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https://www.fool.com/investing/2017/08/24/boy-were-we-wrong-about-rite-aid-and-opko-health.aspx

Aug 24, 2017 at 6:15PM

Todd, I'm going to take myself out of the mistakes spotlight and pivot over to you. In our July 27, 2016, show, we talked about CEOs that were enormously successful in one business venture who were back at it trying to catch lightning in a bottle again. We featured Tesaro, NantKwest, Puma Biotech, and OPKO Health (NASDAQ:OPK). And in an effort to put you on the spot, or give our readers a tidy conclusion, I asked you to pick your favorite. Here's a refresher of what you said:

We've talked about four different companies today -- Tesaro, NantKwest, OPKO, and Puma. If you could only buy one of them, which would it be?

Campbell: That's a great question. I'm going to have to go with Phillip Frost and OPKO Health, mainly because we have a pathway to profitability on that one. We know that they've got drugs that are already approved, we know that they're doing a lot of business in their lab business right now, and we have a pretty good idea that they're going to be able to translate that into shareholder profit in a relatively short period of time. So that would be the one that I would focus on if I were an investor today.

Harjes: Any thoughts on that?

Campbell: I could have picked Tesaro's Lonnie Moulder. Tesaro got an approval for their PARP inhibitor, and sure enough, its shares have gone from $95 to a high of $180 and still trading around $120. That would have worked. I could have picked Puma. It got its approval of Nerlynx recently, and its shares have gone from $49 to $80. But no, [laughs] I settled with the safe play, going with Phillip Frost, OPKO Health. And sure enough, its shares have been flushed down the toilet bowl, falling from $10 to about $6, which is even more painful when you think about the fact that this has been one of the strongest periods for market returns in recent memory.

Harjes: So. [laughs] What did you learn from this?

Campbell: There were reasons that I sided with and picked Phillip Frost. Phillip Frost is a proven leader. And I love investing in companies with proven leaders. Rome wasn't built in a day. Phillip Frost has been starting, successfully, running companies, and then selling them since the 1970s, and he's one of the wealthiest healthcare entrepreneurs in America. So I think sidling up next to him was not necessarily a mistake long-term, but certainly a mistake short-term. And I think the short-term mistake I made was to fail to understand how much shares could fall if a couple of key catalysts were either slow to develop or outright disappointed. Do you me want to walk through those catalysts, Kristine?

Harjes: Yeah, there's been a handful of them over the last year or so since we talked about this. Do you want to start with maybe the slow launch of Rayaldee?

Campbell: Yeah. Rayaldee is a very intriguing drug, because it's a prohormone for vitamin D that works better than existing vitamin D supplements that are given to patients with chronic kidney disease, that suffer from vitamin D insufficiency. Vitamin D insufficiency can cause calcium loss in bones, bone weakness, and all sorts of other problems. So it's an important indication; it's important to have treatment options available for it. The problem is, after Rayaldee launched, it did not have widespread early-on inclusion in drug formularies at insurers. So the patient population that was covered by insurers that would pay for these drugs was pretty small, and sales, frankly, have been a rounding error and aren't even broken out in OPKO Health's quarterly results yet. Perhaps, according to Phillip Frost in the second-quarter conference call, they'll start to break those numbers out for us in the fourth quarter of this year. And there's opportunities there theoretically for Rayaldee to finally deliver on its promise.

But Rayaldee wasn't the only disappointment. You also had Varubi, which is a drug that's approved for use in patients who are suffering from vomiting and nausea after receiving chemotherapy. That's a very important market. It's worth hundreds of millions of dollars a year, and Varubi is licensed by Tesaro, which is Lonnie Moulder's company. So far, sales have been slow to grow. Sales in the second quarter were only about $2.9 million, and with OPKO collecting double-digit royalties, again, a rounding error considering that the company is doing $300 million roughly in quarterly revenue because of its diagnostics business.

Harjes: And that wasn't even the only disappointment.

Campbell: Yeah. They also came up shy in a very important trial that was evaluating the long-lasting human growth hormone treatment in adults. They have a drug that's partnered up with Pfizer. A lot of people thought that if this drug reached the market and eventually got approved for use in kids, pediatric use, then this could be a big moneymaker for OPKO Health. Unfortunately, in December, they announced that the trial missed its mark. They haven't given up on the drug, but that trial was a failure. So overall, you have this confluence of disappointments over the course of the last 12 months that has really taken a toll on the company's stock price. You add that together with the fact that sales in the diagnostic business, which is basically the specialty lab that they run, have pretty much flatlined at around $300 million, a little over $300 million, there hasn't been a lot of excitement or enthusiasm to drive up the market cap of this company.

Harjes: So, clearly, it's been a disappointing year for OPKO shareholders. Where do you stand now going forward on it, Todd? Do you think it's, "Looking back on it, I was wrong, this is a terrible company, investors should stay far away from it," or do you think that now, at the lower share price, there might be an even better opportunity for investors to scoop up some shares at a discounted price, because now, going forward, is where the real promise is? Or something in between the two?

Campbell: There's a couple different takeaways I guess I have on this whole thing. I think, yes, you stick with proven leaders, and yes, there's a lot of opportunity still ahead for OPKO. I don't like buying drug-development stocks on sale as using the value argument only because, as we saw last year, a lot can happen with clinical trials. You can say, "There's all sorts of opportunities still in the pipeline," which there is, drugs that could rack up lots of sales for this company over time. But those trials could fail. You have to take a look at it and say, "I'm not going to buy it solely because it's cheap relative to where it was last year. Things happened that the outlook now has changed."

But I think you can look at it and say, Rayaldee could still deliver on the goods. We'll know better early next year what the sales trend, the prescription trend is for that. Varubi, which again is marketed by Tesaro, there's a PDUFA date at the FDA that could approve an IV formulation. If that formulation gets approved, that opens up the vast majority of the marketplace for this type or this class of drugs. That, theoretically, could start meaningfully generating revenue in 2018. And there's a pediatric study ongoing in human growth hormone still that reads out in 2019. If that trial is good, then Pfizer and OPKO will split the profits on both OPKO's drug and Pfizer's existing drug in that indication, Genotropin, which is selling at a clip of over $100 million per quarter. So there's still reasons besides value that you'd want to own OPKO Health. And certainly, Phillip Frost remains incredibly committed as a shareholder in this company. He continues and has continued to increase the number of shares he owns over the past year, even in the face of all these disappointments.

 

Duh!

 

https://books.google.com/books?id=ysW6DV-FRRoC&pg=PP5&lpg=PP5&dq=dr.+phil+frost+private+plane&source=bl&ots=iJaFR_W2N3&sig=NZazBLzo9E3VHeGQ2dGjCXw8dbs&hl=en&sa=X&ved=0ahUKEwjExsXlk4DWAhXCOyYKHdWCDlQ4ChDoAQguMAE#v=onepage&q=dr.%20phil%20frost%20private%20plane&f=false


Insider trading - page 17

 

http://www.secactions.com/lessons-from-two-sec-losses-in-court/

 

Cramer's lightning round: After Opko Health's quarter, it's a 'neighborhood of pain'
Elizabeth Gurdus
CNBC November 16, 2017
CNBC. Jim Cramer sped through his take on callers' favorite stocks, including a struggling medical play.
Opko Health Inc.

(NASDAQ: OPK)

: "Oh my god, the quarter, not good. I mean, this thing has become a genuine house of pain. No, this is like a neighborhood of pain. And until [CEO] Dr. Frost comes on, we're going to back away. We have to. We have to."

 

Taking a Fresh Look at Opko Health, Inc. (OPK)
By Jerome Gibson

November 27, 2017
Opko Health, Inc. (OPK) is an interesting player in the Healthcare space, with a focus on Biotechnology. The stock has been active on the tape, currently trading at $5.01, up from yesterday’s close by 4.38%. Given the stock’s recent action, it seemed like a good time to take a closer look at the company’s recent data.

Fundamental Analysis

Money managers are always interested in a company that can find the right recipe of fundamental data because it reflects something important going on underneath the surface. Opko Health, Inc. (OPK) currently trades with a market capitalization of $2.69 Billion. That value represents a market adjusting for revenues that have been falling by -11.59 % on a quarterly year/year basis as of the company’s last quarterly report.

The balance sheet health of any company plays a key role in its ability to meet its obligations and maintain the faith of its investment base. For OPK, the company currently has $100.36 Million of cash on the books, which is offset by $19.6 Million current liabilities. You can get a sense of how sustainable that is by a levered free cash flow of $-97.48 Million over the past twelve months. Generally speaking, earnings are expected to grow in coming quarters. Analysts are forecasting earnings of $-0.08 on a per share basis this quarter. Perhaps, that suggests something about why 23.69% of the outstanding share supply is held by institutional investors.

Technical Analysis

Sometimes, we can understand most about a stock by simply looking at how it has been trading. Looking at the stock’s movement on the chart, Opko Health, Inc. recorded a 52-week high of $12.15. It is now trading 7.14% off that level. The stock is trading $6.34 its 50-day moving average by 1.33%. The stock carved out a 52-week low down at $4.50.

In recent action, Opko Health, Inc. (OPK) has made a move of -24.43% over the past month, which has come on Strong relative transaction volume. Over the trailing year, the stock is underperforming the S&P 500 by 17.96, and it’s gotten there by action that has been more volatile on a day-to-day basis than most other stocks on the exchange. In terms of the mechanics underlying that movement, traders will want to note that the stock is trading on a float of 19.38% with $330.18 Million sitting short, betting on future declines. That suggests something of the likelihood of a short squeeze in shares of OPK.

 

Is Opko Health Inc. a Buy?
Has the market beaten this healthcare stock into bargain territory?
Nov 15, 2017 at 9:31PM
Longtime Opko Health Inc. (NASDAQ:OPK) shareholders have a lot to be upset about. Using about $1.47 billion of its own stock to acquire a big lab service provider a couple years ago was supposed to give the company a springboard to enhance sales of its fancy new prostate cancer screen.

Unfortunately, total sales from Opko's new clinical lab operations have been declining too quickly for the diagnostic to push the entire needle forward. When the company reported a year-to-year total revenue slide in the third quarter instead of the slight gain the market was expecting, the stock fell hard as institutional investors threw in the towel.

The stock has fallen so far, in fact, that it might be a bargain. After all, Opko has a handful of potential growth engines idling in the garage. Let's take a closer look to see if the stock is a bargain right now or a value trap.

The bad news
When Opko made its bid for Bioreference Labs (BRL) in mid-2015, the diagnostic service provider had been growing at a 20% annual rate for over 21 years and just reported a $30.9 million operating profit during the six-month period ended April 30, 2015. Demand for the sort of genetic testing BRL conducts is stronger than ever, but during the first year Opko held the reins, the lab service operations lost $3.4 million.

In the first nine months of 2017, lab service revenue fell 4.7% compared to the prior-year period and the segment's operating loss ballooned to $25.7 million. Remember, BioReference Labs was generating positive cash flows when Opko bought it, and the losses are accelerating. When it reported third-quarter results, lab service revenue fell 11.6% because the company has been forced to cut genetic testing prices in the face of fierce competition that has always been a hallmark of the medical diagnostics industry.

More bad news
To date, Opko Health's execution of the BRL acquisition has been dismal, but management thinks that by fixing America's prostate cancer overdiagnosis problem, it can turn the sinking ship around. Around 6 million Americans receive positive prostate-specific antigen (PSA) test scores that suggest they have an aggressive malignancy each year, but roughly two-thirds of subsequent biopsies turn up negative at an enormous cost.

At a reimbursement rate of just $602.10 from Medicare, Opko's 4KScore test is an ideal stepping stone between positive PSA results and expensive biopsy procedures that unscrupulous urologists wish you never heard of. Unfortunately, relatively few patients have heard of Opko's 4Kscore test and the word doesn't seem to be spreading very fast.

More than three years since its U.S. launch, the number of 4KScore tests performed has stagnated at a tiny sliver of the total market. Opko performed about 17,760 4KScore tests in the third quarter. That was 11% higher than the prior-year period, but well below the 18,700 performed during the previous quarter and fewer than the 18,600 tests ordered during the first quarter of 2017.

Beyond diagnostics
Opko Health's diagnostics segment may appear doomed, but the company sports a pharmaceutical arm with two commercial-stage drugs and a human growth hormone (hGH) candidate partnered with Pfizer that's in late clinical-stage development. Although hGH-CTP missed the mark in a pivotal trial that would have made the drug available for the larger pediatric market, the company thinks the Food and Drug Administration could be convinced to review an eventual submission for the much smaller population of adults. If approved, annual sales of the growth hormone therapy are expected to peak at around $200 million.

Opko launched Rayaldee for adults with advanced-stage chronic kidney disease and secondary hyperparathyroidism last November, and it isn't going well. At the end of September, the company still hadn't recognized any revenue from sales of the drug.

In partnership with Tesaro (NASDAQ:TSRO), Opko launched anti-chemo-induced-nausea drug Varubi about two years ago with blockbuster hopes that are fading fast. Opko remains eligible to receive double-digit royalties on sales of Varubi, but the launch has been a major disappointment. Opko's partner reported Varubi sales reached just $2.4 million in the third quarter.

A bargain buy on the dip?
I'm not the first to notice the company has fallen on hard times lately. The stock has fallen about 41% this year of about 2.7 times trailing sales. That's a couple multiples lower than most commercial-stage biotechs but relatively high for companies that mostly record low-margin laboratory service revenue.

We can't use price-to-earnings ratios to measure Opko because it doesn't have any. In fact, it burned through $95 million during the first nine months of the year. Unless 4KScore, Varubi, and Rayaldee make dramatic turnarounds starting yesterday, the $100.4 million cash cushion on the balance sheet at the end of September won't last another year. The company is still working off substantial debts incurred during its acquisition spree, which means Opko will probably raise capital through another dilutive share offering that will reduce existing investors slice of any potential profits.

With 4KScore, Varubi, and Rayaldee in commercial stages, it sure looks like Opko has the tools it needs to turn itself around, and a handful of new drug candidates in mid-stage clinical trials could be worth a mint years down the road. Until we know this company can execute a product launch or a merger, the market needs to beat this stock down a lot further before I'd consider it a buy.

 

Scary.

 

https://www.fool.com/investing/2018/01/30/could-opko-health-inc-be-a-millionaire-maker-stock.aspx

Could Opko Health Inc. Be a Millionaire-Maker Stock?
What it would take for this embattled stock to become a huge winner.

Keith Speights
Jan 30, 2018 at 7:31AM

Longtime losers have the potential to turn into big winners. And there's no question that Opko Health (NASDAQ:OPK) stock is a longtime loser.

The stock is down more than 40% over the last 12 months. And it plunged nearly 70% over the last 10 years. There's also no getting around Opko's share price, which is up by a measly 7% since the company conducted its initial public offering back in 1995. Sure, Opko shareholders went on a joyride from mid-2009 to mid-2015, but it's been pretty much downhill ever since.

Could Opko Health, despite its dismal track record, actually be a millionaire-maker stock? Here's what it would take.

Breakout for Rayaldee
Opko won Food and Drug Administration (FDA) approval for Rayaldee in treating secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) in June 2016, with a commercial launch following in November. Since that time, the company has recorded a grand total in revenue for the drug of... $0. That's right -- despite being on the market for over a year, Opko hasn't booked any revenue for Rayaldee. Why? The company says that it can't estimate sales deductions and product returns yet.

While that's obviously bad news, there are reasons for hope. Opko now has secured reimbursement from payers representing roughly 68% of patients. Prescription volume is growing for Rayaldee. More nephrologists increasingly are prescribing the drug. The Kidney Disease Improving Global Outcomes (KDIGO) organization updated its standard-of-care guidelines for SHPT in patients with CKD stages 3 or 4 in a way that should create opportunities for Rayaldee.

Opko also has taken steps to improve the situation. The company doubled its sales force and expects to see the results from this expansion in 2018. Opko also struck a deal with Japan Tobacco to develop and market Rayaldee for the treatment of SHPT in non-dialysis and dialysis patients with CKD in Japan.

Even though the commercial launch of Rayaldee has been painfully slow, the drug still has significant potential. The unmet need in treating SPHT is huge. I'm not sure that Rayaldee will achieve the peak sales estimate of $700 million that some analysts initially predicted, but a breakout for the drug would light a fire beneath Opko Health stock.

Diagnostics delivering on potential
Nearly 85% of Opko Health's total revenue currently stems from its diagnostics business. The problem, though, is that diagnostics segment sales fell in 2017 from their 2016 levels. For Opko to succeed, its diagnostics unit must deliver on its potential.

Bio-Reference Labs (BRL) generates most of the diagnostics segment revenue. Opko brought in a new head of sales in 2017 to shake things up. BRL president Gregory Henderson recently resigned, with Opko now searching for his replacement. It's possible that new leadership could turn things around.

There's at least one bright spot within Bio-Reference Labs' business -- its GeneDx subsidiary that performs genetic sequencing. GeneDx could bring in more money in the future for Opko as it adds tests in new clinical areas and serves more patients.

Opko also has high expectations for its 4Kscore prostate cancer test. The company now has more BRL sales representatives promoting 4Kscore. Opko also began a direct-to-consumer marketing campaign that included regional TV ads. Both efforts could lead to higher sales for 4Kscore.

Pipeline victories
Even if sales for Rayaldee pick up nicely and the diagnostics business regains momentum, Opko also needs help from its pipeline. The company experienced a big setback in late 2016 when its experimental long-acting human-growth-hormone product (hGH-CTP) failed in a late-stage study in treating adults. It's not the end of the road for hGH-CTP, though.

Opko is currently conducting a late-stage study of hGH-CTP in treating children. This study is critical, because the pediatric segment represents around 80% of the commercial market for treatment of hGH deficiency. Opko has partnered with Pfizer (NYSEFE) to commercialize hGH-CTP if it ultimately wins approval.

As for use of hGH-CTP in treating adults, Opko and Pfizer haven't thrown in the towel. Opko completed a post hoc sensitivity analysis to evaluate the influence of some statistical outliers on the data from the failed late-stage study, and planned to meet with the FDA to discuss the analysis. It's still possible that Opko and Pfizer will be able to move forward with a regulatory filing.

Other key pipeline candidates for Opko include OPK88004, an androgen receptor modulator for androgen deficiency indications, and GLP1-glucagon dual agonist OPK88003. Opko expects to report results from a phase 2b study of OPK88004 in treating men with enlarged prostates by late 2018. The company plans to begin a phase 2b study of OPK88003 in treating type 2 diabetes in the first half of this year.

One other key ingredient
There also is one other key ingredient for Opko Health stock to become a millionaire-maker stock. That ingredient is time.

You could buy a large number of shares in Opko right now, but even if the company had nothing but good luck, you wouldn't become a millionaire anytime soon. However, given enough time and sustained business success, Opko Health could generate significant returns.

It's possible that the best is yet to come for Opko. The main thing the company needs to do now, though, is get some successes rolling.

 

Does the company pay Motley Fool to write an Opko article every couple of months? Interesting how all of a sudden all the managed care wins are happening. Good news. Maybe the Miami office realized that anyone can access MMIT's Formulary app and verify whether or not coverage is real. HF can't keep saying that Rayaldee has 68% coverage on the Investor Conference Calls because now someone can verify whether or not it is true. Transparency at its finest. Now that the company can brag amount increased coverage and sales' improvements, time to sell the drug. Hopefully, the stock will go upwards.

 

http://files.shareholder.com/downloads/OPKO/5943246840x0x969595/7950482E-93C2-4200-BA27-21122C9DE57B/OPKO_Health--fullset_draft_10.pptx.pdf

December 2017 Investor report.

 

Oh yes, Motley Fool that most respected source of financial information.

 

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of OPKO Health, Inc. - OPK

ACCESSWIRE•May 22, 2018

NEW YORK, NY / ACCESSWIRE / May 22, 2018 /

Pomerantz LLP is investigating claims on behalf of investors of OPKO Health, Inc. ("OPKO" or the "Company&quot (OPK). Such investors are advised to contact Robert S. Willoughby at rswilloughby@pomlaw.com or 888-476-6529, ext. 9980.

The investigation concerns whether OPKO and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.

On May 18, 2018, OPKO announced the issuance of a draft local coverage determination ("LCD") for the Company's 4Kscore test for prostate cancer. OPKO advised investors that "[t]he draft LCD is a proposed non-coverage policy for the 4Kscore test for Medicare and, prior to its effectiveness, is subject to a public comment period ending July 5, 2018." Following this announcement, OPKO's share price fell $0.89, or 18.24%, to close at $3.99 on May 18, 2018.

 

Jim Cramer Shares His Thoughts On Altria, Corning And More
Craig Jones
Benzinga•May 23, 2018

Altria Group Inc (NYSE: MO) as a buy. He's concerned about competition from the Juul device.

Corning Incorporated (NYSE: GLW).

Beacon Roofing Supply, Inc. (NASDAQ: BECN) missed the quarter and Cramer wants to be careful. He added that anything related to housing is going down.

Verint Systems Inc. (NASDAQ: VRNT) is all right.

Sprint Corp (NYSE: S), Cramer would rather own T-Mobile Us Inc(NASDAQ: TMUS).

Opko Health Inc. (NASDAQ: OPK) has been a disaster since it bought BioReference Lab, said Cramer.

Flex Ltd (NASDAQ: FLEX) because of accounting irregularities.

First Data Corp (NYSE: FDC) had a great quarter said Cramer.

 

OPKO Plans to Address Draft Local Coverage Determination Published by Novitas Solutions for 4Kscore Test

GlobeNewswire•May 18, 2018

OPKO Health, Inc. (OPK) today announced that Novitas Solutions, Inc. issued a draft local coverage determination (LCD) for the 4Kscore test®. The draft LCD is a proposed non-coverage policy for the 4Kscore test for Medicare and, prior to its effectiveness, is subject to a public comment period ending July 5, 2018. OPKO plans to submit comments during this time period.

The 4Kscore test has been included in the National Comprehensive Cancer Network Guidelines® (NCCN) since 2015, and European Association of Urology Prostate Cancer Guidelines since 2016. Recommendations are based upon expert panels’ assessment of peer reviewed literature to provide clinical standards for prostate cancer care. Both guidelines recommend the 4Kscore test can be used as an aid in decision making before a first or repeat prostate biopsy in men with elevated PSA or other clinical symptoms. 4Kscore test has 95% sensitivity and 93% Negative Predictive Value for the identification of aggressive prostate cancer in patient population recommended by NCCN.

The 4Kscore test has been ordered by more than 9,000 practicing physicians worldwide and extensively studied with results presented in 18 peer-reviewed scientific publications involving more than 25,000 patients. Results of five new studies covering the 4Kscore test will be presented at the American Urological Association's 2018 Annual Meeting this weekend in San Francisco, including the second study demonstrating the 4Kscore test’s ability to predict prostate cancer mortality in men with elevated PSA. A study will also be presented at the American Society Clinical Oncology meeting in June 2018 demonstrating the 4Kscore has clinical utility for management decisions of men diagnosed with low and intermediate risk prostate cancer due to its strong association with radical prostatectomy pathology outcome.

“The 4Kscore test has proven to be a significant benefit to my patients, by both identifying those men who are at higher risk of significant prostate cancer who would benefit from a prostate biopsy, while also helping me to avoid biopsies in men who are at low risk,” said Edward Schaeffer, MD, PhD, Chair of the Department of Urology at Feinberg School of Medicine and Program Director of the Genitourinary Oncology Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. “There are numerous cases where the PSA may not have led to a biopsy, but an elevated 4Kscore led to finding aggressive prostate cancer early enough to be beneficial. It would be a real loss if 4Kscore was not available to assist in making the best decision for my patients.”

Novitas Solutions is an administrative services processing company for government-sponsored health care programs on behalf of the federal government, including the Centers for Medicare and Medicaid Services. Novitas serves as the Medicare Administrative Contractor for a jurisdiction that includes the State of New Jersey, where OPKO’s BioReference Laboratories is located and where all 4Kscore test samples are processed.

About OPKO Health, Inc.

OPKO Health is a diversified healthcare company that seeks to establish industry leading positions in large, rapidly growing markets. Our diagnostics business includes BioReference Laboratories, the nation's third largest clinical laboratory with a core genetic testing business and a 400-person sales and marketing team to drive growth and leverage new products, including the 4Kscore® prostate cancer test and the Claros® 1 in-office immunoassay platform. Our pharmaceutical business features RAYALDEE, an FDA-approved treatment for secondary hyperparathyroidism in stage 3 and 4 chronic kidney disease patients with vitamin D insufficiency (launched in November 2016), OPK88003, a once- or twice-weekly oxyntomodulin for type 2 diabetes and obesity which is a clinically advanced drug candidate among the new class of GLP-1 glucagon receptor dual agonists, OPK88004, a SARM (Selective Androgen Receptor Modulator) for treating BPH (Benign Prostatic Hypertrophy), OPK88002, an NK-1 antagonist to treat pruritus (itching) in dialysis patients, and OPK88001, a proprietary oligonucleotide to treat Dravet syndrome. In addition, the Company is advancing its CTP technology, which includes a long-acting hGH-CTP, a once-weekly human growth hormone injection (in Phase 3 and partnered with Pfizer). OPKO also has production and distribution assets worldwide, multiple strategic investments and an active business development strategy. More information is available at www.opko.com.

 

Still no merit increase.


MIAMI, May 08, 2018 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) reports financial results and business highlights for the three months ended March 31, 2018.

Financial Highlights

• Consolidated revenues for the three months ended March 31, 2018 were $254.9 million compared with $266.4 million for the comparable period of 2017.
  • Revenue from services were $211.3 million for the three months ended March 31, 2018 compared with $228.6 million for the comparable 2017 period. While not directly comparable, this represents a marked improvement from the most recently completed quarter ended December 31, 2017.
  • Revenue from products included $3.7 million of revenue from RAYALDEE during the first quarter of 2018. Revenues from RAYALDEE were deferred during the initial launch period so there is no prior-year comparison.
    
• During the three months ended March 31, 2018, operating expenses included investment in commercial activities supporting the launch of RAYALDEE of $7.3 million and continued investment in our pharmaceutical pipeline, with R&D expense increasing $6.3 million to $32.9 million compared with $26.6 million for the 2017 period.
  
• Net loss of $43.1 million or $0.08 per share during the three months ended March 31, 2018 compares with a net loss of $34.5 million or $0.06 per share for the comparable period of 2017.
  
• Cash, cash equivalents and marketable securities were $99.9 million as of March 31, 2018.

“We are pleased to report steady sequential-quarter growth for RAYALDEE and 4Kscore, as well as improvement in our lab business from Q4 of last year,” said Phillip Frost, Chairman and Chief Executive Officer of OPKO Health. “The improved first quarter results were in line with our expectations, starting 2018 positively coming off challenging fourth quarter 2017 results. These factors, taken together, reflect progress across the breadth of our commercial and laboratory services.”

Business Highlights

• RAYALDEE total prescriptions reported by IMS for Q1 2018 increased 730% compared with Q1 2017 and 38% compared with Q4 2017: As of May 1, 2018, more than 79% of patients had access to RAYALDEE under their insurance plans.
  
• 4Kscore utilization in Q1 2018 increased 13% compared with Q1 2017: Five abstracts of studies further demonstrating the utility of the 4Kscore test in the management of prostate cancer are to be presented at the American Urological Association meeting May 18-21.
  
• Appointed Geoff Monk as General Manager, BioReference Laboratories: Mr. Monk is well prepared to lead BRL with more than 20 years of management experience in the diagnostic laboratory business. Mr. Monk was previously Managing Director of the New York and New Jersey unit of Quest Diagnostics.
  
• Advanced the Phase 2b trial for our SARM (selective androgen receptor modulator) to treat benign prostatic hyperplasia (BPH): Enrollment is ongoing in this dose-ranging study for our orally administered SARM. This medicine is expected to improve the symptoms of BPH by reducing prostate size and, on the basis of data from a previous trial in 350 men, increase muscle mass and bone strength and decrease body fat. BPH affects approximately 50 million men in the U.S.
  
• Initiated a Phase 2b clinical trial for OPK88003, our once-weekly oxyntomodulin dual GLP1-Glucagon agonist to treat type 2 diabetes and obesity: In a previous Phase 2 trial in 420 overweight patients with type 2 diabetes, the drug was shown to be safe and effective. The current trial is to study a new dosing schedule to achieve even greater weight loss.

• Premarket Approval (PMA) application for Claros® point-of-care PSA test under review by FDA: OPKO has submitted a PMA for a PSA test utilizing the Claros 1 immunoassay analyzer, a novel diagnostic instrument that can provide rapid, quantitative blood test results in 10 minutes in the physician’s office with only a finger stick drop of whole blood. A second product utilizing the Claros platform to measure testosterone is advancing toward a 510(k) submission to the FDA later this year.

• Global and Japanese Phase 3 registration trials for hGH-CTP in pediatric growth hormone deficient children are continuing to enroll patients: The global pediatric study compares a single weekly administration with daily injections of a currently marketed growth hormone product. The global and Japanese pediatric studies utilize the pen device and formulation that will be launched commercially upon approval. The pediatric segment represents more than 80% of the market for treatment of hGH deficiency.
  
• Initiation of three additional Phase 2 clinical trials are anticipated in 2018:
  • RAYALDEE line extension in dialysis patients with secondary hyperparathyroidism (SHPT): Together with our partners, Vifor Fresenius and Japan Tobacco, OPKO is developing RAYALDEE for Stage 5 chronic kidney disease (CKD) patients with SHPT undergoing dialysis and anticipates initiating a global Phase 2 trial during Q3 of this year.
  • OPKO’s NK-1 antagonist to treat pruritus (itching) in Stage 5 CKD patients undergoing dialysis: An Investigational New Drug application was submitted to the FDA and plans are being finalized to begin a single-dose Phase 2a trial in dialysis patients to treat severe itching. Approximately 50% of renal dialysis patients experience pruritus.
  • OPKO’s AntagoNAT oligonucleotide OPK88001 to treat Dravet’s syndrome: Three clinical research centers in the United States are expected to participate in this first-in-human trial of OPKO’s AntagoNAT to treat Dravet’s syndrome.

 

https://finance.yahoo.com/news/under-armour-valero-3-other-162722524.html

 

Another suspect “news” blurb. Look at the last data point, 5/18/2018. OPK has RISEN in the past week. Like is too short to make your investment decisions based on a nameless short blog.

 

Why OPKO Health, Inc. Stock Rocketed Higher in May
June 09, 2018, 01:53:00 PM EDT By George Budwell, Motley Fool
S&P Global Market Intelligence . What sparked this double-digit rally?

Opko's shares surged higher last month in response to a strong first-quarter earnings report that topped Wall Street's revenue forecast by a stately $18 million.

So what
Over the past few years, Opko's shares have struggled mightily due to the poor commercial launches of the company's prostate cancer test known as 4Kscore, as well as the secondary hyperparathyroidism drug Rayaldee. In the first quarter of this year, however, Opko reported that Rayaldee's prescriptions rose by a healthy 730% year over year, giving investors hope that this key drug may finally start to become a major growth driver moving forward.

Now what
Unfortunately, Opko ended last month on a sour note. The company reported that the Medicare Administrative Contractor, Novitas Solutions, released a draft policy that would deny coverage for Opko's 4Kscore test. While Opko does have a chance to offer a rebuttal to this initial guidance early next month, this forthcoming coverage decision could become a major overhang for the company. Despite 4kscore's anemic sales so far, Opko has been counting on it to eventually transform into a blockbuster product.

Compounding matters, Opko clearly needs to raise additional capital soon based on its last stated cash balance of less than $100 million and a current quarterly burn rate that presently exceeds a whopping $43 million. When looked at together, Opko's weak financial position and 4Kscore's shaky reimbursement status arguably make this stock far too risky to own at this point.

 

So what
Over the past few years, Opko's shares have struggled mightily due to the poor commercial launches of the company's prostate cancer test known as 4Kscore, as well as the secondary hyperparathyroidism drug Rayaldee. In the first quarter of this year, however, Opko reported that Rayaldee's prescriptions rose by a healthy 730% year over year, giving investors hope that this key drug may finally start to become a major growth driver moving forward.

Now what
Unfortunately, Opko ended last month on a sour note. The company reported that the Medicare Administrative Contractor, Novitas Solutions, released a draft policy that would deny coverage for Opko's 4Kscore test. While Opko does have a chance to offer a rebuttal to this initial guidance early next month, this forthcoming coverage decision could become a major overhang for the company. Despite 4kscore's anemic sales so far, Opko has been counting on it to eventually transform into a blockbuster product.

Compounding matters, Opko clearly needs to raise additional capital soon based on its last stated cash balance of less than $100 million and a current quarterly burn rate that presently exceeds a whopping $43 million. When looked at together, Opko's weak financial position and 4Kscore's shaky reimbursement status arguably make this stock far too risky to own at this point.