Sandoz Group AG Stock Price, News & Analysis

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.

Sandoz (SIX:SDZ/OTCQX:SDZNY) has announced significant financial restructuring moves to strengthen its balance sheet. The company has fully repaid USD 750 million equivalent in USD and EUR term loans from September 2023 through three successful bond issuances:

- A dual-tranche CHF bond: CHF 165M (3-year, 1.25% coupon) and CHF 235M (8-year, 1.75% coupon)
- A EUR 500M single-tranche bond (10-year, 4.0% coupon)

The EUR tranche achieved a six-times oversubscription rate. Additionally, Sandoz has secured a new USD 2.0 billion multi-currency revolving credit facility, replacing the previous USD 1.25 billion facility. These transactions are expected to reduce the annual interest rate on gross debt to below 4%, while extending the debt-maturity profile to 2035 with an average maturity of 5.5 years.

Sandoz (SIX:SDZ/OTCQX:SDZNY) announces the US launch of Pyzchiva® (ustekinumab-ttwe), a biosimilar medicine for treating chronic inflammatory diseases. The product, developed by Samsung Bioepis and commercialized by Sandoz, is now available across the US with the same indications as reference medicine Stelara®.

This launch represents a key value driver for Sandoz's growth strategy, advancing its goal to become the leading biosimilar provider in the US. The product offers a complete suite of dosing options and enhanced stability features, including re-refrigeration capability. Sandoz expects to obtain interchangeability status in the first half of 2025.

The company is providing comprehensive patient support resources, including insurance coverage information, self-injection training, and a co-pay program for commercially insured patients. This launch follows a settlement agreement with Johnson & Johnson and a commercialization agreement with Samsung Bioepis, giving Sandoz rights to commercialize Pyzchiva® in multiple territories.

Sandoz, the global leader in generic and biosimilar medicines, has announced key leadership changes. Francisco Ballester, President Region International and Executive Committee member, will retire on March 1, 2025, after 34 years of service. Peter Stenico, currently Global Platform Head Biosimilars and Country President Sandoz Austria, will succeed Ballester as President Region International and join the Sandoz Executive Committee.

Ballester has been responsible since 2019 for driving business growth and access in markets outside North America and Europe. Stenico, who joined Sandoz in 2002, brings extensive experience in biosimilars and generics through various strategic, M&A, and commercial roles. He previously served as Country Head for Sandoz Germany and President of the German Generics Association.

Sandoz, the global leader in generic and biosimilar medicines, presented its strategic roadmap at the 43rd Annual J.P. Morgan Healthcare Conference. The company operates in a USD 200 billion market for generics and biosimilars, expected to grow at 7% annually for the next decade.

Key highlights include:

• An expanded biosimilar pipeline now comprising 28 molecules
• Three planned US biosimilar launches in 2025
• Strong market position with Europe representing half of total sales
• Significant market opportunity with reference medicines worth over USD 400 billion losing exclusivity from 2029-2034

The company reported over 30% sales growth in the first nine months of 2024, with biosimilars as the primary growth driver. Sandoz plans five biosimilar launches in the mid-term, including Pyzchiva®, Tyruko®, Wyost®/Jubbonti®, and Afqlir®. The company also has an ambitious GLP-1 strategy in place, addressing opportunities through internal capabilities and external partnerships.

Sandoz has announced significant steps to resolve the US Generic Drug Antitrust Class Action Litigation. The company has reached a $275 million settlement with end payer plaintiffs' class, to be paid by December 31, 2024. Additionally, Sandoz has established a $265 million provision for outstanding claims from opt-out plaintiffs and State Attorneys' General.

The settlement with end payer plaintiffs includes no admission of wrongdoing and covers alleged conduct between 2009 and 2019. Class members can opt out, potentially reducing the settlement by up to $45 million. The agreement follows previous settlements with the US Department of Justice (2020-2021) and direct purchaser plaintiffs (February 2024).

These financial commitments will be reflected in Sandoz's 2024 financial results but will not affect the company's full-year 2024 and mid-term guidance.