Get All Access for FREEMarket News & Research,
Live Transcripts & Audio,
and a whole lot more…
$REGN 1Q15 10-Q: Expecting CapEx of approx. $535-635MM during remainder of 2015 in connection with renovating new Limerick, Ireland facility, tenant improvement related to two new buildings under construction at leased Tarrytown, New York facilities, expanding & renovating portion of manufacturing facilities at Rensselaer, New York facility etc.
$REGN and ISA Pharmaceuticals announced a clinical collaboration to advance ISA101, an immunotherapy targeting human papillomavirus type 16-induced cancer, in combination with cemiplimab (REGN2810), a PD-1 (programmed cell death protein 1) antibody. $REGN and ISA will jointly conduct trials of treatment in cervical cancer and head-and-neck cancer.
Pharma firm $REGN has joined hands with Decibel Therapeutics, a provider of hearing therapies, to develop new treatments for hearing problems. As per the terms of the deal, Regeneron will provide Decibel with access to its proprietary technologies, besides participating in the latter’s research programs through R&D funding and an equity investment.
$REGN said results from two Phase 2 studies that added the angiopoietin2 to EYLEA injection did not provide sufficient differentiation to warrant Phase 3 development. EYLEA results were consistent with the findings in previous clinical studies.
$REGN said Sanofi reimbursement of its commercialization-related expenses, was $90MM for 3Q17. "We are tightening and lowering our FY17 guidance of Sanofi reimbursement of Regeneron commercialization-related expenses to $350-375MM from our previous guidance range of $370-400MM," the company said.
$REGN reported double-digit growth in top and bottom-line growth in 3Q17, driven by solid sales of EYLEA injection and Praluent. Revenues improved 23% from last year to $1.5Bil, while net income rose 46% to $388MM, or $3.32 per share. On an adjusted basis, net income grew 27% to $3.99 per share.
$REGN and $SNY announced positive results from a Phase 2 study of dupilumab in adults with active moderateto-severe eosinophilic esophagitis (a condition that causes swallowing difficulty). The study showed that patients who received dupilumab weekly reported a significant improvement in the ability to swallow versus placebo.
$REGN and Sanofi announced positive results from a Phase 2 investigational study of dupilumab in adults with active moderate-to-severe eosinophilic esophagitis. Eosinophilic esophagitis is a chronic, allergic inflammatory disease that damages the esophagus and prevents it from working properly, leading to difficulties swallowing and food impaction.
Sanofi and $REGN said the U.S. Court of Appeals for the Federal Circuit has ordered new trial and vacated permanent injunction in the dispute concerning $AMGN's asserted patent claims for antibodies targeting PCSK9. This ruling means that Sanofi and $REGN will continue marketing, selling and manufacturing Praluent (alirocumab) injection in the U.S.
Pharma company $REGN has entered into collaborations with the Biomedical Advanced Research & Development Authority to develop treatments for infectious diseases. The first collaboration is focused on development of antibodies targeting up to 10 pathogens, while the second builds on a prior agreement to develop a potential therapy for Ebola virus.
$REGN and $SNY have announced that the European Commission has granted marketing authorization for DUPIXENT (dupilumab), for use in adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. AD, a form of eczema, is a chronic inflammatory disease with symptoms often appearing as a rash on the skin.
Pharma company $REGN and healthcare firm $SNY said a study showed that Dupixent, which is indicated for the treatment of atopic dermatitis, significantly improved overall disease severity. It also met the primary end point - the proportion of patients that achieved a 75% or greater improvement at 16 weeks from baseline.
$REGN and Sanofi announced positive dupilumab topline results from phase 3 trial in uncontrolled persistent asthma. The investigational dupilumab lowered severe asthma attacks and improved lung function. The companies plan to submit a Supplemental Biologics License Application (sBLA) to the U.S. FDA by the end of this year.
$REGN has announced that it would discontinue developing its drug to prevent respiratory syncytial virus (RSV) infections in infants. Its Phase 3 study evaluating suptavumab, an antibody to RSV, did not meet its primary endpoint of preventing the infection following which the company planned to stop further clinical development of this antibody.
The US sales of $REGN’s flagship macular degeneration drug EYLEA rose 10% YoY in the first half of 2017, driven by higher demand and increased market share. Regeneron expects to fully utilize the $130MM annual funding from its collaborator Sanofi, under an antibody discovery agreement, by the end of the third quarter.
$REGN said its arthritis drug Kevzara received approval from the US FDA and the European Commission in 2Q17. In the second half of this year, topline data from phase-2 studies on wet age related macular degeneration and diabetic macular edema are expected to be published. Results from study on a cardiovascular drug will be released in early 2018.
$REGN raised sales growth forecast for FY17 to 10% from the earlier outlook of single-digit increase. The company anticipates non-GAAP R&D expenses between $925MM and $965MM. The guidance of non-GAAP selling, general and administrative expenses has been raised to the range of $1.12-$1.16Bil. Regeneron sees effective tax rate of 27-31% for the year.