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From: Sultan Sulayem 
To: [email protected] 
Subject: Praluent's sales could eclipse $7 billion. 
Date: Sun, 09 Aug 2015 18:11:11 +0000 
Will Regeneron's New Drug Break The Bank? 
Regeneron and Sanoties newly-launched Praluent could cause healthcare costs to soar. 
Todd Campbell 
TMFEBCapital 
Aug 5, 2015 at 8:03AM 
,,,Money Inside Pills Flickr User Chris Potter 
Source: Flickr user stockmonkeys.com
Nose-curling, sky-high drug prices are drawing everyone's ire, and while a lot of that fury is being directed at 
recently-launched hepatitis C drugs, a new target could soon emerge in the form of a new class of cholesterol 
busting medicines that includes Regeneron (NASDAQ:REGN) and Sanofi SA's (NYSE:SNY) recently-
approved Praluent. 
The FDA gave Regeneron and Sanofi a green light to begin selling Praluent last week, and the two companies 
wasted little time before announcing that their new drug will cost a jaw-dropping $14,600 per year. 
Innovating treatment 
There's no question that there's a massive need for new therapeutic approaches that can reduce the risk of 
heart disease. More than 600,000 Americans die from heart disease every year, making it the number one 
cause of death among both men and women. 
For decades, cholesterol-lowering statins have been the primary weapon used by doctors to battle heart 
disease. Statins, which work by reducing cholesterol production in the liver, have been proven to both lower 
bad cholesterol levels and reduce the risk of major cardiac events, such as heart attack and stroke. As a result, 
statins have become the most widely-prescribed drugs in the United States, with millions of patients taking 
them every year. 
Although statins do a solid job of reducing cholesterol levels, they don't work for everyone. Some people 
don't respond to statin therapy, others discontinue using them because of their side effects, and some achieve 
only a marginal benefit from them. 
For that reason, Regeneron and Sanofi believe that Praluent could become part of a new standard of care for 
these patients. 
As a PCSK9 inhibitor, Praluent works differently from statins by blocking the activity of a protein that is 
responsible for breaking down bad cholesterol receptors in the liver, in turn improving the body's ability to 
flush cholesterol out of the blood stream. 
During clinical trials, patients taking a combination of Praluent and statins saw their bad cholesterol drop by 
62% versus statins alone, and that kind of efficacy suggests that combining a PCSK9 inhibitor like Praluent 
and a statin delivers an incredibly potent one-two punch. 
Not for everyone (yet) 
Although Praluent put up strong results in clinical trials, its use -- at least initially -- will be limited primarily 
to people with stubbornly high cholesterol, such as those suffering from genetic mutations like homozygous 
familial hypercholesterolemia, or HoFH, and heterozygous familial hypercholesterolemia, or HeFH, and to 
people who have already suffered a heart attack or stroke and require additional intervention. 
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Although that is a more limited pool of patients than statins treat today, industry watchers think that ongoing 
studies evaluating PCSK9 inhibitors more thoroughly could lead to it becoming a standard used to treat all 
patients at risk of heart disease. 
If so, then Praluent and other PCSK9 inhibitors could pose a major threat to healthcare payers, who would 
likely have to respond to surging expenses with increasingly larger monthly insurance premiums or patient co-
pays. 
According to pharmacy benefit manager Express Scripts, a company that manages drug programs for 
millions of patients, up to 71 million Americans could someday qualify for treatment with PCSK9 inhibitors 
like Praluent. At its current price, treating all those patients would cost more than $1 trillion annually. For 
comparison, Americans currently spend about $374 billion per year on all their medications. 
Looking ahead 
Early on, Regeneron and Sanofi estimate that the addressable patient pool likely ranges between 8 million and 
10 million Americans. If the companies succeed in treating 500,000 of those patients in the coming year, 
Praluent's sales could eclipse $7 billion. 
Of course, that number doesn't reflect the likely discounts that will be offered to payers, so the amount could 
prove to be significantly lower than that. Also, other companies are likely to launch their own PCSK9 drugs 
soon, including Amgen, which is expecting an FDA decision later this month. As new competitors roll-out 
their products, it should result in larger gross to net price cuts that will bring down the amount spent on these 
drugs too. 
Regardless, Regeneron and Sanofi's newly-approved drug and the billions of dollars in potential revenue that 
could be coming due to its lofty price tag sets the stage for yet another contentious debate over whether or not 
drug prices are justified. 
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