OPKO Health Inc.

Declaration of Voting Results & Voting Rights Announcements • Jun 16, 2017

UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 8-K

CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): June 15, 2017

OPKO Health, Inc.

(Exact Name of Registrant as Specified in Charter)

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)

(305) 575-4100

Registrant's telephone number, including area code

Not applicable

(Former name or former address if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934(§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

ITEM 5.07. Submissionof Matters to a Vote of Security Holders.

On June 15, 2017, OPKO Health, Inc. (the "Company") held its 2017 Annual Meeting of Stockholders (the "Annual Meeting"). Below is a summary of the proposal and corresponding vote.

1. All eight nominees were elected to the Board of Directors with each director receiving votes as follows:

Election of Directors	For	Withheld
Phillip Frost, M.D.	313,587,917	34,590,555
Jane H. Hsiao, Ph.D.	305,500,426	42,678,046
Steven D. Rubin	304,154,561	44,023,911
Richard M. Krasno, Ph.D.	344,682,759	3,495,713
Richard A. Lerner, M.D	286,997,023	61,181,449
John A. Paganelli	291,162,570	57,015,902
Richard C. Pfenniger, Jr.	333,531,789	14,646,683
Alice Lin-Tsing Yu, M.D., Ph.D.	296,686,376	18,792,096

1. The approval, on a non-binding advisory basis, of the compensation of the named executive officers of the Company ("Say On Pay") as disclosed in the Company's Proxy Statement for the Annual Meeting. The votes on this proposal were as follows:

For	Against	Abstain
316,825,919	30,329,801	1,022,752

1. The selection of one year, on a non-binding advisory basis, as the frequency with which the stockholders are provided a non-binding advisory vote on Say on Pay in future years. The votes on this proposal were as follows:

1 Year	2 Years	3 Years	Abstain
309,086,990	692,622	37,254,593	1,144,267

Based on this result and in accordance with the previous recommendation of the Company's Board of Directors, the Company will hold a non-binding, advisory vote on Say On Pay every year.

There were no broker non-votes for the proposals. No other matters were considered or voted upon at the meeting.

ITEM 7.01. RegulationFD Disclosure.

On June 15, 2017, the Company held its Annual Meeting of Stockholders. Copies of the presentations presented at the Annual Meeting are furnished with this Current Report on Form 8-K as Exhibit 99.1.

Statements are made in the presentations which are not historical are forward-looking statements that reflect management's current views with respect to future events and performance and may include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions. Such statements are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The fact that these presentation materials are being furnished should not be deemed an admission as to the materiality of any information contained in the materials.

The information contained in Item 7.01 to this Current Report on Form 8-K and Exhibit 99.1 shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing by the Company under the Act, unless expressly stated otherwise.

ITEM 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number	Description
99.1	OPKO Presentation – 2017 Annual Meeting of Stockholders held June 15, 2017.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

OPKO Health, Inc.

Date: June 15, 2017 By /s/ Adam Logal

Name: Adam Logal Title: Senior. Vice President, Chief Financial Officer

ОРКО НЕАЦТН, INC.

ANNUAL SHAREHOLDERS MEETING

JUNE 15, 2017

Exhibit 99

OPKO

This presentation contains "forward-looking statem is defined under the Private Securities Liligation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "projects," "will," "may, "anticipates," "believes" "should," "hends" "estimates," "potential," and other words of similar meaning, including statements regarding our essimated revenues and financial projections, whether we will improve profitability and cash flow through revenue cycle management, our ability to reduce costs and of 2017 and grow profit through 2018 in ine with industry, the potential for our products under expansion in adoplion rates and patient access for Rayaldee, expected growth in sales of Rayaldee and the 4Kscore test, the expansion of our renal field sales force and the timelines for doing so, expectations regarding the KDGO guideline recommendations, expected miles from the outlicense of our products, our ability to develop Rayaldee for additions, including stage 5 CKD, that the outcome of our clinical trias and validation studies will support marketing approval or commercialization for our products, the expected market for our products, the expected timing for commencing and announcing results for our dinical trials, the timing for release of trial data and seeking and obtaining FDA and European regulator approvals as well as reimbursement coverage for our products, our ability to obtain a posilive coverage delemination for the 4Kscore, and the timing of commercial launch of our product candidates. These forward-looking statements are reflect our views as of the date they were made, and we unders statements. Such statements are subject to many risks and uncertainlies that could cause our actual results to differ materially from the activities and results anticipated in forward looking statements, including risks inherent in funding and obtaining regulatory approvals of new, commercially viable and competitive products and treatments, the success of our collaboration with Fresenius, general market factors, competive product development, product availability, federal and state regulation, delays associated with development of novel technologies, unexpected difficulties and delays in validating and testing product candidates, the regulats and indicalions, manufacturing issues that may arise, the cost of funding lenghy research programs, the need for additional capital, the possibility of infinging a third party's patents or other intellectual property rights, the uncertainty of obling our products and in successfully enforing them against third parties, and the possibility of fitigation, anony in of the risks identfied under the heading Risk Factors in our Anual Report on Form 10-K and other filings with the Securities and Exchange Commission.

opko

ADOPTION OF RAYALDEE IS STEADILY EXPANDING

Source: IMS Data

PATIENT ACCESS TO RAYALDEE IS STEADILY EXPANDING

SALES AND MEDICAL FORCES ARE EXPANDING

• Our field sales force at launch (35 Reps and 5 Regional Managers) was sized significantly smaller than most competitive field forces in nephrology.
• Our field medical force at launch (12 MSLs) was sized significantly smaller than most competitive medical forces in nephrology.
• Over the next 90 days, we are planning to increase the size of the field sales force (to 70 Reps and 7 Regional Managers).

UPDATED CLINICAL PRACTICE GUIDELINE EXPECTED THIS MONTH OPKO

= Updated KDIGO guideline for CKD-Mineral and Bone Disorder is expected to be available online in June, and published shortly afterwards in Kidney International.

Under the draft guideline:

= Calcitriol and its 1α-hydroxylated vitamin D analogs are not suggested for routine use in adult patients with SHPT and CKD stages 3-4 (non-dialysis).

· Nutritional vitamin D supplements (cholecalciferol or ergocalciferol) are characterized as "unproven".

RAYALDEE LICENSE WITH VIFOR FRESENIUS JOINT VENTURE

Terms of global collaboration with Vifor Fresenius Medical Care Renal Pharma (VFMCRP):

FINANCIAL	Up to \$282 million in upfront and milestone payments to OPKO (\$50M to date) · Up to \$555 million more if VFMCRP exercises option for U.S. dialysis market Double digit tiered royalties
DEVELOPMENT	· OPKO and VFMCRP funding development program for hemodialysis indication · VFMCRP responsible for funding: · All commercialization activities in the territory · All development costs necessary for approval in stage 3-4 CKD
COMMERCIAL	· VFMCRP has rights to commercialize RAYALDEE worldwide excluding OPKO's territory: U.S., Central and South America (except for Mexico), Russia, China, Taiwan, Japan

• · New Drug Submission (NDS) filed in Canada in May 2017
• · Phase 2 trial in hemodialysis patients targeted to start in Q4 2017
• · Licensing efforts for other ex-US territories ongoing
• · Marketing Authorization Application (MAA) in EU targeted for H1 2018

4Kscore

STRONG GROWTH - BUILD FURTHER MOMENTUM

• · Specialized sales force for Urology
• · Sales incentive program
• TV advertisement in Northeast
• · Expanded coverage

4KSCORE MARKETING UPDATE

• · Medicare and all large national payers providing good coverage
• · Strong scientific and commercial presence at AUA (Boston, May 2017)
• · VA clinical trial -> VA formulary
• · Study to address Palmetto LCD issue underway
• · NCCN Guidelines update: positive for 4Kscore and Prostate Cancer Hereditary Panel testing

CLAROS UPDATE

• PSA clinical trial data collection closing in early July
• · PMA preparation underway
• · Testosterone assay meets performance goals and in final stages of development
• · 510(k) filing in 1Q2018

hGH-CTP PROGRAM STATUS

• · Initiated Phase 3 pediatric hGH-CTP study in December 2016
  • 220 patients, non-inferiority comparison of weekly hGH-CTP to daily growth hormone
  • Global study CROs selected; sites initiated in December
  • Easy-to-use, disposable, refrigerated pen device
• · Phase 3 adult hGH-CTP
  • Conducting post hoc outlier analysis
  • No safety concerns -
  • Switching to pen device in open label extension
• · Initiating pediatric hGH-CTP registration study in Japan
  • 44 patients, comparison of weekly hGH-CTP to daily growth hormone
  • Same pen device, dosage and formulation used in global study

PEN INJECTION DEVICE FOR GROWTH HORMONE

OPK-88004 SELECTIVE ANDROGEN RECEPTOR MODULATOR (SARM) FOR THE TREATMENT OF BPH

• · Enlarged prostate in men caused by changes in hormone balance and in cell growth
• · > 50% of male over 70 years of age have BPH

MECHANISM OF ACTION

• · OPK-88004, a selective androgen receptor modulator
  • Antagonistic effects on prostate
  • Anabolic effects on other tissues (i.e. muscle and bone)

OPK-88004 PHASE 2 STUDY IN 350 MALE SUBJECTS

OPK-88004 SELECTIVE ANDROGEN RECEPTOR MODULATOR (SARM) FOR THE TREATMENT OF BPH

OPK-88004 PHASE 2b CLINICAL STUDY (SAR 202)

• · Once-a-day Dosing in Men with Signs and Symptoms of Benign Prostatic Hyperplasia
• · 100 naïve BPH patients
• · Expected to start in 2H 2017

OPK-88004 -OTHER POTENTIAL INDICATIONS

• · Urinary stress incontinence
  • Bladder leakage with physical activity
  • One in three women experiences stress incontinence in her life
• · Frailty in dialysis patients
  • Frailty is common in dialysis patients of all ages and is a sensitive marker of morbidity
  • As high as 73% of hemodialysis patients may experience frailty and subsequent decrease in quality of life

OPK-88003 OXYNTOMODULIN ANALOG FOR THE TREATMENT OF TYPE 2 DIABETES AND OBESITY

• · 26 million diabetics in US: drug development focused on: blood glucose control and reducing body weight
• · OPK-88003 is an once-weekly analog with both GLP-1 and glucagon activity
• · Data support that combining GLP-1 and glucagon activity provides superior weight loss
• · Data from phase 2 study in 420 type 2 diabetes patients (week 12):

OPK-88003 CLINICAL DEVELOPMENT

• · Phase 2b dose-escalation study expected to start by the end of the year
• · Preparation of pen and formulation for phase 3 is ongoing

OPK-88002 NK 1 ANTAGONIST FOR THE TREATMENT OF PRURITUS IN DIALYSIS PATIENTS

PRURITUS

• · Acute and chronic pruritus ("itching") occurs in 10% to 15% of the population
  • Most prevalent in skin, kidney and liver diseases
• · Substance P is implicated in pruritus
• · NK-1 antagonists block substance P activity and has been shown to reduce itching in human trials

PRURITUS IN DIALYSIS PATIENTS

• · Major medical need and requires management
• · 70 to 90% of patients Kidney dialysis patients suffer from Pruritus

PHASE 2a CLNICAL STUDY

· Expected to begin in 2H 2017

BioReference Laboratories

OPKO Shareholders Presentation June 15th, 2017

The Vision ...

We will be the premium provider of laboratory medicine and pathology consultation services and the definitive leader in diagnostic innovations.

The Focus ...

Partner with healthcare providers, integrated health systems, payers, and patients to provide diagnostic information that preserves and prolongs health and more efficiently and effectively guides the precision treatment of disease.

The Metric ...

We will be the laboratory that physicians, healthcare systems, and patients request for their testing and diagnosis.

Why?

It's the right thing to do.

BioReference ABORA an OPKO Health Company

The economic ecosystem is finally aligning with the right thing to do.

Tectonic Shifts In The Healthcare Ecosystem In Recent Years

• · Consolidation and Integration
• · Move from reimbursement by volume of care to risk-based, metric-driven "value" of care

The pace of transition is accelerating ...

But we are still in transition.

Company Highlights

• · Third largest clinical lab in USA
• · Receives specimens from 40,000 patient per day
• · Accounts in all 50 states
• · 300 Patient Service Centers and 600 In-Office Phlebotomists
• · Central laboratory in Elmwood Park, NJ
• · GeneDx laboratory in Gaithersburg, MD
• · Satellite clinical laboratories:
  • Campbell, CA O
  • Melbourne, FL O
  • Tampa, FL O
  • Houston, TX O

Key Assets - BRLI

• · Complete portfolio of testing from routine to esoteric
• · 42 board-certified, subspecialty trained pathologists
• · 30 years of patient data, highly diverse and longitudinal

Key Assets - GeneDx

• · Premium brand in germline genomic testing "the doctor's doctor"
• · Over 100 MD and PhD specialists in genomic medicine
• · Over 100 Certified Genetic Counselors
• · Largest portfolio of genomic tests in the country
• · Leader in whole exome sequencing with largest patient database
• · Proprietary software tools for bioinformatic analysis

Laboratorio Buena Salud BioReference Laboratories Clinical Laboratory GenPath Women's Health GenPath Oncology GeneDx

BioReference Laboratories

Company Challenges and Solutions

BioReference

LABORATOR an OPKO Health Company

Divisional Challenges

BioReference LABORATOR an OPKO Health Company

• * Value based payment systems
  • 20 Continued price compression
    • * PAMA

GenPath Oncology

• Consolidation of oncology practices into integrated healthcare systems
• * Requires IT expertise to rapidly interface into enterprise sytems

GenPath Women's Health

• * Major changes in clinical guidelines for testing
• * Pap Testing every 3 years

GeneDx

• * Pricing pressures by top-line focused startups
• * Increasing demand for ease of access

The Strategy - Collaborative Partnerships

Hospital Systems 4K Score

• Northwell Joint Venture
• University of California -Exclusive Contract
• Vanderbilt University
• Kaiser DAMMANANA
• · Adoption by integrated healthcare systems
• · Key Opinion Leader Support

Lead with GeneDx

• · Opens the door to the remainder of the portfolio
• · Growth by adoption of tests by owned and affiliated practicees

Patient-Centric Integration

Clinical Testing Decision Support

It's All About The Data

Improvement in Revenue Collection

Machine Learning/Artificial Intelligence for Clinical Predictive Analytics

BioReference - our focus

Profitability and cash flow

• · Improve profitability and cash flow through a revenue cycle management program
• · Focus on operational effectiveness to meaningfully reduce costs
• · Target improved profit margins during 2017
• · Grow profit in 2018 and beyond to be in line with the industry

BioReference LABORATORIES an OPKO Health Company

Historical growth and profitability (in 000's)

	Fiscal Year
			2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
NetRevenues 163,896 193,134 250,431 301,071 362,654 458,024 522,081 614,255 715,354 832,282										1,010,442
Net Income			7,621 11,291 13,957 15,617 21,850 26,381 36,359 42,156 45,825 46,758							24,711

· As a result of the acquisition, 2015 is not comparable and therefore is not reflected in the table or chart.

Historical Cash Flows

(in 000's)

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 Stub