THOUSAND OAKS, Calif., May 2, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the first quarter 2024.
"With many of our innovative products delivering strong growth and promising new medicines advancing through our pipeline, we are excited about delivering attractive long-term growth," said Robert A. Bradway, chairman and chief executive officer.
Key results include:
- For the first quarter, total revenues increased 22% to $7.4 billion in comparison to the first quarter of 2023. Product sales grew 22%, driven by 25% volume growth.
- Ten products delivered at least double-digit volume growth in the first quarter, including Repatha® (evolocumab), TEZSPIRE® (tezepelumab-ekko), EVENITY® (romosozumab-aqqg), BLINCYTO® (blinatumomab), and TAVNEOS® (avacopan).
- U.S. volume grew 29% and ex-U.S. volume grew 17%.
- Our performance included $914 million of sales from our Horizon Therapeutics (Horizon) acquisition, driven by several first-in-class, early-in-lifecycle medicines, including TEPEZZA® (teprotumumab-trbw), KRYSTEXXA® (pegloticase) and UPLIZNA® (inebilizumab-cdon).
- Excluding sales from Horizon, our product sales grew 6%, driven by volume growth of 9%.
- GAAP loss per share was $0.21 for the first quarter of 2024 compared with GAAP earnings per share (EPS) of $5.28 for the first quarter of 2023, driven by a mark-to-market loss on our BeiGene, Ltd. equity investment and higher operating expenses, including higher amortization expense from Horizon-acquired assets and incremental expenses from Horizon, partially offset by higher revenues.
- GAAP operating income decreased from $1.9 billion to $1.0 billion, and GAAP operating margin decreased 19.0 percentage points to 13.9%.
- Non-GAAP EPS decreased 1% from $3.98 to $3.96, due to higher operating and interest expenses driven by the Horizon acquisition, partially offset by higher revenues.
- Non-GAAP operating income increased from $2.8 billion to $3.1 billion, and non-GAAP operating margin decreased 5.1 percentage points to 43.2%.
- The Company generated $0.5 billion of free cash flow for the first quarter of 2024 versus $0.7 billion in the first quarter of 2023. This decrease was driven by an $800 million tax deposit, partially offset by timing of working capital items.
| 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 22% for the first quarter of 2024 versus the first quarter of 2023, driven by 25% volume growth.
General Medicine
- Repatha® sales increased 33% year-over-year to $517 million in the first quarter, driven by 44% volume growth, partially offset by 13% lower net selling price. Repatha remains the global proprotein convertase subtilisin/kexin type 9 (PCSK9) segment leader, with over 2.9 million patients treated since launch.
- Prolia® (denosumab) generated $999 million of sales in the first quarter. Sales increased 8% year-over-year primarily driven by volume growth.
- EVENITY® sales increased 35% year-over-year to $342 million for the first quarter, primarily driven by volume growth.
Oncology
- BLINCYTO® sales increased 26% year-over-year to $244 million for the first quarter, driven by broad prescribing across academic and community segments for patients with B-cell precursor acute lymphoblastic leukemia (B-ALL).
- Vectibix® (panitumumab) generated $247 million of sales in the first quarter. Sales increased 6% year-over-year driven by higher net selling price and volume growth, partially offset by unfavorable foreign exchange impact.
- KYPROLIS® (carfilzomib) sales increased 5% year-over-year to $376 million for the first quarter, primarily driven by volume growth outside the U.S.
- LUMAKRAS®/LUMYKRAS™ (sotorasib) sales increased 11% year-over-year to $82 million for the first quarter, driven by volume growth.
- XGEVA® (denosumab) sales increased 5% year-over-year to $561 million for the first quarter, primarily driven by volume growth outside the U.S. and higher net selling price, partially offset by lower volume in the U.S.
- Nplate® (romiplostim) generated $317 million of sales in the first quarter. Sales decreased 12% year-over-year, primarily driven by volume decline in comparison to the first quarter of 2023, which included a U.S. government order of $82 million. Excluding the U.S. government order from this comparison, Nplate sales grew 13% year-over-year, primarily driven by volume growth.
- MVASI® (bevacizumab-awwb) generated $202 million of sales in the first quarter. Sales were flat year-over-year for the first quarter. Volume growth was largely offset by lower net selling price and unfavorable changes to estimated sales deductions. Going forward we expect continued net selling price erosion driven by competition.
Inflammation
- TEZSPIRE® generated $173 million of sales in the first quarter. Sales increased 80% year-over-year, primarily driven by volume growth. Healthcare providers recognize TEZSPIRE's unique, differentiated profile and its broad potential to treat the 2.5 million patients worldwide with severe asthma who are uncontrolled, without any phenotypic or biomarker limitation.
- Otezla® (apremilast) generated $394 million of sales in the first quarter. Sales increased 1% year-over-year for the first quarter.
- Enbrel® (etanercept) generated $567 million of sales in the first quarter. Sales decreased 2% year-over-year driven by volume decline, partially offset by higher inventory levels. Moving forward, we expect modest volume growth offset by declining net selling price.
Otezla and Enbrel typically have lower sales in the first quarter relative to subsequent quarters due to the impact of benefit plan changes, insurance reverifications and increased co-pay expenses as U.S. patients work through deductibles.
- AMJEVITA®/AMGEVITA™ (adalimumab) generated $168 million of sales in the first quarter. Sales increased 2% year-over-year primarily driven by international growth, partially offset by lower inventory levels and unfavorable change to estimated sales deductions.
Rare Disease
Except for TAVNEOS®, the products listed below were added through the acquisition of Horizon on Oct. 6, 2023.
- TEPEZZA® (teprotumumab-trbw) generated $424 million of sales in the first quarter. TEPEZZA is the first and only FDA-approved treatment for thyroid eye disease (TED).
- KRYSTEXXA® (pegloticase) generated $235 million of sales in the first quarter. KRYSTEXXA is the first and only FDA-approved treatment for chronic refractory gout.
- UPLIZNA® (inebilizumab-cdon) generated $80 million of sales in the first quarter. UPLIZNA is used to treat adults with neuromyelitis optica spectrum disorders.
- TAVNEOS® generated $51 million of sales in the first quarter. Sales increased 122% year-over-year, driven by volume growth.
- Ultra rare products, which consist of RAVICTI® (glycerol phenylbutyrate), PROCYSBI® (cysteamine bitartrate), ACTIMMUNE® (interferon gamma-1b), BUPHENYL® (sodium phenylbutyrate) andQUINSAIR® (levofloxacin), generated $169 million of sales in the first quarter.
Established Products
- Our established products, which consist of EPOGEN® (epoetin alfa),Aranesp® (darbepoetin alfa),Parsabiv® (etelcalcetide) andNeulasta® (pegfilgrastim), generated $613 million of sales. Sales decreased 19% year-over-year for the first quarter, driven by unfavorable changes to estimated sales deductions and volume declines. In the aggregate, we expect the year-over-year volume declines for this portfolio of products to continue.
Product Sales Detail by Product and Geographic Region
$Millions, except percentages | | Q1 '24 | | Q1 '23 | | YOY Δ |
| | US | | ROW | | TOTAL | | TOTAL | | TOTAL |
Repatha® | | $ 273 | | $ 244 | | $ 517 | | $ 388 | | 33 % |
Prolia® | | 657 | | 342 | | 999 | | 927 | | 8 % |
EVENITY® | | 236 | | 106 | | 342 | | 254 | | 35 % |
BLINCYTO® | | 153 | | 91 | | 244 | | 194 | | 26 % |
Vectibix® | | 120 | | 127 | | 247 | | 233 | | 6 % |
KYPROLIS® | | 234 | | 142 | | 376 | | 358 | | 5 % |
LUMAKRAS®/LUMYKRAS™ | | 53 | | 29 | | 82 | | 74 | | 11 % |
XGEVA® | | 366 | | 195 | | 561 | | 536 | | 5 % |
Nplate® | | 190 | | 127 | | 317 | | 362 | | (12 %) |
MVASI® | | 105 | | 97 | | 202 | | 202 | | — % |
TEZSPIRE® | | 173 | | — | | 173 | | 96 | | 80 % |
Otezla® | | 293 | | 101 | | 394 | | 392 | | 1 % |
Enbrel® | | 561 | | 6 | | 567 | | 579 | | (2 %) |
AMJEVITA®/AMGEVITA™ | | 30 | | 138 | | 168 | | 164 | | 2 % |
TEPEZZA®** | | 419 | | 5 | | 424 | | — | | N/A |
KRYSTEXXA®** | | 235 | | — | | 235 | | — | | N/A |
UPLIZNA®** | | 70 | | 10 | | 80 | | — | | N/A |
TAVNEOS® | | 45 | | 6 | | 51 | | 23 | | * |
Ultra rare products** | | 166 | | 3 | | 169 | | — | | N/A |
EPOGEN® | | 41 | | — | | 41 | | 60 | | (32 %) |
Aranesp® | | 100 | | 249 | | 349 | | 355 | | (2 %) |
Parsabiv® | | 65 | | 40 | | 105 | | 91 | | 15 % |
Neulasta® | | 87 | | 31 | | 118 | | 249 | | (53 %) |
Other products*** | | 301 | | 56 | | 357 | | 309 | | 16 % |
Total product sales | | $ 4,973 | | $ 2,145 | | $ 7,118 | | $ 5,846 | | 22 % |
| | | | | | | | | | |
*Change in excess of 100% | | | | | | | | | | |
**Horizon-acquired products, and the Ultra rare products consist of RAVICTI®, PROCYSBI®, ACTIMMUNE®, BUPHENYL®, and QUINSAIR® |
***Consists of (i) KANJINTI®, Aimovig®, RIABNI®, Corlanor®, NEUPOGEN®, AVSOLA®, IMLYGIC®, Sensipar®/Mimpara™, BEKEMV™, and WEZLANA™/WEZENLA™, where Biosimilars total $176 million in Q1 '24 and $121 million in Q1 '23; and (ii) Horizon-acquired products including RAYOS®, PENNSAID®, and DUEXIS® |
N/A = not applicable | | | | | | | | | | |
Operating Expense, Operating Margin and Tax Rate Analysis
On a GAAP basis:
- Total Operating Expenses increased 54%. Cost of Sales as a percentage of product sales increased 15.6 percentage points driven by higher amortization expense from Horizon acquisition-related assets and, to a lesser extent, higher profit share and royalty expense, partially offset by the Puerto Rico excise tax. Research & Development (R&D) expenses increased 27% due to higher spend in later-stage clinical programs and marketed product support, including Horizon-acquired programs. Selling, General & Administrative (SG&A) expenses increased 44% primarily driven by commercial expenses related to Horizon-acquired products, general and administrative expenses, and acquisition-related costs. Other operating expenses consisted primarily of a net impairment charge for an in-process R&D asset and changes in contingent consideration liabilities, both related to our Teneobio, Inc. acquisition from 2021.
- Operating Margin as a percentage of product sales decreased 19.0 percentage points in the first quarter to 13.9%.
- Tax Rate decreased 83.7 percentage points primarily due to the GAAP net loss described above and the change in earnings mix as a result of the inclusion of the Horizon business.
On a non-GAAP basis:
- Total Operating Expenses increased 33%. Cost of Sales as a percentage of product sales increased 1.4 percentage points driven by higher profit share and royalty expense, partially offset by the Puerto Rico excise tax. R&D expenses increased 26% due to higher spend in later-stage clinical programs and marketed product support, including Horizon-acquired programs. SG&A expenses increased 40%, primarily driven by commercial expenses related to Horizon-acquired products, and general and administrative expenses.
- Operating Margin as a percentage of product sales decreased 5.1 percentage points in the first quarter to 43.2%.
- Tax Rate decreased 2.4 percentage points primarily due to the change in earnings mix as a result of the inclusion of the Horizon business and net favorable items in the quarter.
$Millions, except percentages | | GAAP | | Non-GAAP |
| | Q1 '24 | | Q1 '23 | | YOY Δ | | Q1 '24 | | Q1 '23 | | YOY Δ |
Cost of Sales | | $ 3,200 | | $ 1,720 | | 86 % | | $ 1,340 | | $ 1,016 | | 32 % |
% of product sales | | 45.0 % | | 29.4 % | | 15.6 pts | | 18.8 % | | 17.4 % | | 1.4 pts |
Research & Development | | $ 1,343 | | $ 1,058 | | 27 % | | $ 1,317 | | $ 1,044 | | 26 % |
% of product sales | | 18.9 % | | 18.1 % | | 0.8 pts | | 18.5 % | | 17.9 % | | 0.6 pts |
Selling, General & Administrative | | $ 1,808 | | $ 1,258 | | 44 % | | $ 1,712 | | $ 1,224 | | 40 % |
% of product sales | | 25.4 % | | 21.5 % | | 3.9 pts | | 24.1 % | | 20.9 % | | 3.2 pts |
Other | | $ 105 | | $ 148 | | (29 %) | | $ — | | $ — | | N/A |
Total Operating Expenses | | $ 6,456 | | $ 4,184 | | 54 % | | $ 4,369 | | $ 3,284 | | 33 % |
| | | | | | | | | | | | |
Operating Margin | | | | | | | | | | | | |
operating income as % of product sales | | 13.9 % | | 32.9 % | | (19.0) pts | | 43.2 % | | 48.3 % | | (5.1) pts |
| | | | | | | | | | | | |
Tax Rate | | (66.2) % | | 17.5 % | | (83.7) pts | | 15.4 % | | 17.8 % | | (2.4) pts |
| | | | | | | | | | | | |
pts: percentage points | | | | | | | | | | | | |
N/A = not applicable | | | | | | | | | | | | |
Cash Flow and Balance Sheet
- The Company generated $0.5 billion of free cash flow in the first quarter of 2024 versus $0.7 billion in the first quarter of 2023. This decrease was driven by an $800 million tax deposit, partially offset by timing of working capital items.
- The Company's first quarter 2024 dividend of $2.25 per share was declared on December 12, 2023, and was paid on March 7, 2024, to all stockholders of record as of February 16, 2024, representing a 6% increase from this same period in 2023.
- Cash and investments totaled $9.7 billion and debt outstanding totaled $64.0 billion as of March 31, 2024.
$Billions, except shares | | Q1 '24 | | Q1 '23 | | YOY Δ |
Operating Cash Flow | | $ 0.7 | | $ 1.1 | | $ (0.4) |
Capital Expenditures | | $ 0.2 | | $ 0.3 | | $ (0.1) |
Free Cash Flow | | $ 0.5 | | $ 0.7 | | $ (0.3) |
Dividends Paid | | $ 1.2 | | $ 1.1 | | $ 0.1 |
Share Repurchases | | $ — | | $ — | | $ — |
Average Diluted Shares (millions) | | 536 | | 538 | | (2) |
| | | | | | |
Note: Numbers may not add due to rounding | | | | |
$Billions | | 3/31/24 | | 12/31/23 | | YTD Δ |
Cash and Investments | | $ 9.7 | | $ 10.9 | | $ (1.2) |
Debt Outstanding | | $ 64.0 | | $ 64.6 | | $ (0.6) |
| | | | | | |
Note: Numbers may not add due to rounding | | | | |
2024 Guidance
For the full year 2024, the Company now expects:
- Total revenues in the range of $32.5 billion to $33.8 billion.
- On a GAAP basis, EPS in the range of $7.15 to $8.40, and a tax rate in the range of 9.5% to 11.0%.
- On a non-GAAP basis, EPS in the range of $19.00 to $20.20, and a tax rate in the range of 15.0% to 16.0%.
- Capital expenditures to be approximately $1.1 billion.
- Share repurchases not to exceed $500 million.
FirstQuarter Product and Pipeline Update
The Company provided the following updates on selected product and pipeline programs:
General MedicineMariTide (maridebart cafraglutide, AMG 133)
- A Phase 2 study of MariTide, a multispecific molecule that inhibits the gastric inhibitory polypeptide receptor (GIPR) and activates the glucagon like peptide 1 (GLP-1) receptor, in adults with overweight or obesity with or without type 2 diabetes mellitus is ongoing, with topline data anticipated in late 2024.
- Planning for a comprehensive Phase 3 program across multiple indications remains on track.
AMG 786
- A Phase 1 study of AMG 786, a small molecule obesity program, is complete.
Olpasiran (AMG 890)
- The Ocean(a)-Outcomes trial, a Phase 3 cardiovascular outcomes study of olpasiran in patients with atherosclerotic cardiovascular disease and elevated Lp(a), is fully enrolled. Olpasiran is a potentially best-in-class small interfering ribonucleic acid (siRNA) molecule that reduces lipoprotein(a) (Lp(a)) synthesis in the liver.
Repatha
- EVOLVE-MI, a Phase 4 study of Repatha administered within 10 days of an acute myocardial infarction to reduce the risk of cardiovascular (CV) events, continues to enroll patients.
- VESALIUS-CV, a Phase 3 CV outcomes study of Repatha in patients at high CV risk without prior myocardial infarction or stroke, is ongoing.
- In April, data were presented from the FOURIER trial demonstrating that intensive LDL-C lowering with Repatha may lead to greater relative and absolute CV event reduction in patients with autoimmune or inflammatory diseases.
- In April, data were presented from the FOURIER and FOURIER-OLE studies demonstrating that elderly patients (≥75 years) with atherosclerotic cardiovascular disease derived similar to greater CV benefit compared to younger patients (
