Biotech Values

[DewDiligence]

IDIX: Guessing the IDX899 Milestones from GSK

The events that trigger IDX899 milestone payments from GSK to
IDIX are set forth in IDIX’s 2008 10-K report; although the sum of
these milestone payments is known to be $416M (#msg-35391933),
the amount of each individual payment is redacted in the SEC filing.
The numbers shown below are my guesses for the individual milestone
payments, and they are based on the way other licensing deals have
been structured. My numbers could be off, of course, but I think they
are accurate enough for gauging IDIX’s future needs for capital.
Feedback welcome.

http://sec.gov/Archives/edgar/data/1093649/000095013509001542/b73455ipexv10w28.htm [page 20]


Preclinical milestones:

[Guess: $9M consisting of $1.5M for each milestone listed below.]

• Completion of the monotherapy formulation.
• Completion of a single-pill combination formulation.
• Completion of a segment II reproductive toxicity study.
• Completion of a six-month rodent chronic toxicology study.
• Completion of a nine-month non-rodent chronic toxicology study.
• Completion of a rodent carcinogenicity study.


Clinical milestones:

[Guess: $30M all told.]

• First patient dosed in a phase-2 study of IDX899 + HIV backbone regimen (e.g. Truvada) with a duration of at least 24 weeks. [Guess: $10M.]

• First patient dosed in a phase-3 study. [Guess: $20M.]


Regulatory milestones:

[Guess: $87M all told.]

• FDA acceptance of NDA for review. [Guess: $15M.]

• EMEA acceptance of MAA (NDA) for review. [Guess: $10M.]

• Japanese acceptance of NDA for review [Guess: $5M.]

• FDA approval for marketing [Guess: $45M.]

• Japanese approval for marketing [Guess: $12M.]


Commercialization milestones:

[Guess: $290M all told.]

• First commercial sale in a major country. [Guess: $40M.]

• Three sales-based milestones based on attaining specified thresholds of worldwide sales. [Guess: $50M, $80M, and $110M, respectively—i.e. $240M in all—for the low , middle, and high sales triggers.]