Full Press Release Details
OPKO Health Reports Improved Financial and Operating Results
MIAMI (August 8, 2016) OPKO Health, Inc. (NYSE:OPK), reports financial and operating results for the three and six months ended June 30,
Financial Highlights
Our improved financial performance this quarter was fueled by continued growth in our
diagnostics business through increases in patient volume at BioReference Laboratories and its GeneDx unit, as well as continued growth in the utilization of our innovative 4Kscore test for predicting the probability of aggressive prostate
cancer, stated Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO. We were pleased with the FDA s decision to approve RAYALDEE before its PDUFA date, and we are building an impressive commercial team to make
this important medicine available to the large number of chronic kidney disease patients suffering from SHPT. Other drug development programs are
progressing well and we anticipate having topline data from our phase 3 clinical trial for long acting human growth hormone in adults later this year. We also anticipate clinical data late this
year or early next year for our long acting Factor VIIa-CTP, as well as clinical data for our Phase 1 clinical trial for long acting oxyntomodulin. We look forward to the closing of the Transition Therapeutics acquisition and adding
Transition s important products to our robust late stage drug pipeline, continued Dr. Frost.
CONFERENCE CALL & WEBCAST
OPKO s senior management will provide a business update and discuss results in greater detail in a conference call and live audio
webcast at 4:30 p.m. Eastern time today.
The conference call dial in information is listed below. To access the webcast, please log on to the OPKO
website at www.opko.com.
WHEN: Monday, August 8, 2016, 4:30 p.m. ET
DOMESTIC DIAL-IN: (866) 634-2258
INTERNATIONAL DIAL-IN:
participate in the conference call or webcast, a replay will be available beginning August 8, 2016 at 7:30 p.m. ET for a period of time. To access the replay, dial (855) 859-2056 or (404) 537-3406. The replay passcode is: 56394307.
The replay can also be accessed for a period of time on OPKO s website at www.opko.com.
About OPKO Health, Inc.
OPKO Health, Inc. is a
diversified healthcare company that seeks to establish industry-leading positions in large, rapidly growing markets. Our diagnostics business includes Bio-Reference Laboratories, the nation s third-largest clinical laboratory with a core
genetic testing business and a 420-person sales force to drive growth and leverage new products, including the 4Kscore prostate cancer test and the Claros 1 in-office immunoassay platform. Our pharmaceutical business features
RAYALDEE, an FDA approved treatment for SHPT in stage 3-4 CKD patients with vitamin D insufficiency, and VARUBI for chemotherapy-induced nausea and vomiting (oral formulation launched by partner Tesaro and IV formulation PDUFA is
January 2017). Our biologics business includes hGH-CTP, a once-weekly human growth hormone injection (in Phase 3 and partnered with Pfizer), a long-acting Factor VIIa drug for hemophilia (in Phase 2a) and a long acting oxyntomodulin for diabetes and
obesity (in Phase 1). We also have production and distribution assets worldwide, multiple strategic investments and an active business development strategy. More information is available at 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, our product development efforts and the expected benefits of our products, including whether our ongoing and future clinical
trials will be completed on a timely basis or at all and whether the data from any of our trials will support approval, validation and/or reimbursement for our products, the expected timing for launch of our products in development, including
RAYALDEE and hGH-CTP, the expected timing of our clinical trials, enrollment in clinical trials, and disclosure of results for the trials, the timing of completion for our trials, our ability to market and sell any of our products in development,
including RAYALDEE, the 4Kscore, and hGH-CTP, expectations about potential milestone payments and royalties from our partners, our ability to obtain broad reimbursement coverage for the 4Kscore test, increased adoption rates for the 4Kscore by
Urologists, our ability to increase the number of 4Kscore tests performed, and expectations about the Transition acquisition, including the closing date, 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 in our other filings with the Securities and Exchange Commission, as well as integration
challenges for Bio-Reference, EirGen, Transition, and other acquired businesses, 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 the 4Kscore, RAYALDEE, Varubi , hGH-CTP, 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 being studied 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.
Tara Mackay, 305-575-4100
Terry Rooney, 212-223-0689
Anne Marie Fields, 212-838-3777
Bruce Voss, 310-691-7100
OPKO Health, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
| As of | ||||||||
| June 30, 2016 | December 31, 2015 | |||||||
| Assets: | ||||||||
| Cash, cash equivalents and marketable securities | $ | 171.6 | $ | 193.6 | ||||
| Other current assets | 334.0 | 260.5 | ||||||
| Total Current Assets | 505.6 | 454.1 | ||||||
| In-process Research and Development and Goodwill | 1,297.1 | 1,535.6 | ||||||
| Other assets | 971.3 | 809.5 | ||||||
| Total Assets | $ | 2,774.0 | $ | 2,799.2 | ||||
| Liabilities and Equity: | ||||||||
| Current liabilities | $ | 281.2 | $ | 251.9 | ||||
| 2033 Senior Notes, net | 45.2 | 49.0 | ||||||
| Deferred tax liabilities | 207.6 | 226.0 | ||||||
| Other long-term liabilities, principally deferred revenue and contingent consideration | 224.4 | 292.5 | ||||||
| Total Liabilities | 758.4 | 819.4 | ||||||
| Equity | 2,015.6 | 1,979.8 | ||||||
| Total Liabilities and Equity | $ | 2,774.0 | $ | 2,799.2 |
OPKO Health, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(in millions, except
| For the three months ended June 30, | For the six months ended June 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Revenues | ||||||||||||||||
| Revenue from services | $ | 266.0 | $ | 1.9 | $ | 518.5 | $ | 4.0 | ||||||||
| Revenue from products | 22.8 | 22.8 | 42.7 | 38.3 | ||||||||||||
| Revenue from transfer of intellectual property | 68.3 | 17.7 | 86.9 | 30.2 | ||||||||||||
| Total revenues | 357.1 | 42.4 | 648.1 | 72.5 | ||||||||||||
| Costs and expenses | ||||||||||||||||
| Cost of revenues | 153.4 | 14.4 | 301.0 | 24.7 | ||||||||||||
| Selling, general and administrative | 117.5 | 20.9 | 245.5 | 38.4 | ||||||||||||
| Research and development | 31.3 | 29.6 | 59.1 | 55.1 | ||||||||||||
| Contingent consideration | 10.8 | (0.3 | ) | 12.5 | 4.8 | |||||||||||
| Amortization of intangible assets | 15.8 | 3.2 | 29.2 | 5.9 | ||||||||||||
| Grant repayment | 25.9 | |||||||||||||||
| Total Costs and expenses | 328.8 | 67.8 | 647.3 | 154.8 | ||||||||||||
| Operating income (loss) | 28.3 | (25.4 | ) | 0.8 | (82.3 | ) | ||||||||||
| Other income and (expense), net | 5.1 | (16.8 | ) | 2.5 | (70.6 | ) | ||||||||||
| Income (loss) before income taxes and investment losses | 33.4 | (42.2 | ) | 3.3 | (152.9 | ) | ||||||||||
| (Provision for) benefit from income taxes | (15.9 | ) | (0.3 | ) | 4.6 | (5.8 | ) | |||||||||
| Income (loss) before investment losses | 17.5 | (42.5 | ) | 7.9 | (158.7 | ) | ||||||||||
| Loss from investments in investees | (2.0 | ) | (0.8 | ) | (4.3 | ) | (2.6 | ) | ||||||||
| Net income (loss) | 15.5 | (43.3 | ) | 3.6 | (161.3 | ) | ||||||||||
| Less: Net loss attributable to non-controlling interests | (0.5 | ) | (1.4 | ) | ||||||||||||
| Net income (loss) attributable to common shareholders | $ | 15.5 | $ | (42.8 | ) | $ | 3.6 | $ | (159.9 | ) | ||||||
| Basic income (loss) per share | $ | 0.03 | $ | (0.09 | ) | $ | 0.01 | $ | (0.35 | ) | ||||||
| Diluted income (loss) per share | $ | 0.02 | $ | (0.09 | ) | $ | 0.00 | $ | (0.35 | ) |