Full Press Release Details
OPKO Health Reports Financial Third Quarter Operating Results
MIAMI (November 7, 2016) OPKO Health, Inc. (NASDAQ:OPK), reports financial and operating results for the three months
ended September 30, 2016.
Financial Highlights
We are finalizing the details of our commercial launch of RAYALDEE and have completed the selection and hiring of a very talented commercial
team, all of whom bring deep relationships in the nephrology and specialty pharmaceutical sales market, stated Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO. RAYALDEE will be an important medicine for a
large number of chronic kidney disease patients suffering from SHPT and vitamin D insufficiency. We are working closely with the Vifor Fresnius Medical Care Renal Pharma team to bring RAYALDEE to market outside the U.S. and are presently
planning the start of a Phase 3 trial in dialysis patients which represents the first potential line extension for RAYALDEE in addition to its currently approved indication.
With the Transition Therapeutics acquisition, we now have two additional important drugs in Phase 2 development; one for patients who could benefit from
its effects on increasing bone and muscle strength while decreasing fat mass; the other for type 2 diabetes and obesity. Each drug has already been studied and shown to be safe in approximately 400 patients. We are also very pleased to now
have the benefit of an experienced Transition Therapeutics team led by its CEO, Tony Cruz. Our BioReference Laboratories and its GeneDx unit continue to grow and the utilization of our innovative 4Kscore test for predicting the
probability of aggressive prostate cancer remains strong. Last, we have made great progress on our Claros point of care diagnostic system and anticipate starting clinical trials for our PSA and testosterone tests in the coming months,
continued Dr. Frost.
CONFERENCE CALL & WEBCAST INFORMATION:
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
WHEN: Monday, November 7, 2016, 4:30 p.m. ET
DOMESTIC DIAL-IN: (866) 634-2258
INTERNATIONAL DIAL-IN: (330)
participate in the conference call or webcast, a replay will be available beginning November 7, 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: 12830677.
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 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, VARUBI
for chemotherapy-induced nausea and vomiting (oral formulation launched by partner TESARO and IV formulation PDUFA date: January 2017), TT401, a once or twice weekly oxyntomodulin for type 2 diabetes and obesity which is a clinically advanced drug
candidate among the new class of GLP-1 glucagon receptor dual agonists, and TT701, an androgen receptor modulator for androgen deficiency indications. 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, the expected timing of commencing and concluding our clinical trials, enrollment in clinical trials, and disclosure of results for the trials, the timing of our regulatory submissions, our ability to
market and sell any of our products in development, expectations about developing RAYALDEE for dialysis patients, our ability to obtain broad reimbursement coverage for the 4Kscore test, increased adoption rates for the 4Kscore, our expectations
Transition Therapeutics products in development, 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
Marion Janic, 212-223-4017
Anne Marie Fields, 212-838-3777
Bruce Voss, 310-691-7100
OPKO Health, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
| As of | ||||||||
| September 30, 2016 | December 31, 2015 | |||||||
| Assets: | ||||||||
| Cash, cash equivalents and marketable securities | $ | 144.6 | $ | 193.6 | ||||
| Other current assets | 357.4 | 260.5 | ||||||
| Total Current Assets | 502.0 | 454.1 | ||||||
| In-process Research and Development and Goodwill | 1,347.5 | 1,535.6 | ||||||
| Other assets | 950.5 | 809.5 | ||||||
| Total Assets | $ | 2,800.0 | $ | 2,799.2 | ||||
| Liabilities and Equity: | ||||||||
| Current liabilities | $ | 254.5 | $ | 251.9 | ||||
| 2033 Senior Notes, net | 51.5 | 49.0 | ||||||
| Deferred tax liabilities | 184.5 | 226.0 | ||||||
| Other long-term liabilities, principally deferred revenue and contingent consideration | 204.1 | 292.5 | ||||||
| Total Liabilities | 694.6 | 819.4 | ||||||
| Equity | 2,105.4 | 1,979.8 | ||||||
| Total Liabilities and Equity | $ | 2,800.0 | $ | 2,799.2 |
OPKO Health, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(in millions, except
| For the three months ended September 30, | For the nine months ended September 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Revenues | ||||||||||||||||
| Revenue from services | $ | 259.0 | $ | 103.9 | $ | 777.6 | $ | 107.9 | ||||||||
| Revenue from products | 20.6 | 20.8 | 63.3 | 59.1 | ||||||||||||
| Revenue from transfer of intellectual property | 18.4 | 18.3 | 105.3 | 48.5 | ||||||||||||
| Total revenues | 298.0 | 143.0 | 946.2 | 215.5 | ||||||||||||
| Costs and expenses | ||||||||||||||||
| Cost of revenues | 151.2 | 67.3 | 452.2 | 92.1 | ||||||||||||
| Selling, general and administrative | 124.9 | 55.3 | 370.3 | 93.6 | ||||||||||||
| Research and development | 24.4 | 18.9 | 83.6 | 74.0 | ||||||||||||
| Contingent consideration | 3.1 | 1.6 | 15.6 | 6.5 | ||||||||||||
| Amortization of intangible assets | 18.1 | 8.1 | 47.3 | 14.0 | ||||||||||||
| Grant repayment | 25.9 | |||||||||||||||
| Total Costs and expenses | 321.7 | 151.2 | 969.0 | 306.1 | ||||||||||||
| Operating (loss) income | (23.7 | ) | (8.2 | ) | (22.8 | ) | (90.6 | ) | ||||||||
| Other income and (expense), net | (10.5 | ) | 47.0 | (8.1 | ) | (23.6 | ) | |||||||||
| (Loss) income before income taxes and investment losses | (34.2 | ) | 38.8 | (30.9 | ) | (114.2 | ) | |||||||||
| (Provision for) benefit from income taxes | 20.0 | 93.0 | 24.6 | 87.2 | ||||||||||||
| (Loss) income before investment losses | (14.2 | ) | 131.8 | (6.3 | ) | (27.0 | ) | |||||||||
| Loss from investments in investees | (0.8 | ) | (3.6 | ) | (5.1 | ) | (6.0 | ) | ||||||||
| Net (loss) income | (15.0 | ) | 128.2 | (11.4 | ) | (33.0 | ) | |||||||||
| Less: Net loss attributable to non-controlling interests | (1.4 | ) | ||||||||||||||
| Net (loss) income attributable to common shareholders | $ | (15.0 | ) | $ | 128.2 | $ | (11.4 | ) | $ | (31.6 | ) | |||||
| Basic income (loss) per share | $ | (0.03 | ) | $ | 0.26 | $ | (0.02 | ) | $ | (0.07 | ) | |||||
| Diluted income (loss) per share | $ | (0.03 | ) | $ | 0.18 | $ | (0.02 | ) | $ | (0.07 | ) |