Sean Laaman

Sean Laaman questioned BRUKINSA's long-term growth potential and strategy to gain market share from CALQUENCE, given its strong performance against Imbruvica.

Answer

Aaron Rosenberg, CFO, expressed confidence in BRUKINSA's data, highlighting its 50% new patient share in the continuous use BTK market and ample opportunity for continued growth. John V. Oyler, Co-Founder, Chairman, and CEO, emphasized the overwhelming body of evidence for BRUKINSA's superiority across various data points.

Sean Laaman sought to understand BRUKINSA's long-term growth potential, particularly how BeOne Medicines plans to gain market share from CALQUENCE given BRUKINSA's best-in-class data.

Answer

Aaron Rosenberg, CFO, expressed confidence in BRUKINSA's evidence translating to market performance, noting its 50% new patient share in the continuous use BTK market and ample opportunity for further growth. John Oyler, Co-founder, Chairman, and CEO, emphasized that the challenge is to ensure the overwhelming body of evidence for BRUKINSA's superiority is recognized.

Sean Laaman asked management to size the potential market opportunity for sonrotoclax compared to Venclexta, given its potential profile. He also inquired about BRUKINSA's commercial performance in Europe and whether the investment in the sales force there is adequate for growth.

Answer

Wang Lai, Global Head of R&D, highlighted sonrotoclax's potency and selectivity, expressing confidence that head-to-head trials could establish it as the best-in-class BCL-2 inhibitor. Matt Shaulis, GM of North America, noted the BCL-2/CD20 opportunity is about a quarter of the frontline CLL market, with potential for expansion. Xiaobin Wu, President and COO, commented on Europe, citing 75% growth for BRUKINSA and increasing new patient share, affirming that launch activities are on track.

Sean Laaman from Morgan Stanley & Co. inquired about clinician feedback on the long-term viability of Calquence and the potential market impact of a competing fixed-duration doublet therapy.

Answer

CFO Aaron Rosenberg noted Calquence's slowing growth. CEO John Oyler asserted that the competitor's doublet data is unimpressive, citing inferior MRD negativity and PFS in a highly selective patient group compared to continuous BRUKINSA. Global Head of R&D Lai Wang added that physicians have safety and complexity concerns with venetoclax-based regimens.

Sean Laaman asked for clinician feedback on the long-term viability of competitor drug Calquence, given BRUKINSA's growth, and questioned the potential market impact of a potential Calquence doublet approval.

Answer

CEO John Oyler asserted that the competitor's doublet data is unimpressive, citing statistically worse MRD negativity and unfavorable PFS compared to continuous BRUKINSA, making it an insignificant threat. Lai Wang, Global Head of R&D, added that physicians have safety and complexity concerns with venetoclax-based combinations. CFO Aaron Rosenberg also noted Calquence's substantially weaker growth rates.

Sean Laaman from Morgan Stanley & Co. asked for management's perspective on the long-term viability of competitor drug Calquence, given BRUKINSA's rapid market share growth, and the potential impact from a competitor's doublet therapy approval.

Answer

CFO Aaron Rosenberg affirmed BRUKINSA's superior growth trajectory. CEO John Oyler added that the competitor's doublet data is unimpressive, showing worse MRD negativity and an unfavorable PFS curve compared to continuous BRUKINSA, particularly given the trial's highly selective patient population. Global Head of R&D Lai Wang noted physician concerns regarding the safety and complexity of venetoclax-based combinations.

Sean Laaman questioned the expected impact of DAYBUE STIX's broader rollout in early Q2 2026, specifically on net new patient capture versus switching, and whether it will meaningfully expand the addressable Rett population.

Answer

Tom Garner, Chief Commercial Officer, stated that Acadia estimates STIX could unlock over 400 additional patients (treatment-naïve or those who discontinued due to formulation concerns) over the next 2-3 years. He confirmed that STIX, combined with expanded field teams and educational efforts, is expected to further penetrate and potentially expand the addressable Rett market, now estimated at 6,000 diagnosed patients in the U.S.

Sean Laaman inquired about the broader rollout of DAYBUE STIX in early Q2 2026, specifically asking about the balance between net new patient capture versus switching, and whether STIX is expected to meaningfully expand the addressable Rett population.

Answer

Tom Garner, Chief Commercial Officer, expressed encouragement from early STIX excitement, estimating an incremental opportunity of over 400 patients (naive or those who discontinued due to formulation concerns) to be unlocked over 2-3 years. He noted that combined with expanded field teams and direct-to-consumer efforts, DAYBUE aims to further penetrate and potentially expand the estimated 6,000 diagnosed Rett patients in the U.S. Catherine Owen Adams, CEO, reiterated excitement for STIX and anticipated providing full insights on the next call.

Catherine, on behalf of Sean Laaman from Morgan Stanley, asked for details on the observations from the Phase I MAD cohorts for the early-stage pipeline asset ACP-711 and an update on its study status.

Answer

An executive responded that the company was pleased with the safety and tolerability profile observed in the ACP-711 study. They also mentioned that interesting biomarker data from the study will be presented at the upcoming R&D Day and that the program is progressing toward a planned Phase II start in 2026.

Sean Laaman asked how Immunocore evaluates success in early autoimmune studies, particularly for the Type 1 diabetes candidate entering Phase I in 2026, and the potential capital intensity of the autoimmune platform.

Answer

Bahija Jallal, CEO, explained that for Type 1 diabetes, success will be evaluated early by confirming target binding (e.g., with soluble PD-1) and measuring C-peptide as a surrogate for efficacy, allowing for early determination of activity potential before larger trials.

Sean Laaman from Morgan Stanley asked for clarification on the future competitive positioning of Chemtrac, particularly in relation to emerging therapies for uveal melanoma.

Answer

Ralph Torbay, EVP of Commercial, emphasized that while new developments for HLA-A2 negative patients are welcome, Chemtrac is the established standard of care for HLA-A2 positive patients with a median OS of 22 months and 27% of patients alive at three years. David Berman, EVP of R&D, added that based on analogs in cutaneous melanoma, starting with immunotherapy like Chemtrac provides better long-term survival, setting a high hurdle for any new therapy.

Sean Laaman asked about the differentiation of AXS-12 in narcolepsy versus existing therapies, particularly regarding cataplexy control and physician adoption, given the upcoming NDA submission.

Answer

Ari Maizel (Chief Commercial Officer, Axsome Therapeutics) highlighted that AXS-12 offers a compelling treatment option due to its novel mechanism, strong data in cataplexy relief, daytime dosing appeal, and positive impact on functional scores, with high interest from market research. Herriot Tabuteau (CEO, Axsome Therapeutics) added that AXS-12 targets norepinephrine, similar to how orexin neurons stimulate its production, making mechanistic sense. He emphasized profound effects on cataplexy, excessive daytime sleepiness, and cognition, delivered with a favorable safety profile, and noted its potential to impact depression, a common comorbidity.

Sean Laaman inquired about the differentiation strategy for AXS-12 in narcolepsy, particularly concerning cataplexy control and physician adoption, ahead of its NDA submission.

Answer

Ari Maizel, Chief Commercial Officer, highlighted AXS-12 as a compelling treatment option due to its novel mechanism, strong cataplexy relief, favorable safety and tolerability profile, and high interest from physicians, especially given the polypharmacy common in narcolepsy treatment.

Sean Laaman asked about the market positioning for AXS-12 in narcolepsy against existing treatments and upcoming orexin-2 agonists, and also inquired about the data to be included in the NDA filing.

Answer

Chief Commercial Officer Ari Maizel positioned AXS-12 as a rapid-acting, once-daily treatment with benefits in cataplexy, sleepiness, and cognitive function. He stated the NDA package will include data from the CONCERT, SYMPHONY, and ENCORE trials, along with long-term safety data.

Sean Laaman sought clarification on whether the two Hypercon Phase 1 starts are existing ENHANZE products, inquired about the potential number of ENHANZE products that could transition to Hypercon, and asked about the anticipated clinical benefits of Hypercon compared to existing ENHANZE products.

Answer

Helen Torley, President and CEO of Halozyme Therapeutics, stated that due to confidentiality, she could only confirm the Hypercon targets are established blockbuster drugs with approved mechanisms of action. She explained that the value proposition for Hypercon involves moving treatment to smaller volumes for at-home or short doctor's office visits, particularly for conditions like autoimmune diseases, neurology, and nephrology. This aims to empower patients with greater control over their treatment, representing a logical evolution of sub-Q treatment.

Sean Laaman sought clarification on whether the two Hypercon Phase I starts are existing ENHANZE products. He also asked about the potential number of ENHANZE products that could transition to Hypercon over time and the anticipated clinical benefits of Hypercon compared to existing ENHANZE products.

Answer

Helen Torley, President and CEO, stated that due to confidentiality, she could only confirm the Hypercon targets are established blockbuster drugs with approved mechanisms of action. She explained that the value proposition for Hypercon is moving treatment to smaller volumes for at-home or short doctor's office visits, allowing patients more control over their treatment. This evolution aims for a three to four times reduction in volume for many drugs, enhancing patient convenience and throughput.

Sean Laaman from Morgan Stanley asked for an update on the regulatory front, particularly regarding the CMS draft guidance and the IRA. He also inquired about the process for setting financial guidance and the company's target leverage ratios in light of its share repurchase program.

Answer

President and CEO Dr. Helen Torley expressed confidence that their arguments against the flawed CMS draft Part B policy will prevail, expecting no change. CFO Nicole LaBrosse stated that guidance is based on internal trend analysis, partner inputs, and royalty reports. LaBrosse also noted a comfortable current leverage ratio of about 1.2x and a willingness to go up to around 3x for the right M&A opportunity, highlighting the balance between share repurchases and strategic growth.

Sean Laaman from Morgan Stanley inquired about the specific areas of strength that drove the Q1 earnings beat and guidance upgrade. He also sought details on the small volume auto-injector, including the partner's identity, the deal's economics, and the potential commercialization timeline.

Answer

Dr. Helen Torley, President and CEO, attributed the strong performance to broad-based growth from its three blockbuster products: DARZALEX subcutaneous, Phesgo, and VYVGART Hytrulo. She noted a VYVGART milestone was also achieved a quarter early. Regarding the auto-injector, she explained the partner's identity is confidential for competitive reasons but might be disclosed upon entering clinical studies. She clarified the current agreement is for development, with commercial supply and financial terms to be determined later.

Sean Laaman asked about Halozyme's long-term growth outlook beyond the 2028 guidance, questioning the terminal value and confidence in new programs mitigating potential earnings reductions post-2030.

Answer

President and CEO Dr. Helen Torley responded by highlighting the durability of the current product portfolio, with many royalties extending to the mid-2030s and 2040s. She noted that while confident in the Argenx pipeline, revenues are not forecasted until data is available. Dr. Torley emphasized that additional growth will come from derisked pipeline assets like relatlimab Opdivo, new partner nominations, and future deals, which will layer on top of the strong existing revenue base.

Sean Laaman asked a pipeline question about NBI-890, specifically whether it is expected to surpass INGREZZA's 80% receptor occupancy or if its primary goal is to expand the patient population through a long-acting profile.

Answer

Sanjay Keswani, Chief Medical Officer, stated that NBI-890 is expected to achieve at least the same receptor occupancy as INGREZZA. He highlighted its potential for long-acting injectable formulations due to reduced clearance and solubility, aiming to capture patients who struggle with compliance on current treatments. Kyle Gano, Chief Executive Officer, added that INGREZZA is not well-suited for long-acting formulations, expressing excitement for NBI-890 and NBI-675 as next-generation VMAT2 inhibitors with a competitive profile, with Phase 2 data expected by the end of next year.

Sean Laaman asked a pipeline question regarding NBI-890, specifically whether it's expected to surpass INGREZZA's 80% receptor occupancy and if its primary value lies in expanding the patient population through a long-acting injectable profile.

Answer

Chief Medical Officer Sanjay Keswani stated that NBI-890 is expected to achieve at least the same receptor occupancy as INGREZZA. He confirmed that its potential for long-acting injectable formulations, due to reduced clearance and aqueous solubility, is a key design feature aimed at patients with compliance issues. CEO Kyle Gano added excitement for NBI-890 and NBI-675 as next-generation VMAT2 inhibitors with a competitive profile.

Sean Laaman asked about the INGREZZA neurology versus psychiatry split, inquiring if there's a focus on psychiatry at the expense of neurology, and outlining plans for the neurology segment.

Answer

Eric Benevich, Chief Commercial Officer, stated that neurology represents about 15% of INGREZZA's total volume and is the smallest segment, though all segments are growing. He explained that the reorganization combines psychiatry and neurology teams, as these customer types are more similar, allowing resources to be placed where growth potential is highest, particularly with advanced practice providers in behavioral health. The LTC team remains separate and is also expanding. Kyle Gano, Chief Executive Officer, added that the Huntington's chorea indication (a neurology focus) has a smaller patient population (30,000) compared to tardive dyskinesia (800,000), influencing investment decisions.

Sean Laaman asked about INGREZZA's neurology versus psychiatry split, inquiring if there's a focus on psychiatry at the expense of neurology, and outlining plans for neurology given its strong uptake during COVID.

Answer

Eric Benevich, Chief Commercial Officer, stated that neurology represents about 15% of total volume and, while important, has less patient potential than psychiatry. He explained the reorganization combines psychiatry and neurology teams to focus resources where growth potential is highest, particularly with advanced practice providers in behavioral health. Kyle Gano, Chief Executive Officer, added that the Huntington's chorea indication (a neurology focus) is significantly smaller than the tardive dyskinesia population, influencing investment decisions.

A representative for Sean Laaman asked about the potential for INGREZZA to capture patients who discontinue treatment with AUSTEDO, citing data suggesting those patients often do not reach a therapeutic dose.

Answer

Chief Medical Officer Dr. Eiry Roberts emphasized that INGREZZA's therapeutic dosing from day one is a key differentiator. Chief Commercial Officer Eric Benevich added that the market dynamic involves very little switching between VMAT2 inhibitors; the vast majority of INGREZZA's growth comes from newly diagnosed patients who are new to the drug class.

Sean Laaman asked about the anticipated impact of positive non-liver metastases OS final analysis data for STELLAR-303 in mid-2026 on Exelixis' commercial strategy and physician communication.

Answer

P.J. Haley (EVP of Commercial, Exelixis) explained that the non-liver metastases data would provide further opportunity to elucidate the benefit of zanzalintinib plus atezolizumab across advanced third-line plus CRC. He highlighted positive feedback from market research on the combination's mechanism of action and the potential for an immune checkpoint inhibitor for a broader CRC patient population.

Sean Laaman asked how positive data from the non-liver metastases OS final analysis in mid-2026 for STELLAR-303 might impact the commercial strategy or communication with physicians.

Answer

P.J. Haley (EVP of Commercial) explained that positive non-liver mets data would provide more opportunity to elucidate zanzalintinib's benefit across advanced third-line plus CRC. He highlighted that the current positive data in the ITT population, especially for harder-to-treat liver mets patients, is already significant, and physicians are responding positively to the mechanism of action and the potential for an immune checkpoint inhibitor for a broader CRC patient population.

Sean Laaman from Morgan Stanley inquired about the long-term durability of cabozantinib's market share gains and the potential to achieve similar market share in neuroendocrine tumors (NET) as seen in renal cell carcinoma (RCC).

Answer

CEO Michael Morrissey expressed high confidence in replicating RCC success in the NET space, citing the strong 35% market share achieved in the first full quarter of launch. EVP of Commercial P.J. Haley added that the 'best-in-class' perception in NET is a strong leading indicator of future prescribing behavior and expects demand to grow as refills accumulate.

Sean Laaman asked for context on CABOMETYX's seasonality and the rationale for raising full-year revenue guidance by $100 million following a $50 million quarterly beat.

Answer

CFO Christopher Senner explained that historical Q1 seasonality from gross-to-net deductions is no longer a factor due to Exelixis's 'specified small manufacturer' status, leading to more stability. He also noted that unlike in past years, there was no significant inventory destocking in Q1. This stability and underlying business strength support the guidance raise.

Sean Laaman questioned the company's capital allocation strategy, describing the balance sheet as 'lazy' due to high liquidity despite buybacks, and asked about the balance between further share repurchases and M&A.

Answer

President and CEO Michael Morrissey refuted the 'lazy' characterization, emphasizing the company's disciplined approach to capital allocation. He affirmed that Exelixis has the financial flexibility to simultaneously advance its internal pipeline, repurchase shares, and pursue strategic business development, highlighting the planned ~$1 billion in R&D spending for the year as a key investment.

Sean Laaman from Morgan Stanley asked for more detail on the Q4 data for the proprietary pipeline, whether other programs would also be partnered, and the potential revenue impact from the expanded Ajax collaboration.

Answer

Karen Akinsanya, President and Head of Therapeutics R&D, said the Q4 update for SGR-2921 and SGR-3515 will include safety, PK/PD, and preliminary activity data, and confirmed the company believes partnerships are the best path forward for all three assets. CFO Richie Jain added that the Ajax expansion will have a modest 2025 revenue impact but offers future milestone and royalty opportunities.

Sean Laaman of Morgan Stanley asked about the importance of additional indications for VOXZOGO, such as hypochondroplasia, to achieving the company's $4 billion revenue target for 2027.

Answer

Brian Mueller, EVP and CFO, stated that the company plans to provide an updated long-term revenue forecast by the end of the year. He clarified that in the original $4 billion guidance for 2027, hypochondroplasia was the only new VOXZOGO indication included and was expected to make a modest contribution within that timeframe.

Sean Laaman from Morgan Stanley asked about the importance of VOXZOGO's label expansion into other indications, like hypochondroplasia, for achieving the company's $4 billion revenue target in 2027.

Answer

Brian Mueller, EVP and CFO, responded that the company plans to provide an updated view on its 2027 revenue guidance and long-term targets by the end of the year, taking into account recent developments. He clarified that in the original $4 billion guidance, hypochondroplasia was the only VOXZOGO indication expansion included and was expected to make a modest contribution within that timeframe.

Sean Laaman from Morgan Stanley asked for a strategic overview of how the business will evolve, considering its new profitability, growing cash balance, and upcoming clinical trial readouts, specifically questioning the balance sheet strategy and margin outlook.

Answer

CEO Tim Van Hauwermeiren deferred on margin targets, focusing on innovation. CFO Karl Gubitz outlined a clear five-point capital allocation strategy: 1) fully fund efgartigimod development, 2) invest in the broader pipeline (like MPA), 3) invest in the global supply chain, 4) consider business development with smaller biotechs, and 5) eventually return cash to shareholders, though this is not a near-term priority.

Sean Laaman asked management to size the market opportunity for sonrotoclax relative to Venclexta, given its potential advantages. He also questioned if the commercial investment in Europe for BRUKINSA was adequate, noting its revenue seemed underweight compared to peers.

Answer

Lai Wang, Global Head of R&D, and Matt Shaulis, GM of North America, detailed sonrotoclax's potential to become a best-in-class BCL-2 inhibitor and expand the fixed-duration treatment market. Xiaobin Wu, President and COO, addressed the Europe question by highlighting strong 75% growth for BRUKINSA and successful new launches, indicating good momentum and effective investment.

Sean Laaman asked how BeiGene sizes the market opportunity for sonrotoclax against Venclexta, given its potential profile. He also questioned if the commercial investment in Europe for BRUKINSA is adequate, noting its revenue seemed underweight compared to peers.

Answer

Lai Wang, Global Head of R&D, and Matt Shaulis, GM of North America, highlighted sonrotoclax's potent profile and its potential to expand the BCL-2 class opportunity, which is currently about a quarter of the frontline CLL market. Xiaobin Wu, President and COO, addressed the Europe question, noting strong 75% growth for BRUKINSA, increasing patient share, and successful new launches, indicating the investment is paying off.

An analyst on for Sean Laaman asked for a more granular breakout of Xywav narcolepsy patient adds (new-to-oxybate vs. switches) and about its value proposition in IH against potential competition from LUMRYZ.

Answer

President & COO Renée Galá stated that recent narcolepsy adds were primarily new-to-oxybate patients. For IH, she emphasized Xywav's position as the only low-sodium option with flexible dosing. CEO Bruce Cozadd added that a recent court ruling upholding Jazz's IP means he sees no viable path for Avadel to launch LUMRYZ in IH before the relevant patent expires in 2036.