Mitanshu Shah
Senior Vice President, Finance
Alembic Pharmaceuticals Ltd
Mitanshu Shah talks about the overview of the Pharma industry and major challenges in US market. He also spoke about the product launches and revenue guidance going ahead.
The sequential moderation in price erosion in USA will help the pharmaceutical industry and new product launches will drive growth domestic as well as internationally. The margins in pharma space are back on track.
The US business continues to remain challenging on account of competitive intensity. Despite difficult US market scenario and some delay in commercialisation of new plants, we still did managed to grow our volume by 18% in last financial year in US. Generating healthy earnings is becoming difficult in US market, if you consider that large portion of R&D is attributable to US business. We are focusing on complex / speciality products to protect from price pressure
India Branded Business continues to outperform the market especially on focused products / therapeutic segments. Clubbed with growth in Rest of the World (RoW) and API business, we are looking for good numbers going ahead. We have started commercialization of products from our injectable and oncology facilities. We believe we have created niche capabilities to capture future opportunities in International markets. We already have strong balance sheet and if needed can be leveraged for growth.
We commercialized F2 and F3 plants during the quarter. United States Food and Drug Administration (USFDA) conducted an inspection at the company’s Injectable and Ophthalmic Facility (F-3) located at Karkhadi from 16th March, 2023 to 24th March, 2023. The USFDA issued a Form 483 with 2 minor procedural observations. The Company is committed to maintain the highest quality standards and compliance at all times. All our plants are FDA approved and there is no regulatory overhangs.
The company has received 7 ANDA approvals and we filed 4 ANDAs during the quarter. We are planning to launch 20-25 products in FY24 in the US market and are confident of growth going ahead. We have cumulative 245 + ANDA filing in USA now.
It was a muted quarter. The sales were flat at Rs. 1406 crore and large portion of this was attributable to US de-growth. For the quarter ended 31st March, 2023, the company’s net sales for the quarter was at Rs.1406 crores, while net profit for the quarter was at Rs.153 crores. The company met its entire capex, as well as the dividend payment out of its internal accruals. The cash flow for the company continues to remain robust. The launches in US from new and existing facilities will drive growth in upcoming quarters in US.Going ahead, we are eyeing growth in Rest of the World (RoW) markets of 10-12% and branded business to grow 12-13%. API business also expect to grow at 12% in FY24.
India Branded Business recorded 9% growth with top-line of Rs 490 crores for Q4 FY23, while Specialty segment grew 13%. The growth in specialty segment was driven by gynaecology, cardiology, anti-Diabetic, ophthalmology. The new product launches as well as dossier extensions are on track to accelerate growth. Our veterinary business also saw growth of 21% in quarter. This business is becoming valuable growth driver for us.
The strong momentum delivering growth of 24% on annualized basis, largely led by high off-take and better product mix for FY23. Our API business grew 41% at Rs. 313 crores in this quarter, backed by strong order book. We are eyeing 12-15% growth in API business in FY24.
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