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Item 1. Business

2023-02-27 compared with 2022-03-01 · 138 added, 120 removed, 591 unchanged (30% of the section changed)

We are a diversified healthcare company that seeks to establish industry-leading positions in large and rapidly growing medical markets.

Our diagnostics business includes BioReference Laboratories, Inc.

(“BioReference”), one of the nation’s largest full service laboratories with an almost 250-person sales and marketing team to drive growth and leverage new products.

Our diagnostics business includes BioReference Health, LLC (“BioReference”), one of the nation’s largest full service laboratories with a 180-person sales and marketing team to drive growth and leverage new products, and we offer our 4Kscore prostate cancer test through BioReference.

Our pharmaceutical business features Rayaldee , a U.S.

Food and Drug Administration (“FDA”) approved treatment for secondary hyperparathyroidism (“SHPT”) in adults with stage 3 or 4 chronic kidney disease (“CKD”) and vitamin D insufficiency, and a pipeline of products in various stages of development.

Our leading product in development is Somatrogon (hGH-CTP), a once-weekly human growth hormone injection for which we completed a successful phase 3 study in August 2019 and is partnered with Pfizer Inc.

Regulatory applications for Somatrogon have been submitted to several countries around the world for review.

In February 2022, the European Commission granted marketing authorization in the European Union for Somatrogon under the brand name NGENLA® to treat children and adolescents from as young as 3 years of age with growth disturbance due to insufficient secretion of growth hormone.

In January 2022, the Ministry of Health, Labour and Welfare in Japan approved NGENLA® (Somatrogon) for the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone.

In October 2021, Health Canada approved NGENLA® for the long-term treatment of pediatric patients who have growth hormone deficiency, and in November 2021, Australia’s Therapeutic Goods Administration approved NGENLA® for the long-term treatment of pediatric patients with growth disturbance due to insufficient secretion of growth hormone.

We also submitted the initial Biologics License Application (“BLA”) with the FDA for approval of Somatrogon in the United States and Pfizer received a complete response letter in January 2022.

Pfizer and OPKO are evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward for the advancement of hGH (Somatrogon).

Food and Drug Administration (“FDA”) approved treatment for secondary hyperparathyroidism (“SHPT”) in adults with stage 3 or 4 chronic kidney disease (“CKD”) and vitamin D insufficiency, and Somatrogon (hGH-CTP), a once-weekly human growth hormone injection for which we completed a successful phase 3 study in August 2019 and is partnered with Pfizer Inc.

Regulatory applications for Somatrogon (hGH-CTP) have been submitted to the applicable regulatory bodies for review in several countries around the world.

In February 2022, the European Commission granted marketing authorization in the European Union for Somatrogon (hGH-CTP) under the brand name NGENLA® to treat children and adolescents from as young as 3 years of age with growth disturbance due to insufficient secretion of growth hormone and has been granted pricing approval in Germany.

NGENLA® has also been approved in Japan, Canada, and Australia.

We also submitted the initial Biologics License Application (“BLA”) with the FDA for approval of Somatrogon (hGH-CTP) in the United States and Pfizer received a complete response letter in January 2022.

Pfizer and OPKO have evaluated the FDA’s comments and will work with the agency to determine an appropriate path forward for the advancement of Somatrogon (hGH-CTP).

In May 2022, we acquired ModeX Therapeutics, Inc.

(“ModeX”), a biotechnology company focused on developing innovative multi-specific immune therapies for cancer and infectious diseases candidates.

ModeX has a robust early-stage pipeline with assets in key areas of immuno-oncology and infectious diseases, and we intend to further expand our pharmaceutical product pipeline through ModeX’s portfolio of development candidates.

Through BioReference, we provide laboratory testing services, primarily to customers in the larger metropolitan areas in New York, New Jersey, Florida, Texas, Maryland, California, Pennsylvania, Delaware, Washington, DC, Illinois and Massachusetts, as well as to customers in a number of other states.

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We operate established pharmaceutical platforms in Spain, Ireland, Chile, and Mexico, which are generating revenue and from which we expect to generate positive cash flow and facilitate future market entry for our products currently in development.

We have a development and commercial supply pharmaceutical company as well as a global supply chain operation and holding company in Ireland.

We have a development and commercial supply pharmaceutical company as well as a global supply chain operation.

We also own a specialty active pharmaceutical ingredients (“APIs”) manufacturer in Israel, which we expect will facilitate the development of our pipeline of molecules and compounds for our proprietary molecular diagnostic and therapeutic products.

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GROWTH STRATEGY

We expect our future growth to come from leveraging our commercial infrastructure, proprietary technology and development strengths.

We launched our first pharmaceutical product, Rayaldee, in the U.S.

market in the fourth quarter of 2016.

We expect to grow by leveraging our commercial infrastructure, proprietary technology and development strengths.

We have under development a broad and diversified portfolio of diagnostic tests, small molecules, and biologics targeting a broad range of unmet medical needs.

We also operate one of the largest full service laboratories in the U.S.

We intend to continue to leverage

our proprietary technology and our strengths in all phases of research and development to further develop and commercialize our portfolio of proprietary pharmaceutical and diagnostic products.

In support of our strategy, we intend to:

We intend to continue to leverage our proprietary technology and our strengths in all phases of research and development to further develop and commercialize our portfolio of proprietary pharmaceutical and diagnostic products.

In support of our strategy, we plan to:

• continue to enhance our commercialization capability in the U.S.

and internationally;

• develop and commercialize Rayaldee for new indications, including the treatment of SHPT in patients with vitamin D insufficiency and stage 5 CKD requiring regular hemodialysis;

• obtain requisite regulatory approval and compile clinical data for our most advanced product candidates;

• expand into other medical markets that provide significant opportunities and that we believe are complementary to and synergistic with our business;

In addition, we expect to leverage the BioReference business and infrastructure to drive rapid and widespread uptake of our diagnostic products.

Our strategy with respect to BioReference Laboratories is comprised of three pillars:

the core business, digital health and strategic ventures.

Because of the COVID-19 outbreak, we have added a fourth pillar as the COVID-19 pandemic impacted all parts of our organization.

• continue marketing and commercialization of Rayaldee, and potentially expand the label into additional indications;

• Continue to support Pfizer’s efforts to secure regulatory approval for Somatrogon (hGH-CTP) in the U.S.

and potentially seek approval for additional indications, including adult growth hormone deficiency.

Somatrogon under the brand name NGENLA® is being sold by Pfizer in 15 countries, including Germany, Japan and the United Kingdom.

Pfizer expects to have launched in all priority markets by the end of 2023 and is continuing to work with the FDA to obtain approval in the U.S.

Additionally, we plan to leverage our acquisition of ModeX to further expand our pharmaceutical product line.

ModeX is developing next-generation multispecifics biologics antibodies and vaccines for the treatment of cancer and infectious disease.

ModeX’s growing portfolio has been developed through its proprietary multispecific antibody technology.

As compared to traditional approaches, ModeX’s MSTAR platform unites the power of multiple biologic components in a single molecule to create multispecific antibodies and vaccines with greater versatility and potency to better fight complex disease.

Its pipeline includes product candidates intended to treat both solid and liquid tumors, as well as several of the world’s most pressing viral threats.

We also plan to continue to commercialize and increase adoption of our 4K score test for use in men age 45 and older who have not had a prior prostate biopsy or a biopsy negative and have an age specific abnormal total PSA or abnormal digital rectal exam.

4K score is available through BioReference.

In addition, we expect to leverage the BioReference business and infrastructure to drive rapid and widespread uptake of our diagnostic products and additional tests such as our 4K score test.

Our strategy with respect to BioReference is comprised two pillars:

the core business and strategic ventures.

In support of this strategy:

• We have made significant investments to rebuild and reconfigure our main laboratory in Elmwood Park, NJ and have also made significant investments in our labs in Melbourne, Florida, Houston, Texas, California and the GeneDx laboratory in Maryland.

• We have facilitated increased patient access through preferred relationships with payors.

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We now also have access to Blue Cross/Blue Shield of Texas with another approximately 5.9 million patients and access to Blue Cross/Blue Shield of Alabama with another approximately 2 million patients.

• We intend to continue to expand large-scale COVID-19 screening programs nationwide.

We offer customized solutions to different types of environments and to different types of clients.

We are one of the largest providers of these programs, which include both PCR COVID-19 testing and point of care testing, across a variety of touch points, including the travel and leisure industry, airlines, cruise industry and education.

BioReference has provided COVID-19 testing to the NFL, NBA, NHL, US National Soccer Teams, Winter X Games and the US Golf Association, among other organizations.

• We intend to continue to expand our offerings among our core laboratory service businesses in clinical, genetics, women’s health, oncology and urology.

• We intend to initiate digital health advances that aim to increase flexibility and convenience for patients.

We recently introduced an important initiative in digital health through the launch of Scarlet™ Health, a fully-integrated digital platform providing mobile phlebotomy and laboratory services to patient’s homes, offices and other preferred locations.

• We intend to continue to expand and seek new strategic ventures to provide laboratory services for large health care groups and systems.

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We were originally incorporated in Delaware in October 1991 under the name Cytoclonal Pharmaceutics, Inc., which was later changed to eXegenics, Inc.

(“eXegenics”).

On March 27, 2007, we were part of a three-way merger with Froptix Corporation and Acuity Pharmaceuticals, Inc., both research and development companies.

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diagnostics and pharmaceuticals.

The pharmaceutical segment consists of the pharmaceutical operations we operate in Chile, Mexico, Ireland, Israel and Spain and our pharmaceutical research and development operations.

The pharmaceutical segment consists of the pharmaceutical operations we operate in Chile, Mexico, Ireland, Israel, Spain, Ecuador, France, the United States, and our global pharmaceutical research and development operations.

The diagnostics segment primarily consists of the clinical laboratory operations of BioReference, as well as our point-of-care operations.

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CURRENT PRODUCTS AND SERVICES AND RELATED MARKETS

BioReference Laboratories

BioReference Health, LLC

Through BioReference, one of the largest full service laboratories in the United States, we offer comprehensive laboratory testing services utilized by healthcare providers in the detection, diagnosis, evaluation, monitoring, and treatment of diseases, including esoteric testing, molecular diagnostics, anatomical pathology, genetics, women’s health and correctional healthcare.

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insured lives.

BioReference has an almost 250-person sales and marketing team and operates a network of 128 active patient service centers.

BioReference has a 180-person sales and marketing team and operates a network of approximately 124 active patient service centers.

Our BioReference laboratory testing business consists of routine testing and esoteric testing.

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Through BioReference, we operate in the following highly specialized laboratory divisions:

• BioReference Laboratories.

• BioReference Health.

BioReference constitutes our core clinical testing laboratory offering automated, high volume routine testing services, COVID-19 testing, STAT testing, informatics, HIV, Hep C and other molecular tests.

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Innovative technology platform for sexually transmitted infections has enabled expansion nationally with specimens coming from 41 states, including Image Directed Paps analysis, HPV Plus, and STI Testing.

Industry leading national laboratory for testing rare and ultra-rare genetic diseases with international reach, performing testing on specimens from more than 50 countries.

We recently entered into an Agreement and Plan of Merger and Reorganization (the “GeneDx Merger Agreement”) with Sema4 Holdings Corp., a Delaware corporation (“Sema4”), pursuant to which Sema4 has agreed to acquire our wholly-owned subsidiary, GeneDx, Inc.

(“GeneDx”), subject to the satisfaction of customary closing conditions.

We have one of the largest marketing staffs of any laboratory in the country with sales and marketing groups dedicated to urology, oncology, women’s health, genetic testing and correctional health, as well as cross-over groups selling to large institutions.

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These large-scale screening programs include both PCR COVID-19 testing and point of care testing.

We offer testing across a variety of touch points, including the travel and leisure industry, airlines, cruise industry and education.

We have substantial relationships with local and state governments to provide testing services across all 50 states, with substantial service relationships in New York, New Jersey, and Michigan.

Through our relationships with CVS and RiteAid, we provide access to testing services for the general public and currently provide testing at more than 700 CVS and RiteAid storefronts.

BioReference has provided COVID-19 testing for the NFL, NBA, NHL, U.S.

National Soccer Teams, Winter X Games and the US Golf Association, among other organizations.

We offer testing across a variety of touch points, including the travel and leisure industry, airlines, cruise industry and education and have developed substantial relationships with local and state governments to provide testing services across all 50 states, with substantial service relationships in New York, New Jersey, and Michigan.

We expect the clinical laboratory testing industry will continue to experience growth in testing volumes due to aging of the population in the U.S., patient awareness of the value of laboratory tests, a decrease in the cost of tests, the development of sophisticated and specialized tests for detection and management of disease, increased recognition of early detection and prevention as a means of reducing healthcare costs, and ongoing research and development in genetics and genomics and personalized medicine.

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BioReference provides us with a significant diagnostics commercial infrastructure for marketing and sales that reached approximately 12 million and 21 million patients, respectively, in 2022 and 2021.

In addition, its large team of managed care experts complement our efforts to ensure that payors recognize the value of our diagnostic and laboratory tests for reimbursement purposes.

We continue to leverage the national marketing, sales and distribution resources of BioReference, along with its almost 250-person sales and marketing team, to enhance sales of and reimbursement for our 4Kscore test, a laboratory developed blood test that provides a personalized risk score for aggressive prostate cancer.

In addition, its large team of managed care experts complements our efforts to ensure that payors recognize the value of our diagnostic and laboratory tests for

reimbursement purposes.

We continue to leverage the national marketing, sales and distribution resources of BioReference, along with its 180-person sales and marketing team, to enhance sales of and reimbursement for our 4Kscore test, a laboratory developed blood test that provides a personalized risk score for aggressive prostate cancer.

We plan to leverage the BioReference commercial infrastructure and capabilities, as well as its extensive relationships with payors, to commercialize OPKO’s other diagnostic products under development.

Disposition of GeneDx

On January 14, 2022, the Company entered into an Agreement and Plan of Merger and Reorganization (the “GeneDx Merger Agreement”) with Sema4 Holdings Corp., a Delaware corporation (“Sema4”), pursuant to which Sema4 acquired the Company’s former subsidiary, GeneDx LLC, (f/k/a GeneDx, Inc.

“GeneDx”), (the “GeneDx Transaction”) in a transaction that closed on April 29, 2022 (the “GeneDx Closing”).

GeneDx is an industry leading national laboratory for testing rare and ultra-rare genetic diseases with international reach, performing testing on specimens from more than 50 countries.

Upon the GeneDx Closing, GeneDx Holdings paid to the Company aggregate consideration of $150 million in cash (before deduction of transaction expenses and other customary purchase price adjustments), together with 80.0 million shares (the “Closing Shares”) of GeneDx Holdings’ Class A common stock, par value $0.0001 per share (“GeneDx Holdings Common Stock”).

Additionally, subject to GeneDx achieving certain revenue targets for the fiscal years ending December 31, 2022 and 2023, we are eligible to receive an earnout payment in cash or stock (at GeneDx Holdings’ discretion) equal to a maximum of 30.9 million shares of GeneDx Holdings’ Class A common stock if paid in stock.

Based on the closing price of GeneDx Holdings Common Stock on April 29, 2022, the total upfront consideration was approximately $322 million, and the total aggregate consideration, including the potential Milestone Consideration, was approximately $447 million.

We offer the 4Kscore test through BioReference.

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In separate clinical studies, use of the 4Kscore test led to 64.6% fewer biopsies and was able to discriminate between men with high-grade aggressive prostate cancer and those with no findings of cancer.

The National Comprehensive Cancer Network (“NCCN”) has included the 4Kscore test as a recommended test in its Guidelines for Prostate Cancer Early Detection since 2015.

The National Comprehensive Cancer Network has included the 4Kscore test as a recommended test in its Guidelines for Prostate Cancer Early Detection since 2015.

The panel making this recommendation concluded that the 4Kscore test is indicated for use prior to a first prostate biopsy, or after a negative biopsy, to assist patients and physicians in further defining the probability of high-grade cancer.

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A Category I CPT code is critical to facilitate reimbursement in government programs such as Medicare and Medicaid, as well as private insurance programs.

Effective December 30, 2019, Novitas Solutions (“Novitas”), the local Medicare Administrative Contractor (“MAC”) for the 4Kscore testing laboratory in New Jersey, provided positive coverage through a local coverage determination (an “LCD”) with defined coverage criteria.

Effective December 30, 2019, Novitas Solutions (“Novitas”), the local Medicare Administrative Contractor for the 4Kscore testing laboratory in New Jersey, provided positive coverage through a local coverage determination with defined coverage criteria.

Since that date, 4Kscore test orders meeting the coverage criteria have been reimbursed by Novitas and Medicare Advantage Health Plans.

Point-of-Care Diagnostics

OPKO Diagnostics, LLC (“OPKO Diagnostics”), formerly Claros Diagnostics, Inc., has developed a novel diagnostic instrument system to provide rapid, high performance blood test results in the point-of-care setting (the “Claros Analyzer”).

The technology requires only a finger stick drop of blood introduced into the test cassette that can then be used to run a quantitative test.

The instrument performs the tests on a disposable, one time usable cassette that is a microfluidics-based diagnostic test system.

The credit card-sized test cassette works with a sophisticated desktop analyzer to provide high performance quantitative blood test results within 10-15 minutes and permits the transition of immunoassays from the centralized reference laboratory to the physician’s office, hospital nurses station, or other decentralized location.

We completed multiple in vitro analytical validation and field use tests for the PSA test in mid-2017 and filed the premarket approval application (“PMA”) for the Claros Analyzer and Sangia Total PSA Test with the FDA in November 2017.

The FDA approved the PMA for the Sangia Total PSA Test using the Claros Analyzer in January 2019.

The key clinical study with patients suspected of having prostate cancer found that the sensitivity of the Sangia Total PSA Test together with a DRE was improved versus the sensitivity of a DRE alone, to 91%, detecting 2.9 times the prostate cancers compared to a DRE alone.

The FDA has categorized Sangia total PSA test as a moderately complex device under Clinical Laboratory Improvement Amendments of 1988 (“CLIA”).

We are currently evaluating commercialization strategies for the Claros system, and have several tests in development on the Claros system biomarkers.

Pharmaceutical Business

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The FDA approval of Rayaldee was supported by successful results from two identical randomized, double-blind, placebo-controlled, multi-site phase 3 studies which established the safety and efficacy of Rayaldee as a new treatment for SHPT in adults with stage 3 or 4 CKD and vitamin D insufficiency.

Vitamin D insufficiency arises in CKD due to the abnormal upregulation of CYP24A1, an enzyme that destroys vitamin D and its metabolites, from obesity and from many other causes as well.

Studies in CKD patients have demonstrated that currently available over-the-counter and prescription vitamin D supplements cannot reliably and sufficiently raise blood vitamin D prohormone levels to effectively treat SHPT, a condition commonly associated with CKD in which the parathyroid glands secrete excessive amounts of PTH.

Prolonged elevation of blood PTH causes excessive calcium and phosphorus to be released from bone, leading to elevated serum calcium and phosphorus levels, softening of the bones (osteomalacia) and calcification of vascular and renal tissues.

Vitamin D insufficiency can arise in CKD due to the abnormal upregulation of CYP24A1, an enzyme that destroys vitamin D and its metabolites, from obesity and from many other causes as well.

SHPT affects 33% and 54% of patients with stage 3 and 4 CKD respectively, and approximately 95% of patients with stage 5 CKD.

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In the fourth quarter of 2022, total Rayaldee prescriptions decreased approximately 4.9% and 2.0% as compared to the fourth quarter of 2021 and the third quarter of 2022, respectively.

Sales of Rayaldee have not increased in accordance with its expected growth trajectory as a result of challenges in onboarding new patients due to the COVID-19 pandemic.

Sales of Rayaldee have not increased in accordance with its expected growth trajectory as a result of challenges in onboarding new patients due to several factors, including the COVID-19 pandemic.

Efforts are underway to obtain broader commercial and Part D insurance coverage for Rayaldee .

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covered lives as of the end of 2022.

In May 2016, we entered into a development and license agreement (the “VFMCRP Agreement”) with Vifor Fresenius Medical Care Renal Pharma (“VFMCRP”) for the development and commercialization of Rayaldee in Europe, Canada, Mexico, Australia, South Korea and certain other international markets for the treatment of SHPT in patients with stage 3, 4 or 5 CKD and vitamin D insufficiency.

In May 2016, we entered into a development and license agreement (as amended, the “VFMCRP Agreement”) with Vifor Fresenius Medical Care Renal Pharma (“VFMCRP”, now CLS Vifor) for the development and commercialization of Rayaldee in Europe, Canada, Mexico, Australia, South Korea and certain other international markets for the treatment of SHPT in patients with stage 3, 4 or 5 CKD and vitamin D insufficiency.

The VFMCRP Agreement was later amended to exclude South Korea, the Middle East and all of the countries of Africa from the VFMCRP Territory (as defined in the VFMCRP Agreement), and further amended to include Japan as part of the VFMCRP Territory.

VFMCRP initiated the commercial launch of Rayaldee in Germany in February 2022 and has received marketing authorization from eleven European countries to date and is preparing for product launches in additional territories in 2022.

The launch in Germany triggered a $3 million payment to EirGen Pharma Ltd.

(“EirGen”), our wholly owned subsidiary.

In connection with the VFMCRP Agreement, the parties entered into a letter agreement pursuant to which EirGen granted to VFMCRP an exclusive option (the “Option”) to acquire an exclusive license under certain EirGen patents and technology to use, import, offer for sale, sell, distribute and commercialize the Product in the U.S.

VFMCRP initiated the commercial launch of Rayaldee in Germany in February 2022 and received marketing authorization from eleven European countries to date and is preparing for product launches in additional territories in 2023.

The launch in Germany triggered a $3 million payment to our wholly-owned subsidiary, EirGen Pharma Ltd.

(“EirGen”), and another $7 million payment to EirGen in February 2023 tied to achievement of an acceptable final price in Germany as of the 1 year anniversary of launch.

solely for the treatment of SHPT in dialysis patients with CKD and vitamin D insufficiency (the “Dialysis Indication”).

Upon exercise of the Option, VFMCRP will reimburse EirGen for all of the development costs incurred by EirGen with respect to the Product for the Dialysis Indication in the U.S.

VFMCRP would also pay EirGen up to an additional aggregate amount of $555 million of sales-based milestones upon the achievement of certain milestones and would be obligated to pay royalties at percentage rates that range from the mid-teens to the mid-twenties on sales of the Product in the U.S.

Upon exercise of the Option, VFMCRP has agreed to reimburse EirGen for all of the development costs incurred by EirGen with respect to Rayaldee for the Dialysis Indication in the U.S.

teens to the mid-twenties on sales of Rayaldee in the U.S.

for the Dialysis Indication.

To date, VFMCRP has not exercised its option.

On June 18, 2021, EirGen and NICOYA Macau Limited (“Nicoya”), a Macau corporation and an affiliate of NICOYA Therapeutics, entered into a Development and License Agreement (the “Nicoya Agreement”) granting Nicoya the exclusive rights for the development and commercialization of extended release calcifediol (the “Nicoya Product”) in Greater China, which includes mainland China, Hong Kong, Macau, and Taiwan (collectively, the “Nicoya Territory”).

Extended release calcifediol is marketed in the U.S.

by OPKO under the tradename Rayaldee .

To date, VFMCRP has not exercised the Option.

On June 18, 2021, EirGen and NICOYA Macau Limited (“Nicoya”), a Macau corporation and an affiliate of NICOYA Therapeutics, entered into a Development and License Agreement (as amended, the “Nicoya Agreement”) granting Nicoya the exclusive rights for the development and commercialization of extended release calcifediol (the “Nicoya Product”) in Greater China, which includes mainland China, Hong Kong, Macau, and Taiwan (collectively, the “Nicoya Territory”).

The license grant to Nicoya covers the therapeutic and preventative use of the Nicoya Product for SHPT in non-dialysis and hemodialysis chronic kidney disease patients (the “Nicoya Field”).

Nicoya notified EirGen in February 2023 that it had submitted an IND for the Nicoya Product to the Chinese Center of Drug Evaluation (“CDE”) which triggered a $2.5M milestone payment to EirGen.

OPKO and VFMCRP collaborated to complete a phase 2 study evaluating a higher strength dosage form of Rayaldee for the treatment of SHPT in hemodialysis patients.

The study commenced in the 3rd quarter of 2018 and topline data were presented in an abstract titled “Initial Evaluation of High-Dose Extended-Release Calcifediol (ERC) in Patients with Stage 5 Chronic Kidney Disease on Hemodialysis” at the American Society of Nephrology’s Kidney Week Annual Meeting in November 2021.

Further development of Rayaldee for hemodialysis patients is on hold due to unfavorable reimbursement for new drugs for the care of these patients under the current Prospective Payment System established by the Centers for Medicare and Medicaid Services (“CMS”).

In October 2020, we commenced a placebo controlled Phase 2 trial with Rayaldee as a treatment for mild-to-moderate COVID-19.

In August 2021, the trial completed enrollment of 171 symptomatic patients from multiple U.S.

sites and randomized in a 1:1 ratio for 4 weeks of treatment with Rayaldee or placebo and a 2-week follow-up.

The trial ended in November 2021 and topline data were reported in December 2021 which indicated that improving vitamin D status with oral Rayaldee results in earlier resolution of respiratory symptoms associated with COVID-19.

Data from the trial and potential next steps in the development program for this indication will be reviewed with the FDA later this year.

We have also completed a Phase 4 clinical trial comparing Rayaldee with three common treatment regimens for SHPT in adults with stage 3 or stage 4 CKD and vitamin D insufficiency.

Preliminary results indicate that a daily dose of 60 micrograms of Rayaldee is the only one of four treatment regimens that reliably raises serum total 25-hydroxyvitamin D to the range of 50-100 mg/ml level required to effectively suppress elevated plasma parathyroid hormone levels in CKD patients.

These patients were randomized in a 1:1 ratio for 4 weeks of treatment with Rayaldee or placebo and a 2-week follow-up.

The trial ended in November 2021 and the resulting final data were published in Nutrition in in December 2022.

The data indicated that improving vitamin D status with oral Rayaldee resulted in earlier resolution of respiratory symptoms associated with COVID-19.

We have completed a Phase 4 clinical trial comparing Rayaldee with three common treatment regimens for SHPT in adults with stage 3 or stage 4 CKD and vitamin D insufficiency.

Final data show that a daily dose of 60 micrograms of Rayaldee is the only one of four competitive treatment regimens that reliably raises serum total 25-hydroxyvitamin D to the range of 50-100 mg/mL, a level required to effectively suppress elevated plasma PTH levels in CKD patients.

We presented interim results in an abstract titled “Comparison of Extended-Release Calcifediol (ERC), Immediate-Release Calcifediol, Cholecalciferol, and Paricalcitol for Treating Secondary Hyperparathyroidism (SHPT) in CKD” at the American Society of Nephrology’s Kidney Week Annual Meeting in October 2020.

Final results of the study are scheduled for publication in March 2023 in Kidney Diseases.

We also have completed a retrospective study of medical records for 376 adult patients with stage 3-4 CKD from 15 U.S.

nephrology clinics who were treated for SHPT and vitamin D insufficiency with Rayaldee (n=174) or competitive products considered to be standard of care (n=202).

The data, published in part in the American Journal of Nephrology in October 2021 and in full in BMC Nephrology in November 2022, confirmed the efficacy and safety of Rayaldee in real world clinical practice and demonstrated its superiority versus dietary vitamin D supplements and vitamin D hormones for reducing elevated PTH levels and correcting vitamin D insufficiency.

We believe the CKD patient population is large and growing as a result of obesity, hypertension and diabetes;

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According to the U.S.

Renal Data System, CKD afflicts over 37 million people in the U.S., including more than 18 million patients with stage 3 or 4 CKD.

In stage 5 CKD, kidney function is minimal to absent and most patients require regular dialysis or a kidney transplant for survival.

Renal Data System, CKD afflicts 14% of U.S.

adults and its prevalence is highest in non-Hispanic Black individuals (18.9%).

An estimated 71-97% of CKD patients have vitamin D insufficiency which can lead to SHPT and its debilitating consequences.

CKD continues to be associated with poor outcomes, reflecting the inadequacies of the current standard of care.

We intend to develop and commercialize Rayaldee to constitute part of the foundation for a new and markedly improved standard of care for CKD patients having SHPT and/or hyperphosphatemia.

We intend to develop and commercialize Rayaldee to constitute part of the foundation for a new and markedly improved standard of care for CKD patients having SHPT.

In May 2022, we acquired ModeX, a biotech company developing multi-specific immune therapies focused on oncology, infectious diseases, vaccines and immunology.

ModeX utilizes several platforms in furtherance of its targets:

the MSTAR with which we believe we can reliably and rapidly generate candidates that target up to six distinct biological pathways in a single molecule;

the STEALTH platform which utilizes antibody-masking technology and aims to deliver the power of multispecific immuno-modulation to widely expressed targets by building in a safety net that localizes immune attack specifically to tumors, and the Nanoparticle Vaccine platform, built on naturally occurring and self-assembling ferritin molecules, which ensures the right combination of antigens are presented in the right amount and in the right place to enhance the immune response.

We believe the versatility and potency of our approach will enable us to tackle many major infectious diseases that have eluded effective vaccination due to their continual evolution and immune evasion.

ModeX currently has a tetra-specific antibody developed utilizing our proprietary MSTAR technology platform targeting several types of refractory solid tumors;

it is designed to activate and sustain the activation of the T-cells, and simultaneously target two antigens highly expressed on diverse tumors.

Dual targeting increases tumor specificity and mitigates escape resistance through loss of a single glycoprotein.

Major solid tumor opportunities include lung, triple negative breast cancer, ovarian, prostate, and other solid tumors.

The antibody has demonstrated potent in vitro tumor cell killing in multiple cell lines and in vivo tumor regression in mice challenged with cancer cells.

This antibody, currently in preclinical and CMC development stage, is anticipated to enter clinical testing in 2024.

ModeX also has a multi-specific antibody developed using the MSTAR technology platform targeting two antigens for hematological tumors, such as several types of lymphomas and leukemias.

Dual targeting minimizes chance of resistance due to tumor heterogeneity or downregulation of target levels.

The antibody has demonstrated preferential in vitro killing on tumor cells over normal B cells and in vivo anti-tumor efficacy in disseminated mouse tumor model.

This project is in preclinical development stage and is anticipated to enter into CMC development in 2023.

ModeX’s Epstein Barr Virus (“EBV”) vaccine is developed using a modular nanoparticle vaccine platform built on naturally occurring and self-assembling ferritin molecules which enables the presentation of a 24-symmetrical array of each antigen that enhances the presentation of key components of the virus and stimulate durable protective immunity.

The EBV vaccine presents antigens from four viral proteins involved in viral entry into host cells.

These include a recombinant antigen designed from the proteins gH, gL and gp42, as well as an antigen derived from gp350.

By using ModeX’s multi-targeted approach, this combination inhibits infection in two cell types, B cells and epithelial cells, which contrasts from efforts that previously focused on gp350 alone.

ModeX has a trispecific HIV mAb (SAR441236), licensed from Sanofi, aimed at treatment of HIV infection in combination with other anti-retroviral treatment to achieve viral suppression in adults and pediatric patients with multidrug-resistant HIV that have limited therapeutic options.

SAR441236 is currently being evaluated in a phase I clinical trial sponsored by the National Institute of Allergy and Infectious Diseases.

Through the acquisition of Transition Therapeutics, a Toronto-based biotechnology company (“Transition”), we acquired OPK88004, an orally administered selective androgen receptor modulator (“SARM”).

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On September 14, 2021, we and LeaderMed Health Group Limited (“LeaderMed”), a pharmaceutical development company with operations based in Asia, announced the formation of a joint venture under which we granted the joint venture exclusive rights to develop, manufacture and commercialize (a) OPK88003, an oxyntomodulin analog being developed for the treatment of obesity and diabetes, and (b) Factor VIIa-CTP, a novel long-acting coagulation factor being developed to treat hemophilia, in exchange for a 47% ownership interest in the joint venture.

In addition, we have received an upfront payment of $1 million and will be reimbursed for clinical trial material and technical support it provides the joint venture.

LeaderMed will be responsible for funding the joint venture’s operations, development and commercialization efforts and will, with its syndicate partners, initially invest $11 million in exchange for a 53% ownership interest in the joint venture.

In addition, we received an upfront payment of $1 million and will be reimbursed for clinical trial material and technical support provided to the joint venture.

LeaderMed is responsible for funding the joint venture’s operations, development and commercialization efforts and has with its syndicate partners, initially invested $11 million in exchange for a 53% ownership interest in the joint venture.

We retain full rights to oxyntomodulin and Factor VIIa-CTP in all other geographies.

We believe oxyntomodulin has potential to be a safe, long term therapy for obesity and diabetes type II patients, representing significant market opportunities.

More than 380 million are living with diabetes worldwide, of which approximately 90% have type II diabetes.

We believe oxyntomodulin has potential to be a safe, long term therapy for obesity and diabetes type 2 patients, representing significant market opportunities.

More than 380 million are living with diabetes worldwide, of which approximately 90% have type 2 diabetes.

According to the World Health Organization, there are more than 500 million severely overweight or obese people.

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In December 2014, we entered into an exclusive worldwide agreement with Pfizer (the “Pfizer Transaction”) for the development and commercialization of hGH-CTP for the treatment of GHD in adults (“Adult GHD”) and in children (“Pediatric GHD”), as well as for the treatment of growth failure in children born small for gestational age (“SGA”).

In connection with the Pfizer Transaction, we granted Pfizer an exclusive license to commercialize hGH-CTP worldwide, and we

received non-refundable and non-creditable upfront payments aggregating $295 million and are eligible to receive up to an additional $275 million upon the achievement of certain regulatory milestones.

Upon the launch of hGH-CTP we are entitled to either regional, tiered gross profit sharing for both hGH-CTP and Pfizer’s Genotropin® once certain necessary pricing approvals are obtained, or tiered royalty payments on sales of Somatrogon with percentage rates ranging from the high teens to mid-twenties until such necessary pricing approval are obtained.

In connection with the Pfizer Transaction, we granted Pfizer an exclusive license to commercialize hGH-CTP worldwide, and we received non-refundable and non-creditable upfront payments aggregating $295 million and are eligible to receive up to an additional $275 million upon the achievement of certain regulatory milestones.

Upon the launch of hGH-CTP we are entitled to either regional, tiered gross profit sharing for both hGH-CTP and Pfizer’s Genotropin® once certain necessary pricing approvals are obtained, or tiered royalty payments on sales of Somatrogon (hGH-CTP) with percentage rates ranging from the high teens to mid-twenties until such necessary pricing approval are obtained.

GHD occurs when the production of growth hormone, secreted by the pituitary gland, is disrupted.

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the least square mean was higher in the hGH-CTP group (10.12 cm/year) than in the Genotropin® (somatropin) group (9.78 cm/year);

the treatment difference (hGH-CTP—Genotropin® (somatropin)) in HV (cm/year) was 0.33 with a two-sided 95% confidence interval of the difference of (-0.39, 1.05).

the treatment difference (hGH-CTP—Genotropin® (somatropin)) in HV (cm/

year) was 0.33 with a two-sided 95% confidence interval of the difference of (-0.39, 1.05).

In addition, change in height standard deviation scores at six and 12 months, key secondary endpoints, were higher in the hGH-CTP dosed once-weekly cohort in comparison to the Genotropin® (somatropin) dosed once-daily cohort.

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The least squared means for the annual height velocity was higher in the Somatrogon group (9.65 cm/year) than in the Genotropin group (7.87 cm/year).

We submitted the initial Biologics License Application (“BLA”) with the FDA for approval of Somatrogon in the United States and Pfizer recently received a Complete Response Letter.

Pfizer and OPKO are evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward.

Regulatory applications for Somatrogon have been submitted to several countries around the world for review.

We submitted the initial Biologics License Application (“BLA”) with the FDA for approval of Somatrogon (hGH-CTP) in the United States and Pfizer received a Complete Response Letter in January 2022.

Pfizer and OPKO have evaluated the FDA’s comments and will work with the agency to determine an appropriate path forward.

Regulatory applications for Somatrogon (hGH-CTP) have been submitted to the applicable regulatory bodies for review in several countries around the world.

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EirGen is focused on the development and commercial supply of high potency, high barrier to entry, pharmaceutical products.

Through its facility in Waterford, Ireland, EirGen currently manufactures high potency pharmaceutical products and exports to over 50 countries.

Through its facility in Waterford, Ireland, EirGen currently

manufactures high potency pharmaceutical products and exports to over 50 countries.

High potency drugs such as those used for cancer chemotherapy are typically unsuitable for manufacture in normal multi-product facilities due to cross contamination risks.

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These patents are also filed in multiple countries worldwide.

One patent family claims a sustained release oral dosage formulation and a method of treating 25-hydroxyvitamin D insufficiency or deficiency and will not expire until at least February 2027.

One patent family claims a sustained release oral dosage formulation and a method of treating 25-hydroxyvitamin D

insufficiency or deficiency and will not expire until at least February 2027.

A second patent family claims a method of administering 25-hydroxyvitamin D 3 by controlled release, a formulation for controlled release of a vitamin D compound, a controlled release oral dosage formulation of a vitamin D compound and a method of treatment, and will not expire until at least April 2028.

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The hGH-CTP line of patents, which is exclusively licensed to Pfizer, includes multiple U.S.

patent families that cover modified human grown hormone (Somatrogon), uses of Somatrogon in adult and pediatric patient populations, and methods of making Somatrogon.

patent families that cover modified human grown hormone (Somatrogon), uses of Somatrogon (hGH-CTP) in adult and pediatric patient populations, and methods of making Somatrogon (hGH-CTP).

Equivalent patents have also been filed in multiple countries around the world.

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Additional U.S.

patent applications are pending which cover Somatrogon formulations, methods of manufacture and pediatric dosing regimens and, if granted, would expire in 2033.

patent applications are pending which cover Somatrogon (hGH-CTP) formulations, methods of manufacture and pediatric dosing regimens and, if granted, would expire in 2033.

Equivalent patents are granted in Europe and Japan and which expire in 2032 and 2034.

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Multiple other U.S.

patents cover Somatrogon and its uses or methods of making including U.S.

patents cover Somatrogon (hGH-CTP) and its uses or methods of making including U.S.

and 11,197,915, where no Patent Term Adjustment was awarded by the USPTO.

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and internationally.

Patent term extensions will be sought in those countries where Somatrogon is approved.

Patent term extensions will be sought in those countries where Somatrogon (hGH-CTP) is approved.

OPK88003 and OPK88004

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Previously, we (or entities we have acquired) have completed strategic licensing transactions with the President and Fellows of Harvard College, Academia Sinica, The Scripps Research Institute, TESARO, INEOS Healthcare, and Arctic Partners, among others.

ModeX and Sanofi, a French corporation are parties to a license agreement dated July 1, 2021, as amended, pursuant to which ModeX licenses certain intellectual property underlying its EBV technology.

The pharmaceutical and diagnostic testing industries are highly competitive and require an ongoing, extensive search for technological innovation.

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This enables them, among other things, to make greater research and development investments and efficiently utilize their research and development costs, as well as their marketing and promotion costs, over a broader revenue base.

This also provides our competitors with a competitive advantage in connection with the highly competitive product acquisition and product in-licensing process, which may include auctions in

which the highest bidder wins.

This also provides our competitors with a competitive advantage in connection with the highly competitive product acquisition and product in-licensing process, which may include auctions in which the highest bidder wins.

Our competitors may also have more experience and expertise in obtaining marketing approvals from the FDA and other regulatory authorities.

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(ii) the Centers for Medicare & Medicaid Services (“CMS”), which administers the Medicare and Medicaid programs;

(iii) the Office of

Inspector General (“OIG”), which enforces various laws aimed at curtailing fraudulent or abusive practices, including by way of example, the Anti-Kickback Statute, the Physician Self-Referral Law, commonly referred to as the Stark law, the Civil Monetary Penalty Law (including the beneficiary inducement prohibition) (“CMP”), and the laws that authorize the OIG to exclude healthcare providers and others from participating in federal healthcare programs;

(iii) the Office of Inspector General (“OIG”), which enforces various laws aimed at curtailing fraudulent or abusive practices, including by way of example, the Anti-Kickback Statute, the Physician Self-Referral Law, commonly referred to as the Stark law, the Civil Monetary Penalty Law (including the beneficiary inducement prohibition) (“CMP”), and the laws that authorize the OIG to exclude healthcare providers and others from participating in federal healthcare programs;

and (iv) the Office of Civil Rights, which administers the privacy aspects of the Health Insurance Portability and Accountability Act of 1996.

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Healthcare is also provided or regulated, as the case may be, by the Department of Defense through its TRICARE program, the Department of Veterans Affairs, especially through the Veterans Health Care Act of 1992, the Public Health Service within HHS under Public Health Service Act § 340B (42 U.S.C.

§ 256b), the Department of Justice through the Federal False Claims Act and various criminal statutes, and state governments under the Medicaid and other state sponsored or funded programs and their internal laws regulating all healthcare activities.

§ 256b), the Department of Justice through the Federal False Claims Act (the “False Claims Act”) and various criminal statutes, and state governments under the Medicaid and other state sponsored or funded programs and their internal laws regulating all healthcare activities.

The testing, manufacture, distribution, advertising, and marketing of drug and diagnostic products and medical devices, as well as the performance of clinical testing services, are subject to extensive regulation by federal, state, and local governmental authorities in the U.S., including the FDA, and by similar agencies in other countries.

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Our clinical laboratory operations are subject to regulations, which are designed to ensure the quality and reliability of clinical laboratories by mandating specific standards in the areas of personnel qualifications, administration and participation in proficiency testing, patient test management, quality control, quality assurance and inspections.

Laboratories must undergo on-site surveys at least every two years, which may be conducted by CMS under the CLIA program or by a private CMS approved accrediting agency.

Laboratories must undergo on-

site surveys at least every two years, which may be conducted by CMS under the CLIA program or by a private CMS approved accrediting agency.

The sanction for failure to comply with CLIA requirements may be suspension, revocation or limitation of a laboratory’s CLIA certificate, which is necessary to conduct business, as well as significant fines and/or criminal penalties.

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phase 1 consists of testing the drug product in a small number of humans, normally healthy volunteers, to determine preliminary safety and tolerable dose range.

Phase 2 usually involves studies in a limited patient population to evaluate the

effectiveness of the drug product in humans having the disease or medical condition for which the product is indicated, determine dosage tolerance and optimal dosage, and identify possible common adverse effects and safety risks.

Phase 2 usually involves studies in a limited patient population to evaluate the effectiveness of the drug product in humans having the disease or medical condition for which the product is indicated, determine dosage tolerance and optimal dosage, and identify possible common adverse effects and safety risks.

Phase 3 consists of additional controlled testing at multiple clinical sites to establish clinical safety and effectiveness in an expanded patient population of geographically dispersed test sites to evaluate the overall benefit-risk relationship for administering the product and to provide an adequate basis for product labeling.

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Even if regulatory approvals are obtained, a marketed product is subject to continual review, and later discovery of previously unknown problems or failure to comply with the applicable regulatory requirements may result in restrictions on the marketing of a product or withdrawal of the product from the market as well as possible civil or criminal sanctions.

For marketing outside the U.S., we also will be subject to foreign regulatory requirements governing human clinical trials and marketing approval for pharmaceutical products.

For marketing outside the U.S., we also will be subject to foreign regulatory requirements governing human clinical trials and marketing approval for

pharmaceutical products.

The requirements governing the conduct of clinical trials, product licensing, pricing, and reimbursement vary widely from country to country.

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The FDA review process for premarket notifications submitted pursuant to section 510(k) takes, on average, about 90 days, but it can take substantially longer if the FDA has concerns, and there is no guarantee that the FDA will “clear” the device for marketing, in which case the device cannot be distributed in the U.S.

There is also no

guarantee that the FDA will deem the applicable device subject to the 510(k) process, as opposed to the more time-consuming, resource-intensive and problematic, PMA process described below.

There is also no guarantee that the FDA will deem the applicable device subject to the 510(k) process, as opposed to the more time-consuming, resource-intensive and problematic, PMA process described below.

The second, more comprehensive, PMA process, which can take a year or longer, applies to a new device that is not substantially equivalent to a pre-1976 product or that is to be used in supporting or sustaining life or preventing impairment.

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In December of 2016, Congress enacted the 21st Century Cures Act (P.L.

114-255) which contained provisions establishing a new Breakthrough Device pathway to allow faster patient access to devices and breakthrough technologies that provide for more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases, for which no approved or cleared treatment exists or that offer significant advantages over existing approved or cleared alternatives.

FDA has just begun to implement this program and it is not clear if any of our products would be eligible.

approved or cleared treatment exists or that offer significant advantages over existing approved or cleared alternatives.

It is not clear if any of our products would be eligible.

Even when a clinical study has been approved by the FDA or deemed approved, the study is subject to factors beyond a manufacturer’s control, including, but not limited to the fact that the institutional review board at a given clinical site might not approve the study, might decline to renew approval which is required annually, or might suspend or terminate the study before the study has been completed.

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Certain of our diagnostic products in development are subject to regulation by the FDA and similar international health authorities.

For these products, we have an obligation to adhere to the FDA’s cGMP regulations.

For these products, we have an obligation to adhere to the FDA’s current good manufacturing practices (“cGMP”) regulations.

Additionally, we are subject to periodic FDA inspections, quality control procedures, and other detailed validation procedures.

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In furtherance of that position, the FDA issued two draft guidance documents in October 2014:

(1) Framework for Regulatory Oversight of Laboratory Developed Tests (the “Framework Guidance”);

and (2) FDA Notification and Medical Device Reporting for Laboratory Developed Tests (the “Notification Guidance”), but has taken no action on the draft guidance.

(1) Framework for Regulatory Oversight of Laboratory Developed Tests;

and (2) FDA Notification and Medical Device Reporting for Laboratory Developed Tests, but has taken no action on the draft guidance.

Rather, Congress is considering various legislation that, if enacted, could formalize an FDA oversight role for LDTs, including both the Verifying Accurate Leading-edge IVCT Development (VALID) Act, and the Verified Innovative Testing in American Laboratories (VITAL) Act.

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For example, in certain foreign markets, pricing or profitability of therapeutic and other pharmaceutical products is subject to governmental control.

In the U.S., there have been, and we expect that there will continue to be, a number of federal and state proposals to implement

similar governmental control.

In the U.S., there have been, and we expect that there will continue to be, a number of federal and state proposals to implement similar governmental control.

In addition, in the U.S.

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Recognizing that the Anti-Kickback Statute is broad and may technically prohibit many innocuous or beneficial arrangements, Congress authorized the U.S.

Department of Health and Human Services Office of Inspector General, or OIG, to issue a series of regulations, known as “safe harbors.” These safe harbors set forth requirements that, if met

in their entirety, will assure health care providers and other parties that they will not be prosecuted under the Anti-Kickback Statute.

Department of Health and Human Services Office of Inspector General, or OIG, to issue a series of regulations, known as “safe harbors.” These safe harbors set forth requirements that, if met in their entirety, will assure health care providers and other parties that they will not be prosecuted under the Anti-Kickback Statute.

The failure of a transaction or arrangement to fit precisely within one or more safe harbors does not necessarily mean that it is illegal, or that prosecution will be pursued.

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We are also subject to the physician self-referral laws, commonly referred to as the Stark law, which is a strict liability statute that generally prohibits physicians from referring Medicare patients to providers of “designated health services,” including clinical laboratories, with whom the physician or the physician’s immediate family member has an ownership interest or compensation arrangement, unless an applicable exception applies.

Moreover, many states have adopted or are considering adopting similar laws, some of which extend beyond the scope of the Stark law to prohibit the payment or receipt of remuneration for the prohibited referral of patients for designated healthcare services and physician self-referrals, regardless of the source of the payment for the patient’s care.

Moreover, many states have adopted or are considering adopting similar laws, some of which extend beyond the scope of the Stark law to prohibit the payment or receipt of

remuneration for the prohibited referral of patients for designated healthcare services and physician self-referrals, regardless of the source of the payment for the patient’s care.

If it is determined that certain of our practices or operations violate the Stark law or similar statutes, we could become subject to civil and criminal penalties, including exclusion from the Medicare programs and loss of government reimbursement.

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The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect their transactions and to devise and maintain an adequate system of internal accounting controls.

Our international activities create the risk of unauthorized payments or offers of payments by our employees, consultants, sales agents or distributors, even though they may not always be subject to our control.

international activities create the risk of unauthorized payments or offers of payments by our employees, consultants, sales agents or distributors, even though they may not always be subject to our control.

We discourage these practices by our employees and agents.

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SALES & MARKETING

Our diagnostics business includes BioReference’s almost 250-person sales and marketing team in the U.S.

Our diagnostics business includes BioReference’s 180-person sales and marketing team in the U.S.

to drive growth and leverage new products.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business