Full Press Release Details
AMGEN REPORTS SECOND QUARTER 2021 FINANCIAL RESULTS
THOUSAND OAKS, Calif. (August 3, 2021) - Amgen (NASDAQ AMGN) today announced financial results for the second quarter of 2021. Key results include
Total revenues increased 5% to $6.5 billion in comparison to the second quarter of 2020, driven by higher unit demand, partially offset by lower net selling prices.
Product sales increased 3% globally, driven by double digit volume growth across a number of our products including Prolia (denosumab), Repatha (evolocumab) and our biosimilar products MVASI (bevacizumab-awwb) and KANJINTI (trastuzumab-anns).
GAAP earnings per share (EPS) decreased 73% to $0.81 driven by the write-off of $1.5 billion in acquired in-process research development (acquired IPR D) associated with our acquisition of Five Prime Therapeutics, partially offset by increased revenues.
GAAP operating income decreased 64% to $0.8 billion and GAAP operating margin decreased 25.8 percentage points to 13.5%.
Non-GAAP EPS increased 4% to $4.38 driven by increased revenues and the impact of fewer weighted average shares outstanding.
Non-GAAP operating income decreased 4% to $3.1 billion and non-GAAP operating margin decreased 4.1 percentage points to 50.9%.
The Company generated $1.7 billion of free cash flow in the second quarter versus $2.7 billion in the second quarter of 2020 driven by a difference in the timing of tax payments.
2021 total revenues guidance reaffirmed at $25.8-$26.6 billion EPS guidance revised to $8.84-$9.90 on a GAAP basis, and reaffirmed at $16.00-$17.00 on a non-GAAP basis.
We achieved solid, volume-driven growth in the quarter as our business recovered from the effects of the pandemic," said Robert A. Bradway, chairman and chief executive officer. As we look to the balance of the year, we are excited to be launching LUMAKRAS , a first-in-class lung cancer treatment, and advancing a robust pipeline of potential new medicines to meet the demands of patients around the world.
AMGEN REPORTS SECOND QUARTER 2021 FINANCIAL RESULTS
| $Millions, except EPS, dividends paid per share and percentages | Q2 '21 | Q2 '20 | YOY | |||||||||||||
| Total Revenues | $ | 6,526 | $ | 6,206 | 5% | |||||||||||
| GAAP Operating Income | $ | 828 | $ | 2,323 | (64%) | |||||||||||
| GAAP Net Income | $ | 464 | $ | 1,803 | (74%) | |||||||||||
| GAAP EPS | $ | 0.81 | $ | 3.05 | (73%) | |||||||||||
| Non-GAAP Operating Income | $ | 3,111 | $ | 3,247 | (4%) | |||||||||||
| Non-GAAP Net Income | $ | 2,522 | $ | 2,484 | 2% | |||||||||||
| Non-GAAP EPS | $ | 4.38 | $ | 4.20 | 4% | |||||||||||
| Dividends Paid Per Share | $ | 1.76 | $ | 1.60 | 10% |
References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis" and to "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. For comparability of results to the prior year, non-GAAP net income and non-GAAP EPS amounts for 2020 have been revised to reflect the update to our non-GAAP policy that excludes gains and losses on certain equity investments. Refer to Non-GAAP Financial Measures below for further discussion.
Product Sales Performance
COVID-19 update Compared to the first quarter of 2021, we have seen gradual recovery from the impacts of the COVID-19 pandemic. Patient visits and lab test procedure trends continued to improve but remained below pre-COVID-19 levels. The cumulative decrease in diagnoses over the course of the pandemic has suppressed the volume of new patients starting treatment, which we expect to continue to impact our business during the second half of the year.
Total product sales increased 3% for the second quarter of 2021 versus the second quarter of 2020. Unit volumes grew 8% while net selling price declined 5%. On a sequential basis, product sales grew 9% quarter-over-quarter, driven by 6% volume growth.
Results for individual products are as follows
Prolia sales increased 24% year-over-year for the second quarter, driven by 20% volume growth as new and repeat patient volumes continued to recover from the pandemic. With osteoporosis diagnosis rates remaining at approximately 90% of pre-COVID-19 levels in the quarter, we are focused on driving patient growth and are optimistic about Prolia's continued strength in the second half of the year.
EVENITY (romosozumab-aqqg) sales increased 30% year-over-year for the second quarter, driven by 32% volume growth. U.S. sales nearly doubled year-over-year, driven by 97% volume growth as we continued to focus on new patient activation. Rest of world (ROW) sales decreased 15% year-over-year due in part to the timing of purchases by our partner Astellas during the first half of 2020.
Repatha sales increased 43% year-over-year for the second quarter, driven by 49% volume growth. In the U.S., volumes grew 37% year-over-year, and outside the U.S. volumes grew 66% year-over-year. Volume growth in the quarter was partially offset by lower net selling price as a result of an increase in the number of U.S. Medicare Part D patients receiving Repatha and entering the coverage gap. We expect further reduction in the net selling price on a sequential basis as the number of Medicare Part D patients receiving Repatha increases. Repatha has now been prescribed for more than one million patients.
AMGEN REPORTS SECOND QUARTER 2021 FINANCIAL RESULTS
Aimovig (erenumab-aooe) sales decreased 16% year-over-year for the second quarter. Unit volume growth of 11% was offset by lower net selling price and unfavorable changes to estimated sales deductions. Aimovig retains strong payer coverage and remains the segment leader within the preventive calcitonin gene-related peptide (CGRP) class. To date, more than 500,000 patients worldwide have been prescribed Aimovig for the preventive treatment of migraine.
Otezla (apremilast) sales decreased 5% year-over-year for the second quarter, primarily driven by unfavorable changes to estimated sales deductions and lower net selling price, partially offset by 5% volume growth. In the U.S., Otezla continued to maintain first-line share leadership in psoriasis. New-to-brand prescription (NBRx) volumes grew 10% year-over-year, even as patient visits to dermatologists remained 15% below pre-pandemic levels. The number of new patients that started treatment with Otezla in Q2 was near pre-pandemic levels, but those gains were largely offset by a lower percentage of 90-day prescriptions and lower prescription refill rates. We expect that recovery in the dermatology segment will continue to progress over the coming quarters. Looking forward, we are preparing for the anticipated approval of the mild-to-moderate psoriasis indication in the U.S., and continued geographic expansion, including the launch in China.
Enbrel (etanercept) sales decreased 8% year-over-year for the second quarter, primarily driven by lower net selling price and unfavorable changes in estimated sales deductions. On a year-over-year basis volumes declined 1%. Going forward, we expect net selling price to continue to decline year-over-year.
AMGEVITA (adalimumab) sales increased 73% year-over-year for the second quarter, primarily driven by volume growth. AMGEVITA continued to be the most prescribed adalimumab biosimilar in Europe.
LUMAKRASTM (sotorasib) has been well received by the oncology community. LUMAKRAS has been added to the National Comprehensive Cancer Network (NCCN) guidelines and unaided awareness among oncologists has increased significantly since launch. KRAS testing of patients with metastatic non-small cell lung cancer (NSCLC) now stands at approximately 70%, driven by increased next generation sequencing (NGS) utilization and KRAS G12C educational efforts, and 46 of the 50 top testing laboratories are now identifying the KRAS G12C mutation as actionable in their lab reports.
KYPROLIS (carfilzomib) sales increased 11% year-over-year for the second quarter, primarily driven by volume growth and net selling price. For the remainder of the year, we expect continued growth from Kyprolis use in combination with CD38 antibodies.
XGEVA (denosumab) sales increased 12% year-over-year for the second quarter, driven by volume growth as the segment recovered from the earlier effects of the pandemic.
Vectibix (panitumumab) sales increased 23% year-over-year for the second quarter, driven by 20% volume growth that benefited from increased shipments to Takeda, our partner in Japan. We expect lower demand from Takeda in the third quarter.
Nplate (romiplostim) sales increased 27% year-over-year for the second quarter, driven by 17% volume growth and higher inventory levels.
BLINCYTO (blinatumomab), our BiTE immunotherapy, sales increased 16% year-over-year for the second quarter, driven by 18% volume growth as we benefited from broader adoption in the community hospital setting.
AMGEN REPORTS SECOND QUARTER 2021 FINANCIAL RESULTS
MVASI sales increased 71% year-over-year for the second quarter, driven by strong volume growth, partially offset by lower net selling price. In the U.S., MVASI continued to hold leading volume share with 50% of the bevacizumab segment in the quarter. Sales were flat quarter-over-quarter as volume growth was offset by unfavorable changes to estimated sales deductions. Going forward on a sequential basis, we expect continued worldwide volume growth to be more than offset by declines in net selling price due to increased competition.
KANJINTI sales increased 27% year-over-year for the second quarter, primarily driven by volume growth, partially offset by lower net selling price. In the U.S., KANJINTI continued to hold leading volume share with 42% of the trastuzumab segment in the quarter. Sales decreased 3% quarter-over-quarter, primarily driven by unfavorable changes to estimated sales deductions. Going forward, we expect sales to decline sequentially in the second half of the year driven by net selling price.
Neulasta (pegfilgrastim) sales decreased 18% year-over-year for the second quarter, driven by declines in both net selling price and volume, partially offset by a $75 million year-over-year benefit from favorable changes in reimbursement mix, resulting from the comparison of a $39 million favorable adjustment to estimated sales deductions in the quarter to a $36 million unfavorable adjustment in the second quarter last year. In the long-acting granulocyte colony-stimulating factor (G-CSF) segment, Neulasta Onpro continued to be the preferred choice for physicians and patients with volume share of 52% in the quarter. The most recent published Average Selling Price for Neulasta in the U.S. declined 35% year-over-year and 12% quarter-over-quarter. Going forward, we expect increased competition to result in further declines in net selling price.
NEUPOGEN (filgrastim) sales increased 4% year-over-year for the second quarter, driven by favorable changes in estimated sales deductions, partially offset by volume declines.
EPOGEN (epoetin alfa) sales decreased 19% year-over-year for the second quarter, driven by volume declines and lower net selling price resulting from our contractual commitment with DaVita.
Aranesp (darbepoetin alfa) sales decreased 5% year-over-year for the second quarter, driven by lower net selling price due to competition.
Parsabiv (etelcalcetide) sales decreased 62% year-over-year for the second quarter, driven by volume declines. With Parsabiv's inclusion in the U.S. end-stage renal disease (ESRD) bundled payment system, dialysis clinics rapidly implemented new treatment protocols, switching patients from Parsabiv to generic oral cinacalcet. As a result, we expect a 50-60% year-over-year Parsabiv sales decline in 2021. For patients on hemodialysis, Parsabiv is the only IV-administered calcimimetic that treats secondary hyperparathyroidism and provides the opportunity to reduce patient pill burden.
Sensipar Mimpara (cinacalcet) sales decreased 70% year-over-year for the second quarter, primarily driven by volume declines in response to generic competition.
AMGEN REPORTS SECOND QUARTER 2021 FINANCIAL RESULTS
Product Sales Detail by Product and Geographic Region
| $Millions, except percentages | Q2 '21 | Q2 '20 | YOY | |||||||||||||||
| US | ROW | TOTAL | TOTAL | TOTAL | ||||||||||||||
| Prolia | $ | 538 | $ | 276 | $ | 814 | $ | 659 | 24% | |||||||||
| EVENITY | 79 | 52 | 131 | 101 | 30% | |||||||||||||
| Repatha | 143 | 143 | 286 | 200 | 43% | |||||||||||||
| Aimovig | 82 | - | 82 | 98 | (16%) | |||||||||||||
| Otezla | 423 | 111 | 534 | 561 | (5%) | |||||||||||||
| Enbrel | 1,113 | 31 | 1,144 | 1,246 | (8%) | |||||||||||||
| AMGEVITA | - | 107 | 107 | 62 | 73% | |||||||||||||
| KYPROLIS | 190 | 90 | 280 | 253 | 11% | |||||||||||||
| XGEVA | 355 | 133 | 488 | 435 | 12% | |||||||||||||
| Vectibix | 92 | 147 | 239 | 195 | 23% | |||||||||||||
| Nplate | 136 | 109 | 245 | 193 | 27% | |||||||||||||
| BLINCYTO | 62 | 46 | 108 | 93 | 16% | |||||||||||||
| MVASI | 206 | 88 | 294 | 172 | 71% | |||||||||||||
| KANJINTI | 132 | 24 | 156 | 123 | 27% | |||||||||||||
| Neulasta | 434 | 52 | 486 | 593 | (18%) | |||||||||||||
| NEUPOGEN | 36 | 15 | 51 | 49 | 4% | |||||||||||||
| EPOGEN | 130 | - | 130 | 161 | (19%) | |||||||||||||
| Aranesp | 135 | 232 | 367 | 387 | (5%) | |||||||||||||
| Parsabiv | 37 | 34 | 71 | 186 | (62%) | |||||||||||||
| Sensipar Mimpara | 4 | 20 | 24 | 81 | (70%) | |||||||||||||
| Other** | 47 | 30 | 77 | 60 | 28% | |||||||||||||
| Total product sales | $ | 4,374 | $ | 1,740 | $ | 6,114 | $ | 5,908 | 3% | |||||||||
| ** Other includes Corlanor , GENSENTA, IMLYGIC , LUMAKRAS , AVSOLA , Bergamo, and RIABNI . |
Operating Expense, Operating Margin and Tax Rate Analysis
Total Operating Expenses increased 47% primarily driven by the recent acquisition of Five Prime Therapeutics. Cost of Sales margin increased 1.6 percentage points primarily due to product mix, including COVID-19 antibody shipments to Eli Lilly and Company (Lilly) that began this quarter, profit share and royalties, partially offset by lower amortization expense from acquisition-related assets. Research Development (R D) expenses increased 12% primarily due to higher research and early pipeline spend and late-stage development program spend, including our recent business development activities. Acquired IPR D expenses in 2021 were driven by the Five Prime Therapeutics acquisition. Selling, General Administrative (SG A) expenses increased 7% driven by marketed product support due to increased customer engagement in response to the pandemic recovery and investment in new product launches.
Operating Margin as a percentage of product sales decreased 25.8 percentage points to 13.5%.
Tax Rate increased 5.6 percentage points primarily driven by the non-deductible acquired IPR D expense arising from the acquisition of Five Prime Therapeutics.
AMGEN REPORTS SECOND QUARTER 2021 FINANCIAL RESULTS
Total Operating Expenses increased 15%. Cost of Sales margin increased 4.1 percentage points primarily due to product mix, including COVID-19 antibody shipments to Lilly that began this quarter, profit share and royalties. R D expenses increased 11% primarily due to higher research and early pipeline spend and late-stage development program spend, including our recent business development activities. SG A expenses increased 6% driven by marketed product support due to increased customer engagement in response to the pandemic recovery and investment in new product launches.
Operating Margin as a percentage of product sales decreased 4.1 percentage points to 50.9%.
Tax Rate decreased 1.0 percentage points primarily driven by a prior year change in foreign loss utilization.
| $Millions, except percentages | GAAP | Non-GAAP | ||||||||||||||||||
| Q2 '21 | Q2 '20 | YOY | Q2 '21 | Q2 '20 | YOY | |||||||||||||||
| Cost of Sales | $ | 1,637 | $ | 1,488 | 10% | $ | 1,034 | $ | 758 | 36% | ||||||||||
| % of product sales | 26.8 | % | 25.2 | % | 1.6 pts. | 16.9 | % | 12.8 | % | 4.1 pts. | ||||||||||
| Research Development | $ | 1,082 | $ | 964 | 12% | $ | 1,036 | $ | 936 | 11% | ||||||||||
| % of product sales | 17.7 | % | 16.3 | % | 1.4 pts. | 16.9 | % | 15.8 | % | 1.1 pts. | ||||||||||
| Acquired IPR D | $ | 1,505 | $ | - | * | $ | - | $ | - | -% | ||||||||||
| % of product sales | 24.6 | % | - | % | 24.6 pts. | - | % | - | % | 0 pts. | ||||||||||
| Selling, General Administrative | $ | 1,384 | $ | 1,295 | 7% | $ | 1,345 | $ | 1,265 | 6% | ||||||||||
| % of product sales | 22.6 | % | 21.9 | % | 0.7 pts. | 22.0 | % | 21.4 | % | 0.6 pts. | ||||||||||
| Other | $ | 90 | $ | 136 | (34%) | $ | - | $ | - | -% | ||||||||||
| Total Operating Expenses | $ | 5,698 | $ | 3,883 | 47% | $ | 3,415 | $ | 2,959 | 15% | ||||||||||
| Operating Margin | ||||||||||||||||||||
| operating income as % of product sales | 13.5 | % | 39.3 | % | (25.8) pts. | 50.9 | % | 55.0 | % | (4.1) pts. | ||||||||||
| Tax Rate | 16.8 | % | 11.2 | % | 5.6 pts. | 12.6 | % | 13.6 | % | (1.0) pts. | ||||||||||
| pts percentage points | ||||||||||||||||||||
| * Change in excess of 100% |
Cash Flow and Balance Sheet
The Company generated $1.7 billion of free cash flow in the second quarter of 2021 versus $2.7 billion in the second quarter of 2020, driven by a difference in the timing of tax payments.
The Company's second quarter 2021 dividend of $1.76 per share was declared on March 3, 2021, and was paid on June 8, 2021, to all stockholders of record as of May 17, 2021, representing a 10% increase from 2020.
During the second quarter, the Company repurchased 6.5 million shares of common stock at a total cost of $1.6 billion. At the end of the second quarter, the Company had $3.9 billion authorization remaining under its stock repurchase program.
Cash and investments totaled $8.1 billion and debt outstanding totaled $32.8 billion as of June 30, 2021.
AMGEN REPORTS SECOND QUARTER 2021 FINANCIAL RESULTS
| $Billions, except shares | Q2 '21 | Q2 '20 | YOY | ||||||||||||||||
| Operating Cash Flow | $ | 1.9 | $ | 2.8 | $ | (0.9) | |||||||||||||
| Capital Expenditures | $ | 0.2 | $ | 0.2 | $ | 0.0 | |||||||||||||
| Free Cash Flow | $ | 1.7 | $ | 2.7 | $ | (0.9) | |||||||||||||
| Dividends Paid | $ | 1.0 | $ | 0.9 | $ | 0.1 | |||||||||||||
| Share Repurchases | $ | 1.6 | $ | 0.6 | $ | 1.0 | |||||||||||||
| Average Diluted Shares (millions) | 576 | 592 | (16) | ||||||||||||||||
| Note Numbers may not add due to rounding |
| $Billions | 6 30 21 | 12 31 20 | YTD | |||||||||
| Cash and Investments | $ | 8.1 | $ | 10.6 | $ | (2.6) | ||||||
| Debt Outstanding | $ | 32.8 | $ | 33.0 | $ | (0.2) | ||||||
| Note Numbers may not add due to rounding |
For the full year 2021, the Company now expects
Total revenues in the range of $25.8 billion to $26.6 billion, unchanged from previous guidance.
On a GAAP basis, EPS in the range of $8.84 to $9.90 and a tax rate in the range of 13.0% to 14.5%.
Previously, the Company expected GAAP EPS in the range of $9.11 to $10.71 and a tax rate in the range of 14.0% to 15.5%.
On a non-GAAP basis, EPS in the range of $16.00 to $17.00, unchanged from previous guidance and a tax rate in the range of 13.5% to 14.5%, also unchanged from previous guidance.
Capital expenditures to be approximately $900 million.
Share repurchases at the upper end of our previous guidance of $3.0 billion to $5.0 billion.
AMGEN REPORTS SECOND QUARTER 2021 FINANCIAL RESULTS
Second Quarter Product and Pipeline Update
The Company provided the following updates on selected product and pipeline programs
In May, the U.S. Food and Drug Administration (FDA) approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. LUMAKRAS received accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Regulatory reviews continue in Europe, Japan and other jurisdictions.
Top-line results from the event-driven confirmatory Phase 3 study comparing LUMAKRAS to docetaxel in patients with KRAS G12C-mutated advanced NSCLC are expected in H1 2022.
Primary results from the Phase 2 monotherapy study in patients with advanced KRAS G12C-mutated colorectal cancer (CRC) have been submitted for publication.
Additional data from the Phase 1 2 CodeBreaK 100 monotherapy study in advanced NSCLC have been accepted for presentation at the World Conference on Lung Cancer in September, including biomarker analyses and post hoc analyses of efficacy and safety in patients with stable brain metastases. Enrollment continues in a cohort of patients with active brain metastases in the CodeBreaK 101 study.
Exploration of LUMAKRAS in multiple Phase 1b combination cohorts continues to progress.
Initial data from LUMAKRAS in combination with Vectibix in patients with advanced KRAS G12C-mutated CRC have been accepted for presentation at the European Society for Medical Oncology Congress in September.
Initial data from LUMAKRAS in combination with a mitogen-activated protein kinase kinase (MEK) inhibitor and LUMAKRAS in combination with an oral EGFR inhibitor are planned to be submitted for presentation at a Q4 2021 medical conference.
The Company is collaborating with Novartis on a LUMAKRAS combination study with their SHP-2 inhibitor TNO155. A cohort is expected to initiate in the CodeBreaK 101 study in Q3 2021. Enrollment continues in a combination cohort with Revolution Medicine's SHP-2 inhibitor RMC-4630.
Initiation of a Phase 2 study is planned for Q3 2021 in first-line patients with KRAS G12C mutated NSCLC whose tumors express 1% programmed death-ligand 1 (PD-L1) and or serine threonine kinase 11 (STK11) mutations.
Data from the Phase 2 monotherapy study in patients with KRAS G12C-mutated solid tumors other than NSCLC and CRC are expected in H1 2022.
In June, the European Commission approved an expanded indication for the use of BLINCYTO in the treatment of pediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome negative CD19 positive B-precursor acute lymphoblastic leukemia as part of the consolidation therapy.
AMGEN REPORTS SECOND QUARTER 2021 FINANCIAL RESULTS
The Company has initiated discussions with regulators on the Phase 3 study design for bemarituzumab, a first-in-class anti-fibroblast growth factor receptor 2b (FGFR2b) antibody for the treatment of patients with human epidermal growth factor receptor 2 (HER2) negative, FGFR2b-positive gastric and gastroesophageal junction cancer. Initiation of the registrational program is planned for Q4 2021.
Bemarituzumab has been granted Breakthrough Therapy Designation by the FDA as first-line treatment for patients with at least 10% FGFR2b overexpression and HER2-negative metastatic and locally advanced gastric and gastroesophageal adenocarcinoma in combination with modified FOLFOX6 (fluoropyrimidine, leucovorin, and oxaliplatin).
Planning is underway for bemarituzumab clinical studies in other solid tumors, including squamous NSCLC.
Acapatamab (AMG 160)
A dose expansion cohort of acapatamab, a half-life extended (HLE) BiTE molecule targeting prostate-specific membrane antigen (PSMA), has completed enrollment of patients with metastatic castrate resistant prostate cancer (mCRPC). Enrollment of acapatamab is ongoing in cohorts with reduced levels of monitoring during cycle one to explore outpatient administration.
An acapatamab dose escalation study has initiated for patients with NSCLC expressing PSMA.
A master protocol evaluating combinations of acapatamab with AMG 404, an anti-programmed cell death 1 (PD-1) antibody, or the novel hormone therapies enzalutamide or abiraterone, continues to enroll patients with earlier-line mCRPC.
Tarlatamab (AMG 757)
The Company has begun planning a potentially pivotal Phase 2 study and will initiate discussions with regulators for tarlatamab, an HLE BiTE molecule targeting delta-like ligand 3 (DLL3), in patients with relapsed or refractory small cell lung cancer.
A Phase 1b study of tarlatamab has begun recruiting patients with neuroendocrine prostate cancer.
A Phase 1b study of tarlatamab in combination with AMG 404 is planned to initiate in Q3 2021 for patients with small cell lung cancer.
Additional Phase 1 Oncology Programs
AMG 509, a bivalent T-cell engager XmAb 2+1 antibody targeting six transmembrane epithelial antigen of the prostate 1 (STEAP1) was recently granted Fast Track designation by the FDA and continues to enroll patients with mCRPC.
Pavurutamab (AMG 701), an HLE BiTE molecule targeting B-cell maturation antigen (BCMA), has resumed enrolling patients with relapsed or refractory multiple myeloma.
AMG 330, a BiTE molecule targeting CD33, continues to enroll patients with acute myeloid leukemia.
Enrollment has been paused in the Phase 1 study of AMG 427, a BiTE molecule targeting fms-like tyrosine kinase 3 (FLT3) for patients with acute myeloid leukemia.