Why? [Now] You Know Why.

Sometimes, it's what isn't said that may be as important or more so than what's said. Sometimes, it's not just how you say what you say, but how you say what you don't say.

We don't talk at all about serious adverse events ("SAEs") related to PV-10 trials and the compassionate use program ("CUP"). We rarely talk about AEs in general, aside from the mild to moderate ones experienced thus far in the trials and CUP.

Sometime between last year, sometime, and this year, sometime, Provectus arrived at an agreement with the FDA on a special protocol assessment ("SPA") for its pivotal metastatic melanoma ("MM") Phase 3 trial. How do I know? I don't. Do I know for sure? No. If one presumes or contends management is feckless or incompetent, then they're still working to convince the FDA that the local agent PV-10 has some sort of value, and wasting value cash in a pointless task. The SPA still is M.I.A.

I don't presume anything of the sort, even though there have been breadcrumbs of the SPA scattered among company communications and medical conference presentations, that tantalize us about parameters, timing, enrollment, etc. With each of these crumbs we thought the SPA and trial commencement are upon us, or within our grasp.

I think the breakthrough therapy designation ("BTD") arrived essentially in the middle of the process of management working towards the SPA with the Agency, "upsetting" the old SPA path and setting the company onto a new BTD one (whether in parallel, or as an extension). I'm guessing the supposed agreement was verbal in nature, proffered to Eric and his regulatory team, but set it aside in pursuit of an accelerated path to approval.

But, not everyone sang from the same hymn book. In hindsight, those "off key" notes were prescient.

It's not a bad thing the SPA up and vanished like a fart in the wind. It's the "good" option. It always has been. Interim Phase 3 results would provide Big Pharma with the traditional data they required to consider a worldwide license or acquisition of the company.

It might feel to some like we've been down this road before. High expectations: 2010. Accelerated approval. 2012. SPA. Today, nothing...yet.

Is this time different? Everyone seems to be singing from the same hymnal. Finally.

The current regulatory affairs narrative seems to have several facets to it:

• The company has filed its BTD application. Previously, there'd been, at times, an almost absurd did-they-file, did-they-not-file charade to the process.

• The company filed for BTD around October 1st, starting the/a so-called 60-day clock. Adding about 15 days because of the recent partial federal government shutdown (precisely, October 1-16), an expectation for communication from the FDA on this conceivably could come around or before mid-December. Since you never know about federal government mailrooms, and with business time inevitably slowing after Thanksgiving, it's conceivable Provectus, and thus we, don't hear until the end-of-December or January.

• The BTD process to date [sort of] works like this: Work with the FDA and their process, such as it is, get "pre-qualified," and you get BTD. 100% of the companies [purportedly] that worked with the Agency in such a fashion received the designation. Don't work with the FDA, don't follow their process, don't get pre-qualified, and you don't get BTD. 100% of the companies [purportedly] that did not work with the Agency in the required fashion did not receive the designation. Provectus worked with the FDA. So, they'll get BTD, right? BTD was the "better" option.

• They asked for a meeting with the FDA to discuss BTD, and how (how best?) to request accelerated approval ("AA") or outright approval ("OA") in this context. I don't believe management has any doubt, and if one of them has it's small or de minimis, that they've successfully demonstrated PV-10's clinical value proposition for MM Stage IIIb-IIIc patients refractory to prior treatments. AA/OA was the "best" option.

I said I wouldn't discuss the details of my call with Dr. Weber, but here's a small perspective of how he said what he said, and how he said what he didn't. I have no doubt he is very experienced talking to "outsiders" like me. Dr. Weber was generous with his time, and thoughtful in his answers. "Methought the professor dost protested too much."

The commercial validation narrative appears singular: Regional deals and the Big Pharma end-game follow regulatory clarity.

[Now] you know why.

Tipper: You know what? I can get a couple of my brother's loser ass friends to go over to Mason's apartment, knock on the door and when he opens it wham! They'll junk-punch him all up in his man business and he'll fall to the floor whaling and crying "why?" and then we'll say "you know why!" (What Happens In Vegas)

Horserace (updated)

In illustrating the horse race, I mean to convey or say "crossing the finish line" implies a funded transaction. So, while it will be interesting to watch if Provectus inks an MOU with Chinese pharmaceutical company Hisun-Pfizer (or another Chinese company) this week, the funding of this transaction might more likely occur within 30-60 days after the MOU is signed/announced.

The current perspective is an Indian company is more likely to consummate (i.e., fund) a regional transaction, and thus deliver the upfront payment to Provectus first, followed by a Japanese pharmaceutical company. At the moment, it would seem the Chinese upfront payment is viewed as arriving third behind the Indian and Japanese payments.

I will review the situation after Peter returns from Japan.

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The above written or said, a regional transaction may not occur until the FDA provides regulatory clarity to Provectus. As I wrote in my "$PVCT is Going for BTD. BTD is Tantamount to Approval." post, the company sought this clarity through its original, initial pursuit of accelerated approval ("AA"), followed by initiating a parallel path to pursue a special protocol assessment ("SPA") and eschewing a traditional "non-SPA" MM Phase 3 trial. While both paths, AA and SPA, remain viable, the breakthrough therapy designation ("BTD") arrived last year and now appears the more active or likely path to clarity.

While management certainly could be blown away by the pricing and structure of a regional transaction from an interested party, it is not unreasonable to think these companies, as do potential investors, also are waiting for regulatory clarity before they present Provectus with terms and conditions.

As I wrote in my "#PVCT's #China #Arbitrage Opportunity post," on the one hand, while many Western Big Pharma companies are very interested in the drug, they still desire to understand the story of how and why a very effective local agent can have as comparable systemic and immunologic benefit. Thus, we waited for Moffitt. On the other hand. the Chinese (and the Indians and the Japanese) are much more interested in understanding whether PV-10 works and works cost-effectively. Both hemispheres agree the drug is safe, and both acknowledge PV-10 is effective. It is possible, however, that cultural differences might contribute to each party's thinking and decision-making processes. One wants to know why and how, while the other wants to know how much.

But Moffitt arrived in early-April. So what gives?

It is not unreasonable to think these regional pharmaceutical companies are waiting for regulatory clarity before they present Provectus with terms and conditions. It's also not unreasonable to think management also is waiting for regulatory clarity before they accept any terms and conditions on regional and/or global license transactions.

If the path of clarity is a decision of "better" (a truncated MM P3 trial) or "best" (AA), with "good" (SPA) available but not chosen, it strikes me that all parties -- management, regional pharmaceutical companies, Pfizer and Big Pharma -- have their respective reasons and rationale to wait until regulatory clarity is made transparent.

Wouldn't you think the topic of what "we" (Provectus & Pfizer) do after BTD is attained (and then, more specifically, AA or a truncated trial) might have been discussed?

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Take for example the "non-unique" story of a fund that desires to put money into Provectus via an open market purchase of common stock (i.e., the shares you and I own), by dipping its toe in the water to establish an initial position of 1.5 to 4.5 million shares.

Without regulatory clarity, there's no clear exit for the fund and its managers. They cannot and do not buy, but merely wait on the sidelines. As do many others.

To most, including the above mentioned fund, the question of regulatory clarity -- in its mind and most others -- boils down to Provectus attaining the SPA from the FDA and then having to run a $30-$50 million Phase 3 trial. In the minds of this fund, dip its toes in the water now, at 63 cents, and following the clarity of an SPA, suffer 20-40% dilution (roughly) when Provectus raises aforementioned money to fund the trial. Better to wait and buy after the fund raising or, better, participate in it at the lower price with the prospect of warrant coverage too -- a much more attractive risk-reward.

As I previously wrote in my "With the FDA, It's Good, Better, Best for PV-10 and $PVCT," the closer you are to the company, the greater your awareness of Provectus' situation, the higher expectations or anticipation you have of an SPA, BTD or AA. The less familiar you are with the company or situation, the lower your level of expectations. The FDA's decision will validate Provectus and PV-10 in some form and fashion.

The above mentioned fund has done due diligence, but doesn't have the perspective Provectus watchers do. The fund, like its sistren and brethren, invests broadly across a variety of companies, diversifies risk, plays the numbers, is not early, and endeavors to generate alpha (which for the vast majority of such funds merely and actually is beta).

Provectus watchers would tell you they believe the situation now is an outcome between "better" and "best." The consensus view appears to be the company already has submitted a/the BTD application. Opinions vary as to when, from early-May to early-June, which would indicate a result as late as early-August (perhaps early-September if one leaves room for summer vacation and/or the dog days of summer) and as early as "now."

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An e-mail from a blog reader:

My PVCT buddies and I have long since learned to take your predictions with a handful of salt BUT - we're sure going to be prepared when that Great Day finally arrives and it will be because you have prepared us so well in advance. I don't think I need to tell you how very much I appreciate all that you put into the Blog. Reading it every day has made hanging on to this losing position this past year and a half almost a pleasure.

Yes, the forecast is always wrong, but I love receiving e-mails like this. Thank you.

How Could A $PVCT-$PFE Story Unfold?

I hope to have some fun with the first part of this three-part post. Indulge me.

As you know, I beat the drum from time to time about Provectus and Pfizer. The relationship, as I see it, has steadily grown in depth, but has not yet been consummated.

November 2010: Craig Eagle first engaged Provectus when he traveled to Australia for Dr. Agarwala's presentation of preliminary MM Phase 2 trial data.

Early-2011: Pfizer and Dr. Eagle proffered a unique deal to Provectus that ultimately did not materialize.

Summer/Fall-2011: There is/was the rumor of a cash bid by Pfizer for the company, which management denied (to me) was made and that would have valued Provectus at approximately $1B ($7 in cash per share) at the time. Earlier that year, BioVex (T-Vec) and Plexxikon (Zelboraf) were acquired by Amgen and Daiichi Sankyo, respectively, for approximately $1B (top-line figure) each.

August 2011: Craig Eagle joined the company's corporate advisory board.

March-October 2012: The joint patent application, for combining local and systemic immunomodulative therapies, worked its way through Pfizer (legal) before being filed.

September 2012: The company made an SEC filing for a preferred stock offering, the rationale and structure of which purportedly was to facilitate a strategic equity investment by Pfizer in Provectus.

October 2012: Pfizer supposed role as co-lead on the PVCTP "IPO" did not materialize.

Yet, the stock price has refused to budge upwards, and in actuality has fallen a lot. I previously wrote about disbelief.

The stock market, some/many in the Wall Street community, some/many potential investors and some/many existing shareholders do not believe in nor trust management, and thus do not believe in the data. If they did, they would buy or buy more shares. These disbeliefs, the first more problematic and resulting in the second, have led to the obscuring of value that clearly exists in Provectus and that Big Pharma very much sees and desires. 

Although disbelief in or lack of trust in management mostly results from self-inflicted wounds, these wounds are far from fatal, and there should be no doubt about the immense value management has created in its innovation of PV-10. 

Simple, angelic or divine regulatory clarity will transform disbelief in both management and PV-10 overnight.

One has to assume disbelief of Provectus extends to or has enveloped the notion and reality of a Pfizer relationship, too. Clarity about a monetary relationship with this Big Pharma also will additively transform disbelief in both management and PV-10 overnight.

June 2013: Which brings us to last week and Provectus' Empire State of Mind, where there apparently/purportedly were several meetings between Provectus principals (Peter, Peter and Eric) and Pfizer folks (broadly speaking), as there has been since the relationship began. I think I have a good idea of who, what, where and when, but not why.

It's fair to say there is no small amount of anticipation or expectation brewing for something to happen, soon, whether it is some portion of regulatory clarity or commercial validation through a regional license transaction.

I can't help but think of, anticipate or expect a monetary relationship finally being put into place between Provectus and Pfizer. Without regulatory clarity of any sort (e.g., SPA, breakthrough therapy designation, accelerated approval), it's too early for a global license with or the end game by Pfizer.

But how does Provectus get from here to there, from Friday's 63 cent share price to a multi-billion dollar upfront payment from Pfizer? I wrote the Empire State of Mind post to clarify some things. I also understand there was some chatter about a strategic equity investment by Pfizer last week. I would have to believe the topic of investment has been a longstanding discussion between the two companies.

Maybe, now, whenever now becomes today, and today becomes a PR, there might/could/will be an investment in Provectus by Pfizer (or possibly but less likely some other Big Pharma). Why "now?" With regularity clarity in the offing, potentially simple leading to angelic or divine, an investment from Pfizer assists Provectus to get from here to there.

A substantial investment (say, $25-$75MM) investment by Pfizer at a significantly higher share price (say, $3.50-4 per share) should put a floor under the stock.

The upcoming annual meeting of shareholders on June 27 potentially will help resolve the issue and company proposal to increase the number of shares of common stock Provectus is authorized to issue from 200-250 million shares. As of March 31, the total shares of common stock issued and outstanding and reserved for issuance for outstanding warrants, options and preferred stock totaled 188 million (no shares of common stock are held in treasury), leaving about 12 million shares for a strategic equity investment by Pfizer (or another Big Pharma). Maybe 11,853,076 unreserved shares of common stock available for issuance is enough.

If an equity investment starts the ball rolling, then one hopes that event is followed by some regulatory clarity, like the receipt of the SPA. Leveraging Provectus board member Al Smith, among others, to build greater awareness in the financial and investment management communities creates more momentum. A regional license deal or two, next, like for India and then China, or for China and then India, helps more. More regulatory clarity, like BTD or AA, speeds up the ball's rolling. And then...

But it's very early Sunday morning at my favorite Starbucks (this blog will post Monday morning at midnight EST), it's just the here and now, and I'm having a little fun.

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A Chicago stockbroker organized a conference call for his clients holding Provectus stock with Peter before ASCO 2013. The broker also invited me to join the call, which lasted about an hour. There were about 50 people on the call. Peter used the company’s website presentation as his talking points, providing informative comments about the company's progress or situation on several fronts. Below are notes that, while not meant to be an exhaustive description of the call or a transcript of it, essentially were a list of things Peter said that I found to be interesting to varying degrees.

Peter used the company’s website presentation as his talking points, providing informative comments about where the company is several fronts as well as some very candid commentary.

The mechanisms of action of PV-10 for oncology and PH-10 for dermatology are not the same but have interesting similarities and high profile researchers are currently investigating.

The synthesis patent application has been approved. Peter described some of the implications of the now approved patent. Provectus will issue a press release next week where I expect the company will describe several key aspects that drive significant shareholder value.

A Phase 3 trial under the SPA that should be agreed to with the FDA, should such a trial ultimately be run, would have treatment without any limits of any concern (i.e., as many retreatments of as many visible tumors as necessary).

In addition to breast cancer and melanoma for which Moffitt (a) confirmed from its murine studies that PV-10 chemoablation resulted in both a direct effect on injected lesions as well as a systemic response that leads to regression of uninjected subcutaneous and lung lesions and (b) concluded intralesional PV-10 treatment led to the induction of tumor-specific immunity, Moffitt also has done work in other indications.

Moffitt seeks to finish its Phase 1 feasibility study of human patients as quickly as possible.

The FDA and Big Pharma realize that to kill cancer one has to effectively kill tumors in a clinically relevant manner.  PV-10 is singularly unique in the approved and emerging cancer agent universe.

Peter mentioned they are having license talks with global and regional pharmaceutical companies, including active dialogue with Dr. Craig Eagle of Pfizer.

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The follow-up to my regulatory clarity and commercial validation pathways post is below.

$PVCT's 10-Q: Q1 2013

Provectus released its 10-Q filing for Q1 2013 today. See here. Some thoughts...

#1. Quarter-over-quarter ("QoQ") -- Q1 2013-over-Q4 2012 -- monthly cash expenditure appears to have decreased by about 11%. Provectus' quarterly and annual filings since and including Q1 2012, the company appears to suggest an average monthly cash burn of approximately $950K (with a standard deviation of $133K).

#2.  Management expanded on their Q4 2012 MD&A statement via the 10-K of...

"We are seeking to improve our cash flow through both the licensure of PH-10 on the basis of our Phase 2 atopic dermatitis and psoriasis results, and the geographic licensure of PV-10 on the basis of our Phase 2 metastatic melanoma and Phase 1 liver results in certain areas of the world, as well as pursuing a strategic investment strategy, including equity sales to potential pharmaceutical and or biotech partners, and continuing with the majority stake asset sale and licensure of our OTC products as well as other non-core assets. The geographic areas of interest for PV-10 principally include China, India, Japan and Middle East and North Africa (MENA). 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."

...with the following in their Q1 2013 statement:

"We are seeking to improve our cash flow through both the licensure of PH-10 on the basis of our Phase 2 atopic dermatitis and psoriasis results, and primarily the geographic licensure of PV-10 on the basis of our Phase 2 metastatic melanoma and Phase 1 liver results in certain areas of the world, as well as pursuing a strategic investment strategy, including equity sales to potential pharmaceutical and/or biotech partners. In addition, the data now available from Moffitt Cancer Center in Tampa, Florida has been particularly helpful in supporting our development plans with both the FDA and prospective partners. The geographic areas of interest for PV-10 principally include China, India, Japan and Middle East and North Africa (MENA). 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."

primarily suggests to me management is prioritizing a series or string of regional/other licenses (e.g., China, India, Japan, PH-10) to boost company valuation towards their end game valuation expectation.

In addition... suggests repetition of the importance of Moffitt to what the FDA and Big Pharma needed regarding PV-10's systemic benefit and potential, and that is very likely crucial to securing and most assuredly dispositive of receiving breakthrough therapy designation for PV-10 for recurrent and metastatic melanoma.

However... suggests focus on smartly, intelligently and thoughtfully protecting valuation to, again, achievement management's end game valuation expectation. Noteworthy to me was the inclusion of the verbiage "an appropriate Merger and Acquisition transaction."

#3.  Noteworthy to me was the issuance of 1.92MM warrants to consultants in exchange for services in the quarter. To whom and why?

$PVCT & Hisun-Pfizer Pharmaceuticals Co., Ltd.

The release of Pfizer's Q1 earnings earlier this week reminded me of the Big Pharma's joint venture with Chinese pharmaceutical company Zhejiang Hisun Pharmaceuticals, Hisun-Pfizer Pharmaceuticals Co., Ltd. ("Hisun-Pfizer" or "HPP").

From Pfizer's September 30, 2012 10-Q, "On September 6, 2012, Pfizer and Zhejiang Hisun Pharmaceuticals (Hisun"), a leading Chinese pharmaceutical company, created a new company, Hisun-Pfizer Pharmaceuticals Co., Ltd. (HPP), to develop, manufacture and commercialize off-patent pharmaceutical products in China and global markets. In accordance with our international reporting periods, this transaction will be accounted for in the fourth quarter of 2012. HPP was established with registered capital of $250 million. Zhejiang Hisun Pharmaceuticals holds a 51% equity interest and Pfizer holds a 49% equity interest in HPP. The parties will contribute select existing products to HPP, which will have a broad portfolio covering cardiovascular disease, infectious disease, oncology, mental health, and other therapeutic areas. The parties will also contribute manufacturing sites, cash and other relevant assets. Our investment in HPP will be accounted for under the equity method."

The equity method of accounting, "...the process of treating equity investments, usually 20–50%, in associate companies...," means Pfizer's "...proportional share of the associate company's net income increases the investment (and a net loss decreases the investment), and proportional payment of dividends decreases it." Source here.

As Pfizer characterized the HPP in its 2012 annual report: "During 2012, we continued to pursue “bolt-on” business development opportunities to supplement our research efforts and product offerings. These are acquisitions or collaborative arrangements that we can readily integrate and that expand our reach or capabilities...Together with Zhejiang Hisun Pharmaceuticals, we launched Hisun Pfizer Pharmaceuticals Company Limited, a joint venture to develop, manufacture and commercialize off-patent pharmaceutical products in China and global markets."

The stated goal of "[T]he joint venture between Hisun and Pfizer aims to strengthen the  ability of both companies to address health care needs in China and reach more patients with high quality and low cost  medicines in the branded generics arena."

HPP is an investment vehicle, with a limited staff, the senior leadership of whom (e.g., the CFO) appears to be resident in New York City. In many respects, one might view Hisun-Pfizer as, perhaps, a tax-efficient or effective, China-focused and effective operations, pass-through entity of sorts, allowing business in China to be conducted by Pfizer and Hisun but without comparable overhead of either a Hisun or a Pfizer.

The $490 million gain Pfizer registered in Q1 2013 from the transfer of some product rights to HPP puts a finer point on this.

A blog reader wrote to me that it's one or the other, a regional license deal in China or a global license deal but not both. I disagree. There is a legitimate discussion about China influencing global and global influencing China, per my China vs. The World post. The key to a decision, I think, ultimately lies in the answer to this math equation:

d(China) + d(Global) < > d(China, Global), where d(x) is the value of a deal for geography x

China pharmaceutical companies, local players, are interested in PV-10. Global pharmaceutical companies are interested in PV-10 in China. Global players have relationships with local players that include ownership, joint ventures and strategic relationships.

Path A: A deal with a Chinese company could pay Provectus and, thus, its endgame global/Big Pharma acquirer 20%+ in annual royalties.

Path B: A deal with a Big Pharma-related Chinese company would pay 20%+ and {20%+ times the Big Pharma's ownership percentage of the Chinese company}, a number greater than 20%+.

Path C: A deal with a JV like Hisun-Pfizer would pay Pfizer 49% (the outcome could be different for another Big Pharma's China JV).

(The above is a theoretical or academic exercise, and not necessarily overly precise).

A deal for China between Provectus and HPP, rather than a local player or Hisun, is more valuable in the long-term for Pfizer or another Big Pharma with a comparable JV set-up than acquiring Provectus after a deal was done with a local Chinese player.

As such, a deal with Hisun-Pfizer tells much more about the end-game and Pfizer's potential or likely intentions and future action.

$PVCT: China vs. The World

Big Pharma interest in a global license of PV-10 steadily grows. Regional license interest in PV-10 also is growing.

On page 20 of the recently filed S-1: "The geographic areas of interest for PV-10 principally include China, India, Japan and Middle East and North Africa (MENA). 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."

The world continues to get smaller and smaller. Big Pharma operates where it does and can -- mainly, the U.S. and Europe, and also elsewhere -- but with an eye to so-called developing markets (recall the now or near obsolete BRIC moniker for Brazil, Russia, India and China), and beyond, where it has entered as foreign wholly owned subsidiaries together with partnerships and joint ventures with as well as acquisitions of local players.

I appreciate management's enthusiasm and persistence in pursuing a regional license deal in China. In the S-1 mentioned above: "According to Global Cancer Facts & Figures, 2nd Edition, liver cancer is the fifth leading cause of deaths related to cancer in the world in men and seventh in women. Approximately 750,000 people are newly diagnosed annually with primary liver cancer, also known as Hepatocellular carcinoma (HCC), with China alone accounting for about 55% of the cases diagnosed each year. The world market for liver cancer drugs is projected to exceed $2.0 billion by 2015 and does not include the full impact of the China market potential." Like with most things China-related, it is Big Pharma's new frontier, and a monstrously-sized addressable market at that.

I also understand and appreciate management having to balance enthusiasm for and the potential of near-term cash upfront with China with Big Pharma interest in a global PV-10 license.

I don't want management to do a premature or cheap China deal simply for the cash or to bump up the share price, and diminish the value of a global license and/or the end-game. On the other hand, I don't want management to pursue a global license without taking into consideration sufficiently raising valuation through a string of regional deals before giving way to a global license and/or the end game. I don't think management is doing either.

Rather, regional deals like China (and others) are being considered in the context of a global license and the end game, and vice versa.

$PVCT: What Could A Relationship with Daiichi Sankyo Mean?

Daiichi Sankyo's interest in Provectus might range from something simple or narrow to something more robust.

You can read about Daiichi Sankyo's new 5-year business plan here.

$PVCT: Big Pharma Interest

This blog is one of the primary sources of information about Provectus. 

The blog can see, among several other things, where visitors come from (e.g., IP address, city, state/region, country, etc.) and how often they stay and read (page views, visits, visit lengths, etc.). Anytime you visit any destination on the world wide web, you are being tracked. Unless you use something like Tor to protect your privacy.

About 10 days ago I speculated about Daiichi Sankyo interest in PV-10. Why? Because...

First, folks from Daiichi Sankyo ("DS") in Japan visited multiple times and spent many, many hours on the blog. These visitors' IP address(es) originated from the pharmaceutical company's headquarters in Tokyo.

Then, folks from DS in the U.S. visited the blog. These visitors' IP address(es) originated from the pharmaceutical company's U.S. headquarters in Parsippany, New Jersey.

So, I began connecting dots available to connect; those above, and others. I think DS has been informal (formal, in this context, means one engages the target company) doing due diligence on Provectus. Why? For one thing, simple activities like scouring web-based sources of information and data is merely one way of doing due diligence on a target, without directly engaging the entity in which you're interested. If you spend a lot of time reading a blog about a biotechnology company not written by said company, you're either really bored or really interested. For another, historical information about Daiichi Sankyo does suggest they can and will do global licenses. DS is a global Big Pharma company, with additional regional interests in Japan and India (through Rambaxy Laboratories) and maybe elsewhere in Asia Pacific. For example, in February 2011, Daiichi Sankyo announced its acquisition of Plexxikon for $805 million up-front and near-term milestone payments associated with the approval of PLX4032 (vemurafenib, now Zelboraf) for up to an additional $130 million. The deal closed in April.

The next course action would be to ask various questions of Provectus management and gauge their responses, should of course they respond to questions about this topic.


At his presentation in New York in March, Craig noted Provectus was in the due diligence process of a pharmaceutical company for a global license. One presumes he did so because this Big Pharma had formally approached Provectus and were in formal due diligence with the company.

Is DS in formal due diligence with Provectus yet? If so, DS would make at least two Big Pharmas with a stated interest in the company.

If one assumes Pfizer has stated interest through Dr. Eagle's presence on Provectus' corporate advisory board, that would make three Big Pharmas. 

There's a fourth. It's IP address(es) comes from...

$PVCT: Regional Licenses v. Global License vs. Endgame

As management continues to work towards regional license deals in China, India and Japan, and sees growing interest from Big Pharma in a global license, it is interesting to note a few things.

Pfizer India is an autonomous organization that can and does enter into transactions in India as it deems appropriate.

Relationships Pfizer has in China are more state-governed, requiring more direct contact between Provectus and local pharmaceutical players there.

Should Provectus enter into a global license with Big Pharma, it neither precludes regional license transactions being contemplated in certain geographies from being done nor does it prevent another Big Pharma from acquiring the company entirely (i.e., the end-game).

$PVCT's 2012 10K

Filed today here. Of note (but not exhaustive):

A. Fund raising. The company raised cash proceeds of $5.2 million in 2013 (see Subsequent Events of page F-33):

• $2.6MM at year-end 2012 placed by Network 1, common stock priced at 75 cents (the share around the time may have been in the $0.50s), 1-for-1 5-year warrants struck at $1.00, and
• $2.6MM in February 2013 also placed by Network 1, convertible preferred stock at 75 cents, 1.25-for-1 warrants struck at $1.00.

Raising more than $5MM was necessary, according to Peter, because BDO (Provectus' accounting firm) was more conservative regarding requirements of cash on hand.

B. Preferred Stock. The figure at 12/31/12 was 2.5MM shares. At 9/30/12 it was 2.9MM. I think this security, aside from what was issued in February, could be near or at zero at 3/31/13, as these holdings have been or are being converted this quarter (trading volume has been very heavy).

C. Lawsuit. There is a [presumably] shareholder lawsuit (see Legal Proceedings on page 21): "The Shareholder Derivative Complaint alleges (i) breach of fiduciary duties, (ii) waste of corporate assets, and (iii) unjust enrichment, all three claims based on the Plaintiff’s allegations that the defendants authorized and/or accepted stock option awards in violation of the terms of the Company’s 2002 Stock Plan (the “Plan”) by issuing stock options in excess of the amounts authorized under the Plan and delegated to defendant H. Craig Dees the sole authority to grant himself and other executive officers of the Company cash bonuses that the Plaintiff alleges to be excessive."

D. Warrants. A warrant reset related to the where the share price was in relation to the strike prices of certain warrants resulted in the issuance of 3.8MM 3-year warrants struck at $0.68 (see page F-26).

E. Regional licenses. In the last 10Q, the company wrote: "We are seeking to improve our cash flow through both the licensure of PH-10 on the basis of our Phase 2 atopic dermatitis and psoriasis results, and the geographic licensure of PV-10 on the basis of our Phase 2 metastatic melanoma and Phase 1 liver results in certain areas of the world, as well as pursuing a strategic investment strategy, including equity sales to potential pharmaceutical and or biotech partners, and continuing with the majority stake asset sale and licensure of our OTC products as well as other non-core assets."

In the 10K, Provectus wrote: "We are seeking to improve our cash flow through both the licensure of PH-10 on the basis of our Phase 2 atopic dermatitis and psoriasis results, and the geographic licensure of PV-10 on the basis of our Phase 2 metastatic melanoma and Phase 1 liver results in certain areas of the world, as well as pursuing a strategic investment strategy, including equity sales to potential pharmaceutical and or biotech partners, and continuing with the majority stake asset sale and licensure of our OTC products as well as other non-core assets. The geographic areas of interest for PV-10 principally include China, India, Japan and Middle East and North Africa (MENA)."

I will watch closely for information and/or PRs related to this item next week.

F. Placement Agreements. Also in Subsequent Events:  "The Company entered into a Placement Agent’s Agreement dated March 11, 2013, with Network 1 Financial Securities, Inc. (“Network 1”) as placement agent, which allows for the sale of the Company’s common stock at a purchase price of $0.75 per share and 100% warrant coverage to purchase shares of common stock at an exercise price of $1.00 per share."

According to Peter, it was necessary to have an "open placement agent agreement" as a placeholder for BDO's going concern opinion. The placement agreement with Network 1 appears to be viewed by BDO much like it views the Lincoln Park equity line of credit agreement.

G. Global license. In the 10K, in addition to expanded and more specific language on regional PV-10 licenses, the company also added language on global PV-10 licensure: "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."

I do not think this refers to Pfizer, but rather several other competitors (at least 2 American and 2 European Big Pharma companies) including one in particular that continues to do clinical due diligence, but may well have wrapped up its business diligence.