CytoSorbents Publishes Responses to Frequently Asked Questions - May 2012 (CTSO)

CytoSorbents Corporation (OTC.BB: CTSO) is a critical care focused therapeutic device company using blood purification to modulate the immune system and fight multi-organ failure in life-threatening illnesses. Its purification technology is based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and adsorption.

The Company has prepared a list of Frequently Asked Questions ("FAQs") and responses in answer to a number of questions from shareholders on May 16, 2012. Other common inquiries are also included. 

The company provides detailed answers to the following questions:

• If there is so much interest in CytoSorb®, why are Q1 2012 sales low and why the decline from Q4 2011? 
• Why has it taken longer to hear news on things that were discussed in presentations or press releases months ago? 
• What are your thoughts about focus on Germany, versus expansion through distributors elsewhere? 
• What are the plans to publish the data from the European Sepsis Trial and can you give an update on the dosing study and other studies? Are the results of the dosing study needed to sell CytoSorb? 
• Are you contemplating manufacturing in Europe or utilizing a contract manufacturer? 
• There seems to be a lot of bashers on the stock message boards that post negative comments constantly, always trying to instill fear and doubt into shareholders who believe in the company. What can be done? 
• If there is so much potential in the company, why is your stock so low and what do you plan to do about it? 

Read the answers at CytoSorbents.com. 

Market Current on Dara Bioscience: Dara slips after reporting a Q1 net loss of $2M @ Seeking Alpha (DARA)

DARA BioSciences, Inc.(Nasdaq:DARA) is a specialty pharmaceutical company focused on the development and commercialization of oncology treatment and supportive care products. DARA holds the exclusive U.S. marketing rights to Soltamox®, a novel oral liquid formulation of tamoxifen citrate, a product used widely in the treatment and prevention of breast cancer. Soltamox is the only FDA approved oral liquid version of tamoxifen citrate and fulfills a vital clinical need for patients who cannot tolerate existing tablet formulations of this drug. DARA plans to begin marketing Soltamox in the U.S. in Q3 2012.

At Seeking Alpha, a Market Current was issued about the company:

Monday, May 21, 11:24 AM Dara Biosciences (DARA -2.3%)) slips after reporting a Q1 net loss of $2M, or $0.29 cents per share, compared to a net loss of $1.3M, or $0.26 cents per share in the same period last year. The higher net loss was due primarily to business acquisition costs and the hiring of experienced staff to help execute its new oncology-focused business strategy.

Read more at Seeking Alpha. 

6 Low Debt Pharmaceutical Stocks Rated Buy Or Better @ Seeking Alpha (KERX, VTUS)

At Seeking Alpha, contributor ZetaKap wrote an article asking, "Interested in pharmaceutical companies? In search of companies that can manage their debt well? Do you prefer companies that can manage their long term debt? Are you after stocks that analysts are calling 'buy' or 'strong buy'? If so, you'll probably like this list."

Two of the six companies listed were Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) and Ventrus Biosciences (NASDAQ: VTUS).

About Keryx, ZetaKap wrote,

"Keryx Biopharmaceuticals Inc. has a Debt/Equity Ratio of 0.00 and Long Term Debt/Equity Ratio of 0.00 and Analysts' Rating of 1.80. The short interest was 13.77% as of 05/12/2012. Keryx Biopharmaceuticals, Inc., a biopharmaceutical company, together with its subsidiaries, focuses on the acquisition, development, and commercialization ofpharmaceutical products for the treatment cancer and renal disease. The company's products under development include KRX-0401 (perifosine), an oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, as well as affects other pathways associated with programmed cell death, cell growth, cell differentiation, and cell survival. Its KRX-0401 is in Phase III clinical development stage for the treatment of refractory advanced colorectal cancer and multiple myeloma, as well as in Phase I and Phase II clinical development stages for the treatment of other tumor types."

About Ventrus Biosciences, ZetaKap writes,

"Ventrus Biosciences Inc. has a Debt/Equity Ratio of 0.00 and Long Term Debt/Equity Ratio of 0.00 and Analysts' Rating of 1.40. The short interest was 3.14% as of 05/12/2012. Ventrus Biosciences, Inc., a development stage specialty pharmaceutical company, focuses on the development and commercialization of late-stage prescription drugs for gastrointestinal disorders, primarily hemorrhoidal disease, anal fissures, and fecal incontinence. It is developing three late-stage product candidates, including Iferanserin ointment (VEN 309) for the topical treatment of symptomatic internal hemorrhoids; Diltiazem cream (VEN 307), a topical treatment for the relief of pain associated with anal fissures; and Phenylephrine gel (VEN 308) for the treatment of fecal incontinence associated with ileal pouch anal anastomosis, an FDA orphan indication. The company was formerly known as South Island Biosciences, Inc."

Read the full article at SeekingAlpha.com.  

Vertex Reports First Quarter 2012 Financial Results and Provides Update on Launch of KALYDECO™ ($VRTX)

Vertex (Nasdaq: VRTX) creates new possibilities in medicine. Their team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and collaborators are working on new medicines to advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases. Vertex isn’t a conventional pharmaceutical company. Each and every person at Vertex is driven by a passion for fearless innovation and a bold desire to transform the lives of millions with new medicines. Vertex has ongoing worldwide research programs and sites in the U.S., U.K. and Canada and employs over 1800 people.

Vertex has announced their first quarter financial results for 2012.  The Company released that it earned revenues of approximately $439 million, including net product revenues of approximately $357 million from INCIVEK^® (telaprevir) and approximately $18 million from KALYDECO^TM (ivacaftor).  KALYDECO^TM and INCIVEK^®, The Company reports continued investment which will allow them to continue multiple clinical studies including Phase 2b studies of all-oral, short-duration treatment regimens for hepatitis C and JAK3 inhibitor VX-509 for rheumatoid arthritis, as well of KALYDECO in people with types of cystic fibrosis. 

Jeffrey Leiden, M.D., Ph.D., President and Chief Executive Officer of Vertex commented,  

"Since January, approximately 600 people with cystic fibrosis have started treatment with KALYDECO in the U.S., underscoring the importance of this new medicine to the CF community and further demonstrating our ability to develop and launch transformative new medicines. With INCIVEK, we continue to treat thousands of people with hepatitis C, and we are highly encouraged by the early success seen with this medicine outside the U.S., where our collaborator Janssen has attained a market-leading position in Europe and availability of INCIVO in more than 15 countries around the world."

The full press release can be viewed here.  

Market watchers have also commented about these results.  Brean Murray Carret & Co. stated, 

"Vertex launched Kalydeco in 1Q12 and in a little more than two months captured a

large portion of G551D patients.    This is a strong indication that the closely knit CF

community was anxious for a new treatment option and reinforces the potential for a

blockbuster market opportunity if Vertex can expand beyond the G551D patient

population.   Incivek sales were disappointing coming in below our expectations. We

continue to see declining Incivek sales as a drag on the stock despite the positive early

signals from the company’s CF franchise.  Vertex launched Kalydeco in 1Q12 and in a little more than two months captured alarge portion of G551D patients.    This is a strong indication that the closely knit CFcommunity was anxious for a new treatment option and reinforces the potential for ablockbuster market opportunity if Vertex can expand beyond the G551D patientpopulation.   Incivek sales were disappointing coming in below our expectations. Wecontinue to see declining Incivek sales as a drag on the stock despite the positive earlysignals from the company’s CF franchise."

 

Read the Brean Murray full report here.  

Human Genome ($HGSI) RBC says current GSK bid for Human Genome undervalues sum of parts over long-run ($14.64)

• The firm sees $15-23 fair value but notes that a CVR might make sense for GSK if no compromise can be made. RBC believes GSK could raise its bid at least once but assumes that HGSI wants the higher end of RBC's valuation range. However, the firm notes there is no guarantee GSK will raise its bid and they don't see any other serious bidders that would bid materially higher.
• Rating is sector perform for HGSI. Target raised to $15 from $10.
• Analyst is Michael J. Yee

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Brean Murray, Carret on Achillion Pharmaceuticals - $ACHN

Brian Skorney of Brean Murray put out the following on Achillion Pharmaceuticals (ACHN, $7.92, Buy, $20 Target Price):

"Defending ACHN - GS-7977 Data Is Great but ACH-1625 Can Be Head-to-Head Competitive With 7977 or Be the Best Option To Combine With 7977

We believe the sharp decline in ACHN shares is being driven from a superficial read-through from the GILD/BMS data. We believe that a protease inhibitor is not a necessary component of an all-oral regimen. However, we believe that the valuation assumes that a protease inhibitor is also not sufficient in an oral combination that does not include a nuc. Abbott (ABT, $59.27, Hold) has already demonstrated that a potent PI with a differentiated resistance profile can be an anchor for an all-oral regimen. We believe the upcoming oral presentations of Abbott's PILOT (today) and COPILOT (Saturday) studies will reaffirm this thesis.

7977/052 Combo Data Actually Supports ACH-1625 Potential. We believe the high SVR rates seen in the 7977/052 combo, particularly in Gt 2/3 patients, actually supports the potential of ACH-1625 as it indicates that if you have one potent antiviral with a high barrier to resistance, you can get by with a weaker agent with a low barrier to resistance. BMS052 readily selects for resistance and is 10-15x less potent in Gt. 2/3 compared to Gt. 1b. We believe ACH-1625 is one of only four drugs in clinical development that could be effectively substituted for GS-7977 in this combo and show similar results – the others being INX-189, MK-5172, and ABT-450/r. We believe Achillion will successfully run this experiment with its own NS5a inhibitor, ACH-3102, later this year."

JMP Securities issues update on Human Genome ($HGSI)

JMP Securities is a full-service investment bank that provides equity research, institutional brokerage and investment banking services to growth companies and their investors. They issued the following update on HGSI:

Human Genome Sciences, Inc.

HGSI - $7.17, $1,424M market cap

Liisa A. Bayko; +1 312 768-1785; lbayko@jmpsecurities.com

"Let the bidding begin GSK makes a move for Human Genome Sciences (HGSI); reiterate Market Outperform rating and $20 price target for HGSI . This morning, HGSI announced an unsolicited proposal from GSK to acquire HGSI at $13 cash per share. We remind investors that GSK and HGSI share in the profits for Benlysta, and HGSI has up to 30% rights to the drug candidate, darapladib, in an event driven Phase 3 study for coronary heart disease, which we expect to report data within 12 months, as well as a small royalty in abiglutide for diabetes. The launch of Benlysta has gotten off to a slow start but our market research suggests there is a potentially larger market for Benlysta amongst lupus patients for an subcutaneously delivered formulation, which is currently in Phase 3 development. Our price target of $20 is based on a risk adjusted discounted cash flow model based solely on contributions from Benlysta and so there could be significant upside to our model should darapladib have a positive read out in its Phase 3 study. HGSI has rejected the initial offer from GSK and has formerly initiated a process to find higher bidders for the company. In our view, the value proposition to GSK likely trumps those from other companies given the leverage it can gain from HGSI's sales and marketing efforts against Benlysta and potentially Darapladib."

Human Genome ($HGSI) announces rejection of unsolicited offer from Glaxo (GSK) to acquire HGSI for $13/sh cash

Human Genome Sciences (NASDAQ: HGSI) exists to place new therapies into the hands of those battling serious disease.

• HGSI announced that it has received an unsolicited proposal from GSK to acquire HGSI for $13.00 per share in cash.
• The New York Times Deal Book is now saying it has been rejected - SEE NY TIMES DEAL BOOK
• The HGSI board, in consultation with independent financial and legal advisors, has carefully reviewed and considered the GSK offer and has determined that the offer does not reflect the value inherent in HGSI
• HGSI also announced that its board has authorized the exploration of strategic alternatives in the best interests of shareholders, including, but not limited to, a potential sale of the company.
• HGSI has retained Goldman, Sachs & Co. and Credit Suisse Securities (USA) LLC to assist in this process, with Skadden, Arps, Slate, Meagher & Flom LLP and DLA Piper LLP (US) serving as legal counsel.
• GSK has been invited to participate in this process and HGSI has requested additional information regarding investigational products in GSK’s clinical pipeline to which HGS has substantial financial rights, including darapladib, currently in Phase 3 development for the treatment of cardiovascular disease, and albiglutide, currently in Phase 3 development for the treatment of type 2 diabetes.
• There can be no assurance that any transaction will occur or if so on what terms.
• HGSI does not intend to discuss the status of its evaluation unless and until a specific transaction has been approved
• StreetAccount notes there have been a number of rumors over a period of time regarding a potential bid by GSK for HGSI as the two companies are commercialization and development partners in Benlysta

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