$ 62 M for Q2 would be a disappointment, my expectation would be Q2:66/ Q3:70 and Q4:85 from cosmetic sales. An extra $ 10 M in 2024 from the therapeutic indication(s) and mile stone payments from Fosun. Anything below $ 65 M for Q2 will be an indication that the year goal of M$ 280 in sales is in jeaopardy and the short seller will be back in action.

Fosun made two press releases in April and July 2023 in regard to the submission of Daxxify, for cosmetic treatment and the treatment of cervical dystonia, stating that China's NMPA accepted both applications for review. Other source state that median approval for compounds was 15,4 months (2017 -2021). Generally imported drugs take longer but the trend for approval times is going down. My guess is thus that we will see approval this Q3 or Q4 - and yes I agree that we will not see a significant impact of royalty payments from Fosun this FY. Buckle-up for 2025 as RVNC will make a significant impact in relaxing those necks in the PR of China.

Any news on the registration in the PR of China? That should be a big boost.

merci mouton

Cell penetrating peptide: DAXXIFY is the only botulinum toxin with cell penetrating peptide technology (1, 6-10). On the RVNC website in the cervical dystonia chapter, one can find the latter statement. I never heard the claim of "cell penetration" before. The references after this statements are the prescription informations of Daxxi and of the other bot. toxins - not any article in a learned journal. Have I fallen asleep behind the wheeel - thus far the story of the adjuvant was its postive charge which thus allowed the toxin to remain close the negatively charged cell surface, allowing for better endocytosis. I never read anywhere that the adjuvant aids in cell penetration. Cell penetration from outside directly into the cytoplasm? Is this just a marketing message, keep it simple? For medical products any statement needs to be backed up with published facts - are there any? Anybody know? Thanks Rockmountain

... market cap. of less than 1 x annual sales. For a pharma company with a block-buster in the making - unheard off.

There was a recent post on potency testing of Daxxi which does not use the LD50 mouse testing. Is such a non-animal-testing method a prerequisite for the registration of Daxxi with the European Medical Agency? Is it because of this that we have not submitted in the EU yet?

First reported transmission of HIV-AIDS as a result of beauty treatment! In Morbidity and Mortality Weekly Report April 25. 2024 (73(16):372) the CDC reports on the first reported transmission of HIV-AIDS as a result of micro-needling. As this raises concern, I hope that RVNC again reiterates the point that DAXXI does not contain human blood by-products, whereas BOTOX does contain stabalizers derived from human blood. I know that the infections in this report was due to contaminated needles and using microneedling - but as this spreads throughout the industry, one can throw in the slogan - "If you want the best and the safest , you can trust DAXXY"

Hey Emannow, any info from those RVNC employees if Q1 is going to be north of 60 million in sales?

Daxxi for CD has longer duration and significantly less side effects for dysphagia and xerostomia. Best of both worlds, you would think this is a slam-dunk for RVNC , what am I missing? Are docs, hospital and insurers so set in their ways that switching a drug is so difficult? Thanks for a any views on this.

Foley was never CFO, but a board member. When Dan Browne resigned over "missjudgement in handling an employee related matter" he took over Dan's job.
Those were the days when a CEO was fired over handling an employee matter - these days you keep your job even if you "missjudge" a product launch or "missjudge" the pricing startegy.

Hoping that we will have > M$ 60 sales, do we have sales in CD aleady??

At last years JPM, first day, they released the Q422 numbers and the stock jumped by 30%. Same thing this year I presume.

The JP Morgan Health Care Conference is upon us and hopefully a press release on prelim. Q4 numbers. Last year we closed at $ 19.7 on Jan 6th and closed at $ 30.42 on Monday Jan 9th, after the press releases on Q4 22 numbers. Monday $ 15 here we come!!

Dangerously close to break-even in 2024. If Q4 23 would indeed be around the 90M mark, that would take us to a projected > 400M sales in '24 and very close to break-even. Once RVNC shows profitabilty for more than 2 Q in 2025 this stock will open up for many more institutional investors. Board the bus now.

Is the addition of human serum albumin as a stabilizer in Allergan's Botox not a concern for Botox users. Currently the use of medical products derived from human blood are considered safe, but from a publication on this topic:

"However, based on a review of the hitherto available data, it is impossible to conclude at this time that CJD is NOT transmitted by blood or plasma transfusion or by the administration of pooled plasma derivatives. " (such as HSA)

Would I use Botox if there is any possibility of getting Creuzfeld-Jacob disease (spongiform encephalitis) or dementia)? Hey, 30 years ago they said human derived hormones were save and then along came BSE and CJD, before that HCV, before that HIV. I am surprised that the HSA/adjuvant story has not been used in full force.

Emannow, re the comments on sales meeting, do we know if the Q3 sales will show an up-tick vs. Q2 sales or will the price change and resulting increase of sales be only visible in the Q4 sales numbers, which we will get in Feb 2024?
In the last investor presentation of RVNC, slide 26 showed the historic sales of the other new Botox products in the 4 Q after launch and all had a dip in their Q4 after market introduction. If RVNC can show better sales numbers for DAXXI in their Q3 numbers (= 4th quarter after launch) this would be a strong message and it would put DAXXI sales to > 60 million in the first year after launch. Extrapolating, hopefully, on Q3 sales of close or over 25 million would put us to above 100 million in annual sales and at about/just below 5% market share. After one year on the market is 5% market share disappointing? I believe that such a gain against an entrenched opponent is not bad at all and the market kinetics are showing into the right direction. The next 2 Qs will be decisive to show us if this bird will soar or not. Until then I would not bet on any significant advances in the market.

... I bought into this stock in mid 2019 at pretty well the same price that we have now. Unbelievable that we have slid back to this level on the back of all the good news and two FDA approvals. Market cap is getting close to the current value of the company if one applies the usual multiples on sales and projected cash flow.

Over M 80 in Q2, that's optimistic. Looking at Q4 22 and Q1 23 numbers, I expect max M 40 for RHA and M 22 for Daxxi for Q2 23. So if Q2 sales exceed M 65, I would be very happy. Those numbers would not help lift the stock price, I am expecting a pop after the CD clearance by the FDA.

On the making waves article: The autor refers to Daxxy as a candidate and fails to mention that the drug is a) not a candidate but a drug for sale and b) we are beyond phase III we are selling since Q4 23. What an amateure.

"Its drug candidate, DaxibotulinumtoxinA for injection, has completed phase III clinical trials for the treatment of glabellar lines and cervical dystonia and is currently undergoing phase II clinical trials to treat upper facial lines and dynamic forehead and lateral canthal lines."

Zacks Research expects 45,4 M revenue for Q1/23, that would be below Q4/22's revenues which were at 49.9 M. Don't know what Zack's staff are smoking, anything below 55 M for Q1 would be seen as a disappointment, anything north of 55 would float our boat.

.. does anybody have an indication what the word is on Q1 2023 sales results?

All areas are being treated (glabellar,canthal, frontalis, lip flip ...) although only glabellar lines is the indication for which the FDA gave the approval.
I wonder if the same will be the case for the clinical indications - i.e. once we get the nod for cervical dystonia, will docs use it off-label for upper limb spasticity, lower limb, over active bladder, migrane etc. Any thoughts?

Dr.Song's comment is wild: He explains the peptide excipient vs human serum albumin and then goes on: "... we use peptides in skin care to hydrate your skin, to give you that glow. This is the first product that we have that can actually inject the peptides into your skin. So while you are getting your Daxxify treatment, you are getting a skin treatment as well!! ...those peptides in this product are giving people a glow, that glow, you have to see it."

So basically he claims you get a 2 in 1 - never in my wildest marketing dreams would I have believed that Revance's MD customers come up with such a story. Than glow, man, that glow.

Cramer: Not "Bye, bye" but "BUY, BUY, BUY"

Am unhappy that EU,UK and CH registration has not started as of yet; a contractual wrangling with Teoxane may be an explanation. Then I would however expect that RVNC could at least file for the clinical indications for Daxxibotulinumtoxin. Thus far nothing published and seeing as the registration with the EMA is a 2 year process, I would have expect that RVNC would have started in 2019 with the submission in the EU, instead they drag their feet. I wonder why we hired a new Medical Director???

With Daxibotulinum toxin not even submitted to the EMA, there is no hope to have this in Europe in 2024 and unlikely in 2025. For reference Evolus submitted Nuceiva (sold as Jeuveau in the USA) to the EMA in June 2017 and received the approval in July 2019. I do not understand why Revance is dragging their feet on this submission, this is a very long process in in those 2 years there is ample of time to figure out commerical paths. But you have to submit and RVNC has not started. UK will be a separate submission again. RVNC get going!!

The RTP004 peptide is contains a 9 aa sequence described in HIV's TAT (Transactivator of Transcription). This synthetic 9 amino acid is the ingenious part of the the excipient which helps the toxin to bind to the membrane of the nerve cells and get across it.

Calling out that you are "injecting HIV" was to be expected. If you are trying to displace the El Primo do not expect him to play nice. I would just say:

1) Daxxi contains a purely synthetic peptide with scienced-out sequences. Do you prefer an injection with the others which contains human albumin derived from expired blood and human tissue products and which contains, and I quote: " it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease
(CJD) is also considered extremely remote." (Extremely remote,? Woah I heard that one before!)or do you prefere a pharmacetically produced synthetic peptide which encases the botulinum toxin?

2) In case of Botox we are discussing injecting one of the most lethal toxins known to man - so lets not worry about a a synthetic peptide which was made in a pharmaceutical process taking a text book sequence.

3) Science and medicine derives many of its medicines and compounds from bacteria, viruses plants and others: penicillin was first derived from molds, aspirin from birch bark and Botox from clostridium botulinum and RTP004 from a segment of a retrovirus. We do not inject those organisms but get inspired to use their building blocks.

I do not know how tofurther dumb-down the message but this was to be expected, so I am sure RVNC is prepared for the mud slinging.

European launch requires EMA,MHRA (UK),SwissMedic submission and approval first and that takes time. What I am disappointed in is that RVNC has not even started this process, which takes years (we all remember the FDA odyssey). Such activities do not interfere with commercial activities in the US launch, neither with cosmetic nor with clinical and are not very expensive either. Why then this hesitance? In the meantime anything below $ 30 is a buying opportunity pour moi.

The CC lacked the "go-get-em" spirit and lack-lustre in regard to what is next, the mantra was lets take it slow, lets make sure we get it right, lets stay in the US market

- Clinical indication: only CD was mentioned and there it was a slow release, lets do a prevU with the 1000 or so injectors in the USA once we have the approval and then lets slowly find out how much to use and maybe we can then learn something for the next indications. There was no clear plan on which indications to do next, we all know how long this takes and if you have NO plan now, there will be NO sales forthcoming for the next 2 plus years.

- Europe and other markets: again no plan or vision at all. Almost vertbatim it was "Lets do USA first and then we will see" Again EMA and China FDA take just as long and if you do not start now - nothing will be on the books in regard to sales in the next two years.

In all, no vison and no agressive expansion plans.

Grow the business I say, at $ 240 a share in September of 2026 I am looking forward to a dividend of $ 5,20 a share, with the alpine sun burning wrinkles into my forehead.
I hope RVNC shareholders and management believe in its product and opportunity for a long and profitable business.

The data on Cervical Dystonia will renew interest and willingness by clinicians to test Daxxi for other indications.

Botox Prescription Information for CD states: " ... most subjects ... returned to pre-treatment status by 3 months post treatment" . Daxxi improvent to 20 - 24 weeks is cjlinically very relevant and will lead to huge excitement especially when paired with a decrease of dysphagia from 19% (Botox) to 2,7 and 4,2% (Daxxi).

This bodes very well for a strong interest to start new trials for the far more interesting indications such as spacticity, migrane, bladder dysfunction

Daxxi sales in Europe, 2017 European Medical Agency waiver for the use of Daxxi in the paediatric population:

https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002149-pip01-17

I am not certain if this is a waiver for the treatment for glabellar lines in the under 18 year population (sound really stupid) or if this waiver means that Daxxi can be used for i.m. injection, for example in over active bladder in the paediatric population. Can RVNC build on this to get rapid EMA approval?

Rebuttal to Dr.Ostad's comments:
1) the person on the clip matches the portrait on his website. Check.
2) He states that Daxi is being ".... touted as a more longer lasting filler." Daxi is no filler, its a neurotoxin, RHA is the filler. Maybe he got fillers mixed up LOL
3) " ... based on the FDA studies that I actually looked at there was not a significant difference in terms of longevity compared to Botox."
There are no FDA studies, the studies are those submitted by Revance to the FDA, which are part of the package insert. And those do show a significant improvement.
4) Dr.Ostad has not tried Daxi himself, he is simply making a case for staying with his tried and trusted Botox. I would suggest he goes and figures out the difference between a dermal filler and a neurotoxin, actually tries the product and then come back.

What a schlepp.

Correct Mouton, the FDA does not do their own testing. As sence that starts: "While FDA testing found ...." is in itself misleading the public. The FDA checks if the instructions and indications are backed by correct data.

Hiya Bio_pet, if you look at the graphs of the clinical studies from the prescription information from Botox and Daxxi you see that Botox only graphs the data for investigators. Daxxi publishes both investigators and subject. Subjects tend to be more pessimistic and investigators more optimistic. Comparing apples with apples, the investigator's 50% line is at about 22 weeks. So one could spin it that after 22 weeks, is the 23rd week of treatment ... whatya think. But a tight call.

Daxxify versus Botox. Some people were worried why RVNC does not come out with an outright statement on 6 months between treatment in its Package Insert /Prescription Information. Statements on time between treatments are not present in either Botox Consmetic nor Daxxi's prescription information. What remains for any professional is to look at the chapter 14.: Clinical studies. There it becomes very clear that Daxxi is better and lasts, well we hope twice as long. All great,

BUT

1) Botox has indications and usage for the treatment of glabellar lines, forehead lines and canthal lines, Daxxi only for glabellar lines.

2) Daxxi is currently lacking any therapeutic indication, with Cervical Dystonia coming, Botox on the other side has all the indications covered from CD, upper and lower limb spasticity, bladder, strabismus .... and most importantly migrane.

I believe the cosmetic applications for Daxxi will spread rapidly, independent on the indications only being for glabellar lines, already we are seeing the community singing its praises in the US. But for RVNC to really get the lion share of business in the neurotoxin market, we need the clinical indications. I am hoping that Daxxi will blow Botox out of the water in regard to its rather tepid results in cervical dystonia and draw the attention to this superior product. The CD results and the presentation of the results to the physicians will be key and it will take time. We are a looking at 2024 or 2025 for RVNC to be firmly entrenched in the clinical segment. But I hope we all know this is a loooong stock and it up to us share holders to press management to build on the clinical applications, the current info on the web site is dismal.

The US market is by far the biggest singular national market for neurotoxins, but does anyone know if Revance has filed with Canada, European Medical Agency, Japan and China for the treatment of glabellar lines or CD?

Vegan- nice point but lets focus on what really counts

Human Serum Albumin versus synthetic and pure RTP004

All Botulinum Toxin neurotoxins are stabilised with Human Serum Albumin (HSA), with the exception of DAXXIFY, which uses a pure synthetic peptide. In all others the major protein in the injection is HSA rather than BoTox. HSA is manufactured from human plasma and time-expired human blood (Matejtschuk P. et al., BJA 2000, 85(6):887) and as with all blood product there remains the small risk of viral or prion contamination (Chuang V. et al., Drugs Today 2007, 43(8):547).

Of course Revance's RTP004 is a high end excipient with a whole list of other benefits and key to DAXXIFY's performance but what do you want injected, human albumin made from expired human blood and not-so-safe-at-all plasma donors or a clean synthetic peptide? Of course medical companies are not allowed to advertise trash-talk, denigrating the competition. But hey it is the truth and yes we can.

Care diem yes, but do the math. Nice article, nimble fingers on the key board but not on the calculator. If the author expects $ 820 Million in sales by 2030, that is less than $ 10 sales / share (we have 82,7 Mio shares outstanding). The EPS would be, if we are doing really, really well, at about $ 4. At a reasonable P/E ratio for the industry, lets say 30, that would put us at a share price of $ 120 or a market cap of 9,9 billion by 2030. Still not bad. Thoughts?