Amgen Delivers Solid Q3 Sales, Little Insight On Key R&D Programs
Question Of Omecamtiv, Sotorasib Filing Plans Unanswered
Executive Summary
Amgen had a good third quarter despite some COVID-19 impacts but did not shed any light on filing plans for two key late-stage programs nor provide any insight into Phase III asthma results for tezepelumab.
Amgen, Inc.’s third quarter financials generally met or beat analyst consensus despite COVID-19 impacts on individual product sales and the company essentially maintained its revenue guidance for 2020. However, investors’ biggest questions going into Amgen’s 28 October earnings call about three key late-stage programs remained unanswered.
The company did not say whether it will seek accelerated approval from the US Food and Drug Administration for sotorasib (AMG 510) in the treatment of non-small cell lung cancer (NSCLC) patients with KRAS G12C mutations. Executives also did not commit to regulatory filings for omecamtiv mecarbil in the treatment of heart failure nor did they give an update on Phase III results for tezepelumab in asthma, which are expected in the fourth quarter of this year.
Amgen said earlier this month that the potentially pivotal Phase II study of sotorasib generated efficacy and safety results in NSCLC that were similar to those seen in Phase I but did not provide any detailed data, which are slated for presentation at the World Congress of Lung Cancer in January. (Also see "Amgen’s KRAS Inhibitor Shows Durability; Pivotal Data Possible This Year" - Scrip, 21 Sep, 2020.) During the earnings call, executive vice president of R&D David Reese reiterated Amgen’s prior statement that it looks forward to sharing the Phase II data with regulators globally without commenting on near-term plans to file for approvals in the US and other markets.
“Based on the data we have accumulated and the evolution of the field, we are extremely optimistic about the potential of sotorasib, and we'll continue to aggressively advance the development program,” Reese said.
“We also reviewed with interest a data presentation made a few days ago,” he continued, referring to Mirati Therapeutics, Inc.’s KRAS G12C inhibitor MRTX849 (adagrasib). “Based on our assessment of available efficacy and safety data, including durability measures, we remain extremely confident in our molecule. To date, we have treated over 550 patients with sotorasib, and we are looking forward to discussions with the FDA and other regulatory agencies to determine the best path forward.” (Also see "Mirati’s KRAS Inhibitor Gains Edge On Efficacy, But Safety Trails Amgen’s Competing Drug" - Scrip, 26 Oct, 2020.)
Even though sotorasib is not as far along in development as omecamtiv mecarbil and tezepelumab, it is Amgen’s most closely watched R&D program because of its potential to treat patients with poor prognoses and the possibility that it could be the first-to-market KRAS G12C inhibitor.
Reese answered several questions about the company’s plans for the drug but did not share any new data nor comment directly on Mirati’s updated results.
Omecamtiv Filing Plans May Be Clearer Next Month
Amgen and its partners Cytokinetics, Inc. and Les Laboratoires Servier reported results earlier this month from the Phase III GALACTIC-HF clinical trial testing the selective cardiac myosin activator omecamtiv mecarbil in the treatment of heart failure with reduced ejection fraction (HFrEF). The trial’s primary composite endpoint of reduction in heart failure events and cardiovascular deaths was met but the trial was not successful on the secondary endpoint of reduction in CV deaths alone, which analysts viewed as a requirement for commercial success.
The question of whether Amgen and its partners will seek approvals for omecamtiv remains open but could be answered next month after the GALACTIC-HF results are presented during the American Heart Association Scientific Sessions, which will take place online 13-17 November.
“We've got data coming out at the American Heart Association in just a couple of weeks,” Reese said. “And I think in the wake of that, we'll be discussing next steps.”
Asked about Amgen’s perspective on continued investment in cardiovascular disease in light of the omecamtiv results, CEO Robert Bradway indicated that the company is not backing down in terms of its interest and investment in treatment for CV diseases.
“We continue to look for business development opportunities and continue to look for internal programs in cardiovascular disease,” Bradway said. “We're moving rapidly with our Phase II program [for AMG 890] directed against [lipoprotein(a) or Lp(a) in the treatment of atherosclerotic cardiovascular disease] so we're excited to have some fast studies going for that molecule.” (Also see "Amgen’s R&D Group Focuses On Efficiency As Drug Cost Concerns Continue" - Scrip, 29 Jan, 2020.)
“And we'll continue to look for ways to invest in that [CV] franchise,” he continued. “Cardiovascular disease, as you know, is the leading killer of people on the planet. We continue to think what we need in that field is more innovation, not less, so we'll continue looking for that.”
Tezepelumab Data Coming Soon
Phase III results for the thymic stromal lymphopoietin (TSLP) inhibitor tezepelumab in the fourth quarter will come from the NAVIGATOR study in adults and adolescents with severe uncontrolled asthma and from the SOURCE study evaluating the reduction of oral corticosteroid use in adults with oral corticosteroid-dependent asthma. Amgen is developing the monoclonal antibody in partnership with AstraZeneca PLC, which is scheduled to report third quarter earnings on 5 November. (Also see "Tezepelumab Deemed Breakthrough But Can Phase III Reproduce Data? " - Scrip, 7 Sep, 2018.)
Analysts sought some insight into the potential NAVIGATOR results for patients based on levels of eosinophils – cells that cause inflammation in the lungs – but Reese did not offer much perspective on whether he expected any major differences in results based on eosinophil levels. However, he confirmed that the study’s primary endpoint is the reduction in asthma exacerbations across all patients with a subanalysis built in to look at the outcome in patients with low eosinophil levels.
“In our Phase II data, which are currently our best predictor, we showed relatively comparable efficacy regardless of eosinophil status, and it certainly would be our hope that we're able to replicate that in Phase III,” Reese said.
Financial Results In-Line, Guidance Steady
Amgen reported $6.42bn in revenue for the third quarter, which was up 12% from Q3 2019 and beat analyst consensus of $6.37bn. Product sales totaled $6.1bn during the recent quarter, in line with consensus of $6.09bn and also up 12% year-over-year. The company narrowed its guidance for full-year 2020 revenue to a range of $25.1bn-$25.5bn versus its prior forecast of $25bn-$25.6bn, noting that revenue still may fluctuate based on COVID-19 concerns as the year comes to a close.
The company continues to see sales of blockbusters like Neulasta (pegfilgrastim) and Neupogen (filgrastim) for neutropenia, anemia therapy Epogen (epoetin alfa) and Sensipar (cinacalcet) for hyperparathyroidism decline due to biosimilar and generic competition, with sales down by double digits for each drug in Q3. (See table below.)
Enbrel (etanercept) remains Amgen’s top seller with $1.33bn in third quarter sales, which were down 3% year-over-year. The drug for rheumatoid arthritis and other inflammatory diseases has increased competition from novel medicines and biosimilars of other TNF inhibitors and is facing pricing pressure, which is compounded by reduced doctor visits by patients eligible for treatment with Enbrel who are at higher risk of severe COVID-19 infection.
Murdo Gordon, executive vice president of global commercial operations, said doctor office visits remain below pre-COVID-19 levels across the board but patients increasingly are going back to see their physicians about ongoing health concerns.
Gordon noted that the osteoporosis therapy Prolia (denosumab), which grew 11% in Q3 to $701m, typically has lower sales in the first and third quarters of each year than in the second and fourth quarters – but Amgen expects the opposite this year. Prolia is administered in doctors’ offices, so patients put off treatment early on in the pandemic but are now returning for therapy, he said.
Getting patients back to see their doctors is one of multiple important factors going forward for one of the company’s newer products – the CGRP inhibitor Aimovig (erenumab) for the prevention of episodic and chronic migraine.
“We are down substantially in new patients per week because of COVID and a lot of migraine sufferers, unfortunately, are just not seeking care,” Gordon said. “Neurology as a prescribing specialty is down more than some others, like cardiology [which] recovered nicely in the quarter. Neurology is still down in terms of total prescribing and that's the COVID impact.”
“And then there's another opportunity, which we're focused on, and that is to have both neurologists and patients moving quicker through older, less effective preventative agents and to try biologic CGRPs like Aimovig,” he continued. “We've seen movement there, and it was going well [pre-COVID-19.]”
Gordon also noted that marketing for more recently approved oral CGRP inhibitors, which are indicated for acute treatment of migraine attacks, is helping to build awareness of CGRP inhibitors for migraine prevention.
Aimovig achieved its highest quarter of sales to date with $105m in Q3 sales, up 59% year-over-year.