Caplin Point Laboratories Ltd Share Price – NSE  / BSE

Pharmaceuticals, Small Cap

The approved ANDA is a generic therapeutic equivalent version of the reference listed drug (RLD) Durezol, from Sandoz Inc.

Difluprednate Ophthalmic Emulsion (Eye drops) is a topical corticosteroid that is indicated in the treatment of inflammation and pain associated with ocular surgery, and in the treatment of endogenous anterior uveitis.

According to IQVIA (IMS Health), the approved drug had US sales of approximately $21 million for the 12-month period ending October 2024.

“We’re pleased to receive a first cycle approval for this complex emulsion product. Few more emulsion and suspension products have been filed or in the pipeline, which should augment Caplin Steriles’ portfolio in the US and emerging markets”, commented Chairman C.C.Paarthipan.

Caplin Point Laboratories is a fast-growing pharmaceutical company with a unique business model catering predominantly to emerging markets of Latin America and Africa. The company has manufacturing facilities that cater to a complete range of finished dosage forms.

The company’s consolidated net profit grew 14.04% to Rs 130.80 crore on 17.81% increase in revenue from operations to Rs 483.10 crore in Q2 FY25 over Q2 FY24.

The scrip shed 0.56% to currently trade at Rs 2,432.35 on the BSE.

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Caplin Steriles (Caplin), a Subsidiary Company of Caplin Point Laboratories has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Difluprednate Ophthalmic Emulsion, 0.05% (Eye drops), a generic therapeutic equivalent version of the Reference Listed Drug (RLD) DUREZOL, from Sandoz Inc.

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Profit before tax (PBT) increased 15.38% YoY to Rs 168.46 crore in the quarter ended 30 September 2024.

EBITDA stood at Rs 185.53 crore in second quarter of FY25, registering a growth of 17.5% YoY. EBITDA margin improved to 36.8% in Q2 FY25 as against 36.7% posted in same quarter previous fiscal.

The company's Latin America business drove robust growth in both top and bottom lines, with benchmark cash flows.

The growth in Emerging Markets was aided by new product launches in both existing and new markets, across the branded generic and generic segments. The generics segment contributed 75% of the company’s revenue, while the branded generics segment contributed 25%.

The company has filed 23 products in its key target market of Mexico, consisting of both in-house and outsourced products. Dossier compilation and review are ongoing for over 40 products, which are expected to be filed in the next 12-18 months.

In US & regulated markets, Caplin Steriles continued impressive revenue growth, aided by expanded capacity in Phase II and new ANDA launches from ophthalmic line.

Caplin Steriles USA Inc. has received 49 out of 50 state licenses, as the company launches its first 14 products in the US. The products have already been shipped to a 3PL warehouse in the US.

The company said that it has allocated an overall capex budget of approximately over Rs 700 crore for the investment projects, most of which are nearing completion.

The intended capex aims to enhance existing production capacities, widen the product range, and achieve backward integration for a majority of the products. The capex will be financed solely through internal accruals, and the firm will remain net cash positive throughout the process.

As of 30 September 2024, the company's free cash reserves stand at Rs 1,039 crore, and total liquid assets are at Rs 1,984 crore.

C.C. Paarthipan, chairman said, “Consistency and Stability are key factors in the sustainability of any business. When we add our unique business model of taking the road less travelled and catering to the bottom of the pyramid, you have a potent combination. Our relentless focus towards high degree of compliance, supply chain efficiency and robustness in cashflows has led to another strong quarter, driven both by our Emerging Markets business in LatAm and our growing business in the US. We remain confident of keeping up these fundamentals in the years to come.”

Caplin Point Laboratories is a fast-growing pharmaceutical company with a unique business model catering predominantly to emerging markets of Latin America and Africa. The company has manufacturing facilities that cater to a complete range of finished dosage forms.

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Net profit of Caplin Point Laboratories rose 13.87% to Rs 130.80 crore in the quarter ended September 2024 as against Rs 114.87 crore during the previous quarter ended September 2023. Sales rose 17.81% to Rs 483.10 crore in the quarter ended September 2024 as against Rs 410.06 crore during the previous quarter ended September 2023.

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