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    Luca Issi • RBC Capital Markets

    Luca Issi's questions to Ascendis Pharma A/S (ASND) leadership

    Luca Issi's questions to Ascendis Pharma A/S (ASND) leadership • Q2 2025

    Question

    Luca Issi of RBC Capital Markets asked about SG&A expense trends, the timeline for achieving quarterly profitability, and the company's potential exposure to U.S. tariffs or Most Favored Nation (MFN) pricing policies.

    Answer

    EVP & CFO Scott Smith suggested that quarterly operating expenses of around €190 million is a reasonable run rate and confirmed the company expects to reach quarterly cash flow positivity this year, noting Q2 was near breakeven excluding currency impacts. Regarding tariffs/MFN, he stated they are well-positioned to mitigate impacts. CEO Jan Møller Mikkelsen added that since they do not import finished product into the U.S., the material impact should be limited.

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    Luca Issi's questions to Ascendis Pharma A/S (ASND) leadership • Q1 2025

    Question

    Luca Issi asked for Ascendis's latest perspective on the competitive threat from molecules in development at BridgeBio and MBX Biosciences. He also inquired about the SG&A expense outlook for the rest of the year.

    Answer

    President and CEO Jan Mikkelsen expressed skepticism about both potential competitors. He characterized BridgeBio's drug as targeting a very small ADH1 patient niche and questioned its scientific rationale in the broader hypoparathyroidism population. Regarding MBX's once-weekly PTH, he questioned the clinical need for a weekly formulation given patient titration needs and also expressed doubts about its scientific mechanism of action. The question on SG&A was not addressed.

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    Luca Issi's questions to Intellia Therapeutics Inc (NTLA) leadership

    Luca Issi's questions to Intellia Therapeutics Inc (NTLA) leadership • Q2 2025

    Question

    Luca Issi from RBC Capital Markets asked for a comparison of the enrollment pace for the TTR cardiomyopathy trial against competitors like AstraZeneca, questioning if it reflects patient preference, and also asked about the impact of existing commercial options on enrollment.

    Answer

    EVP & Chief Medical Officer David Lebwohl described Intellia's enrollment pace as "astounding" and noted their trial has different inclusion criteria than the competitor's depleter study. He emphasized that enrollment has actually accelerated despite new commercial therapies becoming available, which he interprets as strong interest from both patients and physicians in Intellia's approach.

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    Luca Issi's questions to Intellia Therapeutics Inc (NTLA) leadership • Q1 2025

    Question

    Luca Issi asked for the company's reaction to Alnylam maintaining its price upon label expansion to TTR cardiomyopathy and how this influences Intellia's pricing strategy for its one-and-done therapies.

    Answer

    CEO John Leonard stated that Intellia is closely monitoring the entire, rapidly growing TTR market. He views the competitor pricing and market dynamics as indicative of a very significant opportunity for Intellia's differentiated product profile. He expressed confidence that Intellia will perform very well in this market upon entry.

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    Luca Issi's questions to Intellia Therapeutics Inc (NTLA) leadership • Q4 2024

    Question

    An analyst on behalf of Luca Issi asked if Alnylam's decision to run a larger pivotal trial for its next-generation TTR silencer has prompted Intellia to reconsider the design of its MAGNITUDE study, such as increasing its size.

    Answer

    CFO Edward Dulac stated that while Intellia monitors competitor activity, they see important differences and are pleased with their current trial design. CMO David Lebwohl added that Alnylam's recent commentary reinforces Intellia's hypothesis about the importance of achieving very low TTR levels for better patient outcomes.

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    Luca Issi's questions to Intellia Therapeutics Inc (NTLA) leadership • Q3 2024

    Question

    A representative for Luca Issi asked why the MAGNITUDE-2 study has an 18-month primary endpoint, unlike a competitor who filed on 9 months of data, and whether this longer duration was a regulatory requirement.

    Answer

    CMO David Lebwohl clarified that the 18-month endpoint was the company's own decision, not a regulatory requirement. He stated that Intellia believes 18 months is the optimal time to demonstrate the full clinical benefit of the drug.

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    Luca Issi's questions to Moderna Inc (MRNA) leadership

    Luca Issi's questions to Moderna Inc (MRNA) leadership • Q2 2025

    Question

    Luca Issi asked a broader question about Moderna's business development strategy, particularly regarding in-licensing, and inquired about the likely filing sequence for the COVID-plus-flu combination vaccine with the FDA.

    Answer

    CEO Stéphane Bancel explained that the company's focus is on finding partners for its own abundant pipeline assets, like EBV, rather than in-licensing, though it remains open to partnerships for non-mRNA technology. President Stephen Hoge stated that for the combo vaccine, a sequential filing (flu monotherapy first) is the most pragmatic and likely path with the U.S. FDA.

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    Luca Issi's questions to Moderna Inc (MRNA) leadership • Q4 2024

    Question

    Luca Issi asked a big-picture question about whether Moderna's management has engaged with the Trump administration or other political candidates this election cycle, and also inquired about the timing of the GBS case in the Norovirus trial relative to vaccination.

    Answer

    CEO Stéphane Bancel stated that Moderna worked productively with the previous Trump administration and looks forward to working with the new team. President Stephen Hoge described the GBS case as 'relatively proximal' to vaccination due to the rapid trial enrollment but noted that determining causation is very difficult for such rare events.

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    Luca Issi's questions to Moderna Inc (MRNA) leadership • Q3 2024

    Question

    Luca Issi asked if it's fair to assume Moderna could capture one-third of the RSV market next year and requested color on U.S. COVID market share dynamics, noting a potential loss of share this year.

    Answer

    CEO Stéphane Bancel declined to provide market share guidance for RSV but noted that a full contracting season in 2025 will be a key difference. For COVID, he acknowledged a loss of share in the U.S. retail market amid a competitive environment but stated that the full picture, including IDN and government channels, is not yet clear.

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    Luca Issi's questions to Amgen Inc (AMGN) leadership

    Luca Issi's questions to Amgen Inc (AMGN) leadership • Q2 2025

    Question

    Luca Issi asked about Amgen's interest in adding an oral small molecule to its obesity pipeline and for its view on the eventual market split between oral and injectable treatments.

    Answer

    Robert Bradway, Chairman & CEO, confirmed openness to BD. James Bradner, EVP of R&D, mentioned earlier-stage research into potential oral candidates. Murdo Gordon, EVP of Global Commercial Operations, acknowledged orals will be a significant market segment but emphasized the differentiation of their injectable, Meritide, for chronic management.

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    Luca Issi's questions to Alnylam Pharmaceuticals Inc (ALNY) leadership

    Luca Issi's questions to Alnylam Pharmaceuticals Inc (ALNY) leadership • Q2 2025

    Question

    Luca Issi of RBC Capital Markets suggested the updated TTR guidance appeared conservative given the strong Q2 results and upcoming international launches, asking for management's perspective.

    Answer

    CFO Jeff Poulton reiterated the context for the guidance, which implies approximately $1 billion in year-over-year TTR growth. While expressing high confidence, he emphasized that it is only one quarter into the launch and they will reassess in Q3, stopping short of labeling the guidance as conservative.

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    Luca Issi's questions to Alnylam Pharmaceuticals Inc (ALNY) leadership • Q1 2025

    Question

    Luca Issi asked about the likelihood of step-edits for AMVUTTRA, suggesting they are less likely for Medicare fee-for-service but more likely for commercial plans, and questioned where Medicare Advantage plans would fall on that spectrum.

    Answer

    Chief Commercial Officer Tolga Tanguler reported a "very nice broad uptake on all payer mix" with no significant restrictions. He confirmed no step-edits for fee-for-service and stated that they are "not seeing any step edits so far" for commercial or Medicare Advantage plans. He credited their value-based agreements for providing an advantage in securing access.

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    Luca Issi's questions to Alnylam Pharmaceuticals Inc (ALNY) leadership • Q4 2024

    Question

    Luca Issi asked about the forward-looking trajectory for gross margin, given the significant royalty burden on AMVUTTRA sales.

    Answer

    Chief Financial Officer Jeff Poulton confirmed that gross margin on product sales, which was 81% in 2024, is expected to decrease. This is driven by AMVUTTRA being the fastest-growing product and having the highest royalty burden, with the average rate expected to rise from 21% into the mid-to-high 20s. He noted this could be offset in the future by high-margin collaboration revenue and the potential success of royalty-free Nucresiran.

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    Luca Issi's questions to Ionis Pharmaceuticals Inc (IONS) leadership

    Luca Issi's questions to Ionis Pharmaceuticals Inc (IONS) leadership • Q2 2025

    Question

    Luca Issi of RBC Capital Markets asked if the physician view that triglyceride lowering is sufficient (without needing AP outcome data) applies globally or just in the U.S., and how uptake outside the U.S. might be affected without strong AP data. He also asked if the upcoming AP data statement would be qualitative or quantitative.

    Answer

    CEO Brett Monia asserted that U.S. physicians are convinced of the need to lower triglycerides to reduce AP risk. CGO Kyle Jenne added that while triglyceride lowering is sufficient for EU regulatory approval, payer dynamics are more complex. He noted their partner Sobi could leverage existing FCS data and potentially focus on high-risk SHTG subgroups for reimbursement. Monia declined to specify if the AP statement would be qualitative or quantitative.

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    Luca Issi's questions to Ionis Pharmaceuticals Inc (IONS) leadership • Q3 2024

    Question

    Luca Issi questioned the rationale for selecting expressive communication as the primary endpoint for the Angelman syndrome study over cognition. He also asked for Ionis's reaction to Eli Lilly discontinuing its APOCIII siRNA program and the potential implications for olezarsen.

    Answer

    Chief Clinical Development Officer Eugene Schneider explained that expressive communication was chosen as the endpoint because it showed robust results in the HALO study and is what families consistently identify as most important. Regarding Lilly, Chief Development Officer Richard Geary and CEO Brett Monia suggested Lilly may have been deterred by olezarsen's first-mover advantage and noted that Ionis had long ago concluded that the primary unmet need for an APOCIII inhibitor is in sHTG, not cardiovascular outcomes, a conclusion Lilly appears to have recently reached.

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    Luca Issi's questions to Uniqure NV (QURE) leadership

    Luca Issi's questions to Uniqure NV (QURE) leadership • Q2 2025

    Question

    Luca Issi asked about any interactions with senior FDA leadership, specifically Dr. Vinay Prasad, and whether the current data could support full approval versus accelerated approval. He also inquired about the timing for a potential confirmatory trial.

    Answer

    CEO Matt Kapusta shared that he had met Dr. Prasad and was confident in his openness to external control data. He clarified that accelerated approval is the base case, but the FDA indicated the Phase 1/2 study results could be leveraged to support a full approval, possibly with incremental data.

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    Luca Issi's questions to Uniqure NV (QURE) leadership • Q1 2025

    Question

    Luca Issi inquired about uniQure's confidence in the regulatory path for AMT-130, particularly in light of the new leadership at CBER, and whether previous productive conversations with the FDA could be at risk.

    Answer

    CEO Matthew Kapusta expressed confidence and stated he looks forward to working with the new CBER Director, Dr. Prasad. He emphasized that uniQure's strength lies in its data and its approach of seeking accelerated approval based on a clinical outcome (cUHDRS), not a surrogate biomarker, which he believes is a key differentiator for AMT-130's path forward.

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    Luca Issi's questions to Arrowhead Pharmaceuticals Inc (ARWR) leadership

    Luca Issi's questions to Arrowhead Pharmaceuticals Inc (ARWR) leadership • Q2 2025

    Question

    Luca Issi of RBC Capital Markets asked for details on the SHASTA-5 study design, including patient enrollment criteria and powering assumptions, and questioned the company's ex-U.S. commercialization strategy for plozasiran.

    Answer

    Interim Chief Medical Scientist, Dr. Bruce Given, stated that the SHASTA-5 trial enrolls patients with a recent history of pancreatitis but did not provide specific enrollment numbers. An executive clarified the ex-U.S. strategy, noting the company is preparing to commercialize independently in major European markets and Canada for the rare FCS indication.

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    Luca Issi's questions to Arrowhead Pharmaceuticals Inc (ARWR) leadership • Q1 2025

    Question

    Luca Issi asked about the clinical strategy for the obesity candidate ARO-INHBE, questioning if it's viewed as a monotherapy or an add-on, and inquired about the data expectations for the upcoming readout. He also asked for the company's reaction to Novartis delaying its Lp(a) data.

    Answer

    James Hamilton, Chief of Discovery and Translational Medicine, explained that ARO-INHBE is being studied as both a monotherapy and in combination, with the final development path pending data. President and CEO Dr. Christopher Anzalone added that the obesity market requires a suite of options. Regarding Lp(a), an executive expressed more excitement for Amgen's olpasiran due to its efficacy and convenience but noted a lack of inside information on competitor programs.

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    Luca Issi's questions to Arrowhead Pharmaceuticals Inc (ARWR) leadership • Q3 2024

    Question

    Luca Issi questioned the rationale behind describing the Sixth Street debt deal as having 'favorable economics,' asking for context on the interest rate. He also asked how payers might differentiate between genetically and clinically confirmed FCS patients.

    Answer

    President and CEO Dr. Christopher Anzalone described the deal's favorability due to its long 7-year term, non-dilutive nature, and attractive risk-sharing structure with no regular coupon payments. CFO Ken Myszkowski added its cost was reasonable compared to equity. Dr. Bruce Given, Interim Chief Medical Scientist, opined that payers will likely follow the package insert, and since the patients are clinically identical, coverage for both groups is expected if approved.

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    Luca Issi's questions to Ultragenyx Pharmaceutical Inc (RARE) leadership

    Luca Issi's questions to Ultragenyx Pharmaceutical Inc (RARE) leadership • Q1 2025

    Question

    Luca Issi asked if the DSMB would share the p-value with the company if the second interim look for OI is not met, and whether a Priority Review Voucher (PRV) is only achievable if the trial succeeds at this interim due to the 2026 deadline.

    Answer

    CEO Emil Kakkis confirmed that if the interim analysis is not positive, they will only be told to continue the study and will not receive a p-value. Regarding the PRV, he acknowledged the October 2026 approval deadline makes hitting the interim more favorable, but noted the program's Breakthrough Therapy Designation could help accelerate the review process even if they file later. He also expressed confidence that the PRV program would be reauthorized by Congress.

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    Luca Issi's questions to Ultragenyx Pharmaceutical Inc (RARE) leadership • Q4 2024

    Question

    Luca Issi asked about the expected duration of therapy for OI (chronic vs. capped) and the rationale for using a sham-controlled trial design for Angelman syndrome.

    Answer

    CEO Emil Kakkis stated that for OI, they believe chronic therapy is necessary, as patients lose ground after stopping treatment, and they are educating the FDA on this. For Angelman syndrome, CEO Emil Kakkis and CMO Eric Crombez explained that a sham control was chosen over placebo due to ethical feedback from regulators (FDA/EMA) regarding placebo injections in this pediatric population.

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    Luca Issi's questions to Allogene Therapeutics Inc (ALLO) leadership

    Luca Issi's questions to Allogene Therapeutics Inc (ALLO) leadership • Q4 2024

    Question

    Shelby Tucker on for Luca Issi asked about the administration setting for the ALPHA3 trial, inquiring if the choice between inpatient and outpatient treatment is left to the investigator and what the expected mix might be.

    Answer

    EVP of R&D and CMO Dr. Zachary Roberts and President and CEO Dr. David Chang both responded. Dr. Roberts confirmed the decision is entirely up to the investigator and a significant number of patients are already being treated as outpatients. Dr. Chang added that not requiring hospitalization provides flexibility, making the trial operate like standard cancer care.

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    Luca Issi's questions to WAVE Life Sciences Ltd (WVE) leadership

    Luca Issi's questions to WAVE Life Sciences Ltd (WVE) leadership • Q3 2024

    Question

    Luca Issi from RBC Capital Markets asked if Wave is considering running the pivotal Huntington's disease trial for WVE-003 solo or if a partner is a gating item, and questioned the trade-off between subcutaneous delivery and editing efficiency for WVE-006 compared to potentially more efficient IV methods.

    Answer

    CEO Paul Bolno addressed the partnership question by stating that while they are actively engaged in discussions to optimize the program, the immediate focus is on advancing it, leveraging the new regulatory clarity. On the delivery method, he argued that direct comparisons of preclinical models can be misleading and that the most relevant metric is M-protein levels in the clinic. He asserted that their clinical data demonstrates high efficiency for subcutaneous delivery, with significant potential for improvement from the current low starting dose.

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    Luca Issi's questions to Regenxbio Inc (RGNX) leadership

    Luca Issi's questions to Regenxbio Inc (RGNX) leadership • Q3 2024

    Question

    Luca Issi of RBC Capital Markets asked for a reaction to Pfizer's recent Duchenne data, where expression didn't translate to functional benefit, and whether this could change FDA standards. He also asked new CFO Mitchell Chan about his motivation for joining REGENXBIO.

    Answer

    Dr. Steve Pakola, CMO, attributed the difference to construct design, emphasizing that RGX-202's second-generation construct more closely mimics native dystrophin, preserving the 'reasonably likely to predict' standard. CEO Curran Simpson added that the FDA already considers functional data supportive. CFO Mitchell Chan cited the company's scientific excellence, the potential for multiple BLAs in the next 18-24 months, and the opportunity to help build a commercial-stage company.

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    Luca Issi's questions to Beam Therapeutics Inc (BEAM) leadership

    Luca Issi's questions to Beam Therapeutics Inc (BEAM) leadership • Q3 2024

    Question

    Luca Issi of RBC Capital Markets asked about Beam's commitment to commercializing BEAM-101 independently if the ESCAPE program does not prove to be a game-changer, versus potentially partnering the asset.

    Answer

    CEO John Evans affirmed a long-term commitment to the hematology franchise and stated that BEAM-101 holds significant value on its own. He clarified that any partnership would be strategic, aimed at accelerating patient access, rather than a financial necessity. While an unexpected outcome for ESCAPE would alter the long-term view, it would not change the near-term value of BEAM-101 or the strategic calculus for partnering.

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    Luca Issi's questions to Beam Therapeutics Inc (BEAM) leadership • Q3 2024

    Question

    Luca Issi from RBC Capital Markets asked if Beam would remain committed to commercializing BEAM-101 alone if ESCAPE proves not to be game-changing, or if they would consider a partnership.

    Answer

    CEO John Evans affirmed Beam's commitment to its long-term hematology strategy and stated the company is well-financed and would only partner strategically to accelerate patient access, not for financial reasons. He clarified that even if ESCAPE's outlook changed, the significant value of BEAM-101 for its target population would remain, and the strategic calculus for partnering would not fundamentally change.

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