On May 2, 2023, Laurus Labs announced that it has received provisional FDA approval for the world's first pediatric ARV (antiretroviral) oral membrane (ODF) drugs, dolutegr**IR (dolutegravir) 5mg and 10mg for **HIV AIDS. This innovative pediatric drug delivery via orodispersible membrane technology developed by Laurus Labs will simplify the dosing process in children, which will help bring significant benefits to antiretroviral adherence in pediatric HIV**. Laurus Labs is also the first generic drug company to be approved for the fixed-dose combination of abacavir dolutegravir lamivudine 600 50 300 mg for second-line use in adult HIV patients.
Commenting on the FDA's approval, Dr. Satyarayana Ch**a, Founder and CEO of Laurus Labs, said, "We are pleased to have received FDA approval for the world's first pediatric antiretroviral drugs, dolutegr**ir 5mg and 10mg orolytic membranes. This option will facilitate strict adherence and adherence to HIV** and benefit caregivers. ”
Company Overview
Yaorong Cloud Data wwwpharnexcloud.com monitoring revealed: Dr. Satyarayana Ch**aFounded Laurus Labs in 2005Prior to founding the company, Dr. Ch**A spent 10 years in the pharmaceutical industry as CTO of Matrix Labs (2006** to Mylan, a U.S. pharmaceutical company). Through its outstanding leadership skills, Laurus Labs has been awarded the ...... of Most Promising Companies in 2021 at the CNBC-TV18 India Business Leaders AwardsV., Executive Director and Chief Financial Officer of Laurus Labsv.R**i Kumar said that he has known Dr. Ch**A for almost 30 years, and in the five years from 2017 to 2021, the company's turnover has doubled and its profit has increased by 36 times, the company is very promising under its leadership. Under Dr. Ch**A's leadership, the company has become a leading API** provider in the antiretroviral (ARV) space, with 1 in 3 people living with HIV in emerging countries taking medicines using its API, in addition to 9 of the world's top 10 pharmaceutical companies being its customers.
Currently, Laurus Labs manufactures and markets products in four key areas – generic active ingredients (APIs), generic finished drug formulations (FDFs), synthesis (contract development and manufacturing services, and specialty ingredients) and recombinant proteins. In addition to focusing on generic drug ingredients, the company also sells its own proprietary drugs, bringing cost-effective generic alternatives to the global market, with a major market share in HIV, oncology and hepatitis C.
At the end of 2020, Laurus Labs acquired Richcore Lifesciences 725% stake, adding a new business unit. In 2021 and 2023, it has invested in Immunoact, and has invested more than 9Rs 400 million ($11.28 million, $1.)00 USD = 83INR 33, based on the exchange rate below) and further enhance the GMP facility to serve more patients. The combination of ImmunoAct's R&D pipeline, technology, and Laurus Labs' support in building manufacturing capabilities accelerates its pursuit of next-generation innovation in cellular** and new drug discovery. In October 2023, ImmunoACT launched NEXCAR19, India's first locally developed CAR-T cell** product, for adult patients with *** or refractory B-cell lymphoma and leukemia. The product has demonstrated a favorable safety profile and efficacy in clinical trials, with significant improvements over other commercially approved CD19-directed CAR-T cells**, and is expected to bring an affordable** option to India and resource-constrained countries.
Four main business units
Rich product pipeline
Since its inception, Laurus Labs has followed a "research-first" approach, investing in R&D to develop difficult-to-manufacture products in a cost-effective manner across multiple segments of the small molecule market segment, including formulations and APIs, with the aim of driving market leadership and providing sustainable solutions to partners. The following is a list of some of the products that can be used:
Source: Pharmaoffer
To date, Laurus Labs has submitted more than 130 applications worldwide and is accelerating the filing of high-growth** products such as anti-diabetic, cardiovascular, and central nervous systemand has established a strong and extensive customer base in the CDMO business in the United States, the European Union and JapanThere are more than 60 active projects, including Phase I, Phase II, and III clinical investigational products and CMOs (Contract Processing Outsourcing);There are 4 APIs and multiple intermediates in more than 10 commercial projects. The following is a summary of the number of R&D pipelines in the United States and the European Union as of September 30, 2023:
Business Units
Laurus Labs currently has four business units: FDF, APIS, CDMO Synthesis and Bio, and the company's business expansion has been aimed at expanding the business unit and finding sustainable ways to develop, expand and strengthen existing relationships. With the initial success of the antiretroviral drug substance business, Laurus Labs has developed its capabilities in oncology and other ** and has become an established API company, entering the formulation space to become an integrated pharmaceutical company, the company will continue to have full confidence in the CDMO division and has made significant investments in the CDMO divisions Laurus Synthesis and Laurus Bio.
The Generics segment, which contributes approximately 62% to revenue, is the primary revenue of Laurus Labs**, and its products and services include the antiretroviral (ARV), antidiabetic, cardiovascular, proton pump inhibitor (PPI) and central nervous system (CNS) areasAt the same time, the company also leverages the core competitiveness it has accumulated over the years to develop and sustainably expand projects in the field of small molecule CDMO business and nutraceutical raw materials, strive to expand pipeline projects with overseas small and medium-sized innovative drug companies, and develop relationships with large pharmaceutical companies. The CDMO Synthesis segment's products and services include commercial-scale contract manufacturing, clinical-stage supplies, analytical and research services, as well as nutraceuticals, dietary supplements, and cosmeceuticalsFinally, the Bio division provides in-depth fermentation product development and manufacturing expertise, supporting customers at every step of the microbial precision fermentation value chain, from clone development, strain engineering, process development and scale-up to large-scale commercial production.
Global footprint and recent results
Laurus Labs is expanding its footprint in high-growth markets such as Latin America, the United States, Canada, and Europe, and the following is the company's global distribution and the percentage of revenue revenue by region in the previous year
Financials
Yaorong Cloud Data wwwpharnexcloud.com monitoring shows: from 2018 to fiscal year 2023 (2022.)04.01-2023.03.31) shows that each business unit has maintained a different rate of growth. Despite the challenges in FY2023, the company achieved significant growth in both revenue and profit. Operating income from 493Rs 600 million (5.)$9.2 billion) to 604Rs 100 million（7.$2.5 billion)., an increase of 224%；ebidtaFrom 143Rs 600 million ($172 million) grew to 159Rs 400 million (1.)$9.1 billion), despite EBIDTA margins of 264%, but the margin was slightly lower than the previous year's 291%, however, the CDMO CMO product significantly offset the margin pressure in the ARV segment. Due to the increase in ebidta, the profit before tax also increased from 108400 million (1.)$3 billion) increased slightly to 110900 million (1.)$3.3 billion). However, the profit after tax increased from 82Rs 800 million ($99.36 million) fell to 79Rs 900 million($95.86 million)., mainly due to an effective tax rate of 282%, up from 23 last year2%。As companies transition to the new tax regime, the effective tax rate is expected to remain at 2517%。
The first half of fiscal year 2024 (2023.)04.01-2023.09.30) Income 240Rs 600 million (2.)$8.9 billion), down 23% compared to the same period last yearDriven by particularly strong CDMO Synthesis revenue in the base year, partially offset by improved performance in the API and FDF segments;Basic income grew by 14 percentExcludes large purchase orders**Gross margin was 516%, down 470 basis points from the same period last yearThis is due to the change in the share of each business segment;Earnings before interest, taxes, depreciation and amortization (EBITDA) was 35Rs 600 million ($42.72 million),This represents a decrease of 61% compared to the same period last yearNet profit was 6200 million rupees ($7.44 million).
By segment, the year-over-year recovery in the FDF segment's antiretroviral business in the second quarter drove 24% growth in the first half of the year and continued to track underlying demand for health;Sales growth in developed markets was driven by higher volume growth and stable pricing, with additional products to be launched in the coming period. Strong deliveries in the APIS segment's stable antiretroviral drug ingredients and oncology businesses, which increased by 51%, compensated for declines in other APIs (-24%);The continued advantage of the diversification of the global ** chain, and the optimistic demand for CMO opportunities. The CDMO Synthesis segment declined due to the execution of a large number of purchase orders in the previous year;The first agrochemical ** contract was signed in the first quarter and the manufacturing plant will be ready within 15 to 18 monthsCommercial validation of the Animal Health Center's products will begin in the second half of the yearThe R&D site will be ready by March 2024. The Bio segment achieved record growth of 56%, driven by CDMO services;Biocatalysis expertise is enhanced in selected small molecule projects. Here's what revenue was in place by business segment in the first half of FY24:
FY24 will be a year of consolidation, with key priorities for the second half of the year being improving capacity utilization across the network to support growth acceleration, expanding new animal health commercial assets, and continuous improvement programs.
Reference:
nmpa/cde；
Yaorong Cloud Data wwwpharnexcloud.com；
fda/ema/pmda；
Public disclosure by the relevant company;
Wait a minute.