Showing posts with label Insiders. Show all posts
Showing posts with label Insiders. Show all posts

Saturday, 21 September 2013

Insiders Are Selling Raptor Pharmaceuticals

Raptor Pharmaceutical Corp. (RPTP): Insiders Are Selling Raptor Pharmaceuticals - Seeking Alpha (function(_,e,rr,s){_errs=[s];var c=_.onerror;_.onerror=function(){var a=arguments;_errs.push(a); c&&c.apply(this,a)};var b=function(){var c=e.createElement(rr),b=e.getElementsByTagName(rr)[0]; c.src="//beacon.errorception.com/"+s+".js";c.async=!0;b.parentNode.insertBefore(c,b)}; _.addEventListener?_.addEventListener("load",b,!1):_.attachEvent("onload",b)}) (window,document,"script","4ffae9d6f05d1da630000008"); if (SA.Data && SA.Data.Cache) { var adata = SA.Data.Cache.get('campaign_content'); }.market_currents_list li .ticker_date_left .mc_list_tickers a{font-weight: normal} var ms_slug = ''; var article_dashboards = '@investing-ideas@sectors@'; var article_sectors_themes = '@insider-ownership@us@drug-manufacturers-major@healthcare@article@'; var ratings_hash={}; var ARTICLE_ID = 1705512; var ARTICLE_TYPE = "standard"; var ARTICLE_LOCK = ""; var author_slug = "markus-aarnio"; var pticker_for_ads = "rptp"; var time_left; var lock_comments = false; var machine_cookie = readCookie('machine_cookie'); var middle_version = ABTest.identity%10; var sector_name = "Healthcare"; var sector_slug = "healthcare"; try { window.sessionStorage.setItem("/article/"+ARTICLE_ID, '1'); } catch (error) {}var mone_article_tags = "{rptp};;;{healthcare};;;{insider-ownership,us,drug-manufacturers-major,investing-ideas,sa-exclusive};;;{markus-aarnio}"var ord = Math.floor(Math.random()*1000000000);Seeking Alpha Seeking Alpha Portfolio App for iPad Finance (1) var ipadData; SeekingAlpha.Initializer.AddAfterLoad(function(){ if (SA.Utils.Env.isIPad && !/3/.test(SA.Data.Cookies.get("user_devices"))){ Mone.event("ipad_promotion_top","top_ipad_banner_large","ipad_promotion_displayed"); ipadData = new SA.Data.iPad(); ipadData.instanceName = "ipadData"; var responseHandler = new Object(); responseHandler.handleResponse = function(data){ if (!data.averageUserRating) return; var stars = data.averageUserRating Home | Portfolio | Market Currents | Investing Ideas | Dividends & Income | ETFs | Macro View | ALERTS | PRO   This article was sent to 863 people who get email alerts on  . Which cover: new articles | breaking news | earnings results | dividend announcements Get email alerts on   » This article was sent to 344,726 people who get the Investing Ideas newsletter. Get the Investing Ideas newsletter » Insiders Are Selling Raptor Pharmaceuticals Sep 20 2013, 12:06 by: Markus Aarnio  |  about: RPTP BOOKMARKED / READ LATER Bookmarked

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In this article, I will feature one healthcare company that has seen intensive insider selling during the last 30 days. Intensive insider selling can be defined by the following three criteria:

The stock was sold by three or more insiders within one month. The stock was not purchased by any insiders in the month of intensive selling. At least two sellers decreased their holdings by more than 10%.

Raptor Pharmaceuticals (RPTP) is a biopharmaceutical company focused on developing and commercializing life-altering therapeutics that treat rare, debilitating and often fatal diseases.


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Insider selling during the last 30 days

Christopher Starr sold 25,000 shares on September 16 pursuant to a 10b5-1 trading plan. Christopher Starr currently holds 699,370 shares and 1,167,330 options or 3.3% of the company. Christopher Starr is CEO and Co-founder of Raptor. Christopher Starr decreased his holdings by 1.3% in September. Erich Sager sold 17,000 shares on September 16 pursuant to a 10b5-1 trading plan. Erich Sager currently holds 130,727 shares and 495,531 options or 1.1% of the company. Erich Sager serves as a director of the company. Erich Sager decreased his holdings by 2.6% in September. Timothy Walbert sold 5,520 shares on September 13 pursuant to a 10b5-1 trading plan. Timothy Walbert currently holds zero shares and 224,480 options or 0.4% of the company. Timothy Walbert serves as a director of the company. Timothy Walbert decreased his holdings by 2.4% in September. Suzanne Bruhn sold 2,760 shares on September 13 pursuant to a 10b5-1 trading plan. Suzanne Bruhn currently holds zero shares and 227,240 options or 0.4% of the company. Suzanne Bruhn serves as a director of the company. Suzanne Bruhn decreased her holdings by 1.2% in September. Thomas Daley sold 25,000 shares on September 9 pursuant to a 10b5-1 trading plan. Thomas Daley currently holds 69,906 shares and 24,969 options or 0.2% of the company. Thomas Daley is Chief Business Officer. Thomas Daley decreased his holdings by 20.9% in September. Raymond Anderson sold 15,000 shares on September 9 pursuant to a 10b5-1 trading plan. Raymond Anderson currently holds zero shares and 18,306 options or less than 0.1% of the company. Raymond Anderson serves as a director of the company. Raymond Anderson decreased his holdings by 45.0% in September. Richard Franklin sold 10,715 shares on September 9 pursuant to a 10b5-1 trading plan. Richard Franklin currently holds zero shares and 329,254 options or 0.6% of the company. Richard Franklin serves as a director of the company. Richard Franklin decreased his holdings by 3.2% in September. Georgia Erbez sold 7,400 shares on August 30 and currently holds zero shares and zero options of the company. Georgia Erbez serves as Raptor's Chief Financial Officer. Georgia Erbez decreased her holdings by 100% in August.

Insider selling by calendar month

Here is a table of Raptor's insider-trading activity by calendar month.

Month Insider selling / shares Insider buying / shares September 2013 100,995 0 August 2013 7,400 0 July 2013 0 0 June 2013 0 0 May 2013 0 0 April 2013 0 0 March 2013 0 0 February 2013 0 0 January 2013 0 0

There have been 108,395 shares sold and there have been zero shares purchased by insiders this year.

Financials

Raptor reported the second-quarter financial results on August 8 with the following highlights:

Revenue $21,000 Net loss $24.1 million Cash $74.6 million Debt $50.1 million

Outlook

Raptor believes that its cash balance will be sufficient to meet its projected operational requirements and obligations through the end of 2014.

Pipeline

Raptor's lead product, Procysbi (cysteamine bitartrate) delayed-release capsules, received FDA approval on April 30, 2013 and EU approval on September 12, 2013.

Raptor's clinical-stage product pipeline includes two active development programs based on the company's proprietary delayed-release formulation of cysteamine bitartrate (RP103 capsules), as well as the company's Convivia (oral 4-methylpyrazole) program which the company licensed to Uni Pharma, Taiwan. Raptor's preclinical pipeline includes two development programs based upon the company's proprietary molecules.


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Upcoming milestones

Raptor has the following upcoming milestones during the next 12 months.

Phase 2/3 18 month treatment data on RP103 in HD Q1/2014 Health Canada NDS submission H1/2014 NAFLD Phase 2b enrollment completed H1/2014

Competition

Cystinosis

Raptor is aware of only one pharmaceutical product currently approved by the FDA and the EMA to treat cystinosis, Cystagon (immediate-release cysteamine bitartrate capsules), is marketed in the U.S. by Mylan Pharmaceuticals (MYL), and by Recordati (RCDTF.PK) and Orphan Europe in markets outside of the U.S. Cystagon was approved by the FDA in 1994 and by EMA in 1997 and is the standard of care for cystinosis treatment.

Raptor is not aware of any pharmaceutical company with an active program to develop an alternative therapy for cystinosis. There are companies developing and/or marketing products to treat symptoms and conditions related to, or resulting from cystinosis, but none developing products to treat the underlying metabolic disorder (toxic cystine accumulation). Academic researchers in the U.S. and Europe are pursuing potential cures for cystinosis through gene therapy, stem cell therapy, pro-drug and pegylated drug approaches as alternatives to cysteamine bitartrate. Raptor believes that the development timeline to an approved product for these approaches is many years with substantial uncertainty.

Huntington's Disease

Raptor is not aware of any currently available treatment alternatives for HD, although there are products available such as Haldol, Klonopin and Xenazine to treat uncontrollable movements and mood swings that result from the disease. There are several pharmaceutical companies pursuing potential cures and treatments for HD, as well as numerous academic and foundation sponsored research efforts. Raptor's product candidate, RP103, is the only compound in clinical development which specifically targets the fundamental metabolic defect of the disease (deficient brain-derived neurotrophic factor), with the goal of slowing disease progression.

Companies with HD product candidates in development include Eli Lilly & Co. (LLY) and Pfizer (PFE). Several other companies have drug candidates in preclinical development. Additionally, nutritional supplements including creatinine and coenzyme Q10 have been investigated as potential treatments for HD. The Huntington Study Group sponsors numerous studies of potential therapies for HD, including coenzyme Q10 and the antibiotic minocycline.

Conclusion

There have been eight different insiders selling Raptor and there have not been any insiders buying Raptor during the past 30 days. Three of these eight insiders decreased their holdings by more than 10%.

The next catalyst for the stock will be the Phase 2/3 18 month treatment data on RP103 in HD anticipated in the first quarter of 2014. Raptor is currently fully funded through the end of 2014.

There are eight analyst buy ratings, one neutral rating and zero sell ratings with an average price target of $13.78.

Before entering short Raptor, I would like to get a bearish confirmation from the Point and Figure chart. The two main reasons for the proposed short entry are bearish analyst target prices and the intensive insider selling activity.

Source: Insiders Are Selling Raptor Pharmaceuticals

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)

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Wednesday, 28 August 2013

Insiders Are Buying Sarepta Therapeutics

When insiders accumulate a stock intensively, the stock can be expected to outperform the market during the next six months. Insiders tend to buy more often than usual before large price increases and to sell more than usual before price decreases.

In this article, I will feature one biotech company that has seen intensive insider buying during the last 30 days. Intensive insider buying can be defined by the following three criteria:

The stock is purchased by three or more insiders within one month.

The stock is sold by no insiders in the month of intensive purchasing.

At least two purchasers increase their holdings by more than 10%.

Sarepta Therapeutics (SRPT) is focused on developing RNA-based therapeutics to improve and save the lives of people affected by serious and life-threatening rare and infectious diseases. The company's diverse pipeline includes its lead program eteplirsen, for Duchenne muscular dystrophy [DMD], as well as potential treatments for some of the world's most lethal infectious diseases.

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Insider buying by insider (last 30 days)

Anthony Chase purchased 3,500 shares on August 22 and currently holds 31,744 shares or 0.1% of the company. Anthony Chase serves as a director of the company.Gil Price purchased 500 shares on August 19 and currently holds 35,330 shares or 0.1% of the company. Gil Price serves as a director of the company.Sandesh Mahatme purchased 5,000 shares on August 20 and currently holds 5,000 shares or less than 0.1% of the company. Sandesh Mahatme joined Sarepta as Senior Vice President and Chief Financial Officer in November 2012.

Insider buying by calendar month

Here is a table of Sarepta's insider-trading activity by calendar month.

There have been 19,000 shares purchased and there have been zero shares sold by the insiders since June 2013.

Financials

The company reported the second-quarter financial results on August 8 with the following highlights:

Subsequent to second quarter end and up to August 7, Sarepta raised $37.9 million in proceeds and issued approximately 1.0 million shares of common stock under the At-The-Market equity financing that was put in place in July 2013.

Upcoming milestones

Sarepta plans to submit a New Drug Application [NDA] for the approval of eteplirsen for the treatment of Duchenne muscular dystrophy patients with genotypes amenable to skipping of exon 51. The decision to submit an NDA for eteplirsen was based on productive interactions with the FDA including a meeting with the agency in July. In pre-meeting comments, the FDA stated it was open to considering an NDA based on results from the Phase IIb clinical study of eteplirsen. Sarepta expects to submit the NDA to the FDA in the first half of 2014.

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Competition

DMD program competition

Currently, no product has been approved for the treatment of DMD. Companies including, but not limited to, Prosensa (RNA) in collaboration with GlaxoSmithKline (GSK), have product candidates in development for the treatment of DMD.

The Prosensa/GSK program commenced treatment in January 2011 in a Phase III clinical study in ambulant individuals with DMD who have a dystrophin gene mutation amenable to treatment by skipping exon 51. Prosensa's candidate for skipping exon 51, GSK2402968, utilizes a different chemistry, 2'O-methyl-phosphorothioate, which has the potential for different performance, safety and tolerability characteristics than eteplirsen. This randomized, placebo controlled study is fully enrolled, with approximately 180 participants who are being dosed for 48 weeks. The primary efficacy endpoint is a measure of muscle function using the 6MWT. Results for this Phase III study are anticipated by the end of 2013.

In September 2010, the Prosensa/GSK program commenced a Phase II double-blind, placebo-controlled study. This study is designed to assess the efficacy of two different dosing regimens of GSK2402968 administered over 24 weeks in DMD patients, and then to continue observing the patients over a second 24 week interval for a total study time frame of 48 weeks. This study completed enrollment with 54 DMD patients in October 2011 and has since concluded with results expected after the Phase III clinical study is complete.

Hemorrhagic fever virus programs

No specific treatment has been proven effective, and no approved vaccine currently exists for either Ebola or Marburg. Investigational compounds cannot be tested for efficacy on humans except in outbreak environments so these agents must be tested extensively in animals and meet strict government regulations.

Vaccine development is in the early stages in both the biotech industry and by U.S. government agencies (e.g., the National Institute of Allergy and Infectious Diseases and the Centers for Disease Control and Prevention). The government is also supporting early stage research on broad-spectrum therapeutics effective against hemorrhagic fever viruses.

With respect to therapeutics in advanced development, in February 2012 Tekmira Pharmaceuticals (TKMR) initiated a Phase I trial for TKM-Ebola, a systemically delivered RNAi therapeutic for the treatment of Ebola virus infection. Sarepta commenced initial human safety studies of its therapeutic candidates against Marburg and Ebola viruses in May 2011.

Influenza program

Currently, there are two therapeutic products for influenza that have received market approval from the FDA and are recommended for use in the United States. These are:

Oseltamivir (Tamiflu), a Roche (RHHBY.OB) and Gilead (GILD) product.Zanamivir (Relenza), a GSK product.

In addition to these products, Daiichi Sankyo's (DSKYF.PK) laninamivir (Inavir) and BioCryst's (BCRX) peramivir were launched in 2010 in Japan. Currently, DHHS funding is helping support clinical trials of Biota's (BOTA) laninamivir. In addition, other companies including, Toyama Chemical (a subsidiary of Fujifilm (FUJIF.PK)), have influenza therapeutic compounds in development. Toyama Chemical's favipiravir is in a Phase II clinical trial in the United States and has completed a Phase III trial in Japan. DHHS is currently seeking additional antiviral therapeutics for the treatment and/or prophylaxis of influenza A and B infections.

In addition to therapeutic products, other companies are focusing development efforts on universal influenza vaccines, including BiondVax Pharmaceuticals Ltd., which initiated a Phase IIa trial of its universal influenza vaccine candidate in October 2010. Successful development of a universal influenza vaccine could lead to a reduction in the number of influenza cases and, therefore, the market size.

Conclusion

There have been three different insiders buying Sarepta and there have not been any insiders selling Sarepta during the last 30 days. Two out of these three insiders increased their holdings by more than 10%. Sarepta has an insider ownership of 0.40%. There are nine analyst buy ratings, three neutral ratings and one sell rating with an average target price of $47.17. The next major catalyst for the stock will be the NDA submission to the FDA in the first half of 2014. I have a cautiously bullish bias for the stock currently based on the intensive insider buying.

Disclosure: I have no positions in any stocks mentioned, but may initiate a long position in SRPT over the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)

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