Today, investors saw a new press release from Celsion, specifically announcing that the company has entered into a long-term supply agreement with Hisun Pharmaceuticals for the manufacturing of ThermoDox in the China market. The market did not seem to pay much attention to this announcement, but I would argue this represents a key milestone along the commercialization path for ThermoDox, particularly since China represents the largest market for the company in HCC. The agreement includes the following:
- Tech transfer for proprietary manufacturing process, and non-dilutive funds to support that endeavor (I imagine there is a lot of legal work there, IP in emerging markets is a scary topic, read about Bayer's experiences with Nexavar in India)
- Production of China registration batches
- Option for Hisun to globally manufacture ThermoDox following SFDA approval
- Support for regulatory approval activities in China
- An undisclosed manufacturing price that "will support high gross margins across global territories"
In other news, Michael Tardugno also presented at the 37th Annual Deutsche Bank Health Care Conference. There was nothing particularly new or exciting presented:
- Reconfirmed final data from the HEAT study would be available at the end of 2012
- Final confirmatory OS data due 18-24 months after top-line PFS results
- Reiterated enough cash on hand to last until Q3 of 2013, burn rate of $1.7M for next 18 months (company likely has just over $20M as of right now)
- Revenue potential of $500M by 2017 in HCC using 10% global share capture rate
- Phase II RCW trial to commence patient enrollment in the second half of 2012
- Company working to establish "redundant manufacturing capability" from high quality sites, "which we believe would be very important to a successful high quality license with a multinational company"
- In response to the sole Q&A question regarding business development, Mr. Tardugno said the "enthusiasm coming from our investigators [HCC] is nothing short of remarkable". He added, "We would be looking forward to firm license discussions with what we think would be a multinational partner post data for markets outside the US"
The last point was probably the most interesting one, as it tells me the company is really playing hard ball with potential partners. Post data, assuming success, the terms of such a licensing deal exponentially change in the company's favor. That said, if the company is truly not seeking a deal until end of the year, I see a cash raise likely in Q3, as I have mentioned before, hopefully in the 3-5 range. Absent a cash raise, the company will have $10M in cash by the end of 2012, and I sense they are no longer looking to "scrape the barrel" as they have done in the past.
It's hard to believe that we are already nearing mid-2012, and rapidly approaching final data from the HEAT study. Feel free to leave questions or comments.