OPKO to List on Tel Aviv for Prolor Deal

Tel Aviv Stock Exchange

Billionaire Phillip  Frost to List Shares…

Tel Aviv Stock ExchangeOpko Health Inc. (OPK:US), led by billionaire Phillip Frost, is set to list shares on the Tel Aviv Stock Exchange as it seeks to complete the acquisition of Israeli drugmaker Prolor Biotech Inc. (PBTH:US)

 

OPKO Health IncShares of the Miami-based drug developer, which are already listed on the New York Stock Exchange, will begin trading in Tel Aviv on Aug. 21, a bourse spokeswoman said by telephone today. In October, the stock will enter the Tel Aviv 25 Index (TA-25), a gauge of the exchange’s largest companies by market value, she said.

Prolor-Biotech_OPKOOpko’s listing would enable it to pay Prolor shareholders in locally listed stock. The deal announced in April gave them 0.9951 Opko shares for each stock in Prolor. While the share swap valued Prolor at $480 million in April, a 12 percent increase in Opko’s shares since then has boosted the value to about $540 million.

Prolor’s stock, which will be delisted, has gained 27 percent since the deal was announced. The transaction is expected to close in the second half of this year, provided Opko and Prolor shareholders approve the merger in a vote on Aug. 28.

After selling Ivax Corp. to Teva (TEVA) for $7.4 billion in 2006, Frost and his associates began assembling Opko, a health-care holding company for diagnostic equipment and medical products. Frost is the chairman and largest shareholder in both Opko and Prolor and one of Prolor’s early investors. He’s also chairman of Teva.

Sourced From:
http://www.businessweek.com/news/2013-08-19/billionaire-frost-s-opko-to-list-in-tel-aviv-for-prolor-deal
by David Wainer in Tel Aviv – Bloomberg

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OPKO – News

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Second Quarter 2013 Financial Highlights

opko-160x160MIAMI — OPKO Health, Inc. (NYSE: OPK), a multi-national biopharmaceutical and diagnostics company, today reported operating and financial highlights for the second quarter of 2013.

OPKO Health Inc. (OPK: Quote) on Friday said that its second quarter net loss improved as revenue more than doubled compared to the year-ago quarter.

TESARO_OPKO_DAYTRADERPICKSTop-line results from a phase III trial of Rolapitant, which OPKO out-licensed to biopharmaceutical company TESARO Inc., are anticipated in the second half of 2013. Rolapitant is under phase III testing for the treatment of chemotherapy-induced nausea and vomiting.

OPK closed Friday ( 8/9/13)  trading at $7.49. In after-hours, the stock was up 0.53% to $7.53.

Second Quarter 2013 Financial Highlights

Consolidated revenues more than doubled to $23.8 million during the three months ended June 30, 2013, from $10.2 million in the prior year period and nearly tripled to $55.2 million for the six months ended June 30, 2013, from $19.0 million in the prior year period. Revenue for the six months ended June 30, 2013, includes $12.5 million of revenue resulting from a strategic partnership in the field of RNA interference with RXi Pharmaceuticals Corporation.

Net loss for the three months ended June 30, 2013, was $ 3.4 million, compared to a net loss of $10.8 million for the 2012 period. Net loss for the three months ended June 30, 2013, includes the impact of:

$9.9 million non-cash benefit related to the change in fair value of embedded derivatives which are part of our January 2013 convertible senior notes due in 2033 (the “2033 Senior Notes”). This non-cash benefit resulted principally from the decrease in the closing market price of our common stock as of June 30, 2013, as compared to the previous quarter end; and

$8.5 million related to other income from the sale of available for sale securities.

Net loss for the six months ended June 30, 2013, was $38.0 million, compared to a net loss of $20.0 million for the 2012 period. Net loss for the six months ended June 30, 2013, includes the impact of:

$14.9 million in net non-cash charges related to the change in fair value of embedded derivatives which are part of our 2033 Senior Notes, principally as a result of the increase in the closing market price of our common stock as of June 30, 2013, as compared to the date of issuance of such notes; and

$10.8 million related to other income from the sale of available for sale securities.

Cash, cash equivalents and marketable securities were $169.1 million as of June 30, 2013.

Business Highlights

PHARMADIET_OPKO_DAYTRADERPICKS

Our Spanish subsidiary, Pharmadiet, S.L.U., received regulatory approval for commercialization of its oral and injectable formulations of citicoline to treat memory disorders and behavior related to stroke, head injury, chronic disease, as well as degenerative brain disorders.

The two Phase 3 trials of Rayaldy™, our vitamin D prohormone to treat patients with secondary hyperparathyroidism with stage 3 or 4 chronic kidney disease and vitamin D insufficiency, are progressing on schedule. We anticipate top-line data from this pivotal program in mid-2014.

Prolor-Biotech_OPKOOur acquisition of PROLOR Biotech, Inc. (NYSE MKT: PBTH), a biopharmaceutical company focused on developing longer-acting proprietary forms of presently marketed therapeutic proteins and peptides, is expected to close during the third quarter of 2013. PROLOR has reported that its long-acting version of human growth hormone, hGH-CTP, can reduce the dosing frequency from one injection per day to a single weekly injection. A Phase 2 trial in children with GHD is currently ongoing, and a Phase 3 trial in adults with GHD was initiated in June 2013. PROLOR also recently announced results from preclinical studies of its long-acting clotting factor VIIa (Factor VIIa-CTP), a next-generation investigational therapy in advanced preclinical development for the potential treatment of hemophilia. The data indicate that Factor VIIa-CTP can be administered by subcutaneous (SC) injection in contrast to presently used products which must be given intravenously; this would facilitate its prophylactic at home use.

Enrollment, now surpassing 90%, continues by our licensee, TESARO, Inc. in each of three Phase 3 trials of Rolapitant for the prevention of chemotherapy induced nausea and vomiting. TESARO anticipates that top-line data from this pivotal program will be announced by year end. TESARO also presented results from a pharmacokinetic study of Rolapitant at the recent Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) International Symposium in Berlin. These data support concomitant administration of Rolapitant with other pharmaceutical products that are metabolized by the liver microsomal enzyme CYP3A4, without a requirement for dose adjustment of the co-administered product.

The U.S. commercial launch of the OPKO 4Kscore™ prostate cancer test as a laboratory developed test will be through our CLIA-certified laboratory based in Nashville, TN.

“We continue to build and strengthen the foundation for a sound profitable business,” said Phillip Frost, M.D., OPKO’s Chairman and Chief Executive Officer. “We are pleased that Pharmadiet, our Spanish subsidiary, has received regulatory approval for our oral and injectable formulations of citicoline, and we are beginning the process for marketing them in Spain as well as through our Latin American units. These products will be sold by prescription to improve memory in certain patients,” continued Dr. Frost. “We are also very proud of the pipeline of new products in various stages of development in OPKO and soon to be acquired PROLOR. They can provide the basis for an important health care company.”

About OPKO Health, Inc.

A  multi-national biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large and rapidly growing medical markets by leveraging our discovery, development and commercialization expertise and our novel and proprietary technologies.

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OPKO Health, Inc – Merger News

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Dr Phillip Frost can vote on Prolor-Opko merger

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Jul 28, 2013  –Dr. Phillip Frost, the chairman of both Prolor Biotech Inc. PBTH(tase:PBTH) and Opko Health Inc.  OPK has the right to vote on the merger of the two companies on August 28, states Prolor in the summons to the general shareholders meeting which will vote on the merger. Each company will hold a separate vote on the merger. Frost is also chairman of Teva Pharmaceutical Industries Ltd. TEVA(tase:TEVA).

Frost is the biggest shareholder in both Prolor and Opko, owning 26.5 percent of the former and 50 percent of the latter. In contrast to Israeli law, under US law, Frost and his associates who are parties at interest in the deal are not banned from voting on it. This means that the vote by Opko shareholders is essentially a done deal. As for Prolor, the parties will have to secure a third of the independent shareholders to approve the merger.

“Although Frost initiated the merger, he was not personally involved in the negotiations, which were managed by a team of external directors of each party. The law therefore allows Frost to vote as an ordinary shareholder,” Prolor president Shai Novik.

The description of the negotiations in the proxy statement, which the companies published for the merger, Frost proposed the merger and the price, which were not changed during the negotiations. Prior to this proposed merger, Prolor was in acquisition talks with Teva, but the parties could not agree on terms.

Prolor has a market cap of 442 million, and Opko has a market cap of 2.5 billion. Under the merger terms of 0.9951 Opko shares for each Prolor share, the deal gives Prolor a share price of 7.64, a 9.6 percent premium on Friday’s closing price of 6.96, and a 30 percent premium on its share price when the merger was announced.

Frost has bought Opko shares since the merger was announced. He bought shares in the company in previous years, but picked up the pace following the announcement, helping boost the share price. This also affected the company value of Prolor for the deal, which will be through a share swap. The purchases also boosted Frost’s stake in Opko to over 50 percent, which means that he can decide the vote on the merger by himself.

At the same time, Frost also bought shares in Prolor. “I am buying Opko because it’s a good investment and Prolor because it’s like buying Opko at a discount,” he says.

In the proxy statement, Opko says that, after the merger with Prolor, it is considering a listing on the Tel Aviv Stock Exchange (TASE). It is a diversified life sciences company with diagnostic and drug development operations, most of which it acquired from third parties. It posted a loss of 34 million on 31 million revenue for the first quarter of 2013, compared with a loss of 8.6 million on 8.7 million for the corresponding quarter of 2012.

Besides Frost, Opko has an Israeli connection through two pharmaceutical manufacturing companies which it acquired for small amounts: Nesher-based FineTech Pharmaceutical Ltd. and Rehovot-based SciGen Israel Ltd.

Prolor is developing delayed-release injectable drugs. Its flagship product is a longer acting human growth hormone, which can be delivered once a week or every other week, instead of daily. The company is about to begin a Phase III clinical trial (multicenter efficacy trial) on the drug.

 

About Prolor Biotech

PROLOR Biotech is developing proprietary versions of already-approved therapeutic proteins. The Company’s Carboxyl Terminal Peptide technology can be attached to an array of existing therapeutic proteins, stabilizing the therapy in the bloodstream and extending its lifespan without additional toxicity or loss of desired biological activity.

PROLOR products under development include Human Growth Hormone (“hGH”) for the long-term treatment of children and adults with growth failure due to inadequate secretion of endogenous growth hormone (a $3 billion market opportunity). PROLOR’s hGH could potentially be injected once a week or twice per month instead of daily. PROLOR’s hGH is scheduled for Phase III trials in 2013.

PROLOR’s GLP-1 / Glucagon dual receptor agonist for Diabetes Type II (a $2 billion market opportunity) could be injected once a week and may have a dramatically better weight-loss profile than current GLP-1 therapies.

PROLOR is also developing Factor VIIa and Factor IX for Hemophilia (a $2 billion market opportunity); Anti-Obesity Peptide Oxyntomodulin; Interferon ß and Erythropoietin; and Atherosclerosis and Rheumatoid Arthritis long-acting therapies.

PROLOR’s offices and research and development facilities are located in Israel in the Weizmann Science Park, Nes-Ziona.

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