Delaware | 001-33528 | 75-2402409 | ||
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
4400 Biscayne Blvd. Miami, Florida | 33137 | |
(Address of Principal Executive Offices) | (Zip Code) |
Not Applicable |
Former name or former address, if changed since last report |
o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Emerging growth company | o |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Common Stock | OPK | NASDAQ Global Select Market |
ITEM 2.02. | Results of Operations and Financial Condition. |
ITEM 7.01. | Regulation FD Disclosure. |
ITEM 9.01. | Financial Statements and Exhibits. |
(d) | Exhibits |
Exhibit No. | Description | |
99.1 | Press Release of the Company dated May 7, 2019 | |
99.2 | Press Release of the Company dated April 30, 2019 |
Exhibit No. | Description | |
99.1 | ||
99.2 |
OPKO Health, Inc. | |||
By: | /s/ Adam Logal | ||
Date: May 7, 2019 | Name: | Adam Logal | |
Title: | Senior Vice President, Chief Financial Officer | ||
• | RAYALDEE total prescriptions reported by IQVIA increased 121% in 1Q 2019 compared with 1Q 2018: Total prescriptions for the first three months of 2019 increased to over 10,400, compared with approximately 4,700 during the comparable period of 2018. |
• | RAYALDEE Marketing Authorization Applications filed by Vifor Fresenius accepted for review in several European countries: These applications request approval to market RAYALDEE for the treatment of secondary hyperparathyroidism (SHPT) in adult non-dialysis patients with chronic kidney disease (CKD). |
• | American Journal of Nephrology published article and editorial: A post hoc analysis of RAYALDEE pivotal trials was published in the March edition of the American Journal of Nephrology and provides the first prospective data demonstrating that the current clinical practice guideline target for serum total 25-hydroxyvitamin D (30 ng/ml) is too low to decrease elevated serum PTH levels in CKD patients. These data show that the correct target is at least 51 ng/mL, and possibly as high as 93 ng/mL, levels no competitive therapy can reliably attain. This analysis received a favorable review in a co-published editorial by prominent nephrology KOLs. |
• | OPK88003 topline results reported from Phase 2 diabetes and obesity trial: In the mITT patient population, which included all patients who had a single dose of drug and one post-baseline efficacy value, HbA1c decreased by -1.3% (p-value <0.0001) and body weight decreased by -4.4 Kg (p-value <0.0001) from baseline. In the Per Protocol patient population, which included patients who were treated for at least 26 weeks and were compliant with the protocol for the duration of the trial, HbA1c decreased by -1.47% (p-value <0.0001) and body weight decreased by -5.5 Kg (p-value <0.0001) from baseline. The safety profile was similar to that expected for the incretin class of drugs, with GI side effects such as nausea, vomiting and diarrhea mostly mild and occurring during the dose-escalation phase. |
• | 4Kscore® utilization remained strong during 1Q 2019 with approximately 19,400 tests performed: With all required documentation nearly complete, the company plans to make a |
• | BioReference and its GeneDx subsidiary expand access to commercially insured lives: BioReference and GeneDx have been selected for inclusion in the UnitedHealthcare Preferred Lab Network beginning July 1, 2019. This was a comprehensive process that evaluated service standards, turnaround time, quality and accreditation. More than 300 laboratories were invited to apply; only 100 submitted applications due to the complexity of the requirements, and BioReference and GeneDx, along with five other laboratories, earned a place in the Preferred Lab Network. In addition, effective April 1, 2019, BioReference and GeneDx are now in-network providers with Humana, which provides access to 11 million additional lives. |
• | Consistent with financial guidance issued in February 2019, the net loss for the first quarter of 2019 was $80.8 million, compared with a net loss of $43.1 million for the comparable period of 2018. |
• | Consolidated revenues for the first quarter of 2019 were $222.5 million, compared with $254.9 million for the comparable period of 2018. During the 2019 quarter, revenue from services was $178.9 million, revenue from products was $25.3 million, including RAYALDEE net revenue of $5.8 million, and revenue from licensing and intellectual property was $18.3 million. The decrease in revenue from services principally reflect reimbursement headwinds from higher denial rates in the company’s esoteric testing lines of business. |
• | Operating expenses for the first quarter of 2019 of $297.8 million included continued investment in the company’s pharmaceutical pipeline, with R&D expense of $36.5 million, principally for pediatric trials with the hGH-CTP long-acting human growth hormone product. |
• | In February 2019 OPKO completed the sale of $200 million aggregate principal amount of 4.5% Convertible Senior Notes due 2025, as well as retired and repaid $28.8 million of its 2033 Convertible Notes. |
• | Cash, cash equivalents and marketable securities were $207.3 million as of March 31, 2019. |
OPKO Health, Inc. and Subsidiaries Condensed Consolidated Balance Sheets (in millions) | |||||||
As of | |||||||
March 31, 2019 | December 31, 2018 | ||||||
Assets: | |||||||
Cash, cash equivalents and marketable securities | $ | 207.3 | $ | 96.5 | |||
Other current assets | 227.9 | 221.2 | |||||
Total Current Assets | 435.2 | 317.7 | |||||
In-process Research and Development and Goodwill | 1,334.1 | 1,335.8 | |||||
Other assets | 806.0 | 797.6 | |||||
Total Assets | $ | 2,575.3 | $ | 2,451.1 | |||
Liabilities and Equity: | |||||||
Current liabilities | $ | 396.1 | $ | 288.3 | |||
Convertible Notes | 203.7 | 57.3 | |||||
Deferred tax liabilities, net | 116.0 | 115.2 | |||||
Other long-term liabilities, principally deferred revenue, contingent consideration and lines of credit | 96.8 | 199.0 | |||||
Total Liabilities | 812.6 | 659.8 | |||||
Equity | 1,762.7 | 1,791.3 | |||||
Total Liabilities and Equity | $ | 2,575.3 | $ | 2,451.1 | |||
For the three months ended March 31, | |||||||
2019 | 2018 | ||||||
Revenues | |||||||
Revenue from services | $ | 178.9 | $ | 211.3 | |||
Revenue from products | 25.3 | 27.9 | |||||
Revenue from transfer of intellectual property | 18.3 | 15.7 | |||||
Total revenues | 222.5 | 254.9 | |||||
Costs and expenses | |||||||
Cost of revenues | 144.0 | 154.1 | |||||
Selling, general and administrative | 95.2 | 91.5 | |||||
Research and development | 36.5 | 32.9 | |||||
Contingent consideration | 4.8 | 1.7 | |||||
Amortization of intangible assets | 16.6 | 17.3 | |||||
Asset impairment charges | 0.7 | 0.0 | |||||
Total Costs and expenses | 297.8 | 297.5 | |||||
Operating loss | (75.3) | (42.6) | |||||
Other income and (expense), net | (2.8) | 1.0 | |||||
Loss before income taxes and investment losses | (78.1) | (41.6) | |||||
Income tax benefit (provision) | (0.8) | 1.0 | |||||
Loss before investment losses | (78.9) | (40.6) | |||||
Loss from investments in investees | (1.9) | (2.5) | |||||
Net loss | $ | (80.8 | ) | $ | (43.1 | ) | |
Loss per share, basic and diluted | $ | (0.14 | ) | $ | (0.08 | ) | |
$=UZ2&/SK-#'9\'
M?6]YRPYVR&,K]*@'/-#QC4B,H;_N7 ,_CL)