Aug 13, 2026 earnings call — Revtopik approval and launch plans
FDA approved Revtopik; shipments expected late in the third quarter of 26 and WAC set at $10 thousand per vial.
Revenue $0.0B (est $0.0B) · EPS $-1.44 (est $-1.16)
Key quotes
"Based on the positive data from the PIK3CA mutant cohort of the phase 3 VICTORIA-1 study, we plan to submit a supplemental NDA or sNDA in the third quarter of 26."
"Now wholesale acquisition cost or WACC of Reptarpic which has been reported to the drug pricing compendia, will be $10 thousand per vial or $30 thousand per cycle of treatment."
"Cash, cash equivalents, and short term investments were $754 million as of 06/30/2026, compared to $441.5 million as of 12/31/2025."
Analyst Q&A 10
Confidence in late Q3 shipments
Q (Tara Bancroft · TD Cowen): Analyst wanted to know what underpins the company's confidence in late Q3 shipments. She asked if they will launch using existing clinical supply, how long that supply would last, and how long backup manufacturing setup would take.
A: Management said they expect the FDA review to proceed as they expect and they are confident there will be no surprises. They said they are very confident they can begin shipping at the end of this quarter and that their validation data is consistent with the first site, so they anticipate a straightforward review; the FDA can inspect but typically does not when a manufacturer has met requirements.
"And we are very confident about being able to ship beginning at the end of this quarter." — Brian F. Sullivan (CEO)
Second site FDA filing and EAP status
Q (Maury Raycroft · Jefferies): Analyst asked whether the validation data package has been submitted to the FDA, what remaining rate-limiting steps exist, and whether FDA sign-off is required before shipping from the new site. He also asked how many sites/doctors are in the expanded access program (EAP), if patients are enrolled, and whether quarterly enrollment updates will be provided.
A: Management said they submitted the validation data almost immediately after approval and that the FDA review for use of the second site has begun. They said you cannot ship from the new site until you receive the go-ahead from the FDA, and said the EAP started last week after FDA and central IRB approvals and they have already begun shipping drug to physicians and sites; they do not plan to provide quarterly updates.
"you cannot ship from that new site until you have received the go ahead from the FDA." — Brian F. Sullivan (CEO)
Endometrial and prostate cancer potential
Q (Brad Canino · Guggenheim): Analyst asked whether endometrial cancer is an opportunity for gedatolisib and how they would bring it into development. He also asked what can be learned from capivasertib data for prostate cancer and what could be different for gedatolisib.
A: Management said there is a strong rationale to consider endometrial cancer and that some prior data show gedatolisib can induce objective responses even as monotherapy; they noted PIK3CA and hormonal pathways are relevant in a subset of endometrioid patients and they will update development plans later in the year. On prostate, they compared recent capivasertib results and said those data support the importance of the PAM pathway and that combining a pathway inhibitor with an androgen receptor inhibitor is their hypothesis; they will update encouraging data later this year.
"some preliminary data that was generated previously was indicating that even as monotherapy, GEDA can induce a objective response." — Brian F. Sullivan (CEO)
Transitioning EAP patients to commercial
Q (Eva Fortea-Verdejo · Wells Fargo): Analyst asked how long it will take to transition patients from the EAP to commercial supply after the planned late Q3 launch.
A: Management would not commit to a fixed timeline and said they must avoid any interruption in patient supply. They said the intent is to transition EAP patients to commercial supply, that this is embedded in the protocol, and that transition timing may be site- and patient-specific and could occur between day 15 and day 29 of a cycle depending on circumstances.
"The intent is certainly to transition those patients to commercial supply." — Brian F. Sullivan (CEO)
Expected gross-to-net percentage
Q (Leerink Partners): Analyst asked for more color on the expected gross-to-net (discounts to revenue) for the drug.
A: Management said they completed a robust analysis of the discount components and channel differences. They said for their drug they expect a gross-to-net percentage to be about 80% and indicated discounts from WACC will be about 20%, and noted oral therapies often see about a 30% gross-to-net discount.
"So we have done an analysis that we think is fairly robust, actually very robust, that kind of identifies the various components of the discounts." — Brian F. Sullivan (CEO)
Community infusion access for IV therapy
Q (Oliver McCammon · LifeSci Capital): Analyst asked what proportion of community oncology practices and associated infusion centers are amenable to IV therapy and whether lessons from IV use in HER2 disease apply.
A: Management said nearly every community practice has access to infusion centers because many key breast cancer therapies are infused. They said there should be no barrier for community oncologists to prescribe gedatolisib and ensure patients can get infused, noting infusion is standard in treating breast cancer.
"Well, we think nearly every community practice has access to infusion centers because some of the most important therapies in breast cancer used to treat breast cancer are infused therapies." — Brian F. Sullivan (CEO)
Q4 prostate data details and benchmarks
Q (Kalpit Patel · Wolfe): Analyst asked what data to expect in the fourth quarter (PSA response, progression-free survival) and what would be considered success for progression-free survival.
A: Management said they expect to provide additional data that could include PSA50 and updated progression-free survival data across subgroups and data from the 240 milligram dose; 300 milligram data may not be mature. They said current second-line median PFS after prior abiraterone is 5 to 6 months, and the minimum bar would be roughly 3 to 4 months better than those options; they also referenced Pluvicto offering north of 10 months and said they would need at least to be comparable to it.
"So we expect to provide additional data that could include PSA 50 data as well as updated progression free survival data and looking at different subgroups of patients." — Brian F. Sullivan (CEO)
Supplemental review timeline and supply mix
Q (Needham): Analyst asked what timeline to expect for FDA review of the supplemental filing and, if approved, what percent of supply would come from the second site at full capacity.
A: Management said the supplemental review is not an sNDA and can follow multiple processes; reviews can be as brief as 2 months or 4 months and there is a standard 4-month review process though it can be shorter or longer if issues arise. On supply, they said they will use inventory from both sites, manage inventory and balance the mix between sites, and keep both sites running rather than assigning a fixed percent to the second site.
"And so, you know, there is a standard process of 4-month review process." — Brian F. Sullivan (CEO)
Publication, compendia listing, launch metrics
Q (Stifel): Analyst asked where the company is in preparing a publication of the mutant data, whether compendia (NCCN) listing could happen before label expansion, and how the company will communicate launch progress and which metrics it will provide.
A: Management said they have submitted an article to a journal and that peer review timing is variable and could take 3 to 6 months. They said NCCN panels require peer-reviewed journal data before changing recommendations, they cannot promote mutant use themselves, and they will report sales but lack the prescriber-level granularity of oral therapies; they will run surveys covering roughly 40% to 50% of patients with a 2 to 3 month lag and track vials shipped in near real time.
"They need to see data from a peer reviewed journal." — Brian F. Sullivan (CEO)
sNDA review timing and priority review
Q (Josh Boen · Citizens): Analyst asked about regulatory timelines for the sNDA submitted in March, including filing and whether a priority review is possible and what that timeline would look like.
A: Management said because it is an sNDA the review clock starts when the final submission is made. They said if the submission receives a priority review the review would be 6 months from submission, and if it is a regular review it would be 10 months from submission.
"If it is a priority review, it would be 6 months from submission. If it is a regular review, it would be 10 months, from submission." — Brian F. Sullivan (CEO)