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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 | |
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 |
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. | |
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) Indication: Cardiovascular 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.
This blog post is from The Biotech Watcher
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And about us, see http://alanhobbes.blogspot.com/2014/12/welcome-to-my-personal-thoughts-about.html
Original Article: Esperion (ESPR) Q3-2017 Results
