or performance obligation related to the separate manufacturing agreement at the inception of the Licensing Agreement primarily given (i) supply agreement pricing subject to reasonable and customary contract manufacturing terms reflecting a reasonable stand-alone selling price without a significant and incremental discount and (ii) no obligation by Viatris to purchase any minimum amount or quantities of the supply from the Company.
8. Income Taxes
Effective Tax Rate Reconciliation. A reconciliation of the statutory tax rate to the effective tax rate for the years ended December 31, 2024, 2023 and 2022 consists of the following:
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| Year Ended December 31, | |||||||||||||||||
| 2024 | 2023 | 2022 | |||||||||||||||
| (in thousands) | |||||||||||||||||
Expected income tax expense (benefit) at 21% | $ | ( | $ | ( | $ | ( | |||||||||||
| State income taxes, net of federal benefit | ( | ||||||||||||||||
| Equity compensation | |||||||||||||||||
| Research and development credit | ( | ( | |||||||||||||||
| State income taxes, tax rate change | ( | ||||||||||||||||
| Write off of NOL carryovers due to expiration | |||||||||||||||||
| Change in valuation allowance | |||||||||||||||||
Other (1) | |||||||||||||||||
| Income tax benefit | $ | $ | $ | ||||||||||||||
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Deferred Tax Assets and Liabilities. Lexicon recognizes deferred tax liabilities and assets for the expected future tax consequences of events that have been recognized differently in the financial statements and tax returns. The components of Lexicon’s deferred tax assets (liabilities) at December 31, 2024 and 2023 are as follows:
| As of December 31, | |||||||||||
| 2024 | 2023 | ||||||||||
| (in thousands) | |||||||||||
| Deferred tax assets: | |||||||||||
| Net operating loss carryforwards | $ | $ | |||||||||
| Research and development tax credits | |||||||||||
| Orphan drug credits | |||||||||||
| Capitalized research and development | |||||||||||
| Stock-based compensation | |||||||||||
| Interest | |||||||||||
| Other | |||||||||||
| Total deferred tax assets | |||||||||||
| Deferred tax liabilities: | |||||||||||
| Other | ( | ( | |||||||||
| Total deferred tax liabilities | ( | ( | |||||||||
| Less: valuation allowance | ( | ( | |||||||||
| Net deferred tax liabilities | $ | $ | |||||||||
Net Operating Losses/Valuation Allowance. At December 31, 2024, Lexicon had both federal and state NOL carryforwards of approximately $1.4 billion and $158.6 million, respectively. The Company had $778.9 million of U.S. federal NOL carryforwards as of December 31, 2024, which can be carried forward indefinitely. The remaining federal and state NOL carryforwards will begin to expire in 2025.
The Company maintains a valuation allowance on net operating losses and other deferred tax assets. Accordingly, the Company has not reported any tax benefit relating to the remaining net operating loss carryforwards and income tax credit carryforwards that are available for utilization in future periods. On a periodic basis, the valuation allowance is reassessed on deferred income tax assets, weighing positive and negative evidence to assess the recoverability of the deferred tax assets. In 2024, the Company reassessed the valuation allowance and considered negative evidence, including the cumulative losses over the three years ended December 31, 2024 and positive evidence including the projections of future income. After assessing both the negative and the positive evidence, the Company concluded that it should continue to maintain the valuation allowance on net operating losses and other deferred tax assets as of December 31, 2024 given the significance of the weight of the negative evidence. Based on recent financial performance and future projections, the Company could record a reversal of all, or a portion of the valuation allowance associated with U.S. deferred tax assets in future periods. However, any such change is subject to actual performance and other considerations that may present positive or negative evidence at the time of the assessment. Significant judgment is required in making these assessments to maintain or reverse valuation allowances and, to the extent future expectations change the Company would have to assess the recoverability of these deferred tax assets at that time.
Based on the federal tax law limits and the Company’s cumulative loss position, the Company concluded it was appropriate to establish a full valuation allowance for its net deferred tax assets until an appropriate level of profitability is sustained. During the year ended December 31, 2024, the valuation allowance increased $30.8 million, primarily due to NOLs generated, increases in deferred tax assets associated with capitalized research and development expense and deferred tax assets for state jurisdictions.
Other. As of December 31, 2024 and 2023, the Company did no no
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9. Debt Obligations
Oxford Term Loans Overview. In March 2022, Lexicon and one of its subsidiaries entered into a loan and security agreement with Oxford Finance LLC (“Oxford”) (as subsequently amended) that provides up to $150 million in borrowing capacity (the “Oxford Term Loans”).
The Oxford Term Loans are available in five tranches, each maturing in March 2029. The first two $25 50 million were funded in 2022 and the third $50 million tranche was funded in June 2023. The fourth $25 million tranche will be available for draw at Lexicon’s option upon the achievement of specified INPEFA net sales and until April 15, 2025. An unused fee will be due in the event Lexicon does not draw the full amount if made available under the fourth tranche. The fifth $25 million tranche is available for draw at Lexicon’s option, subject to Oxford’s consent, at any time prior to the expiration of the 60-month interest-only payment period with an amortization date of May 1, 2027 as described below.
As of December 31, 2024, the carrying value of the Oxford Term Loans on the consolidated balance sheet was $100.3 million, reflecting an unamortized discount of $6.7 million to the face value of long-term debt related to original debt issuance costs and other financing fees (including $1.3 million paid in 2024), the final payment exit fee described below, and the warrant fair value described below. These costs are being amortized into interest and other expense. A final payment exit fee of $7 million equal to 7 % of the amount funded under the Oxford Term Loans is due upon prepayment or maturity and is recorded as a debt discount on the consolidated balance sheet as of December 31, 2024.
Oxford Warrants. Concurrent with the funding of the first three tranches, Lexicon granted Oxford warrants to purchase 420,673 shares of Lexicon’s common stock at an exercise price of $2.08 per share, 224,128 shares of Lexicon’s common stock at an exercise price of $1.95 per share and 183,824 shares of Lexicon’s common stock at an exercise price of $2.38 per share, respectively. Subject to and upon funding of the fourth tranche, Lexicon will grant Oxford a warrant to purchase shares of its common stock having a value equal to 1.75 % of such tranche, as determined by reference to a 10 -day average closing price of the shares, and having an exercise price equal to such average closing price. All warrants are exercisable for five years from their respective grant dates and feature a net cashless exercise provision. The Company allocated the proceeds from each term loan tranche to the corresponding warrant using the relative fair value method and used the Black-Scholes model to calculate the fair value of the warrants. These warrants reduced the carrying value of long-term debt and are classified as equity instruments in additional paid-in capital on the condensed consolidated balance sheet.
Interest and Principal Payments. Monthly interest-only payments are due during an initial 60 -month period from the original March 2022 borrowing date. The interest-only period will be followed by an amortization period extending through the maturity date with monthly principal payments beginning May 1, 2027. Payments of $34.8 million, $52.2 million, and $20.0 million, including debt principal and final exit fee payments, will be due during the fiscal years ended December 31, 2027, December 31, 2028 and December 31, 2029, respectively, with respect to all borrowed loan tranches as of December 31, 2024. Any prepayment of the Oxford Term Loans is subject to prepayment fees of up to 3 % which decline over the three years following the funding date of each loan tranche.
Following the June 2023 amendment to the Loan Agreement, the floating interest rate is currently based on the sum of (a) the 1-month CME Term Secured Overnight Financing Rate (SOFR), (b) 0.10 %, and (c) 7.90 7.00 7.90 %, but not less than 8.01 %, subject to additional interest if an event of default occurs and is continuing. During the year ended December 31, 2024, 2023 and 2022, the Company recognized interest expense of $14.8 million, $11.6 million and $2.8 million, respectively, including $1.8 million, $1.5 million and $0.6 million in amortization of discount and related debt issuance costs, respectively. As of December 31, 2024, the weighted average interest rate of the Oxford Term Loans was 12.10 %.
Restrictive Provisions/Covenants. If an event of default occurs and is continuing, Oxford may declare all amounts outstanding under the loan and security agreement to be immediately due and payable. Additionally, Lexicon may prepay the Oxford Term Loans in whole at its option at any time.
Lexicon’s obligations under the Oxford Term Loans are secured by a first lien security interest in all of the assets of the Company and its subsidiaries. The loan and security agreement contains certain customary representations and warranties, affirmative and negative covenants and events of default applicable to Lexicon and its subsidiaries. The Loan Agreement includes a financial covenant which requires Lexicon to maintain a minimum unrestricted cash and investments balance of 50 % of the outstanding principal amount through June 30, 2026, tested monthly as of the last day of each month. In addition, Lexicon is separately required to maintain a quarterly minimum unrestricted cash and investments balance of $10 million until
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10. Commitments and Contingencies
Operating Lease Obligations. Lexicon’s operating leases include leases of office space in The Woodlands, Texas and Bridgewater, New Jersey that will expire in August 2025 and January 2034, respectively. The Texas lease provides for escalating yearly base rent payments which are $557,000 for 2025, the final year of the lease. The New Jersey lease provides for escalating yearly base rent payments which started at $820,000 and increase to $986,000 in the final year of the lease. In July 2024, Lexicon entered into a new lease agreement for the existing office space in The Woodlands, Texas. The term of the lease begins September 2025, extends through January 2031 and provides for escalating yearly base rent payments starting at $774,000 and increasing to $875,000 in the final year of the lease and total undiscounted cash payments of $4.1 million. Under its lease agreements, Lexicon is obligated to pay property taxes, insurance, and maintenance costs.
As of December 31, 2024 and 2023, the right-of-use assets for the office space leases of $4.8 million and $5.5 million, respectively, are separately included in operating lease right-of-use-assets in the consolidated balance sheet. Current liabilities relating to the leases are included in accrued liabilities in the consolidated balance sheet (as further described in Note 5) and long-term liabilities of $4.6 million and $5.3 million, respectively, as of December 31, 2024 and 2023, are included in other long-term liabilities in the consolidated balance sheet.
During the years ended December 31, 2024 and 2023, the Company incurred lease expense of $1.6 1.4 million and $0.8 million, respectively. As of December 31, 2024 and 2023, the weighted-average remaining lease terms were 8.6 years and 9 years, respectively, with weighted-average discount rates of 9.7 % and 9.6 %, respectively.
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The following table reconciles the undiscounted cash flows of the operating lease liability to the recorded lease liability at December 31, 2024:
| (in thousands) | |||||
| 2025 | $ | ||||
| 2026 | |||||
| 2027 | |||||
| 2028 | |||||
| 2029 | |||||
| Thereafter | |||||
| Total undiscounted operating lease liability | $ | ||||
| Less: amount of lease payments representing interest | ( | ||||
| Present value of future lease payments | |||||
| Less: short-term operating lease liability | ( | ||||
| $ | |||||
Employment Arrangements. Lexicon has entered into employment arrangements with certain of its corporate officers. Under the arrangements, each officer receives a base salary, subject to adjustment, with an annual discretionary bonus based upon specific objectives to be determined by the compensation committee. The employment arrangements are at-will and some contain non-competition agreements. Some of the arrangements also provide for certain severance payments for either six or 12 months and, in some cases, payment of a specified portion of the officer’s bonus target for such year, in the event of a specified termination of the officer’s employment.
11. Equity Incentive Awards
The Company has stockholder-approved equity incentive plans further described below that permit the grant of stock options, restricted stock unit awards, and other stock-based awards to employees, directors, and consultants of the Company.
2017 Equity Incentive Plan. The Company’s 2017 Equity Incentive Plan permits the grant of incentive stock options to employees and nonstatutory stock options to employees, directors and consultants of the Company. The plan also permits the grant of stock bonus awards, restricted stock awards, restricted stock unit awards, stock appreciation rights and performance stock awards. Incentive and nonstatutory stock options have an exercise price of 100 % or more of the fair market value of the Company’s common stock on the date of grant. Most stock options granted under the 2017 Equity Incentive Plan become vested and exercisable over a period of four years . Stock options granted under the Equity Incentive Plan have a term of 10 years from the date of grant. Vesting of restricted stock units issued under this plan generally vest in three annual installments.
2017 Non-Employee Directors’ Equity Incentive Plan (the “Directors’ Plan”). Under the Company’s Directors’ Plan, non-employee directors may be granted awards under the plan with an aggregate grant date fair value of no more than $500,000 during any calendar year, taken together with any cash fees paid to such non-employee director in compensation for service on Lexicon’s board of directors during such calendar year. Stock options granted under the Directors’ Plan have an exercise price equal to the fair market value of the Company’s common stock on the date of grant and a term of 10 years from the date of grant. Vesting of restricted stock units granted under this plan occurs on the first anniversary of the grant date.
The total number of shares of common stock that may be issued pursuant to stock awards under the Equity Incentive Plan and the Directors’ Plan shall not exceed in the aggregate 55,000,000 and 2,000,000 shares at December 31, 2024, respectively. Under the combined plans, as of December 31, 2024, an aggregate of 21,688,672 shares of common stock were reserved for issuance upon exercise of outstanding stock options and vesting of outstanding restricted stock units and 24,057,667 additional shares were available for future grants. The Company has a policy of using either authorized and unissued shares or treasury shares, including shares acquired by purchase in the open market or in private transactions, to satisfy equity award exercises. As of December 31, 2024, options to purchase 15,388,915 shares and 6,299,757 restricted stock
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units were outstanding, 2,336,349 shares had been issued upon the exercise of stock options, 8,700,164 shares had been issued pursuant to restricted stock units and 217,148 shares had been issued pursuant to stock bonus awards or restricted stock awards granted under the aggregate of both plans.
For the years ended December 2024, 2023, and 2022 stock-based compensation costs was $13.5 million, $14.3 million, and $11.5 million, respectively. As of December 31, 2024, future stock-based compensation cost for all outstanding unvested stock options and restricted stock units was $18.3 million, which is expected to be recognized over a weighted-average period of 1.2 years.
Stock Options. The following is a summary of stock option activity under Lexicon’s equity incentive plans for the year ended December 31, 2024:
| As of December 31, 2024 | ||||||||||||||
| (in thousands, except exercise price data) | Options | Weighted Average Exercise Price | ||||||||||||
| Outstanding at beginning of year | $ | |||||||||||||
| Granted | ||||||||||||||
| Exercised | ( | |||||||||||||
| Expired | ( | |||||||||||||
| Forfeited | ( | |||||||||||||
| Outstanding at end of year | ||||||||||||||
| Exercisable at end of year | $ | |||||||||||||
The weighted average estimated grant date fair value of stock options granted during the years ended December 31, 2024, 2023 and 2022 was $1.54 , $1.78 and $2.30 , respectively. The weighted average remaining contractual term of stock options outstanding and exercisable was 7.5 and 6.0 years, respectively, as of December 31, 2024. At December 31, 2024, there was no
The fair value of stock options is estimated at the date of grant using the Black-Scholes method requiring the input of subjective assumptions. For purposes of determining the fair value of stock options, the Company segregates its options into two homogeneous groups, based on exercise and post-vesting employment termination behaviors, resulting in different assumptions used for expected option lives. Historical data is used to estimate the expected option life for each group. Expected volatility is based on the historical volatility in the Company’s stock price. The following weighted-average assumptions were used for stock options granted in the years ended December 31, 2024, 2023 and 2022, respectively:
| Expected Volatility | Risk-free Interest Rate | Expected Term | Dividend Rate | ||||||||||||||||||||
| December 31, 2024: | |||||||||||||||||||||||
| Employees | % | ||||||||||||||||||||||
| Officers and non-employee directors | % | ||||||||||||||||||||||
| December 31, 2023: | |||||||||||||||||||||||
| Employees | % | ||||||||||||||||||||||
| Officers and non-employee directors | % | ||||||||||||||||||||||
| December 31, 2022: | |||||||||||||||||||||||
| Employees | % | ||||||||||||||||||||||
| Officers and non-employee directors | % | ||||||||||||||||||||||
Restricted Stock Units. During the years ended December 31, 2024, 2023 and 2022, Lexicon granted its employees restricted stock units in lieu of or in addition to annual stock option awards. The total fair value of shares vested in 2024, 2023 and 2022 was $5.1 million, $2.9 million and $2.9 million, respectively.
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During the years ended December 31, 2024, 2023 and 2022, Lexicon granted its non-employee directors 257,670 , 64,256 and 74,416 restricted stock units, respectively. The restricted stock granted in 2024, 2023 and 2022 had weighted average grant date fair values of $1.79 , $2.36 and $1.77 per share, respectively.
The following is a summary of restricted stock units activity under Lexicon’s stock-based compensation plans for the year ended December 31, 2024:
| Shares | Weighted Average Grant Date Fair Value | |||||||||||||
| (in thousands) | ||||||||||||||
| Outstanding at December 31, 2023 | $ | |||||||||||||
| Granted | ||||||||||||||
| Vested | ( | |||||||||||||
| Forfeited | ( | |||||||||||||
| Outstanding at December 31, 2024 | $ | |||||||||||||
During the year ended December 31, 2022, the Company issued $6.3 million of Treasury shares in lieu of issuing additional authorized common shares in order to satisfy the annual vesting of restricted stock units for its employees and officers.
12. Benefit Plan
13. Other Capital Agreements
Convertible Preferred Stock. On March 11, 2024, Lexicon entered into an agreement with certain accredited investors pursuant to which the Company agreed to sell 2,304,147 shares of its Series A Convertible Preferred Stock, par value $0.01 per share, in a private placement at a price of $108.50 per share. The Company received net proceeds of $241.3 million, after deducting placement agent fees and offering expenses from the private placement offering. An affiliate of Invus, L.P. elected to participate on the same terms as each other purchaser on a pro rata basis and also agreed to vote at the Company’s 2024 annual meeting of stockholders in favor of the approval of an amendment to the Company’s certificate of incorporation increasing the total authorized common shares thereunder from 300,000,000 to 450,000,000 shares (the “New Charter”).
On May 10, 2024, following the approval of the New Charter by the Company’s shareholders, the adoption of the New Charter by the Company’s board of directors, and the filing and acceptance of the New Charter by the Secretary of State of Delaware, each share of preferred stock was converted into 50 shares of common stock at par value, or 115,207,350 shares in the aggregate.
Common Stock. In June 2023, Lexicon sold an aggregate of 55,288,460 shares of its common stock at a price of $2.60 per share in a public offering and concurrent private placement to an affiliate of Invus, L.P., resulting in net proceeds of approximately $139 million, after deducting underwriting discounts and commissions and offering expenses.
In August 2022, Lexicon sold an aggregate of 39,100,000 shares of its common stock at a price of $2.50 per share in a public offering and concurrent private placement to two affiliates of Invus, L.P., resulting in net proceeds of $94.2 million, after deducting underwriting discounts and commissions and offering expenses.
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14. Segment Information
Lexicon operates as a single reportable segment, primarily focusing on the discovery, development and commercialization of pharmaceutical products for the treatment of human disease. Substantially all of the Company’s revenues have been derived from drug discovery alliances, target validation collaborations for the development and, in some cases, analysis of the physiological effects of genes altered in knockout mice, technology licenses, subscriptions to its databases, product sales, government grants and contracts and compound library sales, as well as from commercial sales of its approved drug product.
The chief operating decision maker (“CODM”) is the Company’s chief executive officer (“CEO”). The CEO manages and allocates resources on a total company basis by assessing the overall level of resources available and how to best deploy these resources across research and development projects in line with the Company’s long-term company-wide strategic goals.
The CEO evaluates single-segment consolidated financial information against budget for purposes of making operating decisions, planning and forecasting for future periods, and deciding the level of investment in the Company’s various operating activities and other capital allocation activities. The CODM assesses financial performance based on consolidated net income (loss) (as reported on the consolidated statement of comprehensive loss). The CEO also uses consolidated cash and cash equivalents and short-term investments (which can be found on our Consolidated Balance Sheets) as a measure of segment assets for allocating resources.
Summary of segment net loss, including segment expenses were as follows:
| Years Ended December 31, | ||||||||||||||||||||
| 2024 | 2023 | 2022 | ||||||||||||||||||
| (in thousands) | ||||||||||||||||||||
| Revenues: | ||||||||||||||||||||
| Net product revenue | $ | $ | $ | |||||||||||||||||
| Licensing revenue | ||||||||||||||||||||
| Royalties and other revenue | ||||||||||||||||||||
| Total revenues | ||||||||||||||||||||
| Operating expenses: | ||||||||||||||||||||
| Cost of sales | ||||||||||||||||||||
| Research and development | ||||||||||||||||||||
| Sales and marketing | ||||||||||||||||||||
| General and administrative | ||||||||||||||||||||
Other segment expense (1) (2) | ||||||||||||||||||||
| Total operating expenses | ||||||||||||||||||||
| Loss from operations | ( | ( | ( | |||||||||||||||||
| Interest and other expense | ( | ( | ( | |||||||||||||||||
| Interest income and other, net | ||||||||||||||||||||
| Net loss | $ | ( | $ | ( | $ | ( | ||||||||||||||
(1) For the years ended December 31, 2024, 2023 and 2022, other segment expense includes stock compensation of $5.8 million, $5.1 million and $4.3 million related to research and development personnel, respectively; $2.0 million, $2.3 million and $0.5 million related to sales and marketing personnel, respectively; and $5.7 million, $6.9 million and $6.8 million related to general and administrative personnel.
Significant Customers. In support of the commercial launch of INPEFA in 2023, the Company entered into distribution agreements with wholesalers and limited retail pharmacies. The Company’s net product sales are generated from sales to these customers. In 2024 and 2023, twelve United States-based customers accounted for all of the Company’s net product revenue and one customer accounted for royalties and other revenues. Three large wholesalers accounted for greater than 10% of total net product revenues and in the aggregate accounted for greater than 85 2.3 million, $1.4 million and $1.4 million in 2024 and $0.4 million, $0.3
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million and $0.3 million in 2023. In 2022 the Company’s revenues were solely derived from royalties and other revenues from one customer. For further information regarding the Company’s licensing revenue agreement, see Note 7.
Exhibit 10.1 [**] Certain information has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. LEXICON PHARMACEUTICALS, INC. MANAGEMENT SEVERANCE PLAN ARTICLE I PURPOSE This Lexicon Pharmaceuticals, Inc. Management Severance Plan has been established by the Company on March 4, 2025 (the “Effective Date”) to provide Participants with the opportunity to receive severance protection. The purpose of the Plan is to attract and retain talent and to assure the present and future continuity, objectivity, and dedication of management in the event of any Change in Control to maximize the value of the Company on a Change in Control. The Plan is intended to be a top hat welfare benefit plan under ERISA. Capitalized terms used but not otherwise defined herein have the meanings set forth in Article 2. ARTICLE II DEFINITIONS Section 2.1 “Administrator” means the Compensation Committee of the Board or any other person or committee appointed by the Board to administer the Plan. Section 2.2 “Affiliate” means any person that directly or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with, the Company and any predecessors to such entity; provided, however, that a natural person shall not be considered an Affiliate. Section 2.3 “Board” means the Board of Directors of the Company. Section 2.4 “Cause” means a termination of Participant’s employment directly resulting from (a) Participant having engaged in intentional misconduct causing a material violation by the Company of any state or federal laws, (b) Participant having engaged in a theft of Company funds or Company assets or in a material act of fraud upon the Company, (c) an act of personal dishonesty taken by Participant that was intended to result in personal enrichment of Participant at the expense of the Company, (d) Participant’s final conviction (or the entry of any plea other than not guilty) in a court of competent jurisdiction of a felony, or (e) a breach by Participant of any contractual or fiduciary obligation to the Company, if such breach results in a material injury to the Company. Section 2.5 “Change in Control” shall be deemed to have occurred if any of the following shall have taken place: (a) any “person” (as such term is used in Sections 13(d) and 14(d)(2) of the Securities Exchange Act of 1934 (the “Exchange Act”)) other than Invus, L.P. and its affiliates (collectively, “Invus”) is or becomes the “beneficial owner” (as defined in Rule 13d-3 under the Exchange Act, or any successor provisions thereto), directly or indirectly, of securities of the Company representing 35% or more of the combined voting power of the 2 Company’s then-outstanding voting securities; (b) the consummation of a reorganization, merger, or consolidation, in each case with respect to which persons who were stockholders of the Company immediately prior to such reorganization, merger or consolidation do not, immediately thereafter, own or control more than 50% of the combined voting power of the reorganized, merged or consolidated Company’s then-outstanding securities entitled to vote generally in the election of directors in substantially the same proportions as their ownership of the Company’s outstanding voting securities prior to such reorganization, merger or consolidation; (c) a liquidation or dissolution of the Company or the sale of all or substantially all of the Company’s assets; or (d) following the election or removal of directors, a majority of the Board consists of individuals who were not members of the Board two years before such election or removal. The Administrator, in its discretion, may deem any other corporate event affecting the Company to be a “Change in Control” hereunder. Notwithstanding the Change in Control definition above, in the event that any payment or benefit payable pursuant to this Plan provides for a deferral of compensation under Section 409A, to the extent the impact of a Change in Control on such payments or benefits would subject a Participant to additional taxes under Section 409A, a Change in Control described above shall mean both a Change in Control and a “change in the ownership of a corporation,” “change in the effective control of a corporation,” or a “change in the ownership of a substantial portion of a corporation’s assets” within the meaning of Section 409A. Section 2.6 “Change in Control Severance” has the meaning set forth in Section 4.02(a). Section 2.7 “CIC Severance Multiplier” shall be the number assigned to each Eligible Person on Appendix A attached hereto in order to calculate his or her Change in Control Severance. Section 2.8 “CIC Severance Benefits Period” shall mean the number of months assigned to each Eligible Employee on Appendix A attached herein in order to calculate his or her CIC COBRA Benefit. Section 2.9 “COBRA” means the Consolidated Omnibus Budget Reconciliation Act of 1985. Section 2.10 “Code” means the Internal Revenue Code of 1986, as amended. Any reference to a section of the Code shall be deemed to include a reference to any regulations promulgated thereunder. Section 2.11 “Covered Period” means the period of time beginning upon the occurrence of a Change in Control and lasting through the twenty-four (24) month anniversary of the occurrence of the Change in Control. Section 2.12 “Effective Date” has the meaning set forth in Article 1. Section 2.13 “Eligible Employee” means, subject to Section 8.02 of this Plan, any member of the management team that the Board has appointed as an officer of the Company as of the Effective Date or thereafter; provided however, that each Eligible Employee shall be limited 3 to a select group of management or highly compensated employees within the meaning of Sections 201, 301 and 401 of ERISA. Section 2.14 “ERISA” means the Employee Retirement Income Security Act of 1974, as amended. Section 2.15 “Good Reason” means the occurrence of any of the following events without the Participant’s express written consent: (a) a material diminution in Participant’s base salary, (b) a material diminution in the Participant’s authority, duties, or responsibilities, or (c) any other action or inaction that constitutes a material breach by the Company of any contractual obligation to the Participant. The Company and the Participant agree that Good Reason does not exist unless and until the Participant provides the Company with written notice of the acts alleged to constitute Good Reason within ninety (90) days of the Participant’s knowledge of the occurrence of such event, and the Company fails to cure such acts within thirty (30) days of receipt of such notice. Participant must terminate employment within sixty (60) days following the expiration of such cure period for the termination to be on account of Good Reason. Section 2.16 “LTIP” means the Company’s 2017 Equity Incentive Plan, as amended, or any successor or replacement plan. Section 2.17 “Participant” has the meaning set forth in Section 3.01. Section 2.18 “Participation Agreement” means a participation agreement delivered by the Company to a Participant containing any terms and conditions that may be applicable to the Eligible Employee in addition to or contrary to the terms of this Plan. In the event that an Eligible Employee does not receive a Participation Agreement, that individual will have his or her rights to Severance Benefits governed solely by the provisions of this Plan. Section 2.19 “Plan” means this Lexicon Pharmaceuticals, Inc. Management Severance Plan, as may be amended and/or restated from time to time. Section 2.20 “Qualifying Termination” means the termination of a Participant’s employment either: (a) by the Company without Cause; or (b) by the Participant for Good Reason. For purposes of clarity, a termination due to death or disability shall not be deemed to be a Qualifying Termination pursuant to this Plan. Section 2.21 “Release” has the meaning set forth in Section 5.01(b). Section 2.22 “Release Expiration Date” means that date that is twenty-one (21) days following the date upon which the Company delivers the Release to the Employee (which shall occur no later than seven (7) days after the Participant’s Termination Date) or, in the event that such termination of employment is “in connection with an exit incentive or other employment 4 termination program” (as such phrase is defined in the Age Discrimination in Employment Act of 1967), the date that is forty-five (45) days following such delivery date. Section 2.23 “Section 409A” means Section 409A of the Code, and all regulations promulgated thereunder. Section 2.24 “Severance” has the meaning set forth in Section 4.01(a). Section 2.25 “Severance Benefits” shall mean, as the context requires, the amounts to be paid pursuant to Article 4. Section 2.26 “Severance Benefits Period” shall mean the number of months assigned to each Eligible Employee on Appendix A attached herein in order to calculate his or her COBRA Benefit. Section 2.27 “Severance Multiplier” shall be the number assigned to each Eligible Person on Appendix A attached hereto in order to calculate his or her Severance. Section 2.28 “Specified Employee Payment Date” has the meaning set forth in Section 8.13(b). ARTICLE III PARTICIPATION Participants. The Administrator shall designate and provide written notice to each Eligible Employee chosen by the Administrator to participate in the Plan (each, a “Participant”). Updates to Appendix A shall not require an amendment of the Plan and the Administrator has the ability to amend or modify Appendix A at any time without Participant consent. ARTICLE IV SEVERANCE BENEFITS Section 4.01 Severance Outside of Covered Period. If a Participant has a Qualifying Termination outside of a Covered Period, then, subject to Article 5, the Company will provide the Participant with the following: (a) A cash severance payment calculated by multiplying the Participant’s Severance Multiplier by the aggregate amount of the Participant’s base salary for the year in which the applicable termination occurs (the “Severance”). The Severance will be paid in a lump sum within sixty (60) days following the date of such Qualifying Termination. (b) In the event that the Qualifying Termination occurs between September 1 and December 31 of any calendar year, a lump-sum cash payment equal to the pro-rated amount of the Participant’s target cash bonus award set for the year in which the applicable Qualifying Termination occurs, pro-rated on a daily basis for the applicable calendar year, and paid in a lump sum within sixty (60) days following the date of such Qualifying Termination.
5 (c) If the Participant elects to continue coverage for the Participant and the Participant’s spouse and eligible dependents, if any, under the Company’s group health plans pursuant to COBRA, then the Company shall provide the Participant with a lump- sum cash payment equal to the difference between the amount Employee is estimated to pay to effect and continue such coverage and the employee contribution amount that similarly situated employees of the Company pay for the same or similar coverage under such group health plans for a period equal to the months within the Participant’s Severance Benefits Period (the “COBRA Benefit”). (i) The COBRA Benefit shall be paid to the Participant in a lump sum within sixty (60) days following the date of the applicable Qualifying Termination event. (ii) Notwithstanding the foregoing, if the Company’s provision of the COBRA Benefit under this Section 4.01(c) would violate the nondiscrimination rules applicable to non-grandfathered plans, or would result in the imposition of penalties under the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, and the related regulations and guidance promulgated thereunder (the “ACA”), the Company shall reform this Section 4.01(c) in a manner as is necessary to comply with the ACA. (d) Payment or reimbursement, as applicable, of (i) earned but unpaid base salary as of the date of the applicable termination; (ii) all incurred but unreimbursed expenses for which the Participant is entitled to reimbursement; and (iii) benefits to which Employee is entitled under the terms of any applicable Company benefit plan or program (collectively, the “Accrued Benefits”). Any amounts due to the Participant pursuant to clause (i) of this paragraph shall be paid in a lump sum within sixty (60) days following the applicable termination date; amounts due pursuant to clauses (ii) or (iii) will be paid in accordance with the terms of the applicable plan, policy, or arrangement to which they relate. Section 4.02 Change in Control Severance. If a Participant has a Qualifying Termination during the Covered Period, then, subject to Article 5, the Company will provide the Participant with the following: (a) A cash severance payment calculated by multiplying the Participant’s CIC Severance Multiplier by the aggregate amount of the Participant’s base salary for the year in which the applicable termination occurs (the “Change in Control Severance”). The Change in Control Severance will be paid in a lump sum within sixty (60) days following the date of such Qualifying Termination. (b) A lump-sum cash payment equal to the amount of the Participant’s target cash bonus award set for the year in which the applicable Qualifying Termination occurs, paid in a lump sum within sixty (60) days following the date of such Qualifying Termination. (c) If the Participant elects to continue coverage for the Participant and the Participant’s spouse and eligible dependents, if any, under the Company’s group health 6 plans pursuant to COBRA, then the Company shall provide the Participant with a lump- sum cash payment equal to the difference between the amount Employee is estimated to pay to effect and continue such coverage and the employee contribution amount that similarly situated employees of the Company pay for the same or similar coverage under such group health plans for a period equal to the months within the Participant’s CIC Severance Benefits Period (the “CIC COBRA Benefit”). (i) The CIC COBRA Benefit shall be paid to the Participant in a lump sum within sixty (60) days following the date of such Qualifying Termination. (ii) Notwithstanding the foregoing, if the Company’s provision of the COBRA Benefit under this Section 4.02(c) would violate the nondiscrimination rules applicable to non-grandfathered plans, or would result in the imposition of penalties under the ACA, the Company shall reform this Section 4.02(c) in a manner as is necessary to comply with the ACA. (d) The Accrued Benefits, paid under the terms and conditions set forth in Section 4.01(d) above. Section 4.03 LTIP Awards. Upon a termination of a Participant’s employment for any reason, whether or not during a Covered Period, all outstanding LTIP awards that the Participant holds at the time of the applicable termination of employment shall be governed by the terms and conditions of the LTIP and the Participant’s individual LTIP award agreements. ARTICLE V CONDITIONS Section 5.01 Required Conditions. A Participant’s entitlement to any Severance Benefits under this Plan, or the right to continue receiving such Severance Benefits, will be subject to: (a) the Participant executing on or before the Release Expiration Date and not revoking within any time provided by the Company to do so, a release of all claims in a form acceptable to the Company (the “Release”), which Release shall release the Company’s respective shareholders, members, partners, officers, managers, directors, fiduciaries, employees, representatives, agents, and benefit plans (and fiduciaries of such plans) from any and all claims, including any and all causes of action arising out of the Participant’s employment with the Company or the termination of such employment, but excluding all claims to Severance Benefits the Participant may have under Article 4; provided, however, that if the Release is not executed and returned to the Company on or before the Release Expiration Date, and the required revocation period has not fully expired without revocation of the Release by the Participant, then the Participant shall not be entitled to any portion of the Severance Benefits under Article 4; 7 (b) if applicable, the Participant must be in compliance with, and remain in compliance with, any Employee Proprietary Information Agreement that exists between the Participant and the Company; and (c) with respect to the COBRA Benefit only, the Participant timely and properly electing continuation coverage under COBRA. Section 5.02 Contingent Conditions. A Participant’s entitlement to any Severance Benefits under this Plan, or the right to continue receiving such Severance Benefits, may be subject to additional conditions to those set forth in Section 5.01 above, as determined at the sole discretion of the Company and communicated to each individual Participant, as applicable, including: (a) the Participant executing and delivering to the Company his or her Participation Agreement in accordance with the terms thereof; or (b) the Participant entering into an Employee Proprietary Information Agreement or other restrictive covenant agreement with the Company, with the terms and conditions of such agreement(s) to be determined in good faith by the Company. ARTICLE VI 280G MATTERS Notwithstanding anything to the contrary in the Plan, if a Participant is a “disqualified individual” (as defined in Section 280G(c) of the Code), and the payments and benefits provided for in the Plan, together with any other payments and benefits which such Participant has the right to receive from the Company or any of its Affiliates, would constitute a “parachute payment” (as defined in Section 280G(b)(2) of the Code), then the payments and benefits provided for in the Plan shall be either: (a) reduced (but not below zero) so that the present value of such total amounts and benefits received by such Participant from the Company will be one dollar ($1.00) less than three (3) times such Participant’s “base amount” (as defined in Section 280G(b)(3) of the Code) and so that no portion of such amounts and benefits received by such Participant shall be subject to the excise tax imposed by Section 4999 of the Code; or (b) paid in full, whichever produces the better net after-tax position to such Participant (taking into account any applicable excise tax under Section 4999 of the Code and any other applicable taxes). The reduction of payments and benefits hereunder, if applicable, shall be made by reducing, first, payments or benefits to be paid in cash hereunder in the order in which such payment or benefit would be paid or provided (beginning with such payment or benefit that would be made last in time and continuing, to the extent necessary, through to such payment or benefit that would be made first in time) and, second, reducing any benefit to be provided in-kind hereunder in a similar order. The determination as to whether any such reduction in the amount of the payments and benefits provided hereunder is necessary shall be made by the Company in good faith. If a reduced 8 payment or benefit is made or provided and through error or otherwise that payment or benefit, when aggregated with other payments and benefits from the Company used in determining if a “parachute payment” exists, exceeds one dollar ($1.00) less than three (3) times such Participant’s base amount, then such Participant shall be required to immediately repay such excess to the Company upon notification that an overpayment has been made. Nothing in this Article 6 shall require the Company to be responsible for, or have any liability or obligation with respect to, such Participant’s excise tax liabilities under Section 4999 of the Code. ARTICLE VII ADMINISTRATION, AMENDMENT AND TERMINATION Section 7.01 Administration. The Administrator has the exclusive right, power, and authority, in its sole and absolute discretion, to administer and interpret the Plan. The Administrator has all powers reasonably necessary to carry out its responsibilities under the Plan including (but not limited to) the sole and absolute discretionary authority to: (a) administer the Plan according to its terms and to interpret Plan policies and procedures; (b) resolve and clarify inconsistencies, ambiguities, and omissions in the Plan, and among and between the Plan and other related documents; (c) take all actions and make all decisions regarding questions of eligibility and entitlement to benefits, and benefit amounts; (d) make, amend, interpret, and enforce all appropriate rules and regulations for the administration of the Plan; (e) process and approve or deny all claims for benefits; and (f) decide or resolve any and all questions, including benefit entitlement determinations and interpretations of the Plan, as may arise in connection with the Plan. The decision of the Administrator on any disputes arising under the Plan, including (but not limited to) questions of construction, interpretation and administration shall be final, conclusive and binding on all persons having an interest in or under the Plan. Any determination made by the Administrator shall be given deference in the event the determination is subject to judicial review and shall be overturned by a court of law only if it is arbitrary and capricious. Section 7.02 Amendment and Termination. The Company reserves the right to amend or terminate the Plan at any time, by providing at least ninety (90) days advance written notice to each Participant; provided that no such amendment or termination that has the effect of reducing or diminishing the right of any Participant will be effective without the written consent of such Participant.
9 ARTICLE VIII GENERAL PROVISIONS Section 8.01 At-Will Employment. The Plan does not alter the status of each Participant as an at-will employee of the Company. Nothing contained herein shall be deemed to give any Participant the right to remain employed by the Company or to interfere with the rights of the Company to terminate the employment of any Participant at any time, with or without Cause. Section 8.02 Other Plans, Agreements and Benefits. (a) Subject to Section 8.02(b) below, on the Effective Date, if any Eligible Employee is a party to an individual offer letter, employment agreement or other individual arrangement with the Company (as applicable, an “Individual Employment Contract”), that individual will be eligible to become a Participant pursuant to this Plan, subject to that individual signing a Participation Agreement properly releasing his or her rights to all potential severance payments or benefits contained within that Individual Employment Contract, and any other terms that the Company has determined to be necessary or appropriate to clarify the parties rights with respect to severance benefits for that individual. (b) In the event that the Company, in its sole discretion, determines that the severance payments or benefits provided within any Individual Employment Contract are subject to Section 409A, this Plan will not be used to terminate, replace, substitute, enhance or otherwise impermissibly modify the applicable provisions of the Individual Employment Contract in a manner that would subject the individual employee or the Company to any excise, penalty or other taxes pursuant to Section 409A. (c) Any Severance Benefits payable to a Participant under the Plan will not be counted as compensation for purposes of determining benefits under any other benefit policies or plans of the Company, except to the extent expressly provided therein. Section 8.03 Mitigation and Offset. If a Participant obtains other employment, then such other employment will not affect the Participant’s rights or the Company’s obligations under the Plan. The Company may reduce the amount of any Severance Benefits otherwise payable to or on behalf of a Participant by the amount of any obligation of the Participant to the Company, and the Participant shall be deemed to have consented to such reduction. Section 8.04 Severability. The invalidity or unenforceability of any other provision of the Plan shall not affect the validity or enforceability of any other provision of the Plan. If any other provision of the Plan is held by a court of competent jurisdiction to be illegal, invalid, void, or unenforceable, such provision shall be deemed modified, amended, and narrowed to the extent necessary to render such provision legal, valid, and enforceable, and the other remaining provisions of the Plan shall not be affected but shall remain in full force and effect. Section 8.05 Headings and Subheadings. Headings and subheadings contained in the Plan are intended solely for convenience and no provision of the Plan is to be construed by reference to the heading or subheading of any section or paragraph. 10 Section 8.06 Unfunded Obligations. The amounts to be paid to Participants under the Plan are unfunded obligations of the Company. The Company is not required to segregate any monies or other assets from its general funds with respect to these obligations. Participants shall not have any preference or security interest in any assets of the Company other than as a general unsecured creditor. Section 8.07 Successors. The Plan will be binding upon any successor to the Company, its assets, its businesses, or its interest (whether as a result of the occurrence of a Change in Control or otherwise), in the same manner and to the same extent that the Company would be obligated under the Plan if no succession had taken place. In the case of any transaction in which a successor would not by the foregoing provision or by operation of law be bound by the Plan, the Company shall require any successor to the Company to expressly and unconditionally assume the Plan in writing and honor the obligations of the Company hereunder, in the same manner and to the same extent that the Company would be required to perform if no succession had taken place. All payments and benefits that become due to a Participant under the Plan will inure to the benefit of his or her heirs, assigns, designees, or legal representatives. Section 8.08 Transfer and Assignment. Neither a Participant nor any other person shall have any right to sell, assign, transfer, pledge, anticipate, or otherwise encumber, transfer, hypothecate, or convey any amounts payable under the Plan prior to the date that such amounts are paid, except that, in the case of a Participant’s death, such amounts shall be paid to the Participant’s beneficiaries. Section 8.09 Waiver. Any party’s failure to enforce any provision or provisions of the Plan will not in any way be construed as a waiver of any such provision or provisions, nor prevent any party from thereafter enforcing each and every other provision of the Plan. Section 8.10 Governing Law. To the extent not pre-empted by federal law, the Plan shall be construed in accordance with and governed by the laws of Delaware without regard to conflicts of law principles. Any action or proceeding to enforce the provisions of the Plan will be brought only in a state or federal court located in the state of Delaware, and each party consents to the venue and jurisdiction of such court. The parties hereby irrevocably submit to the exclusive jurisdiction of such courts and waive the defense of inconvenient forum to the maintenance of any such action or proceeding in such venue. Section 8.11 Clawback. Any amounts payable under the Plan are subject to any policy (whether in existence as of the Effective Date or later adopted) established by the Company providing for clawback or recovery of amounts that were paid to the Participant. The Company will make any determination for clawback or recovery in its sole discretion and in accordance with any applicable law, regulation or Company policy, as applicable. Section 8.12 Withholding. The Company shall have the right to withhold from any amount payable hereunder any Federal, state and local taxes in order for the Company to satisfy any withholding tax obligation it may have under any applicable law or regulation. 11 Section 8.13 Section 409A. (a) The Plan is intended to comply with Section 409A or an exemption thereunder and shall be construed and administered in accordance with Section 409A. Notwithstanding any other provision of the Plan, payments provided under the Plan may only be made upon an event and in a manner that complies with Section 409A or an applicable exemption. Any payments under the Plan that may be excluded from Section 409A either as separation pay due to an involuntary separation from service or as a short- term deferral shall be excluded from Section 409A to the maximum extent possible. For purposes of Section 409A, each installment payment provided under the Plan shall be treated as a separate payment. Any payments to be made under the Plan upon a termination of employment shall only be made upon a “separation from service” under Section 409A. Notwithstanding the foregoing, the Company makes no representations that the payments and benefits provided under the Plan comply with Section 409A and in no event shall the Company be liable for all or any portion of any taxes, penalties, interest or other expenses that may be incurred by a Participant on account of non-compliance with Section 409A. (b) Notwithstanding any other provision of the Plan, if any payment or benefit provided to a Participant in connection with his or her Qualifying Termination is determined to constitute “nonqualified deferred compensation” within the meaning of Section 409A and the Participant is determined to be a “specified employee” as defined in Section 409A(a)(2)(b)(i) of the Code, then such payment or benefit shall not be paid until the first payroll date to occur following the six (6)-month anniversary of the Qualifying Termination or, if earlier, on the Participant’s death (the “Specified Employee Payment Date”). The aggregate of any payments that would otherwise have been paid before the Specified Employee Payment Date and interest on such amounts calculated based on the applicable federal rate published by the Internal Revenue Service for the month in which the Participant’s separation from service occurs shall be paid to the Participant in a lump sum on the Specified Employee Payment Date and thereafter, any remaining payments shall be paid without delay in accordance with their original schedule. Notwithstanding any other provision of the Plan, if any payment or benefit is conditioned on the Participant’s execution of a Release, then the first payment shall include all amounts that would otherwise have been paid to the Participant during the period beginning on the date of the Qualifying Termination and ending on the payment date if no delay had been imposed. (c) To the extent required by Section 409A, each reimbursement or in-kind benefit provided under the Plan shall be provided in accordance with the following: (i) the amount of expenses eligible for reimbursement, or in-kind benefits provided, during each calendar year cannot affect the expenses eligible for reimbursement, or in-kind benefits to be provided, in any other calendar year; and (ii) any right to reimbursements or in-kind benefits under the Plan shall not be subject to liquidation or exchange for another benefit. ARTICLE IX CLAIMS PROCEDURES Section 9.01 Initial Claims. A Participant who believes he or she is entitled to a payment under the Plan that has not been received may submit a written claim for benefits to the 12 Plan within sixty (60) days after the Participant’s Qualifying Termination. Claims should be addressed and sent to: Lexicon Pharmaceuticals, Inc. Attn: General Counsel 2445 Technology Forest Blvd., 11th Floor The Woodlands, Texas 77381 If the Participant’s claim is denied, in whole or in part, the Participant will be furnished with written notice of the denial within ninety (90) days after the Administrator’s receipt of the Participant’s written claim, unless special circumstances require an extension of time for processing the claim, in which case a period not to exceed 180 days will apply. If such an extension of time is required, then written notice of the extension will be furnished to the Participant before the termination of the initial ninety (90)-day period and will describe the special circumstances requiring the extension, and the date on which a decision is expected to be rendered. Written notice of the denial of the Participant’s claim will contain the following information: (a) The specific or reasons for the denial of the Participant’s claim; (b) References to the specific Plan provisions on which the denial of the Participant’s claim was based; (c) A description of any additional information or material required by the Administrator to reconsider the Participant’s claim (to the extent applicable) and an explanation of why such material or information is necessary; and (d) A description of the Plan’s review procedures and time limits applicable to such procedures, including a statement of the Participant’s right to bring a civil action under Section 502(a) of ERISA following a benefit claim denial on review. Section 9.02 Appeal of Denied Claims. If the Participant’s claim is denied and he or she wishes to submit a request for a review of the denied claim, then the Participant, or his or her authorized representative, must follow the procedures described below: a. Upon receipt of the denied claim, the Participant (or his or her authorized representative) may file a request for review of the claim in writing with the Administrator. This request for review must be filed no later than sixty (60) days after the Participant has received written notification of the denial. b. The Participant has the right to submit in writing to the Administrator any comments, documents, records, and other information relating to his or her claim for benefits. c. The Participant has the right to be provided with, upon request and free of charge, reasonable access to and copies of all pertinent documents, records, and other information that is relevant to his or her claim for benefits.
13 d. The review of the denied claim will take into account all comments, documents, records, and other information that the Participant submitted relating to his or her claim, without regard to whether such information was submitted or considered in the initial denial of his or her claim. Section 9.03 Administrator’s Response to Appeal. The Administrator will provide the Participant with written notice of its decision within sixty (60) days after the Administrator’s receipt of the Participant’s written claim for review. There may be special circumstances which require an extension of this sixty (60)-day period. In any such case, the Administrator will notify the Participant in writing within the sixty (60)-day period and the final decision will be made no later than 120 days after the Administrator’s receipt of the Participant’s written claim for review. The Administrator’s decision on the Participant’s claim for review will be communicated to the Participant in writing and will clearly state: a. The specific reason or reasons for the denial of the Participant’s claim; b. Reference to the specific Plan provisions on which the denial of the Participant’s claim is based; c. A statement that the Participant is entitled to receive, upon request and free of charge, reasonable access to, and copies of, the Plan and all documents, records, and other information relevant to his or her claim for benefits; and d. A statement describing the Participant’s right to bring an action under Section 502(a) of ERISA. Section 9.04 Exhaustion of Administrative Remedies. The exhaustion of these claims procedures is mandatory for resolving every claim and dispute arising under the Plan. As to such claims and disputes: a. No claimant shall be permitted to commence any legal action to recover benefits or to enforce or clarify rights under the Plan under Section 502 or Section 510 of ERISA or under any other provision of law, whether or not statutory, until these claims procedures have been exhausted in their entirety; and b. In any such legal action, all explicit and implicit determinations by the Administrator (including, but not limited to, determinations as to whether the claim, or a request for a review of a denied claim, was timely filed) shall be afforded the maximum deference permitted by law. Section 9.05 Attorney’s Fees. The Company and each Participant shall bear their own attorneys’ fees incurred in connection with any disputes between them. 14 APPENDIX A Eligible Employees and Applicable Multipliers Name/Title or Position Severance Multiplier CIC Severance Multiplier Severance Benefits Period CIC Severance Benefits Period Chief Executive Officer (“CEO”) 1.0x 1.5x 12 months 18 months Non-CEO Executive Officers1 1.0x 1.0x 12 months 12 months [**]2 [**] [**] [**] [**] 1 For purposes of this Appendix A, the term “Executive Officer” shall mean a member of the executive management team (other than the CEO), as determined by the Company in its discretion. When an Eligible Person is deemed to become a Participant in this Plan, they will be informed of the participation level in which they will participate. 2 For purposes of this Appendix A, the term [**] shall mean [**]. When an Eligible Person is deemed to become a Participant in this Plan, they will be informed of the participation level in which they will participate.
Exhibit 10.11
STOCK OPTION AGREEMENT
(Officer Stock Option)
This Stock Option Agreement (this “Agreement”), effective as of ____________ (the “Grant Date”), is by and between Lexicon Pharmaceuticals, Inc., a Delaware corporation (the “Company”), and _______________ (“Employee”).
To carry out the purposes of the Company’s 2017 Equity Incentive Plan (the “Plan”) and the determination of the compensation committee (the “Compensation Committee”) of the Company’s board of directors (the “Board”) to grant Employee the opportunity to purchase shares of the Company’s Common Stock, par value $0.001 per share (“Stock”), in order to provide Employee with incentives to exert maximum efforts for the Company’s success by providing Employee the opportunity to benefit from increases in the value of the Stock, and in consideration of the mutual agreements and other matters set forth herein and in the Plan, the Company and Employee hereby agree as follows:
1. Grant of Option. The Company hereby grants to Employee the right and option (the “Option”), on the terms and conditions set forth in this Agreement and the Plan, to purchase all or any part of an aggregate of __________ shares of Stock. The Option shall be treated as an “incentive stock option” within the meaning of section 422(b) of the Internal Revenue Code of 1986, as amended (the “Code”), to the maximum extent permitted under the Code, and as a non-statutory stock option to the extent it exceeds the limitations imposed by the Code for incentive stock options.
2. Exercise Price. The price at which Employee may purchase Stock upon exercise of the Option (the “Exercise Price”) shall be ________ per share, which has been determined to be the Fair Market Value (as defined in the Plan) of the Stock on the Grant Date. The Exercise Price is subject to adjustment under certain circumstances as provided in the Plan.
3. Term. The Option shall expire on the 10th anniversary of the Grant Date, subject to earlier termination under the circumstances specified in Section 8 of this Agreement.
4. Exercisability and Vesting. (a) Subject to the terms and conditions set forth in this Agreement and the Plan, the Option may be exercised, in whole or in part, at any time and from time to time during the term of the Option, to purchase the number of shares of Stock that have vested and become exercisable in accordance with this Agreement. The Option shall vest and become exercisable with respect to (i) 25% of the total number of shares of Stock subject to the Option on the first anniversary of the Grant Date and (ii) an additional 1/48 of the total number of shares subject to the Option each month thereafter; provided that such options shall become vested with respect to all remaining unvested shares in the event of (i) a Change in Control (as defined below) [or (ii) a termination of Employee’s Continuous Service (as defined in the Plan) as a result of Employee’s death or Disability (as defined in the Plan)].
(b) A “Change in Control” shall be deemed to have occurred if any of the following shall have taken place: (i) any “person” (as such term is used in Sections 13(d) and 14(d)(2) of the Securities Exchange Act of 1934 (the “Exchange Act”)) other than Invus, L.P. and its affiliates (collectively, “Invus”) is or becomes the “beneficial owner” (as defined in Rule 13d-3 under the Exchange Act, or any successor provisions thereto), directly or indirectly, of securities of the Company representing 35% or more of the combined voting power of the Company’s then-outstanding voting securities; [(ii) Invus
becomes the “beneficial owner” (as defined in Rule 13d-3 under the Exchange Act, or any successor provisions thereto), directly or indirectly, of securities of the Company representing 50% or more of the combined voting power of the Company’s then-outstanding voting securities] (iii) [the approval by the stockholders of the Company] [the consummation] of a reorganization, merger, or consolidation, in each case with respect to which persons who were stockholders of the Company immediately prior to such reorganization, merger or consolidation do not, immediately thereafter, own or control more than 50% of the combined voting power of the reorganized, merged or consolidated Company’s then-outstanding securities entitled to vote generally in the election of directors in substantially the same proportions as their ownership of the Company’s outstanding voting securities prior to such reorganization, merger or consolidation; (iv) a liquidation or dissolution of the Company or the sale of all or substantially all of the Company’s assets; [(v) in the event any person is elected by the stockholders of the Company to the Company’s board of directors (the “Board”) who has not been nominated for election by a majority of the Board or any duly appointed committee thereof;] or (vi) following the election or removal of directors, a majority of the Board consists of individuals who were not members of the Board two years before such election or removal, unless the election of each director who is not a director at the beginning of such two-year period has been approved in advance by directors representing at least a majority of the directors then in office who were directors at the beginning of the two-year period [; provided that notwithstanding the foregoing, neither the execution by the Company of the Securities Purchase Agreement and Stockholders’ Agreement with Invus, L.P., each dated June 15, 2007 (as amended, supplemented or otherwise modified, the “Invus Transaction Agreements”), nor the consummation of the transactions contemplated in the Invus Transaction Agreements, including, without limitation, the acquisition by Invus of the Initial Shares and the Rights Shares (as defined in the Invus Transaction Agreements), the election of any representatives of Invus to the board of directors of the Company, or the acquisition by Invus of additional shares of Stock, as permitted or contemplated under the Invus Transaction Agreements, will constitute a “Change in Control.”] The Compensation Committee of the Board, in its discretion, may deem any other corporate event affecting the Company to be a “Change in Control” hereunder.
5. Forfeiture upon Termination of Service. Simultaneously with termination of Employee’s Continuous Service [for any reason other than as a result of Employee’s death or Disability (as defined in the Plan)], the Option shall cease to vest and shall terminate with respect to all shares of Stock that have not vested and become exercisable prior to such time in accordance with Section 4 of the Agreement.
6. Procedures for Exercise. Subject to the terms and conditions set forth in this Agreement and the Plan, the Option may be exercised by delivery to the Company at its principal executive office of (i) written notice addressed to the Secretary of the Company specifying the number of shares of Stock as to which the Option is being exercised and (ii) payment in full of the Exercise Price for such shares. The Exercise Price shall be paid in cash or in such other manner as may be authorized by the administrator of the Plan in accordance with the terms of the Plan. If the offering, sale and delivery of the shares of Stock issuable upon exercise of the Option have not been registered under the Securities Act of 1933 (the “Securities Act”), the Company may require Employee, as a condition to Employee’s exercise of the Option, to enter into a stock purchase agreement containing such representations and warranties as the Company may deem necessary to permit the issuance of the Stock purchased upon exercise of the Option in compliance with the Securities Act and applicable state securities laws.
7. No Rights of Ownership in Stock Before Issuance. No person shall be entitled to the rights and privileges of stock ownership with respect to any shares of Stock issuable upon exercise of the Option until such shares have been issued in accordance with the terms of this Agreement and the Plan.
8. Non-Transferability. Employee’s rights under this Agreement, including with respect to the Option, may not be transferred by Employee otherwise than by will or the laws of descent and
distribution or pursuant to a qualified domestic relations order (as defined in Title I of the Employee Retirement Income Security Act of 1974, as amended, or the rules thereunder).
9. Termination of Option. If Employee’s Continuous Service is terminated for any reason other than (i) the Disability (as defined in the Plan) or death of Employee or (ii) the Company’s termination of Employee’s employment without cause, the Option shall remain exercisable, with respect to the shares of Stock that had vested under the terms of this Agreement before the date of such termination, for a period of 90 days after the date of such termination (but in no event later than the expiration date of the Option specified in Section 3 of this Agreement), following which 90‑day period this Agreement and Employee’s right to exercise the Option shall terminate. If Employee’s Continuous Service is terminated because of (i) the Disability or death of Employee or (ii) the Company’s termination of Employee’s employment without cause, the Option shall remain exercisable, with respect to the shares of Stock that had vested under the terms of this Agreement before the date of such termination, for a period of one year after the date of such termination (but in no event later than the expiration date of the Option specified in Section 3 of this Agreement), following which one-year period this Agreement and Employee’s right to exercise the Option shall terminate; provided that the Option shall not be treated as an “incentive stock option” within the meaning of the Code if the Option is exercised more than 90 days following the termination of Employee’s Continuous Service as a result of the Company’s termination of Employee’s employment without cause. Notwithstanding the foregoing, if the employment of Employee by the Company is terminated for cause, this Agreement and Employee’s right to exercise any portion of the Option, whether or not vested, shall terminate at the commencement of business on the date of such termination. For purposes of this Agreement, “cause” shall mean (x) the breach of a material obligation of Employee under any agreement between Employee and the Company, (y) gross negligence or willful or intentional wrongdoing or misconduct on the part of Employee, or (z) Employee’s conviction of a felony offense or a crime involving moral turpitude.
10. Withholding of Tax. Employee shall be liable for any and all federal, state or local taxes, including withholding taxes, arising out of the grant or exercise of the Option hereunder. To the extent that the Company is required under applicable federal or state income tax laws to withhold any amount on account of any present or future tax imposed as a result of the exercise of the Option, Employee shall pay the Company, at the time of such exercise, funds in an amount sufficient to permit the Company to satisfy such withholding obligations in full. If Employee fails to pay such amount, the Company shall be authorized (i) to withhold from any cash remuneration then or thereafter payable to Employee any tax required to be withheld or (ii) to refuse to issue or transfer any shares otherwise required to be issued pursuant to the terms of this Agreement.
11. Status of Stock. (a) Unless the offering, sale and delivery of the shares of Stock issuable upon exercise of the Option have been registered under the Securities Act, Employee agrees that any shares of Stock purchased upon exercise of the Option shall be acquired for investment without a view to distribution, within the meaning of the Securities Act, and shall not be sold, transferred, assigned, pledged or hypothecated in the absence of an effective registration statement under the Securities Act and applicable state securities laws or an applicable exemption from the registration requirements of the Securities Act and any applicable state securities laws. Employee further agrees that the shares of Stock which Employee may acquire by exercising the Option will not be sold or disposed of in any manner which would constitute a violation of any other applicable federal or state securities laws. In addition, Employee agrees (i) that the certificates representing the shares of Stock issued under this Agreement may bear such legend or legends as the administrator of the Plan deems appropriate in order to assure compliance with applicable securities laws, and (ii) that the Company may give instruction to its transfer agent, if any, to stop transfer of the shares of Stock issued under this Agreement on the stock transfer records of the Company, if such proposed transfer would, in the opinion of counsel to the Company, constitute a violation of any applicable securities law or any such agreements.
(b) Employee further agrees that the Option granted herein shall be subject to the requirement that if at any time the administrator of the Plan shall determine, in its discretion, that the listing, registration or qualification of the shares of Stock subject to such Option upon any securities exchange or market or under any state or federal law, or the consent or approval of any governmental regulatory body, is necessary or desirable as a condition of, or in connection with, the purchase or issuance of shares of Stock hereunder, such Option may not be exercised in whole or in part unless such listing, registration, qualification, consent or approval shall have been effected or obtained free of any conditions not reasonably acceptable to the administrator of the Plan.
12. No Right to Continued Employment. Nothing in this Agreement or the Plan shall confer upon Employee any right to continue in the employ of the Company or shall interfere with or restrict in any way the right of the Company, which is hereby expressly reserved, to terminate Employee’s employment at any time for any reason whatsoever, with or without cause and with or without advance notice.
13. 2017 Equity Incentive Plan. The Plan, a copy of which is available for inspection by Employee or other persons entitled to exercise this Option at the Company’s principal executive office during business hours, is incorporated by reference in this Agreement. The Option is subject to, and the Company and Employee agree to be bound by, all of the terms and conditions of the Plan. In the event of a conflict between this Agreement and the Plan, the terms of the Plan shall control. Subject to the terms of the Plan, the administrator of the Plan shall have authority to construe the terms of this Agreement, and the determinations of the administrator of the Plan shall be final and binding on Employee and the Company.
14. Binding Agreement. This Agreement shall be binding upon and inure to the benefit of any successors to the Company and all persons lawfully claiming under Employee.
15. Governing Law. This Agreement and all actions taken hereunder shall be governed by and construed in accordance with the laws of the State of Delaware.
IN WITNESS WHEREOF, the Company has caused this Agreement to be duly executed and Employee has executed this Agreement effective for all purposes as of the Grant Date.
LEXICON PHARMACEUTICALS, INC.
By:
Michael S. Exton, Ph.D.
Chief Executive Officer
EMPLOYEE
Exhibit 10.12
RESTRICTED STOCK UNIT AGREEMENT
THIS RESTRICTED STOCK UNIT AGREEMENT (this “Agreement”), effective as of _____________ (the “Grant Date”), is by and between Lexicon Pharmaceuticals, Inc., a Delaware corporation (the “Company”), and _______________ (“Employee”).
To carry out the purposes of the Company’s 2017 Equity Incentive Plan (the “Plan”) and the determination of the compensation committee (the “Compensation Committee”) of the Company’s board of directors (the “Board”) to grant Employee a Restricted Stock Unit Award (as defined in the Plan) under the Plan, subject to the terms and conditions of this Agreement, of shares of the Company’s Common Stock, par value $0.001 per share (“Stock”), in order to provide Employee with incentives to exert maximum efforts for the Company’s success by providing Employee the opportunity to benefit from increases in the value of the Stock, and in consideration of the mutual agreements and other matters set forth herein and in the Plan, the Company and Employee hereby agree as follows:
1. Grant of Restricted Stock Unit Award. The Company hereby grants to Employee a Restricted Stock Unit Award, on the terms and conditions set forth in this Agreement and in the Plan, consisting of the right to receive an aggregate of ___________ shares of Stock (the “Shares”) or, as provided in Section 4 below and in the sole discretion of the Board, a lump sum cash payment equal to the fair market value of the Shares on the date of vesting.
2. Vesting. (a) Subject to the terms and conditions set forth in this Agreement and the Plan, the right of Employee to receive the Shares shall vest with respect to one third of the total number of Shares on February 28 of each of the three years following the year of grant; provided that, if not already vested in accordance with the foregoing, the right of Employee to receive the Shares shall become vested upon (i) a termination of Employee’s Continuous Service (as defined in the Plan) by the Company without Cause (as defined below) or by Employee for Good Reason (as defined below) that occurs [after] [within 24 months following] the occurrence of a Change in Control (as defined below) or (ii) the termination of Employee’s Continuous Service as a result of Employee’s death or Disability (as defined in the Plan).
(b) For purposes of the foregoing:
(i)A “Change in Control” shall be deemed to have occurred if any of the following shall have taken place: (A) any “person” (as such term is used in Sections 13(d) and 14(d)(2) of the Securities Exchange Act of 1934 (the “Exchange Act”)) other than Invus, L.P. and its affiliates (collectively, “Invus”) is or becomes the “beneficial owner” (as defined in Rule 13d-3 under the Exchange Act, or any successor provisions thereto), directly or indirectly, of securities of the Company representing 35% or more of the combined voting power of the Company’s then-outstanding voting securities; [(B) Invus becomes the “beneficial owner” (as defined in Rule 13d-3 under the Exchange Act, or any successor provisions thereto), directly or indirectly, of securities of the Company representing 50% or more of the combined voting power of the Company’s then-outstanding securities;] (C) the consummation of a reorganization, merger, or consolidation, in each case with respect to which persons who were stockholders of the Company immediately prior to such reorganization, merger or consolidation do not, immediately thereafter, own or control more than 50% of the combined voting power of the reorganized, merged or consolidated Company’s then-outstanding securities entitled to vote generally in the election of directors in substantially the same proportions as their ownership of the Company’s outstanding voting securities prior to such reorganization, merger or consolidation; (D) a liquidation or dissolution of the Company or the sale of all or substantially all of the Company’s assets; or (E)
following the election or removal of directors, a majority of the Board consists of individuals who were not members of the Board two years before such election or removal, unless the election of each director who is not a director at the beginning of such two-year period has been approved in advance by directors representing at least a majority of the directors then in office who were directors at the beginning of the two-year period [; provided, that notwithstanding the foregoing, neither the execution by the Company of the Securities Purchase Agreement and Stockholders’ Agreement with Invus, L.P., each dated June 15, 2007 (as amended, supplemented or otherwise modified, the “Invus Transaction Agreements”), nor the consummation of the transactions contemplated in the Invus Transaction Agreements, including, without limitation, the acquisition by Invus of the Initial Shares and the Rights Shares (as defined in the Invus Transaction Agreements), the election of any representatives of Invus to the board of directors of the Company, or the acquisition by Invus of additional shares of Stock, as permitted or contemplated under the Invus Transaction Agreements, will constitute a “Change in Control.”] The Compensation Committee, in its discretion, may deem any other corporate event affecting the Company to be a “Change in Control” hereunder.
(ii) “Cause” means a termination of Employee’s employment directly resulting from (A) Employee having engaged in intentional misconduct causing a material violation by the Company of any state or federal laws, (B) Employee having engaged in a theft of Company funds or Company assets or in a material act of fraud upon the Company, (C) an act of personal dishonesty taken by Employee that was intended to result in personal enrichment of Employee at the expense of the Company, (D) Employee’s final conviction (or the entry of any plea other than not guilty) in a court of competent jurisdiction of a felony, or (E) a breach by Employee of any contractual or fiduciary obligation to the Company, if such breach results in a material injury to the Company.
(iii) “Good Reason” means the occurrence of any of the following events without Employee’s express written consent: (A) a material diminution in Employee’s base salary, (B) a material diminution in Employee’s authority, duties, or responsibilities, or (C) any other action or inaction that constitutes a material breach by the Company of any contractual obligation to Employee.
3. Forfeiture upon Termination of Service. Simultaneously with termination of Employee’s Continuous Service for any reason other than as a result of Employee’s death or Disability (as defined in the Plan) prior to the vesting of Employee’s rights to receive the Shares in accordance with Section 2 of this Agreement, Employee shall automatically forfeit all rights to receive the Shares, unless and except to the extent otherwise agreed by the Company, in its sole discretion.
4. Issuance of Shares upon Vesting. Subject to the provisions of Sections 3 and 6 of this Agreement, upon vesting of the Shares in accordance with Section 2 of this Agreement, the Company shall (a) provide Employee with prompt notice of such vesting event and (b) issue (i) the Shares to Employee for no additional consideration or (ii) in the sole discretion of the Board, to Employee a lump sum cash payment equal to the closing sale price of the Shares as of the last trading date immediately prior to the date of vesting multiplied by the number of Shares vesting on such date.
5. Non-Transferability. Employee’s rights under this Agreement, including with respect to any Shares as to which the interest of Employee has not vested in accordance with Section 2 of this Agreement, may not be transferred by Employee otherwise than by will or the laws of descent and distribution or pursuant to a qualified domestic relations order (as defined in Title I of the Employee Retirement Income Security Act of 1974, as amended, or the rules thereunder).
6. Withholding of Tax. Employee shall be liable for any and all federal, state or local taxes, including withholding taxes, arising out of the grant or vesting of Shares hereunder. Unless Employee elects otherwise as provided below, Employee shall satisfy such withholding tax obligation by withholding from any cash payment to the Employee or by forfeiting to the Company that number of Shares having a Fair Market Value (as defined in the Plan) equal to the Company’s withholding obligation relating to such grant or vesting of Shares hereunder. Employee may alternatively elect to satisfy such withholding tax obligation by making a cash payment to the Company equal to the Company’s minimum withholding obligation, in which case Employee shall (a) provide the Company with written notice of such election and (b) pay to the Company in immediately available funds an amount equal to the Company’s minimum withholding obligation, in each case by no later than the date giving rise to such withholding tax obligation. No Shares shall be issued to Employee unless and until Employee shall have paid or otherwise satisfied the withholding tax obligations with respect thereto.
7. Dividend Equivalents; Voting. If the Board declares any dividends with respect to the Stock prior to the vesting of Employee’s rights to receive the Shares in accordance with Section 2 of this Agreement, dividend equivalents shall be credited to Employee in respect of the Shares and shall be converted into additional shares of Stock covered by this Agreement and such additional shares shall be subject to all of the terms and conditions of the underlying Shares. Employee shall have no voting rights with respect to the Restricted Stock Unit Award or the Shares subject thereto until such time as the Shares are issued or the cash payment is made to Employee pursuant to Section 4 of this Agreement.
8. Status of Shares. (a) Unless the offering, sale and delivery of the Shares have been registered under the Securities Act of 1933 (the “Securities Act”), Employee agrees that such Shares shall be acquired for investment without a view to distribution, within the meaning of the Securities Act, and shall not be sold, transferred, assigned, pledged or hypothecated in the absence of an effective registration statement under the Securities Act and applicable state securities laws or an applicable exemption from the registration requirements of the Securities Act and any applicable state securities laws. Employee further agrees that the Shares will not be sold or disposed of in any manner which would constitute a violation of any other applicable federal or state securities laws. In addition, Employee agrees (i) that the certificates representing the Shares issued under this Agreement may bear such legend or legends as the administrator of the Plan deems appropriate in order to assure compliance with applicable securities laws, and (ii) that the Company may give instruction to its transfer agent, if any, to stop transfer of the Shares issued under this Agreement on the stock transfer records of the Company, if such proposed transfer would, in the opinion of counsel to the Company, constitute a violation of any applicable securities law or any such agreements.
(b) Employee further agrees that the Restricted Stock Unit Award granted herein shall be subject to the requirement that if at any time the administrator of the Plan shall determine, in its discretion, that the listing, registration or qualification of the Shares upon any securities exchange or market or under any state or federal law, or the consent or approval of any governmental regulatory body, is necessary or desirable as a condition of, or in connection with, the issuance of the Shares hereunder, the Shares may not be issued in whole or in part unless such listing, registration, qualification, consent or approval shall have been effected or obtained free of any conditions not reasonably acceptable to the administrator of the Plan.
9. No Right to Continued Employment. Nothing in this Agreement or the Plan shall confer upon Employee any right to continue in the employ of the Company or shall interfere with or restrict in any way the right of the Company, which is hereby expressly reserved, to terminate Employee’s employment at any time for any reason whatsoever, with or without cause and with or without advance notice.
10. 2017 Equity Incentive Plan. The Plan, a copy of which is available for inspection by Employee at the Company’s principal executive office during business hours, is incorporated by reference in this Agreement. This Agreement is subject to, and the Company and Employee agree to be bound by, all of the terms and conditions of the Plan. In the event of a conflict between this Agreement and the Plan, the terms of the Plan shall control. Subject to the terms of the Plan, the administrator of the Plan shall have authority to construe the terms of this Agreement, and the determinations of the administrator of the Plan shall be final and binding on Employee and the Company.
11. Binding Agreement. This Agreement shall be binding upon and inure to the benefit of any successors to the Company and all persons lawfully claiming under Employee.
12. Governing Law. This Agreement and all actions taken hereunder shall be governed by and construed in accordance with the laws of the State of Delaware.
WHEREOF, the Company has caused this Agreement to be duly executed and Employee has executed this Agreement effective for all purposes as of the Grant Date.
LEXICON PHARMACEUTICALS, INC.
By:
Michael S. Exton, Ph.D.
Chief Executive Officer
EMPLOYEE
Exhibit 10.15 [**] Certain information has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. EXCLUSIVE LICENSE AGREEMENT THIS EXCLUSIVE LICENSE AGREEMENT is dated and effective as of October 14, 2024, by and between LEXICON PHARMACEUTICALS, INC., a corporation incorporated under the laws of Delaware, USA, with its principal place of business located at 2445 Technology Forest Blvd. 11th floor, The Woodlands, Texas 77381 (“Lexicon”) and VIATRIS INC., a corporation incorporated under the laws of Delaware, USA, with its principal place of business located at 1000 Mylan Blvd., Canonsburg, PA 15317 (“Viatris”). WHEREAS Lexicon is the owner of the Product (as hereinafter defined) and has compiled a Registration Dossier (as hereinafter defined) in relation to the Product; WHEREAS Viatris is a pharmaceutical company engaged in the marketing, sale and distribution of various healthcare products; WHEREAS Viatris is interested in acquiring the exclusive right and license to use the Registration Dossier and related Licensed Intellectual Property (as hereinafter defined) for the purpose of obtaining Marketing Approvals (as hereinafter defined) in the Territory (as hereinafter defined), and, thereafter, maintaining Marketing Approvals and Commercializing the Product in the Field in the Territory; WHEREAS Lexicon wishes to grant such exclusive right and license to Viatris in the Territory, in accordance with the terms and conditions hereinafter set forth; NOW THEREFORE in consideration of the mutual covenants herein contained and for other good and valuable consideration, the Parties hereby agree as follows: Article 1 Definitions and Interpretation 1.1 Definitions. For the purposes of this Agreement, the following terms shall have the following meanings, respectively, unless the context otherwise requires: (a) “ADE” has the meaning set forth in Section 7.1. (b) “Accounting Standards” means United States generally accepted accounting principles (GAAP), consistently applied. (c) “Affiliate” means any Person (as hereinafter defined) which is directly or indirectly controlled by, or controls or is under common control with another Person, provided that “control” means ownership as to more than fifty percent (50%) of another Person or the power to direct decisions of another Person, including the power to direct management and policies of another Person, whether by reason of ownership, by contract or otherwise. Notwithstanding the foregoing, Invus, L.P., a Bermuda limited partnership, and any of its Affiliates that would not otherwise be 2 Affiliates of Lexicon but for its and their ownership of Lexicon’s capital stock, shall be deemed not to be Affiliates of Lexicon in their capacity as an investor, but will be deemed an Affiliate of Lexicon to the extent they exercise ownership or control over the Registration Dossier, Licensed Intellectual Property, Licensed Trademarks or the Product. (d) “Agreement” means this Exclusive License Agreement and all instruments supplemental hereto or in amendment or confirmation hereof; “herein”, “hereof”, “hereto”, “hereunder” and similar expressions mean and refer to this Agreement and not to any particular Article, Section, Subsection or other subdivision; “Article”, “Section” other subdivision of this Agreement means and refers to the specified Article, Section or other subdivision of this Agreement. (e) “Alliance Manager” has the meaning set forth in Section 5.1. (f) “ANZ” means Australia and New Zealand. (g) “Calendar Quarter” means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and October 1, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 or October 1 after the Effective Date and the last Calendar Quarter shall end on the last day of the Term. (h) “Calendar Year” means each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the Term shall commence on January 1 of the year in which the Term ends and end on the last day of the Term. (i) “cGMP” means all applicable standards relating to manufacturing practices for fine chemicals, intermediates, bulk products and/or finished pharmaceutical products, including all applicable requirements detailed in the FDA’s current Good Manufacturing Practices regulations, 21 CFR Parts 210 and 211, and The Rules Governing Medicinal Products in the European Community, Volume IV, Good Manufacturing Practice for Medicinal Products, as each may be amended from time to time. (j) “CHF” means Chronic Heart Failure. (k) “Commercialization” means any and all activities directed to the preparation for sale of, offering for sale or sale of the Product, including activities related to marketing, promoting, selling, distributing and importing the Product. When used as a verb, “to Commercialize” and “Commercializing” means to engage in Commercialization and “Commercialized” has a corresponding meaning. (l) “Commercial Milestone” has the meaning set forth in Section 6.2. 3 (m) “Commercial Milestone and Royalty Report” has the meaning set forth in Section 6.4. (n) “Commercialization Plan” has the meaning set forth in Section 4.2. (o) “Commercially Reasonable Efforts” means, with respect to the efforts to be expended on any obligation under this Agreement by a Party or its Affiliates, the use of reasonable, diligent, good faith efforts and resources as commonly used in the pharmaceutical industry to conduct similar activities. With respect to the Commercialization of the Product, Commercially Reasonable Efforts shall include the level of effort commonly used in the pharmaceutical industry to Commercialize a product that is at a similar stage in its lifecycle and is of comparable market potential, taking into account all scientific, commercial and other relevant factors, consistent with the exercise of prudent scientific and business judgment as applied by an entity of similar size and resources; such efforts and resources shall, at a minimum, be consistent with the efforts and resources Viatris applies to its own products that are at a similar stage with similar market potential, taking into account competitiveness of Third Party products, efficacy, safety, patent and regulatory exclusivity, anticipated or approved labelling, present and future market potential, competitive market conditions and the profitability of the product in light of pricing and reimbursement issues. Commercially Reasonable Efforts shall be determined on a market-by-market and indication-by-indication basis, and it is anticipated that the level of efforts and resources required may be different for different markets and indications and may change over time. (p) “Confidential Information” has the meaning set forth in Section 11.1. (q) “Control” or “Controlled” means, with respect to any Registration Dossier, Trademarks or Intellectual Property, the possession by a Party, whether by ownership or license (other than by licenses granted under this Agreement), of the ability to grant to the other Party access, a license or a sublicense as provided herein without requiring the consent of a Third Party or violating the terms of any agreement or other arrangement with any Third Party. (r) “Defensive Action” has the meaning set forth in Section 10.2.1. (s) “Development” means all activities related to research, pre-clinical and other non- clinical testing, clinical development, statistical analysis and report writing in support thereof, and interactions with Regulatory Authorities regarding any of the foregoing, including for obtaining and maintaining Marketing Approval, and any post-approval activities (such as label expansion). When used as a verb, “Develop” means to engage in Development. (t) “Development Data” has the meaning set forth in Section 3.4. (u) “Development Plan” has the meaning set forth in Section 3.3. (v) “Disclosing Party” has the meaning set forth in Section 11.1. 4 (w) “Educational Materials” means training, educational and communication materials for the Product, including without limitation, any patient support or safety training materials. (x) “Effective Date” means the date of this Agreement as set forth above. (y) “FDA” means the United States Food and Drug Administration. (z) “First Commercial Sale” means, with respect to the Product and a country, the first sale for monetary value for use or consumption by the end user of such Product in such country after Marketing Approval for such Product has been obtained in such country. (aa) “Field” means all uses in humans. (bb) “Generic Market” has the meaning set forth in Section 6.3.3. (cc) “Generic Product” means, with respect to a country in the Territory, any drug product (including any authorized generic product) that: (i) contains the same active ingredient as the Product; and (ii) is marketed or sold by a Third Party without the right to reference any Marketing Authorization held by or on behalf of Viatris or any of its Affiliates in such country in the Territory. (dd) “Governmental Body” means (i) any domestic or foreign national, federal, provincial, state, municipal or other government or body, (ii) any international or multilateral body, (iii) any subdivision, ministry, department, secretariat, bureau, agency, commission, board, instrumentality or authority of any of the foregoing governments or bodies, (iv) any quasi-governmental or private body exercising any regulatory, expropriation or taxing authority under or for the account of any of the foregoing governments or bodies, or (v) any domestic, foreign, international, multilateral, or multinational judicial, quasi-judicial, arbitration or administrative court, grand jury, tribunal, commission, board or panel. (ee) “HCM” means Hypertrophic Cardiomyopathy. (ff) “Indemnified Party” has the meaning set forth in Section 9.4. (gg) “Indemnifying Party” has the meaning set forth in Section 9.4. (hh) “Improvements” means any dosages, reformulations, line-extensions advances in, modifications or improvements to the Product made by or on behalf of Lexicon, its Affiliates, and their sublicensees, including the use for additional indications. (ii) “Indirect Taxes” has the meaning set forth in Section 6.8.2. (jj) “Infringement Notice” has the meaning set forth in Section 10.7.
5 (kk) “Intellectual Property” means, whether or not reduced to writing, all discoveries, inventions, rights to inventions, patent applications and issued patents, supplementary protection certificates, patents of additions, extensions, renewals, designs, design applications and design registrations, Know-How (as hereinafter defined) and all other intellectual property rights, but excluding any Trademarks. (ll) “Inventions” has the meaning set forth in Section 10.4. (mm) “Joint Invention” has the meaning set forth in Section 10.4. (nn) “Joint Patent” has the meaning set forth in Section 10.4. (oo) “JSC” has the meaning set forth in Section 5.2.1. (pp) “Know-How” means all know-how, information, data, knowledge, discoveries, technology, formulae, trade secrets, data, analytical reference materials and confidential or proprietary processes or information. (qq) “Labels” means all labels and other written, printed or graphic matter upon: (i) the Product or any primary or secondary packaging, container or wrapper utilized with the Product, and (ii) any written material accompanying the Product, including any package inserts. (rr) “Laws” means all laws, statutes, rules, codes, regulations, orders, judgments, ordinances, decisions, rulings, policies, practices and guidelines of any Governmental Body currently or subsequently in place and in force, in each case binding on or affecting the Party or Person referred to in the context in which such word is used; and “Law” means any one of them. (ss) “Lexicon” has the meaning set forth in the preamble. (tt) “Licensed Intellectual Property” means any Intellectual Property owned or Controlled by Lexicon or its Affiliates as of the Effective Date and during the Term that is reasonably necessary or useful in Developing, obtaining or maintaining Marketing Approval of, or Commercializing the Product, including without limitation, those issued patents and patent applications set forth in Exhibit A attached hereto. (uu) “Licensed Trademarks” means any Trademarks owned or Controlled by Lexicon or its Affiliates as of the Effective Date and during the Term that are reasonably necessary or useful in Commercializing the Product, including (a) those Trademarks set forth in Exhibit B-1 and (b) those internet domain names set forth in Exhibit B-2, attached hereto, but excluding all corporate names and logos of Lexicon and its Affiliates. (vv) “Losses” means liabilities, damages, costs or expenses actually incurred, including reasonable fees and expenses of attorneys and other professionals, as well as court costs. 6 (ww) “Manufacture” and “Manufacturing” means to make, have made and all activities related to the production, manufacture, processing, filling, finishing, packaging, labeling, release, shipping and holding of the Product or any intermediate thereof, including process development, process qualification and validation, scale-up, pre-clinical, clinical and commercial manufacture and manufacturing analytics development and the use of such analytics in relation to such activities, product characterization, stability testing, quality assurance and quality control, and chemistry, manufacturing and controls. (xx) “Manufacturing and Supply Agreement” has the meaning set forth in Section 4.1. (yy) “Manufacturing Costs” means (a) with respect to Product supplied to Viatris from Lexicon’s existing inventory as of the Effective Date, the cost per unit set forth in Exhibit C and (b) with respect to Product supplied to Viatris that is Manufactured by or on behalf of Lexicon after the Effective Date, Lexicon’s actual costs of Manufacturing the Product, calculated consistently with other products Manufactured by Lexicon and in accordance with Accounting Standards, as may be set forth in more detail in the Manufacturing and Supply Agreement. For clarity, in the event that Lexicon uses a Third Party contract manufacturer to perform any Manufacturing activities under this Agreement (or under the Manufacturing and Supply Agreement, as may be set forth in more detail in the Manufacturing and Supply Agreement) after the Effective Date, Manufacturing Costs for such activities means the amount paid by Lexicon or its Affiliates to such a Third Party in connection with the Manufacture and supply of such Product. Manufacturing Costs shall exclude general administrative or corporate overhead and any other costs not directly attributable or allocable to the Manufacture of the Product. (zz) “Marketing Approval” means all approvals, licenses, registrations or authorizations of any Regulatory Authority necessary for the marketing, distribution and sale of the Product in any country in the Territory, including necessary pricing and reimbursement approvals. (aaa) “Milestones” has the meanings set forth in Section 6.2. (bbb) “Milestone Payments has the meaning set forth in Section 6.2. (ccc) “Net Sales” means, with respect to the Product, for any period, the gross amount received by Viatris, its Affiliates and permitted sublicensees for sales of the Product in the Territory to a Third Party customer, less deductions for (i) any rebates, quantity, trade and cash discounts, and other usual and customary discounts, including re-procurement and back-order charges; (ii) charge-backs and rebates granted to customers, including managed health care organizations or to national, state or local governments, their respective agencies, purchasers or reimbursers (including rebates and payments required to be paid to governmental entities in connection with the sales of the Product(s)), adjustments arising from consumer discount programs, co-pay assistance programs or other similar programs; 7 (iii) retroactive price reductions, credits or allowances, including for recalls or damaged goods; (iv) customary fees paid to distributors, including wholesalers, logistics providers, and group purchasing organizations; (v) sales credits accrued in accordance with Accounting Standards, including price protection, shelf stock adjustments, adjustments for uncollectible accounts and other price adjustments; (vi) returns of a Product for any reason; (vii) freight, postage, shipping and insurance charges with respect to such Product(s); and (viii) sales taxes, excise taxes, use taxes, import/export duties or other governmental charges actually due or incurred with respect to such Product(s), including value-added taxes, in each case to the extent not reimbursed. Each of the foregoing deductions shall be determined as occurred in the ordinary course of business in accordance with Accounting Standards. For clarity, sales of Product(s) between Viatris and its Affiliates for resale shall be excluded from Net Sales, but subsequent sales of Product(s) shall be included in Net Sales. Sales of the Product(s) used for promotional or advertising purposes or used for research or development purposes (including for clinical trials) or for compassionate use or other donations shall not be included in Net Sales. (ddd) “Parties” means Viatris and Lexicon collectively; and “Party” means either Viatris or Lexicon. (eee) “Patent Prosecution” has the meaning set forth in Section 10.6. (fff) “Person” means an individual, corporation, company, co-operative, partnership, organization or any similar entity. (ggg) “Pharmacovigilance Agreement” has the meaning set forth in Section 7.1. (hhh) “Product” means sotagliflozin and pharmaceutical dosage forms comprising sotagliflozin, including tablets, in both 200mg and 400mg formulations, both as a branded and as an authorized generic product, including all Improvements, for use in the Field. (iii) “Promotional Materials” means all promotional materials, detail aids and pieces, journal ads, films, artwork and graphics, and any other marketing literature and information used in the marketing, distribution or sale of the Product. (jjj) “Quality Agreement” has the meaning set forth in Section 4.2.3. (kkk) “Receiving Party” has the meaning set forth in Section 11.1. (lll) “Regulatory Authority” means each and every Governmental Body from which approvals are required for Commercialization of the Product in any country in the Territory. (mmm)“Registration Dossier” means any and all Developmental, scientific, technical or pharmacovigilance documentation (e.g. risk management plans and associated 8 documents) and information, processes, techniques and data in Lexicon’s, its Affiliates’, or their other licensees’ Control during the Term as may be required to obtain and maintain Marketing Approval for the Product in the T1D and CHF indications and any other indication for which Lexicon or any of its Affiliates, or their licensees, applies or obtains regulatory approval outside the Territory, including clinical and non-clinical study data, results, reports (including toxicology reports), and regulatory data, filings, communications and other documentation associated with any regulatory approval outside the Territory Controlled by Lexicon during the Term with respect to the Product. (nnn) “Regulatory Milestone” has the meaning set forth in Section 6.2. (ooo) “Representatives” has the meaning set forth in Section 11.2. (ppp) “Royalty Term” means, on a country-by-country basis, the period of time commencing upon the first sale by Viatris, its Affiliates and permitted sublicensees of the Product in each country in the Territory and continuing until [**]. (qqq) “Term” has the meaning set forth in Section 12.1. (rrr) “Territory” means worldwide, but excluding (a) the United States of America and (b) all members of the European Union as of October 4, 2024, and Albania, Andorra, Bosnia and Herzegovina, Iceland, Kosovo, Liechtenstein, Moldova, Monaco, Montenegro, North Macedonia, Norway, San Marino, Serbia, Switzerland, United Kingdom (including Ireland) and Vatican City. (sss) “Trade Control Laws” has the meaning set forth in Section 8.4(a). (ttt) “T1D” means Type 1 Diabetes. (uuu) “Third Party” means any Person other than a Party or an Affiliate of a Party. (vvv) “Trademark” means any word, name or symbol, or any combination thereof, whether registered or unregistered, including any trademark, trade dress, or trade name. (www) “Unauthorized Product Sales” has the meaning set forth in Section 4.6. (xxx) “Valid Claim” means: (a) a claim of an issued and unexpired patent within the Licensed Intellectual Property that has not been (i) held permanently revoked, unenforceable, unpatentable or invalid by a decision of a court or Governmental Body of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, (ii) rendered unenforceable through disclaimer or otherwise, (iii) abandoned or (iv) permanently lost through an interference, inter parties review, opposition or other proceeding without any right of appeal or review; or (b) a pending claim of a pending patent application within the Licensed Intellectual Property, where [**].
9 (yyy) “Viatris” has the meaning set forth in the preamble. (zzz) “Viatris Reversion Intellectual Property and Trademarks” means any Intellectual Property and Trademarks (excluding all corporate names and logos of Viatris and its Affiliates) that are owned or Controlled by Viatris or its Affiliates as of the effective date of termination of this Agreement and is (a) invented, discovered, developed, or otherwise generated by or on behalf Viatris or any of its Affiliates in the performance of activities under this Agreement and (b) is reasonably necessary or used by or on behalf of Viatris in Developing, obtaining or maintaining Marketing Approval of, or Commercializing the Product. Article 2 License 2.1 Grants of Rights. Subject to Section 2.3, Lexicon hereby grants to Viatris, and Viatris hereby accepts, an exclusive (including as to Lexicon and its Affiliates) right and license (with the right to grant sublicenses, solely in accordance with Section 2.2) during the Term to use the Registration Dossier and the Licensed Intellectual Property to Develop and Commercialize the Product in the Field in the Territory in accordance with this Agreement. For the avoidance of doubt, no license to Manufacture the Product is granted hereunder; any and all Manufacturing rights and obligations shall be set forth in and specified in the Manufacturing and Supply Agreement. 2.2 Sublicenses. Viatris may grant sublicenses under the licenses granted to it under Sections 2.1 and 4.4.2 to its Affiliates without Lexicon’s prior written consent and to other Third Parties with Lexicon’s prior written consent, such consent not to be unreasonably withheld, delayed or conditioned, and provided that: (a) each sublicense is in writing and its terms are consistent with the terms and conditions of this Agreement and Lexicon is provided notice of each such sublicense and (b) Viatris shall be responsible and solely liable to Lexicon for the performance of its sublicensees. Viatris shall provide Lexicon with a copy of any such sublicense within thirty (30) days after entering into any such sublicense. 2.3 Retained Rights. Notwithstanding anything to the contrary in this Agreement, Lexicon hereby retains the right to Develop and Manufacture the Product in the Territory for the purpose of (a) performing its obligations hereunder and under the Manufacturing and Supply Agreement, and (b) supporting Development and Commercialization of the Product outside the Territory; provided that Lexicon shall provide Viatris with Lexicon’s development plans for the Product outside the Territory, and if Viatris reasonably determines that Lexicon’s development activities outside the Territory may have a material adverse effect on Development or Commercialization of the Product in the Territory, then Lexicon shall take into consideration Viatris’s reasonable input regarding any such potential material adverse effect as supported by reasonable documentation provided by Viatris. 10 2.4 No Implied Licenses or Rights. Nothing in this Agreement will be interpreted to grant a Party any rights under any Intellectual Property owned or Controlled by the other Party that are not expressly granted herein, whether by implication, estoppel, or otherwise. 2.5 Exclusivity. Subject to Section 2.3, during the Term, Lexicon shall not, and shall not assist any Third Party to, Develop, Manufacture, or Commercialize any product in the Field in the Territory that contains sotagliflozin, whether alone or in combination with any other active ingredient. Article 3 Registration Dossier; Marketing Approvals; Development 3.1 Registration Dossier. Lexicon shall transmit the Registration Dossier (including the Registration Dossier submitted by Lexicon to the FDA) in eCTD format and written in English to Viatris within thirty (30) days after the Effective Date (or within thirty (30) days after such Registration Dossier becomes available for a particular indication). Lexicon represents and warrants that the information contained in the Registration Dossier is true and correct in all material respects and complies in all material respects with all applicable Laws. Lexicon shall, from time to time, promptly provide Viatris with any material updates to the Registration Dossier. 3.2 Marketing Approvals. Viatris shall use Commercially Reasonable Efforts to (a) obtain and maintain Marketing Approvals for the Product and obtain favorable formulary access for the Product in each country in the Territory [**], and (b) achieve the Regulatory Milestones. Viatris shall apply for Marketing Approval for the Product [**] in the Territory at Viatris’ sole expense. Lexicon shall, upon Viatris’ written request, (y) provide Viatris with such reasonable assistance and cooperation as may be reasonably necessary to obtain and maintain Marketing Approvals, including without limitation, by participating in meetings or conference calls with Regulatory Authorities in the Territory as Viatris may reasonably request from time to time and (z) make its key personnel reasonably available to address any regulatory and development issues relating to the application for or maintenance of Marketing Approvals as they arise. 3.3 Development; Development Plan. 3.3.1 Any Development of the Product by Viatris shall be conducted only in accordance with a clinical development plan pre-approved by the JSC (the “Development Plan”) and Viatris shall use Commercially Reasonable Efforts with respect to any such Development activities. Such Development Plan shall include, among other things, (a) Development objectives and strategy, (b) Development activities to be performed (including clinical study design), and (c) timelines for all planned Development activities. Viatris shall bear all costs and expenses incurred in connection with such Development efforts. 3.3.2 Viatris, in consultation with Lexicon, shall present the initial Development Plan to the JSC within [**] following receipt of all input and communications from the relevant Regulatory Authorities necessary for the finalization of the initial Development Plan as determined by the JSC, and thereafter present an updated Development Plan to the JSC on at least an annual basis. Following any such submission of a Development Plan to the JSC, the JSC shall review the 11 Development Plan to identify any material study design or safety issues that may adversely impact global Development and Commercialization of the Product, including Development and Commercialization of the Product by Lexicon or its Affiliates and licensees outside the Territory. The Parties agree to meet at either Party’s reasonable request in order to discuss the Development Plan and any clinical study or other Development matters. 3.4 Development Data; Conduct. Viatris shall, subject to applicable Laws, promptly share with Lexicon all data, results and supporting documentation generated by Development activities conducted under the Development Plan (the “Development Data”). Viatris hereby grants to Lexicon, its Affiliates and other licensees a non-exclusive, sublicensable, irrevocable, fully paid-up right and license to exploit the Development Data, including the right to use and reference the Development Data for its and their Development, applications for Marketing Approval, and Commercialization of the Product solely for use outside the Territory. 3.5 Compliance with Laws. Viatris shall comply in all material respects with all applicable Laws in relation to the Development of the Product in the Territory under this Agreement, including with respect to the obtaining of informed consents from clinical study participants and all privacy and data protection Laws. Article 4 Manufacturing and Supply Agreement; Commercialization; Product Trademarks 4.1 Manufacturing and Supply Agreement. Within [**] following the Effective Date, the Parties shall negotiate in good faith and enter into a definitive manufacturing and supply agreement (the “Manufacturing and Supply Agreement”) under which Lexicon shall Manufacture and supply Product to Viatris for its Development and Commercialization activities in the Territory, on substantially the terms set forth on Exhibit D, attached hereto, as well as other reasonable and customary contract manufacturing terms. 4.2 Commercialization; Commercialization Plan. 4.2.1 Viatris shall use Commercially Reasonable Efforts to (a) Commercialize the Product in the Field in each country in the Territory [**], in accordance with a commercialization plan pre-approved by the JSC (the “Commercialization Plan”) and (b) achieve the Commercial Milestones. Such Commercialization Plan shall include, among other things, (w) Commercialization objectives and strategy (including branding and pricing strategies), (x) Commercialization activities to be performed (including marketing, sales, market access and medical communications, publications and education), (y) infrastructure and other capabilities required for all planned Commercialization activities and (z) resources and timelines for all planned Commercialization activities. Viatris shall be solely responsible and shall have sole decision-making authority for all Commercialization activities in the Territory, including but not limited to, marketing, sales, market access, medical affairs in support of Commercialization, customer service, order processing, invoicing and collection and local qualified persons for Pharmacovigilance (to the extent legally required) and pricing for all Product sales in the Territory. Viatris shall bear all costs and expenses incurred in connection with all Commercialization efforts. 12 4.2.2 Viatris, in consultation with Lexicon, shall present the initial Commercialization Plan to the JSC no less than [**] prior to the first anticipated Marketing Approval in Brazil, Mexico, South Korea, Australia, New Zealand, or Canada, and thereafter present an updated Commercialization Plan to the JSC on at least an annual basis. The Parties agree to meet at either Party’s reasonable request in order to discuss the Commercialization Plan and any marketing, sales, pricing, distribution, or other Commercialization matters. 4.3 Promotional and Educational Materials. Lexicon will provide Viatris with representative samples of Lexicon’s material Promotional Materials and Educational Materials that are used by Lexicon outside the Territory. In order to ensure global standardization to the extent permitted by Law, Viatris will create, prepare, produce, reproduce, use, and (if required or advisable) file with the applicable Regulatory Authorities the Promotional Materials and Educational Materials for the Product in the Territory that are consistent with Lexicon’s Promotional Materials and Educational Materials provided hereunder to the extent allowed by applicable Laws. Viatris will ensure that all Promotional Materials and Educational Materials in the Territory comply in all respects with all applicable Laws in all material respects. The Parties shall mutually agree upon protocols governing Lexicon’s review of the core Promotional Materials and Educational Materials for the Territory in advance of finalizing such Promotional Materials and Educational Materials and will consider all of Lexicon’s comments with respect to such Promotional Materials and Educational Materials in good faith. Viatris will also provide Lexicon with copies of representative samples of its Promotional Materials and Educational Materials upon request. Each Party may use the information contained in the Promotional Materials or Educational Materials provided by the other Party under this Section 4.3 free of charge for preparation of Promotional Materials and Educational Materials for Commercialization of the Product in such Party’s territory and for no other purpose. 4.4 Product Trademarks; Trademark License. 4.4.1 Each Party shall retain all right, title and interest in and to its and their respective corporate names and logos. 4.4.2 Lexicon (or its Affiliates, as appropriate) shall own and retain all rights to the Licensed Trademarks, and all goodwill associated therewith throughout the Territory and worldwide. Lexicon shall also own and retain all rights to any Internet domain names incorporating the applicable Licensed Trademarks or any variation or part of such Licensed Trademarks, such as its URL address or any part of such address. Subject to the foregoing, Lexicon hereby grants to Viatris an exclusive right and license, with the right to sublicense pursuant to Section 2.2, to use the Licensed Trademarks and such Internet domain names solely to Develop and Commercialize the Product in the Field in the Territory in accordance with this Agreement, subject to Lexicon’s right to use the Licensed Trademarks and such Internet domain names pursuant to Lexicon’s retained rights set forth in Section 2.3. At Viatris’ request and expense, Lexicon shall file any additional national marks for a country in the Territory which are equivalent to or otherwise incorporate any Licensed Trademarks if such national marks are reasonably necessary or useful in the Development or Commercialization of the Product in such country. Viatris shall use the Licensed Trademarks to Develop and Commercialize the Product in the Field in the Territory, unless such Licensed Trademarks are not approved by the applicable Regulatory Authority in the applicable country in the Territory (in which case the JSC shall approve alternative Trademark(s)
13 for use with the Product in the applicable country(ies)), or if the JSC otherwise agrees. Lexicon shall not use the Licensed Trademarks to identify products other than the Product. 4.4.3 In the event either Party becomes aware of any infringement of any Licensed Trademarks by a Third Party, such Party shall promptly notify the other Party and the Parties shall consult with each other and jointly determine the best way to prevent such infringement, including, without limitation, by the institution of legal proceedings against such Third Party. Lexicon shall have the sole responsibility, in its discretion and at its sole cost and expense, to maintain, enforce and defend any Licensed Trademarks from any such Third Party infringement. In the event Lexicon elects not to maintain, enforce or defend any Licensed Trademarks from any such Third Party infringement in the Territory, Lexicon shall provide Viatris reasonable written notice to such effect, sufficiently in advance to permit Viatris, in its sole discretion and expense, to undertake such maintenance, enforcement or defense in the Territory, and Viatris may, upon written notice to Lexicon thereafter undertake such maintenance, enforcement or defense. The Party undertaking such maintenance, enforcement or defense in the Territory shall keep the other Party reasonably informed with respect to the status of the maintenance, enforcement or defense, including by providing the other Party with copies of all material documentation or correspondence concerning the maintenance, enforcement or defense. Any recovery from the foregoing shall be allocated in the same manner as Section 10.3, mutatis mutandis. 4.5 Compliance with Laws. Viatris shall comply with all applicable Laws in all material respects in relation to the Commercialization of the Product in the Territory under this Agreement, including with respect to the handling, storage, distribution and sale of the Product. Lexicon shall comply with all applicable Laws in all material respects in relation to the Manufacture and supply of the Product under this Agreement. 4.6 Unauthorized Product Sales by Viatris. Viatris shall refer to Lexicon all orders or inquiries received by it from sources outside the Territory in connection with the Product. Lexicon shall refer to Viatris all orders or inquiries received by it from sources inside the Territory in connection with the Product in the Field. Viatris shall use Commercially Reasonable Efforts to not knowingly, and shall obligate its Affiliates to not knowingly, import, distribute, market, promote, offer for sale or sell the Product (a) to any Person for use outside the Field, (b) to any Person outside the Territory or (c) to any Person that Viatris or its Affiliates, as applicable, knows or should (after reasonable investigation) know (i) has directly or indirectly imported, distributed, marketed, promoted, offered for sale or sold the Product outside the Territory or assisted another Person to do so or (ii) is reasonably anticipated to do any of the actions set forth in clause (i). If Lexicon notifies Viatris of any sales of Product to or by any Person that are prohibited by this Section 4.6 (“Unauthorized Product Sales”), Viatris will and will cause its Affiliates to promptly discontinue and prevent sales of Product to such Person to the extent permitted under applicable Laws. Article 5 Joint Steering Committee; Governance 14 5.1 Collaboration Management. Promptly after the Effective Date, each Party shall appoint one representative who shall be an employee of such Party having appropriate qualifications and experience in business management and the coordination of licensing and collaborations to serve as an alliance manager (“Alliance Manager”) with responsibility for (a) coordinating and managing day-to-day communications between the Parties, (b) overseeing the Parties’ activities conducted in accordance with this Agreement, (c) ensuring appropriate liaison between the Parties and any applicable project teams and (d) facilitating the resolution of issues between the Parties. 5.2 Joint Steering Committee. 5.2.1 Establishment. Promptly after the Effective Date, the Parties shall establish a joint steering committee comprised of an equal number of representatives from Lexicon and Viatris to oversee and discuss the activities of the Parties under this Agreement (the “JSC”). The JSC shall act as an advisory forum for information exchange between the Parties; provided, that the JSC shall not manage the day-to-day operations of either Party in its performance of its obligations under this Agreement. The JSC shall not have decision-making authority, except for the purposes of: (a) approving the Development Plan pursuant to Section 3.3; (b) approving the Commercialization Plan pursuant to Section 4.2, and (c) approving Viatris’ use of any Trademarks other than the Licensed Trademarks in the Commercialization of the Product pursuant to Section 4.4.2. 5.2.2 Membership; Meetings. The JSC shall have up to six (6) members, with up to three (3) representatives designated by Lexicon and up to three (3) representatives designated by Viatris, or such other number as the Parties may agree. Each Party may change its JSC representatives from time to time, in its sole discretion, effective upon delivery of written notice to the other Party. The JSC shall be co-chaired by a representative of Lexicon and a representative of Viatris. The JSC will meet as agreed by the Parties and minutes will be taken upon mutual agreement. 5.2.3 Voting. Each Party’s representatives on the JSC will collectively have one (1) vote on all matters that are within the responsibility of the JSC and subject to its decision- making authority pursuant to Section 5.2.1. Such representatives shall collectively determine how that one (1) vote shall be exercised during a voting session. The representatives of the JSC shall use reasonable efforts to reach unanimous consensus on all decisions. If the JSC is unable to reach consensus on a particular decision within thirty (30) days, then such issue shall be referred to the chief executive officers of each Party (or a senior executive designated by such chief executive officer) and such chief executive officers (or their designees) shall attempt in good faith to resolve such issue. If such issue remains unresolved within thirty (30) days following such referral, then Viatris shall have the final decision-making authority in its reasonable discretion with respect to such issue; provided, that if such issue could reasonably have a material adverse effect on Development or Commercialization of the Product outside the Territory, then Viatris shall have final decision-making authority taking into consideration Lexicon’s reasonable input regarding any such potential material adverse effect as supported by reasonable documentation provided by Lexicon; and provided further, that neither Viatris or Lexicon may make a decision that is inconsistent with the terms of this Agreement. 15 5.2.4 Limitations. Notwithstanding anything to the contrary set forth in this Agreement, the JSC shall not have the right to (a) amend, modify or waive compliance with any term or condition of this Agreement, (b) make any decision that is expressly stated in this Agreement to require the mutual agreement of the Parties, would conflict with the terms and conditions of this Agreement, or render a determination on a Party’s breach of this Agreement, or (c) resolve any claim or dispute regarding the interpretation of this Agreement, including whether or in what amount a payment is owed under this Agreement or whether a Party is in breach of this Agreement. Article 6 Upfront Payment; Milestone Payments; Royalties 6.1 Upfront Payment. In consideration for the rights and licenses granted to Viatris under Sections 2.1 and 4.4.2, Viatris shall pay to Lexicon Twenty Five Million United States Dollars ($25,000,000) in a single lump sum payment, payable within five (5) business days of Viatris’s receipt of an invoice from Lexicon with respect thereto, such invoice to be issued following the execution of this Agreement. 6.2 Milestone Payments. In consideration for the rights and licenses granted to Viatris under Sections 2.1 and 4.4.2, Viatris shall make one-time, non-refundable milestone payments to Lexicon as described in Subsections 6.2.1 and 6.2.2 (“Milestone Payments”) upon the occurrence of each the events set forth in Subsections 6.2.1 (each, a “Regulatory Milestone”) and 6.2.2 (each, a “Commercial Milestone, and collectively with the Regulatory Milestones, the “Milestones”), respectively. Each Milestone Payment shall be payable only upon the first achievement of such Milestone in the first Calendar Year in which such Milestone has been achieved and shall be payable only once. 6.2.1 Regulatory Milestones. Territory Marketing Approval and Indication Payment Marketing Approval of Product in [**] indication in [**] [**] United States Dollars ($[**]) Marketing Approval of Product in [**] indication in [**] [**] United States Dollars ($[**]) Marketing Approval of Product in [**] indication in [**] [**] United States Dollars ($[**]) Marketing Approval of Product in [**] indication in [**] [**] United States Dollars ($[**]) Marketing Approval of Product in [**] indication in [**] [**] United States Dollars ($[**]) Marketing Approval of Product in [**] indication in [**] [**] United States Dollars ($[**]) Viatris shall provide written notice to Lexicon within fifteen (15) days of the achievement of each Regulatory Milestone. Upon receipt of such notice, Lexicon shall provide an invoice to 16 Viatris, and payment to Lexicon of the corresponding Milestone Payment shall be due within thirty (30) days of receipt by Viatris of such invoice. Following Lexicon obtaining Marketing Approval for the Product for the HCM indication in the United States of America, (a) Viatris shall, based on Commercially Reasonable Efforts, determine in its sole discretion, whether it will Develop and Commercialize the Product in the Territory for the HCM indication in any of the countries in the Territory and (b) upon such determination, the parties shall negotiate in good faith economic terms for the HCM indication, including potential additional upfront payments and regulatory milestones. 6.2.2 Commercial Milestones. Milestone Event Payment First achievement of annual Net Sales of the Product in the Territory of [**] United States Dollars ($[**]) [**] United States Dollars ($[**]) First achievement of annual Net Sales of the Product in the Territory of [**] United States Dollars ($[**]) [**] United States Dollars ($[**]) First achievement of annual Net Sales of the Product in the Territory of [**] United States Dollars ($[**]) [**] United States Dollars ($[**]) First achievement of annual Net Sales of the Product in the Territory of [**] United States Dollars ($[**]) [**] United States Dollars ($[**]) 6.3 Royalties. 6.3.1 During the Royalty Term, Viatris shall pay to Lexicon a royalty based upon the aggregation of annual Net Sales in the Territory as follows (each 6.3.1 (a)-(e), a “Royalty Tier” and collectively, the “Royalties”): (a) [**] Percent ([**]%) of Viatris’ annual Net Sales of the Product in the Territory below [**] United States Dollars ($[**]); (b) [**] Percent ([**]%) of Viatris’ annual Net Sales of the Product in the Territory between [**] United States Dollars ($[**]) and [**] United States Dollars ($[**]); (c) [**] Percent ([**]%) of Viatris’ annual Net Sales of the Product in the Territory between [**] United States Dollars ($[**]) and [**] United States Dollars ($[**]); (d) [**] Percent ([**]%) of Viatris’ annual Net Sales of the Product in the Territory between [**] United States Dollars ($[**]) and [**] United States Dollars ($[**]); (e) [**] Percent ([**]%) of Viatris’ annual Net Sales in the Territory above [**] United States Dollars ($[**]).
17 6.3.2 Royalties shall be paid on a progressive tier basis. The higher Royalty Tier shall only apply to the incremental annual Net Sales in such applicable Royalty Tier above the previous Royalty Tier as illustrated in the following example: Example: If Viatris achieves annual Net Sales of the Product in the Territory of [**] United States Dollars ($[**]), it would owe the following collective Royalties: Tier 6.3.1(a): $[**] ([**]% of $[**]) Tier 6.3.1(b): $[**] ([**]% of $[**]) Tier 6.3.1(c): $[**] ([**]% of $[**]) Tier 6.3.1(d): $[**] ([**]% of $[**]) Total: $[**] 6.3.3 Generic Entry. On a country-by-country basis, in the event that (a) one or more Generic Product(s) are launched in a country in the Territory and such Generic Product(s) obtain a share of at least [**] percent ([**]%) but less than [**] percent ([**]%) of the combined Generic Product and Product market for such country, by unit volume (as demonstrated by reputable Third Party data) (the “Generic Market”), calculated as [**] or (b) [**], the Royalties for such country shall be reduced by [**] percent ([**]%) from the original rate. In the event that one or more Generic Product(s) are launched in a country in the Territory and such Generic Product(s) obtain a [**] percent ([**]%) or greater share of the Generic Market, the Royalties for such country shall be reduced by [**] percent ([**]%) from the original rate. In the event that [**], the Parties shall [**]. 6.3.4 Third Party Patents. Viatris may deduct [**] percent ([**]%) of any royalties, milestones, and other payments that Viatris or any of its Affiliates or permitted sublicensees pays to any Third Party for a license under any patent owned or Controlled by such Third Party that covers and is reasonably necessary for the exploitation of the Product in the Field in the Territory from the royalties otherwise owed to Lexicon pursuant to this Section 6.3, provided that no such deduction may reduce any royalty payment to less than [**] percent ([**]%) of the royalty payment amount otherwise owed to Lexicon pursuant to this Section 6.3. 6.4 Reporting. Within forty-five (45) days following the end of each Calendar Quarter following the First Commercial Sale, Viatris will provide to Lexicon a report specifying (a) the achievement of any Commercial Milestones during such Calendar Quarter, and (b) for each country in the Territory in which sales of the Product occurred during such Calendar Quarter, (i) the gross sales of Products during such Calendar Quarter on a country-by-country basis; (ii) the Net Sales of Products during such Calendar Quarter on a country-by-country basis, including an accounting of deductions taken in the calculation of Net Sales; and (iii) the Royalties payable in United States Dollars for such Calendar Quarter (including currency conversion performed pursuant to Section 6.10) both on a country-by-country basis and following the aggregation of Net Sales across all countries included in such report (the “Commercial Milestone and Royalty Report”). Upon receipt of each Commercial Milestone and Royalty Report, Lexicon shall provide an invoice to Viatris for the Commercial Milestone and Royalty payments for such Calendar 18 Quarter and Viatris shall make the Commercial Milestone and Royalty payments owed to Lexicon hereunder for each Calendar Quarter within [**] business days of Viatris’s receipt of such invoice. 6.5 Mode of Payment. All payments due to Lexicon hereunder shall be paid by wire transfer in immediately available funds to an account designated by Lexicon or by such other reasonable method as Lexicon may request. All payments to either Party under this Agreement shall be made by deposit of United States Dollars in the requisite amount to such bank account as the receiving Party may from time to time designate by notice to the paying Party. 6.6 Records Retention; Audit Procedures. Viatris shall keep (and shall assure that its relevant Affiliates and sublicensees keep) complete and accurate financial books and records pertaining to all sales of Product in sufficient detail to confirm the accuracy of Net Sales and Royalty calculations hereunder and shall retain such books and records until [**] after the end of the period to which such books and records pertain or for such longer period as may be required by applicable Law. At the request of Lexicon, Viatris shall (and shall assure that its relevant Affiliates and sublicensees) permit an independent certified or chartered accountant of internationally recognized standing, appointed by Lexicon, reasonably acceptable to Viatris, at reasonable times and upon reasonable notice (but no less than thirty (30) days’ prior written notice), to examine such books and records to ensure the accuracy of all Commercial Milestone and Royalty Reports and payments made hereunder during [**]. If such examination reflects an underpayment of any amounts payable to Lexicon, such underpayment shall be remitted to Lexicon by Viatris within thirty (30) days after the notification of the results by Lexicon to Viatris, together with interest calculated in the manner provided in Section 6.9. If such examination reflects an overpayment of any amounts payable to Lexicon, such overpayment shall be credited against Viatris’ subsequent payments to Lexicon hereunder. Such examination shall be at the expense of Lexicon unless it reveals an error resulting in Lexicon having received an amount that is less than ninety percent (90%) of the payment due to Lexicon for the period covered by the examination, in which case Viatris shall pay the costs of such examination. Any period subject to such examination may only be examined once (unless such examination for a given period reflects a greater than ten percent (10%) discrepancy in the amount reported by Viatris for such period, in which case such period may be reexamined to ensure that such discrepancy has been properly addressed). 6.7 No Non-Monetary Consideration for Sales. Without the prior written consent of Lexicon, Viatris and its Affiliates, sublicensees and other agents shall not accept or solicit any non-monetary consideration for the sale of Products. 6.8 Taxes. 6.8.1 Lexicon shall be responsible for all income taxes arising from all payments made to it under this Agreement. Viatris will make all payments to Lexicon under this Agreement without deduction or withholding except to the extent that any such deduction or withholding is required under applicable Law. Subject to Section 6.8.3, to the extent that Viatris is required to deduct and withhold taxes on any payment to Lexicon, Viatris (a) will deduct and withhold such taxes, (b) pay the amounts of such withheld taxes to the proper Governmental Body in a timely manner, and (c) promptly submit to Lexicon an official tax certificate or other evidence of such 19 withholding sufficient to enable Lexicon to claim a credit or refund in regard to any such payment of withheld taxes. 6.8.2 All charges and fees to be paid to Lexicon under this Agreement are exclusive of all value-added taxes, consumption taxes, goods or services taxes, surcharges or other similar taxes or costs (“Indirect Taxes”) required by applicable Law and shall be paid and borne by Viatris. To the extent that any transaction under this Agreement is subject to the reverse-charge mechanism under applicable Law, Viatris will be responsible for the payment any such Indirect Taxes amount, or will self-assess such Indirect Taxes and, subject to any applicable input deduction of such self-assessed Indirect Taxes, remit such amount to the applicable Governmental Authority. To the extent that Viatris is required to pay or remit such Indirect Taxes in respect of any payment to Lexicon, then, pursuant to Section 6.8.3, Lexicon will reasonably assist Viatris to obtain any available recovery of such Indirect Taxes, if applicable. 6.8.3 The Parties agree to cooperate with one another and use reasonable efforts to minimize obligations for any taxes required by applicable law to be withheld or deducted from any Royalties, Milestone Payments or other payments hereunder or to recover any such withholding taxes, including by completing all procedural steps and taking all reasonable measures to ensure that any withholding tax is reduced or eliminated to the extent permitted under applicable Law, including income tax treaty provisions and related procedures for claiming treaty relief. 6.9 Interest on Late Payments. Any payments that are not paid on or before the date such payments are due under this Agreement shall bear interest at an annual rate equal to the lesser of (a) the “prime rate” as reported by The Wall Street Journal, Eastern Edition, plus two percent (2%), or (b) the highest rate permitted by applicable Law; in each case calculated on the number of days such payment is delinquent, compounded monthly. 6.10 Currency Exchange. If any currency conversion will be required in connection with the calculation of amounts payable under this Agreement, such conversion shall be calculated using the conversion rate methodology consistently applied by such Party in reporting its financial statements. 6.11 Blocked Payments. In the event that, by reason of applicable Law in any country, it becomes impossible or illegal for Viatris (or any of its Affiliates or sublicensees) to transfer, or have transferred on its behalf, payments owed to Lexicon hereunder, Viatris will promptly notify Lexicon of the conditions preventing such transfer and such payments will be deposited in local currency in the relevant country to the credit of Lexicon in a recognized banking institution designated by Lexicon or, if none is designated by Lexicon within a period of thirty (30) days, in a recognized banking institution selected by Viatris (or its Affiliate or sublicensees) and identified in a written notice given to Lexicon. Article 7 Regulatory Matters 7.1 ADE Reporting. No later than the earlier of the date that is (a) [**] in advance of the First Commercial Sale or first patient dosing of the Product in a clinical trial conducted by 20 Viatris or its Affiliates or sublicensees under the Development Plan and (b) [**] following the effective date of any Manufacturing and Supply Agreement, the Parties shall negotiate in good faith and enter into a definitive pharmacovigilance agreement (the “Pharmacovigilance Agreement”) setting forth the procedures regarding the coordination between the Parties of collection, investigation, reporting and exchange of information regarding adverse drug events related to the Product (“ADE”). The Pharmacovigilance Agreement shall enable collaboration between the Parties on all matters of safety of use of the Product including the exchange of ADE information sufficient to permit each Party to comply with all drug safety reporting Laws. The Pharmacovigilance Agreement shall also set forth the location and responsibility for holding the global pharmacovigilance database, which shall be maintained by Lexicon and established as soon as reasonably feasible to enable the Parties to comply with international requirements and regulations and monitor patient safety. Unless otherwise provided by the Pharmacovigilance Agreement, serious and unexpected ADE reports shall be forwarded without delay to the other Party as soon as such reports come to a Party’s attention and any other ADE reports shall be reported by each Party to the other on a quarterly basis. Each Party shall furthermore notify the other Party immediately of any information regarding any threatened or pending action by any Regulatory Authority which may affect the safety of the Product or the continued marketing thereof. Each Party shall inform the other Party within a reasonable period of time if it determines that any measures are reasonably necessary to remove or to minimize any drug safety risk with respect to the Product. 7.2 Communications with Regulatory Authorities. Viatris shall be responsible for all submissions to, and communications and interactions with, Regulatory Authorities in the Territory relating to Viatris’ Development and Commercialization activities hereunder. Each Party shall keep the other Party reasonably informed regarding (and shall provide copies of) any material regulatory submissions and communications relating to the Product impacting the other Party’s rights or obligations hereunder and, if feasible, shall provide the other Party with reasonable advance notice with respect thereto. 7.3 Inspections. 7.3.1 Subject to Viatris’s confidentiality obligations to Third Parties, Viatris shall permit duly authorized representatives of Lexicon to visit and inspect the storage and distribution facilities used for the Product in support of Viatris’ Development or Commercialization of the Product under this Agreement. Such inspection shall only be conducted upon reasonable prior notice by Lexicon but not less than forty-five (45) days prior to the inspection, during normal business hours, no more frequently than reasonably necessary (and in any event, no more than once per year) and provided that such authorized representatives of Lexicon are subject to appropriate confidentiality obligations to Viatris. 7.3.2 Subject to Lexicon’s confidentiality obligations to Third Parties, Lexicon shall permit duly authorized representatives of Viatris to visit and inspect the facilities of Lexicon and their subcontractors used for the Development (to the extent Lexicon has such rights to permit such access from its subcontractors), Manufacture and supply of the Product under this Agreement and the Manufacturing and Supply Agreement. Such inspection shall only be conducted upon reasonable prior notice by Viatris but not less than forty-five (45) days prior to the inspection, or earlier if required by a Regulatory Authority, during normal business hours, no more frequently
21 than reasonably necessary (and in any event, no more than once per year) and provided that such authorized representatives of Viatris are subject to appropriate confidentiality obligations to Lexicon or their subcontractors. 7.3.3 The Parties shall cooperate with each other during any inspection, investigation or other inquiry by any appropriate Regulatory Authority relating to the Product, including providing information and documentation, as may be requested by such Regulatory Authority. The Parties shall discuss any response to observations or notifications received and shall give each other an opportunity to comment on any proposed response before it is made. In the event of any disagreement concerning the form or content of such response, however, Lexicon shall be responsible for deciding the appropriate form and content of any response with respect to any of Lexicon’s cited activities and Viatris shall be responsible for deciding the appropriate form and content of any response with respect to any of Viatris’ cited activities. 7.4 Medical Inquiries. With respect to the Product in the Territory, Viatris will have responsibility for all correspondence regarding medical information about the Product. Lexicon will make available to Viatris all relevant resources in Lexicon’s possession reasonably required and requested by Viatris to answer questions relating to medical information about the Product. At the reasonable request of Viatris, Lexicon will cooperate with Viatris to jointly develop form response letters that contain information responding to routine questions received regarding medical information about the Product. 7.5 Product Recalls. 7.5.1 In the event that either Party has reason to believe that any amount of the Product should be recalled or withdrawn from distribution in the Territory, such Party shall immediately notify the other Party in writing. In the event that (a) any Regulatory Authority issues a request, directive or order that the Product be recalled in the Territory, or (b) a court of competent jurisdiction in the Territory orders such a recall or (c) the Parties jointly determine that the Product should be recalled in the Territory, Viatris shall take all appropriate corrective actions to conduct and effect such recall. Viatris shall be responsible for all costs and expenses of any such recall in the Territory, except to the extent that such recall is required because of (y) a negligent act or omission of Lexicon; or (z) a breach by Lexicon of the Manufacturing and Supply Agreement, in each such case Lexicon shall be responsible for all costs and expenses of any such recall in the Territory, including without limitation, recall expenses, cost of replacement Product, any customer penalties or damages, each without limiting Lexicon’s obligations under Section 9.2; provided, that Lexicon’s responsibility for the cost of such replacement Product and customer penalties and damages shall be subject to the Manufacturing and Supply Agreement, including any limitations on liability therein. 7.5.2 In the event that (a) any Governmental Body issues a request, directive or order that the Product be recalled outside the Territory, (b) a court of competent jurisdiction outside the Territory orders such a recall or (c) Lexicon determines in its sole discretion that the Product should be recalled outside the Territory, Lexicon shall notify Viatris as expeditiously as possible and shall provide Viatris with all information and assistance as Viatris may reasonably request in order to enable the Parties to jointly determine any appropriate actions to be taken relating to the Product in the Territory. 22 Article 8 Representations, Warranties and Covenants 8.1 Representations and Warranties of Viatris. Viatris hereby represents, warrants and covenants to Lexicon the following: (a) Status. Viatris is a corporation organized and existing under the Laws of the State of Delaware. No action has been taken by the directors, officers or shareholders of Viatris to dissolve the corporation. Viatris has the corporate power and authority to enter into the present Agreement and to perform all its obligations hereunder. (b) All Necessary Proceedings. The execution and delivery by Viatris of this Agreement, the performance by Viatris of all the terms and conditions thereof to be performed by it and the consummation of the transactions contemplated hereby have been duly authorized by all necessary corporate actions and proceedings, and no other act or approval of any Person is required to authorize such execution, delivery and performance. (c) No Violation. Viatris represents and warrants that its execution, delivery and performance of this Agreement: (i) does not and will not violate or conflict with any provision of Law or any provision of its articles of incorporation or by-laws; and (ii) does not and will not, with or without the passage of time or the giving of notice, result in the breach of, or constitute a default, cause the acceleration of performance, or require any consent under, or result in the creation of any lien, charge or encumbrance upon any of its property or assets pursuant to, any material instrument or agreement to which it is a party or by which it or its properties may be bound or affected. (d) Compliance. Viatris shall comply with all applicable Laws in all material respects in relation to the exercise of Viatris’ rights, and the performance of Viatris’ obligations, under this Agreement, including with respect to the Development and Commercialization of the Product. (e) Trademarks. Viatris shall not authorize or undertake any use of the Licensed Trademarks or any other Trademark which is confusingly similar to the Licensed Trademarks in connection with any products or materials other than the Product or materials associated with the Product. 8.2 Representations and Warranties of Lexicon. Lexicon hereby represents, warrants and covenants to Viatris the following: (a) Status. Lexicon is a corporation organized and existing under the Laws of Delaware, USA. No action has been taken by the directors, officers or shareholders of Lexicon to dissolve the corporation. Lexicon has the corporate power and authority to enter into the present Agreement and to perform all its obligations hereunder. 23 (b) All Necessary Proceedings. The execution and delivery by Lexicon of this Agreement, the performance by Lexicon of all the terms and conditions thereof to be performed by it and the consummation of the transactions contemplated hereby have been duly authorized by all necessary corporate actions and proceedings, and no other act or approval of any Person is required to authorize such execution, delivery and performance. (c) No Violation. Lexicon represents and warrants that its execution, delivery and performance of this Agreement: (i) does not and will not violate or conflict with any provision of Law or any provision of its articles of incorporation or by-laws; and (ii) does not and will not, with or without the passage of time or the giving of notice, result in the breach of, or constitute a default, cause the acceleration of performance, or require any consent under, or result in the creation of any lien, charge or encumbrance upon any of its property or assets pursuant to, any material instrument or agreement to which it is a party or by which it or its properties may be bound or affected. (d) Third Party Claims. As of the Effective Date, Lexicon has not received and is not aware of any written claim or allegation that the use of the Licensed Intellectual Property or the Development, Manufacture, Commercialization and sale of the Product, whether in the Territory or elsewhere, infringes upon any rights of a Third Party. (e) Clear Title. As of the Effective Date, Lexicon or its Affiliates are the owners or licensees of, and hold valid rights to, the Licensed Intellectual Property and has (have) the full right, power and authority to grant the rights to Licensed Intellectual Property granted to Viatris hereunder. (f) Specifications. The Product, as delivered by Lexicon or its Affiliates to Viatris under this Agreement, will conform to the specifications for the Product under Lexicon’s Marketing Approval in the USA, or otherwise with the specifications the Parties agree to in the Manufacturing and Supply Agreement, and in all material respects with all applicable Laws. (g) Complete Licensed Intellectual Property. As of the Effective Date, there is no Intellectual Property Controlled by Lexicon or its Affiliates that claim or is directed to the Manufacture, Development or Commercialization of the Product other than the Licensed Intellectual Property. (h) Validity. To Lexicon’s knowledge, as of the Effective Date, the Licensed Intellectual Property is subsisting, valid, and enforceable, and is not subject to any pending or threatened opposition, interference or litigation proceedings. (i) Infringement. To Lexicon's knowledge, as of the Effective Date, the Development, Manufacture or Commercialization of the Product and the use of the Licensed Intellectual Property as contemplated herein has not and does not infringe the Intellectual Property rights of any Third Party. 24 (j) Third Party Obligations. Lexicon shall remain responsible for all of its obligations to Third Parties as of the Effective Date or arising at any time thereafter with respect to the Product and Licensed Intellectual Property. (k) Regulatory Authority Communications. Lexicon has not, nor to its knowledge, has any Third Party acting under Lexicon’s authority, made an untrue statement of a material fact to any Regulatory Authority with respect to the Product, or knowingly failed to disclose a material fact required to be disclosed to any Regulatory Authority with respect to the Product. (l) Oxford Consent. Lexicon has obtained all consents to the execution, delivery and performance of this Agreement as may be required under the Loan and Security Agreement, dated as of June 28, 2024 and as amended from time to time, by and among Oxford Finance LLC, the Lenders party thereto, Lexicon, and Lexicon Pharmaceuticals (New Jersey), Inc. (m) Trademarks. Lexicon shall not authorize or undertake any use of the Licensed Trademarks or any other Trademark which is confusingly similar to the Licensed Trademarks in connection with any products or materials other than the Product or materials associated with the Product in the Territory. 8.3 Anti-Corruption Laws. (a) Each Party understands that the other Party is required to and does abide by the United States Foreign Corrupt Practices Act, the United Kingdom Bribery Act and any other applicable anti-corruption laws. Each Party represents and warrants that no one acting on its behalf will give, offer, agree or promise to give, or authorize the giving directly or indirectly, of any money or other thing of value to anyone as an inducement or reward for favorable action or forbearance from action or the exercise of influence (a) to any governmental official or employee (including employees of government-owned and government-controlled corporations or agencies), (b) to any political party, official of a political party, or candidate, (c) to an intermediary for payment to any of the foregoing, or (d) to any other Person or entity in a corrupt or improper effort to obtain or retain business or any commercial advantage, such as receiving a permit or license. (b) Each Party further warrants and represents that should it learn or have reason to suspect any breach of the covenants in this Section 8.3, it will immediately notify the other Party. 8.4 Trade Control Laws. (a) Each Party will fully comply with all applicable export control, economic sanctions laws and anti-boycott regulations of the United States of America and other governments, including the U.S. Export Administration Regulations (Title 15 of the U.S. Code of Federal Regulations Part 730 et seq.) and the economic sanctions rules
25 and regulations implemented under statutory authority or President’s Executive Orders and administered by the U.S. Treasury Department’s Office of Foreign Assets Control (Title 31 of the U.S. Code of Federal Regulations Part 500 et seq.) (collectively, “Trade Control Laws”). (b) No Product will be directly or indirectly shipped by the other Party to any country subject to U.S. or U.N. economic sanctions without the necessary licenses, even for transfer to non-sanctioned countries. (c) Neither Party shall be required by the terms of this Agreement to be directly or indirectly involved in the provision of goods, services or technical data that may be prohibited by applicable Trade Control Laws. (d) Each Party hereby represents and warrants that it is not included on any of the restricted party lists maintained by the U.S. Government, including the Specially Designated Nationals List administered by the U.S. Treasury Department’s Office of Foreign Assets Control; the Denied Persons List, Unverified List or Entity List maintained by the U.S. Commerce Department’s Bureau of Industry and Security; or the List of Statutorily Debarred Parties maintained by the U.S. State Department’s Directorate of Defense Trade Controls. (e) Each Party shall commit to maintaining awareness of the importance of Trade Control Laws throughout its organization. Each Party shall take such actions as are necessary and reasonable to prevent Product from being exported or re-exported to any country, entity or individual subject to U.S. trade sanctions, unless prior approval of the other Party, and relevant permission or license from the U.S. government has been obtained. (f) Each Party will keep accurate and consistent records of all transactions under this Agreement covered by the Trade Control Laws for a minimum of five (5) years from the date of export or re-export; the date of expiration of any applicable license; or, other approval or reliance on any application of license exception or exemption. 8.5 No Implied Warranties. EXCEPT AS SET FORTH IN THE MANUFACTURING AND SUPPLY AGREEMENT, AND WITHOUT LIMITING EITHER PARTY’S INDEMNIFICATION OBLIGATIONS UNDER SECTION 9.2, THE WARRANTIES EXPRESSLY SET OUT IN THIS AGREEMENT ARE THE ONLY WARRANTIES GIVEN BY EITHER PARTY HEREIN AND ARE MADE IN LIEU OF, AND EACH PARTY EXPRESSLY DISCLAIMS, ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY, IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE, OR IMPLIED WARRANTY OF NON-INFRINGEMENT. Article 9 Indemnification 26 9.1 By Viatris. Viatris shall indemnify Lexicon, and its directors, officers, employees and agents, and hold each of them harmless from and against any and all Losses (including personal injury, death or property damage) arising out of or resulting from any Third Party claim, to the extent based on or attributable to: (a) the negligence, willful misconduct or fraud of Viatris, or its Affiliates, or their respective directors, officers, employees or agents in performing any of Viatris’ obligations, or exercising any of Viatris’ rights, under this Agreement, (b) any breach or misstatement by Viatris of any of its representations or warranties under this Agreement, (c) any breach by Viatris of any of Viatris’ covenant or obligations under this Agreement (d) any Development by or on behalf of Viatris or any of its Affiliates of the Product, or (e) any Commercialization by or on behalf of Viatris or any of its Affiliates of the Product, except in each case (a)-(e) to the extent any claims are related to the failure of the Product as delivered by Lexicon to Viatris to meet the specifications set forth in the Manufacturing and Supply Agreement. Viatris shall not be liable under this Section 9.1 in the event that Lexicon settles any such claim without the prior written consent of Viatris, which consent shall not be unreasonably withheld, conditioned, delayed or denied. 9.2 By Lexicon. Lexicon shall indemnify Viatris, and its directors, officers, employees and agents, and hold each of them harmless from and against any and all Losses (including personal injury, death or property damage) arising out of or resulting from any Third Party claim, to the extent based on or attributable to: (a) the negligence, willful misconduct or fraud of Lexicon or its Affiliates, or their respective directors, officers, employees or agents, in performing any of Lexicon’s obligations, or exercising any of Lexicon’s rights, under this Agreement, (b) any breach or misstatement by Lexicon of any of its representations or warranties under this Agreement or (c) any breach by Lexicon of any of Lexicon’s obligations under this Agreement. Lexicon shall not be liable under this Section 9.2 in the event that Viatris settles any such claim without the prior written consent of Lexicon, which consent shall not be unreasonably withheld, delayed or denied. 9.3 Exceptions. No indemnification shall be made to a Party to the extent the applicable Losses arise out of, result from or involve (a) the gross negligence, willful misconduct or fraud of such Party or its Affiliates, or their respective directors, officers, employees or agents, or (b) the material breach by such Party of its obligations, representations or warranties under this Agreement or the Manufacturing and Supply Agreement. 9.4 Procedure. A Party seeking indemnification (the “Indemnified Party”) shall notify, in writing, the other Party (the “Indemnifying Party”) within fifteen (15) days of the assertion of any claim or discovery of any fact upon which the Indemnified Party intends to base a claim for indemnification under Article 9. An Indemnified Party’s failure to so notify the Indemnifying Party shall not, however, relieve such Indemnifying Party from any liability under this Agreement to the Indemnified Party with respect to such claim except to the extent that such Indemnifying Party is actually denied, during the period of delay in notice, the opportunity to remedy or otherwise mitigate the event or activity giving rise to the claim for indemnification and thereby suffers or otherwise incurs additional liquidated or other readily quantifiable damages as a result of such failure. The Indemnifying Party, while reserving the right to contest its obligations to indemnify hereunder, shall be responsible for the defense of any claim, demand, lawsuit or other proceeding in connection with which the Indemnified Party claims indemnification hereunder. The Indemnified Party shall have the right, at its expense, to participate jointly with the Indemnifying Party in the defense of any such claim, demand, lawsuit or other proceeding, but with respect to 27 any issue involved in such claim, demand, lawsuit or other proceeding with respect to which the Indemnifying Party has acknowledged its obligation hereunder, the Indemnifying Party shall have the right to select counsel, settle, try or otherwise dispose of or handle such claim, demand, lawsuit or other proceeding on such terms as it shall deem appropriate, subject to any reasonable written objection of the Indemnified Party. 9.5 Limitation. Except with respect to fraud, any breach of Section 2.5, Article 10, Article 11, or a Party’s indemnification obligations under Section 9.1 or 9.2 (as applicable), in no event shall either Party be liable to the other for any indirect, incidental special, consequential or punitive damages, arising in any way out of this Agreement, whether based UPON WARRANTY, CONTRACT, TORT, STRICT LIABILITY, OR OTHERWISE, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES OR LOSS. 9.6 Risk Insurance. Each Party shall, during the Term [**], obtain and maintain at its own cost and expense from a qualified insurance company (provided however that either Party may satisfy all or part of its obligation through its insurance captive or self-insurance) product liability insurance providing protection against any and all claims, demands, and causes of action arising out of any defects, alleged or otherwise, of the Product or its use, design or Manufacture, or any material incorporated in the Product. The amount of coverage shall be a minimum of [**] US Dollars ($[**] USD) combined single limit coverage for each occurrence for bodily injury or for property damage and shall be provided from an insurance company qualified to write global product liability coverage. Each Party agrees, upon request, to furnish the other Party with a certificate of insurance evidencing such insurance coverage (at the execution of this Agreement and at each subsequent renewal) and shall provide the other Party with a thirty (30) calendar day notice of cancellation or non-renewal of such coverage. Article 10 Intellectual Property 10.1 Litigation Strategy and Management. With regard to the Licensed Intellectual Property and subject to the terms and conditions of this Article 10, Viatris shall have the right to conduct applicable intellectual property searches and freedom-to-operate analyses, and control and initiate strategic decisions relating to potential intellectual property litigation and post-grant review proceedings, using counsel of its choice. 10.2 Defensive Actions. 10.2.1 Notice. Each Party shall promptly notify the other Party if any Third Party claims or asserts that the Manufacture, Development or Commercialization of the Product by either Party, its Affiliates, or their respective licensees or sublicensees infringes or misappropriates any Intellectual Property of a Third Party, or otherwise threatens or initiates any litigation or proceeding in any court or Governmental Body that could delay Marketing Approval of the Product or result in withdrawal or suspension of such Marketing Approval, including, without limitation, litigation arising from or related to patent infringement litigation and citizen’s petitions (any such litigation or proceeding, a “Defensive Action”). 28 10.2.2 Control. Viatris shall have the exclusive right to defend and control any such Defensive Action that is initiated or pursued in the Territory, or to bring and control any declaratory judgment action with respect thereto, using counsel of its own choice, as well as negotiating and settling any Defensive Action subject to the restrictions provided below in Section 10.2.3. Lexicon agrees to provide reasonable assistance in any such proceeding, at Viatris’s request and expense, including joining as a party plaintiff as necessary or useful and entering into a common interest or joint defense agreement wherein the Parties agree to their shared, mutual interest in the outcome of such Defensive Action or declaratory judgment action. 10.2.3 Costs of Defensive Actions in the Territory. In the event that any Defensive Action is initiated or pursued in the Territory, or Viatris pursues a declaratory judgment proceeding in the Territory with respect thereto, Viatris shall bear all legal defense costs and expenses, attorneys’ fees and liability incurred in connection with such Defensive Action or declaratory judgment action or proceeding, when and as incurred; provided that Viatris may deduct a portion of such costs and expenses from any Royalty payments due pursuant to Section 6.3 to the extent set forth in Section 6.3.4, mutatis mutandis. In the event that Viatris, its Affiliate or sublicensee is required, under a license agreement, settlement agreement or otherwise, to pay to a Third Party royalties, milestones, and other payments for patent rights owned or Controlled by such Third Party that are reasonably necessary for the exploitation of the Product in the Field in the Territory, then Viatris shall be entitled to offset such amounts against royalties payable to Lexicon hereunder to the extent set forth in Section 6.3.4. 10.3 Favorable Settlement. Should a favorable settlement or judgment in such Defensive Action be reached, any such amount or valuable consideration shall be allocated first to Viatris as reimbursement for its costs and expenses incurred with respect to such Defensive Action and any remainder after such reimbursement shall treated as Net Sales. 10.4 Ownership of Inventions. Subject to the licenses set forth in Article 2 and the rights set forth in this Article 10, Lexicon shall retain ownership of the Licensed Intellectual Property. As between the Parties, all right, title and interest to any Intellectual Property or Trademark (including any goodwill thereunder) conceived, created or first reduced to practice in connection with the exercise of rights or performance of obligations under this Agreement (“Inventions”) (a) by or under the authority of Viatris or its Affiliates or sublicensees independently of Lexicon and its Affiliates (each, a “Viatris Invention”) shall be owned by Viatris; (b) by or under the authority of Lexicon or its Affiliates or other licensees independently of Viatris and its Affiliates shall be owned by Lexicon; and (c) jointly by personnel of Viatris or its Affiliates and Lexicon or its Affiliates (each, a “Joint Invention”) shall be jointly owned by Viatris and Lexicon. Any patent or patent application that claims a Joint Invention may be referred to herein as a “Joint Patent”. Lexicon’s interest in any Inventions that are necessary or useful to Develop, Manufacture or Commercialize the Product in the Field in the Territory, and all Intellectual Property rights therein, shall be automatically included in the Licensed Intellectual Property. Except as expressly provided otherwise in this Agreement, neither Party shall have any obligation to obtain any approval of the other Party for, nor pay the other Party any share of the proceeds from or otherwise account to the other Party for, the practice, enforcement, licensing, assignment or other exploitation of such jointly owned Inventions, and each Party hereby waives any right it may have under the laws of any country to require such approval, sharing or accounting.
29 Notwithstanding anything to the contrary in this Agreement, but subject to the rights and licenses granted to Viatris under Article 2 and this Article 10, as between the Parties, each Party retains ownership of its Intellectual Property conceived, created or first reduced to practice before the Effective Date. 10.5 Joint Research Agreement. Subject matter disclosed or claimed in any patent application filed by either or both Parties after the Effective Date that relates to an Invention may be considered as having been made under a “joint research agreement” within the meaning of 35 U.S.C. § 102(c). 10.6 Prosecution and Maintenance of Licensed Intellectual Property and Joint Patents. Lexicon shall have the sole right (but not the obligation) to prepare, file, prosecute (including the handling of inter partes review, post grant review, ex parte reexamination, supplemental examination, opposition and similar proceedings) and maintain (e.g., manage annuity payments for) (collectively, “Patent Prosecution”) the Licensed Intellectual Property and Joint Patents (but, for clarity, not patents or patent applications that claim any Viatris Inventions), for each country in the Territory, at the Parties’ equally shared expense. In the event Lexicon elects not to exercise such right, Lexicon shall provide Viatris reasonable written notice to such effect, sufficiently in advance to permit Viatris, in its sole discretion and expense, to undertake such Patent Prosecution, and Viatris may, upon written notice to Lexicon thereafter undertake such Patent Prosecution. The Party undertaking such Patent Prosecution shall keep the other Party reasonably informed with respect to the status of the Licensed Intellectual Property and Joint Patents, including by providing the other Party with copies of all material documentation or correspondence concerning the Licensed Intellectual Property and Joint Patents. The party undertaking such Patent Prosecution shall solicit the other Party’s comments prior to responding to patent office actions or communications pertaining to the Licensed Intellectual Property and Joint Patents before filing any new Intellectual Property in the Territory relating to the Product in the Field, and shall consider the other Party’s reasonable comments with respect thereto in good faith. The Party undertaking such Patent Prosecution shall not intentionally abandon or otherwise fail to prosecute or maintain any Licensed Intellectual Property or Joint Patents without first notifying the other Party in writing at least ninety (90) days prior to any applicable filing deadline, and shall notify the other Party immediately upon learning of the inadvertent abandonment of any Licensed Intellectual Property or Joint Patents. 10.7 Enforcement of Licensed Intellectual Property and Joint Patents. Each Party shall promptly report to the other Party during the Term after the Effective Date any known or suspected infringement or unauthorized use of any Licensed Intellectual Property in the Territory or Joint Patent (each, an “Infringement Notice”), as the case may be, of which such Party becomes aware, and, upon request, shall provide the other Party with all evidence within its possession or control supporting such known or suspected infringement or unauthorized use. Viatris will have the first right but not the obligation to enforce (a) the Licensed Intellectual Property against any Third Party infringement based on the Manufacture, Development or Commercialization of the Product in the Field in the Territory or (b) the Joint Patents against any Third Party infringement in the Field in the Territory. If Viatris elects to pursue such an enforcement action, Viatris shall be solely responsible for the expenses associated with such action and Lexicon shall cooperate in any such enforcement action at Viatris’s expense (including by joining as a party plaintiff to the extent 30 necessary for the purposes of sustaining such enforcement action or as reasonably requested by Viatris). In the event that Viatris does not undertake such an enforcement action within ninety (90) days of the Infringement Notice, Lexicon shall be permitted to do so and, if it elects to undertake such an enforcement action, Lexicon shall be solely responsible for the expenses associated with such action. If a Party is authorized to bring an enforcement action under this Section 10.7, but the Party is not recognized by the applicable court or other relevant body as having the requisite standing to pursue such action, then the other Party shall, at the enforcing Party’s request and expense, join as a party-plaintiff. Any damages, awards, settlement payments or other recoveries resulting from an enforcement action brought by Viatris pursuant to this Section 10.7 with respect to infringement of the Licensed Intellectual Property in the Field in the Territory based on the Manufacture, use, sale or importation of the Product, or with respect to infringement of the Joint Patents in the Field in the Territory, shall be shared in the following manner: (i) Viatris shall be reimbursed for all expenses incurred in connection with bringing and maintaining the enforcement action; (ii) the remainder of the recovery, after payment of expenses, shall be [**]. Any damages, awards, settlement payments or other recoveries resulting from an enforcement action brought by Lexicon pursuant to this Section 10.7 with respect to infringement of the Licensed Intellectual Property in the Field in the Territory based on the Manufacture, use, sale or importation of the Product, or with respect to infringement of the Joint Patents in the Field in the Territory, shall be allocated to Lexicon. Article 11 Confidentiality 11.1 Confidential Information. For the purposes of this Agreement, “Confidential Information” means all confidential or proprietary verbal, written, electronically transmitted or machine reproduced information, chemical structures, data, documents, methods and Intellectual Property of or relating to the Product or to the business of a Party (the “Disclosing Party”) or its Affiliates, already provided or disclosed by the Disclosing Party or its Affiliates to the other Party (the “Receiving Party”), or which will be provided to the Receiving Party under this Agreement, and all internal materials, data, results, reports and other documents generated by or on behalf of the Receiving Party to the extent containing or regarding such information, data, documents, methods and Intellectual Property of the Disclosing Party. 11.2 Obligations. The Receiving Party shall hold the Disclosing Party’s Confidential Information in confidence using not less than the efforts such Receiving Party uses to maintain in confidence its own confidential or proprietary information of similar kind and value, but in no event less than a reasonable degree of care. The Receiving Party shall not use any Confidential Information of the Disclosing Party except as necessary to perform the Receiving Party’s obligations, or exercise rights granted to the Receiving Party, under this Agreement, and the Receiving Party shall maintain the Disclosing Party’s Confidential Information in confidence and shall not disclose the Disclosing Party’s Confidential Information to any Third Party without the prior written consent of the Disclosing Party, except that the Receiving Party may disclose the Disclosing Party’s Confidential Information: (a) to the Receiving Party’s employees, consultants, and advisors, and to the employees, consultants, and advisors of such Receiving Party’s Affiliates (collectively, “Representatives”), who have a need to know such information and materials for performing the Receiving Party’s obligations, or exercising rights expressly granted to the 31 Receiving Party, under this Agreement and are subject to obligations of non-use and confidentiality with respect to such information that are no less protective of such Confidential Information than are the provisions of this Agreement; (b) to Regulatory Authorities in order to seek or obtain Marketing Approvals with respect to the Product; or (c) if such disclosure is required by applicable Law or to defend or prosecute litigation or arbitration or to the extent, and to the individuals and entities, required by rules of any securities exchange, as long as (i) prior to such disclosure, to the extent permitted by applicable Law, the Receiving Party notifies the Disclosing Party of such requirement to enable to the Disclosing Party to seek any available exemptions from or limitations on such disclosure requirement and will reasonably cooperate in such efforts by the Disclosing Party and (ii) the Receiving Party furnishes only that portion of the Disclosing Party’s Confidential Information that the Receiving Party is legally required to furnish. The Receiving Party shall remain liable for any breach of this Agreement by its Representatives. 11.3 Exceptions. The Receiving Party shall not have any obligation under this Article 11 with respect to any of the Disclosing Party’s Confidential Information which: (a) at the time of disclosure to the Receiving Party by the Disclosing Party is already generally available or known to the public; (b) after disclosure by the Disclosing Party to the Receiving Party becomes generally available or known to the public through no wrongful act or omission by or on behalf of the Receiving Party; (c) is already lawfully in the possession of the Receiving Party at the time disclosure by the Disclosing Party to the Receiving Party and such possession is documented by written evidence; or (d) is received, under no obligation of confidentiality, from a Third Party with lawful possession of such Confidential Information and having the right to disclose same to the Receiving Party and who is not bound by a similar confidentiality agreement. 11.4 Unauthorized Use. In case either Party becomes aware or has knowledge of any unauthorized use or disclosure of the other Party’s Confidential Information, it shall promptly notify the other Party of such unauthorized use or disclosure and, at the other Party’s reasonable request and expense, shall take all reasonable steps to assist the other Party in attempting to minimize any potential or actual damages or losses resulting from such unauthorized use or disclosure. 11.5 Return of Documents. Each Party, following the expiration or termination of this Agreement or upon receipt of a written request from the other Party at any time, shall promptly return to the other Party or destroy all Confidential Information of such other Party, including all reproductions and copies thereof together with all internal material and documents generated by it containing such Confidential Information or references thereto, from which references the substance of such Confidential Information can be implied or understood, and shall delete all references thereto stored electronically. However, notwithstanding the foregoing, each Party may retain electronic files containing Confidential Information that are made in the ordinary course of its business information back-up procedures pursuant to its electronic record retention and 32 destruction practices that apply to its own general electronic files and information, subject to the confidentiality and non-use provisions set forth in this Article 11. 11.6 Ownership Rights. Each Party agrees that it shall not claim to have any rights, title or ownership in the Confidential Information provided by the other Party, and that rights, title and ownership in such Confidential Information shall, as between the Parties, rest in the other Party. 11.7 Publicity; Filing of this Agreement. Any publication, news release or other public announcement, in any media form or channel, relating to this Agreement or to the performance hereunder shall first be reviewed and approved by both Parties; provided, however, that any publication, news release or other public announcement relating to this Agreement which is required to be made by applicable Law as advised by the Disclosing Party’s counsel may be made without the prior consent of the other Party; provided further, however, to the extent practicable, the Confidential Information of the Disclosing Party shall be redacted, the Disclosing Party shall be given at least three (3) business days advance notice of any such legally required disclosure, and the other Party shall provide any comments on the proposed disclosure during such period. To the extent that either Party determines that it or the other Party is required to file or register this Agreement or a notification thereof to comply with the requirements of an applicable securities exchange or any Governmental Body, prior to making any such filing, registration or notification, the Parties shall agree on the provisions of this Agreement for which the Parties shall seek confidential treatment, it being understood that if one Party determines to seek confidential treatment for a provision for which the other Party does not, then the Parties will use reasonable efforts in connection with such filing to seek the confidential treatment of any such provision. The Parties shall cooperate, each at its own expense, in such filing, registration or notification, including without limitation such confidential treatment request, and shall execute all documents reasonably required in connection therewith. Without limiting the generality of the foregoing, the Parties acknowledge and agree that the press release attached as Exhibit E hereto may be issued and used by either Party without any further approval from the other Party. Notwithstanding the foregoing, Viatris may publish the results of its Development activities in the Territory without Lexicon’s prior written consent; provided that (a) Viatris shall provide Lexicon a copy of any manuscript or other disclosure of such results at least thirty (30) days prior to its submission for publication and (b) Viatris shall consider in good faith Lexicon’s reasonable comments and suggestions with respect to such publications or disclosures. 11.8 Term. The provisions of this Article 11 shall survive the expiry or termination of the Agreement with respect to each item of Confidential Information for a period of five (5) years following the date of such expiry or termination. 11.9 Injunctive Relief. In the event of a breach of this Article 11 by a Party, money damages may be inadequate and, in such case, the non-breaching Party would not have adequate remedy at law and the non-breaching Party, in addition and supplementary to other rights and remedies existing in their favor, may apply to any court of law or equity of competent jurisdiction for specific performance, injunctive relief, or other relief in order to enforce or prevent any violations of such covenants or agreements (without posting a bond or other security).
33 Article 12 Term and Termination 12.1 Term. This Agreement shall commence on the Effective Date and shall continue until all payment obligations hereunder have been satisfied, unless earlier terminated in accordance with the terms hereof (the “Term”). Following the expiration of the Term (but not following an earlier termination of this Agreement), the licenses granted to Viatris under Section 2.1 and 4.4.2 shall become fully paid-up and shall survive such expiration. 12.2 Termination. This Agreement may be terminated as follows: (a) By either Party, if the other Party commits a material breach of this Agreement and: (i) fails to remedy the breach within thirty (30) days of being notified by the non- breaching Party in writing to do so; or (ii) where remedy of the breach is not reasonably possible within thirty (30) days, fails to propose a plan within fifteen (15) days which, in the reasonable opinion of the non-breaching Party, is capable of providing a remedy of the breach within ninety (90) days and thereafter fulfills such plan within such ninety (90) day period. (b) By either Party upon written notice if any of the following events has occurred with respect to the other Party: (a) the making by the other Party of a general assignment for the benefit of creditors, (b) the commencement by the other Party of any voluntary petition in bankruptcy or suffering by it of the filing of an involuntary petition of its creditors, (c) the suffering by the other Party of the appointment of a receiver to take possession of all, or substantially all, of its assets, (d) the suffering by the other Party of the attachment or other judicial seizure of all, or substantially all, of its assets, (e) the admission by the other Party in writing of its inability to pay its debts as they come due, or (f) the making by the other Party of an offer of settlement, extension or composition to its creditors generally. (c) By Viatris upon written notice, on a country-by-country basis in any country where there is a permanent recall or withdrawal of the Product. (d) By Viatris, on a country-by-country basis or this Agreement in its entirety, in its sole discretion, upon six (6) months’ written notice to Lexicon. 12.3 Effects of Termination. Following termination by Viatris pursuant to Section 12.2(d): (a) at Lexicon’s option, Viatris shall, as soon as reasonably practicable, transfer and assign to Lexicon, at Lexicon’s expense, all (i) regulatory filings and approvals (including any Marketing Approvals) and other documented technical and other information or materials received by Viatris from Lexicon pursuant to this Agreement and (ii) any other material documentation, records and data then in Viatris’ possession that has been generated with respect to the Product and is necessary or useful to enable Lexicon to continue Development and Commercialization of the Product in the Territory, except that Viatris may retain a copy of such items solely for its legal records, in each case (i) and (ii), solely for the country(ies) subject to such termination; (b) Lexicon shall have the option, exercisable within thirty (30) days following the effective date of such termination, to 34 purchase all or any portion of Viatris’ inventory of the Product at the price at which Viatris received the Product under the Manufacturing and Supply Agreement, which option Lexicon may exercise by written notice to Viatris during such thirty (30) day period (and, in the event Lexicon exercises such right to purchase such inventory, Viatris shall grant, and hereby does grant, a royalty-free right and license to any trademarks, names, and logos of Viatris contained therein for the remaining shelf life of the inventory solely to permit the orderly sale of such inventory); (c) Viatris shall grant, and is hereby deemed to grant, to Lexicon, effective as of the effective date of termination of this Agreement pursuant to Section 12.2(d), a non-exclusive worldwide, sublicensable (through multiple tiers), royalty-free, fully paid-up right and license under the Viatris Reversion Intellectual Property and Trademarks to Develop and Commercialize the Products in the Field; and (d) if [**], then Viatris shall [**]. 12.4 Remedies Not Limited. The termination of this Agreement by either Party shall not limit remedies that may be otherwise available. 12.5 Survival. Expiration or termination of this Agreement for any reason shall not relieve either party of its obligations that have accrued prior to the expiration or termination of this Agreement. In addition, Article 1, Article 7, Article 8, Article 9, Article 11, Article 13 and Sections 3.4, 6.3.5, 6.4, 6.6, 6.8, 6.9, 6.10, 6.11, 12.4, and 12.5 shall survive expiration or termination of this Agreement. Article 13 Miscellaneous 13.1 Force Majeure. Each Party shall be excused from the performance of its obligations under this Agreement, and no failure or omission by a Party in the performance of any obligation of this Agreement shall be deemed a breach of this Agreement or create any liability if the same shall arise from any cause or causes beyond the control of such Party, (including the following: acts of God; acts or omissions of any government; any rules, regulations or orders issued by any governmental authority or by any officer, department, agency or instrumentality thereof; labor disputes, epidemic, failure or default of public utilities or common carriers, fire; storm; flood; earthquake; accident; war; rebellion; terrorism; insurrection; riot; and invasion) and such excuse shall be continued so long as the condition constituting force majeure continues; provided, that such failure or omission resulting from one of the above causes is cured as soon as is practicable after the end of the occurrence of one or more of the above-mentioned causes. The Party claiming such force majeure shall notify the other Party with notice of the force majeure event as soon as practicable, but in no event longer than five (5) business days after its occurrence, which notice shall reasonably identify the affected obligations under this Agreement and the extent to which performance thereof will be affected. In such event, the Parties shall meet and/or discuss promptly to determine an equitable solution to minimize and if reasonably feasible, overcome, the effects of any such event. 13.2 Notices. Any notice required or permitted to be given hereunder shall be in writing and shall be delivered in person, by a nationally recognized overnight courier, or by registered or certified airmail, postage prepaid, to the addresses given below or such other addresses as may be 35 designated in writing by the Parties from time to time during the Term, and shall be deemed to have been given upon receipt. (a) if to Lexicon: Lexicon Pharmaceuticals, Inc. 2445 Technology Forest Blvd., 11th Floor The Woodlands, Texas 77381 USA Attention: Chief Executive Officer with copies (which shall not constitute notice) to: Lexicon Pharmaceuticals, Inc. 2445 Technology Forest Blvd., 11th Floor The Woodlands, Texas 77381 USA Attention: General Counsel and Wilmer Cutler Pickering Hale & Dorr LLP 60 State Street Boston, Massachusetts 02109 USA Attention: Steven D. Barrett Facsimile: +1 (617) 526-5000 (b) if to Viatris: Viatris Inc. 1000 Mylan Blvd. Canonsburg, PA 15317Attention: Brian Roman, Chief Legal Officer with copies (which shall not constitute notice) to: Wilson Sonsini Goodrich & Rosati, P.C. 1700 K Street NW, Fifth Floor Washington, D.C. 20006-3814 US Attention: Daniel Keating Any such notice or other communication shall be deemed to have been given and received on the day on which it was delivered or transmitted (or, if such day is not a business day, on the next following business day) or, if mailed, on the date on which it was received. Either Party may change its address for service from time to time by giving notice thereof to the other Party in accordance with this Section. 13.3 Amendments. No amendment or waiver shall be binding on either Party unless consented to in writing by such Party. No waiver of any provision of this Agreement shall 36 constitute a waiver of any other provision, nor shall any waiver constitute a continuing waiver unless otherwise expressly provided. 13.4 Jurisdiction. Any dispute arising out of or relating to this Agreement shall be subject to the exclusive jurisdiction of the state and federal courts in New York City, New York, U.S.A. and each Party hereby submits to such jurisdiction. 13.5 Entire Agreement. This Agreement constitutes the entire agreement between the Parties with respect to the subject matter hereof and supersedes all prior and contemporaneous agreements, understandings, letters of intent, negotiations and discussions, whether written or oral, with respect to such subject matter including the Confidentiality Agreement between Viatris and Lexicon dated May 6, 2024. There are no conditions, covenants, agreements, representations, warranties or other provisions, express or implied, collateral, statutory or otherwise, relating to the subject matter hereof except as herein provided. This Agreement shall not be changed or modified except in writing. 13.6 Assignment. Neither this Agreement nor any interest hereunder will be assignable or delegable by either Party without the prior written consent of the other Party, except as follows: (a) a Party may, subject to the terms of this Agreement, assign its rights and delegate its obligations under this Agreement in whole to its successor-in-interest in connection with the sale of all or substantially all of its assets to which this Agreement specifically relates, whether in a merger, acquisition, or similar transaction or series of related transactions, as long as such successor-in- interest agrees in writing to be bound by the terms and conditions of this Agreement and any ancillary agreements, including the Manufacturing and Supply Agreement and Pharmacovigilance Agreement; and (b) a Party may assign its rights and delegate its obligations under this Agreement to any of its Affiliates; provided that, in the case of Lexicon’s assignment of this Agreement pursuant to the foregoing, if the JSC is unable to reach a consensus on a particular issue over which the JSC governs, subject to the escalation process set forth in Section 5.2.3, the assignee or successor in interest shall have no final decision making authority under the JSC under Article 5 and Viatris shall have sole final decision making authority under the JSC under Article 5. The assigning Party shall remain liable for all of its rights and obligations under this Agreement except as may otherwise be agreed in writing by the non-assigning Party (such agreement not to be unreasonably withheld, conditioned, delayed or denied). This Agreement and all ancillary agreements, including the Manufacturing and Supply Agreement and Pharmacovigilance Agreement, will be binding upon the successors and permitted assigns of the Parties and the name of a Party appearing herein will be deemed to be replaced by the names of such Party’s successors and permitted assigns to the extent necessary to carry out the intent of this Agreement. Any assignment not in accordance with this Section 13.6 will be null, void, and of no legal effect. 13.7 Further Assurances. Each Party will, from time to time subsequent to the date hereof, at the request and expense of any other Party, execute and deliver all such documents and do all such other reasonable acts and things as that other Party, acting reasonably, may from time to time request be executed or done in order to better evidence or perfect or effectuate any provision of this Agreement or any of the respective obligations intended to be created hereby or thereby.
37 13.8 Counterparts. This Agreement may be executed in counterparts, each of which shall constitute an original and all of which taken together shall constitute one and the same instrument in effect as of the Effective Date. 13.9 Governing Law. This Agreement shall be governed by and interpreted in accordance with the Laws of the State of New York of the United States, without reference to its conflict of law provisions. 13.10 Relationship of the Parties. The relationship between the Parties is that of independent contractors and each Party agrees to conduct its affairs accordingly. Neither Party shall, by reason of this Agreement, be deemed to be a member of a partnership or joint venture with the other Party. 13.11 International Sale of Goods. The Parties acknowledge that the Convention on the International Sale of Goods shall not apply to this Agreement. 13.12 Currency. Unless otherwise specified, all references to money amounts are to the lawful currency of the United States. 13.13 Severability. If any provision or portion thereof in this Agreement is for any reason invalid, illegal, or unenforceable, then the same will not affect any other portion of this Agreement, as it is the intent of the Parties that this Agreement will be construed in such fashion as to maintain its existence, validity, and enforceability to the greatest extent possible. In any such event, this Agreement will be construed as if such provision or portion thereof had never been contained in this Agreement, and there will be deemed substituted therefor such provision as will most nearly carry out the intent of the Parties as expressed in this Agreement to the fullest extent permitted by applicable Law unless doing so would have the effect of materially altering the rights and obligations of the Parties, in which event, this Agreement may be terminated by mutual written agreement of the Parties. 13.14 Interpretation. In this Agreement, words importing the singular number only shall include the plural and vice versa and words importing gender shall include all genders. Except where the context expressly requires otherwise, (a) the words “include”, “includes,” “including,” and “e.g.” will be deemed to be followed by the phrase “without limitation,” (b) the word “will” will be construed to have the same meaning and effect as the word “shall,” (c) the term “or” will be interpreted in the inclusive sense commonly associated with the term “and/or,” and (d) the captions to the Articles and Sections hereof are not a part of this Agreement and shall not be used to inform interpretation of this Agreement, but are merely guides or labels to assist in locating and reading the several Articles and Sections hereof. 13.15 Data Room. Promptly upon execution of this Agreement Lexicon shall deliver to Viatris a complete and correct copy of the entire contents of the data room which Lexicon made available to Viatris in connection with Viatris’s due diligence with respect to this Agreement. 38 IN WITNESS WHEREOF this Exclusive License Agreement has been executed by the Parties as of the date first hereinabove set out. LEXICON PHARMACEUTICALS, INC. By: ____________________________________ Name: Michael S. Exton, Ph.D. Title: Chief Executive Officer VIATRIS INC. By: ____________________________________ Name: Andrew Cuneo Title: President, JANZ and Emerging Markets Exhibit 10.15 [**] Certain information has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. EXHIBIT A Licensed Patents [**] EXHIBIT B-1 Licensed Trademarks [**]
Exhibit 10.15 [**] Certain information has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. EXHIBIT B-2 Internet Domain Names [**] Exhibit 10.15 [**] Certain information has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. EXHIBIT C Manufacturing Costs for Existing Lexicon Inventory [**] Exhibit 10.15 [**] Certain information has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. EXHIBIT D Manufacturing and Supply Agreement Terms1 1. Supply. During the term of the Manufacturing and Supply Agreement, Lexicon shall Manufacture (or have Manufactured) and sell to Viatris all of Viatris’ requirements of the Product for its Development and Commercialization activities in the Territory; provided, that such requirements shall not exceed the quantities of the Product reasonably necessary for such Development and Commercialization activities. Lexicon shall supply Viatris with drug substance or finished dosage form (with such primary and secondary packaging as the Parties from time to time agree upon) of the Product, as agreed by the Parties (such agreement not to be unreasonably withheld, delayed or conditioned) and specified in the Manufacturing and Supply Agreement, and shall promptly notify Viatris of any manufacturing issues that may affect the supply of the Product to Viatris, including quality issues, capacity limitations and expected supply shortage. 2. Supply Cost. Viatris shall pay Lexicon, within [**] following Viatris’ receipt of Lexicon’s invoices, Lexicon’s Manufacturing Costs plus [**] percent ([**]%) for all supply of the Product, up to a maximum of $ [__] per each unit of Product. Lexicon shall use Commercially Reasonable Efforts to make continuous improvements that will achieve cost savings with respect to its Manufacturing Costs. Lexicon shall promptly notify Viatris as to the nature and amount of any cost savings with respect to its Manufacturing Costs and the Manufacturing Cost as a result of such cost savings shall be reduced accordingly. 3. Term. The term of the Manufacturing and Supply Agreement will be [__] years. The Manufacturing and Supply Agreement will automatically renew for additional [__] year periods until terminated in accordance with the terms thereof. The Manufacturing and Supply Agreement shall automatically terminate upon the expiration or earlier termination of this Agreement. Viatris may terminate the Manufacturing and Supply Agreement for any reason upon [**] prior written notice to Lexicon. 4. Discontinuation of Supply Obligations. Effective at any time following the expiration or termination of the Royalty Term, Lexicon may elect, by providing [**] prior written notice to Viatris to such effect, to discontinue its supply obligations pursuant to the Manufacturing and Supply Agreement. Upon the expiration or earlier termination of the Manufacturing and Supply Agreement, Lexicon shall (i) reasonably support Viatris (or its designated Third Party) in transitioning the Manufacturing of the Product to Viatris (or its designated Third Party) for its Development and Commercialization needs in the Territory and (ii) grant Viatris (or its designated Third Party) a non-exclusive, irrevocable, perpetual right and license (with the right to grant sublicenses, solely in accordance with Section 2.2) to any Licensed Intellectual Property reasonably necessary or useful for the Manufacture of the Product. 5. Delivery Terms. 1 Note to Exhibit: The Parties will further discuss any bracketed terms in good faith and will conform such terms with Lexicon’s contract manufacturing agreement(s) for the Product, as applicable. Lexicon shall deliver the Product to Viatris [**] (Incoterms 2020). The Product shall be delivered with a minimum of [**] remaining shelf-life. Title and risk of loss and damage to the Product shall remain with Lexicon until the Product is delivered to Viatris or its carrier in accordance with the foregoing. At the time of delivery, Lexicon shall, to the extent applicable, provide to Viatris all necessary shipping and import/export documentation. 6. Forecasts and Purchase Orders. Within [**] following the approval of a clinical study by a Regulatory Authority in a country in the Territory (as contemplated by a Development Plan), Viatris shall provide Lexicon with an initial forecast of the quantities of the Product and placebo estimated to be required for such clinical study (which quantities shall be in multiples of the minimum quantities referenced in Exhibit C; provided that such quantities may be aggregated between multiple countries in the Territory). At least [**] prior to the anticipated receipt of the first Marketing Approval of the Product in any country in the Territory, Viatris shall provide Lexicon with an initial forecast of the quantities of the Product estimated to be required for its Commercialization activities for the initial [**] period (which quantities shall be in multiples of the minimum quantities referenced in Exhibit C; provided that such quantities may be aggregated between multiple countries in the Territory); provided that no portion of the initial forecast shall be binding until [**] prior to the Marketing Approval in the applicable Territory. Thereafter during the term of the Manufacturing and Supply Agreement, on the [**], Viatris shall prepare and deliver to Lexicon a rolling forecast of the quantities of the Product estimated to be required for each month during the next [**] period (each, a “Forecast”). For each Forecast, the forecasted quantities for the first [**] shall be binding on the Parties and the forecasted quantities for months [**] through [**] shall be non-binding on the Parties. Together with each Forecast, Viatris shall place purchase orders for the binding portion of the Forecast. Such purchase order will specify the quantity of the Product and delivery dates in accordance with reasonable delivery schedules and lead times as may be agreed upon from time to time by the Parties; provided, however, that the required lead time shall not be less than [**] unless otherwise mutually agreed. Lexicon shall accept all purchase orders submitted by Viatris in accordance with this Section 6 within five (5) business days from receipt of the order, provided that the quantities of the Product ordered do not exceed [**] of the binding portion of Viatris’s then-current Forecast. Lexicon shall use Commercially Reasonable Efforts to accept orders for quantities in excess of [**] of the binding portion of the Forecast. In the event that Viatris receives no response from Lexicon regarding a purchase order within the five (5) business day period, the purchase order shall be deemed to have been confirmed by Lexicon on the terms set forth in the purchase order. 7. Supply Failure. Lexicon will promptly notify Viatris in writing in the event that Lexicon is unable or anticipates that it will be unable to supply compliant Product in accordance with the requirements of the Manufacturing and Supply Agreement in no less than [**] of the quantities specified in the most recent Forecast and within the delivery times requested by Viatris pursuant to Section 6 above (each a “Failure to Supply”). In the event of a Failure to Supply, in addition to any other rights or remedies available to Viatris (but subject to customary and reasonable limitation of liability provisions for a supply arrangement entered into pursuant to a license, development and commercialization agreement), Viatris shall have the right to take any measures available to it to mitigate such Failure to Supply, including using an alternate supplier of the Product during the period affected by such Failure to Supply. In the event that Lexicon anticipates a Failure to Supply, Lexicon shall, at Lexicon’s cost and expense, provide such assistance as is reasonably requested by Viatris to assist the alternate supplier in meeting Viatris’s requirements for the Product sufficiently in advance of any anticipated Failure to Supply. Viatris shall also have the right to terminate the Manufacturing and Supply Agreement in its entirety immediately upon written notice to Lexicon in the event a Failure to Supply (other than as caused by a force majeure event) continues for more than [**]. Viatris shall also have the right to cancel orders for any quantities of Product affected by such Failure
to Supply effective upon notice to Lexicon, and Viatris shall have no further obligations to purchase any such cancelled quantities of Product. Lexicon will, at Lexicon’s cost and expense, provide such assistance as is reasonably requested by Viatris to assist the alternate supplier in meeting Viatris’s requirements for the Product until Lexicon has remedied the cause of such Failure to Supply and is able to supply Product to Viatris in its requested quantities pursuant to Section 6 above. For any Failure to Supply (other than as caused by a force majeure event), Lexicon shall be liable for: (a) the cost of delivery to Viatris by freight, if required to meet Viatris’s commitments to its customers; and (b) any Third Party customer penalties, costs and expenses incurred by Viatris as a result of such Failure to Supply, subject in each case to customary and reasonable limitation of liability provisions for a supply arrangement entered into pursuant to a license, development and commercialization agreement. 8. Allocation. In the event of a global supply shortage, Lexicon shall allocate available supplies among Viatris and Lexicon’s other customers pro-rata. This paragraph shall, however, not apply to Viatris’ orders of the Product for Development activities conducted by Viatris, its Affiliates or sublicensees under this Agreement, which shall be fulfilled and timely delivered in full without allocation. 9. Quality Agreement. Lexicon shall Manufacture (or have Manufactured) the Product in accordance with the product specifications and cGMP and as set forth in a quality agreement setting out the responsibility of the Parties in connection with the Product’s quality control and quality assurance, to be negotiated in good faith and entered into by the Parties within [**] following the Effective Date (the “Quality Agreement”). 10. Representations and Warranties; Indemnity. The Manufacturing and Supply Agreement shall contain reasonable and customary representations and warranties, including, without limitation, that (a) the Product complies with the specifications as set forth in the Manufacturing and Supply Agreement and (b) the Manufacture, supply, testing and quality release of the Product complies with all applicable Laws. Each party shall indemnify the other party against all losses as a result of third party claims arising out of such party’s breach of any of its representations and warranties under the Manufacturing and Supply Agreement, except to the extent any such losses arise from a breach by the other party of any of its representations and warranties under the Manufacturing and Supply Agreement. 11. Miscellaneous. The Manufacturing and Supply Agreement shall also contain other reasonable and customary contract manufacturing terms. EXHIBIT E Mutually Agreed Press Release
Exhibit 19.1 Page 1 of 7 INSIDER TRADING AND CONFIDENTIALITY POLICY SECTION 1. PURPOSE The purpose of this Policy is to set forth the obligations and responsibilities of each director, officer and employee of Lexicon Pharmaceuticals, Inc. (“Lexicon” or the “Company”) with respect to Confidential Information and the prohibitions against insider trading. SECTION 2. DEFINITIONS 2.1. “Confidential Information.” Any proprietary information that is generally not known to the public and has not been purposefully disclosed to the public, including any information that Lexicon has obtained through a contractual relationship with another company and has agreed not to disclose through a confidentiality agreement or the like and any information that is subject to a confidentiality agreement, employment agreement or any other agreement between an Insider and Lexicon and any of its affiliates. 2.2. “Insiders.” Lexicon employees, officers, directors, members of their households, their designees, and entities controlled by any of the foregoing. SECTION 3. RESPONSIBILITY/APPLICABILITY 3.1. Applicability. This Policy applies to the Company and all Insiders, as well as any third- parties performing services on behalf of the Company that may, in the scope of that work, be exposed to material nonpublic information about the Company. 3.2. This Policy also applies to material nonpublic information relating to other companies, including Lexicon’s current or potential business partners, when that information is obtained by an Insider in the course of his or her employment or association with the Company. 3.3. This Policy continues to apply after an Insider has terminated his or her employment or association with the Company. SECTION 4. POLICY/GUIDELINES 4.1. Confidential Information. 4.1.1. Confidential Information is owned by Lexicon or its current or potential business partners from whom such Confidential Information is obtained. Serious problems may be caused by the unauthorized disclosure of Confidential Information, whether or not for the purpose of facilitating improper trading in the Company’s securities. Lexicon personnel should not discuss Confidential Information or any other internal Company matters or developments with anyone outside of the Company, except as required in the performance of regular corporate duties. Consistent with the foregoing, Insiders should be discreet with Confidential Information and not discuss it in places where it can be overheard, such as elevators, restaurants, taxis and airplanes. Insiders are strictly prohibited from discussing the Company, or posting Confidential Information, in Internet chat rooms, on Internet message boards or weblogs, or on Internet social media sites. Page 2 of 7 4.1.2. These prohibitions apply specifically (but not exclusively) to inquiries about the Company that may be made by the media, investment analysts or others in the financial community. It is important that all such communications on behalf of the Company, whether or not they involve confidential information, be made by or under the direction of an appropriately designated officer under carefully controlled circumstances. Unless you are expressly authorized to the contrary, if you receive any inquiries of this nature or any other inquiries from third parties, you should decline comment and refer the inquirer to the Corporate Communications Department. For more information please refer to Lexicon’s Corporate Communications Policy. 4.2. Insider Trading Prohibition. 4.2.1. General. It is Lexicon’s policy that no Insider shall purchase or sell any Company stock or other securities when such person is aware of material nonpublic information about the Company. Purchases and sales may be made on an Insider’s behalf under the terms of a trading plan established at a time when such person was not aware of material nonpublic information about the Company, provided that the trading plan satisfies the conditions of Rule 10b5-1 under the Securities Exchange Act of 1934. To promote compliance with the securities laws, it is Lexicon’s policy that directors, officers and designated employees will clear their transactions in advance in accordance with procedures established by the Company. 4.2.2. Material Nonpublic Information. Information should be considered material if it is information that a reasonable investor would consider to be important in deciding whether to purchase or sell Company stock. Examples of such information may include, depending on the particular circumstances, the following: • Clinical trial results • Financial results • Projections of future earnings or losses • News of a pending or proposed merger or acquisition • News of a significant strategic alliance or licensing agreement • Impending financial liquidity problems • News of the disposition of a subsidiary, division or line of business • Gain or loss of a significant customer, collaborator or supplier • Gain or loss of a significant license or other contract • Significant new product, discovery or line of business • Stock splits or dividends • New equity or debt offerings • Significant litigation exposure due to actual or threatened litigation • Major changes in management Page 3 of 7 Information should be considered to be public only if it has been sufficiently publicized by official announcements for the public to have had an opportunity to evaluate it. Thus, information is not public merely because it is reflected by rumors or other unofficial statements in the marketplace. Moreover, Insiders may not attempt to “beat the market” by trading simultaneously with, or shortly after, the official release of such information. In most cases, information should not be regarded as public until at least twenty four (24) hours after it has been disseminated through a national news medium. Obviously, though, what constitutes a reasonable waiting period will be dictated by the circumstances, such as the form of dissemination and the complexity of the information. If an Insider has doubts as to whether certain information is material nonpublic information, he or she should either consult with the Legal Department, or not trade in Company stock or other securities until such time as he or she is confident that such information has been made public or that such information is not material. 4.2.3. Periods in Which Purchases and Sales May Be Made. Lexicon policy does not strictly prohibit purchases and sales of Company stock and other securities during specified time periods following the end of a calendar quarter or year, provided that such purchases or sales are made (a) when such person is not aware of any material nonpublic information about the Company or (b) under the terms of a trading plan that satisfies the conditions of Rule 10b5-1 (described in more detail below). To limit even the appearance of improper trading, however, Lexicon strongly encourages all Insiders not to engage in transactions (purchases or sales) in Company stock or other securities, except for purchases or sales made under the terms of a preexisting Rule 10b5-1 trading plan, following the end of a calendar quarter or year, even if such individual is not aware of any material nonpublic information about the Company, until: • Such time as the Company has publicly announced results of operations and financial condition for such quarter or year (i.e., until twenty four (24) hours following the press release announcing such results), or • The Company has widely disseminated similar information (e.g., through distribution of a prospectus relating to a new securities offering). The Company’s public announcement of results of operations and financial condition for a quarter or year should not be construed as creating a “safe harbor” for purchases or sales of Company stock or other securities. No Insider should purchase or sell Company stock or other securities, even in the period following an annual or quarterly release of financial results, if he or she is aware of material nonpublic information about the Company. 4.2.4. Rule 10b5-1 Trading Plans. As noted above, Lexicon policy permits purchases and sales of Company stock and other securities to be made at any time on an Insider’s behalf under the terms of a trading plan established at a time when such person was not aware of material nonpublic information about the Company, provided that the trading plan satisfies the conditions of Rule 10b5-1 under the Securities Exchange Act of 1934. Page 4 of 7 Rule 10b5-1 provides an affirmative defense to insider trading liability for purchases and sales made under the terms of a trading plan established at a time when such person was not aware of material nonpublic information about the Company. A Rule 10b5-1 trading plan must: • specify the amount of securities to be purchased or sold, and the price and date on which such securities are to be purchased or sold; or • include a written formula for determining such amount(s), price(s), and date(s); or • delegate to a third party all decisions about how, when or whether to effect purchases or sales (and not permit the person establishing the plan to exercise any subsequent influence over such matters); provided that the third party to whom such decisions are delegated must not make such decisions when aware of material nonpublic information. For purposes of such trading plans: • the amount of the securities to be purchased or sold may be defined as either a specified number of shares or a specified dollar value of securities; • the price that the securities are to be purchased or sold may be defined as the market price on a particular date, a limit price or a particular dollar price; and • the date that the securities are to be purchased or sold may be defined, in the case of a market order, as the day of the year on which the order is to be executed (or as soon as possible under principles of best execution) and, in the case of a limit order, as any day of the year in which the limit order is enforced. Purchases and sales under a Rule 10b5-1 trading plan must be made in accordance with the terms of the plan. Any purchases or sales that deviate from those terms, and any opposite-way or hedging transactions that are made by the person establishing the plan, do not fall within a Rule 10b5-1 trading plan. A person establishing a Rule 10b5-1 trading plan may modify such plan when such person is not aware of material nonpublic information about the Company. To limit even the appearance of improper trading, Lexicon strongly encourages Insiders not to establish or modify a Rule 10b5-1 trading plan following the end of a calendar quarter or year until such time as the Company has publicly announced results of operations and financial condition for such quarter or year (i.e., until twenty four (24) hours following the press release announcing such results). In addition, Lexicon strongly encourages all persons establishing a Rule 10b5-1 trading plan to evidence such plan in writing. It is Lexicon’s policy that any Insider who purchases or sells Company stock or other securities under a Rule 10b5-1 trading plan shall be responsible for complying with all of the conditions of Rule 10b5-1. 4.2.5. Pre-Clearance Required for Transactions by Directors, Officers and Designated Employees. Because Lexicon’s directors, officers and certain employees generally
Page 5 of 7 have greater access to material nonpublic information, and because the securities laws impose special obligations and restrictions on directors and executive officers, it is Lexicon’s policy that directors, officers and other employees designated by the General Counsel as having unique access to clinical, financial or other sensitive information must always obtain clearance from the General Counsel (or his or her designee) before: • Effecting any transaction in Company stock or other securities (including gifts, but excluding purchases or sales made under the terms of a previously approved Rule 10b5-1 trading plan), regardless of the timing of such transaction; or • Establishing or modifying a Rule 10b5-1 trading plan. Clearance must also be obtained for transactions by family members living in the director or officer’s household or receiving financial support (e.g., students living away from home) and for all transactions in which the director or officer may have an indirect interest or the ability to direct the transaction. Clearance under this policy will generally be effective for the time period requested, after which time new clearance must be obtained. 4.2.6. No Restrictions on Purchases of Company Stock under Equity Incentive Plans. Purchase of Lexicon stock pursuant to the exercise of stock options granted under the Company’s equity incentive plans are not subject to the insider trading or pre- clearance policies set forth above. Any sale of stock issued upon the exercise of stock options (in a cashless exercise or otherwise), however, are subject to such policies. 4.2.7. Tipping. Employees, officers and directors should be aware that if someone else (e.g., a spouse, family member, friend or acquaintance) trades in Lexicon stock or other securities on the basis of material nonpublic information they received from such individual, the securities laws may impose civil and/or criminal liabilities both on such individual and on the person trading in the stock. In this regard, employees, officers and directors should be sure that their spouses are made aware of Lexicon policy and the legal ramifications of such activity. 4.3. Speculation Discouraged. To promote compliance with the securities laws and the applicable policies of Lexicon, Insiders should view all their transactions in the Company’s stock and other securities as involving investment decisions and not speculation. In-and- out trading (i.e., opposite-way purchase and sale transactions within a short period of time) and other speculative transactions in Company stock and other securities are strongly discouraged. In order to avoid any appearance of speculative trading in the Company’s stock or other securities or a financial bet against Lexicon, it is Lexicon’s policy that no Insider should purchase financial instruments (including prepaid variable forward contracts, equity swaps, collars and exchange funds), or otherwise engage in transactions that hedge or offset, or are designed to hedge or offset, any decrease in the market value of any of the Company’s securities. Without limiting the foregoing, it is also Lexicon’s policy that no Insider should engage in trading of options to purchase or sell Company stock or other securities (e.g., exchange-traded puts and calls). Lexicon recognizes that holders of Company stock options may find it necessary or desirable to sell common stock purchased on the exercise of such options shortly after such Page 6 of 7 purchase. Such sales are permissible under Company policy, although as a general matter the Company wishes through operation of its equity incentive plans to encourage employee ownership of its securities. 4.4. Special Provisions Applicable to Directors, Executive Officers and Certain Other Persons. Additional trading restrictions and certain reporting requirements are imposed on Lexicon’s directors and executive officers by Section 16 of the Securities Exchange Act of 1934 and Rule 144 under the Securities Act of 1933. Section 16(a) of the Securities Exchange Act imposes Form 3, 4 and 5 filing requirements for transactions in Lexicon securities, while Section 16(b) imposes liability for purchases and sales of Company securities within a six-month period. The consequences of a late filing or a failure to file under Section 16(a) include public embarrassment to the individual and the Company from required disclosures in the Company’s proxy statement and Form 10-K and the possibility of substantial fines or even criminal liability. Rule 144 under the Securities Act imposes volume limitations on sales by executive officers and directors of Lexicon stock and other securities and requires the filing of a report on Form 144 with the SEC no later than the day the director or officer places a sell order. 4.5. Conclusion. In addition to providing guidance in specific situations involving trading, this Policy will foster awareness among Insiders of the basic considerations that underlie their responsibilities with respect to Confidential Information and the purchase and sale of Company stock or other securities. Securities and disclosure laws and regulations are constantly changing. If there are developments of substantial importance, special publications may be issued or this Policy may be revised or supplemented. It is almost certain, however, that there will be no change in the basic philosophy of the law regarding insider trading and of the Company in this area – fairness to Lexicon’s stockholders. Although the securities laws frequently seem complex and difficult to understand, adherence to that philosophy by all Insiders will contribute greatly to recognizing and preventing potentially embarrassing and costly problems. We expect the strictest compliance with these policies by all personnel at every level. Failure to observe them may result in serious legal difficulties for you as well as Lexicon. Failure to follow their letter and spirit would be considered a matter of extreme seriousness and a basis for termination of employment and may lead to civil and/or criminal liabilities for you personally. If you have any doubt as to your responsibilities under these policies, seek clarification and guidance from the Legal Department before you act. Do not try to resolve uncertainties on your own. SECTION 5. OTHER MATTERS 5.1. Amendment. The Corporate Compliance Committee reserves the right to amend this Policy as appropriate at any time without prior notice. 5.2. Failure to Comply. EMPLOYEES WHO VIOLATE ANY LEXICON POLICIES AND PROCEDURES WILL BE SUBJECT TO DISCIPLINARY ACTION, UP TO AND INCLUDING TERMINATION OF EMPLOYMENT. 5.3. Reporting Concerns. Any person (whether an employee or person acting on behalf of Lexicon) who knows of and/or suspects a violation of this Policy shall immediately discuss the matter with her/his supervisor (in the case of an employee) or vendor coordinator (if a Page 7 of 7 consultant or agent). If such a discussion is impracticable or if a person should prefer, she/he may also report the matter to the General Counsel, any member of the Legal Department or the Human Resources Department, or through the Lexicon Compliance Helpline. However, any person must raise her/his suspicions or knowledge of a violation as contained in this Section. Report a Concern Helpline Options Phone: 833-222-7543 Website: lexpharma.ethicspoint.com Lexicon does not tolerate any form of retaliation or adverse action against any employee who submits a good faith report of misconduct.
Exhibit 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the incorporation by reference in the following Registration Statements:
(1)Registration Statements (Form S-8 Nos. 333-41532, 333-168678, 333-183020, 333-210145, 333-217873, 333-234569, 333-240169, 333-258568, and 333-273683) pertaining to the 2017 Equity Incentive Plan and to the 2017 Non-Employee Directors’ Equity Incentive Plan of Lexicon Pharmaceuticals, Inc., and
(2)Registration Statement (Form S-3 No. 333-281208) of Lexicon Pharmaceuticals, Inc.;
of our report dated March 7, 2025, with respect to the consolidated financial statements of Lexicon Pharmaceuticals, Inc., included in this Annual Report (Form 10-K) of Lexicon Pharmaceuticals, Inc. for the year ended December 31, 2024.
/s/ Ernst & Young LLP
Houston, Texas
March 7, 2025
Exhibit 31.1
CERTIFICATIONS
I, Michael S. Exton, certify that:
| 1. | I have reviewed this Annual Report on Form 10-K of Lexicon Pharmaceuticals, Inc.; | ||||||||||
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; | ||||||||||
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; | ||||||||||
| 4. | The registrant's other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: | ||||||||||
| a) | designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | ||||||||||
| b) | designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | ||||||||||
| c) | evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | ||||||||||
| d) | disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and | ||||||||||
| 5. | The registrant's other certifying officers and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of registrant's board of directors (or persons performing the equivalent functions) | ||||||||||
| a) | all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and | ||||||||||
| b) | any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting. | ||||||||||
Date: March 7, 2025
| /s/ Michael S. Exton | |||||
Michael S. Exton, Ph.D. Chief Executive Officer | |||||
Exhibit 31.2
CERTIFICATIONS
I, Scott M. Coiante, certify that:
| 1. | I have reviewed this Annual Report on Form 10-K of Lexicon Pharmaceuticals, Inc.; | ||||||||||
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; | ||||||||||
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; | ||||||||||
| 4. | The registrant's other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: | ||||||||||
| a) | designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | ||||||||||
| b) | designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | ||||||||||
| c) | evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | ||||||||||
| d) | disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and | ||||||||||
| 5. | The registrant's other certifying officers and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of registrant's board of directors (or persons performing the equivalent functions): | ||||||||||
| a) | all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and | ||||||||||
| b) | any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting. | ||||||||||
Date: March 7, 2025
| /s/ Scott M. Coiante | |||||
Scott M. Coiante Senior Vice President and Chief Financial Officer | |||||
Exhibit 32.1
CERTIFICATION
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. 1350, as adopted), Michael S. Exton, Ph.D., Principal Executive Officer of Lexicon Pharmaceuticals, Inc. (“Lexicon”), and Scott M. Coiante, Principal Financial Officer of Lexicon, each hereby certify that:
| 1. | Lexicon's Annual Report on Form 10-K for the year ended December 31, 2024, and to which this Certification is attached as Exhibit 32.1 (the “Periodic Report”), fully complies with the requirements of section 13(a) or section 15(d) of the Securities Exchange Act of 1934, and | |||||||
| 2. | The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of Lexicon. | |||||||
IN WITNESS WHEREOF, the undersigned have set their hands hereto as of the March 7, 2025.
| By: | /s/ Michael S. Exton | |||||||
Michael S. Exton, Ph.D. Chief Executive Officer | ||||||||
| By: | /s/ Scott M. Coiante | |||||||
Scott M. Coiante Senior Vice President and Chief Financial Officer | ||||||||