AMGEN REPORTS THIRD QUARTER 2022 FINANCIAL RESULTS


THOUSAND OAKS, Calif., Nov. 3, 2022 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced financial results for the third quarter of 2022. Key results include:

  • Total revenues decreased 1% to $6.7 billion in comparison to the third quarter of 2021, resulting from a 1% decline in global product sales, which reflected 8% volume growth offset primarily by 5% lower net selling price and 2% negative impact from foreign exchange. Excluding the 2% negative impact of foreign exchange on product sales, total revenues increased 2%.

  • GAAP earnings per share (EPS) increased from $3.31 to $3.98 driven by a decrease in operating expenses due to a $0.4 billion licensing-related upfront payment to Kyowa Kirin Co., Ltd. (KKC) in Q3 2021 and lower weighted-average shares outstanding in Q3 2022.

  • Non-GAAP EPS increased from $4.08 to $4.70 driven by a decrease in operating expenses due to a $0.4 billion licensing-related upfront payment to KKC in Q3 2021 and lower weighted-average shares outstanding in Q3 2022.

  • The Company generated $2.8 billion of free cash flow for the third quarter versus $2.2 billion in the third quarter of 2021.

  • 2022 total revenues guidance revised to $26.0$26.3 billion; EPS guidance revised to $11.46$12.17 on a GAAP basis, and $17.25$17.85 on a non-GAAP basis.

“Our medicines generated 8% volume growth in the quarter globally, with 11 products achieving record quarterly sales,” said Robert A. Bradway, chairman and chief executive officer. “This growth reflects the strong underlying demand for our medicines and the value they bring to patients.”

Non-GAAP EPS has been recast due to an update to our non-GAAP policy effective January 1, 2022, resulting in a $0.59 reduction of previously-reported non-GAAP EPS for the third quarter of 2021. Refer to Non-GAAP Financial Measures below for further discussion.

$Millions, except EPS, dividends paid per share and
percentages

Q3 ’22

Q3 ’21

YOY Δ

Total Revenues

$ 6,652

$ 6,706

(1 %)

GAAP Operating Income

$ 2,660

$ 2,378

12 %

GAAP Net Income

$ 2,143

$ 1,884

14 %

GAAP EPS

$ 3.98

$ 3.31

20 %

Non-GAAP Operating Income

$ 3,277

$ 3,052

7 %

Non-GAAP Net Income

$ 2,530

$ 2,324

9 %

Non-GAAP EPS

$ 4.70

$ 4.08

15 %

Dividends Paid Per Share

$ 1.94

$ 1.76

10 %

References in this release to “non-GAAP” measures, measures presented “on a non-GAAP basis,” “free cash flow” (computed by subtracting capital expenditures from operating cash flow) and “total revenues adjusted for foreign currency impact” (computed by converting our current period local currency product sales using the prior period foreign currency exchange rates and comparing that to our current period product sales) refer to non-GAAP financial measures. Beginning January 1, 2022, the Company’s non-GAAP financial measures no longer exclude adjustments for upfront license fees, development milestones and IPR&D expenses of pre-approval programs related to licensing, collaboration and asset acquisition transactions. For purposes of comparability, the non-GAAP financial results for the third quarter of 2021 have been updated to reflect this change. 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 decreased 1% for the third quarter of 2022 versus the third quarter of 2021. Unit volumes grew 8% but were more than offset by 5% lower net selling price, 2% negative impact from foreign exchange, 1% lower inventory levels and 1% unfavorable changes to estimated sales deductions.

General Medicine

  • Prolia® sales increased 7% year-over-year for the third quarter, driven by 8% volume growth.

  • EVENITY® sales increased 35% year-over-year to a record $201 million for the third quarter, driven by strong volume growth across our markets. U.S. volumes grew 45% year-over-year and volumes outside the U.S. grew 30%.

  • Repatha® sales increased 14% year-over-year for the third quarter, driven by 52% volume growth, partially offset by lower net selling price. In the U.S., sales grew 2%, driven by 32% volume growth, offset by lower net selling price resulting from higher rebates to support and expand access for patients. Outside the U.S., sales grew 26%, driven by 73% volume growth partially offset by lower net selling price; this volume growth and lower net selling price were both impacted 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 1.2 million patients treated since launch.

  • Aimovig® (erenumab-aooe) sales increased 35% year-over-year for the third quarter, driven by favorable changes to estimated sales deductions and higher net selling price, partially offset by a 7% decline in volume.

Inflammation

  • TEZSPIRE® (tezepelumab-ekko) generated $55 million of sales in the third quarter, driven by continued strong adoption in the U.S. by both allergists and pulmonologists across patients with all types of severe asthma. Healthcare providers acknowledge 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 and biomarker limitation.

  • Otezla® (apremilast) sales increased 3% year-over-year for the third quarter, driven by 9% volume growth, partially offset by lower inventory levels and unfavorable foreign exchange impact. We expect continued volume growth given Otezla’s unique, broad indication to treat patients suffering from mild, moderate or severe psoriasis.

  • Enbrel® (etanercept) sales decreased 14% year-over-year for the third quarter, driven by lower net selling price, a 5% decline from unfavorable changes to estimated sales deductions, and a 3% decline in volume. The 5% unfavorable impact of changes to estimated sales deductions results from a $114 million favorable adjustment in the third quarter of 2021, more than offsetting a $47 million favorable adjustment in this quarter. Going forward, we expect net selling price to continue to decline year-over-year, driven by increased competition.

  • AMGEVITA™ (adalimumab) sales increased 5% year-over-year for the third quarter, driven by 27% volume growth, partially offset by foreign exchange impact and lower net selling price resulting from increased competition. AMGEVITA continued to be the most prescribed adalimumab biosimilar in Europe.

Hematology-Oncology

  • LUMAKRAS®/LUMYKRAS™ (sotorasib) generated $75 million of sales for the third quarter, driven by volume growth. Quarter-over-quarter sales declined 3% driven by lower net selling price due to an unfavorable price adjustment resulting from a reimbursement approval in Germany, partially offset by 15% volume growth. In the U.S., LUMAKRAS has been prescribed to over 3,700 patients by over 2,200 physicians in both academic and community settings. Outside the U.S., LUMYKRAS has now been approved in over 45 countries around the world. We are actively launching in 30 markets and pursuing reimbursement in the remaining countries.

  • KYPROLIS® (carfilzomib) sales increased 9% year-over-year for the third quarter, driven by 11% volume growth.

  • XGEVA® (denosumab) sales decreased 4% year-over-year for the third quarter, driven by a 3% decline in volume, lower inventory levels, and unfavorable foreign exchange impact, partially offset by higher net selling price.

  • Vectibix® (panitumumab) sales increased 24% year-over-year for the third quarter, driven by volume growth. In the third quarter, volume growth benefited from the timing of shipments to Takeda, our partner in Japan.

  • Nplate® (romiplostim) sales increased 5% year-over-year for the third quarter, primarily driven by 12% volume growth, partially offset by unfavorable changes to estimated sales deductions. In the third quarter, volume growth benefited from increased shipments to KKC, our partner in Japan.

  • BLINCYTO® (blinatumomab) sales increased 14% year-over-year for the third quarter, driven by volume growth.

  • MVASI® sales decreased 24% year-over-year for the third quarter, primarily driven by lower net selling price. The most recently published Average Selling Price (ASP) for MVASI in the U.S. declined 37% year-over-year and 12% quarter-over-quarter. Looking forward, we expect continued net selling price erosion and declining volume driven by increased competition and continued ASP erosion.

  • KANJINTI® (trastuzumab-anns) sales decreased 38% year-over-year for the third quarter, primarily driven by lower net selling price and decline in volume, partially offset by favorable changes to estimated sales deductions. The most recently published ASP for KANJINTI in the U.S. declined 38% year-over-year and 11% quarter-over-quarter. Going forward, we expect continued net selling price deterioration and volume declines driven by increased competition and continued ASP erosion.

Established Products

  • Total sales of our established products, which include Neulasta® (pegfilgrastim), NEUPOGEN® (filgrastim), EPOGEN® (epoetin alfa), Aranesp® (darbepotein alfa), Parsabiv® (etelcalcetide), and Sensipar®/Mimpara™ (cinacalcet), decreased 17% year-over-year for the third quarter, primarily driven by lower net selling price and lower inventory levels. In the third quarter, the published ASP for Neulasta in the U.S. declined 24% year-over-year and 7% quarter-over-quarter. In the aggregate, we expect the year-over-year net selling price and volume erosion for this portfolio of products to continue.

Product Sales Detail by Product and Geographic Region

$Millions, except percentages

Q3 ’22

Q3 ’21

YOY Δ

US

ROW

TOTAL

TOTAL

TOTAL

Prolia®

$ 590

$ 272

$ 862

$ 803

7 %

EVENITY®

136

65

201

149

35 %

Repatha®

142

167

309

272

14 %

Aimovig®

103

4

107

79

35 %

TEZSPIRE®

55

55

NM

Otezla®

529

98

627

609

3 %

Enbrel®

1,086

20

1,106

1,289

(14 %)

AMGEVITA

117

117

111

5 %

LUMAKRAS®/LUMYKRAS

61

14

75

36

*

KYPROLIS®

217

101

318

293

9 %

XGEVA®

363

132

495

517

(4 %)

Vectibix®

106

141

247

200

24 %

Nplate®

162

126



Read More: AMGEN REPORTS THIRD QUARTER 2022 FINANCIAL RESULTS

2022-11-03 13:01:00

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