2 Hotly Debated Drugs Due For FDA Decisions Next Week

In the week before Memorial Day, the FDA is due to decide whether to approve two of the most divisive drugs in the biotech industry, both of them crucial for the companies that make them, Sarepta Therapeutics and Intercept Pharmaceuticals. Thursday is the deadline for eteplirsen, Sarepta Therapeutics ‘ ( SRPT ) treatment for Duchenne muscular dystrophy (DMD). Just getting to the filing took years of negotiation between Sarepta and the FDA, and May 26 is three months later than the decision was originally supposed to be made. And after all that, Wall Street is placing low odds on the drug’s approval. That’s based mainly on last month’s advisory committee meeting on eteplirsen, which voted 7 to 3 (with 3 abstentions) that the drug’s effectiveness wasn’t adequately proven by Sarepta’s tiny clinical trial. Sarepta stock hit a four-year low of 8, on April 26, as multiple analysts downgraded it on the assumption the drug will be rejected. Nonetheless, DMD is a devastating disease without a current treatment, and the families of the children affected have turned into a formidable lobby to get something on the market — especially after BioMarin Pharmaceutical ‘s ( BMRN ) rival drug Kyndrisa was rejected in January. Some observers say the families’ desperation might be enough to move the agency. Oppenheimer analyst Christopher Marai on May 2 upgraded Sarepta on the grounds that, in the past, the FDA has been more flexible in such cases of unmet need. He also pointed out that the stock was now cheap. Sarepta stock has remained volatile but has steadied somewhat the past couple of weeks. On Friday, shares jumped 8.8%, to 19.15. Intercept’s Liver-Disease Treatment Expected To Get OK A day after the Sarepta decision, Intercept Pharmaceuticals ‘ ( ICPT ) liver-disease treatment Ocaliva is due for a verdict. Ocaliva’s advisory committee vote last month went the opposite way of eteplirsen’s, with the panel unanimously supporting approval for the drug, which treats the rare disease primary biliary cholangitis (PBC). As a result, Wall Street generally expects approval. Bears, however, are still growling about Ocaliva’s safety, which they say could limit the drug’s label. The day after the panel vote, Morgan Stanley analyst Andrew Berens drove down Intercept’s stock with the theory that the FDA would discourage use in patients with advanced cirrhosis. This might affect not only the relatively small PBC market, but also the much, much bigger possibilities for Ocaliva in non-alcoholic steatohepatitis (NASH). Intercept is testing the drug in NASH, and approval wouldn’t be for a couple of years, but it’s a major part of the stock’s bull thesis, as analysts see annual sales in the multi-billions. Intercept stock has been on a downtrend this month, but it rose 2.4% this past week. On Friday, shares closed up 2.2%, at 134.28.

The Dead Model

Click to enlarge How Lucky Do You Feel? Nine years ago, I wrote about the so-called “Fed Model.” The insights there are still true, though the model has yielded no useful signals over that time. It would have told you to remain in stocks, which given the way many panic, would not have been a bad decision. I’m here to write about a related issue this evening. To a first approximation, most investment judgments are a comparison between two figures, whether most people want to admit it or not. Take the “Fed Model” as an example . You decide to invest in stocks or not based on the difference between Treasury yields and the earnings yield of stocks as a whole. Now with interest rates so low, belief in the Fed Model is tantamount to saying “there is no alternative to stocks.” [TINA] That should make everyone take a step back and say, “Wait. You mean that stocks can’t do badly when Treasury yields are low, even if it is due to deflationary conditions?” Well, if there were only two assets to choose from, a S&P 500 index fund and 10-year Treasuries, and that might be the case, especially if the government were borrowing on behalf of the corporations. Here’s why: in my prior piece on the Fed Model, I showed how the Fed Model was basically an implication of the Dividend Discount Model. With a few simplifying assumptions, the model collapses to the differences between the earnings yield of the corporation/index and its cost of capital. Now that’s a basic idea that makes sense, particularly when consider how corporations work. If a corporation can issue cheap debt capital to retire stock with a higher yield on earnings, in the short-run it is a plus for the stock. After all, if the markets have priced the debt so richly, the trade of expensive debt for cheap equity makes sense in foresight, even if a bad scenario comes along afterwards. If true for corporations, it should be true for the market as a whole. The means the “Fed Model” is a good concept, but not as commonly practiced, using Treasuries – rather, the firm’s cost of capital is the tradeoff. My proxy for the cost of capital for the market as a whole is the long-term Moody’s Baa bond index, for which we have about 100 years of yield data. It’s not perfect, but here are some reasons why it is a reasonable proxy: Like equity, which is a long duration asset, these bonds in the index are noncallable with 25-30 years of maturity. The Baa bonds are on the cusp of investment grade. The equity of the S&P 500 is not investment grade in the same sense as a bond, but its cash flows are very reliable on average. You could tranche off a pseudo-debt interest in a way akin to the old Americus Trusts , and the cash flows would price out much like corporate debt or a preferred stock interest. The debt ratings of most of the S&P 500 would be strong investment grade. Mixing in equity and extending to a bond of 25-30 years throws on enough yield that it is going to be comparable to the cost of capital, with perhaps a spread to compensate for the difference. As such, I think a better comparison is the earnings yield on the S&P 500 vs the yield on the Moody’s BAA index if you’re going to do something like the Fed Model. That’s a better pair to compare against one another. Click to enlarge A new take on the Equity Premium! That brings up another bad binary comparison that is common – the equity premium. What do stock returns have to with the returns on T-bills? Directly, they have nothing to do with one another. Indirectly, as in the above slide from a recent presentation that I gave, the spread between the two of them can be broken into the sum of three spreads that are more commonly analyzed – those of maturity risk, credit risk and business risk. (And the last of those should be split into an economic earnings factor and a valuation change factor.) This is why I’m not a fan of the concept of the equity premium . The concept relies on the idea that equities and T-bills are a binary choice within the beta calculation, as if only the risky returns trade against one another. The returns of equities can be explained in a simpler non-binary way, one that a businessman or bond manager could appreciate. At certain points lending long is attractive, or taking credit risk, or raising capital to start a business. Together these form an explanation for equity returns more robust than the non-informative academic view of the equity premium, which mysteriously appears out of nowhere. Summary When looking at investment analyses, ask “What’s the comparison here?” By doing that, you will make more intelligent investment decisions. Even a simple purchase or sale of stock makes a statement about the relative desirability of cash versus the stock. ( That’s why I prefer swap transactions .) People aren’t always good at knowing what they are comparing, so pay attention, and you may find that the comparison doesn’t make much sense, leading you to ask different questions as a result. Disclosure: None

Facebook’s Alleged Liberal News Bias Gets Comedy Treatment

Facebook ( FB ) CEO Mark Zuckerberg met with conservative news figures this week to address concerns that editors of the social network’s Trending Topics feature have been suppressing conservative viewpoints. That gave comedians and satirists a great opening to take some shots at Facebook for its alleged liberal bias. “Late Show” host Stephen Colbert slammed Facebook for having misplaced priorities. “Apparently, Facebook censored popular stories about conservative topics from appearing on the trending news section. Folks, I think this is wrong,” Colbert said. “If Facebook is going to censor things, why not get rid of the stuff people really don’t want to see, like your ex’s tropical honeymoon? Or invitations to co-workers’ improv shows?” Satirical news website The Onion presented a fake response from Zuckerberg, who questioned why people are getting their news from Facebook to begin with. “Facebook is a great place to connect with friends and family, but frankly, if you’re on our site for 20 minutes or longer during the day and you’re reading the articles on here as your main connection to what’s actually happening in the world, then I’d say you’re a little mistaken about what this site is actually all about,” fake Zuckerberg said. “I’m happy to show anyone how to get to a regular news site if you need a little help.” Online comic The Joy of Tech also took a jab at the Facebook bias controversy. Plus, the story was material for political cartoonists including Jeff Darcy of Cleveland.com and Rick McKee of the Augusta Chronicle . Amazon, Tesla Also Come In For Some Zingers Facebook’s trending-news hullabaloo isn’t the only tech subject tickling funny bones lately. What follows are recent jokes from late-night comedians Jimmy Fallon, Conan O’Brien and James Corden. Their zingers were directed at Amazon.com ( AMZN ), CBS ( CBS ), Alphabet ( GOOGL )-owned Google, Priceline ( PCLN ), Tesla Motors ( TSLA ), Twitter ( TWTR ) and Uber Technologies. Fallon: Tesla unveiled its new model 3 electric car. And I saw that fans were camping outside Tesla stores to reserve one. Camping out is actually great practice for when their cars run out of power 30 miles from the nearest outlets. Fallon: Amazon Prime just unveiled new buttons you can press to order Doritos, Red Bull, and Trojan condoms. Yeah, Doritos, Red Bull and condoms. Or as that’s called in New Jersey, “A gift basket.” Fallon: The CEO of Priceline just resigned after it was revealed that he had an affair with an employee. As you can imagine, his wife is pretty mad, but on the bright side, at least he knows where to find a good deal on hotels. Fallon: CBS announced that season 33 of “Survivor” will be called “Survivor: Millennials vs. Gen-X.” It’ll start in September, and end 20 minutes later when both teams realize there’s no Wi-Fi. Conan: This week is the 43rd anniversary of the first cellphone call. Historians still don’t know which movie theater it took place in. Conan: Over the weekend, a man broke the world record for “Donkey Kong,” making it through the entire game using up just one life. That’s right — his own. Conan: Google has created several new emojis aimed at empowering women. So congratulations women, you asked for equal pay and you got five new emojis. Corden: The social media platform Twitter just signed a historic deal with the NFL to live stream Thursday Night Football games this coming season. Before this, the only thing Twitter ever live streamed was Kanye West’s meltdowns. Corden: The driverless car thing seems like it’s really catching on lately. In fact, the ride-sharing company Uber has begun testing driverless cars on the streets of Pittsburgh. Finally, Uber found a way to make out-of-work actors even more out of work. Corden: But don’t worry, for all of you who love Uber, the experience isn’t really going to change. To keep in line with Uber’s brand, their driverless cars will be programmed to smell like cologne and also make female passengers really uncomfortable.