Current Report Filing (8-k)
September 01 2015 - 9:44AM
Edgar (US Regulatory)
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): September 1, 2015
OPKO Health, Inc.
(Exact
Name of Registrant as Specified in Charter)
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| Delaware |
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001-33528 |
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75-2402409 |
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Jurisdiction of
Incorporation) |
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(Commission
File Number) |
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(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):
¨ 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 7.01. Regulation FD Disclosure.
On September 1, 2015, members of management for OPKO Health, Inc. (the “Company”) attended the Barrington Research Fall
Investment Conference in Chicago and participated in one on one meetings with investors. A copy of the Company’s slides used in the meetings is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
The presentation slides are also available on the OPKO website at www.opko.com under Investor Relations. The information contained on OPKO’s website shall not be deemed part of this report.
The information contained in Item 7.01 to this Current Report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed
“filed” for purposes of Section 18 of the Exchange Act, 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
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Description |
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| 99.1 |
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OPKO Health, Inc. Presentation Materials. |
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.
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OPKO Health, Inc. |
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By |
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/s/ Adam Logal |
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Name: |
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Adam Logal |
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Title: |
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Senior Vice President, Chief
Financial Officer |
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Date September 1, 2015
EXHIBIT INDEX
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| Exhibit
No. |
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Description |
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| 99.1 |
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OPKO Health, Inc. Presentation Materials |
| September 2015 1 Exhibit 99.1 |
| What’s New? • Completed Acquisition of Bio-Reference Laboratories August 20,
2015
• Acquired EirGen Pharma, a Growing, Profitable Specialty Pharmaceutical Developer and Manufacturer • Rayaldee™ PDUFA Date – March 29, 2016 • 4Kscore® Included in NCCN Guidelines - CPT Code Became Active on July 1, 2015 – Company Began Billing Insurance for the Test • Enrolling Patients for Long-Acting Factor VIIa-CTP Phase IIa Clinical Trial to Commence Q4 3 |
| A High-Growth Diversified Medical Products Company - Innovative technologies: Antibodies Anti-virals Cardiovascular devices RNAi 4 Diagnostics - Bio Reference Laboratories – a unique clinical lab - 4Kscore® blood test for aggressive prostate cancer risk
- Claros 1® immunoassay system for rapid, lab quality in-office
testing
Pharmaceuticals
- Vitamin D therapeutics for SHPT - Platform technology to make peptides and proteins long-
acting for treatment of growth hormone deficiency,
hemophilia, obesity, etc.
- Calcium-free, magnesium-based phosphate binder Opportunistic Investments - Established businesses in: United States Chile Spain Uruguay Israel Mexico International Markets Ireland |
| Acquired EirGen Pharma, Ltd. • Developer of High Potency Specialty Pharmaceutical Products
– Growing, profitable and cash flow positive – Cancer chemotherapy and other niche, high potency drugs require
special expertise and infrastructure -
significant barriers to entry
• Rich Pipeline of Products – 10 product applications filed with the FDA, 3 approved, 4 filings in
Europe, all approved, and 5 in Japan, 4 approved
– Over 27 additional drugs in development – Opportunities to commercialize products through OPKO operations
world-wide
• Product registrations by OPKO Chile with others expected • State-of-the-Art High Containment R&D and Manufacturing Facility
– Approved by the FDA, EMEA (European Health Authorities) and PMDA
(Japan)
– Potential to manufacture OPKO’s current and future products with
resulting higher gross margins
• Co-Founded by Former IVAX Pharmaceuticals Executives 5 |
| Bio-Reference is a Unique Clinical Lab Asset – Acquisition closed August 20, 2015 6 Demonstrated strong, consistent organic growth - 21 years of ~20% compound annual revenue growth Created and expanded franchises in multiple specialty markets including oncology,
women’s health and genetics in lab testing and healthcare
provider communities Commercialized
innovations in clinical testing and informatics: GenPap,
PanEthnic Carrier Screen, OnkoSight, Genome DX,
Next-Gen Clinical Testing, Whole Exome
Sequencing, PsiMedica
and CareEvolve
Positioned
itself securely on the cutting edge of Genetic Medicine through
GeneDx Built
a strong corporate culture with an outstanding industry leading
medical and scientific team with long company
tenure and strong commitment to BRLI 1
2 3 4 5 |
| Transaction Rationale: Near-term Extensive phlebotomy draw stations offer synergistic opportunity for efficient
commercialization of 4Kscore test for high-grade prostate
cancer ~175 BRLI patient service centers located
throughout the US for collection of patient
specimens
Leverage
the
national
marketing,
sales,
and
distribution
resources
of
BRLI
to
enhance
sales
of
OPKO’s diagnostic platforms
~420 sales and marketing personnel
~5,000 people working together to support the needs of clients
and patients Near-term profitability supports
the development of existing pharmaceutical pipeline 7
Leverage BRLI’s channels to accelerate the adoption of
OPKO’s diagnostic products 1 |
| Transaction Rationale: Longer-term 8 Utilization of genomic data for personalized therapy 2 BRLI’s vast array of genetics and genomics data should benefit OPKO in its drug discovery
and clinical trial programs
GeneDx
was
the
first
commercial
laboratory
to
offer
next
generation
sequencing
for
panels
Offers 620+ single gene tests along with numerous panel-based
tests, including inherited cancers, to over 250
providers in 25 countries, many unique to GeneDx
Performs more whole exome testing than any other commercial
laboratory in the world OPKO’s research
capabilities deepen the insights into the genetic information and further strengthen the GeneDx offering |
| Shared Resources: infrastructure and senior management, scientific expertise and clinical acumen Unique Specialty Capabilities: market (product) specific expertise, specialized clinical connection and applications and focused product managers and marketing materials Each Specialty Sales unit shares some resources but distinctly identifies itself by specialty
Target Markets:
• Hematologists • Oncologists • Hospital Pathologists Key Services: • Bone Marrow Morphology • Flow Cytometry • Cancer Genetics • MicroArray, FISH • NextGen Seq for Bloods and Solid tumors • Special Coagulation Studies Oncology Routine Clinical Testing Target Markets: • Physician Offices • Health Facilities • FQHCs Key Services: • Automated, High Volume, Routine Testing • HIV, HepC and Other Molecular Tests • GCI Informatics • Heart Health • Regulatory Reporting Women’s Health Target Markets: • Obstetricians • Gynecologists Key Services: • Image Directed Paps • HPV Genotyping • GenPap STI Testing • NonInvasive PreNatal • Reproductive Genetics • Prenatal Cytogenetics • Special Coagulation Studies Genetics Target Markets: •Geneticists
•Medical Centers •Children’s
Hospitals
•Clinicians with Specialties Affected by Genetics Key Services: •DNA
Sequencing •aCGH Array Testing •NextGen
Sequencing
Laboratorio
Buena
Salud
Target Markets:
• Medical Clinics • Diabetes Programs • Latino Physicians Key Services: • Automated, High Volume, Routine Testing • GCI Informatics • HIV, HepC and Other Molecular Tests • Formularies • Regulatory Reporting Bio-Reference has Developed Capability in Specialty Areas |
| The 4Kscore Test as a Minimally Invasive Alternative to Prostate Biopsy Clinical utility is based on three decades of clinical biomarker research and over 20,000
men tested in Europe and the US
Identifies
the
actual
risk
of
aggressive
prostate
cancer
for
the
individual
patient
with:
High grade prostate cancer pathology
Poor prostate cancer clinical outcomes within 20
years Has
high
sensitivity
and
high
negative
predictive
value
for
aggressive
prostate
cancer
40–56% cost savings to potentially avoid unnecessary MRI and
prostate biopsies The
only
blood
test
that
accurately
identifies
risk
for
aggressive
prostate
cancer
10 1 million U.S. biopsy patients per year; over 2 million patients world-wide |
| What is the 4Kscore Test? 11 + 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 OncotypeDx or Prolaris 100,000 Standard TRUS or mp MRI-Guided Biopsy Negative Biopsy Histopathology 55,000 25,000 Gleason score 6 Histopathology Biopsy Result Primary Treatment Surgery / Radiation Gleason score 7 Histopathology 20,000 140,000 Abnormal PSA or DRE 700,000 PSA Screenings 12,000 with Confirmed Indolent Disease Active Surveillance 7,500 Primary Treatment Surgery / Radiation 17,500 12 4,000 Serious Infections |
| Monitor w PSA if abnormal, 4Kscore Biopsy Result Primary Treatment Surgery / Radiation Active Surveillance Primary Treatment Surgery / Radiation Negative Biopsy Histopathology Gleason score 7 Histopathology Gleason score 6 Histopathology OncotypeDx or Prolaris Standard TRUS or mp MRI-Guided Biopsy 36% Biopsy Reduction $78M Savings 29% Reduction$16 M Savings 29% Reduction$146 M Savings $143 M net savings / $1,400 per patient 100,000 Prostate Biopsy Patients 700,000 PSA Screenings 13 51% Reduction$22 M Savings |
| The 4Kscore Test Predicts Metastases Within 20 years¹ 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) 14 |
| 4Kscore Commercial Update • 4Kscore ProtecT study published – over 6,000 subjects – Total now 22,000 subjects studied with 4K panel • Over 1,000 US urologists have used the 4Kscore test in routine practice • American Urological Society Meeting in New Orleans May, 2015 – six podium or poster presentations • NCCN Early Detection Guidelines Published July 2015 • Next milestone: – Medicare and private insurance coverage for test: 2015/16
15 |
| Claros ® 1: Rapid Testing in the Physician Office 1-2 mins 10 mins 16 Quantitative Results Insert cassette into Claros®1 analyzer Snap cartridge into Sangia™ cassette Finger stick blood sample |
| Claros 1 Platform Addresses Large Testing Markets • PSA – US test volume: 30 million tests, $750 M – Intended use to focus on detection claim – Modular PMA filing with FDA in 2016 • Other Test Menus in Development – Aligned with BRL specialty sales focus • Sectors – Oncology – Women’s Health – Health and Wellness 17 |
| OPKO Pharmaceuticals–Advanced, Deep Pipeline 18 Product Indication Preclinical Phase 1 Phase 2 Phase 3 Milestone Market Size Rayaldee™ (CTAP101) SHPT (CKD Stage 3-4 Patients) PDUFA date March 29, 2016 $12.0 BN hGH-CTP hGH deficiency $3.0 BN Alpharen™ (Fermagate) Hyperphosphatemia (CKD Stage 5 Patients) $1.2 BN Rolapitant CINV PDUFA date September 5, 2015 $1.5 BN CTAP201 Mild to moderate SHPT (CKD Stage 5 Patients) $1.1 BN Factor VIIa- CTP Hemophilia Phase 2a trial expected in 4Q 2015 $1.7 BN Oxyntomodulin Diabetes, Obesity Phase I trial targeted for Q1 2016 $15 BN AntagoNAT Platform Cancer, CV, metabolic and orphan disease $1.0 BN CYP24 Inhibitors SHPT, CKD, cancer $1.0 BN Collaboration with Pfizer Outlicensed to TESARO |
| Rayaldee – A Late-Stage Investigational Drug • Modified-release (MR) oral formulation of 25D 3 * addresses significant unmet market need • Safe and effective treatment for elevated PTH (SHPT) associated with
low 25D levels in Stages 3–4 CKD
• Achieves more reliable increases in serum 25D and reductions in
plasma PTH than nutritional vitamin D
• Lower risk of side effects compared to active 1,25D ** products • Preserves protective renal feedback mechanism, reducing upregulation of CYP24 which limits effectiveness of current hormone
replacement therapies
• Additional potential for new indications including stage 5 CKD,
institutionalized elderly, osteoporosis & cancer
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Product Overview
Product Overview
* 25-Hydroxyvitamin
D3 or Calcifediol ** 1,25-Dihydroxyvitamin
D3 or Calcitriol |
| Market Opportunity: Chronic Kidney Disease (US) • The CKD patient population is large and growing as a result of:
– Obesity – Hypertension – Diabetes 20 *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 % of CKD Patients
with Stage
Kidney Function
CKD Prevalence Vitamin D Insufficiency ( 25D) SHPT ( PTH)
Hyperphosphatemia
( Phosphorus)
3 Moderate impairment 18.7 Million* 71% 40% 37% 4 Severe impairment 1.4 Million* 83% 82% 50% 5 Failure 0.5 Million* 97% 95% 70% |
| Comparison of Vitamin D Therapies for Stage 3-4 CKD Effect on Blood Levels of: Drug Active Type 25D ** Ca iPTH Rayaldee Calcifediol (25-hydroxyvitamin D3) Rx Vitamin D Cholecalciferol/Ergocalciferol (vitamin D3/vitamin D2)
OTC
Drisdol
™*
Ergocalciferol
(vitamin
D2)
Rx
Rocaltrol
™*
Calcitriol
(1a,25-dihydroxyvitamin
D3)
Rx
Hectorol
™*
Doxercalciferol
(1a-hydroxyvitamin
D2)
Rx
Zemplar
™*
Paricalcitol
(19-nor-1a,25-dihydroxyvitamin D2) Rx *And generics **25-hydroxyvitamin D 21 |
| Rayaldee - Commercial Opportunity Source: BioTrends Research Group, Inc. December 2013 Untreated 26-44% Vitamin D Hormone 14-25% Nutritional Vitamin D 39-44% Untreated 31-47% Safety concerns; exacerbates vitamin D insufficiency Efficacy Concerns Stage 3 & 4 CKD Treatment for SHPT Rayaldee is expected to take significant market share in Stage 3 and 4 CKD patients
suffering
from
SHPT
–
a
potential
$12
billion
revenue
opportunity
22 |
| Rayaldee Top-Line Phase 3 Data: Plasma iPTH 23 |
| Rayaldee Top-Line Phase 3 Data: Serum 25D 24 |
| Rayaldee Top-Line Phase 3 Data: Serum Ca & P 25 * Significantly different from placebo, p < 0.05 3.0 4.0 5.0 6.0 7.0 8.0 9.0 10.0 0 4 8 12 16 20 24 28 32 36 40 44 48 52 Time (Weeks) Placebo Placebo to Modified-Release Calcifediol Modified-Release Calcifediol Modified-Release Calcifediol Continuation Placebo-Controlled Extension Serum Calcium Serum Phosphorus * * * * * * * |
| Rayaldee – Steps to Commercialization • NDA filing (accepted for full FDA review) in late July
• Marketing & sales management team to be hired in Q3-Q4 2015
• PDUFA date: March 29, 2016 • Launch expected within 3 months of PDUFA date • Initial line extension plans: – Additional phase 3 clinical trial(s) planned in stage 5 CKD
– Initial clinical trial ongoing for new oncology indication
– Other indications being evaluated 26 |
| OPKO Biologics: Extends the Half-Life of Protein Drugs • Significant reduction in injection frequency • Safety profile comparable to non-modified active therapeutic agents
• Potential expanded prophylactic uses with longer half life agents, in
addition to short-term treatment
• Maintain drug bio-activity 27 Reversible Pegylation Technology CTP Technology Developing biobetter long acting proteins and peptides |
| CTP Increases Protein Circulation Time 28 + = Any Short-Lasting Protein CTP Long-Lasting Protein CTP – A Natural Chemical Entity Created During Evolution to Enhance Longevity of the Hormone hCG |
| Global Collaboration with Pfizer for OPKO’s Long- Acting Human Growth Hormone (hGH-CTP) 29 Collaboration Terms: – $295 M up-front payment – $275 M for achievement of regulatory based milestones – OPKO responsible for funding development program for the key
indications:
• Adult and Pediatric Growth Hormone Deficiency (GHD) • Pediatric Short for Gestational Age – Pfizer responsible for funding: • Development programs for additional indications • All Post Marketing Studies • All Commercialization Activities – Initial double digit tiered royalties on sales of Adult GHD
– Profit sharing commencing upon launch for Pediatric GHD encompassing combined sales for all indications of OPKO’s hGH-CTP
and Pfizer’s Genotropin
– Pfizer Genotropin represents about 25% of the world market with annual revenues exceeding $700 M Financial Commercial Development |
| hGH-CTP Competitive Advantages • New molecular entity and maintain natural native sequence of GH
• Human growth hormone is used for: – Growth hormone deficient children – Growth hormone deficient adults – SGA, PWS, ISS • Once-a-week injection (current products require daily injections)
• Final Presentation: – The drug product will be a refrigerated, liquid non viscous formulation
– Injected using a disposable easy to handle pen device with a thin
needle and low injection volume
• Pivotal Phase 3 study in growth hormone deficient adults (on-going)
• Phase 2 study in naive growth hormone deficiency pediatric
population has been completed
• Orphan drug designation in the US & EU for the treatment of children
& adults with GHD
30 |
| Daily hGH Market is $3B, Undifferentiated and Growing 31 Established and growing Established and growing Fragmented Fragmented Daily 2013 Daily 2018 Long-acting potential market Projected market growth Projected market growth Competition based on history, service and device innovation Competition based on history, service and device innovation $3B+ ~$4B Pediatric GHD Pediatric GHD ($1.5B)
Adult GHD
ISS, Turner
Syndrome
Other
80%
Source: Market Research 2013 & 2014
Novo Nordisk
(Norditropin)
31%
Pfizer
(Genotropin)
23%
Eli Lilly
(Humatrope)
12%
Sandoz
(Omnitrope)
8%
Merck KGaA
(Saizen,
Serostim)
8%
Roche
(Nutropin)
12%
Others
6% |
| MOD-5014: Long-acting Factor VIIa for Hemophilia A & B • $1.7 billion market – Growing 7% annually – Only 25% of patients are treated • Current product (NovoSeven®) requires frequent IV doses
– 3-4 times a day during bleeding episodes – 1-2 times a day for prophylactic treatment • Pharmacological studies in hemophilic mice and dogs FVIIa-CTP demonstrated: – Potential for via subcutaneous administration – Reduced frequency of injection during on-demand therapy
– Enable prophylactic treatment while reducing the frequency of
injections to 2-3 times a week
• Phase 2a study to Commence Q4 • Orphan drug designation in the US and EU 32 |
| Oxyntomodulin – Nature’s Appetite Control Mechanism • Natural appetite suppressor • Oxyntomodulin is a dual GLP-1/Glucagon receptor agonist • Secreted by the digestive system following food intake and induces satiety in the brain • Crosses blood-brain barrier to induce satiety • Increases glucose tolerance in insulin resistance pre-diabetic state associated with obesity 33 Development challenge: Oxyntomodulin has short half-life which requires multiple daily injections
OPKO solution: MOD-6030, a reversible PEG
30
formulation which provides 12-fold reduction in dosing
frequency |
| MOD 6031: Meets Unmet Market Need • MOD-6031 significantly inhibits food intake and reduces body
weight by reduction in fat
• MOD-6031 improves glycemic control by inducing glucose
dependent insulin secretion (direct mechanism) and by reducing
fat (indirect mechanism)
• MOD-6031 improves lipid profile • MOD-6031 is expected to provide effective long-term therapy for
obese and type II diabetes patients
• A battery of comprehensive toxicological studies have been
completed confirming the safety of MOD-6031 following a
single injection
• Phase 1 study evaluating the safety and pk-pd profile of MOD-6031 in overweight or obese health volunteers is scheduled to be initiated
in early Q1 2016
34 |
| Rolapitant – Potential Near-Term Revenue Driver • Rolapitant out-licensed to Tesaro in December 2010 – Payments of up to $121 million – Double-digit tiered royalties • Differentiated cancer supportive care product with $1.5B US Market
Opportunity
– Potent neurokinin-1(NK-1) receptor antagonist for chemotherapy-induced nausea
and vomiting (CINV)
– Opportunity to differentiate on convenience, market access and safety
• Single dose • Lack of CYP 3A4 drug-drug interactions • Long acting • Oral and IV formulations allow full market access • PDUFA Date September 5, 2015 – All three Phase 3 trials (MEC* and HEC**) achieved primary endpoint
– Primary endpoint: complete response (no emesis and no use of rescue
medication)
– Third Phase 3 trial (HEC) also achieved all secondary endpoints, including:
• Complete response in acute (0-24 hrs) and overall (0-120 hrs) phase of CINV
• No significant nausea – Successful completion of bioequivalence study for intravenous formulation
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¹ Moderately
emetogenic chemotherapy ² Highly
emetogenic chemotherapy |
| Strategic Investments • ARNO Therapeutics, Inc. (OTC: ARNI) (~4% equity interest) – Anti-progestin therapy for breast (phase 2) , endometrial and prostate cancers
• Zebra Biologics, Inc. (~27% equity interest) – Combinatorial antibody libraries based on function in human cell screens
• OAO Pharmsynthez (MICE: LIFE) (~17% equity interest) – Russian developer and marketer of new drugs • RXi Pharmaceuticals Corporation (NASDAQ: RXII) (~10% equity interest)
– sRNA to prevent hypertrophic scars (phase 2) • Cocrystal Pharma, Inc. (OTC: COCP) (~8% equity interest) – New anti-virals (Hepatitis C, flu) superior molecules for combination therapy (pan-genotypic)
• Sevion Therapeutics, Inc. (OTC: SVON) (~ 4% equity interest*)
– Antibodies against difficult targets (e.g., G protein-coupled receptor, ion channels)
• Neovasc, Inc. (NASDAQ: NVCN) (~ 5% equity interest) – Cardiology devices (transcutaneous mitral valve) • ChromaDex, Inc. (OTC: CDXC) (~ 2% equity interest) – New nutritional supplement APIs • MabVax Therapeutics Holdings, Inc. (OTC: MBVX) (~7% equity interest)
– Cancer Immunotherapy Company • SciVac Therapeutics, Inc (TSX: VAC) (~25% equity interest) – Third-generation hepatitis B vaccine As of June 30, 2015
Proprietary
Technologies with Significant
Upside Potential 36 |
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