On November 5, 2019 OPKO Health, Inc. (NASDAQ: OPK) reported business highlights and financial results for the three months ended September 30, 2019 (Press release, Opko Health, NOV 5, 2019, View Source [SID1234550333]).

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Business Highlights

Somatrogon meets primary and key secondary endpoints in global Phase 3 trial: On October 21, OPKO and Pfizer announced that the global Phase 3 trial evaluating somatrogon dosed once weekly in pre-pubertal children with growth hormone deficiency met its primary endpoint of non-inferiority to GENOTROPIN (somatropin) injected daily, as measured by annual height velocity at 12 months. Key secondary endpoints including change in height standard deviation scores at six and 12 months, and change in height velocity at six months, were also higher in the somatrogon group.

RAYALDEE total prescriptions reported by IQVIA increased 83% in 3Q 2019 compared with 3Q 2018: Total prescriptions for the three months ended September 30, 2019 increased to approximately 14,600, compared with approximately 8,000 during the comparable period of 2018.

BioReference Laboratories continued to establish new alliances: During the third quarter BioReference Laboratories formed a strategic collaboration with SOMOS, New York City’s largest multicultural physician-led network, and was named the preferred provider for the IPA Association of America in laboratory services and, also, to assist with data analytics for member patients. These wins build upon successes earlier in the year, including selection as part of the preferred lab network with UnitedHealthcare and new in-network status with Humana.

JAMA Oncology published data from a GeneDx study addressing cancer risk estimates for gastric cancers in patients with gene variants of CDH1: Results indicated that the lifetime risk of gastric cancer for individuals with pathogenic variants in the CDH1 gene is significantly lower than previously described; the lifetime risk of gastric cancer associated with pathogenic CDH1 variants was 42% in men and 33% in women, compared to published estimates of 40-70% in men and 56-83% in women. These results allow for a more personalized risk assessment and better informed decision making for patients at risk for hereditary gastric cancer.

Pharmaceutical pipeline continues to advance:

The open-label Phase 2 trial for RAYALDEE in hemodialysis patients is progressing and initial data are expected in 1Q 2020.

The somatrogon registration study in Japanese pediatric GHD patients to assess pharmacokinetics and compare efficacy of weekly somatrogon to daily GENOTROPIN is on track for data readout in 2020.

Financial Highlights

Consolidated revenues for the third quarter of 2019 were $228.8 million, compared with $249.8 million for the comparable period of 2018. Revenue from services in the third quarter was $181.1 million, revenue from products was $26.2 million, including RAYALDEE net revenue of $7.4 million, and revenue from licensing and intellectual property was $21.5 million.

Operating expenses for the third quarter of 2019 were $267.8 million. This included R&D expenses of $30.0 million, principally for the completion of the pediatric Phase 3 study for our long-acting human growth hormone product and other ongoing clinical trials.

Accounting rules require marking strategic investments to market at the end of each quarter, which had a negative impact on the net loss for the third quarter of 2019 of $13.6 million, or $0.02 per share. The net loss for the third quarter of 2019, after giving effect to the decrease in market value of our strategic investments, was $62.0 million, or $0.11 per share, compared with a net loss of $27.7 million, or $0.05 per share, for the comparable period of 2018. The 2018 period’s net loss benefited from an $11.6 million income tax benefit primarily resulting from a change in state income tax rates during that period.

Cash, cash equivalents and marketable securities were $64.7 million as of September 30, 2019. Subsequent to the close of the third quarter, the Company raised gross proceeds of $75.0 million from an underwritten public offering of common stock.

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, Tuesday, November 5, 2019. The conference call dial-in and webcast information is as follows:
DOMESTIC DIAL-IN:

866-634-2258
INTERNATIONAL DIAL-IN:

330-863-3454
PASSCODE:

7270239
WEBCAST:

OPKO 3Q19 Results Conference Call
For those unable to participate in the live conference call or webcast, a replay will be available beginning approximately 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 7270239. The replay can be accessed for a period of time on OPKO’s website at OPKO 3Q19 Results Conference Call.