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Like this company a lot. But always thought of them as a research boutique destined to be acquired at some point in the near future. Now I am thinking very differently.
APP. Could be something big going on here. AF acknowledging that vaccines are not working.
Small biotechs had a good week. (XBI +8%.)
Curious if the significant bump the last week is excitement around the HBV or SARS program or both?
If anyone would like to comment or elaborate on #msg-165620670, I’m all ears.
Re: HBV functional-cure market size
Let’s use the HCV market as a comparator, based on the assumption that ENTA (or somebody’s combination regimen) will be is successful in providing a functional cure for HBV.
The number of patients infected with chronic HBV is considerably larger than it ever was for HCV. However, a larger proportion of chronic-HBV patients live in poor countries as compared to HCV, which offsets the larger number of total patients. Thus, as a rough first-order approximation, we could hypothesize that the peak annual size of the addressable market for an HBV-curing regimen will be comparable to what it was for HCV.
The peak-sales year for HCV (2015) saw worldwide sales of approximately $23B, which dropped to about $19B the following year (2016) and has declined steadily since then as more and more patients are cured and the average selling price for a course of treatment has come down.
For HBV, the sales trajectory will not be as parabolic as it was for HCV; due to the greater difficulty diagnosing and treating patients in poorer countries, the initial bolus will be smaller and the rate of decline following the peak will be more gradual. Therefore, as compared to HCV, we should probably model a somewhat lower number for peak annual sales, but perhaps an equal or higher NPV for the total (all years) revenue stream.
For ENTA, specifically, an important question is what proportion of the total HBV functional-cure market will be comprised of all-oral regimens, assuming that an all-oral regimen exists. I would submit that this proportion will likely be at least 50%.
What is your estimate (or range) of successful HBV combo pricing and total addressable market?
This phase 1 work is being run by
Principal Investigator: ED Gane, MD
https://clinicaltrials.gov/ct2/show/NCT04971512?term=Enanta&cond=hbv&draw=2&rank=3
"Dr. Gane is an investigator for many international clinical trials with particular interest in early phase development of new direct acting antiviral therapies against chronic hepatitis C, hepatitis B, NASH and HCC. He has published almost 350 papers in peer-reviewed journals including The Lancet and The New England Journal of Medicine."
(my comment) Enanta seemed pretty confident about EDP-721. The guy they chose to run the phase 1 trial is also top notch, IMHO.
ENTA doses first patient in EDP-721 phase-1:
https://www.businesswire.com/news/home/20210816005078/en
Please see #msg-164540806 for background info.
Yes, that's been a problem for some time.
There is no liquidity. I bought 2K shares and the price jumped 75 cents.
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.
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