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. InJanuary 2021 , BRL announced COVID-19 testing agreements for players and officials, as well as team and league staff for the 2020-2021 seasons for theNational Basketball Association (NBA) andNational Hockey League . BRL is also supporting the COVID-19 testing needs of the Winter X Games inAspen ,U.S. Soccer's Women's and Men's National Teams and theNBA G League inOrlando .
- BRL introduced Scarlet Health™ to expand digital health access. In
January 2021 , BRL launchedScarlet 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 inJapan for somatrogon to treat pediatric patients with growth hormone deficiency. TheU.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 isOctober 2021 . In addition, a New Drug Application was submitted to theMinistry of Health, Labour, and Welfare inJapan for somatrogon. Pfizer remains on schedule with respect to its regulatory submission for marketing approval of somatrogon inEurope 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 inEurope , 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, addingSpain ,Portugal ,Italy andSwitzerland to previously announced approvals in theUnited Kingdom ,Germany ,Sweden ,Norway ,Ireland ,Denmark andthe 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 ofDecember 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
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 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
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Condensed Consolidated Balance Sheets
(in millions)
Unaudited
As of | |||||||
2020 | 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 | |||||
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 |
Condensed Consolidated Statements of Operations
(in millions, except share and per share data)
Unaudited
For the three months ended | For the year ended | ||||||||||||||
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 |
Source:
2021 GlobeNewswire, Inc., source