Reported Earnings • May 28
First quarter 2026 earnings released: US$1.31 loss per share (vs US$3.16 loss in 1Q 2025) First quarter 2026 results: US$1.31 loss per share (improved from US$3.16 loss in 1Q 2025). Revenue: US$108.0k (down 90% from 1Q 2025). Net loss: US$3.73m (loss narrowed 58% from 1Q 2025). Revenue is forecast to grow 58% p.a. on average during the next 3 years, compared to a 3.8% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 61% per year but the company’s share price has only increased by 23% per year, which means it is significantly lagging earnings growth. Breakeven Date Change • May 20
No longer forecast to breakeven The analyst covering Sol-Gel Technologies no longer expects the company to break even during the foreseeable future. The company was expected to make a profit of US$10.1m in 2027. New forecast suggests the company will make a loss of US$52.0m in 2028. Anuncio • Mar 24
Sol-Gel Technologies Ltd. has completed a Follow-on Equity Offering in the amount of $33.056064 million. Sol-Gel Technologies Ltd. has completed a Follow-on Equity Offering in the amount of $33.056064 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 459,112
Price\Range: $72
Discount Per Security: $4.32 Anuncio • Dec 17
Sol-Gel Technologies, Ltd. Provides Update Following Unblinding of Phase 1b Study of SGT-210 in Darier Disease Sol-Gel Technologies Ltd. provided an update following the unblinding of clinical data from its vehicle-controlled proof-of-concept Phase 1b study of SGT-210 on Darier disease. Following unblinding, the data from the vehicle-controlled Phase 1b proof-of-concept study did not show differentiation between SGT-210 and vehicle on the study's efficacy assessments. Mutations in the PTCH1 gene may cause a loss of PTCH1 function, release of SMO, and may allow BCC tumor cells to divide uncontrollably. 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. Anuncio • Sep 26
Sol-Gel Technologies Ltd., Annual General Meeting, Nov 11, 2025 Sol-Gel Technologies Ltd., Annual General Meeting, Nov 11, 2025. Location: offices of mintz, levin, cohn, ferris, glovsky and, popeo, p.c., 919 third avenue, floor 38, ny 10022., new york United States Anuncio • Sep 04
Sol-Gel Announces Health Canada Approval of EPSOLAY®? Sol-Gel Technologies Ltd. conducting a Phase-3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome, a Phase-1b, double blinded clinical trial of SGT-210 (erlotinib appointment, 5%) on Darier disease patients and with two approved large-category dermatology products, TWYNEO and EPSOLAY, announced that on August 27, 2025Health Canada issued a Notice of Compliance (NOC) for EPSOLAY for the treatment of inflammatory lesions of rosacea in adults. Based on current plans, launches in many of these territories are expected to begin in 2027 and 2028, and partners forecasts indicate that ex-U.S. contribution to the EBITDA of the company are expected to gradually increase and potentially reach approximately $10 million annually by 2031. Mutations in the PTCH1 gene may cause a loss of PTCH1 function, release of SMO, and may allow BCC tumor cells to divide uncontrollably. Board Change • Dec 30
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 5 non-independent directors. Independent External Director Yuval Yanai was the last independent director to join the board, commencing their role in 2024. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Anuncio • Nov 21
Sol-Gel Technologies Receives 180-Day Extension to Regain Compliance with Nasdaq Minimum Bid Requirement Sol-Gel Technologies Ltd. announced that it has received an extension of the period to regain compliance with The Nasdaq Stock Market LLC’s (‘Nasdaq’) minimum bid price rule. On November 19, 2024, the Company received a letter from Nasdaq notifying the Company that, while the Company has not regained compliance with the Minimum Bid Price Requirement, Nasdaq has determined that the Company is eligible for an additional 180 calendar day period, or until May 19, 2025, (the ‘Second Compliance Period’) to regain compliance. Nasdaq's determination was based on (i) the Company meeting the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on The Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, and (ii) the Company's written notice to Nasdaq of its intention to cure the deficiency during the Second Compliance Period by effecting a reverse stock split, if necessary. In order to be provided with a Second Compliance Period, the Company submitted an application to transfer the listing of its Ordinary Shares from the Nasdaq Global Market to the Nasdaq Capital Market. This transfer to the Nasdaq Capital Market was approved and became effective as of November 15, 2024. If at any time during the Second Compliance Period, the closing bid price of the Company’s Ordinary Shares meet or exceed USD 1.00 per Ordinary Share for at least ten consecutive business days, Nasdaq will provide written confirmation of compliance and this matter will be closed. The Company intends to continue to actively monitor its compliance with the Minimum Bid Price Requirement and, as appropriate, will consider available options to resolve any deficiencies and regain compliance, including the implementation of a reverse share split, if necessary. Reported Earnings • Nov 17
Third quarter 2024 earnings released: US$0.013 loss per share (vs US$0.20 loss in 3Q 2023) Third quarter 2024 results: US$0.013 loss per share (improved from US$0.20 loss in 3Q 2023). Revenue: US$5.36m (up US$5.15m from 3Q 2023). Net loss: US$366.0k (loss narrowed 94% from 3Q 2023). Revenue is forecast to grow 28% p.a. on average during the next 3 years, compared to a 3.4% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has fallen by 43% per year but the company’s share price has fallen by 62% per year, which means it is performing significantly worse than earnings. Reported Earnings • Aug 18
Second quarter 2024 earnings released: EPS: US$0.071 (vs US$0.22 loss in 2Q 2023) Second quarter 2024 results: EPS: US$0.071 (up from US$0.22 loss in 2Q 2023). Revenue: US$5.43m (up US$4.84m from 2Q 2023). Net income: US$1.98m (up US$7.95m from 2Q 2023). Profit margin: 36% (up from net loss in 2Q 2023). The move to profitability was primarily driven by higher revenue. Revenue is forecast to grow 52% p.a. on average during the next 3 years, compared to a 3.7% growth forecast for the Pharmaceuticals industry in Germany. Reported Earnings • May 22
First quarter 2024 earnings released: US$0.23 loss per share (vs US$0.41 loss in 1Q 2023) First quarter 2024 results: US$0.23 loss per share (improved from US$0.41 loss in 1Q 2023). Net loss: US$6.34m (loss narrowed 38% from 1Q 2023). Revenue is forecast to grow 56% p.a. on average during the next 3 years, compared to a 3.7% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has fallen by 15% per year but the company’s share price has fallen by 58% per year, which means it is performing significantly worse than earnings. New Risk • May 22
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 0.5% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (14% average weekly change). Earnings are forecast to decline by an average of 0.5% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$8.5m net loss in 3 years). Shareholders have been diluted in the past year (8.4% increase in shares outstanding). Revenue is less than US$5m (US$1.6m revenue). Market cap is less than US$100m (€18.1m market cap, or US$19.6m). Reported Earnings • Mar 13
Full year 2023 earnings released: US$1.01 loss per share (vs US$0.65 loss in FY 2022) Full year 2023 results: US$1.01 loss per share (further deteriorated from US$0.65 loss in FY 2022). Net loss: US$27.2m (loss widened 83% from FY 2022). Revenue is forecast to grow 60% p.a. on average during the next 3 years, compared to a 3.3% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 3% per year but the company’s share price has fallen by 56% per year, which means it is significantly lagging earnings. Anuncio • Nov 21
Sol-Gel Technologies Ltd. Announces Resignation of Shmuel Ben Zvi from Board Sol-Gel Technologies Ltd. announced on November 19, 2023, Dr. Shmuel Ben Zvi submitted to the Board of Directors of the company his resignation from the Board, effective immediately. Dr. Ben Zvi’s decision to resign was due to his recent appointment as chairman of Bank Leumi Le-Israel B.M. Reported Earnings • Nov 11
Third quarter 2023 earnings released: US$0.20 loss per share (vs US$0.15 loss in 3Q 2022) Third quarter 2023 results: US$0.20 loss per share (further deteriorated from US$0.15 loss in 3Q 2022). Net loss: US$5.71m (loss widened 68% from 3Q 2022). Revenue is forecast to grow 103% p.a. on average during the next 2 years, compared to a 3.2% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 22% per year but the company’s share price has fallen by 43% per year, which means it is significantly lagging earnings. Reported Earnings • Aug 13
Second quarter 2023 earnings released: US$0.22 loss per share (vs US$0.006 loss in 2Q 2022) Second quarter 2023 results: US$0.22 loss per share (further deteriorated from US$0.006 loss in 2Q 2022). Net loss: US$5.97m (loss widened US$5.84m from 2Q 2022). Revenue is forecast to grow 26% p.a. on average during the next 3 years, compared to a 3.1% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 41% per year but the company’s share price has fallen by 24% per year, which means it is significantly lagging earnings. Anuncio • Jul 30
Sol-Gel Technologies Ltd. Appoints Sharon Kochan to the Board of Directors Sol-Gel Technologies Ltd. at its Annual Meeting of Shareholders held on July 26, 2023, approved the appointment of Mr. Sharon Kochan to the Board of Directors until the annual general meeting to be held in 2024. Anuncio • Jun 15
Sol-Gel Technologies Ltd., Annual General Meeting, Jul 26, 2023 Sol-Gel Technologies Ltd., Annual General Meeting, Jul 26, 2023, at 16:00 Israel Standard Time. Location: 7 Golda Meir St., Weizmann Science Park Ness-Ziona Israel Agenda: To appoint Kesselman & Kesselman, certified public accountants in Israel and a member of PricewaterhouseCoopers International Limited, as the Company's independent auditors for the year 2023 and for an additional period until the following annual general meeting; and to inform the shareholders of the aggregate compensation paid to the auditors for the year ended December 31, 2022; to approve the election of Mr. Sharon Kochan and the re-election of Dr. Alon Seri-Levy, Mr. Moshe Arkin, Mr. Itai Arkin, Ms. Hani Lerman, Dr. Shmuel Ben Zvi and Mr. Jonathan B. Siegel to Board of Directors, each for an additional one-year term until the annual general meeting to be held in 2024; to approve the grant of an award of options to and an amendment to the terms of engagement of Dr. Alon Seri-Levi; and to approve amendments to the Company's Compensation Policy. Reported Earnings • May 14
First quarter 2023 earnings released: US$0.41 loss per share (vs US$0.24 loss in 1Q 2022) First quarter 2023 results: US$0.41 loss per share (further deteriorated from US$0.24 loss in 1Q 2022). Revenue: US$758.0k (up US$755.0k from 1Q 2022). Net loss: US$10.3m (loss widened 83% from 1Q 2022). Revenue is forecast to grow 34% p.a. on average during the next 3 years, compared to a 3.8% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 57% per year but the company’s share price has fallen by 26% per year, which means it is significantly lagging earnings. Reported Earnings • Mar 12
Full year 2022 earnings released: US$0.65 loss per share (vs US$0.14 profit in FY 2021) Full year 2022 results: US$0.65 loss per share (down from US$0.14 profit in FY 2021). Revenue: US$3.88m (down 88% from FY 2021). Net loss: US$14.9m (down US$18.1m from profit in FY 2021). Revenue is forecast to grow 29% p.a. on average during the next 3 years, compared to a 3.4% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 66% per year but the company’s share price has fallen by 18% per year, which means it is significantly lagging earnings. Valuation Update With 7 Day Price Move • Mar 11
Investor sentiment deteriorates as stock falls 17% After last week's 17% share price decline to €3.40, the stock trades at a trailing P/E ratio of 19.2x. Average forward P/E is 17x in the Pharmaceuticals industry in Germany. Total loss to shareholders of 46% over the past three years. Valuation Update With 7 Day Price Move • Jan 24
Investor sentiment improves as stock rises 21% After last week's 21% share price gain to €5.05, the stock trades at a trailing P/E ratio of 25.1x. Average forward P/E is 16x in the Pharmaceuticals industry in Germany. Total loss to shareholders of 56% over the past three years. Reported Earnings • Nov 25
Third quarter 2022 earnings released: US$0.15 loss per share (vs US$0.056 profit in 3Q 2021) Third quarter 2022 results: US$0.15 loss per share (down from US$0.056 profit in 3Q 2021). Revenue: US$261.0k (down 97% from 3Q 2021). Net loss: US$3.41m (down 365% from profit in 3Q 2021). Revenue is forecast to grow 24% p.a. on average during the next 3 years, compared to a 3.8% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 72% per year but the company’s share price has fallen by 16% per year, which means it is significantly lagging earnings. Board Change • Nov 16
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 1 highly experienced director. Independent Director Jonathan Siegel was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Board Change • Nov 16
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 1 highly experienced director. Independent Director Jonathan Siegel was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • Aug 05
Second quarter 2022 earnings released: US$0.006 loss per share (vs US$0.35 loss in 2Q 2021) Second quarter 2022 results: US$0.006 loss per share (up from US$0.35 loss in 2Q 2021). Revenue: US$3.52m (up 279% from 2Q 2021). Net loss: US$134.0k (loss narrowed 98% from 2Q 2021). Over the next year, revenue is expected to shrink by 26% compared to a 8.0% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has increased by 60% per year but the company’s share price has fallen by 5% per year, which means it is significantly lagging earnings. Valuation Update With 7 Day Price Move • Jul 19
Investor sentiment improved over the past week After last week's 27% share price gain to €5.15, the stock trades at a trailing P/E ratio of 69.4x. Average forward P/E is 14x in the Pharmaceuticals industry in Germany. Total loss to shareholders of 38% over the past three years. Valuation Update With 7 Day Price Move • Jun 18
Investor sentiment deteriorated over the past week After last week's 21% share price decline to €4.10, the stock trades at a trailing P/E ratio of 66.5x. Average forward P/E is 12x in the Pharmaceuticals industry in Germany. Total loss to shareholders of 57% over the past year. Board Change • Apr 27
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 1 highly experienced director. Independent Director Jonathan Siegel was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Anuncio • Apr 26
Sol-Gel Technologies Announces FDA Approval of EPSOLAY Sol-Gel Technologies Ltd. announced the Food and Drug Administration (FDA) approval of its drug product, EPSOLAY®, a proprietary cream formulation of benzoyl peroxide, 5%, for the treatment of inflammatory lesions of rosacea in adults. The benzoyl peroxide in EPSOLAY is encapsulated within silica-based patented microcapsules. The silica-based shell is designed to slowly release benzoyl peroxide over time to provide a favorable efficacy and safety profile. The approval of EPSOLAY is supported by data from two positive, identical Phase 3 randomized, double-blind, multicenter, 12-week, clinical trials that evaluated the safety and efficacy of EPSOLAY compared to vehicle in people with inflammatory lesions of rosacea (N = 733). The coprimary endpoints in both trials were the proportion of subjects with treatment success and the absolute change from baseline in lesion counts at Week 12. EPSOLAY was more effective than vehicle cream on the co-primary efficacy endpoints starting from 4 weeks of treatment in both trials. With EPSOLAY treatment, inflammatory lesions of rosacea were reduced by nearly 70% by the end of both 12-week trials vs. 38-46% with vehicle. Nearly 50% of subjects were ‘clear’ (IGA=0) or ‘almost clear’ (IGA=1) at 12 weeks vs. 38-46% with placebo. Post-hoc analysis of lesion count and IGA success at Week 2 confirmed a significantly greater treatment effect for EPSOLAY relative to vehicle as early as Week 2. In the open-label extension, 73% of subjects were ‘clear’ (IGA=0) or ‘almost clear’ (IGA=1) at 52 weeks (N = 547). Sol-Gel has granted to Galderma Holding SA (“Galderma”) the exclusive rights to commercialize EPSOLAY in the United States. Anuncio • Apr 15
Sol-Gel Technologies Announces the Commercial Availability of TWYNEO Sol-Gel Technologies Ltd. announced that TWYNEO®, a topical cream containing a fixed-dose combination of tretinoin, 0.1%, and benzoyl peroxide (BPO), 3% for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older, is now available for purchase by consumers who obtain a prescription from their physician. TWYNEO Cream was approved by the U.S. Food and Drug Administration on July 27, 2021 and is being commercialized in the U.S. by Galderma. It is the first and only tretinoin and benzoyl peroxide (BPO) 2-in-1 combination ever approved by FDA and has been proven to rapidly treat even moderate to severe facial acne. TWYNEO Cream is now available at all major pharmacy chains throughout the U.S. by prescription. TWYNEO Cream is a once-daily application that can be used any time of day and even for severe cases of acne, as indicated by a physician’s prescription. Anuncio • Apr 09
Sol-Gel Technologies Ltd., Annual General Meeting, May 19, 2022 Sol-Gel Technologies Ltd., Annual General Meeting, May 19, 2022, at 16:00 Israel Standard Time. Location: 7 Golda Meir Street Ness Ziona Israel Agenda: To appoint Kesselman & Kesselman, certified public accountants in Israel and a member of PricewaterhouseCoopers International Limited, as the Company's independent auditors for the year 2022 and for an additional period until the following annual general meeting; and to inform the shareholders of the aggregate compensation paid to the auditors for the year ended December 31, 2021; to approve an amendment to the Company's Amended and Restated Articles of Association to provide that all Company directors will be elected or re-elected every year rather than every three years; to approve the re-election of Mr. Alon Seri-Levy, Mr. Moshe Arkin, Mr. Itai Arkin, Ms. Hani Lerman, Mr. Shmuel Ben Zvi, Ms. Yaffa Krindel-Sieradzki, Mr. Jonathan B. Siegel, Mr. Ran Gottfried and Mr. Jerrold S. Gattegno to the board of directors of the Company, each for an additional one-year term until the annual general meeting to be held in 2023. Reported Earnings • Apr 02
Full year 2021 earnings released: EPS: US$0.14 (vs US$1.30 loss in FY 2020) Full year 2021 results: EPS: US$0.14 (up from US$1.30 loss in FY 2020). Revenue: US$31.3m (up 257% from FY 2020). Net income: US$3.22m (up US$32.5m from FY 2020). Profit margin: 10% (up from net loss in FY 2020). The move to profitability was primarily driven by higher revenue. Over the next year, revenue is expected to shrink by 66% compared to a 8.2% growth forecast for the pharmaceuticals industry in Germany. Breakeven Date Change • Dec 23
Forecast to breakeven in 2021 The 4 analysts covering Sol-Gel Technologies expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$1.15m in 2021. Earnings growth of 47% is required to achieve expected profit on schedule. Anuncio • Dec 22
Sol-Gel Technologies Announces Positive Update Related to FDA Review Status of EPSOLAY® Sol-Gel Technologies Ltd. announced that the Food and Drug Administration (FDA) has informed the Company that it intends to conduct a pre-approval inspection of the production site for the Company’s drug product, EPSOLAY®, a proprietary topical formulation of benzoyl peroxide, 5%, during the week of February 14th, 2022. EPSOLAY is under review by the FDA for the treatment of the inflammatory lesions. EPSOLAY is a topical cream containing benzoyl peroxide, 5%, under FDA review for the treatment of inflammatory lesions of rosacea in adults. EPSOLAY utilizes a proprietary technology to encapsulate benzoyl peroxide within silica-based microcapsules to create a barrier between the medication and the skin. The silica-based shell is designed to slowly release benzoyl peroxide over time to provide a favorable efficacy and safety profile. EPSOLAY is protected by granted patents until 2040. Inflammatory lesions of rosacea is a chronic and recurrent skin disorder that affects millions of Americans. The condition is especially common in fair-skinned people of Celtic and northern European heritage. Onset is usually after age 30 and typically begins as flushing and subtle redness on the cheeks, nose, chin or forehead. If left untreated, rosacea can slowly worsen over time. As the condition progresses, the redness becomes more persistent, blood vessels become visible, and inflammatory lesions often appear. Other symptoms may include burning, stinging, dry skin, plaques and skin thickening. Reported Earnings • Nov 13
Third quarter 2021 earnings released: EPS US$0.056 (vs US$0.38 loss in 3Q 2020) The company reported a strong third quarter result with improved earnings, revenues and profit margins. Third quarter 2021 results: Revenue: US$8.84m (up 318% from 3Q 2020). Net income: US$1.29m (up US$9.91m from 3Q 2020). Profit margin: 15% (up from net loss in 3Q 2020). The move to profitability was primarily driven by higher revenue. Reported Earnings • Aug 05
Second quarter 2021 earnings released: US$0.35 loss per share (vs US$0.31 loss in 2Q 2020) The company reported a poor second quarter result with increased losses, weaker revenues and weaker control over costs. Second quarter 2021 results: Revenue: US$928.0k (down 18% from 2Q 2020). Net loss: US$8.03m (loss widened 14% from 2Q 2020). Reported Earnings • May 14
First quarter 2021 earnings released: US$0.18 loss per share (vs US$0.33 loss in 1Q 2020) The company reported a soft first quarter result with weaker revenues and control over costs, although losses reduced. First quarter 2021 results: Revenue: US$701.0k (down 80% from 1Q 2020). Net loss: US$4.06m (loss narrowed 43% from 1Q 2020). Breakeven Date Change • May 14
Forecast breakeven pushed back to 2024 The 4 analysts covering Sol-Gel Technologies previously expected the company to break even in 2023. New consensus forecast suggests the company will make a profit of US$37.4m in 2024. Average annual earnings growth of 63% is required to achieve expected profit on schedule. Anuncio • Apr 28
Sol-Gel Technologies Provides Update on FDA Review of Epsolay® Sol-Gel Technologies Ltd. announced an update regarding the U.S. Food and Drug Administration (FDA) approval process for EPSOLAY® (benzoyl peroxide) 5% topical cream for the treatment of Inflammatory lesions of rosacea in adults. In September of 2020, Sol-Gel was informed by the FDA that the PDUFA goal date for EPSOLAY is April 26, 2021. Subsequently, the COVID-19 pandemic restricted the FDA’s ability to conduct pre-approval inspections. In our most recent written communication with the FDA regarding EPSOLAY, the final content of the labeling was discussed and agreed to. As of today, Sol-Gel has received no notification from the FDA, but did receive email confirmation that that action on the NDA for EPSOLAY could not be taken since a pre-approval inspection of the production site of EPSOLAY still needs to be conducted. The Company continues to follow-up with the FDA on the scheduling of this inspection. Reported Earnings • Mar 06
Full year 2020 earnings released: US$1.30 loss per share (vs US$1.26 loss in FY 2019) The company reported a poor full year result with increased losses, weaker revenues and weaker control over costs. Full year 2020 results: Revenue: US$8.77m (down 62% from FY 2019). Net loss: US$29.3m (loss widened 19% from FY 2019). Analyst Estimate Surprise Post Earnings • Mar 06
Revenue beats expectations Revenue exceeded analyst estimates by 5.7%. Over the next year, revenue is forecast to grow 97%, compared to a 2.4% growth forecast for the Pharmaceuticals industry in Germany. Is New 90 Day High Low • Feb 18
New 90-day high: €8.70 The company is up 35% from its price of €6.45 on 19 November 2020. The German market is up 10.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 13% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €71.18 per share. Is New 90 Day High Low • Jan 04
New 90-day high: €8.25 The company is up 39% from its price of €5.95 on 06 October 2020. The German market is up 8.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 7.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €70.80 per share. Anuncio • Dec 10
Sol-Gel Technologies, Ltd Announces FDA Acceptance for Filing of New Drug Application for Twyneo for the Treatment of Acne Vulgaris Sol-Gel Technologies Ltd. announced that its New Drug Application (NDA) for Twyneo (benzoyl peroxide and tretinoin), an investigational proprietary fixed-dose combination of 3% encapsulated benzoyl peroxide and 0.1% encapsulated tretinoin cream for the treatment of acne vulgaris, has been accepted for filing by the U.S. Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for Twyneo is August 1, 2021. The NDA filing is based on two positive pivotal Phase 3 randomized, double-blind, multicenter, 12-week, clinical trials that evaluated the safety and efficacy of Twyneo compared to vehicle in patients 9 years of age and older with moderate-to-severe acne vulgaris (N = 858). In both trials, Twyneo demonstrated statistically significant improvement in all co-primary endpoints in the treatment of patients with acne vulgaris of (i) the proportion of patients who succeeded in achieving at least a two grade reduction from baseline and Clear (grade 0) or Almost Clear (grade 1) at Week 12 on a 5-point Investigator Global Assessment (IGA) scale, (ii) an absolute change from baseline in inflammatory lesion count at Week 12 and (iii) an absolute change from baseline in non-inflammatory lesion count at Week 12. The most common adverse events were local reactions, such as pain, dryness, exfoliation, erythema, dermatitis, pruritus and irritation, with nearly all adverse events (AEs) being mild or moderate in severity and no treatment-related serious AEs. Acne vulgaris is a multifactorial disease that is often treated with a combination of drugs. Twyneo combines two active ingredients that have a complementary mechanism of action in a compelling once-daily treatment. Is New 90 Day High Low • Dec 05
New 90-day high: €7.55 The company is up 21% from its price of €6.25 on 04 September 2020. The German market is up 5.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €76.37 per share. Analyst Estimate Surprise Post Earnings • Nov 16
Revenue beats expectations Revenue exceeded analyst estimates by 16%. Over the next year, revenue is forecast to grow 131%, compared to a 2.8% growth forecast for the Pharmaceuticals industry in Germany. Is New 90 Day High Low • Nov 14
New 90-day high: €7.10 The company is up 9.0% from its price of €6.50 on 14 August 2020. The German market is up 1.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is down 1.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €77.69 per share. Reported Earnings • Nov 13
Third quarter 2020 earnings released: US$0.38 loss per share The company reported a poor third quarter result with increased losses and weaker revenues and control over expenses. Third quarter 2020 results: Revenue: US$2.12m (down 55% from 3Q 2019). Net loss: US$8.62m (loss widened 17% from 3Q 2019). Anuncio • Nov 05
Sol-Gel Technologies Ltd. to Report Q3, 2020 Results on Nov 12, 2020 Sol-Gel Technologies Ltd. announced that they will report Q3, 2020 results at 7:05 AM, Eastern Standard Time on Nov 12, 2020 Is New 90 Day High Low • Sep 30
New 90-day low: €5.80 The company is down 23% from its price of €7.55 on 02 July 2020. The German market is up 3.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is down 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €54.55 per share.