$REGN (Regeneron Pharmaceuticals, Inc.)

$REGN {{ '2016-03-04T19:43:28+0000' | timeago}} • SEC

As of December 31, 2015, $REGN had $809.1MM in cash and cash equivalents and $868.3MM in marketable securities. Net cash provided by operating activities was $1.3Bil in 2015. Net cash used in investing activities was $907.6MM and net cash used in financing activities was $262.8MM in 2015.

$REGN {{ '2017-07-21T15:50:38+0000' | timeago}} • Announcement

$REGN and $SNY announced that the European Medicine Agency's Committee for Medicinal Products for Human Use has given a positive opinion for the marketing authorization of Dupixent (dupilumab), recommending its approval in Europe for use in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.

$REGN {{ '2017-06-22T14:02:42+0000' | timeago}} • Announcement

$REGN provided details of the royalty it receives on any sales of canakinumab (ACZ885). $REGN received a royalty on worldwide net sales of canakinumab; the royalty rate starts at 4% and reaches 15% when canakinumab annual sales exceed $1.5Bil.

$REGN {{ '2017-06-12T10:58:03+0000' | timeago}} • Announcement

$REGN and $SNY announced positive results from two Phase 3b/4 ODYSSEY-DM trials in patients with diabetes. In the studies, Praluent, when administered on top of maximally tolerated doses of statins, significantly reduced low-density lipoprotein cholesterol, the primary endpoint of the study.

$REGN {{ '2017-06-05T12:01:45+0000' | timeago}} • Announcement

$REGN and Sanofi announced positive preliminary results with investigational REGN2810 in patients with advanced cutaneous squamous cell carcinoma (CSCC). CSCC is the second most common type of skin cancer in the U.S.

$REGN {{ '2017-05-23T12:31:01+0000' | timeago}} • Announcement

$REGN said the U.S. Food and Drug Administration (FDA) approval of Kevzara (sarilumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease modifying antirheumatic drugs, such as methotrexate (MTX).

$REGN {{ '2017-05-08T12:57:32+0000' | timeago}} • Announcement

$REGN and SillaJen, Inc. announced a new clinical and supply agreement for a Phase 1b dose-escalation study in renal cell carcinoma. Under the terms of the agreement, the trial will be solely conducted and funded by SillaJen based upon a mutually developed study design and $REGN will provide REGN2810.

$REGN {{ '2017-05-08T12:56:18+0000' | timeago}} • Announcement

$REGN and SillaJen, Inc. announced a new clinical and supply agreement for a Phase 1b dose-escalation study in renal cell carcinoma. The open-label trial is expected to begin later this year, and is designed to evaulate the safety and efficacy of REGN2810 in combination with Pexa-Vec compared to treatment with REGN2810 as monotherapy.

$REGN {{ '2017-05-08T12:38:36+0000' | timeago}} • Announcement

$REGN and $INO announced a clinical study agreement for a phase 1b/2a immuno-oncology trial for glioblastoma combination therapy. Glioblastoma is the most common and aggressive type of brain cancer. The open-label trial is expected to begin later this year.

$REGN {{ '2017-05-04T19:05:59+0000' | timeago}} • Webcast

$REGN said that the FDA's advisory group had pushed the company to start a trial for younger populations even sooner than one might normally in the development program. The company added that it will move towards younger age groups steadily.

$REGN {{ '2017-05-04T12:17:34+0000' | timeago}} • Infographic

$REGN Regeneron Pharmaceuticals Earnings AlphaGraphics: Q1 2017 highlights

$REGN {{ '2017-05-04T11:15:52+0000' | timeago}} • Announcement

$REGN now sees FY17 capex at $300-350MM, with an effective tax rate of 32-38%. EYLEA U.S. net product sales are expected to grow in single-digit percentage over last year. Sanofi reimbursement of Regeneron commercialization-related expenses ae expected at $385-425MM, while non-GAAP SG&A is projected at $1.14-$1.20Bil for the year.

$REGN {{ '2017-05-04T11:07:43+0000' | timeago}} • Announcement

Total revenues of $REGN rose 10% to $1.32Bil in 1Q17, as the pharma company posted a 38% jump in net income of $249MM from last year's $181MM. Earnings hiked 36% to $2.16 per diluted share, as its EYLEA U.S. net product sales saw a 9% surge to $854MM for the quarter.

$REGN {{ '2017-04-28T16:21:45+0000' | timeago}} • Announcement

$REGN and Sanofi said the U.S. Food and Drug Administration has accepted the resubmission of the Biologics License Application for Kevzara (sarilumab) as a Class I response with a two month review timeline. Kevzara will treat moderately to severely active rheumatoid arthritis (RA).

$REGN {{ '2017-03-28T15:56:35+0000' | timeago}} • Announcement

$REGN and Sanofi said the U.S. Food and Drug Administration (FDA) approved Dupixent (dupilumab) Injection, the biologic medicine approved for the treatment of adults with moderate-to-severe atopic dermatitis (AD). AD, the most common form of eczema, is a chronic inflammatory disease with symptoms often appearing as a rash on the skin.

$REGN {{ '2017-02-09T19:49:08+0000' | timeago}} • Webcast

$REGN's adjusted R&D expenses were $404MM for 4Q16 and $1.64Bil for FY16. The company added that its adjusted unreimbursed R&D expenses came in below its 2016 guidance, driven by less spending than forecasted in the Sarilumab and Dupilumab programs and lower OpEx than forecasted in the Rensselaer manufacturing facility.

$REGN {{ '2017-02-09T19:37:17+0000' | timeago}} • Webcast

$REGN said that Eylea will continue to be a major revenue driver for the company over the years to come. In 2016, global net sales of Eylea exceeded $5Bil. The company added that it will continue its focus on the promotional efforts in the clinical efficacy and safety of Eylea.

$REGN {{ '2017-02-09T12:10:45+0000' | timeago}} • Announcement

$REGN's global net sales of EYLEA in 4Q16 increased 17% YoY to $1.35Bil, with sales in the U.S. growing 15% to $858MM. R&D expenses were $479MM in the quarter, an increase of 4% from a year ago.

$REGN {{ '2017-02-09T12:03:17+0000' | timeago}} • Announcement

For FY17, $REGN expects EYLEA U.S. net product sales to be in single digit percentage growth over 2016. CapEx for 2017 is expected to be in the range of $375-450MM.

$REGN {{ '2017-02-09T11:57:45+0000' | timeago}} • Announcement

$REGN reported a 63% YoY jump in its 4Q16 earnings to $253MM, or $2.19 per diluted share. On a non-GAAP basis, the company's earnings increased 36% to $3.04 per diluted share. Revenue for the quarter stood at $1.2Bil, an increase of 12% YoY.

$REGN {{ '2017-02-09T11:48:44+0000' | timeago}} • Announcement

$REGN and Sanofi announced that the United States Court of Appeals for the Federal Circuit has stayed (suspended) the permanent injunction for Praluent (alirocumab) Injection pending the companies' appeal. This ruling means that Sanofi and $REGN will continue marketing, selling and manufacturing Praluent in the U.S. during the appeal process.

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