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ENTA’s fully-diluted* share count @3/31/21=24.1M—an increase of 0.2M since 12/31/20 (#msg-161707883).
The 24.1M figure above consists of: 20.2M basic shares on the 3/31/21 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/1177648/000156459021026025/enta-10q_20210331.htm#CONSOLIDATED_BALANCE_SHEETS ); and 3.9M options outstanding at 3/31/21 (whether or not exercisable) (ibid, page 13).
*Non-treasury method.
ENTA’s pro forma cash @3/31/21=$426.1M—a decrease of $15.3M since 12/31/20 (#msg-161707561).
The $426.1.4M figure above consists of: $401.6M of net current assets on the 3/31/21 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/1177648/000156459021026025/enta-10q_20210331.htm#CONSOLIDATED_BALANCE_SHEETS ); and $24.5M of marketable securities on the 3/31/21 balance sheet designated as long-term (e.g. bonds with a time to maturity greater than one year).
Yes, HBV is now the lead program, for all practical purposes. RSV is ready to roll—as soon as the virus makes a re-appearance, which might not be for another six months or so. NASH has been relegated to an afterthought.
Compact, yes.
Each presentation seems to suggest to me the order of importance.
Lately I've been feeling like HBV is getting top billing.
They (and in the last pitch Q and A) have mentioned EDP 514 antiviral and EDP 721 (RNA destabilizer) AND EASL and a submission on 721. They speak of HBV as if it may be on the threshold of becoming curable; at the least a large step towards that.
I become more and more confident about the RSV program.
The last mentioned was the NASH program, and indeed, the covid was mentioned before it.
That was the sequence and that seemed to me also the areas of opportunity ranked, although that was not expressed.
RBC webcast today was compact and informative:
https://event.on24.com/view/presentation/flash/endedNew.html?eventid=3173662&eventuserid=442649498
It will be available for replay in due course.
https://www.journal-of-hepatology.eu/article/S0168-8278(21)00158-6/fulltext (complete text) (partial text available @ natap https://www.natap.org/
Glecaprevir/pibrentasvir + sofosbuvir + ribavirin offers high cure rate for hepatitis C virus retreatment in real-world settings
(My comment- this only has 6 people in it but the implications on re-treating those with DAA resistance AND cirrhosis is of interest. ~Willy)
We read with interest the recent publication by Dietz et al: “Failure on voxilaprevir, velpatasvir, sofosbuvir and efficacy of rescue therapy” and would like to present additional data regarding salvage hepatitis C virus (HCV) treatment in this difficult-to-cure patient population.
Patients who fail to achieve sustained virologic response (SVR) with approved direct-acting antiviral (DAA) regimens have limited options for successful retreatment. Usage of a regimen containing an NS3/4A protease inhibitor, NS5A replication complex inhibitor, and NS5B polymerase inhibitor with weight-based ribavirin is appropriate for patients for whom even triple-DAA rescue therapy with sofosbuvir/velpatasvir/voxilaprevir did not achieve cure.
........
Results
Six patients began 16-24 weeks of HCV retreatment with glecaprevir/pibrentasvir, sofosbuvir, and ribavirin between July 2018 and March 2020. All patients achieved SVR. Baseline resistance was present in most patients (5/5 assessed for NS5A and 3/4 for NS3), and all had cirrhosis. No patients were on dialysis or had HIV or hepatitis B virus. No patients experienced serious adverse events or died during treatment. See Table 1 for additional patient details.
(One final comment- with newer more effective treatments the vast multitude of infected can be cured. That small segment that fails can be "rescued" with various therapies. That small group which fails those still has hope for a cure. Add to this people who are cured and become re-infected but have DAA resistant variants are not without options. ~W)
Are you asking about EDP-514? The phase-1b data, so far, look fine.
Thoughts on the PR and updates ?
ENTA reports HBV data_from_ 200mg_and_400mg_cohorts_of EDP-514 phase-1b:
https://www.enanta.com/investors/news-releases/press-release/2021/Enanta-Pharmaceuticals-Reports-Positive-Data-from-Part-2-of-its-Phase-1b-Study-of-EDP-514-in-Chronic-Hepatitis-B-Virus-Patients-on-Treatment-with-a-Nucleoside-Reverse-Transcriptase-Inhibitor/default.aspx
ENTA FY2Q21 results—royalty_revenue=$20.1M—3/31/21_cash=$400M:
https://www.enanta.com/investors/news-releases/press-release/2021/Enanta-Pharmaceuticals-Reports-Financial-Results-for-its-Fiscal-Second-Quarter-Ended-March-31-2021-with-Webcast-and-Conference-Call-Today-at-430-p.m.-ET/default.aspx
ENTA’s royalty rate from ABBV is tiered, as shown in the table in #msg-142808661. The royalty rate is applied to the 50% Glecaprevir component of Mavyret, a 2-drug combination. The royalty tiers reset at the start of each calendar year (like tax brackets), so ENTA’s royalty rate is highest in the fourth calendar quarter (ENTA’s fiscal* Q1) and is lowest during the first calendar quarter (ENTA’s fiscal* Q2—the quarter just reported).
During calendar 1Q21 (ENTA’s FY2Q21*), ABBV sold $415M of Mavyret. ABBV has issued calendar-2021 guidance for Mavyret sales of $2.0B (#msg-163517997), expecting Mavyret sales to pick up as the COVID pandemic recedes, which will enable more backlogged HCV patients to seek treatment.
ENTA’s 3/31/21 cash balance of $400M was down $5M from 12/31/20 (#msg-161624309).
ENTA previously issued FY2021* guidance for gross operating expenses (including non-cash components such as stock-based compensation): $145-165M for R&D; and $27-33M for G&A. The FY2Q21 numbers ($41.5M for R&D; $8.3M for G&A) were consistent with the prior guidance.
*ENTA’s fiscal year ends on September 30.
ABBV maintained its full-year 2021 Mavyret guidance of $2.0B.
ABBV 1Q21 Mavyret sales=$415M, -14% QoQ:
https://news.abbvie.com/news/press-releases/abbvie-reports-first-quarter-2021-financial-results.htm
The $415M consisted of: $170M US (-23% QoQ); and $245M ex-US (-6%, QoQ).
ABBV’s prior guidance for full-year 2021 Mavyret sales is $2.0B (#msg-161451655). This figure could still be met if patient starts (especially in the US) pick up due to lessening of COVID; however, ABBV may lower the guidance during today’s CC.
ENTA could have a meaningful update on the COVID-19 program in the May-6 earnings release. Unlikely, but possible.
“Today we announced our plans to report our financial results for our fiscal second quarter ended March 31, 2021, at 4:30 p.m. on May 6, 2021. We will also provide an update on the company’s business, including our research and development pipeline. To listen, please register for the webcast here: https://lnkd.in/dpWng-A”
The only difference between the 4/1/21 slide set and the 2/8/21 slide set is that the latter shows the phase-2 pediatric RSV trial (RSVPEDSs) started in March, 2021.
Any ideas why we fell off a cliff this week so far? Ouch.
All-in-one_nasal-swab_Dx_for_ respiratory_viruses_gets_full_FDA_approval—(not_just_an_EUA):
https://www.prnewswire.com/news-releases/fda-permits-marketing-of-first-sars-cov-2-diagnostic-test-using-traditional-premarket-review-process-301249713.html
Bullish for ENTA for the reason mentioned in #msg-156795547.
BioFire Diagnostics LLC, the company selling this test, is private.
Interesting read posted on Seeking Alpha today:
https://seekingalpha.com/article/4412162-bottom-fishing-club-enanta-pharmaceuticals
ENTA’s_enterprise value_at_the_current_share_ price ($54.78) is ~$870M, based on 23.9M fully-diluted shares (#msg-161707883) and pro forma cash of $441.4M (#msg-161707561).
ENTA’s fully-diluted* share count @12/31/20=23.9M—an increase of 0.6M since 9/30/20 (#msg-159770202).
The 23.9M figure above consists of: 20.1M basic shares on the 12/31/20 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/1177648/000156459021004983/enta-10q_20201231.htm#CONSOLIDATED_BALANCE_SHEETS ); and 3.8M options outstanding (whether or not exercisable) (ibid, page 13).
*Non-treasury method.
ENTA’s pro forma cash @12/31/20=$441.4M—a decrease of $3.9M since 9/30/20 (#msg-159770118).
The $441.4M figure above consists of: $422.9M of net current assets on the 12/31/20 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/1177648/000156459021004983/enta-10q_20201231.htm#CONSOLIDATED_BALANCE_SHEETS ); and $18.5M of marketable securities on the 12/31/20 balance sheet designated as long-term (e.g. bonds with a time to maturity greater than one year).
While RVS program is the closest to being an approved product, I am pleased about developments in the anti-HBV program. I am also pleased to hear that ENTA is getting closer to selecting anti-Covid-19 drugs, and that their approach is to attack the virus polymerase and virus protease rather than using an entry inhibitor. I know some expressed disappointment that the pace of development wasn't faster but ENTA has great expertise in antivirals and i is better to take a bit longer to generate a better drug. Both drugs are being designed to be orally administered and the idea is that someone beginning to show symptoms or testing positive would get a prescription and begin taking tablets that they can take everyday for a specified time frame. Still a long way to go but the approach sounds really smart.
ENTA FY1Q21* results—royalty_revenue=$31.7M—12/31/20_cash=$405M:
https://www.enanta.com/investors/news-releases/press-release/2021/Enanta-Pharmaceuticals-Reports-Financial-Results-for-its-Fiscal-First-Quarter-Ended-December-31-2020-with-Webcast-and-Conference-Call-Today-at-430-p.m.-ET/default.aspx
ENTA’s royalty rate from ABBV is tiered, as shown in the table in #msg-142808661. The royalty rate is applied to the 50% Glecaprevir component of Mavyret, a 2-drug combination. During calendar 4Q20 (ENTA’s FY1Q21), ABBV sold $481M of Mavyret. (ABBV issued full-year 2021 guidance for Mavyret sales of $2.0B.)
ENTA’s 12/31/20 cash balance of $405M was down $14M from 9/30/20 (#msg-159678084).
ENTA previously issued FY2021* guidance for gross operating expenses (including non-cash components): $145-165M for R&D; and $27-33M for G&A. FY1Q21 actual operating expenses ($36.7M for R&D; $7.4M for G&A) were inline with the prior guidance.
*ENTA’s fiscal years end on Sep 30.
ABBV’s 2021 Mavyret guidance=$2.0B—(up from actual $1.83B in 2020).
ABBV 4Q20 Mavyret sales=$481M, +16% QoQ, -23% YoY:
https://news.abbvie.com/news/press-releases/abbvie-reports-full-year-and-fourth-quarter-2020-financial-results.htm
The $481M consisted of: $420M US; $461M ex-US.
Mavyret full-year 2020 sales were $1.83B, slightly below ABBV’s most recent guidance of $1.9B.
ENTA upgrades to neutral by JP Morgan. Price target $55
ENTA’s CSO exercised and held ~$700K of stock two days ago:
https://www.sec.gov/Archives/edgar/data/1177648/000117764821000008/xslF345X03/edgar.xml
The exercised options did not expire until mid-2022 or later.
ENTA hires head of business development:
https://www.enanta.com/investors/news-releases/press-release/2021/Enanta-Pharmaceuticals-Announces-the-Appointment-of-Brendan-Luu-as-Senior-Vice-President-Business-Development/default.aspx
ENTA announces two new programs: 1) an oral HBV RNA destablizer; and 2) an RSV-L inhibitor. These are possible combination agents for ENTA’s existing compounds, EDP-514 and EDP-938, respectively.
https://www.enanta.com/investors/news-releases/press-release/2021/Enanta-Pharmaceuticals-to-Provide-Updates-on-its-Research-and-Development-Programs-and-Outlook-for-2021-at-the-39th-Annual-J.P.-Morgan-Healthcare-Conference/default.aspx
ENTA hires RSV researcher/clinician as VP, Translation Virology:
https://www.enanta.com/investors/news-releases/press-release/2021/Enanta-Pharmaceuticals-Announces-the-Appointment-of-John-P.-DeVincenzo-M.D.-as-Vice-President-of-Translational-Virology/default.aspx
ENTA hires VRTX executive as SVP for new-product strategy:
https://www.enanta.com/investors/news-releases/press-release/2020/Enanta-Pharmaceuticals-Announces-the-Appointment-of-Tara-L.-Kieffer-Ph.D.-as-Senior-Vice-President-New-Product-Strategy-and-Development/default.aspx
ENTA’s enterprise value at the current share price—($42.90)—is ~$550M, based on 23.3M fully-diluted shares (#msg-159770202) and pro forma cash of $445.3M (#msg-159770118).
ENTA’s fully-diluted* share count @9/30/20=23.3M—an increase of 0.6M since 9/30/19 (#msg-152977518).
The 23.3M figure above consists of: 20.1M basic shares on the 9/30/20 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/1177648/000156459020055233/enta-10k_20200930.htm#CONSOLIDATED_BALANCE_SHEETS ); and 3.3M options outstanding (whether or not exercisable) (ibid, page F-19).
*Non-treasury method.
ENTA’s pro forma cash @9/30/20=$445.3M—a decrease of $9.6M since 6/30/20 and an increase of $1.1M since 9/30/19 (#msg-152977520).
The $445.3M figure above consists of: $412.7M of net current assets on the 9/30/20 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/1177648/000156459020055233/enta-10k_20200930.htm#CONSOLIDATED_BALANCE_SHEETS ); and $32.6M of marketable securities on the 9/30/20 balance sheet designated as long-term (e.g. bonds with a time to maturity greater than one year).
ENTA never needs to raise capital, which makes it harder to garner respect from sell-side analysts.
Enanta price target lowered to $45 from $52 at RBC Capital
Read more at:
https://thefly.com/n.php?id=3202032
ENTA FY4Q20* results—royalty_revenue=$23.6M—9/30/20_cash=$419M:
https://www.enanta.com/investors/news-releases/press-release/2020/Enanta-Pharmaceuticals-Reports-Financial-Results-for-its-Fiscal-Fourth-Quarter-and-Year-Ended-September-30-2020/default.aspx
ENTA’s FY4Q20 royalty revenue of $23.6M was +27% QoQ, but it remained suppressed relative to pre-COVID levels (#msg-159211912). (ENTA’s royalty rate from ABBV is tiered, as shown in the table in #msg-142808661. The royalty rate is applied to the 50% Glecaprevir component of Mavyret, a 2-drug combination.)
ABBV guided for calendar 4Q20 (ENTA’s FY1Q21) Mavyret sales of approximately $560M (#msg-159212040), up from $414M in 3Q20, but this guidance was given before the recent surge in COVID-19 infections.
ENTA’s 9/30/20 cash balance of $419M was down $16M from 6/30/20 (#msg-157373145).
ENTA’s FY2021* guidance for gross operating expenses (including non-cash components) is: $145-165M for R&D (up from $137M in FY2020); and $27-33M for G&A (versus $27M in FY2020).
*ENTA’s fiscal years end on Sep 30.
Thoughts on this PR today?
Enanta Pharma EPS misses by $0.52, misses on revenue
Nov. 23, 2020 4:06 PM ETEnanta Pharmaceuticals, Inc. (ENTA)By: Manshi Mamtora, CFA
Enanta Pharma (NASDAQ:ENTA): Q4 GAAP EPS of -$1.46 misses by $0.52.
Revenue of $23.6M (-54.0% Y/Y) misses by $2.16M.
2021 Guidance: R&D Expense $145M-165M; G&A Expense $27M-33M
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