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Q & A Highlights

Q: You noted that based on FDA feedback for Phase 3 Flu efficacy data, you now expect an extended review timeline and you're targeting approval in 2026. Could you comment any further on your interactions with the FDA and why they decided to require this? And more broadly, just to the potential risk of the vaccine business outlook under the new administration? A: Thank you, Salveen, for the question. We have moved forward quickly in enrolling cases for the flu efficacy study, which we originally thought might be a two-season study. We now expect a readout soon with a large number of cases. It makes scientific sense to include this in the review for our flu COVID combination. We have demonstrated efficacy for the COVID component, and now we are focusing on the flu component. We continue to have productive exchanges with the FDA across all submissions, and we see a real need for COVID vaccination, especially this fall.

Q: What's the latest on your thinking, whether seeing INT Phase 3 data in 2026 is still a reasonable expectation? What are your plans for new trials, expansions, and other indications for both INT and the newly prioritized Checkpoint? A: The Phase 3 melanoma study reached its target enrollment in September 2024. Based on historical event rates, we expect to have enough events for an efficacy analysis in 2026. We are pleased with the enrollment in the non-small cell lung cancer study but haven't provided a specific timeline. For Checkpoint, we are encouraged by early data and plan to expand into additional cancer indications.

Q: Given how close we are to the PDUFA, it's business as usual for the 1283 review. Can you talk about how interactions are going for that program and your confidence in approval given the new leadership and recent denial of the Novavax program? A: It has been business as usual with the FDA. We have had constructive exchanges of scientific information, and we are confident in making the existing PDUFA date. We continue to provide high-quality data to all regulators, including the FDA, to support their assessments.

Q: Regarding a recent media article about vaccine trials requiring placebo controls, what do you think that will do to enrollment? Will it be harder to enroll, and is that going to be required for all respiratory vaccines? A: We can't comment on a policy change that hasn't been communicated to us. Our COVID, RSV, CMV, and norovirus vaccines have been conducted as placebo-controlled studies. It will depend on FDA and HHS guidance at a program level. Our responsibility is to provide the data that regulators need to stand behind our products.

Q: Can you elaborate on the process for COVID strain selection moving forward given the regulatory uncertainties? A: It is up to regulators in each country to tell us what updates they may want for the coming year. We expect to hear from WHO, EMA, and the US FDA within the next month about what they would like to see for the fall. The process is up to them, and we will follow their guidance.

Q: Regarding the flu COVID combination and the updated timing, is it your expectation that you would need to refile with updated flu efficacy data, or could it be a major amendment? A: It will depend on consultation with the FDA. It is appropriate to submit the data as an amendment to the BLA, but it could also make sense to update the BLA submission broadly. We will follow the FDA's guidance on the most pragmatic approach.

Q: What particular milestones or expectation changes drove you to increase the cost-cutting program? A: Much of this is extending our guidance to 2027, reflecting the completion of large Phase 3 trials by then. We are focusing on what we can control, which is our cost base, to fulfill our commitment to breakeven by 2028. The majority of cost reductions will come from the completion of Phase 3 trials and continued improvements in procurement and operational efficiency.

Q: For norovirus, have you identified the source of the GBS case, and have there been any additional cases noted? A: We have not seen additional GBS cases, which is encouraging. Causality may never be known, as GBS cases occur in the background population. We will continue to monitor for additional cases in our ongoing Phase 3 study.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

This article first appeared on GuruFocus.