SANDOZ GROUP AG S/ADR - SDZNY STOCK NEWS

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.

The FDA has approved Pyzchiva® (ustekinumab-ttwe), a biosimilar developed by Samsung Bioepis, for all indications of its reference medicine, Stelara®. Pyzchiva® is set to be commercialized by Sandoz in the US starting February 2025, following a settlement with Janssen Biotech. This biosimilar will be available in various forms, including pre-filled syringes and vials for subcutaneous and intravenous administration. FDA's provisional determination also makes Pyzchiva® interchangeable with Stelara®. This approval is a significant milestone for Sandoz, enhancing its immunology portfolio and market position. The medication is approved for treating multiple conditions including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. The approval is based on robust clinical studies demonstrating equivalent efficacy and safety compared to its reference medicine.

Sandoz has secured European Commission approval for Wyost® and Jubbonti®, the first biosimilars of denosumab in Europe. Wyost® is approved for cancer-related bone disease, while Jubbonti® is for osteoporosis. These approvals, based on a robust development program, mark a significant growth milestone for Sandoz.

Wyost® and Jubbonti® will launch in November 2025. The approvals aim to increase access to essential treatments and align with Sandoz's strategy to provide sustainable healthcare solutions. Cancer and osteoporosis are significant health burdens, with cancer-related bone diseases affecting many patients and osteoporosis increasing fracture risks in the aging population.

Sandoz reported strong first quarter 2024 sales with net sales of USD 2.5 billion, up 6% in constant currencies. Biosimilar business grew by 21%, all regions contributed to growth. Acquisition of CIMERLI® completed in March 2024. Generics sales remained steady. Full-year net sales guidance of mid-single digits in constant currencies.

Sandoz Group AG shareholders approved all proposals by the Board of Directors at the Annual General Meeting. Gilbert Ghostine was re-elected as Chairman, with Mathai Mammen, Graeme Pitkethly, and Michael Rechsteiner joining as new Board members. A dividend of CHF 0.45 per share was approved. The AGM also re-elected auditors and the independent proxy.

Sandoz has reached an agreement with Amgen to resolve all patent litigation related to its US denosumab biosimilars, allowing for the launch of Jubbonti® and Wyost® on May 31, 2025, or earlier under certain conditions. These biosimilars are the first and only FDA-approved alternatives to Prolia® and Xgeva®. The settlement strengthens Sandoz's biosimilar portfolio and growth strategy.