OPK Opko Health Inc.

4.62
-0.25  -5%
Previous Close 4.87
Open 4.8
52 Week Low 1.1171
52 Week High 6.47
Market Cap $3,095,400,111
Shares 670,000,024
Float 400,512,267
Enterprise Value $3,102,698,102
Volume 10,340,041
Av. Daily Volume 9,363,966
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Upcoming Catalysts

Drug Stage Catalyst Date
RAYALDEE
Secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) - Stage 5
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Somatrogon (hGH-CTP)
Children - growth hormone deficiency
Phase 3
Phase 3
Phase 3 trial met primary endpoint - October 8, 2020.
RAYALDEE (REsCue)
Mild-to-moderate COVID-19
Phase 2
Phase 2
Phase 2 trial initiation announced September 15, 2020.
OPK88004
Benign Prostatic Hyperplasia (BPH)
Phase 2b
Phase 2b
Phase 2b trial suspension announced January 31, 2019.
OPK88003
Obesity and diabetes
Phase 2b
Phase 2b
Phase 2b top-line data March 21, 2019 met primary endpoint. Phase 3 trial planned.
Rolapitant
Prevention of chemotherapy induced nausea and vomiting, or CINV
Approved
Approved
Approved September 2, 2015.
RAYALDEE
Secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) and vitamin D insufficiency - Stage 3 and 4
Approved
Approved
Announced June 21 2016 FDA Approval
hGH-CTP
Adults - growth hormone deficiency
Phase 3
Phase 3
Phase 3 data released December 30, 2016 - primary endpoint not met.

Latest News

  1. 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…

    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.

    ***

    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

    ***

    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

    /

    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).



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  2. Highlights that Just Two Weeks after Sian Capital Sent Its 220 Demand Letter to OPKO, the Company has Agreed to Release A Subset of the Documents Requested, Which We Believe Will Validate our Valuation Assertions

    Announces OPKO Has Agreed to Enact Important Governance Enhancements to Protect Stockholders, Including the Addition of a New, Independent Director and Further Stockholder-Friendly Governance Changes by January 2021

    Sets the Record Straight Regarding the Apparent Falsehoods and Misrepresentations OPKO is Peddling to Stockholders, Including Management's Assertion that Its Ownership of >40% Renders Stockholders Powerless

    Urges the Board to Formally Announce and Initiate a Credible Strategic Review to Help Enact Change, Restore Stockholder

    Highlights that Just Two Weeks after Sian Capital Sent Its 220 Demand Letter to OPKO, the Company has Agreed to Release A Subset of the Documents Requested, Which We Believe Will Validate our Valuation Assertions

    Announces OPKO Has Agreed to Enact Important Governance Enhancements to Protect Stockholders, Including the Addition of a New, Independent Director and Further Stockholder-Friendly Governance Changes by January 2021

    Sets the Record Straight Regarding the Apparent Falsehoods and Misrepresentations OPKO is Peddling to Stockholders, Including Management's Assertion that Its Ownership of >40% Renders Stockholders Powerless

    Urges the Board to Formally Announce and Initiate a Credible Strategic Review to Help Enact Change, Restore Stockholder Confidence and Identify Steps for Delivering the Value Long-Suffering Stockholders Deserve

    NEW YORK, Nov. 12, 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 issued the below letter to stockholders. Recently, Sian issued a presentation outlining paths to enhanced value creation at OPKO and posted other relevant materials at www.siancapital.com/resources.

    November 12, 2020

    Fellow Stockholders,

    Sian Capital, LLC (together with its affiliates, "Sian" or "we") has been overwhelmed by the positive investor response to our October 2020 presentation that outlines several viable paths to unlocking the tremendous value trapped within OPKO Health, Inc.'s ("OPKO" or the "Company") underperforming stock. After receiving messages from more than 400 supportive stockholders over the past two weeks, one thing has become crystal clear to us: investors are fed up with leadership's self-serving decisions and believe now is the time to pursue the many high-potential opportunities that exist across the industry.

    We believe the public market does not fully appreciate OPKO's prized assets because it has lost confidence in the Company's management and Board of Directors (the "Board"). It appears these leaders are either unable or unwilling to address the array of governance, financial and strategic issues that continue to depress the Company's stock price. Moreover, it has recently come to our attention that OPKO's representatives are going so far as to attempt to dissuade stockholders from supporting change at the Company and making baseless claims regarding Sian and the Company's governance. For this reason, we want to expose OPKO's misinformation campaign and refute its recent effort to miscast Sian and our value-enhancing ideas.

    FACT: OPKO's Investor Relations Team is Waging a Misinformation Campaign Against Sian

    Despite Sian frequently engaging with Chairman and CEO Dr. Phillip Frost, Executive Vice President and director Steven Rubin, OPKO's investor relations team, as well as other members of OPKO senior management to discuss paths to unlock value for stockholders over the past six months, OPKO's investor relations team is now falsely claiming to stockholders that they have "never heard of Sian" in an apparent attempt to discredit us and our research. The reality is OPKO proactively reached out to Sian within 24 hours of the release of our public presentation to continue our dialogue. In spite of the Company's misinformation campaign, investors have been studying our materials, resulting in positive feedback and support from analysts who follow OPKO closely. Just today at the H.C. Wainwright 6th Annual Israel Virtual Conference, an analyst asked multiple questions regarding some of the very same strategic options we have urged OPKO to examine. The analyst specifically asked if OPKO would consider splitting its Pharma and Laboratory division since neither is getting the value it deserves, to which the Company responded that they are exploring this and "may in fact do that," especially since the Pharma division will be self-funding once hGH and Rayaldee royalties begin shortly and is something they intend to look at going forward. The analyst further asked about rumors they independently heard of regarding acquiror interest, to which the Company responded, "we engage in strategic decisions [consistently] and at this time won't comment." Several savvy investors highlighted these comments to us today noting they signal the Company seems willing to take the steps Sian has outlined. We believe investors can now clearly see the direct path to unlock the value that long-suffering investors deserve.

    FACT: The Delaware Court of Chancery and OPKO's Board have Approved the Institution of Several Corporate Governance Changes by January 2021

    Stockholders should know that within just two weeks of Sian sending its 220 Demand Letter to OPKO, and just one week after it was publicly disclosed on October 29th by press release and Sian Capital's website,1 the OPKO Board and the Delaware Court of Chancery approved a settlement that requires OPKO to implement certain important governance enhancements no later than January 31, 2021. These include but are not limited to:

    • The Mandatory Appointment of a New Independent Director to the Board – OPKO is required to add a new, independent director, specifically required to have less than 5% stock ownership (to prevent further concentration of ownership) and no previous employment or ties with current management.



    • The Nominating Committee of the Board This committee may be the only Committee to recommend new Board members. The Chairman is also disallowed from participating on the Nominating Committee, preventing further hand-picked directors by the Chairman.



    • Stockholder Consultation Required for Director SelectionThe Nominating Committee is required to consider the input from significant stockholders, which must be done explicitly in good faith, including on issues of director independence, qualifications and selection.



    • Lead Independent Director – Mandatory checks have been put in place delivering greater power to the Lead Independent Director: (i) at each Board meeting there shall be a separately convened session of non-management Board directors, and (ii) the Lead Independent Director has sole approval over the schedule of all Board meetings, and is required to be consulted on the agenda of each Board meeting, as well as all information sent to the Board.



    • Independent Investment Committee – A new Independent Investment Committee ("IIC") is required to consist of exclusively independent directors who shall be given sole authority, in its discretion, to hire its own independent advisors when making investment decisions on minority investments. Members of the IIC are required to recuse themselves if they or any family members have a material investment, or affiliation, with a potential transaction partner.2

    The full list of corporate governance enhancements OPKO is required to undertake can be found on Sian's website here.

    ____________________

    1https://siancapital.com/wp-content/uploads/2020/10/2020-10-21-Ltr-OPKO-Health-Inc.-re-Del-220-Demand_5577783.pdf

    2 In re Opko Health, C.A. No. 2018-0740-SG (2020).

    OPKO has Agreed to Send Sian Requested Documents – In addition to these enhancements, the Company has agreed to send Sian a subset of the documents we requested in our 220 Demand Letter, which we believe will affirm our fundamental analysis. Predictably, OPKO has denied our request for certain other documents, which we find suspicious because this information would help verify various allegations we learned from in-depth interviews conducted during our extensive due diligence. We will continue to work to obtain these documents on behalf of all OPKO stockholders.

    FACT: Dr. Frost and the Board Have a Fiduciary Duty to Act in the Best Interests of Stockholders

    Dr. Frost's aggressive stock purchases this year have caused Company insiders to exceed a 40% ownership position, which is a key threshold we have been eyeing for quite some time. The rise of insider control was a factor we were watching closely and conscious of well before deciding to publicize our view of the value opportunity at OPKO, as it not only verified our thesis that the Company's fundamentals are set to inflect in over the next year, but also provided us with a path to help ensure improved governance changes would be made. As a result of Dr. Frost and the Board's actions, we believe Dr. Frost is now considered a "Controlling Stockholder" and the OPKO Board is "Conflicted," as both are specifically defined under Delaware law. As we describe in our Corporate Governance White Paper, the simultaneous presence of a "Controlling Stockholder" and "Conflicted Board" in the same public company actually has specific ramifications under Delaware law, precisely because of the enhanced potential for misuse of power. In fact, in these situations, Delaware law actually imposes stricter duties on the stockholder and the Board to protect minority stockholders in these situations from abuses of power.

    FACT: Filings Show That OPKO Leaders Could be Personally Liable for Breaches of Their Fiduciary Duties, Leaving Them Highly Vulnerable and Exposed to Potential Litigation

    Through our conversations with fellow stockholders, we found that it was largely unknown that the Company's history of egregious violations has left its Board with the possibility that no insurance company will cover them, and if they do, it could be costly for inadequate and limited coverage, thereby leaving them potentially personally liable for any breach – a risk we cannot fathom any Board member would take. We also note that the Company's insurance premiums nearly doubled over 2019, costing stockholders an astounding $25 million while they suffered incredible financial loses. We believe upon reading our Corporate Governance White Paper, investors will have a sharply different view of stockholders' ability to effect change than the one espoused by the Company over the past several days.

    FACT: There is a Clear Path to Unlock Value for OPKO Stockholders

    Many stockholders agree with our view that OPKO is deeply undervalued, worth at least 3x its current stock price, and that the multiple paths we have outlined for maximizing that value are viable. Sian believes that our significant alignment with stockholders and strong track record helping companies optimize returns for investors will serve us in helping reverse the billions of dollars in destruction of value at OPKO. Given that OPKO's stock continues to trade at a significant discount, we believe the Board should initiate a formal strategic review process to determine how the Company can realize the true potential of its assets. Recent feedback has shown that a critical mass of stockholders agree it is time for OPKO's leaders to honor their fiduciary duties and quickly move to deliver the value that long-suffering investors deserve by announcing and initiating a credible review process. Further, we believe multiple potential suitors have come forward, unsolicited, to discuss partnerships, acquisitions, royalty agreements and other value-enhancing alternatives. We urge stockholders to ask OPKO themselves: has the Company received interest in its assets? We believe the answer will be telling.

    We encourage investors to closely read the three White Papers we have posted to our website. These contain further details on the Company's true fundamental value, which should be read in conjunction with Sian's previous investor presentation, an examination on corporate governance under Delaware law, and examples of how we can continue to enact change. These papers also include short commentary on the election results and Pfizer's tepid vaccine announcement last week, which we believe have only made the industry tailwinds more pronounced.

    In the weeks ahead, we will continue to communicate frequently and transparently with you regarding the best path forward for OPKO. We encourage you to engage with us on a one-to-one basis in the meantime by e-mailing .

    Sincerely,

    Anish Monga

    Founder and Managing Partner

    Sian Capital LLC

    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

    /   

     

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  3. MIAMI, Nov. 11, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) today announced that management will be participating in three upcoming virtual investor conferences.

    • H.C. Wainwright 6th Annual Israel Virtual Conference, November 12, 2020. Management will participate in a fireside chat on Thursday, November 12th at 9:00 a.m. ET and will be available for one-on-one meetings.

    • Jefferies 2020 Virtual London Healthcare Conference, November 17-19, 2020. Management will deliver a company presentation on Wednesday, November 18th at 10:15 a.m. ET and will be available for one-on-one meetings. A live and archived webcast of the presentation will be available in the Investors section of OPKO's website here.

    • Piper Sandler 32nd Annual Virtual

    MIAMI, Nov. 11, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) today announced that management will be participating in three upcoming virtual investor conferences.

    • H.C. Wainwright 6th Annual Israel Virtual Conference, November 12, 2020. Management will participate in a fireside chat on Thursday, November 12th at 9:00 a.m. ET and will be available for one-on-one meetings.



    • Jefferies 2020 Virtual London Healthcare Conference, November 17-19, 2020. Management will deliver a company presentation on Wednesday, November 18th at 10:15 a.m. ET and will be available for one-on-one meetings. A live and archived webcast of the presentation will be available in the Investors section of OPKO's website here.



    • Piper Sandler 32nd Annual Virtual Healthcare Conference, December 1-3, 2020. Management will participate in a fireside chat and will be available for one-on-one meetings. A replay of the fireside chat will be available in the Investors section of OPKO's website here.

    About OPKO Health

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Contacts:

    LHA Investor Relations

    Yvonne Briggs, 310-691-7100

     

    or

    Bruce Voss, 310-691-7100

     

    Primary Logo

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  4. Issues Presentation Outlining Viable Paths to Unlocking OPKO's Intrinsic Value, Which is ~3x the Company's Current Market Capitalization Based on its Diagnostic and Pharmaceutical Assets

    Releases Letter to OPKO Demanding Books and Records After Amassing Serious Concerns About Boardroom Conflicts and the Company's Ability to Objectively Assess Alternatives

    Underscores that Sian has the Ability to take Appropriate Action in Accordance with Delaware Law, Which Offers Specific Protections from Conflicted Boards and Controlling Stockholders as Outlined in our Presentation

    NEW YORK, Oct. 29, 2020 (GLOBE NEWSWIRE) -- Sian Capital, LLC (together with its affiliates, "Sian" or "we"), a sizable stockholder of OPKO Health, Inc. (NASDAQ:OPK) ("OPKO…

    Issues Presentation Outlining Viable Paths to Unlocking OPKO's Intrinsic Value, Which is ~3x the Company's Current Market Capitalization Based on its Diagnostic and Pharmaceutical Assets

    Releases Letter to OPKO Demanding Books and Records After Amassing Serious Concerns About Boardroom Conflicts and the Company's Ability to Objectively Assess Alternatives

    Underscores that Sian has the Ability to take Appropriate Action in Accordance with Delaware Law, Which Offers Specific Protections from Conflicted Boards and Controlling Stockholders as Outlined in our Presentation

    NEW YORK, Oct. 29, 2020 (GLOBE NEWSWIRE) -- Sian Capital, LLC (together with its affiliates, "Sian" or "we"), a sizable stockholder of OPKO Health, Inc. (NASDAQ:OPK) ("OPKO" or the "Company"), today released a detailed presentation outlining viable paths to unlocking the Company's tremendous upside potential following years of significant underperformance and value destruction. In addition, Sian released a demand letter that it has sent OPKO pursuant to Delaware Law. These materials are available at https://siancapital.com/resources/.

    Anish Monga, Sian's Managing Partner and Portfolio Manager, commented:

    "OPKO's stockholders have been forced to endure billions of dollars in losses due to, in our view, leadership's missteps, poor communication and self-interested decisions. Rather than take prompt steps to increase stockholder value, we contend that Chairman and Chief Executive Officer Dr. Phillip Frost and the Company's leadership team have ignored high-potential opportunities in the marketplace and demonstrated an inability to unlock the true value of the Company's prized assets. In addition, we believe Dr. Frost and his associates have given disinterested stockholders cause for significant concern by filing for approval under the Hart–Scott–Rodino Antitrust Improvements Act to increase their ownership to more than 50% and by purchasing stock (at all-time lows) frequently from January through June. It is time for OPKO's leadership to honor its fiduciary duties and quickly move to deliver the value that long-suffering investors deserve.

    "Sian has spent months conducting industry research, holding conversations with ex-employees and consultants, and engaging with potential acquirers for OPKO's presently undervalued assets. We have provided OPKO with a roadmap for success and tried to sustain a productive dialogue. It is time for a viable, value-enhancing roadmap to be implemented at OPKO."

    A summary of Sian's detailed presentation is as follows:

    We believe BioReference ("BRL") is worth $3 billion to $6 billion given its true annual earnings power is between $300 million and $400 million.

    • COVID-19 and serology testing revenue in 3Q'20 will be over $200 million while BRL's base business has recovered more rapidly than Quest and LabCorp.
    • BRL's 4Q COVID-19 revenue will increase >20% to >$250 million.
      • BRL's base business will grow ~10-15% for the foreseeable future. GeneDx, Oncology and Women's Health are the three fastest growing divisions in the industry, which comprise 40% of BRL's business growing an average of 15%. If the remainder of the business grows just half of that, 10%-15% is highly achievable.
      • BRL has significantly increased insurance coverage, recently becoming one of just five labs, and one of just three national labs with scale, to be selected for United Healthcare's Network. BRL also recently won the in-network contract for Humana and Blue Cross Blue Shield in Texas.
        • Quest has named a similar opportunity as $4 billion total available market of which they assume 25% share, anticipating $1 billion growth in revenue. If BRL achieved just half of that, this would unlock an additional $500 million in revenue (more than 50% of BRL's entire revenue base in 2019).
        • BRL has signed multi-year significant strategic partnerships with, among others, Pediatrix Medical Group, Inc., a 2,200 nationwide physician network, Westchester Medical Center's 10 hospital network that conducts over 7 million tests on a yearly basis, exclusive partnerships with the NFL, NBA and MLS, as well as government contracts with the Centers for Disease Control and Prevention to test weekly all 950 schools in New York City and to test all 50,000 NY MTA employees on a weekly basis.
        • Last quarter BRL's profit margins were ~10% against Quest and LabCorp reporting ~27% profit margins. If BRL only made up half of that difference, BRL's annualized EBITDA would be >$400 million a year.
    • Somatrogon, OPKO's hGH crown jewel is worth north of $2 billion. Pfizer paid OPKO ~$600 million upfront for OPKO to complete clinical trials across the world (over 24 trials in 83 countries) from 2017-2019 and Pfizer announced just a few weeks ago that the trial has passed Phase 3. Pfizer also discussed Somatrogon's 2021 launch on a recent earnings call. OPKO is owed ~20% royalties on both of Pfizer's currently selling $500 million hGH drug, as well as on sales of Somatrogon and an additional $275 million in milestones. We estimate this will produce an annual profit stream of ~$200 million.
      • Somatrogon's only competitor, Ascendis, has no commercial partner, little to no revenue and has never successfully commercialized a drug. Further, due to Somatrogon's orphan drug status, it is afforded regulatory protections in the U.S. and Europe for 7-12 years, effectively making it among the most consistent drugs in the industry with scarcity value due to the dearth of 9-figure royalty drugs in the market.
        • $2 billion is extraordinarily conservative: Ascendis, trades at a market capitalization of $8.5 billion = ~3 times the entire value of OPKO.
      • We believe many royalty partners would pay OPKO >$1 billion TODAY, for the rights to just a portion of the Somatrogon royalty stream because we are in an environment starved for yield with interest rates at all-time lows and the scarcity value of the asset, its regulatory protections and top-grade commercial partner in Pfizer makes Somatrogon among the highest quality royalty assets in the market.

    Today on OPKO's earnings call, investors and sell-side analysts will have the ability to ask management important questions. We believe if investors ask these questions and read through our presentation, they will have little trouble in understanding the staggering disconnect between OPKO's current trading value and its current market value:

    Do you believe Somatrogon can produce a 9-figure royalty stream, and given OPKO is not getting anywhere near the true value for the asset today, would you consider selling some of the royalty, which would bring in near-term cash to be used to purchase undervalued shares back, a dividend or other accretive uses? If so, do you believe there is interest for these assets?

    1) BioReference's margins are less than half that of Quest and LabCorp. Is there an opportunity to close that margin gap at least partway, or is 10% the maximum BioReference can produce?



    2) Dr. Jon R. Cohen, CEO of BioReference, has described the COVID-19 "halo effect" which has helped grow the BRL base customer business, in turn increasing the base business growth rate. Is this still the case?



    3) Rayaldee is already a royalty stream, licensed to Vifor Pharma in Europe and JT in Japan, however OPKO has an 89-person sales force1 to sell Rayaldee in the U.S., which is subscale. We believe management should consider also licensing the current use of Rayaldee in the U.S., thereby incurring $75 million in cost savings while still receiving a rapidly growing royalty stream. Is management open to considering additional usage licenses of Rayaldee in the U.S.?



    4) Is management confident in the prospects of success for Rayaldee's trial as a treatment of COVID-19 for mild to moderate symptoms with two primary endpoints?

    1. Rayaldee has been fast tracked for approval for treatment of COVID-19 for mild to moderate symptoms with two primary endpoints. One endpoint was reached already in its Phase IV trial. OPKO has done a poor job of marketing this fact, allowing unproven, reckless drugs like anti-malaria tablets to be touted by the President and others as a treatment, but it's little known that OPKO is sitting on a >$1 billion opportunity that could save countless lives.2

    2. We trust should investors ask management's belief in the prospects of success for the trial, they will be encouraged by the answer, and magnitude of the opportunity.

    We believe if investors ask these questions on today's earnings call, it will become quickly clear why there is such a staggering disconnect between OPKO's market price and its intrinsic value.

    We expect management to cite the inflection and tailwinds in their business, but should any investors remain unsatisfied, we will be hosting a conference call to be announced after the earnings release.

    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

    /

    _______________

    1 As disclosed in OPKO's recent 10-K filing.

    2 https://medium.com/microbial-instincts/the-first-clinical-trial-to-support-vitamin-d-therapy-for-covid-19-906a9d907468

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  5. MIAMI, Oct. 29, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) reports business highlights and financial results for the three months ended September 30, 2020.

    Third Quarter Business Highlights

    • BioReference Laboratories' COVID-19 PCR testing volume increased 61% over the second quarter of 2020. During the third quarter, BioReference Laboratories (BRL) processed approximately 3.5 million COVID-19 PCR tests and currently has the capacity to process more than 70,000 tests per day. In addition, the laboratory performed approximately 300,000 COVID-19 serology tests to measure SARS-CoV-2 specific antibody levels with the capacity to process more than 400,000 serology tests per day.

      BRL announced additional COVID-19 testing agreements…

    MIAMI, Oct. 29, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) reports business highlights and financial results for the three months ended September 30, 2020.

    Third Quarter Business Highlights

    • BioReference Laboratories' COVID-19 PCR testing volume increased 61% over the second quarter of 2020. During the third quarter, BioReference Laboratories (BRL) processed approximately 3.5 million COVID-19 PCR tests and currently has the capacity to process more than 70,000 tests per day. In addition, the laboratory performed approximately 300,000 COVID-19 serology tests to measure SARS-CoV-2 specific antibody levels with the capacity to process more than 400,000 serology tests per day.



      BRL announced additional COVID-19 testing agreements for New York City schools through a continued collaboration with New York City, the Department of Health and Hospital Corporation, the Test & Trace Corp. and the Department of Education. Through these agreements, BRL is testing students, teachers and staff in nearly 1,000 public schools across New York. BRL continues to provide COVID-19 testing services to numerous states, cities, professional sports associations and healthcare organizations, as well as to over 600 drive-thru and retail pharmacy testing sites nationwide.
    • Positive somatrogon Phase 3 topline results reported from crossover pediatric study. A global Phase 3 study of somatrogon administered once-weekly to children 3 to <18 years of age with growth hormone deficiency met its primary objective of improved treatment burden compared to daily injection of Genotropin® as measured by the mean overall Life Interference total score after 12 weeks of treatment.



    • Somatrogon global regulatory submissions: Pfizer remains on schedule with respect to its regulatory submissions for marketing approval of somatrogon for children with growth hormone deficiency in the U.S. in the fourth quarter of this year and in Europe and Japan in the first half of 2021.



    • RAYALDEE has received marketing authorizations in seven European countries. Vifor Fresenius Medical Care Renal Pharma, OPKO's commercial partner for RAYALDEE in Europe, has received marketing authorizations for RAYALDEE for the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency in the United Kingdom, Germany, Sweden, Norway, Ireland, Denmark and the Netherlands. Market authorizations from Spain, Portugal, Italy and Switzerland are still pending. Market launch of RAYALDEE in authorized countries is expected to begin next year.



    • RAYALDEE total prescriptions reported by IQVIA increased 13% compared with the third quarter of 2019.   Total prescriptions for the three months ended September 30, 2020 increased to approximately 16,700, compared with approximately 14,800 for the third quarter of 2019. During the third quarter of 2020, demand for RAYALDEE was impacted by challenges in onboarding new patients because of the COVID-19 pandemic.



    • RAYALDEE Phase 2 clinical trial initiated in patients with mild-to-moderate COVID-19.   OPKO initiated a Phase 2 clinical trial with RAYALDEE as a treatment for mild to moderate COVID-19.  The trial, "A Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of RAYALDEE (calcifediol) Extended-releasCapsules to Treat Symptomatic Patients Infected with SARS-CoV-2 (REsCue)," is expected to enroll approximately 160 subjects, many with stage 3 or 4 CKD who are at increased risk for developing more severe illness. The REsCue trial will randomize COVID-19 outpatients in a 1:1 ratio to 4 weeks of treatment with RAYALDEE or placebo, and 2 weeks of follow-up. Primary efficacy endpoints are raising and maintaining serum total 25-hydroxyvitamin D within the range of 50-100 ng/mL and time to resolution of COVID-19 symptoms. Numerous independent studies report a correlation between vitamin D status and COVID-19 risk and severity.



    • GeneDx enters into agreement with Pediatrix Medical Group to offer neonatal genomic services. In August 2020, BRL's GeneDx subsidiary announced an agreement with Pediatrix Medical Group, the nation's leading provider of maternal-fetal, and pediatric medical and surgical subspecialty physician services, to offer state-of-the-art, next-generation genomic sequencing to support clinical diagnosis in neonatal intensive care units staffed by neonatologists affiliated with Pediatrix. The sequencing is designed to enhance diagnostic capabilities in order to lessen the impact of disease and to facilitate the development of novel precision medicine solutions for pediatric care.



    • BioReference Laboratories launches best-in-class next-generation sequencing assay.   In September 2020, BRL, along with its GenPath specialty oncology division, announced the launch of OnkoSight Advanced™, a next-generation sequencing (NGS) assay that enables revolutionary deoxyribonucleic acid (DNA) mutational profiling of tumor samples. OnkoSight Advanced NGS testing provides targeted gene content that is aligned with the latest National Comprehensive Cancer Network and World Health Organization guideline recommendations to provide critical insight into many of the most common cancer types. Each OnkoSight Advanced panel includes key biomarkers – Tumor Mutation Burden and Tumor-Only Microsatellite, critical when profiling advanced-stage malignancies to guide potential immunotherapy.

    Third Quarter Financial Results

    • Net income for the third quarter of 2020 was $23.7 million, or $0.04 per diluted share, compared with a net loss of $62.0 million, or $0.11 per share, for the comparable period of 2019.   Consolidated revenues for the third quarter of 2020 were $428.1 million compared with $228.8 million for the comparable period of 2019. 
    • Diagnostics: Revenue from services in the third quarter of 2020 was $392.5 million compared with $181.1 million in the prior-year period, primarily due to increased COVID-19 testing volumes, partially offset by reduced clinical and genomic test volumes related to the pandemic and lower clinical and genomic test reimbursement. In addition, the Company received a $10.0 million grant from the CARES Act in the third quarter. Total costs and expenses were $346.4 million in the third quarter of 2020 compared with $197.5 million in the third quarter of 2019.   This increase represents higher volumes from both COVID-19 testing and from the core testing business.   Operating income was $46.2 million in the third quarter of 2020 compared with an operating loss of $16.4 million in the prior-year period, an improvement of $62.5 million.
    • Pharmaceuticals: Revenue from products in the third quarter of 2020 was $28.7 million compared with $26.2 million in the third quarter of 2019, with the increase primarily attributable to higher sales at OPKO Chile and an increase in net sales of RAYALDEE to $8.1 million in the third quarter of 2020 compared with $7.4 million in the prior-year period. Revenue from transfer of intellectual property was $6.8 million in the third quarter of 2020 compared with $20.7 million in the third quarter of 2019 reflecting a decrease in the amortization of payments received from Pfizer with respect to somatrogon. Total costs and expenses were $49.9 million in the third quarter of 2020 compared with $61.1 million in the prior-year period, with the decline primarily attributable to lower research and development expenses due to the completion of the pediatric human growth hormone Phase 3 trial. The operating loss was $14.4 million in the third quarter of 2020 compared with $14.2 million in the third quarter of 2019.
    • Cash and equivalents: Cash, cash equivalents and marketable securities were $36.3 million as of September 30, 2020, which reflects the repayment, in full, of its line of credit with JP Morgan utilizing cash generated from operations of $63.0 million during the three months ended September 30, 2020.   In addition, the Company has availability under its line of credit with JP Morgan of $64.7 million and an unutilized $100 million credit facility that provides access to incremental capital on a non-dilutive basis.  

    CONFERENCE CALL & WEBCAST INFORMATION

    OPKO's senior management will provide a business update and discuss third quarter financial results in greater detail during a conference call and live audio webcast at 4:30 p.m. Eastern time today, October 29, 2020. Participants are requested to pre-register for the conference call using the link here, or dialing (888) 869-1189 or (706) 643-5902 and using conference ID 4542807. Upon registering, participants will receive dial-in numbers, an event passcode and a unique registrant ID to gain immediate access to the call and bypass the live operator. Participants may pre-register at any time, including up to and after the start of the call.

    To access the live call via webcast, please click on the link OPKO 3Q20 Results Conference Call. Individual investors and investment community professionals who do not plan to ask a question during the call's Q&A session are encouraged to listen to the call via the webcast.

    For those unable to listen to the live conference call, a replay can be accessed for a period of time on OPKO's website at OPKO 3Q20 Results Conference Call. A telephone replay will be available beginning approximately two hours after the completion of the conference call. To access the replay, please dial (855) 859-2056 or (404) 537-3406, and use conference ID 4542807.

    About OPKO Health

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding expected financial performance and expectations regarding the market for and sales of our products, expectations about COVID-19 testing, the demand for testing, our capacity for testing and expected turnaround time, the impact of COVID-19 on all of our businesses, positively and negatively, our ability to expand our capacity should there be additional demand, the availability of resources, including labor, equipment and supplies, to meet demand for testing and the potential impact on us should these resources be constrained, whether our turnaround time be extended or our performance quality decline, our product development efforts and the expected benefits of our products, whether our products in development will be commercialized, the possibility of unfavorable new clinical data and further analyses of existing clinical data, the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities, whether regulatory authorities will be satisfied with the design of and results from our clinical studies, whether we will be able to make the expected regulatory submissions for somatrogon during the expected time periods or at all, whether the applicable regulatory agencies will accept our submissions, whether the Rayaldee study for patients with mild-to moderate COVID-19 will initiate or begin enrolling subjects later this quarter or be completed at all, whether our other ongoing and future clinical trials will be successfully enrolled or completed on a timely basis or at all and whether the data from any of our trials will support submission or approval, validation and/or reimbursement for our products, whether RAYALDEE prescriptions will continue to increase, our ability to market and sell any of our products in development, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and under the heading "Risk Factors" in our other filings with the Securities and Exchange Commission, as well as the ongoing effects of the COVID-19 pandemic, the continuation and success of our relationship with Pfizer and our other partners, liquidity issues and the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, that earlier clinical results of effectiveness and safety may not be reproducible or indicative of future results, that somatrogon, RAYALDEE, and/or any of our compounds or diagnostic products under development may fail, may not achieve the expected results or effectiveness and may not generate data that would support the approval or marketing of products for the indications being studied or for other indications, that currently available over-the-counter and prescription products, as well as products under development by others, may prove to be as or more effective than our products for the indications being studied. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

    Contacts:

    LHA Investor Relations

    Yvonne Briggs, 310-691-7100



    or

    Bruce Voss, 310-691-7100

    OPKO Health, Inc. and Subsidiaries

    Condensed Consolidated Balance Sheets

    (in millions)

     As of
     September 30,

    2020
     December 31,

    2019
    Assets:       
    Cash, cash equivalents and marketable securities$36.3  $85.5 
    Other current assets 391.8   238.5 
    Total Current Assets 428.1   324.0 
    In-process Research and Development and Goodwill 1,266.0   1,262.1 
    Other assets 677.2   723.2 
         Total Assets$2,371.3  $2,309.3 
            
    Liabilities and Equity:       
    Current liabilities$335.9  $249.1 
    Convertible Notes 219.2   211.2 
    Deferred tax liabilities, net 119.2   118.7 
    Other long-term liabilities, principally contract liabilities,

    contingent consideration and lines of credit
     

    73.2
       115.5 
    Total Liabilities 747.5   694.5 
    Equity 1,623.8   1,614.8 
         Total Liabilities and Equity$2,371.3  $2,309.3 





    OPKO Health, Inc. and Subsidiaries

    Condensed Consolidated Statements of Operations

    (in millions, except share and per share data)

     For the three months ended

    September 30,
     For the nine months ended

    September 30,
      2020   2019   2020   2019 
    Revenues               
    Revenue from services$382.5  $181.1  $804.3  $538.5 
    Revenue from products 28.7   26.2   89.1   80.1 
    Revenue from transfer of intellectual property 16.9   21.5   47.3   59.0 
         Total revenues 428.1   228.8   940.7   677.6 
    Costs and expenses               
    Cost of revenues 272.8   141.9   575.7   430.2 
    Selling, general and administrative 99.9   80.6   253.7   264.2 
    Research and development 18.5   30.0   57.9   94.8 
    Contingent consideration 1.1   (1.1  1.3   (0.1
    Amortization of intangible assets 13.9   16.4   43.8   49.4 
    Asset impairment charges 0.0   0.0   0.0   0.7 
         Total Costs and expenses 406.2   267.8   932.4   839.2 
    Operating income (loss) 21.9   (39.0)  8.3   (161.6)
    Other income and (expense), net (1.3)  (20.9)  (5.6)  (35.0)
    Loss before income taxes and investment losses 20.6   (59.9)  2.7   (196.6)
    Income tax benefit (provision) 3.2   (1.8)  (4.0)  (3.6)
    Loss before investment losses 23.8   (61.7)  (1.3)  (200.2)
    Loss from investments in investees (0.1)  (0.3)  (0.4)  (2.4)
    Net income (loss)$23.7  $(62.0) $(1.7) $(202.6)
    Income (loss) per share,

        basic and diluted
    $0.04  $(0.11) $(0.00) $(0.35)
    Weighted average common shares

      outstanding, basic and diluted
     640,699,982   586,351,045   640,619,485   586,348,791 

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