Q1FY25 results: Gland Pharma Limited on Tuesday announced its financial results for the first quarter (Q1FY25) ended on June 30th, 2024. The company’s consolidated revenue surged 16 percent YoY to Rs. 1401.7 crore.
According to the company’s statement, its consolidated EBITDA decreased 11 percent YoY to Rs. 265.4 crore. The consolidated EBITDA margin was at 19 percent versus 25 percent in Q1FY24.
The base business (ex-Cenexi) revenue grew 14% YoY to Rs. 1013.4 crore, the base business (ex-Cenexi) EBITDA jumped 12% YoY to Rs. 294.1 crore and the base business (ex-Cenexi) EBITDA margin was at 29% versus 30% in Q1FY24.
“We reached Rs. 1401.7 crore in total revenue, a 16% increase from Q1FY24. This growth aligns with our projections and is primarily driven by the US market, which saw a 27% revenue increase led by existing and certain new products. Our base business EBITDA margins were at 29%, and consolidated EBITDA margins for the quarter were 19%, mainly affected by Cenexi. We’re confident in our ability to meet our fiscal year goals and are excited about the growing opportunities and even stronger results expected in the coming quarters,” Srinivas Sadu, Executive Chairman and CEO of Gland Pharma, said.
For the Gland’s business, the R&D expense stood at Rs. 48.9 crore (5% of revenue). With respect to regulatory filings, the company stated that 8 ANDAs filed, and 7 ANDAs approved in Q1FY25.
The total filings were 356 ANDAs in the U.S. (295 approved, 61 pending). Global product registrations were 1,708. Total Capex incurred during the quarter ended June 30th, 2024, was Rs. 63.7 crore.
In the US Market, eight molecules, including Eribulin mesylate, Plerixafor, Nelarabine, and Edaravone, were launched in the market. In the China Market, nine products have been filed to date, of which three have been approved and one has been commercialized.
In complex injectables, six approvals have been received out of 19 molecules under development to date. To accelerate growth, we are exploring acquisitions, in-licensing, and co-development opportunities, it stated.
“Our biologics facility in Genome Valley is attracting advanced-stage interest from multiple players for contract manufacturing of monoclonal antibodies and novel plasma-based proteins. In addition, we are in discussions with a leading biologics company for a potential strategic collaboration. This collaboration could involve large-scale contract manufacturing of key biosimilars, with a possible in-licensing opportunity for Gland in specific markets of interest. Although this discussion is in the early stages, it represents promising avenues for Gland to maximize its value in both CDMO and complex portfolio expansion. We will continue to update you on our progress,” the company said in a statement.
It also informed that the USFDA made two surprise inspections of our manufacturing sites in Hyderabad. The inspections concluded with two and three form 483 observations at Dundigal and Pashamylaram, respectively. “As previously communicated, these observations are procedural and do not affect our compliance status,” it added.
For the Cenexi business, the company revealed that Fontenay Site (Paris, France) is a significant revenue contributor and is showing improved operational performance due to efficiency enhancements, additional shifts, organizational changes, optimized production planning, and maintenance reorganization.
“A new ampoule line will be commissioned in August, with commercial production starting in early 2025. This line is expected to increase capacity, improve customer service, and generate approximately €10 million in revenue in 2025,” the company said.
In its exchange filing, the company also reported that Hérouville Site (Normandy, France) is poised for future growth with new business from technology transfer projects. New aseptic ophthalmic gel line to begin commercial production for a key customer before the end of the year, it added.
Belgium and Osny Sites (France) are on track with business plan expectations.
The company also presented an outlook for Q2FY25 and said that lower activity levels are expected due to the European holiday season and planned summer maintenance shutdowns. The Fontenay plant will have an extended 3-week shutdown for new ampoule line installation.
“We expect positive EBITDA for Q4 of this fiscal year and a positive EBITDA for the next fiscal year, driven by increased revenue exceeding the €200 million threshold,” it added.
