Around 20 million Americans have a progressive, life-threatening liver condition called non-alcoholic steatohepatitis (NASH), and there's isn't much doctors can do about it besides recommending fewer calories and more exercise.
Any day now, Intercept Pharmaceuticals (ICPT 3.64%) will share long-awaited pivotal trial results that could make its Ocaliva drug the first approved NASH treatment. The lead candidate at Madrigal Pharmaceuticals (MDGL -3.38%) is behind Ocaliva on the development timeline, but results so far tick all the right boxes. Let's examine the case for both stocks to decide which one is the better pick right now.
The case for Intercept Pharmaceuticals
Investigators are going to present long-awaited interim results for Intercept's only drug, Ocaliva in the first quarter. It's been five long years since midstage results sent the stock rocketing higher. A surprising 45% of patients given Ocaliva for 72 weeks showed significant NASH improvements, compared with just 21% of the placebo group.
Defining NASH is still a work in progress, but it involves liver cells that retain more lipids than they should, which causes them to balloon and become too inflamed to function properly. Since the condition progresses slowly, the FDA is willing to grant accelerated approval to the first candidate that can reduce NASH symptoms or reduce the scarring caused by long-term inflammation. Ocaliva hit both marks in its midstage study, and a repeat performance could send the stock soaring again.
The FDA approved Ocaliva in 2016 for the treatment of primary biliary cholangitis (PBC), a condition in which the immune system damages the path bile takes from liver to the stomach. Bile acids that back up into liver tissue cause all sorts of problems for an estimated 130,000 Americans with PBC, and this population needed a new treatment option.
Ocaliva is a super-potent analog of a natural bile acid, but PBC patients with seriously impaired livers should start with just 5 mg per week. More than a few patients with severe cirrhosis died after taking the recommended dosage for healthier patients, which is 5 mg every day. A more stringent risk mitigation strategy is doing its job, and sales are climbing again.
During the first nine months of 2018, Ocaliva sales rose 36% over the previous-year period to $125 million. That will help extend the company's cash runway, but not by much. Intercept's operating expenses reached $330 million during the same period.
At the end of September, the company had $489 million in cash after losing $221 million during the first nine months of 2018. If Intercept's long-awaited NASH results disappoint, raising any more cash will become nearly impossible. Beyond Ocaliva, the company doesn't have anything coming through its pipeline.
The case for Madrigal Pharmaceuticals
This pre-commercial biotech is developing a tablet that acts on the thyroid hormone receptor beta (TRB), which seems like the right target for treating NASH. Biopsies taken during a midstage study with MGL-3196 showed that 56% of patients given the drug experienced a significant reduction of NASH symptoms after 36 weeks, compared with just 32% of the placebo group.
Madrigal's experimental treatment ticked another box by reducing fibrosis as well. If MGL-3196 can produce improvements to NASH and the fibrosis it causes in a pivotal study as well, the drug should clear the FDA's hurdles without any trouble.
Although the agency is primarily concerned with inflammation and scarring, MGL-3196 impressed investors by helping NASH patients lower liver fat content, measured with an MRI, by 37%, compared with a 9% reduction in the placebo group. Shortly after Madrigal's day in the sun, though, Viking Therapeutics (VKTX 1.41%) released data for its TRB agonist that showed a liver fat reduction that was much stronger, but we haven't seen any biopsy results from a Viking candidate yet.
Madrigal doesn't have a revenue stream yet, but the clinical-stage biotech is running a much smaller operation than Intercept. In fact, Madrigal licensed its only clinical-stage candidate from Roche (RHHBY 1.05%) and owes the pharma giant a single-digit royalty percentage if MGL-3196 hits pharmacy shelves. Despite a complete lack of revenue during the first nine months of 2018, Madrigal lost just $21 million during the first nine months of 2018.
Phase 2 results for MGL-3196 hit the mark last May, but Madrigal still hasn't told investors if its phase 3 study for MGL-3196 will begin before the end of 2019. Madrigal finished September with $489 million in cash, which means it can probably afford to wait for a deep-pocketed drugmaker to make a buyout offer, or at least a partnership deal.
The better buy
If trial results on the way this quarter fall in line with earlier observations, Intercept could have a gigantic addressable patient population all to itself. The NASH market probably won't stay sewn up for long. A large underserved patient population has inspired a great deal of drug development, and right now there are dozens of potential competitors in mid- to late-stage testing.
Madrigal's $2.1 billion market cap seems like a compelling bargain for a drugmaker that wants to jump into NASH with a drug ready for late-stage testing, but we'll probably have to wait until at least one proves itself in the commercial setting. Intercept's a little more expensive than Madrigal, with a recent market cap of $3.2 billion, but Ocaliva's revenue stream now, coupled with a great chance at becoming the NASH population's first treatment option, makes it the better buy at the moment.
Check out he latest Intercept Pharmaceuticals earnings call transcript.