Amgen 2019: Building capacity to innovate and grow
Amgen continues to set the stage for the future after a record-setting 2018, strengthening the company’s long-term ability to innovate, compete and grow.
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All sales are in millions of dollars.
All figures are in millions of dollars, except EPS.
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All figures are in millions of dollars, except EPS.
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MM&M Awards – 9
Global Awards – 1
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Amgen’s total revenue performance during 2018 was a record setter for the company, growing 4 percent to nearly $23.75 billion. Amgen additionally achieved a company-high non-GAAP earnings per share of $14.40, up 14 percent compared to the prior year, along with free cash flow of $10.6 billion, another record.
“Our achievements in 2018 capped a five-year period of intense transformation during which we met or exceeded the ambitious financial commitments that we made to our shareholders,” states Amgen Chairman and CEO Robert Bradway.
“During our transformation, we generated approximately $1.9 billion in gross cost savings that we redeployed into our business while embedding a set of productivity capabilities throughout our organization,” Bradway continues. “These capabilities open new options for Amgen’s business as we have built foundational flexibility in what is a highly dynamic operating environment.”
Amgen executives say innovation continues to be the lifeblood of the company’s business. During the past five years, Amgen invested almost $19 billion in R&D and, as a result, the company is advancing a company-record amount of clinical assets through the pipeline. The R&D portfolio includes an oncology pipeline with 20 molecules.
The late-stage pipeline for Amgen includes the first-in-class biologic tezepelumab for treating severe asthma. The U.S. FDA has granted Breakthrough Therapy Designation for tezepelumab in a significant subset of asthma patients – those without an eosinophilic phenotype.
During the five-year transformation period completed during 2018, Amgen’s research and development pipeline yielded nine approved and launched products. This group includes two in new therapeutic areas for Amgen: Repatha in cardiovascular disease (introduced to the marketplace during 2015) and Aimovig in neuroscience (launched during 2018 in collaboration with Novartis AG).
2019 Performance & Outlook
Amgen’s total product sales during the first six months of 2019 decreased 1 percent to $10.86 billion compared to first-half 2018. The year-over-year sales decline was driven primarily by a decrease in net selling price and unfavorable changes in inventory, offset partially by higher unit demand. For second-half 2019, Amgen expected a lower net selling price to continue compared with 2018. Total revenue for the 2019 first half fell 2 percent to $11.43 billion, driven primarily by lower milestone payments and offset partially by higher royalties.
In announcing Amgen’s first-half 2019 results, the company reported that the full-year total revenue guidance was revised to $22.4-$22.9 billion (previously $22.0 billion-$22.9 billion). EPS guidance was updated to $12.10-$12.71 (previously $11.68-$12.73) on a GAAP basis and $13.75-$14.30 (previously $13.25-$14.30) on a non-GAAP basis.
The company’s top-selling medicines during the first six months of 2019 were Enbrel ($2.51 billion, up 4 percent versus same-time 2018), Neulasta ($1.85 billion, decreasing 18 percent year-over-year), Prolia ($1.29 billion, growing 17 percent compared to the drug’s January-June 2018 performance), XGEVA ($970 million, an 8 percent improvement), Aranesp (down 8 percent to $850 million), Kyprolis (growing 6 percent year-over-year to $512 million), and Epogen (decreased 11 percent to $494 million).
Therapeutic Product Approvals/Launches & Pipeline Updates During 2019
Evenity was approved by the U.S. Food and Drug Administration and launched in April for treating osteoporosis in postmenopausal women at high risk for fracture. Evenity represents the first bone builder with a unique dual effect that both increases bone formation and to a lesser extent reduces bone resorption (or bone loss) to rapidly reduce the risk of fracture.
The humanized monoclonal antibody is designed to work by inhibiting the activity of sclerostin, which simultaneously leads to increased bone formation and to a lesser extent decreased bone resorption. The Evenity development program includes 19 clinical trials that enrolled more than 14,000 patients. The product has been evaluated for the drug’s potential to reduce the risk of fractures in an extensive worldwide Phase III program that included two large fracture studies comparing Evenity to either placebo or active comparator in nearly 12,000 postmenopausal women with osteoporosis.
Amgen and UCB S.A. are jointly developing Evenity via a worldwide collaboration. Astellas Pharma Inc. is Amgen’s strategic alliance partner for Evenity in Japan through the companies’ Amgen Astellas BioPharma joint venture.
Evenity (romosozumab-aqqg) was granted marketing approval during January in Japan for treating osteoporosis in patients at high risk of fracture.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency during June adopted a negative opinion on the Marketing Authorization Application for Evenity as a treatment of severe osteoporosis. During July, UCB filed a written notice to the European Medicines Agency requesting a re-examination of the CHMP opinion.
Amgen reported positive results in September from two Phase III Blincyto (blinatumomab) trials in pediatric patients with relapsed acute lymphoblastic leukemia. The Phase III ‘215 and Children’s Oncology Group (COG) studies were both stopped early due to the medicine’s treatment benefit of over chemotherapy.
Blincyto is a bispecific CD19-directed CD3 T cell engager (BiTE) antibody construct, which binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells. BiTE antibody constructs are a type of immunotherapy being studied for combating cancer by helping the body’s immune system to detect and target malignant cells.
The medicine has been granted breakthrough therapy and priority review designations by the U.S. FDA. Blincyto is available in the United States for treating: relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children; and B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children.
The European Commission approved Blincyto in January in patients with Philadelphia chromosome negative minimal residual disease-positive B-cell precursor ALL. Blincyto represents the first therapy for minimal residual disease approved in the European Union. Marketing clearance was based on data from the Phase II BLAST trial, the largest prospective study in minimal residual disease-positive ALL.
Amgen reported during September that the Phase III CANDOR trial combining Kyprolis (carfilzomib) and Darzalex (daratumumab) met the study’s primary endpoint of progression-free survival. CANDOR marks the first Phase III trial combining those two medicines, which represent two critical mechanisms of action in treating multiple myeloma. Compared to Kyprolis and dexamethasone alone (Kd), treatment with the Kyprolis-Darzalex (KdD) regimen resulted in a 37 percent reduction in the risk of progression or death in patients with relapsed or refractory multiple myeloma.
Kyprolis won initial FDA approval in 2012, with more than 130,000 patients worldwide having received the medicine. Kyprolis is FDA-approved in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy, and as a single agent for treating relapsed or refractory multiple myeloma who have received one or more lines of therapy. Johnson & Johnson’s Darzalex (daratumumab) is the first CD38-directed antibody approved anywhere worldwide and is the only available medicine from that drug class marketed for the treatment of multiple myeloma.
The Phase III GALACTIC-HF cardiovascular outcomes clinical study for the novel, selective cardiac myosin activator omecamtiv mecarbil completed enrollment in July. During March, Amgen, Cytokinetics Inc. and Servier announced that the Data Monitoring Committee (DMC) for GALACTIC-HF had completed the first planned interim analysis, which included consideration of pre-specified criteria for futility. The DMC reviewed data from GALACTIC-HF and recommended that the Phase III study of omecamtiv mecarbil continue without changes to the clinical trial’s conduct.
Omecamtiv mecarbil is being developed via a collaboration between Amgen and Cytokinetics, with funding and strategic support provided by Servier. GALACTIC-HF opened to enrollment during late 2016 and is designed to enroll 8,000 patients in more than 35 countries who are either currently hospitalized for a primary reason of heart failure or have had a hospitalization or admission to an emergency room for heart failure within one year prior to screening. The study is designed to assess whether treatment with omecamtiv mecarbil, when added to standard of care, reduces the risk of heart failure events (heart failure hospitalization and other urgent treatment for heart failure) and cardiovascular (CV) death in patients with chronic heart failure with reduced ejection fraction.
The second Phase III study of omecamtiv mecarbil began in February. METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure) is designed to test the effect of treatment with omecamtiv mecarbil versus placebo on exercise capacity as determined by cardiopulmonary exercise testing (CPET) in patients with heart failure with reduced ejection fraction (HFrEF).
For the most prescribed anti-CGRP therapy Aimovig, Amgen revealed long-term efficacy and safety data across the spectrum of migraine at the 2019 meetings of the American Academy of Neurology and American Headache Society. The data showed that after long-term Aimovig treatment, two-thirds of chronic migraine patients converted to episodic migraine, experiencing 11 fewer migraine days per month on average. A separate study demonstrated the majority of episodic migraine patients on Aimovig reported at least a 50 percent reduction in monthly migraine days at one year, with one in five being completely migraine-free.
Aimovig is the only FDA-approved medicine specifically developed to prevent migraine by blocking the CGRP-R, which is associated with migraine. The product has been studied in several large global, randomized, double-blind, placebo-controlled trials to evaluate Aimovig’s efficacy and safety in migraine prevention. More than 3,000 patients have participated in the Aimovig clinical program across four placebo-controlled Phase II and Phase III trials and their open-label extensions.
More than 200,000 U.S. patients have been prescribed Aimovig since the drug’s market introduction. The product is developed in collaboration with Novartis.
AMG 510 is a novel molecule being developed by the company to target KRAS G12C-mutant solid tumors. The first clinical data results for AMG 510 were provided by Amgen during June, including tumor responses in colorectal and appendiceal cancer patients, completion of enrollment in the dose expansion arm and enrollment initiation in the checkpoint inhibitor combination arm of the first-in-human study. Initiation of a potentially registrational monotherapy study was expected during 2019.
Amgen revealed new data in September from the Phase I study evaluating AMG 510 in patients with previously treated KRAS G12C-mutant solid tumors. Included in the clinical data was the first evidence of anti-tumor activity reported in patients with colorectal cancer (CRC) and appendiceal cancer, as well as previously presented non-small cell lung cancer (NSCLC) findings. According to the company, AMG 510 continues to be well-tolerated with no dose-limiting toxicities. These data were presented during a poster discussion at the European Society for Medical Oncology (ESMO) 2019 Congress.
“KRAS is the most frequently mutated oncogene in human tumors. Although KRASG12C has been a formidable target for nearly four decades, we can now report responses in patients with non-small cell lung, colorectal and appendiceal cancers,” states David M. Reese, M.D., executive vice president of R&D at Amgen. “We are encouraged by these early results, particularly since these patients have progressed after receiving a median of four prior therapies, and in some cases as many as 10. The data suggest there are relevant molecular differences between tumor types. We are initiating combination studies to further explore the potential of AMG 510 in lung and colorectal tumors.”
Amgen announced plans in March to conduct VESALIUS-CV, a multinational clinical outcomes study for Repatha (evolocumab). The clinical trial will involve at least 13,000 patients globally at high risk of experiencing a first cardiovascular (CV) event, despite optimized treatment with lipid-lowering therapy. The study is the first to investigate long-term outcomes in this patient population with Repatha for a minimum of four years.
The human monoclonal antibody Repatha inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). The drug binds to PCSK9 and inhibits circulating the enzyme from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and allowing LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the amount of LDLRs available to clear LDL from the blood, thereby reducing LDL-C levels.
Repatha is cleared for marketing in 60-plus countries, including the United States, Japan, Canada and in all 28 EU member countries. During January, Amgen garnered NMPA approval for Repatha in China to reduce the risk of cardiovascular events. Regulatory applications in other countries are awaiting approval. Additionally in January, Amgen made all Repatha device options available in the United States at a 60 percent reduced list price.
2019 Acquisitions, Deals & Partnerships
Amgen bolstered the product portfolio in August by acquiring the worldwide rights to the blockbuster medicine Otezla from Celgene Corp. in connection with that company’s previously announced merger with Bristol-Myers Squibb Co. Approved for U.S. marketing during 2014, Otezla (apremilast) represents the only oral, non-biologic treatment for psoriasis and psoriatic arthritis. Amgen obtained the global rights to Otezla along with certain related assets and liabilities for $13.4 billion in cash, or $11.2 billion net of the present value of $2.2 billion in anticipated future cash tax benefits.
Otezla is the leading treatment in the post-topical, pre-biologic segment in the drug’s approved indications. The medicine has been approved by the FDA for three indications: the treatment of patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy; adult patients with active psoriatic arthritis; and adults with oral ulcers associated with Behçet’s Disease. Otezla is approved in more than 50 countries and has U.S. patent exclusivity through at least 2028. The product generated 2018 global sales of $1.6 billion, driven by strong volume growth.
Amgen management believes that the acquisition of the innovative therapy Otezla will strengthen the company’s inflammation portfolio for patients around the globe. Company executives believe other benefits from the acquisition include: at least low double-digit Otezla sales growth, on average, over the next five years; acceleration of Amgen’s near- and long-term revenue growth; immediate non-GAAP EPS accretion; and support of increased R&D investment during 2020 to advance Amgen’s innovative pipeline of first-in-class molecules.
Amgen completed the acquisition of Nuevolution AB during July and is rapidly integrating that company’s world-class DNA-encoded library and other technologies. On May 22, Amgen announced a recommended public cash offer to the shareholders of Nuevolution to tender all their shares in that company to Amgen for SEK 32.50 per share in cash. During the initial acceptance period, which ended on July 4, Nuevolution shareholders representing 97.6 percent of the total amount of issued and outstanding shares and votes in Nuevolution had accepted the offer.
A broad collaboration was agreed upon in June by Amgen with the University of Washington’s Institute for Protein Design (IPD), which is revolutionizing the non-profit research center’s field of science by creating custom-designed proteins from scratch to improve human health. The unique strategic research partnership will cover multiple projects with a goal of testing new technologies and creating protein-building approaches that can be broadly applied to the search for new medicines.
Amgen has provided initial funding for three sponsored research projects intended to apply IPD’s de novo design technique to increase the versatility of traditional protein-based medicines. This includes optimizing Amgen’s repertoire of BiTE (bispecific T cell enager) antibodies, with the goal of expanding the types of tumors that can be targeted with those molecules. IPD’s expertise could additionally help the company to generate antibodies against very challenging drug targets and to devise new ways to modulate the activity of the immune system. In the longer term, the broad-based collaboration could help form the discovery and development of protein-based therapies.
A worldwide collaboration was announced during June that combines Intermountain Healthcare’s internationally recognized expertise in precision medicine and clinical care with deCODE genetics Inc.’s world-class expertise in human population genetics. The study involves the analysis of genomes of up to 500,000 individuals. The study marks the largest DNA mapping effort undertaken in the United States from a single population, primarily in Utah and Idaho. deCODE is a wholly owned subsidiary of Amgen based in Iceland.
The Amgen Community Oncology Research Collaborators (ACORC) debuted during May. The new initiative is intended to enhance access by community centers to innovative oncology clinical research. Less than one in 20 adult cancer patients in the United States have participated in a clinical study. The collaboration in conjunction with leading community oncology networks allows Amgen to significantly expand the company’s clinical research footprint to more than 200 U.S. patient care sites. ACORC will help community centers reach more than 900,000 new patients each year with investigational medicines.
Amgen and Syapse, a company powering precision medicine insights via its global provider network, unveiled a precision medicine collaboration in oncology during May. The companies will develop observational research analytics to evaluate treatment outcomes for areas of unmet need in oncology. This effort will identify existing patients within the Syapse Learning Health Network that could be eligible for Amgen-sponsored studies and seek to bring these clinical trials to community health system sites. Amgen and Syapse will create opportunities for physicians and researchers within the Syapse Network to gain access to analytics, real-world evidence-based insights, and collaborative research opportunities. Amgen has access to real-world evidence for potential use in regulatory submissions in support of certain agreed-upon development candidates in oncology. Amgen is additionally working with Syapse to develop real-world evidence standards to support the acceleration of therapies to the marketplace.
Biosimilar Progress During 2019
Amgen has a total of 10 biosimilars in the company’s portfolio, three of which have been approved for marketing in the United States. “Several years ago, Amgen made the strategic decision to invest in building a global biosimilars business, leveraging our nearly four decades of experience in developing and manufacturing best-in-class biologics,” states Murdo Gordon, executive VP of Global Commercial Operations at Amgen. “Following several recent launches in Europe, we are excited to be launching our first two biosimilars in the U.S., which will provide for immediate savings for Medicare patients and commercial payers. We have several more biosimilars advancing through our pipeline, even as we continue to drive innovation through novel therapies for cancer and other serious diseases.”
Amgen and Allergan plc during July launched in the United States MVASI (bevacizumab-awwb), which is a biosimilar to Roche/Genentech’s blockbuster drug Avastin (bevacizumab), and Kanjinti (trastuzumab-anns), a biosimilar to Roche/Genentech’s best-seller Herceptin (trastuzumab). MVASI represents the first oncology therapeutic biosimilar approved by the U.S. Food and Drug Administration. The biosimilar is approved for treating five types of cancer: in combination with chemotherapy for metastatic colorectal cancer (mCRC); in combination with chemotherapy for non-squamous NSCLC; recurrent glioblastoma; in combination with interferon-alfa for metastatic renal cell carcinoma; and in combination with chemotherapy for persistent, recurrent or metastatic cervical cancer.
Kanjinti represents the third FDA approval to emerge from Amgen’s biosimilars portfolio. Kanjinti was cleared for U.S. marketing in June for all approved indications of the blockbuster Herceptin: for treating HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
Amgen and Allergan reported positive top-line clinical results in August from a comparative study of ABP 798, which is a biosimilar candidate to Roche/Genentech’s blockbuster anti-cancer agent Rituxan (rituximab). The clinical trial assessed the efficacy and safety of ABP 798 compared to Rituxan in patients with CD20-positive B-cell non-Hodgkin’s lymphoma. The primary endpoint – an assessment of overall response rate (ORR) by week 28 – was within the prespecified margin for ABP 798 compared to Rituxan, demonstrating clinical equivalence. Safety and immunogenicity of ABP 798 were comparable to Rituxan.
This is the second of two studies intended to support regulatory filings for ABP 798. The first was carried out in patients with moderate-to-severe rheumatoid arthritis (RA) and met the primary endpoint of pharmacokinetic similarity, as reported in January. This RA study showed clinical equivalence within the prespecified efficacy margin, and a similar safety and immunogenicity profile.
Amgen announced that the U.S. regulatory agency set a Dec. 14, 2019, Biosimilar User Fee Act target action date for ABP 710’s Biologics License Application. ABP 710 is a biosimilar candidate to Johnson & Johnson’s blockbuster medicine Remicade (infliximab), which is approved in many regions for treating moderate to severe rheumatoid arthritis, chronic severe plaque psoriasis, moderate to severe Crohn’s disease, moderate to severe ulcerative colitis, psoriatic arthritis and ankylosing spondylitis.