On October 31, 2023 Amgen (NASDAQ:AMGN) reported financial results for the third quarter of 2023 (Press release, Amgen, OCT 31, 2023, View Source [SID1234636513]).
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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 (blinatumomab), EVENITY (romosozumab-aqqg), Repatha (evolocumab) and Nplate (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.
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 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 (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 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 (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 (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 (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 (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 (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/AMGEVITA (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 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 (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 (carfilzomib) sales increased 10% year-over-year for the third quarter, primarily driven by 8% volume growth.
LUMAKRAS/LUMYKRAS (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 (denosumab) sales increased 5% year-over-year for the third quarter, driven by higher net selling price.
Nplate 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 (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 (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 (epoetin alfa), Aranesp (darbepoetin alfa), Parsabiv (etelcalcetide) and Neulasta (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.
Product Sales Detail by Product and Geographic Region
$Millions, except percentages
Q3 ’23
Q3 ’22
YOY Δ
US
ROW
TOTAL
TOTAL
TOTAL
Repatha
$ 183
$ 223
$ 406
$ 309
31 %
Prolia
673
313
986
862
14 %
EVENITY
214
93
307
201
53 %
Aimovig
88
6
94
107
(12 %)
TEZSPIRE
161
—
161
55
*
TAVNEOS
32
5
37
—
NM
Otezla
462
105
567
627
(10 %)
Enbrel
1,026
9
1,035
1,106
(6 %)
AMJEVITA/AMGEVITA
23
129
152
117
30 %
BLINCYTO
147
73
220
142
55 %
Vectibix
116
136
252
247
2 %
KYPROLIS
231
118
349
318
10 %
LUMAKRAS/LUMYKRAS
48
4
52
75
(31 %)
XGEVA
374
145
519
495
5 %
Nplate
322
97
419
288
45 %
MVASI
140
73
213
209
2 %
KANJINTI
7
13
20
72
(72 %)
EPOGEN
50
—
50
136
(63 %)
Aranesp
107
216
323
358
(10 %)
Parsabiv
59
36
95
100
(5 %)
Neulasta
92
32
124
247
(50 %)
Other products**
136
31
167
166
1 %
Total product sales
$ 4,691
$ 1,857
$ 6,548
$ 6,237
5 %
*Change in excess of 100%
**Consists of AVSOLA, RIABNI, Corlanor, NEUPOGEN, IMLYGIC, Sensipar/Mimpara and BEKEMV, as well as sales in prior periods of our divested Bergamo and GENSENTA subsidiaries.
NM = not meaningful
Operating Expense, Operating Margin and Tax Rate Analysis
On a GAAP basis:
Total Operating Expenses increased 22%. Cost of Sales margin increased 2.1 percentage points, primarily driven by higher profit share, higher amortization expense from acquisition-related assets and changes in product mix. Research & Development (R&D) expenses decreased 3%, as lower spend in research and early pipeline was partially offset by higher spend in later-stage clinical programs and marketed products. Selling, General & Administrative (SG&A) expenses increased 5%, primarily driven by higher general and administrative expenses, including higher acquisition-related expenses. Other operating expenses consisted of a net impairment charge for AMG 340.
Operating Margin as a percentage of product sales decreased 11.7 percentage points to 30.9%.
Tax Rate increased 0.7 percentage points, primarily driven by the 2022 Puerto Rico tax law change that replaced the excise tax with an income tax beginning in 2023, partially offset by net favorable items and earnings mix, including the tax benefit from the net impairment charge for AMG 340.
On a non-GAAP basis:
Total Operating Expenses increased 4%. Cost of Sales margin increased 1.3 percentage points, primarily driven by higher profit share and changes in product mix. R&D expenses decreased 2%, as lower spend in research and early pipeline was partially offset by higher spend in later-stage clinical programs and marketed products. SG&A expenses increased 1%.
Operating Margin as a percentage of product sales decreased 0.5 percentage points in the third quarter to 52.0%.
Tax Rate increased 3.2 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 earnings mix.
Cash Flow and Balance Sheet
The Company generated $2.5 billion of free cash flow in the third quarter of 2023 versus $2.8 billion in the third quarter of 2022.
The Company’s third quarter 2023 dividend of $2.13 per share was declared on August 1, 2023, and was paid on September 8, 2023, to all stockholders of record as of August 18, 2023, representing a 10% increase from 2022.
Cash and investments totaled $34.7 billion and debt outstanding totaled $60.5 billion as of September 30, 2023.
2023 Guidance
For the full year 2023, the Company now expects:
Total revenues in the range of $28.0 billion to $28.4 billion.
On a GAAP basis, EPS in the range of $11.23 to $12.73, and a tax rate in the range of 14.0% to 15.5%.
On a non-GAAP basis, EPS in the range of $18.20 to $18.80, and a tax rate in the range of 16.5% to 17.0%.
Capital expenditures to be approximately $950 million.
Share repurchases not to exceed $500 million.
Third Quarter Product and Pipeline Update
The Company provided the following updates on selected product and pipeline programs:
Oncology
Tarlatamab (AMG 757)
In October, data were presented from the global Phase 2 DeLLphi-301 study and simultaneously published in the New England Journal of Medicine, evaluating tarlatamab, a first-in-class investigational delta-like ligand 3 (DLL3) targeting BiTE (bispecific T-cell engager) molecule, in patients with advanced-stage small cell lung cancer (SCLC) who had failed two or more prior lines of treatment. With a median follow-up of 10.6 months, an intention-to-treat analysis that included 100 patients at the selected 10 mg dose for tarlatamab demonstrated an objective response rate (ORR; primary endpoint) of 40% (97.5% confidence interval: 29-52). There were no new safety signals observed compared to the Phase 1 study.
Data from the DeLLphi-301 study are being submitted to the U.S. Food and Drug Administration (FDA) which recently granted Breakthrough Therapy Designation to tarlatamab for the treatment of adult patients with extensive-stage SCLC with disease progression on or after platinum-based chemotherapy.
DeLLphi-304, a Phase 3 study comparing tarlatamab with standard of care chemotherapy in second-line SCLC, is enrolling patients.
Two additional Phase 3 studies of tarlatamab in earlier lines of SCLC are planned.
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 protein 1 (PD1) 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, has completed enrollment.
BLINCYTO
In September, based upon the E1910 study, the FDA granted Breakthrough Therapy Designation to BLINCYTO for the treatment of adult and pediatric patients with CD19-positive, Philadelphia chromosome-negative (Ph-), B-cell precursor acute lymphoblastic leukemia (B-ALL) during the consolidation phase of multiphase therapy. Global regulatory authority submissions are planned in late 2023 to early 2024 for the Phase 3 E1910 study conducted by the National Cancer Institute, the Eastern Cooperative Oncology Group and the American College of Radiology Imaging Network (ECOG ACRIN) Cancer Research Group.
In October, National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology1 (NCCN Guidelines) for Pediatric Acute Lymphoblastic Leukemia were updated to broaden the recommendation for BLINCYTO as consolidation to include both early and late first relapse patients with bone marrow relapse with or without extramedullary involvement and adding the COG1331 regimen to the list of recommended treatment regimens.
Golden Gate, a Phase 3 study of BLINCYTO alternating with low-intensity chemotherapy in older adults with newly diagnosed Ph- B-ALL, continues to enroll patients.
A Phase 1/2 study of subcutaneous BLINCYTO in adults with relapsed or refractory Ph- B-ALL continues to enroll patients.
Xaluritamig (AMG 509)
In October, initial data from a Phase 1b study were presented and simultaneously published in Cancer Discovery on xaluritamig, a first-in-class bispecific molecule targeting six-transmembrane epithelial antigen of prostate 1 (STEAP1) demonstrating encouraging anti-tumor activity in heavily pretreated patients with metastatic castrate-resistant prostate cancer (mCRPC). Efficacy was greater at higher doses (doses ≥0.75 mg target dose) where PSA50 was 59% (n=44) and RECIST objective response rate was 41% (n=37). The safety profile was clinically manageable, with CRS that was generally low grade and primarily in cycle 1.
A Phase 1b monotherapy and combination dose-escalation and expansion study of xaluritamig in mCRPC continues to enroll patients.
Two additional Phase 1 studies of xaluritamig to evaluate preliminary efficacy and safety in patients with early prostate cancer are planned.
AMG 193
Initial results from a Phase 1/1b study of AMG 193, a first-in-class small molecule methylthioadenosine (MTA)-cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor, demonstrate promising monotherapy activity across six methylthioadenosine phosphorylase (MTAP)-null tumor types. Dose-limiting adverse events and treatment discontinuations were typically due to gastrointestinal events and were manageable and reversible.
This Phase 1/1b/2 study of AMG 193 continues to enroll patients with advanced MTAP-null solid tumors.
A Phase 1/2 study of AMG 193 in combination with IDE397, an investigational methionine adenosyltransferase 2A (MAT2A) inhibitor, is enrolling patients.
LUMAKRAS/LUMYKRAS
In October, data were presented and simultaneously published in the New England Journal of Medicine from the global Phase 3 CodeBreaK 300 trial evaluating two doses of LUMAKRAS (960 mg or 240 mg) in combination with Vectibix. Both doses demonstrated a statistically significant superiority in PFS over the investigator’s choice of standard therapy in patients with chemorefractory KRAS G12C-mutated metastatic colorectal cancer (CRC). No new safety signals were observed. Discussions continue with regulatory agencies on a potential approval pathway for this indication.
In September, LUMAKRAS was included in the colon cancer and the rectal cancer NCCN Guidelines1 (category 2A) and is recommended for treatment of previously treated metastatic colorectal or rectal cancer with KRAS G12C-mutated tumors in combination with cetuximab or panitumumab.
The Company is planning to initiate a Phase 3 study of LUMAKRAS in combination with Vectibix and FOLFIRI in first-line KRAS G12C-mutated CRC.
In September, data were presented from an arm of the CodeBreaK 101 clinical trial, a Phase 1b study evaluating LUMAKRAS with carboplatin and pemetrexed in adult patients with KRAS G12C-mutated advanced NSCLC. LUMAKRAS treatment resulted in encouraging objective response rates and disease control rates in first-line and second-line patients.
A global, randomized Phase 3 study of LUMAKRAS plus chemotherapy vs. pembrolizumab plus chemotherapy in first-line KRAS G12C-mutated and programmed cell death protein ligand-1 (PD-L1) negative advanced NSCLC was initiated.
Regulatory review by the FDA and the European Medicines Agency (EMA) of the CodeBreaK 200 Phase 3 trial of previously treated patients with KRAS G12C-mutated advanced NSCLC, along with data from the Phase 2 dose comparison substudy, is ongoing.
In November, data2 comparing sotorasib 960 mg versus 240 mg in adults with pretreated KRAS G12C-mutated advanced NSCLC will be presented at a European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Plenary session.
Bemarituzumab
FORTITUDE-101, a Phase 3 study of bemarituzumab, a first-in-class 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-301, a Phase 1b/2 basket study of bemarituzumab monotherapy in solid tumors with FGFR2b overexpression, is ongoing.
FORTITUDE-201, a Phase 1b study of bemarituzumab monotherapy and in combination with standard of care therapy, in squamous NSCLC with FGFR2b overexpression, will be discontinued.
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 will be discontinued.
General Medicine
Maridebart cafraglutide (AMG 133)
A Phase 2 study of maridebart cafraglutide, 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 has completed enrollment with topline data anticipated in late 2024.
AMG 786
A Phase 1 study of AMG 786, a small molecule obesity program, is ongoing with initial data readout anticipated in H1 2024. This molecule has a different target than AMG 133 and is not an incretin-based therapy.
Olpasiran (AMG 890)
A Phase 3 cardiovascular outcomes study of olpasiran, a potentially best-in-class small interfering ribonucleic acid (siRNA) molecule that reduces lipoprotein(a) (Lp(a)) synthesis in the liver, in participants with atherosclerotic cardiovascular disease and elevated Lp(a) continues to enroll patients.
In August, data were presented from the final analysis of the Phase 2 OCEAN(a)-DOSE study. The results from the off-treatment extension period (at least 24 weeks since the last dose) show that patients previously dosed every 12 weeks for up to 36 weeks with ≥ 75 mg of olpasiran sustained a ~ 40-50% placebo-adjusted percent reduction in Lp(a) nearly a year after the last dose. No new safety concerns were identified during the off-treatment extension period.
Repatha
New data from the FOURIER Open Label Extension (OLE) study reinforcing the safety and efficacy of Repatha, including results from the evaluation of long-term neurocognitive safety in atherosclerotic cardiovascular disease patients treated with Repatha, will be presented at the American Heart Association Scientific Sessions in November.
EVOLVE-MI, a Phase 4 study of Repatha administered shortly after an acute myocardial infarction and designed to reduce the risk of cardiovascular events in hospitalized acute coronary syndrome patients, continues to enroll patients.
A Phase 3 cardiovascular outcomes study (VESALIUS-CV) in patients at high cardiovascular risk without prior myocardial infarction or stroke is ongoing.
Inflammation
TEZSPIRE
In severe asthma, the WAYFINDER Phase 3b study is fully enrolled. The PASSAGE Phase 4 real-world effectiveness study and the SUNRISE Phase 3 study continue to enroll patients.
A Phase 3 study of TEZSPIRE in chronic rhinosinusitis with nasal polyps is fully enrolled.
A Phase 3 study of TEZSPIRE in eosinophilic esophagitis continues to enroll patients.
A Phase 2 study of TEZSPIRE in chronic obstructive pulmonary disease is fully enrolled. Data readout is anticipated in H1 2024.
A Phase 2b study of TEZSPIRE in chronic spontaneous urticaria did not meet the primary endpoint comparing tezepelumab with placebo in the overall and anti-IgE-naïve populations at week 16. By the end of the study at week 32 (18 weeks after last dose), a sustained treatment effect was observed in both tezepelumab dose groups in anti-IgE naïve patients. The Company and its partner AstraZeneca are determining next steps for this indication and plan to publish full results in the future.
Rocatinlimab (AMG 451/KHK4083)
In October, three posters of post-hoc analysis data from the Phase 2b study of rocatinlimab, a first-in-class anti-OX40 monoclonal antibody, in patients with moderate to severe atopic dermatitis were presented. These included patient reported outcomes data demonstrating the benefit of rocatinlimab.
The ROCKET Phase 3 program, composed of seven studies evaluating rocatinlimab in moderate to severe atopic dermatitis, continues to enroll adult and adolescent patients. To date, over 1,500 patients have been randomized into the ROCKET program.
A Phase 2 study of rocatinlimab in moderate to severe uncontrolled asthma is planned.
Otezla
In October, results were presented from the DISCREET Phase 3 study which demonstrated that Otezla treated patients across subgroups experienced greater improvement in genital psoriasis and genital itch at week 16 compared to placebo, with women achieving numerically greater responses.
A Phase 3 study evaluating the efficacy and safety of Otezla in Japanese patients with palmoplantar pustulosis successfully met the primary and secondary endpoints.
TAVNEOS
Data will be presented from the ADVOCATE study at the American College of Rheumatology and American Society of Nephrology Scientific sessions in November on the efficacy and safety of TAVNEOS in key sub-groups including patients 65 years old and older and patients with renal involvement.
Efavaleukin alfa (AMG 592)
A Phase 2b study of efavaleukin alfa, an interleukin 2 (IL 2) mutein Fc fusion protein, 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.
Biosimilars
The clinical comparative study portion of a randomized, double-blind pivotal study evaluating pharmacokinetic (PK) similarity of ABP 206 compared with OPDIVO (nivolumab) in resected stage III or stage IV melanoma patients in the adjuvant setting was initiated.
The FDA accepted the Biologics License Application for ABP 938, an investigational biosimilar to EYLEA (aflibercept).
1National Comprehensive Cancer Network (NCCN) makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
2 Previously provided in the publicly available ODAC briefing book.
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, a Sanofi company. For the purposes of the collaboration, Provention Bio conducts a clinical trial and leads certain development and regulatory activities for the program.
Xaluritamig, formerly AMG 509, is being developed pursuant to a research collaboration with Xencor, Inc.
IDE397 is an investigational MAT2A inhibitor from IDEAYA Biosciences.
OPDIVO is a registered trademark of Bristol-Myers Squibb Company.
EYLEA is a registered trademark of Regeneron Pharmaceuticals, Inc.