Core Viewpoint - Alvotech anticipates that potential U.S. tariffs on imported pharmaceuticals will have minimal impact on its product revenues in 2025, estimating the effect of a 10% tariff to be less than 1% of total expected revenues [1][2]. Group 1: Tariff Impact - Alvotech manufactures its biosimilars in Iceland, which currently faces a minimum tariff of 10% on goods imported to the U.S. [1][2] - The estimated impact of a 10% tariff on Alvotech's sales to the U.S. in the second half of 2025 would be less than 1% of expected product revenues [2]. - Customers are responsible for all costs of transport and import duties to the U.S., meaning Alvotech will not bear these costs [1][2]. Group 2: Company Overview - Alvotech is a biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a global leader in the biosimilar space [3]. - The company has two approved biosimilars, Humira® (adalimumab) and Stelara® (ustekinumab), and a pipeline of nine disclosed biosimilar candidates targeting various diseases [3]. - Alvotech has established strategic commercial partnerships across multiple regions, including the U.S., Europe, Japan, and parts of Asia and South America [3].

The U.S. Food and Drug Administration (FDA) has approved Teva Pharmaceutical Industries Ltd. TEVA and Alvotech’s ALVO Selarsdi (ustekinumab-aekn) injection as interchangeable with the reference biologic Johnson & Johnson’s JNJ Stelara (ustekinumab).As of April 30, 2025, Selarsdi is available and interchangeable in all presentations matching the reference product, including the treatment of adults and pediatric psoriatic arthritis and plaque psoriasis, as well as Crohn’s disease, and ulcerative colitis.Also ...

The U.S. FDA has approved SELARSDI™ (ustekinumab-aekn) as interchangeable with the reference biologic Stelara® (ustekinumab) in all presentations matching the reference product, effective as of April 30, 2025SELARSDI is approved for all indications matching the reference productSELARSDI is indicated for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adults and pediatric patients 6 years and older, and the treatment of adult patients with moderately to severely active ...

Amneal Pharmaceuticals (AMRX) Q1 2025 Earnings Call May 02, 2025 08:30 AM ET Speaker0 Good morning, and welcome to the Amneal Pharmaceuticals First Quarter twenty twenty five Earnings Call. I'd now like to turn the call over to Amneal's Head of Investor Relations, Tony DeMayo. Speaker1 Good morning, and thank you for joining Amneal Pharmaceuticals' first quarter twenty twenty five earnings call. Today, we issued a press release reporting Q1 results. The earnings press release and presentation are available ...

REYKJAVIK, Iceland, May 02, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will release financial results for the first quarter ended March 31, 2025, after U.S. markets close on Wednesday, May 7, 2025. Alvotech will also conduct a conference call with analysts to present the financial results and recent business highlights on Thursday, May 8, 2025, at 8:00 am EDT ...

The Cigna Group (CI) Q1 2025 Earnings Call May 02, 2025 08:30 AM ET Company Participants Ralph Giacobbe - Senior VP - IRDavid Cordani - Chairman & Chief Executive OfficerBrian Evanko - President & COOAnn Dennison - EVP & CFOLisa Gill - Managing DirectorA.J. Rice - Managing DirectorCharles Rhyee - Managing DirectorAndrew Mok - DirectorJoshua Raskin - Partner - Managed Care & Providers Conference Call Participants Justin Lake - Analyst - Healthcare ServicesAnn Hynes - Senior Healthcare Services Equity Analyst ...

Core Viewpoint - Sandoz reported a net sales growth of 3% in Q1 2025, marking the fourteenth consecutive quarter of growth, driven by a strong biosimilar pipeline and commercial excellence [3][5][6]. Financial Performance - Q1 2025 net sales reached USD 2,480 million, with volume contributing six percentage points to growth, while price erosion accounted for a three percentage point decline [5][6]. - The company anticipates mid single-digit net sales growth for the full year 2025 and a core EBITDA margin of around 21% [7][4]. Segment Performance - Generics net sales were USD 1,809 million, stable with a 2% growth on a comparable growth rate (CGR) basis, representing 73% of total net sales [9][8]. - Biosimilars net sales amounted to USD 671 million, reflecting an 11% growth (14% on a CGR basis), accounting for 27% of total net sales [10][8]. Regional Performance - Europe net sales grew by 7% to USD 1,372 million, driven by recent launches in biosimilars [14][12]. - International net sales declined by 2% to USD 590 million, but grew by 2% when adjusted for the divestment of the China business [15][12]. - North America net sales increased by 1% to USD 518 million, with a 3% growth when excluding the impact of the Cimerli withdrawal [16][12]. Future Outlook - Sandoz plans to launch several major biosimilars in the second half of 2025, including Wyost®/Jubbonti® and Tyruko® [6][4]. - The company is also experiencing favorable regulatory developments, which may streamline biosimilar development processes [20][4]. Legal Developments - Sandoz has filed an antitrust lawsuit against Amgen in the US, alleging anti-competitive practices related to the market position of Enbrel® [21].

Core Insights - Sandoz has signed a global collaboration agreement with Shanghai Henlius Biotech to commercialize a biosimilar of ipilimumab, with a total consideration of up to USD 301 million, including an upfront payment of USD 31 million, targeting net reference-medicine sales of USD 2.5 billion [2][3][7] Company Overview - Sandoz is a global leader in generic and biosimilar medicines, with a strategic ambition to occupy the leading position in the US biosimilars market, having recently moved up to third position [5][9] - The company has a robust biosimilars pipeline comprising 28 molecules and around 450 generic pipeline medicines, supporting its goal of sustainable long-term growth [5][9] - In 2024, Sandoz recorded net sales of USD 10.4 billion [9] Collaboration Details - Under the agreement, Sandoz has exclusive commercial rights for the biosimilar of ipilimumab in Australia, Canada, Europe, Japan, and the US, with the core sequence patent for ipilimumab having expired in March 2025 in the US and set to expire no later than February 2026 in the EU [3][4] - Henlius is developing its own proposed biosimilar of ipilimumab in an integrated Phase I/III trial targeting 656 patients [4] Market Potential - The combination therapy of ipilimumab and nivolumab is used in 95% of eligible patients, indicating a significant market opportunity for Sandoz's biosimilar [7] - The agreement aims to address considerable unmet medical needs and increase worldwide access to cancer treatments, reinforcing Sandoz's commitment to expanding patient access and driving sustainable savings for healthcare systems [7]

Investment Rating - The report assigns an "In-Line" investment rating for the biopharma industry in North America [7] Core Insights - The latest weekly Total Prescription (TRx) year-over-year (YoY) growth for the week ending April 11, 2025, was +2.7%, a decrease from +3.5% the previous week, but consistent with the +2.7% growth over the past 12 weeks [1][2] - The report highlights the launch performance of new drugs, including BMY's Cobenfy for schizophrenia and VRTX's Journavx for acute pain, with specific TRx targets needed to meet consensus sales estimates [3][4] Summary by Sections Market Overview - The US total market weekly TRx YoY change was +2.7% compared to +2.3% a year ago, with a rolling 4-week TRx YoY also at +2.7% [2] - Extended unit (EUTRx) weekly YoY growth was +1.4%, indicating a slower growth rate compared to TRx YoY [2] Drug Launch Analysis - BMY's Cobenfy, approved for schizophrenia, recorded approximately 1,660 scripts for the week, up from 1,580 the previous week, with a target of 105K TRx needed to meet 2025 consensus estimates [3] - VRTX's Journavx, approved for acute pain, had around 2,950 scripts for the week, with an estimated average script size of 35-37 pills, indicating a need for approximately 229K scripts for a 14-day duration to achieve $87 million in sales [4] Prescription Trends - The report includes a detailed analysis of prescription trends for major pharmaceuticals, highlighting significant YoY changes for key products such as Humira, Rinvoq, and Skyrizi [19][21] - The GLP-1 franchise, particularly Mounjaro and Zepbound, showed notable growth, with Mounjaro experiencing a 69% YoY increase [21] Seasonal Vaccine Tracking - The report tracks seasonal respiratory vaccines, noting that RSV vaccine volumes are approximately 65% below last year's levels, while COVID vaccine volumes are also down year-over-year [10]

Kamada Ltd. (NASDAQ:KMDA) Q4 2024 Earnings Conference Call March 5, 2025 8:00 AM ET Company Participants Brian Ritchie – LifeSci Advisors Amir London – Chief Executive Officer Chaime Orlev – Chief Financial Officer Conference Call Participants Annabel Samimy – Stifel Anthony Petrone – Mizuho Group James Sidoti – Sidoti & Co. Operator Greetings, and welcome to the Kamada Fourth Quarter and Full Year 2024 Earnings Conference Call. At this time all participants are in a listen-only mode. A brief question-and-a ...