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    Gregory Renza • RBC Capital Markets

    Gregory Renza's questions to Agios Pharmaceuticals Inc (AGIO) leadership

    Gregory Renza's questions to Agios Pharmaceuticals Inc (AGIO) leadership •

    Question

    Gregory Renza of RBC Capital Markets questioned the potential for community mistrust in the sickle cell space following the Oxbryta withdrawal, what Agios is doing to manage this, and if there have been any new communications with regulators about risks at African trial sites.

    Answer

    CEO Brian Goff highlighted the company's strategy of building trust through high-touch engagement, listening to the patient community, and incorporating their feedback into trial design. CMO Dr. Sarah Gheuens added that the trial is closely monitored and that the high unmet need reinforces their commitment to delivering a meaningful therapy for patients.

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    Gregory Renza's questions to Agios Pharmaceuticals Inc (AGIO) leadership • Q1 2025

    Question

    Gregory Renza of Mizuho Securities inquired about the FDA review for PYRUKYND in thalassemia, seeking confirmation on the absence of an advisory committee and the status of the mid-cycle review. He also asked how the withdrawal of Oxbryta has impacted the sickle cell disease trial landscape and patient recruitment.

    Answer

    CEO Brian Goff and CMO Dr. Sarah Gheuens confirmed consistent engagement with the FDA for PYRUKYND in thalassemia, noting the agency has communicated that no advisory committee meeting is planned at this time as the review progresses toward the September 7 PDUFA date. Regarding sickle cell disease, Dr. Gheuens stated they have not observed any impact on their clinical trial conduct from the Oxbryta withdrawal. CCO Tsveta Milanova added that the event reinforces the high unmet medical need in the community.

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    Gregory Renza's questions to Agios Pharmaceuticals Inc (AGIO) leadership • Q4 2024

    Question

    Gregory Renza of RBC Capital Markets inquired about the company's enthusiasm for the pipeline asset AG-181, its mechanism as a PAH stabilizer, and its potential for non-responders. He also asked about Agios's strategy for external asset acquisition given the active market.

    Answer

    CEO Brian Goff expressed pride in the entire diversified pipeline, highlighting AG-181 as a Phase I asset addressing a high unmet need in a population of 35,000-40,000 patients. On business development, Goff stated that Agios has scaled up its search and evaluation capabilities and maintains a disciplined approach, leveraging its strong balance sheet to find assets that align with its rare disease expertise.

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    Gregory Renza's questions to Exelixis Inc (EXEL) leadership

    Gregory Renza's questions to Exelixis Inc (EXEL) leadership • Q1 2025

    Question

    An analyst on behalf of Gregory Renza asked for clarification on the source of the $100 million revenue guidance increase, specifically the contribution from the new NET indication, and when to expect more clarity on NET's impact.

    Answer

    President and CEO Michael Morrissey clarified that the guidance raise is driven predominantly by the strength of the base RCC business. He stated that while a small amount for NET is factored in, the company is waiting to gain more clarity and confidence in the launch momentum before providing more specific updates on its contribution.

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    Gregory Renza's questions to Exelixis Inc (EXEL) leadership • Q4 2024

    Question

    Gregory Renza asked about the strategy for a potential regulatory submission for cabozantinib in prostate cancer (CONTACT-02), particularly given the absence of an overall survival benefit, and the company's confidence in that process.

    Answer

    President and CEO Michael Morrissey stated that the company's 'singular focus' from a regulatory perspective is currently on securing approval for the NET indication. He deferred detailed comments on the CONTACT-02 prostate cancer opportunity, indicating that the company will 'circle back' to it after the NET review is complete.

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    Gregory Renza's questions to Exelixis Inc (EXEL) leadership • Q3 2024

    Question

    Gregory Renza requested further elaboration on the assumptions behind the long-term peak sales opportunity for zanzalintinib and asked about the optimal portfolio construct for Exelixis moving forward.

    Answer

    President and CEO Michael Morrissey explained that CABOMETYX provides the foundation for zanzalintinib's future growth. He stated that now is the right time to focus on the future post-ANDA ruling, and while detailed modeling assumptions will be shared over time, the company's goal is to build a multi-product, multi-franchise oncology business.

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    Gregory Renza's questions to Beigene Ltd (ONC) leadership

    Gregory Renza's questions to Beigene Ltd (ONC) leadership • Q1 2025

    Question

    Gregory Renza asked about the BTK CDAC's positioning, the company's confidence in its head-to-head trial against pirtobrutinib, and potential resistance mechanisms. He also inquired about the strategy for the I&I (Immunology & Inflammation) portfolio, particularly the IRAK4 degrader.

    Answer

    Wang Lai, Global Head of R&D, stated that confidence in the BTK degrader is increasing daily with new data, leading to the decision to initiate the head-to-head trial. He mentioned they are exploring its use in earlier lines. Regarding the I&I portfolio, Lai expressed excitement about the IRAK4 degrader, highlighting its best-in-class potential and a dozen other preclinical programs, signaling a growing focus on this area.

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    Gregory Renza's questions to BGNE leadership

    Gregory Renza's questions to BGNE leadership • Q1 2025

    Question

    Gregory Renza questioned the company's confidence in its BTK CDAC being able to beat pirtobrutinib in a head-to-head trial and its views on using degraders in earlier treatment lines. He also asked about the strategy for the I&I (Immunology & Inflammation) portfolio, including the IRAK4 program.

    Answer

    Lai Wang, Global Head of R&D, expressed growing confidence in the BTK degrader based on emerging data and KOL feedback. He also highlighted the excitement around the I&I portfolio, which includes a dozen preclinical programs and a potentially best-in-class IRAK4 degrader, signaling a key area for future expansion.

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    Gregory Renza's questions to Jazz Pharmaceuticals PLC (JAZZ) leadership

    Gregory Renza's questions to Jazz Pharmaceuticals PLC (JAZZ) leadership • Q1 2025

    Question

    Gregory Renza of RBC Capital Markets requested more detail on the effectiveness of Xywav's marketing campaigns and the specific impacts driving confidence in the growth of the idiopathic hypersomnia (IH) market.

    Answer

    Renée Galá, President and COO, reported that the campaigns are successfully increasing disease awareness among physicians and patients. She highlighted strong performance from digital and media initiatives, field team execution, and the nurse educator program. She quantified the success by noting that total net patient adds for Xywav grew 5% year-over-year, while IH patient adds specifically grew 39% over the last 12 months.

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    Gregory Renza's questions to Jazz Pharmaceuticals PLC (JAZZ) leadership • Q4 2024

    Question

    On behalf of Gregory Renza, an analyst from RBC Capital Markets asked about the timelines for subsequent overall survival (OS) analyses for the Ziihera GEA trial following the top-line PFS readout. They also inquired about the key levers that can be used to further enhance the uptake of Epidiolex.

    Answer

    Robert Iannone, EVP and Global Head of R&D, explained that the first interim OS analysis will occur with the PFS readout, and the updated timeline allows for greater maturity in that analysis but does not alter the timing for the second and final OS readouts. Renée Galá, President and COO, identified several growth levers for Epidiolex, including leveraging data on non-seizure benefits, expanding in the adult and long-term care settings, improving market access, and executing targeted commercial programs.

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    Gregory Renza's questions to Jazz Pharmaceuticals PLC (JAZZ) leadership • Q4 2024

    Question

    Anish, on behalf of Gregory Renza at RBC Capital Markets, asked about the timeline for subsequent overall survival analyses for the Ziihera GEA trial and what levers could further enhance Epidiolex uptake.

    Answer

    EVP, Global Head of R&D Rob Iannone explained that the first interim OS analysis will occur with the PFS readout, but the updated timeline for PFS has no direct implication for the second or third OS analyses. President & COO Renée Galá highlighted that Epidiolex growth is driven by data on non-seizure benefits, penetration in adult/long-term care, strong access, and new commercial programs.

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    Gregory Renza's questions to Jazz Pharmaceuticals PLC (JAZZ) leadership • Q3 2024

    Question

    An analyst on behalf of Gregory Renza asked for Jazz's current thinking on the peak sales assumption and commercial ramp for zanidatamab in its initial second-line biliary tract cancer (BTC) indication.

    Answer

    President and COO Renée Galá reiterated that the company does not provide product-specific guidance. She emphasized that BTC is a rare cancer with a very small patient population, leading to low initial revenue expectations. The significant $2B+ peak potential for zanidatamab is expected to come from larger indications like GEA and breast cancer.

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    Gregory Renza's questions to Jazz Pharmaceuticals PLC (JAZZ) leadership • Q3 2024

    Question

    An analyst on behalf of Gregory Renza at RBC Capital Markets inquired about the company's current thinking on peak sales assumptions and the commercial ramp for zanidatamab in second-line biliary tract cancer (BTC).

    Answer

    President and COO Renée Galá stated that while the company does not provide product-specific guidance, the initial BTC indication represents a very small patient population of about 3,000 U.S. patients, leading to modest revenue expectations. She emphasized that the larger $2 billion-plus peak sales opportunity for zanidatamab is expected to come from future indications like GEA, breast cancer, and a potential pan-tumor approval.

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    Gregory Renza's questions to CorMedix Inc (CRMD) leadership

    Gregory Renza's questions to CorMedix Inc (CRMD) leadership • Q1 2025

    Question

    Gregory Renza asked for an update on the large dialysis operator (LDO) partnership, including engagement evolution and what the LDO needs to see for a broader rollout, and also inquired about inventory control and potential macro volatility impacts.

    Answer

    CEO Joseph Todisco expressed optimism for a mid-year 2025 LDO implementation start, citing increased preparatory activities. He clarified that recent order lumpiness was due to a specific customer's price-incentivized early purchase, not macro issues, and affirmed that CorMedix has significant inventory and manufacturing capacity, making supply a non-issue.

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    Gregory Renza's questions to CorMedix Inc (CRMD) leadership • Q3 2024

    Question

    Gregory Renza from RBC Capital Markets asked for details on the operational dynamics of DefenCath, including inventory stocking levels at facilities and order frequency. He also inquired about potential macro impacts on the business, such as hurricanes in the Southeast, and requested an update on manufacturing and API supply sufficiency for future demand.

    Answer

    CEO Joseph Todisco stated that initial customers hold about 10 days of inventory, shipping direct-to-clinic, while the new large dialysis organization (LDO) may stock 15-30 days. He acknowledged minor disruption from hurricanes but noted trends have returned to normal. On manufacturing, Todisco assured that CorMedix has more than sufficient finished dose inventory for a decent part of the next year, has stockpiled key active ingredients, and utilizes two finished dosage manufacturers, ROVI and Siegfried, to ensure supply.

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    Gregory Renza's questions to CorMedix Inc (CRMD) leadership • Q2 2024

    Question

    An associate on behalf of Gregory Renza asked for a comparison of CLABSI and CRBSI infection rates, how this distinction affects DefenCath's marketing strategy, and how the product's pass-through status can be leveraged to boost uptake.

    Answer

    CEO Joseph Todisco and EVP & Chief Clinical Strategy and Operations Officer Elizabeth Masson-Hurlburt clarified the clinical distinctions. Masson-Hurlburt explained that CRBSI is a specific subset of the broader CLABSI category, which is relevant for the TPN study design. Todisco added that pass-through status is meaningful because it allows for buy-and-bill reimbursement when a catheter is first installed, enabling protection of the line from the very beginning.

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    Gregory Renza's questions to Amgen Inc (AMGN) leadership

    Gregory Renza's questions to Amgen Inc (AMGN) leadership • Q1 2025

    Question

    Gregory Renza of RBC Capital Markets asked for an elaboration on Amgen's KRAS franchise strategy, particularly concerning the AMG 410 asset, and management's confidence in its potential to be a best-in-class molecule in a competitive field.

    Answer

    James Bradner, EVP of R&D, described AMG 410 as a highly selective, reversible, pan-KRAS inhibitor, which should confer an excellent therapeutic index. While acknowledging the competitive landscape, he emphasized Amgen's leadership in the KRAS field and the positive reception the molecule received from experts at the recent AACR conference.

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    Gregory Renza's questions to Amgen Inc (AMGN) leadership • Q4 2024

    Question

    Gregory Renza inquired about the commercial opportunity in China, especially for oncology drugs through the BeiGene partnership, and how this collaboration fits into Amgen's long-term goals.

    Answer

    CEO Robert Bradway highlighted that the Japan/Asia Pacific region is Amgen's fastest-growing. Murdo Gordon, EVP of Global Commercial Operations, added that the BeiGene partnership has exceeded expectations, with strong execution for KYPROLIS, BLINCYTO, and XGEVA, complementing the solid growth of Amgen's own affiliate business in China.

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    Gregory Renza's questions to Amgen Inc (AMGN) leadership • Q3 2024

    Question

    Gregory Renza inquired about Amgen's strategy for replenishing its rare disease pipeline and supporting its current portfolio, particularly following a recent discontinuation.

    Answer

    CEO Robert Bradway noted the current rare disease products are early in their life cycles with significant potential. EVP of R&D James Bradner added that the Horizon acquisition has energized R&D, leading to new projects and a dedicated rare disease initiative. He highlighted a strategy blending internal innovation with the external deal-making Horizon was known for.

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    Gregory Renza's questions to Pacira Biosciences Inc (PCRX) leadership

    Gregory Renza's questions to Pacira Biosciences Inc (PCRX) leadership • Q4 2024

    Question

    Gregory Renza inquired about the relative contributions of EXPAREL, Zilretta, and iovera to the 2025 revenue guidance and any sequential trends to consider beyond the NOPAIN Act ramp. He also asked what assumptions about the competitive landscape are factored into the company's '5/30' plan, which targets a double-digit compound annual growth rate for product revenue.

    Answer

    CEO Frank Lee and CFO Shawn Cross clarified that while EXPAREL remains the flagship product driving growth, the company is investing to support all three products. They reiterated that the most significant uptake from the NOPAIN Act is expected in the second half of the year. Regarding long-term growth, Lee stated that the '5/30' plan was developed with high confidence, as management does not believe a generic version of EXPAREL will launch in the foreseeable future, supported by a continually strengthening IP estate.

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    Gregory Renza's questions to ACADIA Pharmaceuticals Inc (ACAD) leadership

    Gregory Renza's questions to ACADIA Pharmaceuticals Inc (ACAD) leadership • Q4 2024

    Question

    Gregory Renza inquired about Acadia's business development strategy, asking where the current gaps in the pipeline are and what the company considers an optimal pipeline state.

    Answer

    CEO Catherine Owen Adams stated that Acadia is actively exploring opportunities in its core neuroscience and neuro-rare areas, as well as adjacent rare disease fields like endocrine and immunology. She emphasized the strategy is not stage-specific but focuses on a high bar for scientific evidence, unmet need, and the potential to deliver first-in-class or best-in-class therapies.

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    Gregory Renza's questions to ACADIA Pharmaceuticals Inc (ACAD) leadership • Q3 2024

    Question

    Gregory Renza of Mizuho Securities inquired about new CEO Catherine Owen Adams's strategic framework for business development and the early-stage pipeline. He also asked about expected Daybue utilization patterns heading into the Q4 holiday season and the Q1 2025 transition.

    Answer

    CEO Catherine Owen Adams stated that business development is a key growth driver, with a focus on neuropsychiatry and rare diseases, supported by Acadia's strong cash position. Executive Brendan Teehan addressed the Daybue transition, explaining that a more mature patient mix (over 60% on therapy for 10+ months) and enhanced hub capabilities should create a more dependable Q1 demand base compared to the prior year, although new patient appointments might slow in January.

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    Gregory Renza's questions to Fulcrum Therapeutics Inc (FULC) leadership

    Gregory Renza's questions to Fulcrum Therapeutics Inc (FULC) leadership • Q3 2024

    Question

    Gregory Renza from RBC Capital Markets asked how the losmapimod experience is informing risk assessment for pociredir and other programs, how the company balances internal discovery with external asset acquisition, and for details on the 2025 spending allocation.

    Answer

    Executive Alexander Sapir contrasted losmapimod's novel endpoint with pociredir's well-established biomarker (fetal hemoglobin). He stated that while the company has a strong balance sheet for external deals, the focus remains on its promising internal pipeline. CFO Alan Musso confirmed the 2025 spend guidance of $55-$65 million fully funds the advancement of pociredir and preclinical programs, providing a cash runway into at least 2027.

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    Gregory Renza's questions to Fulcrum Therapeutics Inc (FULC) leadership • Q2 2024

    Question

    Gregory Renza asked about Fulcrum's payer engagement strategy for losmapimod, including potential tailwinds and challenges, and also inquired about the plan and timing for building out the commercial organization.

    Answer

    CEO Alexander Sapir stated that early payer research indicates it will be difficult to restrict access due to high unmet need, with payers expecting rare disease pricing. A key factor will be the likely requirement for a confirmed genetic test, which Fulcrum is working to facilitate. Sapir also confirmed the commercial build-out has begun, a Chief Commercial Officer will be appointed in Q3 2024, and the launch is fully funded within the current cash runway.

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    Gregory Renza's questions to Viridian Therapeutics Inc (VRDN) leadership

    Gregory Renza's questions to Viridian Therapeutics Inc (VRDN) leadership • Q1 2024

    Question

    Gregory Renza of RBC Capital Markets inquired about the competitive landscape for clinical trial patient enrollment, given other active trials in the TED space. He asked what strategies Veridian is using to drive demand and accelerate trial execution.

    Answer

    President and CEO Stephen Mahoney pointed to the over-enrollment of the THRIVE trial as clear evidence of strong patient demand for new IGF-1R therapies. Chief Medical Officer Thomas Ciulla added that promising Phase II results have generated significant investigator excitement and that the STRIVE study's design (active control, no placebo) is expected to drive enrollment.

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