Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of 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 is currently in Phase 3 clinical development for both refractory advanced colorectal cancer and multiple myeloma, and in Phase 1 and 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 studies is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. Keryx is also developing Zerenex (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to an SPA agreement with the FDA. Keryx is headquartered in New York City .
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JMP Securities - Keryx Biopharmaceuticals ($KERX)
1. Biotechnology - Company Report November 14, 2011
Keryx Biopharmaceuticals, Inc. (1,2)
Charles C. Duncan, PhD
cduncan@jmpsecurities.com
Zerenex Cost Savings Potential Overlooked
(212) 906-3510
MARKET OUTPERFORM KERX $2.82
Jason N. Butler, PhD
jbutler@jmpsecurities.com
(212) 906-3505 Price $2.82 FY Dec 2010A 2011E 2012E
Target Price $8.00 Revenue (M) 1Q $0.0 $0.0A --
Gena H. Wang, PhD 52-Wk Range $2.58 - $5.91 2Q $0.0 $5.0A --
gwang@jmpsecurities.com Shares Out. (M) 59 3Q $0.0 $0.0A --
Market Cap. (M) $166 4Q $0.0 $0.0 --
(212) 906-3528
Average Daily Vol. (000) 683 FY $0.0 $5.0 $8.0
Roy Buchanan, PhD Float (M) $67
rbuchanan@jmpsecurities.com
2010A 2011E 2012E
LT Debt (M) $0 EPS 1Q ($0.07) ($0.10)A --
(212) 906-3514 Cash (M) $47.2 2Q ($0.09) ($0.05)A --
Enterprise Value (M) $119 3Q ($0.10) ($0.15)A --
Cash/Share $0.80 4Q ($0.09) ($0.15) --
FY ($0.34) ($0.45) ($0.42)
P/E NM NM NM
Previous FY -- NC NC
CY ($0.34) ($0.45) ($0.42)
PE NM NM NM
NC indicates no change to previous estimate. NE indicates no previous estimate.
Source: Company reports and JMP Securities
INVESTMENT HIGHLIGHTS
• DaVita looks at Zerenex clinical data and provides compelling evidence for cost savings;
reiterate Market Outperform rating and $8 price target on Keryx Biopharmaceuticals. Keryx
released this morning two abstracts from presentations by DaVita Clinical Research at the
American Society of Nephrology meeting over the weekend. The posters describe cost savings
analyses carried out using data from the prior clinical studies of Zerenex. Zerenex is currently in
Phase III testing for use in end-stage renal disease patients on dialysis and we anticipate data
sometime in 2H12 and potential sales of ~$200MM in 2016. Our $8 price target is derived using
a risk-adjusted, sum-of-the-parts analysis including perifosine (~$4) and Zerenex (~$4).
• Cost savings analysis highlights potential for Zerenex to add value. In poster #1566, DaVita
took historical changes of the iron-storage markers serum ferritin and transferring saturation
(TSAT) and correlated changes in those values to project reductions in erythropoietin stimulating
agent (ESA) and IV-iron usage for patients switching to Zerenex. A sensitivity analysis illustrating
the major cost drivers is provided in Figure 1. The company derived an estimated cost savings from
Zerenex usage, of ~$125/patient for moderate ESA use (4,500-9,000 units per session) and
$320/patient for high ESA use (9,000 or more units per session). Our diligence suggests that ~80%
of ESRD patients require ESAs and ~90% require phosphate binders. Using the derived savings of
~$90/patient/month for all patients, and our estimate of 7% Zerenex penetration in 2016 in the U.S.,
provides a potential cost savings of ~$38MM annually.
• Physician behavior largely dictates cost benefit potential. The second poster presented by
DaVita, #2647, analyzed ~130,000 patient records from DaVita's hemodialysis (HD) patient
database from June 2008 to May 2010. The database was filtered to include patients whose TSAT
increased by 10% or more and whose serum ferritin increased by 15 to 25%, to eventually include
approximately two thousand HD patients. The company examined physician responses to the
increases in TSAT and serum ferritin, finding a mean decrease in ESA dose of ~500 units and for
iron of ~5.8mg per patient. With pressures on cost savings likely to only increase going forward, we
view results such as these as likely to be useful in demonstrating Zerenex's utility in this setting and
to drive robust clinical uptake.
• The posters are available at http://www.davitaclinicalresearch.com/directory.asp
FOR DISCLOSURE AND FOOTNOTE INFORMATION, REFER
TO THE JMP FACTS AND DISCLOSURES SECTION
2. FIGURE 1: Sensitivity Analysis for Cost Savings Potential
Source: DaVita Clinical Research
INVESTMENT RISKS
Clinical risk. Keryx's product candidates may fail to demonstrate adequate efficacy, safety, and/or
tolerability in one or more clinical studies.
Regulatory risk. Even if the company's product candidates do successfully complete clinical
development, regulatory approval may not be granted by the FDA or foreign regulatory authorities, and
additional studies may be required.
Industry risk. The biotechnology industry is highly competitive with many firms developing novel
therapies that address Keryx's target diseases. It is possible that breakthrough competitor products or
therapies may render Keryx's pipeline obsolete and affect the future survival of the company.
Additionally, there are a number of established products in several of the markets Keryx is targeting.
Shifting patients to Keryx's products may require significant capital and resources.
Balance sheet risk. The company has a history of losses, and consistent profitability is still several years
away. Since Keryx is burning cash in order to develop products and is expected to do so over the near
future, raising additional capital is crucial to the viability of the company. Keryx ended 4Q10 with
approximately $28.5MM in cash and equivalents with an average operational burn rate of $4.1MM per
quarter for the past four quarters. Keryx anticipates that it has funding sufficient to complete the current
Phase III programs; however, after that, it may require additional funding.
COMPANY DESCRIPTION
Keryx Biopharmaceuticals focuses on the development of novel treatments for cancer and renal
disease. The company's lead product candidates are perifosine and Zerenex, both of which are
currently being evaluated in Phase III programs. Perifosine is an inhibitor of the PI3-kinase pathway and
is being developed for the treatment of cancer. Keryx has ongoing Phase III programs for perifosine in
metastatic advanced colorectal cancer and multiple myeloma that are being conducted under Special
Protocol Assessments (SPAs) as well as early stage programs in other indications. The company's
second product candidate, Zerenex, is a phosphate binder being developed for the treatment of
hyperphosphatemia in patients with end-stage renal disease. Keryx recently released positive top line
results from the first of two Phase III trials for Zerenex, which met its primary and secondary endpoints.
2
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