On April 27, 2023 Amgen (NASDAQ:AMGN) reported its financial results for the first quarter of 2023 (Press release, Amgen, APR 27, 2023, View Source [SID1234630586]).
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"We delivered 14% volume growth driven by the breadth of our portfolio and strong demand for our products globally," said Robert A. Bradway, chairman and chief executive officer. "We look forward to closing the acquisition of Horizon Therapeutics and joining forces to reach more patients around the world with their innovative medicines."
Key results include:
Total revenues decreased 2% to $6.1 billion in comparison to the first quarter of 2022, resulting from lower Other Revenue from our COVID-19 manufacturing collaboration, partially offset by a 2% increase in product sales. Product sales growth was driven by 14% volume growth, partially offset by 5% lower net selling price, 3% unfavorable changes to estimated sales deductions, 2% lower inventory levels and 2% negative impact from foreign exchange. Excluding the 2% negative impact of foreign exchange on product sales, total revenues were largely unchanged from Q1 2022.
Volume growth of 14% included double-digit volume growth from EVENITY (romosozumab-aqqg), BLINCYTO (blinatumomab), Nplate (romiplostim), LUMAKRAS/LUMYKRAS (sotorasib), AMJEVITA/AMGEVITA (adalimumab), Repatha (evolocumab), KYPROLIS (carfilzomib) and Vectibix (panitumumab).
Ex-U.S. volume grew 22%, including 47% volume growth in the Asia Pacific region.
GAAP earnings per share (EPS) increased 97% from $2.68 to $5.28, driven by other income due to a mark-to-market gain on our investment in BeiGene, Ltd. and lower weighted-average shares outstanding in Q1 2023.
GAAP operating income decreased from $2.5 billion to $1.9 billion, and GAAP operating margin decreased 10.7 percentage points to 32.9%.
Non-GAAP EPS decreased 6% from $4.25 to $3.98, driven by decreased revenues and higher operating expenses, primarily related to research & development, in Q1 2023.
Non-GAAP operating income decreased from $3.1 billion to $2.8 billion, and non-GAAP operating margin decreased 6.5 percentage points to 48.3%.
The Company generated $0.7 billion of free cash flow for the first quarter of 2023 versus $2.0 billion in the first quarter of 2022, driven by the timing of payments for sales incentives, rebates and discounts, lower operating income, and higher capital expenditures from the build-out of our new North Carolina and Ohio facilities.
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 and product sales adjusted for foreign exchange impact" (computed by converting our current period local currency product sales using the prior period foreign exchange rates and comparing that to our current period product sales) 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 2023 versus the first quarter of 2022. Unit volumes grew 14%, partially offset by 5% lower net selling price, 3% unfavorable changes to estimated sales deductions, 2% lower inventory levels and 2% negative impact from foreign exchange.
General Medicine
Repatha sales increased 18% year-over-year to a record $388 million for the first quarter. Volume growth of 33% for the quarter was partially offset by lower net selling price. In the U.S., sales grew 19%, driven by 32% volume growth, partially offset by lower net selling price and inventory levels. Outside the U.S., sales grew 16%, driven by 34% volume growth, partially offset by lower net selling price and unfavorable foreign exchange impact. Repatha remains the global proprotein convertase subtilisin/kexin type 9 (PCSK9) segment leader, with over 1.7 million patients treated since launch.
Prolia (denosumab) sales increased 9% year-over-year for the first quarter, driven by 8% volume growth.
EVENITY sales increased 49% year-over-year to a record $254 million for the first quarter, primarily driven by strong volume growth across our markets. U.S. volumes grew 43% year-over-year and volumes outside the U.S. grew 77%.
Aimovig (erenumab-aooe) sales decreased 32% year-over-year for the first quarter, driven by unfavorable changes to estimated sales deductions and lower net selling price. For 2023, we expect continued year-over-year net selling price declines in order to maintain broad formulary access for patients in response to competitive dynamics.
Inflammation
TEZSPIRE (tezepelumab-ekko) generated $96 million of sales in the first quarter, driven by strong adoption in the U.S. by both allergists and pulmonologists. Quarter-over-quarter sales increased 22%, driven by volume growth. Healthcare providers appreciate 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. During the first quarter, the U.S. Food and Drug Administration (FDA) approved TEZSPIRE for self-administration in a pre-filled, single-use pen, which improves accessibility and provides more flexibility in treatment options for patients in the U.S.
TAVNEOS (avacopan) generated $23 million of sales in the first quarter. Quarter-over-quarter sales increased 10%, driven by higher net selling price and inventory levels, partially offset by lower ex-U.S. volume driven by the timing of shipments to our ex-U.S. partner in the fourth quarter of 2022. U.S volume grew 27% quarter-over-quarter, driven by an increase in new patients starting treatment.
Otezla (apremilast) sales decreased 13% year-over-year for the first quarter, driven by lower inventory levels and net selling price, partially offset by 5% volume growth. Otezla followed the historical pattern of lower first quarter 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 worked through deductibles. U.S. sales in the first quarter were also impacted by lower specialty pharmacy inventory levels compared to previous years, and price declines resulting from patient mix and additional rebates to improve the quality of coverage. In the U.S., Otezla new patient demand was impacted by free drug programs for newly launched topical and systemic competitors. We expect new patient demand to continue to be impacted by free drug programs from newly launched competition throughout 2023.
We continue to see strong growth potential for Otezla given its established efficacy and safety profile, strong payor 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 that cannot be optimally addressed by a topical and can benefit from a systemic treatment like Otezla.
Enbrel (etanercept) sales decreased 33% year-over-year for the first quarter, driven by decline in net selling price, lower inventory levels in the distribution channel compared to previous years and a 9% unfavorable impact of changes to estimated sales deductions related to prior periods. Consistent with Otezla, sales in the first quarter were also impacted by typical patterns of benefit plan changes and higher co-pay expenses. Year-over-year volume was flat in the first quarter, with U.S. volume growing 1%, supported by improved payor coverage. For the remainder of 2023, we expect low single-digit volume growth, reduced year-over-year decline in net selling price and a gradual recovery in inventory levels.
AMJEVITA/AMGEVITA sales increased 52% year-over-year to a record $164 million for the first quarter, driven by higher inventory levels and 35% volume growth, partially offset by unfavorable foreign exchange impact. AMJEVITA launched in the U.S. early in the first quarter, and a majority of U.S. sales in the quarter were related to inventory build.
Hematology-Oncology
BLINCYTO sales increased 41% year-over-year to a record $194 million for the first quarter, driven by 49% volume growth supported by strong adoption across academic and community centers.
Vectibix sales increased 16% year-over-year for the first quarter, driven by 15% volume growth supported by positive data from the Phase 3 PARADIGM trial demonstrating the superiority of Vectibix over bevacizumab in combination with chemotherapy.
KYPROLIS sales increased 25% year-over-year to a record $358 million for the first quarter, driven by 18% volume growth, higher net selling price and strong global execution.
LUMAKRAS/LUMYKRAS generated $74 million of sales for the first quarter. Year-over-year sales increased 19% for the first quarter, driven by 40% volume growth, partially offset by lower net selling price. Outside the U.S., LUMYKRAS has been approved in 50 countries around the world. We are actively launching in over 30 markets and pursuing reimbursement in the remaining countries.
XGEVA (denosumab) sales increased 7% year-over-year for the first quarter, driven by higher net selling price and 4% volume growth.
Nplate sales increased 36% year-over-year for the first quarter, driven by 41% volume growth. Nplate sales in the first quarter included $82 million related to an order from the U.S. government.
MVASI (bevacizumab-awwb) sales decreased 17% year-over-year for the first quarter, driven by lower net selling price, partially offset by 15% volume growth. The published first quarter Average Selling Price (ASP) for MVASI in the U.S. declined 27% year-over-year and increased 5% quarter-over-quarter. Going forward, we expect continued net selling price erosion driven by increased competition.
KANJINTI (trastuzumab-anns) sales decreased 51% year-over-year for the first quarter, driven by lower net selling price and volume. The published first quarter ASP for KANJINTI in the U.S. declined 36% year-over-year and increased 3% quarter-over-quarter. Going forward, we expect continued net selling price erosion and declining volume driven by increased competition.
Established Products
Total sales of our established products, which include EPOGEN (epoetin alfa), Aranesp (darbepoetin alfa), Parsabiv (etelcalcetide), and Neulasta (pegfilgrastim), decreased 17% year-over-year for the first quarter, driven by lower net selling price, unfavorable changes to estimated sales deductions, and lower volume. The published first quarter ASP for Neulasta in the U.S. declined 26% year-over-year and increased 3% 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
Q1 ’23
Q1 ’22
YOY Δ
US
ROW
TOTAL
TOTAL
TOTAL
Repatha
197
191
388
329
18 %
Prolia
623
304
927
852
9 %
EVENITY
164
90
254
170
49 %
Aimovig
64
5
69
101
(32 %)
TEZSPIRE
96
—
96
7
*
TAVNEOS
23
—
23
—
NM
Otezla
294
98
392
451
(13 %)
Enbrel
564
15
579
862
(33 %)
AMJEVITA/AMGEVITA
51
113
164
108
52 %
BLINCYTO
126
68
194
138
41 %
Vectibix
111
122
233
201
16 %
KYPROLIS
234
124
358
287
25 %
LUMAKRAS/LUMYKRAS
48
26
74
62
19 %
XGEVA
384
152
536
502
7 %
Nplate
246
116
362
266
36 %
MVASI
121
81
202
244
(17 %)
KANJINTI
33
14
47
96
(51 %)
EPOGEN
60
—
60
120
(50 %)
Aranesp
115
240
355
358
(1 %)
Parsabiv
58
33
91
86
6 %
Neulasta
211
38
249
348
(28 %)
Other products**
152
41
193
143
35 %
Total product sales
$ 3,975
$ 1,871
$ 5,846
$ 5,731
2 %
*Change in excess of 100%
** Other products include Corlanor, AVSOLA, NEUPOGEN, RIABNI, IMLYGIC and Sensipar/Mimpara, as well as sales by Bergamo and GENSENTA subsidiaries.
NM = not meaningful
Operating Expense, Operating Margin and Tax Rate Analysis
On a GAAP basis:
Total Operating Expenses increased 12%. Cost of Sales margin increased 2.2 percentage points, primarily driven by amortization of intangible assets from acquisitions, asset-related impairments, changes in product mix, and higher profit share. Research & Development (R&D) expenses increased 10%, primarily due to higher investments in late-stage programs, research and the early pipeline, and marketed product support. Selling, General & Administrative (SG&A) expenses increased 2%.
Operating Margin as a percentage of product sales decreased 10.7 percentage points to 32.9%.
Tax Rate increased 5.6 percentage points, primarily driven by the 2022 Puerto Rico tax law change that replaced the excise tax with an income tax beginning in 2023 and an increase in the interest expense on tax reserves.
On a non-GAAP basis:
Total Operating Expenses increased 6%. Cost of Sales margin increased 0.8 percentage points, primarily driven by changes in product mix and higher profit share. R&D expenses increased 12%, due to higher investments in late-stage programs, research and the early pipeline, and marketed product support. SG&A expenses increased 1%.
Operating Margin as a percentage of product sales decreased 6.5 percentage points in the first quarter to 48.3%.
Tax Rate increased 3.7 percentage points, primarily due to the 2022 Puerto Rico tax law change that replaced the excise tax with an income tax beginning in 2023 and an increase in the interest expense on tax reserves.
$Millions, except percentages
GAAP
Non-GAAP
Q1 ’23
Q1 ’22
YOY Δ
Q1 ’23
Q1 ’22
YOY Δ
Cost of Sales
$ 1,720
$ 1,561
10 %
$ 1,016
$ 951
7 %
% of product sales
29.4 %
27.2 %
2.2 pts
17.4 %
16.6 %
0.8 pts
Research & Development
$ 1,058
$ 959
10 %
$ 1,044
$ 934
12 %
% of product sales
18.1 %
16.7 %
1.4 pts
17.9 %
16.3 %
1.6 pts
Selling, General & Administrative
$ 1,258
$ 1,228
2 %
$ 1,224
$ 1,213
1 %
% of product sales
21.5 %
21.4 %
0.1 pts
20.9 %
21.2 %
(0.3) pts
Other
$ 148
$ (10)
*
$ —
$ —
NM
Total Operating Expenses
$ 4,184
$ 3,738
12 %
$ 3,284
$ 3,098
6 %
Operating Margin
operating income as % of product sales
32.9 %
43.6 %
(10.7) pts
48.3 %
54.8 %
(6.5) pts
Tax Rate
17.5 %
11.9 %
5.6 pts
17.8 %
14.1 %
3.7 pts
pts: percentage points
* change in excess of 100%
NM = not meaningful
Cash Flow and Balance Sheet
The Company generated $0.7 billion of free cash flow in the first quarter of 2023 versus $2.0 billion in the first quarter of 2022, driven by the timing of payments for sales incentives, rebates and discounts, lower operating income, and higher capital expenditures from the build-out of our new North Carolina and Ohio facilities.
The Company’s first quarter 2023 dividend of $2.13 per share was declared on December 12, 2022, and was paid on March 8, 2023, to all stockholders of record as of February 15, 2023, representing a 10% increase from 2022.
During the first quarter, there were no repurchases of common stock.
Cash and investments totaled $31.6 billion and debt outstanding totaled $61.6 billion as of March 31, 2023.
$Billions, except shares
Q1 ’23
Q1 ’22
YOY Δ
Operating Cash Flow
$ 1.1
$ 2.2
$ (1.1)
Capital Expenditures
$ 0.3
$ 0.2
$ 0.2
Free Cash Flow
$ 0.7
$ 2.0
$ (1.3)
Dividends Paid
$ 1.1
$ 1.1
$ 0.1
Share Repurchases
$ —
$ 6.3
$ (6.3)
Average Diluted Shares (millions)
538
551
(13)
Note: Numbers may not add due to rounding
$Billions
3/31/23
12/31/22
YTD Δ
Cash and Investments
$ 31.6
$ 9.3
$ 22.3
Debt Outstanding
$ 61.6
$ 38.9
$ 22.7
Note: Numbers may not add due to rounding
2023 Guidance (Excludes any contribution from the announced acquisition of Horizon Therapeutics plc)
The Company expects the announced acquisition of Horizon Therapeutics plc (Horizon) to close in the first half of 2023. For the full year 2023, excluding any contribution from the announced acquisition of Horizon, the Company now expects:
Total revenues in the range of $26.2 billion to $27.3 billion.
On a GAAP basis, EPS in the range of $15.38 to $16.59, and a tax rate in the range of 17.0% to 18.5%.
On a non-GAAP basis, EPS in the range of $17.60 to $18.70, and a tax rate in the range of 18.0% to 19.0%.
Capital expenditures to be approximately $925 million.
Share repurchases not to exceed $500 million.
First Quarter Product and Pipeline Update
The Company provided the following updates on selected product and pipeline programs:
General Medicine
Olpasiran (AMG 890)
A Phase 3 cardiovascular outcomes study of olpasiran, a small interfering RNA molecule that reduces Lp(a) synthesis in the liver, in participants with atherosclerotic cardiovascular disease (ASCVD) and elevated Lipoprotein(a) (Lp(a)), continues to enroll.
In March, a new analysis from the OCEAN(a) Phase 2 Dose study was presented at the American College of Cardiology’s 72nd Annual Scientific Session, together with World Heart Federation’s World Congress of Cardiology. This analysis demonstrated that olpasiran treatment resulted in a placebo-adjusted percentage reduction in Lp(a) of > 95% when dosed 75 mg or higher every 12 weeks irrespective of baseline Lp(a) level in individuals with ASCVD and Lp(a) > 150 nmol/L.
In February, the Company announced the initiation of the African American Heart Study, in collaboration with the Association of Black Cardiologists and the Morehouse School of Medicine. This study will measure the association between Lp(a) and ASCVD in 5,000 African American individuals to better understand the association between Lp(a) levels and incident ASCVD in persons of African American descent.
AMG 133
A Phase 2 study of AMG 133, a multispecific molecule that inhibits the gastric inhibitory polypeptide receptor (GIPR) and activates the glucagon like peptide 1 (GLP 1) receptor, in overweight or obese adults, with or without type 2 diabetes mellitus, continues to enroll.
AMG 786
A small-molecule obesity program continues to enroll patients in a Phase 1 study. This molecule has a different target than AMG 133 and is not an incretin-based therapy.
Repatha
In March, analyses from the Repatha FOURIER and FOURIER open-label extension studies were presented at the American College of Cardiology’s 72nd Annual Scientific Session, together with World Heart Federation’s World Congress of Cardiology, demonstrating that earlier initiation with Repatha was associated with a reduced number of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, unstable angina, or coronary revascularization.
EVOLVE-MI, a Phase 4 study of Repatha administered very early to reduce the risk of cardiovascular events in patients hospitalized with acute myocardial infarction, continues to enroll patients.
Prolia
In May, the Company will present results of the largest head-to-head, real-world study in postmenopausal osteoporosis, comparing fracture risk reduction of Prolia with bisphosphonates at the European Society for Clinical and Economic Aspects of Osteoporosis meeting.
Aimovig
A randomized, double-blind, placebo-controlled Phase 4 trial investigating the efficacy and safety of Aimovig in patients with chronic migraine and medication overuse headache (MOH) met its primary endpoint (absence of MOH at month 6) in the 140 mg dose group. This group also experienced statistically significant improvements on the secondary endpoints of change from baseline in acute headache medication days and sustained MOH remission. Other secondary endpoints were consistent in favoring the Aimovig-treated groups; however, they did not achieve statistical significance with the testing methodology applied. There were no new safety signals observed in the study, and the overall safety profile was consistent with what has been described.
Inflammation
TEZSPIRE
In February, the FDA approved TEZSPIRE for self-administration in a prefilled, single-use pen for patients aged 12 years and older with severe asthma.
In severe asthma, the PASSAGE Phase 4 real-world effectiveness study, the WAYFINDER Phase 3b study and the SUNRISE Phase 3 study continue to enroll patients.
A Phase 3 study of TEZSPIRE in chronic rhinosinusitis with nasal polyps continues to enroll patients.
A Phase 3 study of TEZSPIRE in eosinophilic esophagitis has begun enrolling patients.
A Phase 2b study of TEZSPIRE in chronic spontaneous urticaria is complete, with top-line data anticipated in mid-2023.
A Phase 2 study of TEZSPIRE in chronic obstructive pulmonary disease is fully enrolled. Data read out is anticipated in H1 2024.
Rocatinlimab (AMG 451 / KHK4083)
The ROCKET Phase 3 program, composed of seven studies evaluating rocatinlimab, an anti-OX40 monoclonal antibody, is enrolling adult and adolescent patients with moderate to severe atopic dermatitis.
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, in systemic lupus erythematosus (SLE), was stopped for futility.
Efavaleukin alfa (AMG 592)
A Phase 2b study of efavaleukin alfa, an interleukin-2 (IL-2) mutein Fc fusion protein, in SLE was stopped for futility.
A Phase 2b study of efavaleukin alfa in ulcerative colitis continues to enroll patients.
Ordesekimab (AMG 714 / PRV-015)
A Phase 2b study of AMG 714, a monoclonal antibody that binds interleukin-15, in nonresponsive celiac disease continues to enroll patients.
Oncology
BLINCYTO
Global regulatory authority submissions are planned in H2 2023 for E1910, a Phase 3 trial conducted by the National Cancer Institute, the Eastern Cooperative Oncology Group and the American College of Radiology Imaging Network (ECOG ACRIN) Cancer Research Group that 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 B-cell acute lymphoblastic leukemia (ALL) who were measurable residual disease (MRD) negative following induction and intensification chemotherapy.
Golden Gate, a Phase 3 study of BLINCYTO alternating with low-intensity chemotherapy in older adults with newly diagnosed Philadelphia chromosome negative B-cell ALL, continues to enroll patients.
A Phase 1/2 study of subcutaneous BLINCYTO in adults with relapsed or refractory Philadelphia chromosome negative B-cell ALL continues to enroll patients.
Tarlatamab (AMG 757)
DeLLphi-304, a Phase 3 study comparing tarlatamab, a half-life extended BiTE molecule targeting delta-like ligand 3, with standard of care chemotherapy in second-line small-cell lung cancer (SCLC), will be initiated this month.
DeLLphi-301, a potentially registrational Phase 2 study of tarlatamab being studied in heavily pretreated patients with SCLC, continues to enroll patients. Data readout is anticipated in H2 2023.
DeLLphi-300, a Phase 1 study of tarlatamab in relapsed/refractory SCLC, continues to enroll patients.
DeLLphi-302, a Phase 1b study of tarlatamab in combination with AMG 404, an anti-programmed cell death-1 monoclonal antibody, in second-line or later SCLC, is ongoing.
DeLLphi-303, a Phase 1b study of tarlatamab in combination with standard-of-care in first-line SCLC, continues to enroll patients.
DeLLpro-300, a Phase 1b study of tarlatamab, in de novo or treatment-emergent neuroendocrine prostate cancer, continues to enroll patients.
Bemarituzumab
FORTITUDE-101, a Phase 3 study of bemarituzumab, a fibroblast growth factor receptor 2b (FGFR2b) targeting monoclonal antibody, plus chemotherapy in first-line gastric cancer, continues to enroll patients.
FORTITUDE-102, a Phase 1b/3 study of bemarituzumab plus chemotherapy and nivolumab in first-line gastric cancer, continues to enroll patients in the Phase 3 portion of the study.
FORTITUDE-103, a Phase 1b study of bemarituzumab plus oral chemotherapy regimens with or without nivolumab in first-line gastric cancer, continues to enroll patients.
FORTITUDE-201, a Phase 1b study of bemarituzumab monotherapy and in combination with standard-of-care therapy, in squamous non-small cell lung cancer (NSCLC) with FGFR2b overexpression, continues to enroll patients.
FORTITUDE-301, a Phase 1b/2 basket study of bemarituzumab monotherapy in solid tumors with FGFR2b overexpression, continues to enroll patients in the Phase 2 portion of the study.
LUMAKRAS/LUMYKRAS
The Company continues to investigate novel combinations and is advancing a comprehensive global clinical development program in NSCLC, colorectal cancer (CRC), and other solid tumors to further explore the potential of LUMAKRAS.
A Phase 3 study of LUMAKRAS in combination with Vectibix in third-line CRC is fully enrolled. Data readout is anticipated in H2 2023.
Combination study data of LUMAKRAS in combination with standard of care chemotherapy in NSCLC and LUMAKRAS in combination with Vectibix and standard of care chemotherapy in CRC will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.
In March, the Company completed submission of the LUMAKRAS CodeBreak 200 Phase 3 confirmatory data, along with data from the Phase 2 dose comparison substudy, to the FDA and to the European Medicines Agency (EMA).
In February, results from a Phase 3 multicenter, randomized, open label, active-controlled, study of LUMAKRAS versus docetaxel for the treatment of previously treated locally advanced and unresectable or metastatic NSCLC subjects with mutated KRAS G12C (CodeBreak 200) were published in The Lancet.
Xaluritamig (formerly AMG 509)
A Phase 1 dose-escalation/expansion study of xaluritamig, a bispecific molecule targeting six-transmembrane epithelial antigen of prostate 1 (STEAP1) in metastatic castrate-resistant prostate cancer (mCRPC), continues to enroll patients. Initial data readout is anticipated in H2 2023.
AMG 340
A Phase 1 dose-escalation study of AMG 340, a lower T-cell affinity BiTE molecule targeting prostate-specific membrane antigen (PSMA), in mCRPC, continues to enroll patients.
AMG 193
A Phase 1/1b/2 study of AMG 193, a small-molecule methylthioadenosine (MTA)-cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor, continues to enroll patients with advanced methylthioadenosine phosphorylase (MTAP)-null solid tumors.
Biosimilars
In April 2023, the European Commission (EC) granted marketing authorization for BEKEMV (eculizumab, formerly ABP 959), a biosimilar to SOLIRIS (eculizumab). BEKEMV is the first biosimilar to SOLIRIS approved by the EC. BEKEMV is approved only for the treatment of adults and children with paroxysmal nocturnal hemoglobinuria (PNH), a rare, life-threatening bone marrow disorder. In February, the Company submitted the U.S. Biologics License Application to the FDA for this molecule.
A Phase 3 switching study to support an interchangeability designation in the U.S. for AMJEVITA, using an investigational high-concentration formulation of AMJEVITA (ABP 501, 100 mg/mL) evaluating multiple switches between Humira (adalimumab) and AMJEVITA compared with continued use of Humira, met its primary endpoint of similarity for the primary pharmacokinetics (PK) endpoints, based on a prespecified PK similarity range.
A Phase 3 switching study to support an interchangeability designation in the U.S. for ABP 654, an investigational biosimilar to STELARA (ustekinumab), is ongoing. Data readout is anticipated in H1 2023.
The final analysis from a Phase 3 study evaluating the efficacy and safety of ABP 938, an investigational biosimilar to EYLEA (aflibercept) compared with EYLEA in patients with neovascular age-related macular degeneration, is expected in H1 2023.
TEZSPIRE is being developed in collaboration with AstraZeneca.
Rocatinlimab, formerly AMG 451 / KHK4083 is being developed in collaboration with Kyowa Kirin.
Ordesekimab formerly AMG 714 and also known as PRV-015 is being developed in collaboration with Provention Bio.
AMG 509 is being developed in collaboration with Xencor.
Humira is a registered trademark of AbbVie, Inc.
STELARA is a registered trademark of Janssen Pharmaceutica NV.
EYLEA is a registered trademark of Regeneron Pharmaceuticals, Inc.
SOLIRIS is a registered trademark of Alexion Pharmaceuticals, Inc.
Non-GAAP Financial Measures
In this news release, management has presented its operating results for the first quarters of 2023 and 2022, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2023 EPS and tax guidance in accordance with GAAP and on a non-GAAP basis. These non-GAAP financial measures are computed by excluding certain items related to acquisitions, divestitures, restructuring and certain other items from the related GAAP financial measures. Beginning January 1, 2022, following industry guidance from the U.S. Securities and Exchange Commission, the Company no longer excludes adjustments for upfront license fees, development milestones and in-process research and development (IPR&D) expenses of pre-approval programs related to licensing, collaboration and asset acquisition transactions from its non-GAAP financial measures. GAAP financial measures are included in the news release. Management has presented Free Cash Flow (FCF), which is a non-GAAP financial measure, for the first quarter of 2023 and 2022. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP. Management has also presented Total Revenues and Product Sales Adjusted for Foreign Exchange Impact, which is a non-GAAP financial measure, for the first quarter of 2023. Total Revenues and Product Sales Adjusted for Foreign Exchange Impact is computed by converting our current period local currency product sales using the prior period foreign exchange rates and comparing that to our current period product sales.
The Company believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. The Company uses certain non-GAAP financial measures to enhance an investor’s overall understanding of the financial performance and prospects for the future of the Company’s ongoing business activities by facilitating comparisons of results of ongoing business operations among current, past and future periods. The Company believes that FCF provides a further measure of the Company’s liquidity. The Company believes Total Revenues and Product Sales Adjusted for Foreign Exchange Impact provides supplementary information on the Company’s product sales performance by excluding changes in foreign exchange rates between comparative periods.
The Company uses the non-GAAP financial measures set forth in the news release in connection with its own budgeting and financial planning internally to evaluate the performance of the business, including to allocate resources and to evaluate results relative to incentive compensation targets. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.