Jul 31, 2026 earnings call — Flu PDUFA, Intismeran progress and 2026 guidance
Company reported Q2 revenue of $145 million, above guidance.
Revenue $0.1B (est $0.1B) · EPS $-1.97 (est $-2.03)
Key quotes
"In adjuvant melanoma, the Phase III study is fully enrolled, and we look forward to the interim analysis in 2026."
"We are lowering our cost of sales projection by $0.1 billion to $1.7 billion, reflecting additional manufacturing efficiency gains."
Analyst Q&A 11
INT melanoma interim and tumor read-through
Q (Salveen Richter · Goldman Sachs): Two parts: how to interpret passing the first interim in Phase III INT (powering, disclosure), and if a positive result would read through to other tumors like lung.
A: Management said they will not disclose the statistical powering or early efficacy thresholds. They said the press release wording will depend on the data. They also said read-through depends on degree of efficacy and validating the mechanism; ASCO translational data shows neoantigen T cells that can kill tumor.
"And I think with regard to that, the answer to that -- the data that we've shown at ASCO confirms that we do give -- when we give the neoantigen vaccine, we do see neoantigen-specific T cells, and we know those T cells can kill the tumor." — David Berman
Timing, review, and manufacturing capacity
Q (Tyler Van Buren · TD Cowen): How close is the INT study to the first analysis events and confidence for a readout this year? If it succeeds, could it get priority review and what is manufacturing capacity on approval?
A: They declined to give more timing details, only saying the study is powered into the second half. They said priority review would depend on the data and could be considered; they expect to seek accelerated review if interim is positive. They said their Massachusetts facility can support the launch and the commercial profile with Merck for several years.
"We believe that facility can support our commercial profile that ourselves and our partner, Merck have articulated for several years to come." — Stephen Hoge (PRESIDENT)
Flu strain selection and neoantigen algorithm
Q (Eliana Merle · Barclays): Did FDA discussions cover late strain selection for 2027 flu and ability to update strains? Also, any learnings on neoantigen selection algorithm given patient variability in responses?
A: They said yes, they have discussed strain selection with FDA including at the advisory committee; public health agencies would need to decide how to accommodate a late strain selection. On neoantigen selection, they said about 29% of cassette neoantigens are immunogenic; patients had 1 to 18 reactive neoantigens; they are using AI to try to improve the algorithm and need efficacy linkage to validate improvements.
"So we see that about 29% of our neoantigens that go into our cassettes in general are immunogenic." — David Berman
Flu pricing and norovirus interim
Q (Terence Flynn · Morgan Stanley): Any update on flu pricing thinking or analogs? And what does the norovirus interim tell you about effect size?
A: On pricing they said it is premature and discussions are ongoing; they view their flu profile as in an enhanced category and will assess value with payers. On norovirus they said the study is still blinded, they cannot disclose the statistical plan, and they need additional cases from another cohort to strengthen the analysis.
"There will not be much more I can say than what we have right now because we are still -- the study is blinded and continuing." — Stephen Hoge (PRESIDENT)
INT immunogenicity for RCC and low TMB
Q (Cory Kasimov · Evercore): What immunogenicity data supports confidence that Intismeran will work in low TMB RCC similar to melanoma and NSCLC?
A: They said the RCC trial is still ongoing and they do not yet have that data. They will show additional data later this year on other hard-to-treat tumors. They noted demonstrating immunogenicity in pancreatic cancer gives reason to believe they can identify neoantigens for RCC and have confidence it can be done.
"But we will be showing some data later this year on other tumors that are hard to treat." — David Berman
Horizon 2 IDO and triple T-cell engager
Q (Lin Tsai · Jefferies): For Horizon 2, what is the approvable bar for the IDO program in first/second-line melanoma? For the 3-engager T-cell program, what would positive myeloma data look like and is there a plan to go earlier?
A: On 4359 (IDO PD-L1) they said they are confirming the signal in Phase II expansion and will decide if and where a pivotal path exists; approval bar depends on showing sufficiently high and durable response rates and safety in combinations. For 2808 (triple engager) they said they are testing production, safety/tolerability, and whether there is evidence of complete and partial responses and how durable they are in heavily pretreated myeloma.
"For us, the reason we're excited is we have the first 3 T-cell engagers in a single product ever being studied." — David Berman
Norovirus delay and CCO priorities
Q (Courtney Breen · Bernstein): Is the norovirus delay due to enrollment, efficacy, or events, and what drove the slower case accrual? Also, what are the top priorities for the new Chief Commercial Officer and changes needed for growth?
A: They said norovirus remained blinded, and case accrual was slower because a unique outbreak of different strains in the first season did not contribute to the primary endpoint; they expect another season to accrue cases. On commercial priorities they listed multiple upcoming product launches, Europe reopening in 2026, coordination with Merck for INT, and that the new CCO will help prepare commercial, medical and marketing functions for growth.
"As we had previously discussed, some of that in the first season for that trial was the result of a unique outbreak of a different set of strains of norovirus that were not contributing to that primary endpoint." — Stephen Hoge (PRESIDENT)
INT hazards and Europe combo contracting
Q (Michael Yee · UBS): On INT, could effect increase over time with nonproportional hazards and how should we view interim expectations? And for the COVID-flu combo in Europe, when do contracting and revenues start to appear?
A: They said they won't disclose the statistical plan but noted Phase II showed nonproportional hazards with separation at ~12 months; Phase III requires minimum 18 months follow-up so every patient has been followed beyond that separation, which they view positively. On Europe they said pricing negotiations start after approval with HTA submissions and tenders; some countries may contribute in 2027 but full effect likely in 2028 and beyond depending on country requirements.
"The good news in the Phase III study, which was designed with Merck, who has a lot of expertise in melanoma is that it requires also a minimum of 18 months follow-up." — David Berman
Revenue drivers and PA trial timing
Q (Geoffrey Meacham · Citi): What are the puts and takes behind the 10% revenue growth guidance across geographies? And for rare disease 3927, what determines timing and regulatory usefulness of the readout?
A: They said first-half revenue was about $0.5 billion, roughly 70% international and 30% U.S., and the main second-half variable is U.S. vaccination rates; international strategic partnerships supply is an upside. On PA they said ~20 patients were enrolled, the primary endpoint is metabolic decompensation events over 12 months with each patient as their own control, and readout should occur in the fourth quarter; prior releases showed about 60% to 80% efficacy.
"So we're sitting pretty good after the first half year in terms of $0.5 billion in revenue, roughly 70% international, 30% in the U.S." — James Mock (CFO)
Micrometastatic proportion clarification
Q (Myles Minter · William Blair): Can you confirm Dr. Carlino's comment that ~2/3 of patients would have micrometastatic disease and whether that applied to Stage III or the whole trial? Also, impact of shifting micrometastatic proportion from Phase I/II to Phase III?
A: They said they don't recall the exact comment and have not released baseline demographics. They described the trial eligibility as Stage IIB to fully resected Stage IV and said earlier stages should have healthier immune systems and lower tumor burden, which supports giving the vaccine earlier. They did not confirm the 2/3 micrometastatic figure.
"But the trial -- we haven't released the baseline demographics of the trial." — David Berman
How will Street learn about interim and biomarker sample size
Q (Jessica Fye · JPMorgan): If the Phase III interim passes without stopping, how will investors be informed? And why was the ASCO translational poster based on only a few patients versus the larger Phase II?
A: They said they will issue a press release for the interim result. They explained the translational set had only 7 patients because leukapheresis was required, which is more burdensome and needs consent, and they hope to expand such analyses and explore less burdensome ways.
"So we will be issuing a press release on that data, Jess, for the interim." — David Berman