425

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 18, 2015

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)

Registrant’s telephone number, including area code: (305) 575-4100

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):

x 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))

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

ITEM 8.01 Other Events.

On June 18, 2015, OPKO Health, Inc. (the “Company”) held its 2015 Annual Meeting of Stockholders (the “Annual Meeting”). Below is a summary of the proposal and corresponding vote.

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

Election of Directors	For		Withheld
Phillip Frost, M.D.		280,567,245		20,412,282
Jane H. Hsiao, Ph.D.		272,686,765		28,292,762
Steven D. Rubin		272,299,987		28,679,540
Robert A. Baron		298,914,343		2,065,184
Thomas E. Beier		292,111,995		8,867,532
Dmitry Kolosov		299,367,867		1,611,660
Richard A. Lerner, M.D		299,273,701		1,705,826
John A. Paganelli		292,228,594		8,750,933
Richard C. Pfenniger, Jr.		298,892,008		2,087,519
Alice Lin-Tsing Yu, M.D., Ph.D.		266,896,935		34,082,592

There were no broker non-votes for the proposal. No other matters were considered or voted upon at the Annual Meeting.

ITEM 7.01. Regulation FD Disclosure.

On June 18, 2015, 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 Exhibits 99.1, 99.2, and 99.3, respectively.

The information contained in Item 7.01 to this Current Report on Form 8-K and Exhibits 99.1, 99.2, and 99.3 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.

Important Information For Investors And Shareholders

This communication does not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities or a solicitation of any vote or approval. This communication relates to a proposed business combination between Bio-Reference Laboratories, Inc. (“Bio-Reference Laboratories”) and OPKO Health, Inc. (“OPKO”). In connection with this proposed business combination, Bio-Reference Laboratories and/or OPKO will file relevant materials with the Securities Exchange Commission (the “SEC”), including an OPKO registration statement on Form S-4 that will include a proxy statement of Bio-Reference Laboratories and constitute a prospectus of OPKO. INVESTORS AND SECURITY HOLDERS OF BIO-REFERENCE LABORATORIES AND OPKO ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS AND OTHER DOCUMENTS THAT MAY BE FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Any definitive proxy statement (if and when available) will be mailed to shareholders of Bio-Reference Laboratories. Investors and security holders will be able to obtain free copies of these documents (if and when available) and other documents filed with the SEC by Bio-Reference Laboratories and/or OPKO through the website maintained by the SEC at www.sec.gov. Copies of the documents filed with the SEC by Bio-Reference Laboratories will be available free of charge on Bio-Reference Laboratories’ website at http://www.bioreference.com or by contacting Bio-Reference Laboratories’ Investor Relations Department by email at tmackay@bioreference.com or by phone at (201) 791-2600. Copies of the documents filed with the SEC by OPKO will be available free of charge on OPKO’s website at www.opko.com or by contacting OPKO’s Investor Relations Department by email at contact@opko.com or by phone at (305) 575-4100.

Participants in Solicitation

Bio-Reference Laboratories, OPKO, their respective directors and certain of their respective executive officers may be considered participants in the solicitation of proxies in connection with the proposed transaction. Information about the directors and executive officers of Bio-Reference Laboratories is set forth in its Annual Report on Form 10-K for the year ended October 31, 2014, which was filed with the SEC on January 13, 2015, its Quarterly Report on Form 10-Q for the quarter ended April 30, 2015 which was filed with the SEC on June 9, 2015 and its Current Reports on Form 8-K, which were filed with the SEC on March 5, 2015, April 29, 2015 and June 4, 2015. Information about the directors and executive officers of OPKO is set forth in its amended Annual Report on Form 10-K for the year ended December 31, 2014, which was filed with the SEC on February 27, 2015 and April 30, 2015, its proxy statement for its 2015 annual meeting of stockholders, which was filed with the SEC on May 7, 2015, its Quarterly Report on Form 10-Q for the quarter ended March 31, 2015 which was filed with the SEC on May 11, 2015, its Current Report on Form 8-K, which was filed with the SEC on March 19, 2015 and its Quarterly Report on Form 10-K, which was filed with the SEC on June 18, 2015.

These documents can be obtained free of charge from the sources indicated above. Additional information regarding the participants in the proxy solicitations and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the proxy statement/prospectus and other relevant materials to be filed with the SEC when they become available.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements in this communication regarding the proposed acquisition of Bio-Reference Laboratories by OPKO, including any statements regarding the expected timetable for completing the proposed transaction, synergies, benefits and opportunities of the proposed transaction, future opportunities for the combined company and products, future financial performance and any other statements regarding OPKO’s and Bio-Reference Laboratories’ future expectations, beliefs, plans, objectives, financial conditions, assumptions or future events or performance that are not historical facts are “forward-looking” statements made within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “anticipate,” “believe,” “ensure,” “expect,” “if,” “intend,” “estimate,” “probable,” “project,” “forecasts,” “predict,” “outlook,” “aim,” “will,” “could,” “should,” “would,” “potential,” “may,” “might,” “anticipate,” “likely” “plan,” “positioned,” “strategy,” and similar expressions, and the negative thereof, are intended to identify forward-looking statements.

All forward-looking information are subject to numerous risks and uncertainties, many of which are beyond the control of Bio-Reference Laboratories and OPKO, that could cause actual results to differ materially from the results expressed or implied by the statements. These risks and uncertainties include, but are not limited to: failure to obtain the required vote of Bio-Reference Laboratories’ shareholders; the timing to consummate the proposed transaction; the risk that a condition to closing of the proposed transaction may not be satisfied or that the closing of the proposed transaction might otherwise not occur; the risk that a regulatory approval that may be required for the proposed transaction is not obtained or is obtained subject to conditions that are not anticipated; the diversion of management time on transaction-related issues; ability to successfully integrate the businesses; risk that the transaction and its announcement could have an adverse effect on Bio-Reference Laboratories’ ability to retain customers and retain and hire key personnel; the risk that any potential synergies from the transaction may not be fully realized or may take longer to realize than expected; new information arising out of clinical trial results; and the risk that the safety and/or efficacy results of existing clinical trials will not support continued clinical development, as well as risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this communication may become outdated over time. OPKO and Bio-Reference Laboratories do not assume any responsibility for updating any forward-looking statements. Additional information concerning these and other factors can be found in Bio-Reference Laboratories’ and OPKO’s respective filings with the SEC and available through the SEC’s Electronic Data Gathering and Analysis Retrieval system at www.sec.gov, including Bio-Reference Laboratories’ and OPKO’s most recent Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The foregoing list of important factors is not exclusive. Bio-Reference Laboratories and OPKO assume no obligation to update or revise any forward-looking statements as a result of new information, future events or otherwise, except as may be required by law. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof.

ITEM 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number	Description
99.1	Renal Division Presentation – 2015 Annual Meeting of Stockholders held June 18, 2015.
99.2	Diagnostics Division Presentation – 2015 Annual Meeting of Stockholders held June 18, 2015.
99.3	EirGen Presentation – 2015 Annual Meeting of Stockholders held June 18, 2015.

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 18, 2015	By	/s/ Adam Logal
	Name:	Adam Logal
	Title:	Senior. Vice President,
		Chief Financial Officer

EXHIBIT INDEX

Exhibit No.	Description
99.1	Renal Division Presentation – 2015 Annual Meeting of Stockholders held June 18, 2015.
99.2	Diagnostics Division Presentation – 2015 Annual Meeting of Stockholders held June 18, 2015.
99.3	EirGen Presentation – 2015 Annual Meeting of Stockholders held June 18, 2015.

EX-99.1

Exhibit 99.1

Exhibit 99.1

Confidential

Update on

Rayaldee Capsules

June 18, 2015

Cautionary Statement

This presentation contains “forward-looking statements,” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,”

“potential” and other words of similar meaning, including statements regarding our estimated revenues and financial projections, our ability to achieve high levels of growth, the potential for our products under development, the potential of the 4Kscore™ to reduce prostate biopsies and predict the risk of aggressive prostate cancer, our ability to develop, test and launch new products, the expected timing of the clinical studies and regulatory submissions relating to our products under development, the outcome of our clinical trials and validation studies and that such outcomes will support commercialization, the expected market penetration and size of the market for our products under development, including without limitation, Rolapitant™, Rayaldee™ (CTAP-101), hGH-CTP™, the 4Kscore, Factor VIIa-CTP, oxyntomodulin, and our point-of-care diagnostic products for Total-PSA, testosterone, and Vitamin D, the potential benefits of our products under development, including whether the 4Kscore will improve selection of candidates for prostate biopsy, predict the risk of distant metastases, and result in $2 to 4 billion in healthcare savings, expected per patient savings, whether MOD-6031 will provide superior long-term therapy for obesity and Type II diabetes patients, our ability to successfully commercialize our product candidates such as Rolapitant, the 4Kscore, Rayaldee (CTAP-101), hGH-CTP, Factor VIIa-CTP, and oxyntomodulin, as well as products for other markets such as urology, women’s health, cardiology, oncology, iPTH, and infectious disease, whether we will be able to develop Rayaldee (CTAP-101) for additional indications and whether Rayaldee (CTAP-101) will take significant market share in Stage 3 and 4 CKD patients with SHPT, whether Rayaldee (CTAP-101) will raise serum total 25-hydroxyvitamin D (25D) more effectively than any over-the-counter (OTC) or prescription (Rx) product currently marketed without the risk of hypercalcemia, whether we can reach more than half of the CKD population with a small sales force, our ability to establish a sales and marketing and clinical support infrastructure for Rayaldee and the timeline for doing so, the expected acceptance date of our Rayaldee NDA and PDUFA date, expectations regarding patent coverage, the expected timing for commencing, completing and obtaining results for our clinical trials and publication date for NCCN guidelines, the timing for release of trial data and seeking and obtaining FDA and European regulatory approvals as well as reimbursement coverage, and the timing of commercial launch of our product candidates, as well as other non-historical statements. These forward-looking statements are only predictions and reflect our views as of the date they were made, and we undertake no obligation to update such statements. Such statements are subject to many risks and uncertainties that could cause our activities or actual results to differ materially from the activities and results anticipated in forward-looking statements, including risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, the success of our collaboration with Pfizer, general market factors, competitive product development, product availability, federal and state regulations and legislation, and integration issues arising from the transactions, delays associated with development of novel technologies, unexpected difficulties and delays in validating and testing product candidates, the regulatory process for new products and indications, manufacturing issues that may arise, the cost of funding lengthy research programs, the need for and availability of additional capital, the possibility of infringing a third party’s patents or other intellectual

property rights, the uncertainty of obtaining patents covering our products and processes and in successfully enforcing them against third parties, and the possibility of litigation, among other factors, including all of the risks identified under the heading Risk Factors in our Annual Report on Form 10-K and other filings with the Securities and Exchange Commission.

2

Rayaldee – Initial Indication Requested in New Drug Application

“Prevention and treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease

(CKD) and vitamin D insufficiency”

Significance: First drug to target this important indication

2

What is Vitamin D Insufficiency?

25 hydroxy- 1,25 dihydroxy- Vitamin D Liver Enzyme Kidney Enzyme vitamin D vitamin D

Limited and unreliable efficacy

Ergocalciferol

Cholecalciferol

Vitamin D insufficiency is serum 25-hydroxyvitamin D3 below 30 ng/mL

4

Diseases Associated with Vitamin D Insufficiency

CKD

SHPT Cystic Fibrosis

Bone Diseases

Autism

Skeletal-related Vitamin D

Events (SRE’s)

Insufficiency

Obesity

Infection

Diabetes

Psoriasis Critical Illness

Cancer

5

SHPT = Secondary Hyperparathyroidism

Vitamin D Insufficiency: Increases Mortality in CKD

1.0 Time to dialysis 25D?15 ng/ml

0.75 25D?15 ng/ml 25D<15 ng/ml

0.75 0.50 0.00

Survival probability

0

12

24

36

48

60

Time (months)

1.00

Time to dealth

0.75

25D?15 ng/ml

0.50

25D<15 ng/ml

0.00

0

12

24

36

48

60

Time (months)

Ravani et al Kidney Int 2008 6

Market Opportunity: Chronic Kidney Disease (US)

The CKD patient population is large and growing as a result of:

– Obesity

– Hypertension

– Diabetes

% of CKD Patients with

Stag Vitamin D SHPT Hyperphosphatemia Kidney Function CKD Prevalence e Insufficiency (?25D) (? PTH) (? Phosphorus)

Moderate

3 18.7 Million* 71% 40% 37% impairment Severe

4 1.4 Million* 83% 82% 50% impairment

5 Failure 0.5 Million* 97% 95% 70%

*US Renal Data Service 2013 Annual Data Report

Sources: Levin, A et al., Kidney International 2007; 71: pp.31-38; Gonzalez, E et al. Am J Nephrol 2004;24:503-510; LaClair, R et al. Am J Kidney Dis 2005;45:1026-1033; Tentori, F et al., Clin J Am Soc Nephrol 2015; 10:98-109

7

Comparison of Vitamin D Therapies for Stage 3-4 CKD

Effect on Blood Levels of:

Drug Active Type 25D** Ca iPTH

Rayaldee Calcifediol Rx

(25-hydroxyvitamin D3)

Cholecalciferol/Ergocalciferol OTC

Vitamin D (vitamin D3/vitamin D2)

Drisdol™* Ergocalciferol Rx

(vitamin D2)

Rocaltrol™* Calcitriol Rx

(1?,25-dihydroxyvitamin D3)

Hectorol™* Doxercalciferol Rx

(1?-hydroxyvitamin D2)

™* Paricalcitol Rx Zemplar

(19-nor-1?,25-dihydroxyvitamin D2)

*And generics **25-hydroxyvitamin D

8

Rayaldee—Commercial Opportunity

Stage 3 & 4 CKD Treatment for SHPT

Vitamin D Hormone 14-25%

Untreated Safety concerns; 31-47% exacerbates vitamin D insufficiency

Nutritional Vitamin D

39-44%

Efficacy Concerns

Rayaldee is expected to take significant market share in Stage 3 and 4 CKD patients suffering from SHPT – a potential $12 billion revenue opportunity

Source: BioTrends Research Group, Inc. December 2013

9

Rayaldee: Phase 3, NDA and US Launch Timelines

2012 2013 2014 2015 2016

Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3

Top-line SPA CL-3001 trial Data

Top-line CL-3002 trial Data

Open Label Extension study NDA Approval NDA

Submission

NDA Safety Filing Update

US Launch

10

Rayaldee: Phase 3, NDA and US Launch Timelines

2012 2013 2014

Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2

Data

Top-line CL-3002 trial Data Ope (OLE)

11

Rayaldee Top-Line Phase 3 Data: Plasma iPTH

Change from Baseline (%)

30

20

10

0

10

20

30

40

0

4

8

12

16

20

24

28

32

36

40

44

48

52

Weeks

Stage 3 placebo

Stage 4 plaebo

Stage 3 Active

Stage 4 Active

12

Rayaldee Top-Line Phase 3 Data: Serum 25D

85

75

65

55

45

35

25

15

0

1

2

4

6

8

10

12

14

16

18

20

22

24

26

Meen Conc(ngml)

13

Rayaldee Top-Line Phase 3 Data: Serum Ca & P

Placebo Placebo to Modified-Release Calcifediol Modified-Release Calcifediol Modified-Release Calcifediol Continuation

10.0 Placebo-Controlled Extension *

* * *

SE) *

± 9.0

Mean Serum Calcium

8.0

(mg/dL; 7.0

6.0

5.0

Serum Phosphorus

Calcium/Phosphorus 4.0 * * Serum

3.0

0 4 8 12 16 20 24 28 32 36 40 44 48 52

Time (Weeks)

* Significantly different from placebo, p < 0.05

14

Rayaldee – Key Steps to Commercialization

NDA filing (accepted for full FDA review) in late July

Marketing & sales management team to be hired in late 2015

Sales representatives and clinical support specialists to be hired pre-launch

PDUFA date: late May 2016

Launch expected within 3 months of PDUFA date

Initial line extension plans:

Additional phase 3 clinical trial(s) planned in stage 5 CKD

Phase 1 clinical trial ongoing for new oncology indication

Other indications being evaluated

14

OPKO Pharmaceuticals–Advanced, Deep Pipeline

Product Indication Preclinical Phase 1 Phase 2 Phase 3 Milestone Market Size

Rayaldee™ SHPT NDA submitted

$12.0 BN

(CTAP101) (CKD Stage 3-4 Patients) May 2015

hGH-CTP hGH deficiency $3.0 BN

Collaboration with Pfizer

Alpharen™ Hyperphosphatemia

$1.2 BN

(Fermagate) (CKD Stage 5 Patients)

PDUFA date

Rolapitant CINV September 5, $1.5 BN

Outlicensed to TESARO

2015

Hepatitis B

Sci-B-Vac™ $0.2BN

(CKD Stage 5 Patients)

Mild to moderate SHPT

CTAP201 $1.1 BN

(CKD Stage 5 Patients)

Phase 2a trial

Factor VIIa-CTP Hemophilia will commence $1.7 BN in 3Q 2015

Phase I trial

Oxyntomodulin Diabetes, Obesity targeted for $15 BN

2H 2015

AntagoNAT Cancer, CV, metabolic and

$1.0 BN

Platform orphan disease

Phase 1 trial

CYP24 Inhibitors SHPT, CKD, cancer targeted for $1.0 BN

4Q 2016

16

Thanks!

17

EX-99.2

June

2015

1

Exhibit 99.2

BioReference

Laboratories Snapshot

2

Division

Key

Products

Markets

Physician Offices,

Health Facilities,

Correctional Facilities

Flow Cytometry,

IHC, FISH, ISH, Microarray,

Morphology

Hematologists,

Oncologists,

Hospital

Pathologists

Obstetricians,

Gynecologists,

Maternal-Fetal Medicine

NextGen

& Sanger Sequencing,

Array

Comparative Genomic

Hybridization (aCGH)

Geneticists,

Medical Centers,

Children’s Hospitals,

Physicians

managing genetic

disease

Automated, high volume IVD,

Health Informatics,

HIV, HCV, other Molecular Dx

Physicians’ offices in Spanish-

Speaking Communities

Oncology

Women’s Health

Automated, high volume IVD,

Health Informatics,

HIV, HCV, other Molecular Dx 

Image-Directed Cytology (PAP)

HPV, STI

BioReference

Laboratories + OPKO Health

= Strong Customer and Product Benefits

•

BioReference

Laboratories

–

The 3

rd

largest clinical laboratory in the US (after Quest and LabCorp) with scale to reach large

markets in the Northeastern US, Florida, California, and Texas

–

Fast growing, innovative molecular diagnostics business with expertise in technologies enabling

–

Full service routine testing menu for primary care physicians and specialists

–

High value testing capabilities serving key specialties (Women’s Health, Oncology) and other

clinicians managing genetic disease

–

Team of about 400 sales, customer service and marketing personnel

–

Patient Service Centers with blood draw capability at over 170 locations

•

OPKO Health

–

Specialists in Uropathology, including anatomic pathology, IHC, cytology and FISH, serving the

diagnostic testing needs of urologists

–

The 4Kscore Test for aggressive prostate cancer

–

•

Combined Strengths

–

Nation wide insurance contract coverage and large payer relationships

–

Access to the Primary Care Physician market for 4Kscore and Claros platform

–

Access to over 170 BRL patient service centers for 4Kscore blood draw

–

Blood specimen transportation network and high volume testing operation

–

Addition of urology to BRL specialty diagnostic services capability

3

meaningful molecular medicine (NextGen sequencing, aCGH)

Claros 1 for in-office immunoassay results in 10 minutes from a fingerstick blood sample

What is the 4Kscore Test?

4

+

Age, DRE, and

prior biopsy

status

% risk of having

aggressive

prostate cancer

for an individual

patient

Components

Components

OPKO

{

4 kallikrein levels:

Total PSA

Free PSA

Intact PSA

hK2

Results

Results

OPKO ALGORITHM

Monitor w

PSA

or PCA3, ConfirmMDx

Monitor w

PSA

or PCA3, ConfirmMDx

OncotypeDx

or Prolaris

OncotypeDx

or Prolaris

100,000

Standard TRUS or

mp

MRI-Guided Biopsy

100,000

Standard TRUS or

mp

MRI-Guided Biopsy

Negative Biopsy

Histopathology

Negative Biopsy

Histopathology

55,000

25,000

Gleason score 6

Histopathology

Gleason score 6

Histopathology

Biopsy Result

Biopsy Result

Primary Treatment

Surgery / Radiation

Primary Treatment

Surgery / Radiation

Gleason score

7

Histopathology

Gleason score

7

Histopathology

20,000

140,000

Abnormal PSA or DRE

140,000

Abnormal PSA or DRE

700,000

PSA Screenings

700,000

PSA Screenings

4,000 Serious

Infections

4,000 Serious

Infections

12,000 with Confirmed

Indolent Disease

12,000 with Confirmed

Indolent Disease

Active

Surveillance

Active

Surveillance

7,500

Primary Treatment

Surgery / Radiation

Primary Treatment

Surgery / Radiation

17,500

6

Monitor w

PSA

if abnormal, 4Kscore

Monitor w

PSA

if abnormal, 4Kscore

Biopsy Result

Biopsy Result

Primary Treatment

Surgery / Radiation

Primary Treatment

Surgery / Radiation

Active

Surveillance

Active

Surveillance

Primary Treatment

Surgery / Radiation

Primary Treatment

Surgery / Radiation

Negative Biopsy

Histopathology

Negative Biopsy

Histopathology

Gleason score

7

Histopathology

Gleason score

7

Histopathology

Gleason score 6

Histopathology

Gleason score 6

Histopathology

OncotypeDx

or Prolaris

OncotypeDx

or Prolaris

Standard TRUS or

mp

MRI-Guided Biopsy

Standard TRUS or

mp

MRI-Guided Biopsy

36% Biopsy

Reduction

$78M Savings

36% Biopsy

Reduction

$78M Savings

29% Reduction

$16 M Savings

29% Reduction

$16 M Savings

29% Reduction

$146 M Savings

29% Reduction

$146 M Savings

$143 M net savings / $1,400 per patient

$143 M net savings / $1,400 per patient

100,000

Prostate Biopsy Patients

100,000

Prostate Biopsy Patients

700,000

PSA Screenings

700,000

PSA Screenings

7

51% Reduction

$22 M Savings

51% Reduction

$22 M Savings

The

4Kscore

Test

Predicts

Metastases

Within

20

years

1

16%

< 2%

4Kscore Test

> 7.5%

4Kscore Test

7.5%

¹

Improving the Specificity of Screening for Lethal Prostate Cancer Using Prostate-specific

Antigen and a Panel of Kallikrein Markers: A Nested Case–Control Study

European Urology (in press)

8

4Kscore Commercial Update

•

4Kscore ProtecT study published

–

over 6,000 subjects

•

Total dossier for the 4Kscore Test now includes clinical

data on over 22,000 subjects in 12 peer reviewed

publications

•

Over 900 US urologists have used the 4Kscore test in

routine practice

•

American Urological Society Meeting in New Orleans

May, 2015

–

six podium or poster presentations

•

Next milestones:

–

NCCN Early Detection Guidelines 3Q2015

–

CPT

Code

active

July

1,

2015

–

billing Medicare and Private

Insurance

–

Medicare and private insurance coverage for test: 2015/16

9

Claros

®

1: Rapid Testing in the Physician Office

10

Claros 1 Platform Addresses Large Testing Markets

Commercial Leverage with Bio-Reference Sales Team

•

Testosterone

–

US test volume: 15 million tests, $525 M

–

510(k) filing in 1H2016

•

PSA

–

US test volume: 30 million tests, $750 M

–

Intended use to focus on detection claim

–

Modular PMA filing in 1H2106

•

Renal panel in Development

–

Vitamin D

•

US test volume: 70 million tests, $3.5 B

–

iPTH

–

Cystatin

C

•

Lyme Disease

–

Claros 1 selected as platform for an NIH funded diagnostic development

–

OPKO has all rights to diagnostic test ($120M US Market)

11

EX-99.3

General Overview

18 June 2015

Exhibit 99.3

Our

Vision

We

are

a

leading

specialty

pharmaceutical

company

To

be

the

leading

developer

and

supplier

of

highly

potent

pharmaceutical

products for

global

markets

Click

above

to

view

EirGen’s

expanded

facility

Ireland: Fact Sheet

Waterford

Cork

Dublin

•

Population

4.2

million

•

Largest

Exporter

of

Pharmaceuticals

in

the

World,

8

th

largest

producer.

9

of

World’s

Top

10

Pharma

Companies

Located

in

Ireland

•

Home

to

120

Pharma

companies;

33

pharma

and

biopharma

plants

are

FDA

approved.

25,000

direct

&

25,000

indirect

employees

serviced

by

excellent

university

programs

•

English

speaking

and

excellent

compliance

track

record

•

Waterford

is

situated

in

the

South

East

of

Ireland.

Population

of

50,000

people.

Business Overview

A Specialty

Pharmaceutical Company

Focused on the development and

commercial supply of highly potent

pharmaceutical products

In a purpose built, state of the art,

high containment facility

Introductions –

EirGen Founders

PATSY CARNEY

Chief Executive Officer/ Co-Founder

»

Co-founded EirGen

»

Previously Head of Operations and BD for IVAX Ireland (14 years)

»

Holds a BSc In Industrial Chemistry from University of Limerick

and an MBA from University of Limerick

TOM BRENNAN

Chief Technical Officer/ Co-Founder

»

Co-Founded EirGen

»

Previously held senior  technical positions with IVAX and Stada

»

10 Years IVAX Ireland as R&D Manager

»

Holds a BSc in Chemistry from Cork  IT, an MSc in Industrial Pharmacy

from University of Manchester and an MBA from University of Limerick

»

Qualified Person, Six Sigma Black Belt, Packaging Technologist

EirGen Key Milestones

2005

2006

2008

2009

2011

2012

2013

Successful

Regulatory Audit

OPEN FOR

BUSINESS

Submission of First

Pan EU EirGen

License

1.

1

st

License

Approval

in Canada

2.

5

th

Oncology

product

license submitted to

US FDA

3.

1

st

commercial

product launch in EU

1.

Two oncology product

licenses submitted to

Japanese PMDA

2.

US FDA facility

approval and product

approval

1.

Japanese PMDA

facility approval

and

1

st

product

approval

2.

US FDA

Inspection, zero

483’s

EirGen

Founded

Facility

expansion

complete

2014

1.

US FDA Inspection,

zero 483’s

2.

Soft-gel fitout

complete

3.

31

st

clinical

study

complete and passed

4.

10

th

ANDA

submitted

to

US FDA

2015

1.

5

th

IMB

(EMA) 

Inspection –

no

major

observations

2.

Acquisition by

OPKO Health

Current Position: where we are now

»

98 employees, all graduates

»

31 successful Clinical Studies

»

42 countries for commercial product supply

»

27 products in R&D

»

10 Products filed with US FDA to date, 3 approved

»

4

Pan EU CTD Dossiers filed to date and approved

»

5

Oncology Products filed with Japanese PMDA; 4 approved

Current Position: Regulatory Status

»

Global license submission strategy

»

FDA, Aug 2014, no 483’s

»

IMB (EMA), May 2015, no major observations

»

Licensed to handle Cytotoxic Materials

Therapeutic  Focus

»

Oncology Molecules

»

Immunosuppressants

»

Prostaglandins

»

Cytotoxic Molecules

»

Hormonals

»

Steroids

7

Global

Presence

Category

Countries

Commercial

(BLUE)

42

Licenses

Pending

(ORANGE)

20

Customer

Contracts

(GREEN)

85

EirGen Existing Business Model

R&D (non-

GMP and

GMP)

Clinical

studies and

license

approval

Routine on-

going

commercial

supply

Sales,

marketing &

distribution

Strategic Partner

EirGen OPKO Opportunities

»

API

Vertical

Integration

-

Synergies

with

OPKO

Finetech,

Israel

»

Product

Development

&

Manufacturing

-

OPKO’s

current

&

future

products

»

Irish

based

Supply

Chain

Hub

-

global

distribution

of

OPKO

Products

»

Tax

efficient

R&D

Hub

-

proven

R&D

track

record

since

incorporation

Thank You

www.EirGen.com