Foamix Reports Fiscal Year 2017 Financial Results and Provides Corporate Update
Long Term Open Label Clinical Results Confirm That FMX101 Appears to be Safe and Well Tolerated; Continued Improvement of Treatment Effect Demonstrated at 52 Weeks
Conference Call and Webcast on
Clinical and Corporate Update:
- FMX101, the Company’s minocycline foam 4% is currently being evaluated in a third Phase 3 study (Study 22) in patients with moderate-to severe acne.
○ Top-line results are expected in the third quarter of 2018.
○ The expected timing of an NDA filing for FMX101 is planned for the end of 2018.
- FMX103, 1.5% minocycline foam, is currently being evaluated in two Phase 3 studies (Studies 11 and 12) in patients with moderate-to severe papulopustular rosacea. Long term safety is concurrently being evaluated in the open label Study 13.
○ Top-line results are expected in late third quarter or early fourth quarter of 2018.
○ Enrollment in the open-label long term safety study (Study 13) continues to progress as scheduled. A significant number of patients have enrolled into this study and we continue to observe low discontinuation rates.
○ The expected timing of an NDA filing for FMX103 is planned for 2019.
- In January and
February 2018, Bayer and Foamix filed joint complaints against each of Teva and Perrigo, respectively, alleging patent infringement under U.S. patent laws arising out of the submissions by Teva and Perrigoof ANDAs seeking approval to manufacture and sell generic versions of Bayer’s Finacea® Foam. We are committed to defending our own intellectual property rights globally, including patents we have licensed to other pharmaceutical companies as part of our collaboration efforts.
January 2018, as part of the orderly transition in management, CEO David Domzalskiwas appointed to the Board of Directors to replace former CEO and co-founder Dr. Dov Tamarkin.
January 2018, the Company changed its filing status with the SECand Nasdaq from a “Foreign Private Issuer” to a U. S. Domestic filer.
FMX101 Open Label Safety Study Results
- A total of 657 patients were enrolled in the open-label safety extension after an initial 12 weeks of double-blinded therapy in Phase 3 studies 04 and 05. Of these, 291 completed an additional 40-weeks for a total of 52 weeks on FMX101 therapy. The primary endpoint was safety.
- As previously communicated, no serious drug-related adverse events were reported during the open-label safety extension, validating earlier data demonstrating that FMX101 appears to be well tolerated with an acceptable safety profile. Specific findings included:
○ Non-dermal adverse events were comparable in type and frequency with those reported during the double-blinded portion of Studies 04 and 05, with the most frequently reported treatment-emergent adverse event being nasopharyngitis (common cold).
○ Application-site adverse events occurred in less than 2% of patients during the additional 40 weeks of open-label treatment. Four patients discontinued the study for an application-site adverse event.
○ In the assessment of facial dermal tolerability at week 52, more than 95% of patients had “none” or “mild” scoring of erythema, dryness, hyperpigmentation, peeling, and itching. No severe local tolerability scores were recorded.
Efficacy Results at 52 weeks:
- Efficacy was also measured as a secondary endpoint in the open-label study for FMX101. During the study, patients were allowed to discontinue therapy with FMX101 if they believed their acne had sufficiently improved. Patients could re-start therapy as needed and were also allowed to use other acne medications concomitantly.
- The following summarizes efficacy results for subjects who had been assigned FMX101 therapy for 52 weeks:
○ At week 52, 37.7% of patients from Study 04 had an Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear); 50.3% of subjects from Study 05 had an IGA score of 0 or 1.
○ At week 52, patients from Study 04 had a 64.3% reduction in inflammatory lesions; patients from Study 05 had a 78% reduction in inflammatory lesions.
○ At week 52, patients from Study 04 had a 52.5% reduction in non-inflammatory lesions; patients from Study 05 had a 59.6% reduction in non-inflammatory lesions.
- Details on the open-label study results for FMX101 are contained within the most recent Investor Presentation, available on the Company’s website at http://investors.foamix.com/events
Financial Results for the Year Ended
Revenues for the year ended
Research and Development Expenses
Research and development expenses for the year were
Selling, General and Administrative Expenses
Selling, general and administrative expenses for the year were
For the year ended
Cash & Cash Equivalents
|Conference Call & Webcast
|Wednesday, February 28 @ 8:30am Eastern Time
|Replays, Available through March 14:
Foamix is a specialty pharmaceutical company focused on the development and commercialization of proprietary, innovative and differentiated topical drugs for dermatological therapy. Our leading clinical stage product candidates are FMX101, our novel minocycline foam for the treatment of moderate-to-severe acne and FMX103, our novel minocycline foam for the treatment of rosacea. We continue to pursue research & development of our proprietary, innovative foam technologies for the treatment of various skin conditions. We currently have development and license agreements relating to our technology with various pharmaceutical companies including
Foamix uses its website (www.Foamix.com) as a channel to distribute information about Foamix and its product candidates from time to time. Foamix may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Foamix’s website in addition to following its press releases, filings with the
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 created by those sections. 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.
Finacea® is a registered trademark of
|Contact:||U.S. Investor Relations|
|Ilan Hadar, CFO & Country Manager||Michael Rice|
|Foamix Pharmaceuticals Ltd.||LifeSci Advisors, LLC|
|Foamix Pharmaceuticals, Inc.|
|Consolidated Statement of Operations Data|
|Year ended December 31,|
|(in thousands of U.S. dollars, except loss per share)|
|Statements of operations data:|
|Cost of revenues(1)||13||59|
|Research and development(1)||57,779||25,897|
|Selling, general and administrative(1)||11,491||9,221|
|Total operating expenses||69,270||35,118|
|Loss per share basic and diluted||1.76||0.91|
(1) Includes share-based compensation expenses as follows:
|Year ended December 31,|
|(in thousands of U.S. dollars)|
|Cost of revenues||$2||$3|
|Research and development||1,711||1,135|
|Selling, general and administrative||2,453||1,774|
|Total share-based compensation||$4,166||$2,912|
|Foamix Pharmaceuticals, Inc.|
|Consolidated Balance Sheet Data|
|(in thousands of U.S. dollars, other than number of shares)|
|Balance sheet data:|
|Cash and investments(1)||$76,412||$130,988|
|Total long-term liabilities||1,425||379|
|Total shareholders’ equity (capital deficiency)||68,601||129,985|
|Number of ordinary shares||37,498,128||37,167,791|
(1) Cash and investments includes cash and cash-equivalents, restricted cash, bank deposits, marketable securities and restricted marketable securities.
(2) Working capital is defined as total current assets minus total current liabilities.
Source: Foamix, Ltd.