Thibault Boutherin

Thibault Boutherin asked for the outlook on SUBLOCADE ex-U.S. revenues following organizational changes, and the potential impact of upcoming phase II go-no-go decisions on the 2026 OpEx guidance, considering scenarios of advancing 0, 1, or 2 assets to phase III.

Answer

CFO Ryan Preblick expects SUBLOCADE ex-U.S. revenues to be relatively flat year-over-year, with growth in Australia and Canada offset by volume loss in the Nordics. CEO Joe Ciaffoni confirmed that the 2026 OpEx budget already contemplates advancing programs if opportunities arise. Chief Scientific Officer Christian Heidbreder detailed that phase II trials completed in Q4, with data closeout and statistical programming ongoing, database log by end of Q1, and top-line results in Q2. He added that the decision for INDV-6001 phase III also depends on manufacturing feasibility, payer-validated differentiation research, and its impact on trial design.

Thibault Boutherin asked about the expected trajectory of SUBLOCADE ex-U.S. revenues in 2026 following organizational changes, and the potential impact of upcoming phase III go/no-go decisions on R&D operating expenses.

Answer

CFO Ryan Preblick indicated that SUBLOCADE ex-U.S. revenues are expected to be relatively flat year-over-year, with growth in Australia and Canada offset by volume loss from the Nordics. CEO Joe Ciaffoni confirmed that the 2026 operating budget already contemplates advancing pipeline programs if opportunities arise. CSO Christian Heidbreder detailed that phase II trials were completed in Q4 2025, with database lock expected by end of Q1 2026 and top-line results in Q2 2026. He also outlined additional factors for INDV-6001's phase III decision, including manufacturing feasibility, payer-validated differentiation, and impact on trial design.

Thibault Boutherin of Morgan Stanley requested clarification on the Q2 SUBLOCADE results, specifically asking if the favorable stocking and gross-to-net dynamics were sustainable or likely to reverse. He also asked if past market headwinds, such as Medicaid redetermination, are now considered resolved.

Answer

CFO Ryan Preblick stated that the Q2 stocking impact was minimal and is expected to remain relatively stable for the rest of the year. CEO Joe Ciaffoni addressed market dynamics by focusing on future tailwinds and the abundant growth opportunity from low LAI penetration, noting that significant proposed Medicaid changes do not begin until 2027.

Thibault Boutherin requested clarification on the SUBLOCADE price and mix impact in Q1, sought to understand the CJS funding dynamics that led to strong 2024 growth followed by a 2025 decline, and asked for an update on partnerships for alternate sites of administration.

Answer

CFO Ryan Preblick explained the unfavorable SUBLOCADE mix was due to losing profitable CJS business and a growing Medicaid mix, plus some Q1 destocking. CEO Mark Crossley clarified the CJS decline was caused by a few large accounts shifting to oral treatments due to short-term budget issues, not a move to competitors. On alternate sites of care, he reported progress, growing from one partner to eight, with about 1,500 sites now available, and a continued focus on finding more foundational partners.

Thibault Boutherin asked about the dynamics in the HS market for Cosentyx, noting stabilizing shares between Cosentyx and its main competitor, and whether both drugs are expected to grow in line with the market, specifically if the 15% market growth rate is still being observed.

Answer

Vasant Narasimhan, CEO of Novartis, confirmed stabilization in NBRX share for Cosentyx in the 48-50% range, with strong performance in naive patients and competitors doing well in the switched segment. He expects all brands to grow with the market, which has a large potential of $3 billion-$5 billion. He also mentioned studying Rhapsido in HS to further build and expand this market.

Thibault Boutherin asked about the dynamics in the HS market for Cosentyx, specifically if market shares have stabilized and if both Cosentyx and its main competitor are expected to grow in line with the market's previously estimated 15% growth rate.

Answer

Vasant Narasimhan, CEO of Novartis, confirmed that NBRX share in the HS market has stabilized, with Cosentyx in the 48%-50% range, performing well in the naive population. He expects all brands to grow with the market, which has a large potential ($3 billion-$5 billion), and mentioned studying Rhapsido in HS to further expand this market by bringing lost-to-treatment patients back to therapy.

Thibault Boutherin asked about the opportunity size for abelacimab, the injectable factor XI acquired with Anthos Therapeutics, particularly for patients at high risk of bleeding, and if Novartis plans to target a broader patient population.

Answer

CEO Vasant Narasimhan described abelacimab as a multibillion-dollar opportunity, especially for patients ineligible for DOACs/NOACs, offering monthly dosing. He noted that the ultimate scale depends on the performance of competitors' oral factor XI programs in broader populations. He stated that with an injectable antibody, Novartis would likely focus on more refractory patients, but still anticipates a significant asset for the cardiovascular portfolio.

Thibault Boutherin asked about the opportunity size for abelacimab, the injectable factor XI acquired from Anthos Therapeutics, particularly in Afib patients at high risk of bleeding, and potential expansion into broader patient populations.

Answer

Vasant Narasimhan, CEO of Novartis, described abelacimab as a multibillion-dollar asset, noting that the 2026 study will target Afib patients ineligible for DOACs/NOACs, offering a significant option with monthly dosing. He explained that the ultimate scale of the opportunity depends on competitors' oral factor XI programs, with a larger potential if oral medicines are unsuccessful in broader populations.

Thibault Boutherin of Morgan Stanley asked about the YTB immune reset program, specifically if the Phase II studies are considered pivotal for a 2027 filing and whether the opportunity is a niche market or a large one.

Answer

CEO Vasant Narasimhan confirmed that with highly positive data, the Phase II studies could support a regulatory filing in 2027. He framed the initial opportunity as a multi-billion dollar market even when focused on refractory patients, with the potential to become significantly larger as the therapy becomes more accessible.

Thibault Boutherin asked about the goal of the new Phase III study for Kesimpta's dosing regimen and its potential impact on IP. He also inquired about the implications of a generic Lutathera, including pricing, penetration, and supply chain challenges for a potential competitor.

Answer

CEO Vasant Narasimhan explained the Kesimpta study aims to increase the dosing interval to extend the franchise, noting U.S. biosimilars are not expected until the early 2030s. For Lutathera, he outlined three hurdles for generics: IP infringement, the lack of a clear regulatory standard for radioligand therapies, and the significant challenge of replicating the complex, time-sensitive supply chain.

Thibault Boutherin asked about the timing of the MFN negotiated price implementation for Ozempic in Medicare and Medicaid, and any associated volume uplift or expected market share loss. He also asked Martin Holst Lange about Wegovy pill adherence, specifically the impact on efficacy and tolerability if a patient misses a dose or a few days, and if they can resume at the highest dose.

Answer

Dave Moore (EVP, Novo Nordisk) clarified that MFN and MFP for Ozempic are more of a 2027 event, though Ozempic is available in self-pay for those without coverage. Martin Holst Lange (EVP and Chief Scientific Officer, Novo Nordisk) explained that due to semaglutide's long half-life, missing a dose of the Wegovy pill has minimal impact on blood exposure, allowing patients to reinitiate at the 25mg dose without significant untoward effects, unlike shorter half-life orals.

Thibault Boutherin inquired about the timing and implementation of the MFN price for Ozempic in Medicare and Medicaid, and any associated volume uplift or market share loss. He also asked about the Wegovy pill's adherence profile, specifically the impact of missed doses on efficacy and tolerability, and if patients could resume at 25mg after missing days.

Answer

EVP, U.S. Operations, Dave Moore clarified that the MFN and MFP for Ozempic are more of a 2027 event for Medicare and Medicaid, noting the current self-pay offering sees 8,000 scripts per week. EVP and Chief Scientific Officer, Martin Holst Lange, explained that due to semaglutide's long half-life, skipping a Wegovy pill dose (once at steady state) has minimal impact on blood exposure, allowing patients to reinitiate at 25mg without significant untoward effects, benefiting both efficacy and tolerability.

Thibault Boutherin from Morgan Stanley inquired about the clinical study timeline for the single-chamber version of CagriSema and how it compares to amicretin's timeline. He also asked for reasons behind the general market slowdown for GLP-1 diabetes drugs in the U.S.

Answer

Martin Lange (CSO) stated the single-chamber study will be smaller than a Phase III and will start around the turn of the year. Ludovic Helfgott (EVP - Product & Portfolio Strategy) emphasized the value of having a diverse portfolio. Regarding the diabetes market, David Moore (EVP - US Operations) acknowledged the slowdown but noted it's still growing (~15%). He attributed it to higher market penetration (around 30% in the U.S.) and a normalization of demand now that supply issues have subsided.

Thibault Boutherin of Morgan Stanley requested clarification on the timeline for the single-chamber device's clinical equivalence study and its comparison to amicretin's timeline. Later, he asked about the key reasons for the slowdown in the U.S. GLP-1 diabetes market.

Answer

Martin Lange, EVP & Chief Scientific Officer, stated the single-chamber study would be smaller and shorter than a typical Phase III, starting around year-end. Ludovic Helfgott, EVP of Product & Portfolio Strategy, emphasized the value of a diverse portfolio. Regarding the diabetes market, David Moore, EVP of US Operations, confirmed a growth slowdown to about 15% but noted there is still room for growth as the market stabilizes after previous supply-driven fluctuations.

Thibault Boutherin from Morgan Stanley asked about the impact of the revised regulatory guidelines, specifically the reduced requirement for Phase 3 efficacy trials, on Alvotech's plans for earlier-stage biosimilars like Keytruda and Cimzia, and how this might affect their development timelines.

Answer

Róbert Wessman, CEO, noted that Alvotech anticipated this regulatory change over two years ago and adjusted its R&D approach accordingly, leading to a robust pipeline of over 30 products. Joseph McClellan, COO, confirmed that they are "doubling down" on this strategy, leveraging their proven development engine, and applying it to products like Cimzia.

Thibault Boutherin asked about the impact of the mentioned change in regulation, specifically the lower requirement for Phase 3 trials, on Alvotech's plans for earlier-stage biosimilars like Keytruda and Cimzia, and how this might affect their timelines.

Answer

Róbert Wessman, CEO, stated that Alvotech anticipated this regulatory change over two years ago and adjusted its R&D approach accordingly, resulting in a robust pipeline of over 30 products. Joseph McClellan, Chief Operating Officer, confirmed that the company is leveraging its proven development engine and applying this strategy to products like Cimzia.

Thibault Boutherin from Morgan Stanley asked about the operational status of the newly acquired ImmunoTek plasma centers and whether they are contributing to supply. He also inquired about the expected phasing of free cash flow for the remainder of the year.

Answer

CEO Nacho Abia confirmed that some of the acquired ImmunoTek centers are already operating and contributing to the plasma collection plan as expected. Regarding free cash flow, he noted that while Q2 was positive, the company still needs to overcome the negative FCF from Q1 and build inventory for 2025, thus reaffirming the guidance for positive FCF for the full year without providing further phasing details.

Thibault Boutherin of Morgan Stanley asked for clarification on how interest expenses could decline in 2024, given that debt is being refinanced at higher rates. He also inquired if any elements of the previously provided free cash flow bridge for 2024 now look materially different.

Answer

VP of Investor Relations Daniel Segarra explained that total financial expenses are expected to be lower because the Shanghai RAAS proceeds will be used to repay debt with higher variable interest rates, specifically the 2027 notes, offsetting the cost of the new placement. CEO Nacho Abia confirmed that no material items have changed in the free cash flow bridge presented previously.

Thibault Boutherin inquired about the expected business dynamics for Q2, asking if it would be similar to Q1 with performance skewed to the second half. He also asked about the margin difference between Transactional Services and Discovery and the potential impact of a mix shift.

Answer

CFO Laetitia Rouxel confirmed that the revenue and EBITDA ramp-up would become more visible in the second half of the year, as it takes a few months for new contracts to translate into revenue. CBO Matthias Evers declined to comment on specific margin differences, emphasizing that the company's value proposition and differentiation are strongest in its integrated offerings.