Cowen Conference Spotlight: Biogen, Regeneron and Lilly Provide Insight

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With Cowen and Company’s 39th Annual Health Care Conference going on in Boston this week, a lot of stories in the biopharma industry are coming out. Here are a few highlights.

Biogen Emphasizes Pipeline Other Than Aducanumab

Biogen’s chief executive officer Michel Vounatsos participated in an interview with Cowen & Company analyst Phil Nadeau. One of the striking things was that Vounatsos stated almost immediately that “Importantly, we have enriched and advanced our pipeline portfolio very well beyond aducanumab.”

An ongoing area of intense interest is Biogen’s aducanumab for Alzheimer’s disease, which in a desert wasteland of failed clinical trials, aducanumab sometimes feels like the sole survivor, with big expectations for its clinical trials in the next year or two. But Vounatsos’ discussion emphasized the company’s many efforts and pipeline projects other than aducanumab, saying, “Beyond aducanumab and the leading AD (Alzheimer’s disease) portfolio, Biogen certainly has ALS compounds, has PSP compounds. So, beyond, MS, SMA, we have now neuromuscular franchise opportunity, we have ophtha franchise opportunity, we have AD franchise opportunity, movement disorders and stroke where we are now in Phase III. So, this opportunity to bring forward this pipeline in the early 2020 is actually what this team was able to deliver, while at the same time, continue to deliver on the current base.”

Regeneron’s Praluent Grows Despite Patent Battles

Regeneron Pharmaceuticals’ senior vice president, Portfolio Management, Jay Markowitz, and executive vice president, Finance, and chief financial officer, Robert Landry, spoke with Cowen analyst Yaron Werber. The discussion was wide-ranging, and of course, the company’s relationship with Paris-based Sanofi came up because of their long-term development and commercialization partnerships. The two companies have been engaged in patent lawsuits with Amgen over their Praluent versus Amgen’s Repatha, both for hard-to-treat cholesterol. A recent court decision in Germany went to Amgen, there’s an injunction in Japan, and there was an appeal decision in the U.S. recently, with the U.S. Supreme Court refusing to hear Amgen’s case. As a result, Werber asked about Regeneron’s strategy and outlook for the drug.

Landry responded, “I would say with that product, everything is on the table. What we’re trying to do with our Sanofi friends are to ensure that the OpEx (operating expense) pertaining to that product right now is in a space where we continue to maintain some share of voice because we’re going against a pretty big competitor with regards to Repatha. So we want to maintain some share of voice but yet have it very monitored in such a way that if it’s only going to develop X amount of sales, that we’re able to make profitability off of that product. So currently, it is wait-and-see, and we continue to look at options in terms of how this is going to play out.”

Which seems to be a way of saying they don’t plan to abandon it, but they’re working on ways to keep it profitable.

And Markowitz notes that, considering cardiovascular disease is the leading cause of death in the developed world and the class of drugs that Praluent and Repatha belong in are safe and effective, “It’s stunning to me that the class of drugs is not used more broadly and more widely and that these—and that the whole focus of this has been on what’s the IP position in the patents.”

Which is a tiny bit disingenuous, given that the PCSK9 inhibitors like Praluent and Repatha run about $14,000 per year compared to the standard-of-care, statins, which run about $600 per year.

For all the IP issues, Praluent sales grew about 40 percent in the U.S., bringing about $300 million globally.

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Eli Lilly Closes Elanco Separation, Digs into Oncology and Focuses Diabetes

Eli Lilly’s executive vice president and chief financial officer Josh Smiley was interviewed by Cowen’s Steve Scala. It began with the recent news on the Elanco separation, which was announced last year, and made up about 15 percent of Lilly’s topline. Smiley said, “We IPOed 20 percent of the shares in September of last year, and then we concluded that exchange this morning and announced that it was successful. We actually had about a little bit more than five times the oversubscription. So, the Proration factor was about 13 percent for people who chose to participate.”

He noted that some of the company’s debt will drop because of Elanco, but that will be offset by the debt the company incurred when it acquired Loxo Oncology for about $8 billion. That led to a discussion of the Loxo deal, with Smiley saying, “What got us the most excited was as we looked at that LOXO-292 data and understood the patient population around the world … we felt quite confident that there is a big enough patient base and the efficacy and safety data that we see so far is compelling that there is a significant commercial opportunity. So, we think the 292 is derisked clinically. We’re confident that we’ll have enough data before the end of the year to submit and be ready to launch the product in 2020.”

LOXO-292 is a first-in-class oral RET inhibitor granted Breakthrough Therapy designation by the FDA for three indications.

They also discussed the diabetes drug Trulicity, particularly as it faces competition from other GLP-1 analogs. Smiley said “We see lots of opportunity in the GLP space overall. From an overall patient population perspective, our data still says that only about 3 out of 10 patients who get a first injection are getting a GLP versus a basal insulin, I think that that data should be much closer to 100 percent. So, there’s a lot of room for patient growth in the class. Now, what we see with Trulicity is we think a very well-positioned product to help continue to enable that growth.”

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