Thibault Boutherin

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 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 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 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 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 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 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 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.