Sol-Gel Reports First Quarter 2024 Financial Results and Provides Corporate Updates
Sol-Gel Technologies (NASDAQ: SLGL) announced its Q1 2024 financial results and corporate updates. Key highlights include an ongoing Phase 3 trial of SGT-610 for Gorlin Syndrome and a proof-of-concept study for SGT-210 in Darier disease. The company entered an Asset Purchase Agreement with Beimei Pharma to commercialize TWYNEO® in several regions, potentially earning up to $15M. Financially, Q1 revenue was $0.5M, up from $0.3M in Q1 2023. However, total prescriptions for TWYNEO and EPSOLAY declined by 23% and 14% respectively. R&D expenses decreased to $5.3M, contributing to a reduced net loss of $6.3M compared to $10.7M in Q1 2023.
- Ongoing Phase 3 trial for SGT-610 in Gorlin Syndrome with potential market of over $300M.
- Asset Purchase Agreement with Beimei Pharma for TWYNEO® worth up to $15M.
- Proof-of-concept study for SGT-210 in Darier disease initiated.
- First-to-file ANDA submission for generic Zoryve® Cream by collaboration partner Padagis.
- Cash runway maintained into the second half of 2025.
- Revenue increased to $0.5M in Q1 2024 from $0.3M in Q1 2023.
- Net loss decreased to $6.3M from $10.7M in Q1 2023.
- R&D expenses reduced to $5.3M from $9.4M in Q1 2023.
- General and administrative expenses decreased to $1.8M from $2.0M in Q1 2023.
- Total prescriptions for TWYNEO dropped by 23% in Q1 2024.
- Total prescriptions for EPSOLAY declined by 14% in Q1 2024.
- Patient refills for TWYNEO and EPSOLAY declined by 18% and 8% respectively.
- Net loss of $6.3M in Q1 2024, although reduced, remains significant.
- Potential uncertainty due to patent infringement action related to generic Zoryve® Cream.
Insights
Sol-Gel Technologies has reported its financial results for the first quarter of 2024, showing some notable trends. The revenue for Q1 was
The company reported a net loss of
Sol-Gel's cash runway is projected to last into the second half of 2025, supported by
The Phase 3 clinical trial for SGT-610, a hedgehog signaling pathway blocker, is a pivotal development for Sol-Gel Technologies. This therapy, if approved, could be the first treatment for the prevention of basal cell carcinomas (BCC) in Gorlin syndrome patients. Given the trial size of approximately 140 subjects across 40 clinical centers, this is a substantial and well-funded effort. The potential market for this treatment is estimated to be over
Additionally, the recent initiation of a proof-of-concept study for SGT-210 in Darier disease and its compassionate use in a pediatric patient with an ultra-rare disease are promising. The highly encouraging response in compassionate use treatment could pave the way for broader applications. However, these are early-stage studies and the outcomes will need to be closely monitored for both efficacy and safety before drawing any conclusive impact on the stock's long-term performance.
Sol-Gel's strategic agreement with Beimei Pharma to commercialize TWYNEO in several Asian markets, including China, Hong Kong and Taiwan, indicates a focused effort to expand its international footprint. The agreement, valued up to
However, it is essential to monitor the prescription trends for TWYNEO and EPSOLAY. Both products saw a decline in total prescriptions and patient refills in Q1 2024 compared to Q4 2023. The declines were partially attributed to a strong previous quarter influenced by targeted adherence campaigns and promotional model adjustments. Although the new prescriber count is increasing, the company needs to tackle the underlying issues causing the prescription declines for sustained growth.
- Phase 3 clinical trial of SGT-610 for Gorlin Syndrome with the first patient screened, is ongoing.
- Sol-Gel and Beimei Pharma announced an Asset Purchase Agreement to commercialize TWYNEO® in China, Hong Kong, Macau, Taiwan and Israel, for a total consideration of up to $115 million.
- Sol-Gel recently initiated a proof-of-concept study for SGT-210 (topical erlotinib) in patients with Darier disease.
- Highly encouraging clinical response for SGT-210 from a Compassionate use treatment for a pediatric patient suffering from an ultra-rare disease.
- Sol-Gel's collaboration partner, Padagis, submitted First-to-File ANDA Drug Product Generic to Zoryve® Cream.
- Sol-Gel maintains its cash runway into the second half of 2025.
NESS ZIONA, Israel, May 20, 2024 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company, pioneering treatments for patients with severe skin conditions, conducting a Phase 3 clinical trial of SGT-610 (patidegib gel,
Q1 2024 and Recent Corporate Developments
- On May 16, Sol-Gel and Beimei Pharma announced an Asset Purchase Agreement, pursuant to which Beimei purchases and licenses the rights to commercialize and manufacture TWYNEO® in China, Hong Kong, Macau, Taiwan and Israel. Sol-Gel is expected to receive, subject to applicable government approvals, a total consideration of up to
$15 million , out of which$10 million will be paid as upfront and regulatory milestones, and the remaining$5 million will be paid as royalties on net sales.
- We initiated a proof-of-concept study for SGT-210 (topical erlotinib) in patients with Darier disease, and have been using SGT-210 in a compassionate use treatment for a pediatric patient suffering from an ultra-rare disease.
- On April 1, 2024, Sol-Gel announced that Padagis Israeli Pharmaceuticals, Sol-Gel's collaboration partner, submitted a first-to-file Abbreviated New Drug Application (ANDA) for Roflumilast Cream
0.3% , a drug product generic to Zoryve® Cream (roflumilast cream0.3% ) indicated for the treatment of plaque psoriasis in patients six years of age and older. On March 26, 2024, Arcutis Biotherapeutics Inc initiated a patent infringement action in the US District Court in New Jersey regarding the Padagis Roflumilast0.3% ANDA. Should the ANDA is approved by the FDA, Padagis believes that its product may be entitled to 180 days of generic market exclusively. According to IQVIA, the annual market sales in the 12 months ended in January 2024 for Zoryve® Cream were approximately$ 95 million . - SGT-610 Phase 3 clinical trial is ongoing. On November 30, 2023, Sol-Gel announced that it had begun for Gorlin syndrome, with the first patient screened. Sol-Gel acquired topically applied patidegib, a hedgehog signaling pathway blocker
2% from PellePharm Inc. and is currently the only therapy in development to prevent the development of new BCC lesions in Gorlin syndrome patients. SGT-610 is a new topical hedgehog inhibitor to prevent the new basal cell carcinoma (BCC) lesions in patients with Gorlin syndrome that is expected to have an improved safety profile compared to oral hedgehog inhibitors. Sol-Gel is conducting a Phase 3 clinical trial to investigate SGT-610 in approximately 140 subjects at about 40 experienced clinical centers in North America, the United Kingdom, and Europe. - Total prescriptions for TWYNEO in Q1 2024 totaled approximately 21,000, declining
23% from Q4 2023. Patient refills in Q1 declined by18% for the same time period. This is in part due to a targeted patient adherence campaign facilitated in Q4 2023 and to the adjustments in the promotional model. TWYNEO new prescribers continue to grow with a5% quarterly increase. Average weekly TWYNEO prescriptions/prescriber remained relatively constant at 1.6/week for Q1 with commercial managed care coverage for TWYNEO increasing by 1.5M lives since Q4 2023 to 102.2M commercial lives covered.
- Total prescriptions for EPSOLAY in Q1 2024 totaled approximately 12,500, declining
14% from Q4 2023. Patient refills declined by8% for Q1 2024 vs. Q4 2023. Consistent with TWYNEO, the quarterly decrease for EPSOLAY was negatively impacted by strong prescriptions in Q4 2023 influenced by a targeted patient adherence campaign and to the adjustments in the promotional model. EPSOLAY new prescribers continue to grow with a6% increase vs. Q4 2023. Average weekly EPSOLAY prescriptions/prescriber remained consistent at 1.3/week for Q1. Managed care coverage for EPSOLAY has grown since Q4 2023 with total commercial lives covered increasing by over 1M lives to 67.1M commercial lives covered.
Alon Seri-Levy, Ph.D., Chief Executive Officer of Sol-Gel, stated: "We continue to focus on rare indications affecting the skin which have no approved treatments. In this regard, we are continuing to enroll patients for our pivotal Phase 3 clinical trial of SGT-610 for the prevention of new basal cell carcinomas in patients with Gorlin Syndrome, with a potential market estimated at more than
"We recently signed an agreement with Beimei Pharma for the commercialization of TWYNEO in China, Hong Kong, Macau, Taiwan and Israel. This agreement demonstrates the potential of TWYNEO, and we expect to announce other agreements regarding the commercialization of both our FDA-approved assets, TWYNEO and EPSOLAY, in other territories,” further added Dr. Seri-Levy.
Financial Results for the First Quarter Year Ended March 31st, 2024
Total revenue in the first quarter was
Research and development expenses were
General and administrative expenses were
Sol-Gel reported a net loss of
As of March 31, 2024, Sol-Gel had
About Gorlin Syndrome and SGT-610
SGT-610, a hedgehog signaling pathway blocker, has the potential to be the first ever treatment for prevention of BCCs in Gorlin syndrome patients, if approved. Gorlin syndrome, an autosomal dominant genetic disorder affecting approximately 1 in 27,000-31,000 people in the U.S., is mostly caused by inheritance of one defective copy of the tumor suppressor patched homolog 1 (PTCH1) gene. Normally, the PTCH1 gene blocks the smoothened, frizzle class receptor (SMO) gene, turning off the hedgehog signaling pathway when it is not needed. Mutations in the PTCH1 gene may cause a loss of PTCH1 function, release of SMO, and may allow BCC tumor cells to divide uncontrollably. Patidegib, the active substance in SGT-610, is designed to block the SMO signal, thus, allowing cells to function normally and reducing the production of new tumors.
About Sol-Gel Technologies
Sol-Gel Technologies, Ltd. is a dermatology company focused on identifying, developing, and commercializing or partnering drug products to treat skin diseases. Sol-Gel developed TWYNEO, which is approved by the FDA for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older, and EPSOLAY, which is approved by the FDA for the treatment of inflammatory lesions of rosacea in adults. both drugs are exclusively licensed to and commercialized by Galderma in the US; and are exclusively licensed to Searchlight in Canada. TWYNEO was purchased and licensed by Beimei Pharma to be exclusively commercialized by them in China, Hong Kong, Macau, Taiwan and Israel.
The Company’s pipeline also includes a Phase 3 clinical trial of Orphan and Breakthrough Drug candidate SGT-610, which is a new topical hedgehog inhibitor being developed to prevent the new basal cell carcinoma lesions in patients with Gorlin syndrome that is expected to have an improved safety profile compared to oral hedgehog inhibitors as well as topical drug candidate SGT-210 under investigation for the treatment of rare hyper-keratinization disorders.
For additional information, please visit our new website: www.sol-gel.com
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 amounts to be received under the agreement with Beimei, out-licensing Epsolay and Twyneo in additional territories, the potential of Sol-Gel’s assets including Twyneo, Epsolay SGT-610, and SGT-210, and SGT-610’s market value. 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 expectations 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, a delay in the timing of our clinical trials, the success of our clinical trials, and an increase in our anticipated costs and expenses, as well as the following factors: (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, the potential delay in receiving such regulatory approvals and the possibility of adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; (v) our collaborators’ ability to commercialize our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate protection of our intellectual property; (vii) our collaborators’ ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our collaborators’ 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 the United States, China, Europe or Israel; and (xv) loss or retirement of key executives and research scientists; (xvi) general market, political and economic conditions in the countries in which the Company operates; and, (xvii) the current war between Israel and Hamas and any deterioration of the war in Israel into a broader regional conflict involving Israel with other parties. These factors and other important factors discussed in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 13, 2024, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Except as required by law, we undertake no obligation to update any forward-looking statements in this press release.
Sol-Gel Contact :
Gilad Mamlok
Chief Financial Officer
info@sol-gel.com
+972-8-9313433
Source: Sol-Gel Technologies Ltd.
SOL-GEL TECHNOLOGIES LTD. | |||||||
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Three months ended | |||||||
| 2023 | 2024 | |||||
LICENSE REVENUES | $ | 300 | $ | 466 | |||
RESEARCH AND DEVELOPMENT EXPENSES | 9,386 | 5,345 | |||||
GENERAL AND ADMINISTRATIVE EXPENSES | 1,977 | 1,833 | |||||
OPERATING LOSS | $ | 11,063 | $ | 6,712 | |||
FINANCIAL INCOME, net | (342 | ) | (368 | ) | |||
LOSS FOR THE PERIOD | $ | 10,721 | $ | 6,344 | |||
BASIC AND DILUTED LOSS PER ORDINARY SHARE | 0.43 | 0.23 | |||||
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE | 24,944,220 | 27,857,620 | |||||
SOL-GEL TECHNOLOGIES LTD. CONDENSED CONSOLIDATED BALANCE SHEETS (U.S. dollars in thousands, except share and per share data) (Unaudited) | ||||||||
| ||||||||
| December 31, | | March 31, | |||||
| 2023 | | 2024 | |||||
Assets | |
|
| | |
| ||
CURRENT ASSETS: | |
|
| | |
| ||
Cash and cash equivalents | | $ | 7,513 | | $ | 11,210 | | |
Bank deposits | 10,012 | 5,012 | | |||||
Marketable securities | 20,471 | 16,795 | | |||||
Accounts receivables | 377 | 869 | | |||||
Prepaid expenses and other current assets | 2,794 | 2,121 | | |||||
TOTAL CURRENT ASSETS | |
| 41,167 | |
| 36,007 | | |
|
| |
| |||||
NON-CURRENT ASSETS: | ||||||||
Restricted long-term deposits and cash equivalents | |
| 1,284 | |
| 1,264 | | |
Property and equipment, net | 434 | 366 | | |||||
Operating lease right-of-use assets | |
| 1,721 | |
| 1,612 | | |
Other long-term assets | 55 | 45 | | |||||
Funds in respect of employee rights upon retirement | |
| 626 | |
| 617 | | |
TOTAL NON-CURRENT ASSETS | |
| 4,120 | |
| 3,904 | | |
TOTAL ASSETS | | $ | 45,287 | | $ | 39,911 | | |
Liabilities and shareholders' equity | |
| |
| ||||
CURRENT LIABILITIES: | |
| |
| ||||
Accounts payable | | $ | 154 | | $ | 582 | | |
Other accounts payable | |
| 3,921 | |
| 4,257 | | |
Current maturities of operating leases | |
| 447 | |
| 386 | | |
TOTAL CURRENT LIABILITIES | | 4,522 | |
| 5,225 | | ||
|
| |
| |||||
LONG-TERM LIABILITIES: | ||||||||
Operating leases liabilities | 1,206 | 1,133 | | |||||
Liability for employee rights upon retirement | |
| 915 | |
| 902 | | |
TOTAL LONG-TERM LIABILITIES | |
| 2,121 | |
| 2,035 | | |
TOTAL LIABILITIES | | 6,643 | |
| 7,260 | | ||
|
| |
| |||||
SHAREHOLDERS' EQUITY: | ||||||||
Ordinary shares, NIS 0.1 par value – authorized: 50,000,000 as of December 31, 2023 and March 31, 2024, respectively; issued and outstanding: 27,857,620 and 27,857,620 as of December 31, 2023 and March 31, 2024, respectively | |
| 774 | |
| 774 | | |
Additional paid-in capital | 258,173 | 258,524 | | |||||
Accumulated deficit | (220,303 | ) | (226,647 | ) | ||||
TOTAL SHAREHOLDERS' EQUITY | 38,644 | 32,651 | | |||||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | | $ | 45,287 | | $ | 39,911 | |
_____________________________
1 All $ amounts are in U.S. dollars
FAQ
What is the latest update on Sol-Gel's SGT-610 clinical trial for Gorlin Syndrome?
What are the financial results for Sol-Gel Technologies in Q1 2024?
What is the status of the Asset Purchase Agreement between Sol-Gel and Beimei Pharma?
What is the significance of the ANDA submission for generic Zoryve® Cream?
How did the prescriptions for TWYNEO and EPSOLAY perform in Q1 2024?
What are the ongoing studies for Sol-Gel's products?