Good morning, one and all. How does the old saying go? When it rains, it pours? It's certainly been true of our Featured Stocks this week - we've had more good news to deliver than time to deliver it. We'll do a little catching up today, putting Pivot Pharmaceuticals (PVOTF) in the spotlight following news posted yesterday morning.
Don't worry... this news is still quite meaningful. On the other hand, knowing what we know about how quickly Pivot Pharmaceuticals is moving behind the scenes, I wouldn't put the news on the shelf to review at a later date. Once PVOTF gets going in earnest, it may never look back again.
Just as a quick refresher, Pivot Pharmaceuticals specializes in treating rare diseases that only affect women. It's not your typical biopharma up-and-comer though. There's a long-term R&D aspect with a big payoff to the company, as well as a near-term opportunity to drive some respectable revenue. And, there's even a possibility for some major mid-term revenue. It's a rarity for a small biopharma name like this to have so much diversity in terms of opportunity and timing of future sales.
Pivot Pharmaceuticals' major projects take aim at metastatic endometrial cancer and triple-negative breast cancer therapy, both of which are underserved aspects of the $80 billion cancer drug market.
What's compelling about PVOTF is that it's not just taking a scattershot approach to find a cancer cure-all, where it could become a jack of all trades and a master of none. It's focusing on a small niche within the cancer world that's (1) currently not well addressed, and (2) where Pivot can do well in that market. As was noted, these therapies treat metastatic endometrial cancer with recurrent metastatic disease (PVT-005), and triple-negative breast cancer for patients with DNA repair deficiencies (PVT-006). Those specific markets are worth at least $250 million and $200 million per year, respectively. For perspective, PVOTF is only a $22 million organization.
Both are preclinical drugs, so it's going to be a while before they drive revenue. That's ok though. The market will reward milestones met along the way. One of those milestones will be the beginning of at least one clinical trial this year.
In the meantime, Pivot's got a plan to generate near-term revenue by taking a different development path.
Ever heard of rule 505(b)(2)? It's an FDA rule allowing pharmaceutical companies to circumvent the regular, lengthy three-phase development of a drug when it's not actually a new drug, but rather, a reformulation, repackaging or repurposing of an existing drug. This can include a new means of delivering these drugs.
Well, Pivot has a sizeable handful of intellectual property and access to several possible drugs that could be turned into marketable products relatively quickly. In fact, it's specifically evaluating a dysmenorrhea and a LUTS (lower urinary tract symptoms) therapy that could be worth more than $460 million and more than $300 million per year, respectively.
There's one more dimension to the company, though.... something the company quietly added to its recent letter to PVOTF shareholders. As part of its 2016 plans, it said it aims to:
"... augment its anticancer pipeline, Pivot continues to opportunistically evaluate additional licensing opportunities for proprietary and patented molecules addressing unmet medical needs affecting women's health. Acquisition of a late-stage asset remains a top priority."
Translation: Look for PVOTF to add another revenue path in the foreseeable future.
It really is one of the best biopharma stories we've seen in while, in terms of breadth and depth, which is what makes yesterday's news so interesting - the rest of the market is finally waking up to the buried treasure here, and it could be a very good sign of what's to come.
Long story made short, SeeThru Equity has established a target price of $2.10 for PVOTF, which is 600% better than yesterday's closing price of $0.30.
The press release from the company and the link to the SeeThru Equity research report on Pivot Pharmaceuticals are below. Be sure to check it out. Before you do, though, let me just say this is the most robust look at Pivot I've seen yet.
I know that $2.10 target seems wildly high, but SeeThru isn't throwing some pie-in-the-sky number out there just for effect. It's worked through all the R&D and acquisition scenarios and likely timeframes, and come up with a plausible scenario that is, to be clear, a long-term target using a reasonable discounted cash flow model. The target also considers the amount of fund-raising Pivot will need to do in the meantime. Nevertheless, if anything, I think the target price is based on numbers that are a little too conservative in terms of market share. But, you can decide that for yourself.
The SeeThru Equity also explains in detail the relationship Pivot Pharmaceuticals has with potential partners thanks to its acquisition of IndUS Pharmaceuticals in November of last year. I don't want to use too much of the report, but check out this snippet:
"We are intrigued by the further possibilities from the IP resources and research and development advantages that come with IndUS's access to India via its partnership with the Indian Institute of Chemical Technology (IICT), a Council of Scientific and Industrial Research (CSIR) institution. This is a key partnership in which IndUS has an its option for worldwide rights to small molecules and other IP from CSIR including PBDs...."
You get the idea - there may be a lot more to Pivot Pharmaceuticals than we see on the surface. The SeeThru report will shed some light on that whole situation.
Bottom line? If you're a current owner of PVOTF or are still on the fence with it, the report and corresponding target price are a real accolade. A look at the report would be time well spent. Here you go.
SeeThruEquity Initiates Coverage on Pivot Pharmaceuticals Inc. (OTCQB: PVOTF) with a Price Target of $2.10
NEW YORK, NY / ACCESSWIRE / April 12, 2016 / SeeThruEquity, a leading independent equity research and corporate access firm focused on smallcap and microcap public companies, today announced it has initiated coverage on Pivot Pharmaceuticals Inc. (OTCQB: PVOTF) with a price target of $2.10.
The report is available here: PVOTF Initiation Report (http://www.seethruequity.com/#!pvotf/cg9i). SeeThruEquity is an approved equity research contributor on Thomson First Call, Capital IQ, FactSet, and Zack's. The report will be available on these platforms. The firm also contributes its estimates to Thomson Estimates, the leading estimates platform on Wall Street.
With offices in Woburn, MA, and Vancouver, BC, Pivot is a late pre-clinical biotechnology company focused on developing novel therapeutics for unmet needs in women's health. We see women's heath as having massive potential for Pivot. Despite the fact that women's health therapeutics is a large market - expected to reach $22.5 billion in 2018E - we believe women's health issues have received comparatively little attention beyond the areas of reproductive health and fertility, which leaves significant room for focused companies such as Pivot to emerge as key players in the space. With a compelling late pre-clinical pipeline focused on the treatment of women's cancer and gynecological disturbances and an experienced management team led by Boston biotech industry veteran CEO Dr. Pravin Chaturvedi, Pivot appears well-positioned to make its mark in women's health over the next many years. We see several potential catalysts ahead for the company as it advances its anticancer drugs toward clinical trials, pursues an acquisition and/or licensing of a late-stage asset, and explores a listing on the NASDAQ exchange.
"Pivot is a late pre-clinical biotechnology company focused on developing novel therapeutics for unmet needs in women's health. Through the recent acquisition of IndUS Pharmaceuticals, Pivot is initially focused on advancing its portfolio of anti-cancer drug candidates - PBDs, which address significant women's cancer markets. PBDs, or pyrrolobenzodiazepine dimers are DNA damage response (DDR) inhibitors that can treat "genetically resistant" women's cancers. Pivot management has indicated that the PBD candidates have shown promising data in preclinical studies for the treatment of refractory cancer. Initially, we expect Pivot to focus on developing two drug candidates from its portfolio of anticancer molecules, PVT-005 and PVT-006, targeting metastatic endometrial cancer and basal-like triple-negative breast cancer - BL-TNBC. The company estimates the market opportunity for these two candidates to be approximately $500mn per year," stated Ajay Tandon, CEO of SeeThruEquity. "We are initiating coverage with a 12-month price target of $2.10 per share."
Additional highlights from the report are as follows:
Novel portfolio targeting genetically resistant women's cancers
Pivot is initially focused on advancing a novel portfolio of anti-cancer drug candidates (PBDs) that address significant women's cancer markets. PBDs, or (pyrrolobenzodiazepine dimers) are DNA damage response (DDR) inhibitors that can treat "genetically resistant" women's cancers, such as metastatic endometrial cancer (mEC) and basal-like triple-negative breast cancer (BL-TNBC). Pivot has indicated that its first two PBD candidates, PVT-005 and PVT-006, have shown promising data in preclinical studies for the treatment of mEC and BL-TNBC. These are orphan indications, which represent a collective market opportunity of approximately $500mn per year, according to Pivot management. The company plans to initiate a Phase 1/2 clinical trial this year, pending funding, to evaluate safety for at least one of these candidates. In line with goals set out by management, we have assumed commercialization of PVT-005 by FY22E and PVT-006 by FY23. Importantly, Pivot should be able to benefit from better economics inherent in developing drug candidates for orphan indications, as they carry exclusivity for seven years following FDA marketing approval. Beyond these initial candidates, Pivot sees the potential for candidates targeting Non-small cell lung cancer (NSCLC), Refractory Acute Myelogenous Leukemia (AML) and Metastatic Colorectal Cancer (mCRC), among others.
Top notch leadership team
We see Pivot's leadership team as a key positive attribute and note that management is a critical factor in early-stage pharmaceutical companies, given the given the cost and multi-year timeline required to achieve regulatory clearance and bring drug candidates to market. The company is led by Dr. Pravin Chaturvedi, a well-known figure in the Boston biotechnology scene who previously founded and served as CEO of Scion Pharmaceuticals, which was acquired by Wyeth in 2005. Dr. Chaturvedi brings more than 25 years of industry experience to Pivot, spearheading a leadership team which, collectively, has developed and/or commercialized 12 drugs representing global sales of over $10 billion. Pivot continues to add to its leadership team, with the recent appointments of Steven Grossman, MD, PhD and Grannum Sant, MD, FRCS, FACS to its Scientific Advisory Board.
Please review important disclosures at www.seethruequity.com.
About Pivot Pharmaceuticals, Inc.
Pivot is an emerging pharmaceutical company engaged in the development of novel therapies to address unmet medical needs in women's health including oncology and urology. The Company has a strategic emphasis on innovative drugs that will provide new treatment options for women's cancers as well as for unmet gynecological and urological problems. Pivot has a portfolio of novel anticancer candidates for the treatment of gynecological and breast cancers and it is also developing novel treatments to address disturbances such as lower urinary tract symptoms (LUTS). The Company has a global drug development platform that combines the strengths of the United States, Canada and India which allows accelerated drug development strategies to provide novel therapeutic options to address unmet medical needs in women's health. www.PivotPharma.com
About SeeThruEquity
SeeThruEquity is an equity research and corporate access firm focused on companies with less than $1 billion in market capitalization. The research is not paid for and is unbiased. The company does not conduct any investment banking or commission based business. SeeThruEquity is approved to contribute its research to Thomson One Analytics (First Call), Capital IQ, FactSet, Zacks, and distribute its research to its database of opt-in investors. The company also contributes its estimates to Thomson Estimates, the leading estimates platform on Wall Street.
For more information visit www.seethruequity.com.
Contact:
Ajay Tandon
SeeThruEquity
info@seethruequity.com
SOURCE: SeeThruEquity