AMGEN REPORTS THIRD QUARTER FINANCIAL RESULTS
PR Newswire
THOUSAND OAKS, Calif., Oct. 31, 2023
THOUSAND OAKS, Calif., Oct. 31, 2023 — Amgen (NASDAQ:AMGN) today announced financial results for the third quarter of 2023(1) .
“We are excited about our pipeline progress and our operating performance in the third quarter,” said Robert A. Bradway, chairman and chief executive officer. “With the completion of the Horizon acquisition, Amgen has added rare disease medicines that fit well with our broad innovative portfolio.”
Key results include:
-- Total revenues increased 4% to $6.9 billion in comparison to the third
quarter of 2022, resulting from a 5% increase in product sales. Product
sales growth was driven by 11% volume growth, partially offset by 3%
lower net selling price and 3% unfavorable changes to estimated sales
deductions.
-- Volume growth of 11% included double-digit volume growth from
BLINCYTO(R) (blinatumomab), EVENITY(R) (romosozumab-aqqg),
Repatha(R) (evolocumab) and Nplate(R) (romiplostim).
-- U.S. volume grew 11% and ex-U.S. volume grew 12%, including 27%
volume growth in the Asia Pacific region.
-- GAAP earnings per share (EPS) decreased 19% from $3.98 to $3.22, driven
by a net impairment charge in Q3 2023 of approximately $650 million
following a decision to discontinue development of AMG 340, partially
offset by increased revenues.
-- GAAP operating income decreased from $2.7 billion to $2.0 billion,
and GAAP operating margin decreased 11.7 percentage points to
30.9%.
-- Non-GAAP EPS increased 6% from $4.70 to $4.96, driven by increased
revenues, partially offset by higher operating expenses.
-- Non-GAAP operating income increased from $3.3 billion to $3.4
billion, and non-GAAP operating margin decreased 0.5 percentage
points to 52.0%.
-- The Company generated $2.5 billion of free cash flow for the third
quarter of 2023 versus $2.8 billion in the third quarter of 2022.
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.
(1) The accounting impact of this acquisition and the results of operations for Horizon Therapeutics plc will be included in our consolidated financial statements beginning in the fourth quarter of 2023.
Product Sales Performance
Total product sales increased 5% for the third quarter of 2023 versus the third quarter of 2022. Unit volumes grew 11%, partially offset by 3% lower net selling price and 3% unfavorable changes to estimated sales deductions.
General Medicine
-- Repatha(R) sales increased 31% year-over-year for the third quarter,
driven by 44% volume growth, partially offset by lower net selling price.
In the U.S., sales grew 29%, driven by 45% volume growth, partially
offset by lower net selling price resulting from higher rebates to
support and expand access for patients. Outside the U.S., sales grew 34%,
driven by 43% volume growth, partially offset by lower net selling price.
Repatha remains the global proprotein convertase subtilisin/kexin type 9
(PCSK9) segment leader, with over 2 million patients treated since
launch.
-- Prolia(R) (denosumab) sales increased 14% year-over-year for the third
quarter, primarily driven by 7% volume growth and higher net selling
price. We are on track to treat over 7 million patients with Prolia in
2023.
-- EVENITY(R) sales increased 53% year-over-year to a record $307 million
for the third quarter, driven by strong volume growth. U.S. volumes grew
41% year-over-year and volumes outside the U.S. grew 63%.
-- Aimovig(R) (erenumab-aooe) sales decreased 12% year-over-year for the
third quarter, driven by lower net selling price, partially offset by
favorable changes to estimated sales deductions.
Inflammation
-- TEZSPIRE(R) (tezepelumab-ekko) generated $161 million of sales in the
third quarter. Quarter-over-quarter sales increased 21%, driven by 18%
volume growth that benefited from the pre-filled, single-use pen, which
was approved for self-administration by the U.S. Food and Drug
Administration (FDA) in the first quarter. Healthcare providers are
increasingly recognizing 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.
-- TAVNEOS(R) (avacopan) generated $37 million of sales in the third
quarter. Quarter-over-quarter sales increased 23%, driven by volume
growth. U.S. volumes grew 18% quarter-over-quarter. In the U.S.,
approximately 2,300 patients have now been treated with TAVNEOS.
-- Otezla(R) (apremilast) sales decreased 10% year-over-year for the third
quarter, driven by lower net selling price, unfavorable changes to
estimated sales deductions and lower inventory levels, partially offset
by 1% volume growth. In the U.S., net selling price declined, driven by
higher rebates to support and expand access for commercial and Medicare
Part D patients. Otezla demand in the quarter continued to be impacted by
free drug programs for newly launched competition. For the remainder of
2023, we expect demand to be affected by these free drug programs.We
expect future growth for Otezla to be driven by its established efficacy
and safety profile, strong payer coverage with limited prior
authorization requirements and ease of administration. 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 who cannot be optimally addressed by a topical
and can benefit from a systemic treatment like Otezla.
-- Enbrel(R) (etanercept) sales decreased 6% year-over-year for the third
quarter, primarily driven by an 8% decline from unfavorable changes to
estimated sales deductions, resulting from a $47 million favorable
adjustment in the third quarter of 2022 compared to a $37 million
unfavorable adjustment in this quarter. Year-over-year volume increased
1% in the third quarter, driven by an increase in new patients starting
treatment as a result of improved payer coverage. For the remainder of
2023, we expect this improved coverage will lead to growth in new
patients and declining net selling price.
-- AMJEVITA(R)/AMGEVITA(TM) (adalimumab) sales increased 30% year-over-year
for the third quarter, driven by 53% volume growth, partially offset by
lower net selling price. Ex-U.S. sales increased 10% year-over-year,
driven by 22% volume growth, partially offset by lower net selling price.
U.S. sales increased 21% quarter-over-quarter, driven by 41% volume
growth, partially offset by lower inventory levels.
Hematology-Oncology
-- BLINCYTO(R) sales increased 55% year-over-year to a record $220 million
for the third quarter, driven by 56% volume growth, supported by broad
prescribing for patients with B-cell precursor acute lymphoblastic
leukemia.
-- Vectibix(R) (panitumumab) sales increased 2% year-over-year for the third
quarter to a record $252 million, driven by higher net selling price and
4% volume growth, partially offset by unfavorable foreign exchange
impact.
-- KYPROLIS(R) (carfilzomib) sales increased 10% year-over-year for the
third quarter, primarily driven by 8% volume growth.
-- LUMAKRAS(R)/LUMYKRAS(TM) (sotorasib) generated $52 million of sales for
the third quarter. Year-over-year sales decreased 31% for the third
quarter, primarily driven by unfavorable changes to estimated sales
deductions related to ongoing reimbursement negotiations in France.
-- XGEVA(R) (denosumab) sales increased 5% year-over-year for the third
quarter, driven by higher net selling price.
-- Nplate(R) sales increased 45% year-over-year for the third quarter,
driven by 43% volume growth resulting from a $142 million order from the
U.S. government.
-- MVASI(R) (bevacizumab-awwb) sales increased 2% year-over-year for the
third quarter, driven by 17% volume growth and favorable changes to
estimated sales deductions, partially offset by lower net selling price.
The published third quarter Average Selling Price (ASP) for MVASI in the
U.S. declined 19% year-over-year and 1% quarter-over-quarter. Going
forward, we expect continued net selling price erosion driven by
increased competition.
-- KANJINTI(R) (trastuzumab-anns) sales decreased 72% year-over-year for the
third quarter, driven by lower net selling price, unfavorable changes to
estimated sales deductions and volume declines.
Established Products
-- Total sales of our established products, which include EPOGEN(R) (epoetin
alfa), Aranesp(R) (darbepoetin alfa), Parsabiv(R) (etelcalcetide) and
Neulasta(R) (pegfilgrastim), decreased 30% year-over-year for the third
quarter, driven by lower net selling price and volume declines. In the
aggregate, we expect the year-over-year net selling price and volume
erosion for this portfolio of products to continue.