Foamix Reports Year End 2016 Financial Results and Provides Business Update

REHOVOT, Israel, Feb. 22, 2017 /PRNewswire/ -- Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX) ("Foamix" or the "Company"), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, announced today financial results for the year ended December 31, 2016.

"2016 was a year of many accomplishments for Foamix. Most notably, in November we completed the enrollment in our two Phase 3 clinical trials evaluating our minocycline foam FMX101 in the treatment of moderate-to-severe acne, with expected topline results in the first half of 2017. We were further encouraged by the successful outcome of our Phase 2 clinical trial of FMX103 for the treatment of moderate-to-severe papulopustular rosacea, which demonstrated significant clinical efficacy and a favorable safety and tolerability profile. We plan to initiate Phase 3 trials for FMX103 around mid-year – another important milestone for our company," said Dov Tamarkin, Ph.D., Foamix's Chief Executive Officer.  "With our strong balance sheet, we have the resources to continue to advance our pipeline of proprietary products through key milestones."

Clinical, business and corporate developments for the three months ended December 31, 2016 and to date:

• Completed patient enrollment according to plan in the Company's two Phase 3 clinical trials to evaluate the efficacy and safety of FMX101, a topical 4% minocycline foam, in the treatment of moderate-to-severe acne.
  • Topline results are expected in the first half of 2017. The Company plans to complete the studies, including the open-label safety extension, by the end of the year.
• Completed a pre-IND meeting with the FDA in December 2016 to discuss initiation of U.S. clinical trials for FMX103 in papulopustular rosacea.
  • The planned Phase 3 program will consist of two randomized, multicenter, double-blind, vehicle controlled 2-arm trials to evaluate the safety and efficacy of FMX103 1.5% minocycline foam and compare it to vehicle. We plan to initiate the Phase 3 trials for FMX103 around mid-year.
  • The trials will be conducted primarily in the US with approximately 80 investigator sites in total.  Each trial will enroll approximately 600 patients, for a total of 1,200 patients between both trials. 
  • The 12-week efficacy portion of both trials will be followed by a 40-week open label safety extension phase.
  • The Company's decision to proceed to Phase 3 trials is based on positive results from a Phase 2 trial in rosacea completed in 2016, which demonstrated statistically significant clinical efficacy in the primary and secondary endpoints for FMX103 compared to vehicle and a favorable safety and tolerability profile.
• In November 2016, the Company held a key opinion leader (KOL) event for the investment community in New York. 
  • The meeting featured presentations by Guy Webster, MD, PhD, from Thomas Jefferson University, and Linda Stein Gold, MD, from the Henry Ford Health System, who provided an overview of the acne and rosacea markets and discussed current and novel approaches to therapy.

Financial highlights for the 12 months ended December 31, 2016:

• Total revenues were $5.5 million, compared with $849,000 for the twelve months ended December 31, 2015. The increase is mainly due to the increase of $2.7 million in royalty payments from Bayer HealthCare AG for the sales of Finacea^® Foam, and additional contingent payments totaling $2.5 million, due to Bayer's achievement of certain sale targets during 2016.
• Research and development expenses were $25.9 million, compared to $10.7 million in the year ended December 31, 2015. The increase in research and development expenses resulted primarily from an increase in costs relating to the FMX101 and FMX103 clinical trials as well as an increase in payroll and payroll-related expenses due to an increase in the number of R&D employees.
• Selling, general and administrative expenses were $9.2 million, compared to $7.0 million in the year ended December 31, 2015. The increase in selling, general and administrative expenses resulted primarily from an increase in payroll and other payroll-related expenses; market research expenses; travel expenses; and expenses related to the Company's board of directors.
• Net loss for the year ended December 31, 2016 was $29.3 million, or 91 cents per basic and diluted share, compared to $16.5 million, or 58 cents per basic and diluted share for the year ended December 31, 2015.
• We had generated cumulative revenues, from inception, of approximately $24.5 million under development and license agreements.
• Cash, cash equivalents, short and long-term investments as of December 31, 2016 totaled $131.0 million, compared to approximately $103.8 million as of December 31, 2015. The increase was mostly due to the $54.1 million dollars, net of commission and expenses, raised in the follow-on offering which closed on September 30, 2016, offset by the operating expenses we incurred during the year.
• The Company estimates that existing cash and investments provide sufficient financial flexibility to finance clinical and business operations into 2019. 

Conference Call

Management will host an investment community conference call on February 22, 2017 at 8:30 a.m. Eastern / 5:30 a.m. Pacific / 3:30 p.m. Israel to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing Domestic: 888-278-8446; International: +1-913-312-1473; Conference ID: 6799077.  Webcast: http://public.viavid.com/index.php?id=122682

A replay of the call will be accessible two hours after its completion through March 8, 2017 by dialing Domestic: 844-512-2921; International: 412-317-6671; Passcode: 6799077.  The call will also be archived for 90 days at www.streetevents.com and www.foamixpharma.com.

About Foamix Pharmaceuticals Ltd.

Foamix is a specialty pharmaceutical company focused on the development and commercialization of proprietary, innovative and differentiated topical drugs for dermatological therapy.

Our clinical stage product candidates include FMX101, our novel minocycline foam for the treatment of moderate-to-severe acne, FMX103 for the treatment of moderate-to-severe rosacea, FMX102 for the treatment of impetigo, and FDX104, our doxycycline foam for the management of acne-like rash induced by EGFRI anticancer drugs.

In addition, we have development and license agreements relating to our technology with various pharmaceutical companies including Bayer HealthCare and others.

For more information, please visit www.foamixpharma.com.

Cautionary Note Regarding Forward-Looking Statements

This release includes forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995.  Forward-looking statements are statements that are not historical facts, such as statements regarding assumptions, expectations, forecasts, beliefs or intentions related to financial results, commercial results, timing and results of clinical trials and U.S. FDA and other regulatory agencies authorizations.  Forward-looking statements are based on our current knowledge and our present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions.  Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of various factors including, but not limited to, unexpected delays, excess costs or unfavorable results of clinical trials, delays or denial in the U.S. FDA approval process, additional competition in the acne market, denial of reimbursement by third party payors or inability to raise additional capital. We discuss many of these risks in greater detail under the heading "Risk Factors" in our most recent Annual Report on Form 20-F filed on February 21, 2017, and elsewhere in that Annual Report. Although we believe these forward-looking statements are reasonable, they speak only as of the date of this announcement and Foamix 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.

Finacea^® is a registered trademark of Bayer Healthcare.
    
Contact:                                                      US Investor Relations
Ilan Hadar, Chief Financial Officer                   Michael Rice
Foamix Pharmaceuticals Ltd.                         LifeSci Advisors, LLC
+972-8-9316233                                            +1-646-597-6979
[email protected]                                 [email protected]

SOURCE Foamix Pharmaceuticals Ltd