Opko Health, Inc. is estimated to report earnings on 03/06/2017. The upcoming earnings date is derived from an algorithm based on a company's historical reporting dates.Our vendor, Zacks Investment Research, might revise this date in the future, once the company announces the actual earnings date. According to Zacks Investment Research, based on 3 analysts' forecasts, the consensus EPS forecast for the quarter is $-0.05. The reported EPS for the same quarter last year was $0. How bad will it be? Rayaldee is doing poorly. Pfizer's product failed Phase 1. VP of Sales kicked out. Dan in Sales OPs gone. How many reps will hang on until the end?
http://www.barrons.com/articles/11-ceos-who-buy-their-own-stock-ge-akamai-1497002855?mod=BOLFeed&tesla=y As far as finding an executive with an unshakeable faith, one need not look further than Phillip Frost, chairman and CEO of OPKO Health Inc. Now in the 10th year of his tenure, Frost has steadily bought shares of the drugmaker that entire time. Hardly a week has gone by in which the good doctor (he was chairman of the Department of Dermatology at Mt. Sinai Medical Center of Greater Miami from 1972 to 1986) didn’t buy Opko shares. Shares still haven’t recovered from a late December disappointment, but that hasn’t dampened Frost’s enthusiasm. So far this year, Frost Gamma Investments Trust (a trust that he controls) has bought 2.7 million shares, most recently paying $25,000 on June 6 for 3,850 shares, or $6.39 each. That trust owns 163.1 million Opko shares and is the company’s largest holder with a stake of more than 29%, according to S&P Capital IQ. Frost Group LLC, of which Frost Gamma is a principal member, holds an additional 20 million shares, or 3.6% Opko stake. A year ago, we said that Opko looked pricey at $9 a share. ------------------------------ Yet, he is too cheap to give severance to the inside sales force that was fired or the two RSSs that were fired.
OPKO Health Inc. (NYSEMKT:OPK) Q1 2017 Earnings Conference Call May 9, 2017 4:30 PM ET Executives Anne Marie Fields – LHA-Investor Relations Phillip Frost – Chairman and CEO Steve Rubin – Executive Vice President Adam Logal – Chief Financial Officer Analysts Kevin DeGeeter – Ladenburg Yale Jen – Laidlaw Operator Hello and welcome to the OPKO Health Business Update Conference Call. At this time all participants are in a listen-only mode. Following managements prepared remarks we will hold a Q&A session. [Operator Instructions] As a reminder this conference in being recorded Tuesday, May 9, 2017. I would now like to turn the conference over to Anne Marie Fields. Ma’am, you may being you conference. Anne Marie Fields Thank you. Good afternoon, this is Anne Marie Fields with LHA. Thank you all for joining today’s call. I’d like to remind you that any statements made during this call other than statements of historical fact will be considered forward-looking and as such will be subject to risks and uncertainties that could materially affect the Company’s expected results. Those forward-looking statements include, without limitation, the various risks described in the Company’s annual report on Form 10-K for the year ended December 31, 2016 and its subsequent filings with the SEC. Before we begin, let me review the format for today’s call. Steve Rubin, OPKO’s Executive Vice President, will provide an update on the Company’s various businesses and clinical programs; followed by Adam Logal, OPKO’s Chief Financial Officer, for who will review of the Company’s 2017 first quarter financials performance. Dr. Phillip Frost, Chairman and Chief Executive Officer of OPKO, will provide closing remarks and then we will open the call to your questions. Now, I’d like to turn the call over to Steve Rubin. Steve? Phillip Frost This is Dr. Frost. Before Steve Rubin and Adam Logal talk about the Company and this quarter in a more granular way I’d like to give you my view of where we are. We have a large diagnostics laboratory, Bio-Reference in which we are very proud. So much though that we have decided to invest heavily in its future. And we’ve restructured management with a new CEO Dr. Greg Henderson, a new COO of Warren Erdmann. And new genomics division head Dr. Ben Solomon and a new Director of Sales for GeneDx Vicky Laughman all experienced professionals who would be rated among the best by any standard. They joined in an existing team of dedicated leaders. Together they position us to launch forward with new products, greater revenues and more profit. We've been investing in new systems of every sort that will result in better financial data that will give us more information about our customers, our products, our sales team and very important will permit better collection of receivables. For GeneDx this means we'll be able to gather and store and analyze sequencing formation to provide new services for better patient diagnosis more family genetic information and more success with our marketing and sales effort. We're now ready to go to the next level. The 4Kscore test is being marketed and sold through Bio-Reference but our urology team has been busy designing and performing new trials to even further document the unique value of 4K to identify men with serious prostate cancer. These trials will of course result in more publications presentations of medical meetings and more embedded tools for our marketing and sales effort. My goal for the year is to increase sales of our 4Kscore test in a very meaningful way. On the therapeutic side we will be very aggressive of with our efforts to make RAYALDEE the huge commercial success it was meant to be. RAYALDEE is an effective and safe product that will help manage the increasingly large number of patients with chronic kidney disease.
May 09, 2017 (GLOBE NEWSWIRE via COMTEX) -- U.S. commercial launch of RAYALDEE underway 4Kscore test utilization continues to grow; Level 1 CPT code and CMS pricing in place Pediatric global phase 3 initiated and Japanese registration trial for hGH-CTP commencing shortly Adult study trial data analysis near completion; preparation for Biologics License Application (BLA) submission underway Clinical trials of Claros point of care (POC) PSA test began in January 2017; PMA filing anticipated upon completion; Claros POC testosterone test clinical trials and 510(k) filing to follow Initiation of four Phase 2 trials anticipated in 2H 2017 and early 2018 - RAYALDEE for dialysis patients with secondary hyperparathyroidism (SHPT) - OPK88003, an orally administered selective androgen receptor modulator (SARM) for BPH (Benign Prostatic Hypertrophy) - OPK88004, a once weekly oxyntomodulin dual GLP1-Glucagon agonist for type 2 diabetes and obesity - OPK88002, an NK-1 inhibitor to treat pruritus (itching) in dialysis patients OPK8801, Orphan Drug Status received in the U.S. and EU for new Oligonucleotide to treat Dravet Syndrome; IND planned for 2H 2017 Clinical trials ongoing for long acting Factor VII-CTP Consolidated revenue for the quarter ended March 31, 2017 increased to $296.1 million from $291.0 million for the comparable 2016 period For the three months ended March 31, 2017, net loss was $31.0 million compared to net loss of $12.0 million for the comparable 2016 period Financial results reflect significant investments in our pipeline development and marketing and sales expenses related to the introduction of RAYALDEE Business Highlights U.S. commercial launch of RAYALDEE underway: RAYALDEE was launched by our experienced commercial marketing and sales teams and substantial progress has been made in obtaining formulary access for RAYALDEE, with more than 60% of potential patient lives now covered under insurance plans. Obtaining broad insurance coverage is a critical step in the adoption of the use of RAYALDEE. Forthcoming revisions to the Kidney Disease Improving Global Outcomes (or KDIGO) Clinical Practice Guidelines for Chronic Kidney Disease - Mineral and Bone Disorder CKD-MBD) are expected to recommend against the routine use of vitamin D receptor activators (VDRAs) for the treatment of SHPT in this population. This guideline is also expected to highlight the unproven effectiveness of nutritional vitamin D as a treatment for SHPT and is anticipated to greatly enhance the adoption of RAYALDEE therapy by physicians and patients. Dr. Akhtar Ashfaq, a board certified nephrologist with significant industry experience, has joined OPKO as Senior Vice President, Clinical Research & Development and Medical Affairs. Dr. Ashfaq will support commercial and scientific development strategies for RAYALDEE. 4Kscore test utilization continues to grow; Level 1 CPT code and CMS pricing in place, negotiations with payors continue. Level 1 CPT code and CMS pricing became effective on January 1, 2017, and the Company is actively working to secure coverage with additional payors. During the quarter ended March 31, 2017 approximately 18,600 4Kscore tests were ordered which represents growth of more than 100% from the first three months of 2016. Phase 3 pediatric trial for hGH-CTP initiated; Analyses of data from long acting hGH-CTP trial in adults continue and BLA preparation for FDA submission underway: OPKO will complete a statistical outlier analysis of data from its Phase 3 trial study in adults and, together with Pfizer, is preparing a BLA for FDA submission. Phase 2a trial for intravenously administered Factor VII-CTP and Phase 1 trial for subcutaneously administered Factor VII-CTP are ongoing. These long acting forms of Factor VII utilizing OPKO's CTP platform technology are expected to better support prophylaxis, provide for easier administration and decrease the frequency of dosing. Analytical and clinical validation trials for Claros point of care (POC) PSA test began in January 2017; PMA filing anticipated upon completion; Claros POC testosterone test trials and 510(k) filing to follow. OPKO has begun analytic and clinical validation studies of its POC diagnostic test for prostate specific antigen (PSA) utilizing its proprietary diagnostic platform and intends to submit its PMA application to the FDA for approval in 2017. OPKO expects to begin an additional multi-center study of its POC testosterone test in 2017 followed by a 510(k) submission. Initiation of four Phase 2 clinical trials anticipated in 2H 2017 and early 2018 - RAYALDEE line extension in dialysis patients with SHPT: Together with its partner, Vifor Fresenius, OPKO is developing RAYALDEE for Stage 5 CKD patients with SHPT undergoing dialysis and anticipates initiating a Phase 2 trial during the second half of 2017. - OPK88003, an orally administered selective androgen receptor modulator (SARM): The Company plans to initiate a Phase 2b dose ranging study in the second half of 2017 to evaluate the use of OPK88003 to treat men with benign prostate hypertrophy (BPH) (enlarged prostate). It is expected to ameliorate symptoms of BPH by reducing prostate size and, on the basis of data from a previous trial in 350 men, provide other benefits such as increase in muscle mass and bone strength and decreased fat mass. - OPK88004,a once weekly oxyntomodulin dual GLP1-Glucagon agonist for type 2 diabetes and obesity: OPKO plans to initiate a Phase 2b study in early 2018 to determine optimal dosing. The drug has been shown to be safe and effective in a previous 400 patient Phase 2a trial. - OPK88002, an NK-1 inhibitor to treat pruritus (itching) in Stage 5 CKD patients undergoing dialysis: Approximately 50% of renal dialysis patients experience difficult to control pruritus. An IND was recently filed for a Phase 2a trial of OPK88002, obtained as part of the transaction with Schering Plough in which OPKO also obtained Rolapitant, licensed to TESARO, and now on the market. Orphan Drug Status received in the U.S. and EU for its new Oligonucleotide to treat Dravet Syndrome IND planned for 2H 2017; OPKO's oligonucleotide based AntagoNAT (OPK88001) for the treatment of Dravet Syndrome has received orphan drug designation in the US and EU and OPKO plans to initiate clinical trials of OPK88001 for treatment of Dravet Syndrome later this year. Currently, there is no globally approved treatment for Dravet Syndrome. AntagoNAT, anti-Natural Antisense Transcripts, is an OPKO platform technology in which single strand oligonucleotide molecules are designed to interfere with regulatory gene expression in order to enhance production of endogenous functional proteins. The combination of our expanding and maturing pipeline of products in clinical development and the expected increase in sales of existing products currently in the market positions the company well for significant growth Financial Highlights Consolidated revenues for the three months ended March 31, 2017 of $296.1 million improved incrementally over the comparable period of 2016 of $291.0 million. During the first three months of 2017, operating expenses included significant investment in the commercial activities supporting the launch of RAYALDEE, as well as continued investment in advancement of the Company's pharmaceutical pipeline. The three month period ended March 31, 2016 benefited from a non-recurring income tax rate change in Israel, which was the principal result of the $20.5 million income tax benefit. Cash, cash equivalents and marketable securities were $131.1 million as of March 31, 2017.
Do you think KDIGO might haven't gotten angry at OPKO for discussing the new guidelines before they were actually published?
Looks like Pfhizer hasn't given up on hGH-CTP (Human growth hormone-CTP; Lagova; MOD-4023; PF-06836922; Somatropin long-acting) http://www.pfizer.com/sites/default/files/product-pipeline/01302018_PipelineUpdate.pdf Page 10 Maybe the stock will go up
Maybe having Reimbursement coverage PRIOR to the KDIGO guidelines being published would have helped the Rayaldee Rocket reach the stars?
