Replies to post #137397 on Biotech Values

[mcbio]

Based on the R&D Day telecon this behavior is either not universal or something they have overcome since they publicly terminated several programs in that mtg. Do you remember what the last stealth termination you saw from them was?

(if I had to guess I'd suggest that they might be more transparent now because they have such a fat pipeline. If so it would provide a good cal of their threshold for hiding data.)

PS have they had a recent technology breakthrough? They seem to be killing a fair number drugs to replace them with next gen products.

Tx in advance for any answers you might provide and saving me the time (a rare commodity for me)

I have always thought ISIS was an interesting little company given the breadth of their pipeline, technology, and partnerships. And, yeah, valuation doesn't seem to be too crazy to me. But, I assume you would have to have confidence in their lead drug, mipomersen, getting approved to take a position here. The approval decision on that drug is presumably a pretty key binary event for them, notwithstanding the fact that they do have a deep pipeline behind it. So, do you have confidence that mipomersen will be approved at least in the higher unmet medical need patient population? And, if so, is that likely to be a big value driver for them going forward? I just don't know enough about mipomersen to consider a position in ISIS yet. I know there is efficacy but also some safety questions as well, which makes it likely the drug might only be approved for the higher unmet medical need patient population. Presumably as long as the drug is at least approved for the smaller patient population, there wouldn't be a lot of downside risk in the stock.

ISIS also had $365M in cash as of the end of 3Q11, which is pretty impressive, though it looks like they also have over $200M in notes due/LT liabilities as well.

[acgood]

Based on the R&D Day telecon this behavior is either not universal or something they have overcome since they publicly terminated several programs in that mtg. Do you remember what the last stealth termination you saw from them was?

I guess my standards are different. ISIS had been promising the SGLT2 phase 1 data for ages. They never presented it or issued a press release describing it. Instead, they bury it (and the program cancellation) at the end of a multi-hour R&D day and slide deck. Likewise, the PCSK9 had been "poised" to reenter the clinic very recently and repeatedly until the 1/5 R&D day. Both programs also were listed on the pipeline slides displayed early in the R&D day slide deck. I happen to agree with the termination of both programs, but I will note that the investing community seems to collectively be calling BS on ISIS's stated reason for axing the PCSK9 program, by showing no signs of concern towards anyone else's PCSK9 programs.

The more egregious example is the PTP1b program. They completed a phase 2a study and excitedly talked about their plans for phase 2b. They had to do some longer term tox studies first. Then they stammered on about this for about 18 months, giving very fishy answers the whole time about the progress towards starting the phase 2b. Finally, the termination of the lead drug and the advancement of a follow-on version was tucked into a 10q, and never mentioned in the corresponding earnings PR or conference call. Of course the analysts were too pathetic to ask about it on that call either.

They have dozens of drugs in the pipeline, of course there will be failures. Not sure why they insist on acting like everything is always advancing perfectly. They also rarely meet their own projected development timelines, even for entering/completing phase 1 healthy volunteer studies. They need to prove they can do this before I get excited about the broadening pipeline.