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ENTA is up over $3 today. I figured the rise over the release of the safety data on friday would continue this week. The questions remaining in my mind are how many days in a row will the stock price rise, and will it get to the mid $60s or, dare I say it, get back to $70 before the earnings report is released?
Shionogi’s S-217622 has some issues:
#msg-168536263 teratogenicity
#msg-169462279 efficacy not proven
More info on S-217622 than you probably wanted to know:
https://www.biorxiv.org/content/10.1101/2022.01.26.477782v1.full
Conclusions
• Data presented in Ph1 first-in-human study indicate that S-217622 was well tolerated in healthy individuals, and the pharmacokinetics evaluations highlighted the potential for once-daily administration
• In Ph2a, treatment with 5-day oral administration of S-217622 demonstrated a rapid clearance of SARS-CoV-2 and was well tolerated in patients with mild-to- moderate or asymptomatic infection
• The results support further clinical development of S-217622 through large-scale clinical studies for the treatment of mild-to-moderate or asymptomatic SARS- CoV-2 infection
https://www.shionogi.com/content/dam/shionogi/global/investors/ir-library/presentation/2022/ECCMID%20Ph1_2a%20presentation%20final2.1.pdf
Yesterday was a great day for Enanta.
I'm sure that the Earnings call will shed more light on the covid development plan.
Covid isn't going anywhere. Covid is evading vaccines, and other troubling issues like reinfection, long covid and additive damages from reinfections suggests we need a better antiviral.
It also seems that problems with viral rebound are happening (Paxlovid -too weak or too short a duration??)
Recent virus strains are evading vaccines.
Many doctors are hesitating to prescribe due to the complicated nature of drug interactions w/ Ritonavir.
So the emergency isn't really quite over- infections are once again rising.
There is a need for a faster pathway to approval for EDP- 235
The last thing on the sheet I really liked?
"Select third mechanism for HBV combination regimen with EDP-514" (in 2022)
I believe that Enanta has reinforced confidence in their capabilities with antivirals.
If they can come up with a third compound for HBV......
ENTA’s updated corporate slide set—(including new EDP-235 info):
https://ir.enanta.com/static-files/fb5db89a-b15b-4820-9e77-b8c5b087f869
Slides 17-21 pertain to EDP-235. Slide 20 shows comparative potency vs other agents.
Agreed. EDP-235 is plainly more potent than Paxlovid. And without the manifold drug-drug interactions consequent to ritonavir, EDP-235 should be considerably safer than Paxlovid too.
The clean safety profile of EDP-235 is the biggest news in today's dataset. That's because the MoA of EDP-235 is well understood, so efficacy at the doses selected for phase-2 is almost a fait accompli.
ENTA’s PR on EDP-235 phase-1/1b data:
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-announces-positive-data-phase-1-clinical
Based on these positive safety and PK results, ENTA is advancing the 200mg qD and 400mg qD doses (without ritonavir boosting) to phase-2, which is expected to start in 4Q22.
Yes, as far as I know.
Are we due for a PR today or tomorrow on EDP235?
All of those reasons plus the scary stuff people some people are writing about Omicron BA.5.
ENTA broke $51 this morning. The stock price dropped to just under $39 in mid June. This rebound could be a delayed response to the the law suit for patent infringement against PFE, anticipation of the phase I safety data for their Covid-19 protease inhibitor EDP-235, a general rebound after a long decline or all three. We should soon know about the phase I data as ENTA is expected to release that data this month.
The Canada approval is for the pediatric market (age 3-11). Mavyret was already approved in Canada for adults and adolescents.
I just saw that Canada approved the use of Maviret and stated that ~250,000 patients are in this category. I wonder if Canada is just late to the party or whether they are early so a new substantial patient population may soon be realized in many countries.
https://finance.yahoo.com/news/maviret-glecaprevir-pibrentasvir-approved-health-120000965.html
Wow!
Thanks for providing the link as it gets into the specifics of the suit.
Even so it is difficult for me to clearly see what the courts will decide.
One must assume that Pfizer must have some sort of IP and response.
I am reminded of Gilead being sued for Sovaldi.
This is going to be a nail biter.
I hope that it has a Hollywood ending for Enanta investors.
It may be as simple as Enanta was the first to patent. The Pfizer PI entered trials spring of 2021.
(ENTA)—PFE’s guidance for 2022 Paxlovid sales is $22B, of which a substantial portion is from the US market.
If ENTA’s patent suit resulted in even a low-single-digit royalty on US sales of Paxlovid, it would amount to a very sizable payday relative to ENTA’s existing enterprise value.
Addendum—ENTA is not seeking an injunction against Paxlovid, which would be morally deplorable. Rather, ENTA is seeking monetary compensation for the alleged patent infringement.
ENTA sues PFE for patent infringement wrt Paxlovid:
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-files-patent-infringement-suit-against
ENTA’s CEO exercised and held $140K of stock from an expiring option:
https://pro.edgar-online.com/displayfilinginfo.aspx?source=external&tabindex=2&FilingID=15902360&Type=HTML&Text=
Exercising and holding—paying the withholding tax with cash rather than forfeited shares—is mathematically equivalent to an open-market purchase.
EDP-235 data release will occur in July (not June).
This is a positive change, IMO—please see #msg-169100861.
ENTA has committed to releasing some or all of the EDP-235 phase-1 data during the current calendar quarter (i.e. by Jun 30). On the recent CC, Jay Luly was asked whether the initial data release would include all of the dosing cohorts or just some of them, and he said that the decision hadn’t yet been made.
Apropos the safety data set for EDP-235. What is the expectation on the release from a timing perspective? Admittedly I apologize I lost track. Thank you in advance.
Thanks Dew. The second to last slide (#29) lists the key catalysts for 2022. One of them is to select a third mechanism for combination regimen with EDP-514 for HepB treatment. I will feel better when the candidate(s) are announced and into trials.
Follow-up—After all the commotion, ENTA closed down only 4% today. Thus, the EV still has some value baked in for EDP-235, but not a lot.
New corporate slide set (5/18/22):
https://ir.enanta.com/static-files/fb5db89a-b15b-4820-9e77-b8c5b087f869
Only update is the RSVP result.
ENTA’s valuation:
https://twitter.com/DewDiligence/status/1527054722707992577
Please see #msg-168831164 and #msg-168831159 for calculations regarding ENTA’s EV.
ENTA’s phase-2b trial in RSV misses primary endpoint:
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-reports-topline-data-rsvp-study-edp-938
From the recent price action, it seems that this result may have been leaked.
NIH wants_to_study longer treatment_course for Paxlovid:
https://finance.yahoo.com/news/u-study-whether-longer-paxlovid-162143570.html
The Paxlovid treatment course under the existing EUA is 5 days. However, this is not because 5 days is necessarily optimal, but rather because 5 days is how long the treatment was in PFE’s phase-3 clinical trial.
I added last week at about $50.00
....after I swore I wouldn't till there was some hard data or positive catalyst. : )
I rather expect at some point another HBV candidate to combine with EDP 514.
Or the announcement of a partner in covid after the drug shows promise.
We are half way thru the 2nd quarter so news on Covid and RSV are right around the corner.
Out of Ignorance profile picture
Out of Ignorance
Today, 10:18 AM
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@George Rho
Thanks for reading and for your interesting comment.
I appreciate your insights on its COVID therapy. I seldom discuss early stage projects in my articles, no matter how potentially transformative they may be. This goes doubly for early stage COVID therapies. There are just too many molecules with fabulous potential and intriguing clinical breadcrumbs for me to highlight any one. Every time I think something will break free from the pack, I am disappointed. Most recently Omeros' narsoplimab was my fair hair boy.
As for the reason underlying the spike last year, you sound like you have better insights on that than I do; you played it well selling at $90.
George Rho profile picture
George Rho
Today, 4:21 AM
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I read your bio with some interest. I, too, like to learn from the responses of readers, although some can be harsh. Indeed, I started to pen an article on Alector recently, mainly to glean what others might see that I was apparently missing. Just briefly, the stock about doubled in price last summer after it inked a significant partnership with Glaxo, but has been on an extended slide ever since, the huge cash horde and pipeline prospects notwithstanding. In any case, laziness set in and I didn’t get far beyond the starting point.
As to your article, it left me feeling that you’d left out way too much, especially for someone who is familiar with the March quarter conference call. Principally, you completely ignore the Covid pill that’s under development. It apparently has the potential to be superior to both Pfizer’s and Merck’s Covid drugs, in terms of efficacy, dosing, and administration. As you undoubtedly know, both are huge sellers, massive enough to move the needle on the bottom line even though both companies have billions of shares outstanding.
To be sure, it’s only in phase 1. But it has received fast track designation. Plus, as evidenced but Pfizer’s and Merck’s, the clinical program shouldn’t take too long since there are many eligible patients out there and the drug is taken for only four or five days. Also important to note is Enanta’s minuscule equity base, at about 20 million shares outstanding. Imagine the impact of a billion dollars in sales on the bottom line.
Another fact you didn’t cover in your article was the reason for the sharp rise in share price last year. For whatever it’s worth, I bought the stock many years ago for the company’s hcv products and sold it last year at $90. I’ve been rebuilding my position over the past several weeks. If I were a betting man, I’d put my money on Enanta partnering with Abbvie for the Covid product, too. Full disclosure, I’m long both and have written articles on each.
https://seekingalpha.com/article/4512678-enanta-slow-drip
A very worth while reply to the article is in a first response in the reply section.
The SA article seems to ignore the Enanta covid candidate EDP-325.
Per J.Luly CEO the SAD & MAD dosing studies- and phase 1 of testing of the covid drug EDP 325 will be done in the 2nd quarter, and are presumed to be starting Phase 2 in the 3rd quarter.
One could surmise that if indeed EDP 325 is able to prove once a day ritonovir free dosing that it could soon be shown to be a best in class covid drug.
Per Enanta; " Fast Track designation [of EDP-325] enables more frequent communication with the FDA and eligibility for FDA programs such as priority review and rolling review, if relevant criteria are met. "
More clarity on what this means exactly could come in the next few months.
In short, the article took pains to ignore any of Enanta's pipeline other than RSV.
It seems to me that if the covid candidate is successful it could have more value- and sooner than the RSV pipeline. If that were the case it would seem a glaring omission in the article.
Thoughts on this post on “seeking alpha”
“Enanta: Slow Drip
May 17, 2022 6:06 PM ETEnanta Pharmaceuticals, Inc. (ENTA)1 Comment
Out of Ignorance profile picture
Out of Ignorance
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Summary
Enanta's pipeline is stuffed with mid-stage RSV therapies and other earlier-stage programs.
Enanta is one of many little biotechs which has a cash cow that can't keep up.
Enanta has a solid balance sheet and a strong albeit recently stressed share price.
Alcohol distillation process in Laos.
Varaporn_Chaisin/iStock via Getty Images
I last checked in on Enanta (NASDAQ:ENTA) in 2016's "Parsing Liver Therapy Perspectives: Gilead And Enanta". At the time I contrasted the two, with Gilead a major player and Enanta a mere small-time character actor.
This article evaluates Enanta on its own with particular attention to its 05/09/2022 fiscal Q2, 2022 earnings call (the "Call").
With the exception of its lead marketed therapy, Enanta's pipeline is a yawn
Enanta's pipeline below is devoid of late-stage molecules likely to bring it near-term cash. As shown by its pipeline slide below it has no phase 3 candidates. It has one molecule, its N-Protein Inhibitor EDP-938, which is in three phase 2 trials in treatment of RSV for differing patient groups:
Enanta Q2, 2022 Earnings Presentation
Enanta Q2, 2022 Earnings Presentation (ir.enanta.com)
During the Call, CEO Luly described its EDP-938 program at considerable length. He characterizes the study molecule as the "most advanced N-protein inhibitor in development". In the phase 2 challenge study, it was safe and well-tolerated. In terms of effect, it reduced viral load and symptoms of infection.
This 179 participant challenge study (NCT03691623) was written up in an 02/2022 article in the New England Journal of Medicine supporting its effects. It concluded, in addition to its favorable safety profile, all four dosing regimens were superior to placebo in terms of their effect as noted and in lowering mucus weight.
During the Call, Luly characterized the RSVP study as:
...a Phase 2b trial in otherwise healthy adults with community-acquired RSV infection... designed to confirm in a community-acquired setting the positive results of our Phase IIa challenge study and to further characterize efficacy by measuring symptom alleviation and viral load decline.
The good news for Enanta shareholders is that enrollment in the study is complete. The plan is to report topline data later this quarter.
Enanta's other two phase 2 studies are expected to see enrollment extending into 2023. They include:
RSVPEDs, a phase 2 study in pediatric patients with RSV (NCT04816721, estimated completion date of 12/2023) and
RSVPTx, a study in adult hematopoietic cell transplant recipients with RSV (NCT04633187, estimated completion date of 12/2022).
The cell transplant study is a larger study of 200 patients. Since enrollment is extending into 2023, its completion date will obviously extend beyond the date listed above from clinicaltrials.gov.
Enanta is going "all in", on its RSV trials. It plans to start yet another phase 2b trial in high-risk adult patients in the fourth quarter of 2022. Its strategy is to focus its RSV treatment on high-risk populations where it believes their suboptimal RSV immunity and greater RSV disease severity and mortality can best showcase EDP-938's full potential.
As an aside, Enanta has some 34 clinical trials listed on clinicaltrials.gov; the overwhelming majority of which (27) are shown as completed. That is a tremendous body of completed trials which have resulted in but two marketed therapies as discussed below.
Enanta's revenues help it with its expenses, but they are slowing
Enanta's main claim to fame is its highly successful research and development collaboration with AbbVie (ABBV) which resulted in two successful HCV therapies. First was its paritaprevir included in AbbVie's Viekira Pak (ombitasvir/paritaprevir/ritonavir tablets; dasabuvir tablets) in treatment of HCV.
Viekira Pak FDA approval generated a $75 million milestone for Enanta. Subsequently, AbbVie discontinued Viekira Pak after it was associated with rare cases of liver toxicity.
More recently Enanta discovered glecaprevir which it developed with AbbVie. Glecaprevir was co-formulated as part of AbbVie's direct-acting antiviral combination treatment for HCV, which is marketed under the tradenames MAVYRET (U.S.) and MAVIRET (ex-U.S.).
The FDA approved MAVYRET in 08/2017. Enanta earns royalties in accordance with the schedule below:
Enanta Q2, 2022 Earnings Presentation
Enanta Q2, 2022 Earnings Presentation (ir.enanta.com)
Since its 2017 approval, Glecaprevir generated royalties totaling $722 million per Enanta's fiscal year ending 09/2021 10-K. As of 03/31/2022, it generated an additional ~$46 million.
The pandemic has negatively impacted sales of MAVYRET, as have declining patient counts as more patients are cured. AbbVie's 10-K shows sequential MAVYRET revenue declines of ~37% from pre-pandemic year 2019 to year 2020. The decline moderated to a decline of ~7% from year 2020 to year 2021. AbbVie has guided to essentially flat MAVYRET revenues for 2022. Enanta's fiscal 2021 MAVYRET revenues were ~$97 million.
Enanta's liquidity is easily sufficient for its near to mid-term needs
Enanta offered no projections for future revenue during the Call. CFO Mellett did offer the following revenue observation:
..for our second fiscal quarter ended March 31, 2022...total revenue was $18.7 million and consisted entirely of royalty revenue earned on AbbVie's global HCV product sales of $380 million. This compares to total revenue of $20.1 million for the same period in 2021. This decrease is due to treated patient volumes continuing to remain suppressed compared to pre-COVID levels.
Additionally, Mellett noted:
Enanta ended the quarter with $322.5 million in cash and marketable securities. Enanta expects that its current cash, cash equivalents and marketable securities as well as its continuing royalty revenue will be sufficient to meet the anticipated cash requirements of its existing business and development programs for at least the next two years.
With so many little biotechs stretched for cash, Enanta situation appears enviable. Its cash flows are in good shape over the near term. Nonetheless as shown by its operating results below from its Q2, 2022 10-Q, it is slowly running through its liquidity:
Enanta Q2, 2022 10-Q excerpt
Enanta Q2, 2022 10-Q excerpt (seekingalpha.com)
Enanta's operations as shown above are leaking solvency; its pristine balance sheet below presents a much brighter picture:
Enanta Q2, 2022 10-Q excerpt, 1st column showing Q2, 2022, 2d column showing previous quarter
Enanta Q2, 2022 10-Q excerpt, 1st column showing Q2, 2022, 2d column showing previous quarter (seekingalpha.com)
Enanta's aggregate liabilities for its latest quarter are easily manageable and show no signs of operational stress.
As for Enanta's share price, it is likewise comforting, although it has popped and dropped over the last year as shown below:
Chart
Data by YCharts
Conclusion
Existing Enanta shareholders are likely kicking themselves for holding during its brief 11/05/2021 run to over $100 for no apparent compelling reason. Been there, done that.
As I write on 05/17/2022, Enanta shares trade at ~$50 with a market cap of ~$1 billion. By my thinking that is a fair price for a company with its finances and prospects as described. In this regard, I am mindful that Seeking Alpha's Quant Ratings and Wall Street Analysts both hold it in higher regard.”
ENTA’s enterprise value at the current share price ($51.50) is about $900M. This is based on 24.7M fully-diluted shares (#msg-168831164) and pro forma cash of $353.3M (#msg-168831159), both figures as of 3/31/22.
ENTA’s fully-diluted share count @3/31/22=24.7M—unchanged since 12/31/21 (#msg-167844216).
The 24.7M figure above consists of: 20.6M basic shares on the 3/31/22 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017022008483/enta-20220331.htm#consolidated_balance_sheets ); and 4.1M options outstanding at 3/31/22 (whether or not exercisable) (ibid, p.12).
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