Ever since the move to the USA and higher SBP compensation and now a 60m raise with no apparent need for cash at these lows has me out.
Sales for Avita in their latest report were flat however a reasonable result given the affects of Covid19. They were also consistent with most medical companies in the sector.
A plus was that the business added another 7 accounts out of a total of 120 (from memory) in such a difficult environment where emergency procedures are only being conducted. There is plenty of upside to this as the majority of cases are coming from 20 accounts.
The other catalyst to the share price is the ongoing vitaligo announcements to come in the following 12 months.
Hard to put a value on this one atm but happy to hold for now.
AVITA Medical Reports Full Second Quarter 2021 Financial Results
Second Quarter Highlights
~ Reported U.S based RECELL® revenue of $5.0 million in the second quarter of 2021 ended December 31, 2020, a 62% increase over the same quarter in the prior year
~ Reported total global revenue of $5.1 million in the second quarter of 2021 ended ~ecember 31, 2020, a 57% increase over the same quarter in the prior year
~Commercial metrics: o Procedural volumes were 487 in the second quarter of 2021 versus 496 in the prior quarter ended September 30, 2020 o Added 7 new accounts in the second quarter 2021 for a total of 93 accounts
~ Enrolled nine patients in the pivotal study assessing the use of the RECELL® System to treat stable vitiligo
AVITA Medical Announces Preliminary Fiscal Second Quarter 2021 Results - shares up ~ 15%
From MorningStar Premium on 11 Nov:
We maintain our AUD 18 fair value estimate for no-moat Avita following first-quarter fiscal 2021 results based on an AUD/USD exchange rate of 0.72. U.S.-based RECELL revenue increased 59% on the previous corresponding period to USD 5 million as procedure volumes recovered. Although pandemic restrictions initially saw a significant decline in burns due to lower levels of manufacturing and travel, since April 2020 the company has seen a steady recovery. Procedural volumes in the first quarter increased 27% sequentially to 496. As burns treatment is acute and not elective, it cannot be deferred and the reduction in both hospital duration and treatment costs when using RECELL, as opposed to a skin graft, should underpin its use amid a stretched healthcare system. Therefore, while we continue to monitor the resurgence of COVID-19 in the U.S., we think Avita can sustain the estimated first-quarter run-rate of 770 RECELL units and leave our full-year fiscal 2021 unit sales and revenue forecasts of 3,060 and USD 20 million, respectively, unchanged.
The current U.S. approval of the RECELL system is limited to adult burn wounds, however, the applications are far broader. Pivotal clinical trials are underway, and we still anticipate the roll-out of RECELL to be phased to adults outside burn centres in fiscal 2022, paediatric use and vitiligo treatment in fiscal 2023, and soft-tissue reconstruction in fiscal 2025. Key to our valuation is RECELL achieving 45% market share in adults and 20% in children treated at burn centres in the U.S. by fiscal 2025.
Avita is in a healthy financial position and held USD 66 million in cash and no debt as at Sept. 30, 2020. We forecast the company to report a loss of USD 28 million in fiscal 2021, reducing to USD 14 million in fiscal 2022, before positing a USD 5 million profit in fiscal 2023 alongside positive free cash flow. As such, we do not forecast it to require additional funding or experience any financial distress.
AVITA Therapeutics and the Houston Methodist Research Institute Enter into Collaboration to Explore Novel Approaches for Skin Rejuvenation
Preclinical research will pair AVITA Therapeutics’ Spray-On Skin™ Cells with Houston Methodist Research Institute’s technologies to reverse cellular aging
Phase 1... Burns... Avita's Recell System harvests the bodies own skin. The skin donor site the size of a EPTPOS card can spray your entire back. The procedure takes as little as half an hour at point of service. The recell system is a single use device, (patent to be extended to 2024) that has been approved for burns use in the US and other places. The wounds heal faster, scar less and heal more evenly than traditional skin grafts etc. Once this area scales, (there has been sales issues with the Covid thing, doctors need to get familiar with this product/device and obviously there needs to be scale in order to progress to profitability.) According to "Grand View Research" by 2027 Global Burn care market will be 3.4 Billion USD
Phase 2...Vitiglo... After sufficient scale in the burns market, Avita intends to use the same tech for Vitiglo... The most common example of this skin pigment issue is Michael Jackson and the white Grandpa from the Cosby show. Basically, Vitiglo is an auto immune disease where the body attacks the pigment of the skin. Its hereditary, or can be caused by burns, industrial chemicals and stress. The pigment disappears in blotches and does so unpredictably. Trials are already underway to prove that RECELL is a great way to treat Vitiglo and once approval happens, everyone will already be using it for burns so it will open another immediate avenue for sales. This is estimated to affect about 1% of the global population
Phase 3... Wrinkles, tatoos etc.. Once Recell is used in phases 1 and 2 the next natural use is cosmetically.... Now this may appear to be wishful thinking, however, the TAM for skincare is massive. RECELL may be more expensive than Botox however, it could last longer. It could be used for non wrinkle things such as tatoo removal, removal of scars, and bringing back skin elasticity....Less crows feet for us oldies.
Avitas management do not consider its competitors as competitors, more like complimentry treatments.
The U.S. Biomedical Advanced Research and Development Authority (BARDA) has authorized procurement of the RECELL® System for the U.S. strategic national stockpile as part of the HHS mission to build preparedness for public health medical emergencies.
Read the full news release here: https://bit.ly/2WfUXzg
I sold 50% last Friday, I think it was, at $8. I like what they do but the cash burn is high which, as reported, could see more capital raising and thus sp dilution. Coupled with the sentiment driven rise recently it was a good selling price. Long term this company could be massive.
First Patient Enrolled in AVITA Therapeutic’s Pivotal Study Evaluating the RECELL System for Repigmentation of Stable Vitiligo
Valencia, Calif, USA, and Melbourne, Australia, September 14, 2020 — AVITA Therapeutics, Inc. (NASDAQ: RCEL, ASX:AVH), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, announced today the initiation of the pivotal study assessing the use of the RECELL® System to treat stable vitiligo with the enrollment of the first patient at Miami Dermatology and Laser Institute in Miami, FL. The study will evaluate the safety and effectiveness of AVITA Therapeutic’s RECELL System to repigment skin in patients who have vitiligo that has been stable for at least one year.
“The initiation of the vitiligo clinical study is a milestone in advancing AVITA Therapeutic’s pipeline to leverage the utility and full potential of our innovative RECELL technology platform to address unmet medical needs in dermatological applications,” said Dr. Mike Perry, AVITA Therapeutic Chief Executive Officer. “Globally, there have been several published case series and pilot randomized clinical trials reporting positive results with the use of RECELL for treating patients with stable vitiligo and repigmenting depigmented skin lesions. We are pleased to initiate this pivotal study as a next step toward offering a treatment option for the millions of Americans who live with vitiligo.”
15-June-2020: Redomiciliation Scheme Meeting - Chair's Address
AVITA Medical Limited proposed redomiciliation to the USA (to have their primary listing on the NASDAQ and a secondary listing on the ASX) Chair’s address to Scheme Meeting - click on the link above for the Chairman's script for today's meeting which explains the company's rationale for the move.
02-Jun-2020: AVITA Files IDE with FDA for Vitiligo Pivotal Study
AVITA Medical Limited (ASX:AVH, NASDAQ:RCEL), a regenerative medicine company with a technology platform positioned to address unmet medical needs in therapeutic skin restoration, today announced that it has submitted an Investigational Device Exemption (IDE) supplement with the U.S. Food and Drug Administration (FDA) for the initiation of a pivotal clinical trial to investigate the RECELL® System for the treatment of vitiligo.
“We are very pleased to have filed the supplement and look forward to advancing the RECELL® System into the clinic for treatment of vitiligo following acceptance of the application,” said Andrew Quick, Chief Technology Officer of AVITA Medical. “The data from the pivotal trial will form the basis of the FDA submission for consideration to expand use of the RECELL® System for repigmentation of depigmented lesions associated with stable vitiligo. In parallel, and as previously announced, we are also conducting a complementary and more scientifically-oriented feasibility study.”
“Globally, the RECELL® System is approved for additional skin applications, including vitiligo, which is supported by a substantive body of clinical evidence with patients internationally and in peer-reviewed publications, providing us with valuable experience and confidence in pursuing expanded labelling in the U.S.,” said Dr. Mike Perry, Chief Executive Officer of AVITA Medical. “The submission of this pivotal IDE is an important milestone as we continue to explore opportunities to expand the patient populations who can benefit from treatment with the RECELL® System platform.”
Vitiligo affects approximately 6.5 million people in the United States, rivalling the prevalence of psoriasis; however, there are limited treatment options available to patients to permanently restore skin pigmentation.
Vitiligo is a disease resulting in loss of color, or pigmentation, in patches of skin that impacts the quality of life for those living with the condition. There is currently no cure for vitiligo, nor a universally accepted method for limiting the spread of the disease. Although many treatments are being used for the management of vitiligo, they are often temporary with a high rate of recurrence.
Authorized for release by the Chief Financial Officer of AVITA Medical Limited.
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ABOUT AVITA MEDICAL LIMITED: AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medical’s patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. The medical devices work by preparing a RES® REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment. AVITA Medical’s first U.S. product, the RECELL® System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin™ Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 8,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL® Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings and precautions. In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe. To learn more, visit www.avitamedical.com.
--- click on link at the top for more, including their "Cautionary Note regarding Forward Looking Statements" and their contact details ---
Disclosure: I don't current hold AVH shares, due to the fact that they are in the process of moving their primary listing to the NASDAQ and making their ASX listing their secondary listing. AVITA Medical are already a US-based company soon to have a primary US-listing, despite being originally formed here in Australia. I tend to avoid those companies personally, not because they don't make good investments, but just because I prefer to invest in Australian based companies directly, and leave my US and other global exposure to my LICs and LITs such as MGG & WQG (and PAI for Asian exposure) or via ETFs.
That's just a personal preference and is in no way supposed to infer that I don't think AVITA will do OK. They have wonderful tech (and IP) and I both hope and expect that they will do very well, particularly after they move their primary listing to the US (via the NASDAQ) and get onto the radar of so many more investors and fund managers. To give some context, I also like Resmed (ASX: RMD), but I likewise don't hold RMD shares directly because their primary listing is in the US, and they are headquartered in the US, with a secondary listing on the ASX, despite originally being an Australian company when they first started out. That doesn't mean they won't do well either. They've done pretty well so far. But you can't pat all the fluffy dogs, and it's a personal preference for me to invest directly only in ASX-listed companies and to gain exposure to other companies via ASX-listed LICs and LITs (listed investment companies/trusts) - or ETFs.
AVITA Medical Reports Third Quarter Fiscal 2020 Financial Results and Company Update
U.S. RECELL® System product sales of A$5.81M for fiscal third quarter.
AVITA Medical Limited (ASX: AVH, NASDAQ: RCEL), a regenerative medicine company with a technology platform positioned to address unmet medical needs in therapeutic skin restoration, reported financial results for the fiscal third quarter ended 31 March 2020 (Q3) today in its Appendix 4C - Quarterly Cash Flow Report filed with the Australian Securities Exchange (ASX).
U.S. Commercial Sales of RECELL® System for Quarter Ended 31 March 2020
[I can't reproduce the numbers in their proper format here - so click on the link above for that. Suffice to say that revenue for the March 2020 quarter was almost double the revenue for the same three months that ended March 31, 2019, and revenue for the 9 month period ending March 31, 2020 was also almost double the revenue for the 9 month period ending March 31, 2019.]
“Our strong fiscal third quarter results demonstrate continued growing adoption trends within both our existing and new RECELL ® System customers,” said Dr. Mike Perry, AVITA Medical’s Chief Executive Officer. “In the current COVID-19 environment, we are deploying various strategies, including supply redundancies and digital training, to drive usage and continue serving burn surgeons and their patients. While severe burn treatments are not elective procedures, there has been a pause in enrollment in some of our clinical trials due to COVID-19; however, we are advancing our pipeline and are currently developing the protocol and FDA Investigational Device Application for the RECELL ® vitiligo pivotal study. In addition, we are continuing to make progress toward redomiciling the Company to the United States to better align the Company’s corporate structure with our U.S. business operations.”
Our commercial efforts in Q3 progressed well with quarterly growth exceeding 20% across both procedural volume and U.S. RECELL ® System revenue. Q3 represents our strongest quarter since launching in the United States in January last year reflecting strong customer uptake, even with the COVID-19 pandemic beginning toward the end of the quarter. In the quarter ended 31 March 2020, we also added nine new customers and certified an additional 21 surgeons, bringing our total to 69 customers and 205 certified burn surgeons, together with progressing our ongoing clinical investigations with first patient enrollment in our soft tissue and pediatric partial thickness studies. All of these factors collectively demonstrate ongoing high interest in the RECELL ® System, together with consistent usage and acceptance across our growing customer base.
We have seen consistent growth since the launch of the RECELL ® System and we have, so far, been somewhat insulated from the COVID-19 challenges to-date given the treatment of burns patients is generally not elective nor deferrable. While we didn’t see any impact to the rate of burn incidence or RECELL ® System utilization during the quarter, it continues to be difficult to predict the breadth of potential impacts over the coming months due to the current COVID-19 macroenvironment. These considerations operate in addition to the overarching burn environment which is inherently “lumpy” and difficult to forecast.
...click on link above for more, and there is plenty more...
23-Apr-2020: 7:43pm: Just to answer some of @Hackenbacker's questions in relation to AVH's intention to move their primary listing to the NASDAQ and have a secondary listing on the ASX. Reading through their documentation - like pages 2 to 4 of this announcement - it sounds like the Australian listing will be not shares but CDIs - which are explained here and here.
CHESS Depository Interests (CDI's) are shares of international companies traded on the Australian exchange markets. This allows investors to receive the same ownership in foreign companies as holding them on the international exchange, but instead these CDI's are traded here in Australia on the ASX. Companies which are incorporated overseas cannot transfer their shares through to the ASX. CDI's open up more opportunities for Australian investors as they can access products which are not available in the local market. For example, News Corp (NWS) is incorporated in the US and only trades in the US. However Australian investors can own shares in NWS via CDI's. My understanding is that Resmed (RMD) "shares" on the ASX are also CDI's. These are often scaled differently to the shares listed on the primary market (Resmed and News Corp both have primary market listings in the USA). RMD CDI's on the ASX are scaled 10:1, so ten of our RMD CDIs are worth one NASDAQ: RMD.
There are some differences between CDI’s and ordinary shares. You can not vote at a company meeting like you would with ordinary shares unless laws from the country where the company is domiciled allow you to.
Initially you would receive 5 Avita US CDIs for every 100 AVH.ASX shares that you currently own, and these should, all things being equal, be worth roughly 20 times what they were trading at here, so if it happened today, theoretically, if you held 1,000 AVH shares currently trading at $0.44 (44 cents each), you would instead own 50 Avita US CDI's which would still trade on the ASX, but at about $8.80 each. Currently, AVH has a secondary listing on the NASDAQ under the code RCEL - these are ADS's (American Depositary Shares which are foreign stock issued in the US and registered in the ADR system - the American Depositary Receipt system) - their equivalent to our CDI's - which are currently trading at around $6.12.
AVH have proposed a way for those people who currently hold NASDAQ-listed RCEL ADS's to have those swapped for Avita US shares, and they say:
"Therefore, shareholders in eligible jurisdictions and ADS holders (on the Record Date), upon receiving Avita US CDIs or Avita US Shares, will hold an equivalent proportional interest in Avita US as they held in the Company prior to implementation of the Redomiciliation."
In other words, nobody will be better off or worse off, regardless of whether they owned ADH shares on the ASX or RCEL ADS on the NASDAQ before the reorganisation.
In local terms, you'll own one twentieth of the number of shares you held before, but they'll be worth around 20 times as much, so the value will be unchanged.
In reality, it depends on the local sentiment. When News Corp did this - moved from a primary listing on the ASX to a primary listing in the USA, their share price went down, but they were a big company and some fund managers here were not allowed to continue to hold them (because they were no longer an Australian-domiciled company) and so had to sell. That would not be such an issue for AVH, I would think. However, there still might be shareholders who would rather own shares in companies whose primary listing is here in Australia on the ASX rather than the listing being a secondary listing here for a US-domiciled company.
Liquidity: AVH are a reasonably liquid company here, with over 12 millions shares (over $5m worth) being traded most days, and often up to 60 million shares ($25 m) or more traded on a busy day. That may change, but they're already dual listed; they're just proposing to change their NASDAQ listing into their primary listing and their ASX listing into their secondary listing. I would expect that would increase the liquidity on the NASDAQ, but it's hard to say if less Avita US shares would trade here on the ASX. Liquidity could well reduce, but it would be unlikely to dry up altogether. Resmed has their primary listing on the NASDAQ and their secondary listing on the ASX and it hasn't hurt their liquidity. They are clearly a lot bigger, but Avita is no minnow. At 44 cents/share Avita are a one billion dollar company.
This is not advice, but if I held AVH shares, and I currently don't, I would not see this as a reason to sell them. I think the opportunity remains the same, regardless of where they choose to be domiciled and where their primary sharemarket listing is. As a US domiciled company with a primary listing on the NASDAQ, I imagine that, like RMD, they will attract a lot more investor attention globally, particularly in the USA, and that will be good for the company - and ultimately for their share price.
20-Apr-2020: 7:30pm: AVITA Announces Intention to Redomicile to the USA
AVITA Medical Announces Intention to Redomicile to the United States of America
Intention to establish primary listing on NASDAQ with continued (secondary) listing on ASX
Valencia, Calif., USA, and Melbourne, Australia, 20 April 2020: AVITA Medical Limited (Company) (ASX: AVH, NASDAQ: RCEL), a regenerative medicine company with a technology platform positioned to address unmet medical needs in therapeutic skin restoration, announced today its intention to redomicile the Company and its subsidiaries (Avita Group) from Australia to the United States of America by way of a scheme of arrangement under Part 5.1 of the Corporations Act 2001 (Cth) (Redomiciliation).
To implement the Redomiciliation, the Company has entered into a Scheme Implementation Agreement dated 20 April 2020 with AVITA Therapeutics, Inc. (Avita US), a newly-formed company incorporated in Delaware in the United States. A copy of the Scheme Implementation Agreement is attached and will be available on the Company’s website.
If the Redomiciliation is implemented:
The Redomiciliation is subject to regulatory and court approvals, as well as approval by the Company’s shareholders at an extraordinary general meeting which will be convened to address the Redomiciliation (Scheme Meeting).
Reasons for the Redomiciliation
After carefully considering the advantages, disadvantages and risks of the Redomiciliation, the directors of the Company (Board) are of the unanimous view that the advantages of the Redomiciliation materially outweigh its disadvantages and risks. In particular, the Board believes that the Redomiciliation will:
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