This article first appeared on GuruFocus .
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Net Loss:GAAP net loss of $78.9 million, or $1.44 per share, for Q2 2026, compared to $45.3 million, or $1.04 per share, in the prior-year period.
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Non-GAAP Adjusted Net Loss:$58.7 million, or $1.07 per share, for Q2 2026, compared to $40.5 million, or $0.93 per share, in the prior-year period.
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Research and Development (R&D) Expenses:$31.1 million for Q2 2026, down from $36.4 million in the prior-year period.
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Selling, General and Administrative (SG&A) Expenses:$35.0 million for Q2 2026, up from $7.6 million in the prior-year period, driven by commercial launch preparations.
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Cash Used in Operating Activities:$55.4 million for Q2 2026, compared to $36.2 million in the prior-year period.
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Cash Position:Cash, cash equivalents, and short-term investments totaled $754 million as of June 30, 2026, up from $441.5 million as of December 31, 2025.
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Product Pricing:Wholesale acquisition cost (WAC) for REVTORPYK is $10,000 per vial, or $30,000 per treatment cycle.
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Market Opportunity:Estimated total addressable market for REVTORPYK is potentially over $6 billion annually, based on 37,000 US patients receiving second-line treatment.
Release Date: August 13, 2026
For the complete transcript of the earnings call, please refer to the full earnings call transcript .
Positive Points
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FDA approval of REVTORPYK for HR-positive, HER2-negative advanced breast cancer without PIK3CA mutation, with shipments expected to begin late Q3 2026.
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Positive Phase 3 VIKTORIA-1 results in PIK3CA mutant cohort, showing median PFS of 11.1 months vs 5.6 months for alpelisib, with a hazard ratio of 0.5.
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NCCN guidelines updated to recommend REVTORPYK triplet and doublet as preferred Category 1 regimens for second-line treatment.
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Expansion of VIKTORIA-2 trial to include endocrine-sensitive patients, potentially broadening first-line treatment opportunities.
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Strong cash position of $754 million, expected to fund operations into 2029, supporting ongoing development and commercial launch.
Negative Points
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Net loss increased to $78.9 million in Q2 2026, up from $45.3 million in the prior-year period, driven by higher SG&A expenses.
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Commercial launch is dependent on FDA approval for a second manufacturing site, with no guaranteed timeline for review.
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Gross-to-net discount of approximately 20% from WAC, which may impact revenue expectations.
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Limited real-time visibility into prescription data due to buy-and-bill model, making it difficult to track launch progress accurately.
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Potential delays in sNDA submission for PIK3CA mutant cohort, with review timelines of 6-10 months, delaying label expansion.
Q & A Highlights
Q: What underscores your confidence in the late Q3 shipments of REVTORPYK, and what is the process for the backup manufacturing site? A: Brian Sullivan, CEO, stated that the company is confident about shipping at the end of Q3 2026. The validation data for the second manufacturing site is consistent with the first site, and the company anticipates a straightforward review process with the FDA. The FDA can require an inspection, but the company believes the review will proceed as expected.
Q: Can you clarify if the validation work for the second manufacturing site has been submitted to the FDA, and what are the rate-limiting steps? A: Brian Sullivan, CEO, confirmed that the validation package was submitted to the FDA almost immediately after approval. The company cannot ship from the new site until receiving FDA approval, but remains confident in shipping late in Q3 2026.
Q: How many sites or doctors are participating in the Expanded Access Program (EAP), and will you provide quarterly updates? A: Brian Sullivan, CEO, noted the EAP started last week after receiving FDA and central IRB approval. Shipments to physicians have already begun. The company does not plan to provide quarterly updates as the program will transition to commercial supply. Patients will be converted to commercial drug once launched, as reflected in the protocol.
Q: How do you think about the opportunity for gedatolisib in endometrial cancer, given competitor activity? A: Brian Sullivan, CEO, acknowledged a strong rationale for considering endometrial cancer, citing preliminary data showing gedatolisib can induce objective responses as monotherapy. The PIK3CA pathway and hormonal pathway are involved in the endometroid patient population, making it a viable development opportunity. The company will update on development plans later in the year.
Q: What can we learn from capivasertib's data in prostate cancer, and how does it foreshadow the opportunity for gedatolisib? A: Brian Sullivan, CEO, explained that capivasertib's efficacy in breast cancer was comparable to alpelisib, while gedatolisib showed double the activity. Capivasertib's approval in PTEN loss patients (about 40% of prostate cancer patients) validates the PAM pathway as a driver. The company believes its data, to be updated later this year, will demonstrate that combining gedatolisib with an androgen receptor inhibitor improves outcomes.
Q: How long will it take to transition patients from the EAP to commercial drug following the launch? A: Brian Sullivan, CEO, stated the transition timeline will be site- and patient-specific, depending on insurance situations. The goal is to ensure no disruption in supply. The transition may occur during the 2-week gap between treatment cycles, but the company will accommodate whatever is required for a smooth transition.
Q: What is the expected gross-to-net percentage for REVTORPYK? A: Brian Sullivan, CEO, expects the gross-to-net percentage to be about 80%, with discounts from WAC of about 20%. This compares favorably to oral therapies in the category, which typically see discounts of about 30%. The company believes it can capture a higher percentage of WAC than oral therapies.
Q: What proportion of community oncology practices would be amenable to IV therapy, and are there learnings from HER2 use? A: Brian Sullivan, CEO, stated that nearly every community practice has access to infusion centers because many standard breast cancer therapies (e.g., HER2 antibodies, chemotherapies) are infused. Community oncologists treat about 80% of patients, and there should be no barrier to prescribing gedatolisib.
Q: What data should we expect from the prostate cancer program in Q4, and what would success look like? A: Brian Sullivan, CEO, expects to provide PSA50 data, updated progression-free survival data, and subgroup analyses. The 300mg dose data may not be mature. Success would be demonstrating a three-to-four-month superiority over standard of care (five to six months median PFS) or comparable efficacy to PLUVICTO (north of 10 months).
Q: What is the timeline for the FDA's review of the second manufacturing site, and what percent of supply would come from it? A: Brian Sullivan, CEO, stated the review process can take two to four months, with interactions with the agency providing early feedback. The company will balance inventory from both sites to maintain a rhythm, but did not specify a percentage split.
Q: Where are you in preparing a publication of the VIKTORIA-1 mutant cohort data, and could compendium listing be achieved before label expansion? A: Brian Sullivan, CEO, confirmed an article has been submitted to a journal, with a timeline of three to six months. NCCN recommendations require peer-reviewed data, and if made, payers would likely follow. The company cannot promote mutant usage but could benefit from NCCN recommendations. Launch progress will be reported via sales, though granularity will be lower than oral therapies due to the buy-and-bill model.
For the complete transcript of the earnings call, please refer to the full earnings call transcript .
