OPKO Health Reports First Quarter 2018 Financial Results

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OPKO Health Reports First Quarter 2018 Financial Results
Conference Call begins today at 4:30 p.m. Eastern Time
MIAMI, May 08, 2018 (GLOBE NEWSWIRE) -- OPKO Health, Inc.(NASDAQ:OPK) reports financial results and business highlights for the three months ended March 31, 2018.

Financial Highlights

  • Consolidated revenues for the three months ended March 31, 2018 were $254.9 million compared with $266.4 million for the comparable period of 2017.
    • Revenue from services were $211.3 million for the three months ended March 31, 2018 compared with $228.6 million for the comparable 2017 period. While not directly comparable, this represents a marked improvement from the most recently completed quarter ended December 31, 2017.
    • Revenue from products included $3.7 million of revenue from RAYALDEE during the first quarter of 2018. Revenues from RAYALDEE were deferred during the initial launch period so there is no prior-year comparison.
  • During the three months ended March 31, 2018, operating expenses included investment in commercial activities supporting the launch of RAYALDEE of $7.3 million and continued investment in our pharmaceutical pipeline, with R&D expense increasing $6.3 million to $32.9 million compared with $26.6 million for the 2017 period.
  • Net loss of $43.1 million or $0.08 per share during the three months ended March 31, 2018 compares with a net loss of $34.5 millionor $0.06 per share for the comparable period of 2017.
  • Cash, cash equivalents and marketable securities were $99.9 million as of March 31, 2018.
“We are pleased to report steady sequential-quarter growth for RAYALDEE and 4Kscore, as well as improvement in our lab business from Q4 of last year,” said Phillip Frost, Chairman and Chief Executive Officer of OPKO Health. “The improved first quarter results were in line with our expectations, starting 2018 positively coming off challenging fourth quarter 2017 results. These factors, taken together, reflect progress across the breadth of our commercial and laboratory services.”

Business Highlights

  • RAYALDEE total prescriptions reported by IMS for Q1 2018 increased 730% compared with Q1 2017 and 38% compared with Q4 2017: As of May 1, 2018, more than 79% of patients had access to RAYALDEE under their insurance plans.
  • 4Kscore utilization in Q1 2018 increased 13% compared with Q1 2017: Five abstracts of studies further demonstrating the utility of the 4Kscore test in the management of prostate cancer are to be presented at the American Urological Association meeting May 18-21.
  • Appointed Geoff Monk as General Manager, BioReference Laboratories: Mr. Monk is well prepared to lead BRL with more than 20 years of management experience in the diagnostic laboratory business. Mr. Monk was previously Managing Director of the New York and New Jersey unit of Quest Diagnostics.
  • Advanced the Phase 2b trial for our SARM (selective androgen receptor modulator) to treat benign prostatic hyperplasia (BPH): Enrollment is ongoing in this dose-ranging study for our orally administered SARM. This medicine is expected to improve the symptoms of BPH by reducing prostate size and, on the basis of data from a previous trial in 350 men, increase muscle mass and bone strength and decrease body fat. BPH affects approximately 50 million men in the U.S.
  • Initiated a Phase 2b clinical trial for OPK88003, 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.
  • Premarket Approval (PMA) application for Claros® point-of-care PSA test under review by FDA: OPKO has submitted a PMA for a PSA test utilizing the Claros 1 immunoassay analyzer, a novel diagnostic instrument that can provide rapid, quantitative blood test results in 10 minutes in the physician’s office with only a finger stick drop of whole blood. A second product utilizing the Claros platform to measure testosterone is advancing toward a 510(k) submission to the FDA later this year.
  • Global and Japanese Phase 3 registration trials for hGH-CTP in pediatric growth hormone deficient children are continuing to enroll patients: The global pediatric study compares a single weekly administration with daily injections of a currently marketed growth hormone product. The global and Japanese pediatric studies utilize the pen device and formulation that will be launched commercially upon approval. The pediatric segment represents more than 80% of the market for treatment of hGH deficiency.
  • Initiation of three additional Phase 2 clinical trials are anticipated in 2018:
    • RAYALDEE line extension in dialysis patients with secondary hyperparathyroidism (SHPT): Together with our partners, Vifor Fresenius and Japan Tobacco, OPKO is developing RAYALDEE for Stage 5 chronic kidney disease (CKD) patients with SHPT undergoing dialysis and anticipates initiating a global Phase 2 trial during Q3 of this year.
    • OPKO’s NK-1 antagonist to treat pruritus (itching) in Stage 5 CKD patients undergoing dialysis: An Investigational New Drug application was submitted to the FDA and plans are being finalized to begin a single-dose Phase 2a trial in dialysis patients to treat severe itching. Approximately 50% of renal dialysis patients experience pruritus.
    • OPKO’s AntagoNAT oligonucleotide OPK88001 to treat Dravet’s syndrome: Three clinical research centers in the United States are expected to participate in this first-in-human trial of OPKO’s AntagoNAT to treat Dravet’s syndrome.
Conference Call & Webcast Information
 












anonymous said:
OPKO Health Reports First Quarter 2018 Financial Results
Conference Call begins today at 4:30 p.m. Eastern Time
MIAMI, May 08, 2018 (GLOBE NEWSWIRE) -- OPKO Health, Inc.(NASDAQ:OPK) reports financial results and business highlights for the three months ended March 31, 2018.

Financial Highlights

  • Consolidated revenues for the three months ended March 31, 2018 were $254.9 million compared with $266.4 million for the comparable period of 2017.
    • Revenue from services were $211.3 million for the three months ended March 31, 2018 compared with $228.6 million for the comparable 2017 period. While not directly comparable, this represents a marked improvement from the most recently completed quarter ended December 31, 2017.
    • Revenue from products included $3.7 million of revenue from RAYALDEE during the first quarter of 2018. Revenues from RAYALDEE were deferred during the initial launch period so there is no prior-year comparison.
  • During the three months ended March 31, 2018, operating expenses included investment in commercial activities supporting the launch of RAYALDEE of $7.3 million and continued investment in our pharmaceutical pipeline, with R&D expense increasing $6.3 million to $32.9 million compared with $26.6 million for the 2017 period.
  • Net loss of $43.1 million or $0.08 per share during the three months ended March 31, 2018 compares with a net loss of $34.5 millionor $0.06 per share for the comparable period of 2017.
  • Cash, cash equivalents and marketable securities were $99.9 million as of March 31, 2018.
“We are pleased to report steady sequential-quarter growth for RAYALDEE and 4Kscore, as well as improvement in our lab business from Q4 of last year,” said Phillip Frost, Chairman and Chief Executive Officer of OPKO Health. “The improved first quarter results were in line with our expectations, starting 2018 positively coming off challenging fourth quarter 2017 results. These factors, taken together, reflect progress across the breadth of our commercial and laboratory services.”

Business Highlights

  • RAYALDEE total prescriptions reported by IMS for Q1 2018 increased 730% compared with Q1 2017 and 38% compared with Q4 2017: As of May 1, 2018, more than 79% of patients had access to RAYALDEE under their insurance plans.
  • 4Kscore utilization in Q1 2018 increased 13% compared with Q1 2017: Five abstracts of studies further demonstrating the utility of the 4Kscore test in the management of prostate cancer are to be presented at the American Urological Association meeting May 18-21.
  • Appointed Geoff Monk as General Manager, BioReference Laboratories: Mr. Monk is well prepared to lead BRL with more than 20 years of management experience in the diagnostic laboratory business. Mr. Monk was previously Managing Director of the New York and New Jersey unit of Quest Diagnostics.
  • Advanced the Phase 2b trial for our SARM (selective androgen receptor modulator) to treat benign prostatic hyperplasia (BPH): Enrollment is ongoing in this dose-ranging study for our orally administered SARM. This medicine is expected to improve the symptoms of BPH by reducing prostate size and, on the basis of data from a previous trial in 350 men, increase muscle mass and bone strength and decrease body fat. BPH affects approximately 50 million men in the U.S.
  • Initiated a Phase 2b clinical trial for OPK88003, 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.
  • Premarket Approval (PMA) application for Claros® point-of-care PSA test under review by FDA: OPKO has submitted a PMA for a PSA test utilizing the Claros 1 immunoassay analyzer, a novel diagnostic instrument that can provide rapid, quantitative blood test results in 10 minutes in the physician’s office with only a finger stick drop of whole blood. A second product utilizing the Claros platform to measure testosterone is advancing toward a 510(k) submission to the FDA later this year.
  • Global and Japanese Phase 3 registration trials for hGH-CTP in pediatric growth hormone deficient children are continuing to enroll patients: The global pediatric study compares a single weekly administration with daily injections of a currently marketed growth hormone product. The global and Japanese pediatric studies utilize the pen device and formulation that will be launched commercially upon approval. The pediatric segment represents more than 80% of the market for treatment of hGH deficiency.
  • Initiation of three additional Phase 2 clinical trials are anticipated in 2018:
    • RAYALDEE line extension in dialysis patients with secondary hyperparathyroidism (SHPT): Together with our partners, Vifor Fresenius and Japan Tobacco, OPKO is developing RAYALDEE for Stage 5 chronic kidney disease (CKD) patients with SHPT undergoing dialysis and anticipates initiating a global Phase 2 trial during Q3 of this year.
    • OPKO’s NK-1 antagonist to treat pruritus (itching) in Stage 5 CKD patients undergoing dialysis: An Investigational New Drug application was submitted to the FDA and plans are being finalized to begin a single-dose Phase 2a trial in dialysis patients to treat severe itching. Approximately 50% of renal dialysis patients experience pruritus.
    • OPKO’s AntagoNAT oligonucleotide OPK88001 to treat Dravet’s syndrome: Three clinical research centers in the United States are expected to participate in this first-in-human trial of OPKO’s AntagoNAT to treat Dravet’s syndrome.
Conference Call & Webcast Information
Click to expand...

79% what a freaking lie!!!
 


















Did they hire Kirk to cook the books ? Product stinks , management stinks , bonus stinks. Here’s an idea how about you pay reps instead of worrying about credit cards and sign in sheets you have bigger issues your sales force is miserable and you put together a council and won’t fix the issues discussed ? Great job .
 












anonymous said:
OPKO Health Reports First Quarter 2018 Financial Results
Conference Call begins today at 4:30 p.m. Eastern Time
MIAMI, May 08, 2018 (GLOBE NEWSWIRE) -- OPKO Health, Inc.(NASDAQ:OPK) reports financial results and business highlights for the three months ended March 31, 2018.

Financial Highlights

  • Consolidated revenues for the three months ended March 31, 2018 were $254.9 million compared with $266.4 million for the comparable period of 2017.
    • Revenue from services were $211.3 million for the three months ended March 31, 2018 compared with $228.6 million for the comparable 2017 period. While not directly comparable, this represents a marked improvement from the most recently completed quarter ended December 31, 2017.
    • Revenue from products included $3.7 million of revenue from RAYALDEE during the first quarter of 2018. Revenues from RAYALDEE were deferred during the initial launch period so there is no prior-year comparison.
  • During the three months ended March 31, 2018, operating expenses included investment in commercial activities supporting the launch of RAYALDEE of $7.3 million and continued investment in our pharmaceutical pipeline, with R&D expense increasing $6.3 million to $32.9 million compared with $26.6 million for the 2017 period.
  • Net loss of $43.1 million or $0.08 per share during the three months ended March 31, 2018 compares with a net loss of $34.5 millionor $0.06 per share for the comparable period of 2017.
  • Cash, cash equivalents and marketable securities were $99.9 million as of March 31, 2018.
“We are pleased to report steady sequential-quarter growth for RAYALDEE and 4Kscore, as well as improvement in our lab business from Q4 of last year,” said Phillip Frost, Chairman and Chief Executive Officer of OPKO Health. “The improved first quarter results were in line with our expectations, starting 2018 positively coming off challenging fourth quarter 2017 results. These factors, taken together, reflect progress across the breadth of our commercial and laboratory services.”

Business Highlights

  • RAYALDEE total prescriptions reported by IMS for Q1 2018 increased 730% compared with Q1 2017 and 38% compared with Q4 2017: As of May 1, 2018, more than 79% of patients had access to RAYALDEE under their insurance plans.
  • 4Kscore utilization in Q1 2018 increased 13% compared with Q1 2017: Five abstracts of studies further demonstrating the utility of the 4Kscore test in the management of prostate cancer are to be presented at the American Urological Association meeting May 18-21.
  • Appointed Geoff Monk as General Manager, BioReference Laboratories: Mr. Monk is well prepared to lead BRL with more than 20 years of management experience in the diagnostic laboratory business. Mr. Monk was previously Managing Director of the New York and New Jersey unit of Quest Diagnostics.
  • Advanced the Phase 2b trial for our SARM (selective androgen receptor modulator) to treat benign prostatic hyperplasia (BPH): Enrollment is ongoing in this dose-ranging study for our orally administered SARM. This medicine is expected to improve the symptoms of BPH by reducing prostate size and, on the basis of data from a previous trial in 350 men, increase muscle mass and bone strength and decrease body fat. BPH affects approximately 50 million men in the U.S.
  • Initiated a Phase 2b clinical trial for OPK88003, 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.
  • Premarket Approval (PMA) application for Claros® point-of-care PSA test under review by FDA: OPKO has submitted a PMA for a PSA test utilizing the Claros 1 immunoassay analyzer, a novel diagnostic instrument that can provide rapid, quantitative blood test results in 10 minutes in the physician’s office with only a finger stick drop of whole blood. A second product utilizing the Claros platform to measure testosterone is advancing toward a 510(k) submission to the FDA later this year.
  • Global and Japanese Phase 3 registration trials for hGH-CTP in pediatric growth hormone deficient children are continuing to enroll patients: The global pediatric study compares a single weekly administration with daily injections of a currently marketed growth hormone product. The global and Japanese pediatric studies utilize the pen device and formulation that will be launched commercially upon approval. The pediatric segment represents more than 80% of the market for treatment of hGH deficiency.
  • Initiation of three additional Phase 2 clinical trials are anticipated in 2018:
    • RAYALDEE line extension in dialysis patients with secondary hyperparathyroidism (SHPT): Together with our partners, Vifor Fresenius and Japan Tobacco, OPKO is developing RAYALDEE for Stage 5 chronic kidney disease (CKD) patients with SHPT undergoing dialysis and anticipates initiating a global Phase 2 trial during Q3 of this year.
    • OPKO’s NK-1 antagonist to treat pruritus (itching) in Stage 5 CKD patients undergoing dialysis: An Investigational New Drug application was submitted to the FDA and plans are being finalized to begin a single-dose Phase 2a trial in dialysis patients to treat severe itching. Approximately 50% of renal dialysis patients experience pruritus.
    • OPKO’s AntagoNAT oligonucleotide OPK88001 to treat Dravet’s syndrome: Three clinical research centers in the United States are expected to participate in this first-in-human trial of OPKO’s AntagoNAT to treat Dravet’s syndrome.
Conference Call & Webcast Information
Click to expand...


Where do you think the stock will end up with the Q3 numbers are announced?
 












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