THOUSAND OAKS, Calif., April 27, 2022 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced financial results for the first quarter of 2022. Key results include:

• Total revenues increased 6% to $6.2 billion in comparison to the first quarter of 2021, resulting from 2% growth in global product sales and increased Other Revenue from our COVID-19 manufacturing collaboration.
• Volumes grew double-digits for a number of products including Repatha® (evolocumab), Prolia® (denosumab) and EVENITY® (romosozumab-aqqg).
• GAAP earnings per share (EPS) decreased 5% to $2.68 driven by a decrease in other (expense) income, net, partially offset by increased revenues and lower weighted-average shares outstanding. The decrease in other (expense) income, net, was primarily driven by net losses recognized on our strategic equity investments in the current year compared with net gains recognized in the prior year.
• GAAP operating income increased 17% to $2.5 billion, and GAAP operating margin increased 5.5 percentage points to 43.6%.
• Non-GAAP EPS increased 15% to $4.25, driven by increased revenues and lower weighted-average shares outstanding.
• Non-GAAP operating income increased 10% to $3.1 billion, and non-GAAP operating margin increased 3.6 percentage points to 54.8%.
• The Company generated $2.0 billion of free cash flow for the first quarter versus $1.9 billion in the first quarter of 2021.
• 2022 total revenues guidance reaffirmed at $25.4-$26.5 billion; EPS guidance revised to $12.53-$13.58 on a GAAP basis, and reaffirmed at $17.00-$18.00 on a non-GAAP basis.
• Amgen will vigorously contest the adjustments and penalties proposed by the Internal Revenue Service (IRS) for the 2010-15 period as discussed in more detail on pages 7-8 of this release. Amgen is confident in its position in the dispute, and in the level of reserves the Company has established.

"We achieved strong, volume-driven growth in the quarter, while launching two very promising first-in-class medicines," said Robert A. Bradway, chairman and chief executive officer. "We are also advancing a robust pipeline with data for several mid-to-late stage candidates expected during the year."

References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis" and "free cash flow" (computed by subtracting capital expenditures from operating cash flow) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented on the attached reconciliations. Refer to Non-GAAP Financial Measures below for further discussion.

Product Sales Performance

Total product sales increased 2% for the first quarter of 2022 versus the first quarter of 2021. Unit volumes grew 9%, offset by 7% lower net selling price and 2% negative impact from foreign exchange, and sales in the first quarter benefited 2% ($110 million) from year-over-year favorable changes to estimated sales deductions. Consistent with prior years, Enbrel® (etanercept) and Otezla® (apremilast) followed the pattern of lower Q1 sales relative to the remainder of the year due to the impact of benefit plan changes, insurance reverifications and increased co-pay expenses as U.S. patients work through deductibles.

COVID-19 continued to affect our business around the world in the first quarter. In March and April, we have seen the impact of the pandemic recede in the U.S., which has led to improved demand patterns and allowed us to engage in increased field-facing activities.

General Medicine

• Prolia sales increased 12% year-over-year for the first quarter, driven by 10% volume growth and higher net selling price.
• EVENITY sales increased 59% year-over-year to a record $170 million for the first quarter, driven by strong volume growth across our markets. U.S. sales grew 93% year-over-year, driven by 79% volume growth.
• Repatha sales increased 15% year-over-year for the first quarter, driven by 49% volume growth partially offset by lower net selling price. Sales grew 19% in the U.S., driven by 41% volume growth partially offset by lower net selling prices resulting from higher rebates to support and expand access for patients. Sales grew 12% outside the U.S., with 57% volume growth partially offset by lower net selling price primarily driven by the inclusion of Repatha on China's National Reimbursement Drug List as of January 1, 2022. Repatha remains the global proprotein convertase subtilisin/kexin type 9 (PCSK9) segment leader, with over 1 million patients treated since launch.
• Aimovig® (erenumab-aooe) sales increased 53% year-over-year for the first quarter, driven by favorable changes to estimated sales deductions and higher net selling price, partially offset by a 4% decline in volume.

Inflammation

• TEZSPIRE™ (tezepelumab-ekko) generated sales of $7 million for the first quarter. TEZSPIRE has been well received by prescribers, with initial adoption by both allergists and pulmonologists. Healthcare providers have welcomed the product's novel approach to treating the approximately 2.5 million worldwide patients with severe asthma who are uncontrolled or biologic eligible, without any phenotypic and biomarker limitation.
• Otezla® (apremilast) sales decreased 5% year-over-year for the first quarter, primarily driven by lower net selling price and lower inventory levels, partially offset by 7% volume growth. In the U.S., we saw strengthening of the market, with Otezla remaining the market share leader among patients who are new to systemic agents for psoriasis. U.S. sales were impacted in the first quarter as both wholesalers and specialty pharmacies reduced inventory levels. Otezla sales in the U.S. were also impacted by price declines in the first quarter, driven primarily by enhancements to our co-pay and patient assistance programs to support new patients starting treatment as well as additional rebates to improve the quality of coverage. Going forward, we expect continued strong volume growth and lower year-over-year price erosion for the remaining quarters of 2022.
• Enbrel® (etanercept) sales decreased 7% year-over-year for the first quarter, driven by declines in net selling price and inventory levels. Year-over-year volume remained flat in the first quarter, supported by Enbrel's long track record of efficacy and safety.
• AMGEVITA™ (adalimumab) sales increased 2% year-over-year for the first quarter, driven by 16% volume growth, partially offset by foreign exchange impact and lower net selling price resulting from increased competition. AMGEVITA continues to be the most prescribed adalimumab biosimilar in Europe.

Hematology-Oncology

• LUMAKRAS®/LUMYKRAS™ (sotorasib) generated $62 million of sales for the first quarter, representing 38% quarter-over-quarter growth. In the U.S., LUMAKRAS has been prescribed to approximately 2,500 patients by over 1,500 physicians in both academic and community settings. Outside the U.S., LUMYKRAS has now been approved in nearly 40 countries around the world, with recent reimbursement approvals in the United Kingdom and Japan.
• KYPROLIS® (carfilzomib) sales increased 14% year-over-year for the first quarter, driven by 13% volume growth.
• XGEVA® (denosumab) sales increased 7% year-over-year for the first quarter, driven by favorable changes to estimated sales deductions and higher net selling price, partially offset by a 2% decline in volume growth.
• Vectibix® (panitumumab) sales increased 5% year-over-year for the first quarter, driven by volume growth in ex-US markets. Vectibix remains the EGFR (epidermal growth factor receptor) inhibitor of choice across all lines of therapy.
• Nplate® (romiplostim) sales increased 17% year-over-year for the first quarter, driven by 7% volume growth and favorable changes to estimated sales deductions.
• BLINCYTO® (blinatumomab) sales increased 29% year-over-year for the first quarter, driven by volume growth.
• MVASI® sales decreased 17% year-over-year for the first quarter, primarily driven by lower net selling price that was partially offset by 13% volume growth. In the U.S., MVASI continues to hold leading volume share with 49% of the bevacizumab segment in the quarter. For the full-year, we expect continued net selling price erosion and volume declines driven by increased competition and Average Selling Price (ASP) erosion.
• KANJINTI® (trastuzumab-anns) sales decreased 40% year-over-year for the first quarter, primarily driven by declines in net selling price and volume. In the U.S., KANJINTI continues to hold leading volume share with 39% of the trastuzumab segment in the quarter. Going forward, we expect continued net selling price deterioration and volume declines driven by increased competition and ASP erosion.

Established Products

• Total sales of our established products, which include Neulasta® (pegfilgrastim), NEUPOGEN® (filgrastim),EPOGEN® (epoetin alfa),Aranesp® (darbepotein alfa),Parsabiv® (etelcalcetide), andSensipar®/Mimpara™ (cinacalcet), decreased 12% year-over-year for the first quarter, primarily driven by lower net selling price and volume declines. In the aggregate, we expect the year-over-year net price and volume erosion for this portfolio of products to continue.

Product Sales Detail by Product and Geographic Region

Operating Expense, Operating Margin and Tax Rate Analysis

On a GAAP basis:

• Total Operating Expenses decreased 1%. Cost of Sales margin increased 0.6 percentage points primarily driven by manufacturing cost, including COVID-19 antibody manufacturing, and increased royalties and profit share, partially offset by lower amortization expenses from acquisition-related assets. Research & Development (R&D) expenses decreased 1%. The first quarter of 2021 included $53 million related to the Rodeo Therapeutics acquisition. Selling, General & Administrative (SG&A) expenses decreased 2%.
• Operating Margin as a percentage of product sales increased 5.5 percentage points to 43.6%.
• Tax Rate increased 0.5 percentage points primarily driven by current year net unfavorable items compared to last year partially offset by changes in earnings mix.

On a non-GAAP basis:

• Total Operating Expenses increased 2%. Cost of Sales margin increased 1.1 percentage points primarily driven by manufacturing cost, including COVID-19 antibody manufacturing, and increased royalties and profit share. R&D expenses decreased 1%. The first quarter of 2021 included $53 million related to the Rodeo Therapeutics acquisition. SG&A expenses decreased 1%.
• Operating Margin as a percentage of product sales increased 3.6 percentage points to 54.8%.
• Tax Rate increased 0.5 percentage points primarily driven by current year net unfavorable items compared to last year partially offset by changes in earnings mix. 

Cash Flow and Balance Sheet

• The Company generated $2.0 billion of free cash flow in the first quarter of 2022 versus $1.9 billion in the first quarter of 2021.
• The Company's first quarter 2022 dividend of $1.94 per share was declared on December 3, 2021, and was paid on March 8, 2022, to all stockholders of record as of February 15, 2022, representing a 10% increase from 2021.
• On February 24, 2022, the Company entered into Accelerated Stock Repurchase (ASR) agreements to repurchase an aggregate of up to $6 billion of the Company's common stock with an initial 23.3 million shares received and retired. The final number of shares to be repurchased by the Company under the ASR will be based on the daily volume-weighted average stock price of the Company's common stock, subject to the terms of the ASR agreements. In total, the Company repurchased 24.6 million shares of common stock at a total cost of $6.3 billion during the first quarter of 2022, including shares received under the ASR agreements.
• Cash and investments totaled $6.5 billion and debt outstanding totaled $36.9 billion as of March 31, 2022.  

2022 Guidance

For the full year 2022, the Company now expects:

• Total revenues in the range of $25.4 billion to $26.5 billion.
• On a GAAP basis, EPS in the range of $12.53 to $13.58 and a tax rate in the range of 10.5% to 12.0%.
• On a non-GAAP basis, EPS in the range of $17.00 to $18.00 and a tax rate in the range of 13.5% to 14.5%.
• Capital expenditures to be approximately $950 million.
• Share repurchases in the range of $6.0 billion to $7.0 billion. 

U.S. Tax Petition

On April 18, 2022, Amgen received a notice of deficiency from the IRS for the 2013-2015 period proposing adjustments primarily related to the allocation of profits between certain of the Company's entities in the United States and the U.S. territory of Puerto Rico similar to those previously proposed by the IRS for the 2010-2012 period. This notice seeks to increase Amgen's U.S. taxable income for the 2013-2015 period by an amount that would result in additional federal tax of approximately $5.1 billion, plus interest. In addition, the notice proposes penalties of approximately $2 billion.

Amgen firmly believes that the adjustments proposed by the IRS for the 2010-2015 period and the penalties proposed by the IRS for the 2013-2015 period are without merit: 

• Puerto Rico is the site of the Company's flagship manufacturing complex responsible for the majority of Amgen's global manufacturing. Amgen has had a substantial manufacturing presence in Puerto Rico for 30 years, and the Company's Puerto Rico subsidiary produces sophisticated biologic medicines for millions of patients around the world. The many valuable contributions of the Company's Puerto Rico subsidiary include the effort and expertise of its 2,400 highly skilled staff members, the nearly $4 billion in capital investments it has made on the Island, the valuable assets it possesses, and the significant risks it has assumed in connection with its business. It is through these investments that Amgen has been able to meet the needs of every patient, every time. 
• Amgen's allocation of profit between its U.S. and Puerto Rico entities appropriately recognizes the key contributions made by the Company's Puerto Rico subsidiary. The IRS position fails to adequately account for the importance of these value drivers. The proposed adjustments would result in Amgen's Puerto Rico subsidiary earning little or no profit from its operations despite the value of and risk associated with its contributions.
• The IRS audited Amgen at length for many years on the allocation of profit between the U.S. and Puerto Rico. These audits were resolved through agreements with the IRS, resulting in no financial statement detriment to the Company. Refer to Footnote 5, Income Taxes, in Amgen's 2007 and 2008 Form 10-K filings, and Footnote 4, Income Taxes, in Amgen's 2012 and 2013 Form 10-K filings.  

Further, the amount of the adjustments proposed by the IRS for the 2010-2015 period overstates by billions of dollars the magnitude of the dispute: 

• Amgen believes, based upon the positions advanced by the IRS, that the IRS adjustments for the 2010-2015 period are overstated by approximately $2 billion due to the IRS failure to account for certain income and expenses. Amgen has reported its income and expenses in a consistent manner for many years and the IRS has appropriately accounted for the Company's income and expenses in all prior audits.
• Any additional tax that could be imposed for the 2010-2015 period would be reduced by up to approximately $3.1 billion of repatriation tax previously accrued with respect to the Company's Puerto Rico earnings.
• Amgen previously made advance tax deposits to the IRS totaling $1.1 billion for the 2010-2015 period. These deposits would further reduce any additional cash tax that could be imposed. 

In addition, Amgen believes the IRS assertion of approximately $2 billion in penalties for the 2013-2015 period is wholly unwarranted. Amgen has applied a consistent transfer pricing methodology since 2002, has documented that transfer pricing methodology as required under relevant tax regulations, and has extensively discussed that methodology with the IRS across multiple tax audits over multiple years. The IRS has never previously proposed transfer pricing penalties.

Amgen believes that the Company has appropriate tax reserves. The Company filed a petition in the U.S. Tax Court in July 2021 to contest the adjustments previously proposed for the 2010-2012 period and plans to file another petition in the U.S. Tax Court to contest the adjustments proposed in the notice for the 2013-2015 period. Amgen will seek consolidation of the two periods into one case in Tax Court. The dispute is expected to take several years to resolve. 

The IRS is currently auditing the 2016-2018 period. Amgen expects the audit to continue for several years, and it is possible the 2010-2015 dispute will be resolved before the conclusion of the 2016-2018 audit and administrative appeals process. Any transfer pricing adjustments the IRS may propose for this period will be lessened by the change in tax rates resulting from the 2017 tax reform law, which reduced the difference between the tax rates applicable in the U.S. and Puerto Rico by approximately two thirds beginning in 2018. 

First Quarter Product and Pipeline Update

The Company provided the following updates on selected product and pipeline programs:

Inflammation 

TEZSPIRE

• In February, data were presented at the American Academy of Allergy, Asthma, and Immunology Annual meeting that demonstrated reductions in the annualized asthma exacerbation rate across biomarker subgroups of patients with severe asthma and consistent efficacy throughout the year, regardless of season.
• The WAYFINDER Phase 3b study, designed to demonstrate a reduction in oral corticosteroid use in adult participants with severe asthma on long-term oral corticosteroid therapy, was initiated.
• The PASSAGE Phase 4 real-world effectiveness study was initiated in adult and adolescent participants with severe asthma, including underrepresented populations such as Black Americans, smokers and patients with asthma-chronic obstructive pulmonary disease overlap.
• A Phase 3 study continues to enroll patients with chronic rhinosinusitis with nasal polyps.
• Planning is underway for a Phase 3 study in patients with eosinophilic esophagitis.
• A Phase 2b study continues to enroll patients with chronic spontaneous urticaria.
• A Phase 2 study continues to enroll patients with chronic obstructive pulmonary disease. 

Otezla

• In March, data were presented at the American Academy of Dermatology Association meeting. Among others, the Company presented new results from both the ADVANCE and PROMINENT Phase 3 studies reinforcing the efficacy of Otezla in patients with mild to moderate plaque psoriasis, and results from the Phase 2 Japanese trial (PPP-001) in palmoplantar pustulosis (PPP). Results from PPP-001 indicated that Otezla was associated with statistically significant improvements in the primary endpoint and all secondary endpoints vs. placebo.
• In March, a Phase 3 study for the treatment of Japanese patients with PPP was initiated. 

Rocatinlimab (AMG 451 / KHK4083)

• Phase 3 planning continues for rocatinlimab, an anti-OX40 monoclonal antibody being investigated in patients with heterogeneous moderate to severe atopic dermatitis.
• Rocatinlimab binds activated pathogenic T-cells expressing OX40. Through its unique mechanism of action, rocatinlimab inhibits and prevents the expansion of activated pathogenic T-cells, and reduces their number.
• Initiation of the comprehensive ROCKET Phase 3 program is anticipated in mid-2022. 

Rozibafusp alfa (AMG 570)

• A Phase 2b study of rozibafusp alfa, an antibody-peptide conjugate that simultaneously blocks inducible T-cell costimulatory ligand (ICOSL) and B-cell activating factor (BAFF) activity, continues to enroll patients with systemic lupus erythematosus (SLE). 

Efavaleukin alfa (AMG 592)

• A Phase 2b study of efavaleukin alfa, an interleukin-2 (IL-2) mutein Fc fusion protein, continues to enroll patients with SLE while a Phase 2 study continues to enroll patients with ulcerative colitis. 

Ordesekimab (AMG 714 / PRV-015)

• A Phase 2b study of AMG 714, a monoclonal antibody that binds interleukin-15 (IL-15), continues to enroll patients with nonresponsive celiac disease.

Oncology 

LUMAKRAS/LUMYKRAS

• LUMAKRAS/LUMYKRAS is now approved in nearly 40 countries for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy. Regulatory reviews continue in other jurisdictions.
• In April, data were presented at the American Association for Cancer Research annual meeting on the long-term outcomes from a two-year analysis of the CodeBreak 100 trial in patients with KRAS G12C-mutated advanced NSCLC. These data showed that 32.5% of patients were still alive at two years and that prolonged tumor response was also observed with a 40.7% objective response rate by central review. There were no new safety signals reported over the course of this 2-year follow-up analysis.
• In February, data were presented at the American Society of Clinical Oncology plenary series demonstrating a centrally confirmed objective response rate of 21% and disease control rate of 84% in 38 patients with heavily pre-treated advanced pancreatic cancer. The Company continues to explore the benefit of LUMAKRAS in this setting.
• Initial data from cohorts exploring LUMAKRAS in combination with the anti-programmed cell death 1 protein (PD-1) antibody pembrolizumab in patients with KRAS G12C-mutated NSCLC were submitted to a medical congress taking place in the late summer.
• Initial data from cohorts exploring LUMAKRAS in combination with the Src homology-2 domain-containing protein tyrosine phosphatase-2 (SHP2) inhibitor RMC-4630 from Revolution Medicines in patients with KRAS G12C-mutated NSCLC were submitted to a medical congress taking place in the late summer.
• Top-line results from the event-driven, confirmatory Phase 3 study comparing LUMAKRAS to docetaxel in patients with KRAS G12C-mutated advanced NSCLC are expected in Q3-2022.
• Top-line results from a study comparing the 960 mg/day dose of LUMAKRAS with a lower dose of 240 mg/day in patients with KRAS G12C-mutated advanced NSCLC are expected in Q4-2022.
• A Phase 2 study in first-line patients with KRAS G12C-mutated NSCLC whose tumors express serine/threonine kinase 11 (STK11) mutations and/or less than 1% programmed death-ligand 1 continues to enroll.
• A Phase 3 study of LUMAKRAS in combination with Vectibix in third-line KRAS G12C-mutated colorectal cancer is enrolling patients.

Bemarituzumab

• A Phase 3 study (FORTITUDE-101) of bemarituzumab, a fibroblast growth factor receptor 2b (FGFR2b) targeting monoclonal antibody plus chemotherapy, versus placebo plus chemotherapy in first-line gastric cancer with FGFR2b overexpression continues to enroll patients.
• A Phase 1b/3 study (FORTITUDE-102) of bemarituzumab plus chemotherapy and nivolumab versus chemotherapy and nivolumab in first-line gastric cancer with FGFR2b overexpression continues to enroll patients.
• A Phase 1b study (FORTITUDE-103) of bemarituzumab plus oral chemotherapy regimens in first-line gastric cancer with FGFR2b overexpression was initiated.
• A Phase 1b study (FORTITUDE-201) of bemarituzumab monotherapy and in combination with docetaxel is enrolling patients with squamous NSCLC with FGFR2b overexpression.
• Planning is underway for a signal-seeking basket study in other solid tumors.

Tarlatamab (AMG 757)

• DeLLphi-301, a potentially registrational Phase 2 study of tarlatamab, an HLE BiTE molecule targeting delta-like ligand 3 (DLL3), for the treatment of relapsed/refractory small cell lung cancer (SCLC) after two or more prior lines of treatment continues to enroll patients.
• A Phase 1b study of tarlatamab in combination with AMG 404 continues to enroll patients with second-line or later SCLC.
• DeLLphi-303, a Phase 1b study, testing tarlatamab in combination with standard of care in first-line SCLC, is on track to start enrolling patients this quarter.
• Updated exploration and first expansion Phase 1 data of tarlatamab in patients with relapsed/refractory SCLC were submitted to a medical congress taking place in late summer.
• A Phase 1b study of tarlatamab continues to enroll patients with de novo or treatment emergent neuroendocrine prostate cancer.

Acapatamab (AMG 160)

• Data continue to mature in a dose-expansion cohort of acapatamab, a half-life extended (HLE) BiTE molecule targeting prostate-specific membrane antigen (PSMA) for the treatment of patients with metastatic castrate-resistant prostate cancer (mCRPC). Decision-enabling data are expected in H1 2022.
• A master protocol evaluating combinations with acapatamab continues to enroll patients with earlier-line mCRPC. 

AMG 340

• A Phase 1 dose-escalation study of AMG 340, a lower T-cell affinity BiTE molecule targeting PSMA, is enrolling patients with mCRPC.

AMG 509

• A Phase 1 dose-escalation study of AMG 509, a bi-specific molecule targeting six-transmembrane epithelial antigen of prostate 1 (STEAP1) continues to enroll patients with mCRPC.

AMG 193

• A Phase 1/1b/2 study of AMG 193, a novel small-molecule methylthioadenosine (MTA) cooperative protein arginine methyltransferase 5 (PRMT5) molecular glue, continues to enroll patients with advanced methylthioadenosine phosphorylase (MTAP)-null solid tumors.

AMG 330

• Development of AMG 330, a BiTE molecule targeting CD33, being investigated for the treatment of acute myeloid leukemia (AML) has been discontinued based on the overall benefit:risk profile observed and the Company's on-going efforts to prioritize programs with the greatest potential  benefit to AML patients. These on-going programs include AMG 176, a small-molecule inhibitor of myeloid cell leukemia 1 (MCL-1) and AMG 427, an HLE BiTE molecule targeting anti-fms-like tyrosine kinase 3 (FLT3).

General Medicine

Repatha

• In April, the Company announced results from two Repatha open label extension (OLE) studies (FOURIER-OLE) designed to assess the long-term safety and tolerability of Repatha in more than 6,600 high-risk adults with clinically evident atherosclerotic cardiovascular disease.
• In the OLE studies, patients received Repatha for approximately 5 years, with some patients receiving Repatha for up to 8.5 years in aggregate across the FOURIER and OLE studies.
• No new long-term safety findings were observed.
• Medically significant and sustained reduction in low-density lipoprotein cholesterol (LDL-C) levels were observed, with more than 85 percent of patients achieving an LDL-C level of