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    Seamus FernandezGuggenheim Securities

    Seamus Fernandez's questions to Mineralys Therapeutics Inc (MLYS) leadership

    Seamus Fernandez's questions to Mineralys Therapeutics Inc (MLYS) leadership • Q2 2025

    Question

    Seamus Fernandez of Guggenheim Partners requested clarification on the proton-pump inhibitor (PPI) drug interaction mentioned in past filings and asked about lorunderstat's 24-hour blood pressure profile and expectations for the OSA study.

    Answer

    CEO Jon Congleton explained the PPI interaction is an exposure issue, not safety, as acidity affects bioavailability, and suggested physicians could monitor and adjust dosage if needed. He affirmed high confidence in the 24-hour blood pressure control, citing robust morning trough measurements from four trials. For the OSA study, he noted the goal is to improve AHI and nighttime blood pressure, with data anticipated in 2026.

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    Seamus Fernandez's questions to Mineralys Therapeutics Inc (MLYS) leadership • Q1 2025

    Question

    Seamus Fernandez of Guggenheim Partners questioned how the company's target of 47,000 physicians intersects with its need for a partner and what the key gating factors are for finalizing and filing the NDA.

    Answer

    Executive Jon Congleton responded that while the 47,000 physicians represent an efficient initial target, a partner is crucial to maximize lorundrostat's value ex-U.S. and to broaden reach within the U.S. He identified the primary NDA gating factor as the completion of the 52-week open-label extension study for a majority of subjects, with a key pre-NDA meeting with the FDA scheduled for Q4 to gain clarity on submission timing.

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    Seamus Fernandez's questions to Eli Lilly and Co (LLY) leadership

    Seamus Fernandez's questions to Eli Lilly and Co (LLY) leadership • Q2 2025

    Question

    Seamus Fernandez from Guggenheim Partners inquired about the future pricing strategy for orforglipron and other assets, particularly in light of growing competition and the ongoing issue of drug compounding.

    Answer

    David Ricks, Chair and CEO, stated that Lilly will continue to price to value, anticipating single-digit net price erosion typical for chronic medications. He stressed the patient safety risks of compounding and called for stronger regulatory enforcement. Ricks also confirmed Lilly will continue offering consumer-level pricing through channels like LillyDirect to address coverage gaps.

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    Seamus Fernandez's questions to Eli Lilly and Co (LLY) leadership • Q1 2025

    Question

    Seamus Fernandez asked how Ebglyss is tracking against Lilly's ambition of a best-in-class launch and whether its peak sales potential could be materially higher than the consensus of $2 billion, questioning if any barriers exist like competitor rebates or label breadth.

    Answer

    Dr. Dan Skovronsky, Chief Scientific Officer, stated that Lilly has high aspirations for Ebglyss, supported by strong clinical data. He noted good early uptake, with physicians reporting positive results in severe patients and subsequently moving the drug into first-line use. Regarding access, he reiterated earlier comments that coverage is growing and expressed confidence in overcoming any competitive rebate challenges.

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    Seamus Fernandez's questions to Eli Lilly and Co (LLY) leadership • Q4 2024

    Question

    Colleen on for Seamus Fernandez of Guggenheim Securities asked about the sustainability of operating margin expansion and whether consensus estimates nearing 50% are realistic.

    Answer

    An executive stated that while margin expansion is guided for 2025, reaching the high 40s or 50% is not considered a good way to drive sustainable growth, as it would require under-investing in R&D. The low 40s range is seen as the right balance.

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    Seamus Fernandez's questions to Eli Lilly and Co (LLY) leadership • Q3 2024

    Question

    Seamus Fernandez from Guggenheim asked how the future availability of an oral small molecule like orforglipron could resolve the compounding issue and whether the FDA would act on a product-by-product basis.

    Answer

    CEO David Ricks acknowledged the long-term importance of oral drugs for market scale but noted orforglipron's launch is still some time away. He reiterated that compounding is a patient safety issue, not a financial crisis for Lilly, and that the FDA's analysis is product-specific. Since tirzepatide is not in shortage, he argued mass compounding should not be permitted.

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    Seamus Fernandez's questions to Amylyx Pharmaceuticals Inc (AMLX) leadership

    Seamus Fernandez's questions to Amylyx Pharmaceuticals Inc (AMLX) leadership • Q2 2025

    Question

    Seamus Fernandez inquired about the market opportunity for Avexatide, specifically the size of the severe post-bariatric hypoglycemia (PBH) patient population and the pace of enrollment for the Phase III LUCIDITY trial.

    Answer

    Co-CEO & Co-Founder Josh Cohen addressed the market size, citing Dr. Craig's estimate of 160,000 patients with 'medically important PBH' and a subset of 30,000 with 'critical PBH.' He also reiterated confidence in completing trial enrollment by year-end, with data expected in 2026.

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    Seamus Fernandez's questions to Arcutis Biotherapeutics Inc (ARQT) leadership

    Seamus Fernandez's questions to Arcutis Biotherapeutics Inc (ARQT) leadership • Q2 2025

    Question

    Seamus Fernandez of Guggenheim Partners inquired about the revenue trajectory for Q3 2025, asking whether to expect a decline, flat performance, or moderated growth. He also asked about the company's long-term growth strategy, specifically the balance between pursuing further label expansions for XERIV versus external business development.

    Answer

    President and CEO Frank Watanabe clarified that Arcutis's business development strategy focuses on leveraging its best-in-class development capabilities for differentiated, development-stage assets, not on acquiring on-market revenue. Chief Commercial Officer Todd Edwards addressed Q3 guidance, stating the company anticipates continued sequential growth, though the rate will be moderated due to typical market seasonality before returning to robust growth in Q4.

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    Seamus Fernandez's questions to Arcutis Biotherapeutics Inc (ARQT) leadership • Q1 2025

    Question

    Seamus Fernandez from Guggenheim Securities asked how the new scalp and body psoriasis indication could expand ZORYVE foam's utilization, whether it might cannibalize the cream formulation, and if the product was too early in its lifecycle to see significant seasonality effects.

    Answer

    Todd Edwards, Chief Commercial Officer, stated that he does not anticipate meaningful cannibalization, expecting instead a broader use of the ZORYVE portfolio as clinicians choose the best formulation for the patient's specific needs. He noted that with 80% of psoriasis patients having scalp involvement, foam utilization should increase. He reiterated that while some seasonality is expected, the 'portfolio effect' of prescribers using ZORYVE across indications will continue to drive strong demand. CEO Frank Watanabe added that it's unlikely existing cream patients will switch, but new starts may favor the foam, especially since competitors lack a good scalp formulation.

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    Seamus Fernandez's questions to Arcutis Biotherapeutics Inc (ARQT) leadership • Q4 2024

    Question

    Seamus Fernandez of Guggenheim Partners inquired about the business momentum in Q4, asking for specifics on refill rates and tubes per patient per year. He also asked for the company's perspective on the 2025 consensus revenue estimates and the sustainability of the strong script trajectory.

    Answer

    Chief Commercial Officer Todd Edwards provided refill rates of approximately 40% for psoriasis cream and 38% for seborrheic dermatitis foam, with tubes per patient per year expected to be around 2 for cream and 2-3 for foam. Chief Financial Officer David Topper stated the company is 'very comfortable' with the 2025 consensus revenue of $280M-$285M, while cautioning about typical Q1 gross-to-net headwinds from deductible resets.

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    Seamus Fernandez's questions to Arcutis Biotherapeutics Inc (ARQT) leadership • Q3 2024

    Question

    Seamus Fernandez of Guggenheim Securities asked if there was any channel stocking that contributed to the strong quarterly results and questioned the timing and progression of Medicare coverage in 2025, particularly for seborrheic dermatitis.

    Answer

    Chief Commercial Officer Todd Edwards confirmed there was no inventory stocking in the quarter. He attributed the strong gross-to-net improvement to a higher percentage of paid prescriptions, efficient prior authorization processes, and lower patient deductibles. Regarding Medicare, he noted that while discussions are positive, the Inflation Reduction Act has slowed PBM operations, delaying 2024 coverage wins, but the company expects to secure coverage in 2025.

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    Seamus Fernandez's questions to Rhythm Pharmaceuticals Inc (RYTM) leadership

    Seamus Fernandez's questions to Rhythm Pharmaceuticals Inc (RYTM) leadership • Q2 2025

    Question

    Seamus Fernandez of Guggenheim Partners asked about Rhythm's long-term growth opportunity, particularly how management views the potential of the BBS and acquired hypothalamic obesity (AHO) markets and the company's evolution into a more significant specialty player.

    Answer

    David Meeker, Chairman, President & CEO, expressed high confidence in the long-term, steady growth of BBS, which he sees growing for decades as new global markets are added. He described AHO as a larger opportunity with a potentially steeper ramp due to its specialty-like nature, but still characterized by steady, long-term growth rather than an explosive launch. He believes the AHO epidemiology could ultimately prove to be larger over time.

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    Seamus Fernandez's questions to Rhythm Pharmaceuticals Inc (RYTM) leadership • Q1 2025

    Question

    Seamus Fernandez of Guggenheim Securities inquired about the development timeline and efficacy expectations for bivamelagon, and asked about the potential opportunity for MC4R agents in Prader-Willi syndrome (PWS) given previous trial results.

    Answer

    David Meeker, CEO, stated his hope is for bivamelagon to show efficacy north of a 10% weight reduction, which would establish it as a viable drug, and that the company would move aggressively into Phase III for HO if data is positive. Regarding PWS, he noted the biology is relevant but the disease is complex. He believes there is a legitimate 50-50 chance of success and that any meaningful weight loss would be significant, as nothing currently helps these patients lose weight.

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    Seamus Fernandez's questions to Rhythm Pharmaceuticals Inc (RYTM) leadership • Q4 2024

    Question

    Seamus Fernandez asked about the expected market uptake for hypothalamic obesity (HO) given its prevalence, and whether a patient's pre-injury obesity 'set point' could affect treatment outcomes.

    Answer

    CEO David Meeker explained that HO uptake should be faster than for BBS due to a concentrated, diagnosed patient base, though reimbursement remains a factor. He theorized that setmelanotide aims to restore physiology to the pre-injury state, suggesting it would not address pre-existing obesity but would still be a major health restoration.

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    Seamus Fernandez's questions to Rhythm Pharmaceuticals Inc (RYTM) leadership • Q3 2024

    Question

    Seamus Fernandez inquired if the new French hypothalamic obesity (HO) data could accelerate the expansion of early access programs in Europe and asked for a progress update on the next-generation pipeline assets, RM-718 and bivamelagon.

    Answer

    EVP, Head of International Yann Mazabraud confirmed the local French data will help with uptake in France and Italy and could spur named patient sales in other countries. Chairman, CEO and President David Meeker stated that for RM-718, they plan to submit toxicology data to the FDA and target first patient dosing in Q1 2025. For bivamelagon, enrollment is now over 50% complete, with full enrollment expected in Q1 2025, making a mid-year data readout possible.

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    Seamus Fernandez's questions to Sanofi SA (SNY) leadership

    Seamus Fernandez's questions to Sanofi SA (SNY) leadership • Q2 2025

    Question

    Seamus Fernandez from Guggenheim Partners asked about the Dupixent patent estate, life cycle management with Regeneron, and the potential for using amlotelimab in combination therapies.

    Answer

    EVP & General Counsel Roy Papatheodorou confirmed the U.S. compound patent for Dupixent expires in 2031 but noted a portfolio of other patents extends well into the 2040s. EVP & Head of R&D Houman Ashrafian stated that while the current focus is on amlotelimab monotherapy, the OX40 ligand mechanism opens future combination possibilities.

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    Seamus Fernandez's questions to Sanofi SA (SNY) leadership • Q4 2024

    Question

    Seamus Fernandez of Guggenheim Partners asked CEO Paul Hudson and executive Houman Ashrafian to each name their most exciting pipeline catalysts for 2025, noting investor interest in itepekimab.

    Answer

    Executive Houman Ashrafian highlighted the Dupixent COPD launch, the potential of itepekimab for former smokers, amlitelimab's progress, and the internally generated bispecific lunsekimig. CEO Paul Hudson expressed excitement for all Phase II programs, specifically mentioning the game-changing potential of itepekimab in COPD and tolebrutinib in primary progressive MS.

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    Seamus Fernandez's questions to Sanofi SA (SNY) leadership • Q2 2024

    Question

    Seamus Fernandez asked for color on the expected growth trajectory for Dupixent's upcoming COPD launch and inquired about the most appropriate opportunities for the CD40 ligand asset outside of multiple sclerosis.

    Answer

    Brian Foard, EVP and Head of Global Hub, Specialty Care GBU, stated that while the Dupixent COPD launch will begin this year, most of the growth is expected in 2025, leveraging their existing relationships with the physician population. Houman Ashrafian, EVP and Head of R&D, identified Type 1 diabetes and transplant rejection as the most obvious biological fits for the CD40 ligand asset beyond MS.

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    Seamus Fernandez's questions to Bristol-Myers Squibb Co (BMY) leadership

    Seamus Fernandez's questions to Bristol-Myers Squibb Co (BMY) leadership • Q2 2025

    Question

    Seamus Fernandez from Guggenheim Securities inquired if previous launch analogs are still relevant for COBENFI's trajectory and asked about the sustainability of current spending levels and operating margins.

    Answer

    EVP & Chief Commercialization Officer Adam Lenkowsky responded that COBENFI is outperforming all historical launch benchmarks in schizophrenia, making analogs less relevant. EVP & CFO David Elkins addressed margins, stating that while currently pressured by legacy product declines, they are expected to improve long-term, driven by the growing, higher-margin new product portfolio.

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    Seamus Fernandez's questions to Bristol-Myers Squibb Co (BMY) leadership • Q1 2025

    Question

    Speaking for Seamus Fernandez, Zac Dunn asked how defensible Camzyos's first-in-class position is against potential competition and what the read-through is from the non-obstructive HCM trial failure to the HFpEF development program.

    Answer

    CCO Adam Lenkowsky expressed confidence in maintaining leadership with Camzyos, citing a strong base, high persistency, and a lack of meaningful clinical differentiation in competitor data. CMO Samit Hirawat explained it's too early to determine the read-through to HFpEF, as the diseases are different and key biomarkers have historically tracked differently in HFpEF studies.

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    Seamus Fernandez's questions to Bristol-Myers Squibb Co (BMY) leadership • Q4 2024

    Question

    Seamus Fernandez of Guggenheim Securities asked about the early real-world patient experience with Cobenfy, specifically regarding tolerability and dosing, and questioned where novel oral drugs like iberdomide will fit in the multiple myeloma market.

    Answer

    CCO Adam Lenkowsky reported positive feedback on Cobenfy, noting that tolerability issues like nausea are manageable as physicians are titrating doses more slowly in the real world. CMO Samit Hirawat positioned novel orals like iberdomide as crucial for the community setting, where complex cell therapies are difficult to administer, and can be combined with or replace older standards of care.

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    Seamus Fernandez's questions to Bristol-Myers Squibb Co (BMY) leadership • Q3 2024

    Question

    Seamus Fernandez asked about the company's enthusiasm for its CD19 asset ahead of ACR data and whether volume benefits are included in the 'net neutral' assumption for the 2025 IRA impact.

    Answer

    Head of Global Drug Development Samit Hirawat expressed excitement for the CD19 cell therapy data, outlining key metrics to watch. He also contrasted the single-treatment CAR-T approach with repeatable bispecifics. Chief Commercialization Officer Adam Lenkowsky confirmed the IRA impact is seen as net neutral, with favorability for Eliquis being offset by negative impacts on Revlimid and Pomalyst.

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    Seamus Fernandez's questions to AstraZeneca PLC (AZN) leadership

    Seamus Fernandez's questions to AstraZeneca PLC (AZN) leadership • Q2 2025

    Question

    Seamus Fernandez of Guggenheim Partners asked for details on the path for Enhertu to exceed $10 billion in revenue and inquired about the company's strategy and opportunity in the obesity market.

    Answer

    EVP of Oncology Business, David Fredrickson, outlined Enhertu's growth path via new indications like DB-09 in the frontline setting, expansion in the ultra-low segment, and future combinations. CEO Pascal Soriot and EVP of BioPharmaceuticals Business Unit, Ruud Dobber, detailed the obesity strategy, focusing on addressing the metabolic syndrome with a differentiated portfolio of oral agents and combinations, targeting central fat and associated risk factors rather than just cosmetic weight loss.

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    Seamus Fernandez's questions to AstraZeneca PLC (AZN) leadership • Q1 2025

    Question

    Seamus Fernandez asked for commentary on potential legislative action to align incentives for small and large molecules under the IRA and what the positive DB09 results might predict for Enhertu's success in the adjuvant setting.

    Answer

    CEO Pascal Soriot responded that aligning small molecule incentives would be a positive development for the industry and for AstraZeneca's pipeline, including camizestrant. EVP, Oncology R&D, Susan Galbraith explained that DB09's success against a strong three-drug regimen demonstrates Enhertu's power, which provides confidence for its potential to improve upon current standards of care in the upcoming adjuvant (DB05) and neoadjuvant (DB11) trial readouts.

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    Seamus Fernandez's questions to AstraZeneca PLC (AZN) leadership • Q2 2024

    Question

    Seamus Fernandez asked why Enhertu's growth isn't stronger given its robust data and inquired about AstraZeneca's broader strategic approach to the obesity market.

    Answer

    EVP, Oncology Business Unit, David Fredrickson, expects more robust sequential growth for Enhertu in H2, citing its 'early innings' status and pending guideline updates. CEO Pascal Soriot detailed a holistic 'cardiac, kidney, metabolism' strategy, segmenting the market into 'weight management' for oral therapies and 'obesity' for titrated combinations, expressing high confidence in the plan.

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    Seamus Fernandez's questions to Novartis AG (NVS) leadership

    Seamus Fernandez's questions to Novartis AG (NVS) leadership • Q2 2025

    Question

    Seamus Fernandez of Guggenheim Partners asked about the opportunity for the B-cell therapy inalumab in Sjogren's disease and other conditions, following the update on its development in hidradenitis suppurativa (HS).

    Answer

    CEO Vasant Narasimhan explained that while the HS hypothesis for inalumab did not prove successful, it does not diminish the company's conviction in the drug's potential in B-cell-driven diseases like Sjogren's and lupus. He emphasized that learnings across multiple platforms (BTK, anti-BAFF, CAR-T) are advancing their overall strategy in B-cell management.

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    Seamus Fernandez's questions to Novartis AG (NVS) leadership • Q1 2025

    Question

    Seamus Fernandez asked about Novartis's focus areas for value-creating bolt-on M&A, specifically inquiring about opportunities for life cycle management within its hypertension and heart failure portfolio ahead of Entresto's loss of exclusivity.

    Answer

    CEO Vasant Narasimhan responded that the company feels very good about its existing cardiovascular pipeline, which includes Leqvio, pelacarsen, and the recently acquired abMAA. While always evaluating opportunities, he stated there is no particular focus on bolt-on deals in the cardiovascular space at this time.

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    Seamus Fernandez's questions to Novartis AG (NVS) leadership • Q4 2024

    Question

    Seamus Fernandez asked about the opportunity for Ianalumab, specifically where the company is most excited about its potential, highlighting the upcoming Sjogren's syndrome data as a key catalyst.

    Answer

    CEO Vasant Narasimhan expressed significant excitement for Ianalumab in both immunology and hematology. He highlighted the Sjogren's readout as a foundational catalyst, followed by lupus and ITP. He noted that with six Phase III studies running, the drug has the potential to be a very significant, and likely underappreciated, medicine for the company.

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    Seamus Fernandez's questions to Novartis AG (NVS) leadership • Q2 2024

    Question

    Seamus Fernandez of Guggenheim Securities asked for Novartis's strategic thinking on the obesity market, questioning whether a late entry would make sense and how the company might approach it.

    Answer

    CEO Vasant Narasimhan stated that Novartis will not pursue a 'fast follower' strategy with GLP-1 type mechanisms, viewing the market as difficult to penetrate late due to the entrenchment of incumbents. Instead, the company's focus is on developing next-generation, differentiated medicines. This includes long-acting agents, new mechanisms for muscle sparing, or centrally acting pathways, reflecting a disciplined approach learned from past experiences like its late entry into PD-1 inhibitors.

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    Seamus Fernandez's questions to Vaxcyte Inc (PCVX) leadership

    Seamus Fernandez's questions to Vaxcyte Inc (PCVX) leadership • Q4 2024

    Question

    Seamus Fernandez from Guggenheim asked about the strategic decision-making between advancing VAX-24 or pivoting directly to VAX-31 in the pediatric setting, and also explored the potential for a post-approval efficacy study for an otitis media claim.

    Answer

    CEO Grant Pickering explained that both the VAX-24 and VAX-31 infant programs are advancing in parallel, with VAX-24 data arriving first. The ultimate strategy will be informed by the strength of the upcoming VAX-24 data. EVP & COO Jim Wassil highlighted the significant opportunity in otitis media, noting VAX-31's superior serotype coverage (~90% vs. ~40% for PCV20) could make a post-approval efficacy study both feasible and highly compelling.

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