Sol-Gel Technologies Reports First Quarter 2019 Financial Results and Corporate Update
Top-line results from Phase III Epsolay® and TWIN trials remain on track; mid-2019 and 4Q19, respectfully
Reports top-line generic product revenues of
NESS ZIONA,
“This year is an exciting year for
Corporate Highlights and Recent Developments
- In the first quarter,
Sol-Gel realized first-time revenues of$6.3 million from the sale of a first generic version of Zovirax® (acyclovir) cream, 5% with partnerPerrigo .
- On
April 15, 2019 ,Sol-Gel announced that it had completed 50% patient enrollment in both pivotal Phase III clinical trials of TWIN for the treatment of acne vulgaris. TWIN is a once daily topical cream containing a fixed-dose combination of encapsulated benzoyl peroxide and encapsulated tretinoin using Sol-Gel’s proprietary microencapsulation platform.
Clinical Program Update
- Top-line results from the pivotal Phase III Epsolay® trials in papulopustular rosacea continue to be expected in mid-2019.
- Top-line results from the two pivotal Phase III TWIN trials in acne vulgaris continue to be expected in the fourth quarter of 2019.
- Results from a bioequivalence study for generic 5-fluorouracil cream, 5%, indicated for actinic keratosis, continue to be expected in 2019 with a planned abbreviated new drug application (ANDA) during 2019. This study is part of a generics collaboration with partner
Douglas Pharmaceuticals .
Financial Results for the Three Months Ended
Research and development expenses were
General and administrative expenses were
As of
About
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, including, but not limited to, the clinical progress of our product candidates, plans and timing for the release of clinical data, our expectations surrounding the progress of our generic product pipeline, and the sufficiency of our cash resources to meet our operational and capital expenditure requirements. 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 commercialize our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate protection of our intellectual property; (vii) our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our ability to establish adequate sales, marketing and distribution channels; (ix) acceptance of our product candidates by healthcare professionals and patients; (x) the possibility that we may face third-party claims of intellectual property infringement; (xi) 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; (xii) 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; (xiii) potential product liability claims; (xiv) potential adverse federal, state and local government regulation in
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
December 31, 2018 |
|
March 31, 2019 |
||||||
A s s e t s | ||||||||
CURRENT ASSETS: | ||||||||
Cash and cash equivalents | $ | 5,325 | $ | 8,175 | ||||
Bank deposit | 1,000 | 1,000 | ||||||
Marketable securities | 56,662 | 45,253 | ||||||
Accounts receivable | - | 6,354 | ||||||
Prepaid expenses and other current assets | 2,987 | 2,518 | ||||||
TOTAL CURRENT ASSETS | 65,974 | 63,300 | ||||||
NON-CURRENT ASSETS: | ||||||||
Restricted long-term deposits | 462 | 466 | ||||||
Property and equipment, net | 2,604 | 2,507 | ||||||
Operating lease right-of-use assets | - | 1,058 | ||||||
Funds in respect of employee rights upon retirement | 642 | 662 | ||||||
TOTAL NON-CURRENT ASSETS | 3,708 | 4,693 | ||||||
TOTAL ASSETS | $ | 69,682 | $ | 67,993 | ||||
Liabilities and shareholders' equity | ||||||||
CURRENT LIABILITIES: | ||||||||
Accounts payable | $ | 2,924 | $ | 4,093 | ||||
Other account payable | 1,971 | 2,898 | ||||||
Current maturities of operating leases | - | 647 | ||||||
TOTAL CURRENT LIABILITIES | 4,895 | 7,638 | ||||||
LONG-TERM LIABILITIES - | ||||||||
Operating leases liabilities | - | 445 | ||||||
Liability for employee rights upon retirement | 878 | 940 | ||||||
TOTAL LONG-TERM LIABILITIES | 878 | 1,385 | ||||||
COMMITMENTS | ||||||||
TOTAL LIABILITIES | 5,773 | 9,023 | ||||||
SHAREHOLDERS' EQUITY: | ||||||||
Ordinary Shares, NIS 0.1 par value – authorized: 50,000,000 as of December 31, 2018 and March 31, 2019; issued and outstanding: 18,949,968 as of December 31, 2018 and March 31, 2019 |
520 | 520 | ||||||
Additional paid-in capital | 190,853 | 191,642 | ||||||
Accumulated deficit | (127,464) | (133,192) | ||||||
TOTAL SHAREHOLDERS' EQUITY | 63,909 | 58,970 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 69,682 | $ | 67,993 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
Three months ended March 31, |
|||||||
2018 | 2019 | ||||||
REVENUES | $ | 44 | $ | 6,358 | |||
RESEARCH AND DEVELOPMENT EXPENSES | 4,645 | 10,793 | |||||
GENERAL AND ADMINISTRATIVE EXPENSES | 1,142 | 1,694 | |||||
TOTAL OPERATING LOSS | $ | 5,743 | $ | 6,129 | |||
FINANCIAL INCOME, NET | (30 | ) | (401 | ) | |||
LOSS FOR THE PERIOD | $ | 5,713 | $ | 5,728 | |||
BASIC AND DILUTED LOSS PER ORDINARY SHARE | $ | 0.39 | 0.30 | ||||
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE |
14,523,161 | 18,949,968 |
For further information, please contact:
Sol-Gel Contact:
Chief Financial Officer
+972-8-9313433
Investor Contact:
Solebury Trout
+1-617-221-9197
[email protected]
Source:
Source: Sol-Gel Technologies Ltd.