Sol-Gel Technologies Reports Fourth Quarter and Full Year 2017 Financial Results
NESS ZIONA,
“2017 was an exciting year for
Corporate Highlights and Recent Developments
- In
February 2018 , data was presented from the Company’s Phase II clinical trial of TWIN for the treatment of acne vulgaris and from its Phase II clinical trial of Epsolay® (formerly VERED) for the treatment of subtype II rosacea at the 2018 American Academy of Dermatology (AAD) Annual Meeting which took place February 16-20 in San Diego,California .
- On
February 5, 2018 , the Company successfully completed its initial public offering of 7,187,500 ordinary shares at a public offering price of$12.00 per share, which included the exercise in full by the underwriters of their option to purchase up to an additional 937,500 ordinary shares, aggregating gross proceeds of approximately$86.3 million , before underwriting discounts, commissions and estimated offering expenses.
- On
January 29, 2018 , the U.S,Food and Drug Administration (FDA ) grantedPerrigo Company plc (NYSE;TASE PRGO ) a tentative approval for ivermectin cream, 1%, the active molecule in Soolantra®, that was developed in collaboration with the Company. Soolantra® is indicated for the treatment of inflammatory lesions of rosacea. In our collaboration withPerrigo , we shared development costs and will share the gross profit 50/50.
Clinical Program Update
- Plan to have an end-of-phase II meeting with the
FDA in the first half of 2018 and initiate the pivotal Phase III TWIN trials in acne vulgaris in the second half of 2018.
- Plan to initiate the pivotal Phase III Epsolay® trials in subtype II rosacea in the first half of 2018.
- Plan to initiate bioequivalence study for a generic drug candidate in 2018.
Financial Results
Fourth quarter 2017 Financial Results
Research and development expenses were $4.4 million in the fourth quarter of 2017, compared to $3.9 million for the same period in 2016. The increase was primarily due to an increase of
General and administrative expenses were $1.2 million in the fourth quarter of 2017, compared to $0.9 million for the same period in 2016. The increase was primarily due to share-based compensation expenses.
Full Year 2017 Financial Results
Revenues were
Research and development expenses were $25.8 million for the year ended
General and administrative expenses were $6.0 million for the year ended
As of December 31, 2017,
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. 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
For further information, please contact:
Sol-Gel Contact:
Chief Financial Officer
+972-8-9313433
Investor Contact:
Westwicke Partners
+1-415-513-1284
[email protected]
SOL-GEL TECHNOLOGIES LTD. | ||||||||||||||
BALANCE SHEET | ||||||||||||||
(U.S. dollars in thousands, except share and per share data) | ||||||||||||||
December 31 | ||||||||||||||
2016 | 2017 | |||||||||||||
Assets | ||||||||||||||
CURRENT ASSETS: | ||||||||||||||
Cash and cash equivalents | $ | 7,001 | $ | 5,024 | ||||||||||
Bank deposit | - | 4,000 | ||||||||||||
Prepaid expenses and other current assets | 472 | 1,511 | ||||||||||||
Advance payment | 823 | 13 | ||||||||||||
TOTAL CURRENT ASSETS | 8,296 | 10,548 | ||||||||||||
NON-CURRENT ASSETS: | ||||||||||||||
Long term receivables | 1,190 | 1,653 | ||||||||||||
Restricted long term deposits | 107 | 120 | ||||||||||||
Property and equipment, net | 798 | 2,314 | ||||||||||||
Funds in respect of employee rights upon retirement | 594 | 680 | ||||||||||||
TOTAL NON-CURRENT ASSETS | 2,689 | 4,767 | ||||||||||||
TOTAL ASSETS | $ | 10,985 | $ | 15,315 | ||||||||||
Liabilities net of capital deficiency | ||||||||||||||
CURRENT LIABILITIES: | ||||||||||||||
Accounts payable | $ | 667 | $ | 534 | ||||||||||
Accrued expenses and other | 3,623 | 1,332 | ||||||||||||
Loans from the controlling shareholder | 37,338 | 65,338 | ||||||||||||
TOTAL CURRENT LIABILITIES | 41,628 | 67,204 | ||||||||||||
LONG-TERM LIABILITIES – | ||||||||||||||
Liability for employee rights upon retirement | 694 | 810 | ||||||||||||
TOTAL LONG-TERM LIABILITIES | 694 | 810 | ||||||||||||
COMMITMENTS | ||||||||||||||
TOTAL LIABILITIES | 42,322 | 68,014 | ||||||||||||
CAPITAL DEFICIENCY: | ||||||||||||||
Ordinary shares, NIS 0.1 par value – authorized: 8,775,783 and 50,000,000 as of December 31, 2016 and 2017, respectively; issued and outstanding: 6,290,242 and 6,290,244 as of December 31, 2016 and December 31, 2017, respectively | 82 | 82 | ||||||||||||
Additional paid-in capital | 32,274 | 42,480 | ||||||||||||
Accumulated deficit | (63,693 | ) | (95,261 | ) | ||||||||||
TOTAL CAPITAL DEFICIENCY | (31,337 | ) | (52,699 | ) | ||||||||||
TOTAL LIABILITIES NET OF CAPITAL DEFICIENCY | $ | 10,985 | $ | 15,315 |
SOL-GEL TECHNOLOGIES LTD. | |||||||||||||||||||||||
STATEMENT OF OPERATIONS | |||||||||||||||||||||||
(U.S. dollars in thousands, except share and per share data) | |||||||||||||||||||||||
Year ended December 31, | |||||||||||||||||||||||
2015 |
2016 | 2017 | |||||||||||||||||||||
REVENUES | 174 | ||||||||||||||||||||||
RESEARCH AND DEVELOPMENT EXPENSES | $ | 7,184 | $ | 17,023 | $ | 25,805 | |||||||||||||||||
GENERAL AND ADMINISTRATIVE EXPENSES | 2,463 | 3,733 | 6,002 | ||||||||||||||||||||
TOTAL OPERATING LOSS | 9,647 | 20,756 | 31,633 | ||||||||||||||||||||
FINANCIAL EXPENSES (INCOME), NET | 13 | 15 | (65) | ||||||||||||||||||||
LOSS FOR THE YEAR | $ | 9,660 | $ | 20,771 | $ | 31,568 | |||||||||||||||||
BASIC AND DILUTED LOSS PER ORDINARY SHARE | $ | 1.53 | $ | 3.30 | $ | 5.02 | |||||||||||||||||
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE | 6,290,242 | 6,290,242 | 6,290,244 |
Source: Sol-Gel Technologies Ltd.