The 39th Annual J.P. Morgan Healthcare Conference was sans Celgene Corp.'s annual tradition of kicking off the conference with preliminary revenue and earnings from the previous year, but plenty of other companies stepped up and offered preliminary results of their own.
Unfortunately, some companies continued to face headwinds selling drugs during the pandemic as patients avoided their doctors' offices.
Esperion Therapeutics Inc., for example, estimated its fourth quarter 2020 U.S. net product revenue landed between $8 million and $8.5 million. The Ann Arbor, Mich.-based company launched its cholesterol-lowering drugs, Nexletol (bempedoic acid) tablets and Nexlizet (bempedoic acid and ezetimibe), on March 30, 2020, and June 4, 2020, respectively, just as the pandemic was ramping up.
Things could be turning around, however. "While the initial launch was affected due to COVID-19, Esperion anticipates an acceleration of sales growth with improving conditions as office-visits normalize aided by the vaccine rollout," J.P. Morgan analyst Jessica Fye wrote in a note to clients.
Karyopharm Therapeutics Inc. said it expected fourth quarter sales of multiple myeloma treatment Xpovio (selinexor) to fall in the $20 million to $20.5 million range, a decrease of approximately 4% to 6% compared to the third quarter. "Sales were impacted by the hampering of patients' ability to visit health care providers due to the pandemic, as well as reduced access for the company’s commercial team to physician customers," H.C. Wainwright & Co. analyst Edward White wrote in a note to clients.
The Newton, Mass.-based company is looking for the downward trend to reverse itself in the first quarter with an FDA approved label change allowing Karyopharm to market Xpovio in combination with Velcade (bortezomib, Takeda Pharmaceutical Co. Ltd.) and dexamethasone as a treatment for second-line multiple myeloma.
Seagen Inc., of Bothell, Wash., didn't release preliminary fourth quarter results at J.P. Morgan – we'll have to wait until the official announcement on Feb. 11 – but for its third quarter results, management blamed the 3% year-over-year decrease in sales of Adcetris (brentuximab vedotin) on decreased diagnosis of Hodgkin lymphoma (HL) as patients postponed visits to their doctors. "Recent claims data and electronic medical records data indicate that new HL diagnosis trends are approximately 15% lower than historic levels," Chip Romp, Seagen's executive vice president, commercial, U.S., explained during the third quarter conference call.
Plenty of companies fighting through the pandemic
Amicus Therapeutics Inc. reported 2020 global product sales of $261 million for its Fabry disease drug, Galafold (migalastat), which slightly beat management's guidance of $250 million to $260 million. The company highlighted the excellent compliance rate of more than 90% for the better-than-expected results. Unlike injectable enzyme replacement therapies, which are the current standard of care, Galafold is taken orally.
The Cranbury, N.J.-based company is looking for Galafold sales of at least $300 million in 2021. "Although Amicus is having to manage some COVID headwinds and is experiencing increased lag time between new patient identification, the company is building a queue of patients that bodes well for the base business," SVB Leerink analyst Joseph Schwartz noted.
Boston-based Ironwood Pharmaceuticals Inc. and its partner North Chicago-based Abbvie Inc., haven't had too much trouble selling their irritable bowel syndrome with constipation and chronic idiopathic constipation treatment, Linzess (linaclotide), during the pandemic. Preannounced Linzess sales of approximately $930 million in 2020 implies a 16% quarter-over-quarter growth in the fourth quarter and 10% growth over the fourth quarter of 2019. "The quarter volumes benefited from incremental reception by the abdominal symptoms claims, telemedicine and virtual-detailing, along with modest price appreciation," J.P. Morgan analyst Eric Joseph noted.
Likewise, Rigel Pharmaceuticals Inc., of South San Francisco, has worked through issues with virtual detailing of its thrombocytopenia treatment, Tavalisse (fostamatinib disodium hexahydrate), helping sales increase 28% year over year in the fourth quarter to $17.7 million and increase 41% for the full year to $61.7 million. H.C. Wainwright & Co. analyst Joseph Pantginis called out the impressive effort: "With sales rep office visits down or virtually shut down, Rigel has made significant efforts to increase the number and effectiveness of virtual interactions with physicians as profile education continues. As expected, this is nowhere near a replacement for in-person interactions, including meeting with broader team members; further, as mentioned before by the company, doctors are not easily agreeing to Zoom meetings, and the company is having encouraging hit rates."
Of course, some companies don't have to worry about patients not seeing their doctor during the COVID-19 pandemic because their drugs treat COVID-19.
Management of Gilead Sciences Inc. increased its 2020 product sales guidance to a range of $24.30 billion to $24.35 billion on the back of better-than-expected sales of Veklury (remdesivir). Sales of the COVID-19 treatment for 2020 are expected to fall in the $2.8 billion to $2.825 billion range, implying $1.927 billion to $1.952 billion in fourth quarter sales. "The increase in fiscal year 2020 remdesivir guidance is largely due to the escalating pandemic and increasing rates of hospitalization where one in two patients in the U.S. receives remdesivir. As of now, Gilead is seeing no capacity or supply constraints," J.P. Morgan analyst Cory Kasimov noted.
In December, Eli Lilly and Co., of Indianapolis, issued guidance for 2021 revenue of $26.5 billion to $28 billion, including an estimated $1 billion to $2 billion of revenue from COVID-19 therapies. The company also increased its 2020 guidance to reflect increased sales of bamlanivimab to the U.S. government, although management didn't break out expected sales of the SARS-CoV-2 antibody.
Regeneron Pharmaceuticals Inc., the other major player in the COVID-19 treatment landscape, announced $144 million in preliminary sales of its antibody cocktail, casirivimab/imdevimab, for the fourth quarter of 2020.
On January 12, the Tarrytown, N.Y.-based company announced that the U.S. Department of Health and Human Services and the Department of Defense had committed to purchasing up to 1.25 million doses of the cocktail for up to $2.625 billion – in addition to the 300,000 doses that were previously contracted for. At the current dose of 2,400 mg, Regeneron only expects to be able to supply approximately 750,000 finished doses by the end of June when the contract expires, but the company is testing a 1,200-mg dose in the outpatient setting. If the lower dose is authorized, Regeneron believes it'll be able to meet the request for all 1.25 million doses.