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I'm not sure I like Daxxify but I do like this one: Twice upon a time.
link
59.6 million shares traded today. Who's buying? Hedge funds hoping to extort a few dollars from J&J?
Good news which we may come to regret given all the potential here. We have a bird in the hand at what seems like a good time to raise cash.
Interesting that this occurs soon after all the insider selling that Jbog was documenting.
I don't think it's a Daxi name but rather a name for an educational/marketing program.
From the CC:
In August, we hope to have onboarded our full sales force, 65% of whom have accepted offers. This group will launch the RHA collection starting with
our special PREVU program. Revance has spent the last 3 years working closely with key aesthetic opinion leaders. Our new PREVU program was
designed in concert with this group and align with their desire to experience RHA firsthand. This experienced program, coupled with the ongoing RHA
education program, will provide a solid foundation of experienced injectors to lead this full-scale rollout.
...
With the PDUFA date of November 25 for DaxibotulinumtoxinA for Injection, we are planning a sequential launch of our neuromodulator. Once
approved, that will first involve a targeted PREVU program focused on hands-on training and education.
I draw the opposite conclusion from your link. It's getting harder and harder to put in new pipelines so the existing ones become more valuable.
Maybe you have to be old to remember it.
Let it be Daxi. Daxi or nothing.
Who recognizes what that's a riff on?
I assume "Sickle Cell" is a poor transcription of Subcutaneous.
Seems kind of slimy for that Electrek reporter to suggest people use his referral code.
Thanks for posting that. I didn't see the reference to 2021 though. I wonder if people will hold off buying an EV until the newer batteries are available.
Those CATL batteries will be available to all EV companies, not just TSLA right?
China just reduced subsidies so they apply only to cars priced below the Model 3 (causing April sales to plunge) and now TSLA is reducing the price so that the subsidies apply again. I would expect that if TSLA can lower the battery cost, China will again force them to lower the price.
Those articles are computer generated click bait. The same article comes out for every ticker eventually with only the numbers differing.
Mizuho comments dated today FWIW:
We apply a weighted-average valuation methodology to derive our $35 PT (DCF +
EV/Sales). Our assumptions include:
DAXI (Glabellar Lines): Commercialization in 2021 in the U.S. with unadjusted peaksales of $355 mil in 2025 (current PoS: 90%).
DAXI (Cervical Dystonia): Commercialization in 2021 in the U.S. with unadjusted
peak-sales of $60 mil in 2025 (current PoS: 90%).
DAXI (plantar fasciitis): Commercialization in 2021 in the U.S. with unadjusted peaksales of $124 mil in 2025 (current PoS: 20%).
RHA: Commercialization in 2020 in the U.S. with unadjusted peak-sales of $159 mil
in 2025.
DCF Assumptions: We project total (PoS adjusted) revenue of $1.30 billion in 2029.
Terminal value of 4.5x 2029 estimated FCF and a 13% discount rate to derive a $33
PT. EV/Sales Assumptions: 4.0x multiple of 2028 sales, discounted at 13% to derive
a $37 PT.
Bull case: Our bull case assumes better than expected uptake and adoption of RT-002 in
the US for glabellar lines resulting in peak market share of 32% in 2025. This translates
into a $54 PT.
Bear case: Our bear case assumes slower than anticipated uptake and adoption of
RT-002 in the US for glabellar lines resulting in peak market share of 13% in 2025
($235 mil unadjusted sales). We also assume a 0% probability of success in therapeutic
indications. This translates into a $17 PT.
Janet should follow Peter.
twitter
Somewhat relevant to MNTA as they are still working on Eylea biosimilar with Mylan:
Endpoint news
The overallotment was exercised so it's actually:
Revance paid $28.9 million of the proceeds of the $287.5 million offering for the capped call. Pretty close to 10% charge on top of the 1.75% interest rate.
It seems to me that the purchase of the calls shows a high degree of confidence by Revance Management. Whether that confidence is justified is a separate issue.
Transcipt (Seeking Alpha)
Excerpt on the new NASH drug:
Sure. So shifting gears to FXR now. So 297 are follow-on FXR agonist. We spent a lot of time trying to optimize whatever characteristics of the molecule we could. Obviously looking at potency and selectivity and other kinds of things. What surprised us as you know with 305 in the ARGON study was that the doses that we used, we saw more pruritus than we would have expected from all the information we saw in Phase 1. And so for us thinking about how to use 305 in a way that gives better tolerability going forward is the path that we’re thinking about for 305, but 297 then it became clear that pruritus perhaps more so than lipids is the thing we needed to really try to figure out how to improve upon. The confounding part of that is that nobody -- nobody really understands what’s causing pruritus with these various FXRs that have seen it, is it on target, is it off target, is it on target in certain tissues, but not others and so absent having the sort of confirmed mechanistic understanding of how to reduce pruritus, what we did was took other approaches that we could do sort of independent of knowing the mechanism.
So number one is drill down the potency to as good a potency is you could possibly do. So we worked and worked and worked on that you’ve -- we put the data out at JP Morgan initially, we’ll have more at EASL, but it’s a very, very potent FXR. It is the most potent one based on the data that we’ve generated side by side versus any other FXR agonist that’s in development today. So number one, that’s good because you will reduce the amount of drug that it takes to deliver the punch. So we know that FXR receptors are in the intestine and also in the liver in terms of the sites of efficacy for a compound that we would be looking for in NASH. And so in addition to making these exquisitely potent for FXR and hopefully less potent for something else that we might not know, we aimed it directly at liver and intestine and not had plasma and skin, because obviously if you have high plasma levels you are going be circulating the drug around to all kinds of other tissues in the body and we specifically thought it would be interesting to minimize the skin exposure of the drug as well.
So it’s really the twofold combination of having very, very good potency. So that we’ll be dosing just very small amounts of drug and then having that drug go directly to the sites where we need the drug and hopefully not at the sites where we don’t need the drug were only -- were only -- were only other things could happen. So that’s our thesis and there is a scenario where it might not play out as we hoped, but that sort of narrow scenario of bad luck would be, if it is FXR mediated, the pruritus and if it’s FXR mediated by FXR receptors inside the liver or intestine, then we may only have achieved a super, super potent version of 305 or some of the other FXRs that are out there today. But if it’s any other scenario, we have the chance to come up with benefit and that’s what we’ll be exploring. We think we can learn actually, a fair amount in Phase 1 and we’re on track to start that Phase 1 study in the middle of this year with -- with the -- with the data coming in the first half of next year. So it’s a pretty straightforward plan, it looks like an excellent molecule chemical profile more at EASL, but it’s a -- it’s a polished entrant into the field.
Raised target on RVNC, downgraded AGN, reduced target on EOLS. Dew hacked into Wells Fargo!
Thanks. I guess the yahoo chart I looked at didn't go back that far. Wonder if that early morning surge was short covering. Seems to have calmed down now.
Volume is increasing also. About 1.6 million in first 10 minutes versus 3.5 million for whole day yesterday and 2 million for whole day Monday.
Just realized that is an all time high for MNTA.
Already exceeded JPM $30 target.
Totally agree the market will expand. The current market is supply constrained. Plenty of articles about desperate patients unable to get it at times. Also, the time burden for patients and staff must be discouraging IVIG use in many cases. Probably a lot of patients are underdosed.
$MNTA @ SUNT - buy - $50 tgt up from $29 - our confidence has increased in MNTA's drug candidate M254 being a more potent drug than currently used to treat autoimmune diseases (shorthanded IVIg), which has market sales of $6B. Have increased the market potential for M254 in our model and increased our adjusted peak sales to $1B from $600M - $MNTA @ SUNT - buy - $50 tgt up from $29
Volumes aren't that high for this big a move. I wonder how much is short covering.
Quite a move today. Lowest dose of M254 was 60 mg/kg (one patient under dosed at 43) and effect comparable to 1000 IVIG so potentially more than the 10 times effect they thought would be a homerun. The confusing thing is what happened in the higher cohorts. They talk of variability so maybe no clear trend with higher doses?
The NR was poorly written. The presentation provides some further clarity but I guess they are withholding the specifics for a conference presentation.
Here is their chart of catalysts.
YE19 / Early 2020 DAXI Glabellar Lines FDA Acceptance of BLA
By April 30, 2020 DAXI Glabellar Lines Decision on biosimilar with Mylan
1H20 DAXI Forehead lines Forehead lines phase 2 data
1H20 DAXI Crow's feet Lateral canthal lines (Crow's feet) phase 2 data
2H20 DAXI Glabellar Lines Potential FDA approval and subsequent commercial launch
2H20 DAXI Cervical Dystonia Phase 3 data
2H20 DAXI Adult Uper Limb Spasticity Phase 2 data
2H20 DAXI Plantar Fasciitis Phase 2 data
1Q21 DAXI Glabellar Lines Potential product launch in Glabellar Lines, if approved
2020/2021 DAXI Glabellar Lines Potential new patnership ex-US
2020 DAXI Glabellar Lines Potential developments on regulatory pathway in China
From Mizuho today highlighting top picks for 2020:
Maybe the full settlement is more than 35 million. The wording seems clear that 35 is MNTA's share.
Momenta's crack legal team loses again.
On December 10, 2019, Momenta Pharmaceuticals, Inc. (“Momenta”) entered into a settlement agreement (the “Settlement Agreement”) with the plaintiffs in the antitrust class action lawsuit pending in the United States District Court, Middle District of Tennessee (the “Court”) under the caption The Hospital Authority of Metropolitan Government of Nashville and Davidson County, Tennessee, et al. v. Momenta Pharmaceuticals, Inc., et al., Case No. 3:15-cv-01100 (the “Class Action Suit”). Under the Settlement Agreement, in consideration for a full release of Momenta from all alleged claims, Momenta has agreed to pay to plaintiffs an aggregate of $35.0 million, of which $200,000 is to be paid within five business days of the entry of the Court’s order directing notice of the settlement agreement to the class, $14.8 million is to be paid within five business days of final approval of the Settlement Agreement by the Court, and $20.0 million is to be paid on the later of 270 calendar days of the execution date of the Settlement Agreement or five business days after the final approval of the Settlement Agreement by the Court. The Settlement Agreement is subject to class notice periods and Court approval pursuant to Rule 23 of the Federal Rules of Civil Procedure and the Class Action Fairness Act (“CAFA”). Momenta denies all claims and allegations of wrongdoing made in the Class Action Suit.