Provectus Pharmaceuticals: Small Cap, Huge Upside Sep 6 2013, 10:25 by: Trust Intelligence | about: PVCT.OB BOOKMARKED / READ LATER Bookmarked Added to your bookmarks on the Seeking Alpha homepage
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EXECUTIVE SUMMARY
Provectus (PVCT.OB) is a small biotech company whose lead candidate, PV-10 has been granted FDA Orphan Drug Status for the treatment of highly lethal metastatic melanoma and metastatic liver cancer. It has a successful and expanding Compassionate Use program in operation and successfully completed trials on metastatic cancer of the breast, liver and melanoma, with positive results. The data suggest that intralesional injection kills cancer cells and not normal cells, with no debilitating side-effects. As if that is not enough, a single injection acts as immunotherapy, prompting the patient's immune system to attack tumors remote from the one injected. Given that PV-10 has an outstanding safety profile, no debilitating treatment side effects, and has been effective in treating solid tumors that normally have a high mortality rate, the remarkably low market capitalization makes the investment premise obvious.
COMPANY OVERVIEW
Provectus Pharmaceuticals, Inc. (OTC:BB - PVCT) is a small research organization that has started to get some significant recognition for its lead cancer drug candidate, PV-10, recently spurred on by research results and papers by the well-respected Moffitt Cancer Center (see "Single Injection May Revolutionize Melanoma Study", in Practical Dermatology) in addition to the research papers on PV-10 in treatment of melanoma, liver, breast and gastric cancers in scientific articles, the popular press, and other venues, including Twitter and an informative investor blog.
BUSINESS: Plan & Strategy
Provectus' business plan is focused "on establishing paths to licensure, broadening clinical applications and expanding business development". The Chairman and CEO, Dr. Craig Dees, has stressed that Provectus is about research and innovation, not production, marketing and distribution, so their plan is to do joint ventures, license and/or sell the drugs and/or the company to a major marketing power when it can be done in a way advantageous for the PVCT shareholders. Corporate presentations recently have mentioned ongoing licensing discussions, especially for the company's dermatology candidates. Dr. Craig Eagle, Head of Pfizer's Oncology global medical group, is a member of the PVCT Advisory board and a named inventor on a joint Pfizer-Provectus patent. There have been rumors of discussions, in the US and in China, with PFE's Chinese joint venture partner, Zhejiang Hisun Pharmaceuticals, and other Chinese firms where the company estimates it has a $30 billion opportunity.
INTELLECTUAL PROPERTY
Provectus holds Over 25 US patents and 30 international patents. This year it was granted a synthesis patent for PV-10 and about 20 related halogenated xanthenes. Pfizer and Provectus also filed a combination-drug cancer treatment patent in 2013, which included the use of a wide variety of anti-cancer agents in conjunction with PV-10.
FINANCIALS: Burn Rate & Dilution
With only minimal investment revenue and no approved drugs, the company needs to sell or issue between $14 million to $18 million in shares per year, depending upon research pace. This includes pay for their 4 permanent employees, consultants and their single office in Knoxville, TN. This adds up to between 18 million and 24 million shares added each year until Provectus successfully executes their plan to bring in revenue by making a deal to license or sell their drug candidates in the US and/or abroad. In their private placements, they have (and are likely to continue, until there is a deal) issued warrants with exercise prices of $1.05, along with the new shares. Outstanding warrants plus stock options total about 30 million. As they have issued new warrants, old warrants have expired without being exercised because the stock price stayed lower than the warrant exercise price. In calculating company valuation, I have included all these potential warrant-related shares in the fully diluted share count, for valuation purposes. If/when the warrants get exercised at some point, the exercise proceeds will fund almost 2 years of research at the company's current burn rate. In other words, once the share price climbs above $1, additional share dilution will cease for a year or two (excluding via the warrant exercising), depending upon research pace. If the company's plan to monetize their intellectual property is successful, the added warrant exercise cash will just make it easier to run the company for years without further share dilution.
Three Months
Ended
June 30, 2013
Three Months
Ended
June 30, 2012
Six Months
Ended
June 30, 2013
Six Months
Ended
June 30, 2012
Cumulative
Amounts from
January 17, 2002
(Inception)
Through
June 30, 2013
Revenues
OTC product revenue
$
-
$
-
$
-
$
-
$
25,648
Medical device revenue
-
-
-
-
14,109
Total revenues
-
-
-
-
39,757
Cost of sales
-
-
-
-
15,216
Gross profit
-
-
-
-
24,541
Operating expenses
Research and development
778,349
1,657,586
1,518,865
3,223,019
44,617,718
General and administrative
2,340,706
2,459,867
4,679,109
4,931,588
70,864,998
Amortization
167,780
167,780
335,560
335,560
7,125,057
Total operating loss
(3,286,835
)
(4,285,233
)
(6,533,534
)
(8,490,167
)
(122,583,232
)
Gain on sale of fixed assets
-
-
-
-
55,075
Loss on extinguishment of debt
-
-
-
-
(825,867
)
Investment income
256
495
283
1,015
653,500
(Loss) gain on change in fair value of warrant liability
909,206
452,145
(14,304
)
188,981
5,897,897
Net interest expense
-
-
-
-
(8,098,004
)
Net loss
(2,377,373
)
(3,832,593
)
(6,547,555
)
(8,300,171
)
(124,900,631
)
Dividends on preferred stock
(73,024
)
(51,194
)
(1,149,958
)
(101,825
)
(11,988,020
)
Net loss applicable to common shareholders
$
(2,450,397
)
$
(3,833,787
)
$
(7,697,513
)
$
(8,401,996
)
$
(136,888,651
)
Basic and diluted loss per common share
$
(0.02
)
$
(0.03
)
$
(0.06
)
$
(0.08
)
Weighted average number of common shares outstanding - basic and diluted
127,114,868
112,267,336
123,926,235
111,521,253
The above is from the Prospectus Supplement dated April 16. 2013.
Management is confident it can continue to finance current and planned trials with much less cash than is typical in the industry. In their most recent Corporate Presentation, they stated "cash on hand supports planned operations until 2014". To minimize dilution (and Management ownership of 17% of the shares aligns their interest with shareholders on this goal) and to fund operations in 2014 and beyond, the Company is actively exploring a near-term JV, licensing and/or sale of rights for PH-10. They are also open to immediate licensing of foreign rights to PV-10. The CFO is scheduled to be traveling in Asia the week of September 2nd, to speak to Chinese and Indian companies that have expressed serious enough interest to justify the trip.
DRUG CANDIDATE: PH-10
PH-10 is a hydrogel topical-application version (patented by PVCT) of Rose Bengal, a derivative of fluorescein, an agent that has been used safely for over 80 years to stain necrotic tissue in the cornea and as an IV diagnostic of liver impairment. PVCT has successfully completed Phase II trials for the treatment of inflammatory dermatoses, like psoriasis and atopic dermatitis. According to NIH, 2.2% of the population has psoriasis. The National Psoriasis Foundation estimates that 125 million people have the condition, worldwide. GlobalData estimate the number of Atopic Dermatitis patients to hit 40 million by 2016. As already explained, Provectus hopes to license or sell the rights in order to fund work on its lead drug candidate.
LEAD DRUG CANDIDATE: PV-10
PV-10 is Provectus' patented injectible version of purified Rose Bengal. It an immune-chemoablative agent that selectively goes into diseased cells, where it localizes in the lysosomes. It doesn't go into the nucleus so, unlike many treatments, and there is no worry about it being mutagenic or carcinogenic which would instigate a DNA time-bomb that can cause new cancers years after patients go into remission.. The PV-10-infiltrated lysosomes in the cancer cells rupture highly acidic contents. This, in effect, kills the abnormal cell from the inside, chemically "cooking" it like vinegar "cooks" steak tartar. This action makes PV-10 similar in action to antibiotics, killing cells that are causing illness.
PV-10 also has anti-inflammatory characteristics and characteristics of a vaccine; not only killing the cancer cell at the injection site, like an antibiotic, but stimulating the patient's own T-cells to seek out other cancer cells and kill them. The immunotherapeutic effect is illustrated by a study where T-cells from PV-10-treated cancerous mice acted as a vaccine, leading to death of cancer cells in the recipient, not treated with PV-10, after being injected with the T-cells from mice that were treated.
PVCT research has demonstrated that PV-10 treatment of one tumor can lead to clearing up remote, untreated, even deep, visceral tumors and tumors in the lymph nodes in both animals and humans. All this is accomplished without suppressing the ill person's natural immune system or making them feel sicker than before treatment. A non-debilitating, effective treatment that can kill injection-site and remote cancer cells, and presumably even cancer that has not yet grown large enough to be imaged seems too good to be true. Perhaps that is one of the reasons why the stock price is so inexpensive.
REGULATORY STATUS
Phase II trials have been successfully completed for treatment of Psoriasis, and Atopic Dermatitis with PH-10. Provectus is looking for a partner to buy the rights or JV the Phase III trials for these treatments because PV-10's treatment for cancer is a higher priority.
Orphan Drug Status: granted PV-10 for treatment of Metastatic Melanoma and Metastatic Liver Cancer, which conveys 7 years of competition-free marketing.Melanoma: Phase II trials have been completed and Phase 3 is expected to take 30 months once there is a Special Protocol Assessment in place, if via Breakthrough Therapy Designation doesn't come through first. Currently Recruiting: Detection of Immune Cell Infiltration Into Melanomas Treated by PV-10, a Feasibility Study.Liver: Initial Phase 1 trials have been completed and expanded. Currently Recruiting: A Study to Assess PV-10 Chemoablation of Cancer of the LiverBreast: Phase I trials have been completed.Some initial work has been done to use PV-10 for cancers of the prostate, gall bladder, lung, colon, pancreas, and kidney where it has potential to tackle solid tumors and metastases.Progress on the ongoing trials for PV-10 will likely be accelerated if PV-10 is granted Breakthrough Therapy Designation or if cash becomes available because of the sale or licensing of PH-10 or of PV-10 in Asia. Following initial clinical trials, when researchers saw the obvious beneficial effect of PV-10, they requested permission to use it for their patients. Based upon the long historical safety record of the drug, the FDA approved what has become an expanding Compassionate Use program in America and in Australia, which has the highest per capita Melanoma incidence.
CLINICAL VALUE PROPOSITION & MARKET
There are four significant aspects to Provectus' market opportunity for PV-10:
It is effective for indications for which there are no adequate treatments and short survival times.It has a competitive advantage to other therapies because treating a solid tumor can reduce metastatic tumor load at remote and untreated (and otherwise inaccessible) sites.Treatment is not debilitating to the patient and does not damage normal tissue, unlike most chemotherapy or radiation.The same drug is effective in a wide variety of solid tumors and their remote metastases, and studies have shown enhanced effectiveness in combination with more traditional chemotherapy and radiation.Metastatic Liver Cancer. Metastatic disease accounts for 95% of all hepatic malignancies. Worldwide estimates of new liver cancers in 2008 were 750,000. Based upon expected population growth alone, in 2017 or 2018, when PVCT could have PV-10 approved for liver cancer, worldwide new cases are likely to be over 850 thousand. Global Industry Analysts indicate 600,000 new cases of primary liver (Hepatocellular) carcinoma, the 3rd leading cause of cancer death in the world. They project the market for therapeutics to be $1.1 billion by 2015.
Metastatic Melanoma. There were approximately 200 thousand cases of Melanoma worldwide in 2008. An American has a 1 in 50 chance of getting it in his/her lifetime and it is the fastest growing cancer worldwide, especially in places where light-skinned people live, probably because of the destruction of the ozone layer of the atmosphere. Cases are most common in places like North America, Europe and Australia, with well developed insurance coverage. About 13% of melanoma cases spread and are lethal despite current treatment.
Breast Cancer. In 2008 there were over 1.4 million cases of breast cancer in the world. It is estimated that between 20% and 30% of breast cancers become metastatic.
The quickest path to approval of PV-10 is via the FDA Breakthrough Program. Provectus has made clear their intention to file for this. If it has not been filed already, I expect them to file soon. The next factor that affects the timeline is if/when the non-cancer skin disorder use of PH-10 can be monetized. When it has, I think Provectus will use up-front and milestone payment to increase the pace of research on PV-10, because this will allow them get to market faster without further share dilution.
Breakthrough Fast Track Application/Approval at any timePH-10 dermatology JV or sale at any timeCurrently Available and being expanded (not just for Melanoma): Expanded Access Protocol for PV-10 for Cutaneous or Subcutaneous TumorsFDA SPA agreement expected Q3'13 for Phase III Metastatic MelanomaPV-10 Metastatic Melanoma Phase III begins enrollment Q4'13PV-10 Liver: continues with the expanded Phase I trial and meeting with FDA about starting a combined Phase II/III trial by the end of the year.Initial Data on PV1- Melanoma Phase III trials Q4, 2014FDA approval for Malignant Melanoma, if not fast-tracked, midyear 2016. With Breakthrough designation, it could come more than a year earlier. Breakthrough designation could also speed up the timeline of the use of PV-10 for other indications.STOCK MARKET
Stock performance has not been strong and therein lies the opportunity. Inside ownership has been increasing and, as of March 2013, it was up to 17.5% of the 129 million common shares currently outstanding. There are also about 5 million preferred shares and 30 million warrants and stock options out for a total of about 164 million shares, fully diluted. There is insignificant institutional ownership, which I believe is a plus for individual investors.
In 2012 the company adjusted the makeup of the Board of Directors in order to bring in enough outside Directors to be eligible for a NASDAQ listing (if/when the share price gets high enough to qualify) in obvious recognition that trading in the OTC market deters a lot of investors and institutions from owning shares, no matter how likely PV-10 research suggests it will become a significant breakthrough in the war on cancer. When the Market views PVCT more favourably, the company will apply for a NASDAQ listing.
VALUATION
The recent failure of Vical's Allovectin and GlaxoSmithKline's cancer immunotherapy MAGE-A3 in Phase III melanoma trials improves Provectus' prospects for eventually capturing the market, although the Market has yet to recognize that. Current treatment of metastatic melanoma is still about survival time, not elimination of the tumors. For example, Bristol-Myers Squibb's Yervoy not only has annoying side-effects affecting quality of life, its benefit is only the extension of life to a median 10 month period with 10 injections costing $60,000.
An analyst from Rodman & Renshaw, with a Buy rating on the stock and a $3.50 price target is the only one (I know of) who has published a Provectus valuation. To account for the risks inherent in research and getting Regulatory approval, and before Phase II trials were successfully completed, he used a Net Present Value discount of 40% per year. His $3.50 price target is based upon PV-10 obtaining 13% of the melanoma market and assumed a cost of $20,000 per patient. While metastatic and regional (lymph node involvement) melanoma makes up about 13% of melanoma cases, the official metastatic-only incidence is 4%. I am going to use the 13% because, if you take the fatalities per year and divide by the total new cases of melanoma, you get about 13%. And the cases with disease spread to remote areas, being the most likely to be fatal, are the cases most likely to need PV-10. It is also likely that some people with non-metastatic Melanoma may choose PV-10 over chemotherapy or radiation to avoid possible side effects or because they may prefer a one-shot treatment. I have not included this Market in my assumptions.
I have estimated the approximate date that PV-10 will get approved and enter the market for Melanoma, Liver and Breast cancer, and ignored all other targets without completed Phase I trials. I have also estimated the number of cases of each cancer and the percentage that could be treated by PV-10.
PV-10 Market Shares of Metastatic cases during period: Scenario A
Cancer Type
cases/yr (1000s)
% Metastatic
2017
2018
2019
2020-2026
2027-2031
Melanoma: 30% NPV discount
225
13%
20%
35%
40%
45%
30%
Liver: 40% NPV discount
830
95%
0%
0%
5%
12%
10%
Breast: 40% NPV discount
1550
25%
0%
0%
2%
12%
10%
Given that PV-10, in addition to its prospects in melanoma, also has Orphan Status for metastatic liver cancer and has produced successful results with breast cancer, and has successfully completed Phase II trials, I have recalculated the Net Present Value of the stock using a 30% discount factor for Melanoma and retaining the 40% discount for breast and liver cancer to adjust for risk. I have assumed a constant PV-10 cost of $20,000 per patient and that the numbers of new patients yearly do not increase, despite population growth, ozone destruction, or radiation or toxic chemical loads in the environment.
In Scenario B, the model is the same as in Scenario A, except that the FDA grants Breakthrough Status to PV-10, which leads to Regulatory approvals 1 year earlier. Scenario B is also a model for the increased pace of research possible if Provectus monetizes PH-10 and has enough money to fund research at a significantly faster pace. Note that, for both Scenarios, I have calculated the Net Present Value with and without added dilution, which is also a function of whether and when PVCT monetizes PH-10.
NET PRESENT VALUE of PROJECTED PV-10 REVENUES/SHARE
Cancer Type
Scenario A NPV/share w/PH-10 revenue
Scenario A NPV/share w/o PH-10 revenue
Scenario B NPV/share w/PH-10 revenue
Scenario B NPV/share w/o PH-10 revenue
Melanoma
$ 1.90
$ 1.51
$ 2.47
$ 2.19
Liver Cancer
$ 8.47
$ 6.74
$ 11.01
$ 9.76
Breast Cancer
$ 3.94
$ 3.14
$ 5.13
$ 4.55
Total NPV/share
$ 14.31
$ 11.39
$ 18.60
$ 16.49
Diluted shares (1000)s
164000
206000
164000
185000
treatment cost assumed at a constant
$20,000
per patient
disease incidence held constant
diluted =+21 million shares/year when the company has no revenue
Scenario B is PV-10 coming to market 1 year earlier than in Scenario A
Share price as of close Sept. 4, 2013
$ 0.75
Debt outstanding as of June 30, 2013
none
Cash per share at June 30, 2013
$ 0.03
This Table shows the heavily discounted net present value of the modeled revenue from future PV-10 sales is in double digits no matter which Scenario you prefer. At minimum, NPV is more than 15 times the PVCT share price on September 4th. With the low production cost of PV-10, and given that Orphan Drug designation means that there are no other adequate treatments as competition (for two of the indications), gross profit and EBITDA should be high before G, S & A expenses. An acquiring drug company can be expected to value the company on the basis of drug EBITDA, which I would guess would be at least 75% of revenue. If you think production, marketing, and distribution expenses will be higher, or that the market penetration is too optimistic, cut the total NPV in half and you still get a price that is significantly higher than today's market price. On the other hand, treatment charges may start out higher than $20,000 given the current Yervoy cost of $60,000, and increase yearly. Over time, successful trial results would logically reduce the substantial 30% and 40% yearly NPV discount in valuation calculations.
RISKS COME ALONG WITH OPPORTUNITY
With all drug development programs, there is the risk that the treatment will not work. Effective drugs may not be approved by the FDA or other regulatory agencies and approval may be delayed for unpredictable reasons. It is also possible, although unlikely, that there are as-yet-undiscovered side effects (after over 100 years of human use of Rose Bengal) that restrict the size of the market or lead to FDA rejection. Another company may find more effective or safer treatments for the diseases and conditions that Provectus' drugs target. It is also possible that Provectus will not be able to find a partner to market and fund research on PH-10 or PV-10 and that, at some time in the future, the company finds it impossible to raise money to continue their research, as they have been doing for over 10 years. It seems to me that it is worth incurring these risks, given the promise of PV-10 and the rewards for success.
Source: Provectus Pharmaceuticals: Small Cap, Huge UpsideDisclosure: I am long PVCT.OB. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)
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