8-K
VYNE Therapeutics Inc. (VYNE)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 8, 2020
VYNE Therapeutics Inc.
(Exact name of registrant as specifiedin its charter)
| Delaware | 001-38356 | 45-3757789 |
|---|---|---|
| (State or other jurisdiction<br><br> <br>of incorporation) | (Commission<br><br> <br>File Number) | (IRS Employer<br><br> <br>Identification Number) |
520 U.S. Highway 22, Suite 204
Bridgewater, New Jersey 08807
(Address of principal executive offices,including Zip Code)
(800) 755-7936
(Registrant’s telephone number,including area code)
(Former name or former address, if changedsince last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| --- | --- |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | TradingSymbol(s) | Name of each exchange<br><br> <br>on which registered |
|---|---|---|
| Common Stock, $0.0001 par value | VYNE | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company x
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. x
Item 5.02. Departure of Directors or Certain Officers; Electionof Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On September 8, 2020, the Board of Directors (the “Board”) of VYNE Therapeutics Inc. (the “Company”) appointed Mr. Patrick G. LePore to serve as a director of the Company, effective as of September 10, 2020, for a term continuing to the Company’s 2021 Annual Meeting. Mr. LePore has not been appointed to serve on any committees of the Board at this time. The Board has determined that Mr. LePore satisfies the definition of an “independent director” under the Nasdaq Stock Market listing standards and applicable U.S. Securities and Exchange Commission (“SEC”) rules.
Mr. LePore, 65, served as Chairman, Chief Executive Officer and President of Par Pharmaceutical Companies, Inc. until its sale to affiliates of TPG Capital in 2012. He remained as chairman of the company through its sale to Endo International in 2015. He began his career with Hoffmann-LaRoche. He later founded Boron, LePore & Associates, a medical communications company, which he took public in 1997 and was eventually sold to Cardinal Health in 2002. Mr. LePore is currently Chairman of the Board of Lannett Co. Inc., Vice Chair of Matinas BioPharma and is a trustee of Villanova University. He previously served on the boards of PharMerica and Innoviva. Mr. LePore earned a bachelor’s degree from Villanova University and a Master of Business Administration from Farleigh Dickinson University.
Mr. LePore will receive the standard director compensation that the Company provides to its non-employee directors pursuant to its director compensation policy as described in the Company’s Definitive Proxy Statement on Schedule 14A filed with the SEC on June 22, 2020, prorated from the commencement of his service on the Board. Mr. LePore was not appointed as a director pursuant to any arrangements or understandings with the Company or with any other person, and there are no related party transactions between Mr. LePore and the Company that would require disclosure under Item 404(a) of Regulation S-K.
On September 14, 2020, the Company issued a press release announcing the appointment of Mr. LePore. A copy of the press release is attached hereto as Exhibit 99.1.
Item 7.01. Regulation FD Disclosure.
Members of management of the Company intend to use the investor presentation attached hereto as Exhibit 99.2 at the H.C. Wainwright 22nd Annual Global Investment Conference on September 14, 2020 and the Cantor Fitzgerald Virtual Global Healthcare Conference on September 16, 2020.
The information in this Item 7.01 and Exhibit 99.2 hereto is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall they be deemed incorporated by reference in any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description |
|---|---|
| 99.1 | Press release, dated September 14, 2020. |
| 99.2 | Investor Presentation, dated September 2020. |
| 104 | Cover Page Interactive Date File (embedded within the Inline XBRL document). |
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 hereunto duly authorized.
| VYNE THERAPEUTICS INC. | ||
|---|---|---|
| Date: September 14, 2020 | By: | /s/ Mutya Harsch |
| Mutya Harsch | ||
| Chief Legal Officer and General Counsel |
Exhibit 99.1
****
VYNE TherapeuticsAnnounces the Appointment of Patrick G. LePore to its Board of Directors
Bridgewater, NJ – September 14, 2020 – VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”) today announced that the Board of Directors of the Company appointed Mr. Patrick G. LePore to serve as a director of the Company, effective as of September 10, 2020.
“We are delighted to welcome Pat to our Board. Pat brings extensive experience from a long and successful career as a senior level executive and board member for several highly regarded companies in the pharmaceutical sector,” said David Domzalski, President and Chief Executive Officer of VYNE. “As VYNE establishes itself as a commercial stage pharmaceutical company, it is important to have Board members with the appropriate areas of expertise. Pat has relevant experience in M&A, operations and the sales and marketing of branded pharmaceuticals, which will be very helpful as we make preparations for our second commercial launch in 2020 and build our franchise in dermatology. We are confident that he will bring valuable insight and make important contributions to our company.”
Mr. LePore stated “I am enthusiastic to be joining the Board of Directors of VYNE, and to work with a highly dedicated organization. VYNE is committed to making a meaningful difference in the lives of patients, and has a strong culture of innovation, a recent track record of regulatory approvals and a great opportunity to build valuable therapeutic brands.”
Mr. LePore has more than 40 years of experience in the pharmaceutical industry, in both private and public sectors, and with board and operational experience in each. He served as Chairman, Chief Executive Officer and President of Par Pharmaceutical Companies, Inc. from September 2006 to 2012. During his tenure at Par, Mr. LePore oversaw the management of over 2,000 employees with facilities across the United States and India. He also directed the growth of its brand business, Strativa, its sales force and the acquisition of several specialty pharmaceutical products. Through Mr. LePore’s leadership, Par increased its value and market presence culminating in its sale to affiliates of TPG Capital for approximately $2 billion in 2012. He remained as chairman of the new company through its sale to Endo International for approximately $8 billion in 2015. Mr. LePore began his career with Hoffmann-LaRoche in 1978 as a sales representative. Later, he founded and took public Boron, LePore & Associates, a medical communications company, which was eventually sold to Cardinal Health. Mr. LePore is currently Chairman of the Board of Lannett Co. Inc., the Vice Chairman of the Board of Matinas BioPharma and is a trustee of Villanova University. Mr. LePore earned a bachelor’s degree from Villanova University and a Master of Business Administration from Fairleigh Dickinson University.
520 US Highway 22 • 2^nd^ Floor • Bridgewater, NJ 08807
About VYNE Therapeutics Inc.
VYNE Therapeutics’ mission is to improve the lives of patients by developing proprietary, innovative and differentiated therapies in dermatology and beyond.
With expertise in topical medicine innovation as a springboard, VYNE is working to develop and commercialize a variety of solutions using its proprietary Molecule Stabilizing Technology (MST^™^), and has received FDA approval for AMZEEQ^®^ (minocycline) topical foam, 4%, the world’s first topical minocycline, and for ZILXI^™^ (minocycline) topical foam, 1.5%, the first minocycline product of any kind to be approved by the FDA for use in rosacea. For more information about our approved products, please see AMZEEQ’s Full Prescribing Information at amzeeq.com and ZILXI’s Full Prescribing Information at zilxi.com.
For more information about VYNE Therapeutics Inc. or its investigational products, visit www. vynetherapeutics.com or follow VYNE on Twitter. VYNE may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor VYNE’s website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts.
Media Relations:
Bridgette Potratz
Zeno Group
312-755-5462, x5516
bridgette.potratz@zenogroup.com
Investor Relations:
Joyce Allaire
LifeSci Advisors, LLC
646-889-1200
jallaire@lifesciadvisors.com
Andrew Saik
Chief Financial Officer
VYNE Therapeutics
908-731-6180
Andrew.Saik@vynetx.com
520 US Highway 22 • 2^nd^ Floor • Bridgewater, NJ 08807
Cautionary Statement Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the development and commercialization of VYNE’s products and product candidates and other statements regarding the future expectations, plans and prospects of VYNE. All statements in this press release which are not historical facts are forward-looking statements. Any forward-looking statements are based on VYNE’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the COVID-19 pandemic and its impact on our business operations; adverse events associated with the commercialization of AMZEEQ and ZILXI; the outcome and cost of clinical trials for current and future product candidates; determination by the FDA that results from VYNE’s clinical trials are not sufficient to support registration or marketing approval of product candidates; the outcome of pricing, coverage and reimbursement negotiations with third party payors for AMZEEQ, ZILXI or any other products or product candidates that VYNE may commercialize in the future; whether, and to what extent, third party payors impose additional requirements before approving AMZEEQ and ZILXI prescription reimbursement; the eligible patient base and commercial potential of AMZEEQ, ZILXI or any of VYNE’s other products or product candidates; risks that VYNE’s intellectual property rights, such as patents, may fail to provide adequate protection, may be challenged and one or more claims may be revoked or interpreted narrowly or will not be infringed; risks that any of VYNE’s patents may be held to be narrowed, invalid or unenforceable or one or more of VYNE’s patent applications may not be granted and potential competitors may also seek to design around VYNE’s granted patents or patent applications; additional competition in the acne and dermatology markets; risks related to our indebtedness; inability to raise additional capital on favorable terms or at all; VYNE’s ability to recruit and retain key employees; and VYNE’s ability to stay in compliance with applicable laws, rules and regulations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause VYNE’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in VYNE’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as well as discussions of potential risks, uncertainties, and other important factors in VYNE’s subsequent filings with the U.S. Securities and Exchange Commission. Although VYNE believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and VYNE undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions of future events.
520 US Highway 22 • 2^nd^ Floor • Bridgewater, NJ 08807
Exhibit 99.2
Investor Presentation September 2020
Forward Looking Statements This presentation includes forward - looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 , including, but not limited to statements regarding the development and commercialization of VYNE’s products and product candidates and other statements regarding the future expectations, plans and prospects of VYNE . All statements in this presentation which are not historical facts are forward - looking statements . Any forward - looking statements are based on VYNE’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied by such forward - looking statements . These risks and uncertainties include, but are not limited to, the outcome and cost of clinical trials for current and future product candidates ; determination by the FDA that results from VYNE’s clinical trials are not sufficient to support registration or marketing approval of product candidates ; adverse events associated with the commercialization of AMZEEQ ® and ZILXI™ ; the outcome of pricing, coverage and reimbursement negotiations with third party payors for AMZEEQ ® , ZILXI™ or any other products or product candidates that VYNE may commercialize in the future ; whether, and to what extent, third party payors impose additional requirements before approving AMZEEQ ® or ZILXI™ prescription reimbursement ; the eligible patient base and commercial potential of AMZEEQ ® , ZILXI™ or any of VYNE’s other product or product candidates ; risks that VYNE’s intellectual property rights, such as patents, may fail to provide adequate protection, may be challenged and one or more claims may be revoked or interpreted narrowly or will not be infringed ; risks that any of VYNE’s patents may be held to be narrowed, invalid or unenforceable or one or more of VYNE’s patent applications may not be granted and potential competitors may also seek to design around VYNE’s granted patents or patent applications ; additional competition in the acne and dermatology markets ; inability to raise additional capital on favorable terms or at all ; VYNE’s ability to recruit and retain key employees ; and VYNE’s ability to stay in compliance with applicable laws, rules and regulations . For a discussion of other risks and uncertainties, and other important factors, any of which could cause VYNE’s actual results to differ from those contained in the forward - looking statements, see the sections titled “Risk Factors” in VYNE’s most recent quarterly report on Form 10 Q as well as discussions of potential risks, uncertainties, and other important factors in VYNE’s subsequent filings with the U . S . Securities and Exchange Commission . Although VYNE believes these forward - looking statements are reasonable, they speak only as of the date of this presentation and VYNE undertakes no obligation to update publicly such forward - looking statements to reflect subsequent events or circumstances, except as otherwise required by law . Given these risks and uncertainties, you should not rely upon forward - looking statements as predictions of future events . The trademarks included herein are the property of the owners thereof and are used for reference purposes only . This presentation concerns product candidates that are under clinical investigation . None of such product candidates have been approved for marketing by the FDA or the EMA, and such product candidates are currently limited to investigational use, and no representation is made as to their safety or effectiveness for the purposes for which they are being investigated . 2
VYNE Investment Highlights x Commercial stage company focused on large and growing markets in dermatology x Two commercial products: AMZEEQ ® and ZILXI TM employ proprietary differentiated MST TM technology x Strong intellectual property with latest patent into 2037 and barriers to genericization inherent among topical medications x Addition of FCD105 expands potential product offering and enhances company position as a scaled leader in dermatology x Portfolio synergies allow for leverageable commercial infrastructure x Experienced management team demonstrating execution capabilities with AMZEEQ ® ramp x Well capitalized with $100M in cash as of June 30 th and ~168M shares outstanding x Broad investor base with a healthy mix of institutional and retail investors 3
Proprietary Technology Innovative and Proprietary Molecule Stabilizing Technology (MST™) 1. Hazot Y, et al. J Anal Pharm Res. 2017;4(5):00117. 2. Amzeeq (minocycline) topical foam, 4% [package insert]. Bridgewater, NJ; Foamix Pharmaceuticals Inc. • Stabilizes hydrophobic molecules • Surfactant & irritant free formulation designed to maintain barrier function, improve tolerability and compliance 1 • Low mechanical sheer designed to enhance spreadability • Delivers unstable drugs that have been difficult to formulate topically 4 • Targets delivery of minocycline directly into the pilosebaceous unit • Enabled the first topical minocycline 2 • Intellectual property/patents out to 2037
Products/Pipeline Advancing a leading dermatology portfolio Dermatology assets positioned for growth and value creation Safety and efficacy of these investigational products have not been established. There is no guarantee that pipeline products will receive FDA approval or become commercially available. 5 Product Preclinical Phase 1 Phase 2 Phase 3 Approved / Marketed Key Milestones FCD105 Foam • NDA approval and launch of first topical minocycline • NDA approval and launch anticipated Q4 2020 • Phase 2 topline results Q2 2020 • Anticipate FPI Phase 3 Trial 1H 2021
Commercial Strategy for AMZEEQ ® and ZILXI™ 6 • Opportunity for ownable, unique product positioning rooted in novel delivery (MST TM ) and first - to - market topical minocycline Brand Positioning and Messaging • Untapped opportunity in consumer space • Target gen Z (age 9 - 24) consumers digitally for AMZEEQ • Target millennials (age 30 - 50) via traditional media for ZILXI Consumer Activation • Use prescribing behavior as focused guide for HCP targeting • Synergistic cross - brand footprint for efficient sales activity Smart Deployment • Ensure broad access, manage corporate gross - to - net and limit patient out - of - pocket burden Comprehensive Access
The minocycline you know and trust. The tolerability of a gentle foam. The innovation you’ve been waiting for. INDICATIONS AND USAGE AMZEEQ ® (minocycline) topical foam, 4% is indicated for the treatment of inflammatory lesions of non - nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older. Limitations of Use: This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug - resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, AMZEEQ should be used only as indicated. IMPORTANT SAFETY INFORMATION Contraindications: Persons who have shown hypersensitivity to any of the tetracyclines or any other ingredient in AMZEEQ. Please see Important Safety Information on slide 26 7 The touch of minocycline
AMZEEQ ® Opportunity Large, Growing Acne Market 1. Symphony Health Solutions METYS, data ending DEC’19 - weighted 2. Symphony Health Solutions, MAT ending April ’19 3. AAD. Acne Stats and Facts. https://www.aad.org/media/stats - numbers . Accessed June 1, 2020 4. Symphony Health Solutions IDV Vantage, 2/19 8 $5.1B in sales in 2019 1 >2M active, diagnosed acne patients per year under HCP care 2 Consistently 40 - 50M acne sufferers 3 (of which 10M are moderate - to - severe) Prevalence data yield 60% of acne patients are managed by 5K HCPs 4 22M TRxs in 2019 growing YOY ~5% 1
AMZEEQ ® Market Research Feedback In market research, physicians and health care providers have consistently expected Amzeeq to disrupt the acne market and displace a broad range of products. 1. Source: Data on File, Foamix Pharmaceuticals, 2019. 9 “It’s quite unique in that it’s a minocycline topical; I don’t like a lot of the minocycline oral [products], but minocycline topical – I can certainly get excited about.” US Dermatologist(s), Core Visual Aid Market Research, September 2019 “This is new and exciting. Not your grandfather’s acne medication!” - KOL MD, Amzeeq Advisory Board May 2019 “No one has done it (topical tetracycline) like this before. It’s a big step – pretty powerful.” US Dermatologist(s), Creative Market Research, June 2019
AMZEEQ ® Prescription Volume Performance • Rapid uptake of Amzeeq reflected in strong Rx performance in Q1 pre COVID - 19 • Implemented virtual sales and speaker efforts during state and local stay - at - home orders to stabilize business • As statewide and county restrictions have lifted , direct selling efforts have resumed resulting in monthly Rx growth surpassing pre - COVID levels Symphony METYS – LTD as of 1/10/20 to present 10 COVID - 19 Shutdown 3,035 8,120 8,819 5,504 7,050 9,040 10,337 11,394 0 2,000 4,000 6,000 8,000 10,000 12,000 2020-1 2020-2 2020-3 2020-4 2020-5 2020-6 2020-7 2020-8 Amzeeq TRxs
AMZEEQ ® Target Penetration and Productivity Launch - to - date (LTD), 62% of platinum targets have prescribed at least 1 Rx and on average prescribed 25 Rx’s 11 45% 62% 49% 0% 10% 20% 30% 40% 50% 60% 70% Gold Platinum Total Target Penetration LTD* 14 25 17 0 5 10 15 20 25 30 Gold Platinum Total Prescriber Productivity by Segment (Prescriptions LTD) Source: Symphony Vantage Prescriber Insights – LTD as of 1/10/20 to present; Prescriber Segment 3Q Target List, AMZEEQ ® Weekly TRx by Segment LTD as of 8/14/20 * Percent of target segment that has prescribed since launch, as of August 28 th , 2020
AMZEEQ ® Weekly Total Prescribers Continued WoW growth of total prescribers despite limitations in face - to - face selling during COVID - 19 Source: Symphony Vantage Prescriber Insights 12 10 262 607 959 1,291 1,632 1,959 2,242 2,500 2,734 2,898 3,003 3,090 3,183 3,259 3,323 3,401 3,477 3,563 3,650 3,739 3,825 3,940 4,020 4,121 4,207 4,320 4,429 4,542 4,634 4,745 4,873 - 500 1,000 1,500 2,000 2,500 3,000 3,500 4,000 4,500 5,000 1/10/20 2/28/20 4/17/20 6/5/20 7/24/20 AMZEEQ Total Prescribers COVID - 19 Shutdown
AMZEEQ ® Market Access ~63% of Covered Lives with Additional Contract Talks Ongoing * Includes Express Scripts, EnvisionRx, OptumRx Source: 2020 Managed Markets Insight & Technology, LLC. 13 • Approximately 63% of commercial lives with covered or better status* • Ongoing discussions with payors are productive and in process. Covered 63% In Process 37% Covered vs. Non - Covered
14 Please see Important Safety Information on slide 27 ZILXI is indicated for the treatment of inflammatory lesions of rosacea in adults. Limitations of Use: This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug - resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, ZILXI should be used only as indicated. Indication
ZILXI™ (FMX103) Clinical Results: Highlights 1. Co - primary endpoint: Investigator's Global Assessment (IGA) Treatment Success at W eek 12 [Score Clear (0) or Almost Clear (1) ]; Significantly greater number of subjects receiving FMX103 achieved IGA treatment success defined as an IGA score of 0 (clear) or 1 (almost clear) a nd at least a 2 - grade improvement at Week 12 when compared to vehicle treatment, (50.6% vs.41.0%; p<0.001; integrated summary of efficacy), respect iv ely. 2. ZILXI Prescribing Information, June 2020. 3. Study FX2016 - 13, data on file, Foamix Pharmaceuticals. 4. Assessment of facial local tolerability using a 5 - point severity scale in studies FX2016 - 11 and FX2016 - 12 double - blind studies, integrated summary of safety. 15 Baseline IGA 3 “Moderate” Week 12 IGA 1 “Almost Clear” Efficacy: • 51% of patients treated with ZILXI were assessed to be clear or almost clear at week 12 1,2 • 83% reduction in lesion count and 82% achieved IGA treatment success after 52 weeks of therapy 3 Safety: • Cutaneous TEAEs occurred in <1% of subjects in the ZILXI treatment groups2 • ~45% of patients’ erythema (redness) was clear or almost clear at week 12 in facial local tolerability assessments 2,4
ZILXI Opportunity 1. Symphony Health Solutions METYS, data ending DEC’19 - weighted 2. Kantar Media, Jan. 2015 thru Dec. 2018 3. FMX103 Demand Study, Consumer Arm June 2019 4. Symphony Health unprojected patient claims data Period of Analysis – Jan 2015 – Dec 2018 16 Large, Unsatisfied Rosacea Market 4.4M TRxs in 2019 1 >$1B in sales in 2019 1 98% of competitor promotional spend on HCPs 2 73% of patients indicate that they are likely to seek a better solution than their current treatment 3 70% switch or discontinue Rosacea therapy after first diagnosis. 4 Over
ZILXI Market Research: Intent to Prescribe • 76% of physicians are likely to prescribe ZILXI based on blinded product profile and 8.5 out of 10 are likely to use after hearing the complete ZILXI promotional story. Source: Ipsos HCP ATU September 2020 Topline Report Q630. How likely would you be to prescribe Product X for patients with moderate - to - severe papulopustular rosacea? 17 Physicians Likely to Prescribe 2% 4% 19% 49% 27% Definitely would prescribe Probably would prescribe Might or might not prescribe Probably would not prescribe Definitely would not prescribe 8.5 0 2 4 6 8 10 Likehood to Use Likelihood to Use After Hearing Complete ZILXI Story Source: Zilxi Core Visual Aid Testing, July 2020
Portfolio Synergies Complimentary Patient Types and Call Points 18 COMMON STRATEGIES Similar HCP Targets Focused Positioning Predictive Analytics Consumer Outreach Broad Market Access ACNE PATIENTS, AGE 13 - 24: bacteria and in f la mm a t i o n ROSACEA PATIENTS, AGE 30 - 60: inflammatory lesions
Layering ZILXI™ Targeting with AMZEEQ ® Sales Efforts 19 Zilxi™ targets are already being called on 87% Amzeeq Only 40% Zilxi Only 6% Both 54% ~6700 Unique Targets of diagnosed patient volume captured within target universe 75% High volume prescribers captured without field footprint alternative ~85%
FCD105 Combines the bacteriostatic and anti - inflammatory properties of minocycline with the comedolytic, antiproliferative and anti - inflammatory properties of adapalene 3% minocycline, 0.3% adapalene combination foam formulation being investigated for the treatment of moderate - to - severe acne vulgaris in patients 12 years of age and older. 20 • 3 - week dermal toxicity complete • 12 - week dermal toxicity started April 2019 • Phase 2 started September 2019 • Phase 2 completed June 2020 Development Milestones :
FCD105 Commercial Opportunity - Adapalene is one of the most widely prescribed retinoids available for acne therapy. - Adapalene and its combination products represent a 1.7M annual Rx opportunity, with branded adapalene products representing ~15% of total acne branded market. Source: Symphony Health Solutions METYS, data ending 5/15/20, acne weighted market 21 $630M Adapalene $ Volume 2019 1.7M Adapalene TRx Volume 2019
FCD105 Study Design (Study FX2016 - 40*) *A Prospective, Multicenter, Randomized, Double - Blind, Vehicle - Controlled Phase 2 Study to Evaluate the Safety and Efficacy of a Combination of Minocycline and Adapalene Topical Foam Formulation for the Treatment of Acne Vulgaris (Study FX2016 - 40) 22 • Subjects aged 12 years or older. • 20 - 50 inflammatory lesions. • 25 - 100 non - inflammatory lesions. • Score of 3 “Moderate” or 4 “Severe” on 5 point IGA scale. • No more than 2 active nodules on the face. Key Inclusion Criteria: Subjects randomized 5:4:4:3 to either combination, monads or vehicle respectively; Planned N=400 from ~35 US sites FCD105 Foam, N=125 3% Minocycline Foam, N=100 0.3% Adapalene Foam, N=100 Vehicle Foam, N=75 Baseline Week 4 Week 8 Week 12 (End of Treatment) Week 16 (Safety Follow - up) . Co - Primary Efficacy Endpoints: • Absolute change from Baseline in inflammatory and non - inflammatory lesion counts at Week 12. • Proportion of subjects (%) with IGA score of 0/1 (“Clear” or “Minimal”) at Week 12. Safety Assessments: • Treatment Emergent Adverse Events. • Local skin tolerability Assessments (burning/stinging, itching, dryness, scaling, erythema and hyperpigmentation). • Vital signs. • Physical Examination. Secondary Efficacy Endpoints: • Percent change from Baseline in the inflammatory and non - inflammatory lesion counts at Weeks 12, 8 and 4. • IGA Treatment Success of IGA score of 0 or 1 and at least a 2 - grade improvement (decrease) at Weeks 8 and 4. • FCD105 vs. 0.3% adapalene foam, and FCD105 vs. 3% minocycline foam for all co - primary endpoints at Week 12. IGA: Investigator’s Global Assessment
Co - Primary Efficacy Endpoints at Week 12: Absolute Change in Inflammatory & Non - inflammatory Lesion Counts; IGA0/1 Treatment Success (ITT population) 1: Cochran - Mantel - Haenszel test stratified by analysis center. P - value is for the null hypothesis that the Risk Ratio equals 1. 2: P - value obtained from an ANCOVA model with treatment as a main effect, baseline (non)inflammatory lesion count as a covariate, a nd analysis center as a blocking factor. 23 • FCD105 treatment group was statistically superior to Vehicle and 0.3% Adapalene treatment groups at Week 12 for IGA Treatment Su ccess (IGA0/1). • FCD105 treatment group was statistically superior to Vehicle and 0.3% Adapalene treatment groups at Week 12 for reduction in inf lammatory lesions. • FCD105 treatment group was statistically superior to 0.3% Adapalene and 3% Minocycline treatment groups at Week 12 for reduction in non - inflammatory lesions.
Safety: Local Skin Tolerance Assessments (LSTA, Safety Population) Summary of LSTA at Week 12 (Severity Score of 0 “None” or 1 “Mild”) 1 1: Observed cases. 24 • 93% of subjects or greater who received FCD105 treatment had either “None” or “Mild” local skin tolerance scores at Week 12. • In general, subjects receiving 0.3% adapalene experienced lower overall tolerability scores compared to the other treatment g rou ps. • Treatment emergent adverse events were few in type and frequency; most were mild in severity and no serious adverse events were reported. • Subject discontinuations due to a TEAE were low.
Summary • Continued momentum demonstrated as company executes against business plan o AMZEEQ script trends have recovered and are growing on a week/week basis o Prescriber trends are robust and recent formulary addition strengthens coverage o FDA approval of ZILXI in rosacea complements our existing commercial infrastructure • FCD105 showed highly statistically significant improvement in disease burden versus vehicle foam for absolute change in inflammatory lesion count and IGA treatment success (IGA0/1) at Week 12. Numerical superiority was demonstrated between FCD105 and Vehicle for absolute change in non - inflammatory lesion counts at Week 12. o Numerical superiority of FCD105 over both 3% minocycline foam and 0.3% adapalene foam was observed across all endpoints with majority of comparisons being statistically significant • Treatment emergent adverse events were few in type and frequency; most were mild in severity and no serious adverse events were reported, and subject discontinuations due to a TEAE were low. • ≥93% of subjects receiving FCD105 had scores of 0 “none” or 1 “mild” for local skin tolerability assessments at Week 12. • Data is suggestive of a potential best - in - class treatment of moderate - to - severe acne vulgaris. 25
AMZEEQ ® (minocycline) topical foam, 4% Indication and Important Safety Information 26 INDICATIONS AND USAGE AMZEEQ™ (minocycline) topical foam, 4% is indicated for the treatment of inflammatory lesions of non - nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older. Limitations of Use : This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug - resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, AMZEEQ should be used only as indicated. IMPORTANT SAFETY INFORMATION Contraindications: Persons who have shown hypersensitivity to any of the tetracyclines or any other ingredient in AMZEEQ. Warnings and Precautions Flammability: The propellant in AMZEEQ is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application. AMZEEQ is a topical foam. While systemic absorption of AMZEEQ is low, and serious adverse reactions were not seen in clinical studies, the following adverse reactions associated with oral minocycline should be considered: • Teratogenic effects, inhibition of bone growth & permanent tooth discoloration: Use during the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years may cause permanent discoloration of the teeth (yellow - gray - brown) and reversible inhibition of bone growth. • Clostridium difficile associated diarrhea (CDAD): If CDAD occurs, discontinue AMZEEQ. • Hepatotoxicity & metabolic effects: If renal impairment exists or if liver injury suspected, discontinue AMZEEQ. • Central nervous system effects: Patients experiencing light - headedness, dizziness or vertigo should be cautioned about driving vehicles or operating heavy machinery. • Intracranial hypertension: Clinical manifestations include headache, blurred vision, diplopia, and vision loss. Discontinue AMZEEQ immediately if symptoms occur. • Autoimmune syndromes: Symptoms may be manifested by fever, rash, arthralgia, and malaise. Discontinue AMZEEQ immediately if symptoms occur. • Photosensitivity: Patients should minimize or avoid exposure to natural or artificial sunlight while using AMZEEQ. Advise patients to discontinue treatment with AMZEEQ at the first evidence of sunburn. • Hypersensitivity reactions: Discontinue AMZEEQ immediately if symptoms of anaphylaxis, serious skin reactions, erythema multiforme, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome occur. • Tissue hyperpigmentation: Discoloration of organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity (teeth, mucosa, alveolar bone), sclerae and heart valves. • Superinfection: Overgrowth of non - susceptible organisms, including fungi. If superinfection occurs, discontinue AMZEEQ and institute appropriate therapy. Adverse Reactions: The most common adverse reaction reported during clinical trials of AMZEEQ was headache. Please visit www.amzeeq.com for full Prescribing Information. To report side effects of prescription drugs to the FDA, visit http://www.fda.gov/medwatchor call 1 - 800 - FDA - 1088.
ZILXI™ (minocycline) topical foam, 1.5% Indication and Important Safety Information 27 INDICATION ZILXI TM (minocycline) topical foam, 1.5% is a tetracycline - class drug indicated for the treatment of inflammatory lesions of rosacea in adults. Limitations of Use: This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug - resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, ZILXI should be used only as indicated. IMPORTANT SAFETY INFORMATION Contraindications: Persons who have shown hypersensitivity to any of the tetracyclines or any other ingredient in ZILXI. Warnings and Precautions Flammability: The propellant in ZILXI is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application. ZILXI is a topical foam. While systemic absorption of ZILXI is low, and serious adverse reactions were not seen in clinical studies, the following adverse reactions associated with oral minocycline should be considered: • Teratogenic effects, inhibition of bone growth & permanent tooth discoloration: Use during the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years may cause permanent discoloration of the teeth (yellow - gray - brown) and reversible inhibition of bone growth. • Clostridioides difficile associated diarrhea (CDAD): If CDAD occurs, discontinue ZILXI. • Hepatotoxicity & metabolic effects: If renal impairment exists or if liver injury suspected, discontinue ZILXI. • Central nervous system effects: Patients experiencing light - headedness, dizziness or vertigo should be cautioned about driving vehicles or operating heavy machinery. • Intracranial hypertension: Clinical manifestations include headache, blurred vision, diplopia, and vision loss. Discontinue ZILXI immediately if symptoms occur. • Autoimmune syndromes: Symptoms may be manifested by fever, rash, arthralgia, and malaise. Discontinue ZILXI immediately if symptoms occur. • Photosensitivity: Patients should minimize or avoid exposure to natural or artificial sunlight while using ZILXI. Advise patients to discontinue treatment with ZILXI at the first evidence of sunburn. • Hypersensitivity reactions: Discontinue ZILXI immediately if symptoms of anaphylaxis, serious skin reactions, erythema multiforme, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome occur. • Tissue hyperpigmentation: Discoloration of organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity (teeth, mucosa, alveolar bone), sclerae and heart valves. • Superinfection: Overgrowth of non - susceptible organisms, including fungi. If superinfection occurs, discontinue ZILXI and institute appropriate therapy. Adverse Reactions: The most common adverse reaction reported during clinical trials of ZILXI was diarrhea. Please visit www.zilxi.com for full prescribing information.
Investor Presentation September 2020