Menlo's Nasdaq Page Menlo's Edgar Filings
=================================================================== $MNLO; LICENSING ;;;;; 04-23-2020 RE; BRIDGEWATER, N.J., April 23, 2020 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. (MNLO) (“Menlo” or the “Company”),
a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to
address unmet needs in dermatology, today announced that its wholly-owned subsidiary, Foamix Pharmaceuticals Ltd. (“Foamix”), has entered into a licensing agreement with specialty pharmaceutical company Cutia Therapeutics (HK) Limited, an affiliate of Cutia Therapeutics (“Cutia”) for AMZEEQ™ (minocycline) topical foam, 4% as well as its other topical minocycline product candidates, once approved, on an exclusive basis in Greater China. Under the terms of the agreement, Cutia will have an exclusive license to obtain regulatory approval of and commercialize AMZEEQ™ and, if approved in the U.S., FMX103 and FCD105 in the Greater China territory. Foamix will supply the finished licensed products to Cutia for clinical and commercial use. Foamix will receive an upfront cash payment of $10 million and will be eligible to receive an additional $1 million payment upon the receipt of marketing approval in China of the first licensed product. Foamix will also receive royalties on net sales of any licensed products. “We believe that this agreement with Cutia speaks to the importance of our topical minocycline technology and the strong demand for AMZEEQ worldwide,” said David Domzalski, CEO of Menlo. “We intend to partner with other companies outside the U.S. to extend our commercial reach in order to bring AMZEEQ and our topical minocycline product candidates to the hundreds of millions of patients suffering from acne and rosacea.” “We recognized the value of Foamix’s unique foam technology for dermatology and looked to license its minocycline products as anchor assets as we aim to build China’s leading dermatology platform,” said Lele Zhang, CEO of Cutia. Cutia is a portfolio company of 6 Dimensions Capital, a leading global investment firm with a focus on life sciences and
healthcare with over 10B RMB ($1.5B USD) currently under management. In October 2019, Foamix received U.S. Food and Drug Administration (FDA) approval for AMZEEQ, a minocycline topical foam, 4%, for the treatment of non-nodular inflammatory moderate-to-severe acne vulgaris in adults and pediatric patients 9 years of age and older. In addition to AMZEEQ, the Company is working to develop and commercialize in the U.S. a topical minocycline foam, 1.5% (FMX103) for the potential treatment of inflammatory lesions (papules and pustules) of rosacea in adults, which is currently being reviewed by the FDA with a PDUFA action date of June 2, 2020, and FCD105, a topical foam combination of minocycline and adapalene therapy for the potential treatment of acne vulgaris, which is currently in Phase 2 clinical development with top line results expected in the second quarter of 2020. With over 200 granted patents worldwide Menlo is a leader in innovative topical technologies and has out-licensed novel delivery platforms to pharmaceutical companies for the development of proprietary topical products containing various active pharmaceutical ingredients. https://www.otcmarkets.com/stock/MNLO/disclosure https://www.otcmarkets.com/stock/MNLO/news Stock analysts at Piper Sandler decreased their Q2 2020 earnings estimates for
Menlo Therapeutics in a research report issued to clients and investors on
Monday, May 11th. Piper Sandler analyst D. Amsellem now forecasts
the company will post earnings of ($0.18) per share for the quarter,
down from their previous estimate of ($0.11).
Piper Sandler also issued estimates for Menlo Therapeutics’ Q3 2020 earnings at ($0.18) EPS,
Q4 2020 earnings at ($0.14) EPS,
FY2020 earnings at ($0.79) EPS,
Q1 2021 earnings at ($0.12) EPS,
Q2 2021 earnings at ($0.08) EPS,
Q3 2021 earnings at ($0.08) EPS,
Q4 2021 earnings at ($0.05) EPS,
FY2021 earnings at ($0.33) EPS and
FY2022 earnings at $0.03 EPS.
https://www.dispatchtribunal.com/2020/05/15/piper-sandler-brokers-cut-earnings-estimates-for-menlo-therapeutics-inc-nasdaqmnlo.html https://www.otcmarkets.com/stock/MNLO/security https://www.otcmarkets.com/stock/MNLO/profile https://www.otcmarkets.com/stock/MNLO/quote https://www.otcmarkets.com/stock/MNLO/overview https://finance.yahoo.com/news/menlo-announces-settlement-conclude-finacea-120010453.html
Menlo Announces Settlement to Conclude Finacea Foam Litigation and Announces that Partner,
LEO Pharma A/S, Remedies Finacea Foam Supply Issues
BRIDGEWATER, N.J., April 02, 2020 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. (MNLO) (“Menlo” or the “Company”),
a biopharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology,
today announced that its wholly-owned subsidiary, Foamix Pharmaceuticals Ltd. (“Foamix”) has entered into a settlement and license agreement
to resolve the remaining pending patent litigation involving Finacea® Foam.
Details of the settlement agreement are confidential, and the settlement agreement is subject to the review of the Federal Trade Commission and the U.S. Department of Justice.
Foamix is the owner of patents that have been licensed to LEO Pharma A/S (“LEO Pharma”) to market Finacea® Foam,
a topical prescription medicine used to treat the inflammatory papules and pustules of mild to moderate rosacea.
This settlement concludes the litigation relating to Finacea® Foam and comes after the settlements in October 2019 with an
affiliate of Teva Pharmaceutical Industries Ltd. and in April 2019 with affiliates of Perrigo Company plc.
Expected Resupply of Finacea Foam
Menlo further announces that LEO Pharma has remedied the supply chain issues related to Finacea Foam that Foamix previously disclosed in April 2019. *DISCLAIMER *The Board Monitor and The Board Assistants herewith, are not licensed brokers and assume NO responsibility for the actions, investment decisions, and or messages posted on this forum.
Pursuant to the license agreement between Foamix and LEO Pharma, Foamix is entitled to the payment of royalties based on the net sales of Finacea Foam.
This week, LEO Pharma informed Menlo that it has remedied its supply issues and expects to resupply
batches of Finacea Foam for commercial sales in the U.S. in the coming weeks. Following the resupply, we anticipate that our royalty payments for Finacea Foam will increase.
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