Moderna unveiled its Q4 earnings Thursday morning following a busy few days highlighted by its mRNA cancer vaccine in combination with Keytruda receiving a Breakthrough Therapy Designation and announcing a partnership with Life Edit Therapeutics.
The biotech reported quarterly revenues of $5.1 billion and full-year revenues of $19.3 billion, complemented by quarterly net income of $1.5 billion and a full-year net income of $8.4 billion.
Looking ahead, Moderna said it expects $5 billion in sales of Spikevax, its COVID-19 vaccine, in 2023 and plans to increase its research and development (R&D) investments to $4.5 billion.
“Our infectious disease platform continues to progress with positive Phase 3 data in RSV for older adults,” Moderna CEO Stéphane Bancel said in a statement. “We are investing to scale Phase 3 manufacturing for personalized cancer vaccines so that we can run several Phase 3 studies simultaneously. With planned R&D investments of $4.5 billion for the year, I am excited about the new medicines we believe we will bring to patients in the coming few years.”
Moderna’s financial performance, including the considerable net worth of Bancel, has been the subject of headlines in recent weeks as Sen. Bernie Sanders, (I-Vt) and other progressive leaders on Capitol Hill have publicly criticized the company and its business practices.
Earlier this year, Moderna was reportedly considering raising the price of its COVID-19 vaccine to between $110 to $130 per dose, but following criticism from Sanders, vowed that Americans would not have to pay for the shot.
Still, Sanders, who now leads the Senate Health, Education, Labor and Pensions (HELP) Committee, has been consistent with his criticisms of Moderna and Bancel in particular. He has accused Moderna of profiting off the COVID-19 pandemic after receiving federal funding through Operation Warp Speed in 2020 to develop a COVID-19 vaccine.
To that end, Sanders announced last week that Bancel agreed to testify before the Senate HELP Committee in a hearing on March 22 at 10 a.m. EST.
Subsequently, Sanders appeared on the Late Show with Stephen Colbert to continue his public criticism of Moderna and Big Pharma’s business practices in general.
Hours before releasing its earnings, Moderna also announced that the Food and Drug Administration granted a Breakthrough Therapy Designation for mRNA-4157/V940, its investigational cancer vaccine, in combination with Merck’s Keytruda for treating patients with high-risk melanoma.
In mid-December, Moderna and Merck announced that a Phase 2b trial found the combination delivered a “statistically significant and clinically meaningful improvement” in the primary endpoint of recurrence-free survival for patients with stage III/IV melanoma compared to Keytruda alone.”
Additionally, the companies still plan on initiating a Phase III trial in adjuvant melanoma this year.
Another recent development was the FDA’s decision to grant mRNA-1345, Moderna’s respiratory syncytial virus (RSV) vaccine, a Breakthrough Therapy Designation. The company said in its earnings update that it plans on filing for full regulatory approval for the RSV shot in the first half of the year.
Meanwhile, Moderna recently announced that its mRNA-based flu vaccine showed mixed results in a Phase III trial. Still, the company is banking on the continued interest and performance of mRNA technology, inking a decade-long partnership with the U.K. government at the end of 2022 to invest in mRNA technology R&D.
On the topic of partnerships, one day before releasing its earnings, Moderna announced a strategic R&D collaboration agreement with Life Edit Therapeutics, an ElevateBio company focused on gene editing.
A press release announcing the partnership said it will be a multi-target collaboration to advance “potentially life-transformative or curative therapies” for some of the most challenging diseases.
As part of the agreement, Life Edit will receive an upfront payment and remains eligible for receiving potential development, regulatory and commercial milestone payments for each target Moderna exercises an option on.