Long time subscribers to Smart Tech Investor may recall our story from last June on exoskeleton technology (“From Comic Books to Reality: Exoskeletons Are Here to Stay“), which recommended three companies that are currently held in our Special Situations Portfolio: Ekso Bionics (EKSO), ReWalk Robotics (RWLK) and Parker Hannifin (PH). Similar to our recent cancer  stocks recommendation, exoskeleton technology is still in its infancy and offers tremendous long term upside potential once it becomes more widely accepted and less expensive to acquire.

So we were excited to see a press release from Parker Hannfin last week announcing it has received FDA approval to begin selling its motorized leg braces in the United States, even though in the near term it won’t have much impact on the bottom line of this $13 billion in revenue conglomerate. That’s because the insurance industry is not required to cover the cost of this equipment – estimated at $80,000 – which is beyond the reach of most of its potential users. But the fact this technology is now in the public domain is a giant step in the right direction, one that should eventually lead to increased awareness by the general public and greater sympathy from the insurance industry for at least partial coverage.

Presumably anyone requiring this equipment in order to walk will do just about anything in their power to find a way to acquire it, and certainly their family and friends would be happy to help out to the extend they can. And I wouldn’t be surprised to see the general public contribute via crowd sourcing websites since all of us can appreciate the desire for someone to regain the ability to walk, which in turn makes it far easier for someone to live independently and earn gainful employment.

But like all cutting edge technologies the road to riches is not a straight path; none of the three stocks we recommended nine months ago have done much since then, but then again, the stock market hasn’t done much, either. The good news is that provides a buying opportunity for more recent subscribers to STI that have not yet take a look at this opportunity, as all three stocks can be bought for about the same price as last June. 

As for our other two exoskeleton stocks, ReWalk Robotics released its most recent quarterly earnings report three weeks ago which was in line with analysts estimates. Although the financial results were modest (total sales revenue for the 2015 of $3.7 million), of greater significance are the increasing signs of government and regulatory acceptance. The U.S. Department of Veteran Affairs which purchased six units for evaluation purposes, and a couple of legal decisions in favor of exoskeleton technology as a legitimate medical expense.

And just this week, Ekso Bionics released its most recent quarterly earnings report. The company reported a 31% increase in year-over-year fourth quarter earnings to $1.9 million, and disclosed it will sell $13.9 million of warrants to a syndicate of institutional investors giving them the option to buy nearly 15 million shares of common stock. 

To be clear, there is a lot of risk in these types of companies which is why we recommend buying a bundle of three of them at a time to diversify the risk specific to each one. We also suggest combining companies of different sizes to add some stability to the portfolio. Next month we will add a new bundle of stocks from another cutting edge technology to this portfolio, and over time we intend to add many more.  

by Jim Pearce

Next Wave Portfolio Update—FireEye Upgraded to ‘Buy’

By Rob DeFrancesco

At the FireEye (FEYE) analyst day last week, management emphasized the company’s transition to more subscription-based revenue (security software offered as a service) and the associated positive implications in terms of better visibility into cash flow, greater differentiation from competitors and higher profit margins. The company is making a smart move, as IT research firm Gartner predicts that 70% of the growth in enterprise security over the next three years will come from expanded services.

I am upgrading FireEye to a ‘Buy’ from ‘Hold’ in the Next Wave Portfolio because of the company’s new focus on security subscriptions.

The security hardware appliance segment is tough right now because it’s highly competitive from a pricing standpoint. There are many established vendors fighting for market share. Plus, enterprise customers are increasingly realizing they want the flexibility and reduced costs that come with security subscriptions. Instead of being tied to appliances that are expensive to maintain and upgrade, customers like the idea of paying for annual subscriptions that include updates via the cloud based on changing threat environments.

In the fourth quarter, FireEye’s appliance revenue fell 2% year over year, while its product subscription revenue advanced 56% and professional services business was up 60%. The relatively new FireEye-as-a-Service (FaaS) subscription offering reached an annual revenue run rate of $100 million.

The company is already well on its way to a greater contribution from subscriptions. For 2015, FireEye’s total revenue advanced 46% to $623 million, while deferred revenue rose 49% to $527 million thanks to more subscription-based sales (revenue is recognized over the term of a contract).

Last year, FireEye’s pure subscription business (no attachment to an appliance) rose 64%, vs. 29% growth when an appliance sale was involved. For 2016, the unattached subscription business is expected to expand 70%. By 2020, FireEye management believes security subscriptions could account for 75% of total billings.

FireEye has 363 FaaS customers, up 101% from the year-ago level. With FireEye’s total customer base now at 4,400, that’s a penetration rate of just 8%, indicating plenty of upside potential. FireEye’s customers have shown a willingness to buy a number of the company’s offerings (50% have two products and 36% have three or more), so it makes sense that many would consider switching over to more subscription-based solutions, especially because of the overall move to the cloud, which is creating strong demand for cloud-based security and leading the market shift away from appliances.

In the fourth quarter, FireEye debuted its updated MVX threat detection engine, which offers five times the breach detection capabilities at triple the analytics speed. The re-architected MVX engine was also segmented from the core appliance line, setting up the platform to be split into hardware and virtual form factors.

By the end of this year, FireEye will offer a hybrid MVX model, with a full cloud version in the first quarter of 2017. Going forward, FireEye’s real growth will come from its subscription-based offerings for email threat prevention, malware analytics and mobile/endpoint threat prevention.

Wall Street generally came away from the FireEye analyst day with a favorable view. Of course, any major product transition means higher execution risks over the near term, but it’s a move that should pay off for FireEye over the longer term. By transitioning to more software-centric solutions and cloud-based subscriptions, FireEye has the ability to significantly expand its customer base, particularly when it comes to small and midsize businesses. Since those customers generally have smaller security budgets, they are more willing to sign up for subscription-based offerings because they don’t have to spend as much money up front on pricey appliances.

Following the analyst day, Piper Jaffray upgraded FireEye stock to ‘Overweight’ with a price target of $24 (up from $15) based on the belief that the company can successfully transition to a subscription service model, resulting in an increase in recurring revenue.

Piper Jaffray called out several key positives—including a robust product roadmap targeted at new markets (including the endpoint segment), growth in international regions (the longer-term goal is to expand the non-U.S. business to half of total revenue from 30% in 2015), better use of the partner channel (including a greater contribution from value-added distributors such as Westcon Group) and the company’s ability to achieve positive operating income by the second half of next year.

FireEye is a ‘Buy’ in the Next Wave Portfolio.

Emerging Biotech Investment System (EBIS) Update

By J. Duarte MD

In this issue:

• The Big Picture: Big Move Lies Ahead. Fed Likely to Influence
• In Depth: Cerus Beats Estimates. Highlights from Conference Call
• Special Situation Trading Portfolio: Biotech ETF Short Term Trade Details
• Long Term Holding EBIS Portfolio Update:  No Surprises is Good News
• News and Analysis: Has Biotech Finally Bottomed?
• Shopping List

Note to readers:  I am looking forward to meeting you personally at our Las Vegas “Investing Summit 2016”, May 12-13.  As an added bonus and as a special way to thank you I will be revealing a “summit only” stock recommendation in Las Vegas and as a very special bonus I will be discussing my favorite technical indicator in detail to help you in your personal trading.  Hope to see you all there and thanks for your support.

Our chart analysis suggests that biotech stocks could stage a meaningful, possibly to the up side short term move as the sector catches up to the S & P 500.  We are adding a long leveraged ETF recommendation to our Trading Portfolio with strict entry and exit point in order to prepare for this possibility. See our Special Situation Trading Portfolio section below for details.

This week’s Federal Reserve Open Market Committee meeting is likely to be the catalyst for what happens next in the stock market as the charts tell us that the market is poised for a big move. Last week we noted how the Nasdaq Biotech Index (NBI) was lagging the S & P 500 (SPX). And the theme continued during the week that ended on March 11, with the overall biotech sector again failing to rally along with the S & P 500. But there were some important developments to note.  First, the S & P 500 made a new high off of its February bottom. Second the S & P 500 fought its way back to its 200 day moving average, which means that it is now contesting a long term change in the trend, from down to up.  And third, the Bollinger Bands (green lines above and below the indexes) are shrinking around both SPX and NBI.  In fact the bands are much tighter around NBI than SPX, which is one of the reasons that we are making plans for a possible trading rally in biotech as we explain further in the News and Analysis section. 

The shrinking Bollinger Bands are a sign of decreasing volatility, a development that always precedes a large move. The problem is that we can’t really predict the direction of the move, although we can speculate that it is plausible that NBI could move significantly higher from the current levels, at least in the short term because it has failed to move thus far, and thus it is due for a move higher. If this happens, we would consider this a catch-up move, given the significant lag we’ve seen in biotech, and would not necessarily play it as a long term investing opportunity.

This week we’ve added the Ulcer Index (UI) indicator to the charts. This simple oscillator offers a glimpse into the potential risk in the market.  When it rises, risk is higher.  It currently seems to have made a bottom, which is often a sign that the market will consolidate before making up its mind about what to do next  When you put the UI together with the shrinking Bollinger Bands, you can make a case for a significant move getting ready to be unveiled.  So a lot is riding on what happens in the next few days for investors.

Our recommendations continue to err on the side of caution and on specific stocks and ETFs.

1. Pay close attention to the overall market and how health and biotech stocks are faring in comparison especially in the next couple of weeks.
2. Monitor the price of all current positions in your biotech portfolio individually.   Think in terms of individual holdings.  Monitor each separately. If they hold their value there is no need to sell.  If they trip their sell stop we recommend selling.
3. Pay attention to news items, especially as related to products, mergers, takeovers and geopolitical events. Politics may overshadow other fundamentals in the short term.  Be aware of this and follow our price guidelines.
4. Focus on risk management and on the fundamentals of any open position. Our July 27^th, 2015 update has an excellent tutorial on how you may go about doing using this ETF to hedge your portfolio. For further reading on portfolio protection techniques and risk management also consider a copy of Dr. Duarte’s “Trading Options for Dummies.”
5. Don’t get over confident and stick with what’s working. Risk is still high in this market but a long term strategy reduces risk because of the time horizon of the expected payoff.

In Depth: EBIS (Emerging Biotech Investment System) Pick: Cerus Corp. (CERS)

Restated Buy Recommendation: Cerus Corp (CERS).  Earnings Review and Conference Call Highlights

Cerus Corp. (CERS) – Buy Range $5-$7. This stock was initially recommended 11/16/15. Bought 11/16/15 at $5 – 3/11/16 closing price $5.65.

Cerus Corp. is a core long term portfolio holding. The company reported its earnings on March 8^th after the close coming in with a 15 cent per share loss and $9.7 million in revenues.  Estimates were for $9.72 million in revenues and a loss of $0.16 (16 cents per share) in net income. The stock reacted well, especially in a tough period for the overall biotech sector.

Here are some highlights from the conference call:

• The recent contract with the Red Cross in the U.S. is likely to increase the number of Intercept System and components sold. This should start to be noted on the bottom line for Cerus in 2016 and more likely in 2017.
• The company raised revenue guidance to $37-$40 million for the year compared to $34-$36 million range for 2015.
• Cerus remains confident about getting FDA approval for its Intercept System to be used for red blood cells.
• The company has $108 million cash and cash equivalents on its balance sheet, enough for two years of operation.

Here are some of the reasons we like Cerus.

A recent document from the FDA recommends one of two methods for decreasing the chance of Zika virus spread by the blood supply. One is by pathogen reduction techniques, such as Zika’s Intercept system. The other is by obtaining blood products from geographic areas where the virus is not known to be locally transmitted.

Cerus is a niche play on blood testing and the neutralization of infectious agents including hepatitis, HIV, the agent that causes syphilis and other infectious agents and may be a play on the Zika virus based on case reports and recent data from the company. Cerus has a proprietary technology, the Intercept system, which is used to test blood components, plasma and platelets, for parasites and viruses and to inactivate them. Cerus has been expanding its market share steadily in the last 6-12 months, having signed key agreements for the use of Intercept with key regional blood supply agencies in the south of the United States and elsewhere. It already has a presence in Europe, Africa, and South America, which may be its most important asset at the moment.   Cerus, in our opinion, may be a focal company as the Zika virus dynamic plays out, due to its the potentially pivotal role in the prevention of blood supply contamination with resurging infectious agents.  It’s important to recognize that Cerus’s potential market is huge, estimated at $2 billion

A key future development is receiving FDA approval for the Intercept System to be used for red blood cells.  The global market for blood transfusions is huge, with over 100 million potential transfusions per year possible. Consider that there is now a huge influx of immigrants from the undeveloped world entering Europe but also increasingly the United States.   This one dynamic, when coupled with normal travel patterns of Americans to global destinations where mosquito borne diseases are not rare, raises the potential for a resurgence of infectious diseases rarely seen in the U.S., and thus their entering the blood supply. Just recently the incidence of dengue fever, a mosquito transmitted virus that can lead to heart disease has increased in the U.S. where cases have been reported in Texas as well as Hawaii. The state of Hawaii has declared a state of emergency for mosquito borne diseases including dengue fever and the newly recognized and more emergent Zika virus even though their incidence is seen as declining.  Dr. Duarte owns shares in CERS.

CERS gets a +7 EBIS rating, HOLD. It is, however, a very attractive and moderate risk company with excellent long term potential as its focus on blood supply testing seems to be extremely timely given the current geopolitical situation and the resurgence of infectious diseases.

Here are the EBIS details:

The EBIS Score for Cerus Corp (CERS) is + 7 (HOLD) based on September, 2015 data.  

• Cash on hand: (+1) CERS had $58 million in cash on hand in September 2015 compared to $22 million in December 2014.
• Cash on Hand growth (year over year): (+1) The year-over-year cash growth was 32%.
• Revenues (present or not): (+1): Cerus reported $8 million in revenues in its September quarter compared to $9.5 million a year earlier.
• Revenue growth (10% or greater): (+0) Revenues fell by 16% year-over-year in the September 2015 quarter.
• Trailing Total Liabilities/Current Assets (<1=+1 , >1=0): (+1) CERS has a 0.30% ratio, which means that it can cover all its expenses with its cash and current assets in a worst case scenario and continue to operate the company.
• Earnings (Present or Not Present): (+0) CERS had a $16 million loss in its most recent quarter
• Net Income Growth (Year over Year): (+0) CERS cut its losses by 22% year over year in September.
• Products on the market: (+1) CERS has products on the market and is making strides in expanding its market share.
• Pipeline Strength: (+1) CERS has one key product in late development stages in its pipeline.
• Late Stage Clinical Trials and Product Launches: (+1) CERS has several important products in critical stages

The EBIS system consists of ten fundamental criteria that are updated every quarter after the earnings results for each company are published. Each criterion gets a value of +1 or zero. A total of 8 or more points earn a Buy rating. A total of 5-7 points earn a Hold rating. Less than 5 points delivers a Sell or Avoid rating. EBIS was introduced in the June 15, 2015 issue of the Biotech Report. The stocks in this portfolio are companies with long term profits. Our goal for this portfolio is to include stocks which we expect will be held for periods of at least twelve months, but likely longer.

Long Term Holding Portfolio Update

Meridian Biosciences (VIVO) Buy $18-21 – 3/11/16 closing price $20.77.Stock initially recommended on 6/29/15.

We still like Meridian Biosciences and suggest adding to shares on weakness. The company still has a 4.37% dividend yield and despite its decreased earnings, its results are comparable to its peer group. The longer term fundamentals are still positive given the increased likelihood of rising infectious diseases based on immigration and demographic patterns that are emerging in the U.S.

VIVO develops, manufactures, and markets diagnostic testing kits focused on gastrointestinal infections, virus detection, and parasitic illnesses. It also produces reagents and key testing and DNA amplification and enzyme related materials used in research. It has recently released a new product, the Para Pak single vial transport system for parasite testing which simplifies the transport of samples to the lab by using one vial instead of the more complicated multiple package systems that are currently on the market.

Meridian delivered $47.07 million in revenues and $8.47 million, or 20 cents per share in net income for its December 2015 quarter. This was a 10.58% decrease in earnings on flat revenues. And while this sounds disappointing, it’s actually a pretty good set of results.   The company’s gross margins increased as did the amount of cash on its balance sheet, which are both excellent signs of management that is looking toward the future. Vivo also kept its quarterly dividend at 20 cents per share.   Meridian delivered a mixed earnings report on November 5, 2015, beating on revenues at $47.5 million and missing on its net income by one cent at 20 cents per share. Estimates averaged $46.64 million in revenues and 0.21 cents per share for earnings.   This was a reversal of the previous quarter. The stock paid a 20 cent dividend on 11/12/15 and yields 4.4%. Dr. Duarte owns shares in VIVO.

Novo Nordisk A/S (NVO) – Buy Range $50-55. Recommended 12/21/15. Bought at $55 on 12/21/15. 3/11/16 closing price $57.02. Sell Stop at $46.

Special Situations: Short Term Trading Recommendations

These are stocks or ETFs that have the potential for trending profits over shorter periods of time, sometimes days, but mostly weeks to perhaps months. The fundamentals are secondary in this portfolio, which is geared for momentum type stocks.

Trading stocks are only recommended as trades based on technical analysis and momentum.   These are not stocks meant for long term holding periods.

• Special Situation Trading stocks are not EBIS type stocks. This means that they are more volatile and that any moves by these stocks, up or down, can be very fast and treacherous.
• Follow the trading guidelines and recommendations issued with each stock in detail.
• Trading guidelines are not applicable to our longer term holdings in the EBIS portfolio.

New Recommendation Alert – ProShares UltraPro Nasdaq Biotech ETF (UBIO) – Buy $25-$27.  Stop loss at $23.  This is a short term recommendation based on the possibility that the biotech sector may stage a catch up rally to the S&P 500 in the next few days to weeks. If we are correct and this rally exists, we would expect the Ultrashort Biotech ETF (BIS) position that is currently open (see below) to be stopped out.  UBIO is a leveraged ETF that rises and falls at 2X the rate of the Nasdaq Biotech Index (NBI). 

New Recommendation Alert – Medidata Solutions Inc. (MDSO) – Buy $36-$39.  Bought on 3/7/16 at $36.  3/11/16 closing price $37.19.  Sell Stop at $32.

Medidata crunches big data for health care companies at the research level. It not only has apps that help organize and study the research starting from the project stage to the clinical trial stage but it also has an app that allows patient input into the data.  The company also has a financial tracking system that lets its clients keep track of who is getting paid and how much as well as keeping trends and other financial variables in focus.  They are expected to report earnings in late April.  Revenues and earnings have been steadily rising.  In the current environment where money for health care expenses is expected to decrease, MDSO is well positioned.  Dr. Duarte owns shares in MDSO.

Rollins Inc. (ROL) – Buy at $27-29. Bought on 2/22/16 at $27.38. 3/11/16 closing price $27.77. Sell Stop at $22. Initially recommended on 2/22/16.

Rollins Inc. (ROL) is well positioned for the increasing awareness of how infectious diseases are transmitted.  The stock has been steadily climbing since our recommendation on 2/22/16.  This is a very special situation with a relationship to biotechnology in the current environment. Rollins owns Orkin, the exterminating company, and could be a big beneficiary of the current health concerns regarding Zika virus. It also owns other businesses, including TruTech and Critter Control which focus on wild life control. The company also focuses on bed bug and other pest extermination. This is a highly speculative trading situation which may have a short term lifespan but may also be increasingly powerful given the current potential for the rise in incidence of parasitic and animal vector related diseases. Thus, in the current market it’s an interesting story stock to consider.

Rollins is not a cheap stock trading at 39 times past earnings. Its most recent quarter delivered modest growth in both earnings and revenues, in the 5-6% range, which although not too exciting, is likely sustainable given the nature of the business. The company continues with a steady expansion plan including the addition of several international franchises, focusing on areas with large pest populations. It continues to invest in technology, recently updating support and analysis systems and including communication and software tools to its employees in order to maximize their interaction with customers.  Dr. Duarte owns shares in ROL.

Active Trading Recommendations:

•  ProShares Ultrashort Biotech ETF (BIS) Bought 2/28/16 at $48-$50. 3/11/16 closing price $43.99.  Sell stop changed to $42.
  • Note: We opened and closed a position in BIS earlier this year for a net gain of 53%, so this is a new trading recommendation.
• Opko Health Inc. (OPK) Buy Range $8-$11. Bought 2/1/16 at $8. 3/11/16 closing price $10.21. Sell Stop raised to $8.  This stock is in a stealth bull market.
  • Note: We think the market is wrong on this one as management has expanded the company through acquisitions which have already delivered profits and operating capital and that buying it now could prove to be an excellent longer term play. We are also looking to add this company to our EBIS list in the not too distant future.

Opko delivered a well received earnings report in late February that showed that the company is consolidating its recent acquisitions. It has made several advances on its current business lines and products in development as well as ongoing successes and milestone payments from collaborations from other companies.  Dr. Duarte owns shares in OPK.

• Alert –Emergent BioSolutions (EBS) Buy Range $36-39. Bought 1/25/16 at $36. 3/4/16 Stopped out at $34 on 2/8/16.  Total return (-) 5.5%.

News Update and Analysis:  Has Biotech Finally Bottomed?

The health care sector got more bad news this past week.  But an interesting thing happened. The sector did not make a new low despite the news.  This suggests that perhaps, at least in the short term, the bad news (as they say) has already been factored in. 

Last week we noted that money flow into health care was likely to be reduced. We highlighted “the Obama administration’s recent communication which says that it’s ahead of schedule on implementing its “pay for performance” initiative for paying Medicare doctor bills.”  As we described last week  “pay for performance is a government formula that is based on measures that the government thinks are important in patient care, such as whether diabetes and blood pressure measurements are within what the government thinks they should be.  We noted that the bottom line was that “doctors are going to get another pay cut.”  

The latest shoe to drop was the announcement that the White House was planning an initiative to link drug prices to treatment results and other parameters.  But while the biotech sector initially dipped on the news, it didn’t make new lows on the week.  This type of price action suggests that maybe a bottom is now in place.  Does this change anything? Not for the fundamentals of the sector in our view.  However, from a trading standpoint, using a leveraged biotech ETF for a short term trade could be exactly what the doctor ordered.   See our Special Situation Trading Recommendations above for details.

Shopping List

• Regeneron (REGN)
• Bio-Rad Labs (BIO)
• Amgen (AMGN)

2016 EBIS Portfolio Results:

• Emergent BioSolutions (EBS) (Bought 5/11/15 MPP* 30.63) 1/7/16 Stopped out at $36. Return 17.63%.
• Cambrex Corp. (CBM) Position Closed – Sell Stop Triggered at $50 on 12/18/15. Bought 10/20/15 at $44. Return 13.6%.
• Masimo Corporation (MASI) –Buy issued July 20, 2015. MPP: $40.65). Sell Stop triggered at $38 1/6/16. Return (-) 6.5%
• Sirota Dental Systems (SIRO) Buy Range $104-$108. Bought 1/26/16 at $104. 2/5/16 closing price 106.57. Sell Stop hit at $98 on 2/12/18. Return (-) 5.76%.
• Vertex Pharmaceuticals (VRTX) Trading Buy Range $96-100. Bought 2/4/16 at $96. 2/5/16 closing price $86.61. Sell stop hit at on 2/5/16 at $86. Return (-) 10.41%.
• ]Emergent BioSolutions (EBS) Buy Range $36-39. Bought 1/25/16 at $36. 3/4/16 Stopped out at $34 on 2/8/16.  Total return (-) 5.5%.

 2015 EBIS Portfolio Results:

• DYAX Corp (DYAX) – Position Closed: Company taken over. Originally bought 10/7/15 at 22. 11/6/15 closing price was 34.52. Trade return: 56.9%.
• Celldex Therapeutics (CLDX) Trading Recommendation Position Closed: Stopped out at 16. Recommended 10/26/15. Buy range entered 10/26/15 at 13.22. Total Return 21%.  
• Alnylam Pharmaceuticals (ALNY) – Trading Buy triggered at 85 on 10/9/15. Trading Recommendation Position Closed: Stopped out at 100 on 11/16/15. Total Return 15%.
• Edwards Life Sciences (EW) – (Initially recommended 10/19/15- Bought 10-27-15 at $76.50 post 2 for 1 split). Trading Position Closed: Sell Stop Triggered at $78. Return 1.96%.