On November 9, 2018 OPKO Health, Inc. (NASDAQ: OPK) reports financial results and business highlights for the three months ended September 30, 2018 (Press release, Opko Health, NOV 9, 2018, View Source [SID1234531170]).
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Financial Highlights
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Net loss for the three months ended September 30, 2018 decreased by 23% to $27.7 million or $0.05 a share compared to net loss of $35.9 million or $0.06 per share for the comparable 2017 period. Total revenues improved to $249.8 million during the three months ended September 30, 2018 compared to $246.0 million for the comparable period of 2017.
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Revenues from products during the three months ended September 30, 2018 include $5.8 million from RAYALDEE and revenues from services were $202.8 million for the 2018 period compared with $200.9 million for the corresponding 2017 period.
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During the three months ended September 30, 2018, costs of revenue and selling, general and administrative expenses decreased by approximately 8%, or $19.5 million, compared to the 2017 period. Research and Development expenses were $30.2 million compared to $32.5 million for the corresponding 2017 period.
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On November 8, 2018, OPKO secured approximately $150 million of additional capital, consisting of a private placement of common stock resulting in proceeds of $92.5 million, and an unsecured credit line of $60 million.
Business Highlights
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RAYALDEE total prescriptions reported by IMS for Q3 2018 increased 222% compared with Q3 2017 and 18% compared with Q2 2018: As of November 1, 2018, approximatley 79% of patients have access to RAYALDEE under their insurance plans.
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Initiated the Phase 2 clinical trial to study the safety and efficacy of RAYALDEE as a new treatment for secondary hyperparathyroidism (SHPT) in adults with vitamin D insufficiency and stage 5 chronic kidney disease (CKD) requiring hemodialysis. The trial will be conducted at multiple dialysis centers in the U.S. in two sequential cohorts. The first cohort of approximately 44 patients will be treated for 26 weeks in a randomized, open-label fashion with
either RAYALDEE or placebo to identify the appropriate dosing to be studied in the second cohort. Data readout for this first cohort is expected in 2019. The second cohort of more than 200 patients will be treated for 26 weeks in a randomized, double-blind fashion with one of three different doses of RAYALDEE or placebo. The primary efficacy endpoint will be correction of vitamin D insufficiency and control of SHPT. Patients will then be treated with RAYALDEE for another 26 weeks in an open-label extension.
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4Kscore utilization in Q3 2018 was approximately 18,700 tests compared to 18,900 during Q3 2017. Utilization of the 4Kscore remains strong while we continue to work with our Medicare administrator, Novitas, on their proposed local coverage determination. During this process, Novitas has continued to provide coverage of the 4Kscore to Medicare beneficiaries.
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Completed the enrollment of a Global Phase 3 study of somatrogon (hGH-CTP) in Growth Hormone Deficient Children: The somatrogon Phase 3 trial is a randomized, open-label study comparing once-weekly somatrogon to once daily Genotropin. This study has enrolled 228 treatment naïve children with growth hormone deficiency (GHD) in 21 countries. The primary endpoint of the trial is height velocity at 52 weeks. Secondary endpoints are safety and pharmacodynamics.
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Enrollment in Japanese Phase 3 registration trial of somatrogon in growth hormone deficient children expected to complete by year end: The global and Japanese pediatric studies utilize the multiple dose pen device that will be launched commercially upon approval.
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Completed the enrollment of a Phase 2b clinical trial for our once-weekly oxyntomodulin dual GLP1-Glucagon agonist to treat type 2 diabetes and obesity: In a previous Phase 2 trial in 420 overweight patients with type 2 diabetes, the drug was shown to be safe and effective. The current trial is to study a new dosing schedule to achieve even greater weight loss and topline results are anticipated during 1Q 2019.
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Advanced the Phase 2b trial for our SARM (selective androgen receptor modulator) to treat benign prostatic hyperplasia (BPH): Enrollment of approximately 110-120 patients in this dose ranging study of our orally administered SARM is expected to be completed by the end of this year.
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Premarket Approval (PMA) application for Claros point-of-care PSA test under review by FDA; decision anticipated during 1H 2019: OPKO has completed a PMA submission to FDA for Sangia, our point of care PSA test utilizing the Claros 1 immunoassay analyzer. This is the first test on our proprietary diagnostic platform that can provide rapid, quantitative blood test results in the physician’s office with only a finger stick drop of whole blood. Several biomarkers and biological meaningful chemistry tests such as testosterone and Vitamin D utilizing the Claros platform are advancing toward a 510(k) submission to the FDA.
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 4:15 p.m. Eastern time today. The conference call dial-in and webcast information is as follows:
WHEN: Friday, November 9, 2018 at 4:15 p.m. Eastern time
DOMESTIC DIAL-IN: (866) 634-2258
INTERNATIONAL DIAL-IN: (330) 863-3454
PASSCODE: 3487296
WEBCAST: www.investor.opko.com/events
For those unable to participate in the live conference call or webcast, a replay will be available beginning November 9, 2018 two hours after the close of the conference call. To access the replay, dial (855) 859-2056 or (404) 537-3406. The replay passcode is: 3487296. The replay can be accessed for a period of time on OPKO’s website at www.investor.opko.com/events.