Wockhardt , a prominent pharmaceutical and biotechnology company, has made significant strides in its novel antibiotics program while reporting its financial results for the first quarter. The company has also submitted its monitoring agency report for the quarter ended June 30, regarding the utilization of funds from its Qualified Institutions Placement (QIP).

Progress in Novel Antibiotics Program

Wockhardt has successfully completed two pre-New Drug Application (NDA) meetings with the U.S. Food and Drug Administration (FDA) for its novel antibiotic ZAYNICH® (Zidebactam/Cefepime, WCK 5222). The company is targeting to file the NDA dossier in September, marking a crucial step towards bringing this innovative treatment to market.

ZAYNICH® has demonstrated promising results in clinical trials, including:

1. A global, pivotal, registration-enabling Phase III study in hospitalized patients with complicated urinary tract infections (cUTI).
2. A trial in patients with meropenem-resistant infections in India.

The antibiotic has also shown life-saving potential under compassionate use, with successful treatments reported in medical journals for severe pan-drug resistant infections.

Q1 Financial Highlights

For the quarter ended June 30, Wockhardt reported:

The company's financial performance reflects its continued focus on profitability while balancing investments in its innovative portfolio of novel antibiotics and diabetes biosimilars.

Business Segment Performance

Strategic Realignment and US Operations

Wockhardt has decided to exit the US generic pharmaceutical segment. The company has filed for voluntary liquidation under Chapter 7 of the US Bankruptcy Code for its US step-down subsidiaries, Morton Grove Pharmaceuticals Inc. and Wockhardt USA LLC. This strategic move aims to eliminate recurring losses and sharpen focus on innovation-led growth.

As a result of this decision, the company has impaired goodwill of ₹97.00 crore in its books of account as of June 30, which has been disclosed as an exceptional item.

QIP Fund Utilization

Wockhardt Limited submitted its monitoring agency report for the quarter ended June 30, confirming no deviation from stated objectives in utilizing proceeds from its Qualified Institutions Placement of approximately ₹1,000 crore. The report, issued by CRISIL Ratings Limited, shows:

• Total utilization: ₹583.08 crore out of net proceeds of ₹977.79 crore
• Unutilized amount: ₹394.71 crore

Fund allocation and utilization:

1. Debt repayment: ₹500 crore allocated, ₹416.31 crore utilized
2. Capital expenditure and R&D: ₹250 crore allocated, ₹32.77 crore utilized
3. General corporate purposes: ₹227.79 crore allocated, ₹134 crore utilized

Unutilized proceeds of ₹394.71 crore are invested in various mutual funds, earning ₹13.20 crore in returns. The QIP was conducted from November 6-11, with net proceeds revised upward by ₹3.82 crore due to lower actual issue expenses than estimated.

Other Developments

• MIQNAF® (Nafithromycin): Approved and launched in India on May 27, with encouraging initial response from clinicians.
• Intellectual Property: 5 patents filed and 5 patents granted during the quarter, bringing the total to 3,278 filings and 853 granted patents.

Wockhardt continues to progress in its mission to develop innovative pharmaceutical solutions, with a particular focus on addressing the global challenge of antimicrobial resistance through its novel antibiotics program.

Wockhardt Limited , a global pharmaceutical company, has reported its financial results for the quarter ended June 30, revealing a mixed performance across standalone and consolidated figures.

Standalone Performance

On a standalone basis, Wockhardt demonstrated strong growth:

Consolidated Results

However, the consolidated results painted a different picture:

Exceptional Item and US Market Exit

A significant development impacting Wockhardt's financial results was the decision to exit the US generic pharmaceutical segment:

• The company filed for voluntary liquidation under Chapter 7 of the US Bankruptcy Code for its US subsidiaries, Morton Grove Pharmaceuticals Inc. and Wockhardt USA LLC, on July 11.
• As a result, Wockhardt recorded an exceptional item charge of ₹97.00 crore, representing the impairment of goodwill related to its US operations.

Business Segment and Global Presence

• Wockhardt continues to operate exclusively in the pharmaceutical business segment.
• The company maintains a global presence with 28 subsidiaries worldwide.

Outlook

Wockhardt's decision to exit the US generic pharmaceutical market marks a significant shift in its global strategy. The strong standalone performance, coupled with the challenges reflected in the consolidated results, suggests a period of transition for the company. The focus will likely be on how Wockhardt navigates this strategic pivot and leverages its global subsidiaries to drive future growth.

Note: All figures are based on the latest available financial results unless otherwise specified.