Exelixis's Earnings Call Contradictions: STELLAR-304 Timelines, Triplet Therapy Shifts, and Franchise Goals Diverge

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Date of Call: Aug 5, 2026

Financials Results

• Revenue: $629M
• EPS: $0.82 per diluted share

Guidance:

• Lowered and narrowed full-year 2026 total revenues and net product revenue guidance, lowering the midpoint by $50M.
• Lowered R&D expense guidance, lowering the midpoint by $50M.
• Full-year 2026 gross-to-net deductions projected between 30% and 31%.

Business Commentary:

Revenue and Financial Guidance:

• Exilexis reported total revenues of approximately $629 million for Q2 2026, with CaboMedic's net product revenues at $573 million, showing a 10% year-over-year growth.
• The company lowered its total revenues and net product revenue guidance, adjusting the midpoint by $50 million, due to a more gradual ramp for the net indication than initially projected.

Zanzalintinib Development:

• Zanzalintinib is positioned as the next potential franchise molecule, with a focus on the third-line plus CRC filing under review and preparations for a potential launch.
• The strategic priority is to evolve from a single compound company to one with a pipeline of potential oncology franchise opportunities, with seven ongoing or imminent pivotal trials.

CaboMedic's Market Position:

• CaboMedic's net product revenue grew 10% year-over-year, maintaining its position as the leading TKI for RCC and the market leader in the oral second-line plus net segment.
• Growth was driven by strong promotional efforts and high market share, particularly in RCC, with a focus on first-line 9ER data.

Clinical Trial Progress:

• Significant progress was reported on pivotal trials for Zanzalintinib, including the completion of enrollment in Stellar 304 and expectations for top-line results in the second half of 2026.
• Enrollment dynamics and event rates influenced the timelines, with ongoing efforts to expand the development portfolio in GU, GI, and other indications.

Expense Management and Share Repurchase:

• Operating expenses increased sequentially due to higher clinical trial costs, marketing expenses, and stock-based compensation, but the company maintained disciplined expense management.
• Exilexis repurchased approximately $312 million worth of shares in Q2 2026, with $598 million remaining under the company's share repurchase plan.

Sentiment Analysis:

Overall Tone: Positive

• Management expressed confidence in long-term growth, stating 'Our confidence in Cabo's long-term revenue growth trajectory remains unchanged' and 'We are in the early innings of our next phase of growth'. They highlighted strong progress across the pipeline, with Zanzalintinib poised to become the next franchise molecule and positive feedback on upcoming trials.

Q&A:

• Question from PJ (Exilexis): Regarding Stellar 304, do you think it might be able to make a major medical meeting this year and any updated precision on data timing?
  Response: Management expects top-line results in the second half of 2026 but will not speculate on exact timing or meeting announcements.

• Question from Anastasia (Jefferies): Regarding the first-line post-adjuvant study, could patient switching to an existing regimen reduce the patient population?
  Response: Management believes utilization of the new adjuvant regimen will be limited due to historical sensitivity to toxicity and a high bar to beat from pembrolizumab monotherapy.

• Question from Andrew Peters (Exilexis): What is your take on the ongoing Stellar 311 study against the backdrop of guidance lowering?
  Response: Management reiterated excitement about Stellar 311, cited potential cannibalization from clinical trials but emphasized patient kinetics as the main driver of the more gradual ramp for Cabo in NET.

• Question from Sean (Unknown Firm): With the CRC PDUFA date approaching, what label language would be most commercially meaningful and could any limitations constrain uptake?
  Response: Management highlighted excitement about the potential first immunotherapy-containing regimen for CRC but declined to comment on specifics of an ongoing regulatory review.

• Question from Josh (Unknown Firm): Can you highlight progress towards the $5B revenue goal for Zanza by 2033?
  Response: Management noted the $5B figure was an aspirational view from late 2024 and emphasized the depth and breadth of opportunity with seven pivotal trials and a pipeline of potential indications.

• Question from Kalpit (Unknown Firm): If the ANDA gets full approval, does that accelerate generic developer timelines?
  Response: Management stated they cannot comment on specifics of agreements but noted the scenario described is not common in such agreements.

• Question from Yaron (Unknown Firm): How fast can data be generated for Stellar 201 in meningioma, and can a new 505B2 get NCCN guideline placement without clinical data?
  Response: Management indicated a confirmatory Phase III trial is being designed but could not comment on timing. Regarding 505B2, they emphasized focus on patient safety and IP rights, noting the importance of clinical data for guideline recommendations.

• Question from Michelle (Guggenheim Securities): What drove the enrollment delay in Stellar 304 and will it result in more mature OS at top line?
  Response: Management attributed enrollment shifts to unpredictable trial dynamics and confirmed the readout is still expected in the second half of 2026.

• Question from Chris (Unknown Firm): How might Zanza play alongside novel agents like ADCs or radio-pharma in NET?
  Response: Management believes a positive head-to-head Phase III study would position Zanza well as a potential first or second-line oral agent in NET.

• Question from Ash Verna (UBS): Do you expect similar patient inflow dynamics for Zanza in NET as Cabo, and what was NET's contribution to Cabo's revenue this quarter?
  Response: Management expects Zanza's dynamics to differ due to head-to-head study design and patient eligibility; NET's contribution to Cabo's revenue was not specified.

• Question from Edzer (Unknown Firm): Are you still looking to partner Zanza internationally?
  Response: Management stated they are evaluating all options for potential partnerships ex-U.S. carefully and expect continued interest as trial data emerges.

• Question from Ash Verna (UBS): What drove the recent update that the non-liver Mets subgroup in Stellar 303 did not achieve statistical significance?
  Response: Management noted the non-liver Mets subgroup was small, and the treatment effect remained similar to initial interim results; the ITT population data remains the focus of the NDA.

• Question from Stephen Williams (Unknown Firm): How will you ensure persistency in oral TKI maintenance therapy in trials like Stellar 316 and 202?
  Response: Management emphasized selecting the right dose and considering patient population to balance activity and duration, leveraging experience with Cabo to maximize therapeutic ratio.

Contradiction Point 1

Timeline for Top-Line Data for STELLAR-304

Contradictory statements regarding the expected timing for the data release, impacting expectations for key trial outcomes.

Paul (Paul J.) - Paul (Paul J.)

2026Q2: Topline data is expected in the second half of 2026. - Dana Aftab(EVP, R&D)

Can Stellar 304 make a major medical meeting this year, and do you have an updated data timing? - Sean Lehmann (Morgan Stanley) - Catherine on for him

2026Q1: The slower event accrual was not speculated on. The trial is the first phase III in this high unmet need population, and top-line results are still expected in the second half of 2026. - Dana T. Aftab(EVP, R&D)

Contradiction Point 2

Strategy for Triplet Therapy in Clear Cell RCC

Shift in stance regarding the development of triplet therapy combinations, affecting the strategic approach to RCC treatment.

Paul Choi (Goldman Sachs) - Paul Choi (Goldman Sachs)

2026Q2: The strategy with ZANZA is to create the next franchise molecule in RCC for the 2030s. The triplet therapy failure (LITESPARK-012) highlights the challenges of triplets in clear cell RCC. The current focus is on establishing a standard of care... - Dana T. Aftab(EVP, R&D)

Given the LITESPARK-012 study's recent miss, can you share updated thoughts, learnings, and any trial considerations for the belzutifan plus zanza combination program (LITESPARK-033 and LITESPARK-034)? - Kalpit Patel (Wolfe Research)

2026Q1: The current collaboration with Merck (LITESPARK-033) is a different hypothesis (no IO, targeting patients post-adjuvant therapy). Triplets require strong scientific rationale. The company is not opposed but will require the right molecule and setting. They are exploring various orthogonal mechanisms to combine with ZANZA... - Dana T. Aftab(EVP, R&D)

Contradiction Point 3

Strategic Focus for Zanzalintib Franchise

Contradiction on whether Zanza is seen as a second franchise or a replacement for Cabozantinib (Cabo), altering the long-term revenue outlook.

Josh (Josh on for Sylvan) - Josh (Josh on for Sylvan)

2026Q2: The $5 billion figure was an aspirational view for a second franchise molecule. - Mike Morrissey(CEO)

What progress has been made toward the $5 billion revenue goal for Zanzalintib by 2033, and how has the projection's composition evolved? - Akash Tewari (Jefferies)

20260211-2025 Q4: The strategy is to position zanza as a dominant standard of care in RCC for the 2030s. - Michael Morrissey(CEO)

Contradiction Point 4

Importance of Non-Liver Mets Data for STELLAR-303

Contradiction on the significance of non-liver metastases (NLM) subgroup data for the overall trial analysis, impacting the weight given to different data points.

Ash Verna (UBS) - Ash Verna (UBS)

2026Q2: The non-liver mets subgroup was small, and the treatment effect did not evolve to statistical significance over time... The primary ITT population data (overall survival) were the focus of the NDA submission and are what matter most. - Dana Aftab(EVP, R&D)

What drove the lack of statistical significance in the non-liver mets subgroup of the Stellar 303 update, and has this been discussed with the agency? - Sean Laaman (Morgan Stanley)

20260211-2025 Q4: The non-liver metastases (NLM) data are a subset where the trial is already positive. These data, along with the overall survival (OS) benefit in the broader ITT population, will help move the needle... - P. Haley(EVP, Commercial)

Contradiction Point 5

Timing and Specificity of Clinical Data Communication

Contradiction on providing specific vs. vague timing for top-line data readouts, affecting investor expectations and market confidence.

Paul (Paul J.) - Paul (Paul J.)

2026Q2: Topline data is expected in the second half of 2026. It would not be appropriate to speculate on specific timing or medical meeting availability. - Dana Aftab(EVP, R&D)

Is Stellar 304 on track to present at a major medical meeting this year, and when can we expect updated data timing? - Paul Choi (Goldman Sachs)

20251105-2025 Q3: The final analysis for the NLM subgroup is expected to trigger midyear 2026. - Dana Aftab(EVP, R&D)

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