August 9, 2013

A Revealing $PVCT 10-Q

Provectus filed its second quarter 10-Q yesterday. Most revealing, in my view, when combined with other recent information, was the following statement from the Management's Discussion and Analysis of Financial Condition and Results of Operations section on page 13:
"We believe that our prescription drug candidates PV-10 and PH-10 provide us with two products in multiple indications, which have been shown in clinical trials to be safe to treat serious cancers and diseases of the skin, and important immunologic data has been corroborated and characterized by institutions such as Moffitt Cancer Center in Tampa, Florida and another leading research facility. We continue to develop clinical trials for these products to show their safety and efficacy, which we believe will continue to be shown based on data in previous studies, and which will result in one or more license transactions with pharmaceutical and or biotech partners. Together with our non-core technologies, which we intend to sell or license in the future, we believe this combination represents the foundation for maximizing shareholder value this year and beyond."
And, later in the same section, on page 14:
"We are also considering the global licensure of PV-10 as well since it has come to our attention that this is of interest to potential partners. We also expect to continue with the majority stake asset sale and licensure of our non-core assets. However, the primary objective of ours is to strategically monetize the core value of PV-10 and PH-10 through various transactions, leveraging value creation up to and including an appropriate Merger and Acquisition transaction. We believe regulatory clarity insofar as the expected approval pathways of both PV-10 and PH-10, including potential for breakthrough therapy designation as appropriate for PV-10, will help facilitate transactions with potential partners."
The bold emphasis, which is mine, is, I think, management being specific and definitive (particularly with the first bolded item). Transaction parties from China, India and Japan are likely waiting for outcome of regulatory clarity, whatever it is. Management is likely waiting, too. Eric's time in New York last week included meeting with Chinese pharmaceutical company folks, which I would assume (guess) are from Hisun-Pfizer. I expect he will be in Shanghai, China at some near-term point to visit with a liver trial location. According to management, interest has been knowledgeable and purportedly high from potential Indian and Japanese partners.

Will one or more regional license transactions be signed immediately after regulatory clarity is attained?

Have deals effectively been penciled, and are discussions about in-country trials and more operationally-focused post-deal items being carried out, in the interim? This feels to be the case for China, where it was remarked in New York that (paraphrasing) "China is a lot farther ahead than most people think."

How does the outcome of clarity -- per the poll question, the SPA, BTD, etc. -- play into whether global license transactions are signed too, or instead? For example, if BTD is achieved and accelerated or outright approval comes with it, does Pfizer move? How does a global player moving for a worldwide license affect, if at all, license transactions with regional players?

I think Provectus is communicating meaning here.

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