Sandoz Group AG Stock Price, News & Analysis

Sandoz (OTCQX:SDZNY) has signed a non-binding term sheet with Evotec SE to acquire Just-Evotec Biologics EU SAS for approximately USD 300 million. The acquisition includes the J.POD biologics development and manufacturing facility in Toulouse, France.

The strategic move aims to capitalize on the projected USD 300 billion biosimilar market opportunity over the next decade. The acquisition would enhance Sandoz's in-house biosimilar capabilities through JEB's fully automated and high-throughput technology platform, enabling faster development, smarter scaling, and high-quality manufacturing while controlling costs.

The transaction completion is subject to contract finalization, necessary approvals, and mandatory employee processes in France. Upon completion, JEB employees would be integrated into the Sandoz Group. The investment aligns with Sandoz's existing capital expenditure commitments in Europe.

Sandoz (OTCQX:SDZNY), the global leader in generic and biosimilar medicines, has begun construction of a new USD 440 million state-of-the-art biosimilars production center in Brnik, Slovenia. This investment is part of a larger USD 1.1 billion commitment in Slovenia by 2029, which includes a biosimilar drug substance production center in Lendava and a development center in Ljubljana.

The strategic expansion aims to capture a significant portion of the USD 222 billion biosimilar patent-expiry market opportunity expected over the next decade. As the global biosimilar pioneer with 11 marketed molecules and 28 molecules in development, Sandoz is positioning itself to meet growing patient demand through enhanced manufacturing capabilities.

The new Brnik facility will focus on injectable products production, featuring preparation, filling, assembly, and packaging capabilities for sterile injectable products, along with quality control laboratories. The investment aligns with existing capital expenditure commitments and strengthens Sandoz's position as Slovenia's largest direct foreign investor.

[ "Total planned investment of USD 1.1 billion in Slovenia by 2029 demonstrates strong growth commitment", "Company targets USD 222 billion biosimilar patent-expiry market opportunity over next 10 years", "Robust portfolio of 11 marketed molecules and 28 molecules in development pipeline", "Strategic expansion of manufacturing capabilities through new USD 440 million production facility", "Investment strengthens end-to-end European biosimilar hub development" ]

Sandoz (SDZNY) has launched WYOST® and Jubbonti® (denosumab-bbdz), the first and only FDA-approved interchangeable biosimilars for denosumab, in the US. These biosimilars are approved for all indications of reference medicines XGEVA® and Prolia®, treating conditions like osteoporosis and cancer-related skeletal events. The launch represents a significant milestone in Sandoz's growth strategy and biosimilar leadership. The medications will be available with established Q codes and comprehensive patient support resources, including reimbursement and financial assistance. This launch addresses a significant medical need, as over 10 million US adults over 50 live with osteoporosis, and approximately 330,000 people in the US are living with bone metastases.

Sandoz (SDZNY) has launched Pyzchiva®, Europe's first commercially available ustekinumab biosimilar autoinjector. The device, developed by Samsung Bioepis, is approved for treating adults with plaque psoriasis, psoriatic arthritis, Crohn's disease, and pediatric plaque psoriasis patients over 60kg. The autoinjector features improved self-administration capabilities, including accurate automatic dosing, reduced injection pain, and flexible storage options. Currently available in Spain, Pyzchiva® has been launched in 23 European markets. This launch is significant given Europe's high prevalence of psoriasis (6.4 million people) and inflammatory bowel diseases (2.5-3 million people). The product stems from Sandoz's September 2023 agreement with Samsung Bioepis, granting commercialization rights in Brazil, US, EEA, Switzerland, and UK.

Sandoz reports Q1 2025 net sales of USD 2,480 million, showing 3% growth in constant currencies. The company maintains its full-year guidance, expecting mid single-digit net sales growth and a core EBITDA margin of around 21%.

Key performance highlights:

• Generics sales: USD 1,809 million (73% of total sales)
• Biosimilars sales: USD 671 million (27% of total sales)
• Europe net sales grew 7%
• International sales declined 2%
• North America sales grew 1%

The company plans major biosimilar launches in 2025, including Wyost/Jubbonti (denosumab) in Europe and US, Tyruko (natalizumab) in US, and Afqlir (aflibercept) in Europe. Recent US government tariffs impact includes a 20% China tariff implemented March 4, 2025, with effects within guidance expectations.

Sandoz has entered a global collaboration agreement with Shanghai Henlius Biotech to commercialize a biosimilar of the cancer therapy ipilimumab. The milestone-based deal is worth up to USD 301 million, including a USD 31 million upfront payment, targeting reference medicine sales of USD 2.5 billion.

The agreement grants Sandoz exclusive commercial rights in key markets including Australia, Canada, Europe, Japan, and the US. Ipilimumab, used in combination with nivolumab in 95% of eligible patients, treats various cancers including melanoma, lung cancer, and kidney cancer.

Henlius will develop and manufacture the biosimilar, while Sandoz will handle registration and commercialization after patent expiry (March 2025 in US, February 2026 in EU). This collaboration strengthens Sandoz's position as the global biosimilar leader, complementing its development of a nivolumab biosimilar and expanding its oncology portfolio which includes Rixathon, Zarzio, Ziextenzo, and Binocrit.

Sandoz (SIX:SDZ;OTCQX:SDZNY) shareholders approved all Board of Directors' proposals at the Annual General Meeting, with 75.73% of voting shares represented. Gilbert Ghostine was re-elected as Chairman of the Board of Directors.

Key approvals include:

• A dividend of CHF 0.60 per share (24% of core net income), payable April 23, 2025
• Change of registered seat from Risch to Basel
• Capital band expansion up to 10% of share capital
• Introduction of new conditional share capital
• 2024 Compensation Report
• Maximum compensation for Board and Executive Committee

All existing board members were re-elected, including appointments to the Human Capital and ESG Committee. KPMG AG was confirmed as statutory auditors for 2025, and Advoro Zurich AG as independent proxy until 2026 AGM.

Sandoz (SIX:SDZ/OTCQX:SDZNY) has filed an antitrust lawsuit against Amgen in the US District Court for the Eastern District of Virginia regarding access to its etanercept biosimilar. The litigation alleges that Amgen has unlawfully blocked competition by purchasing and using certain patent rights to maintain market dominance for Enbrel®, which generated USD 3.3 billion in US revenue in 2024.

Despite receiving FDA approval in 2016 for Erelzi® (etanercept-szzs), Sandoz has been unable to launch this biosimilar treatment. The medication could potentially benefit approximately 7.5 million Americans living with chronic inflammatory diseases, including rheumatoid arthritis, psoriasis, and other conditions.

Sandoz is seeking both an injunction to prevent Amgen from using patent rights to block biosimilar competition and damages, which could be tripled under applicable laws.

Sandoz (SIX:SDZ/OTCQX:SDZNY) has filed an antitrust lawsuit against Amgen in the US District Court for the Eastern District of Virginia regarding access to its etanercept biosimilar. The litigation challenges Amgen's market dominance with Enbrel®, which generated USD 3.3 billion in US revenue in 2024.

The lawsuit alleges that Amgen unlawfully purchased and used patent rights to block competition from Sandoz's biosimilar Erelzi®, which received FDA approval in 2016. Despite approval nearly a decade ago, the biosimilar remains blocked from the US market, affecting approximately 7.5 million Americans living with chronic inflammatory diseases who could benefit from more affordable treatment options.

Sandoz is seeking both an injunction to prevent Amgen from using certain patent rights to block biosimilar competition and damages, which could be tripled under applicable laws.