Chautauqua Capital Management, a division of Baird Asset Management, is a boutique investment firm that released its second quarter 2025 investor letter for the "Baird Chautauqua International and Global Growth Fund". A copy of the letter can be downloaded here. Global equity markets experienced a significant shift during the quarter, moving from notable losses to reaching new highs. Markets fell following the President's announcement of unexpectedly severe tariffs, which raised recession fears. After a bri ...

PresentationMy pleasure to kick off the next session. It's Sachin Jain here from European team at Bank of America. My pleasure to be hosting Paul Hudson, CEO of Sanofi, we have 40 minutes. I think, Paul, perhaps some interim commentary and then we'll get into Q&A. So with that, over to you.Paul HudsonCEO & Director So it's been an interesting year for me and for us. And while we've advanced the pipeline quite significantly. The only thing that's really irritating me was the itepekimab readout with 1 positiv ...

Industry Overview - The biopharmaceutical industry is experiencing challenges due to ongoing tariffs and drug pricing pressures from the Trump administration, leading to a 5.7% decline in the combined market capitalisation of the top 20 global biopharmaceutical companies, from $3.92 trillion on March 31, 2025, to $3.70 trillion on June 30, 2025 [1] Company Performances - Alnylam achieved the largest market capitalisation growth of 21.8%, reaching $42.5 billion, driven by strong sales of its RNA interference therapeutic Amvuttra, which saw a 59% year-on-year increase in global sales to $310 million in Q1 2025 [2] - Novartis reported a 7.7% increase in market capitalisation in Q2 2025, bolstered by strong sales of blockbuster drugs such as Entresto, Cosentyx, Kesimpta, and Kisqali, along with the acquisition of Regulus Therapeutics for $1.7 billion, enhancing its renal disease portfolio [3] - Bristol Myers Squibb experienced the largest decline in market capitalisation at 22.9% due to mixed Q1 2025 financial results and negative trial outcomes, particularly the failure of its Phase III ARISE trial for Cobenfy [4] - Regeneron and Sanofi saw market capitalisation declines of 18.7% and 13.8%, respectively, following the failure of their partnered drug itepekimab in the Phase III AERIFY-2 trial, which aimed to reduce exacerbations of chronic obstructive pulmonary disease [5]

Core Viewpoint - Sanofi's experimental drug for atopic dermatitis, amlitelimab, has underperformed in late-stage trials, disappointing investors and leading to a pre-market stock drop of up to 9.3% [1]. Group 1: Drug Performance and Market Impact - Amlitelimab showed improvement in skin clearance and disease severity compared to placebo, but the efficacy was still lower than Sanofi's best-selling drug, Dupixent [1]. - The stock has declined by 18% over the past 12 months, reflecting investor concerns about the drug's potential [1]. - Analysts believe the results of the amlitelimab trial are crucial for Sanofi, especially given the uncertain future of another key drug, itepekimab [1]. Group 2: Future Prospects and Comparisons - Sanofi is seeking alternatives to Dupixent, which is projected to generate over €21 billion annually at peak sales [3]. - Amlitelimab is expected to generate approximately €1.5 billion (around $1.75 billion) in annual revenue by 2031 [3]. - Amlitelimab has a dosing advantage, requiring administration only once every three months compared to Dupixent's more frequent dosing schedule [3]. Group 3: Other Drug Developments - The efficacy results of itepekimab have been mixed in recent late-stage trials, as it is being tested for chronic obstructive pulmonary disease in former smokers [4].

Core Viewpoint - Sanofi's experimental drug for atopic dermatitis, amlitelimab, has underperformed in late-stage trials, disappointing investors and leading to a pre-market stock drop of up to 9.3% [1]. Group 1: Drug Performance and Market Impact - Amlitelimab showed improvement in skin clearance and disease severity compared to placebo after 24 weeks of treatment, but the efficacy was still lower than Sanofi's best-selling drug, Dupixent [1]. - The stock has declined by 18% over the past 12 months, reflecting investor concerns about the drug's potential [1]. - Analysts believe the results of the amlitelimab trial are critical for Sanofi, especially given the uncertain future of another key drug, itepekimab [1]. Group 2: Future Projections and Comparisons - Dupixent is projected to generate over €21 billion (approximately $25 billion) annually at its peak, and Sanofi is actively seeking alternatives to replace it [3]. - Amlitelimab is expected to generate around €1.5 billion (approximately $1.75 billion) in annual revenue by 2031 [3]. - Amlitelimab has a dosing advantage, requiring administration every three months compared to Dupixent's more frequent dosing schedule [3]. Group 3: Additional Drug Development - The efficacy results of itepekimab, developed in collaboration with Regeneron, have shown contrasting outcomes in late-stage trials [4].

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Sanofi and its officers or directors [1] Group 1: Company Performance - On May 30, 2025, Sanofi released mixed results from a Phase 3 program for itepekimab, an antibody therapy for chronic obstructive pulmonary disease, with the AERIFY-1 trial meeting its primary endpoint, while the AERIFY-2 trial did not [2] - Following the announcement, Sanofi's American Depositary Receipt (ADR) price dropped by $2.98, or 5.69%, closing at $49.37 per ADR on the same day [3] Group 2: Legal Investigation - The investigation by Pomerantz LLP is aimed at determining if there were any fraudulent activities or misconduct related to Sanofi's business practices [1] - Pomerantz LLP is recognized for its expertise in corporate, securities, and antitrust class litigation, having a long history of fighting for victims of securities fraud and corporate misconduct [4]

Core Viewpoint - Pomerantz LLP is investigating claims of potential securities fraud or unlawful business practices involving Sanofi and its officers or directors [1] Group 1: Company Performance - On May 30, 2025, Sanofi released mixed results from a Phase 3 program for itepekimab, an antibody therapy for chronic obstructive pulmonary disease, with the AERIFY-1 trial meeting its primary endpoint while the AERIFY-2 trial did not [3] - Following the announcement, Sanofi's American Depositary Receipt (ADR) price dropped by $2.98, or 5.69%, closing at $49.37 per ADR on the same day [3] Group 2: Legal Investigation - The investigation by Pomerantz LLP is focused on whether Sanofi and certain officers or directors have engaged in securities fraud or other unlawful business practices [1] - Investors are encouraged to contact Pomerantz LLP for more information regarding the class action [2]

Core Viewpoint - Regeneron Pharmaceuticals' stock has experienced a significant decline due to the failure of its COPD treatment, itepekimab, in a late-stage clinical trial, which was expected to be a blockbuster drug with peak sales projections between $2 billion and $6 billion [1][14]. Stock Performance - Regeneron shares fell 19% on May 30, trading at $490, which is a 60% decrease from its 52-week peak of approximately $1,200 [2]. - The stock has seen a notable drop of 25.8% from a peak of $738.84 on April 8, 2022, to $548.35 on June 14, 2022, compared to a 25.4% decline for the S&P 500 [13]. Financial Metrics - Regeneron has a price-to-sales (P/S) ratio of 4.6, a price-to-free cash flow (P/FCF) ratio of 16.4, and a price-to-earnings (P/E) ratio of 14.4, compared to 3.0, 20.5, and 26.4 for the S&P 500, respectively [8]. - The company's revenues have grown 7.5% from $13 billion to $14 billion in the past 12 months, while the S&P 500 saw a 5.5% growth [8]. - Regeneron's operating income over the last four quarters was $3.8 billion, with an operating margin of 27.2%, significantly higher than the S&P 500's 13.2% [12]. Profitability and Stability - Regeneron has demonstrated very strong profitability, with a net income margin of 31.9% compared to 11.6% for the S&P 500 [12]. - The company's balance sheet is robust, with a debt total of $2.7 billion and a market capitalization of $52 billion, resulting in a low debt-to-equity ratio of 4.2% [12]. Future Growth Potential - Despite the setback with itepekimab, Regeneron is expected to benefit from the strong growth of Dupixent, which saw sales rise 19% to $3.7 billion last quarter, with potential peak annual sales exceeding $20 billion [14]. - The company has a promising pipeline with over a dozen programs in late-stage trials, indicating future growth opportunities [14].

Group 1 - Sanofi and Regeneron Pharmaceuticals announced that itepekimab met the primary endpoint in only one of the two phase 3 trials, leading to a decline in their share prices [2] - The companies are involved in a partnership for the development of itepekimab, which is a significant product in their pipeline [2] Group 2 - The article emphasizes the importance of tracking portfolio stocks and highlights the Growth Stock Forum as a resource for identifying attractive risk/reward situations [1] - The Growth Stock Forum features a model portfolio of 15-20 names, a top picks list of up to 10 stocks, and trading ideas targeting short-term and medium-term moves [1]

Core Insights - Sanofi has made significant advancements in its respiratory pipeline, particularly with the drug amlitelimab for asthma, showing promising preliminary phase 2 results [1][2][3] Group 1: Amlitelimab in Asthma - The TIDE-Asthma phase 2 study revealed that while the primary endpoint of annualized exacerbation rate at week 48 was not met at the highest dose, there were nominally significant reductions in asthma exacerbations at medium and low doses [2] - Amlitelimab demonstrated a more than 70% reduction in exacerbations in a biomarker-defined patient subgroup, indicating its potential to address unmet needs in asthma treatment [2][3] - The treatment regimen involved administration every four weeks for the first 24 weeks, followed by every 12 weeks, supporting a quarterly maintenance dosing schedule [3][11] Group 2: Future Clinical Studies - A phase 3 program for amlitelimab is currently being planned, with full results from the TIDE-Asthma study to be presented at an upcoming medical meeting [2][4] - Sanofi is also exploring lunsekimig in chronic obstructive pulmonary disease (COPD) and chronic rhinosinusitis, with phase 2 study results anticipated in 2026 [5][6] - Itepekimab is expanding its clinical studies into chronic rhinosinusitis and bronchiectasis, with phase 3 readouts expected in H2 2025 [7][9][8] Group 3: Mechanism of Action and Safety Profile - Amlitelimab operates through a unique non-depleting mechanism targeting OX40-Ligand, aiming to restore immune balance with infrequent dosing [3][10] - The safety profile of amlitelimab was consistent with previous studies, with no new safety signals identified, and treatment emergent adverse effects were similar between amlitelimab and placebo groups [3][11]