Actionable news
All posts from Actionable news
Actionable news in REGN: Regeneron Pharmaceuticals, Inc.,

Regeneron: Form, Schedule Or Registration Statement No Filing Party: Date Filed: RELENTLESS INVENTION M E N U > C O N T E N T S 3 R E G E N E R O N AT A G L A NC E 4 S H A R EH O L D ER L E T T E

The following excerpt is from the company's SEC filing.

REGENERON AT A GL A NCE 5 YRS Ranked #1 or #2 employer in the global biopharmaceutical industry in Science 4 12 antibodies in clinical trials across multiple therapeutic areas ~3.5 MILLION doses of EYLEA® sold globally in 2015 FDA-approved medicines Top Employers Survey 5 years in a row 68 2,118 66 4 TH Most Innovative Company, according to Forbes peer-reviewed publications in 2015 organizations through Regeneron in the Community program volunteer hours at Regeneron employees worldwide consented individuals sequenced by the Regeneron Genetics Center annual reduction in greenhouse gas emissions per employee 2 0 1 5 A N N UA L R E P O R T 3 < M E N U >

DE A R SH A REHOLDERS, 2015 was a busy and rewarding year for Regeneron as we made major strides in advancing our mission of bringing important new medicines to people with serious diseases, over and over again. This year, for the first time, our Annual Report integrates reporting on our citizenship priorities and aspirations, in addition to our financial and business We delivered EYLEA® (aflibercept) Injection, our therapy for serious vision-threatening diseases, to more and more patients, and we launched PRALUENT® (alirocumab) Injection, a first-in-class therapy for uncontrolled performance. LDL cholesterol in certain patients. We invite you to read about our 2015 accomplishments, financial performance and citizenship efforts below and in our 2015 Annual Report on Form 10-K, available on the Investor Relations portion of our website. In the next few years, we anticipate additional approvals for a number of new therapies. In 2016, we look forward to potentially launching sarilumab for rheumatoid arthritis, pending U.S. Food and Drug Administration (FDA) review of our application. We also expect a potential U.S. regulatory submission for dupilumab in atopic dermatitis, a serious form of eczema, for which we have been granted a Breakthrough Therapy designation by the FDA. Unfortunately, there was also some sadness in 2015. Our longtime friend, mentor, co-founder and Board member, Dr. Alfred G. Gilman, passed away in December. Dr. Gilman was a Nobel Laureate who made lasting contributions to science and medicine. On a personal level, we all benefited greatly from Als counsel and wry wit over the years, and we will miss him greatly. Our pipeline of a dozen clinical-stage antibodies continues to progress, with important programs in eye disease, cancer, infectious disease, pain, cardiovascular disease and inflammation. We also continue to invest in technology and innovation that will position us to bring needed new medicines to patients for many years into the future. Likewise, we have made important infrastructure investments to ensure our long-term success, including adding two new buildings at our headquarters in Tarrytown, New York, and expanding our Industrial Operations facilities in Rensselaer, New York, and Raheen, Ireland. We look forward to updating you on our progress as we continue building Regeneron into a leading global biopharmaceutical company. Sincerely, Leonard Schleifer, MD, PhD Roy Vagelos, MD We have always run Regeneron by the principle of doing well by doing good. In addition to our work to invent new and needed medicines, we focus on improving our world and operating with the highest standards of integrity. George Yancopoulos, MD, PhD 2 0 1 5 A N N UA L R E P O R T 4 < M E N U >


EYLEA® (AFLIBERCEPT) INJECTION AND RETINAL DISEASE PROGRAMS Market-leading VEGF-Trap approved in more than 100 countries for the treatment of many blindness-causing retinal conditions, including wet age-related macular degeneration and diabetic macular edema (DME). E Y L E A U.S . S A L ES : 5 4% INCRE A SE $2.676 bn EYLEA net sales in the U.S. increased 54% to $2.676 billion for the full year of 2015, from $1.736 billion for the full year 2014. Outside of the U.S., where our collaborator Bayer HealthCare commercializes EYLEA, net sales were $1.413 billion in 2015, compared to $1.039 billion in 2014. Regeneron recognized $467 million from its share of net profit outside the U.S. in 2015, compared to $ 301 million in 2014. This growth was driven in part by the publication in early 2015 of first-year results from an independent National Institutes of Health (NIH) -sponsored comparative effectiveness study in DME. In the study, at one year, EYLEA demonstrated a significantly greater improvement in mean change in best-corrected visual acuity (BCVA) from baseline compared to ranibizumab and bevacizumab, two other VEGF inhibitors used in retinal disease. The rates of most ocular and systemic adverse events were similar across the three study groups. E Y L E A E X-U.S . S A L ES : 36 % INCRE A SE $1.413 bn $1.736 bn $1.409 bn $1.039 bn In 2016, we initiated a Phase 3 study of EYLEA in diabetic retinopathy in patients without DME, a common degenerative eye disease that impacts people with diabetes. We continue to explore EYLEA in combination with other mechanisms, and have two ongoing clinical programs in this area, aflibercept+PDGFR-beta and aflibercept+ANG2, in collaboration with Bayer HealthCare. $427.1 mm 2 0 13 20 1 4 2 0 15 2 0 13 20 1 4 2 0 15 2 0 1 5 A N N UA L R E P O R T 6 < M E N U >

PR ALUEN T ® ( ALIROCUMAB) IN JEC T ION Only monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) available in two doses, allowing for tailored therapy based on a patients LDL-C lowering needs. In July 2015, PRALUENT was approved by the FDA as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-C (often referred to as bad cholesterol). The effect of PRALUENT on cardiovascular morbidity and mortality has not been determined. Together with our collaborator Sanofi, the U.S. launch is underway. We have focused on physician education about this new class, as well as achieving patient access and reimbursement coverage from health plans. PRALUENT was also approved in the E.U., and launches are underway across the region. The ongoing ODYSSEY OUTCOMES clinical trial program, which is evaluating the potential of PRALUENT to prevent heart attacks, stroke and cardiac death, reached full enrollment in 2015, with more than 18,000 patients at more than 2,000 study centers. Interim results are possible in late 2016, and we expect full results in 2017. ODY SSE Y OU T COMES 2 0 1 5 A N N UA L R E P O R T 7 < M E N U >


PIPELINE (as of April 2016) Regeneron has a dozen fully human monoclonal antibodies in clinical development, all of which were developed using our proprietary VelocImmune® technology. P H A S E 1 P H A S E 2 P H A S E3 REGN1979 CD20/CD3 Antibody Cancer DUPILUMAB* IL-4R Antibody Atopic dermatitis in children, nasal polyps, eosinophilic esophagitis EVINACUMAB Angptl3 Antibody Lipid disorders ALIROCUMAB* PCSK9 Antibody Cardiovascular outcomes REGN1908-1909 Allergic disease REGN910-3^ Nesvacumab (Ang2 Antibody) + Aflibercept Ophthalmology AFLIBERCEPT^ VEGF-Trap Diabetic retinopathy without DME SARILUMAB* IL-6R Antibody Non-infectious uveitis SARILUMAB* IL-6R Antibody Rheumatoid arthritis TREVOGRUMAB GDF8 Antibody Skeletal muscle disorders REGN2810* PD-1 Antibody Cancer DUPILUMAB* IL-4R Antibody Atopic dermatitis in adults, asthma FASINUMAB NGF Antibody Chronic lower back pain REGN2176-3^ Rinucumab (PDGFR-beta Antibody) + Aflibercept Wet age-related macular degeneration REGN2222 RSV Antibody Respiratory syncytial virus FASINUMAB NGF Antibody Pain due to osteoarthritis * in collaboration with Sanofi ^ in collaboration with Bayer HealthCare in collaboration with Mitsubishi Tanabe 2 0 1 5 A N N UA L R E P O R T 9 < M E N U >

SARILUMAB An anti-IL-6 monoclonal antibody under U.S. regulatory review for the treatment of rheumatoid arthritis (RA). U N M E T N E E D IN R H E U M AT O ID A R T H R I T IS R E M A IN S In 2015, we reported positive data from three Phase 3 trials of sarilumab in patients with rheumatoid arthritis. Together with our collaborator, Sanofi, we submitted the U.S. Biologics License Application in November 2015 and were assigned a Prescription Drug User Fee Act (PDUFA) date of October 30, 2016. R A IMPA C T S MORE T H A N 1.3 MILLION A MERICA NS 1 In March 2016, the Phase 3 SARIL-RA-MONARCH monotherapy study met its primary endpoint by demonstrating that sarilumab was superior to adalimumab (Humira®) in improving signs and symptoms of active RA at Week 24. The incidence of adverse events, serious adverse events, infections and serious infections was generally similar between groups. While significant strides have been made in the treatment of RA, there are continued unmet needs A central driver of the destructive effects of RA in the joints is persistently elevated levels of IL-6, a signaling protein in the body.2-5 At normal levels, IL-6 is responsible for contributing to the healing process after injury or infection.3,6-7 However, at persistently raised levels, IL-6 triggers inflammation that can destroy bone and cartilage5,8-12 IL-6 may also contribute to the multiple systemic effects of RA, including fatigue, anemia and bone density loss2 2 0 1 5 A N N UA L R E P O R T 10 < M E N U >

DUPILUM A B A first-in-class investigational monoclonal antibody blocking IL-4 and IL-13, two key cytokines believed to be drivers in allergic inflammation. AT O P I C D E R M AT I T IS : U N M E T N E E D IN A D E V A S TAT IN G A N D M I S U N D E R S T O O D D I S E A S E Dupilumab is being studied for the treatment of certain allergic conditions, including atopic dermatitis (AD), uncontrolled asthma, nasal polyps and eosinophilic esophagitis. A P P ROX IM AT ELY 1.6 MILLION U.S. A DULT S A RE E S T IM AT ED T O H AV E UNCON T ROL L ED MODERATE -T O - SE V ERE AT OP IC DERM AT I T IS 13 Dupilumab was granted a Breakthrough Therapy designation by the FDA for the treatment of adults with moderate-to-severe atopic dermatitis who are not adequately controlled with topical prescription therapy and/or for whom these treatments are not appropriate. We expect to submit an application for FDA approval later this year. In 2016, we reported positive topline results from two large Phase 3 studies in atopic dermatitis and continue to enroll patients in a second pivotal study in asthma. In the atopic dermatitis studies, the overall rate of adverse events was comparable between the dupilumab groups and the placebo groups. Currently, only topical therapies have been approved by the FDA Systemic immuno-suppressants are used off-label, but can have significant side effects 2 0 1 5 A N N UA L R E P O R T 11 < M E N U >

REGN2222 A fully human monoclonal antibody being investigated for the prevention of serious lower respiratory tract infections associated with Respiratory Syncytial Virus (RSV). FASINUM A B An antibody targeting nerve growth factor being evaluated for the potential to offer a novel, non-opioid approach to addressing chronic pain. Two clinical trials of fasinumab for pain due to osteoarthritis and chronic back pain were initiated in 2016. In 2015, we entered into a collaboration with Mitsubishi Tanabe Pharma Corporation to develop and commercialize fasinumab in Japan, Korea and nine other Asian countries (excluding China). In 2015, we initiated the Phase 3 NURSERY-Pre-term trial that will evaluate the efficacy, safety, pharmacokinetics and immunogenicity of REGN2222 in infants under the age of six months. U N M E T N E E D IN A V U LN E R A BLE PO P U L AT I O N 1 IN 5 INFA N T S UNDER 6 MON T HS W IL L RE QUIRE MEDIC A L AT T EN T ION F OR RS V14 U N M E T N E E D IN C H R O N I C P A I N A P P ROX IM AT ELY 50 MILLION U.S. A DULT S SUF F ER F ROM SIGNIF IC A N T CHRONIC OR SE V ERE PA IN 15 2 0 1 5 A N N UA L R E P O R T 12 < M E N U >


IMMUNO - ONCOLOGY R A PID RESPONSE + INFEC T IOUS DISE ASE Building on our existing Sanofi antibody collaboration, we launched a new $2.2B global immuno-oncology collaboration with Sanofi. Regenerons Rapid Response capabilities leverage our core VelociSuite® technologies to significantly compress the time required for discovery and preclinical validation of potential treatments for emerging infectious diseases. This new undertaking will provide important new resources to advance our portfolio in this rapidly developing field, which seeks to harness the bodys immune system to fight cancer. In 2015, we identified and validated a novel therapeutic cocktail of three antibodies targeting the Ebola virus, and reached an agreement with the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services to develop, test and manufacture this potential treatment. A Phase 1 study in healthy volunteers is planned for the first half of 2016. We similarly identified and validated an antibody against MERS (Middle East Respiratory Virus) and are working to advance this program, as well as pursuing antibody therapies for other devastating viral diseases such as Zika and Dengue. We continued to explore multiple approaches in immuno-oncology, including bispecific antibodies, checkpoint inhibitors and antibody drug conjugates. We have two antibodies, a CD20/CD3 bispecific antibody and a PD-1 inhibitor, in clinical studies with data expected in 2016. A number of additional immuno-oncology antibodies are expected to enter the clinic this year and next. 2 0 1 5 A N N UA L R E P O R T 14 < M E N U >

REGENERON GENE T ICS CEN T ER In its second full year, the Regeneron Genetics Center (RGC) continued to grow rapidly in terms of scope, scale and speed. The RGC was created to elucidate, on a large scale, genetic factors that cause or influence a range of human diseases. The team has sequenced over 100,000 exomes to date, and is now delivering new target opportunities and validating existing targets in our preclinical and clinical programs. We continued to bring world-class collaborators from industry, academia and leading health-systems on board, and published the RGCs first peer-reviewed publication in the New England Journal of Medicine. 2 0 1 5 A N N UA L R E P O R T 15 < M E N U >


GROW T H In 2015, we grew in many aspects of our business. We continued construction of our world-class, 400,000-square-foot manufacturing facility in Limerick, Ireland, which will significantly expand our biologic supply capabilities for commercial products. We opened new buildings in our Rensselaer Industrial Operations headquarters and our Tarrytown R&D laboratories and corporate headquarters. And we welcomed our 4,000th Regeneron employee, all while remaining focused on sustaining the innovative culture that makes us unique. RE V ENUE $4.104 bn FUL L-T IME EMPL OY EES R & D INVES T MEN T * $1.621 bn 4,300 (650 with PhD and/or MD or PharmD) $1.271 bn $2.820 bn 46 % incr ease 47% incr ease 28 % incr ease 2,925 $860 mm $2.105 bn 2,340 * Generally Accepted Accounting Principles R&D Expenses 2 0 13 20 1 4 2 0 15 2 0 13 20 1 4 2 0 15 2 0 13 20 1 4 2 0 15 2 0 1 5 A N N UA L R E P O R T 17 < M E N U >


of scientific COMMI T T ED T O A BE T T ER FU T URE In addition to our work to invent new and needed F O S T E R ING medicines, we are focused on improving our world the fu ture and operating with the highest standards of innovation integrity. We are proud not only of what we do, but how we do it. These four pillars help us articulate how we view our responsibility and commitment to society: NURT URI N G our C U LTIVATIN G high-engagement, sus t ainable high-integrit ycommunities cult ure S U P P ORT I NG patient communities