As the world awaits Johnson & Johnson’s phase 3 COVID-19 vaccine data, the company is prepping for regulatory filings and a global rollout. Orders for hundreds of millions of doses are pending. But even as rivals face manufacturing and logistics hurdles, a top J&J exec said his company is “comfortable” meeting its 2021 supply commitments.
J&J's one-dose vaccine would provide a major boost to worldwide vaccination efforts as shots from Pfizer/BioNTech, Moderna and AstraZeneca remain in the early stages of their rollouts. News of supply disruptions for the AstraZeneca and Pfizer vaccines has been surfacing in Europe, and U.S. rollouts for the mRNA vaccines have gotten off to a slower-than-expected start.
J&J expects to report phase 3 data for its one-dose vaccine by early next week, execs said Tuesday. If the data are positive, that could “could meaningfully accelerate the rollout of vaccinations across the U.S.” and “potentially disrupt other vaccine manufacturers' demand expectations,” Barclays analyst Carter Gould wrote in a note to clients Tuesday.
Aside from its one-dose advantage, J&J’s vaccine can be stored at refrigerated temperatures for up to three months and will be shipped in a five-dose vial that doesn’t require dilution. The mRNA shots from Pfizer and Moderna require deep-freeze temps as low as 94 degrees below zero Fahrenheit.
J&J intends “to meet all of the firm order commitments that we have,” CFO Joe Wolk said on the company's Tuesday conference call with analysts, adding that there could be some "fluidity" in delivery timelines. In a separate interview with CNBC, Wolk said J&J should be prepared to hit its U.S. supply goal by the end of June.
The drugmaker has agreed to supply 100 million doses to the U.S., plus 200 million to Europe and 100 million to developing countries through Gavi, the Vaccine Alliance. All of the deals carry options for hundreds of millions of additional doses.
The company is “very comfortable” with the deals and “well on track” to deliver on its existing commitments, Wolk said.
J&J is planning to onboard seven factories by the end of next quarter to meet its U.S. dose commitment by the end of June and fulfill its European order by the end of the year, Wolk said on CNBC early Tuesday. The shipments to developing countries will begin in the second half of the year, he said.
As for future supply negotiations, the volume of doses will “impact the selling price,” Wolk said. It’s “somewhat of a fluid situation,” he added. The company will likely have more information to share on its first-quarter earnings call in April.
Meanwhile, the company is also testing a two-dose regimen of the vaccine. Results from that trial are expected later this year.
In all, J&J is on track to produce around 1 billion doses of the vaccine during 2021, executives said. But because there are still many moving parts, the company didn’t provide financial guidance for the shot, which could deliver a sizable revenue boost this year. The company has pledged to sell its vaccine on a not-for-profit basis during the pandemic.
The news came as J&J reported fourth-quarter and full-year results for 2020. During a year dominated by the COVID-19 pandemic, J&J turned in full-year sales of $82.6 billion, a slight increase versus the prior year. The company’s pharma business stood out among its counterparts, generating $45.6 billion in revenues and posting 8% reported growth.
Within pharmaceuticals, eight drugs delivered double-digit revenue growth, including Darzalex, which leapt 49%, and Stelara, which grew 30%.
As for 2021, J&J expects to turn in $88.8 billion to $90 billion in revenues. The guidance doesn't include the COVID-19 vaccine, and J&J execs said the company will provide an update on expectations for that program when it's able.