OPKO Health NR – Aquisition

OPKO Acquires Next Generation Dry Powder Inhaler to Treat Respiratory Disorders

OPKO HEALTH INC(OPK:NYSE, US)

BuySell
8.20USDDecrease0.13(-1.56%)Volume: 
Average
As of 17 Apr 2014 at 11:53 AM EDT.  

QUOTE DETAILS

Open 8.29 P/E Ratio (TTM)
Last Bid/Size 8.19 / 12 EPS (TTM) -0.33
Last Ask/Size 8.20 / 20 Next Earnings 5 May 2014
Previous Close 8.33 Beta 1.01
Volume 1,351,913 Last Dividend
Average Volume 3,501,287 Dividend Yield 0.00%
Day High 8.37 Ex-Dividend Date
Day Low 8.12 Shares Outstanding 412.9M
52 Week High 12.95 # of Floating Shares 221.0759M
52 Week Low 6.14 Short Interest as % of Float 21.06%

Inspiromatic™ Improves Drug Delivery, Monitors Patient Inhalation and Provides Real-Time Patient Feedback

MIAMI–(BUSINESS WIRE)– OPKO Health, Inc. (NYSE:OPK) has entered into a definitive agreement to acquire Inspiro Medical Ltd. (“Inspiro”), an Israeli medical device company developing a new platform to deliver small molecule drugs such as corticosteroids and beta agonists or larger molecules to treat respiratory diseases. Inspiro’s Inspiromatic™ is a “smart” easy-to-use dry powder inhaler with several advantages over existing devices.

Inspiromatic™ offers improved drug deposition to the lower airways of patients and real time data for patient compliance monitoring. The device has an internal microcontroller and flow sensor that controls the delivery of the medication and, using micro-pump technology, dispenses the drug particles at the right speed without the need for forceful inhalation. It also provides instant feedback to the patient with a green or red flasher light to indicate proper inhalation and a beeper after the dose has been delivered. For physicians, Inspiromatic™ provides a built-in logger that stores patient use data for easy access and transmission by electronic devices such as smart phones.

In a recently completed, First In Man double blinded clinical study conducted in 30 asthmatic children comparing Inspiromatic™ to a market leading dry powder inhaler, Inspiromatic™ demonstrated superior pulmonary delivery of the active drug.

“We are pleased to add this next generation inhaler to OPKO’s growing product portfolio,” stated Phillip Frost, M.D., OPKO’s CEO and Chairman. “We expect this innovative device to play a valuable role in the improvement of therapy for asthma, chronic obstructive pulmonary disease, cystic fibrosis and other respiratory diseases. We plan to use the Inspiromatic™ device to test the inhaled form of OPKO’s new sulfated disaccharide drug against these disorders. This drug product is still undergoing pre-clinical testing prior to submission of an IND, but animal data indicates safety and efficacy for both inhaled and orally delivered forms. Of course, we believe that Inspiromatic™ can improve outcomes of treatment with other drugs, those presently available in more ‘standard’ type inhalers, as well as new inhalation drugs being developed. This acquisition fits our strategy of developing new products that address large markets in need of more effective therapeutic solutions.”

Nimrod Kaufmann, CEO and Co-Founder of Inspiro, commented, “We are extremely proud of Inspiro’s success in bringing our smart Inspiromatic™ respiratory drug-delivery device to market. With Inspiro now a part of OPKO, we will be able to help more people faster. Inspiro joining OPKO is a big win for the shareholders of both Inspiro and OPKO, as well as good news for our patients and physicians.”

Eran Feldhay, M.D., CEO of Trendlines Medical, Inspiro’s largest shareholder, added, “The acquisition of Inspiro is our third exit in eight months, all to U.S.-based multinational corporations. This success brings continuing confirmation of the strength of the Trendlines team in fulfilling our vision of creating and developing companies to improve the human condition. We are very pleased to see OPKO take the Inspiro opportunity forward.”

J&J Update

J&J beats forecasts as new drugs shine, shares jump

1 hour ago – Reuters
J&J beats forecasts as new drugs shine, shares jumpBy Ransdell Pierson

(Reuters) – Johnson & Johnson <JNJ.N> reported quarterly earnings well above expectations, as strong sales of new drugs offset weak demand for consumer products and medical devices, and the company slightly raised its full-year profit view.

Shares were up 2.5 percent in premarket trading.

J&J on Tuesday said it earned $4.73 billion, or $1.64 per share, in the first quarter. That compared with $3.5 billion, or $1.22 per share, in the year-ago quarter, when the diversified healthcare company took a big litigation charge.

“Strong pharmaceuticals results showcased a very strong 2014 start for J&J,” said Morningstar analyst Damien Conover, referring to sales growth of almost 11 percent for prescription medicines in the quarter. He cited especially strong sales of immunology medicines and for the company’s recently approved Olysio treatment for hepatitis C.

The hepatitis drug, known as Sovriad in many countries outside the United States, was approved by U.S. regulators in November and captured global sales of $354 million in the first quarter – putting it on track to become a blockbuster product later this year.

The company handily beat earnings forecasts because newer drugs have very high profit margins, Conover said. “They amplified the affect on the company’s bottom line.”

But J&J’s other business units failed to impress. Sales of medical devices and diagnostics were flat at $7.06 billion, hurt by lower prices associated with competitive bidding in the U.S. Medicare insurance program for the elderly and disabled.

Global sales of consumer products fell 3.2 percent to $3.56 billion, as many over-the-counter medicines remain unavailable due to earlier product recalls in the United States.

J&J says it now expects full-year earnings of $5.80 to $5.90 per share, up from its prior forecast of $5.75 to $5.85 per share given in January.

Excluding special items, J&J earned $1.54 per share. Analysts, on average, were expecting $1.48 per share, according to Thomson Reuters I/B/E/S. Sales rose 3.5 percent to $18.1 billion in the quarter, topping Wall Street forecasts of $18 billion.

Global sales of prescription drugs jumped to $7.5 billion. Sales of Simponi, a drug for rheumatoid arthritis, rose 9.3 percent to $259 million, while sales of psoriasis treatment Stelara soared 32 percent to $456 million.

J&J shares were trading at $99.50 in premarket trading, from their closing price on Monday of $97.14 on the New York Stock Exchange.

Novadaq Technologies

NVDQ : NASDAQ : US$23.61
NDQ : TSX
BUY 
Target: US$26.00

COMPANY DESCRIPTION:
Novadaq develops and manufactures intra-operative
fluorescence imaging technologies used in a variety of
open surgeries, such as breast, head, and neck
reconstruction; tumor and bowel re-section; and coronary
artery bypass grafting (CABG). In addition, partner
Intuitive Surgical offers Novadaq’s FIREFLY imaging
system on the da Vinci robot. Founded in 2000, the
company’s products were used by 45 of the top 50
cancer centers in 2011.

All amounts in US$ unless otherwise noted.

Life Sciences — Biomedical Devices and Services
PILLAR II DELIVERS; EXPECT NVDQ
TO GO DIRECT WITH SPY IN 2016;
RAISE TARGET TO $26
Investment recommendation
We remain buyers of NVDQ, which we consider the most
compelling growth story in med-tech; possessing one of, if not
the largest TAM opportunities in our group, with a proprietary
imaging platform that could become ubiquitous in surgery. We
increase our target from $23 to $26, applying an 11x EV/sales
multiple to our 2016 revenue estimate of $118M (discounted
back to mid-2015), which is upwardly revised as we now expect
NVDQ to re-acquire US marketing rights for SPY Elite in Q4:15
and go direct thereafter, resulting in a much higher kit ASP.
Investment highlights
 Final PILLAR II results deliver – 139 patients who underwent
colorectal cancer surgery using PINPOINT imaging had a
1.4% anastomotic leak rate (vs. 12.6% published rate for LAR
patients); 8% of patients benefited from a change in surgical
plan via PINPOINT (0% leak rate). We expect results to be
published in a major surgical journal imminently.
 Next-generation PINPOINT system introduced at SAGES; will
launch in Q2. NVDQ will increase system ASP >30%.
 Expect NVDQ to go it alone with SPY. Our recent meetings
with management lead us to conclude the company will go
direct with SPY Elite once the agreement with LifeCell ends
in Sept. 2015. We increase our 2016 estimates to account for
a higher kit ASP.

 

 

OPKO Health Gains With News Release

 

OPKO HEALTH INC(OPK:NYSE, US)

BuySell
9.25USDIncrease0.29(3.24%)Volume: 
Average
As of 31 Mar 2014 at 12:04 PM EDT.

 

QUOTE DETAILS
Open 9.03 P/E Ratio (TTM)
Last Bid/Size 9.25 / 11 EPS (TTM) -0.33
Last Ask/Size 9.26 / 22 Next Earnings 5 May 2014
Previous Close 8.96 Beta 1.06
Volume 1,102,332 Last Dividend
Average Volume 2,574,977 Dividend Yield 0.00%
Day High 9.26 Ex-Dividend Date
Day Low 8.92 Shares Outstanding 412.9M
52 Week High 12.95 # of Floating Shares 221.0759M
52 Week Low 6.14 Short Interest as % of Float 20.69%

OPKO Announces Launch of 4Kscore Test for Prostate Cancer

 

 

MIAMI–(BUSINESS WIRE)– OPKO Health, Inc. (NYSE:OPK) announced the availability of the 4KscoreTMTest through its CLIA-accredited OPKO Lab in Nashville, TN. The laboratory-developed test is designed to enhance the prostate biopsy decision making process that, in the United States, leads to approximately 1 million biopsies being performed annually, with 80% of the results indicating no cancer or a low-grade cancer. The 4KscoreTM Test will help to reduce unnecessary prostate biopsies by providing information on the risk (probability) of having high-grade prostate cancer.

The 4KscoreTM Test was developed by OPKO Lab, a division of OPKO Health, and tested in collaboration with 26 Urology centers across the United States from October 2013 to March 2014. Results showed that the 4Kscore TestTM was highly accurate for predicting the presence of high-grade cancer (Gleason score 7 or higher) prior to prostate biopsy. The full data from the blinded, prospective U.S. clinical validation study will be presented at the AUA Annual Meeting in Orlando, FL on May 18th at Plenary Session I.

“We are pleased to offer the 4Kscore TestTM at OPKO Lab to provide Urologists with new information to inform them of the risk of a patient’s having high-grade prostate cancer and help clarify the decision process surrounding prostate biopsy,” said David Okrongly, President of OPKO Diagnostics.

“We believe the 4Kscore TestTM will be an important benefit for Urologists and their patients and may lead to lower overall healthcare costs,” said Phillip Frost, M.D., OPKO’s Chairman and Chief Executive Officer.

About the 4Kscore™ Test

The 4Kscore™ Test measures the blood plasma levels of four different prostate-derived kallikrein proteins: Total PSA, Free PSA, Intact PSA and Human Kallikrein 2 (hK2). These biomarkers are combined with a patient’s age, Digital Rectal Exam (DRE) status (nodule / no nodule), and prior biopsy status (yes / no) using a proprietary algorithm to calculate the risk (probability) of finding a Gleason Score 7 or higher prostate cancer. The 4Kscore Test TM was developed by OPKO Lab, a division of OPKO Health, Inc., and will be performed at OPKO Lab’s CLIA-accredited facility in Nashville, Tennessee. The four kallikrein panel of biomarkers utilized in the test is based on over a decade of research conducted by scientists atMemorial Sloan Kettering Cancer Center and leading European institutions. The information provided by the 4Kscore TestTM can add new information to the shared decision making discussion between a Urologist and patient in determining the advisability of a prostate biopsy.

About Prostate Cancer

In 2014, over 233,000 new cases of prostate cancer will be identified and 29,480 men will die from the disease according to estimates released by the National Cancer Institute, making it the second most deadly cancer in U.S. men. Prostate cancer is usually first detected by elevations in serum PSA. However, PSA level is often elevated for reasons unrelated to prostate cancer. Although an elevated PSA level often leads to biopsy, about 80% of all prostate biopsies performed are either negative or indicate a low likelihood of high-grade cancer.

ABOUT OPKO HEALTH, INC.

OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise and novel and proprietary technologies. For more information, visithttp://www.opko.com.

SAFE HARBOR STATEMENT

TINY New Investment

Much like our interest in Opko Health ( OPK) is a new ( to us ) company that invests in other companies . By not investing in pure research OPK hopes to be at the stage  - or closer to the stage of commercial development. In the case of TINY the company  seeks out investments in the field of nanotechnology .

The portfolio of more than two dozen stocks is ” harvested ” as the investments are taken over by larger firms. At this point Harris is trying to raise its own profile . Until that happens the company is undervalued, unknown and unappreciated . This is a long term position for Jack A. Bass Managed Accounts.

Harris & Harris Group, Inc. (TINY)

-Nasdaq

3.57 Up 0.05(1.42%) Mar 28, 4:00PM EDT
Prev Close: 3.52
Open: 3.50
Bid: 2.86 x 3000
Ask: 4.27 x 1000
1y Target Est: 4.25
Beta: 1.59
Earnings Date: May 5 – May 9 (Est.)
Day’s Range: 3.50 - 3.61
52wk Range: 2.83 - 3.94
Volume: 75,918
Avg Vol (3m): 136,115
Market Cap: 111.37M
P/E (ttm): N/A
EPS (ttm): -0.25
Div & Yield: N/A (N/A)
Quotes delayed, except where indicated otherwise. Currency in USD.

Harris & Harris Group, Inc. (TINY)

For an overview here is a potion of their letter to Shareholders

2013 Annual Letter to Shareholders

Fellow Shareholders:

In our 2012 Annual Letter to Shareholders, we ended with the following statement. “The
current market is one in which to be investing, not harvesting. We believe our actions in
2012 position us to realize greater value when the time to harvest is upon us.” We
believe the market of 2012 has evolved into a market, currently, in which we may have
the potential to harvest returns.

In 2013, investments from our portfolio returned $30.4 million in cash to Harris & Harris
Group. In July 2013, our portfolio company Xradia, Inc., was purchased by Carl Zeiss.
We will receive up to $15.2 million in proceeds from the sale, including amounts held in
escrow. To date, we have received $14 million of this $15.2 million. Our investment cost
in Xradia was $4 million. In 2013, we also sold certain assets of SynGlyco, Inc.,
(previously Ancora Pharmaceuticals) to CordenPharma. We retained the vaccine-related
assets. In January 2014, Kovio, Inc., was acquired by Thin Film Electronics ASA, but we
received no proceeds from this sale.

On February 14, 2014, we announced the signing of definitive documents for the sale of
Molecular Imprints Inc’s. semiconductor business to Canon. The merger currently is
expected to be completed by the end of April 2014, after normal shareholder and
government approvals. We expect to receive $7.0 million in proceeds from the sale,
including amounts to be held in escrow. We could receive an additional $1.7 million
upon the achievement of certain milestone payments. Our investment cost in Molecular
Imprints was $4.6 million. Interestingly, because of a strategic investment we were able
to make in April and June 2011, primarily owing to our evergreen status, we will be the
only financial investor to realize a return on our investment at the initial closing.
Additionally, we will hold ownership in a financed new company established to utilize
Molecular Imprints’ technology for applications in the biomedical and consumer
electronics fields without needing to make an additional new investment. This gives us
another opportunity to generate a return on our original investment in Molecular Imprints
on top of the return generated from the acquisition by Canon

 

 

Insmed Update

INSM : NASDAQ : US$15.91

BUY 
Target: US$30.00

COMPANY DESCRIPTION:
Insmed is focused on developing novel, targeted inhaled
therapies for the treatment of serious orphan lung diseases. Its
lead product candidate is Arikace, a liposomal formulation of FDA
approved antibiotic, amikacin.

All amounts in US$ unless otherwise noted.

 

Life Sciences — Biotechnology
DATA ANALYSIS ARBITRAGE:
TOTALITY OF NTM DATA SUPPORTS
ACTIVITY, SAFETY AND APPROVAL
Investment recommendation
Reiterate BUY, $30 PT on Arikace’s potential in nontuberculous
mycobacteria (NTM).

INSM’s lead drug Arikace is an inhaled liposomal form of FDA-approved amikacin. We view the Ph2 US NTM data as
clearly positive, and culture conversion/safety data as supportive of expedited approval. Our $30 target is based on a pNPV analysis.
Investment highlights
 We see a clear, and likely abbreviated path to approval strongly
supported by culture conversion and QoL data. We think six-month
extension culture conversion, conversion over time, and QoL data to
be presented May 20th at ATS (San Diego) will support a subpart H
filing, a positive AdComm and conditional approval, given what we
see as strong clinically meaningful data in an unmet need.
 Primary endpoint statistics confounded by small numbers, unrelated
death. The sensitivity of the primary endpoint Wilcox rank sum
analysis is underscored by the change in p-value from p=0.148 to
p=0.02 when a repeated measures analysis is conducted excluding
the unrelated patient death. We think FDA’s previous strong focus
on cures/QoL (supported by our talks with KOLs) hasn’t changed.
 QDIP/GAIN gives FDA the flexibility to focus on the drug’s activity:
we think breakthrough status is highly likely. While some investors
are focused on safety, we think the lack of renal and ototoxicity and
note FDA has approved antibiotics for unmet needs with much more
problematic safety profiles (e.g. Sirturo’s black box warning

Trading Alert IMRS – Still Strugling

We have a large position in OPK as a result of the sale of IMRS at 2.65

The latest report points to a still struggling for sales – great tech company

IMRIS INC, Tuesday close $2.52, -10.32 pct premarket

Paradigm Capital cut its rating on the Canadian medical equipment maker’s stock to “hold” from “buy” and reduced price target to $2 from $3. Imris on Tuesday reported a bigger-than-expected loss for the fourth quarter as revenue took a hit due to delayed shipment of a major order. The compIMRIS Inc(IMRS:NASDAQ, US)

BuySell

 

2.12USDDecrease0.40(-15.87%)Volume:
Above Average
As of 05 Mar 2014 at 10:41 AM EST.

Quote Details

Open 2.11 P/E Ratio (TTM)
Last Bid/Size 2.11 / 6 EPS (TTM)
Last Ask/Size 2.12 / 43 Next Earnings
Previous Close 2.52 Beta
Volume 816,587 Last Dividend
Average Volume 391,791 Dividend Yield 0.00%
Day High 2.18 Ex-Dividend Date
Day Low 1.84 Shares Outstanding 52.0M
52 Week High 4.30 # of Floating Shares
52 Week Low 1.16 Short Interest as % of Float

any also forecast lower-than-expected full-year revenue

 

OPKO Announces Fourth Quarter and Full Year 2013 Results

OPKO Announces Fourth Quarter and Full Year 2013 Results

Fourth Quarter Revenue Increases About 30%; Full Year Revenue More      Than Doubled to $96.5 Million

Company Has Strong Liquidity, Including Cash and Cash Equivalents of       $185.8 million as of December 31, 2013

Launch of 4Kscore™ Planned in Q1 2014

OPKO Health Inc(OPK:NYSE, US)

BuySell
9.61USDIncrease0.21(2.23%)Volume:
Above Average
As of 04 Mar 2014 at 9:31 AM EST.

Quote Details

Open 9.57 P/E Ratio (TTM)
Last Bid/Size 9.60 / 5 EPS (TTM) -0.29
Last Ask/Size 9.64 / 7 Next Earnings
Previous Close 9.40 Beta 1.05
Volume 50,249 Last Dividend
Average Volume 3,480,807 Dividend Yield 0.00%
Day High 9.64 Ex-Dividend Date
Day Low 9.57 Shares Outstanding 408.0M
52 Week High 12.95 # of Floating Shares 216.217M
52 Week Low 6.14 Short Interest as % of Float 21.53%

MIAMI–(BUSINESS WIRE)–       OPKO Health, Inc. (NYSE:OPK), a multi-national biopharmaceutical and      diagnostics company, today reported operating and financial results for      its 2013 fourth quarter and full year ended December 31, 2013.

Financial Highlights

  •         For the fourth quarter of 2013, consolidated revenues increased about        30% to $20.7 million from $16.2 million in the prior year period. For        the year ended December 31, 2013, consolidated revenues more than        doubled to $96.5 million from $47.0 million in the prior year. Revenue        for the year ended December 31, 2013, included $12.5 million of        revenue resulting from a strategic partnership in the field of RNA        interference with RXi Pharmaceuticals Corporation.
  •         Cash and cash equivalents were $185.8 million as of December 31, 2013,        providing OPKO with liquidity to fund research and development and the        Company’s operations.
  •         Cash used in operations was $58.2 million during the year ended         December 31, 2013, as compared with $25.4 million of cash used in        operations during the year ended December 31, 2012. The increase in        cash used in operations during 2013 reflects the full impact of our        August and March 2013 acquisitions of PROLOR Biotech, Inc. and         Cytochroma Inc., respectively. During 2013, we also utilized        approximately $8.8 million for transaction-related expenses.
  •         Net loss for the 2013 fourth quarter was $16.8 million compared to a        net loss of $1.1 million for the 2012 period. The increase in net loss        for the 2013 fourth quarter was principally related to research and        development expenses incurred in connection with our ongoing Phase 3        clinical trials of Rayaldy™ and human growth hormone        (“hGH-CTP”), and interest expense related to the January 2013        convertible senior notes due in 2033 (the “2033 Senior Notes”), which        expenses were partially offset by $18.9 million in gains recorded on        the successful exit from strategic investments. The 2012 fourth        quarter results also included $9.7 million in net tax benefits        principally related to the acquisition of our laboratory business in        late 2012.
  •         Net loss for the full 2013 year was $114.8 million compared to $31.3        million for the 2012 period. The increase in net loss for the 2013        full year was primarily related to the previously mentioned research        and development expenses related to our Rayaldy™ and hGH-CTP        clinical trials, interest expense on the 2033 Senior Notes, and        non-recurring costs related to strategic and business development        activities, as well as the following non-cash charges:
    • $36.5 million related to the change in fair value of derivative            instruments, principally related to embedded derivatives that are            part of the 2033 Senior Notes;
    • $11.5 million on losses from investments in equity method            investees;
    • $8.7 million loss from early conversion of some of the 2033 Senior            Notes; and
    • $6.9 million related to the change in fair value of contingent            consideration payable in connection with prior acquisitions.

These expenses were partially offset by $29.9 million in gains recorded      on the successful exit from strategic investments during 2013. OPKO’s      2012 results also included $9.6 million in net tax benefits principally      related to the acquisition of our laboratory business in late 2012.

Phillip Frost, M.D., OPKO’s Chairman and Chief Executive Officer,      commented, “From an R&D perspective, all of our programs are      progressing. We made significant strides in 2013 with our ongoing Phase      3 trials for Rayaldy™ and hGH-CTP; 2014 will be a pivotal year      for our development programs. We look forward to announcing top-line      results for Rayaldy™ in mid-2014 and filing a NDA during the      first half of 2015. We are also enthusiastic about the planned launch      later this month of our 4Kscore™ blood test for prostate cancer      which we believe will lead to a great improvement in the diagnosis and      management of prostate cancer.”

“Work has been continuing in our research laboratories on a program to      utilize specific oligonucleotides to up regulate protein production. A      pre-IND meeting has been scheduled with FDA in connection with the      development of the first product to treat Dravet’s Syndrome, a      congenital condition characterized by chronic seizures.”

Dr. Frost added, “During the year, we further strengthened our cash      position by exiting certain strategic investments which provided      attractive returns. Bolstered by our sound financial position, we look      forward to continuing the advance of our robust product development      pipeline of promising diagnostics and pharmaceuticals.”

Business Highlights

  • Finalizing Steps Toward 4Kscore Launch: In         February 2014, OPKO announced successful initial results of the        clinical validation study of the 4Kscore™ test currently        underway at 21 large urology centers in the United States. The study,        involving more than 1,200 men, is now more than 50% complete and        supports the U.S. launch of the 4Kscore™ test later this month.
  • Completed Patient Recruitment In The Second Phase 3 Trial of Rayaldy™:         This trial is the second of two identical randomized,        double-blind, placebo-controlled, multi-site studies for Rayaldy™        — to treat patients with secondary hyperparathyroidism (SHPT), stage        3 or 4 chronic kidney disease (CKD) and vitamin D deficiency. Top-line        results from both trials are expected in mid-2014.
  • Positive Pre-Clinical Results on Long-acting Factor VIIa-CTP        Presented at the 7th Annual Congress of the European Association for        Haemophilia and Allied Disorders (EAHAD); Orphan Drug Designation also        Granted by FDA. Preclinical data presented at EAHAD on February        26-28 in Brussels, showed that OPKO’s long-acting Factor VIIa-CTP        exhibited a four times longer half-life and a four times improved drug        exposure versus Novo Nordisk’s $1.7 billion Factor VIIa product,        NovoSeven. Additionally, on February 27, 2014, the FDA granted orphan        drug designation to OPKO’s long-acting Factor VIIa-CTP for the        treatment and prophylaxis of bleeding episodes in patients with        hemophilia A or B with inhibitions against Factors VIII or IX.
  • TESARO Achieves Successful Primary Endpoints in Phase 3 Trials of        Rolapitant. TESARO recently announced that two Phase 3 trials of        oral rolapitant, one in patients receiving moderately emetogenic        chemotherapy (MEC) and one in patients receiving cisplatin-based        highly emetogenic chemotherapy (HEC), each met the primary endpoint of        complete response (CR) in the delayed (24 to 120 hour) timeframe        following chemotherapy. Enrollment in the third and final Phase 3        trial of oral rolapitant, which is being conducted in patients        receiving cisplatin-based HEC, is expected to conclude during the        first quarter of 2014. TESARO anticipates that results from this study        will be available in the second quarter of 2014. Further, the clinical        trial of intravenous (IV) rolapitant is well underway, and TESARO        anticipates finalizing the dose that will provide comparable exposure        to the oral formulation by the end of the first quarter of 2014.
  • Completed Acquisition of Laboratorio Arama de Uruguay Limitada:        OPKO has continued to grow its Latin American presence with the early         January 2014 acquisition of Laboratorio Arama de Uruguay Limitada        (“Arama”). Arama broadens the global commercial prospects for OPKO’s        product pipeline by establishing a footprint in Uruguay that may        facilitate the Company’s future commercial expansion into neighboring         Argentina, as well as by providing another platform to commercialize        the 4Kscore™ product.
  • OPKO Investee, Neovasc, Successfully Completes First Human Implant        of Tiara™ Transcatheter Mitral Valve: In early February 2014,        Neovasc Inc., announced that a human implantation of its Tiara™        transcatheter mitral valve was successfully performed on January 30th        by physicians at St. Paul’s Hospital in Vancouver, BC. The transapical        procedure resulted in the elimination of mitral regurgitation (MR) and        significantly improved heart function in the patient, without the need        for cardiac bypass support and with no procedural complications.        OPKO’s investment in Neovasc continues to appreciate.
  • Exit from Sorrento Therapeutics: In mid-December 2013, OPKO        reported the highly successful exit of its investment in Sorrento        Therapeutics, Inc. The sale of Sorrento shares added to OPKO’s cash        position and represented an approximate ten-fold return of OPKO’s 2009        investment

STAAR Surgical Company

STAA : NASDAQ : US$14.72 
HOLD  Target: US$14.00

COMPANY DESCRIPTION:

Founded in 1982, STAAR Surgical is a fully integrated medical device company competing in the global ophthalmology sector, and plays in two primary segments: phakic intraocular lenses (PIOL) used to treat refractive errors such as myopia and astigmatism, and intraocular lenses (IOL) used to treat cataracts.

Guidance Disappoints Followers

Investment recommendation

We remain favorably disposed to STAA on pullbacks, owing primarily to our continued bullishness regarding the long-range growth opportunity inherent in the ICL franchise, which we expect will continue to take share in the global refractive surgery market. While there will be puts and takes in the business – as we saw in 2012 (distributor variability in Asia) and 2013 (strong ICL growth in nearly every geography as CentraFLOW adoption accelerated) – we maintain our positive bias on the growth trajectory for the ICL business, thus STAA as a whole. The stock indicated down post-market owing to initial 2014 guidance (8-10% revenue growth; 20% ICL growth), which fell below consensus expectations going into the call. That said, we take a contrarian viewpoint on guidance, which we see as prudently conservative. While we maintain our HOLD rating ahead of the rescheduled Toric ICL ophthalmic device FDA panel on March 14, we increase our price target to $14 from $12 as we roll over our valuation to 2015 revenue estimates.
Investment highlights 

Q4 revenue was $18.9M (+15%), a bit shy of our $19.2M estimate and the Street’s $19.3M projection. ICL sales grew 31% in Q4 to $11.5M, while IOL sales declined 2% to $6.6M – the former a smidge below our estimate; the latter slightly above.
 STAA provided initial 2014 guidance calling for revenue growth of 8-10% vs. our +12% projection and the Street’s +15% estimate. Potential revenue from U.S. TICL and Chinese CentraFLOW approval (estimate year-end ’14 and mid’14, respectively) was not included in guidance, however; therefore, we think STAA has provided a prudently conservative set of expectations for 2014.

Globus Medical Buy

GMED : NYSE : US$24.15 
BUY  Target: US$28.00 

COMPANY DESCRIPTION:

Globus is a medical device company focused exclusively on the design, development, and commercialization of products that promote healing in patients with spine disorders.
All amounts in US$ unless otherwise noted

Life Sciences — Biomedical Devices and Services Q4/13 SOLID AS EXPECTED; NEW PRODUCTS AND DISTRIBUTION SET TO DRIVE 2014 AND BEYOND; MAINTAIN BUY AND $28 TARGET
Investment recommendation

We maintain our BUY rating on Globus following a solid Q4/13. Globus’s ability to continue to take share and generate strong operating margins reinforces our thesis that the company offers investors multiple opportunities to create value. Our thesis remains intact and we are buyers of Globus into 2014 as the company looks well positioned for growth via continuous new product flow, significant distribution expansion in 2013, and best in-class financial discipline.
Investment highlights  Q4/13 revenue of $115.2M was solid and in line with the preliminary numbers. Pro forma EPS of $0.25 came in well above our and consensus estimates of $0.22 on higher-than-expected operating leverage.
 Sixteen new product launches in 2013 and significant new rep additions position Globus for accelerating growth into 2014.
 Management reiterated 2014 guidance for revenues in the range of $480M-$486M, and EPS of $0.90-$0.92
Valuation We are maintaining our $28.00 price target based on a 26.8x PE multiple applied to our 2015 EPS estimate of $1.04.

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