Sol-Gel Technologies Partnered Generic Product Expected to Launch in the Second Quarter of 2021

Rhea-AI Summary

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.

Positive

• Anticipated launch of FDA-approved generic drug in Q2 2021.
• 2019 sales of the brand name product exceeded $180 million, indicating strong market potential.
• New revenue stream expected from the launched product, which could enhance Sol-Gel's financial position.

Negative

• None.

NESS ZIONA, Israel, July 28, 2020 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, today announced that Sol-Gel has been informed by its collaboration partner that the launch of an FDA-approved generic drug is expected in the second quarter of 2021. In 2019, sales of the brand name product exceeded $180 million in the United States. Per terms of the previously announced collaboration agreement, Sol-Gel will receive payments based on product sales beginning at the launch date.

“We are delighted to announce the expected market entry of a second partnered generic dermatology product,” commented Alon Seri-Levy, Chief Executive Officer of Sol-Gel. “Importantly, the launch has the potential to add a new, significant stream of revenue to Sol-Gel in 2021.”

About Sol-Gel Technologies

Sol-Gel is a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases. Sol-Gel leverages its proprietary microencapsulation technology platform for Twyneo, for the treatment of acne vulgaris, and Epsolay, for the treatment of papulopustular rosacea. The Company’s pipeline also includes SGT-210, an early-stage topical epidermal growth factor receptor inhibitor, erlotinib, for the treatment of palmoplantar keratoderma, and preclinical assets tapinarof and roflumilast. For additional information, please visit 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, statements regarding the timing of launch of our partnered generic product and any expectation of increased revenues from sales of this generic product. 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, risks relating to the effects of COVID-19 (coronavirus), the timing of a launch of a branded tapinarof product, the launch of a branded topical roflumilast in the U.S. and the launch of generic product candidate, risks related to the timing of the submission of an NDA for Epsolay and an NDA for Twyneo 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 and the possibility of adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; (v) our ability to commercialize our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate protection of our intellectual property; (vii) our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our 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, Europe or Israel; and (xv) loss or retirement of key executives and research scientists. These 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 24 , 2020 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. Any such forward-looking statements represent management’s estimates as of the date of this press release. Except as required by law, we undertake no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements.

For further information, please contact:

Sol-Gel Contact:
Gilad Mamlok
Chief Financial Officer
+972-8-9313433

Investor Contact:
Lee M. Stern
Solebury Trout
646-378-2922
lstern@soleburytrout.com

Source: Sol-Gel Technologies Ltd.

FAQ

What is the expected launch date for Sol-Gel's FDA-approved generic drug?

The expected launch date for Sol-Gel's FDA-approved generic drug is in the second quarter of 2021.

What were the sales figures for Sol-Gel's brand name product in 2019?

In 2019, sales of the brand name product exceeded $180 million in the United States.

How will the launch of the new generic drug affect Sol-Gel's revenue?

The launch of the new generic drug is expected to add a significant stream of revenue to Sol-Gel in 2021.

What is Sol-Gel Technologies focused on?

Sol-Gel Technologies is focused on developing and commercializing branded and generic topical drug products for skin diseases.

Who is the CEO of Sol-Gel Technologies?

The CEO of Sol-Gel Technologies is Alon Seri-Levy.