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ENTA is a screaming buy, IMO, but it is no longer cash-flow positive because Mavyret sales remain well below pre-pandemic levels.
In 4Q19 (the last full pre-pandemic quarter), Mavyret sales were $632M; in 2Q21, they were $441M. Lower Mavyret sales have caused a more-than-proportional decrease in ENTA’s royalties because the royalty rate is tiered.
it astounds me that this company has not been scooped up by big Pharma. Cash flow positive, solid leadership and promising products in the pipeline.
ENTA files preliminary shelf registration for unspecified amount of capital:
https://www.sec.gov/Archives/edgar/data/1177648/000156459021042633/enta-s3asr.htm
ENTA certainly isn’t planning to raise capital in the near future, so I wouldn’t read anything in particular into this filing.
ENTA’s_enterprise value_at_the_current_share_ price ($45.10) is ~$680M, based on 24.1M fully-diluted shares (#msg-165355921) and pro forma cash of $408.3M (#msg-165355929).
ENTA’s pro forma cash @6/30/21=$408.2M—a decrease of $17.9M since 3/31/21 (#msg-163910195).
The $408.4M figure above consists of: $292.5M of net current assets on the 6/30/21 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/1177648/000156459021042612/enta-10q_20210630.htm#CONSOLIDATED_BALANCE_SHEETS ); and $115.7M of marketable securities on the 6/30/21 balance sheet designated as long-term (e.g. bonds with a time to maturity greater than one year).
ENTA’s fully-diluted share count @6/30/21=24.1M—unchanged since 3/31/21 (#msg-163910230).
The 24.1M figure above consists of: 20.2M basic shares on the 6/30/21 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/1177648/000156459021042612/enta-10q_20210630.htm#CONSOLIDATED_BALANCE_SHEETS ); and 3.9M options outstanding at 6/30/21 (whether or not exercisable) (ibid, page 13).
Who could have known?!?!
Somebody didn't realize until today that ENTA is a COVID play?
A kind of crazy last few minutes of trading.
At 10 minute till 55.4K shares traded; up +.79 cents
at 5 minutes till 60K shares
at 4 minutes till 91K shares +1.74
at 3 minutes till 120K shares +$3.04
at 2 minutes 138K shares +$3.34
at 1 minute 150K shares +$3.67
at closing 225K shares +3.77 gain
Day's Range $42.18 - $46.52 Gain 8.87%
ENTA FY3Q21* results—royalty_revenue=$21.6M—6/30/21_cash=$372.5M:
https://www.enanta.com/investors/news-releases/press-release/2021/Enanta-Pharmaceuticals-Reports-Financial-Results-for-Its-Fiscal-Third-Quarter-Ended-June-30-2021-with-Webcast-and-Conference-Call-Today-at-430-p.m.-ET/default.aspx
ENTA’s royalty rate on Mavyret sales 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).
During calendar 2Q21 (ENTA’s FY3Q21*), ABBV sold $441M of Mavyret. ABBV has issued calendar-2021 guidance for Mavyret sales of $1.9B (#msg-165196250), implying quarterly sales in calendar 2H21 approximately $500M per quarter.
ENTA’s 6/30/21 cash balance of $372.5M was down $27.5M from 3/31/21 (#msg-163650007); the relatively high cash burn was mostly due to R&D spend (see below).
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 actual FY3Q21 R&D spend of $47.0M was well above that range ($188M annualized), while the actual FY3Q21 G&A spend of was at the top end of the prior guidance.
*ENTA’s fiscal year ends on September 30.
I'm sure they will talk about it in today's CC.
It strikes me that Pfizer is a huge company and has a head start; but not by much.
Enanta has a strong history and record with anti-virals; particularly with protease inhibitors.
I was anxious for ENTA to develop a compound. Did Pfizer's haste to create a PI create a best in class PI? ENTA may have a better solution than the goliath company; they have anti-viral expertise, created the best in class PI for HCV, and may have demonstrated the same in RSV and HBV.
It would seem that covid isn't going away.
There is talk about the virus evading vaccines.
This looks encouraging to me.
Thanks willyw!
I posted some excerpts from ENTA’s PR in #msg-165291436.
Below an article on the Pfizer competition.
What was intriguing to me was the time line;
this protease inhibitor was in phase 1 this spring
"Pfizer advanced the experimental drug into phase 2/3 testing in July and thinks it could file for EUA in Q4 if all goes well." EUA = Emergency Use Authorization
https://www.fool.com/investing/2021/08/03/this-could-be-pfizers-next-covid-blockbuster-and-i/
Enanta Pharmaceuticals Announces Nomination of Clinical Candidate EDP-235, its Lead Oral Protease Inhibitor Specifically Designed for the Treatment of COVID-19
August 05, 2021
https://www.enanta.com/investors/news-releases/press-release/2021/Enanta-Pharmaceuticals-Announces-Nomination-of-Clinical-Candidate-EDP-235-its-Lead-Oral-Protease-Inhibitor-Specifically-Designed-for-the-Treatment-of-COVID-19/default.aspx
ABBV's 2021 Mavyret guidance of $1.9B (lowered from $2.0B) implies about $500M per quarter in 3Q/4Q21. I thought ABBV might drop the full-year guidance to $1.8B (or less), so I'm ok with the $1.9B figure.
ABBV 2Q21 Mavyret sales=$441M, +6% QoQ:
https://news.abbvie.com/news/press-releases/abbvie-reports-second-quarter-2021-financial-results.htm
New-patient starts are increasing but are not (yet) back to pre-pandemic levels.
ABBV’s full-year 2021 Mavyret guidance is $1.9B, down from the prior guidance of $2.0B.
Patience is required, but buying now (when nobody wants it) is a good bet, IMO.
The clinical catalysts for 2021 are pretty modest—see slide #38 at the link in #msg-164535206.
Any catalysts - near term? it's been a dog for 2 years... really disappointing for a company w/ great science... just do not understand the market's ignorance
More RSV, but in the midwest.
It seems to re-emerging, albeit off season.
Perhaps Enanta can get their trials enrolled soon.
https://www.yahoo.com/news/cold-weather-virus-summer-baffles-141645322.html
RSV reemerging in US South—(contrary to normal seasonality)—as COVID-related social distancing wanes:
https://www.wsj.com/articles/another-respiratory-virus-is-spreading-as-u-s-gets-back-to-pre-covid-19-life-11625140800
I added shares today in the institutional account I manage.
I'm a long time holder but have been adding on the low price.
I was *certain* that based on generally positive data from ENTA in many of their programs that the price would start climbing. : )
- HA!! That was not in the cards today but I still added again today.
* Hep B- ENTA has a strong plan and candidates, although they are not the furthest along, they may have a basis for an all oral cure- which in a global scheme would be more desirable than w/ injectable programs.
* RSV has been increasing and if they can just complete their trials they are probably a best in class and first approval- and they have a second compound in the wings.
* Even in NASH where no one is a strong leader ENTA looks somewhat successful, and looks to have an even better 2nd gen compound.
* I have also been adding on the number of near term catalysts and a thinning of competitors in many programs.
* Covid is not going away and continues to mutate. An effective anti-viral oral agent could attract Govt funding and accelerated approval.
* Note that ABBV and ENTA were not first in HCV but in the end were FIRST IN CLASS with the most effective and shortest treatment. Gilead was a close second BUT they didn't create their nuke; they bought it in Phase 3.
A G/P pediatric approval just happened in kids 3 years and older.
HCV acute cases also increased 14% 2018-2019.
* Anyone that has held ENTA has seen periods of volatility; both down and upwards- for me a better time to add than to sell.
Above are a few reasons I added today.
Not sure why the big drop in ENTA today but it may entice me to buy a bit more.
ENTA_presents_preclinical_data_on_EDP-721—an_oral_ HBV_RNA_destabilizer ENTA aims to make the third drug (with EDP-514 and a nuke) in an all-oral function-cure regimen; the data presentation was delivered at the International Liver Conference sponsored by EASL (European Association for Study of the Liver) going on now:
https://www.enanta.com/investors/news-releases/press-release/2021/Enanta-Pharmaceuticals-Presents-New-Data-for-EDP-721-an-Oral-Hepatitis-B-Virus-RNA-Destabilizer-at-the-European-Association-for-the-Study-of-the-Liver-EASL-International-Liver-Congress/default.aspx
Also, slide #24 in ENTA’s new slide set reveals new MoA and other info about EDP-721, the small-molecule HBV RNA destablizer that ENTA hopes will be the third drug in an all-oral functional cure.
A 3 log decrease for a single drug looks quite impressive to me. It makes me excited to see what happens when combination studies happen.
ENTA new_corporate_slide_set—includes EDP-514 data reported today:
https://s22.q4cdn.com/306858242/files/doc_presentations/2021/06/Enanta-Corporate-Presentation-Final-6.22.21.pdf
ENTA reports_positive_phase-1b_data_for EDP-514 in_viremic_HBV patients:
https://www.enanta.com/investors/news-releases/press-release/2021/Enanta-Pharmaceuticals-Reports-Positive-Data-from-Phase-1b-Study-of-EDP-514-a-Hepatitis-B-Virus-HBV-Core-Inhibitor-in-Viremic-Chronic-HBV-Patients/default.aspx
Great PR just released on HBV 1B program.
ENTA latest slide set (5/6/21):
https://s22.q4cdn.com/306858242/files/doc_presentations/2021/05/25/Enanta-Corporate-Presentation-5.6.21-updated-v2.pdf
The only differences between the 5/6/21 (latest) slide set and the 3/31/21 (previous version) slide set are the financial info from FY2Q21 and the inclusion of the phase-1b data for EDP-514 in nuke-suppressed HBV patients.
This is exactly what Jay Luly predicted would happen when people ceased wearing masks and socially distancing.. RSV is normally dormant during summer, but these are not normal times!
https://www.yahoo.com/news/another-respiratory-illness-spreading-across-191511447.html
The Centers for Disease Control and Prevention is warning about RSV, a cold-like respiratory illness, amid a spike in cases across the southern U.S."
...."Experts said they’ve seen an uptick in positive infections in at least a dozen states, including Florida, Georgia, Mississippi, Texas, Kentucky, North Carolina and South Carolina."
ENTA will unveil preclinical data on its oral HBV RNA destablizer, EDP-721, at EASL:
https://finance.yahoo.com/news/enanta-pharmaceuticals-present-preclinical-data-110000538.html
Please see #msg-163654846 (bottom) for background info.
ENTA’s_enterprise value_at_the_current_share_ price ($48.59) is ~$740M, based on 24.1M fully-diluted shares (#msg-163910230) and pro forma cash of $426.1M (#msg-163910195).
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)
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