Riociguat

New Delhi: Zydus Lifesciences may take the M&A or licensing route to acquire commercial assets for building a specialty portfolio and prepare ground for the possible launch of its liver therapy, saroglitazar, in the US. The Ahmedabad-based drugmaker is also looking at potential acquisitions to diversify into medical devices and expand diagnostics and nutrition businesses, managing director Sharvil Patel tells Viswanath Pilla and George Smith Alexander. Edited excerpts: US generics has been the most profitable segment for Zydus . Can you sustain this as some products may see competition? We will continue to invest in US market. If we take a two-three-year view of our business, it will continue to perform well and at a very good profitability. We have a robust pipeline with numerous exclusive launches planned, contributing to sustained revenue growth. Each year, we file over 30 abbreviated new drug applications (for generic products) and launch 25-30 products. This ensures a steady flow of new offerings, including high-value products like the generic versions of Revlimid, Asacol HD and mirabegron, along with upcoming launches like sitagliptin 505(b)(2) (FY26F launch), palbociclib tablet (FY27) and riociguat (FY28). What is your US plan, especially around orphan and rare diseases? We are committed to building a specialty play in the US, and economics makes it better if we have something commercially ready and build on it along with saroglitazar. Next year we have a readout on Saro. If we see positive traction, we would want to be in a way that we can have more than one product to go into the market with. So, potentially, licensing or M&A would be an opportunity for us to look at. That is something we will be aggressively pursuing. Analysts say Zydus is passive on acquisitions compared to some competitors who have grown by deals; is this going to change? Not in India, but overseas-yes. More so in the US. So, we will look at other (markets) but those will not be very large, but the US would be the larger ticket item for us. Which are the other geographies that interest you for M&A? Europe is something that we want to see whether we can really create (something). We are not big in Europe right now. We are evaluating to see if that is one geography that does make sense or not. Also, valuations are more reasonable sometimes in these markets. Beyond that, other markets, we are just tactical. Profits have grown more compared with revenue in the past seven years. What can we expect 5-6 years down the line? On financial side, whatever we'll do, we'll do profitably. It's not growth at any cost but profitable growth. (By) 2030 we said we want to be a discovery-led organisation, and make sure that we meet the unmet medical needs that exist. How is Zydus diversification plan into medical devices panning out? In medical devices, we are looking at cardiovascular, orthopaedic and nephrological (or nephrology), through organic and inorganic ways. We are partnering in some places, we are licensing in some places, with the agreement that once it scales up, we can manufacture in India. Do you have plans for going global with your biosimilars portfolio? In India, we have 12-13 biologics. We are seeing approvals in other markets, such as Russia, Mexico. We are seeing globalisation of our biologics from 2025. We are building a facility which is getting commissioned in Q1 of next year. We are bullish on biologics front.

Bayer's shares fell up to 14% on Tuesday as the company slashed its profit guidance for the year and warned of more pain to come in 2025, including further loss of exclusivity on the oral anticoagulant Xarelto. "We expect a muted outlook on top and bottom line next year with likely declining earnings," said chief financial officer Wolfgang Nickl.To mitigate, Bayer may look to further reduce its workforce, having cut 5500 positions this year, including 3200 full-time, mostly managerial jobs in the first half. "We plan to accelerate our cost and efficiency measures to partly compensate," Nickl added.Xarelto is already facing generic competition in some markets — notably Europe and Canada — with sales in the third quarter crumbling 23.8% to €802 million ($851 million). Bright spots for Bayer included Eylea (+5.7%, €848 million), Nubeqa (+79.7%, €417 million), Kerendia (+90.9%, €126 million) and Adempas (+7.1%, €182 million). Overall sales in Bayer's pharmaceutical segment slipped 0.6% to €4.5 billion, as the company's total revenue fell 3.6% to €9.7 billion. Meanwhile, a loss of €4.2 billion was posted in the three-month period, narrowed slightly from a loss of €4.6 billion in the prior year. Despite the relatively flat prescription drug sales, CEO Bill Anderson said Bayer is confident that the division will be able to deliver at the upper end of the 2024 guidance of up to 3% growth. "We're happy with what we see from our launch products." Accelerating Xarelto declineFor next year, Bayer expects to see continued growth momentum for cancer drug Nubeqa and Kerendia, its treatment for patients with chronic kidney disease associated with type 2 diabetes. Anderson hopes that this will offset lower Xarelto sales, which are "expected to accelerate in the other direction."JPMorgan analyst Richard Vosser noted that while the pharmaceutical segment was the bright spot in Bayer's results, the erosion of Xarelto was "more rapid" than anticipated. Meanwhile, Barclays analyst Emily Field said "the key takeaway is that 2025 may be looking a bit worse across business segments than the street has been modelling."($1 = €0.94213593)