Wockhardt , a prominent pharmaceutical company, has reported a significant turnaround in its financial performance for the second quarter and made progress in its drug development efforts.

Financial Highlights

Revenue and Profitability

Wockhardt has demonstrated a remarkable improvement in profitability for Q2. The company's revenue stood at ₹782.00 crore, up by 5.96% from ₹738.00 crore in the previous quarter.

The company's focus on operational efficiency has yielded positive results. The EBITDA (Earnings Before Interest, Taxes, Depreciation, and Amortization) saw a substantial increase of 58.42%, reaching ₹160.00 crore compared to ₹101.00 crore in the previous quarter.

Turnaround in Profit Before Tax

The most striking feature of Wockhardt's Q2 results is the turnaround in profit before tax. The company reported a profit before tax of ₹91.00 crore, reversing the loss of ₹109.00 crore incurred in the previous quarter. This represents a significant improvement in the company's bottom line and reflects positively on its financial health.

Business Segment Performance

• Biotech business: Recorded 42% growth with operations at ₹154.00 crore.
• India business: Stood at ₹172.00 crore with 3% growth compared to the previous year.
• UK business: Reached ₹313.00 crore with 4% growth compared to the previous year.
• Irish business: Achieved ₹59.00 crore with 40% growth compared to the previous year.

Drug Development Milestone

Wockhardt has completed its New Drug Application (NDA) submission to the US FDA for its novel antibacterial agent WCK 5222 (ZAYNICH) for treating complicated urinary tract infections. This marks a significant achievement as it is the first-ever NDA submission to the US FDA for a drug fully discovered and developed by an Indian pharmaceutical company.

Intellectual Property

The company continues to strengthen its intellectual property portfolio:

• Filed 7 patents during the quarter
• Granted 5 patents
• Total patents held now stand at 858

Conclusion

Wockhardt's Q2 results demonstrate a robust financial performance, marked by significant improvements in profitability and operational efficiency across various business segments. The company's ability to enhance its EBITDA and achieve a substantial profit before tax indicates a positive trajectory. Additionally, the submission of the NDA for WCK 5222 represents a major milestone in Wockhardt's drug development efforts, potentially opening new avenues for growth in the future.

Wockhardt , a prominent Indian pharmaceutical company, has reached a significant milestone in its drug development pipeline by submitting a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Zidebactam-Cefepime, a novel antibacterial agent aimed at treating serious Gram-negative infections.

Groundbreaking Achievement for Indian Pharmaceutical Innovation

This NDA submission marks a historic moment for the Indian pharmaceutical industry, as Zidebactam-Cefepime (WCK 5222, ZAYNICH™) is the first drug fully discovered and developed by an Indian pharmaceutical company to reach this stage with the U.S. FDA. The achievement underscores Wockhardt's commitment to addressing the global crisis of antimicrobial resistance (AMR).

Targeting Complicated Urinary Tract Infections

The NDA seeks approval for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, with or without concurrent bacteremia caused by Gram-negative bacteria, including multidrug-resistant (MDR) strains. This addresses a significant medical need, as more than 8 million cUTI cases are reported annually in the U.S. and EU combined.

Novel Mechanism of Action

Zidebactam-Cefepime represents a first-in-class β-lactam enhancer and β-lactam combination, introducing a new mechanism of action to combat difficult-to-treat infections. The drug has shown potent activity against multi-drug resistant (MDR) and extreme drug resistant (XDR) Gram-negative pathogens, including those harboring NDM carbapenemases and PBP mutations.

Robust Clinical Development

The NDA submission is supported by a comprehensive clinical development package, including:

• Nine Phase I studies conducted in the U.S. and China
• A Phase II study conducted in India
• A pivotal Phase III global clinical trial (ENHANCE 1) across 64 sites in multiple countries

Regulatory Support and Designations

Zidebactam-Cefepime has been granted Qualified Infectious Disease Product (QIDP) and Fast Track Designation by the U.S. FDA, highlighting its potential importance in addressing serious infections.

Wockhardt's Antibiotic Innovation

Dr. Habil Khorakiwala, Founder Chairman of Wockhardt Group, commented on the achievement, stating, "This milestone reflects our unwavering commitment to combat antimicrobial resistance through innovative drug discovery. Zidebactam-Cefepime has the potential to address a critical gap in the treatment of serious Gram-negative infections."

Wockhardt has been at the forefront of antibiotic innovation for over 27 years, with a pipeline of six antibiotics at various stages of clinical development and commercialization. The company's focus on combating multi-drug resistant infections has resulted in three novel antibiotics already approved for clinical use, with two more in the final stages of development.

As the global healthcare community continues to grapple with the challenge of antimicrobial resistance, Wockhardt's progress with Zidebactam-Cefepime represents a significant step forward in the development of new treatment options for serious bacterial infections.