NEW YORK – Amgen reported on Wednesday after the close of the market a 6 percent increase in revenues during the first quarter of 2022, along with strong sales of its newly launched KRAS inhibitor Lumakras (sotorasib).
For the three months ending March 31, Amgen reported revenues of $6.24 billion compared to $5.90 billion during the same period in 2021, topping the average Wall Street estimate of $6.15 billion.
During a call to discuss the company's financial performance, Amgen CEO Bob Bradway said Lumakras was "off to a strong start." The US Food and Drug Administration approved Lumakras in May 2021 for patients with previously treated, locally advanced, or metastatic non-small cell lung cancer whose tumors harbor a KRAS G12C mutation.
During Q1 2022, Lumakras recorded $62 million in revenues in the US and in other markets, marking a 38 percent increase sequentially over Q4 2021.
Murdo Gordon, Amgen's executive VP of global commercial operations, said during the call that 80 percent of patients whose KRAS G12C status is known at the point of progression from first-line to second-line treatment are treated with Lumakras. "We're penetrating the population when the identification of KRAS G12C status is there, so that's clearly the lever that we need to ensure is improved," he said. Amgen is working with oncologists to increase the rate of testing for KRAS G12C, mainly in community oncology clinics where testing has lagged somewhat compared to academic centers.
Amgen is anticipating releasing top-line results from a Phase III study comparing Lumakras to docetaxel in Q3 of this year, and results from a study comparing different doses of the KRAS inhibitor in Q4.
A potential dosage change following the Phase III readout at the end of 2022 may coincide with the launch of a competing KRAS G12C inhibitor, Mirati Therapeutics' adagrasib. "We remain confident that the 960 mg dose is the right dose," Murdo said. "Clearly the safety and efficacy benefit of that product looks very good. And given the long-term follow-up data, it's a high bar for us to be able to see if it can be improved upon at a lower dose." The company will make a decision about dosing based on the data and the FDA's guidance, he added.
Sales of Amgen's anti-EGFR monoclonal antibody Vectibix (panitumumab) contributed $201 million in revenues during Q1, a 5 percent increase from $191 million in Q1 of 2021. Most of that growth is attributable to uptake in ex-US markets.
Amgen's Q1 net income was $1.48 billion, or $2.68 per share, compared to net income of $1.65 billion, or $2.83 per share, in Q1 of 2021. Non-GAAP EPS was $4.25 per share in Q1, beating the consensus analyst EPS estimate of $4.16.
The company's R&D expenses declined 1 percent during Q1 to $959 million, compared to $967 million in Q1 2021. Over the same period, selling, general, and administrative expenses also dipped 1 percent, to $1.23 billion from $1.25 billion in the year-ago quarter.
Amgen reported long-term outcomes from its CodeBreak-100 trial at the American Association for Cancer Research annual meeting earlier this month, showing a 40.7 percent objective response rate among NSCLC patients. After two years, 32.5 percent of patients were still alive.
The company is also exploring combination approaches with Lumakras in KRAS G12C-mutated NSCLC and plans to present data at a medical conference from cohorts treated with Lumakras and Merck's Keytruda (pembrolizumab) as well as from those treated with Lumakras and Revolution Medicines' SHP2 inhibitor RMC-4630.
In other tumor types, Amgen presented data on 38 pancreatic cancer patients in February at the American Society of Clinical Oncology plenary series, showing a 21 percent objective response rate on Lumakras treatment and a disease control rate of 84 percent.
Amgen is also enrolling KRAS G12C-mutated colorectal cancer patients in a Phase III trial of Lumakras with Vectibix, exploring the combination as a third-line treatment.
The firm said it will continue to "vigorously" contest adjustments and penalties imposed by the Internal Revenue Service over deficiencies from 2013 through 2015 related to its Puerto Rico operations, and adjustments proposed for 2010 through 2015.
As of March 31, Amgen had $6.54 billion in cash, cash equivalents, and marketable securities.
The company reiterated its previously stated full-year 2022 revenue projection of between $25.4 billion and $26.5 billion and non-GAAP EPS of between $17.00 and $18.00.