Sol-Gel Technologies Reports Full Year 2018 Financial Results and Provides Corporate Update
Company met all milestones in 2018 and this year expects to report Phase III top-line results for Epsolay® and TWIN, potentially best-in-class papulopustular rosacea and acne vulgaris topical medications
Recent approval of
“Sol-Gel made significant clinical progress in 2018 with two branded product candidates entering Phase III development and the launch of our first generic product by
Corporate Highlights and Recent Developments
February 6, 2019, Sol-Gelannounced that Perrigo(NYSE; TASE: PRGO) received final approval from the U.S. Food and Drug Administration( FDA) for the first generic version of Zovirax® (acyclovir) cream, 5%. The product was developed in a collaboration between Sol-Geland Perrigoin which they shared development costs and will equally share the gross profits generated from sales of the product. Perrigohas launched acyclovir cream and sales are in line with Sol-Gel’s expectations.
January 15, 2019, Sol-Gelannounced the appointment of John M. Vieira as U.S. Head of Commercialization. Mr. Vieira’s background includes 25 years of pharmaceutical industry experience in commercial operations, regulatory affairs, sales and marketing, pricing strategy, reimbursement and business development within the healthcare and biopharmaceutical industries in the U.S. with a focus on specialty dermatology products. Mr. Vieira joined Sol-Gelfrom Leo Pharmaceuticalswhere he served in U.S. and Global Marketing roles.
December 17, 2018, Sol-Gelannounced dosing of the first subject in the pivotal Phase III clinical program evaluating the safety and efficacy of TWIN in subjects with acne vulgaris. TWIN is a cream containing a fixed-dose combination of encapsulated tretinoin and encapsulated benzoyl peroxide using Sol-Gel’s proprietary microencapsulation platform.
December 4, 2018, Sol-Gelannounced it has entered into a sixth collaborative agreement with Perrigo Israel, an affiliate of Perrigo, for the development, manufacturing and commercialization of a generic product candidate. The fifth collaboration with Perrigowas announced on November 1, 2018.
- Plans to have pivotal Phase III Epsolay top-line results in papulopustular rosacea in mid-2019.
- Plans to have pivotal Phase III TWIN top-line results in acne vulgaris in the fourth quarter of 2019.
- Plans to report bioequivalence study results for a generic 5-fluorouracil cream, 5%, indicated for actinic keratosis, and to submit an abbreviated new drug application (ANDA) during 2019.
Sol-Gelhas decided to hold the development of SIRS-T, focusing resources on more lucrative products.
Full Year 2018 Financial Results
Research and development expenses were
General and administrative expenses were $5.5 million for the year ended
As of December 31, 2018,
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. These forward-looking statements include information about possible or assumed future results of our business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information we have when those statements are made or our management’s current expectation, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to: (i) the adequacy of our financial and other resources, particularly in light of our history of recurring losses and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; (ii) our ability to complete the development of our product candidates; (iii) our ability to find suitable co-development partners; (iv) our ability to obtain and maintain regulatory approvals for our product candidates in our target markets and the possibility of adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; (v) our ability to rely on data from our Phase II TWIN trial to advance the development of SIRS-T; (vi) our ability to commercialize our pharmaceutical product candidates; (vii) our ability to obtain and maintain adequate protection of our intellectual property; (viii) our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (ix) our ability to establish adequate sales, marketing and distribution channels; (x) acceptance of our product candidates by healthcare professionals and patients; (xi) the possibility that we may face third-party claims of intellectual property infringement; (xii) the timing and results of clinical trials that we may conduct or that our competitors and others may conduct relating to our or their products; (xiii) intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; (xiv) potential product liability claims; (xv) potential adverse federal, state and local government regulation in
(U.S. dollars in thousands, except share and per share data)
|Cash and cash equivalents||$||5,024||$||5,325|
|Prepaid expenses and other current assets||1,524||2,987|
|TOTAL CURRENT ASSETS||10,548||65,974|
|Long term receivables||1,653||-|
|Restricted long-term deposits||120||462|
|Property and equipment, net||2,314||2,604|
|Funds in respect of employee rights upon retirement||680||642|
|TOTAL NON-CURRENT ASSETS||4,767||3,708|
|Liabilities and shareholders' equity (capital deficiency)|
|Other account payable||1,332||1,971|
|Loans from the controlling shareholder||65,338||-|
|TOTAL CURRENT LIABILITIES||67,204||4,895|
|LONG-TERM LIABILITIES –|
|Liability for employee rights upon retirement||810||878|
|TOTAL LONG-TERM LIABILITIES||810||878|
|SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY):|
| Ordinary shares, NIS 0.1 par value – authorized: 50,000,000 as of December
31, 2017 and 2018, respectively; issued and outstanding: 6,290,244 and
18,949,968 as of December 31, 2017 and December 31, 2018, respectively
|Additional paid-in capital||42,480||190,853|
|TOTAL SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY)||(52,699||)||63,909|
|TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY (NET OF
STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
|Year ended December 31,
|Research and Development||17,023||25,805||28,146|
|General and Administrative||3,733||6,002||5,504|
|TOTAL OPERATING LOSS||20,756||31,633||33,521|
|FINANCIAL EXPENSES (INCOME), net||15||(65||)||(1,318||)|
|LOSS FOR THE YEAR||$||20,771||$||31,568||$||32,203|
|BASIC AND DILUTED LOSS PER ORDINARY SHARE||$||3.30||$||5.02||$||1.80|
|WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING
USED IN COMPUTATION OF BASIC AND DILUTED LOSS
For further information, please contact:
Chief Financial Officer
Source: Sol-Gel Technologies Ltd.