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RECELL Go Gets FDA Approval
Massive!!
THIS IS THE WAY.
https://ir.avitamedical.com/news-releases/news-release-details/avita-medical-announces-fda-approval-recell-go
As I stated, how he opines is immaterial (despite the fact that he’s on record for liking the company, which is why he had Perry on twice and talked about liking the product many times thereafter). But that was a long time ago. Though positive sentiment never hurts, his “OPINEion” is largely immaterial in the scheme of the facts: FDA approvals, broadening scope, increasing sales, plenty of cash, halo product, and a path to profitability, to mention a few.
And, yes, he does do quite intensive research. He may be wacky, but he’s extremely thorough and highly intelligent. Both he and CNBC have extensive resources and staff that do serious due diligence. I assure you he will see what we ALL see. And he will like A LOT. Maybe all of it. But yes, in the final analysis, he may hedge because of the market cap. Or because they’re not yet profitable though that’s not an intransigent sentiment with him. He mainly holds that position in a risk-off environment with recessionary risk or looming rate hikes as we’ve been in the last couple years.
But these days are different. Have you seen Bitcoin lately? Upcoming IPOs? Anticipated rate cuts? We’re in a very different market than a few months ago and he may change his tune, especially when this company will be profitable by next year. Or he may not. Doesn’t really matter.
No — this is ALL about visibility. Institutions are very well aware of this stock with a couple having taken deep bites, but the retail investor by and a large? I don’t know. This stock is/was mostly held by retail last I checked, but that doesn’t necessarily indicate plurality. Many may have it off their radars these days. Many may just need a couple of positive comments that piques their interest and jives with their risk tolerance. This is who I would expect to come looking. Thousands will look. Some will buy. Maybe small fish. Maybe big fish. There’s no way to know. All I’m saying is “hold on tight.” TiGETTY-tight.
PS: relying “on the new executives executing what seems like a very workable strategy” is in no way shape or form mutually exclusive to gaining massive visibility. Both can be had.
Mad Money episode tonight 2/29/24 … on Leap Day of all days.
Caller: Cramer what do you think about Avita Medical?
Cramer: I do not know this company! I will have to do some work.
First of all, the question surprised me. Second, I was surprised they allowed the call to go through as the show, I believe, requires a company to have a minimum market cap of $1B or $1.5B for it to be discussed. He had Mike Perry ON his show twice (once in person) around 2019 or 2020 during its huge run up toward all-time highs when it was around that market cap. He will definitely remember once his staff does their due diligence. This is a FAR more advanced company than it was then.
Usually (maybe always) he’ll do a follow-up with his “homework” updating viewers on questions about stocks on which he was stumped by callers.
This should be VERY interesting, not necessarily because of what he does/doesn’t have to say (you should rely on your own research), but for the mere fact that he has a massive audience and massive platform for visibility.
Hold on VERY tightly to your shares until if/that segment airs, potentially within the next few weeks.
Beautiful quarter.
And looking like a beautiful year.
https://ir.avitamedical.com/news-releases/news-release-details/avita-medical-reports-second-quarter-financial-results
Massive catalyst potential.
Forward!
https://ir.avitamedical.com/news-releases/news-release-details/avita-medical-submits-fda-pma-supplement-recell-go
$38 MILLION dollar purchase right at the close!
https://imgur.io/a/mg5QPG3
We should learn more about their overall international rollout strategy by Q4 ‘23, potentially including any timing or plans by Japan to take these latest indications through their PMDA process. Until then, Q3 and Q4 ‘23 should be exciting as sales and revenue ramp to new heights.
The real catalyst starts with their next potential approval: the automated device being submitted for FDA review in a couple weeks and its expected approval by Q1 ‘24.
Victory, healing and growth ahead.
HALLELUJAH!!
APPROVED AGAIN! And AGAIN, this is JUST the start.
Wow. WOW. WOOOOOW!
https://ir.avitamedical.com/news-releases/news-release-details/avita-medical-announces-fda-approval-recell-skin-repigmentation
HALLELUJAH!
APPROVED! And this is JUST the start.
Wow. WOW. WOOOOOW!
https://ir.avitamedical.com/news-releases/news-release-details/avita-medical-announces-fda-approval-recell-treatment-full
One of the prettier cups I’ve even seen.
That 167,000 share buy @$13.97 for $2.3M+ right at the close today was interesting.
I’ve noticed this type of buying right at the close 2 or 3 times this week, but none were nowhere near this size.
Webinar link @4:30PM ET on 2/23/23
https://ir.avitamedical.com/events/event-details/avita-medical-inc-fourth-quarter-2022-earnings-conference-call
Bada bing bada boom!
$51M projected for 2023. That’s 50% up from $34M in 2022!
https://ir.avitamedical.com/node/11056/pdf
Couple of minor corrections on that summary — the FDA submission month for soft tissue and vitiligo approval is December 2022, not 2023.
Also, if 5 “cases“ per month is breakeven for sales reps, does that mean a sales rep hire “costs” $400k/year (5 cases x 12 months x ~$7k/assuming 1 kit only)? How much of that is salary and how much of that is “other” (training, benefits, travel, etc)?
Anyway, the growth potential here is just absolutely massive. With vitiligo patients at even 1/5th of the mentioned number (say 100k patients), with burns and soft tissue on the low end, and at the current laughably low multiple of around 5x, we’re talking about a $200 share price. Increase the multiple to a fair 10x and if they execute even modestly better sales than that, this is a $500 stock! That’s assuming, of course, all things falling into place as expected and at the current float with minimal to no dilution.
Just wow.
This appears to be the transcript template for today’s annual meeting.
https://company-announcements.afr.com/asx/avh/362c3104-79e3-11ed-8de5-92c22c5e7bc7.pdf
Nice summary. I wasn’t able to attend but am about to watch the replay at: https://event.webcasts.com/viewer/event.jsp?ei=1584891&tp_key=7b9bd1b241
Not sure if there were slides on the original meeting, but at first glance the replay seems to be audio only.
At their estimated SAM of 1.4K, could mean revenue around $15M/yr (assuming $10k USD/per at the high end), which is about a 50% boost to current US numbers.
What I most liked hearing:
- no debt or dilution in sight for the near future
- COMPLIMENTARY — not competing as so many cluelessly tout — to other companies like PolyNovo
- will pursue CMS for CPT or HCPC codes for vitiligo service and equipment, which is a surprise considering most payers may consider it cosmetic
Page 7 shows an estimate timeline. Could be as early as late next year.
https://ir.avitamedical.com/static-files/ad3dca90-2206-49d1-8633-8fa420b05625
You don’t need to be an MD to run a world-class biotech or pharma if that’s what you’re implying.
Veterinarians are scientists. Some of the most amazing American companies are led by scientists. Not lawyers. Not accountants. Not engineers.
Among the top of that list is Pfizer, whose longtime CEO Albert Bourla, is a veterinarian himself.
Can you repeat that in English, please?
Sounds worth understanding, but between your post and the broken link, I’m confluffliflixicated.
Cheers
As melody suggested, the 30 minute mark and after IS A MUST LISTEN.
SPIKE!
Be nice if they’d do it before the Olympics. Considering the likely dearth of crowds, tourists and audiences, doubtful though.
Both RCEL and VCEL had unusually massive volume at the close today (~2M and ~500k, respectively).
Interesting.
Only thing I want from VCEL is the nearly 7x spike that stock has seen in the last 12 months. Hit $70 in after hours. Mamasita!
Ok, which one of you cats made that 200k share ($4M+) buy at the close today?
November 2020 Corporate Deck
https://ir.avitamedical.com/static-files/5391035f-89fd-4a8c-a99c-e6511ff967ac
Here’s the transcript of the call.
Covid has really done a number on the company‘s GROWTH, disrupting new sales and existing support in meaningful ways. Manufacturing seems unaffected. New vaccines and new administration open to scientific approach and guidance will only be a benefit.
https://seekingalpha.com/article/4387879-avita-therapeutics-inc-rcel-ceo-michael-perry-on-q1-2021-results-earnings-call-transcript?utm_source=dowjonesnewswire.com&utm_medium=referral
Q1 — YoY:
- EPS $0.48, up from $0.19, or +153%
- Sales $5.1M, up from $3.3M, or +55%
Here’s the recording of the conference call that just ended a few minutes ago. I wanted to ask for an explanation about the ways they‘ve compensated themselves and Perry’s stock sales (or expected someone from this board to do so), but questions seemed to have been reserved for analysts who pre-identified themselves to the operator at the onset.
Surprised no one here or HC is talking about the call.
Was anyone even aware of it?
https://ir.avitamedical.com/events/event-details/avita-therapeutics-inc-first-quarter-2021-earnings-conference-call
EDIT: Correction. I thought the operator said the recording would be up right after the call, but she may have said 5PM Pacific. Just keep refreshing the page below; it should show up at some point. On the call was Perry and the interim CFO with prepared remarks for 30 minutes and about 30 minutes of questions from analysts from: Cowen, Bank of America, Lake Street Capital, Oppenheimer and a couple of others.
https://ir.avitamedical.com
Great idea. I wonder if she’d be up for it.
Are you saying you’re making $40k on .40c swing trades?
Not challenging or questioning you; just making sure I’m understanding you to say that you’re trading 100k shares (aka $1,000,000) for $40k flips.
For those unimpressed with the last quarter, particularly the smaller-than-hoped newly added centers, it appears they have a “go deep” strategy for scaling. Might seem counterintuitive in terms of sales strategy, but their primary focus may be not to “go wide (too soon)”.
In fact, their goal for ALL of 2020 is only 25 new centers. Perhaps that strategy is also dictated by other market forces and conditions into which I have no insight.
——
Snippet from the quarterly, worth a re-read:
2019 in Review
United States In-Patient Burns
31 December 2019 marked the first full calendar year (CY) of sales since the U.S. commercial launch of the RECELL System in early January. During the first half of CY2019, our commercial and clinical support team made concerted efforts to build awareness and to promote the donor-sparing, point-of-care and related clinical benefits of the RECELL System among an initial cohort of the 132 burn centers (i.e. the in-patient setting) that treat approximately 40,000 burn patients each year.
The core of these early efforts involved educating and training many of the 300 certified burn surgeons, proctoring bench and in vivo use of the RECELL System, and ultimately seeking hospital approval to purchase the RECELL System through the respective VAC at each burn center.
With RECELL being the first product in more than 20 years granted Premarket Approval (PMA) by the U.S. Food and Drug Administration (FDA) to treat severe thermal burns, we were able to quickly secure orders in 39 of the 132 U.S. burn centers (and train 136 burn surgeons) by 30 June 2019. Consistent with our two randomized clinical studies and our PMA, early utilization of the RECELL System by the first adopters mainly focused on the less common full thickness or “big burns”; that is, the larger and deeper (full thickness) TBSA burns bracket within the approximately 14,000 of the 40,000 patients treated within the in-patient setting.
In the quarter ended 30 September 2019, we added a further 13 institutions (as well as increasing to 157 trained burn surgeons) and saw our top line revenue consequently benefit from the addition of these new customers, including some larger stocking orders from key customers during that period. With the initial core customer base established within this window, our commercial efforts in Q3 CY2019 shifted to building consistent RECELL utilization by ensuring strong clinical outcomes within those early users of the RECELL System. Creating a strong commercial support presence in centers, paired with excellent RECELL clinical experience was a key focus during the first quarter of fiscal year (FY) 2020 (Q3 CY2019) because the in- patient burn treatment setting is characterized by physician preference and inherent variability in month-to- month patient accrual (i.e. burns are random, or “accident-induced,” and therefore lack a consistent referral path).
The closing three months of 2019 (FQ2 FY2020 / Q4 CY2019) resulted in growing and consistent utilization of the RECELL System across our customer base, including some of the highest procedural rates with the RECELL System since PMA (and 15 to 20% higher than FQ1 FY 2020 / Q3 CY 2019). Furthermore, we were able to add eight new customers late in the quarter and train an additional nine burn surgeons. This brought our 2019 total to 63 ordering customers and 166 trained burn surgeons. Due to our commercial team’s efforts in educating both physicians and burn centers, we have reaped to date 100% success in navigating the VAC approval process and have established a base of “super users,” or physicians using the RECELL System across a broad array of burn sizes and depths, and patient types. In this regard, our top 20 customers are relatively concentrated and delivered approximately 60% of revenue in each of the last two quarters of CY2019. Because of this, we see the opportunity in 2020 to similarly more broadly penetrate our other RECELL customers, as well as to expand our footprint into new burn centers.
In pursuit of wider utilization of the RECELL System, we intend to add 25 new sites in CY2020 and will leverage our current commercial infrastructure to do so. The rate of in-patient burn admissions is inherently variable, but we feel very confident of incremental revenue growth across the entirety of CY2020 as we continue to focus on our “go deep” strategy of (1) broader TBSA burn utilization (i.e. broadening RECELL use from large, full thickness, TBSA wounds, or “big burns,” to the much higher incidence of smaller or partial thickness burns) consistent with usage patterns demonstrated by our most experienced users; and (2) educating and training other burn surgeons within our customer base. We see a total addressable burn market for the RECELL System of U.S. $200 million in in-patient burns.
https://www.asx.com.au/asxpdf/20200131/pdf/44dnn664vbmtlx.pdf
For the 3rd time ever, Avita was on Mad Money.
In tonight’s Lightning Round, Ryan from California asks whether Jimmy Chill (as his daughter calls him), recommends RCEL. Jimmy responds (paraphrased):
“I bless it. Remember, it’s a spec play, but I like it!”
I bought my first shares in this stock in 2007. Held faith though the eFood and Nuvilex scams.
2007. Nearly 13 years ago. Total of 6 digit shares. At WAY higher prices. I even added some in .50s, then down in .5s to average down.
Massively in the red since. Never traded, never flipped, never sold a share. Never sold a single share. Not one.
Until late last month. Sold everything except for a couple hundred “restricted” shares I am unable to sell. I have no idea how, why or where they came from. I sold for tax loss harvesting on other gains. For the first time in 13 years.
Then I see the PR and price doubling last week. I was kicking myself for two days last week and couldn’t believe my crappy timing.
Pete and Bear’s posts actually gave me clarity and understanding on that f&@king PUMP AND DUMP last week ... enough to fight off my temptations to buy back before tomorrow, which would have been about a week short of my 30 day wash rule window. Thanks to you both.
This is getting beyond suspicious, and I don’t think I’ll be buying back in until January, if I ever do. IF they actually file the IND, I’ll consider it. If not, I may trade it until I recoup my 5 digit $ losses.
Now, I don’t blame anyone for my investing decisions, but I definitely feel played here.
13 years. New investors BEWARE and proceed with caution.
Wrong. Very wrong.
It’s a regular segment they do. Some get a thumbs-up, many don’t, like this one:
I happened to catch this on today’s episode of “The Doctors” (a US based globally syndicated talk show since 2008 where doctors discuss various topics).
I watch this show a lot, and I can tell you their effusive reaction is genuine.