Earnings release
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VYNE ™ THERAPEUTICS Exhibit 99.1 VYNE Therapeutics Reports First Quarter 2021 Financial Results and Provides Business Update Conference call and live webcast today at 8:30 am Eastern Time BRIDGEWATER , N.J. , May 6 , 2021 -- VYNE Therapeutics Inc. ( Nasdaq : VYNE ) ( “ VYNE " or the " Company " ) today announced financial results for the first quarter ended March 31 , 2021 and provided a corporate update . " Our sales organization continues to drive utilization of AMZEEQ and ZILXI , with prescriptions for both products gaining momentum , ” said David Domzalski , Chief Executive Officer of VYNE Therapeutics . “ During the first quarter , we unveiled our newest candidate FMX114 , a combination topical gel product candidate for the treatment of mild - to - moderate atopic dermatitis . We plan to take FMX114 into a Phase 2a study in the third quarter , with top- line results expected before year end . " First Quarter and Recent Highlights : FDA approved AMZEEQ® ( minocycline ) label update to include new information indicating the low propensity of Propionibacterium acnes ( more commonly known as “ P. acnes ” ) to develop resistance to minocycline Announced development program for FMX114 , a combination topical gel for mild - to - moderate atopic dermatitis ( AD ) FMX114 is a fixed combination of tofacitinib ( pan - JAK inhibitor ) and fingolimod ( sphingosine 1 - phosphate receptor modulator ) designed to address the multi - factorial nature of AD о Phase 2a clinical study in AD expected to begin in 3Q 2021 with top - line results expected by year end ° Proof of concept demonstrated in an animal model of AD Diluted Net Loss per Share Adjusted Net Loss * Adjusted Diluted Net Loss per Share * Adjusted EBITDA * Raised $ 73.1 million net proceeds from a registered direct offering of common stock and through utilization of an at - the - market equity offering program Executed 1 - for - 4 reverse stock split Financial Performance ( in thousands , except per share amounts ) Total Revenues Net Loss SSSSSS Three Months Ended March 31 , 2021 2020 $ 4,119 $ $ ( 20,550 ) $ 1,750 ( 40,233 ) $ $ ( 0.42 ) $ ( 18,108 ) $ ( 3.79 ) ( 38,474 ) $ ( 0.37 ) $ ( 3.62 ) $ ( 17,024 ) $ ( 37,346 ) * See " Note Regarding the Use of Non - GAAP Financial Measures " elsewhere in this earnings release . Financial Results for the First Quarter Ended March 31 , 2021 Revenues Revenues totaled $ 4.1 million for the three months ended March 31 , 2021 compared to $ 1.8 million for the three months ended March 31 , 2020. For the three months ended March 31 , 2021 , our revenue consisted of $ 3.9 million of product sales , and $ 0.2 million of royalty revenue . For the three months ended March 31 , 2020 , revenues consisted solely of $ 1.8 million of product sales . The increase in product sales is due to the ZILXI product launch in October 2020 and increase in demand for AMZEEQ . Cost of Goods Sold Cost of goods sold was $ 0.6 million for the three months ended March 31 , 2021 compared to $ 0.3 million for the three months ended March 31 , 2020. The increase in cost of goods sold is primarily due to an increase in sales volume . 1