For the third quarter ended 31st December, 2021, Zydus reported consolidated revenues of Rs 3,655 crores. Earnings before Interest, Depreciation and Tax (EBIDTA) stood at Rs 753 crores and net profit for the quarter stood at Rs 500 crores, a company statement notified.
It also informed that Indian formulations business posted revenues of Rs 1,079 crores during the quarter. The branded formulations business posted a robust double-digit growth of 17 per cent on a y-o-y basis. This is after adjusting for sales of COVID-related products, generics portfolio and divested products. The company’s patented product ‘Lipaglyn’ entered the top 100 brands of the Indian pharmaceutical market and was ranked at 92, a jump of 183 ranks i.e. from 275 during the current quarter. On the super-speciality front, the group retained the leadership position in the nephrology market and in the oncology segment, the group is the fastest-growing company in India. The group gained market share in the core therapies of anti-diabetic, cardiovascular, gynaecolog and anti-infective therapeutic areas during the quarter on a y-o-y basis.
Further, according to the statement, the US formulations business registered revenues of Rs 1,504 crores during the quarter. The company filed 12 additional ANDAs with the US Food and Drug Administration (FDA) during the quarter and received nine new product approvals (including five tentative approvals) from the FDA. The company launched three new products in the US market, including nelarabine injection, which was granted 180 days exclusivity and was a day-one launch. It is a chemotherapy drug used to treat certain types of leukemia and lymphoma.
In addition, the statement mentioned that during the quarter, the company announced positive clinical data for CUTX-101, copper histidinate, presented at the 2021 American Academy of Pediatrics National Conference and Exhibition. Cyprium Therapeutics Inc, a partner company of Fortress Biotech Inc, with support from its licensing partner Sentynl Therapeutics, is developing CUTX-101 for the treatment of Menkes disease. An initial module of a New Drug Application (NDA) of CUTX 101 was also filed with the FDA during the quarter.
The statement noted that making headway in research, the ‘first patient’ has been randomised in Evidences-X TM phase II(b) clinical trial of Saroglitazar Mg in Non-Alcoholic Steatohepatitis (NASH) and Fibrosis. The company also received permission from FDA to initiate the phase II(b)/III adaptive pivotal clinical trial of Saroglitazar Mg in Primary Biliary Cholangitis. The company also submitted the NDA to the DCGI for Desidustat, for the treatment of anaemia in patients with Chronic Kidney Disease (CKD) who are on dialysis and not on dialysis.
The company also received permission to begin phase II (a) clinical trial of ZYIL1, a novel oral NLRP3 inflammasome inhibitor in patients with Cryopyrin Associated Periodic Syndrome (CAPS) in Australia. Catering to the unmet critical needs, the company received Orphan Drug Designation from FDA for ZY-19489, a novel compound to treat malaria which is currently being developed in association with Medicines for Malaria Venture (MMV), added the statement.
The group has also started supplies of its COVID-19 vaccine ZyCoV-D, to the government of India from its Zydus Vaccine Technology Excellence Centre at the Zydus Biotech Park in Changodar, Ahmedabad. The group is also planning to make the vaccine available in the private market. ZyCoV-D is a three-dose vaccine administered intradermally using the painless PharmaJet needle-free system, Tropis, on day zero, day 28 and day 56, the statement concluded.