Sol-Gel Technologies Reports First Quarter 2018 Financial Results
NESS ZIONA,
“We are continuing to make progress with our pipeline in our lead indications of acne vulgaris and subtype II rosacea as we prepare to initiate pivotal clinical trials for both programs this year,” stated Dr.
Corporate Highlights and Recent Developments
- In
February 2018 ,Sol-Gel presented TWIN Phase II data for the treatment of acne vulgaris and Epsolay Phase II data for the treatment of subtype II rosacea at the 2018 American Academy of Dermatology (AAD) Annual Meeting.
- In
February 2018 ,Sol-Gel completed an initial public offering (IPO) generating aggregate gross proceeds of approximately$86.3 million , before underwriting discounts and commissions and estimated offering expenses.
- In
January 2018 ,Perrigo Company plc (NYSE: TASE: PRGO) was granted a tentative approval from the U.S Food and Drug Administration (FDA ) for ivermectin cream, 1%, the active ingredient in Soolantra®, indicated for the treatment of inflammatory lesions of rosacea.Perrigo andSol-Gel shared development costs and will share the gross profit 50/50.
Clinical Program Update
Sol-Gel recently held an end-of-phase II meeting with theFDA regarding TWIN and expects to commence the pivotal Phase III trials in acne vulgaris in the second half of 2018 as planned.
Sol-Gel has submitted a Special Protocol Assessment (SPA) request with theFDA regarding Epsolay and expects to commence the pivotal Phase III trials in subtype II rosacea in the first half of 2018 as planned.
Sol-Gel plans to commence bioequivalence study for a generic drug candidate in 2018.
Financial Results
First quarter 2018 Financial Results
Research and development expenses were $4.6 million in the first quarter of 2018, compared to $5.0 million during the same period in 2017. The decrease was primarily due to a decrease of
General and administrative expenses were $1.1 million in the first quarter of 2018, compared to $0.6 million during the same period in 2017. The increase was primarily due to an increase of
As of March 31, 2018,
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 statements regarding the commencement of our planned clinical trials and our existing cash resources being sufficient to fund the completion of our planned Phase III clinical programs for TWIN and Epsolay®. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statement, including but not limited to, the following: (i) the fact that we have and expect to continue to incur significant losses; (ii) our need for additional funding, which may not be available; (iii) our ability to complete the development of our product candidates; (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 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]
NOTES TO THE FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
December 31, |
March 31, |
||||
2017 |
2018 |
||||
A s s e t s | |||||
CURRENT ASSETS: | |||||
Cash and cash equivalents | $ | 5,024 | $ | 79,796 | |
Bank deposit | 4,000 | 4,000 | |||
Prepaid expenses and other current assets | 1,511 | 1,357 | |||
Advance payment | 13 | - | |||
TOTAL CURRENT ASSETS | 10,548 | 85,153 | |||
NON-CURRENT ASSETS: | |||||
Long-term receivables | 1,653 | 1,600 | |||
Restricted long-term deposits | 120 | 120 | |||
Property and equipment, net | 2,314 | 2,396 | |||
Funds in respect of employee rights upon retirement | 680 | 671 | |||
TOTAL NON-CURRENT ASSETS | 4,767 | 4,787 | |||
TOTAL ASSETS | $ | 15,315 | $ | 89,940 | |
Liabilities and shareholders' equity (capital deficiency) | |||||
CURRENT LIABILITIES: | |||||
Accounts payable | 534 | 444 | |||
Accrued expenses and other | 1,332 | 1,527 | |||
Loans from the controlling shareholder | 65,338 | - | |||
TOTAL CURRENT LIABILITIES | $ | 67,204 | $ | 1,971 | |
LONG-TERM LIABILITIES - | |||||
Liability for employee rights upon retirement | 810 | 932 | |||
TOTAL LONG-TERM LIABILITIES | 810 | 932 | |||
COMMITMENTS | |||||
TOTAL LIABILITIES | $ | 68,014 | $ | 2,903 | |
CAPITAL DEFICIENCY: | |||||
Ordinary Shares, NIS 0.1 par value – authorized: 8,775,783 as of December 31, 2017 and March 31, 2018; issued and outstanding: 6,290,244 and 18,949,968 as of December 31, 2017 and March 31, 2018, respectiveley | 82 | 520 | |||
Additional paid-in capital | 42,480 | 187,491 | |||
Accumulated deficit | (95,261) | (100,974) | |||
TOTAL SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY) | (52,699) | 87,037 | |||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY) | $ | 15,315 | $ | 89,940 | |
NOTES TO THE FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
|
Three months ended March 31 |
|||||
2017 | 2018 | |||||
REVENUES | $ | - | $ | 44 | ||
RESEARCH AND DEVELOPMENT EXPENSES | (5,017 | ) | (4,645 | ) | ||
GENERAL AND ADMINISTRATIVE EXPENSES | (611 | ) | (1,142 | ) | ||
TOTAL OPERATING LOSS | $ | (5,628 | ) | $ | (5,743 | ) |
FINANCIAL (INCOME) EXPENSES, net | (2 | ) | 30 | |||
LOSS FOR THE PERIOD | $ | (5,630 | ) | $ | (5,713 | ) |
BASIC AND DILUTED LOSS PER ORDINARY SHARE | $ | 0.89 | $ | 0.39 | ||
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE |
6,290,242 | 14,523,161 |
Source: Sol-Gel Technologies Ltd.