Earnings release
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SOL - GEL Sol - Gel Technologies Reports Second Quarter 2021 Financial Results and Highlights Recent Corporate Developments August 4 , 2021 • Recently obtained FDA approval of TWYNEOⓇ triggers milestone payment from Galderma • Exclusive license agreements with Galderma for U.S. commercialization of EPSOLAYⓇ and TWYNEO • Sol - Gel advancing its early - stage pipeline in plaque psoriasis , palmoplantar keratoderma and other high - value dermatologic indications • FDA action on the NDA for EPSOLAY still pending due to COVID - 19 - related restrictions • Generic ivermectin cream , 1 % launched by Sol - Gel's partner Perrigo in June NESS ZIONA , Israel , Aug. 04 , 2021 ( GLOBE NEWSWIRE ) -- Sol - Gel Technologies , Ltd. ( NASDAQ : SLGL ) , a dermatology company focused on identifying , developing and commercializing branded and generic topical drug products for the treatment of skin diseases , today announced financial results for the second quarter ended June 30 , 2021 and provided an overview of recent corporate developments . Second Quarter Corporate Highlights and Recent Developments • On July 27 , 2021 , Sol - Gel announced that the U.S. Food and Drug Administration ( FDA ) approved its first proprietary drug product , TWYNEOⓇ ( tretinoin and benzoyl peroxide ) cream , 0.1 % / 3 % , indicated for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older . This approval triggers a milestone payment from Galderma . • On June 28 , 2021 , Sol - Gel announced that it signed two exclusive , 5 - year license agreements with Galderma for the commercialization of EPSOLAY® ( benzoyl peroxide ) cream , 5 % , and TWYNEO in the United States . EPSOLAY is under investigation for the treatment of inflammatory lesions of rosacea in adults . In accordance with the terms of these agreements , Sol - Gel received an $ 8 million upfront payment in July , $ 4 million of which is conditional upon FDA approval of EPSOLAY by the end of 2021. In addition , Sol - Gel is entitled to receive additional regulatory milestone payments of up to $ 7 million , $ 3.5 million of which is due following the approval of TWYNEO and $ 3.5 million of which is payable upon approval of EPSOLAY . Sol - Gel is also eligible to receive tiered double - digit royalties ranging from mid - teen to high - teen percentages of net sales as well as up to $ 9 million in sales milestone payments . • On June 28 , 2021 , Sol - Gel also announced that the Company was advancing its early - stage topical drug candidates SGT - 210 ( erlotinib gel ) under investigation for the treatment of palmoplantar keratoderma , SGT - 310 ( tapinarof cream , 1 % ) and SGT - 510 ( roflumilast ) under investigation for the treatment of plaque psoriasis and other dermatologic indications . • On April 26 , 2021 , Sol - Gel received confirmation from the FDA that action on the New Drug Application ( NDA ) for EPSOLAY had not yet been taken due to the inability of the FDA to conduct a pre - approval inspection of the production site for EPSOLAY because of COVID - 19 travel restrictions . The Company maintains ongoing dialogue with the FDA about advancing this NDA approval . • A generic product , ivermectin cream , 1 % was launched by partner Perrigo in June 2021 . Alon Seri - Levy , Ph.D. , Co - Founder and Chief Executive Officer , stated , " The approval of TWYNEO solidifies our Company's reputation as a successful drug developer , and we now look forward to a successful launch of TWYNEO in the U.S. by market leader Galderma . We are extremely proud to have entered into a U.S. partnership with Galderma on attractive terms which permit us to regain our products after a five - year period . This partnership creates a maximum growth opportunity for our products while minimizing future cash needs for our company . It also allows us to focus on our innovative early - stage pipeline and is in line with our vision to establish Sol - Gel as a leading topical dermatology company ” . Financial Results for the Second Quarter Ended June 30 , 2021 Revenue for the second quarter of 2021 was $ 0.9 million . The revenue was mainly due to sales of generic products from collaboration arrangements with Perrigo , compared to $ 1.1 million for the same period in 2020 . Research and development expenses were $ 6.9 million in 2021 compared to $ 6.5 million during the same period in 2020. The increase of $ 0.4 million was mainly attributed to an increase of $ 0.9 million in manufacturing expenses offset by a decrease of $ 0.3 million in R & D expenses and a decrease of $ 0.2 million in other expenses . General and administrative expenses were $ 2.0 million in 2021 compared to $ 2.2 million in 2020. The decrease of $ 0.2 million was mainly attributed to a decrease in commercialization expenses .