Business
JM | Nov 5, 2020

Indies Pharma making moves into United States markets

/ Our Today

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American expansion push being financed by recent successful $805-million private placement

Indies Pharma’s selected target market in the United States is estimated to be worth some US$740 million of a U.S. total pharmaceutical market that earned some US$490 billion in 2019.

By Durrant Pate

Listed Jamaican pharmaceutical company Indies Pharma is pressing ahead with plans for expansion into niche areas of the United States (U.S.) pharmaceutical market for select generic drugs.

This push to penetrate the American market is taking place despite the global business downturn caused by the coronavirus pandemic and the challenge being faced locally by Indies Pharma arising from the global pandemic. The selected target market in the U.S. is estimated to be worth some US$740 million of a U.S. total pharmaceutical market that earned some US$490 billion in 2019 and is estimated to account for about 48 per cent of the global pharma market.

CREATING OPPORTUNITIES FROM COVID-19

Rather than being daunted, Indies Pharma chief executive officer, Dr. Guna Muppuri says the pandemic is creating market penetration opportunities in the global pharmaceutical trade and healthcare segments. To capitalise on the market expansion opportunities, the Montego Bay-based pharmaceutical company recently raised $805 million on the local capital market through a private placement arranged by Sagicor Investments Limited.

Dr Guna Muppuri, chief executive officer of Indies Pharma. (Photo: Contributed)

The money is utilised as growth funds. Some $400 million of the growth funds has been invested into acquiring three acres of prime real estate along the North Coast Highway at Ironshore, part of the so-called ‘Elegant Corridor’ in the second city, where Indies Pharma will be headquartered.

The acquired land is located at the start point of the planned development road for the city, adding a valuable tangible asset to the company. This real estate is expected to be developed into a multipurpose facility including a new state-of-the-art headquarters building and warehousing for Indies Pharma.

Completion of the real estate development is slated for 2023 falling in line with the third anniversary of the successful bond issue. Approximately $405 million of the bond financing is being invested in intellectual property assets for Indies Pharma – specifically the development of two generic drugs and their submission for approval by the United States Food and Drug Administration (USFDA).

COMMERCIALISING TWO GENERIC DRUGS

The company will file an Abbreviated New Drug Application (ANDA) for US market approval in 2021 with approval expected by 2023, at which time Indies Pharma will be launched in the US market.

“We are willing to take carefully calculated risks looking beyond the horizon for global opportunities and are not daunted by the COVID-19 threat.”

DR. GUNA MUPPURI, Indies Pharma chief executive officer

Muppuri says this timeline gives Indies Pharma two years’ lead ahead of the bond maturity date in 2025 to realise revenues from the commercialisation of its generic drugs in the U.S. market.

There are also other commercialisation plans in the pipeline. Once approvals are obtained for the U.S. market, the company intends to explore the opportunity to out-license its intellectual property – drug development technology – to other global markets for a fee, profit share or through royalty arrangements.

“Indies Pharma is keen to make the most of the global opportunities. We are willing to take carefully calculated risks looking beyond the horizon for global opportunities and are not daunted by the COVID-19 threat,” Muppuri said.

TARGETING THE AMERICAN MARKET

The Indies Pharma CEO said the Jamaican company is looking to gain some five per cent of the targeted U.S. market share of approximately US$740 million from its ANDAs. This would translate to US$37 million or approximately J$5.4 billion per year in new annual earnings. Indies Pharma earned $729.4 million in 2019.

The development of the two drugs will give the company access to the U.S. market through the growing demand for generic drugs. This will allow Indies Pharma further reach outside of Jamaica while allowing the business to carve out a sizeable share and presence in one of the world’s most highly regulated and lucrative market. 

“With our planned entry into the U.S. market, Indies Pharma would also be assisting patients in that large market to access medicines at an affordable cost, which is the company’s mission,” Muppuri stated. The U.S. has consistently ranked as the top pharmaceutical market and is projected to maintain the top market position for several years to come.

Drug shortages and supply chain disruptions caused by the pandemic are creating particular advantages for companies, like Indies Pharma, that can maintain high production standards and keep their production and supply infrastructure intact to plug important market gaps. More than a year ago, the majority shareholding entity of Indies Pharma, Bioprist Group, successfully conducted a thorough research of the U.S. market.

Its bold move towards U.S. market entry is backed by the strength of its drug research and development partners in India. After successfully developing its drug formulations earlier this year, Indies Pharma has engaged a U.S.-based manufacturing partner and transferred the drug technology to produce the first exhibit batch of the finished formulations.

The two drug formulations are expected to be ready by the March 2021 for further testing and the full dossiers being filed in the third quarter of 2021 for final USFDA approval. The expected wait time for final approvals is two years which falls in line with the target date of third quarter of 2023 for the first commercial sale of the products on the US market.

Indies Pharma intends to develop additional generic drugs for approval for the U.S. market over the next three years targeting in excess of a US$3 billion block of the multibillion generic pharmaceuticals market and has investment plans for 20 drug approvals at a cost of approximately US$40 million.

INDIES PHARMA HAS BIG NINE-MONTH FINANCIAL PERFORMANCE

In the nine months to July this year Indies Pharma achieved a 35 per cent growth in net profits over the same period in 2019 surpassing the entire prior year profits in three quarters. The Indies Pharma CEO says the company was aiming to close the current fiscal year ending October 2020, with modest increase in net profits despite the anticipated negative impact of one-off costs arising from expired goods at hand and expenses arising from the recent bond issue.

Tara Nunes, general manager of Sagicor Investments Jamaica, says the finance house is proud to have assisted Indies Pharma in its next growth phase through the arrangement of the corporate bond.

According to Nunes: “We are in full support of the work Indies Pharma is doing and see this phase as a natural progression for the Jamaican company. This corporate bond raise fits perfectly with our initiatives and is another example of Sagicor Investments’ commitment to assist in the development of the economic capacity of the country while providing Jamaican businesses and citizens with the means to create, grow and preserve their wealth.” 

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