Esperion Strikes Home Run On First Study For Cholesterol Drug

Summary

• Esperion Therapeutics announced positive results for a late-stage study treating patients with high cholesterol.
• Bempedoic acid was able to beat out placebo by a wide margin.
• There are more than 3 other readouts expected for 2018, which could cause the share price to trader higher in the coming months.
• Competitors have a higher cost and require injections, which gives bempedoic acid an edge.
• Esperion has cash to last until 2020, which will carry it though many other catalysts before running out.

Recently, Esperion Therapeutics (NASDAQ:ESPR) announced positive results for its phase 3 trial treating patients with high cholesterol. Patients recruited into the trial were those who had statin intolerance, and who had atherosclerotic cardiovascular disease or at a high risk for the disease. The results were nothing short of amazing, and although it was only the first study to be reported, I believe this program has a promising future. That's what makes ESPR a great buy.

Phase 3 Data

The newly reported positive phase 3 data is very important. That's because, for starters, it was the first of many to be reported. There are other studies to be reported in the coming year which can shed more light on the entire cholesterol drug program for bempedoic acid. Still, the results were very good. It was shown that patients treated over a 12-week period with bempedoic acid fared better than those who were given placebo. It was shown that there was a statistically significant reduction of LDL-C by 28% for those who took 180 mg of bempedoic acid. This was the primary endpoint of the study. It gave a p-value of p < 0.001.

In addition, the change in baseline of those treated with bempedoic acid was 23%. Why is that important? That's because those treated in the placebo group saw an increase of 5% in LDL-C. This data paints a good picture, but there was something else that was noteworthy from the study. It was shown that patients treated with bempedoic acid also experienced a 33% reduction for a biomarker called C-reactive protein. That's important because C-reactive protein is a biomarker for inflammation of cardiovascular disease. This compared to the placebo group, which saw an increase in C-reactive protein of 2%. The difference in this biomarker between treatment and placebo was also statistically significant with a p-value of p <0.001.

Additional Data

This is just the beginning in terms of data. That's because the next set of data are expected to come from two studies. These will be Study 1 and Study 3 in May 2018. Study 1 is looking at patients with atherosclerotic cardiovascular disease who are on maximum doses of statin. This differs from the study reported above. However, the other trial, Study 3, will be in patients with statin-intolerant ASCVD. Both of these studies are likely to confirm these initial findings and should shed more light on how well bempedoic acid works for patients with elevated levels of LDL-C.

Competitor

Should bempedoic acid eventually receive FDA approval, after the rest of the trials are confirmed, it will have to go up against PCSK9 inhibitors. Some pharmaceutical companies that have already received FDA approval for PCSK9 inhibitors to treat high cholesterol are Regeneron Pharmaceuticals (REGN) with partner Sanofi (SNY), and Amgen (AMGN). Regeneron and Sanofi's PCSK9 treatment is Praluent. Amgen's PCSK9 treatment is Repatha. Both of these treatments were hailed as being the next best thing for bad cholesterol. They were able to knock down LDL-C by as much as 70% in certain clinical trials. The problem is that they carry a heavy price tag of at least $14,000, including discounts. There has been a pushback by insurers to not cover these treatments for patients.

That's where bempedoic acid has the ability to shine. That's because its cost is expected to be cheaper than that for these PCSK9 treatments. That means there is a huge possibility that Esperion can get insurers to pay for bempedoic acid. In addition, bempedoic acid presents itself as a once-daily oral pill. On the other hand, PCSK9 drugs require an injection for treatment. Some of these differences may allow bempedoic acid to beat out its competitors.

Financials

Esperion Therapeutics has cash and cash equivalents of $273.6 million as of December 31, 2017. The company states that it is likely to end 2018 with approximately $130 to $140 million in cash. That means it will have enough cash until 2020. That is significant because it will be enough to carry Esperion through potential approvals for the combo of bempedoic acid, and bempedoic acid alone, by the first quarter of 2020. Of course, that is pending that it receives FDA approval for both of these treatments.

Conclusion

The positive results observed from Esperion Therapeutics' trial are highly bullish. Pending positive data stemming from the other upcoming readouts, I expect the stock to trade higher. The risk here would be the upcoming data readouts. There is no guarantee that those too will be positive, which could send the share price lower.

In addition, Esperion is relying heavily on bempedoic acid for treating patients with high cholesterol. There is nothing else in the pipeline, which means the stock could crash to new lows if the trial fails. However, the results just released were really good, as placebo was beaten by a huge margin. In addition, both the bempedoic acid group and placebo group saw similar side effects. I believe that any dip in share price for Esperion Therapeutics presents itself as a great buying opportunity.

Analyst’s Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Comments

[Bright spot]

$135 here we come again :)

[Helmutzerber]

25%, 40%

[Manzil]

Gemcabene (by Gemphire) is being developed as an add-on treatment to statins, whereas ESPR's Bempedoic Acid is a replacement for statins. Also I think Gemcabene, for what it's worth, was abandoned by Pfizer before Gemphire licensed it.

[nsolot]

"I think Gemcabene, for what it's worth, was abandoned by Pfizer before Gemphire licensed it."

More or less. I think Pfizer ran 17 studies and then concluded:

" The full modeling results, backed by data from multiple trials and displayed in DMX, made it clear to the team that gemcabene combination therapy would not provide superior cholesterol-lowering benefit versus ezetimibe combinations."

http://bit.ly/2vgt0aE

That said, Pfizer still owns Gemcabene, and GEMP, if successful in their studies, will have to pay Pfizer some big royalty payments.

The results from GEMP's phase 2b study, released August 7, 2017 were less than what ESPR just reported in their phase 3:

"Fifty-six (56) females and 49 males with a mean age of 61 years were enrolled. The mean baseline LDL-C was 130 mg/dL. Gemcabene 600 mg produced a mean percent change in LDL-C of -17.2% vs -5.5% for placebo (ANCOVA: p=0.0057). Gemcabene 600 mg produced a median percent change in hsCRP of -40.0% (ranked ANCOVA: p<0.0001) vs -6.1% for placebo. Additional secondary results and subpopulations assessments will be provided once the full dataset has been analyzed."

On the conf call they explained that Gemcabene only lowered LDL-C by ~12% when adjusted for the 5% reduction in the placebo patients.

[Helmutzerber]

You have no idea. Do you know people at both companies?

[Helmutzerber]

So without placebo, espr has 23% ldlc and 33% hscrp. Look at Gemphire.