Exhibit 99.1
Nasdaq: FOMXJune 2016
Disclaimer To the extent that statements contained in this presentation are not descriptions of historical facts regarding Foamix, they are forward-looking statements reflecting management’s current beliefs and expectations. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity, performance, or achievements to be materially different from those anticipated by such statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “intends,” or “continue,” or the negative of these terms or other comparable terminology. Forward-looking statements contained in this presentation include, but are not limited to, (i) statements regarding the timing of anticipated clinical trials for our product candidates; (ii) the timing of receipt of clinical data for our product candidates; (iii) our expectations regarding the potential safety, efficacy, or clinical utility of our product candidates; (iv) the size of patient populations targeted by our product candidates and market adoption of our product candidates by physicians and patients; (v) the timing or likelihood of regulatory filings and approvals; and (vi) our revenues under our agreements with our licensees, including Bayer, Allergan and Merz. Although we believe that the expectations reflected in the forward-looking statements are reasonable, various factors may cause differences between our expectations and actual results, including, but not limited to, unexpected safety or efficacy data, unexpected side effects observed during preclinical studies or in clinical trials, lower than expected enrollment rates in clinical trials, changes in expected or existing competition, changes in the regulatory environment for our product candidates and our need for future capital, the inability to protect our intellectual property, and the risk that we become a party to unexpected litigation or other disputes. You should read the documents filed by Foamix with the SEC, including our prospectuses, the Risk Factors set forth therein and the documents filed as exhibits to our registration statements, of which the prospectuses are a part, completely and with the understanding that our actual future results may be materially different from what we expect. You may obtain those documents by visiting EDGAR on the SEC website at www.sec.gov. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construed as an endorsement of the foam technology or product candidates of Foamix. *
Highlights * Including Bayer, Allergan and Merz Collaborations with leading pharmaceutical companies Proprietary foam-based technology platformUS: 45 patents granted ● Worldwide: 138 patents granted Innovative technology & extensive IP Minocycline FoamFMX101 for moderate-to-severe Acne FMX103 for RosaceaFMX102 for ImpetigoDoxycycline FoamFDX104 for Chemotherapy-Induced Rash Portfolio of clinical stage topical foam product candidates Rehovot Israel & Bridgewater NJStrong dermatology track record Integrated multinational management team
Highlights * Including Bayer, Allergan and Merz Collaborations with leading pharmaceutical companies Proprietary foam-based technology platformUS: 45 patents granted ● Worldwide: 138 patents granted Innovative technology & extensive IP Minocycline FoamFMX101 for moderate-to-severe Acne FMX103 for RosaceaFMX102 for ImpetigoDoxycycline FoamFDX104 for Chemotherapy-Induced Rash Portfolio of clinical stage topical foam product candidates Rehovot Israel & Bridgewater NJStrong dermatology track record Integrated multinational management team
Strong Financial Position * Net proceeds: US$ 42.3 millionPrice per share: US$ 6.00 IPO – September 2014 Net proceeds: US$ 64.2 millionPrice per share: US$ 9.30 Follow-on offering, April 2015 Cash, cash equivalents and investments: US$ 97 millionNet cash burn, Q1 2016: US$ 7 millionExisting cash will provide sufficient financial runway to finance our clinical and business operations, into 2018 Cash position as of March 31, 2016
Experienced Management Team * Name Track record Location Dov Tamarkin, PhD CEO & Director Led multiple product developments in dermatologyLed R&D operations in Israel, EU and US Israel Meir EiniCIO Founder of multiple healthcare ventures Israel David DomzalskiPresident, US Head of Commercial Operations at Warner Chilcott and LEOLed commercial launch of Doryx® and Taclonex® US Ilan HadarCFO Held former finance roles at Israeli subsidiaries of Pfizer, HP and BAE Systems Israel Yohan Hazot CTO Led multiple product developments in dermatology Israel Mitchell Shirvan, PhDSVP, R&D Head of R&D, CNS division at Teva CEO of MacroCure Israel Russell Elliott, DPhilVP, Drug Development VP, Product Development at Stiefel, a GSK companyLed product development at Procter & Gamble US Alvin HowardVP, Regulatory Affairs SVP Regulatory Affairs at Warner ChilcottLed approvals of 14 NDA and sNDAs US Herman Ellman, MDVP, Clinical Development SVP Clinical Development & Medical Affairs at Warner Chilcott US Clilco Flexiprobe
Experienced Management Team * Name Track record Location Dov Tamarkin, PhD CEO & Director Led multiple product developments in dermatologyLed R&D operations in Israel, EU and US Israel Meir EiniCIO Founder of multiple healthcare ventures Israel David DomzalskiPresident, US Head of Commercial Operations at Warner Chilcott and LEOLed commercial launch of Doryx® and Taclonex® US Ilan HadarCFO Held former finance roles at Israeli subsidiaries of Pfizer, HP and BAE Systems Israel Yohan Hazot CTO Led multiple product developments in dermatology Israel Mitchell Shirvan, PhDSVP, R&D Head of R&D, CNS division at Teva CEO of MacroCure Israel Russell Elliott, DPhilVP, Drug Development VP, Product Development at Stiefel, a GSK companyLed product development at Procter & Gamble US Alvin HowardVP, Regulatory Affairs SVP Regulatory Affairs at Warner ChilcottLed approvals of 14 NDA and sNDAs US Herman Ellman, MDVP, Clinical Development SVP Clinical Development & Medical Affairs at Warner Chilcott US Clilco Flexiprobe
Technology *
Differentiated Foam Technology with Multiple Platforms Patented1 - United States: 45 US patents granted - Worldwide: 138 Patents grantedCapability to formulate multiple drugs Suitable for a variety of target sitesDermal alternative to oral delivery * 1. As of January 1, 2016 Cream Foams (Emulsion or Emollient) Ointment Foams (Petrolatum-based) Waterless Hydrophilic Foams (Enhanced penetration) Oil Foams Hydroethanolic Foams Saccharide Foams (For wounds and burns) Potent Solvent Foams(High solubility and delivery) Suspension Foams (Concentrated suspensions) Nano-Emulsion Foams (Enhanced penetration)
Pipeline *
Clinical-Stage Lead Products * Product Candidate Phase 1 Phase 2 Phase 3 Regulatory Pathway / Target Milestone Minocycline Foam Minocycline Foam Minocycline Foam Minocycline Foam Minocycline Foam FMX101 for Moderate-Severe Acne Phase 3 enrollment commenced – May 2016Phase 3 completion – 2017NDA filing – H2 2017/H1 2018 - 505(b)(2) FMX103 for Rosacea Phase 2 enrollment completed – May 2016Phase 2 completion – H2 2016Phase 3 initiation – H2 2017 FMX102 for Impetigo Pre IND meeting completed – Oct 2015Photo-safety Study – H2 2016 Doxycycline Foam Doxycycline Foam Doxycycline Foam Doxycycline Foam Doxycycline Foam FDX104 for Chemotherapy-Induced Rash Phase 2 completed
FMX101 Topical Minocycline Foam For Moderate-to-Severe Acne *
Acne – the US Market ~50 million people of all ages and races have acne in the US1Moderate-to-severe acne affects ~10 million people in the US >14 million physician visits per year for treatment of acne2Classification by severity / current therapies AAD. Acne Stats and Facts. www.aad.org/media-resources/stats-and-facts/conditions. Accessed March 30, 2016.Mancini AJ. Adv Stud Med. 2008;8:100-105.Symphony Health Services PHAST (Pharmaceutical Audit Suite). * Current Branded Market (United States)3 Current Branded Market (United States)3 Current Branded Market (United States)3 US Dollars TRxs Oral antibiotics $1.6 billion 2.0 mm Topical drugs $2.1 billion 5.2 mm Total $3.7 billion 7.2 mm
Phase 2 Clinical Trial Self-apply, once daily, in the evening for 12 weeksAt least 20 inflammatory and 25 non-inflammatory lesionsEndpointsChange in acne lesionsInvestigator’s Global Assessment (IGA)Safety and tolerability * 12-week, randomized, double-blind, dose range-finding study in subjects with moderate-to-severe acne Week 12(End of treatment) Week 16 Week 3 Week 6 Week 9 Randomized (1:1:1), double-blindN=150 Minocycline foam 1%Minocycline foam 4%Foam vehicle Follow-Up
Phase 2 – Results * Dose-dependent reduction of inflammatory and non-inflammatory acne Population: mITT, LOCF % Reduction of Non-Inflammatory Lesions % Reduction of Inflammatory Lesions Foam Vehicle FMX101 1% FMX101 4% 16Follow Up End of Treatment 16Follow Up End of Treatment * ** ** ** ** * * ≤ .05** ≤ .01
Phase 2 - Results * IGA = Clear / Almost Clear (0-1) Statistically significant reduction of IGA score 20% 4% 2% PROPORTION OF SUBJECTS WITH IGA = 0-1 Population: ITT, LOCF P ≤ .01 IGA Improvement ≥ 2 P ≤ .05 34% 20% 14% SUBJECTS WITH IGA IMPROVEMENT ≥ 2
Phase 2 ResultsNo Reported Systemic Adverse Effects * 1. Based on Solodyn product label. / Oral minocycline side effects1 No reported drug-related systemic side effectsEqual incidence of skin reactions in the foam vehicle and active groupsFew casesMildTransient—all reactions subsided by week 12Based on >180 patients in clinical trials (acne and impetigo) Common side effects: Diarrhea; dizziness; drowsiness; indigestion; lightheadedness; loss of appetite; nausea; sore mouth, throat, or tongue; vomiting Severe side effects: Severe allergic reactions; bloody stools; blurred vision; change in the amount of urine produced; fever, chills or sore throat; hearing problems; joint pain; muscle pain or weakness; rectal or genital irritation; red, swollen, blistered or peeling skin; ringing in the ears; seizures; severe or persistent headache; severe skin reaction to the sun; severe, watery diarrhea; stomach cramps or pain; swollen glands; symptoms of pancreatitis; trouble swallowing; unusual bruising or bleeding; unusual tiredness or weakness; vaginal irritation or discharge; white patches in the mouth; yellowing of the skin or eyes Minocycline foam
Visible Effects on Moderate-to-Severe Acne Patients * Baseline 9 Weeks 12 Weeks FMX101 Phase 2 Clinical Trial: Patient with moderate-to-severe acne who responded positively to our treatment (Minocycline Foam 4%)
Visible Effects on Moderate-to-Severe Acne Patients * FMX101 Phase 2 Clinical Trial: Patients with moderate-to-severe acne who responded positively to our treatment (Minocycline Foam 4%) Baseline 12 Weeks
Phase 3: Study Design Self-apply, once daily, in the evening, for 12 weeksInclusion criteriaAt least 20 inflammatory and 25 non-inflammatory lesionsIGA 6 point scale – Moderate or Severe (Grade 3 or 4) Co-Primary Efficacy EndpointsMean change from baseline in inflammatory lesion countProportion of subjects with IGA scores of “Clear” or “Almost Clear”, with improvement of at least 2 grades from baseline * 12-week, randomized, double-blind, vehicle controlled, in subjects with moderate-to-severe acne; followed by 9 month open label safety extension Week 12(End of treatment) 12 Months Week 3 Week 6 Week 9 Double-blinded PhaseRandomized (2:1), double-blindN=450 (X2) Minocycline foam 4%Foam vehicle Minocycline foam 4% – 9 months of treatment Open Label Safety Extension Subjects who complete one of the randomized, Phase 3 studies may enter the open-label phase Topline Phase 3 data expected H1 2017 (blinded phase)
FMX103 Topical Minocycline Foam For Rosacea *
Rosacea – the US Market Chronic acneiform disorder affecting both the skin and the eye~ 16 million adults in the United States1Total US Market: ~$1.2 billion2 * National Rosacea Society. Rosacea Review; Winter 2010. http://www.rosacea.org/rr/2010/winter/article_1.php. Accessed May 16, 2016; Symphony Health Services PHAST (Pharmaceutical Audit Suite). Current Branded Market (United States) Current Branded Market (United States) Current Branded Market (United States) US Dollars TRxs Oral antibiotics $400 million 1.3 mm Topical drugs $800 billion 3.5 mm Total $1.2 billion 4.8 mm
Phase 2: Study Design * 12-week, randomized, double-blind, dose range-finding study in subjects with moderate-to-severe papulo-pustular rosacea Week 12(End of treatment) Week 16 Week: 6 10 Randomized (1:1:1), double-blindN=233 Minocycline foam 1.5%Minocycline foam 3%Foam vehicle 1 2 4 8 0 Topline Phase 2 data expected H2 2016 Follow Up
FMX102 Topical Minocycline Foam For Impetigo (Skin Infections) *
Phase 2 Clinical Trial Self-apply, twice daily, for 7 daysEndpointsClinical success = cure or improvement of treated lesions(Improvement = decline in the size of the affected area, number of lesions, or both)1Safety and tolerability * A randomized, double-blind, Phase 2 clinical trial conducted to assess the efficacy, safety, and tolerability of minocycline foam in pediatric patients with impetigo Randomized (1:1), double-blind, N=32 Minocycline foam 1%Minocycline foam 4% Day 14 Baseline Day 3 Day 7(End of treatment) 1. Adapted from the label of Altabax Follow Up
Phase 2 – Results Treatment was well tolerated; no reported drug-related side effectsAll patients with MRSA were bacteriologically cured at day 7 (end of treatment)Current benchmark BACTROBAN® (mupirocin) achieves 71%–96% of clinical efficacy within 8–12 days of treatment * Patients demonstrated improvement and lesion clearance with minocycline foam 1%1 D. Foam: A unique delivery vehicle for topically applied formulations. In: Dayan N. Apply Topically: A Practical 81.3% 92.3% 100% Day 3 Day 7 (end of treatment) Day 14 (follow-up) 1. 1% and 4% Minocycline were equally effective after Day 14 and substantially similar after Days 3 and 7. Efficacy
Phase 2 – Visible Results Visible improvement / lesion clearance with treatment * Tamarkin D. Foam: A unique delivery vehicle for topically applied formulations. In: Dayan N. Apply Topically: A Practical Guide to Formulating Topical Application. Carol Stream, IL: Allured Publishing Corp.; 2013:233-260. Baseline Day 3 Day 7 (End of treatment) Patient A Patient B Patient C #128, 1% #120, 1% #126, 1%
FDX104 Topical Doxycycline Foam For Management of Acne-Like EGFRI-Induced Rash *
EGFRI-Induced Acneiform Rash * The most common side effect EGFR inhibitors (EGFRIs) Monoclonal antibodies: panitumumab (Vectibix®- Amgen) and cetuximab (Erbitux®- Lilly) Tyrosine kinase inhibitors: erlotinib (Tarceva®- Genentech) and gefitinib (Iressa®- Astra Zeneca)Dermatologic toxic effects are common side effects of anti-EGFR therapyAcneiform rash is the most common, occurring in 50% to 90% of patients1,2The rash can cause significant physical and emotional stressIn many cases, severe rash warrants a change in the oncologic treatment regimen2No approved treatments for EGFRI-induced rashOral minocycline and doxycycline often used off-labelPotential concerns of systemic side effects and drug-drug interactionLiterature suggests prophylactic administration improves outcomes 1. Fabbrocini G, et al. Skin Appendage Disord. 2015;1:31-37.2. Potthoff K, et al. Ann Oncol. 2011;22:524-535.
Phase 2 Clinical Trial 1 Phase 2 – Randomized, double-blind, placebo-controlledTreatmentsFDX104 (Doxycycline foam 4%) vs.Placebo (Matching foam vehicle) Split-face – Right/Left comparison4/5 weeks of treatment, BID24 subjects enrolled = ITT20 subjects completed the study = PP Week 9 (Follow-up) Baseline Week 2 Week 5(End of treatment) EGFRI Therapy (Erbitux or Vectibix) Doxycycline foam 4% / Placebo BID (Right/Left Comparison) Week 3 Week 4 Week 1
Phase 2 Clinical Trial 1 Phase 2 – Randomized, double-blind, placebo-controlledTreatmentsFDX104 (Doxycycline foam 4%) vs.Placebo (Matching foam vehicle) Split-face – Right/Left comparison4/5 weeks of treatment, BID24 subjects enrolled = ITT20 subjects completed the study = PP Week 9 (Follow-up) Baseline Week 2 Week 5(End of treatment) EGFRI Therapy (Erbitux or Vectibix) Doxycycline foam 4% / Placebo BID (Right/Left Comparison) Week 3 Week 4 Week 1
Phase 2 Clinical Trial 1 Phase 2 – Randomized, double-blind, placebo-controlledTreatmentsFDX104 (Doxycycline foam 4%) vs.Placebo (Matching foam vehicle) Split-face – Right/Left comparison4/5 weeks of treatment, BID24 subjects enrolled = ITT20 subjects completed the study = PP Week 9 (Follow-up) Baseline Week 2 Week 5(End of treatment) EGFRI Therapy (Erbitux or Vectibix) Doxycycline foam 4% / Placebo BID (Right/Left Comparison) Week 3 Week 4 Week 1
Phase 2 Clinical Trial * Phase 2 – Randomized, double-blind, placebo-controlledTreatmentsFDX104 (Doxycycline foam 4%) vs.Placebo (Matching foam vehicle) Split-face – Right/Left comparison4/5 weeks of treatment, BID24 subjects enrolled = ITT20 subjects completed the study = PP Baseline Week 2 Week 5(End of treatment) EGFRI Therapy (Erbitux or Vectibix) Doxycycline foam 4% / Placebo BID (Right/Left Comparison)
Phase 2 Clinical Trial 1 Phase 2 – Randomized, double-blind, placebo-controlledTreatmentsFDX104 (Doxycycline foam 4%) vs.Placebo (Matching foam vehicle) Split-face – Right/Left comparison4/5 weeks of treatment, BID24 subjects enrolled = ITT20 subjects completed the study = PP Week 9 (Follow-up) Baseline Week 2 Week 5(End of treatment) EGFRI Therapy (Erbitux or Vectibix) Doxycycline foam 4% / Placebo BID (Right/Left Comparison) Week 3 Week 4 Week 1
Phase 2 Clinical Trial 1 Phase 2 – Randomized, double-blind, placebo-controlledTreatmentsFDX104 (Doxycycline foam 4%) vs.Placebo (Matching foam vehicle) Split-face – Right/Left comparison4/5 weeks of treatment, BID24 subjects enrolled = ITT20 subjects completed the study = PP Week 9 (Follow-up) Baseline Week 2 Week 5(End of treatment) EGFRI Therapy (Erbitux or Vectibix) Doxycycline foam 4% / Placebo BID (Right/Left Comparison) Week 3 Week 4 Week 1
Phase 2 Clinical Trial * Phase 2 – Randomized, double-blind, placebo-controlledTreatmentsFDX104 (Doxycycline foam 4%) vs.Placebo (Matching foam vehicle) Split-face – Right/Left comparison4/5 weeks of treatment, BID24 subjects enrolled = ITT20 subjects completed the study = PP Baseline Week 2 Week 5(End of treatment) EGFRI Therapy (Erbitux or Vectibix) Doxycycline foam 4% / Placebo BID (Right/Left Comparison)
* Efficacy results: Severity grades: None=0, Mild=1, Moderate=2, and Severe=3Based on Photograph Evaluation by an Independent Dermatologist (GSS, Scope et al) Maximum Severity Grade: FDX104 vs. Placebo FDX104 Placebo Mean severity 1.33 1.71 Number of Subjects FDX104 FDX104 FDX104 FDX104 Placebo Placebo Placebo Placebo Statistically significant p<0.05 (Wilcoxon Rank Sum Test) * The results utilizing the MESTT method showed overall similar trends, but were not statistically significant All Subjects (N=24) Severe
Visible Prevention of Rash by FDX104 * FDX104 Placebo FDX104 FDX104 Placebo Placebo Subject No. 7 - Visit 2 Subject No. 11 - Visit 2 Subject No. 16 - Visit 3
Collaborations with Third Parties Development and licensing agreements with pharmaceutical companiesEach license agreement is product specific (Licensee’s drug) Licensed products are currently in preclinical, Phase 2, Phase 3 and commercial stagesFoamix owns the IP for the drug delivery platformFoamix retains the rights to develop products for the same indications using our foam technology in conjunction with other drugs * Upfront payments, contingent payments and royalties on sales of products that are commercializedTotal of ~$20 million revenues received as of March 31, 2016Recurring royalties since Q4, 2015 Revenues
Finacea® Foam – FDA Approved Indication: mild to moderate rosaceaR&D collaboration between Foamix and Bayer, under Foamix’s IPLicense agreement with milestone fees and royaltiesLaunched in the US – September 2015Royalties for Q1, 2016: US$ 682,000 *
Key 2016-2017 Development Milestones * FMX101 Phase 1 MUSE/Bridge results January 2016 FMX103 Phase 2 enrollment completed May 2016 FMX101 Phase 3 initiation May 2016 FMX102 Photo-toxicity study H2 2016 FMX103 Phase 2 results H2 2016 FMX101 Phase 3 results (blinded phase) H1 2017 FMX103 Phase 3 initiation H2 2017 FMX101 Phase 3 completion H2 2017
June 2016