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About Sol-Gel Technologies Ltd.
Sol-Gel Technologies Ltd. (NASDAQ: SLGL) is a clinical-stage specialty pharmaceutical company focused on the development and commercialization of innovative dermatological drug products. The company leverages its proprietary silica-based microencapsulation technology to create topical treatments that aim to improve efficacy, reduce side effects, and enhance patient tolerability. This unique technology encapsulates active drug substances within porous silica microcapsules, forming a protective barrier between the drug and the skin while enabling controlled drug release.
Core Business and Product Portfolio
Sol-Gel operates within the niche dermatology pharmaceutical sector, addressing skin conditions such as acne vulgaris, rosacea, and other dermatological disorders. Its product portfolio includes both branded and generic topical drugs. Notably, the company has developed two FDA-approved products:
- TWYNEO®: A combination treatment for acne vulgaris in adults and pediatric patients aged nine years and older.
- EPSOLAY®: A topical treatment for inflammatory lesions of rosacea in adults.
Both products are exclusively licensed to Galderma for commercialization in the United States and to Searchlight in Canada, showcasing Sol-Gel's collaborative business model.
Proprietary Technology and Innovation
The company's silica-based microencapsulation technology is a cornerstone of its R&D efforts. This platform enables the development of novel fixed-dose combinations and enhances the tolerability of topical drugs by creating a controlled-release mechanism. This technological edge allows Sol-Gel to address unmet needs in dermatology, providing solutions that are potentially more effective and safer than currently available treatments.
Pipeline and Future Opportunities
Sol-Gel's pipeline includes several promising candidates, such as:
- SGT-610: A hedgehog pathway inhibitor in Phase 3 clinical trials for the prevention of basal cell carcinoma lesions in patients with Gorlin syndrome. This candidate has the potential to be the first-ever treatment for this indication, offering an improved safety profile compared to oral alternatives.
- SGT-210: A topical treatment under investigation for rare hyper-keratinization disorders.
The company is also exploring opportunities for generic dermatological drugs, further diversifying its revenue streams and market presence.
Business Model and Partnerships
Sol-Gel's business model combines in-house development with strategic partnerships for commercialization. By licensing its products to established pharmaceutical companies like Galderma and Searchlight, Sol-Gel benefits from their extensive marketing and distribution networks. Additionally, the company has entered agreements with Beimei Pharma for the commercialization of its products in China, Hong Kong, Macau, Taiwan, and Israel.
Competitive Landscape
Operating in the competitive dermatology pharmaceutical industry, Sol-Gel faces challenges from larger firms with greater financial and technological resources. However, its proprietary technology, focus on niche markets, and strategic partnerships provide a competitive edge. The company's emphasis on innovation and addressing unmet medical needs positions it as a significant player in its field.
Key Differentiators
- Innovative Technology: The silica-based microencapsulation platform sets Sol-Gel apart by enabling safer and more effective drug formulations.
- Collaborative Model: Licensing agreements with industry leaders like Galderma enhance commercialization potential while reducing operational risks.
- Diverse Pipeline: A mix of branded, generic, and orphan drug candidates ensures a balanced approach to market opportunities.
Conclusion
Sol-Gel Technologies Ltd. is a forward-thinking pharmaceutical company specializing in dermatological treatments. Its proprietary technology, FDA-approved products, and robust pipeline underscore its commitment to innovation and patient care. By leveraging strategic partnerships and focusing on unmet medical needs, Sol-Gel is well-positioned within the dermatology sector to deliver impactful solutions for skin diseases.
Sol-Gel Technologies (NASDAQ: SLGL) announced its participation in two upcoming virtual investor conferences. The first is the H.C. Wainwright 6th Annual Israel Conference on November 12, 2020, at 8:30 AM ET, featuring CEO Dr. Alon Seri-Levy. The second is the Jefferies Virtual London Healthcare Conference on November 18, 2020, at 5:00 PM GMT, with several executives, including CFO Gilad Mamlok. Webcasts of the presentations will be accessible on the company’s website.
Sol-Gel Technologies, Ltd. (NASDAQ: SLGL) will announce its third quarter 2020 financial results on November 12, 2020, at 7:05 AM ET. The company is a clinical-stage dermatology firm that specializes in developing branded and generic topical products for skin diseases. Their innovative microencapsulation technology is being used for products such as Twyneo and Epsolay, which are under investigation for acne vulgaris and papulopustular rosacea, respectively. Other pipeline projects include SGT-210, tapinarof, and roflumilast.
Sol-Gel Technologies (NASDAQ: SLGL) announced the FDA's acceptance of its New Drug Application (NDA) for Epsolay®, a topical cream targeting inflammatory lesions in rosacea. The PDUFA goal date is set for April 26, 2021, which could make Epsolay the first FDA-approved single-agent benzoyl peroxide prescription product. Results from Phase 3 trials, involving 733 patients, showed significant improvements in treatment outcomes compared to the vehicle. The adverse reactions were mostly mild to moderate, indicating a favorable safety profile.
Sol-Gel Technologies (NASDAQ: SLGL), a clinical-stage dermatology company, announced participation in upcoming virtual investor conferences. CEO Dr. Alon Seri-Levy will provide a company overview, while CFO Gilad Mamlok will represent Sol-Gel at the H.C. Wainwright Healthcare Conference on September 15, 2020, at 10:00 AM ET. Additionally, a fireside chat featuring Dr. Seri-Levy, Mr. Mamlok, and John Vieira is scheduled for the Cantor Fitzgerald Virtual Global Healthcare Conference on September 17, 2020, at 8:40 AM ET. Webcasts will be available on the company's website.
On September 3, 2020, Sol-Gel Technologies (NASDAQ: SLGL) reported that Bausch Health initiated a patent infringement lawsuit regarding Perrigo's ANDA for a generic version of Duobrii® lotion, which treats plaque psoriasis. Perrigo's application, filed on July 23, asserts that certain patents are invalid or will not be infringed. Duobrii® had annual sales of $88.4 million as of July 2020. Sol-Gel collaborates with Perrigo, sharing development costs and profits from the potential commercialization of the generic product.
Sol-Gel Technologies (NASDAQ: SLGL) reported Q2 2020 financial results, achieving $1.1 million in revenue, primarily from a collaboration with Perrigo. The company submitted a New Drug Application for Epsolay, aimed at treating subtype II rosacea, and is on track for another NDA submission for Twyneo in H2 2020. R&D expenses decreased to $6.5 million, down from $11.4 million year-on-year, while general and administrative costs rose to $2.2 million. Sol-Gel reported a net loss of $7.1 million, up from $4.9 million in Q2 2019. The company holds $66 million in cash and marketable securities, sufficient to fund operations into Q3 2021.
Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage dermatology firm, is set to report its second quarter 2020 financial results on August 6, 2020, at 7:05 AM ET. The company focuses on developing branded and generic topical drugs for skin diseases, utilizing its proprietary microencapsulation technology. Key products include Twyneo for acne vulgaris and Epsolay for rosacea. The pipeline also features early-stage and preclinical assets targeting various skin conditions.
Sol-Gel Technologies (NASDAQ: SLGL) announced an anticipated FDA approval of a generic drug in Q2 2021, following a partnership agreement. The brand's sales exceeded $180 million in 2019, indicating significant market potential. This launch could establish a new revenue stream for Sol-Gel in 2021, enhancing its financial outlook. CEO Alon Seri-Levy expressed optimism about the brand's entry into the market, emphasizing its potential benefits for the company's growth.
Sol-Gel Technologies (NASDAQ: SLGL) has expanded its collaboration with Perrigo Company for the development and commercialization of three new generic dermatology product candidates. Perrigo will pursue FDA approval and lead commercialization if successful. This partnership builds on previous agreements and is expected to generate significant revenue for Sol-Gel. Additionally, the company is focused on submitting NDAs for its branded candidates, Epsolay® and Twyneo®, later this year. However, a patent infringement issue has arisen involving Bausch Health regarding a generic version of Bryhali®.
Sol-Gel Technologies (NASDAQ: SLGL) will present at the BMO 2020 Prescriptions for Success Healthcare Conference on June 23, 2020, at 11:00 am Eastern Time. CEO Alon Seri-Levy will speak at the event. Investors can access a live audio webcast on the company's website, with a replay available for 30 days. Sol-Gel focuses on developing topical drug products for skin diseases, leveraging its microencapsulation technology. The company's pipeline includes treatments for acne and rosacea, along with other early-stage and preclinical assets.
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