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OPKO Health Inc.

TICKER: OPK:NYSE

OPKO Health, Inc. is a multinational pharmaceutical and diagnostics company that aims to establish industry-leading positions in large and rapidly growing medical markets by leveraging its discovery, development and commercialization expertise and its novel and proprietary technologies. The company intends to use its global commercialization expertise to pursue acquisitions of commercial businesses that will both drive growth and provide geographically diverse sales and distribution opportunities.


The information provided below is from analysts, newsletters and other contributors. Please contact the company and visit its website before making an investment decision.

Expert Comments:

Kevin DeGeeter, Ladenburg Thalmann (4/21/14) "On April 17, 2014, OPKO Health Inc. acquired Inspiro Medical Ltd. in an important step toward development of a respiratory products franchise, in our view. . .while OPKO has not disclosed a timeline for advancing the sulfated disaccharide program into clinical development, in our view, the acquisition of a proprietary inhaler technology suggests the program may be nearing investigational new drug filing in the next 12–24 months."

Kevin DeGeeter, Ladenburg Thalmann (4/1/14) "On March 31, 2014, OPKO Health Inc. launched the 4KScore blood test in the U.S. as a laboratory-developed test for measuring the probability of a patient having high-grade prostate cancer (defined as Gleason score 7 or higher). . .we view the launch as an important milestone in the company's transition from a development-stage company to a commercial franchise."

Kevin DeGeeter, Ladenburg Thalmann (3/25/14) "OPKO Health Inc. disclosed plans to launch 4Kscore in the U.S. by March 31. . .we continue to view the expected release in August of topline data from two phase 3 studies of Rayaldy for treatment of secondary hyperparathyroidism in stage 3 or 4 chronic kidney disease patients with vitamin D insufficiency as an important catalyst for the company's shares. . .we reiterate our Buy rating and $14.50 price target."

Rohit Vanjani, Oppenheimer & Co. (3/13/14) "We are initiating coverage of OPKO Health Inc. with an Outperform rating and $13 price target. . .OPKO has two diagnostic products set for launch in 2014/2015, and two pharma products set for launch in 2016, which we believe are the most significant for valuation. . .we believe that the diagnostic products, 4Kscore and Claros-1, represent nearest-term opportunity for OPKO; consultant feedback on the 4Kscore test in particular was very positive. Though the ramp may be slow, we forecast that test to eventually expand outside of its initial target market and take significant share. . .we believe that Rayaldy will contribute significant value."

Eun Yang, Jefferies & Co. (3/4/14) "OPKO Health Inc.'s YE/13 cash of ~$186M should be sufficient thru H1/16, by our estimates. Given the delays in diagnostics, we expect data readouts from its proprietary clinical candidates in 2014–2015 (e.g., Rayaldy in phase 3, adult hGH-CTP in phase 3, pediatric hGH-CTP in phase 2, FVII-CTP entering phase 2) to be catalysts for the company's shares in the near/medium term. . .enrollment complete for the second phase 3 trial of Rayaldy in secondary hyperparathyroidism, with data on track for ~mid-2014."

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Kevin DeGeeter, Ladenburg Thalmann (3/4/14) "We continue to expect a steady stream of late-stage development and commercial milestones to offer important catalysts for OPKO Health Inc. shares over the next six months. Management reiterated plans to complete a 1,200-patient validation study and launch the 4KScore by the end of this month; we expect the company to have a significant commercial presence at the American Urological Association meeting in May to support commercial adoption of 4Kscore."

Eun Yang, Jefferies & Co. (2/28/14) "While still in the early stage of development, preclinical pharmacokinetic data for OPKO Health Inc.'s FVIIa-CTP are encouraging (longer half-life, improved exposure, greater bioavailability versus NovoSeven with $1.7B in 2013 sales). We assume a potential market entry of FVIIa-CTP in 2019, with peak annual sales potential of <$500M, which could be conservative if preclinical data is replicated in clinical studies, with no inhibitor development."

Charley Jones, Barrington Research (2/18/14) "On Thursday, Feb. 13, OPKO Health Inc. announced the successful completion of the calibration confirmation of its 4Kscore algorithm validation study currently underway at 21 urology clinics. We had a chance to meet with the new head, Dr. David Okrongly, of the company's diagnostics division recently, and we came away feeling very confident about each of OPKO's diagnostic programs. . .we are reiterating our Outperform rating and $11 price target."

Kevin DeGeeter, Ladenburg Thalmann (2/13/14) "On Feb. 13, 2014, OPKO Health Inc. announced a positive update on the progress of its 4Kscore validation process to prepare for a launch in the U.S. in late March. . .we would look to accumulate shares of the company prior to the 4Kscore launch in March and potential presentation of detailed results from a 1,200-patient validation study at the American Urological Association meeting in May. We reiterate our Buy rating and $14.50 price target."

John Eastman, Seeking Alpha (2/4/14) "OPKO Health Inc. has multiple promising drugs and developments in the making that should serve as catalysts and large revenue stream generators coming up in the next 12–24 months, leading to upticks and an overall stronger financial picture for the company. One drug with super potential is Rayaldy, currently in phase 3 trials for the treatment of secondary hyperparathyroidism. . .another potential gem developed by the company's subsidiary PROLOR Biotech Inc. is GLP-1/Glucagon dual receptor agonist for type 2 diabetes represents a potential market opportunity of $2B."

Charley Jones, Barrington Research (12/20/13) "We expect OPKO Health Inc. to take its 30–50% share in the markets it serves. Its entire strategy is to go after less competitive markets and given the likelihood for clinical improvements and possibly superiority, these platform technologies really have some interesting opportunities; we are reiterating our Outperform investment rating and raising our price target to $11."

Kevin DeGeeter, Ladenburg Thalmann (12/16/13) "OPKO Health Inc.'s partner, Tesaro Inc., has publicly committed to release phase 3 data for rolapitant by 2013E; we believe the product has potential to become the standard of care for late-onset chemotherapy-induced nausea and vomiting with potential peak sales of $700M. OPKO expects to receive double-digit royalties on the program."

John H. Ford, Seeking Alpha (12/5/13) "OPKO Health Inc. is a completely different company than it was 14 months ago when I initiated coverage. The company's pipeline has grown dramatically, as has its future revenue potential."

Sonia Colberg, The Street Sweeper (11/25/13) "OPKO Health Inc. currently has three candidates in phase 3. . .there's an OPKO drug for low vitamin D, when combined with another OPKO drug, is designed to treat advanced chronic kidney disease. . .designed to help 8M U.S. patients, the drug's potential market is $24B. . .second is the human growth hormone, a once-a-week therapy as opposed to the current daily use. . .third is a drug for nausea and vomiting caused by chemotherapy. . .Dr. Frost's track record shows he can grow money and use it to navigate the intricacies of delivering life-saving therapies to people who desperately need them."

Kevin DeGeeter, Ladenburg Thalmann (11/13/13) "We are raising our price target on OPKO Health Inc. from $10 to $14.50; specifically, we are updating our financial forecast to include the acquisitions of Prolor Biotech Inc. (acquired in August) and the Fermagate phosphate binder program from CytoChroma Inc. (acquired in Q1/13). Separately, we believe it is appropriate to transition our valuation methodology from a sum-of-the-parts to a more traditional discounted cash flow model due to the maturing of OPKO's pipeline."

Kevin Quon, Seeking Alpha (9/22/13) "On Sept. 19, OPKO Health Inc. CEO Phillip Frost resumed his regular purchasing of company stock. The zealous billionaire, whose fortune was last estimated to be worth $3 billion by Forbes, has become a motivating force for investors. . .over the last year, OPKO Health has conducted roughly six strategic acquisitions in an aggressive strategy to build a strong product pipeline. . .the officer's latest purchase helps to renew investor confidence following the large acquisition of PROLOR Biotech, a transaction made entirely with company stock. . .OPKO Health remains a speculative investment with a strong insider leading the way."

Carl Cachia, Seeking Alpha (9/11/13) "OPKO Health Inc. has two segments: pharmaceuticals and diagnostics. The diagnostic segment has been the primary focus. . .the company's stock is up 80% so far in 2013 alone, 200% the past two years and 300% the past three years. . .several different smart money investors are aligning their investments in diagnostics."

Eun Yang, Jefferies & Co. (9/9/13) "Since August 21, 2013, Opko Health Inc. has been listed on the Tel Aviv Stock Exchange (TASE) and will be included in Tel Aviv 25 (index of the top 25 market cap companies on TASE). . .the company's valuation lies not only in its fundamental value, but also in its fluid strategy, significant insider ownership/continual insider buying and in the unquantifiable value of [chairman and CEO] Phillip Frost."

Josh Ginsburg, Seeking Alpha (8/23/13) "This week OPKO Health Inc. is trading in the $8.75 range and shows no signs of slowing its momentum. . .today the company sits in a significantly stronger position than ever before and will likely rise into double digits. . .based on the upcoming closing of the Prolor Biotech Inc. buyout and numerous catalysts that the company has on hand before year's end, it is my opinion that its share price will break into the double digit territory within the next one to two months."

The Life Sciences Report Interview with Michael Berry (8/22/13) "I have great respect for (OPCKO Health Inc. CEO) Dr. Phillip Frost. Having just gone through a prostate biopsy procedure myself, I believe that he innately understands the needs and economics of the prostate cancer space, and has assembled a powerful pipeline of therapies. The 4Kscore test alone has major discovery potential, as I can personally attest, and is being readied for commercial launch. Monetizing it will take some thinking.

"OPKO is well diversified into diagnostics, pharmaceuticals and opportunistic healthcare products, including vitamins and human growth hormone. Perhaps more important is the strong share price action, with shares currently selling at $8.58 and in terrific volume. The shares have almost doubled in the past year. They are up 17% year-to-date. What's not to like? Earnings are not far in the future, but wealth creation in this story is about monetizing many of these assets as well." More >

Kevin DeGeeter, Ladenburg Thalmann (8/16/13) "OPKO Health Inc. announced enrollment is 50% complete for the second of two phase 3 studies of Rayaldy for treatment of secondary hyperparathyroidism in stage 3 or 4 chronic kidney disease patients with vitamin D insufficiency. . .based on this timeline, development of Rayaldy appears to be ahead of our forecast and is positioned to potentially reach the market in H2/15 versus our forecast of a 2016 launch. . .we reiterate our Buy rating."

Charley Jones, Barrington Research (8/12/13) "OPKO Health Inc. reported very strong Q2/13 results with revenue more than doubling to $23.8M versus Q2/12. . .on the clinical front, the company made solid progress on a number of different programs. . .we are reiterating our Outperform rating and raising our price target to $9."

Eun Yang, Jefferies & Co. (8/12/13) "OPKO Health Inc.'s cash at the end of Q2/13 of ~$169M should be sufficient into 2015. . .the company's proposed acquisition of Prolor Biotech Inc. is expected to close in Q3/13."

Kevin DeGeeter, Ladenburg Thalmann (8/12/13) "We encourage investors to revisit shares of OPKO Health Inc. based on strengthening fundamentals of the business model and a potential arbitrage trade on the close of the company's pending acquisition of Prolor Biotech Inc. . .OPKO reported Q2/13 financial results largely in line with our forecast. Revenues increased 133% to $23.8M, which was ahead of our forecast of $20M and consensus of $21.9M, driven by acquisitions. . .we reiterate our Buy rating and $10 price target."

Terry Chrisomalis, The Motley Fool (6/30/13) "A biotech that will have substantial value in the future is OPKO Health Inc., which has diversified itself in targeting many types of diseases. . .the company has a lot of mid stage and late stage products that will boost its value in the coming months. As mentioned, many big pharmaceuticals companies are seeking small cap biotechs to acquire so OPKO would definitely be a good stock to own."

Josh Ginsburg, Seeking Alpha (6/30/13) "In evaluating OPKO Health Inc.'s investments in other businesses, we find nine biotech companies with which the company has engaged in strategic investments. . .seeing that the current near term market size the company is entering is an estimated $43.5B (solely in the territories estimated) and OPKO will have around 405M shares outstanding following the completion of its acquisition of Prolor Biotech Inc., I see a high chance of the company breaking the $50/share mark in a few years' time and possibly much higher."

Brian Wilson, Seeking Alpha (6/10/13) "Many claim that OPKO Health Inc. is overvalued based on the prospects of its pipeline compounds, although the company is generating substantial value with business partnerships and equity investments in companies like RXi Pharmaceuticals Corp. and Tesaro Inc. . .RXi in particular has become a favorite of OPKO with the accumulation of 19.9% of shares outstanding up to this point, making a full acquisition of RXi by OPKO very possible."

Kevin Quon, Seeking Alpha (6/10/13) "While OPKO Health Inc.'s shares may appear overvalued when contrasted against typical valuation metrics, its technologies remain promising and able to penetrate a diverse range of markets. . .the company also carries a rather mature pipeline that should soon provide additional justification for its current valuation. . .OPKO also sustains its promising potential, which allows for investors to hold their positions with ease."

Kevin DeGeeter, Ladenburg Thalmann (5/30/13) "We are raising our price target for shares of OPKO Health Inc. to $10 from $8.50 based on our assessment of potential commercial synergies between the company's point of care (POC) diagnostic pipeline (particularly POC vitamin D) and phase 3 programs in urology therapeutics (Cytochroma Inc. acquisition in March) and endocrinology (pending acquisition of Prolor Biotech Inc.). . .with less than one week remaining in the 'go shop' clause of the Prolor merger agreement (expires June 2), in our view, OPKO appears to be well positioned to move toward a close for the transaction."

The Life Science Report with Kevin DeGeeter (5/30/13) "OPKO Health Inc.'s 4Kscore is already approved in Europe and should be approved in the U.S. sometime in 2013. The 4Kscore is used to help reduce the number of patients sent in for a prostate biopsy due to a false positive associated with prostate-specific antigen (PSA) testing.

TLSR: The 4Kscore is used when you do get a positive PSA, as a secondary test to affirm or disprove the routine PSA test. Is that right?

KD: Yes. From a pharmaco-economic standpoint, there's a pretty dramatic economic and clinical incentive to reduce the number of men who are going in for biopsies. We know that a great majority of prostate biopsies are negative despite the positive PSA results. . .our take is that the 4Kscore is the right test at the right time because biopsy overutilization is already a hot-button issue between payers and the urology community. The 4Kscore falls in a very healthy spot, allowing urologists to have a stronger justification for choosing to biopsy without being second-guessed. From the payer perspective, it's not just the frequency of biopsy but also that a lot of biopsy patients have morbidities or complications, including infection. From a system standpoint, I can envision payers being interested in understanding the pharmaco-economic model in light of the total cost of biopsy and potential costly complications, not simply the cost of paying urologists for the procedures." More >

Eun Yang, Jefferies & Co. (5/13/13) "OPKO Health Inc.'s end-of-Q1/13 cash of ~$182M should be sufficient thru 2015. . .revenue of $31.4M in Q1/13 (vs. ours of $21.5M; +257% yoy) included the one-time $12.5M sale of RNAi assets to RXi Pharmaceuticals and ~$3M in service revenues, largely from Prost-Data. . .the company will acquire PROLOR Biotech for $480M in an all-stock transaction."

Markus Aarnio, Seeking Alpha (5/2/13) "In addition to being very active on the acquisition front, OPKO Health Inc. has gained infamy of sorts on Wall Street as the prime example of insider buying in the public markets over the past several years. . . making headlines is nothing new for OPKO Chairman and CEO Dr. Phillip Frost, a multibillionaire who currently sits at number 190 on Forbes 400 list and who has had a storied history of building and selling companies. While he can certainly afford his continuing open market buying spree, such activity still speaks volumes that when Frost's name is heavily associated with a company he will go to great lengths to help ensure its success. . .Frost has shown he still has the Midas touch and that all of his open market purchases have been more than prudent thus far."

Eun Yang, Jefferies & Co. (4/25/13) "OPKO Health Inc. announced it will acquire Prolor Biotech Inc. in an all-stock transaction for $480M. . .the transaction has been approved by the board of directors of both companies and is expected to close in H2/13. . .Prolor's pipeline products include: 1.) Its post-phase 2 lead candidate hGH-CTP, a long- acting recombinant fusion protein of human growth hormone-CTP, targeting growth hormone deficiency currently post-phase 2 (phase 3 to begin in Q2/13); 2.) Several preclinical drugs, including Factor VIIa-CTP (phase 2 to begin in 2014), a recombinant human blood clotting Factor VIIa in the treatment of hemophilia; MOD-6030, a long-acting PEGylated oxyntomodluin in the treatment of obesity; and Factor IX-CTP, a long-acting recombinant clotting Factor IX in the treatment of hemophilia."

Seeking Alpha, (4/16/13) "OPKO Health Inc. is a revolutionary biotech stock that looks to be just getting started. . .in just a year's time, its revenues have grown 180.7%. . .with the company not even releasing any of its main products yet, this shows the numerous products of its overseas subsidiaries are selling extremely well on their own. . .its new diagnostics computer contains all the abilities of a large-scale medical lab and may be the most revolutionary biotech product of this decade. . .the future of the company's business ventures remains extremely bright."

Seeking Alpha (4/15/13) "The prospects of OPKO Health Inc. deserve a higher market price than what currently prevails. . .there is now a great opportunity to buy this cheap, promising stock before the market incorporates its future revenues into the stock price. . .this company is going to be associated with a lot of good news in the coming months that will throw the stock price over the top."

Kevin DeGeeter, Ladenburg Thalmann (3/19/13) "The near term operating leverage from OPKO Health Inc.'s diagnostic franchise remains an underappreciated asset and source for potential upside. . .with launch of the first prostate specific antigen (PSA) test in Europe scheduled for H2/13 and 510(k) submission in 2014, we encourage investors to revisit this part of the company's story. . .in total, we view point of care PSA testing as a $450–500M revenue opportunity for OPKO."

The Life Sciences Report Interview with Kevin DeGeeter (11/29/12) "Most of the OPKO Health Inc.'s value is in its product pipeline, where it is developing both diagnostics and some biotech products. I have focused much of my attention on the company's diagnostic programs, which could be novel and bring unique value. The company's lead commercial product on the diagnostic side is a test for prostate cancer, which is being positioned as a potential alternative to the prostate-specific antigen (PSA) test. We see a very high rate of false positives with PSA and treat a lot of patients when, in fact, they don't have disease. The value of OPKO's lead test is reduced overtreatment of patients. . .

At the core of OPKO's strategy is the desire to have a fully integrated model. That means encompassing everything from discovery of new content to sales and marketing. OPKO did not have commercial infrastructure in place for urology testing. The acquisition [of Prost-Data Inc.] brings in a well-respected commercial organization with a national distribution and sales channel that calls primarily on urologists, and primarily for oncology-oriented testing. What we have found, almost universally in the diagnostic world, is that it's easier to buy commercial infrastructure than to build it. . .OPKO's focus will be less on adding to the customer base and more on building deeper relationships with more proprietary content. I expect the menu will continue to grow within the Prost-Data franchise." More >

The Life Sciences Report Interview with Michael Berry (11/20/12) "OPKO Health Inc. is a company that Dr. Phillip Frost has put together over time. It's what I call a generator company. Frost is chairman of Teva Pharmaceutical Industries Ltd., and owns 47% of OPKO. He is a very significant individual in the life sciences world. I don't own OPKO at this stage of the game, but at some point I may choose to. . .OPKO has many good—and interesting—products. My guess is that over time the company will spin some of these products off into separate companies, or it will joint venture them, or it will sell them to big pharma. Frost has already sold two companies with sales of around $1 billion ($1B) each. I'm guessing that is how he plans to monetize products at OPKO as well. The key thing about the company is that it has been derisked, and it's also quite liquid.

. . .I am very positive on [OPKO's recent acquisition of Prost-Data]. It adds horizontal integration for OPKO's point-of-care diagnostic systems and is another outlet for the company's 4Kscore prostate diagnostic system, a next-generation PSA test. The company is also developing a point-of-care version of 4Kscore. This is a major push forward, in the sense that it is diagnostic, quick, cheap and, hopefully, soon available. It will add significant value to the company." More >

Kevin DeGeeter, Ladenburg Thalmann (11/12/12) "OPKO Health Inc. reported Q3/12 revenues of $11.8M, an increase of 73% from the prior year and $1.2M ahead of our forecast. . .we view Q3/12 as a transitional quarter and, in our view, closing of the OURLab urology testing acquisition in Q4/12 will be a transformational event for the company. . .we continue to expect the transaction to contribute $20M+ in revenue, materially reduce cash burn rate and provide a strategic commercial platform for launching 4Kscore and OPKO's other proprietary tests. . .we are raising our 2012 revenue estimate from $39.9M to $44.7M."

Kevin DeGeeter, Ladenburg Thalmann (10/22/12) "On October 19, OPKO Heath Inc. announced a transformative strategic acquisition of the OURLab urology testing network. . . .importantly, with the acquisition of OURLab, OPKO becomes one of only a small group of diagnostic testing companies with a fully integrated business model from in-house novel content discovery to commercial distribution. . .we believe OURLab generates meaningful positive cash flow and will reduce OPKO's 2013 cash-burn rate."

Kevin DeGeeter, Ladenburg Thalmann (10/3/12) "On 10/1/12, British diagnostic testing service International Health Technology, Ltd. launched the 4Kscore prostate cancer diagnostic blood test in the UK, Ireland, Sweden and Denmark. We view the announcement as a positive step in the build out of OPKO Health Inc.'s diagnostic franchise with three takeaways: 1.) The launch should raise clinician awareness of kallikrein biomarkers as a tool for prostate cancer detection with better specificity than prostate-specific antigens (PSA), 2.) The launch creates opportunity for clinician-sponsored studies to further support clinical utility and 3) Near-term revenues to Opko. . . we continue to view the company's PSA test as a source of significant potential near-term revenue."

Kevin DeGeeter, Ladenburg Thalmann (8/10/12) "In H2/12 we hope to see incremental updates on the go-to-market strategy for one or more of OPKO Health Inc.'s diagnostic programs and additional opportunistic acquisitions of commercial infrastructure in emerging markets and other ex.-U.S. regions. . .we continue to believe many investors may not fully appreciate the potential near- to intermediate-term operating leverage in the Claros model. . . we believe the Claros unit is well positioned to serve as a partner to the urology community during a period of evolving views toward PSA testing. . .we reiterate our Buy rating."

Kevin DeGeeter, Ladenburg Thalmann (5/17/12) "Based on a robust efficacy profile highlighted in an abstract released for June's ASCO conference, and the potential for a better safety/dosing profile than Emend (no CYP3A4 and CYP2C9 drug-drug interaction and one dose compared to three), we believe OPKO Health Inc's rolapitant has the potential to become standard of care for delayed chemically induced nausea and vomiting (CINV) with peak sales of $700M+. . .rolapitant is being commercialized by privately held Tesaro with double-digit royalties to be paid to OPKO Health. . .top-line data is expected in H2/13."

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