CRMD 10-Q
CorMedix Inc. (CRMD)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
(Mark One)
For
the quarterly period ended
For the transition period from ________ to ________
Commission
file number
(Exact Name of Registrant as Specified in Its Charter)
| (State or Other Jurisdiction of Incorporation or Organization) | (I.R.S. Employer Identification No.) | |
| (Address of Principal Executive Offices) | (Zip Code) |
(Registrant’s Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
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.
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 (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that
the registrant was required to submit such files).
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 the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer ☐ | ||
| Non-accelerated filer ☐ | ||
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 Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐
The number of shares outstanding
of the issuer’s common stock, as of November 4, 2020 was
CORMEDIX INC. AND SUBSIDIARIES
INDEX
i
PART
I
FINANCIAL INFORMATION
Item 1. Unaudited Condensed Consolidated Financial Statements.
CorMedix
Inc. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
| September 30, 2020 | December 31, 2019 | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Restricted cash | ||||||||
| Short-term investments | ||||||||
| Trade receivables | ||||||||
| Inventories, net | ||||||||
| Prepaid research and development expenses | ||||||||
| Security deposit | ||||||||
| Other prepaid expenses and current assets | ||||||||
| Total current assets | ||||||||
| Property and equipment, net | ||||||||
| Operating lease right-of-use assets | ||||||||
| TOTAL ASSETS | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued expenses | ||||||||
| Operating lease liabilities, short-term | ||||||||
| Deferred revenue | - | |||||||
| Total current liabilities | ||||||||
| Operating lease liabilities, net of current portion | ||||||||
| TOTAL LIABILITIES | ||||||||
| COMMITMENTS AND CONTINGENCIES | ||||||||
| STOCKHOLDERS’ EQUITY | ||||||||
| Preferred stock - $ | ||||||||
| Common stock - $ | ||||||||
| Accumulated other comprehensive income | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| TOTAL STOCKHOLDERS’ EQUITY | ||||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | $ | ||||||
See Accompanying Notes to Unaudited Condensed Consolidated Financial Statements.
1
CORMEDIX INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
(Unaudited)
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Revenue: | ||||||||||||||||
| Net sales | $ | $ | $ | $ | ||||||||||||
| Cost of sales | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Gross profit (loss) | ( | ) | ( | ) | ||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Selling, general and administrative | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Total Operating Expenses | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Loss From Operations | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other Income (Expense): | ||||||||||||||||
| Interest income | ||||||||||||||||
| Foreign exchange transaction loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Interest expense, including amortization of debt discount | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Total Other Income (Expense) | ( | ) | ( | ) | ||||||||||||
| Loss before income taxes | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Tax benefit | ||||||||||||||||
| Net Loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other Comprehensive Income (Loss): | ||||||||||||||||
| Unrealized (loss) gain from investments | ( | ) | ( | ) | ( | ) | ||||||||||
| Foreign currency translation gain | ||||||||||||||||
| Total Other Comprehensive Income (Loss) | ( | ) | ( | ) | ||||||||||||
| Comprehensive Loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Net Loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Deemed dividend as a result of warrant modification | ( | ) | ( | ) | ||||||||||||
| Deemed dividend as a result of exchange of convertible note and Series C-2, D and F preferred stock, related party | ( | ) | ( | ) | ||||||||||||
| Net Loss Attributable to Common Shareholders | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Net Loss Per Common Share – Basic and Diluted | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Weighted Average Common Shares Outstanding – Basic and Diluted | ||||||||||||||||
See Accompanying Notes to Unaudited Condensed Consolidated Financial Statements.
2
CORMEDIX INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN
STOCKHOLDERS’ EQUITY
(Unaudited)
For the three months ended September 30, 2020
| Common Stock | Preferred Stock – Series C-3, Series E and Series G | Accumulated Other Comprehensive | Additional Paid-in | Accumulated | Total Stockholders’ | |||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Income (Loss) | Capital | Deficit | Equity | |||||||||||||||||||||||||
| Balance at June 30, 2020 | $ | $ | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||||
| Stock issued in connection with public offering, net | ||||||||||||||||||||||||||||||||
| Stock issued in connection with ATM sale of common stock, net | - | - | - | - | ||||||||||||||||||||||||||||
| Issuance of vested restricted stock | ||||||||||||||||||||||||||||||||
| Stock-based compensation | - | - | ||||||||||||||||||||||||||||||
| Other comprehensive loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Balance at September 30, 2020 | $ | $ | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||||
For the nine months ended September 30, 2020
| Common Stock | Preferred Stock – Series C-3, Series E and Series G | Accumulated Other Comprehensive | Additional Paid-in | Accumulated | Total Stockholders’ | |||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Income (Loss) | Capital | Deficit | Equity | |||||||||||||||||||||||||
| Balance at December 31, 2019 | $ | $ | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||||
| Stock issued in connection with public offering, net | ||||||||||||||||||||||||||||||||
| Stock issued in connection with ATM sale of common stock, net | ||||||||||||||||||||||||||||||||
| Stock issued in connection with warrants exercised | ||||||||||||||||||||||||||||||||
| Issuance of vested restricted stock | ( | ) | ||||||||||||||||||||||||||||||
| Stock-based compensation | - | - | ||||||||||||||||||||||||||||||
| Other comprehensive income | - | - | ||||||||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Balance at September 30, 2020 | $ | $ | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||||
See Accompanying Notes to Unaudited Condensed Consolidated Financial Statements.
3
CORMEDIX INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN
STOCKHOLDERS’ EQUITY
(Unaudited)
For the three months ended September 30, 2019
| Common Stock | Preferred
Stock – Series C-3, Series E and Series G | Accumulated Other Comprehensive | Additional Paid-in | Accumulated | Total Stockholders’ | |||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Income (Loss) | Capital | Deficit | Equity | |||||||||||||||||||||||||
| Balance at June 30, 2019 | $ | $ | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||||
| Stock issued in connection with warrants exercised | ||||||||||||||||||||||||||||||||
| Exchange of convertible note for Series G preferred stock, related party | ||||||||||||||||||||||||||||||||
| Exchange of Series C-2, Series D and Series F preferred stock for Series G preferred stock, related party | ( | ) | ( | ) | ||||||||||||||||||||||||||||
| Issuance of Series G preferred stock, related party | ||||||||||||||||||||||||||||||||
| Stock issued in connection with stock options exercised | ||||||||||||||||||||||||||||||||
| Issuance of vested restricted stock | ( | ) | - | |||||||||||||||||||||||||||||
| Stock-based compensation | ||||||||||||||||||||||||||||||||
| Other comprehensive loss | ( | ) | ( | ) | ||||||||||||||||||||||||||||
| Net loss | ( | ) | ( | ) | ||||||||||||||||||||||||||||
| Balance at September 30, 2019 | $ | $ | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||||
For the nine months ended September 30, 2019
| Common Stock | Preferred
Stock – Series C-3, Series E and Series G | Accumulated Other Comprehensive | Additional Paid-in | Accumulated | Total Stockholders’ | |||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Income (Loss) | Capital | Deficit | Equity | |||||||||||||||||||||||||
| Balance at December 31, 2018 | $ | $ | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||||
| Stock issued in connection with ATM sale of common stock, net | ||||||||||||||||||||||||||||||||
| Stock issued in connection with warrants exercised | ||||||||||||||||||||||||||||||||
| Exchange of convertible note for Series G preferred stock, related party | ||||||||||||||||||||||||||||||||
| Exchange of Series C-2, Series D and Series F preferred stock for Series G preferred stock, related party | ( | ) | ( | ) | - | |||||||||||||||||||||||||||
| Issuance of Series G preferred stock, related party | ||||||||||||||||||||||||||||||||
| Stock issued in connection with stock options exercised | ||||||||||||||||||||||||||||||||
| Conversion of Series C-3 non-voting preferred stock to common stock | ( | ) | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Issuance of vested restricted stock | ( | ) | ||||||||||||||||||||||||||||||
| Issuance of common stock as a result of reverse stock split rounding | ( | ) | - | |||||||||||||||||||||||||||||
| Stock-based compensation | ||||||||||||||||||||||||||||||||
| Other comprehensive income | ||||||||||||||||||||||||||||||||
| Net loss | ( | ) | ( | ) | ||||||||||||||||||||||||||||
| Balance at September 30, 2019 | $ | $ | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||||
See Accompanying Notes to Unaudited Condensed Consolidated Financial Statements.
4
CORMEDIX INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
For the Nine Months Ended September 30, | ||||||||
| 2020 | 2019 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | ||||||||
| Amortization of debt discount | ||||||||
| Non-cash interest expense | ||||||||
Non-cash operating lease expense | ||||||||
| Inventory reserve | ||||||||
| Depreciation | ||||||||
| Changes in operating assets and liabilities: | ||||||||
| (Increase) decrease in trade receivables | ( | ) | ||||||
| Decrease in inventory | ||||||||
| Increase in prepaid expenses and other current assets | ( | ) | ( | ) | ||||
| Increase (decrease) in accounts payable | ( | ) | ||||||
| Decrease in accrued expenses | ( | ) | ( | ) | ||||
| Decrease in deferred revenue | ( | ) | ( | ) | ||||
Net cash used in operating activities | ( | ) | ( | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
| Purchase of short-term investments | ( | ) | ( | ) | ||||
| Maturity of short-term investments | ||||||||
| Purchase of equipment | ( | ) | ( | ) | ||||
| Net cash provided by (used in) investing activities | ( | ) | ||||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Proceeds from the public offering, net | ||||||||
| Proceeds from sale of common stock from at-the-market program, net | ||||||||
| Proceeds from exercise of warrants | ||||||||
| Proceeds from exchange agreement, related party | ||||||||
| Proceeds from exercise of stock options | ||||||||
| Net cash provided by financing activities | ||||||||
| Foreign exchange effect on cash | ( | ) | ||||||
| NET INCREASE IN CASH | ||||||||
| CASH, CASH EQUIVALENTS AND RESTRICTED CASH – BEGINNING OF PERIOD | ||||||||
| CASH, CASH EQUIVALENTS AND RESTRICTED CASH – END OF PERIOD | $ | $ | ||||||
| Cash paid for interest | $ | $ | ||||||
| Supplemental Disclosure of Non-Cash Financing Activities: | ||||||||
| Deemed dividend as a result of warrant modification | $ | |||||||
| Deemed dividend as a result of exchange of convertible note, Series C-2, Series D and Series F convertible preferred stock, related party | $ | |||||||
| Conversion of preferred stock to common stock | $ | $ | ||||||
| Unrealized gain (loss) from investments | $ | ( | ) | $ | ||||
| Right-of-use assets obtained in exchange for lease liability | $ | $ | ||||||
| Issuance of common stock for vested restricted stock units | $ | $ | ||||||
See Accompanying Notes to Unaudited Condensed Consolidated Financial Statements.
5
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 1 — Organization, Business and Basis of Presentation:
Organization and Business
CorMedix Inc., together with its wholly owned subsidiaries (collectively “CorMedix” or the “Company”), is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The Company’s primary focus is on the development of its lead product candidate, Defencath™, for potential commercialization in the United States, or the U.S., and other key markets as a catheter lock solution, or the CLS. The name Defencath is the U.S. proprietary name conditionally approved by the U.S. Food and Drug Administration, or the FDA, while the name Neutrolin® is currently used in the European Union, or the EU, and other territories where the Company has received CE-Mark approval for the commercial distribution of Neutrolin as a CLS regulated as a medical device.
The Company has in-licensed the worldwide rights to develop and commercialize Defencath and Neutrolin. The CLS is a formulation of 1.35% taurolidine, 3.5% citrate, and 1000 u/ml heparin and is regulated by the FDA as an investigational new drug, where it is being developed to prevent catheter-related blood stream infections, or CRBSIs, and thrombosis in patients using central venous catheters, or CVCs, for hemodialysis. CRBSIs and thrombosis represent key complications among hemodialysis, intensive care, cancer and total parenteral nutrition, or TPN, patients with CVCs. These complications can lead to treatment delays and increased costs to the healthcare system when they occur due to hospitalizations, need for intravenous, or IV, antibiotic treatment, long-term anticoagulation therapy, removal/replacement of the CVC, related treatment costs and increased mortality. The Company initially expects to sell Defencath directly to dialysis centers and hospitals, but also plans to expand its usage into intensive care, oncology and TPN patients using central venous catheters. The Company believes Defencath addresses a significant unmet medical need and a potential large market opportunity in the U.S.
In late 2013, the Company met with the FDA to determine the regulatory pathway for U.S. marketing approval of Defencath and began discussions on the clinical development program. In January 2015, the FDA granted Fast Track designation to Defencath, which is a program designed to facilitate development of drugs that are intended to treat serious and life-threatening conditions and to address an unmet medical need. Fast Track designation provides eligibility to request Priority Review of the marketing application.
Also, in January 2015, the FDA designated Defencath as a Qualified Infectious Disease Product, or QIDP, which provides an additional five years of marketing exclusivity to be added to any exclusivity for which the application qualifies upon approval. For example, an additional five years of marketing exclusivity will be added to the five years granted to a New Chemical Entity, or the NCE, upon approval of the NDA. QIDP designation also confers eligibility for Priority Review of the NDA.
The Company launched its Phase 3 Prospective, Multicenter, Double-blind, Randomized, Active Control Study to Demonstrate Safety & Effectiveness of Defencath/Neutrolin in Preventing Catheter related Bloodstream Infection in Subjects on Hemodialysis for End Stage Renal Disease, or LOCK-IT-100, in patients with hemodialysis catheters in the U.S. in December 2015. The clinical trial was designed to demonstrate the safety and effectiveness of Defencath compared to the standard of care CLS, Heparin, in preventing CRBSIs. The primary endpoint for the trial assessed the incidence of CRBSI and time to CRBSI for each study subject. Secondary endpoints were catheter patency, which was defined as required use of tissue plasminogen activating factor (“tPA”), or removal of catheter due to dysfunction, and removal of catheter for any reason.
6
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The FDA granted the Company’s request for a rolling submission and review of the NDA, which is designed to expedite the approval process for products being developed to address an unmet medical need. Although the FDA usually requires two pivotal clinical trials to provide substantial evidence of safety and effectiveness for approval of an NDA, the FDA will in some cases accept one adequate and well-controlled trial, where it is a large multicenter trial with a broad range of subjects and study sites that has demonstrated a clinically meaningful and statistically very persuasive effect on a disease with potentially serious outcome. In March 2020, the Company began the modular submission process for the NDA for Defencath for the prevention of CRBSI in hemodialysis patients, and recently announced on July 8, 2020, that submission of all modules for the NDA was completed. In August 2020, the FDA accepted for filing the Defencath NDA and also granted the Company’s request for Priority Review. Priority Review provides for six-month review period instead of the standard ten-month review period, and February 28, 2021 has been set as the Prescription Drug User Fee Act, or PDUFA, date for the completion of the review for approval of the NDA. The FDA noted that it is planning to hold an advisory committee meeting to discuss the application and that it had not identified any potential review issues at this time. The meeting of the Antimicrobial Drugs Advisory Committee to discuss the Defencath NDA has tentatively been scheduled for January 14, 2021. The Company has not been informed of any delays by the FDA in the review of the NDA, but the FDA has limited international and domestic travel due to COVID-19, and pre-approval inspections are required for manufacturing sites.
The FDA also previously agreed that the Company could request consideration of Defencath for approval under the Limited Population Pathway for Antibacterial and Antifungal Drugs, or LPAD. LPAD, passed as part of the 21st Century Cures Act, is a new program intended to expedite the development and approval of certain antibacterial and antifungal drugs to treat serious or life-threatening infections in limited populations of patients with unmet medical needs. Given that the LPAD pathway provides for a streamlined clinical development program for a limited population that may involve smaller, shorter, or fewer clinical trials, the Company believes that LPAD will provide additional flexibility for the FDA to approve Defencath to prevent CRBSIs in the limited population of adult patients with end-stage renal disease receiving hemodialysis through a CVC.
The Company was granted a deferral by the
FDA under the Pediatric Research Equity Act, or PREA, that requires sponsors to conduct pediatric studies for NDAs for a new active
ingredient, such as taurolidine in Defencath, unless a waiver or deferral is obtained from the FDA. A deferral acknowledges that
a pediatric assessment is required but permits the applicant to submit the pediatric assessment after the submission of an NDA.
The Company has made a commitment to conduct the pediatric study after approval of the NDA for use in adult hemodialysis patients.
7
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The Company anticipates that Medicare reimbursement could be available for Defencath in hemodialysis and other catheter indications in intensive care, oncology and TPN through relevant hospital inpatient diagnosis-related groups, or DRGs, or outpatient ambulatory payment classifications, or APCs, the End-Stage Renal Disease Prospective Payment System, or ESRD PPS, base payment, or under the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies, or DMEPOS, Fee Schedule, depending on the setting of care. The Company also plans to seek separate reimbursement as a drug, where available under Medicare, through mechanisms such as pass-through status under the Hospital Outpatient Prospective Payment System, the transitional drug add-on payment adjustment, or TDAPA, under the ESRD PPS, or reimbursement as a drug used with a DMEPOS infusion pump. The Company has engaged U.S. Centers for Medicare & Medicaid Services, or CMS, in preliminary discussions concerning the reimbursement for Defencath under TDAPA, however, qualifications cannot be determined until after FDA approval and CMS evaluates the request for coverage in a quarterly review. If approved under TDAPA, reimbursement of Defencath would be calculated based on its average selling price.
Although the Company cannot fully anticipate changes in reimbursement requirements and mechanisms in the coming years, the Company expects Defencath would be eligible for and would obtain TDAPA. To be eligible for TDAPA, an innovative new renal drug or biologic must be, among other things, identified as having an end action effect that treats or manages a condition or conditions associated with ESRD and as not fitting into an established ESRD PPS functional category. The Company believes that in addition to the Fast Track and QIDP designations granted by the FDA, Defencath meets the criterion of being a new renal dialysis product used to treat or manage a condition associated with ESRD, since infections are the second leading cause of death in patients with ESRD and CVCs are a significant risk factor for infection-associated mortality.
In the EU, Neutrolin is regulated as a Class 3 medical device. In July 2013, the Company received CE Mark approval for Neutrolin. In December 2013, the Company started commercial sales of Neutrolin in Germany for the prevention of CRBSI, and maintenance of catheter patency in hemodialysis patients using a tunneled, cuffed CVC for vascular access. To date, Neutrolin is registered and may be sold in certain European Union and Middle Eastern countries for such treatment.
In September 2014, the TUV-SUD and The Medicines Evaluation Board of the Netherlands, or MEB, granted a label expansion for Neutrolin, to include use in oncology patients receiving chemotherapy, IV hydration and IV medications via CVC for the EU. In December 2014, the Company received approval from the Hessian District President in Germany to expand the label for these same expanded indications. The expansion also adds patients receiving medication and IV fluids via CVC in intensive or critical care units (cardiac care unit, surgical care unit, neonatal critical care unit, and urgent care centers). An indication for use in total parenteral nutrition was also approved.
In May 2020, the Company formed a wholly-owned Spanish subsidiary, CorMedix Spain, S.L.U.
The Company intends to pursue additional indications for Defencath use as a CLS in populations with an unmet medical need that also represent a significant market opportunity. For example, the Company intends to pursue marketing authorization in the U.S. for use as a CLS to reduce CRBSIs in oncology and total parenteral nutrition patients using a CVC.
8
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
In addition to the CLS, the Company is sponsoring a pre-clinical research collaboration for the use of taurolidine as a possible treatment for pediatric tumors. In February 2018, the FDA granted orphan drug designation to taurolidine for the treatment of neuroblastoma in children. The Company may seek one or more strategic partners or other sources of capital to help with the development and commercialization of taurolidine for the treatment of neuroblastoma in children. The Company is also evaluating opportunities for the possible expansion of taurolidine as a platform compound for use in certain medical devices. Patent applications have been filed in several indications, including wound closure, surgical meshes, and wound management. Based on initial feasibility work, the Company is advancing pre-clinical studies for taurolidine-infused surgical meshes, suture materials and hydrogels. The Company will seek to establish development/commercial partnerships as these programs advance.
The FDA regards taurolidine as an NCE and therefore it is currently an unapproved new drug. The Company may in the future pursue product candidates that would involve devices impregnated with taurolidine, and the Company believes that at the current time such products would be combination products subject to device premarket submission requirements, while subject also, under review by the FDA, to the standards for drug approvability. Consequently, given that there is no appropriate predicate medical device currently marketed in the U.S. on which a 510(k) approval process could be based and that taurolidine is not yet approved in any application, the Company anticipates that it would be required to submit a premarket approval application, or PMA, for marketing authorization for any medical device indications that the Company may pursue for devices containing taurolidine. In the event that an NDA for Defencath is approved by the FDA, the regulatory pathway for these medical device product candidates may be revisited with the FDA. Although there may be no appropriate predicate, de novo Class II designation can be proposed, based on a risk assessment and a reasonable assurance of safety and effectiveness.
In December 2019, the novel coronavirus disease, COVID-19, was identified in Wuhan, China. This virus has been declared a pandemic and has spread to multiple global regions. The outbreak and government measures taken in response have also had a significant impact, both direct and indirect, on businesses and commerce, as worker shortages have occurred; supply chains have been disrupted; facilities and production have been suspended; and demand for certain goods and services, such as medical services and supplies, has spiked, while demand for other goods and services, such as travel, has fallen. In response to the COVID-19 outbreak, “shelter in place” orders and other public health guidance measures have been implemented across much of the United States, Europe and Asia, including in the locations of the Company’s offices, clinical trial sites, key vendors and partners. The Company’s program timelines may be negatively affected by COVID-19, which could materially and adversely affect its business, financial condition and results of operations.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, for interim financial information and with the instructions for Form 10-Q and Article 8 of Regulation S-X. Accordingly, the unaudited condensed consolidated financial statements do not include all information and footnotes required by GAAP for complete annual financial statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary to fairly state the interim results. Interim operating results are not necessarily indicative of results that may be expected for the full year ending December 31, 2020 or for any subsequent period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto of the Company which are included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 16, 2020. The accompanying condensed consolidated balance sheet as of December 31, 2019 has been derived from the audited financial statements included in such Form 10-K.
9
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Recently Adopted Accounting Pronouncements
In June 2016, the Financial Accounting Standards Board, or FASB, issued new guidance which replaces the incurred loss impairment methodology in current GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. This adoption on January 1, 2020 did not have a material impact on the Company’s condensed consolidated financial statements.
In August 2018, the FASB issued a new guidance which modifies the disclosure requirements on fair value measurements. The guidance was effective for the Company beginning in the first quarter of fiscal year 2020. This adoption on January 1, 2020 did not have a material impact on the Company’s condensed consolidated financial statements.
In November 2018, the FASB issued new guidance to clarify the interaction between the authoritative guidance for collaborative arrangements and revenue from contracts with customers. The new guidance clarifies that, when the collaborative arrangement participant is a customer in the context of a unit-of-account, revenue from contracts with customers guidance should be applied, adds unit-of-account guidance to collaborative arrangements guidance, and that, in a transaction with a collaborative arrangement participant who is not a customer, precludes presenting the transaction together with revenue recognized under contracts with customers. The guidance was effective for the Company beginning in the first quarter of fiscal year 2020. This adoption on January 1, 2020 did not have a material impact on the Company’s condensed consolidated financial statements.
In November 2019, the FASB issued new guidance which requires that an entity measure and classify share-based payment awards granted to a customer by applying the guidance in FASB’s Accounting Standards Codification, or ASC, 718. The guidance was effective for the Company beginning in the first quarter of fiscal year 2020. This adoption on January 1, 2020 did not have a material impact on the Company’s condensed consolidated financial statements.
Recently Issued Authoritative Pronouncements
In December 2019, the FASB issued new guidance which removes certain exceptions to the general principles of the accounting for income taxes and also improves consistent application of and simplification of other areas when accounting for income taxes. The guidance is effective for the company beginning in the first quarter of fiscal year 2021. Early adoption is permitted. The Company is assessing the impact of adopting this guidance on its consolidated financial statements.
Note 2 — Summary of Significant Accounting Policies:
Liquidity and Uncertainties
The financial statements have been prepared
in conformity with GAAP which contemplate continuation of the Company as a going concern. To date, the Company’s commercial
operations have not generated sufficient revenues to enable profitability. As of September 30, 2020, the Company had an accumulated
deficit of $
10
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
In April 2020, the Company received approximately
$
In April 2020, the Company received from
the FDA a refund for the NDA application fee in the amount of $
The Company’s continued operations
will depend on its ability to raise additional capital through various potential sources, such as equity and/or debt financings,
strategic relationships, or out-licensing of its products, to commercially launch Defencath upon NDA approval, and until profitability
is achieved, if ever. Management can provide no assurances that such financing or strategic relationships will be available on
acceptable terms, or at all. At September 30, 2020, the Company had approximately $
The Company’s operations are subject to a number of other factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the ability to obtain regulatory approval to market the Company’s products; ability to manufacture successfully; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, Company products; the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; the results of clinical testing and trial activities of the Company’s product candidates; and the Company’s ability to raise capital to support its operations.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates.
Basis of Consolidation
The condensed consolidated financial statements include the accounts of the Company, CorMedix Europe GmbH and CorMedix Spain, S.L.U. its wholly owned subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation.
11
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Financial Instruments
Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents and short-term investments. The Company maintains its cash and cash equivalents in bank deposit and other interest-bearing accounts, the balances of which, at times, may exceed federally insured limits.
The following table is the reconciliation of the accounting standard that modifies certain aspects of the recognition, measurement, presentation and disclosure of financial instruments as shown on the Company’s consolidated statement of cash flows:
| September 30, 2020 | December 31, 2019 | |||||||
| Cash and cash equivalents | $ | $ | ||||||
| Restricted cash | ||||||||
| Total cash, cash equivalents and restricted cash | $ | $ | ||||||
The appropriate classification of marketable securities is determined at the time of purchase and re-evaluated as of each balance sheet date. Investments in marketable debt classified as available-for-sale and equity securities are reported at fair value. Fair value is determined using quoted market prices in active markets for identical assets or liabilities or quoted prices for similar assets or liabilities or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Changes in fair value that are considered temporary are reported in the condensed consolidated statement of operations. Realized gains and losses, amortization of premiums and discounts and interest and dividends earned are included in other income (expense). For declines in the fair value of equity securities that are considered other-than-temporary, impairment losses are charged to other income (expense), net. The Company considers available evidence in evaluating potential impairments of its investments, including the duration and extent to which fair value is less than cost. There were no deemed permanent impairments at September 30, 2020 or December 31, 2019.
The Company’s marketable securities are highly liquid and consist of U.S. government agency securities, high-grade corporate obligations and commercial paper with original maturities of more than 90 days. As of September 30, 2020, and December 31, 2019, all of the Company’s investments had contractual maturities of less than one year. As of September 30, 2020, no allowance for credit loss was recorded. The following table summarizes the amortized cost, unrealized gains and losses and the fair value at September 30, 2020 and December 31, 2019:
| Amortized Cost | Gross Unrealized Losses | Gross Unrealized Gains | Fair Value | |||||||||||||
| September 30, 2020: | ||||||||||||||||
| Money Market Funds included in Cash Equivalents | $ | $ | $ | $ | ||||||||||||
| U.S. Government Agency Securities | ||||||||||||||||
| Corporate Securities | ( | ) | ||||||||||||||
| Commercial Paper | ||||||||||||||||
| Subtotal | ( | ) | ||||||||||||||
| Total September 30, 2020 | $ | $ | ( | ) | $ | $ | ||||||||||
| December 31, 2019: | ||||||||||||||||
| Money Market Funds included in Cash Equivalents | $ | $ | $ | $ | ||||||||||||
| U.S. Government Agency Securities | ( | ) | ||||||||||||||
| Corporate Securities | ( | ) | ||||||||||||||
| Commercial Paper | ( | ) | ||||||||||||||
| Subtotal | ( | ) | ||||||||||||||
| Total December 31, 2019 | $ | $ | ( | ) | $ | $ | ||||||||||
12
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Fair Value Measurements
The Company’s financial instruments recorded in the condensed consolidated balance sheets include cash and cash equivalents, accounts receivable, investment securities, accounts payable and accrued expenses. The carrying value of certain financial instruments, primarily cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate their estimated fair values based upon the short-term nature of their maturity dates.
The Company categorizes its financial instruments into a three-level fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets (Level 1) and the lowest priority to unobservable inputs (Level 3). If the inputs used to measure fair value fall within different levels of the hierarchy, the category level is based on the lowest priority level input that is significant to the fair value measurement of the instrument. Financial assets recorded at fair value on the Company’s condensed consolidated balance sheets are categorized as follows:
| ● | Level 1 inputs—Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets. |
| ● | Level 2 inputs— Significant other observable inputs (e.g., quoted prices for similar items in active markets, quoted prices for identical or similar items in markets that are not active, inputs other than quoted prices that are observable such as interest rate and yield curves, and market-corroborated inputs). |
| ● | Level 3 inputs—Unobservable inputs for the asset or liability, which are supported by little or no market activity and are valued based on management’s estimates of assumptions that market participants would use in pricing the asset or liability. |
13
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The following table provides the carrying value and fair value of the Company’s financial assets measured at fair value on a recurring basis as of September 30, 2020 and December 31, 2019:
| Carrying Value | Level 1 | Level 2 | Level 3 | |||||||||||||
| September 30, 2020: | ||||||||||||||||
| Money Market Funds and Cash Equivalents | $ | $ | $ | $ | ||||||||||||
| U.S. Government Agency Securities | - | - | ||||||||||||||
| Corporate Securities | ||||||||||||||||
| Commercial Paper | ||||||||||||||||
| Subtotal | - | $ | ||||||||||||||
| Total September 30, 2020 | $ | $ | $ | $ | ||||||||||||
| December 31, 2019: | ||||||||||||||||
| Money Market Funds and Cash Equivalents | $ | $ | $ | $ | ||||||||||||
| U.S. Government Agency Securities | ||||||||||||||||
| Corporate Securities | ||||||||||||||||
| Commercial Paper | ||||||||||||||||
| Subtotal | ||||||||||||||||
| Total December 31, 2019 | $ | $ | $ | $ | ||||||||||||
Foreign Currency Translation and Transactions
The condensed consolidated financial statements are presented in U.S. Dollars (“USD”), the reporting currency of the Company. For the financial statements of the Company’s foreign subsidiaries, whose functional currency is the EURO, foreign currency asset and liability amounts, are translated into USD at end-of-period exchange rates. Foreign currency income and expenses are translated at average exchange rates in effect during the period in which the income and expenses were recognized. Translation gains and losses are included in other comprehensive income (loss).
The Company has intercompany loans between the parent company based in New Jersey and its German subsidiary. The intercompany loans outstanding are not expected to be repaid in the foreseeable future and unrealized foreign exchange movements related to long-term intercompany loans are recognized in other comprehensive income (loss).
Foreign currency exchange transaction gain (loss) is the result of re-measuring transactions denominated in a currency other than the functional currency of the entity recording the transaction.
Restricted Cash
As of September 30, 2020, and December 31,
2019, the Company has restricted cash in connection with the patent and utility model infringement proceedings against TauroPharm
(see Note 4). The Company was required by the District Courts of Mannheim to provide a security deposit of an aggregate of
approximately $
14
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Prepaid Research and Development and Other Prepaid Expenses
Prepaid expenses consist of payments made in advance to vendors relating to service contracts for clinical trial development, manufacturing, preclinical development, deposits on equipment and insurance policies. These advanced payments are amortized to expense either as services are performed or over the relevant service period using the straight-line method.
Other prepaid expenses consist of the following:
| September 30, 2020 | December 31, 2019 | |||||||
| Deposit on equipment | $ | $ | - | |||||
| Insurance | ||||||||
| Subscription fees | ||||||||
| Software costs | ||||||||
| Other | ||||||||
| Total | $ | $ | ||||||
Inventories, net
Inventories are valued at the lower of cost or net realizable value on a first in, first out basis. Inventories consist of raw materials (including labeling and packaging), work-in-process, and finished goods, if any, for the Defencath product. Inventories consist of the following:
| September 30, 2020 | December 31, 2019 | |||||||
| Raw materials | $ | - | $ | |||||
| Finished goods | ||||||||
| Inventory reserve | ( | ) | ( | ) | ||||
| Total | $ | $ | ||||||
Leases
The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, current portion of operating lease liabilities, and operating lease liabilities, net of current portion, on the condensed consolidated balance sheet.
Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term.
15
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
Company has elected, as an accounting policy, not to apply the recognition requirements in ASC 842 to short-term leases.
The Company has also elected, as a practical expedient, by underlying class of asset, not to separate lease components from non-lease components and, instead, account for them as a single component.
Accrued Expenses
Accrued expenses consist of the following:
| September 30, 2020 | December 31, 2019 | |||||||
| Professional and consulting fees | $ | $ | ||||||
| Accrued payroll and payroll taxes | ||||||||
| Clinical trial related | ||||||||
| Manufacturing development related | ||||||||
| Other | ||||||||
| Total | $ | $ | ||||||
In December 2015, the Company contracted a clinical research organization (“CRO”) to help conduct its LOCK-IT-100 Phase 3 multicenter, double-blind, randomized active control study to demonstrate the safety and effectiveness of Defencath/Neutrolin in preventing catheter-related bloodstream infections and blood clotting in subjects receiving hemodialysis therapy as treatment for end stage renal disease.
Through September 30, 2020, approximately $
Revenue Recognition
The Company recognizes revenue in accordance with ASC 606, “Revenue from Contracts with Customers.” ASC 606 prescribes a five-step model for recognizing revenue which includes (i) identifying contracts with customers; (ii) identifying performance obligations; (iii) determining the transaction price; (iv) allocating the transaction price; and (v) recognizing revenue.
The Company recognizes net sales upon shipment of product and upon meeting the five-step model prescribed by ASC 606 outlined above.
16
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Loss Per Common Share
Basic loss per common share excludes any potential dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per common share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the entity. However, since their effect is anti-dilutive, the Company has excluded potentially dilutive shares. The following potentially dilutive shares have been excluded from the calculation of diluted net loss per share as their effect would be anti-dilutive.
| Nine Months Ended September 30, | ||||||||
| 2020 | 2019 | |||||||
| (Number of Shares of Common Stock Issuable) | ||||||||
| Series C-3 non-voting preferred stock | ||||||||
| Series E non-voting preferred stock | ||||||||
| Series G non-voting preferred stock | ||||||||
| Restricted stock units | ||||||||
| Shares issuable for payment of deferred board compensation | ||||||||
| Shares underlying outstanding warrants | ||||||||
| Shares underlying outstanding stock options | ||||||||
| Total potentially dilutive shares | ||||||||
Stock-Based Compensation
Share-based compensation cost for stock options granted to employees is measured at grant date using the Black-Scholes stock option pricing model in accordance with ASC No. 718, “Compensation-Stock Compensation”, based on the estimated fair value of the award for options with service or performance-based conditions and is recognized as expense over the requisite service period on a straight-line basis. For stock options with performance-based vesting provisions, share-based compensation cost is recorded when the achievement of the performance condition is probable.
Research and Development
Research and development costs are charged
to expense as incurred. Research and development include fees associated with operational consultants, contract clinical research
organizations, contract manufacturing organizations, clinical site fees, contract laboratory research organizations, contract central
testing laboratories, licensing activities, and allocated executive, human resources, facilities expenses and costs related to
the manufacturing of the product that could potentially be available to support the commercial launch prior to marketing approval.
For the nine months ended September 30, 2020, costs related to the manufacturing of commercial pre-launch inventory that were expensed
amounted to approximately $
17
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 3 — Stockholders’ Equity:
Common Stock
On July 30, 2020, the Company completed
an underwritten public offering of its common stock, par value $
The Company is a party to a sales agreement with B. Riley dated
March 9, 2018 for the sale of up to $
During the nine months ended September 30, 2020
and 2019, the Company sold
During the nine months ended September 30, 2020
and 2019, the Company issued an aggregate of
During the nine months ended September 30,
2020 and 2019, the Company issued an aggregate of
During the nine months ended September 30,
2019, the Company issued an aggregate of
18
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Preferred Stock
The Company is authorized to issue up to
| As of September 30, 2020 | As of December 31, 2019 | |||||||||||||||||||||||
| Preferred Shares Outstanding | Liquidation Preference (Per Share) | Total Liquidation Preference | Preferred Shares Outstanding | Liquidation Preference (Per Share) | Total Liquidation Preference | |||||||||||||||||||
| Series C-3 | $ | $ | $ | $ | ||||||||||||||||||||
| Series E | $ | $ | $ | $ | ||||||||||||||||||||
| Series G | $ | $ | $ | $ | ||||||||||||||||||||
| Total | $ | $ | ||||||||||||||||||||||
Stock Options
During the nine months ended September 30,
2020, the Company granted ten-year qualified and non-qualified stock options covering an aggregate of
During the three and nine months ended September 30, 2020, total compensation expense for stock options issued to employees, directors, officers and consultants was $611,000 and $1,973,000, respectively, and $519,000 and $1,835,000 for the three and nine months ended September 30, 2019, respectively.
As of September 30, 2020, there was approximately
$
The fair value of each stock option award estimated on the grant date is determined using the Black-Scholes option pricing model with the following assumptions, for the nine months ended September 30, 2020:
| Expected term, years | ||
| Volatility | ||
| Dividend yield | ||
| Risk-free interest rate | ||
| Weighted average grant date fair value of options granted during the period | $ |
The Company estimated the expected term
of the stock options granted based on anticipated exercises in future periods. The expected term of the stock options granted to
consultants is based upon the full term of the respective option agreements. The expected stock price volatility for the Company’s
stock options is calculated based on the historical volatility since the initial public offering of the Company’s common
stock in March 2010. The expected dividend yield of
19
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The following table summarizes the Company’s stock options activity and related information for the nine months ended September 30, 2020:
| Shares | Weighted Average Exercise Price | Weighted Average Remaining Contractual Term (Years) | Aggregate Intrinsic Value | |||||||||||||
| Outstanding at beginning of period | $ | $ | ||||||||||||||
| Granted | $ | $ | ||||||||||||||
| Forfeited | ( | ) | $ | $ | ||||||||||||
| Expired | ( | ) | $ | $ | ||||||||||||
| Exercised | $ | |||||||||||||||
| Outstanding at end of period | $ | $ | ||||||||||||||
| Exercisable at end of period | $ | $ | ||||||||||||||
The aggregate intrinsic value is calculated as the difference between the exercise prices of the underlying options and the quoted closing price of the common stock of the Company at the end of the reporting period for those options that have an exercise price below the quoted closing price. There were no stock options exercised during the nine months ended September 30, 2020.
Restricted Stock Units
During the nine months ended September 30,
2020, the Company issued an aggregate of
During the three and nine months ended September
30, 2020, compensation expense recorded for the RSUs was $
Warrants
During the nine months ended September 30,
2020 and 2019, the Company issued an aggregate of
As
of September 30, 2020, there were
20
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 4 — Commitments and Contingencies:
Contingency Matters
On September 9, 2014, the Company filed in the District Court of Mannheim, Germany, a patent infringement action against TauroPharm GmbH and Tauro-Implant GmbH as well as their respective CEOs (the “Defendants”) claiming infringement of the Company’s European Patent EP 1 814 562 B1, which was granted by the European Patent Office (the “EPO”) on January 8, 2014 (the “Prosl European Patent”). The Prosl European Patent covers the formulation of taurolidine and citrate with low dose heparin in a catheter lock solution for maintaining patency and preventing infection in hemodialysis catheters. In this action, the Company claims that the Defendants infringe on the Prosl European Patent by manufacturing and distributing catheter locking solutions to the extent they are covered by the claims of the Prosl European Patent. The Company believes that its patent is sound and is seeking injunctive relief and raising claims for information, rendering of accounts, calling back, destruction and damages. Separately, TauroPharm has filed an opposition with the EPO against the Prosl European Patent alleging that it lacks novelty and inventive step. The Company cannot predict what other defenses the Defendants may raise, or the ultimate outcome of either of these related matters. At present, the EPO has revoked the Prosl European Patent as invalid, and the Company has filed an appeal, which is currently pending.
In the same complaint against the same Defendants, the Company also alleged an infringement (requesting the same remedies) of ND Partners’ utility model DE 20 2005 022 124 U1 (the “Utility Model”), which the Company believes is fundamentally identical to the Prosl European Patent in its main aspects and claims. The Court separated the two proceedings and the Prosl European Patent and the Utility Model claims are now being tried separately. TauroPharm has filed a cancellation action against the Utility Model before the German Patent and Trademark Office (the “German PTO”) based on the similar arguments as those in the opposition against the Prosl European Patent.
On March 27, 2015, the District Court held a hearing to evaluate whether the Utility Model has been infringed by TauroPharm in connection with the manufacture, sale and distribution of its TauroLock-HEP100TM and TauroLock-HEP500TM products. A hearing before the same court was held on January 30, 2015 on the separate, but related, question of infringement of the Prosl European Patent by TauroPharm.
The Court issued its decisions on May 8, 2015, staying both proceedings. In its decisions, the Court found that the commercialization by TauroPharm in Germany of its TauroLock catheter lock solutions Hep100 and Hep500 infringes both the Prosl European Patent and the Utility Model and further that there is no prior use right that would allow TauroPharm to continue to make, use or sell its product in Germany. However, the Court declined to issue an injunction in favor of the Company that would preclude the continued commercialization by TauroPharm based upon its finding that there is a sufficient likelihood that the EPO, in the case of the Prosl European Patent, or the German PTO, in the case of the Utility Model, may find that such patent or utility model is invalid. Specifically, the Court noted the possible publication of certain instructions for product use that may be deemed to constitute prior art. As such, the District Court determined that it will defer any consideration of the request by the Company for injunctive and other relief until such time as the EPO or the German PTO made a final decision on the underlying validity of the Prosl European Patent and the Utility Model. We expect that the complaint regarding the infringement of the Utility Model will be dismissed now that the German PTO has voided the Utility Model (see below). This does not, however, have a direct effect on the infringement proceedings concerning the Prosl European Patent.
The opposition proceeding against the Prosl European Patent before the EPO is ongoing. The EPO held a hearing in the opposition proceeding on November 25, 2015. In its preliminary consideration of the matter, the EPO (and the German PTO) had regarded the patent as not inventive or novel due to publication of prior art. However, the EPO did not issue a decision at the end of the hearing but adjourned the matter due to the fact that the panel was of the view that Claus Herdeis, one of the managing directors of TauroPharm, had to be heard as a witness in a further hearing in order to close some gaps in the documentation presented by TauroPharm as regards the publication of the prior art.
21
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The German PTO held a hearing in the validity
proceedings relating to the Utility Model on June 29, 2016, at which the panel affirmed its preliminary finding that the Utility
Model was invalid based upon prior publication of a reference to the benefits that may be associated with adding heparin to a taurolidine
based solution. The Company filed an appeal against the ruling on September 7, 2016. An oral hearing was held on September 17,
2019 in which the German Federal Patent Court affirmed the first instance decision that the Utility Model was invalid. The decision
has only a declaratory effect, as the Utility Model had expired in November 2015. On April 28, 2020, the Company filed a withdrawal
of the complaint on the German utility model, thereby waiving its claims on these proceedings. The Company estimates that the expense
will be less than €
In October 2016, TauroPharm submitted a further writ to the EPO requesting a date for the hearing and bringing forward further arguments, in particular in view of the June 2016 decision of the German PTO on the invalidity of the utility model. On November 22, 2017, the EPO in Munich, Germany held a further oral hearing in this matter. At the hearing, the panel held that the Prosl European Patent would be invalidated because it did not meet the requirements of novelty based on a technical aspect of the European intellectual property law. The Company disagrees with this decision and, after the written opinion was issued by the Opposition Division in September 2018, has appealed the decision. The Company continues to believe that the Prosl European Patent is indeed novel and that its validity should be maintained. There can be no assurance that the Company will prevail in this matter. In addition, the ongoing Unfair Competition litigation brought by the Company against TauroPharm is not affected and will continue.
On January 16, 2015, the Company filed a complaint against TauroPharm GmbH and its managing directors in the District Court of Cologne, Germany. In the complaint, the Company alleges violation of the German Unfair Competition Act by TauroPharm for the unauthorized use of its proprietary information obtained in confidence by TauroPharm. The Company alleges that TauroPharm is improperly and unfairly using its proprietary information relating to the composition and manufacture of Neutrolin, in the manufacture and sale of TauroPharm’s products TauroLockTM, TauroLock-HEP100 and TauroLock-HEP500. The Company seeks a cease and desist order against TauroPharm from continuing to manufacture and sell any product containing taurolidine (the active pharmaceutical ingredient (“API”) of Neutrolin) and citric acid in addition to possible other components, damages for any sales in the past and the removal of all such products from the market. An initial hearing in the District Court of Cologne, Germany was held on November 19, 2015 to consider the Company’s claims. In this hearing, the presiding judge explained that the court needed more information with regard to several aspects of the case. As a consequence, the Court issued an interim decision in the form of a court order outlining several issues of concern that relate primarily to the court’s interest in clarifying the facts and reviewing any and all available documentation, in particular with regard to the question which specific know-how was provided to TauroPharm by whom and when. The Company’s legal team prepared the requested reply and produced the respective documentation. TauroPharm had also filed another writ within the same deadline and both parties have filed further writs at the end of April 2016 setting out their respective argumentation in more detail. A further oral hearing in this matter was held on November 15, 2016. In this hearing, the court heard arguments from CorMedix and TauroPharm concerning the allegations of unfair competition. The Court made no rulings from the bench and indicated that it is prepared to further examine the underlying facts of the Company’s allegations. On March 7, 2017, the Court issued another interim decision in the form of a court order outlining again several issues relating to the argumentation of both sides in the proceedings. In particular the court requested the Company to further specify its requests and to further substantiate in even more detail which know-how was provided by Biolink (the company who developed Neutrolin that was acquired by ND Partners) to TauroPharm by whom and when. The Court also raised the question whether the know-how provided at the time to TauroPharm could still be considered to be secret know-how or may have become public in the meantime. The Court granted both sides the opportunity to reply to this court order and provide additional facts and evidence until May 15, 2017. Both parties have submitted further writs in this matter and the Court scheduled a further hearing on May 8, 2018. After having been rescheduled several times, the hearing took place on November 20, 2018. A decision was rendered by the court on December 11, 2018, dismissing the complaint in its entirety. However, the Company intends to continue to pursue this matter, and still believes firmly that its claims are well-founded. The Company therefore appealed in January 2019 and filed its grounds of appeal in March 2019. An oral hearing was held on September 6, 2019 in which the legal counsel of the Company brought forward further arguments for the fact that the manufacturing process of the respective catheter locking solution is indeed protectable as a trade secret. In view of these new arguments, the Court issued an evidentiary order on September 27, 2019 ordering an expert opinion. The expert opinion was not in the Company’s favor but the Company has filed a response to the expert opinion in reaction to which the Court asked the expert to supplement his opinion to address the issues brought forward in the Company’s submission. In the supplementary expert opinion, the expert confirmed his view. The Company has filed a response and requested an oral hearing which has not yet been scheduled.
22
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
In connection with the aforementioned patent and utility model
infringement and unfair competition proceedings against TauroPharm, the Company was required by the District Courts of Mannheim
and Cologne to provide security deposits of an aggregate of approximately $
Commitments
In-Licensing
In 2008, the Company entered into a License
and Assignment Agreement (the “NDP License Agreement”) with ND Partners, LLP (“NDP”). Pursuant to the NDP
License Agreement, NDP granted the Company exclusive, worldwide licenses for certain antimicrobial catheter lock solutions, processes
for treating and inhibiting infections, a biocidal lock system and a taurolidine delivery apparatus, and the corresponding United
States and foreign patents and applications (the “NDP Technology”). The Company acquired such licenses and patents
through its assignment and assumption of NDP’s rights under certain separate license agreements by and between NDP and Dr.
Hans-Dietrich Polaschegg, Dr. Klaus Sodemann and Dr. Johannes Reinmueller. As consideration in part for the rights to the NDP Technology,
the Company paid NDP an initial licensing fee of $
The Company is required to make payments to
NDP upon the achievement of certain regulatory and sales-based milestones. Certain of the milestone payments are to be made in
the form of shares of common stock currently held in escrow for NDP, and other milestone payments are to be paid in cash. The maximum
aggregate number of shares issuable upon achievement of milestones is
23
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The NDP License Agreement may be terminated by the Company on a country-by-country basis upon 60 days prior written notice. If the NDP License Agreement is terminated by either party, the Company’s rights to the NDP Technology will revert back to NDP.
Employment Agreements
On April 30, 2020,
If the Company terminates Dr. David’s employment other than for Cause (as defined in the agreement), death, disability, or by notice of nonrenewal, or if he resigns for Good Reason (as defined in the agreement), including in each case within 24 months of a Change of Control (as defined in the agreement), Dr. David will receive his base salary and benefits for a period of nine months following the effective date of the termination of his employment, and all unvested stock options held by him that are scheduled to vest on or before the next succeeding anniversary of the date of termination will be accelerated and deemed to have vested as of the termination date, provided that any milestone option whose vesting requirements have not been met as of the termination date will be terminated.
If the Company terminates Dr. David’s employment for Cause (as defined in the agreement), Dr. David will be entitled to receive only the accrued compensation due to him as of the date of such termination, rights to indemnification and directors’ and officers’ liability insurance, and as otherwise required by law. All outstanding equity awards and all outstanding stock options then held by Dr. David that are granted on or after the effective date of his employment agreement, whether or not vested, will be forfeited to us as of such date.
Note 5 — Leases:
The Company entered into a
The Company’s lease on its current
premises at 400 Connell Drive, Berkeley Heights, New Jersey 07922 terminates on
The Company entered into an operating lease for office space in Germany that began in July 2017. The rental agreement has a three-month term which automatically renews and includes a monthly cost of 400 Euros. The Company elected to apply the short-term practical expedient to the office lease. The Company also has an operating lease for office equipment.
24
CORMEDIX INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Operating lease expense in the Company’s
condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2020 was
approximately $
At September 30, 2020, the Company has a total
operating lease liability and operating lease ROU assets of $
For the three and nine months ended September
30, 2020 and 2019, cash paid for amounts included in the measurement of lease liabilities in operating cash flows from operating
leases was $
The weighted average remaining lease term as of September 30, 2020 and 2019 were 7.0 and 2.8 years, respectively, and the weighted average discount rate for operating leases was 9.0% and 10.0% as of September 30, 2020 and 2019, respectively.
As of September 30, 2020, maturities of lease liabilities were as follows:
| 2020 (excluding the nine months ended September 30, 2020) | $ | |||
| 2021 | ||||
| 2022 | ||||
| 2023 | ||||
| 2024 | ||||
| 2025 and thereafter | ||||
| Total future minimum lease payments | ||||
| Less imputed interest | ( | ) | ||
| Total | $ |
Note 6 — Concentrations:
At September 30, 2020,
Note 7 — Subsequent Event:
During October 2020, the Company sold an aggregate
of
25
| Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations. |
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our 2019 Annual Report on Form 10-K, filed with the Securities and Exchange Commission, or the SEC, on March 16, 2020 and the notes to our unaudited consolidated financial statements contained in Item 1 above.
Forward Looking Statements
This Quarterly Report on Form 10-Q contains “forward-looking statements” that involve risks and uncertainties, as well as assumptions that, if they never materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. The statements contained in this Quarterly Report on Form 10-Q that are not purely historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, referred to herein as the Exchange Act. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would” and similar expressions or variations intended to identify forward-looking statements. These statements are based on the beliefs and assumptions of our management based on information currently available to management. Such forward-looking statements are subject to risks, uncertainties and other important factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and those discussed in the section titled “Risk Factors” included in our most recent annual report on Form 10-K, as well as any amendments thereto, as filed with the SEC and which are incorporated herein by reference. The impact of COVID-19 may also exacerbate these risks, any of which could have a material effect on us. Furthermore, such forward-looking statements speak only as of the date of this report. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements.
Overview
CorMedix Inc., together with our wholly owned subsidiaries (collectively referred to herein as “we,” “us,” “our” and the “Company”), is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases.
Our primary focus is on the development of our lead product candidate, Defencath™, for potential commercialization in the United States, or U.S., and other key markets as a catheter lock solution, or CLS. The name Defencath is the U.S. proprietary name conditionally approved by the U.S. Food and Drug Administration, or FDA, while the name Neutrolin® is currently used in the European Union, or EU, and other territories where we received CE-Mark approval for the commercial distribution of Neutrolin as a CLS regulated as a medical device. In May 2020, we formed a wholly-owned Spanish subsidiary, CorMedix Spain, S.L.U.
We have in-licensed the worldwide rights to develop and commercialize Defencath and Neutrolin. The CLS is a formulation of 1.35% taurolidine, 3.5% citrate and 1000 u/ml heparin and is regulated by the FDA as an investigational new drug, where it is being developed to prevent catheter-related blood stream infections, (CRBSIs) and thrombosis in patients using central venous catheters, or CVCs, for hemodialysis. CRBSIs and thrombosis represent key complications among hemodialysis, intensive care, cancer and total parenteral nutrition, or TPN, patients with CVCs. These complications can lead to treatment delays and increased costs to the healthcare system when they occur due to hospitalizations, need for intravenous, or IV, antibiotic treatment, long-term anticoagulation therapy, removal/replacement of the CVC, related treatment costs and increased mortality. We initially expect to sell Defencath directly to dialysis centers and hospitals, but also plan to expand its usage into intensive care, oncology and total parenteral nutrition patients using central venous catheters. We believe Defencath addresses a significant unmet medical need and a potential large market opportunity in the U.S.
26
In December 2015, we launched our Phase 3 Prospective, Multicenter, Double-blind, Randomized, Active Control Study to Demonstrate Safety & Effectiveness of Defencath/Neutrolin in Preventing Catheter related Bloodstream Infection in Subjects on Hemodialysis for End Stage Renal Disease, or LOCK-IT-100, in patients with hemodialysis catheters in the U.S. The clinical trial was designed to demonstrate the safety and effectiveness of Defencath compared to the standard of care CLS, Heparin, in preventing CRBSIs. The primary endpoint for the trial assessed the incidence of CRBSI and time to CRBSI for each study subject. Secondary endpoints were catheter patency, which was defined as required use of tissue plasminogen activating factor, or tPA, or removal of catheter due to dysfunction, and removal of catheter for any reason.
In July 2018, 28 potential cases of CRBSI were identified in LOCK-IT-100 that occurred through early December 2017. As previously agreed with the FDA, an interim efficacy analysis was performed. Based on these first 28 cases, there was a highly statistically significant 72% reduction in CRBSI by Defencath relative to the active control of heparin (p=0.0034). Because the pre-specified level of statistical significance was reached for the primary endpoint and efficacy had been demonstrated with no safety concerns, the independent Data Safety Monitoring Board (“DSMB”) recommended early termination. Following discussions with the FDA, we proceeded with an orderly termination of LOCK-IT-100. The study had continued enrolling and treating subjects until study termination, and the final analysis was based on a total of 795 subjects. We remained blinded until the topline results of the full data set of LOCK-IT-100 were announced in late January 2019. In a total of 41 cases, there was a 71% reduction in CRBSI by Defencath relative to heparin, which was highly statistically significant (p=0.0006), with a good safety profile. During 2019, we had a series of meetings with the FDA to discuss the analyses of data from LOCK-IT-100, including an end of Phase 3 meeting, a pre-NDA meeting and a CMC meeting, in preparation for submission of the NDA.
The FDA granted our request for a rolling submission and review of the New Drug Application, or NDA, which is designed to expedite the approval process for products being developed to address an unmet medical need. Although the FDA usually requires two pivotal clinical trials to provide substantial evidence of safety and effectiveness for approval of the NDA, the FDA will in some cases accept one adequate and well-controlled trial, where it is a large multicenter trial with a broad range of subjects and study sites that has demonstrated a clinically meaningful and statistically very persuasive effect on a disease with potentially serious outcome.
In March 2020, we began the modular submission process for the NDA for Defencath for the prevention of CRBSI in hemodialysis patients, and recently announced on July 8, 2020, that submission of all modules for the NDA was completed. In August 2020, the FDA accepted for filing the Defencath NDA. The FDA also granted our request for Priority Review, which provides for a six-month review period instead of the standard ten-month review period. FDA has set a Prescription Drug User Fee Act, or PDUFA, date of February 28, 2021 for the completion of its review for the approval of the NDA. The FDA noted that it is planning to hold an advisory committee meeting to discuss the application and that it had not identified any potential review issues at this time. The meeting of the Antimicrobial Drugs Advisory Committee to discuss the Defencath NDA has tentatively been scheduled for January 14, 2021. We have not been informed of any delays by the FDA in the review of the NDA, but the FDA has limited international and domestic travel due to COVID-19, and pre-approval inspections are required for manufacturing sites.
We intend to pursue additional indications for Defencath use as a CLS in populations with an unmet medical need that also represent a significant market opportunity. For example, we intend to pursue marketing authorization in the U.S. for use as a CLS to reduce CRBSIs in oncology and total parenteral nutrition patients using a CVC.
In the EU, Neutrolin is regulated as a Class 3 medical device. In July 2013, we received CE Mark approval for Neutrolin. In December 2013, we started commercial sales of Neutrolin in Germany for the prevention of CRBSI, and maintenance of catheter patency in hemodialysis patients using a tunneled, cuffed central venous catheter for vascular access. To date, Neutrolin is registered and may be sold in certain European Union and Middle Eastern countries for such treatment.
27
In September 2014, the TUV-SUD and The Medicines Evaluation Board of the Netherlands, or MEB, granted a label expansion for Neutrolin to include use in oncology patients receiving chemotherapy, IV hydration and IV medications via central venous catheters for the EU. In December 2014, we received approval from the Hessian District President in Germany to expand the label for these same expanded indications. The expansion also adds patients receiving medication and IV fluids via central venous catheters in intensive or critical care units (cardiac care unit, surgical care unit, neonatal critical care unit, and urgent care centers). An indication for use in total parenteral nutrition was also approved.
In addition to the CLS, we are sponsoring a pre-clinical research collaboration for the use of taurolidine as a possible treatment for pediatric tumors. In February 2018, the FDA granted orphan drug designation to taurolidine for the treatment of neuroblastoma in children. We may seek one or more strategic partners or other sources of capital to help with the development and commercialization of taurolidine for the treatment of neuroblastoma in children. We are also evaluating opportunities for the possible expansion of taurolidine as a platform compound for use in certain medical devices. Patent applications have been filed in several indications, including wound closure, surgical meshes, and wound management. Based on initial feasibility work, we are advancing pre-clinical studies for taurolidine-infused surgical meshes, suture materials and hydrogels. We will seek to establish development/commercial partnerships as these programs advance.
The FDA regards taurolidine as a new chemical entity and therefore it is currently an unapproved new drug. We may in the future pursue product candidates that would involve devices impregnated with taurolidine, and we believe that at the current time such products would be combination products subject to device premarket submission requirements, while subject also, under review by the FDA, to the standards for drug approvability. Consequently, given that there is no appropriate predicate medical device currently marketed in the U.S. on which a 510(k) approval process could be based and that taurolidine is not yet approved in any application, we anticipate that it would be required to submit a premarket approval application, or PMA, for marketing authorization for any medical device indications that we may pursue for devices containing taurolidine. In the event that an NDA for Defencath is approved by the FDA, the regulatory pathway for these medical device product candidates may be revisited with the FDA. Although there may be no appropriate predicate, de novo Class II designation can be proposed, based on a risk assessment and a reasonable assurance of safety and effectiveness.
In September 2019, our registration with the Saudi Arabia Food and Drug Administration, or the SFDA, expired. As a result, we cannot sell Neutrolin in Saudi Arabia. We intend to complete the documentation required to renew our registration with the SFDA, however, we cannot predict how long the renewal process will take. There is no assurance that the registration will be renewed by the SFDA or that there will be significant sales in Saudi Arabia.
In April 2020, we received approximately $5.2 million, net of expenses, from the sale of most of our remaining unused New Jersey net operating losses, or NOL, eligible for sale under the State of New Jersey’s Economic Development Authority’s New Jersey Technology Business Tax Certificate Transfer program, or NJEDA Program. The NJEDA Program allowed us to sell approximately $5.5 million of our total $6.0 million in available NOL tax benefits for the state fiscal year 2019.
In April 2020, we received from the FDA a refund for the NDA application fee in the amount of $2.9 million, which was paid in the first quarter of 2020. We met the conditions of the Federal Food, Drug, and Cosmetic Act for the small business waiver of the user fees and our request for a waiver of an application user fee was granted by the FDA.
On July 30, 2020, we completed an underwritten public offering of our common stock, which yielded gross proceeds, before underwriting commissions and estimated expenses, of approximately $23.0 million. The public offering was made pursuant to an underwriting agreement with SunTrust Robinson Humphrey, Inc. and JMP Securities LLC (collectively, the “Underwriters”), relating to the issuance and sale of an aggregate of 5,111,110 shares of common stock, including 666,666 shares of common stock pursuant to the full exercise of the Underwriters’ option, at a public offering price of $4.50 per share. The offering was made pursuant to our effective registration statement on Form S-3 Registration Statement No. 333-223562 previously filed with and declared effective by the SEC and a prospectus supplement and accompanying prospectus filed with the SEC.
28
The novel coronavirus has been declared a pandemic and has spread to multiple global regions. The outbreak and government measures taken in response have also had a significant impact, both direct and indirect, on businesses and commerce, as worker shortages have occurred; supply chains have been disrupted; facilities and production have been suspended; and demand for certain goods and services, such as medical services and supplies, has spiked, while demand for other goods and services, such as travel, has fallen. In response to the COVID-19 outbreak, “shelter in place” orders and other public health guidance measures have been implemented across much of the United States, Europe and Asia, including in the locations of our offices, clinical trial sites, key vendors and partners. Our program timelines may be negatively affected by COVID-19, which could materially and adversely affect its business, financial conditions and results of operations.
Since our inception, our operations have been primarily limited to conducting clinical trials and establishing manufacturing for our product candidates, licensing product candidates, business and financial planning, research and development, seeking regulatory approval for our products, initial commercialization activities for Defencath in the U.S. and Neutrolin in the EU and other foreign markets, and maintaining and improving our patent portfolio. We have funded our operations primarily through debt and equity financings. We have generated significant losses to date, and we expect to use substantial amounts of cash for our operations as we commence pre-launch commercial activities for Defencath for the U.S. market and continue to commercialize Neutrolin in the EU and other foreign markets, pursue business development activities, and incur additional legal costs to defend our intellectual property. As of September 30, 2020, we had an accumulated deficit of approximately $211.4 million. We are unable to predict the extent of any future losses or when we will become profitable, if ever.
Financial Operations Overview
Revenue
We have not generated substantial revenue since our inception. Through September 30, 2020, we have funded our operations primarily through debt and equity financings and the sale of our unused New Jersey NOL.
Research and Development Expense
Research and development, or R&D, expense consists of: (i) internal costs associated with our development activities; (ii) payments we make to third party contract research organizations, or CRO, contract manufacturers, investigative sites, and consultants; (iii) technology and intellectual property license costs; (iv) manufacturing development costs; (v) personnel related expenses, including salaries, stock–based compensation expense, benefits, travel and related costs for the personnel involved in drug development; (vi) activities relating to regulatory filings and the advancement of our product candidates through preclinical studies and clinical trials; (vii) facilities and other allocated expenses, which include direct and allocated expenses for rent, facility maintenance, as well as laboratory and other supplies; and (viii) costs related to the manufacturing of the product that could potentially be available to support the commercial launch prior to marketing approval. For the nine months ended September 30, 2020, costs related to the manufacturing of commercial pre-launch inventory that were expensed amounted to approximately $4.8 million. All R&D is expensed as incurred.
Conducting a significant amount of development is central to our business model. Product candidates in later-stage clinical development generally have higher development costs than those in earlier stages of development, primarily due to the significantly increased size and duration of the clinical trials.
29
The process of conducting pre-clinical studies and clinical trials necessary to obtain regulatory approval is costly and time consuming. The probability of success for each product candidate and clinical trial may be affected by a variety of factors, including, among others, the quality of the product candidate’s early clinical data, clinical trial enrollment, duration, conduct and results, investment in the program, competition, manufacturing capabilities and commercial viability of the product candidate. As a result of the uncertainties associated with clinical trials in specific, and the risks inherent in the development process in general, we are unable to determine the duration and completion costs of current or future clinical stages of our product candidates or when, or to what extent, we will generate revenues from the commercialization and sale of any of our product candidates that may be approved.
Development timelines, probability of success and development costs vary widely. We are currently focused on securing the marketing approval for Defencath in the U.S. In December 2015, we signed an agreement with a CRO, to help us conduct our LOCK-IT-100 Phase 3 clinical trial in hemodialysis patients with central venous catheters to demonstrate the efficacy and safety of Defencath in preventing catheter-related bloodstream infections and blood clotting in subjects receiving hemodialysis therapy as treatment for end stage renal disease. Our LOCK-IT-100 study was completed and all costs related to the agreement with the CRO has been paid.
In March 2020, we were granted a deferral by FDA under the Pediatric Research Equity Act, or PREA that requires sponsors to conduct pediatric studies for NDAs for a new active ingredient, such as taurolidine in Defencath, unless a waiver or deferral is obtained from the FDA. A deferral acknowledges that a pediatric assessment is required but permits the applicant to submit the pediatric assessment after the submission of an NDA. We have made a commitment to conduct the pediatric study after approval of the NDA for use in hemodialysis patients. Pediatric studies for an approved product conducted under PREA may qualify for pediatric exclusivity, which if granted would provide an additional six months of marketing exclusivity. Defencath would then have the potential to receive a total marketing exclusivity period of 10.5 years, including exclusivity pursuant to NCE and QIDP.
We are pursuing additional opportunities to generate value from taurolidine, an active component of Defencath. Based on initial feasibility work, we have completed an initial round of pre-clinical studies for taurolidine-infused surgical meshes, suture materials, and hydrogels, which require a PMA regulatory pathway for approval. We are also involved in a pre-clinical research collaboration for the use of taurolidine as a possible treatment for rare orphan pediatric tumors. In February 2018, the FDA granted orphan drug designation to taurolidine for the treatment of neuroblastoma. We may seek one or more strategic partners or other sources of capital to help us develop and commercialize taurolidine for the treatment of neuroblastoma.
Selling, General and Administrative Expense
Selling, general and administrative, or SG&A, expense includes costs related to commercial personnel, medical education professionals, marketing and advertising, salaries and other related costs, including stock-based compensation expense, for persons serving in our executive, sales, finance and accounting functions. Other SG&A expense includes facility-related costs not included in R&D expense, promotional expenses, costs associated with industry and trade shows, and professional fees for legal services and accounting services. We expect to incur significant sales and marketing expenses for the foreseeable future as we prepare for the potential commercial launch of Defencath in the U.S.
Foreign Currency Exchange Transaction Gain (Loss)
Foreign currency exchange transaction gain (loss) is the result of re-measuring transactions denominated in a currency other than our functional currency and is reported in the condensed consolidated statement of operations as a separate line item within other income (expense). The intercompany loans outstanding between our company based in New Jersey and our subsidiary based in Germany are not expected to be repaid in the foreseeable future and the nature of the funding advanced is of a long-term investment nature. As such, unrealized foreign exchange movements related to long-term intercompany loans are recorded in other comprehensive income (loss).
30
Interest Income
Interest income consists of interest earned on our cash and cash equivalents and short-term investments.
Interest Expense
Interest expense consists of interest incurred on our convertible debt, amortization of debt discount and on financing of expenditures.
Results of Operations
Three and nine months ended September 30, 2020 compared to three and nine months ended September 30, 2019
The following is a tabular presentation of our consolidated operating results:
| For the Three Months Ended September 30, | % Increase | For the Nine Months Ended September 30, | % Increase | |||||||||||||||||||||
| 2020 | 2019 | (Decrease) | 2020 | 2019 | (Decrease) | |||||||||||||||||||
| Revenue | $ | 93,020 | $ | 59,530 | 56 | % | $ | 183,517 | $ | 258,488 | (29 | )% | ||||||||||||
| Cost of sales | (79,913 | ) | (79,026 | ) | 1 | % | (147,614 | ) | (327,109 | ) | (55 | )% | ||||||||||||
| Gross profit (loss) | 13,107 | (19,496 | ) | (167 | )% | 35,903 | (68,621 | ) | (152 | )% | ||||||||||||||
| Operating Expenses: | ||||||||||||||||||||||||
| Research and development | (2,925,355 | ) | (2,520,992 | ) | 16 | % | (11,082,764 | ) | (8,375,896 | ) | 32 | % | ||||||||||||
| Selling, general and administrative | (3,691,507 | ) | (2,631,027 | ) | 40 | % | (10,089,252 | ) | (7,187,535 | ) | 40 | % | ||||||||||||
| Total operating expenses | (6,616,862 | ) | (5,152,019 | ) | 28 | % | (21,172,016 | ) | (15,563,431 | ) | 36 | % | ||||||||||||
| Loss from operations | (6,603,755 | ) | (5,171,515 | ) | 28 | % | (21,136,113 | ) | (15,632,052 | ) | 35 | % | ||||||||||||
| Interest income | 10,843 | 92,094 | (88 | )% | 113,125 | 246,880 | (54 | )% | ||||||||||||||||
| Foreign exchange transaction loss | (35 | ) | (12,997 | ) | (100 | )% | (59,241 | ) | (23,283 | ) | 154 | % | ||||||||||||
| Interest expense, including amortization of debt discount | (7,800 | ) | (172,429 | ) | (95 | )% | (27,904 | ) | (781,212 | ) | (96 | )% | ||||||||||||
| Total other income (expense) | 3,008 | (93,332 | ) | (103 | )% | 25,980 | (557,615 | ) | (105 | )% | ||||||||||||||
| Loss before income taxes | (6,600,747 | ) | (5,264,847 | ) | 25 | % | (21,110,133 | ) | (16,189,667 | ) | 30 | % | ||||||||||||
| Tax benefit | - | - | - | 5,169,395 | 5,060,778 | 2 | % | |||||||||||||||||
| Net loss | (6,600,747 | ) | (5,264,847 | ) | 25 | % | (15,940,738 | ) | (11,128,889 | ) | 43 | % | ||||||||||||
| Other comprehensive income (loss) | (5,931 | ) | (2,339 | ) | 154 | % | 2,402 | 5,479 | (56 | )% | ||||||||||||||
| Comprehensive loss | $ | (6,606,678 | ) | $ | (5,267,186 | ) | 25 | % | $ | (15,938,336 | ) | $ | (11,123,410 | ) | 43 | % | ||||||||
Revenue. Revenue for the three months ended September 30, 2020 was $93,000 as compared to $60,000 in the same period last year, an increase of $33,000. The increase was attributable to the sales in Middle East countries other than Saudi Arabia during the three months ended September 30, 2020 as compared to no sales for the same period in 2019.
31
Revenue for the nine months ended September 30, 2020 was $184,000 as compared to $258,000 in the same period last year, a decrease of $74,000. The decrease was attributable to having no sales in Saudi Arabia during the nine months ended September 30, 2020 due to the expiration of our registration with the Saudi Arabia Food and Drug Administration as compared to the sales of $116,000 for the same period in 2019. The registration must be renewed in order for us to continue selling in Saudi Arabia.
Cost of Sales. Cost of sales for the three months ended September 30, 2020 and 2019 was $80,000 and $79,000, respectively.
Cost of sales for the nine months ended September 30, 2020 was $148,000 as compared to $327,000 in the same period last year, a decrease of $179,000, primarily attributable to the cost of replacement of expired product that occurred during the same period in 2019.
Research and Development Expense. R&D expense was $2,925,000 for the three months ended September 30, 2020, an increase of $404,000, or 16%, from $2,521,000 for the three months ended September 30, 2019. The increase was primarily attributable an increase in personnel expenses of $242,000, primarily due to additional hires, increase in costs related to the purchase of raw materials and manufacturing of Defencath to support the commercial launch prior to its potential marketing approval of $206,000, and an increase in non-cash charges for stock-based compensation of $55,000. These increases were offset, among other items of lesser significance, by a reduction in clinical trial expenses of $86,000, mainly due to the completion of our LOCK-IT-100 clinical trial.
R&D expense was $11,083,000 for the nine months ended September 30, 2020, an increase of $2,707,000, or 32%, from $8,376,000 for the nine months ended September 30, 2019. The increase was primarily attributable to an increase in costs related to the purchase of raw materials and manufacturing of Defencath prior to its potential marketing approval that could potentially support the commercial launch amounting to $3,761,000, an increase in personnel expenses of $593,000, primarily due to additional hires. These increases were offset, among other items of lesser significance, by a reduction in clinical trial expenses of $1,387,000, attributable to the closing of our LOCK-IT-100 clinical trial and a decrease in consulting fees of $264,000.
Selling, General and Administrative Expense. SG&A expense was $3,692,000 for the three months ended September 30, 2020, an increase of $1,061,000, or 40%, from $2,631,000 for the three months ended September 30, 2019. The increase was primarily attributable to increases in costs related to marketing research studies in preparation for the potential marketing approval of Defencath of $647,000; and an increase in personnel expenses of $362,000, due to additional hires; an increase in recruitment costs of $67,000, in search for additional personnel, and increases in investor relations activities and consulting fees of $56,000 and $46,000, respectively. In addition, board cash fees increased by $57,000 as a result of a change in compensation which has eliminated issuance of restricted stock units as compensation. These increases were partially offset, among others of lesser significance, by a reduction in legal fees related to litigation of $180,000.
SG&A expense was $10,089,000 for the nine months ended September 30, 2020, an increase of $2,901,000, or 40%, from $7,188,000 for the nine months ended September 30, 2019. The increase was primarily attributable to increases in personnel expenses of $879,000, primarily for additional hires during the nine months ended September 30, 2020, increases in costs related to marketing research studies in preparation for the potential marketing approval of Defencath of $661,000. Additionally, there was also an increase in insurance expenses of $342,000, driven by higher directors and officers insurance premium that have gone up for all companies in our space; an increase in recruitment fees of $230,000, in search for additional personnel; an increase in board fees of $208,000, as a result of a change in compensation which has eliminated issuance of restricted stock units as compensation; an increase in investor relations and business development activities of $171,000; an increase in consulting fees of $158,000, and increases in dues and subscription and office expenses of $122,000.
32
Foreign Exchange Transaction Gain (Loss). No foreign exchange transaction was recorded for the three months ended September 30, 2020 compared to a loss of $13,000 for the same period last year. These losses occurred due to the re-measuring of transactions denominated in a currency other than our functional currency.
Foreign exchange transaction losses were recorded for the nine months ended September 30, 2020 and 2019 of $59,000 and $23,000, respectively. These losses occurred due to the re-measuring of transactions denominated in a currency other than our functional currency.
Interest Income. Interest income was $11,000 for the three months ended September 30, 2020 compared to $92,000 for the same period last year, a decrease of $81,000. The decrease was attributable to lower average interest-bearing cash balances and short-term investments during the three months ending September 30, 2020 as compared to the same period in 2019.
Interest income was $113,000 for the nine months ended September 30, 2020 compared to $247,000 for the same period last year, a decrease of $134,000. The decrease was attributable to lower average interest-bearing cash balances and short-term investments during the nine months ending September 30, 2020 as compared to the same period in 2019.
Interest Expense. Interest expense was $8,000 for the three months ended September 30, 2020 as compared to $172,000 for the three months ended September 30, 2019. This was attributable to the amortization of debt discount and non-cash interest expense recognized during the three months ended September 30, 2019 in connection with the senior secured convertible note issued in December 2018 that is no longer outstanding.
Interest expense was $28,000 for the nine months ended September 30, 2020 compared to $781,000 for the same period last year. This was attributable to the amortization of debt discount and non-cash interest expense recognized during the nine months ended September 30, 2019 in connection with the senior secured convertible note issued in December 2018 that is no longer outstanding.
Other Comprehensive Income (Loss). Unrealized foreign exchange movements related to long-term intercompany loans, the translation of the foreign affiliate financial statements to U.S. dollars and unrealized movements related to short-term investment are recorded in other comprehensive income (loss) which resulted in losses of $6,000 and $2,000 for the three months ended September 30, 2020 and 2019, respectively.
Unrealized foreign exchange movements related to long-term loans and the translation of the foreign affiliate financial statements to U.S. dollars and unrealized movements related to short term investment are recorded in other comprehensive income (loss) which resulted in gains of $2,000 and $5,000 for the nine months ended September 30, 2020 and 2019, respectively.
Tax Benefit. Tax benefits for the nine months ended September 30, 2020 and 2019 of $5,169,000 and $5,061,000, respectively, was an income tax benefit due to the sale of most of our remaining unused NOL through the NJEDA Program.
Liquidity and Capital Resources
Sources of Liquidity
As a result of our cost of sales, R&D and SG&A expenditures and the lack of substantial product sales revenue, our ongoing operations have not been profitable since our inception. During the nine months ended September 30, 2020, we received net proceeds $3,046,000 from the issuance of 477,721 shares of common stock under our ATM program and $412,000 from the exercise of warrants. Additionally, on July 30, 2020, we completed an underwritten public offering of our common stock, which yielded net proceeds of approximately $21,320,000. The public offering was made pursuant to an underwriting agreement with the Underwriters, relating to the issuance and sale of an aggregate of 5,111,110 shares of common stock, including 666,666 shares of common stock pursuant to the full exercise of the Underwriters’ option, at a public offering price of $4.50 per share. We will continue to be reliant on external sources of cash for the foreseeable future until we are able to generate revenue.
In April 2020, we received approximately $5,200,000, net of expenses, from the sale of most of our remaining unused New Jersey NOL eligible for sale under the NJEDA Program. The NJEDA Program allowed us to sell approximately $5,500,000 of our total $6,000,000 in available NOL tax benefits for the state fiscal year 2019.
33
Net Cash Used in Operating Activities
Net cash used in operating activities for the nine months ended September 30, 2020 was $16,034,000 as compared to $11,167,000 for the same period in 2019, an increase in net cash use of $4,867,000. The increase was mainly attributable to the increase in net loss of $4,812,000, primarily driven by an increase in operating expenses, mainly due to the research and development expense related to the costs related to the manufacturing of Defencath prior to its potential marketing approval and selling, general and administrative expense related to marketing research studies in preparation for the potential marketing approval of Defencath. In addition, the increase was also due to an increase in prepaid expenses and other current assets for the nine months ended September 30, 2020 of $929,000, primarily due to a deposit on the equipment, compared to a $155,000 increase for the same period in 2019, and a decrease in accrued expenses of $2,286,000 for the nine months ended September 30, 2020, as compared to a decrease of $1,212,000 for the same period in 2019. These decreases were partially offset by an increase in accounts payable of $962,000 for the nine months ended September 30, 2020, as compared to a decrease of $1,534,000 for the same period in 2019.
Net Cash Provided by (Used in) Investing Activities
Cash provided by investing activities for the nine months ended September 30, 2020 was $9,274,000 as compared to $12,317,000 cash used in the same period in 2019. The increase in cash provided during the nine months ended September 30, 2020 as compared to the nine months ended September 30, 2019 was due to the maturity of short-term investments and a decline in purchases of short-term investments in 2020.
Net Cash Provided by Financing Activities
Net cash provided by financing activities for the nine months ended September 30, 2020 was $24,778,000 as compared to $26,010,000 for the same period in 2019. During the nine months ended September 30, 2020, we generated net proceeds of $21,320,000 from the public offering of our common stock, $3,046,000 from the sale of our common stock in our at-the-market, or ATM program, and $412,000 from the exercise of warrants. In comparison to the same period in 2019, the net proceeds we generated in the amount of $15,235,000 was from the sale of our common stock in our ATM program, and gross proceeds of $8,658,000 and $118,000 from the exercise of warrants and stock options and proceeds from an exchange agreement of $2,000,000, respectively.
Funding Requirements and Liquidity
Our total cash on hand and short-term investments as of September 30, 2020 was $37.0 million, excluding restricted cash of $0.2 million, compared with $28.3 million at December 31, 2019. As of September 30, 2020, we have approximately $8.7 million available under our current ATM program. We may utilize our ATM program, if conditions allow, to support our activities in connection with the activities required for commercial launch of Defencath, as well as general corporate expenses.
Because our business has not generated positive operating cash flow, additional capital will likely be required in order to fund launch activities for Defencath, as well as other taurolidine-based research and development activities and our operations generally. Our continued operations will depend on our ability to raise sufficient funds through various potential sources, such as equity, debt financings, and/or strategic relationships. We can provide no assurances that financing or strategic relationships will be available on acceptable terms, or at all.
34
We expect to continue to fund operations from cash on hand and through capital raising sources as previously described, which may be dilutive to existing stockholders, through revenues from the licensing of our products, or through strategic alliances. We may continue to utilize our ATM program, if conditions allow, to support our ongoing funding requirements. Additionally, we may seek to sell additional equity or debt securities in one or more transactions, or enter into a strategic alliance arrangement, but can provide no assurances that any such financing or strategic alliance arrangement will be available on acceptable terms, or at all. Moreover, the incurrence of indebtedness would result in increased fixed obligations and could contain covenants that would restrict our operations. Raising additional funds through strategic alliance arrangements with third parties may require significant time to complete and could force us to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or to grant licenses on terms that may not be favorable to us or our stockholders. Our actual cash requirements may vary materially from those now planned due to a number of factors, any change in the focus and direction of our research and development programs, any acquisition or pursuit of development of new product candidates, competitive and technical advances, the costs of commercializing any of our product candidates, and costs of filing, prosecuting, defending and enforcing any patent claims and any other intellectual property rights.
Sales of Neutrolin outside the U.S. are not expected to generate significant product revenues for the foreseeable future, and while we expect to grow product sales for Defencath in the U.S., should we receive the FDA marketing approval. In the absence of significant revenue, we are likely to continue generating operating cash flow deficits. We will continue to use cash as we increase other activities leading to the commercialization of Defencath upon approval, pursue business development activities, and incur additional legal costs to defend our intellectual property.
We currently estimate that as of September 30, 2020 we have sufficient cash on hand to fund operations at least twelve months after the filing date of this report, after taking into consideration the net proceeds received from the ATM sales in October 2020 and the costs for the initial preparations for commercial launch for Defencath. Additional financing may be required to complete the build out of our commercial infrastructure and to continue our operations post commercial launch depending on the rate of sales growth. We anticipate a PDUFA date of February 28, 2021 for the FDA to complete its review for the approval of the Defencath NDA. If we are unable to raise additional funds when needed, we may be forced to slow or discontinue our preparations for the commercial launch of Defencath. We may also be required to delay, scale back or eliminate some or all of our research and development programs. Each of these alternatives would likely have a material adverse effect on our business.
Contractual Obligations
In March 2020, we entered into a seven-year lease agreement for approximately 6,089 square feet of office space at 300 Connell Drive, Berkeley Heights, New Jersey. The average monthly lease payment is approximately $17,000 which commenced on September 16, 2020.
Our lease on our previous premises at 400 Connell Drive, Berkeley Heights, New Jersey terminates on November 30, 2020.
Critical Accounting Policies
Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses. On an ongoing basis, we evaluate these estimates and judgments, including those described below. We base our estimates on our historical experience and on various other assumptions that we believe to be reasonable under the circumstances. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results and experiences may differ materially from these estimates.
For the nine-month period ended September 30, 2020, there were no significant changes to our critical accounting policies as identified in our Annual Report on Form 10-K for the year ended December 31, 2019.
35
Recently Adopted Accounting Pronouncements
In June 2016, the Financial Accounting Standards Board (“FASB”) issued new guidance which replaces the incurred loss impairment methodology in current GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. This adoption on January 1, 2020 did not have a material impact on our condensed consolidated financial statements.
In August 2018, the FASB issued new guidance which modifies the disclosure requirements on fair value measurements. The guidance was effective for us beginning in the first quarter of fiscal year 2020. This adoption on January 1, 2020 did not have a material impact on our condensed consolidated financial statements.
In November 2018, the FASB issued new guidance to clarify the interaction between the authoritative guidance for collaborative arrangements and revenue from contracts with customers. The new guidance clarifies that, when the collaborative arrangement participant is a customer in the context of a unit-of-account, revenue from contracts with customers guidance should be applied, adds unit-of-account guidance to collaborative arrangements guidance, and, in a transaction with a collaborative arrangement participant who is not a customer, precludes presenting the transaction together with revenue recognized under contracts with customers. The guidance was effective for us beginning in the first quarter of fiscal year 2020. This adoption on January 1, 2020 did not have a material impact on our condensed consolidated financial statements.
In November 2019, the FASB issued new guidance which requires that an entity measure and classify share-based payment awards granted to a customer by applying the guidance in FASB ASC 718. The guidance was effective for us beginning in the first quarter of fiscal year 2020. This adoption on January 1, 2020 did not have a material impact on our condensed consolidated financial statements.
Recently Issued Authoritative Pronouncements
In December 2019, the FASB issued new guidance which removes certain exceptions to the general principles of the accounting for income taxes and also improves consistent application of and simplification of other areas when accounting for income taxes. The guidance is effective for us beginning in the first quarter of fiscal year 2021. Early adoption is permitted. We are assessing the impact of adopting this guidance on our consolidated financial statements.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements.
Item 3. Quantitative and Qualitative Disclosure about Market Risk.
None.
36
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Disclosure controls and procedures are designed only to provide reasonable assurance that information to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Under the supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, we carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) as of September 30, 2020. Based on the foregoing evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures are effective to ensure that information required to be disclosed by us in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and our Chief Financial Officer, to allow timely decisions regarding required disclosures.
Changes in Internal Control Over Financial Reporting
Other than the hiring of our new Chief Financial Officer effective May 11, 2020, there were no changes in our internal control over financial reporting during the nine months ended September 30, 2020, or in other factors that could significantly affect these controls, that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. Our former Chief Financial Officer is a consultant to the Company and assists with accounting and financial reporting through the transition.
37
PART II
OTHER INFORMATION
Item 1. Legal Proceedings.
On September 9, 2014, we filed in the District Court of Mannheim, Germany a patent infringement action against TauroPharm GmbH and Tauro-Implant GmbH as well as their respective CEOs, referred to as the Defendants claiming infringement of our European Patent EP 1 814 562 B1, which was granted by the EPO on January 8, 2014, or the Prosl European Patent. The Prosl European Patent covers a low dose heparin catheter lock solution for maintaining patency and preventing infection in a hemodialysis catheter. In this action, we claim that the Defendants infringe on the Prosl European Patent by manufacturing and distributing catheter locking solutions to the extent they are covered by the claims of the Prosl European Patent. We believe that our patent is sound and are seeking injunctive relief and raising claims for information, rendering of accounts, calling back, destruction and damages. Separately, TauroPharm has filed an opposition with the EPO against the Prosl European Patent alleging that it lacks novelty and inventive step. We cannot predict what other defenses the Defendants may raise, or the ultimate outcome of either of these related matters. At present, the EPO has revoked the Prosl European Patent as invalid, and we have filed an appeal, which is currently pending.
In the same complaint against the same Defendants, we also alleged an infringement (requesting the same remedies) of NDP’s utility model DE 20 2005 022 124 U1, referred to as the Utility Model, which we believe is fundamentally identical to the Prosl European Patent in its main aspects and claims. The Court separated the two proceedings and the Prosl European Patent and the Utility Model claims are now being tried separately. TauroPharm has filed a cancellation action against the Utility Model before the German Patent and Trademark Office, or German PTO based on the similar arguments as those in the opposition against the Prosl European Patent.
On March 27, 2015, the District Court held a hearing to evaluate whether the Utility Model has been infringed by TauroPharm in connection with the manufacture, sale and distribution of its TauroLock-HEP100TM and TauroLock-HEP500TM products. A hearing before the same court was held on January 30, 2015 on the separate, but related, question of infringement of the Prosl European Patent by TauroPharm.
38
The Court issued its decisions on May 8, 2015, staying both proceedings. In its decisions, the Court found that the commercialization by TauroPharm in Germany of its TauroLock catheter lock solutions Hep100 and Hep500 infringes both the Prosl European Patent and the Utility Model and further that there is no prior use right that would allow TauroPharm to continue to make, use or sell its product in Germany. However, the Court declined to issue an injunction in favor of us that would preclude the continued commercialization by TauroPharm based upon its finding that there is a sufficient likelihood that the EPO, in the case of the Prosl European Patent, or the German PTO, in the case of the Utility Model, may find that such patent or utility model is invalid. Specifically, the Court noted the possible publication of certain instructions for product use that may be deemed to constitute prior art. As such, the District Court determined that it will defer any consideration of the request by us for injunctive and other relief until such time as the EPO or the German PTO made a final decision on the underlying validity of the Prosl European Patent and the Utility Model. We expect that the complaint regarding the infringement of the Utility Model will be dismissed now that the German PTO has voided the Utility Model (see below). This does, however, not have a direct effect on the infringement proceedings concerning the Prosl European Patent.
The opposition proceeding against the Prosl European Patent before the EPO is ongoing. In its preliminary consideration of the matter, the EPO (and the German PTO) regarded the patent as not inventive or novel due to publication of prior art. Oral proceedings before the Opposition Division at the EPO were held on November 25, 2015, at which the three-judge patent examiner panel considered arguments related to the validity of the Prosl European Patent. The hearing was adjourned due to the fact that the panel was of the view that Claus Herdeis, one of the managing directors of TauroPharm, had to be heard as a witness in a further hearing in order to close some gaps in the documentation presented by TauroPharm as regards the publication of prior art.
The German PTO held a hearing in the validity proceedings relating to the Utility Model on June 29, 2016, at which the panel affirmed its preliminary finding that the Utility Model was invalid based upon prior publication of a reference to the benefits that may be associated with adding heparin to a taurolidine based solution. We filed an appeal against the ruling on September 7, 2016. An oral hearing was held on September 17, 2019 in which the German Federal Patent Court affirmed the first instance decision that the Utility Model was invalid. The decision has only a declaratory effect, as the Utility Model had expired in November 2015. On April 28, 2020, we filed a withdrawal of the complaint on the German utility model, thereby waiving our claims on these proceedings. We estimate that the expense will be less than €40,000.
In October 2016, TauroPharm submitted a further writ to the EPO requesting a date for the hearing and bringing forward further arguments, in particular in view of the June 2016 decision of the German PTO on the invalidity of the utility model. On November 22, 2017, the EPO in Munich, Germany held a further oral hearing in this matter. At the hearing, the panel held that the Prosl European Patent would be invalidated because it did not meet the requirements of novelty based on a technical aspect of the European intellectual property law. We disagree with this decision and, after the written opinion was issued by the Opposition Division in September 2018, have appealed the decision. We continue to believe that the Prosl European Patent is indeed novel and that its validity should be maintained. There can be no assurance that we will prevail in this matter. In addition, the ongoing Unfair Competition litigation against TauroPharm is not affected and will continue.
39
On January 16, 2015, we filed a complaint against TauroPharm GmbH and its managing directors in the District Court of Cologne, Germany. In the complaint, we allege violation of the German Unfair Competition Act by TauroPharm for the unauthorized use of our proprietary information obtained in confidence by TauroPharm. We allege that TauroPharm is improperly and unfairly using our proprietary information relating to the composition and manufacture of Neutrolin, in the manufacture and sale of TauroPharm’s products TauroLockTM, TauroLock-HEP100 and TauroLock-HEP500. We seek a cease and desist order against TauroPharm from continuing to manufacture and sell any product containing taurolidine (the API of Neutrolin) and citric acid in addition to possible other components, damages for any sales in the past and the removal of all such products from the market. An initial hearing in the District Court of Cologne, Germany was held on November 19, 2015 to consider our claims. The judge made no decision on the merits of our complaint. On January 14, 2016, the Court issued an interim decision in the form of a court order outlining several issues of concern that relate primarily to the court's interest in clarifying the facts and reviewing any and all available documentation, in particular with regard to the question which specific know-how was provided to TauroPharm by whom and when. We have prepared the requested reply and produced the respective documentation. TauroPharm has also filed another writ within the same deadline and both parties have filed further writs at the end of April 2016 setting out their respective argumentation in more detail. A further oral hearing in this matter was held on November 15, 2016. In this hearing, the Court heard arguments from CorMedix and TauroPharm concerning the allegations of unfair competition. The Court made no rulings from the bench and indicated that it is prepared to further examine the underlying facts of our allegations. On March 7, 2017, the Court issued another interim decision in the form of a court order outlining again several issues relating to the argumentation of both sides in the proceedings. In particular the Court requested us to further specify our requests and to further substantiate in even more detail which know-how was provided by Biolink (the company who developed Neutrolin that was acquired by ND Partners) to TauroPharm by whom and when. The Court also raised the question whether the know-how provided at the time to TauroPharm could still be considered to be secret know-how or may have become public in the meantime. The Court granted both sides the opportunity to reply to this court order and provide additional facts and evidence until May 15, 2017. Both parties have submitted further writs in this matter and the Court had scheduled a further hearing for May 8, 2018. After having been rescheduled several times, the hearing took place on November 20, 2018. A decision was rendered by the Court on December 11, 2018, dismissing the complaint in its entirety. However, we intend to continue to pursue this matter, and still believe firmly that our claims are well-founded. We have therefore appealed in January 2019 and filed our grounds of appeal in March 2019. An oral hearing was held on September 6, 2019 in which our legal counsel brought forward further arguments for the fact that the manufacturing process of the respective catheter locking solution is indeed protectable as a trade secret. In view of these new arguments, the Court issued an evidentiary order on September 27, 2019 ordering an expert opinion. The expert opinion was not in our favor, but we have filed a response to the expert opinion in reaction to which the Court asked the expert to supplement his opinion to address the issues brought forward in our submission. In the supplementary expert opinion, the expert confirmed his view. We have filed another response and requested an oral hearing which has not yet been scheduled.
Item 1A. Risk Factors.
The outbreak of the novel coronavirus disease, COVID-19, or other pandemic, epidemic or outbreak of an infectious disease may materially and adversely impact our business, including our preclinical studies and clinical trials.
In December 2019, the novel coronavirus disease, COVID-19, was identified in Wuhan, China. This virus has been declared a pandemic and has spread to multiple global regions. The outbreak and government measures taken in response have also had a significant impact, both direct and indirect, on businesses and commerce, as worker shortages have occurred; supply chains have been disrupted; facilities and production have been suspended; and demand for certain goods and services, such as medical services and supplies, has spiked, while demand for other goods and services, such as travel, has fallen. In response to the COVID-19 outbreak, “shelter in place” orders and other public health guidance measures have been implemented across much of the United States, Europe and Asia, including in the locations of our offices, clinical trial sites, key vendors and partners. Such “shelter in place” orders were previously lifted, at least partially, in many locations. However, an increase in the spread of COVID-19, which may be a continuation of the “first wave” or beginning of a “second wave” of the virus, has led to the re-imposition by many states of quarantine requirements for out-of-state travelers and may lead to the re-imposition of “shelter-in-place” or other similar orders. Our clinical development program timelines may be negatively affected by COVID-19, which could materially and adversely affect our business, financial condition and results of operations. Further, due to “shelter in place” orders and other public health guidance measures, we have implemented a work-from-home policy for all staff members excluding those necessary to maintain minimum basic operations. Our increased reliance on personnel working from home may negatively impact productivity, or disrupt, delay or otherwise adversely impact our business.
40
As a result of the COVID-19 outbreak, or similar pandemics, and related travel restrictions and “shelter in place” orders and other public health guidance measures, we have and may in the future experience disruptions that could materially and adversely impact our clinical trials, business, financial condition and results of operations. Potential disruptions include but are not limited to:
| ● | delays or difficulties in enrolling patients in our clinical trials; |
| ● | delays or difficulties in initiating or expanding clinical trials, including delays or difficulties with clinical site initiation and recruiting clinical site investigators and clinical site staff; |
| ● | increased rates of patients withdrawing from our clinical trials following enrollment as a result of contracting COVID-19 or other health conditions or being forced to quarantine; |
| ● | diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials; |
| ● | interruption of key clinical trial activities, such as clinical trial site data monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others or interruption of clinical trial subject visits and study procedures, which may impact the integrity of subject data and clinical study endpoints; |
| ● | interruption or delays in the operations of the FDA or other regulatory authorities, which may impact review and approval timelines for our NDA; |
| ● | delays or disruptions in preclinical experiments and investigational new drug application-enabling studies due to restrictions of on-site staff and unforeseen circumstances at contract research organizations and vendors; |
| ● | interruption of, or delays in receiving supplies of our product candidates from our contract manufacturing organizations due to staffing shortages, production slowdowns or stoppages and disruptions in delivery systems; |
| ● | limitations on our ability to recruit and hire key personnel due to our inability to meet with candidates because of travel restrictions and “shelter in place” orders; |
| ● | limitations on employee resources that would otherwise be focused on the conduct of our preclinical studies and clinical trials, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people; and |
| ● | interruption or delays to our sourced discovery and clinical activities. |
The COVID-19 pandemic continues to rapidly evolve. The extent to which the outbreak impacts our business, preclinical studies and clinical trials will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the pandemic, travel restrictions and social distancing in the United States and other countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease. If we or any of the third parties with whom we engage were to experience shutdowns or other business disruptions, our ability to conduct our business in the manner and on the timelines presently planned could be materially and negatively impacted.
In addition, the trading prices for our common stock and other biopharmaceutical companies have been highly volatile as a result of the COVID-19 pandemic. As a result, we may face difficulties raising capital through sales of our common stock or such sales may be on unfavorable terms.
41
Item 6. Exhibits.
The exhibit index set forth below is incorporated by reference in response to this Item 6.
Exhibit Number |
Description | |
| 31.1 | Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.* | |
| 31.2 | Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.* | |
| 32.1 | Certification of Principal Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.* | |
| 32.2 | Certification of Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.* | |
101.INS |
XBRL Instance Document - The instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. | |
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document. | |
|
101.CAL |
Inline XBRL Taxonomy Extension Calculation Linkbase Document. | |
| 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document. | |
| 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document. | |
| 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document. | |
104 |
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
| * | Filed herewith. |
42
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| CORMEDIX INC. | |||
| Date: November 5, 2020 | By: | /s/ Khoso Baluch | |
| Name: | Khoso Baluch | ||
| Title: | Chief Executive Officer | ||
| (Principal Executive Officer) | |||
43