Heres a great summary of that shareholders meeting in 2010.
SHM Q & A
Brandon Cox asked where the FDA was at regarding Biosimilars. SK said that regulations are in place in Europe, and the company is evaluating which compounds are best for us to take on. Garnick said that Obama's healthcare act provides for biosimilars and that the FDA will be holding a meeting soon to address this. He doesn't think they have to think about it too much, just copy Europe. He said that one of the difficulties that we face is that ALL of the patents on a drug must have expired - not just the original patent, but all of the add-on patents on use, formulation, etc., and this is difficult to figure out. Of course, the drug companies will not cooperate, they don't want you to know. Garnick later said that he thinks the FDA will require companies to publish the final patent expiration date for their compounds. He said that this is evolving quickly.
Roy Alzua asked about the vacant chairman of the board position, and we were told for the first time that Carlton Johnson was the new chairman. Roy said something like 'Was this PR'd? Don't you think that this is a material event?' This was met with a lot of confusion among the board members and officers, with everyone looking at everyone else for an embarrassingly long period of time. Finally SK said that it would be PR'd. He also said that they are still trying to find the right person(s) to expand the board...
As long as I'm on this subject, in an earlier conversation with Brandon Roy, I was bitching about our inbred BOD, and he said that next year he intends to nominate two names for positions on the BOD: his own and Rob Garnick's. He later asked Rob if he would serve if drafted; he chuckled and said he'd make a terrible CEO, but didn't say no. I REALLY hope that Brandon follows through with this - he's got my vote.
Someone asked a question about the process and criteria used to evaluate all of the IST proposals that we are getting. Garovoy said that there is a form on the website that lists all of the questions that need to be answered. We then evaluate the proposal for our interests, and then it's up to the institution to submit all of the paperwork, etc.
Someone asked about whether our intention with Cotara was to partner it or go it alone. SK reiterated that our goal is to bring our data to the FDA to set a clear pathway to approval - then Cotara will be partnerable.
A shareholder asked about the number of outstanding shares. PL said that as of September 1st, the number was 56 million. The shareholder pointed out that that that amounted to 10% dilution since the reverse split. PL allowed that that was true, but said that the ATM is really the best way to finance on-going operations until we are profitable. With the ATM, the company gets 98% of the proceeds, as opposed to a 10% or 20% discount with pipes.
It was also mentioned that we have applied for a government grant under section 48D that would be worth 5 million. We should be hearing about that soon.
After the Q & A, a group of shareholders were talking to Garnick about biosimilars, and he was pointing out the need and the difficulty of exactly matching someone else's compound. His example was imagine reproducing a 747 by disassembling it and copying each piece. I asked him what the approval process would be, once you were convinced that you had an exact duplicate compound. He said that you would have to do a small phI to prove safety, but would be able to skip the phII, since you already know that the compound is efficacious. Then you would need to do a phIII with about 450 to 1000 patients to prove that the compound is not different from the original.
That wrapped up the SHM. For what it's worth, here are a few of my impressions and observations. There were no armed guards at the meeting this year. SK, PL, and even Charlton Johnson seemed very relaxed and much less wooden in their presentations than a few years ago. Maybe they are growing into their jobs. That said, I was very disappointed with the appointment of Johnson to the chairman position. I really hope that Brandon Cox follows through on his intentions. He mentioned trying to contact Chris Smith (? I think that's the share holder who used to submit shareholder proposals each year) to pick his brain and learn from his experience. If anyone knows how to contact Chris, let Brandon know.
In the past, ES has sat though the shm looking totally bored. This year, he brought his laptop with him, and spent the entire time playing with it, probably monitoring his other investments. David Pohl looked over his shoulder a lot.
Overall, I'm impressed with the quality of people that the company is adding to the management team, and the job that they are doing. During the introductions at the beginning of the meeting, there was another ex-Genentec doctor that was introduced. Unfortunately, I didn't get his name.
After the SHM, I had some time to kill before my flight home, so I drove by the company just to see if anything had changed. There is (was) a company across from Avid called ABM Janitorial. They still have their name on the building, but it has been removed from the sign that lists the businesses in the business park where PPHM and Avid are located. As I sat in the parking lot eating lunch and reading a book, there was a lot of foot traffic between the ABM building and PPHM/Avid. this is PURE SPECULATION on my part, but maybe Avid is expanding and this is part of what SK meant by strategically preparing for potential product commercialization.
Michael
PPHM THE COMPANY THAT CRIES WE ARE IN TALKS! All imo.
