Advertisement

Topics

Esperion (ESPR) Q3-2017 Results

04:36 EST 15 Nov 2017 | Biotech Watcher

On Tuesday, November 7, 2017, Esperion Therapeutics (ESPR) releasedits Q3-2017 results and filed its quarterly with the SEC. On the day before, Esperion announced the launch of its pivotal trial for the fixed-dose combination pill of bempedoic acid and ezetimibe. This is in patients with a high cardiovascular risk and LDL levels that are not well-controlled.

Financial Summary

Basic Facts for Quarter Ending September 30, 2017
(in Thousands except Share Price & Market Cap)

Q3-2017
Q2-2017
Q3-2016
  R&D Expense
40,056
38,248
13,498
  SG&A Expenses
5,681
5,412
4,214
Total Operating Expenses
45,737
43,660
17,712
Operating Income (Loss)
(45,737)
(43,660)
(17,712)
Net Income (Loss)
(45,219)
(43,337)
(17,402)
Comprehensive Income (loss)
(45,331)
-
(17,498)
Basic & diluted earnings (loss) per share
(1.86)
(1.92)
(0.77)
Avg. Shares Outstanding
Basic & Diluted
24,312
24,312
22,591
22,591
22,550
22,550
Recent Price (per share)
       46.28
(11/14/17)
       45.17
(8/7/17)
       9.40
(11/3/16)
Market Capitalization
1.2B
1.0B
212M
Cash & Equivalents
21,024
20,373
47,140
Short-term Investments
182,347
147,035
162,961
Long-term Investments
105,717
13,680
49,646

The increase in R&D spend reflects increased clinical trial costs as well as increases in employee headcount.  Esperion should end the year with about $272M in cash and securities, while burning $135M. This should be sufficient cash to last into Q1-2020, after regulatory submissions to the FDA.

The increase in cash reflects Esperion’s underwritten public offering in August 2017. This brought net proceeds of $164M. 

Milestones

Esperion Therapeutics - Clinical Milestones
ETC – 1002 - Bempedoic acid
Bempedoic acid is an inhibitor of ATP citrate lyase (ACL). ACL is the primary enzyme responsible for the synthesis of cytosolic Acetyl-CoA in many tissues. The product, Acetyl-CoA, in animals serves several important biosynthetic pathways, including the metabolic formation of fat and cholesterol synthesis. Bempedoic acid inhibits cholesterol synthesis in the liver, decreases intracellular cholesterol and up-regulates LDL-receptors, resulting in increased Low Density Lipoprotein-Cholesterol (LDL-C) clearance and reduced plasma levels of LDL-C.
CLEAR Program – Establish LDL-Cholesterol Lowering via ETC-1002
CLEAR HARMONY - ETC - 1002-040– 2,230 pts.
A global Phase 3 randomized, multicenter, double-blind, placebo-controlled study evaluating 180 mg of bempedoic acid versus placebo in 2,230 patients with hyperlipidemia at high cardiovascular disease risk and whose LDL-C is not adequately controlled with maximally tolerated lipid-modifying therapy. The study finished enrolling patients from approximately 100 sites in the U.S., Canada and the European Union.

The primary objective is to assess safety and tolerability of patients treated with bempedoic acid for 52 weeks. Secondary objectives include assessing the effects of bempedoic acid on lipid and cardiometabolic risk markers, including LDL-C and hsCRP.
Top-line Results
Q2-2018
Open-Label, Extension Study (1002-050) Results -1,400 Pts
Q4-2019
Phase 3 efficacy and safety study of bempedoic acid in Patients with Hyperlipidemia and Statin Intolerance. Pts on optimized background lipid-modifying therapy, but only able to tolerate less than lowest approved daily starting dose of their statin.
Top-line Results
Q2-2018
Phase 3 efficacy and safety study of bempedoic acid in Hypercholesterolemic Patients with ASCVDand/or HeFH. These are high cholesterol patients who are at risk for a cardio event and are not “Adequately Controlled with Current Lipid-Modifying Therapy” – this includes statin intolerant patients.
Top-line Results
Q3-2018
Phase 3 efficacy and safety study in Hypercholesterolemicpatients that are already taking ezetimibe. Subjects have elevated LDL-C not Adequately Controlled with Current Lipid Modifying Therapy. . Statin intolerant patients will take daily EZ (10 mg) ± BA (180 mg) for 12 weeks.
Top-line Results
Q2-2018
Study Completion
2H-2018
Establish Cardiovascular Risk Reduction (Outcomes)
A Phase 3 trial of outcomes in statin intolerant patients. Esperion management requires a set number of patients to experience a MACE event (CD death, heart attack, stroke, hospitalization for angina, coronary artery bypass). 1,437 events triggers the evaluation of the primary endpoint. Esperion will provide yearly updates in February.
Anticipated Top-line Results
1H-2022
Regulatory Submission
2H-2022
Fixed Dose Combination (FDC) Program
It’s a fixed dose tablet of 180 mg bempedoic acid + 10 mg ezetimibe (BA+EZ).  The aim is to support approval of a low-cost, oral, statin alternative in the United States and Europe. The US FDA has given the go-ahead for Esperion to use the 505(b)2 abbreviated pathway for approval. Although the pathway only provides 3 to 5 years of protection, Esperion owns patents on this treatment.
Phase 3 Bridging (Safety & Efficacy) study – 350 Pts at 125 U.S. sites
Daily 180 mg BA and 10 mg ezetimibe for 12 weeks.
Top-line Results
Q4-2018
Additional Phase 2 Exploratory Studies
Esperion will conduct additional exploratory studies of bempedoic acid in combination with other drugs, aiming to broaden the label.
Dual combination Therapy – Daily 180 mg BA and monthly PCSK9i (Repatha)
130 Pts in placebo-controlled trial.
Top-line Results
Q2-2018
Ex-USA Partnership
The extent of the (hoped for) partnership is unknown. There are several Big Pharma candidates that sorely need to reload or jumpstart its cardiovascular pipeline. While a partnership can be consummated in the near term, Esperion can afford to wait.
Announce Partnership
TBA
Regulatory Filings
Submissions for FDA / EMA Approval
New Drug Application (FDA) / Monotherapy
Indication: LDL-C lowering
Q1-2019
Monotherapy Marketing Authorization Application (EMA) / Monotherapy
Indication: LDL-C lowering
Q2-2019
New Drug Application (FDA) - Fixed-dose Combination Agent - BA+EZ (FDC)
Indication:  LDL-C Lowering
Q1-2019
Monotherapy Marketing Authorization Application (EMA) - FDC
Indication:  LDL-C Lowering
Q2-2019
Commercial Approvals – United States (FDA) & European Union (EU) -
Monotherapy & FDC - Indication:  LDL-C Lowering
1H-2020
New Drug Application (FDA) / Marketing Authorization Application (EMA) 
IndicationCardiovascular Risk Reduction
Q3-2022

Our Thoughts

Esperion has major milestones arriving in the short term.  Three clinical trials, from the Phase 3 CLEAR program, are scheduled for top-line results in Q2-2018: Harmony, Serenity, and Tranquility.  Two additional Phase 3 trial results should arrive in 2H-2018: Wisdomand the Fixed-Dose Combination.

Esperion management is also seeking a partnership, hoping to have it signed during the next few months. We’re perennially cautious about the timing with Big Pharma.

For better or worse, 2018 is shaping up to be a key year for Esperion. We expect ESPR to linger until Q2-2018 draws near.


Original Article: Esperion (ESPR) Q3-2017 Results

NEXT ARTICLE

More From BioPortfolio on "Esperion (ESPR) Q3-2017 Results"

Advertisement
Quick Search
Advertisement
Advertisement