Tag Archives: drugs

IBB: Price Gouging Assertion Is Overblown

Summary Price gouging by Turing Pharmaceuticals and the subsequent comments by Hillary Clinton have exacerbated this sector decline. This price gouging incident has elicited widespread backlash, and in my opinion, rightfully so; however, this criticism has been unfairly painted across the entire sector. Attempts to heavy regulate the sector with government intervention will likely end in a futile effort in arresting drug price increases. The unprecedented secular growth streak in biotech has been more than tested as of late with the biotechnology officially in bear territory. IBB is down 25% from its 52-week high, from $400 to $295 per share during the recent market weakness, presenting a potential buying opportunity. Price gouging assertion and Hilary Clinton Recently, Turing Pharmaceuticals and its CEO Martin Shkreli garnered criticism after the company boosted the price of Daraprim from $13.50 to $750 per pill, resulting in a greater than 5,400% increase after acquiring the drug in August. This price gouging of a decades’ old drug drew fire from the general public on social media, and in particular, the presidential candidate and democratic front-runner Hillary Clinton (Figure 1). Figure 1 – Tweet by presidential candidate and democratic front runner Hillary Clinton referring to the drug price gouging This price gouging incident has elicited widespread backlash, and in my opinion, rightfully so; however, this criticism has been unfairly painted across the entire sector. It’s noteworthy to point out that democratic lawmakers have requested pricing policies and further information on pricing of drugs by Canadian drug marker Valeant Pharmaceuticals (NYSE: VRX ). Despite the public backlash and public statements by lawmakers, I believe this is a temporary headwind rooted in the public relations arena. Although the aforementioned example of Daraprim is an isolated and extreme example, at the end of the day, these companies are in business to make a profit, retain fiduciary responsibilities and return value to shareholders. Many contend that these prices are not sustainable, and the cost to the overall healthcare system is a huge financial burden. Qualitatively, this is true; however, this situation draws parallels to the housing market, education costs and social security. All of these areas of our economy are facing similar fates with unsustainable financial barriers to entry and unfunded liabilities. Attempts to heavy regulate the sector with government intervention will likely end in a futile effort in arresting drug price increases for the following terse reasons: 1) Companies spend billions of dollars in acquiring a company and/or billions of dollars and years of research and development costs to bring a given therapy to the market. 2) These costs must be reasonably factored into the pricing of the product. If government intervention is successful, this will hinder innovation and M&A activity since the back-end reward will no longer generate lucrative rewards. 3) Unlike education costs, housing price increases and social security, drug pricing is negotiated with many insurers and organizations that dispense drugs at a substantial discount to the market price and often along with rebate programs. 4) Loss of exclusivity; drug companies must also capitalize on their window of exclusivity to their drugs. Depending on patent expiration, after varying time on the market, patents will inevitably expire, and these drugs will no longer possess exclusivity and face generic competition. 5) Taken together in concert with the fact that the Affordable Care Act (ACA) is now law of the land, no one will be paying the market price of any drug since the annual deductible and maximum out-of-pocket is established depending on the tier of coverage he/she chooses. 6) Lastly, an often overlooked benefit is the cost savings to the overall healthcare system. This occurs when curative drugs or drugs that increase the overall survival and/or improve the quality of life are introduced to the market. These highly effective drugs can effectively remove patients from the system whereby eliminating years of high-cost medical treatment and hospitalization. While drug prices continue to rise, there’s substantive rational in the form of input costs, loss of exclusivity, curative treatments, increase in quality of life and removal of some patients from the overall healthcare system, thus reducing the overall cost burden of the given healthcare system. For the reasons stated above, I personally feel that these attempts by lawmakers will end in a futile endeavor. Overview The culmination of extraneous events such as sustained lower oil prices, an ostensibly imminent rate hike and weakness in China have indiscriminately plummeted the biotech sector in lock-step with the broader indices. Now, a second and more specific wave of sector-related stories such as price gouging by Turing Pharmaceuticals and the subsequent comments by Hillary Clinton has exacerbated this sector decline. These former events are ostensibly unrelated to the biotechnology sector; yet, this group has been taken along for the downhill ride with the broader indices. The latter events have been detrimental to all biotechnology stocks as this is a direct threat to pricing power and our capitalism-based structure. The unprecedented secular growth streak in biotech has been more than tested as of late with the biotechnology officially in bear territory. These latest events, some unrelated and others directly related to the biotech sector, may provide a unique opportunity to add to a current position or initiate a position over time as this correction continues to unfold. Based on annual and cumulative performance throughout both bear and bull markets, the iShares Nasdaq Biotechnology ETF (NASDAQ: IBB ) may provide the opportunity investors have been waiting for in the face of our current market conditions. IBB is down 25% from its 52-week high, shares have plunged from $400 to $295 per share during the recent market weakness, presenting a potential buying opportunity. Debunking the bubble thesis Many content that this sector is in bubble territory based on its overall high P/E ratio, lack of adequate cash flows, and in some cases, lack of any marketable products. Thus, many companies are not deserving of this generous P/E. Many also try to draw parallels to the dot.com bubble that occurred in the early 2000s and use this as a proxy for the current biotech “bubble”. I would counter that after the most recent correction of ~25% this narrative holds much less weight and that traditional metrics on which to evaluate stocks are not applicable when evaluating clinical-stage biotech companies. Clinical-stage biotech companies are solely evaluated and priced based on potential sales of pipeline candidates and/or valuation to a potential acquirer. Holding clinical-stage biotech companies to the same standards as a traditional Dow Jones stock isn’t appropriate, and thus, I feel that this argument is flawed. Comparison to the dot.com bubble is not an accurate proxy either as the Internet companies relied heavily on user growth, subscribers, ad revenue and crowd-sourced content. This is in sharp contrast to biotech companies that innovate in the many different disease states and may have a multi-billion life-saving blockbuster drug around the corner to drastically change the trajectory of the company and its future. Additionally, major M&A activity has always been a driving factor in this sector due to the fact that companies are willing to pay very high premiums for the rights to potential blockbusters or a robust pipeline to replenish its own outdated pipeline. Taken together, I feel that after the recent sell-off and lack of any substantive argument against the biotech sector, this may be a great entry point. Perennial performer in bear and bull markets Despite the headwinds outlined above, the biotech sector has exhibited its resilience in both bear and bull markets with secular growth over the past decade. The returns for IBB have been very impressive in both annual and cumulative performance, unparalleled by any major index. Over the past 10- and 5-year time frames, IBB has posted cumulative returns of over 310% and 265%, respectively. These results are unrivaled by any major index, outperforming on a 10-year cumulative basis by 3-fold or greater when compared to the S&P 500, NASDAQ, and Dow Jones (Figure 2). These returns are accentuated during the previous 5 years. IBB notched cumulative returns of 265%, outperforming the S&P 500, NASDAQ and Dow Jones by roughly 2.5-fold or greater over this 5-year time frame (Figure 3). (click to enlarge) Figure 2 – Google Finance; comparison of IBB returns relative to the S&P 500, NASDAQ, Dow Jones over the previous 10 years (click to enlarge) Figure 3 – Google Finance; comparison of IBB returns relative to the S&P 500, NASDAQ, Dow Jones over the previous 5 years IBB has displayed impressive resilience in the face of the market crash in 2008, the bear markets of 2011 and the choppy market thus far in 2015. During the market crash of 2008, IBB posted an annual return of -12.2% while the S&P 500, NASDAQ and Dow Jones posted returns of -37.0%, -40.0% and -31.9%, respectively (Figure 3). During the bear market of 2011, IBB posted an annual return of 11.7% while the S&P 500, NASDAQ and Dow Jones posted returns of 2.1%, -0.8% and 8.4%, respectively (Figure 4). Thus far, during the choppy market of 2015, IBB posted an annual return of 4% while the S&P 500, NASDAQ and Dow Jones posted returns of -6.3%, -1.4% and -8.6%, respectively (Figure 5). These data suggest that IBB outperforms during bear markets as well as bull markets to establish itself as a secular growth sector. (click to enlarge) Figure 4 – Morningstar comparison of IBB’s annual returns relative to the NASDAQ over the previous 10 years (click to enlarge) Figure 5 – Google Finance; comparison of IBB’s annual performance thus far in 2015 relative to the S&P 500, NASDAQ and Dow Jones Conclusion As the confluence of broader disconnected factors and price gouging inquiries by leading politicians continue to bring down the biotechnology sector, it may be time to consider capitalizing on this correction via adding to existing positions or initiating a new position in this cohort given this opportunity. As the United States continues to absorb an ageing population alongside growing overall healthcare costs, more specifically prescription drug costs, the biotech sector looks poised to benefit and continue to outperform the broader market. Data suggests, provided a long-term position that volatility within the biotech sector is negated by its long-term performance that is unparalleled by any major index. This sector provides high returns unrivaled by any major index with moderate risk (based on its resilience during the bear markets of 2008 and 2011 and thus far in 2015) and volatility. IBB may be providing investors with a great opportunity to add or initiate a position for any long portfolio desiring exposure to the biotechnology sector with a long-term time horizon given the recent market conditions. Disclosure The author currently holds shares of IBB and is long IBB. The author has no business relationship with any companies mentioned in this article. I am not a professional financial advisor or tax professional. I wrote this article myself and it reflects my own thoughts and opinions. This article is not intended to be a recommendation to buy or sell any stock or ETF mentioned. I am an individual investor who analyzes investment strategies and disseminates my analyses. I encourage all investors to conduct their own research and due diligence prior to investing. Please feel free to comment and provide feedback, I value all responses.

IBB Shockwave: Temporary Hiccup Or Start Of The Bear Market?

Summary IBB has corrected from its all time high by up to 30%. Hillary Clinton’s snowball was catched right in the eye of the pharma industry. The scare is partially unjustified. We look on pharma future growth figures and M&A activity that will drive the secular bull market higher. We believe that IBB is a good place to invest in the long term. We mention two recent picks where we expect further share price growth. iShares NASDAQ Biotechnology Index ETF (NASDAQ: IBB ) has corrected 30% from its all time high of around $401. Several investors start to ask if we have been in the bubble territory. We discuss in this article the facts why the pharmaceuticals industry will continue in a secular bull market towards 2020. We do have a correction now, but it is not the start of the bear market in our opinion. Let’s discuss this in more details. Chart Analysis The IBB bull market started a quick acceleration in 2012. Looking on the quick rise, it is normal to have a correction. No bull market runs up without any significant corrections. Now as China spends more money on drugs also IBB is more correlated with Shanghai SSE index as compared to 2007-2008. IBB data by YCharts Now that we have touched the famous 30% correction line, could we go lower to touch 50%? Let’s have a closer look on what drives this bull market. Pharma Revenues Total pharmaceutical industry revenues are expected to increase from $1.23 trillion in 2014 to $1.61 trillion in 2018. This corresponds to a growth rate of 6-8% annually. Such a 30% increase in revenues would drive the secular bull market higher. Some leading economies are also liberating their drug prices. In June 2015 the communist party in China decided to remove the price caps on a majority of the drugs. That serves as a step towards a more liberalized drug market. We wonder if they tweeted this news to Hillary Clinton. Hillary Clinton’s initiatives might cut the healthcare spending in the United States and set some drug price caps or limitations. We hope that her initiative would not be too disruptive for the industry – if it would be implemented one day. Increasing amount of regulations, restrictions and taxes is typically pushing the businesses to delocalize. These drug firms might also allocate differently their risk capital and not always in the benefit of the patients. For this reason we think that Hillary Clinton’s initiative would end up to be a good compromise. Speaking of delocalizations, we will surely see a wave of startups in China. Currently most big drug firms have large R&D centers in China and the pool of talent has been growing up rapidly. Belgium is no worse, there the politicians compete in attracting new pharmaceutical businesses in the country with tax breaks and benefits. Should Hillary read the tweet streams from Belgium? We think so because Belgium has the highest concentration of life science employees in the whole world and the highest number of Phase I to Phase III drugs in development per capita. Consequently, that has a huge impact on the nation’s economy. We talk later of one Belgian biotechnology company in particular where we hold a long position. Pharma Expenses A topic that is rarely covered in the press is pharma industry’s expenses, i.e. operational costs. Cutting cost is an excellent and quick way to improve the P&L. Well managed companies might be busy cutting down the purchasing and inventory costs and rationalizing the working processes to be more lean and efficient. Pharma industry is still far behind the traditional industries in this. Recent study shows that in 2014 only 32% of the pharma companies procurement organizations’ executives had a full leadership of their key spend areas. The savings generated were slumping down by 45% from year 2009. The study investigated some 185 pharma sector companies with an average revenue of $15 billion. 41% of the companies were based in the U.S. So, the investors should better check how the spend dollars are controlled when investing in individual big pharma companies. A good control over the expenses is the key for creating very profitable businesses. This is why we wanted to discuss this largely uncovered reality of non-optimally managed spends in the pharma industry. There is an opportunity of billions of dollars in savings. Such a greater discipline could have a great impact on IBB over the upcoming years through higher net profitabilities. M&A’s Are Booming There have been a triple amount of mergers and acquisitions in H1 2015 as compared to H1 2014. We have already seen $221b worth of pharmaceutical deals in H1 2015. This hasn’t been considered yet in the long term industry forecasts. It is a very recent news. These M&A’s will give a further necessary tailwind for IBB. These deals will increase the industry’s key players’ profitability through operational synergies. Risks & Opportunities There are many risks and opportunities and we want to highlight here just a few: Risks Hillary Clinton’s initiatives to push down the healthcare spending in the U.S. Patents expiry on several blockbuster drugs Changing regulatory requirements Rich industry valuations: IBB is trading at a PE of 25.19 and Price/Sales ratio of 7.72 Opportunities Increased focus on Orphan indications with higher margin opportunities Drug price cap removal in China Emerging digital healthcare applications market (drug administration, patient monitoring, etc.) Faster drug development with more modern technologies available in R&D Increase of aging patient populations We believe that by balancing out the risks and opportunities the overall picture is quite positive for the pharma industry. The digital healthcare applications will become a hot market in our opinion. Speaking of the healthcare industry in the wide sense we have covered prior some surgical robotics companies. This is a good example of how the modern technology can revolutionize the market segments and bring benefits to the patients and payers. The readers may have a look on TransEnterix as one example. How To Invest? Surprisingly, we are not holding IBB in our portfolio. Such index is better suited for a passive investor. We prefer to pick individual names and do lots of due diligence on them, that we partially publish at SA articles. We currently have two promising companies in our radar with an imminent share price catalyst in Q1-16. If you want to learn more you can read our articles on Mast Therapeutics and TiGenix. Wake-Up Calls for Two Hidden Gems TiGenix has run up already over 44% since our exclusive article at SA but its valuation is still at a ridiculous level in our opinion. TiGenix (OTC: TGXSF ) already published on 23rd August 2015 that their Phase III study primary end-point was met with the final and full results coming out in Q1-16 for a treatment of perianal fistulas in Crohn’s disease. Their Cx601 allogeneic expanded stem cells drug seems to be very safe as no difference was observed between the drug and placebo groups. The peak sales potential is estimated at $900m and TiGenix trades currently at a market cap of $182m. We think that is making no sense and the share price might have quite a lot of potential to go up with the final Phase III results coming out in Q1-16. We covered Mast Therapeutics (NYSEMKT: MSTX ) at SA on 28th September 2015. It has went up quite a lot after our article was published. It is again an example of a very misunderstood company with a good pipeline drug MST-188 running in late Phase III to treat sickle cell patients. SCD patients have had no proper drug for the past 17 years and this is the first one we expect to arrive on the markets. Both these micro-cap stocks offer a good example of what we look for when picking individual names across the biotechnology sector. We are having long positions with both. Conclusions We believe that IBB is in a secular bull market. This index could still correct lower than the latest 30% drop from the all time high. Eventually, the increased industry revenues towards 2018, recent tripling in M&A activity and a better control over the spend dollars could send IBB to much higher levels. We believe that active investors might be more successful in hand picking individual companies instead of buying IBB. This would go along with a higher risk. Disclaimer: Please do your own research prior to investing and taking investment decisions. This article is provided for informal purposes only and any information mentioned may change at any time without a notice. Please consult your investment advisor for finding a proper allocation for your portfolio that is adjusted with your risk levels and personal situation. Editor’s Note: This article covers one or more stocks trading at less than $1 per share and/or with less than a $100 million market cap. Please be aware of the risks associated with these stocks.

Ill At Ease With Biotech? Prescribing #1 Healthcare ETFs

The recent carnage in biotech investing seems more vicious than anticipated. This hot corner of the broad U.S. healthcare market has seen many a correction before, but none seemed as rigorous as it looks now. The recent rout was instigated merely by a tweet – by presidential candidate Hillary Clinton. Her tweet raised concerns over the over pricing on life-saving drugs. Questions over biotech pricing came on the heels of a 5,455% price hike (in about two months) of a drug called Daraprim, used to treat malaria and toxoplasmosis. This gigantic leap in pricing action was taken by a privately held biotech company Turing Pharmaceuticals (read: How Hillary Clinton Crushed Biotech ETFs with One Tweet ). Pricing issues in the biotech space has long been a concern. On the whole, branded drug prices underwent a rise of about 14.8% last year, as per research firm Truveris. There are several other drugs namely cycloserine, Isuprel, Nitropress, and doxycycline that have seen enormous price hikes this year, per the source. This along with overvaluation concerns led to a bloodbath in this otherwise soaring sector last week. In fact, growing pains for biotech investing led the biggest related ETF iShares Nasdaq Biotechnology ETF (NASDAQ: IBB ) to incur the largest weekly loss in seven years. Plus, investors should note that biotech stocks underperformed the broader market during the last four election cycles, as noted by Barrons.com . Barrons’ analysis shows that the broader market indices including S&P 500, Dow Jones and NASDAQ composite gained 11%, 8%, and 18%, respectively, on average against 15% loss incurred by the NASDAQ Biotech index during last four election phases. In such a scenario, it is wise to take some rest off biotech stocks and ETFs, and instead spin your attention toward the more stable but equally promising broader healthcare ETFs (read: Guide to Inverse & Leveraged Biotech ETF Investing ). Why Broader Healthcare? The broader healthcare sector is also loaded with potential. A whirlwind of mergers and acquisitions, promising industry fundamentals, plenty of drug launches, growing demand in emerging markets, ever-increasing healthcare spending and Obama care play major roles in making it a lucrative bet for the long term. Moreover, unlike biotech, healthcare ETFs are relatively defensive in nature and do not completely let investors down even in a broader market sell-off. In the latest biotech tumult, when ETFs like the SPDR Biotech ETF (NYSEARCA: XBI ) , the ALPS Medical Breakthroughs ETF (NYSEARCA: SBIO ) and the BioShares Biotechnology Clinical Trials ETF (NASDAQ: BBC ) retreated in the range of 6% to 8% on September 25, most broader healthcare ETFs lost in the range of 2% to 3%. As a result, Zacks Rank #1 (Strong Buy) healthcare ETFs could be in watch ahead, at least until the penchant for biotech investing returns. Investors should note that the following healthcare ETFs hold a Zacks ETF Rank #1. PowerShares S&P SmallCap Health Care Portfolio ETF (NASDAQ: PSCH ) This ETF has delivered a spectacular performance in the broad healthcare world, returning nearly 25% so far this year and losing just 2.4% in the last one month overruling the biotech woes (as of September 25, 2015). The fund offers concentrated exposure to small cap healthcare securities. It holds 74 securities in its basket, with each security holding less than 4.61% share. From an industry perspective, about one-third of the portfolio is allotted toward healthcare equipment and supplies, followed by healthcare providers and services (28.3%) and pharmaceuticals (15.7%). The ETF has amassed $268.5 million in assets and trades in a lower volume of about 40,000 shares per day, while charging a relatively low fee of 29 bps a year. The fund continues to hold a Zacks ETF Rank #1 with a High risk outlook. SPDR S&P Health Care Equipment ETF (NYSEARCA: XHE ) This product looks to track the S&P Health Care Equipment Select Industry Index. Holding 73 stocks in its basket, each security accounts for less than 1.73% of total assets. This is often an overlooked fund with AUM of $51 million and average daily volume of about 5,000 shares. From an industry look, healthcare equipment accounts for over three-fourth of the portfolio while healthcare supplies have a considerable allocation. The product charges 35 bps in annual fees. XHE gained about 18.6% in the last one year and lost 4.2% in the last one month. It was also upgraded from Zacks Rank #3 (Hold) to Rank #1 in our latest Rank updates. iShares U.S. Medical Devices ETF (NYSEARCA: IHI ) This ETF follows the Dow Jones U.S. Select Medical Equipment Index with exposure to medical equipment companies. In total, the fund holds 52 securities in its basket with major allocations going to Medtronic Plc (NYSE: MDT ) and Abbott Laboratories (NYSE: ABT ) at 14.5% and 710.7%, respectively. The fund has been able to manage about $708 million in its asset base while volume is moderate at about 100,000 shares per day on average. It charges 45 bps in annual fees and expenses. This ETF was also upgraded from a Zacks ETF Rank #3 to Rank #1 recently. The product added 12.6% in the last one year and could be a nice pick for Q4. In the last one month, the fund lost 5.8% which was much lower than double-digit losses incurred by biotech ETFs. Link to the original article on Zacks.com