It was a very successful year for the Company’s largest business viz. the US formulations business. During the year, the Company’s largest formulations manufacturing facility located at Moraiya, started receiving approvals for new products for the US market from USFDA, post successful resolution of the warning letter. The Company received approval for 77 new products (including eight tentativeapprovals)fortheUSmarketduringtheyear,whichwas the highest number of approvals received in a single financial year. Launch of mesalamine 1.2 g DR tablets (generic version of Lialda) in July 2017 with 180 days exclusivity was the Company’s first large First to File (FTF) opportunity. The launch of Oseltamivir Powder for oral suspension 6 mg/ml (generic version of Tamiflu) coupled with the strong flu season also boosted the performance of the US business. During the year, the Company moved a step further in its endeavour to build the specialty pipeline in the US as the USFDA granted approval for pitavastatin magnesium tablets, the first product filed through the 505(b)(2) route, which was recently launched in the US as Zypitamag.
On the regulatory front, both the Moraiya and the Topical formulations facilities successfully completed the USFDA inspections twice without any observations. The API facility at Dabhasa also successfully completed the USFDA inspection with no observations. The year turned out to be a challenging one for the Company’s second largest business viz. the India formulations business on account of the nationwide roll out of the Goods and Services Tax (GST) Act with effect from July 1, 2017, resulting in de-stocking of inventories by distributors, thereby impacting the performance of the first quarter adversely.
The Company is the fourth largest pharmaceutical company in India with approximately 8.1% market share in the covered market and is ranked amongst the top three players in the promoted covered market of gynecology, respiratory, pain management, cardiovascular, dermatology and gastrointestinal therapeutic areas. Sixteen of the Company’s brands feature amongst the top 300 pharmaceutical brands in India with five brands having sales of more than `100 crore (Source: AWACS MAT March 2018). During the year, the Company launched 64 new products, including line extensions, of which 10 were first-in-India launches. During the year, the Company successfully launched the acquired brands of Organon (India) Limited and Astra Zeneca, which were acquired during the previous financial year.
During the year, the Company’s business in Brazil faced several challenges mainly in the form of delays in getting new product approvals and price erosion in the existing portfolio. In Mexico, the emergence of the generic generics market impacted the growth of the branded generics market during the year.
The Company intends to expand its presence in the specialty business in the US to counter the challenges of the generics business in the form of increased competition and resultant price erosion and in turn, build a sustainable, high margin business in times to come. The Company undertook its first major initiative to build the specialty business during the previous financial year 2016-17 by acquiring Sentynl Therapeutics Inc., which is a US based pharmaceutical company, specialising in the pain management therapeutic area.
The Company’s APIs and intermediates’ business is the backbone of the Company’s formulations business globally as it ensures uninterrupted supply of the key input materials to the formulations manufacturing plants in a timely and cost efficient manner which in turn, supplies the finished dosage formulations to different customers globally. The Company is also a preferred source of API supplies for various third party customers in India, United States, select markets of Latin America, the Asia Pacific region and Europe. During the year, the Company continued its thrust on cost optimisation by undertaking various initiatives so as to improve the bottom-line and build a sustainable culture of cost efficiency. The Company filed six more DMFs with the USFDA during the year, taking the cumulative number of filings to 133. The Company’s API business posted sales of Rs. 3,656 million during the year, down 4%.
The Company is one of the leading animal healthcare players in India having a portfolio of drugs, vaccines and feed supplements for livestock, poultry and companion animals. During the year, the Company’s business in India got impacted on account of the rollout of GST with effect from July 1, 2017 which impacted the inventory uptake, especially in the rural areas. During the year, the Company created a separate vertical viz. Farm care for greater focus on the farm care health business. The Company expanded the exports business from India as it commenced export of products to four more countries during the year. The Company received nine new marketing authorisations and launched four new products in India during the year. Post the closure of the financial year, in April, 2018, the Company sold its entire stake in Bremer Pharma GmBH, Germany. Overall, the Company’s animal health business posted sales of Rs. 4,426 million during the year, up 11%. On a like-to-like basis, adjusting for GST impact, the growth in sales was 14%.
During the year, Zydus Wellness Ltd.(a subsidiary) registered sales of Rs. 4,920 million, up 7% and net profit of Rs. 1,339 million, up 23%. On a like-to- like basis, adjusting for GST impact, the growth in sales was 16%.