Alkem Laboratories Limited , a leading Indian pharmaceutical company, has made a significant move in the gut health management sector by launching DSS, the original De Simone formulation probiotic blend, in India. This strategic entry into the prescription probiotic market, valued at approximately INR 2,071 crore, marks Alkem's commitment to addressing the growing demand for gut health solutions in the country.

Product Details

DSS, developed by Prof. Claudio De Simone, is a proprietary probiotic blend that combines eight carefully selected bacterial strains. These strains work synergistically to restore gut microbiota balance and manage various gastrointestinal conditions. The product's launch in India comes with four different strengths, catering to a wide range of patient needs:

Alkem is the first company in India to offer all four strengths of this probiotic, with exclusive marketing rights for the 225 billion CFU and 10 billion CFU variants.

Clinical Backing and Indications

The De Simone formulation is recognized as one of the world's most extensively researched probiotics, supported by over 80 clinical trials and 200 publications spanning two decades. It has received endorsements from leading American and European gastroenterology associations for managing gastrointestinal disorders.

DSS is indicated for various conditions, including:

• Irritable Bowel Syndrome (IBS)
• Ulcerative Colitis (UC)
• Pouchitis
• Hepatic Encephalopathy (HE)
• Non-Alcoholic Fatty Liver Disease (NAFLD)
• Cirrhosis
• Bacterial Vaginosis (BV)
• Antibiotic-Associated Diarrhea (AAD)

Additionally, it is recommended for supplementation during pregnancy and lactation.

Market Outlook

The Indian prescription probiotic market has shown significant growth, with a five-year Compound Annual Growth Rate (CAGR) of approximately 14%. This growth is driven by increasing consumer awareness and a rising prevalence of lifestyle-related digestive issues.

Dr. Vikas Gupta, Chief Executive Officer of Alkem, emphasized the strategic importance of this launch, stating, "The launch of DSS, a globally-trusted, high-potent, multi-strain probiotic, is a strategic addition to our comprehensive product portfolio in the gastrointestinal segment, and underscores our commitment to making innovative and evidence-based health solutions accessible to Indian patients."

As Alkem Laboratories continues to expand its portfolio in chronic therapies, including gastrointestinal health, the launch of DSS represents a significant step in addressing the growing need for effective gut health management solutions in India.

Alkem Laboratories , a leading Indian pharmaceutical company, has reported robust financial results for the second quarter, showcasing strong growth across its key markets.

Key Financial Highlights

• Total revenue from operations reached an all-time high of INR 40,010.00 million, marking a 17.2% year-on-year growth.
• EBITDA grew by 22.3% year-on-year to INR 9,208.00 million, resulting in an EBITDA margin of 23%.
• Net profit after minority interest stood at INR 7,651.00 million, representing an 11.1% year-on-year increase.

Market Performance

Alkem Laboratories demonstrated impressive performance across various segments:

Domestic Market Leadership

The company has achieved notable milestones in the Indian pharmaceutical market:

• Became the number one player in India's acute segment
• Outperformed the Indian Pharmaceutical Market (IPM) in 6 out of 11 therapies
• Demonstrated strong growth in key therapeutic areas:
  • Anti-infectives: 1.2x market growth
  • Gastrointestinal: 3.1x market growth
  • Vitamins, Minerals, and Nutrients (VMN): 2.5x market growth
  • Pain management: 2.3x market growth
  • Respiratory: 1.5x market growth
  • Dermatology: 3.1x market growth

R&D Investment and New Product Launches

Alkem Laboratories continues to focus on innovation and new product development:

• R&D expenses for the quarter were INR 1,302.00 million, representing 3.3% of total revenue
• The company ranks second in the IPM for new product launches in the last 12 months

U.S. Market Developments

The company's U.S. business saw significant growth, driven by new product launches:

• Sacubitril/valsartan launch contributed substantially to U.S. market growth
• Four new product launches in the first half of the fiscal year, with three to four more planned for the second half
• Expecting low double-digit growth (10-11%) in the U.S. market for the full fiscal year

Future Outlook

Alkem Laboratories remains optimistic about its future performance:

• Expects to maintain EBITDA margins between 19.5% to 20% for the full year
• Aims to continue outperforming the Indian pharmaceutical market by 100 to 150 basis points
• Focusing on maximizing output from its newly operational U.S. CDMO plant, with potential for further expansion based on market opportunities

Recent Regulatory Development

The company recently received a GST demand order from the Assistant Commissioner, Division-VIII, Ankleshwar, Central GST and Central Excise, Vadodara-II Commissionerate:

• The order demands GST of INR 180.87 million along with an equal amount as penalty for the period FY2018-2019 to FY2024-2025
• Alkem Laboratories does not agree with the demand order and plans to contest it
• The company states that there is no material impact on its financial, operational, or other activities

Alkem Laboratories' strong performance across key markets, coupled with its focus on innovation and market leadership, positions the company well for continued growth in the pharmaceutical sector. The management remains confident in its ability to navigate challenges and capitalize on emerging opportunities in both domestic and international markets.