Keryx Biopharmaceuticals Inc. Message Board

Upcoming Catalysts 2011/12

Here’s what I view as the key upcoming catalysts for Keryx going forward:

ZERENEX

• Patient enrollment completed for long-term PIII (2Q11)
• PIII top-line data (1H12)

PERIFOSINE

Colorectal:
• Patient enrollment completed (2Q/3Q11)
• Interim DMSB review @ 50% of events (3Q11)
• PIII top-line data (4Q11/1Q12)

Multiple Myeloma:
• Patient enrollment completed (2H11)
• Interim DMSB review @ 1/3 of events (2Q/3Q11)
• Interim DMSB review @ 2/3 of events (4Q11/1Q12)
• PIII top-line data (1H12)

Neuroblastoma:
• ASCO (June 3-7)
• Potential for SPA / Fast Track / Initiation of PIII (2H11/1H12)

Chronic Lymphocytic Lymphoma:
• ASH (December)
• Potential for SPA / Fast Track / Initiation of PIII (1H12)

Other indications:
• Potential for add’l perifosine data at ASCO (June 3-7)
• Potential for add’l perifosine data at ASH (December)

FINANCIAL

• JT Torii milestone payment (~1Q11)
• Add’l cash inflow through warrant exercise (ongoing)
• Potential for analyst upgrades / initiation (ongoing)

STRATEGIC

• Potential for Zerenex and/or perifosine partnership (ongoing)



KEY TAKEAWAYS

• The next 18 months will determine the future of the company especially from ~4Q11 to 1H12 where there will likely be 3 PIII pivotal events

• The company is adequately funded to reach their major value creation milestones

• Some potential for early stopping for benefit of the perifosine CRC trial (and potentially MM although this is probably less likely) if it can come close to replicating the PII results—a lower probability / huge upside scenario.

• The perifosine MM timeline looks to be a bit delayed most likely due to heavy patient competition from Zolinza (Merck) but new int'l sites are apparently close to enrolling.

• Timelines for the PIII perifosine programs could vary widely depending on enrollment, efficacy etc. For example, colorectal PIII results could read out in 1Q12+ if patients are living longer than expected

• Perifosine has all the hallmarks of a blockbuster drug yet the commercial potential is dramatically underestimated. For example, some analysts have perifosine in colorectal cancer at ~$150MM peak sales based on a 9% peak market share and $20-25k per year pricing. However, these estimates run contrary to the following:

o Xeloda currently has significantly greater market penetration in the metastatic segment and perifosine will be used in combination. Xeloda is currently at ~$1.5B in annual revenue although also approved for stomach and breast cancers.
o Current pricing of oral targeted oncology agents are at multiples of the above pricing
o Significant competition in the refractory mCRC segment is at least 4-5 years post perifosine approval
o As a disease category, average oncology revenue is about $500M and colorectal cancer is one of the most prevalent cancers

• Longer term and if perifosine is approved, there is also significant upside for perifosine in terms of off label use and potential front line advanced (or even earlier line) MM and/or CRC indications. It’s worth noting that Avastin derives a substantial portion of its revenue from CRC.

• The strategic rationale is there for a AEZS/KERX combination at some point but the current valuation disparity and potentially divergent management aspirations are barriers for now