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http://www.finanznachrichten.de/...-march-25-2010-at-8-30-a-m-008.htm
Keryx Biopharmaceuticals, Inc. To Hold Conference Call on Fourth Quarter and Year-End 2009 Financial Results on Thursday, March 25, 2010 at 8:30 a.m. EDT
NEW YORK, March 23 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. will hold a conference call on Thursday, March 25, 2010 at 8:30 a.m. EDT to discuss the fourth quarter and year end 2009 financial results and outlook for 2010. Ron Bentsur, Chief Executive Officer of the Company, will host the call. Keryx will announce its financial results for this period in a press release to be issued prior to the call.
In order to participate in the conference call, please call 1-877-869-3847 (U.S.), 1-201-689-8261 (outside the U.S.), call-in ID: KERYX. The audio recording of the conference call will be available for replay at http://www.keryx.com/, for a period of 15 days after the call.
The press release announcing the Company's financial results for this period will be posted on the Company's website, http://www.keryx.com/, prior to the call.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, and also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. KRX-0401 is currently in a Phase 3 trial, under Special Protocol Assessment, or SPA, in multiple myeloma, with a Phase 3 trial in refractory metastatic colorectal cancer, under SPA, pending commencement, and in Phase 2 clinical development for several other tumor types. Keryx is also developing Zerenex(TM) (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex in the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is pending commencement under an SPA agreement with the FDA. Keryx is headquartered in New York City.
KERYX CONTACT: Lauren Fischer Director, Investor Relations Keryx Biopharmaceuticals, Inc. Tel: 212.531.5962
Keryx Biopharmaceuticals, Inc.
CONTACT: Lauren Fischer, Director, Investor Relations, Keryx
Biopharmaceuticals, Inc., +1-212-531-5962
Web Site: http://www.keryx.com/
© 2010 PR Newswire
Keryx Biopharma reports greater 4th-quarter loss as spending on drug candidates triples
On Wednesday March 24, 2010, 6:26 pm EDT
http://finance.yahoo.com/news/...igger-loss-as-apf-344541518.html?x=0
NEW YORK (AP) -- Keryx Biopharmaceuticals Inc. reported a larger fourth-quarter loss Wednesday as its spending on research and development tripled from a year ago.
Keryx said it lost $4.7 million compared with $3.8 million a year ago. On a per-share basis, its loss was unchanged at 8 cents due to a greater number of shares outstanding in the 2009 quarter.
It reported no revenue, compared with a year ago, when it received $327,000 in license payments.
According to Thomson Reuters, analysts expected a loss of 6 cents per share and $210,000 in revenue.
Keryx is a development stage company and has no products on the market. Its most advanced drug candidate is perifosine, an experimental treatment for cancer that it licensed from Canadian drugmaker AEterna Zentaris. The drug is in late-stage testing as a treatment for multiple myeloma, and Keryx plans to start a late-stage trial of perifosine in colorectal cancer during the second quarter.
The company is also testing a drug called Zerenex as a treatment for low phosphate levels in patients with end-stage kidney disease.
During the fourth quarter, Keryx said its research and development costs rose to $3.3 million from $1.1 million.
In 2009 Keryx earned $10.5 million, or 21 cents per share. It posted a loss of $52.9 million, or $1.18 per share, a year earlier. Its annual revenue climbed to $25.2 million from $1.3 million, primarily due to a jump in license revenue.
Keryx stock picked up 4 cents to $3.04 in aftermarket trading. The stock ended the regular session up 16 cents, or 5.6 percent, to $3.
http://biz.yahoo.com/e/100325/kerx10-k.html
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More News related to KERX
Keryx Biopharma (KERX) Receives FDA Fast Track for KRX-0401 (Perifosine)
Keryx Receives FDA Fast Track Designation for KRX-0401 (Perifosine) for the Treatment of Refractory Advanced Colorectal Cancer
Keryx Biopharma (KERX) Reports Q4 Loss of $0.08, Misses by 2c
Keryx Biopharmaceuticals, Inc. Announces Fourth Quarter and Year-End 2009 Financial Results
Keryx Biopharmaceuticals, Inc. To Hold Conference Call on Fourth Quarter and Year-End 2009 Financial Results on Thursday, March 25, 2010 at 8:30 a.m. EDT
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April 5, 2010 8:33 AM EDT
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that the U.S. FDA has granted Fast Track designation for KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, for the treatment of refractory advanced colorectal cancer.
The Fast Track program of the FDA is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process.
A randomized, double-blind Phase 3 trial investigating perifosine in combination with capecitabine (Xeloda®) versus placebo in combination with capecitabine in patients with refractory advanced colorectal cancer is expected to commence in the second quarter of 2010 under a Special Protocol Assessment (SPA) with the FDA.
Ron Bentsur, Chief Executive Officer of Keryx Biopharmaceuticals, commented, "We believe that this Fast Track designation adds substantial value to perifosine's development in refractory advanced colorectal cancer. We intend to initiate the Phase 3 colorectal study in the second quarter, with study completion expected in the second half of 2011. With the SPA and Fast Track designation in place, we believe that commercialization of perifosine in this indication could potentially commence by mid-2012."
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Keryx Biopharmaceuticals Could Easily Triple Within the Next Year 1 comment
April 11, 2010 | about: DNDN / KERX / MRK / PFE / RHHBY.PK / SNY
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Keryx Biopharmaceuticals (Nasdaq: KERX) – Should See Double Digit Prices Again
Recent news for Keryx Biopharmaceuticals was big, but as investors know, the bigger news is yet to come. Even with a recent price move, Keryx is extremely undervalued. Prior to the American Society of Clinical Oncology (ASCO) meeting in June, I expect Keryx to easily double, and I expect to see $14 per share by 2011. The details of my analysis will be presented later in this article, but first, I will address the key drivers that make Keryx a compelling “buy and buy more” proposition:
Promising Pipeline
Keryx has two fast-track drugs, 3 Special Protocols and Orphan Drug Status. Perifosine is the more valuable drug and Keryx has exclusive rights to it in the U.S., Canada , and Mexico. The drugs, indications, and status are summarized below:
Product candidate
Target indication
Development status
KRX-0401 (perifosine)
Multiple myeloma
Colorectal cancer
Multiple other forms of cancer
Phase 3 ongoing, under SPA
Phase 3 pending, under SPA
Phase 2 trials ongoing
ZerenexTM (ferric citrate)
Hyperphosphatemia in patients with end-stage renal disease
U.S. Phase 2 complete;
U.S. Phase 3 program pending;
Japan Phase 2 ongoing by sublicensee (JT and Torii)
Dr. Aschoff, Sr. Analyst at Brean, Murray states:
I've covered Keryx for six years and it's really nice to see perifosine, their Akt-inhibiting cancer drug and main value driver, find two niches where it had positive data in multiple myeloma and in third-line colorectal cancer. In multiple myeloma patients who are failing Velcade, the most widely used drug in multiple myeloma, perifosine resensitizes them to Velcade. Perifosine is also in third-line metastatic colorectal cancer, where it beat Xeloda in a head-to-head trial. So after looking for a niche for this drug ever since I knew the company in early 2004, they have found two really definable areas where perifosine is likely to have a measurable benefit that's worthy of approval… Perifosine is the more valuable of their two drugs, and clearly the market cap of Keryx does not capture the success of just perifosine.
Below, I will provide my estimates which clearly support Dr. Aschoff’s view.
Keryx also has an SPA for Zerenex, its hyperphosphatemia drug, which will start Phase III soon.
Cash Availability and Cash Burn
As any experienced biotech investor knows, cash availability and cash burn are critical to monitor, because most biotechs are development stage companies. Even if a company has a great breakthrough but poor cash management, it can become a trap for an investor. Many go under or do dilutive financing.
Keryx greatly exceeds my standards on the cash test. The company ended 2009 with cash, cash equivalents, interest receivable, and investment securities of $35.9 million, as opposed to $22.7 million at Dec 31, 2008. This is plenty of cash to fund all three phase III studies without any need to dilute equity investors or take on additional debt.
Valuation
According to the American Cancer Society, colorectal cancer is the third most common form of cancer diagnosed in the United States , with nearly 146,000 people diagnosed with some form of colorectal cancer and over 49,000 patients dying from colorectal cancer in 2009. Despite the presence of many products such as Sanofi-Aventis' (SNY) Eloxatin (oxaliplatin), Roche's (RHHBY.PK) Avastin (bevacizumab), Merck’s (MRK) Erbitux (cetuximab), Pfizer's (PFE) Camptosar (irinotecan) in the field of colorectal cancer, the demand still remains unmet.
Keryx has many potential applications of its pipeline, and as stated above, the colorectal cancer application is large. But to be conservative in the valuation estimate, let’s consider only the Myeloma application, which is the first Phase III trial. Back in Q3 of 2009, Ron Bentsur, Chief Executive Officer of Keryx, commented:
The Orphan-Drug designation for perifosine in multiple myeloma is a very important milestone for Keryx, as the market exclusivity protection provided by this designation significantly enhances the commercial opportunity of perifosine in this indication.
To simplify the analysis and be more conservative, let’s just analyze the U.S. market. According to the National Cancer Institute there were 20,580 new cases of multiple myeloma in 2009 with 10,580 deaths as a result of the disease. Assuming that 50% of the 10,580 deaths are to receive Perifosine and that the average cost of treatment is $5,000 per month (Velcade is $45,000). Also note the average course of treatment is 22.5 months (average survival rate from the phase II trial), but for simplicity and a more conservative estimate, I will just assume that treatment is received for only 12 months. Thus, the number of patients to go on and off treatment each month is equal.
$5,000 per month X 5,290 patients X 12 months/year= $317,400,000 Sales / year
Now, let’s assume net profit of 18% (Average Pharmaceutical Industry Profit)
$317,400,000 X 18%= $57,132,000 Net Income
Now, divide by shares outstanding to get net income per share:
$57,132,000 / $56,000,000 shares = $1.02 net income per share
Now, if we multiply that by the average P/E of the pharmaceutical industry:
$1.02/EPS * 14.15 P/E = $14.44 per share
Clearly from this analysis based on Myeloma alone, Keryx is extremely undervalued with a market cap of less than $200 million and a price per share of under $3.50. I expect that Keryx will easily see a double prior to the ASCO meeting in June and should see double-digit prices by the end of this year.
The last stock I bought with such potential was Dendreon (DNDN), which has provided investors enormous returns. I look forward to similar returns with KERX
"About the author: Jeremy Richards
Jeremy Richards is the Manager/Director of Private Wealth Fund. He has twenty years investment expertise. He left Wall Street and is much happier on Main Street."
Die Pipeline von Keryx ist halt eher klein. Was sie jetzt machen, muss sitzen, sonst wärs schlecht.
Ich hab hier in der Tat kürzlich auch zugegriffen. Leider reichlich spät, wenn man den Verlauf betrachtet! Aber das Volumen bei dem Sprung Anfang April war so GEWALTIG (schaut mal unten), das flößte mir spontan Vertrauen ein :-)
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12.04.2010 19:50
http://www.finanznachrichten.de/...hares-jump-on-media-report-020.htm
April 12 (Reuters) - Shares of Keryx Biopharmaceuticals Inc rose to their highest in two years Monday, a day after a media report said the stock could triple in value over the next year.
Brean Murray Carret and Co analyst Jonathan Aschoff pointed to a report Sunday on the Seeking Alpha website that suggests that Keryx's stock could reach $14 by 2011.
Keryx shares, which have gained about 30 percent in the last one month, were up 21 percent at $4.20 Monday afternoon. They touched a high of $4.22 earlier in the day.
On April 5, Keryx stock gained as much as 22 percent as its experimental cancer drug perifosine received fast-track status from the U.S. health regulator.
The status grants the company and its Canadian partner Aeterna Zentaris seven years of market exclusivity.
(Reporting by Vidya L Nathan in Bangalore; Editing by Unnikrishnan Nair) Keywords: KERYXBIOPHARMACEUTICALS/SHARES
(vidya.loganathan@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging: vidya.loganathan.reuters.com@reuters.net)
COPYRIGHT
Copyright Thomson Reuters 2010. All rights reserved.
The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
© 2010 AFX News
Date : 04/13/2010 @ 8:30AM
Source : PR Newswire
Stock : Keryx Biopharmaceuticals (MM) (KERX)
http://ih.advfn.com/...d=nmona&cb=1271165086&article=42355644
Long-term data to be presented suggest that use of Zerenex may also potentially reduce the need for intravenous iron and erythropoietin in hyperphosphatemia patients on dialysis
PR Newswire
NEW YORK, April 13
NEW YORK, April 13 /PRNewswire-FirstCall/ --
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that several posters on Zerenex™ (ferric citrate), the Company's iron-based phosphate binder for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease who are on dialysis, have been accepted for presentation at the National Kidney Foundation (NKF) 2010 Spring Clinical Meeting taking place April 13-17, 2010, in Orlando, Florida.
The following posters will be presented tomorrow, April 14, 2010, from 6:00pm-7:30pm:
LONG-TERM USE OF FERRIC CITRATE IN ESRD PATIENTSTHE SAFETY AND TOLERABILITY OF HIGHER DOSES OF FERRIC CITRATE (FC) IN CONTROLLING SERUM PHOSPHORUS (P) IN ESRD PATIENTSIRON ABSORPTION WITH HIGHER DOSES OF FERRIC CITRATE IN CONTROLLING SERUM PHOSPHORUS IN ESRD PATIENTSThe Company's Phase 3 clinical program of Zerenex as a treatment for hyperphosphatemia in patients with end-stage renal disease who are on dialysis is pending commencement under a Special Protocol Assessment (SPA) agreement with the FDA.
Keryx Biopharmaceuticals retains a worldwide exclusive license (except for the Asian Pacific Region) to Zerenex (ferric citrate) from Panion & BF Biotech, Inc. The Company has sublicensed the development of ferric citrate in Japan to Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, and also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. KRX-0401 is currently in Phase 3 clinical development for both refractory advanced colorectal cancer and multiple myeloma, and in Phase 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 programs are being conducted under Special Protocol Assessment (SPA) agreements with the FDA. Keryx is also developing Zerenex(TM) (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex in the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is pending commencement under an SPA agreement with the FDA. Keryx is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical and business prospects for Zerenex (ferric citrate), may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete clinical trials for Zerenex; the risk that the data (both safety and efficacy) from the Phase 3 program will not coincide with the data analyses from the Phase 2 clinical trials previously reported by the Company, including the effects on IV iron and erythropoietin use observed in the long-term safety extension trial; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information in our website is not incorporated by reference into this press release and is included as an inactive textual reference only.
CONTACT: Lauren Fischer, Director, Investor Relations, Keryx Biopharmaceuticals, Inc., +1-212-531-5962, lfischer@keryx.com
SOURCE Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals: An Interesting Small Cap Value Play
Buzz up!
Apr. 13, 2010 | Filed Under: DNDN , KERX , MRK , PFE , RHHBY.PK , SNY
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I just read an excellent article on Seekingalpha regarding the bullish case for the company Keryx Biopharmaceuticals. I must admit that Biopharma is not my forte and I probably will not buy the stock as it is outside my circle of competence. However, I thought many of the more astute investors might be interested in Keryx.
I must also admit I do not like to use TTM for valuation metrics( I prefer average 3 or 5 years of earnings) but in young companies I do not think this is always fair( this might be hypocritical on my part I admit but I think there is merit to doing this).
I investigated further, the stock was trading at P/E 15 but went up a lot after a buy recommendation several days ago from an analyst . The company is trading at a P/E of 19. The company has plenty of cash and little debt (which is many times a problem for small biotech companies). The company has no long term debt, and has TOTAL liabilities of 9 million versus cash and short term investments of about 34 million. The company is cash flow negative from operations. However, this trend is encouraging the company lost $57 million in 2007 from operations, $38 million in 2008, and only $5 million in 2009(all this despite the "The Great Recession"),.
In terms of earnings the company lost a lot of money in 2007 and 2008 but made $10 million in 2009. It has a return on equity of 51%. In addition its return on sales are 48%, ROA 38%, and ROI of 51%. These figures are all within the top 80 to 90% of companies in the industry.
The seeking Alpha article states that the company has a Myeloma drug Perifosine in stage III. Currently over 10,000 people die from myeloma a year.
The author Jeremy Richards states in his SeekingAlpha article:
"Assuming that 50% of the 10,580 deaths are to receive Perifosine and that the average cost of treatment is $5,000 per month (Velcade is $45,000). Also note the average course of treatment is 22.5 months (averagesurvival rate from the phase II trial), but for simplicity and a more conservative estimate, I will just assume that treatment is received for only 12 months. Thus, the number of patients to go on and off treatment each month is equal.
$5,000 per month X 5,290 patients X 12 months/year= $317,400,000 Sales / year
Now, let’s assume net profit of 18% (Average Pharmaceutical Industry Profit)
$317,400,000 X 18%= $57,132,000 Net Income
Now, divide by shares outstanding to get net income per share:
$57,132,000 / $56,000,000 shares = $1.02 net income per share
Now, if we multiply that by the average P/E of the pharmaceutical industry:
$1.02/EPS * 14.15 P/E = $14.44 per share"
EPS TTM is currently 0.21. So using conservative estimates this new this new drug could increase EPS about fivefold.
In addition, I think the author is using conservative estimates for net profit. The company currently seems to be an industry leader and is dominating in areas like gross margin 29.46%, Operating Margin 29.12% which places above top 91% versus peers, and Pre-tax margin of 48.33% which places it above 95% of its peers.
I can not give an estimate for intrinsic value for this company. However, assuming Perifosine creates as much revenue as the author suggests the stock is worth a lot more than $14.44 a share.
It is also interesting to note guru Kenneth Griffin of Citadel Investment group also owns a small stake in the company.
If anyone wants to see more information on the bullish case for Keryx check out another article on my website
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