The pioneering spirit of Amgen – a hallmark for four decades – gives management confidence that the company can play an increasingly significant role in the global healthcare ecosystem.
By Andrew Humphreys • [email protected]
One Amgen Center Drive
Thousand Oaks, CA 91320-1799
(All figures are in millions of dollars, except EPS)
Net income $7,842
Diluted EPS $12.88
R&D expense $4,116
Net income $3,628
Diluted EPS $6.12
R&D expense $1,916
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(All sales are in millions of dollars)
Note: Otezla was acquired in November 2019.
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2020 marks the 40th anniversary of Amgen. The company was founded as Applied Molecular Genetics (later shortened to Amgen) on April 8, 1980, in Thousand Oaks, California, to explore new business opportunities made possible by the biotech revolution getting under way during that time. Fast-forward to 2020, and Amgen ranks among the largest companies on the Fortune 500, with more than 23,000 employees in 100 countries.
“We are proud of what we have accomplished – and eager to do more,” says Robert A. Bradway, chairman and CEO of Amgen. “We know that an aging global population will require innovative new treatments for illnesses like cancer and heart disease that claim millions of lives and cost society hundreds of billions of dollars each year.”
More than $4.1 billion was invested in the company’s R&D during 2019, up 10% from the previous year, as Amgen advanced numerous potential new medicines across all stages of the company’s pipeline.
Amgen’s total revenue declined 2 percent to $23.36 billion in 2019 as double-digit, volume-driven growth of many of the company’s newer medicines did not fully offset the decrease in sales of off-patent legacy products, which faced increased competition globally. Non-GAAP earnings per share grew 3 percent to a company-record $14.82. Amgen achieved a non-GAAP operating margin of 50.2%, among the highest in the industry, reflecting the company’s ability to manage efficiency and ongoing productivity gains.
Amgen delivered a total shareholder return of 28 percent for 2019, exceeding the 19 percent average return of the company’s peer group. Amgen’s five-year total shareholder return of 73 percent also outpaced the average return of the peer group, which delivered a 46 percent return over the same time period, according to management.
Amgen is on a track to generate a company-record sales year during 2020 despite the impact of the COVID-19 pandemic. Bradway says Amgen’s anticipated resurgence and return to top-line growth in 2020 is being driven by several factors, including recently launched products, ongoing global expansion, a robust pipeline of potential new medicines and the acquisition of Otezla from Celgene.
Amgen further bolstered the company’s product portfolio during 2019 via the $13.4 billion acquisition of Otezla, the first oral, non-biologic treatment for psoriasis and psoriatic arthritis. “Otezla bolsters our existing inflammation franchise, which includes Enbrel, our largest product,” Bradway stated. “Otezla sales in 2019 totaled nearly $2 billion, with Amgen booking $178 million of these sales following the close of the acquisition in late November. We acquired the global rights to Otezla, which is approved in more than 50 countries, including Amgen’s 10 largest markets. Through the acquisition, we also welcomed more than 800 new employees to Amgen and haven’t missed a beat for the more than 400,000 patients worldwide who have been treated with Otezla. We expect this product to be a key growth driver for us in 2020 and beyond.”
Amgen management is “especially excited by our prospects in China and Japan, the world’s second- and third-largest pharmaceutical markets, respectively.” During January 2020, as part of a 2019 collaboration, Amgen acquired a 20.5 percent ownership stake in BeiGene Ltd. for $2.8 billion. The China-based biotech company is expected to contribute up to $1.25 billion to advance 20 medicines from Amgen’s innovative oncology pipeline. “We will use data generated from clinical trials in China to support regulatory filings in that country and around the world,” Bradway says. “Additionally, BeiGene will commercialize select current and future Amgen oncology medicines in China for up to seven years, after which most of these medicines will return to Amgen.”
During 2020, Amgen assumed full ownership of the Amgen Astellas BioPharma K.K. joint venture, enabling the company to do business in Japan through a wholly owned Amgen subsidiary.
2020 Performance & Outlook
Total revenue for Amgen during second-quarter 2020 rose 6 percent year-over-year to $6.2 billion, driven by higher unit demand, offset partially by lower net selling prices. Product sales grew 6 percent worldwide, fueled by 13 percent volume growth across various newer products – including Otezla (apremilast), Mvasi (bevacizumab-awwb), Kanjinti (trastuzumab-anns), Evenity (romosozumab-aqqg) and Repatha (evolocumab) – offset partially by decreases in select products from the impact of COVID- 19 as well as biosimilar and generic competition.
Amgen’s GAAP earnings per share for second-quarter 2020 fell 15 percent versus the one-year-earlier period to $3.05, driven primarily by the amortization of costs associated with the company’s November 2019 acquisition of Otezla, offset partially by increased revenue. According to Amgen, this is the first quarterly period to include the company’s share of BeiGene’s net loss under the equity method of accounting. Non-GAAP EPS rose 7 percent to $4.25, spurred by increased revenues and fewer weighted-average shares outstanding while also taking into account Amgen’s share of BeiGene’s net loss for the previous quarter.
Amgen generated $2.7 billion of free cash flow during April-June 2020 compared to $1.3 billion in second-quarter 2019, an increase driven primarily by the timing of tax payments.
Amgen executives say the COVID-19 pandemic interrupted many physician-patient interactions, which resulted in delays in diagnosis and treatment with varying degrees of impact across the company’s portfolio. Sales of negatively affected products fell most early during the second quarter of 2020 with sales starting to recover in the latter weeks of the April-June period. “As the quarter progressed, our teams increasingly responded to customer needs via remote interactions and also identified innovative solutions to support the delivery of patient care,” company management says. “Our medicines were reliably supplied to patients throughout the quarter.”
For first-half 2020, the company reported total revenue of nearly $12.37 billion versus almost $11.43 billion in the previous year’s first half. Net income for basic and diluted earnings per share reached almost $3.63 billion compared to $4.17 billion in January-June 2019. Amgen reported diluted earnings per share of $6.12, down from $6.75 in first-half 2019.
Total product sales grew during the six-month period ended June 30, 2020, driven primarily by unit demand increases from newer brands including Otezla, Mvasi, Kanjinti, Evenity, and Repatha. According to the company, these unit demand increases were offset partially by declines in net selling prices for certain products, as well as unit demand declines for mature brands that face biosimilar or generic competition. For the remainder of 2020, Amgen management expected continued competition against the company’s mature brands to result in both unit demand and net selling price declines.
For full-year 2020, total revenue guidance was reaffirmed by company management as of July at $25-$25.6 billion. EPS guidance was revised by Amgen to $10.73-$11.43 on a GAAP basis and revised to $15.10-$15.75 on a non-GAAP basis.
According to Amgen, the company’s principal products – those with the most significant annual commercial sales – are Enbrel (etanercept), Prolia (denosumab), Neulasta (pegfilgrastim), Otezla, Xgeva (denosumab), Aranesp (darbepoetin alfa), Kyprolis (carfilzomib), and Repatha.
Leading the global sales charge during the first six months of 2020 was Enbrel at about $2.4 billion, representing a 5 percent decrease compared to the first-half 2019 total. Enbrel sales for second-quarter 2020 declined 9 percent year-over-year, driven by lower unit demand. Amgen management says consistent with prior periods, Enbrel continued to lose share and the effects of such share loss were compounded by lower growth of the rheumatology segment because of COVID-19.
During July 2020, the U.S. Court of Appeals for the Federal Circuit affirmed the judgment of the New Jersey District Court upholding the validity of the two patents that describe and claim Enbrel and methods for making the product. The appellate court affirmed an August 9, 2019 decision by the U.S. District Court for the District of New Jersey that had upheld the validity of two patents asserted against Sandoz Inc., Sandoz International GmbH and Sandoz GmbH based on Sandoz’s biosimilar of Enbrel.
Prolia sales for the January-June 2020 period rose 2 percent year-over-year to $1.31 billion. The product’s April-June 2020 sales fell 6 percent year-over-year, driven by lower unit demand as a result of fewer office visits by osteoporosis patients, a population that is generally older and more vulnerable to COVID-19.
Sales for Neulasta fell 35 percent to $1.2 billion versus the first-half 2019 amount. Second-quarter 2020 Neulasta sales were down versus the same-time 2019 period, driven by the impact of biosimilar competition on net selling price and unit demand. Amgen says unit volumes for the overall long-acting granulocyte colony-stimulating factors (G-CSFs) segment grew, supported by the NCCN guidelines, revised in response to COVID-19 recommending increased use of long-acting G-CSFs in intermediate risk febrile neutropenia cancer patients. Within the long-acting G-CSF segment, Neulasta Onpro continues to be the preferred choice for physicians and patients with share increasing to 58 percent during the second quarter. According to Amgen, Onpro has provided a unique value proposition during the pandemic as the product allows patients to receive their G-CSF treatment without having to return to their doctor’s office for administration.
Otezla was Amgen’s No. 4 seller during the first half of 2020 with sales of $1.04 billion. The medicine generated $561 million of sales in the second quarter of 2020, reflecting 14 percent growth year-over-year driven primarily by volume. U.S. Otezla TRx growth remained strong during the second quarter, Amgen management says. “Although NBRx volumes were negatively impacted by COVID-19 early in the quarter, trends have improved since then. From a competitive standpoint, Otezla’s NBRx share of the psoriasis segment grew slightly in the quarter. Otezla provides a convenient oral option with an established safety profile and does not require lab monitoring, making it an attractive option during this COVID-19 period and for physicians practicing telemedicine.”
Xgeva generated $916 million in the 2020 first half versus $970 million during same-time 2019. Product sales for the 202o first half fell 13 percent year-over-year, due to lower unit demand. The decrease was driven by the impact of COVID-19, including a decline in patient visits and recently revised treatment recommendations from the National Comprehensive Cancer Network (NCCN) in response to COVID-19 to prioritize primary cancer treatments over bone targeting agents.
Aranesp sales dropped off 5 percent in first-half 2020, coming in at $809 million during the period. The medicine’s sales were down 11 percent versus second-period 2019 and down 5 percent for the half, driven by lower net selling price and the impact of competition on unit demand.
Kyprolis produced first-half 2020 sales of $533 million, up 4 percent compared to the product’s January-June 2019 total. Sales decreased 5 percent year-over-year versus second-quarter 2019, driven by lower unit demand. This result was driven by reduced multiple myeloma patient visits to providers due to COVID-19.
Repatha sales rose 46 percent to $429 million versus the 2019 first half. Second-quarter 2020 Repatha sales grew 32 percent year-over-year, paced by 69 percent volume growth, offset partially by lower net selling price. Sales dropped off 13 percent quarter-over-quarter, driven by unfavorable changes to estimated sales deductions. Although U.S. new-to-brand prescriptions (NBRx) for the proprotein convertase subtilisin/kexin type 9 segment were negatively impacted by COVID-19, Repatha maintained share leadership among new patients, exiting the second quarter with 80 percent share. Repatha’s year-over-year net selling price decreased as a result of additional contracting to improve Medicare Part D patient access and patient affordability. Amgen management expected net selling price to be relatively stable for the remainder of 2020.
Amgen reported that other products accounted for about $3.16 billion in first-half 2020 sales, for a year-over-year increase of 22 percent.
Initial data for AMG 510 (sotorasib) from a potentially pivotal Phase II monotherapy study in patients with advanced non-small cell lung cancer (NSCLC) are anticipated by Amgen in second-half 2020. The Phase III CodeBreaK 200 trial comparing sotorasib to docetaxel was enrolling patients with advanced NSCLC as of late July 2020. Amen says CodeBreaK is the most extensive KRAS G12C clinical development program. According to Amgen, six Phase I combination cohorts were enrolling patients as of July.
A Phase II trial in patients with cardiovascular disease started during 2020 for AMG 890, a small interfering RNA molecule that lowers lipoprotein.
For AMG 592, Phase Ib/II studies in systemic lupus erythematosus and chronic graft vs host disease are enrolling patients in 2020. A Phase Ib trial in rheumatoid arthritis was halted due to insufficient benefit-risk for the use with standard of care therapy in active RA patients.
Amgen is a pioneer in the development of bispecific T cell engagers, or BiTE antibody constructs, which are designed to harness a patient’s own immune system to combat cancer. The company’s pipeline includes about a dozen BiTE molecules directed against both liquid and solid tumors, including multiple myeloma, acute myeloid leukemia and prostate cancer.
For Amgen’s Bispecific Programs, management expects initial data from Phase I dose escalation studies of these half-life extended BiTE constructs in second-half 2020: AMG 160 targeting prostate specific membrane antigen for prostate cancer; AMG 701 targeting B-cell maturation antigen for multiple myeloma; and AMG 757 targeting delta-like ligand 3 for small cell lung cancer.
On the COVID-19 therapeutics front, Amgen is pursuing the development of therapeutic antibodies that may be complementary with antibodies directed against the receptor binding domain of the SARS-CoV-2 spike protein. The company also has the option to review and potentially pursue antibody candidates identified by Adaptive Biotechnologies.
During April, Amgen and Adaptive Biotechnologies announced a collaboration aimed at helping address the COVID-19 pandemic. The companies are combining expertise to discover and develop fully human neutralizing antibodies targeting SARS-CoV-2 to potentially prevent or treat COVID-19. The mutually exclusive collaboration joins together Adaptive’s proprietary immune medicine platform for the identification of virus-neutralizing antibodies with Amgen’s expertise in immunology and novel antibody therapy development.
Amgen and Eli Lilly and Company announced in September a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly’s potential COVID-19 therapies. Lilly is evaluating several potential neutralizing antibodies for the prevention and/or treatment of COVID-19 as either monotherapy or in combination. Through the collaboration, the two companies will have the ability to quickly scale up production and serve many more patients around the globed should one or more of Lilly’s antibody therapies prove successful in clinical testing and receive regulatory approval.
Product Approvals & Pipeline Updates In 2020
During the past five years, Amgen has invested nearly $19 billion in research and development. As of March 2020, more than 31,000 patients were enrolled in roughly 150 clinical trials worldwide involving dozens of potential new Amgen medicines. During 2019, the company advanced seven potential new therapies into Phase I clinical trials, and Amgen filed Investigational New Drug applications to bring four additional molecules into the clinic. “In keeping with our enduring commitment to cutting-edge research – two-thirds of the innovative medicines we currently market are first-in-class therapies – a large majority of our pipeline programs aim to take medicine in new directions and provide substantial new benefits to patients,” Bradway notes.
The FDA in August 2020 approved the expansion of the Kyprolis U.S. prescribing information to include the drug’s use in combination with Darzalex (daratumumab) plus dexamethasone (DKd) in two dosing regimens — once weekly and twice weekly — for treating patients with relapsed or refractory multiple myeloma (R/R MM) who have received one to three previous lines of therapy.
“This expanded approval for Kyprolis demonstrates a leap forward in the treatment paradigm for this complex disease by combining two potent agents in their respective drug classes indicated for patients with relapsed or refractory multiple myeloma,” said David M. Reese, M.D., executive VP of Research and Development at Amgen.
In May, Amgen announced that the U.S. District Court in Delaware issued a decision upholding the validity of patent claims from three patents that protect the company’s multiple myeloma therapy Kyprolis. The decision prevents Cipla Limited and Cipla USA Inc. from making, using, selling, offering to sell, or importing its generic version of Kyprolis until expiration of these three U.S. patents. The latest patent expiration is in December 2027.
Amgen in August unveiled positive data from the HAUSER-RCT Phase IIIb trial assessing the safety and efficacy of Repatha in pediatric patients, 10-17 years of age, with heterozygous familial hypercholesterolemia (HeFH). The study demonstrated that Repatha, in combination with statins and other lipid-lowering therapies, significantly reduced low-density lipoprotein cholesterol (LDL-C) compared to placebo.
Members of the COVID R&D Alliance – Amgen, AbbVie and Takeda Pharmaceutical – announced during August the first patients enrolled in the I-SPY COVID Trial (Investigation of Serial Studies to Predict Your COVID Therapeutic Response with Biomarker Integration and Adaptive Learning) clinical trial. The I-SPY COVID Trial is testing the efficacy of Otezla, the chemokine (CCR2 and CCR5) dual-receptor antagonist cenicriviroc, and the bradykinin B2 receptor antagonist Firazyr (icatibant injection) in severely ill, hospitalized COVID-19 patients who require high-flow oxygen.
The study is a collaboration between members of the COVID R&D Alliance, Quantum Leap, and the U.S. FDA. The COVID R&D Alliance represents a group of more than 20 of the world’s leading biopharma and life science companies working to speed the development of potential therapies, novel antibodies, and anti-viral therapies for COVID-19 and its related symptoms.
Otezla is being investigated as a potential immunomodulatory treatment in patients with SARS-CoV-2 infections in multiple COVID-19 platform trials.
During May, the Phase 3 ADVANCE trial in patients with mild to moderate psoriasis met the study’s primary endpoint and all secondary endpoints at week 16. Amgen says Otezla treatment resulted in significant improvements in measures of mild-to-moderate psoriasis compared with placebo. Data will be submitted to the U.S. FDA for inclusion in Otezla’s prescribing info.
For omecamtiv mecarbil, Amgen anticipates clinical data from the Phase III GALACTIC-HF study during fourth-quarter 2020. GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) represents one of the largest Phase III global cardiovascular (CV) outcomes trials in heart failure ever conducted. The studies enrolled 8,256 patients in 35 countries who were either hospitalized at the time of enrollment for a primary reason of heart failure or had a hospitalization or admission to an emergency room for heart failure within one year prior to screening. The studies are 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 CV death in patients with HFrEF.
During May, the U.S. FDA granted Fast Track designation for omecamtiv mecarbil for treating chronic heart failure with reduced ejection fraction. Omecamtiv mecarbil is being developed through a collaboration between Amgen and Cytokinetics Inc., with funding and strategic support coming from Servier.
Amgen is developing the first-in-class investigational monoclonal antibody tezepelumab for severe asthma in collaboration with AstraZeneca. Amgen management expects clinical data from the Phase III NAVIGATOR trial in patients with severe uncontrolled asthma in late 2020. During second-quarter 2020, a Phase II atopic dermatitis trial was halted based on efficacy data that did not support continuation of the study. According to Amgen, no new safety findings were observed and there is no impact to the ongoing studies in chronic obstructive pulmonary disease and asthma.
Amgen is supporting the further study of the phosphodiesterase type 4 (PDE4) inhibitor AMG 634 for the treatment of tuberculosis (TB) and erythema nodosum leprosum (ENL), an inflammatory cutaneous and systemic complication of leprosy. The company acquired AMG 634 (formerly known as CC-11050) as part of Amgen’s acquisition of Otezla from Celgene during 2019. AMG 634 is undergoing Phase 2 trials led by The Aurum Institute NPC (TB study) and The Leprosy Mission Nepal (ENL study).
Other Acquisitions, Deals & Partnerships in 2020
Amgen kicked off 2020 by closing a strategic collaboration with BeiGene to expand the company’s oncology presence in China (as mentioned on page 24). Through the collaboration, BeiGene will commercialize Xgeva, Kyprolis, and Blincyto in China, and Amgen will share profits and losses equally during the initial product-specific commercialization periods; thereafter, product rights may revert to Amgen, which will pay royalties to BeiGene on sales in China.
Amgen will also jointly develop a portion of the company’s oncology portfolio with BeiGene sharing in global R&D costs by providing cash and development services up to $1.25 billion. Upon regulatory clearance, BeiGene will assume commercialization rights in China for a specified period, and the two companies will share profits equally until certain of these product rights revert to Amgen. Upon return of the product rights, Amgen will pay royalties to BeiGene on sales in China for a specified time frame. For product sales outside of China, Amgen will additionally pay BeiGene royalties.
Amgen acquired a 20.5 percent stake in BeiGene for $2.8 billion in cash, representing a purchase price of $174.85 per BeiGene American Depositary Share on NASDAQ, a 36 percent premium to BeiGene’s 30-day volume-weighted average share price as of Oct. 30, 2019, the day prior to the signing of the deals.
During July, Amgen announced an additional investment of $421 million in BeiGene’s registered direct offering of ordinary shares, which maintains Amgen’s pro rata ownership of BeiGene at 20.3 percent. “This additional investment reflects Amgen’s confidence in the progress the companies are making in their ongoing oncology collaboration in China, the world’s second-largest pharmaceutical market,” according to company management.
During March, Amgen consummated the purchase from Astellas Pharma of 49 percent of shares of Amgen Astellas BioPharma (AABP), a joint venture between Amgen and Astellas established in 2013 (as mentioned on page 24). AABP, now a wholly owned Amgen affiliate in Japan renamed Amgen K.K., has enabled Amgen to form a strong presence in Japan as the company advances treatments for serious illnesses.
During January, Amgen announced strategic collaborations with leading diagnostic companies Guardant Health Inc. and Qiagen N.V. to develop blood- and tissue-based companion diagnostics, respectively, for the investigational cancer treatment AMG 510. AMG 510 is the first KRASG12C inhibitor to advance to the clinic for investigation in the treatment of multiple tumor types. KRAS G12C is one of the most frequently mutated oncogenes in human cancers, according to Amgen. The agreements with both companies initially concentrate on tests for NSCLC, but allow for further development of the diagnostic tests for Amgen’s other oncology clinical development programs.
Biosimilar Progress During 2020
Amgen is strengthening the company’s product portfolio by leveraging decades of biomanufacturing experience to bring to patients a reliable supply of high-quality biosimilars. Amgen biosimilars generated $568 million in sales during 2019, and company management believes these medicines represent a significant growth opportunity.
During 2019, the company launched Amgen’s first two biosimilars in the United States, Mvasi and Kanjinti, which are biosimilars to the Roche/Genentech blockbuster cancer treatments Avastin and Herceptin, respectively.
Amgevita (adalimumab) is Amgen’s biosimilar to the autoimmune disease treatment Humira, the world’s top-selling prescription drug. After generating more than $200 million in 2019 worldwide, Amgevita sales came in at $148 million during the first six months of 2020, marking a year-over-year improvement of 78 percent. The product generated $62 million of sales during the second quarter of 2020 and was the most prescribed adalimumab biosimilar in Europe for the fourth consecutive quarter. Amgevita Q2 sales fell 28 percent quarter-over-quarter, driven by lower net selling prices and reductions in customer inventories following COVID-19-related stocking during the first quarter of 2020.
During 2020, Amgen planned to launch in the United States Avsola, a biosimilar to the blockbuster inflammation treatment Remicade. The company continues to advance several additional biosimilars through the pipeline, including ABP 938, a biosimilar to the blockbuster product Eylea for age-related macular degeneration.