Moderna Inc.'s COVID-19 vaccine brought in $1.7 billion in the first quarter of 2021 and the sales for the full year could reach $19.2 billion, executives said on a May 6 earnings call the day after the U.S. joined an effort to share vaccine patents worldwide.

The Cambridge, Mass.-based company's CEO Stephane Bancel pointed out on the call that Moderna had "never run a phase 3 clinical study, never gotten a product authorized by a regulator and never made $100 million in a single quarter" previously.

Moderna's shot became the second authorized in the U.S. in December 2020. Like Pfizer Inc.'s COVID-19 vaccine, Moderna's uses messenger RNA or mRNA technology and requires two shots per person.

Moderna now expects to supply between 800 million and 1 billion doses of its vaccine around the world. Boosters for vaccinated patients are likely needed down the road, although a timeline is still unknown, Bancel said.

Further variants of the coronavirus are likely to emerge in the Southern Hemisphere as winter begins there, and booster shots that protect against more than one strain of the virus will likely be necessary, Bancel said. Moderna is ahead of the curve in that respect, he added.

"The market has changed quite a lot versus what we knew six months ago — mRNA vaccines have emerged as the best-in-class vaccines, high efficacy, good tolerability profile, scaled manufacturing and speed to chase variants in the clinic," Bancel said. "Many companies are still in the clinic with their first-generation vaccine, where we're in the clinic with variant-specific boosters."

Moderna plans to begin filing this month for official approval of the vaccine from the U.S. Food and Drug Administration.

The company also released initial data from a mid- to late-stage study of the COVID-19 vaccine in adolescents ages 12 to 17, showing an efficacy rate of 96%.

IP waivers draw pharma's ire

The Biden administration's May 5 support of waiving intellectual property protection behind the vaccines brought about a sharp rebuke from the biopharmaceutical industry and sparked share price declines for vaccine-makers such as Moderna and Pfizer. The World Trade Organization urged countries to reach an agreement after South Africa and India asked for a waiver.

The decision drew criticism from biopharmaceutical leaders such as Biotechnology Innovation Organization Chairman Jeremy Levin.

"We are extremely disappointed by this decision," Levin said in a May 6 statement. "In the future, this decision will act as a disincentive to companies to respond to the next pandemic."

After dropping more than 6% the evening of May 5 and declining further before markets opened the following morning, Moderna's stock recovered slightly to $160.93.73, down 1.17% as of 2:25 p.m. ET.

The COVID-19 vaccine has changed Moderna's fortunes in a short amount of time and brought the company into the commercial space. But the company, which teamed up with the U.S. National Institutes of Health to develop the vaccine, said in October 2020 that they would not enforce the patents for the COVID-19 vaccine.

As such, Bancel said the potential for a loss of patent protection does not affect Moderna and that the patents themselves would not immediately increase the production of mRNA vaccines around the world despite the intentions.

"This is a new technology — you cannot go hire people who know how to make mRNA; those people don't exist," Bancel said. "And then even if all those things were available, whoever who wants to do mRNA vaccines will have to buy the machine, invent the manufacturing process, invest in verification processes and ethical processes, and then they will have to go run a clinical trial, get the data, get the product approved and scale manufacturing."

Bancel pointed out that smaller mRNA companies are still in the clinic with products that have not yet been authorized.

"This does not happen in six or 12 or 18 months," Bancel said. "We have been working at this for years."

Analysts agreed that the patent waivers would likely have little impact on the industry.

"We continue to believe that the timeline to negotiate the waiver coupled with the potential ramp-up of manufacturing makes the practical implications of such a waiver (if finalized) not significant," Morgan Stanley analyst Matthew Harrison said in a May 6 note.

The waivers could affect long-term viability of the vaccines, however, while doing little to affect distribution during the height of the pandemic, Barclays analyst Carter Gould said in a May 6 note.

"We view this situation as lending itself to negotiations for lower-cost/free vaccines in specific regions in the near to intermediate term," Gould said. "Longer term, this measure is a potential risk to the long-term tail for the vaccine players."