OPK Opko Health Inc.

4.42
-0.16  -3%
Previous Close 4.58
Open 4.52
52 Week Low 1.1171
52 Week High 6.47
Market Cap $2,961,556,464
Shares 670,035,399
Float 400,547,642
Enterprise Value $3,284,425,773
Volume 8,292,947
Av. Daily Volume 8,587,156
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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
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
Somatrogon (hGH-CTP)
Children - growth hormone deficiency
PDUFA
PDUFA
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Drug Pipeline

Drug Stage Notes
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. – If approved, somatrogon will serve as a once-weekly treatment option –

    Pfizer Inc. (NYSE:PFE) and OPKO Health Inc. (NASDAQ:OPK) announced today that the European Medicines Agency (EMA) has validated for review the Marketing Authorization Application (MAA) for somatrogon, a long-acting recombinant human growth hormone that is intended to be administered once-weekly for the treatment of pediatric patients with growth hormone deficiency (GHD). Pfizer expects a decision from the European Commission in 2022.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210226005102/en/

    "Today's announcement is an example of our decades-long commitment to actively support the pediatric growth hormone…

    – If approved, somatrogon will serve as a once-weekly treatment option –

    Pfizer Inc. (NYSE:PFE) and OPKO Health Inc. (NASDAQ:OPK) announced today that the European Medicines Agency (EMA) has validated for review the Marketing Authorization Application (MAA) for somatrogon, a long-acting recombinant human growth hormone that is intended to be administered once-weekly for the treatment of pediatric patients with growth hormone deficiency (GHD). Pfizer expects a decision from the European Commission in 2022.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210226005102/en/

    "Today's announcement is an example of our decades-long commitment to actively support the pediatric growth hormone deficiency community through therapeutic options that help children reach their full potential," said Brenda Cooperstone, MD, Chief Development Officer, Rare Disease, Pfizer Global Product Development. "If approved in the EU, somatrogon will represent an important advancement, as this long-acting, weekly treatment may reduce the burden of daily injections on children, their loved ones, and caregivers. We look forward to continuing to work with the EMA to evolve the treatment paradigm for pediatric patients with growth hormone deficiency."

    "We are very appreciative of the children and their families that participated in the clinical trials, bringing us one step closer to providing a long-acting treatment option for pediatric growth hormone deficiency. If somatrogon is approved, we look forward to positively impacting the quality of life for children living with GHD," said Phillip Frost, Chairman and CEO of OPKO.

    The submission is supported by the results of a global, Phase 3 trial evaluating the safety and efficacy of somatrogon administered once-weekly to pediatric patients with GHD. This study met its primary endpoint of non-inferiority compared to GENOTROPIN® (somatropin) for injection administered once daily, as measured by annual height velocity at 12 months. In addition, change in height standard deviation scores at 6 and 12 months, key secondary endpoints, were higher in the somatrogon dosed once-weekly cohort in comparison to the somatropin dosed once-daily cohort. Moreover, at 6 months, change in height velocity, another key secondary endpoint, was higher in the somatrogon dosed once-weekly cohort in comparison to the somatropin dosed once-daily cohort. These common measures of growth are employed in the clinical setting to measure the potential level of catch-up growth that subjects may experience relative to the heights of their age and gender matched peers.

    Somatrogon was generally well tolerated in the study and comparable to that of somatropin administered once-daily with respect to the types, numbers and severity of the adverse events observed between the treatment arms.

    Separately, in October 2020, Pfizer and OPKO announced findings from the C0311002 trial, a Phase 3, randomized, multicenter, open-label, crossover study evaluating somatrogon dosed once-weekly in children 3 to <18 years of age with GHD, which met its primary endpoint of improved treatment burden compared to GENOTROPIN® (somatropin) for injection administered once-daily. Top-line results from the study demonstrated that treatment with somatrogon once-weekly improved the mean overall Life Interference total score after 12 weeks of treatment compared to treatment with somatropin administered once-daily. In addition, key secondary endpoints showed an overall benefit in treatment experience with the somatrogon once-weekly dosing regimen compared to the somatropin once-daily dosing regimen. These data have also been submitted to the EMA.

    In January 2021, Pfizer and OPKO announced that the US Food and Drug Administration (FDA) accepted for filing the initial Biologics License Application (BLA) for somatrogon with a target PDUFA action date of October 2021. In January 2021, a New Drug Application (NDA) was submitted to PMDA in Japan for somatrogon.

    In 2014, Pfizer and OPKO entered into a worldwide agreement for the development and commercialization of somatrogon for the treatment of GHD. Under the agreement, OPKO is responsible for conducting the clinical program and Pfizer is responsible for registering and commercializing the product.

    About the Studies

    The somatrogon Phase 3 trial is a randomized, open-label, active-controlled study conducted in over 20 countries. This study enrolled and treated 224 pediatric patients, treatment-naïve children with growth hormone deficiency who were randomized 1:1 into two arms: somatrogon administered at a dose of 0.66 mg/kg body weight once-weekly vs GENOTROPIN® (somatropin) administered at a dose of 0.034 mg/kg body weight once daily. The primary endpoint of the trial was height velocity at 12 months. Secondary endpoints included change in height standard deviation at 6 and 12 months, safety and pharmacodynamic measures. Children completing this study had the opportunity to enroll in a global, open-label, multicenter, long-term extension study, in which they were able to either continue receiving or switch to somatrogon. Approximately 95% of the patients switched into the open-label extension study and received somatrogon treatment.

    C0311002 is a Phase 3, randomized, multicenter, open-label, crossover study assessing subject perception of treatment burden with use of somatrogon administered once-weekly versus GENOTROPIN® administered once-daily in children 3 to <18 years of age with growth hormone deficiency (GHD). The primary objective of the crossover study, which included 87 randomized and treated subjects (43 randomized to Sequence 1 [somatropin followed by somatrogon] and 44 randomized to Sequence 2 [somatrogon followed by somatropin], was to evaluate the treatment burden of a somatrogon once-weekly injection schedule and a somatropin once-daily injection schedule, as assessed by the difference in mean overall Life Interference total scores after each 12-week treatment schedule experience.

    About Somatrogon

    Somatrogon is an investigational biologic product that is glycosylated and comprises the amino acid sequence of human growth hormone and one copy of the C-terminal peptide (CTP) from the beta chain of human chorionic gonadotropin (hCG) at the N-terminus and two copies of CTP (in tandem) at the C-terminus. The glycosylation and CTP domains account for the half-life of the molecule. Somatrogon has received Orphan Drug designation in the U.S. and the EU for the treatment of growth hormone deficiency.

    About Growth Hormone Deficiency

    Growth hormone deficiency is a rare disease characterized by the inadequate secretion of growth hormone from the pituitary gland and affects one in approximately 4,000 to 10,000 people. In children, this disease can be caused by genetic mutations or acquired after birth. Because the patient's pituitary gland secretes inadequate levels of somatropin, the hormone that causes growth, his or her height may be affected and puberty may be delayed. Without treatment, he or she will have persistent growth attenuation, a very short height in adulthood, and may experience other health problems.

    About GENOTROPIN® (somatropin)

    GENOTROPIN is a man-made, prescription treatment option, approved in the United States for children who do not make enough growth hormone on their own, have the genetic condition called Prader-Willi syndrome (PWS), were born smaller than most other babies, have the genetic condition called Turner syndrome (TS) or have idiopathic short stature (ISS). GENOTROPIN is also approved to treat adults with growth hormone deficiency. GENOTROPIN is taken by injection just below the skin and is available in a wide range of devices to fit a range of individual dosing needs. GENOTROPIN is just like the natural growth hormone that our bodies make and has an established safety profile.

    About OPKO Health, Inc.

    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 http://www.OPKO.com.

    Pfizer Rare Disease

    Rare disease includes some of the most serious of all illnesses and impacts millions of patients worldwide, representing an opportunity to apply our knowledge and expertise to help make a significant impact on addressing unmet medical needs. The Pfizer focus on rare disease builds on more than two decades of experience, a dedicated research unit focusing on rare disease, and a global portfolio of multiple medicines within a number of disease areas of focus, including rare hematologic, neurologic, cardiac and inherited metabolic disorders.

    Pfizer Rare Disease combines pioneering science and deep understanding of how diseases work with insights from innovative strategic collaborations with academic researchers, patients, and other companies to deliver transformative treatments and solutions. We innovate every day leveraging our global footprint to accelerate the development and delivery of groundbreaking medicines and the hope of cures.

    Click here to learn more about our Rare Disease portfolio and how we empower patients, engage communities in our clinical development programs, and support programs that heighten disease awareness.

    Pfizer Inc.: Breakthroughs that change patients' lives

    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

    DISCLOSURE NOTICE:

    The information contained in this release is as of February 26, 2021. Pfizer and OPKO assume no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

    This release contains forward-looking information about an investigational growth hormone deficiency therapy, somatrogon, including a potential indication in the EU for once-weekly treatment of pediatric patients with growth hormone deficiency, including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as 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 and when applications may be filed in any additional jurisdictions for somatrogon for the treatment of pediatric patients with growth hormone deficiency or in any jurisdictions for any other potential indications for somatrogon; whether and when the European Commission may approve the marketing authorization application for somatrogon for the treatment of pediatric patients with growth hormone deficiency and whether and when regulatory authorities in any jurisdictions may approve any such other applications that may be pending or filed (including the applications pending in the U.S. and Japan), which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether somatrogon will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of somatrogon; uncertainties regarding the impact of COVID-19 on Pfizer's or OPKO's business, operations and financial results; and competitive developments.

    A further description of risks and uncertainties can be found in Pfizer's and OPKO's respective Annual Reports on Form 10-K for the fiscal year ended December 31, 2020 and in their respective subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors", "Forward-Looking Information and Factors That May Affect Future Results" and "Cautionary Statement Regarding Forward-Looking Statements", as well as in their respective subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and, as applicable, www.pfizer.com and www.OPKO.com.

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  2. NEW YORK, Feb. 22, 2021 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), announced its participation in the NY Forward Rapid Testing Program and opened eight locations offering COVID-19 rapid testing around New York. This program is designed to provide New Yorkers, and those visiting, with inexpensive and rapid COVID-19 testing.

    BioReference opened 8 locations for COVID-19 rapid testing around New York, through the NY Forward Rapid Testing Program

    NY Forward is a collaboration with The Empire State Development Corporation, The Real Estate Board of New York (REBNY), the City's leading real estate trade association, CVS Pharmacy, and BioReference to offer rapid COVID-19 specimen collection and testing at locations throughout New York. In the coming weeks, several hundred additional testing locations will open throughout the State.

    Using a mobile device or a computer, an individual can schedule a rapid COVID-19 test by visiting the NY Forward website, here. In following best practices, all individuals must have an appointment and will pay in advance using a cashless experience. Individuals will receive their results within approximately 30 minutes or less, which are sent via secure email, allowing them to show proof of a negative COVID-19 result.       

    Individuals who are not experiencing COVID-19 symptoms and that have not had a recent known exposure to COVID-19 may participate in this initiative by visiting participating locations and completing an eligibility questionnaire. Individuals must continue to comply with all New York Forward guidelines on reopening, including but not limited to the use of face coverings, social distancing, and other protocols. 

    Healthcare providers, businesses and pharmacies interested in participating in the NY Forward can email  for more information on how to participate or request a site near them.

    "Headquartered in the New York City metropolitan area, one of the most iconic places in the world, we are proud to work with the State of New York to support the efforts to help businesses reopen in a safe and efficient manner," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "BioReference designed this digital solution specifically so that individuals can get an affordable COVID-19 test and their results within 30 minutes."

    The following testing locations are available for the New York Forward Rapid Test Program:

    1. 6 West 52nd Street, New York, NY 10019 – one block from the 5th Avenue and 53rd Street subway station
    2. 1700 Broadway, New York, NY 10019 – one block from the 7th Avenue subway station
    3. 599 Lexington Avenue, New York, NY 10022 – one block from the 59th Street subway station
    4. CVS Pharmacy, 27 N 6th Street, Brooklyn, NY 11249 – one block from the North Williamsburg ferry terminal and four blocks from the Bedford Avenue subway station
    5. CVS Pharmacy, 30-97 Steinway Street, Astoria, NY 11103 – two blocks from the Steinway Street subway station and 46 Street subway station
    6. CVS Pharmacy, 1916 Williamsburg Road, Bronx, NY 10461 – about five blocks from the Morris Park subway station
    7. CVS Pharmacy, 2182 Broadway, New York, NY 10024 – two blocks from 79th Street subway station
    8. CVS Pharmacy, 475 6th Avenue, New York, NY10011 – two blocks from the 14th Street subway station and path station, and three blocks from the 9th Street subway station

    To schedule a rapid COVID-19 test and participate in the NY Forward Rapid Testing Program, please visit: https://nyforward.bioreference.com/

    About BioReference Laboratories, Inc. 

    BioReference Laboratories, Inc., is the largest full service specialty laboratory in the United States that gives healthcare providers and patients the power to make confident healthcare decisions. With a focus on genetics, oncology, urology and women's health, BioReference offers comprehensive test solutions and unparalleled expertise based on a 40 year legacy of proven science. The company is in-network with the largest health plans in the United States, serves approximately 19 million patients annually, operates a network of 11 laboratory locations, and is backed by a medical staff of more than 300 M.D., D.O., Ph.D., genetic counselors and other professional clinical and scientific personnel. With a national footprint and niche market experience, BioReference provides credible and innovative solutions that meet the needs of employers, governmental agencies, educational systems, hospitals and health systems, correctional institutions, sports leagues, travel and leisure industries, and retail markets. BioReference provides industry-leading custom solutions for COVID-19, including point-of-care testing and large-scale screening programs. https://www.bioreference.com/ 

    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 BioReference's testing and participation in the NY Forward collaboration, whether we are able to consistently deliver results within 30 minutes, the accuracy of the test, the availability of testing and the role and value of the information provided and its impact on decisions, 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 the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. 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:

    Media Inquiries 

    Hillary Titus, 201-406-9968 

     

    NY Forward Program Inquiries

    Meghan Ziobro, 401-230-7941

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/new-york-state-partners-with-bioreference-laboratories-to-spearhead-the-ny-forward-covid-19-rapid-test-program-to-help-reopen-the-new-york-economy-301232502.html

    SOURCE BioReference Laboratories, Inc

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  3. MIAMI, Feb. 18, 2021 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) reports business highlights and financial results for the three months ended December 31, 2020.

    Business Highlights

    • BioReference Laboratories' volume in the fourth quarter of 2020 increased 170% compared to 2019. COVID-19 PCR testing volume increased 24% over the third quarter of 2020. During the fourth quarter of 2020, BioReference Laboratories (BRL) processed approximately 4.3 million COVID-19 PCR tests and currently has the capacity to process more than 100,000 PCR tests per day. In addition, BRL performed approximately 220,000 COVID-19 serology tests to measure SARS-CoV-2 antibody levels and currently has significant additional capacity.

      BRL continues to provide…

    MIAMI, Feb. 18, 2021 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) reports business highlights and financial results for the three months ended December 31, 2020.

    Business Highlights

    • BioReference Laboratories' volume in the fourth quarter of 2020 increased 170% compared to 2019. COVID-19 PCR testing volume increased 24% over the third quarter of 2020. During the fourth quarter of 2020, BioReference Laboratories (BRL) processed approximately 4.3 million COVID-19 PCR tests and currently has the capacity to process more than 100,000 PCR tests per day. In addition, BRL performed approximately 220,000 COVID-19 serology tests to measure SARS-CoV-2 antibody levels and currently has significant additional capacity.



      BRL continues to provide innovative solutions to the COVID-19 testing needs of physicians, health systems, long-term care facilities, governments, schools, employers, professional sports teams, entertainment venues, and the general public through relationships with Rite-Aid and CVS. In January 2021, BRL announced COVID-19 testing agreements for players and officials, as well as team and league staff for the 2020-2021 seasons for the National Basketball Association (NBA) and National Hockey League. BRL is also supporting the COVID-19 testing needs of the Winter X Games in Aspen, U.S. Soccer's Women's and Men's National Teams and the NBA G League in Orlando.

    • BRL introduced Scarlet Health™ to expand digital health access. In January 2021, BRL launched Scarlet Health, an in-home, fully integrated digital platform providing access to on-demand diagnostic services. Backed by BRL's national presence and infrastructure, with laboratory facilities and professionals across the country, Scarlet Health delivers an innovative, flexible, mobile alternative to traditional patient service centers or other draw locations when phlebotomy and other specimen collection services are needed.



    • GeneDx added repeat expansion analysis genetic tests. GeneDx launched several new genetic tests, including repeat expansion analysis for spinocerebellar ataxia, Friedreich ataxia and other forms of hereditary ataxias. With these additions, GeneDx has created a comprehensive and affordable offering that covers the vast majority of genes involved with pediatric-onset and adult-onset ataxias.



    • Regulatory submission from OPKO's commercial partner, Pfizer, accepted in the U.S. and filed in Japan for somatrogon to treat pediatric patients with growth hormone deficiency. The U.S. Food and Drug Administration (FDA) accepted for filing the initial Biologics License Application for somatrogon, a long-acting human growth hormone intended to be administered once-weekly for the treatment of pediatric patients with growth hormone deficiency. The target Prescription Drug User Fee Act action date for decision by the FDA is October 2021. In addition, a New Drug Application was submitted to the Ministry of Health, Labour, and Welfare in Japan for somatrogon. Pfizer remains on schedule with respect to its regulatory submission for marketing approval of somatrogon in Europe in the first quarter of this year.



    • RAYALDEE has received marketing authorizations in 11 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 and vitamin D insufficiency in 11 European countries, adding Spain, Portugal, Italy and Switzerland to previously announced approvals in the United Kingdom, Germany, Sweden, Norway, Ireland, Denmark and the Netherlands. Market launch of RAYALDEE in authorized countries is expected later this year.

    Fourth Quarter Financial Results

    • Net income for the fourth quarter of 2020 was $32.3 million, or $0.05 per diluted share, compared with a net loss of $112.4 million, or $0.18 per share, for the comparable period of 2019. Consolidated revenues for the fourth quarter of 2020 were $494.6 million compared with $224.3 million for the comparable period of 2019. 



    • Diagnostics: Revenue from services in the fourth quarter of 2020 increased to $457.9 million from $177.9 million in the prior-year period, due to COVID-19 testing volume, partially offset by lower clinical test volume reflecting the negative impact of the pandemic and by reduced clinical and genomic test reimbursement. Total costs and expenses were $388.0 million in the fourth quarter of 2020 compared with $223.4 million in the fourth quarter of 2019, resulting in operating income of $69.9 million compared with an operating loss of $45.4 million in the 2019 period. The increase in operating income of $115.3 million reflects increased volumes as a result of COVID-19 testing and a non-cash impairment charge of $38.7 included in the 2019 period for goodwill and intangible assets related to the acquisition of Claros.



    • Pharmaceuticals: Revenue from products in the fourth quarter of 2020 was $30.8 million compared with $32.0 million in the fourth quarter of 2019, primarily attributable to a decline in sales of Rayaldee, which were negatively impacted by challenges in onboarding new patients due to the intensified COVID-19 pandemic, offset by an increase in sales from OPKO Chile. Total prescriptions of Rayaldee for the fourth quarter of 2020 decreased to approximately 15,000, compared with approximately 17,900 for the fourth quarter of 2019. Revenue from the transfer of intellectual property was $5.9 million in the fourth quarter of 2020 compared with $14.4 million in the fourth quarter of 2019, reflecting a decrease in the amortization of payments received from Pfizer with respect to somatrogon. Total costs and expenses were $45.7 million in the fourth quarter of 2020 compared with $103.2 million in the prior-year period, which included a non-cash impairment charge of $53.1 million for goodwill and intangible assets related to the acquisitions of CURNA and Transition Therapeutics. The operating loss was $9.0 million in the fourth quarter of 2020 compared with $56.8 million in the fourth quarter of 2019.



    • Cash and equivalents: Cash, cash equivalents and marketable securities were $72.2 million as of December 31, 2020. In addition, the Company has availability under its present line of credit with JP Morgan of $57.6 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, discuss fourth quarter financial results and answer questions during a conference call and live audio webcast at 4:30 p.m. Eastern time today, February 18, 2021. 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 8597848. 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 4Q20 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 4Q20 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 8597848.

    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, 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, our product development efforts and the expected benefits of our products, whether our products in development will be commercialized, the possibility of 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 RAYALDEE prescriptions will increase, our ability to market and sell any of our products in development, GeneDx's test offerings and the effectiveness and utility of its ataxias tests, BioReference's Scarlet Health mobile service, the availability of and demand for the service, whether the service and the integrated platform will function or perform as designed, the role and value of the service to patients and healthcare providers and whether the demand for at home health care will continue or increase as anticipated, 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, Vifor 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 proposed 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)

    Unaudited

     As of
     December 31,

    2020
     December 31,

    2019
    Assets:       
    Cash, cash equivalents and marketable securities$72.2  $85.5 
    Other current assets 451.0   238.5 
    Total Current Assets 523.2   324.0 
    In-process Research and Development and Goodwill 1,270.8   1,262.1 
    Other assets 679.1   723.2 
    Total Assets$2,473.1  $2,309.3 
            
    Liabilities and Equity:       
    Current liabilities$375.5  $249.1 
    Convertible Notes 222.0   211.2 
    Deferred tax liabilities, net 137.2   118.7 
    Other long-term liabilities, principally contract liabilities, leases, contingent consideration and lines of credit 66.8   115.5 
    Total Liabilities 801.5   694.5 
    Equity 1,671.6   1,614.8 
    Total Liabilities and Equity$2,473.1  $2,309.3 

    OPKO Health, Inc. and Subsidiaries

    Condensed Consolidated Statements of Operations

    (in millions, except share and per share data)

    Unaudited

     For the three months ended

    December 31,
     For the year ended

    December 31,
      2020   2019   2020   2019 
    Revenues           
    Revenue from services$457.9  $177.9  $1,262.2  $716.4 
    Revenue from products 30.8   32.0   120.0   112.2 
    Revenue from transfer of intellectual property 5.9   14.4   53.2   73.3 
    Total revenues 494.6   224.3   1,435.4   901.9 
    Costs and expenses           
    Cost of revenues 318.7   142.3   894.4   572.5 
    Selling, general and administrative 101.8   79.1   355.6   343.3 
    Research and development 17.5   23.0   75.3   117.9 
    Contingent consideration (5.3)  (14.8)  (4.0)  (14.9)
    Amortization of intangible assets 12.6   15.4   56.4   64.8 
    Asset impairment charges 0.0   91.8   0.0   92.4 
    Total Costs and expenses 445.3   336.8   1,377.7   1,176.0 
    Operating Income (loss) 49.3   (112.5)  57.7   (274.1)
    Other income and (expense), net (3.4)  4.0   (9.0)  (30.8)
    Income loss before income taxes and investment losses 45.9   (108.5)  48.7   (304.9)
    Income tax provision (13.6)  (3.4)  (17.6)  (7.1)
    Income (loss) before investment losses 32.3   (111.9)  31.1   (312.0)
    Loss from investments in investees (0.0)  (0.5)  (0.5)  (2.9)
    Net Income (loss)$32.3  $(112.4) $30.6  $(314.9)
    Loss per share, basic and diluted$0.05  $(0.18) $0.05  $(0.53)
    Weighted average common shares outstanding, basic and diluted 640,590,427   622,474,281   640,655,290   595,454,394 


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  4. MIAMI, Feb. 03, 2021 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) plans to report operating and financial results for the three months ended December 31, 2020, as well as discuss financial guidance, after the close of the U.S. financial markets on Thursday, February 18, 2021. OPKO's senior management will provide a business update and discuss results in greater detail during a conference call and live audio webcast on February 18th beginning at 4:30 p.m. Eastern time.

    CONFERENCE CALL & WEBCAST INFORMATION

    OPKO encourages participants to pre-register for the conference call using the link here or dialing (888) 869-1189 or (706) 643-5902 and using conference ID 8597848. Upon registering, participants will receive dial-in numbers…

    MIAMI, Feb. 03, 2021 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) plans to report operating and financial results for the three months ended December 31, 2020, as well as discuss financial guidance, after the close of the U.S. financial markets on Thursday, February 18, 2021. OPKO's senior management will provide a business update and discuss results in greater detail during a conference call and live audio webcast on February 18th beginning at 4:30 p.m. Eastern time.

    CONFERENCE CALL & WEBCAST INFORMATION

    OPKO encourages participants to pre-register for the conference call using the link here or dialing (888) 869-1189 or (706) 643-5902 and using conference ID 8597848. 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 4Q20 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 4Q20 Results Conference Call. A telephone replay will be available beginning approximately two hours after the close of the conference call. To access the replay, please dial (855) 859-2056 or (404) 537-3406, and use conference ID 8597848.

    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



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  5. MIAMI, Jan. 28, 2021 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) announced today that its partner, Pfizer Japan Inc., submitted a New Drug Application (NDA) to the Ministry of Health, Labour, and Welfare in Japan for somatrogon, a long-acting recombinant human growth hormone that is intended to be administered once-weekly for the treatment of pediatric patients with growth hormone deficiency (GHD).

    This submission is based on the results of the Japan Phase 3 and global Phase 3 clinical studies, conducted in subjects with pediatric GHD, in which the efficacy and safety of somatrogon administered once weekly were compared with GENOTROPIN® (somatropin), a recombinant human growth hormone for injection, administered once daily. In both…

    MIAMI, Jan. 28, 2021 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) announced today that its partner, Pfizer Japan Inc., submitted a New Drug Application (NDA) to the Ministry of Health, Labour, and Welfare in Japan for somatrogon, a long-acting recombinant human growth hormone that is intended to be administered once-weekly for the treatment of pediatric patients with growth hormone deficiency (GHD).

    This submission is based on the results of the Japan Phase 3 and global Phase 3 clinical studies, conducted in subjects with pediatric GHD, in which the efficacy and safety of somatrogon administered once weekly were compared with GENOTROPIN® (somatropin), a recombinant human growth hormone for injection, administered once daily. In both studies, somatrogon showed comparable efficacy to GENOTROPIN for the primary endpoint of annual height velocity at 12 months of treatment. Somatrogon was generally well tolerated in both studies, with comparable safety to that of GENOTROPIN administered once-daily with respect to the types, numbers and severity of the adverse events observed between the treatment arms.

    In 2014, Pfizer Inc. and OPKO Health, Inc. entered into a worldwide agreement for the development and commercialization of somatrogon. Under the agreement, OPKO is responsible for conducting the clinical program, and Pfizer is responsible for registering and commercializing the product.

    About the Japan Phase 3 Study

    The Phase 3 study of somatrogon in 44 treatment-naïve Japanese pre-pubertal children with pediatric GHD was a 12-month, open-label, randomized, active-controlled, parallel-group study of the efficacy and safety of weekly somatrogon compared to recombinant human growth hormone (r-hGH), GENOTROPIN® (somatropin) for injection treatment administered once-daily. Eligible patients were randomized in a 1:1 ratio to receive either once-weekly somatrogon or GENOTROPIN administered once-daily (reference therapy, 0.025 mg/kg/day which is equivalent to 0.175 mg/kg/week). To obtain pharmacokinetic information of three different weekly doses in Japanese pediatric GHD patients, somatrogon treated patients received 0.25 mg/kg/week for 2 weeks, followed by 0.48 mg/kg/week for 2 weeks followed by 0.66 mg/kg/week for the remaining 46 weeks. Somatrogon was administered subcutaneously using a single patient use, multi-dose, disposable, pre-filled pen, the same pen used in the global study, while GENOTROPIN was administered using approved commercial products in Japan.

    About Somatrogon

    Somatrogon is an investigational biologic product that is glycosylated and comprises the amino acid sequence of human growth hormone and one copy of the C-terminal peptide (CTP) from the beta chain of human chorionic gonadotropin (hCG) at the N-terminus and two copies of CTP (in tandem) at the C-terminus. The glycosylation and CTP domains account for the half-life of the molecule. Somatrogon has received Orphan Drug designation in the U.S. and the EU for the treatment of children and adults with growth hormone deficiency.

    About Growth Hormone Deficiency

    Growth hormone deficiency is a rare disease characterized by the inadequate secretion of growth hormone from the pituitary gland and affects one in approximately 4,000 to 10,000 people. In children, this disease can be caused by genetic mutations or acquired after birth. Because the patient's pituitary gland secretes inadequate levels of somatropin, the hormone that causes growth, his or her height may be affected and puberty may be delayed. Without treatment, he or she will have persistent growth attenuation, a very short height in adulthood, and may experience other health problems.

    About GENOTROPIN

    GENOTROPIN (somatropin) is a man-made, prescription treatment option, approved in the United States for children who do not make enough growth hormone on their own, have the genetic condition called Prader-Willi syndrome (PWS), were born smaller than most other babies, have the genetic condition called Turner syndrome (TS) or have idiopathic short stature (ISS). GENOTROPIN is also approved to treat adults with growth hormone deficiency. GENOTROPIN is taken by injection just below the skin and is available in a wide range of devices to fit a range of individual dosing needs. GENOTROPIN is just like the natural growth hormone that our bodies make and has an established safety profile.

    About OPKO Health, Inc.

    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 http://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 whether the Ministry of Health, Labour, and Welfare ("Ministry") may approve the NDA for somatrogon for the treatment of pediatric patients with growth hormone deficiency, whether the Ministry will be satisfied with the results from our clinical study, whether the Ministry will interpret the clinical trial data in a similar manner to us, whether, if approved, somatrogon will be commercially successful in Japan for its approved indication, that the market for somatrogon exists, that earlier clinical results of effectiveness and safety may not be reproducible or indicative of future results, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, 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 the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. 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, and 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



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