Sacubitril/Valsartan

Novartis is buying gene therapy and neuroscience biotech Kate Therapeutics in a deal worth $1.1 billion in upfront and milestone payments, the Swiss pharma confirmed to Endpoints News on Thursday. And Novartis is not done yet. It is still on the lookout for bolt-on M&A opportunities — but don’t expect them to go higher than $3 billion. “That’s not that we couldn’t do a little bit bigger, but that’s the majority of the available target companies, if you will,” Novartis CFO Harry Kirsch told the media ahead of its investor event in London on Thursday. CEO Vas Narasimhan added that a lot of M&A from the recent past has been in the $1 billion to $2 billion range, pointing to its acquisitions of Mariana Oncology and KateTx. Over the past eight years, it made $5 billion to $10 billion deals only “occasionally” because of valuation considerations and “financial discipline,” he added. Novartis will take on KateTx’s pipeline of preclinical candidates in Duchenne muscular dystrophy, facioscapulohumeral muscular dystrophy and myotonic dystrophy type 1. The San Diego biotech’s gene therapy tech features adeno-associated virus capsids that deliver their payloads into specific tissues to avoid off-target issues such as hepatic side effects. In June 2023, it said that it was partnering with Astellas on a neuromuscular disease called X-linked myotubular myopathy. Novartis revealed its purchase of KateTx ahead of its Meet Novartis Management event in London that was intended to reassure investors its pure-play strategy is bearing fruit now and in the next several years. A key part of its growth strategy is more M&A as “replacement power,” with the company facing the loss of exclusivity for key drugs such as Entresto , Kirsch said. When asked if changes to the Federal Trade Commission could lead to Novartis raising its M&A budget, Narasimhan said the FTC is not a major driver of its decisions. As a part of its reorg, the company zeroed in on four therapeutic spaces: cardiovascular-renal-metabolic, immunology, neuroscience and oncology. “Preclinical, Phase 1, Phase 2 area — that’s the opportunity where we can step in” and Novartis can add value to the acquired company, Narasimhan said, adding that it’s challenging to “find synergies, harder to justify” with later-stage candidates. Narasimhan said that when it bought MorphoSys for $2.9 billion, its lead oncology candidate , pelabresib, was in an ongoing Phase 3 trial. “We saw the opportunity in an area of myelofibrosis that we’ve been in for a long period of time, and we took a bet on an ongoing clinical trial,” he said, adding that if it had waited for the late-stage readout, the purchase price would have been “double at least.” But that bet on MorphoSys led to the company taking an $800 million impairment hit just months after the deal closed due to emergent malignancies. “In this case, it didn’t go our way,” he said, nonetheless noting the company’s overall M&A track record . As for pelabresib, the company’s next update should come in the second half of next year. Narasimhan said it is monitoring patients until the middle of next year. “We are also planning to conduct additional studies to look at certain subpopulations of myelofibrosis patients where pelabresib could have a better benefit-risk profile. So I think all of that will take us at least until 2027 — it might take longer, depending on the safety topic,“ he added.

Operating revenue in the first nine months of 2024 was 564.6 million euros, a 5% decrease on the first nine months of 2023, mainly due to the performance of the contract development and manufacturing business ("CDMO"). This division generated (i) lower revenues from the manufacture of the COVID-19 vaccine in comparison to the first nine months of 2023, when ROVI had booked higher encone related to the production of the "pandemic" COVID-19 vaccine; and (ii) lower revenues related to the activities carried out to prepare the plant for production of the vaccine under the agreement with Moderna. However, CDMO sales increased by 16% to 134.4 million euros in the third quarter of 2024 compared to the third quarter of 2023, as a result of (i) higher revenue from existing customers (excluding Moderna); and (ii) higher revenue related to production of the COVID-19 vaccine due to a more concentrated seasonality in the third quarter. It should likewise be noted that the third quarter of 2024 is expected to be the strongest of the year in terms of CDMO sales performance. Positive evolution of Okedi® (Risperidone ISM®), sales of which increased 126% compared to the first nine months of 2023, totalling 20.3 million euros. ROVI announces that Risvan® (Risperidone ISM®), a product indicated for the treatment of schizophrenia in adults, will not be marketed in the United States, following an assessment of the uncertainties and opportunities associated to this launch. ROVI has, therefore, chosen to focus on the European development of Okedi® and expects this product to reach global potential sales of between 100 and 200 million euros in upcoming years. Sales of the heparin franchise (low-molecular-weight heparins (LMWH) and other heparins) decreased by 2% to 177.8 million euros in the first nine months of 2024, mainly due to lower orders from enoxaparin partners. Bemiparin sales, however, increased by 6% to 71.1 million euros in the first nine months of 2024. Additionally, ROVI forecasts full-year sales of bemiparin to increase by a low-single-digit percentage in 2024 compared to 2023, and the fourth quarter of 2024 to be the strongest quarter of the year in terms of enoxaparin sales, as a higher volume of orders from partners is expected. Good performance of Neparvis®, sales of which increased by 13% in the first nine months of 2024 compared to the same period of 2023, rising to 38.1 million euros. Gross margin was 63.6% in the first nine months of 2024, an increase of 4.7 percentage points on the first nine months of 2023. This increase was mainly due to: (i) the decrease in the contribution to the manufacturing business (CDMO) of revenue relating to activities to prepare the plant to produce medicines under the agreement with Moderna, which contributed lower margins to Group sales; (ii) the increased contribution to the CDMO business by existing customers (excluding Moderna), which contributed higher margins; and (iii) the increased contribution of sales of Okedi®, which likewise added higher margins. EBITDA margin increased 0.8 percentage point to 29.6% in the first nine months of 2024 from 28.8% in the same period of 2023. Net profit was 113.5 million euros in the first nine months of 2024. The ROVI General Shareholders Meeting, held on 24 June 2024, approved the payment of a gross dividend of 1.1037 euros per share; which represents approximately a 35% pay-out. This dividend was paid on 10 July 2024. Effective 13 September 2024, ROVI delisted 2,780,395 shares from the Stock-Exchange Interconnection System (Sistema de Interconexión Bursátil) and the Madrid, Barcelona, Bilbao and Valencia Stock Exchanges. As a result, the share capital of ROVI is now EUR 3,074,145.72, divided into 51,235,762 ordinary shares. By redeeming these shares, the shareholders have automatically increased their percentage interest in the capital stock. OUTLOOK For 2024, ROVI expects its operating revenue to decrease by a mid-single-digit percentage in comparison with 2023. For 2025, ROVI expects its operating revenue to decrease by a mid-single-digit percentage in comparison with 2024. Notwithstanding, this guidance is calculated using certain factors that could be relevant to the estimates and that are difficult to specify at the present time. They include, among others, the following: First, the 2024 vaccination campaigns, for flu and COVID-19, are still in progress and, as of today’s date, the Company is unable to forecast how the demand and production might evolve for the vaccination campaigns that will take place in 2025. Second, it is hoped that the expansion of the compounding, aseptic filling, inspection, labelling and packaging capacities at the ROVI facilities in Madrid and the current high market demand for contract manufacturing services (CDMO) will favour obtaining new customers, with the resulting sales impact. This would have to be considered but is impossible to estimate at this time.