Fully half of the ten companies that comprise our Investments Portfolio reported quarterly earnings last week, producing a mixed bag of results that in turn has changed our current recommendations on some of them so please note the change in status as indicated below.

Verizon Communications (VZ) was the first to report on October 20^th, with numbers that came in better than expected driving its share price above $46 after dropping below $44 the previous week. Total operating revenues were 5% higher than a year ago, aided by more 1 million net new connections in the most recent quarter.

The company also added 114,000 FiOS internet subscribers plus 42,000 video users, suggesting that it may be successful in bypassing Netflix for what has become one of the biggest revenue engines in online content. If so, then its recent acquisition of AOL could turn out to be a steal if it can retain and cross-sell those users to its full product suite.

It remains to be seen if Verizon can maintain profit margins in the face of aggressive discounting by competitors Sprint and T-Mobile, but so far it has been able to retain its customer base without offering deep discounts to prevent too much churn. With a current dividend yield of 4.9% it is one of the most attractive income stocks in the entire S&P 500 universe, so we expect to see an increase in demand for its shares from equity-income funds now that the Fed has apparently backed off on its plan to begin raising interest rates. With an STR (Smart Tech Rating) of 9.5, Verizon remains a buy up to $55.

 EMC (EMC) reported on October 21^st, but there the news was overshadowed by the fact it is currently in the process of being merged into Dell with a scheduled completion date of sometime in the second quarter of next year. For what it’s worth, the company reported a 27% decline in operating income and an 18% drop in net income due primarily to a 7% increase in R&D and SG&A costs.

But since the terms of Dell’s acquisition price for EMC are already known, you might think none of this really matters. However, along with the $24.05 in cash each EMC shareholder will receive, they are also entitled to 0.111 shares of a new “tracking stock” that represents EMC’s equity in VMware (VMW). And its VMware that is causing most of the excitement for EMC shareholders since its share price dropped nearly 20% after its quarterly numbers were released.

For EMC shareholders the good news is you now have a floor price of $24.05 protecting you (assuming the Dell deal goes through), so with the stock currently trading around $26 there is very little downside risk in the stock. The bad news it doesn’t look like the VMW deal is going to help you out much, either. So, our advice is to sell EMC to avoid the risk of the Dell deal falling apart and take the money and run.

It’s rare that an earnings report results in reduced share price volatility for a tech stock, but that’s exactly what happened after CA Technologies (CA) released its numbers on the 21^st. After trading as high as $28.49 and as low as $26.84 in the days leading up to the announcement, the stock quickly settled into a very narrow band of $27.50 – $27.90.

I guess that is to be expected when reported earnings per share of 56 cents precisely match the consensus analysts’ estimate of 56 cents, with no change to its forward looking earnings guidance. With no new information to go on, the stock appears to have temporarily gone flat. That’s okay, provided it can live up to its expectation of a 2 – 7% increase in cash flow from operations in 2016.

Regardless, at this point there doesn’t seem to be much upside potential in CA so we don’t see the point in holding it any longer. Its STR score of 6.6 is still above average, but no longer in our “buy zone” above 7.5. Unless you are an income investor that needs the 3.6% dividend yield, it’s time to sell CA.

AT&T (T) released its quarterly report on the 22^nd, with numbers that were generally good. For the fifth straight quarter it beat the consensus estimate for earnings per share, and raised guidance for the remainder of this year. You might thing the stock soared on the news, but instead it lost a dollar off of Thursday’s highs above $34.75 to below $33.75 on Friday.

Without any clear reason for that reversal, one can only assume that the expectation among many of its institutional shareholders was for even better results. When that didn’t materialize, they opted to sell into strength instead. If so, then the stock should soon stabilize given its outsized dividend yield of 5.5% with no apparent threat of a dividend cut in the foreseeable future. AT&T remains a buy up to $39.

But the big name in the news on the 22^nd was Microsoft (MSFT), which saw its share price spike nearly 10% after issuing a strong report that included improved guidance and excitement over the release of its new Surface Book laptop, and the most recent edition of its Surface Pro 4 tablet.

For the first time in a long time, MSFT is trading at a forward P/E ratio higher than its sector average meaning some investors now once again view the company as a growth stock. But with a profit margin of 13.5% and an ROE (return on equity) of 14.6%, we think the stock is fully valued at the moment. We are keeping MSFT in our portfolio, but changing it to a ‘hold’ until its STR gets back above 7.5.

By Jim Pearce

Portfolio Update – Medical Profits
By J. Duarte MD

In this issue:

• The Big Picture: Biotech Shrugs at S & P 500 Momentum Run
• Two More Things: The Fed and Valeant
• In Depth: New EBIS Pick – Cambrex Corp. (CBM) – Overlooked and Underpriced Generic Drug Manufacturer Nears Buy Point
• New Stock Added to Trading Portfolio: Celldex Therapeutics (CLDX)
• EBIS Portfolio Update: Alert: EBS Downgraded to HOLD.
• News Update: Amgen Gets Approval for Virus Mediated Skin Cancer Treatment

The Big Picture: Biotech Shrugs at S & P 500 Momentum Run

The S & P 500 (SPX) is in a big momentum rally. The index is firing on all cylinders with multiple technical indicators pointing toward higher prices in the intermediate term. In fact, barring a major trend reversal we can see this rally heading into the traditional November-December time frame before it consolidates significantly.   Unfortunately, the same can’t be said about the overall biotech sector, although there are some stocks that are not doing terribly there.

Comparing the S & P 500 to the Nasdaq Biotech Index (NBI), several things stand out. First, SPX has moved above its 200-day moving average, the line that traditionally divides bull and bear markets. NBI is still struggling to rise above its 50-day moving average, which is a measure of the intermediate term direction of stocks and indexes. Second, a look at the Accumulation-Distribution line on the chart of SPX (bottom panel) shows a nice, up sloping line which shows that more stocks are being bought than sold in the index.   Third, the bottom panel of the NBI chart is an interesting indicator, known as the Ulcer Index which measures the potential risk in stocks and market indexes. You can see that during the August and September declines in NBI, the Ulcer Index rose but that it has fallen of late. The Ulcer Index was designed to rise during periods of higher risk. A falling Ulcer Index could be a sign that biotech could still surprise to the upside. It’s about time, isn’t it?

So what’s the bottom line? It’s clear that biotech is lagging the overall market during this rebound from the dramatic September-October decline. What is not so clear is what lies ahead. And that’s because earnings for biotech have not yet hit their stride. We will know more in the next two to three weeks as the data is released. Until then, it makes sense to look at each position individually and apply the principles below.

Two More Things: The Fed and Valeant

While Valeant is the story that won’t go away, investors should pay close attention to what happens in the market and the rest of the biotech sector this week after the Federal Reserve’s meeting. Most “experts” expect that interest rates won’t change. And it makes sense, given the market’s recent rally as well as the overall sloppiness in the U.S. and global economies. So, unless the economic data over the next few weeks falls totally off the cliff or there are sudden signs of the economy overheating, rates are likely to stay unchanged. But if the Fed decides to just go on and raise rates because it feels that it better do so while it still can, the whole rally of the last three weeks could be wiped out, and then some.

The situation with Valeant, however, looks as if it’s going to be more active in the next few days to weeks. The company has scheduled a conference call and press conference to explain its current situation for Monday, October 26^th. The latest development involves the relationship that Valeant has with entities known as specialty pharmacies.   Click on CNBC and the Wall Street Journal for the details of that situation.

The reports highlight the presence of a specialty pharmacy called Philidor RX Services LLC, a pharmacy that fills prescriptions for Valeant drugs. Short sellers are alleging that Valeant uses this specialty pharmacy to inflate its sales by selectively accounting for transactions between the two companies. According to the reports, depending on the situation, the numbers that relate to the transactions can be interpreted as either accounts collected or accounts receivables. To be sure these are only allegations.   Furthermore, it’s extremely tricky accounting, which could take a long time to sort out. Finally, it may turn out to be a whole lot of nothing.  But it’s out there now, and there seems to be something new that is revealed every day about this increasingly messy situation.  

So the big questions for investors are:

1) Are the allegations true? Is Valeant not just charging extraordinary prices for its drugs, but is it also cooking the books?

2) Perhaps more important is the question of whether this is a widespread practice in the drug industry.

For anyone wondering why 2) is a prescient question, consider that the Affordable Care Act has sought to limit pricing power for drug firms as well as other health care providers in its quest for reducing spending. Yet, drug company profits are doing pretty well. That means that the money has come from somewhere. Here again, there is nuance. In some cases, rising earnings are at least partially due to stock buy-backs and diminishing shares outstanding making the earnings numbers seem more profitable. It is also clear that drug companies have been raising prices. Yet, if it turns out that Valeant is cooking the books, and that it’s not alone, the situation becomes highly unpredictable, not just for the drug companies, but for the whole health care system, where insurance company and hospital earnings may then be scrutinized.

It’s a big leap to say that if Valeant is guilty, others may be guilty as well. And we have no data to support this at this point. It is a big unknown, and it’s very early in this process. But, because of its plausibility, and its potential for a huge negative disruption in the health care sector, the possibility of this being the tip of the iceberg is something worth keeping in the back of any investor’s mind.

Conclusion:

1. Pay close attention to our new Trading Buy Recommendations and our new EBIS picks as these are our most solid picks at the moment.
2. Monitor the price of all current positions in your biotech portfolio.   Check our weekly updates or any special alerts, if issued, for any changes. If your stocks are holding their own, keep them in your portfolio and add to positions as they re-enter their buy ranges from lower prices as they recover.
3. Earnings season is about to pick up for biotech. Pay special attention to your stock’s action in response to earnings and check our weekly updates for release dates and expectations. Always monitor your portfolio’s response to the market and to any news events and only sell stocks that are showing significant weakness and fall below their sell stop.
4. Consider using BIS to hedge your biotech portfolio during periods of weakness for the market and the biotech sector. BIS is hugely volatile but is still above our sell stop recommendation. See below for details. Our July 27^th, 2015 update has an excellent tutorial on how you may go about doing this. Also, see below for our latest BIS recommendation. For further reading on portfolio protection techniques and risk management also consider a copy of Dr. Duarte’s “Trading Options for Dummies.”
5. If you choose to buy new stocks, be cautious. A good method for building positions in a volatile market is to buy small lots of stock over a few weeks to months, depending on the overall trend. When this is coupled with a long term time horizon it’s much easier to weather the volatility.

Trading Recommendations

We have a new trading recommendation below. Otherwise remember the following:

• Trading stocks are only recommended as trades based on technical analysis.
• 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.

Alert: New Trading Recommendation– Celldex Therapeutics (CLDX) Trading Buy up to $14. Sell Stop at $10. For every dollar of price increase, raise the stop loss by $1. This is almost an EBIS stock. The company is working on a vaccine for aggressive brain cancers. It has plenty of money on its balance sheet but is high risk and has not been able to make money consistently. In this market, it may be worth exploring on a trading basis.

Trading Recommendation Edwards Life Sciences (EW) – (Initially recommended 10/19/15) Trading Buy up to $156. Sell Stop at $139. For every dollar of price increase, raise the stop loss by $1.

Trading Recommendation – Alnylam Pharmaceuticals (ALNY) – Trading Buy triggered at $85 on 10/9/15. 10/16/15 closing price $84.91 – Sell Stop adjusted to $79. For every dollar of price increase, raise the stop loss by $1.

Trading Recommendation – Alexion Pharmaceuticals (ALXN) – (Issued 10/12/15) Trading Buy up to $173. Sell Stop at $159. For every dollar of price increase on a closing basis, raise the stop loss by $1.

In Depth: New EBIS (Emerging Biotech Investment System) Pick: Cambrex Corp. nears Buy Point.

Alert: New Buy Recommendation: Cambrex Corp. (CBM) – Buy Range up to $47. Sell Stop at $39.(Issued 10/19/15).

Cambrex Corp – Overlooked and Underpriced Generic Drug Manufacturer

Cambrex Corp. manufactures active pharmaceutical ingredients for brand name and generic drugs that treat pain management, cardiovascular, central nervous system, endocrine, gastrointestinal, skin, respiratory and urinary conditions. The company specializes in all areas of development and manufacturing from the transition from research and early stages of FDA approval to the full industrial ramp up stage of drug marketing.   Cambrex offers a huge library of compounds that include commonly prescribed drugs as well as potent anesthetics and mood influencing drugs.

The stock has withstood the recent selling spree in the health care sector and will report earnings on October 29, 2015 before the market opens. In its July earnings call management upgraded expectations and guidance noting that it expected “full-year 2015 expectations for revenue growth in the Innovator category to be between 31% and 34% over last year versus our prior expectations of 27% to 30% growth.”

If there is no earnings disappointment, we would expect Cambrex to move up nicely over the next few months, barring negative external events. The company is well positioned, especially in the current market where high priced drugs are under scrutiny.

Here are the EBIS details:

The EBIS Score for Cambrex (CBM) is + 9 (BUY) based June 30, 2015 data.  

• Cash on hand: (+1) Cambrex reported $62.6 million in cash compared to $26.5 million in September 2014.
• Cash on Hand growth (year over year) (+1): The year over year cash grew by 31%.
• Revenues (present or not): (+1): Cambrex reported $106.635 million in revenues in its June quarter.
• Revenue growth (10% or greater)(+1): Revenues grew nearly 31% on a year to year basis.
• Trailing Total Liabilities/Current Assets (<1=+1 , >1=0): (+1) CBM has a 0.94% ratio, which means that it cover all its expenses in the case of a catastrophic hit to the company.
• Earnings (Present or Not Present): (0): CBM has steadily growing earnings.
• Net Income Growth (Year over Year): (0): CBM had a 18.9% earnings growth year over year.
• Products on the market: (+1): DYAX offers a wide array of products on the market.
• Pipeline Strength: (+1): CBM has several important products in late stages in its pipeline.
• Late Stage Clinical Trials and Product Launches: (+1): CBM has several important products in critical stages

The EBIS system consists of eleven 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.

Portfolio Update: Emergent Biosolutions Downgraded to HOLD

Our EBIS portfolio has been more volatile of late. Generally speaking it makes sense to see if these stocks develop some type of sideways pricing action before adding to any position aggressively. Details below:

DYAX Corp (DYAX) – Speculative Buy range changed to $22-25 on October 5, 2015. Original recommendation: September 21, 2015. DYAX bought 10/7/15 at $22. 10/23/15 closing price was $27.53. Sell Stop at $25. Dr. Duarte owns shares in DYAX.

DYAX triggered our long entry point on 10/7/15. It remains a speculative buy. Expect the stock to be volatile.

DYAX is getting very close to having a real shot for FDA approval for DX-2390, a treatment of Hereditary Angioedema (HAE), a genetic disorder that occurs in 1 in 10-50,000 people.   HAE causes swelling of tissues in the body in response to antigens. DX-2930 is a monoclonal antibody that blocks kallikrein, a key substance in the chemical reaction in the body that leads to the swelling. In some cases HAE, especially of the tongue or the airway, can be very serious or deadly.   DYAX already has one product on the market, also aimed at treating HAE; Kalbitor.   Sales for Kalbitor in the second quarter of 2015, at $17.8 million, a 7.2% increase measured year over year. DYAX, although having solid fundamentals for its stage of development as a company, is a high risk stock due to its dependence on niche drugs and potential FDA approval issues.  

Masimo Corporation (MASI) – Buy up to $44. (Buy issued July 20, 2015. MPP: $40.65). 10/16/15 closing price: $38.45. Stop Loss at $34. Dr. Duarte owns shares in MASI.

Update: MASI will announce earnings on 11/5/15 at 4:00 P.M.

Masimo remains within our buying range and has held up well in a volatile market over August and September. Masimo manufactures equipment modules that monitor vital signs during difficult clinical and logistical circumstances.   Masimo pioneered Signal Extraction Technology (SET) a process that lets the pulse oximeter measure the oxygen content of blood without punctures of arteries at states of low blood pressure, where it become a most critical piece of data.

MASI reported adjusted earnings of 43 cents per share, 13 cents ahead of expectations in the second quarter of 2015, while revenues came in at $ 155 million ahead of the $147.93 million estimate. The company raised its full 2015 guidance to total revenues of $621 million, up from $608 million and earnings per share from $1.48 to $1.51.   The stock remains well within its buying range of 40-44 and keeps a 9.5 EBIS rating based on its June 2015 quarter. MASI is a well run company with plenty of cash on its balance sheet and a growth agenda. We like Masimo because it has innovative products, an excellent growth rate, and a nice stash of cash on its balance sheet which it could use to make acquisitions or to plow into research and development.

Meridian Biosciences (VIVO) Buy 18- 21 – 10/23/15 closing price 18.47. Dr. Duarte owns shares in VIVO. Stock initially recommended on June 29, 2015.

Meridian continues its basing action and is expected to report earnings during the November 2-5 time frame.

The stock pays a 20 cent dividend and yields 4.4%.

Earnings/Dividend update: VIVO met its earnings expectations on 7/23 but fell short on its revenues estimates. The company delivered net income of $9.1 million, 22 cents per share on revenues of 48.2 million vs. expectations of 48.9 million.

On September 9, management adjusted expectations for the full year of revenues of $195 to $200 million and expects revenue growth in the 3-5% range with earnings in the .86 to .90 cents range for the full fiscal year. The stock remains near the lower part of its trading range.  

VIVO has a market cap near $800 million but is a consistent money maker. The company 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.

We expect VIVO to benefit from the global immigration trend and the potential for infectious diseases to expand their territory via travel related transmission channels. The company has a well established global platform including a recently opened office in Beijing (January 2015). Dr. Duarte owns shares in VIVO.

Alert: Emergent Biosolutions – Downgraded to HOLD based on technical trends. We would have to see this stock get back above $33 convincingly before we consider upgrading to BUY again.

Emergent Biosolutions (EBS) (Buy 5/11/15 MPP* $30.63 – 10/23/15 Closing price $30.14) Dr. Duarte owns shares in EBS.

EBS will report its latest earnings on November 5 after the close. EBS reported earnings of 36 cents per share for its second quarter of 2015 beating analyst estimates of 26 cents. Revenues climbed 14% from the year-ago period to $126.1 compared to an estimate of 124.25 million.   The company also announced that it will spin off its biosciences unit, whose focus is oncology to investors.  

EBS announced receiving a $44 million contract from the Centers for Disease Controls to increase the supply of smallpox vaccine. The previous week EBS announced a $19.7 million two year contract from the Biomedical Advanced Research and Development Authority (BARDA) on July 20^th an agency of the U.S. Department of Health and Human Services. EBS also makes BioAnthrax, a preventive anthrax vaccine and is working on a new generation of the vaccine. Dr. Duarte owns shares in EBS.

Update: Trend Following ETF Model

Alert – New Entry point established for PowerShares Dynamic Biotech ETF (PBE) – Bought at $48 on 10/23/15. Buy Range: 48-51. Sell Stop at $46.

Alert- Sell Stop- ProShares Ultrashort Biotech ETF (BIS) at $32. ProShares Ultrashort Biotech ETF (BIS) – Sell and close out the position at stop loss of $32. (Buy issued 7/27/15 @ MPP* $27.99. 10/23/15 closing price was $34.27.)

*MPP – Median Purchase Price

News Update and Analysis – Amgen Gets Approval for Virus Mediated Skin Cancer Treatment

In a first of its kind moment, Amgen (AMGN) received European Medicine Agency (EMA) approval for Imlygic, a drug also known as talimogene laherparepvec or “T-Vec” to treat malignant melanoma, usually an aggressive form of cancer. What makes Imlygic interesting is that it harnesses the power of a virus to kill tumor cells, a reversal of role, since some cancers are related to viruses.

Imlygic is specially indicated for the treatment of melanoma that is not treatable by surgery and has spread but is not affecting internal organs. The drug uses a common cold sore virus, herpes simplex, to attack tumor cells. And Imlygic has not cured any patients but has been shown to decrease tumor size.

NASDAQ Composite Index:                                                                       

Friday, October 23 = 5,031.86                                                  

Year to Date = + 6.5%                                        

Trailing 4 Weeks = + 6.9%

Trailing 7 Days = + 3.0%           

Weekly Portfolio Performance