Sandoz Group AG - SDZNY STOCK NEWS

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.

Sandoz has received European Commission approval for Afqlir® (aflibercept), a biosimilar to Eylea®, for treating various retinal diseases including neovascular age-related macular degeneration (nAMD). The treatment will be available as 2 mg vial kit and pre-filled syringe for intravitreal injection, with launch expected in Q4 2025.

nAMD, affecting the central vision zone, is responsible for 90% of severe vision loss in AMD cases. Out of 3.6 million patients with nAMD across major markets, 2.5 million are diagnosed but only 1.7 million receive treatment.

Sandoz reported strong Q3 2024 performance with net sales of USD 2.6 billion, up 12% in constant currencies. Nine-month net sales reached USD 7.6 billion, up 9%. The growth was driven by exceptional biosimilars performance, up 37% in Q3, and accelerating generics growth in Europe. Biosimilar success was attributed to Hyrimoz uptake in the US, Cimerli acquisition, and strong Omnitrope demand. The company received US FDA approvals for Pyzchiva and Enzeevu, while launching Pyzchiva in Europe. Based on strong momentum, Sandoz increased its full-year 2024 net sales guidance to high-single digit growth and confirmed core EBITDA margin guidance of around 20%.

Sandoz, a global leader in generic and biosimilar medicines, has launched a generic paclitaxel formulation in the US. This is the first FDA-approved abbreviated new drug application (ANDA) to reference the original medicine. The product is a single-dose 100 mg vial for intravenous use, approved for metastatic breast cancer treatment.

The launch follows FDA approval on October 8, 2024, and is expected to be a near-term growth driver in the US market. Developed in partnership with Jiangsu Hengrui Pharmaceuticals Co., , this generic version references Abraxane® for Injectable Suspension. Keren Haruvi, President of Sandoz North America, emphasized the company's commitment to providing access to life-changing medicines, noting that an estimated 168,000 women in the US are living with metastatic breast cancer.

Sandoz (SIX:SDZ/OTCQX:SDZNY) has received FDA approval for Enzeevu™ (aflibercept-abzv), a biosimilar to treat neovascular age-related macular degeneration (nAMD). This approval strengthens Sandoz's leading US ophthalmology portfolio and is expected to be a key biosimilar growth driver in the US market. Enzeevu™ is indicated to improve and maintain visual acuity in nAMD patients, a leading cause of vision impairment in North America for those over 50. The FDA also provisionally determined Enzeevu™ to be interchangeable with the reference medicine. The approval follows Sandoz's recent acquisition of the Cimerli® (ranibizumab-eqrn) business, further bolstering its ophthalmology portfolio. Launch timing will depend on various factors, including ongoing litigations and potential settlements.

Sandoz announced strong financial results for Q2 and H1 2024. Net sales for Q2 were USD 2.6 billion, a 9% increase in constant currencies, while H1 sales reached USD 5.0 billion, a 7% rise. The core EBITDA margin for H1 was 17.5%, up 210 basis points from H2 2023. However, the overall EBITDA margin was 11.4% due to one-time costs. Significant drivers included a 29% growth in biosimilars and no impact from price erosion.

By region, Q2 sales rose 3% in Europe, 23% in North America, and 9% internationally. Key products contributing to growth included Hyrimoz, Cimerli, and Omnitrope. Despite positive topline growth, net income fell by 36% to USD 151 million, and operating income declined by 28% to USD 332 million. Net debt increased to USD 3.4 billion. Sandoz raised its full-year growth guidance to mid- to high-single digits in constant currencies and expects a core EBITDA margin of around 20%.

Sandoz has launched Pyzchiva® (ustekinumab), a biosimilar, across Europe to treat chronic inflammatory diseases. This launch strengthens Sandoz's immunology portfolio in Europe, marking their fifth biosimilar in this therapeutic area. Pyzchiva® is the first ustekinumab biosimilar in Europe offering all reference medicine strengths, including the 130mg vial initiation dose for Crohn's disease.

Pyzchiva® is approved to treat adults with plaque psoriasis, psoriatic arthritis, Crohn's disease, and pediatric plaque psoriasis for patients six years and older weighing over 60 kg. This launch is expected to contribute to Sandoz's mid-term growth strategy and aims to improve access to affordable medicines for millions of people with chronic inflammatory diseases in Europe.