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Business Standard
5 days ago
- Business
- Business Standard
Wockhardt exits US generics biz, to focus on innovative portfolio
Mumbai-based pharma major Wockhardt, which is gearing up for the launch of its promising antibiotic candidate Zaynich soon, announced on Friday a shift in its United States (US) operations, deciding to exit the generics pharmaceutical segment in the country. Wockhardt's stock price rose by 3.5% on Friday to ₹1,756 per share, following the announcement after market hours. According to a regulatory filing, the company has filed for voluntary liquidation under Chapter 7 of the US Bankruptcy Code for its two Delaware-incorporated step-down subsidiaries—Morton Grove Pharmaceuticals and Wockhardt USA LLC. This move comes even as the company's US generics business has been incurring losses over the past several years. Wockhardt stated that its generics business had incurred a loss of nearly $8 million in FY2024-25 (FY25) alone. While Wockhardt USA LLC contributed approximately 3% to the company's income in FY25, Morton Grove Pharmaceuticals recorded no income. Morton Grove's net worth stood at 4.6%, primarily from goodwill, while Wockhardt USA's net worth was negative. However, Wockhardt's overall performance has been improving. For FY25, the company reported a net loss of ₹57 crore, compared to ₹472 crore in the previous fiscal. Revenue increased to ₹3,012 crore, up from ₹2,798 crore in FY2023-24. It has also managed to reduce its debt, with net debt standing at ₹1,830 crore in FY25, compared to ₹3,314 crore in FY20. 'Following a comprehensive strategic review, the company has concluded that continuing in this segment would detract from its broader innovation agenda,' the company said in an exchange filing. By exiting the commoditised generics space, Wockhardt is positioning itself to create long-term value through innovation, scientific excellence, and sustainable profitability. The company said this reset would allow for a sharpened focus on building a future-ready business anchored in two key pillars: new antibiotic drug discovery and a biologicals portfolio, particularly in insulin. 'This decision, effective July 11, 2025, enables a clean and structured exit from a legacy segment and unlocks management bandwidth and capital for high-impact areas,' it added. The company had also recently announced plans to launch its new class of antibiotic, Zaynich (WCK5222), targeting complicated gram-negative infections in India this year. The US launch is expected in FY27. Wockhardt estimates that Zaynich will have an addressable market of $7 billion in the US and Europe, and a ₹17,000 crore opportunity in India, bringing the total opportunity to $9 billion. Apart from Zaynich, Wockhardt is also optimistic about other drugs in its antibiotic portfolio (such as Miqnaf or Nafithromycin) and its biotechnology portfolio, including insulins. Miqnaf has already been launched in India and is used to treat Community-Acquired Bacterial Pneumonia (CABP) and Upper Respiratory Tract Infections (RTI). The drug has been granted Qualified Infectious Disease Product (QIDP) status by the USFDA, indicating significant unmet need, as well as Breakthrough Medicinal Product (BMP) designation in Saudi Arabia. Miqnaf is targeting a ₹10,800 crore market opportunity in India with over 96 million potential prescriptions. While exiting the US generics market, the company reaffirmed its commitment to its pharmaceutical operations in India, the United Kingdom (UK), Ireland, and other geographies where its businesses continue to deliver strong performance. In addition to antibiotics, the company is bullish on its biotech capabilities, particularly in diabetes management. Wockhardt sees a significant opportunity in India and emerging markets following Danish major Novo Nordisk's decision to phase out human insulin cartridges. In India, this presents an opportunity of around ₹450 crore, and in emerging markets, the opportunity is approximately $157 million. Wockhardt noted in its investor presentation that with only three players operating in this space in India, it sees significant benefit. Wockhardt's shift towards an innovative portfolio, moving away from plain vanilla generics, comes at a time when Indian pharma firms are increasingly focusing on their innovative portfolios. On Thursday, Glenmark Pharma's American subsidiary signed an exclusive licensing agreement with US-based AbbVie for its oncology and autoimmune diseases asset, ISB-2001, for an upfront payment of $700 million.
Mint
5 days ago
- Business
- Mint
Wockhardt exits its US generics business
Wockhardt Ltd is exiting its loss-making US generics business, as it focuses on its new antibiotics drug discovery and insulin portfolios. The drugmaker said on Friday that it has made a Chapter 7 filing for voluntary liquidation of its US subsidiaries Morton Grove Pharmaceuticals Inc. and Wockhardt USA LLC. The business has been incurring losses over the past several years, clocking nearly $8 million losses in FY25. In an interview with Mint in April, Wockhardt chairman Habil Khorakiwala had said the company is planning to exit the US generics segment, in a move to 'derisk the organization fundamentally'. The company will continue to run its pharmaceutical operations in India, the UK, Ireland, and other geographies. The US market has become 'very uncertain', Khorakiwala had said in the interview, adding the company's focus would be on developing its antibiotics pipeline for the global market, while its generics pharma business will focus on the rest of its existing markets. Exiting the US generics market 'will improve profits because we are losing money in the US," he said. Wockhardt is increasing focus on its new drug discovery programme, with a pipeline of novel antibiotics for drug resistant bacterial infections, and new biosimilar drugs to treat diabetes. It has a pipeline of six novel antibiotics targeting bacterial drug resistance. Two of these, Emrok and Miqnaf, have already been launched in India. Its third drug candidate, Zaynich, has completed global phase 3 trials with promising results. Wockhardt has filed for approval with the Indian drug regulator, and is expecting approval in the second half of FY26. It plans to file with the US FDA in Q2 FY26, with a potential launch in FY27, it said in an investor meeting in June. Zaynich could potentially change the company's fortunes, with an addressable patient pool of two million. The addressable market potential for Zaynich is $7 billion in the US and Europe, the company said. Wockhardt is also looking at building its insulin business more robustly for India and emerging markets. The company is doubling its capacity in the next three years to tap the growing demand in the space.
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Business Standard
05-06-2025
- Business
- Business Standard
Wockhardt eyes $9 bn market opportunity for novel antibiotic Zaynich
Mumbai-based pharmaceutical major Wockhardt, which is set to launch a new class of antibiotic, Zaynich, in India this year, estimates a total addressable market opportunity of $9 billion. This includes a $7-billion market in the US and Europe, and a ₹17,000-crore opportunity in India. The company's stock rose 2.4 per cent on the BSE on Thursday following an investor presentation outlining its growth plans for the next three to five years. Zaynich (or WCK 5222) is a key research candidate in Wockhardt's pipeline. It has completed global Phase 3 clinical trials, demonstrating a 20 per cent higher (statistically superior) composite cure rate compared to Meropenem, the current gold standard in antibiotics. Wockhardt claims Zaynich is the first new class of antibiotic in over 30 years to treat gram-negative infections. The drug has already saved 51 lives under compassionate use, including three in the US, where patients had failed all existing therapies. Zaynich is indicated for complicated urinary tract infections (UTIs), hospital-acquired and ventilator-associated bacterial pneumonia, bloodstream infections, and complicated intra-abdominal infections. The company expects approval from the Drugs Controller General of India (DCGI) shortly and plans to launch the drug in the second half of this financial year. Wockhardt has completed a pre-NDA (New Drug Application) meeting with the US Food and Drug Administration (USFDA) in May and plans to file in Q2FY26, targeting a potential launch in FY27. Regulatory filings in the EU and emerging markets are scheduled for the second half of FY26. Wockhardt estimates that around 1.1 million patients in India may benefit from Zaynich, while 371,000 carbapenem-resistant cases in the US and Europe are potential candidates. Overall, there are 4.3 million hospitalised cases involving key gram-negative pathogens in the US and EU. The firm sees a combined addressable patient pool of 2 million across India, the US, Europe, and China. Apart from Zaynich, Wockhardt is also betting on other antibiotics in its portfolio, such as Miqnaf (Nafithromycin), and its biotechnology portfolio, including insulin products. Miqnaf, already launched in India, treats community-acquired bacterial pneumonia (CABP) and upper respiratory tract infections. It has received Qualified Infectious Disease Product (QIDP) status from the USFDA, signifying unmet medical need, and Breakthrough Medicinal Product (BMP) designation in Saudi Arabia. Miqnaf targets a ₹10,800-crore market in India, with over 96 million potential prescriptions. In the biosimilars segment, Wockhardt is focusing on diabetes care and sees significant opportunity arising as Danish major Novo Nordisk phases out human insulin cartridges. This creates a ₹450-crore opportunity in India and a $157-million market across emerging economies. With only three major players in India, including itself, Wockhardt expects to benefit substantially. The company is doubling its diabetes biosimilars capacity over the next three years to meet growing demand, targeting business growth of 20–25 per cent.
