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From the 10-k filed earlier this year:
https://delcathsystemsinc.gcs-web.com/static-files/286defcc-bbb2-4ca5-8fee-22c01035cd2e
DCTH Delcath Systems, Inc. Announces FDA Approval of HEPZATO KIT™ for the Treatment of Adult Patients with Unresectable Hepatic-Dominant Metastatic Uveal Melanoma
https://delcath.com/investors/press-releases/
Some commentary from social media:
$HRMY Harmony Biosciences is now acquiring a microcap $ZYNE that was at -30 cents. Never a good sign when a one-product pharma co diversifies into a random cannabis-based topical gel, esp one with a long history of utter trial failures. The timing of the diversification…
— Scorpion Capital (@ScorpionFund) August 14, 2023
RVNC
It's a grind for long term holders too, since you are missing returns over 5% in T-bills. When short term rates were close to zero it was a different matter. Can't say where price will be or if it will be higher. I had approval at 99% FWIW and the only question was inclusion of trial data - which was still over 90% IMO.
One other point to repeat is that CD rollout doesn't start until next year. I think that is part of the problem - people expected sales to start ramping.
Not following GSK to know the prospects but I don't see a technical reason to sell here (GSK specific.)
RVNC to initiate rollout (therapeutic) next year. Label includes 52 week clinical data.
Popped to 20.38 for all of a minute and currently down at 18.83, so I think it's fair to say approval was priced in.
Whether or not you can call 20 'support' is a matter of personal opinion here. I'll say it's awfully squishy, kind of like my calling 22.6m in sales 'okay-ish'. Both are a bit light for my tastes. Oh well. It remains to be seen if price settles higher or lower or about the same, the next grind is earnings again in a few months.
The PFE news release on the acquisition, with sales estimates, came a full month before ENTA made this release on 938 failing in low risk:
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-reports-topline-data-rsvp-study-edp-938
Okay.
Sounds like this time next year things could be rosy from 938 and/or 235. Think there is any chance 235 results in a buyout instead of a partnership? Earnings call spent a lot of time on 323, a lot of time on partnering 235.
Thanks.
So the tamiflu comment was made with 323 in mind (looking ahead) should it show benefit in low risk. Long way off and speculative, along with combos. Partnerships might be easier then. It's also more difficult when you are small enough that you have a hard time credibly telling potential partners that you can take it to market yourself.
I'm also assuming that ENTA would need a partnership for commercialization at a minimum and probably for registrational as well in peds RSV. So while 500m/year sales is a big deal for a small company you still need to give it a haircut, size depending on the deal with an interested BP.
On the plus side for ENTA, it seems that 'herd immunity' is unlikely to ever be a factor.
A few thoughts on ENTA post earnings
Since the earnings reaction was worse than anticipated, I wanted to look closer at the earnings call and related filings. The call transcript was useful to get a broad picture but there were a few places where it seemed best to listen to that portion on a replay. Doing so did make a difference in my understanding some of what seems to be going on and frankly was more bullish than just reading the transcript.
That said there were a few key takeaways for me. One is that the clock still hasn’t started on partnership for 235. Yes, there are things that can be done prior to the satisfactory completion of the current regulatory discussions but it is unreasonable to think that any kind of negotiation on partnership can get very far without both ENTA and partner having a clear idea of what regulatory needs to get the approval they seek, and how they can get it. That could happen within a few weeks or it could take longer, depending on all parties involved. Look for something from ENTA to have a better idea on that front:
- Q2 DAXXIFY® revenue of $22.6 million, a QoQ increase of 47.1%.
To get to that level ($10) they would have to commit to burning a good chunk of cash. They clearly aren't close enough on a 235 partnership and the street doubts that it is coming. RSV wasn't exciting before the current trials so it isn't clear what the picture will look like after readouts. I guess the challenge trial for the L compound could increase interest. TBD.
Congrats on your price call Jake. Price dropped to levels only seen in the first day(s) post IPO. I personally did not think it could go this low this fast, and have to reconsider the options plays I was looking at based on last nights earnings call. The setup is not what I was anticipating.
fwiw BIIB can return the rights (opt out).
Don't follow closely enough to know various $$ effects of partnership, etc.
https://twitter.com/markflowchatter/status/1688349914185535488/photo/1
h/t Marc Lehman
@markflowchatter
24 month data will be coming out soon enough. A guess at this time is good data there will allow for extension of label. TBD.
Thanks for the post, very informative. Appreciate the detail.
Some of your points and jbog's snooping raise a question related to the cosmetic side, which I will raise here because it ties into your commentary and not because of your practice.
jbog reported about 50% favorable online. My hypothesis is that is probably not too far off what should be expected given the combination of patient expectation of a duration that in clinical trial is only reached by the median participant, combined with the psychological, so it is not unreasonable to see up to 50% unfavorable comments.
ISEE approved
https://ivericbio.com/wp-content/uploads/IZERVAY-avacincaptad-pegol-intravitreal-solution-PI_Final_8.4.23.pdf
https://www.prnewswire.com/news-releases/iveric-bio-receives-us-fda-approval-for-izervay-avacincaptad-pegol-intravitreal-solution-a-new-treatment-for-geographic-atrophy-301894042.html
The label is interesting:
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to
use IZERVAY safely and effectively. See full prescribing
information for IZERVAY.
---------------DOSAGE AND ADMINISTRATION---------------
The recommended dose for IZERVAY is 2 mg (0.1 mL of 20
mg/mL solution) administered by intravitreal injection to each
affected eye once monthly (approximately 28 ± 7 days) for up to
12 months (2.2).
Never said you did, others have. The paragraph was a comment about what some others do and I thought you would recognize that since you, as stated, haven't done that.
As to the quote, I'm not going to repeat how I replied to that. Nuance is hopeless on this medium.
Valid point about inertia, however my doctor in specific is generally open to new treatments and is not what I would describe as 'older'. Going to vary and yes, will matter with some.
As far as not having a choice pretty soon - that is speculative. Could happen! If and when are very much up in the air and should have zero effect on the early launch. In any case I think Allergan/AbbVie have some pull so who knows.
I think the main point of everything is the sales reps have their work cut out.
RVNC 'annecdata'
Had a minute to talk to my Neuro about Daxi. Not a lot to read into it other than the CD launch may be slower than most are anticipating, even some expecting a slow launch.
He is part of a large Neuro group. Everyone injects BoTN, including the PA's. He has treated with Botox for a long time, participated as an investigator in migraine trials leading to approval in that indication, and trains injectors on a regular basis. He has quite a few CD patients. This group does research studies. RVNC had a trial site in the metro but this group did not participate.
Name awareness of Daxi = none
Awarness of a new BoTN for CD = none
Awarness of duration profile = none
Additional comments:
First priority is if something is working for a patient, don't change it.
He does use BoTN other than Botox if that patient needs it but he is averse to using different unit amounts and so on.
While he did not have specific Daxi duration info (not my place to do that) his comments in general on increased durability showed indifference. It isn't clear if a 2x difference would change anything but the hypothetical he assumed wouldn't change his practice.
As far as speculating on him being a 'Botox man' or anything similar, my advice is don't. There is nothing to read into anything beyond what I wrote. This doctor and this group is patient first, that is why I use them. They are top-notch.
Best of luck.
There is barely any open interest and more of it is on the call side. Congrats on your success thus far!
Not what I said, but like you said there is no reason to fight about it. [eos]
Kind of surprised that no one has commented on PFE reduced Covid related sales.
https://www.cnbc.com/2023/08/01/pfizer-pfe-q2-earnings-report-2023.html