Chairman Habil Khorakiwala said the company is looking at new antibiotics and has identified a segment that promotes biosimilars as it is a promising result demonstrated by Zaynich, developed in IN IN IN IN IN indoors. Wockhardt is seeking the U.S. Food and Drug Administration (FDA) approval of the drug, amid rising drug resistance and new antibiotics.
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The company is building a global business model for its drug discovery and research business, with 10 years of exclusiveness in its regulatory market for novel antibiotics, and 82-year-old Khorakiwala, to treat diabetes and obesity, who established the Mumbai drugmaker in 1967.
“I want to fundamentally demean the organization,” Horakivara said in an interview. “For the next five to seven years, you will see a (new) drug from our portfolio every two years.”
Most large pharmaceutical companies have withdrawn from antibiotic research. Once the leader of antibiotics, Bristol’s giant mycorrhizal (Squibb) withdrew from infectious disease research in the 2000s. Eli Lilly was in the early 2000s, while Sanofi left in the mid-2010s. GlaxoScreen Klin (GSK) and Pfizer have significantly reduced antibiotic studies. Vishal Manchanda, senior vice president of institutional research at Systematix Group, said that the largest antibiotic is Pfizer’s Zavicefta, which has annual sales of approximately $700 million. While that number is trivial for Wockhardt, the chances are great.
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“What we have achieved is significant in drug discovery … We have chosen an area like antibiotics and big pharma companies are taking off. We envision a resistance in the next 15-20 years,” he said.
Potential blockbusters could restore the fate of Wockhardt, once the largest general-purpose manufacturer in India but lost much of its market share over the years.
Khorakiwala talked about Wockhardt’s initial research, which showed the company could enter two areas: pain and antibiotics. It believes painkillers will put the company in opioid analgesics, which is highly regulated due to its abuse and addiction potential. Compared to the billions of dollars Big Pharma invests in drug research, antibiotics offer an opportunity that can be addressed in a capital-efficient way.
“I have promised over $500 million in value over 25 years compared to our financial resources…it’s a very important, sustained, long-term commitment.”
According to Khorakiwala, the U.S. market has become “very uncertain”, adding that Wockhardt’s focus will be on making so-called new drugs for the U.S. market, while its generic drug business will be concentrated in emerging markets and Europe. He said exiting the U.S. generic drug market “will increase profits because we lose money in the U.S..” The U.S. accounted for only 6% of its global revenue in fiscal 24.
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The company has also moved its manufacturing of new drugs in the United States and developed markets to third-party players in Europe. Khorakiwala believes this could quarantine companies from the U.S. reciprocity tariffs, as Europe does not impose tariffs on U.S. goods. But U.S. President Donald Trump said it plans to impose separate tariffs on all drug imports, in which case it could also affect companies. It will continue to be locally manufactured for India and emerging markets.
The company’s winning horse may be Zaynich, a novel antibiotic. The drug was recently conducted in a global Phase 3 trial in hospitalized patients with complex urinary tract infections, achieving a clinical cure rate of 96.8%, the highest efficacy ever. Wockhardt expects the FDA to approve Zaynich in the middle of the following year and launch the U.S. in 2027. The company’s hope is a large addressable market for the drug: there are 250,000 to 300,000 patients in the U.S. who can use the drug. In the United States, the existing categories are processed at $8,000-$10,000.
Khorakiwala avoids sharing the exact income data he expects to get from the drug, but said: “I need about 10,000-15,000 patients and I want to get $15 billion to $200 million.”
Systematix’s Manchanda called Zaynicha “Great Drug” while warning its business opportunities are complex because there is not much success in the antibiotic category.
“Because it is a life-saving antibiotic, doctors want to preserve it for patients who need it and are not responding to all other treatment options,” he said. He noted that Cefiderocol, sold by Japanese company Shionogi, works similarly to Zaynich. “It’s about $230 million and it’s still growing,” he said.
Zaynich is expected to be used as a last resort, even drugs like Cefiderocol are not working properly. “It should be a meaningful opportunity [for Wockhardt] And it will be big. “Manchanda said.
Another Wockhardt antibiotic, MIQNAF, received approval for Indian drug modulators early this year and is expected to enter the market this month. It provides a one-day 3-day course for community-acquired bacterial pneumonia, eliminating the need for hospitalization. The drug may be twice or three times more expensive than azithromycin and hypergenetics (such as azithromycin and hypergenetics). For severe patients, antibiotics used as second or third-end defenses (such as MIQNAF), the market size is ₹Manchangda said 15-30 billion.
Khorakiwala refused to share how much he expected the drug to become the finance.
Although MIQNAF is intended to be available for India and emerging markets in the near future, Zaynich and other antibiotics will be launched in the United States and Europe first.
Wockhardt, once a Pharma Generics giant, has suffered multiple financial challenges over the past two decades, eroding its market position. In the early 2000s, a large number of rapid acquisitions swelled to the peak of debt, ₹4,000 crore rupees in 2008. The losses caused by complex currency derivatives hedging further weakened its financial situation, forcing it to fall into a corporate debt restructuring to avoid potential bankruptcy. In fiscal 2014, the U.S. FDA imposed import alerts on two of its Indian factories, resulting in a large loss of revenue in the U.S. market.
As of fiscal year 24, its total debt was ₹2112 million. Its income, ₹In fiscal year 2.881 billion, almost from ₹Fiscal year 2013 was Rs 561 crore. The company released ₹4.72 million in fiscal year 24.
Wockhardt’s stock has taken off behind the R&D pipeline over the past two decades, almost 10 times over the past two years. Its stock price grew by about 140% last year ₹NSE closed 1,436 on the market on Wednesday.
The company reported net profit as ₹140 million in December quarter, net loss ₹830 million a year ago. This is driven by a 3% increase in operating revenue ₹721 million, from ₹$70.1 billion for the whole year. Prior to that, the company had been posting consecutive quarterly losses.
The company has two new antibiotics – Zaynich and Miqnaf (Zaynich and Miqnaf), and the company expects a shift in profitability.
“They haven’t turned around yet…the turnover may be made by [Zaynich] “Working with a large player in an anti-infection space. If they can work with a large player, they will be able to realize the full potential of this opportunity. This is a key milestone that needs to define how their journey will change,” he said.
Khorakiwala said Wockhardt hopes to build its biosimilar business more firmly over the next five years.
Similar to the antibiotic space, the company identified areas where competition was limited. It plans to introduce insulin and anti-obesity drugs products, such as GLP-1.
“In the anti-diabetes space, there are few competitive scenarios…so if we had the entire range for a long time, we could build a business.”
The focus of the biosimilar business will be in India and emerging markets, and the company sees similar unmet demand and has significant growth potential. The cost of manufacturing and selling these drugs in these areas will also be lower.
Horakivara said Walkerhart will be research-oriented in the next 25 years. The focus will be on new drugs in the anti-infection space based on the current pipeline.
“We’ve identified a problem of 10-15 years from today… Any drug will produce resistance… Like Zaynich, after 20 years, it will produce resistance. So you have to find a better drug.”
