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Conference call begins at 4:30 p.m. Eastern time todayMIAMI, Aug. 03, 2023 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) reports business highlights and financial results for the three and six months ended June 30, 2023. Second quarter business highlights included the following: U.S. FDA approved NGENLA™ for pediatric growth hormone deficiency; OPKO earned a $90 million milestone payment from its commercial partner, Pfizer. In June 2023, the U.S. Food and Drug Administration (FDA) approved NGENLA (somatrogon), a once-weekly, human growth hormone analog indicated for the treatment of pediatric patients aged three years and older with impaired growth due to insufficient growth hormone. Pfizer, OPKO’s commercial partner, expects NGENLA to become available for U.S. prescribing this month. In addition to the $90 million milestone payment earned upon receipt of FDA approval, OPKO is entitled to profit sharing based on regional, tiered gross profit for both NGENLA and Genotropin®, Pfizer’s daily human growth hormone.NGENLA has now been approved in 44 markets including the U.S., Japan, EU Member States, Canada and Australia; sales are underway by Pfizer in over 18 countries with expectations to launch in all priority international markets by year-end. NGENLA is the first once-weekly product approved for the treatment of pediatric growth hormone deficiency in Japan, Canada, Australia, the United Kingdom, Taiwan, United Arab Emirates and Brazil. OPKO is entitled to gross profit sharing in all global markets based on regional, tiered gross profit for both NGENLA and Genotropin, with the U.S. region commencing gross profit sharing in August 2023. OPKO Health’s ModeX Therapeutics, Inc. (ModeX) advanced its antiviral and immune-oncology product pipeline. ModeX continued to advance its pipeline of antiviral and immune-oncology programs utilizing its next-generation multispecific antibodies, and anticipates initiating a Phase 1 clinical trial for certain cancers next year. In addition, ModeX’s collaboration with Merck to develop MDX-2201, its vaccine for Epstein-Barr virus, is progressing. As part of its ongoing business strategy, ModeX is pursuing additional licensing and collaboration opportunities with strategic partners for certain other pipeline candidates.BioReference Health continued on its path to profitability with cost reductions, improved operational efficiencies and enhanced productivity. BioReference continued to implement initiatives to reduce costs and rationalize its business in line with current testing volumes. Additionally, BioReference is focused on improving productivity and enhancing innovation of its higher value specialty testing segments. Other efforts to return this business to profitability include expanding into new market segments, such as providing information for the pharmaceutical market. Second Quarter Financial Results Pharmaceuticals: Revenue from products in the second quarter of 2023 increased to $43.5 million from $35.9 million in the second quarter of 2022, driven by sales in OPKO’s international operating companies and an increase in sales of Rayaldee to $7.7 million from $6.2 million in the prior-year period. Revenue from the transfer of intellectual property was $94.9 million in the second quarter of 2023, reflecting revenue of $90.0 million triggered by the FDA approval of NGENLA, compared with $87.2 million in the 2022 period, which included an $85.0 million milestone payment related to the commencement of NGENLA sales in Europe and Japan. Total costs and expenses were $74.7 million in the second quarter of 2023, up from $67.7 million in the prior-year period. The increase was mainly due to an increase in cost of revenue and a full quarter of research expenses at ModeX, which was acquired in May 2022. Operating income was $63.6 million in the second quarter of 2023, compared with $55.4 million in the second quarter of 2022.Diagnostics: Revenue from services in the second quarter of 2023 was $127.0 million compared with $186.8 million in the prior-year period. Revenue decreased due to lower COVID-19 testing volume and reimbursement. BioReference processed approximately 33,000 COVID-19 PCR tests in the second quarter of 2023, representing 1.5% of total testing volume, versus 874,000 tests in the second quarter of 2022, representing 31% of total testing volume. Furthermore, revenue during the 2022 period included $12.1 million from GeneDx, which was sold in April 2022. Total costs and expenses were $171.3 million in the second quarter of 2023 compared with $244.3 million in the second quarter of 2022, resulting in an operating loss of $44.3 million compared with an operating loss of $57.5 million in the 2022 period. The 2022 period included a $15.4 million gain on the sale of GeneDx offset by $5.8 million of operating losses prior to closing in April 2022. BioReference continues to implement cost-reduction initiatives as it works toward profitability.Consolidated: Consolidated total revenues for the second quarter of 2023 were $265.4 million compared with $309.9 million for the comparable period of 2022. Operating income for the second quarter of 2023 was $7.0 million compared with an operating loss of $10.7 million for the 2022 quarter. Net loss for the second quarter of 2023 included a mark-to-market adjustment of $19.9 million compared to $71.2 million in the 2022 period related to the decrease in share price of GeneDx, resulting in a net loss of $19.6 million, or $0.03 per share, compared with a net loss of $101.7 million, or $0.14 per share, for the 2022 quarter. Cash and cash equivalents: Cash and cash equivalents were $108.1 million as of June 30, 2023, which does not include the $90.0 million milestone payment from Pfizer that is expected to be received in August 2023. Conference Call and Webcast Information OPKO’s senior management will provide a business update, discuss second quarter financial results, provide financial guidance and answer questions during a conference call and audio webcast today beginning at 4:30 p.m. Eastern time. Participants are encouraged to pre-register for the conference call here. Callers who pre-register will receive a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register may participate by dialing 833-630-0584 (U.S.) or 412-317-1815 (International). A webcast of the call can also be accessed at OPKO’s Investor Relations page and here. A telephone replay will be available until August 10, 2023 by dialing 877-344-7529 (U.S.) or 412-317-0088 (International) and providing the passcode 7009686. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here. About OPKO Health OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com. 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, whether our products will launch in all the territories in which they have been approved for sale, the timing of such launches, our product development efforts and the expected benefits of our products, whether the relationship with our commercial and strategic partners will be successful, whether our commercial and strategic partners will be able to commercialize our products and successfully utilize our technologies, our ability to attract new commercial and strategic partners, our ability to market and sell any of our products in development, whether BioReference’s cost-cutting initiatives and attempts at returning to its core business will be successful, 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 continuation and success of our relationship with our commercial partners, liquidity issues and the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. 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 RelationsYvonne Briggs, 310-691-7100ybriggs@lhai.com orBruce Voss, 310-691-7100 bvoss@lhai.com —Tables to Follow— OPKO Health, Inc. and SubsidiariesCondensed Consolidated Balance Sheets(in millions)Unaudited As of June 30, 2023 December 31, 2022Assets: Cash and cash equivalents$108.1 $153.2 Other current assets 325.7 241.3 Total current assets 433.8 394.5 In-process research and development and goodwill 792.4 790.9 Other assets 932.7 981.9 Total Assets$2,158.9 $2,167.3 Liabilities and Equity: Accounts Payable$87.9 $67.0 Accrued expenses 98.6 98.3 Current portion of convertible notes 0.0 3.1 Other current liabilities 39.9 45.1 Total current liabilities 226.4 213.5 Long-term portion of convertible notes 212.3 210.4 Deferred tax liabilities, net 133.0 126.4 Other long-term liabilities, principally contract liabilities, leases, contingent consideration and lines of credit 51.9 55.4 Total Liabilities 623.6 605.7 Equity 1,535.3 1,561.6 Total Liabilities and Equity$2,158.9 $2,167.3 OPKO Health, Inc. and SubsidiariesCondensed Consolidated Statements of Operations(in millions, except share and per share data)Unaudited For the three months endedJune 30, For the six months endedJune 30, 2023 2022 2023 2022 Revenues Revenue from services$127.0 $186.8 $259.4 $473.4 Revenue from products 43.5 35.9 83.9 72.5 Revenue from transfer of intellectual property and other 94.9 87.2 159.7 93.2 Total revenues 265.4 309.9 503.0 639.1 Costs and expenses Cost of revenues 138.9 194.3 277.3 438.2 Selling, general and administrative 79.8 101.5 155.4 219.0 Research and development 18.2 17.2 50.8 35.6 Contingent consideration (0.0) 0.2 0.1 0.1 Amortization of intangible assets 21.5 22.8 43.0 44.8 Gain on sale of assets 0.0 (15.4) 0.0 (15.4)Total costs and expenses 258.4 320.6 526.6 722.3 Operating income (loss) 7.0 (10.7) (23.6) (83.2)Other expense, net (23.5) (75.6) (9.8) (79.8)Loss before income taxes and investment losses (16.5) (86.3) (33.4) (163.0)Income tax benefit (provision) (3.1) (15.1) (4.4) 6.2 Loss before investment losses (19.6) (101.4) (37.8) (156.8)Loss from investments in investees (0.0) (0.3) (0.1) (0.3)Net loss$(19.6) $(101.7) $(37.9) $(157.1)Loss per share, basic and diluted$(0.03) $(0.14) $(0.5) $(0.23)Weighted average common shares outstanding, basic and diluted 751,727,383 612,548,661 751,617,431 686,597,899

Bagsværd, Denmark , 26 May 2023 – Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending once-weekly Sogroya ® (somapacitan) for replacement of endogenous growth hormone (GH) in children aged three years and above, and adolescents with growth failure due to growth hormone deficiency. Symptoms of growth hormone deficiency in children often start early in life, leading to short stature as well as other growth-related health problems. 1 Current treatment for growth hormone deficiency typically requires daily injections of growth hormone. 2 However, frequent injections can be burdensome, disrupting daily life, reducing adherence and thereby affecting clinical outcomes – particularly in children. 3 “Today’s positive CHMP opinion is a step forward to reducing the impact of growth hormone deficiency for children, adolescents and their families in Europe,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk. “We are hopeful that Sogroya ® will help improve the lives of children as young as three years old by offering a simpler treatment option with fewer injections in an easy-to-use device, whilst helping them to achieve their growth targets.” The positive opinion is based on data from the phase 3 REAL4 study, which showed that once-weekly subcutaneous injection of Sogroya ® worked as well as daily injection of Norditropin ® (somatropin). This means that at the end of the trial period, prepubertal children who were treated with once-weekly Sogroya ® achieved similar growth as children who were treated with once-daily Norditropin ® . 4 The European Commission (EC) will now review the CHMP’s positive opinion, and a final decision on the marketing authorisation is expected in the coming months. If approved, Sogroya ® will be available in some European countries starting in Q4 2023. It received approval from the US Food & Drug Administration (FDA) in April 2023. About the REAL4 study The REAL4 (REversible ALbumin) study (NCT03811535) is part of the ongoing REAL clinical study programme and was designed to evaluate the efficacy and safety of Sogroya ® (somapacitan) injection in children with growth hormone deficiency. 5 REAL4 is a randomised, multi-national, open label, active-controlled parallel group phase 3 trial, comprised of a 52-week main phase followed by a three-year extension period. Two-hundred growth hormone treatment naïve, prepubertal children with growth hormone deficiency were randomly assigned in a 2:1 ratio to receive weekly subcutaneous injection of 0.16 mg/kg/week Sogroya ® (n=132) or daily subcutaneous injection of 0.034 mg/kg/day somatropin (Norditropin ® ) (n=68). 4 Results from the study showed that annualised height velocity (centimetres grown in a year) in children with growth hormone deficiency treated with once-weekly Sogroya ® was 11.2 cm/year, compared to 11.7 cm/year for daily Norditropin ® with no statistical difference between the two groups. Sogroya ® was well tolerated, with a similar safety and tolerability profile to the well-known profile of Norditropin ® . 4 Growth hormone deficiency Growth hormone deficiency is a rare disease and a treatable cause of short stature. It is estimated to affect approximately 1 in 3,500 to 10,000 children. 6 , 7 Growth hormone is essential for growth, muscle and bone strength and it helps to control sugar and fat levels in the body. Growth hormone deficiency in children is characterised by slow growth from an early age and a markedly reduced final adult height compared to that predicted. 8 , 9 Other symptoms can include reduction of bone mineral density, slow development of facial bones and long bones, and delayed appearance of teeth. 1 , 10 About Sogroya ® (somapacitan) Sogroya ® is a prescription human growth hormone analogue, similar to current daily growth hormone and can be used to treat adults who do not produce enough growth hormone. Sogroya ® was approved in the EU for the replacement of endogenous growth hormone in adults with growth hormone deficiency (AGHD) in 2021. 11 Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 57,100 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com , Facebook , Twitter , LinkedIn and YouTube . Contacts for f urther information Media: Ambre James-Brown +45 3079 9289 abmo@novonordisk.com Natalia Salomao Abrahao (US) +1 848 304 1027 niaa@novonordisk.com Investors: Daniel Muusmann Bohsen +45 3075 2175 dabo@novonordisk.com Jacob Martin Wiborg Rode +45 3075 5956 jrde@novonordisk.com David Heiberg Landsted +45 3077 6915 dhel@novonordisk.com Mark Joseph Root (US) +1 848 213 3219 mjhr@novonordisk.com References 1 National Organization for Rare Disorders. Growth Hormone Deficiency. https://rarediseases.org/rare-diseases/growth-hormone-deficiency/ Accessed: May 2023. 2 Höybye C, Christiansen JS. Growth hormone replacement in adults - current standards and new perspectives. Best Pract Res Clin Endocrinol Metab . 2015;29(1):115-123. doi:10.1016/j.beem.2014.09.006 3 Brod M, Højbjerre L, Alolga SL, et al . Understanding Treatment Burden for Children Treated for Growth Hormone Deficiency. Patient. 2017;10(5):653-666. doi:10.1007/s40271-017-0237-9 4 Miller BS, Blair JC, Rasmussen MH, et al. Weekly Somapacitan is Effective and Well Tolerated in Children With GH Deficiency: The Randomized Phase 3 REAL4 Trial. J Clin Endocrinol Metab . 2022;107(12):3378-3388. doi:10.1210/clinem/dgac513 5 ClinicalTrials.gov. A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4) (NCT03811535). Available from: https://clinicaltrials.gov/ct2/show/NCT03811535?term=REAL4&draw=2&rank=1 . Accessed: May 2023. 6 Stanley T. Diagnosis of growth hormone deficiency in childhood. Curr Opin Endocrinol Diabetes Obes . 2012;19(1):47-52. doi:10.1097/MED.0b013e32834ec952 7 Tornese G. ‘Growth hormone deficiency’ or rather ‘short stature unresponsive to stimulation tests? Archives of Disease in Childhood Published Online First: 27 January 2022. doi: 10.1136/archdischild-2021-323426 8 Growth Hormone Research Society. Consensus guidelines for the diagnosis and treatment of growth hormone (GH) deficiency in childhood and adolescence: summary statement of the GH Research Society. GH Research Society. J Clin Endocrinol Metab . 2000;85(11):3990-3993. doi:10.1210/jcem.85.11.6984 9 Grimberg A, DiVall SA, Polychronakos C, et al. Guidelines for Growth Hormone and Insulin-Like Growth Factor-I Treatment in Children and Adolescents: Growth Hormone Deficiency, Idiopathic Short Stature, and Primary Insulin-Like Growth Factor-I Deficiency. Horm Res Paediatr . 2016;86(6):361-397. doi:10.1159/000452150 10 Fleseriu, M. Recombinant growth hormone treatment, osteoporosis and fractures, more complicated than it seems! Endocrine 59, 463–465 (2018). https://doi.org/10.1007/s12020-017-1519-7 Accessed: May 2023. 11 Sogroya ® (somapacitan) Summary of Product Characteristics. https://www.ema.europa.eu/en/documents/product-information/sogroya-epar-product-information_en.pdf Accessed: May 2023. Attachment PR230526-Sogroya-CHMP-opinion