Hoosier: What to expect from Geron now?

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Fishermangents
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Hoosier: What to expect from Geron now?

Post by Fishermangents » Tue Jan 12, 2016 6:12 pm

Great article from Hoosier (SA, 12 January 2016). Herewith some parts of it.

Summary
- Second-line myelofibrosis represents a $1.1B net sales opportunity.
- Low & Int-1 risk MDS represents a $3.7B net sales opportunity.
- AML, multiple myeloma, and solid tumors are future opportunities.
- A forthcoming patent will extend patent protection through 2032.

Conclusions
Geron's current share price is undervalued based on Imetelstat's probability of gaining regulatory approvals, patent protection, and the financial projections associated with future hematologic and lymphoid treatment opportunities.

Investor Risk Considerations
The financial analysis outlined in this article is largely based upon achievable (mature) sales figures associated with a second-line (R/R) treatment for myelofibrosis and a first-line treatment for Low & Intermediate-1 risk MDS patients in the US and European markets. Upon approval, Imetelstat sales are likely to ramp quickly due to Janssen's worldwide presence and expertise in commercializing pharmaceutical products. However, following a regulatory approval, Imetelstat's market penetration will be gradual, the actual rate of which is an unknown.
Geron has ~$147M in cash and investments and zero debt. With a cash burn rate less than $20M/year, there's no need for Geron to raise capital in support of 2016 operating expenses.
Geron is investigating potential acquisitions or partnerships involving oncology compounds, products, or companies for the purpose of new product development. The company's short-term strategic plan is clearly focused on the development of Imetelstat in collaboration with Janssen, but significant questions remain relative to Geron's long-term strategic plan.
The risk of another FDA clinical hold is believed to be low based on the unmet need associated with R/R myelofibrosis patients, the FDA's approval of Janssen's Phase 2/3 MDS trial design, and the FDA's previous (2014) comprehensive safety review and complete release of the full clinical hold.
Geron's biggest risk involves the "commitment level" of its collaboration partner, Janssen. This risk appears to be very low based on the following considerations:
· Janssen was selected by Geron over other prospective partners.
· Janssen negotiated a lucrative licensing agreement for Imetelstat during the time of (and in spite of) the FDA's previous clinical hold.
· Hematologic malignancies are one of Janssen's focus areas.
. JNJ has highlighted Imetelstat as a key driver of JNJ revenue growth.
· JNJ has communicated plans for five Imetelstat trials involving MF, MDS, and AML.
· Janssen's second-line R/R myelofibrosis trial features 70+ clinical trial sites and has been registered with multiple international regulatory agencies.
· Janssen's first-line MDS trial already features 49 trial sites and has been registered with multiple international regulatory agencies.
· Janssen has publicly stated plans to file for Imetelstat's regulatory approval in 2017.

Thanks to Hoosier for this great and well documented article!

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