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These “Disruptors” are Shaping the Future of Pharma

Biotech is back, baby. After considerable volatility this year, the biotechnology sector has resumed its winning ways. The benchmark iShares NASDAQ Biotechnology Index ETF (NSDQ: IBB) has returned 20.4% year to date, more than twice the return of about 10% for the S&P 500.

Political scandals and price pressures are starting to fade in the rear-view mirror, as Wall Street focuses again on the relentless demographic trends in biotech’s favor. A growing world population that’s getting grayer and sicker will need an increasing amount and variety of drugs, an unstoppable trend that’s a boon for the right biotech investments.

What’s more, the “patent cliff” is now largely behind the industry and years of painstaking work on new therapies are coming to fruition. The most rewarding investment strategy is to pinpoint disruptive technologies in drug research, to get aboard innovations before they become mainstream.

Two scientific fields of endeavor fit the bill: bioelectronics and immunotherapy. Let’s take a look at two particularly promising plays right now in each field: Big Pharma stalwart GlaxoSmithKline (NYSE: GSK) in bioelectronics and small-cap VBI Vaccines (NSDQ: VBIV) in immunotherapy.

The bioelectronics boom…

Google, subsidiary of Alphabet (NSDQ: GOOGL), recently announced that it is partnering with drug behemoth GlaxoSmithKline to form a new company that will research, develop and market bioelectronic devices.

The two companies are committed to spending $715 million over seven years on the joint venture, named Galvani Bioelectronics, after Luigi Galvini, the 18th-century scientist and father of biomagnetics.

Bioelectronics is based on the meshing of electric and biopharmaceutical treatments. Google, the world’s biggest search engine, remains the revenue and profit engine behind Alphabet. By backing bioelectronics, Google is tapping into the profit potential of bioelectronics (a word that never gets mentioned on CNBC).

Over the past decade, Google has transformed its core business to integrate content and commerce within a widening variety of Google services. As Alphabet’s growth engine, Google has been able to generate huge earnings and revenue gains by continually challenging the status quo in the form of what management calls “moon shots.” Google already has garnered headlines for its research and development of driverless cars. Now, the company is in the vanguard of bioelectronics, another unorthodox pursuit that’s poised to reward investors.

Bioelectronics sends electrical stimuli to parts of the body to treat chronic conditions that are typically resistant to conventional drugs and medical treatments. It’s being tested with promising results against such illnesses as diabetes, asthma and rheumatoid arthritis.

Bioelectronic devices modify how electrical impulses are transmitted around the nervous system, to redress imbalances and restore the human body’s stasis. These devices also incorporate the growing field of nanotechnology, to ensure that bioelectronics is minimally invasive. Each miniaturized bioelectronics device is about as big as a grain of rice.

The new company is based in in the U.K., GlaxoSmithKline’s home country, with a secondary site in San Francisco. The workforce largely consists of scientists, engineers, and clinicians. GSK owns 55% of equity interest, while Google parent Alphabet owns 45%.

Problem is, Alphabet belongs to the overpriced coterie of so-called FANG stocks, along with Facebook (NSDQ: FB), Amazon (NSDQ: AMZN), and Netflix (NSDQ: NFLX). These Silicon Valley darlings will fall the hardest when the stock market inevitably corrects.

That’s why GSK is your best bet now on bioelectronics. With a market cap of $94.6 billion and total cash on hand of $5.36 billion, GSK has the financial wherewithal to provide long-term funding for projects such as bioelectronics. Through its $50 million venture capital arm, Action Potential Venture Capital, GSK also is investing in start-ups and technology platforms that seek to facilitate the development of bioelectronic treatments.

GSK boasts a diversified portfolio of drug products, as well as a pipeline of new treatments under development. Management has targeted certain medical conditions where demand is the greatest and the need for innovation the most urgent, such as HIV, respiratory disease, and oncology.

GSK’s biggest-selling drug, the asthma inhaler Advair, generated $3.5 billion in revenue in 2016, for nearly 13% of sales. GSK’s second-quarter 2017 earnings per share (EPS) jumped 11% year over year, to GBP0.54, exceeding the consensus estimate by 3.6%.

The average analyst expectation is that GSK’s year-over-year earnings growth will come in at 10.8% next quarter, 6.8% for the current year, and 12.4% over the next five years (on an annualized basis). Shares currently trade at about $39 and the consensus for a one-year price target is $48, for an implied gain of more than 23%. And yet, GSK’s forward price-to-earnings ratio is a reasonable 13.7, roughly in line with its Big Pharma peers. The current dividend yield of 5.0% is icing on the cake.

The body’s first line of defense…

VBI Vaccines develops vaccines to treat diseases that are unresponsive to conventional therapies, in untapped markets around the globe where new and novel treatments are the most needed. Headquartered in Cambridge, Mass., VBI also operates research laboratories in Canada and research and manufacturing facilities in Israel.

VBI is developing a proprietary eVLP (enveloped virus-like particle) platform for the bioengineering of immunological vaccines that closely mirror viruses, to trigger potent and lasting responses from the body’s immune system.

Research surrounding immunotherapy is a leading-edge area of scientific research, as health providers attempt to get the body to combat diseases on its own, precluding expensive and painful methods such as chemotherapy and radiation. The winners in the immunotherapy space will prove superb long-term investments.

VBI also is developing a proprietary Lipid Particle Vaccine (LPV) technology, a formulation that allows the stabilization of vaccines through freeze drying. On LPV, the company is working in partnership with giant biopharma players Sanofi (NYSE: SNY) and GlaxoSmithKline.

In addition, VBI offers Sci-B-Vac, a third-generation hepatitis B vaccine for adults, children, and newborn infants. To date, more than 300,000 infants and adults have been vaccinated with Sci-B-Vac around the world.

VBI announced on August 15 that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug Application (IND) for VBI-1901, a novel immunological treatment that targets Glioblastoma Multiforme (GBM), one of the most common and aggressive malignant primary brain tumors in humans.

The FDA’s IND program is an early hurdle that all drug companies most overcome. IND is the avenue by which a drug maker receives federal permission to ship an experimental drug across state lines, typically to clinical investigators, before a marketing application for the drug has been formally approved.

The IND that VBI obtained last week enables the company to initiate a multi-center Phase I/2a clinical study evaluating VBI-1901 in patients with recurrent GBM in the second half of this year. The vaccine candidate mobilizes the body’s defensive cell function and seeks to enhance productive immunity against tumors.

GBM is among the most prevalent and aggressive malignant primary brain tumors in humans. More than 12,000 new cases are diagnosed annually in the U.S. alone. Conventional therapy for GBM is surgery, followed by radiation and chemotherapy. Even with aggressive treatment, GBM under standard care is tantamount to a death sentence. The tumor progresses rapidly and is typically lethal, with median patient survival of less than 16 months. Hence the potentially huge demand for VBI-1901.

The average analyst expectation is that VBI’s year-over-year earnings growth will come in at 4.3% next quarter. Year-over-year quarterly revenue growth (most recent quarter) came in at 319.5%.

With a market cap of $130.2 million, VBI is a small-cap biotech with the potential for the sort of massive gains that can elude the mega-cap blue chips. But as a smaller company, VBI also is better suited for aggressive investors who are willing to shoulder more risk. Regardless, the company is a targeted play on one of the hottest areas of drug research today.

 

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