Amarin Corp Plc (AMRN)

[TalShu]

Studythosestocks
Thank you for your comments. May I in turn ask you to re-read that part of Amarin’s August 3, 2022 Press release regarding its INTERNATIONAL business development.

QUOTE:
PRESS RELEASE
AMARIN REPORTS SECOND QUARTER 2022 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
August 3, 2022 at 7:00 AM EDT


International
Amarin continues to gain traction with its goal to unlock the potential of VASCEPA internationally. The company is in the process of filing regulatory submissions for approval of VASCEPA in 20 additional countries to ensure that patients in the top 50 cardiometabolic markets worldwide can benefit from VASCEPA. In addition, Amarin continues to make meaningful progress in these efforts with our partners.
Amarin received acceptances of the regulatory reviews of VASCEPA market authorization submissions in Australia and New Zealand, with the filings advancing as per local protocols.
In Canada, HLS Therapeutics, Inc. completed negotiations with Canada’s pan-Canadian Pharmaceutical Alliance (pCPA) for the terms and conditions under which VASCEPA would qualify for public market reimbursement in Canada and has received approval from the provinces of Quebec, Ontario, New Brunswick and Northwest Territories, Saskatchewan, as well as the NIHB program for First Nations and Inuit peoples, expanding reimbursement of VASCEPA across the country.
Biologix, Amarin’s partner in the Middle East and North Africa (MENA), received the official registration certificate for VASCEPA from the Kingdom of Saudi Arabia (KSA) regulatory authority for the treatment of severe hypertriglyceridemia. This first approval in KSA enables the preparation and submission of a variation to seek review and approval for the CV risk reduction indication.
Eddingpharm (Asia) Macao Commercial Offshore Limited (Edding), Amarin’s partner in China, received approval for VASCEPA in Hong Kong and is planning for commercial launch by the end of the year. In addition, Edding continues to expect to receive approval for VASCEPA in Mainland China this year.
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NOTA BENE:

1) Point (3) above clearly says “Biologix ….. RECEIVED the official REGISTRATION CERTIFICATE for Vascepa ….” In my post I wrote: “Checking the Human Drugs List of the Saudi Food and Drug Authority (https://www.sfda.gov.sa/en/drugs-list) I found no registration number and mention of Vascepa, Vazkepa or Icosepent ethyl in it.” And “To double check, I contacted Nahdi S.A. – the largest pharmaceutical chain in Saudi Arabia – through their on-line service (https://www.nahdionline.com/en/) and within one minute a pharmacist was talking to me. After checking his data base on his computer, he informed me that Vascepa is NOT AVAILABLE in the entire Kingdom of Saudi Arabia.”

2) Point (4) above asserts “(Edding), Amarin’s partner in China, RECEIVED APPROVAL for VASCEPA in Hong Kong” – a point you clarified in a later post based on a Q10 report submitted to SEC on February 23,2022 – and launch is expected before year’s end. Unfortunately, no reimbursement price was announced.

3) Slide (6) of 2022 Q3 presentation informs us the first wave of international expansion in 2022 includes SIX countries and that the expansion (understand approval) was “ACHIEVED in Hong Kong, Saudi Arabia and Bahrain; Additional markets pending include Australia, New Zealand. On the bottom of the page, a “Note” written in a hardly readable font size reads: “The company is pursuing expansion into these various additional markets and the status of regulatory/or approval will vary market to market”.

4) Why was the sixth country (Israel) omitted from the Slide?

5) The 2nd Wave 2023 and 3rd Wave 2024 will include up to 9 and 5 unidentified countries respectively. Where does China fit? Approval was “anticipated” in early 2021 for the end of that year. Let us take the best-case scenario: approval is announced today. Questions then follow: when will a reimbursement price agreement be reached (in 6, 12, 24 etcetera months)? Will that price be aligned with UK and EU? If lower because of the population size, what will impede Chinese on-line pharmacies from invading Europe? Maybe a Hong Kong price tag would have enlightened us on these issues. Alas that’s not the case.

6) Noteworthy here is that Amarin’s strategy does not focus on the most viable markets first, going down to the least important in terms of population size and per capita income. Instead, it has started with very tiny (insignificant) Hong Kong and Bahraini markets in 2022. While Saudi Arabia’s total estimated population is about 36 million and is endowed with financial resources, 38% are mostly poor emigrants from India and South East Asia. As to the local population, its age structure is such that only 10% are above 55 years of age. Taking into consideration the correlation between age and cardiovascular events, the Prospective Urban Rural Epidemiology study (PURE-Saudi) report on the “Demographic, behavioral, and cardiovascular disease risk factors in the Saudi population” (published on August 8, 2020) concluded that:

“The results of the PURE-Saudi study revealed a high prevalence of unhealthy lifestyle and CVD risk factors in the adult Saudi population, with higher rates in rural vs urban areas. National public awareness programs and multi-faceted healthcare policy changes are urgently needed to reduce the future burden of CVD risk and mortality.” This implies that Vascepa would be an appropriate sizable medication for Saudis in a generation or two.

7) What do we know about our two private partners Biologix and Edingpharm: their management, financial and human capabilities … ? HLS Canada distinguishes itself neatly in this regard.

8) Hope you would agree with me that only a Big Pharma can save Vascepa and poatients. Amarin deserves credit for developing it but is too small to handle it. And a strategy of cutting expenses to show cash positive status cannot hold the road. What are needed are sales and revenues namely in the aging (population) North American, European and Chinese markets.

9) Finally, it is worthwhile noting that India is never mentioned by Amarin or any poster as well.