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 |
ITEM 1.01. | Entry into a Material Definitive Agreement. |
ITEM 2.02. | Results of Operations and Financial Condition. |
ITEM 2.03. | Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant. . |
ITEM 3.02. | Unregistered Sales of Equity Securities. |
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 November 9, 2018 | |
99.2 | Press Release of the Company dated November 8, 2018 |
Exhibit No. | Description | |
99.1 | ||
99.2 |
OPKO Health, Inc. | |||
By: | /s/ Adam Logal | ||
Date: November 9, 2018 | Name: | Adam Logal | |
Title: | Senior Vice President, Chief Financial Officer | ||
• | 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. |
• | 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. |
• | 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. |
• | 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. |
• | 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. |
• | 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 |
• | 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. |
• | 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. |
• | 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. |
• | 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. |
• | 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. |
• | 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. |
OPKO Health, Inc. and Subsidiaries Condensed Consolidated Balance Sheets (in millions) | |||||||
As of | |||||||
September 30, 2018 | December 31, 2017 | ||||||
Assets: | |||||||
Cash, cash equivalents and marketable securities | $ | 43.7 | $ | 91.5 | |||
Other current assets | 246.1 | 257.4 | |||||
Total Current Assets | 289.8 | 348.9 | |||||
In-process Research and Development and Goodwill | 1,360.0 | 1,364.4 | |||||
Other assets | 831.2 | 876.7 | |||||
Total Assets | $ | 2,481.0 | $ | 2,590.0 | |||
Liabilities and Equity: | |||||||
Current liabilities | $ | 286.9 | $ | 316.5 | |||
2033 Senior Notes and 5% Convertible Notes | 87.6 | 29.2 | |||||
Deferred tax liabilities | 134.1 | 148.7 | |||||
Other long-term liabilities, principally deferred revenue, contingent consideration and lines of credit | 183.8 | 240.0 | |||||
Total Liabilities | 692.4 | 734.4 | |||||
Equity | 1,788.6 | 1,855.6 | |||||
Total Liabilities and Equity | $ | 2,481.0 | $ | 2,590.0 | |||
OPKO Health, Inc. and Subsidiaries Condensed Consolidated Statements of Operations (in millions, except share and per share data) | ||||||||||||||||||||
For the three months ended September 30, | For the nine months ended September 30, | |||||||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||||||
Revenues | ||||||||||||||||||||
Revenue from services | $ | 202.8 | $200.9 | $630.2 | $ | 663.3 | ||||||||||||||
Revenue from products | 25.4 | 22.8 | 81.8 | 74.0 | ||||||||||||||||
Revenue from transfer of intellectual property | 21.6 | 22.3 | 56.4 | 67.7 | ||||||||||||||||
Total revenues | 249.8 | 246.0 | 768.4 | 805.0 | ||||||||||||||||
Costs and expenses | ||||||||||||||||||||
Cost of revenues | 150.9 | 151.3 | 455.1 | 463.5 | ||||||||||||||||
Selling, general and administrative | 84.1 | 103.2 | 263.2 | 318.7 | ||||||||||||||||
Research and development | 30.2 | 32.5 | 92.3 | 92.2 | ||||||||||||||||
Contingent consideration | 1.2 | (11.20) | (12.40) | (4.50) | ||||||||||||||||
Amortization of intangible assets | 16.9 | 18.0 | 51.4 | 53.9 | ||||||||||||||||
Total Costs and expenses | 283.3 | 293.8 | 849.6 | 923.8 | ||||||||||||||||
Operating loss | (33.50) | (47.80) | (81.20) | (118.80) | ||||||||||||||||
Other income and (expense), net | (3.90) | (8.50) | 5.4 | 1.0 | ||||||||||||||||
Loss before income taxes and investment losses | (37.40) | (56.30) | (75.80) | (117.80) | ||||||||||||||||
Income tax benefit (provision) | 11.6 | 24.4 | 10.4 | 42.3 | ||||||||||||||||
Income (loss) before investment losses | (25.80) | (31.90) | (65.40) | (75.50) | ||||||||||||||||
Loss from investments in investees | (1.90) | (4.00) | (11.60) | (11.80) | ||||||||||||||||
Net loss | $ | (27.70 | ) | $ | (35.90 | ) | $ | (77.00 | ) | $ | (87.30 | ) | ||||||||
Loss per share, basic and diluted | $ | (0.050 | ) | $ | (0.060 | ) | $ | (0.140 | ) | $ | (0.160 | ) | ||||||||
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