VVUS: Hey, Wha’ Happened?

Vivus (VVUS) is a pharmaceutical company based in Mountain View, CA, that is focused on the development of treatments for obesity, diabetes, and sleep apnea.  One of Vivus’ development programs afforded Qysmia (formerly Qnexa), which was approved by the FDA on July 17th, 2012, for chronic weight management, a potentially huge market.  Various numbers are thrown around; it is estimated that sales for weight management therapeutics may reach $160 million by 2014, and some sources cite the market to top well over $1 billion in 2020.  Regardless of actual market size, obesity is becoming a real threat to global health as it has been linked to both heart disease and type II diabetes.

Interestingly, Qysmia is a combination of two organic molecules: phentermine, an appetite suppressant with a somewhat checkered past (the non-harmful component to the drug combination “fen-phen.”), and topiramate, an anticonvulsant first approved by the FDA in 1996.  Of course, Vivus’ advantage in their technology is the patented controlled release of the combination.

(As an aside, it’s an interesting state of affairs for the pharmaceutical industry when all therapeutics in a company’s pipeline are rehashes of an existing product.  Indeed, it has become rather common to find new therapeutic uses for existing drugs.)

Vivus’ stock has seen large fluctuations in its price and I wanted to delve into how we should approach this potential investment.  Is Vivus a good investment considering the potential market for weight management therapeutics?

In early 2012, Vivus’ stock price was hovering around $12.  On February 22nd, 2012, an FDA Advisory Committee recommended for approval of Qsymia (then Qnexa) (yellow arrow).  Subsequently, the next day the stock nearly doubled to $20.70.  The stock gradually rose on anticipation for the official FDA announcement originally slated for April 17th, but delayed for July 17th (purple arrow).  On July 17th, the FDA approved Qsymia for chronic weight management and on July 18th the stock hit a 15-year high at $31.21 (light blue arrow).

VVUS, Daily chart, freestockcharts.com

As is often typical with biotech stocks around the news of a drug approval (or rejection), there is a large amount of “buy the rumor, sell the news“.  As such, the stock could not sustain the highs and dropped to its pre-approval ranges between $21 and $23 as investors took profits.  They were hit with more bad news as the shares fell on initial concerns that Qsymia would fail EU approval (white arrow).  Just last month, an EU committee rejected Vivus’s application to sell the weight loss drug in the European Union (red arrow).  This was a big hit on a potential market for them and the chart reflects this bearish outlook as we may be heading for lower lows.

Most recently, Vivus announced Q4 earnings on Feb. 25th, and they came in lower than analysts were expecting.  Wall St. analysts were expecting $3.1 million in revenue from scripts of Qsymia, however Vivus announced quarterly earnings of $2 million for the 3 month period and their selling and administrative costs jumped to $50 million.  At this rate of cash burning, they will most likely need to raise capital within the next couple of months, despite the fact that they raised around $170 million by issuing a public offering a little over a year ago.

With such a potentially large market, one has to wonder what in the world is going on over at Vivus?  The situation is similar to Dendreon’s botched rollout of Provenge, a cutting edge, personalized prostate cancer treatment.  Here we have this promising new therapeutic waiting to benefit those that need it and then we have a management team that is unable to bridge the gap from clinic to market.  Often overlooked, the drug launch is a critical step in establishing a market fit for the therapeutic and one that can set the tone for the company’s stock price for months, even years, after the initial FDA approval.

So what is Vivus, Inc, actually worth?  What kind of top-line revenue can we expect in 1 year of Qysmia on the market?  Or in 5 years?  Valuing a company with no real profit margins is a difficult task, but one we can do by discounting future earnings and calculating the net present value.   Bear with me on my crude discounted cash flow analysis excel model, but here’s my shot at it.

VVUS, DCF Analysis, $10M annual revenue in 2013, 30% growth

In our most unrealistic bullish example, let’s assume an aggressive 30% yearly growth, a 0% tax rate, and zero costs (numbers shown are in millions).  Unlikely, but let’s just see how it plays out when they reported revenue of $2 million over the 3 month period with a reasonable quarterly growth rate of about 7%.  Taking a look at the Total Equity Value box, in order for a market capitalization of over $2 billion to be justified, the EBITDA multiple would have to be 100x.  Consider the average EV/EBITDA multiples by industry here and here.  The total market average multiple is around 8.0x, but biotech companies have a higher multiple because of their growth potential, so the average EV/EBITDA multiple for the biotech industry is 22.46x.  At 22.5x, projecting $10 million in revenue for 2013 would justify a market cap of $600 million.

At a current price of $11/share and 100.66 million shares, the market cap is $1.1 billion.  At this price level, one can consider VVUS to be overvalued.  It can also be said that perhaps Wall St. overestimated the market size (or market interest) in weight management therapeutics.

VVUS, DCF Analysis, $100M revenue, 30% growth

Now let’s assume Vivus was able to generate $100 million in top line revenue, and this time let’s tax the revenue at 35%.  This kind of revenue could justify a $5 billion valuation.

The questions, then, are just how big is the market for weight management therapeutics and how big of a slice can Vivus carve out?  Vivus gets first mover advantage when considering the competition in the space.  Arena’s Belviq is scheduled to launch this year, however there is uncertainty in an exact date.  Regardless, competitors are nipping at Vivus’ heels as Piper Jaffray has forecast sales of Belviq to approach $3 billion in 2015.  It may seem as though Doctors are holding out on writing prescriptions for Qysmia until they can get a read on Belviq and its advantages and disadvantages per patient over Qsymia.  Other competitors are readying their pipelines, including Orexigen (with Contrave and Emptic) and Zafgen (with Beloranib), so the space will get crowded fairly quickly.  Vivus’ best bet is to carve out a healthy market share before this happens.

Moving forward, I would like to see the Q1 2013 earnings to be over $5 million.  To me, this would justify its current price above $10/share.  Ideally, I would prefer to see earnings above $10 million for Q1.  If this happens, and guidance is strong (that is, if we will see $20 million in quarterly revenue soon), I could see a pop back above $20/share.

In terms of where we’re heading now, technically it looks rather bearish.  In the 5 days it took for me to conceive of, write, and finalize this blog post, VVUS has dropped almost 10% in price and shed nearly $100 million in value.  We’ll see some support at $10.00, but the next earnings report will be an important one.

As for me?  I can no longer endorse VVUS as a solid investment until we see better prescription numbers and a more solid earnings report.  I’m also skeptical that VVUS can use their first mover advantage and obtain a large portion of the market before competitors begin to enter.

Additionally, I’m more intrigued by their competitor’s chemistry, particularly Zafgen’s ZGN-433, than that of Qsymia.  ZGN-433, or Beloranib, has been extensively written about on The Haystack, C&EN’s blog.  Interestingly, Beloranib is an analog of fumagillin, which has been investigated as an angiogenesis inhibitor for the treatment of cancer.  Beloranib is structurally interesting to me in particular as I have had a working relationship to a number of fumagillin analogs.  The two epoxide rings seem to be critical for MetAP2 inhibition, and the (N,N-dimethylamino) ethyl ether moiety seems to be a popular functional group that may improve potency and resist metabolic oxidation.  (I’ll concede the two epoxides may make one cautious when considering toxicity.  It has been hypothesized that the two epoxides are the cause, at least partially, to the toxicity of fumagillin – would this make FDA approval more difficult?  It will be interesting to see how Zafgen’s ZGN-433 performs in clinical trials.)

It’s a fascinating space, and one that should get more interesting once a few more players enter the market.  VVUS and ARNA are companies to keep an eye in the near future, but I’d like to get a clearer view of the actual weight management market.

So, readers, what do you think?  Is VVUS a buy at $10?  At $5?  Or is ARNA the better buy?  And, maybe more importantly to my science-leaning readers, whose chemistry is more intriguing to you?

Of course, I shouldn’t leave you hanging like that, so here is my favorite Fred Willard scene in A Mighty Wind.

It should be noted that I have no positions in any stocks mentioned (or unmentioned) and no intention on initiating any positions in any stocks mentioned (or unmentioned) in the next 6 months.  Furthermore, the information on this blog should not be considered financial advice; I am not an investment professional nor do I have any credentials designating myself as such.  The main purpose of the blog is to educate its readership, myself included, about concepts and ideas that were previously unknown to me.

New Highs: Where Are We (and how’d we get here)?

S&P 500, Hourly, freestockcharts.com

We’ve just broken into rarified air as the markets moved higher yesterday.  The $1530 mark seemed troublesome in February, but this yesterday morning we blew through it as we hit a high of $1543.47 on the S&P, while we blazed new highs on the blue-chip Dow.  It wasn’t easy getting here, and as I mentioned in an earlier blog post, there has been some volatility as we touched the lower trendline of the megaphone pattern on Feb 25th.  We are now among distinguished company as we are coming up on the highs of 2000 and 2007, $1552 and $1576, respectively.  Wall St. has made a pretty remarkable recovery, when you think about it, considering that Main St. hasn’t necessarily seen the same kind of recovery.  The national unemployment rate has been hovering around 7.9%, whereas it was just under 5% in 2007 and closer to 4% in 2000.  Indeed, it may be true that 8% is the new normal and we will never see pre-2007 unemployment levels again.  I just can’t, however, endorse these new market highs as indicative as a general economic recovery.  Label me all you want as a curmudgeon or a permabear, but hear me out for a second.

Let’s take a look at a very long-term chart:

S&P 500, Monthly, freestockcharts.com

This is a monthly chart of the S&P 500.  As you can see, we were in a reasonable trading channel in the late 80s-early 90s.  Something started clicking in 1995 and the markets shot up and never looked back, until, of course, late 2000-early 2001.  What exactly that something was would probably make for a good post, but I won’t open that can of worms right now.  Previous levels of resistance became support as we crashed down from the highs of 2000 to the lows of late 2002-early 2003.  After peaking again in 2007, we crashed back down to the lower trendline of the 80s/90s trading channel for the crash of 2008.  Clearly, this trading channel has served us well, so there must be something to it.  If you back-calculate the channel, the return for the that late 80s-early 90s trend is about 7%.  Which essentially means that if you put money in the market in the early 80s and took it out during the crash of 2008, you would average about an 7% return per year.  That’s really not so bad and it’s pretty much what the benchmark is for what an ideal return is for the markets.

The question then becomes: is the stock market overvalued or is it undervalued?  Since we seem to be nearing all-time-high levels, and way up above the 7% trendline, one could argue that the markets are overvalued at the moment.  However, the current Price to Earnings ratio of the S&P 500 is around 17.5.   That’s reasonable when you consider that a stock with a P/E under 20 is generally considered to be of fair value.

I would argue that the quantitative easing program by the Fed has artificially inflated equity prices and that when (not a matter of if) the Fed announces an easing of the easing, the markets will come back down to earth.  This was evident on Feb. 25, when the Fed announced they were just considering weaning off the QE program.  I’m not going to sit here and tell you QE hasn’t been a good thing, it’s clear that it has helped.  What I am saying is that as soon as the Fed pulls the plug, there may be some unintended consequences.

Of course, technical analysis has its limits.  It can only tell you where you currently are and how you got there.  Technical analysis is not a crystal ball and cannot tell you where you will go.  That part takes knowledge, experience, and a little bit of luck.  The best we can do is make an educated guess as to where the markets will go when you consider the historical price movements and the overall economic outlook.  The contrarian in me rejects the irrational exuberance of these new highs.  It has been said that early morning traders trade on emotion and impulse, whereas late-day traders trade on experience and knowledge.  Now, I’m not sure about the validity of that claim, but consider the intraday trading of last few days.  We popped up early in the morning on March 6th, Feb 28th, Feb 27th and we dipped on late-day trading on Feb 28th, and Feb 25th.

If I had to predict where we’re heading, I’d argue we’d make new highs here and may even test the all-time-high of the S&P at $1576, possibly testing $1600.  However, I expect to see an exhaustive gap up followed by a healthy pullback from these levels and a 61.8 fibonacci retracement to $1450 or lower to $1350.  It’s only once we create a solid foundation, we’ll push to new highs.  So I would be wary about adding money at these levels, so it may be best to keep equity levels where they are, possibly take profits.

It should be noted that I have no actual positions in any stocks mentioned (or unmentioned) nor will I be initiating any actual positions in the next 6 months.  Furthermore, the information on this blog should not be considered financial advice.  The main purpose of the blog is to educate its readership, myself included, about concepts and ideas that were previously unknown to me.