Indies Pharma looks to earn from FDA-approved drug next year
Following the recent approval of its Regadenoson generic drug by the United States Food and Drug Administration (FDA), Indies Pharma Jamaica Limited, now in advance stages of discussions to finalise distribution agreements, said it is looking to draw down revenues from the product in the new financial year.
“The company is now at an advanced stage of entering into the distribution agreements with the prospective distributor in the United States to realise the revenues from the USFDA approved product within the upcoming fiscal year,” co-founder, executive director and Chief Operating Officer Vishnu V Muppuri said in the recent unaudited fourth quarter performance report to shareholders.
The approval of the drug, which came months earlier than expected, saw the company in August of this year being given the green light to break into the lucrative US market valued at millions. Sales for Regadenoson i9n 2023 were valued at over US$600 million.
The company had previously indicated that it would be engaging the services of about two distribution companies to supply its products throughout the US. With production expected to take up to 90 days or less, the expectation from the company’s directors is to have the product arriving in the United States between November or December
of this year.
The Regadenoson Injection, 0.4 mg/5 mL generic version developed by Indies Pharma can be used to treat heart and other cardiovascular diseases. It is bioequivalent and therapeutically equivalent to the brand name Astellas Pharma US Inc’s Lexiscan. The drug is being manufactured by a company in India.
Looking to recoup funds sourced from the proceeds of a bond raise in 2020, Indies Pharma now on the hunt to push up revenues wants to catapult sales beyond the $1.1 billion mark it secured during its last financial year which ended October 31, 2024.
At the end of that 12-month period, total revenues for the company increased near 10 per cent, amounting to $1.16 billion with an increased net profit of $221 million. For the three-month August to October that corresponds with the companies last quarter of its financial year, revenues were up more than 8 per cent to total $291.7 million with profits for that quarter at $45.5 million in profit — 18.7 per cent above the out-turn of the same quarter in the previous year.
Total assets for the company at the end of the year climbed to $2.3 billion — 2.5 per cent more than that registered in October 2023.
“Shareholder equity was recorded at a value of $ 1.29 billion in the Q4 2023-24 period when compared to $1.22 billion for the similar 2022-23 period, representing an increase of 6.1 per cent. Total liabilities recorded in the current year was also valued at $1.003 billion when compared to $ 1.021 billion in 2023,” the report further noted.