Stock Alert for Keryx Biopharmaceutical Inc. ($KERX)
Keryx Biopharmaceutical Inc. (NASDAQ: $KERX)
Keryx Biopharmaceuticals (KERX) engages in the acquisition, development and commercialization of drug therapies for the treatment of renal disease and cancer. The Company’s novel, oral anti-cancer agent called KRX-0401 (perifosine) is developed to inhibit cell growth and cell transformation. KRX-0401 has cleared phase I clinic trials for safety and efficacy. KRX-0401 is currently in phase II clinical trials to determine efficacy for multiple tumor types, and phase III for the efficacy to treat multiple myeloma. The Company seeks strategic relationships to develop drug candidates, including evaluating compounds for acquisition or licensing.
Founded in 1998, the Company is headquartered in New York, New York.
| Share Statistics (05-May-10) | FY
2008 |
FY
2009 |
%
Chg |
Q4 2008 | Q4 2009 | %
Chg |
||
| Symbol | KERX | Revenue, $Mn | 1.3 | 25.2 | 1.8k% | 0.3 | 0.0 | -100% |
| Current price | $5.57 | Gross marg. | 100% | 85.7% | 1.6k% | 100% | n/m | -100% |
| 52wk Range: | $0.25-6.67 | Oper. margin | -4.2k% | 38.9% | -118% | -1.2k% | n/m | 32.4% |
| Avg Vol (3m): | 3,076,900 | Net margin | -4.1k% | 41.7% | -120% | -1.3k% | n/m | 23.7% |
| Market Cap. | 316.72M | |||||||
| Dil. Shares Outst. | 56.05M | EPS, $ | -0.830 | 0.209 | -125% | -0.082 | -0.083 | 1.22% |
Source: Reuters.com, SEC Filings.
Financial Summary
| Financial Strength (05-May-2010) | Company | Industry | Sector | S&P 500 |
| Quick Ratio (MRQ) | 5.89 | 5.28 | 2.56 | 0.71 |
| Current Ratio (MRQ) | 5.89 | 5.72 | 3.07 | 0.84 |
| Long-Term Debt to Equity (MRQ) | 0.00 | 20.42 | 24.12 | 124.73 |
| Total Debt to Equity (MRQ) | 0.00 | 25.03 | 30.90 | 184.89 |
Source: Reuters.com, SEC Filings.
Analyst Consensus
The mean of four analysts polled by Thomson Reuters rate shares of KERX a “Buy.” The details of the analysts polled are as follows:
Analyst Recommendations and Revisions
| 1-5 Linear Scale | Current | 1 Month Ago |
2 Month Ago |
3 Month Ago |
|
| (1) BUY | 3 | 3 | 3 | 2 | |
| (2) OUTPERFORM | 1 | 1 | 1 | 0 | |
| (3) HOLD | 0 | 0 | 0 | 0 | |
| (4) UNDERPERFORM | 0 | 0 | 0 | 0 | |
| (5) SELL | 0 | 0 | 0 | 0 | |
| No Opinion | 0 | 0 | 0 | 0 | |
| Mean Rating | 1.25 | 1.25 | 1.25 | 1.00 | |
Source: Reuters.com, SEC Filings.
Investment Highlights
Overview
KERX engages in the acquisition, development and commercialization of drug therapies for the treatment of renal disease and cancer. The Company’s novel, oral anti-cancer agent called KRX-0401 (perifosine) is developed to inhibit cell growth and cell transformation. KRX-0401 has cleared phase I clinic trials for safety and efficacy. KRX-0401 is currently in phase II clinical trials to determine efficacy for multiple tumor types, and phase III for the efficacy to treat multiple myeloma. The Company seeks strategic relationships to develop drug candidates, including evaluating compounds for acquisition or licensing.
Market Size
The United States market for end-stage renal disease dialysis is estimated to reach more than $2 billion in 2010, and reach more than $11 billion worldwide. In addition, according to the Cancer Market Outlook report published by Business Insights, the market for cancer therapeutic drugs is expected to reach $40.9 billion by 2012.
In 2009, the National Cancer Institute reported 20,580 new cases of multiple myeloma in the United States, with approximately a 50% fatality rate.
Company Drug Candidates
KRX-0401 (perifosine)
KRX-0401 (perifosine) is the Company’s lead oral anti-cancer agent developed to modulate important signal transduction pathways, including the JNK and MAPK pathways. JNK and MAPK are identified as the pathways associated with the growth, differentiation, death and survival of human cells. KRX-0401 modulates the Akt pathway, which is believed to be the pathway for the development of most cancers. The Company has evidence that these pathways are activated in tumors that have historically resisted traditional anticancer therapies. The Company’s challenge is to inhibit this pathway without excessive toxicity to the patient.
Tested in more than 1,800 patients, the Company has demonstrated a distinctly different safety profile from most cytotoxic agents. Typical cytotoxic agents usually cause flu-like symptoms, decreased platelet count, and/or hair loss; but in contrast, KRX-0401 does not cause these symptoms. KRX-0401 causes different symptoms, however, including nausea, vomiting, diarrhea and fatigue, all of which are easily managed particularly at lower dosages of 50 mg and 100 mg. At this daily dosage level, tumor regression and manageable symptoms were indicated.
Zerenex (ferric citrate)
Zerenex (ferric citrate) is an iron-based compound developed to bind to phosphate, forming non-absorbable complexes. In phase II clinical trials, Zerenex was proved safe and efficacious to treat elevated phosphate levels in patients with end-stage renal failure. In the United States, phase III clinical trials of the drug are nearly complete. In addition to the U.S. market, Zerenex is in phase II clinical trial for the introduction of the drug therapy in the Japanese market, and has undergone development in conjunction with partners, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd.
Recent News
On September 16, the Company said it had received notification by the Food and Drug Administration that KRX-0401 (perifosine) was given Orphan Drug Status—a status given to drugs that have promise to treat rare or untreated conditions or disease. An FDA Orphan Drug Status offers incentives for further development, including a seven-year exclusivity protection period following FDA approval, clinical trial help from the FDA, reduced FDA fees and tax credits.
In December, the FDA notified the Company and partnering pharmaceutical company AEterna Zentaris of its decision to grant fast-track review designation to the multiple myeloma drug candidate perifosine.
Perifosine, an oral anti-cancer drug, has demonstrated FDA efficacy and safety metrics for the treatment of refactory advanced colorectal cancer. Fast-track designation is granted to agents for the treatment of life-threatening conditions or disease presently not adequately addressed in the marketplace.
Recent media coverage of the stock and its leading drug candidate has been accelerating as perifosine nears completion of the FDA process and further demonstrates efficacy, safety and potential to treat other conditions.
The market potential for perifosine and like drugs is estimated to reach more than $10 billion, worldwide, with potential revenue from commercialization of the drug and market capitalization implications of the Company raised substantially if perifosine clears the FDA.
Technical Analysis
Source: http://stockcharts.com/h-sc/ui?s=kerx
KERX trades above its 13-day moving average. This bullish sign is significant because the moving average are also positively trending. In addition, KERX trades above its mean Bollinger band, another bullish indication of the stock’s relative strength.
The MACD reveals an underlying strength in the stock’s momentum. The MACD is above the signal line, a 9-day moving average of the MACD, trending upwardly. The MACD is above the critical level of 0, which implies the past price action had been positive. Overall, the chart is bullish.
Comparative Analysis
| Company Name | Ticker | Price/ | Mrkt. Cap. | P/E | P/S | ||
| May-05-2010 | symbol | Share, $ | $ Mn | 2009 | 2010 | 2009 | 2010 |
| Baxter International Inc. | BAX | 45.65 | 27,510 | 12.60 | 10.59 | 2.14 | n/a |
| CuraGen Corp. | CRGN | – | – | – | – | – | – |
| Shire plc | SHPGY | 64.90 | n/a | n/a | n/a | n/a | n/a |
| Industry Median | 13.59 | n/a | 4.07 | n/a | |||
| Keryx Biopharmaceuticals | KERX | 5.57 | 316.72 | 26.78 | n/a | 14.65 | n/a |
Source: Thomson Financial
Insider Trading Activity
| NET SHARES PURCHASE ACTIVITY
Inside Purchases – Last 6 Months |
||
| Shares | Transaction | |
| Purchases | 10,000 | 1 |
| Sales | 22,981 | 1 |
| Net Shares Purchased (Sold) | (12,981) | 2 |
| Total Insider Shares Held | 3.11M | n/a |
| % Net Shares Purchased (Sold) | (0.4%) | n/a |
| Net Institutional Purchases — Prior Qtr to Latest Qtr | |
| Shares | |
| Net Shares Purchased (Sold) | (12,640,400) |
| % Change in Institutional Shares Held | 307.5% |
Source: Yahoo Finance
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