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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

MONTREAL, Feb. 16, 2023 /PRNewswire/ - Montmed, Inc., a company dedicated to bridging the gap between science and behavior in diabetes care to deliver better outcomes while reducing the cognitive burden associated with living with diabetes, today announced that the United States Patent and Trademark Office (USPTO) has issued a second US Patent 11,517,659, adding to the company's novel technology patent family which aims at helping insulin users to easily and seamlessly develop and implement healthy injection site rotation practices. Insulin users inject themselves anywhere from 1 to 6 or more times daily. This daily repeated administration of exogenous insulin, a growth hormone, combined with the repeated trauma of needle micro-injury, leads to a serious complication called lipohypertrophy. Lipohypertrophy, which is defined as an abnormal accumulation of fat underneath the surface of the skin, is present in up to 64% of insulin users and leads to sub-optimal insulin absorption2. Studies have shown that the lack of injection site rotation is the largest risk factor in developing lipohypertrophy2. Lipohypertrophy has been shown to have important repercussions on glycemic control, such as an elevation in HbA1C, increased glucose variability, increased unexplained hypoglycemia as well as an increase in insulin requirements of up to 22%1. Therefore, in addition to its proven clinical benefits, ensuring insulin users adopt a healthy injection site rotation may also reduce the economic burden of insulin use. Currently, there is no simple and intuitive way to help health care professionals teach, and patients adhere to a structured site rotation routine. As a result, injection site rotation is not broadly adopted resulting in more than half of insulin users using one site only to inject their insulin4. Montmed has developed the Sitesmart™, a novel pen needle system designed to favor the teaching and adherence to a healthy injection site rotation regimen. Each package of Sitesmart contains 100 insulin pen needles distinctively marked with 4 colors, along with educational messages and an association tool labeled directly on the packaging that allows the user to simply and easily create a personalized structured injection site rotation plan, in which each of the four colors of pen needle is associated with a distinct injection area, seamlessly instructing the insulin user where to inject at each injection. Positive clinical data from a randomized controlled trial were published in October 2020, which demonstrated that the sole dispensing of Sitesmart pen needles system by a retail pharmacist was an impactful, low tech and scalable intervention that resulted in a significant improvement in injection site rotation. The study showed Sitesmart delivered a 134.7% increase in the likelihood to improve site rotation over conventional pen needles, without adding any cost to the health care system. It was also hypothesized that the distinctive nature of the Sitesmart pen needle system may also act as a reminder for insulin users to change their pen needles after use, and therefore, reduce needle re-use, in accordance with clinical recommendations. The study demonstrated that, in addition to ensuring healthy injection site rotation, needle re-use was reduced by 25% in Sitesmart users. Montmed's initial patent specifically covers distinctively marked injection devices, including insulin pen needles, in combination with a user-defined association tool that allows the user to create and implement a personalized injection site rotation plan, and thus reduce the risk of developing lipohypertrophy. The newly issued patent 11,517,659 adds to the initial patent by integrating the concept of distinctive marks and user-defined association in a digital device or software. Amir Farzam, chief executive officer of Montmed, commented, "We are extremely pleased that the USPTO has once again recognized our innovation. The issuance of this new US patent, paired with our positive clinical data and the successful proof of concept in the Canadian market is paving the way for us to bring our innovation to insulin users in the US. We remain committed to transforming the utility of an insulin pen needle from a simple insulin delivery device to a clinically valuable tool that can improve health outcomes and reduce costs by helping insulin users seamlessly integrate healthy injection site rotation into their daily routine, and importantly, at no additional direct cost to the healthcare system. To this effect, we are initiating our 510k process in Q1 2023". About Sitesmart™ Montmed has developed Sitesmart, a pen needle system that brings clinical value by helping insulin users seamlessly adopt a healthy site rotation routine, which can reduce the risk of lipohypertrophy, improve insulin action and consequently, clinical outcomes, at no additional direct cost to the healthcare system. The Sitesmart package contains 100 insulin pen needles distinctively marked with 4 colors (4X25), along with an association tool labeled directly on the packaging and on a web app, that allow the user to create a personalized structured injection site rotation plan, in which each of the four colors of pen needle is associated with an injection area. Once the plan is developed by the insulin user or with the help of a health care professional, the user simply picks a pen needle in the box, and injects in the area corresponding to color of the pen needle on his /her plan. And that's it! No tracking, no logging, no need to remember where the last injection was given. The simplicity of Sitesmart makes it easy for any insulin user to get the most out of their insulin by integrating a healthy injection site rotation routine without adding to the cognitive burden associated with diabetes management. The Sitesmart packaging also serves as a counselling tool to favor a rapid and concise educational intervention on site rotation by health care professionals, including prescribers, diabetes educators, and retail pharmacists. Sitesmart: Change Colour, Change Site®. References 1. Frid A, et al. Worldwide Injection techniques questionnaire study. Mayo Clinic Proc. 2016;91(9):1212-1223. doi: 10.1016/j.mayocp.2016.06.011. 2. Blanco M, et al. Prevalence and risk factors of lipohypertrophy in insulin-injecting patients with diabetes. Diabetes Metab. 2013;39(5)445-53. doi: 10.1016/j.diabet.2013.05.006. 3. Forum for Injection Techniques (FIT). 4. Bari B, Corbeil MA, Farooqui H, Menzies S, Pflug B, Smith BK, Vasquez A, Berard L. Insulin Injection Practices in a Population of Canadians with Diabetes: An Observational Study. Diabetes Ther. 2020 Nov;11(11):2595-2609. doi: 10.1007/s13300-020-00913-y.