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): June 2, 2020

 

Menlo Therapeutics Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware 001-38356 45-3757789
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(IRS Employer
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 changed since 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   Trading
Symbol(s)
  Name of each exchange
on which registered  
Common Stock, $0.0001 par value   MNLO   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 8.01 Other Events.

 

On June 2, 2020, Menlo Therapeutics Inc. (the “Company”) issued a press release announcing positive results from a Phase 2 clinical trial evaluating the preliminary safety and efficacy of FCD105 (3% minocycline / 0.3% adapalene foam), the first ever topical minocycline-based combination product, for the treatment of moderate-to-severe acne vulgaris. A copy of the press release is attached as Exhibit 99.1 to this report.

 

In addition, members of senior management of the Company will be using the Investor Presentation attached as Exhibit 99.2 (the “Presentation”) to this report in connection with providing a corporate overview at the Jefferies Virtual Healthcare Conference on June 2, 2020. The Presentation is incorporated into this Item 8.01 by reference.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

The following exhibits are filed herewith.

 

Exhibit No.   Description
99.1   Press release, entitled “Menlo Therapeutics Announces Positive Results from Phase 2 Trial of FCD105 for the Treatment of Moderate-to-Severe Acne Vulgaris.”
     
99.2   Investor Presentation.  

 

 

 

 

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.

 

  MENLO THERAPEUTICS INC.
     
Date: June 2, 2020 By: /s/ Mutya Harsch
    Mutya Harsch
    Chief Legal Officer and General Counsel

 

 

 

Exhibit 99.1

 

 

 

Menlo Therapeutics Announces Positive Results from Phase
2 Trial of FCD105 for the Treatment of Moderate-to-Severe
Acne Vulgaris

 

The Company plans to present trial data along with a proposed Phase 3
development program in an End of Phase 2 meeting with the FDA before the
end of this year.

 

BRIDGEWATER, New Jersey, June 02, 2020 -- Menlo Therapeutics Inc. (Nasdaq: MNLO) (“Menlo” or the “Company”), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced positive results from a Phase 2 clinical trial evaluating the preliminary safety and efficacy of FCD105 (3% minocycline / 0.3% adapalene foam), the first ever topical minocycline-based combination product, for the treatment of moderate-to-severe acne vulgaris. Study FX2016-40 enrolled 447 patients in the United States who were randomized to either FCD105 foam, 3% minocycline foam, 0.3% adapalene foam, or vehicle foam. The Company has begun preparations to conduct an End of Phase 2 meeting with the FDA before the end of this year.

 

FCD105 showed a highly statistically significant improvement compared to vehicle for the endpoints of (1) Investigator’s Global Assessment (IGA) treatment success (IGA score “0” or “1” and at least a two-grade improvement from baseline) and (2) absolute change from baseline in mean inflammatory counts at Week 12. The proportion of patients achieving IGA treatment success in the FCD105 treatment group was 35.9% compared to 15.7% of patients in the vehicle treatment group (p=0.0003). Absolute reduction in inflammatory lesion counts at Week 12 was -19.4 (-64.1%) for the FCD105 treatment group compared to -15.58 (-50.9%) for the vehicle treatment group (p=0.0020).

 

The trial was not originally powered to demonstrate a statistical difference between FCD105 and either 3% minocycline foam or 0.3% adapalene foam treatments; however, the majority of these comparisons did show a statistically significant improvement of FCD105 at Week 12. Numerical improvement was observed for FCD105 on all efficacy endpoints for these comparisons at Week 12.

 

Absolute reduction in non-inflammatory lesion counts at Week 12 was also assessed with a mean lesion count reduction of -24.94 (-51.0%) for the FCD105 treatment group compared to -22.87 (-45.9%) for the vehicle treatment group. Although numerical improvement was shown, this was not statistically significant, which has been attributed to outlier results affecting both FCD105 and vehicle treatment groups. Conversely, absolute reduction in non-inflammatory lesion counts at Week 12 for FCD105 did show a statistically significant improvement compared to each of (1) 3% minocycline foam and (2) 0.3% adapalene foam.

 

The most commonly reported treatment-emergent adverse event in the trial was upper respiratory tract infection (4.9% in the vehicle treatment group) with dry skin being the most commonly reported cutaneous adverse event (3.6% in the 0.3% adapalene treatment group). The majority of adverse events were assessed as mild in severity. There were no serious adverse events. 

 

 

 

 

FCD105 was comparably tolerated to vehicle in all local skin tolerability assessments with 93% or greater of severity scores being assessed as “none” or “mild” for burning/stinging, itching, dryness, scaling, erythema and hyperpigmentation.

 

“We are pleased with the results of this study. The data suggests FCD105 has the potential to be a best-in-class treatment for patients with acne and could provide an important new treatment option for this challenging condition,” said Dr. Iain Stuart, Chief Scientific Officer of Menlo. “We look forward to engaging with the FDA on these data and our plans for the Phase 3 program.”

 

About Study FX2016-40

Study FX2016-40 is a prospective, randomized, double-blind, vehicle-controlled Phase 2 trial that enrolled patients aged 12 years and older with a clinical diagnosis of moderate-to-severe acne vulgaris. Patients were randomized to one of four treatment arms: FCD105 foam, 3% minocycline foam, 0.3% adapalene foam, or vehicle foam and self-applied their assigned treatment once daily for 12 weeks. The primary efficacy endpoints were: (1) the proportion of patients achieving treatment success at Week 12 based on an Investigator's Global Assessment (success is defined as a score of 0 "clear" or 1 "minimal" and at least a two-grade improvement from baseline), (2) the mean change from baseline in inflammatory lesion counts in each treatment group at Week 12, and (3) the mean change from baseline in non-inflammatory lesion counts in each treatment group at Week 12. Safety evaluations include reported adverse events, local skin tolerability assessments, physical examinations and vital signs.

 

About Acne Vulgaris

Acne is a chronic, inflammatory skin condition that affects the skin's oil glands and hair follicles. It is characterized by both inflammatory lesions (papules and pustules) and non-inflammatory lesions (open and closed comedones) affecting primarily the face and other areas of the body. Acne affects approximately 40 to 50 million people in the U.S. alone, of whom approximately 10 million have moderate-to-severe disease that significantly impacts self-esteem and quality of life. For most people, acne diminishes over time and tends to disappear or decrease, by age 25. However, some individuals, particularly women, can experience acne much later in life.

 

About FCD105

FCD105 is Menlo’s proprietary 3% minocycline, 0.3% adapalene combination foam formulation intended for the treatment of moderate-to-severe acne vulgaris. FCD105 combines the bacteriostatic and anti-inflammatory properties of minocycline with the third-generation retinoid, adapalene, which acts in regulating the differentiation of follicular epithelial cells. Oral minocycline and topical adapalene products are approved for use in the treatment of acne vulgaris in the United States, with the latter available in combination and as monotherapy. Pending a successful development program, the FCD105 new drug application is intended to be filed under the FDA’s 505(b)(2) regulatory pathway.

 

About Menlo

Menlo Therapeutics Inc. recently combined with Foamix Pharmaceuticals Ltd. to form a different type of biopharmaceutical company working to solve some of today’s most difficult therapeutic challenges in dermatology and beyond.

 

 

 

 

With expertise in topical medicine innovation as a springboard, the Company 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 now also 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 Menlo or its investigational products, visit www.menlotherapeutics.com. Menlo may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Menlo’s website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts.

 

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 expectations with respect to the financial results of Menlo and statements regarding the development and commercialization of Menlo’s products and product candidates and other statements regarding the future expectations, plans and prospects of Menlo. All statements in this press release which are not historical facts are forward-looking statements. Any forward-looking statements are based on Menlo’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 our products; the outcome and cost of clinical trials for current and future product candidates; determination by the FDA that results from Menlo’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 Menlo 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 Menlo’s other product or product candidates; risks that Menlo’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 Menlo’s patents may be held to be narrowed, invalid or unenforceable or one or more of Menlo’s patent applications may not be granted and potential competitors may also seek to design around Menlo’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; Menlo’s ability to recruit and retain key employees; and Menlo’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 Menlo’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in Menlo’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 Menlo’s subsequent filings with the U.S. Securities and Exchange Commission. Although Menlo believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and Menlo 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.

 

 

 

 

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 

 

 

 

Exhibit 99.2

 

Investor Presentation June 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 Menlo’s products and product candidates and other statements regarding the future ex pec tations, plans and prospects of Menlo. All statements in this presentation which are not historical facts are forward - looking statements. Any forward - looking statements ar e based on Menlo’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions tha t c ould 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 Menlo’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 Menlo may commercialize in the future; whether, and to what extent, t hir d 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 Menlo’s other product or product candidates; risks that Menlo’s intellectual property rights, such as patents, may fail to pr ovi de 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 Menlo’s patents may be held to be narrowed, invalid or unenforceable or one or more of Menlo’s patent applications may not be granted and potential competitors may also seek to design around Menlo’s granted pa ten ts or patent applications; additional competition in the acne and dermatology markets; inability to raise additional capital on favorable terms or at all; Menlo’s ability to r ecr uit and retain key employees; and Menlo’s ability to stay in compliance with applicable laws, rules and regulations. For a discussion of other risks and uncertainties, and other impor tan t factors, any of which could cause Menlo’s actual results to differ from those contained in the forward - looking statements, see the sections titled “Risk Factors” in Menlo’s most recent quarterly report on Form 10Q as well as discussions of potential risks, uncertainties, and other important factors in Menlo’s subsequent filings with the U.S. Securi tie s and Exchange Commission. Although Menlo believes these forward - looking statements are reasonable, they speak only as of the date of this presentation and Menlo undertak es 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 unc ertainties, 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 presenta tio n 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 prod uct 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 be ing investigated. 2

 

 

Menlo Investment Highlights x Commercial stage company focused on large and growing markets in dermatology x Two commercial products: AMZEEQ ® and ZILXI™ 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 3

 

 

Menlo’s Vision and Mission Improve the lives of patients by developing proprietary, innovative and differentiated therapies in dermatology and beyond. We are dedicated to advancing dermatology medicine and redefining standard of care for millions of patients. 4

 

 

Timeline Our execution has led to two major dermatology approvals in two consecutive years IPO 2014 Phase 2 FMX103 trial completed 2016 Initial phase 3 FMX101 trials completed 2017 Third phase 3 FMX101 trial completed FMX101 NDA submitted Two phase 3 FMX103 trials completed 2018 Amzeeq (FMX101) approved /launched FMX103 NDA submitted Long - term safety study FMX103 completed 2019 Zilxi (FMX103) approved Foamix and Menlo Therapeutics Combine Phase 2 FCD105 completed 2020 5

 

 

Corporate Strategy Create a Scaled Leader in Dermatology Grow existing franchises and create durability through focused development and acquisition Mid - term Expand product portfolio into synergistic technologies/ markets Long - term Leverage commercial infrastructure and product synergies of Amzeeq (FMX101) and Zilxi (FMX103) to establish foundation in acne/rosacea markets Near - term 6

 

 

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 • Targets delivery of minocycline directly into the pilosebaceous unit • Enabled the first topical minocycline 2 • Patent - protected 7

 

 

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. 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 8

 

 

Commercial Stage Company Commercial launch team experience in 14 therapeutic areas including 11 dermatology product launches Commercialization Pipeline Regulatory People Clinical Manufacturing 9

 

 

Please see Important Safety Information on slide 28 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. The touch of minocycline 10

 

 

AMZEEQ ® Opportunity Large, Growing Acne Market 1. Symphony Health Solutions METYS, data ending DEC’19 - weighted 2. Symphony Health Solutions, MAT ending October ’18 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 22M TRxs in 2019 growing YOY ~5% 1 $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 11

 

 

AMZEEQ ® Market Research Feedback 1. Source: Data on File, Foamix Pharmaceuticals, 2019. 12 In market research, physicians and health care providers have consistently expected Amzeeq to disrupt the acne market and displace a broad range of products. “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, 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, Creative Market Research, June 2019

 

 

AMZEEQ ® Strategy • Opportunity for ownable, unique product positioning rooted in novel delivery (MST TM ), minocycline potency, and level of systemic absorption Brand Positioning and Messaging • Opportunity to target consumers digitally • Generation Z Focus: Spend 7+ hours consuming media 1 Consumer Activation • Opportunity to use smart analytics to pinpoint HCP targets • Efficient sales footprint Smart Deployment • Ensure broad access, manage corporate gross - to - net and limit patient out - of - pocket burden Comprehensive Access 13 1. Trifecta Research 2015

 

 

0 500 1,000 1,500 2,000 2,500 3,000 AMZEEQ Prescription Trend NRx Count TRx Count AMZEEQ ® Prescription Volume Performance • Rx performance was strong through 1Q until COVID - 19 impacted the acne market and direct sales capability • Implemented virtual sales and speaker efforts during state and local stay - at - home orders • As statewide and county restrictions lift, direct selling efforts have resumed resulting in weekly Rx improvements Source: Symphony Metys – LTD as of 1/10/20 to present 14 COVID - 19 Impact

 

 

AMZEEQ ® Weekly Unique Prescribers Continued week - over - week growth of unique prescribers despite absence of face - to - face selling during COVID - 19 Source: Symphony Vantage Prescriber Insights 15 10 261 606 956 1,287 1,627 1,953 2,234 2,490 2,723 2,886 2,991 3,078 3,170 3,242 3,305 3,383 3,458 - 500 1,000 1,500 2,000 2,500 3,000 3,500 4,000 1/10/2020 1/17/2020 1/24/2020 1/31/2020 2/7/2020 2/14/2020 2/21/2020 2/28/2020 3/6/2020 3/13/2020 3/20/2020 3/27/2020 4/3/2020 4/10/2020 4/17/2020 4/24/2020 5/1/2020 5/8/2020 AMZEEQ Unique Prescribers COVID - 19 Impact

 

 

AMZEEQ ® Market Access ~60% of Covered Lives in the first 5 months * Includes Express Scripts, EnvisionRx , OptumRx Source: 2020 Managed Markets Insight & Technology, LLC • Approximately 60% of commercial lives with covered or better status* • Ongoing discussions with payors are productive and in process. 16 Covered , 60% In Process , 40% Covered vs. Non - Covered

 

 

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 17 Please see Important Safety Information on slide 29

 

 

ZILXI™ (FMX103) Clinical Results: Highlights 1.Co - primary endpoint: Investigator's Global Assessment (IGA) Treatment Success at Week 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) and at lea st a 2 - grade improvement at Week 12 when compared to vehicle treatment, (50.6% vs.41.0%; p<0.001; integrated summary of efficacy), respectively. 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 studie s, integrated summary of safety. 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 groups 2 • ~45% of patients’ erythema (redness) was clear or almost clear at week 12 in facial local tolerability assessments 2,4 Week 12 IGA 1 “Almost Clear” Baseline IGA 3 “Moderate” 18

 

 

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 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 19

 

 

ZILXI™ Launch Strategy • Opportunity for strong, unique and ownable product positioning • Product position rooted in novel delivery and efficacy • First topical minocycline Product Positioning • Competition not investing in consumers which represents an opportunity • Millennials and generation X (age 30 - 50) focus / traditional media opportunity • Pilot efforts to build brand and market over time Consumer Mobilization • Use prescribing behavior as focused guide for HCP targeting • Synergistic targeting with Amzeeq Smart Deployment • Parity pricing to Amzeeq • Ensure broad access • Manage corporate gross - to - net • Limit patient out - of - pocket burden Comprehensive Access 20

 

 

Portfolio Synergies Complimentary Patient Types and Call Points 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 - 50: inflammatory lesions 21

 

 

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. 22 FCD105 Combines the bacteriostatic and anti - inflammatory properties of minocycline with the comedolytic, antiproliferative and anti - inflammatory properties of adapalene • 3 - week dermal toxicity complete • 12 - week dermal toxicity started April 2019 • Phase 2 started September 2019 • Phase 2 completed June 2020 Development Milestones : 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. 1 FCD105 Combines the bacteriostatic and anti-inflammatory properties of minocycline with the comedolytic, antiproliferative and anti-inflammatory properties of adapalene • 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 Source: Symphony Health Solutions METYS, data ending 5/15/20, acne weighted market 23 - 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. $625M Adapalene $ Volume 2019 1.7M Adapalene TRx Volume 2019

 

 

FCD105 Study Design (Study FX2016 - 40*) 24 IGA: Investigator’s Global Assessment • 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. *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)

 

 

- 19.4 0 - 15.58 - 18.67 - 15.78 -25 -20 -15 -10 -5 0 FCD105 Foam Vehicle Foam 3% Minocycline Foam 0.3% Adapalene Foam Absolute Change from Baseline in Inflammatory Lesions at Week 12 P =0.0020 P =0.4053 P =0.0012 Absolute Change in Inflammatory Lesions at Week 12 2 35.9 15.7 30 .0 21.4 0 5 10 15 20 25 30 35 40 45 50 FCD105 Foam Vehicle Foam 3% Minocycline Foam 0.3% Adapalene Foam Percent of Subjects with IGA0/1 Treatment Success at Week 12 P =0.0003 P =0.2569 P =0.0114 IGA0/1 Treatment Success at Week 12 1 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, and analysis center as a b locking factor. 25 • 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 reduct ion in non - inflammatory lesions. - 24.94 - 22.87 - 19.08 - 20.7 0 -30 -25 -20 -15 -10 -5 0 FCD105 Foam Vehicle Foam 3% Minocycline Foam 0.3% Adapalene Foam Absolute Change from Baseline in Inflammatory Lesions at Week 12 P =0.3210 P =0.0033 P =0.0292 Absolute Change in Non - Inflammatory Lesions at Week 12 2 N=142 N=83 N=110 N=112 N=142 N=83 N=110 N=112 N=142 N=83 N=110 N=112

 

 

75 80 85 90 95 100 Burning/Stinging Itching Dryness Scaling Erythema Hyperpigmentation % of Subjects with “None” or “Mild” LSTA Scores Local Skin Tolerance Assessment FCD105 Foam % Vehicle Foam % 3% Minocycline Foam % 0.3% Adapalene Foam % Safety: Local Skin Tolerance Assessments (LSTA, Safety Population) 1: Observed cases. 26 Summary of LSTA at Week 12 (Severity Score of 0 “None” or 1 “Mild”) 1 • 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 we re 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. 27

 

 

AMZEEQ ® (minocycline) topical foam, 4% Indication and Important Safety Information 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. 28

 

 

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. 29 ZILXI™ (minocycline) topical foam, 1.5% Indication and Important Safety Information

 

 

30 Investor Presentation June 2020