Amgen 2023: Breaking records, putting biology first

With the settlement of a big acquisition behind them and a strong portfolio of therapeutics that continues to expand, hopes for smooth sailing are on the horizon.

By Maria Fontanazza • [email protected]

 

 

Amgen

One Amgen Center Drive

Thousand Oaks, CA 91320-1799

805-447-1000 • amgen.com

 

Financial Performance
	2022	2021	1H 2023	1H 2022
Revenue	$26,323	$25,979	$13,091	$12,832
Net income	$6,552	$5,893	$4,220	$2,793
Diluted EPS	$12.11	$10.28	$7.86	$5.13
R&D Expense	$4,434	$4,819	$2,171	$1,998
All figures are in millions of dollars, except EPS.

Best-selling products

All sales are in millions of dollars.

2022 sales

• Enbrel $4,117 $
• Prolia $3,628 
• Otezla $2,288 
• Xgeva $2,014 
• Aranesp $1,421 
• Nplate $1,307 
• Repatha $1,296 
• Kyprolis $1,247 
• Neulasta $1,126 
• Mvasi $901 
• Vectibix $893 
• Evenity $787 
• Blincyto $583 
• Epogen $506

1H 2023 sales

• Prolia $1,955 
• Enbrel $1,647 
• Xgeva $1,066 
• Otezla $992 
• Repatha $812 
• Aranesp $720 
• Kyprolis $704 
• Nplate $672 
• Evenity $535 
• Neulasta $485 
• Vectibix $481 
• Blincyto $400 
• Mvasi $394

Outcomes Creativity Index Score: 10

• Manny Awards — N/A
• Cannes Lions — N/A
• Clio Health — N/A
• Creative Floor Awards — 1
• LIA: Pharma/Health & Wellness – 2
• MM+M Awards — 7
• One Show — N/A

 

With a presence in nearly 100 markets, Amgen has established a strong global foothold in its core therapeutic areas of asthma, cancer, cardiovascular disease, osteoporosis, and rheumatoid arthritis. The company continues to target unmet patient needs through focusing and understanding the “fundamentals of human biology.” Amgen believes that its “biology first” methodology allows its scientists to investigate a disease’s complex molecular pathways and from there, decide the most approrpriate medicine and modality through which they can achieve drug safety and efficacy.

Amgen continues to expand its global reach and diverse product portfolio, and Chairman and CEO Robert A. Bradway is confident about the long-term growth outlook for the company. He stated that the integration of ChemoCentryx, which was completed during October 2022, brought the company Tavneos (avacopan), a first-in-class treatment for antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis. In addition, the anticipated completion of the acquisition of Ireland-based Horizon Therapeutics (not without strong pushback from the U.S. government) will add several key biologic drugs to Amgen’s growth profile through 2030 and beyond. Both deals only strengthen the company’s ability to meet patient needs worldwide.

Amgen is positioning its biosimilars business with the long game in mind. Last year the company reported positive Phase III data for biosimilar candidates to Eylea, Soliris, and Stelara. And in January, it launched Amjevita (adalimumab-atto), the first U.S. biosimilar to Humira (adalimumab). Between January 2023 and 2030, Amgen has planned six additional biosimilar launches, which promise to be a foundation for long-term company growth.

The company’s commitment to R&D perhaps keeps its pipeline ahead of the game. Last fall it opened its second-largest R&D facility in San Francisco’s Oyster Point. The 245,000-sq-ft site employs 650 staff and focuses on drug discovery for treating cancer, inflammatory disease, and cardiometabolic disorders. “Our new site is home to a perfect combination of technology and biotech innovation, making Amgen an attractive place for local scientific professionals looking to build an inspirational, rewarding career,” said Saptarsi Haldar, vice president of cardiometabolic research and site head for Amgen San Francisco. “The team is deeply committed to the evolution of cutting-edge science, and highly motivated to ensure we’re prepared to meet the future needs of patients living with cancer, inflammatory disease, and cardiometabolic diseases.”

The deal of 2022 and more

Amgen ended 2022 with pharma’s biggest deal of the year, the announcement of its intent to buy Horizon Therapeutics for $27.8 billion.

“The acquisition of Horizon is a compelling opportunity for Amgen and one that is consistent with our strategy of delivering long-term growth by providing innovative medicines that address the needs of patients who suffer from serious diseases,” Bradway said of the deal at the time. “Amgen’s decades of leadership in inflammation and nephrology, combined with our global presence and world-class biologics capabilities, will enable us to reach many more patients with first-in-class medicines like Tepezza, Krystexxa, and Uplizna. Additionally, the potential new medicines in Horizon’s pipeline strongly complement our own R&D portfolio. The acquisition of Horizon will drive growth in Amgen’s revenue and non-GAAP EPS and is expected to be accretive from 2024.”

Drawn to Horizon’s rare disease portfolio, Amgen may not have anticipated the strong objection from the U.S. government that followed. Nearly six months after the acquisition announcement, the Federal Trade Commission (FTC) sued Amgen to block the company from acquiring Horizon Therapeutics, stating that the deal would help Amgen create a monopoly via Horizon’s drugs used to treat thyroid eye disease (TED) and chronic refractory gout.

The FTC was sending a message to the pharmaceutical industry, stating their action was the agency’s “first challenge to a pharmaceutical merger in recent memory, [and it] sends a clear signal to the market: The FTC won’t hesitate to challenge mergers that enable pharmaceutical conglomerates to entrench their monopolies at the expense of consumers and fair competition.”

In response to the FTC’s complaint, Amgen stated that the acquisition did not cause any competitive concerns, because the drugs offered by Amgen and Horizon “generally” treat different diseases and patient groups.

“The FTC’s claim that Amgen might ‘bundle’ these medicines (offer a multi-product discount) at some point in the future is entirely speculative and does not reflect the real-world competitive dynamics behind providing rare-disease medicines to patients,” Amgen stated in a press release. “And we committed that we would not bundle the Horizon products raised as issues; however, the Commission still decided to pursue this path. Furthermore, we are unaware of any prior acquisition that has been blocked under a bundling theory.”

Amgen and the FTC reached a settlement on September 1 whereby Amgen is prohibited from bundling one of its products with Horizon’s Tepezza (for TED) or Krystexxa (for chronic refractory gout). Among the several requirements in the consent order, should Amgen want to acquire pre-commercial products that have completed FDA clinical trials for treating either TED or chronic refractory gout, the company will have to receive FTC approval through 2032. Amgen and Horizon expect the acquisition to close in the early fourth quarter of this year.

In May Amgen and TScan Therapeutics announced a multi-year collaboration that leverages TScan’s target discovery platform (TargetScan) and Amgen’s expertise in anti-inflammatory drugs and its research capabilities. The companies will use TargetScan to identify the antigens recognized by T cells in patients with Crohn’s disease, and Amgen will develop potentially first-in-class therapeutics based on those discovered targets. “Anti-inflammatory drugs have traditionally been the standard of care for patients suffering from inflammatory bowel disease, but often lack efficacy and durability,” said Raymond Deshaies, Ph.D., senior VP of global research at Amgen. “TScan’s platform provides a best-in-class approach to identify non-conventional drug targets to enable the development of potential first-in-class therapeutics to address unmet medical needs.”

Under the terms of the agreement, TScan will receive $30 million upfront with the ability to receive commercial payments of more than $500 million based on preclinical, clinical, regulatory, and commercial milestones. Amgen will keep all global development and commercial rights of the therapeutics. 

“We are equally excited about three new collaborations,” said David Reese, M.D., executive VP, R&D at Amgen. “The first two are early research collaborations with LegoChem Biosciences and Synaffix focused on antibody drug conjugates (ADCs). We view ADCs as another tool that will enable us to utilize the best modality to interdict a particular therapeutic target, with applications both within and outside of oncology.”

Under the terms of the license agreement with Netherlands-based Synaffix, which was announced in January, Amgen will have access to the company’s ADC technology platforms GlycoConnect, HydraSpace, and select toxSYN linker-payloads for one ADC program with the option to exercise exclusive research and commercial licenses for four more programs at a later date.

“The third partnership is a collaboration with Illumina and Nashville Biosciences in support of our human data efforts, where we will perform whole genome sequencing on 35,000 Black individuals, a group that has historically been underrepresented in genetic research,” Reese said.

Financial & product performance

“We executed effectively in 2022, delivering strong volume growth, advancing numerous first-in-class medicines in our pipeline, and staying on track to achieve our long-term growth objectives,” said Bradway. Last year’s revenue was up 1 percent from 2021, hitting $26.3 billion, and product sales increased 2 percent, reaching $24.8 billion, driven by a 9 percent increase in volume. GAAP earnings per share (EPS) increased 18 percent from $10.28 to $12.11, mainly driven by the write-off of $1.5 billion in acquired in-process R&D associated with the Five Prime Therapeutics acquisition in 2021. The company achieved record non-GAAP EPS of $17.69, up 27 percent from the prior year, and free cash flow of $8.8 billion in 2022 versus $8.4 billion in 2021.

“Everything we achieved last year and everything we will achieve going forward is due to the hard work and commitment of our people,” said Bradway during the company’s full year 2022 earnings meeting. “They’re passionate about our mission to serve patients. They’re clear on how their work contributes to our success, and they’re ready to seize the opportunities and meet the challenges that await us.”

Ten of Amgen’s products ranked on the Med Ad News Top 200 Prescription Medicines by 2022 Global Sales: Prolia (denosumab), Otezla (apremilast), Xgeva (denosumab), Neulasta (pegfilgrastim), Nplate (romiplostim), Repatha (evolocumab), Kyprolis (carfilzomib), Evenity (romosozumab-aqqg), Mvasi (bevacizumab-awwb), and Vectibix (panitumumab).

Within its general medicine portfolio, total revenue for Prolia, Evenity, Repatha, and Aimovig (erenumab-aooe) grew 18 percent in 2022. Sales of postmenopausal osteoporosis drug Prolia increased 12 percent last year, mainly driven by volume growth. Q2 2023 sales of Prolia increased 11 percent year-over-year to a record $1 billion, and Amgen anticipates that more than 7 million patients will be treated with the bone health drug this year. Complementary drug Evenity experienced a record year-over-year 48 percent increase in 2022 sales and is going strong thus far, with Q2 2023 sales hitting $281 million. Earlier this year Amgen sued Novartis to block generic versions of Prolia and Xgeva, claiming Sandoz infringed on several of its drugs’ patents.

With more than 1.5 million patients treated since its launch, Repatha is holding strong as the global PCSK9 (proprotein convertase subtilisin/kexin type 9) segment leader, experiencing 16 percent sales growth ($1.3 billion) last year. “With the FOURIER long-term follow-up data, in addition to evolving and more aggressive treatment guidelines, there’s a clear rationale that lowering LDL cholesterol as much and as early as possible with Repatha will reduce cardiovascular risk for patients around the world,” said Murdo Gordon, executive VP, global commercial operations at Amgen. Repatha set another Amgen record for Q2 2023, enjoying 30 percent year-over-year growth to hit $424 million, and rounding out the first half of 2023 at $812 million.

Overall decreases in sales were experienced by Aimovig, up 31 percent for full year 2022, but decreasing 11 percent year-over-year for Q2 2023; Epogen (epoetin alfa) was down 3 percent in 2022 and continuing to decline due to lower inventory levels and the contract expiration with DaVita; Aranesp (darbepoetin alfa), dropped 4 percent in sales due to lower net selling price; and Sensipar/Mimpara fell 24 percent last year as a result of volume declines and generic competition.

Amgen’s inflammation portfolio holds blockbusters Enbrel (etanercept) and Otezla, both of which were numbers one and three, respectively, in top company product sales for 2022. Despite Enbrel’s top spot among Amgen’s best sellers, full-year 2022 sales decreased 8 percent, and the company expects further declines moving forward. Yet, Amgen holds fast that Enbrel’s storied track record of efficacy and safety will help keep the product as an important asset to the company. Its future remains to be seen, as Enbrel is one of 10 drugs that made the Centers for Medicare & Medicaid Services’ (CMS) first list of drugs covered under Medicare Part D selected for price negotiation. CMS will publish the agreed-upon negotiated prices for the drugs by September 1, 2024, and the prices will go into effect on January 1, 2026.

Otezla’s 2022 sales increased 2 percent, bringing in $2.3 billion, and its Q2 2023 sales rose 1 percent. New U.S. patient demand was affected by free drug programs or newly launched topical and systemic competitors, and Amgen expects this to be the case for the remainder of 2023. “We continue to see strong growth potential for Otezla given its established efficacy and safety profile, strong payer coverage with limited prior authorization requirements and ease of administration,” Amgen stated in its Q2 2023 results. “Otezla remains the only approved oral systemic therapy with a broad indication and is well-positioned to help the 1.5 million U.S. patients with mild-to-moderate psoriasis that cannot be optimally addressed by a topical and can benefit from a systemic treatment like Otezla.”

In April Amgen won a patent infringement lawsuit against Sandoz and Zydus Pharmaceuticals involving Otezla. The U.S. Court of Appeals for the Federal Circuit upheld a ruling prohibiting the launch of generic versions of Otezla until February 2028. In the United States, Otezla is approved to treat adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy, adults with active psoriatic arthritis, and adult patients with oral ulcers associated with Behçet’s Disease.

Tezspire (tezepelumab-ekko) continues its climb as a first-in-class biologic for treating severe asthma. 2022 closed with the product generating $170 million in sales. In February patient access to Tezspire further opened with FDA’s approval of the biologic for self-administration via a pre-filled single-use pen. Patients 12 years and older with severe asthma can now administer Tezspire either at home or at their doctor’s office. “Severe asthma continues to be a very complex condition to manage, so we welcome the Tezspire pre-filled pen as an option that will empower patients and healthcare providers with increased choice,” said Kenneth Mendez, president and CEO of the Asthma and Allergy Foundation of America, in an Amgen press release. “We believe self-administration alternatives can play an important role in patients’ lives and address unmet needs for those living with severe asthma.” Q2 2023 sales hit $133 million, and Amgen places the market size for Tezspire at 2.5 million patients worldwide.

Amgevita, which is the most prescribed adalimumab biosimilar in Europe, had a 5 percent increase in sales last year, driven by 25 percent volume growth. Q2 2023 sales were up 29 percent year-over-year as a result of 60 percent volume growth; however, quarter-over-quarter sales fell 63 percent due to lower inventory levels following the Q1 2023 launch.

Among the hematology-oncology product portfolio, Lumakras (sotorasib), Kyprolis, Xgeva, Vectibix, Nplate, and Blincyto (blinatumomab) experienced volume gains that generated 13 percent sales growth in 2022.  While sales for Lumakras were $285 million last year and flat in Q2 2023, Amgen expects that the drug’s long-term growth will come from moving into earlier lines of therapy and expanding into additional tumor types. Lumakras has been approved in more than 45 countries outside the United States and has launched in 30 markets. The company states that the drug’s market is focused on 7,000 patients in the United States and 20,000 patients OUS in the second-line setting.

Blincyto was another record-setter, with a 24 percent increase in sales for 2022, which was driven by volume growth and a higher net selling price; and in Q2 2023 its sales increased 48 percent year-over-year, hitting $206 million. This 36 percent volume growth was driven by adoption across academic, community, and pediatric centers, as well as higher net selling price. During June the FDA gave its full approval (previously accelerated approval) for Blincyto for treating adults and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1 percent. “[The] full approval underscores the clinical benefit of Blincyto for people living with B-ALL, and we look forward to exploring how we can continue to make a significant impact for these patients,” said Reese. The company touts Blincyto’s “robust” development program, which seeks to address unmet patient needs, with studies focused on treating patients with MRD-negative B-ALL, trials aimed at minimizing chemotherapy, and the clinical investigation of subcutaneous formulation.

Vectibix experienced a 2 percent sales increase in 2022, bringing in $893 million; for Q2 2023, its sales increased 20 percent year-over-year to $248 million (another Amgen record). The 20 percent volume growth was supported by promotion of positive data from the company’s Phase III PARADIGM trial demonstrating the superiority of Vectibix over bevacizumab in combination with chemotherapy, according to Amgen.

For Q2 2023, Kyprolis and Nplate both reported a 9 percent year-over-year sales increase, while Xgeva decreased 1 percent and Lumakras/Lumykras had flat sales; Mvasi and Kanjinti experienced sales decreases, with declines attributed to net selling price erosion and increased competition.

Overall, Q2 2023 financial results were positive. Total revenues were up 6 percent to $7 billion versus Q2 2022, from a 6 percent increase in product sales. Product sales growth was driven by 11 percent volume growth, partially offset by 2 percent lower net selling price, 1 percent lower inventory levels and 1 percent negative impact from foreign exchange. Excluding the 1 percent negative impact of foreign exchange on product sales, total revenues increased 7 percent. Amgen generated $3.8 billion of free cash flow in the Q2 2023 versus $1.7 billion in Q2 2022, driven by timing of tax payments, higher interest income and higher operating income. The company’s Q2 2023 dividend of $2.13 per share was declared on March 7, 2023, and was paid on June 8, 2023, to all stockholders of record as of May 18, 2023, representing a 10 percent increase from 2022.

Amgen continues to advance its financial stance, and as of August 2023, the company anticipates that it will close the year with total revenue in the range of $26.6 billion to $27.4 billion. This figure excludes any contribution from the Horizon acquisition.

Pipeline updates

Amgen’s $4.3 billion investment in its robust, organic pipeline is a testament to its commitment to longevity. In Q2 2023 R&D expenses increased 7 percent, due to higher spend in late-stage programs and marketed product support. As the loss of exclusivity looms, the company is taking aggressive R&D steps to ensure its pipeline remains healthy. Amgen has roughly 35 product candidates under investigation, with more than half in Phase III. According to Reese, 2022 “was one of high-quality execution and on-time delivery of results, as we continued to progress our innovative pipeline. In general medicine, we strengthened our cardiovascular franchise and emerging portfolio of obesity assets, two areas of significant unmet need, affecting millions of patients globally.” The following are a few of Amgen’s pipeline highlights.

As of August 2023, the company announced several updates to its pipeline programs. Tarlatamab, a first-in-class DLL3 targeting BiTE molecule, in patients with relapsed or refractory small cell lung cancer (SCLC) who had failed two or more prior lines of treatment, showed a durable objective response rate (ORR) (primary endpoint) that substantially exceeds what was previously reported in the Phase 1 study. Safety and tolerability were also more favorable compared to the Phase I study, with no new safety signals identified. Amgen will be discussing the data with regulatory agencies. Tarlatamab is also being evaluated in several studies involving SCLC and neuroendocrine prostate cancer.

Lumakras/Lumykras is under investigation in three therapeutic areas: advanced colorectal cancer, non-small lung cell cancer (NSCLC), and other tumors. According to Amgen, the company “took on one of the toughest challenges of the last 40 years in cancer research by developing Lumakras/Lumykras.” The therapeutic has shown a positive benefit-risk profile with rapid, deep, and durable anticancer activity in patients with locally advanced or metastatic NSCLC harboring the KRAS G12C mutation with a once daily oral formulation. Lung cancer is one of the deadliest cancers worldwide, and overall survival rates for NSCLC, while improving, remain low for patients who have advanced disease.

In September Amgen reported new data from a study arm of the CodeBreaK 101 clinical trial, a Phase Ib study evaluating Lumakras with carboplatin and pemetrexed in adult patients with KRAS G12C-mutated advanced NSCLC. Patients treated in the first-line setting had a confirmed objective response rate of 65 percent with a 100 percent disease control rate. “Notably, these results follow and further expand upon the Phase II investigator-led data demonstrating favorable efficacy and safety of LUMAKRAS plus carboplatin and pemetrexed in the first-line treatment of patients with KRAS G12C-mutated NSCLC,” said Reese. The study results were presented at the International Association for the Study of Lung Cancer 2023 World Conference on Lung Cancer in Singapore on September 10.

“Combination treatment is an important approach to prevent or delay the onset of drug resistance and improve the depth and durability of targeted response in KRAS G12C-mutated NSCLC,” said Jeffrey M. Clarke, M.D., oncologist and associate professor of medicine, Duke Cancer Institute at Duke University. “The CodeBreaK 101 results show exciting efficacy with sotorasib plus chemotherapy and, importantly for a combination treatment, a safety profile consistent with the individual therapies. These data warrant continued investigation in larger trials.” In response to the positive study results, Amgen has started a Phase III study of Lumakras plus carboplatin and pemetrexed in first-line KRAS G12C-mutant and negative for programmed cell death PD-L1 advanced NSCLC (CodeBreaK 202; NCT05920356), with enrollment expected to start before the end of this year.

Amgen is planning global regulatory authority submissions for late 2023/early 2024 for Blincyto’s E1910, a Phase III study, which was conducted by the National Cancer Institute, the Eastern Cooperative Oncology Group, and the American College of Radiology Imaging Network Cancer Research Group. The study demonstrated superior overall survival with Blincyto treatment added to consolidation chemotherapy over standard of care consolidation chemotherapy in newly diagnosed adult patients with Philadelphia chromosome negative (Ph-) B-ALL who were MRD-negative following induction and intensification chemotherapy. In April the New England Journal of Medicine published data demonstrating that Blincyto added to chemotherapy improved two-year survival in lysine (K)-specific methyltransferase 2A (KMT2A)-rearranged B-ALL in infants as compared to historical results with chemotherapy; with Blincyto two-year survival of 93 percent vs chemotherapy two-year survival of 66 percent.

The molecule olpasiran (formerly AMG 890), a small interfering RNA (siRNA), is being investigated for use as a treatment of atherosclerotic cardiovascular disease. Data from the final analysis of the Phase II OCEAN(a)-DOSE study, announced in August, showed a continued reduction of lipoprotein (a) nearly a year after the last dose. “We are dedicated to reducing LDL cholesterol levels in people globally and continuing to pioneer ways to address the greatest risk factors in cardiovascular disease, including Lp(a). Worldwide, millions of people are at an increased risk of cardiovascular events due to elevated Lp(a) levels. Unfortunately, there are no approved medicines,” said Paul Burton, senior vice president and chief medical officer at Amgen. “Data from the off-treatment extension period provide additional evidence of olpasiran’s lasting effect in reducing Lp(a) levels. We are quickly advancing the Phase III cardiovascular outcome trial.”

Additional notable Amgen studies that continue to enroll patients include the Phase I study of xaluritamig, a bispecific molecule targeting six-transmembrane epithelial antigen of prostate 1 in metastatic castrate-resistant prostate cancer; EVOLVE-MI, a Phase 4 study of Repatha administered immediately following acute myocardial infarction and designed to reduce the risk of cardiovascular events in hospitalized patients; and several Tezspire studies, including Phase III for chronic rhinosinusitis with nasal polyps, Phase III for eosinophilic esophagitis, and the PASSAGE Phase IV real-world effectiveness and SUNRISE Phase III study for severe asthma.