Believes OPKO Should Promptly Distribute FDA-Reviewed Rayaldee to Help Treat COVID-19 in the U.S. and Europe
Highlights the Opportunity Being Squandered by Dr. Frost and the Board as Europe Prepares to Distribute 10 Million Doses of a Less Effective Alternative to Rayaldee
NEW YORK, Nov. 20, 2020 (GLOBE NEWSWIRE) -- Sian Capital, LLC (together with its affiliates, “Sian” or “we”), a sizable stockholder with beneficial ownership of approximately 3% of OPKO Health, Inc.'s (NASDAQ: OPK) (“OPKO” or the “Company”) outstanding common stock, today sent a letter to OPKO’s Board of Directors highlighting the urgent need for the Company to act swiftly to distribute Rayaldee – an effective drug shown to help treat COVID-19 – across the U.S. and Europe.
Over the past week, we have had conversations with members of the United States Congress, those living in European countries, and the world’s foremost infectious disease specialists. We look forward to sharing more information regarding how you can encourage your Congressperson to help your loved ones. In the meantime, visit www.SianCapital.com/Resources to learn more about OPKO and Rayaldee.
The full text of the letter is included below.
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VIA E-MAIL
November 20, 2020
The Board of Directors
OPKO Health, Inc.
4400 Biscayne Blvd.
Miami, Florida 33137
Dear Chairman Frost and Members of the Board of Directors (the “Board”):
As of this week, a quarter of a million people have died in the U.S. from COVID-19. New York City is closing public schools amid rising cases, hospitals and first responders across the country are overwhelmed with sick patients, and experts predict that the U.S. could soon be reporting more than 2,000 deaths per day – matching or exceeding our spring peak.1 As Dr. Anthony Fauci recently commented, “we are in for a world of hurt.”
With more than 11.5 million confirmed cases in the U.S., we find our entire nation focused on a singular question: when will we be able to effectively treat patients with the deadly virus?
Sian Capital, LLC (together with its affiliates, “Sian” or “we”) was extremely dismayed to learn that OPKO Health, Inc. (“OPKO” or the “Company”) has a viable solution at its fingertips, yet for reasons unclear to us, has withheld its science from millions of afflicted citizens in the U.S. and abroad. As a substantial investor in OPKO, we believe the Board has not only a fiduciary duty, but a humanitarian duty to distribute Rayaldee to those in need. There is no reason that so many Americans should continue dying without having the opportunity to access potential curative drugs. In this letter, we outline how Rayaldee could save countless lives while also unlocking tremendous revenues for OPKO right away.
How Rayaldee Could Save Countless Lives Amidst the COVID-19 Pandemic
As early as 2008 and as recently as 2016, leading scientists predicted that our population’s widespread deficiency in vitamin D could lead to a global pandemic. There is growing evidence today that COVID-19 patients who are deficient in vitamin D are more likely to experience serious illness, severe complications and increased risk of death. Unfortunately, raising your vitamin D levels is not as easy as taking over-the-counter supplements from your local drug store.
Instead, evidence shows we can fight and prevent COVID-19 through the administration of a vitamin D prohormone, Calcifediol, which naturally interacts with the body to create the necessary levels of pure 25(OH)D serums. Calcifediol is the active ingredient in OPKO’s homegrown drug Rayaldee, which is typically used to treat Chronic Kidney Disease. When treating patients afflicted with both Chronic Kidney Disease and COVID-19, it was discovered that Rayaldee was fighting the virus, as well. This discovery and additional anecdotal evidence led the Food and Drug Administration (“FDA”) to give Rayaldee a high safety indication and fast-track Rayaldee’s phase 2 trial on June 1, 2020 for treatment of mild to moderate COVID-19.2 The FDA required only a 4-week trial and 160 participants to be treated with the drug, in stark contrast to Pfizer’s vaccine trial, which required nearly 45,000 participants. Further, the FDA required that just two primary endpoints be met to pass the trial: 1) Rayaldee raise 25(OH)D levels to between 50ng/ML and 100 ng/ML, and 2) Rayaldee outperform the placebo group.
Rayaldee quickly proved to be effective, with treatment indicating that a daily dose of 60 mcg of Rayaldee is the only one of the four treatment regimens tested that reliably raises 25(OH)D serum totals to the range of 50 to 100 ng/ML passing the first FDA endpoint. In a separate simultaneous trial in Spain, patients in the Calcifediol (Rayaldee) group had a 96% effectiveness rate, with just 2% of patients hospitalized with zero fatalities – compared to those in the placebo group where 50% were hospitalized with a death rate of 7.7%.3
In spite of Rayaldee’s encouraging trial evidence and the highest safety indication the FDA can give, OPKO’s Board and management team are seemingly withholding this effective drug from the U.S. and European populace. Because Calcifediol is an American drug owned by OPKO, both U.S. and European governments cannot utilize Rayaldee unless OPKO sells it to them.4 This is especially troubling given that our European neighbors have already passed legislation requiring the distribution of ~15 million doses of a crude, less effective alternative to Rayaldee, in an attempt to replicate Rayaldee’s protective benefits, to millions of their most vulnerable populations next month. It is well known that the elderly, the sick and those in nursing homes are disproportionately dying at high mortality rates. We believe European countries would likely administer many prescriptions if OPKO were to offer Rayaldee to them instead of obfuscating its benefits and failing to reach out to England, Scotland and many other countries who have already approved millions of doses.
With over 1.34 million deaths globally and the death toll steadily rising, we question what could possibly motivate OPKO to sit on science that could potentially save so many lives?
How OPKO Could Unlock Significant Value for Shareholders by Distributing Rayaldee
It is painfully obvious to Sian that in addition to disregarding its ability to save lives, OPKO is squandering an incredible value opportunity by withholding Rayaldee. In 2019, OPKO sold only ~55,000 scripts of Rayaldee for ~$30 million. If OPKO allowed European countries to purchase the already approved ~15 million doses, even at a 90% discount to its selling price, OPKO could receive over $850 million. Much more importantly, at the current death rate, it could save 100,000 lives over the four-month program enacted by European countries.
Despite the current dysfunction of our political climate, it’s our view that the U.S. should follow Europe’s lead by ordering doses for 12 million of our most vulnerable citizens. Though just 1% of U.S. citizens live in nursing homes, nursing home deaths account for over 20% of our daily death rates. We believe OPKO should similarly discount its selling price of Rayaldee by 90%, which could unlock $3 billion in value and save tens of thousands of American lives.
Beyond selling Rayaldee to the U.S. government, we believe OPKO has a humanitarian duty to distribute Rayaldee across the pond, where a European citizen is dying every 17 seconds from COVID-19.5 When lending assistance to the Europeans during World War II, FDR famously said that when your neighbor’s house is on fire, you don’t haggle over the price of a garden hose. Putting aside economics, from a humanitarian perspective, it is apparent to us that OPKO should move quickly to distribute its valuable drug on an international scale, even if it is at an 90% discount.
Over the last few weeks, the governments of England, Spain, Scotland, Wales and Ireland have all committed to helping their most vulnerable, citing studies that indicate Rayaldee is the best way to do that. We urge you to share one of the only drugs that appears to help treat COVID-19. We believe you have a humanitarian and fiduciary duty to do so.
“If there's a child on the south side of Chicago who can't read, that matters to me, even if it's not my child. If there's a senior citizen somewhere who can't pay for their prescription, who has to choose between medicine and the rent, that makes my life poorer - even if it's not my grandparent. If there's an Arab-American or Mexican-American family being rounded up by John Ashcroft without benefit of an attorney or due process, I know that that threatens my civil liberties. And I don't have to be a woman to be concerned that the Supreme Court is trying to take away a woman's right, because I know that my rights are next. It is that fundamental belief - I am my brother’s keeper, I am my sister’s keeper - that makes this country work.”
-- Barack Obama, 2004
Sincerely,
Anish Monga
Sian Capital LLC
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About Sian Capital
Founded by veteran portfolio manager Anish Monga, Sian Capital, LLC is a New York-based asset management firm that employs a focused, event-driven investment approach. Sian’s unique mix of cross-sector experience and activism expertise enables it to identify and invest in what are often overlooked or under-covered investment opportunities.
Contacts
Profile
Greg Marose / Charlotte Kiaie
gmarose@profileadvisors.com / ckiaie@profileadvisors.com
1 The New York Times: A quarter of a million people have died in the U.S. from Covid-19. (November 19, 2020).
2 https://www.opko.com/investors/news-events/press-releases/detail/394/fda-authorizes-opko-health-clinical-trial-evaluating.
3 Journal of Steroid Biochemistry and Molecular Biology; The Guardian: Covid: UK government requests guidance on vitamin D use (November 14, 2020).
4 To be clear, we are not implying that Vifor Pharma (SWX: VIFN), the holder of the license to sell Rayaldee in Europe in exchange for royalties to OPKO, has not already begun negotiations with these European countries. Our letter references only OPKO, who ultimately makes the decision, regardless if Vifor were (hypothetically) negotiating with these countries.
5 The Washington Post: Someone in Europe is dying every 17 seconds from covid-19, WHO says (November 19, 2020).