Wockhardt has received reaffirmation in credit ratings from CARE Ratings as under:

Long term bank facilities (Rs 527.75 crore) - CARE BBB-; Stable

Short term bank facilities (Rs 171.20 crore) - CARE A3

Non convertible debentures (Rs 200 crore) - CARE BBB-; Stable

Non convertible debentures (Rs 50 crore) - CARE BBB-; Stable

The ratings were given, inter alia, after factoring in the tie-up with various global partners for supply of vaccines and respiratory antibiotic, diversified product portfolio spread across multiple therapeutic segments, accredited manufacturing facilities along with R&D-focused approach, established marketing network with global presence, improvement in total operating income and operating profit margins in FY22 and successful raising of funds through rights issue and NCD issue.

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Wockhardt announced that in view of the changed pharmaceutical market situation in the United States, the management had initiated various cost optimisation measures, including restructuring its USA business model, inter alia, by closing down its manufacturing facility in Illinois, USA and undertaking its business in USA through Contract manufacturing the products sold by it in US/North America by engaging USFDA approved manufacturing partners meeting the superior quality standards acceptable to the Company.

In line with the above, the Company has now engaged multiple USFDA approved manufacturing partners, after thorough due diligence and inspection of their facilities, to manufacture various products of the Company for sale in US/ North America under the same brand and Wockhardt name. Further, the Company is relieving all its staff who were directly engaged by our US subsidiary in its plant in connection with the manufacturing process in a phased manner and in full compliance with the applicable local laws.

The Company believes, that this new arrangement is in the best interest of the Company as this will help the Company to avoid the manufacturing and quality management cost completely resulting in significant savings in operating and overhead cost while allowing the management to completely focus on penetrating and expansion of the market share of its products in US/ North America.

In view of the above and since the concerned site was under 483 observations and warning letters from US FDA, the Company has entered into a Consent Decree with DoJ which resolves and settles all matters with the US FDA, whereby the Company shall stop all manufacturing activities at the plant for the present. There is no financial compensation in the Consent Decree.

The management emphasizes that the above closure of the manufacturing unit will not affect the availability of its products in the US market in view of the alternate arrangement already put in place and on the contrary allow the Company to grow more vigorously in the US market.

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Wockhardt announced the completion of first site initiation visit for the pivotal Phase 3 global Clinical Study of its novel antibiotic WCK 5222.

WCK 5222 is a Super-drug which is entirely a new class of antibiotic known as “â-lactam ENHANCER”.

This is double-blind, multi-center, efficacy, safety, and tolerability study in the treatment of hospitalized adults with Complicated Urinary Tract Infections, including Acute Pyelonephritis. This Study will have 70 centres worldwide in 11 countries including US, Europe, India, China and Latin America. This global study is expected to be completed in 18 months.

WCK 5222 is being developed to treat serious Gram-negative bacterial infections which are becoming increasingly resistant to antibiotics and pose a grave threat to public health. This super-drug is a combination with new chemical entity, Zidebactam which brings forth a novel â-lactam enhancer mechanism to tackle the extreme drug resistant pathogens such as Acinetobacter, Pseudomonas and Klebsiella.

The Food and Drug Administration (USA) has recognised WCK 5222 can address unmet medical needs and designated it as a Qualified Infectious Disease Product (QIDP) which facilitates rapid approval process.

When approved, Wockhardt will be the first Indian company to have developed a new drug to be approved and available worldwide including US, Europe, India, China and many other countries.

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Wockhardt announced the completion of first site initiation visit for the pivotal Phase 3 global Clinical Study of its novel antibiotic WCK 5222.

This is double-blind, multi-center, efficacy, safety, and tolerability study in the treatment of hospitalized adults with complicated urinary tract infections, including acute pyelonephritis. This study will have 70 centres worldwide in 11 countries including US, Europe, India, China and Latin America. This global study is expected to be completed in 18 months.

WCK 5222 is being developed to treat serious Gram-negative bacterial infections which are becoming increasingly resistant to antibiotics and pose a grave threat to public health. This super-drug is a combination with new chemical entity, Zidebactam which brings forth a novel β-lactam enhancer mechanism to tackle the extreme drug resistant pathogens such as Acinetobacter, Pseudomonas and Klebsiella.

The Food and Drug Administration (USA) has recognised WCK 5222 can address unmet medical needs and designated it as a Qualified Infectious Disease Product (QIDP) which facilitates rapid approval process.

Once approved, Wockhardt will be the first Indian company to have developed a new drug to be approved and available worldwide including US, Europe, India, China and many other countries.

Dr. Habil Khorakiwala, Wockhardt's chairman said: We are pleased that WCK 5222 Phase 3 global study has commenced. WCK 5222 is a new class of antibiotic for Gram-negative terrain for complicated Urinary Tract Infections and Hospital Acquired Bacterial Pneumonia (HABP/VABP). Scientific evidence clearly suggest Superdrug WCK 5222, when available will save many lives worldwide.

Wockhardt is a research based global pharmaceutical and biotech company. It has manufacturing and research facilities in India, USA & UK and a manufacturing facility in Ireland. Wockhardt has a significant presence in UK, Europe, USA and India, with over 80% of its global revenues coming from international businesses.

On a consolidated basis, Wockhardt reported net loss of Rs 67 crore in Q1 June 2022 as against net loss of Rs 12.71 crore in Q1 June 2021. Net sales declined 30.78% to Rs 595 crore in Q1 June 2022 over Q1 June 2021.

Shares of Wockhardt were up 2.14% to Rs 236.75 on Friday, 12 August 2022.

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