Company Report
Last edited one year ago
PerformanceCommunity EngagementCommunity Endorsement
ranked
#83
Performance (67m)
0.9% pa
Followed by
77
Straws
Sort by:
Recent
Content is delayed by one month. Upgrade your membership to unlock all content. Click for membership options.
#Bull Case
stale
Added one year ago

A brilliant case study. Someone did a deep excision of a scalp melanoma with brilliant results and aesthetics rather than unsightly residual indentation.

Shariatmadari 2023 Use of NovoSorb BTM in the management of complex scalp defects.pdf

#News
stale
Added 2 years ago

More DW buying this morning and Macquarie set price target of $2.75.

#News
stale
Added 2 years ago

WARNING GRAPHIC MEDICAL content:

DW just sent around a case study of an off label use for BTM in a finger crush injury.

The surgeon stacked layers of BTM to restore thickness. What amazes me more is that the nail bed started to regrow. The result is pretty phenomenal.

You can really understand how stacking MTX under BTM will help to restore shape to wounds. The indentations left for example on the scalp are very unsightly after melanoma removal. This product may help to provide a smooth and even surface wound.

One word- impressed!

Saha 2023 Tissue-engineered minimalistic reconstruction of a severely crushed fingertip.pdf

#A success BTM in diabetes
stale
Added 2 years ago

Just dropped


BTM and diabetes .pdf

from Linked In Professor Toby Coates:

On behalf of Beta Cell Technologies and our collaborating partners, I am delighted to announce the online publication of our pre-clinical studies showing the Biodegradable Temporizing Matrix (BTM, Novosorb) supporting survival of pancreatic islet cells in a completely new intracutaneous transplant site outside of the liver in the American Diabetes Association flagship Journal Diabetes.

In this work, we show for the first time survival and function of pancreatic islets when implanted into a unique fully-vascularised alternative site in the skin. The key advance here is the creation of a dense vascular network in the “intracutaneous” site, that is capable of supplying blood to the islet cells and allowing them to survive for up to three months. 

Our work shows human islet survival and function in the novel intracutaneous site outside of the liver for the first time.

These studies are important because they are the first step towards creating an alternative islet transplant site, where cells can be monitored for function and rejection, which will be applicable for new sources of insulin-secreting tissues (eg xenogeneic /stem cell-derived beta cells) to be transplanted.

With this work, we fulfill the dream of Dr P. Watson Williams who first attempted to implant pancreatic tissue into the skin to treat Diabetes nearly 130 years ago in 1894. 

This work also provides the pre-clinical supporting data for a clinical trial of this promising alternative site. We would like to thank our key collaborators for this work - JDRF International, The Hospital Research Foundation Group and PolyNovo Limited.

Beta Cell Technologies looks forward to sharing our human clinical trial data in the next 18 months.


READ THE FULL PUBLICATION HERE

https://lnkd.in/g5Yzkaiy 


JDRF International The Hospital Research Foundation Group

JDRF Australia Central Adelaide Royal Adelaide Hospital University of Adelaide Kidney Transplant & Diabetes Research AustraliaBeta Cell Technologies

PolyNovo Limited


#Broker view
stale
Added 2 years ago

DW just sent around upward adjustment in SP target to $2.85 based on strong growth.

#Media Article
stale
Added 2 years ago

PNV - looks all set to re-enter the asx 200. Index funds are likely to buy an estimated $67 million dollars worth of shares.

Interestingly the article places short position around 2.5% of the stock. Looks like most shorts have been able to make a graceful exit without a massive short squeeze.


PolyNovo set to re-enter ASX 200 - The Australian.pdf



##perspective
stale
Last edited 2 years ago

New release from biotech daily sent through from David Williams this morning. Does help to put some context to the Aus Biotech space. 2 of my biggest biotech holdings did very well in 2022 PNV and NEU and I anticipate an even better 2023.

BOT even got an honourable mention although I don’t agree with the lumping together with the CBD space. This is a biotech using synthetic CBD for dermatology and anti-biotic clinical trials plus it has a new non-CBD lead drug that is due for FDA approval in Q3 2023. I feel this lumping has meant BOT is one of the most overlooked and poorly understood biotech companies on the ASX.

An interesting summary below in BIOTECH DAILY

d7794d8037d2f546f140feb80ef5cc485bd8ac.png

890fb75459b5d43bb2615777b45fda3e107160.png

3ae1d1294a7592a4953cabfac3628f65241382.png

#ASX Announcements
stale
Added 2 years ago

Like a broken record another $161 K worth of shares bought by DW this morning. He certainly looks motivated to own $25 M shares. A chairman very aligned to shareholders. It’s refreshing.

#CEO Impressions
stale
Added 2 years ago

PNV new CEO impressions.

Apart from a few technical hitches that was a good quick introduction to the new CEO.

My impression is that David has found a visionary with plenty of experience to help shape PNV into a global success story. 

Swami outlined his work history and experience working for J and J across Indonesia, India, Philippines, China and the US. He has worked his way from the ground up in global medical technologies to the ‘head of the table’ – as Global President for J and J Vision Care.

Motivation for coming out of retirement 

He describes PNV as a ‘diamond in the rough.’ He stated that he is amazed at the simplicity of the Novasorb technology to help the body to heal itself. This reduced complexity is what excites him as he sees PNV transforming from a burn and wounds company to a complete soft tissue platform company. 

1.     SIMPLICITY: 

The reduced complexity of the technology is its competitive advantage. He describes the value chain as robust and scalable quickly. He describes the limitation of all other competitors to PNV as they will have difficulty growing and scaling due to the complexity of their manufacturing as opposed to PNV.

2.     BOARD: 

His second stated reason is that he has rarely seen such a unified and motivated Board. They are all unified and motivated to push the company global 

3.     COMMUNITY:

The teams and staff are all very motivated and excited to be working with the Novosorb technology and there is a real belief in the product

4.     MARGINS:

The margins and sales model has huge potential 

US

-       PNV needs to get key influencers and surgeon advocates on board to sell to other surgeons. 

-       Retraining surgeons as this technology is totally different from what most of them were taught in their training

-       There is initial disbelief and suspicion at how simple and effective the technology is – once a doctor tries it they are ‘converted’ – He want these converted ‘Evangelical’ surgeons teaching others about Novosorb

-       Peer to Peer education in the key to PNV sales strategy

EMERGING MARKETS

-       PNV will be the inventor of this sales model- He sees the company as constructing the rule book here.

-       There is a greater need for the product in the developing world as burns and / trauma is more common

-       Swami believes adoption will be quicker and easier here as developing countries are faster at adopting and embracing new technologies. 

NEW PRODUCTS

  PNV can’t keep pace with the number of case studies and ways doctors are successfully finding to use NOVOSORB.

Once again he reiterates that the technology will move to a complete soft tissue reconstruction platform. 

M & A

-       Is possible for acquiring supply chains and capable distributors that already have pathways into plastics and reconstruction

-       If PNV finds good synergy – with income generating companies there may be future acquisitions


DIRECT V DISTRIBUTOR SALES

            -Distributors must add value – not just a warehouse

-They must be involved in surgeon education or else using distributors will not be successful. On this point he does seem very aligned with David Williams 

-Big belief that PNV must impact the customer positively

JAPAN

Swami states that Japan is a great market to attack – as it is evidenced based etc… It is a gateway and provides traction into the Asia Pacific markets. As head of Vision Care (Contact lenses etc…) he will have a wealth of knowledge and experience in navigating this traditionally difficult market. 

He states he is more cautious about entry into China and Brazil

PARTING COMMENTS

Swami is a big believer in company community. This is an area that has been attacked with PNV over the past and shorters have used this instability to their advantage. There was clearly tension with the departure of Paul Brennan. However hopefully this is the start of a calmer and more unified chapter. 

If the team feels good about what they are doing the business will thrive. 

It was also confirmed on this call what most shareholders had suspected PNV is involved in taking Novosorb to the Ukraine. Swami mentioned that ED the head of the US sales division is in Ukraine to support surgeons use their product. If that isn’t feel good I don’t know what is. 

David finished the call saying that there were lots of things happening right now and that he would be communicating these events with shareholders very soon. 

So overall a pretty excited and happy shareholder. 

Cheers

Nnyck

#ASX Announcements
stale
Added 3 years ago

Just another casual $231k purchase this morning by Lawn Pty Ltd - DW and wife’s entity. Keeping the pressure on the shorts for another week. Should be a decent gap up this morning.


#ASX Announcements
stale
Added 3 years ago

Another 200k shares for Lawn. DW and wife’s buying is relentless. On a mission I suspect to bring shorting to a close.

#ASX Announcements
stale
Added 3 years ago

Another 250,000 shares bought this morning by DW and wife’s entity Lawn Pty Ltd. Quite the buying spree.

#Analyst/Fundie Views
stale
Added 3 years ago

David Williams distributed BofA analyst report this week. See below it reiterates a buy rating and SP target of $2.30. BofA acknowledge risk of hospital closures and reduced surgeon access with latest COVID wave.

22PNV01 - indicative revenue.pdf

#Bull Case
stale
Added 3 years ago

#Polynovo Transparency

The latest Tim Boreham / David Williams podcast shared yesterday was a very useful insight into the company. David appeared to be very clear and intentioned about some of his messaging. Shareholders have rightly been nervous of late given the big changes in management. 

You can sense David’s frustration about Covid circumstances and the criticism the company has received while the “world was on fire”. He notes Poly still had 49% growth in the US while hospitals were closed and not buying new medical equipment. This was due to a strategy pivot with lots of zoom meetings and surgeon advocates helping to get the word out.  

The markets have punished Poly and shorters have been quick to pile on insisting a decline in product performance when the reality seems to be quite the opposite. While the FY 20 growth of 100% in the US was remarkable it was never ever going to be matched due to this black swan event. 

The sheer number of case studies being published and surgical reactions to the product are what I have tried to focus on. There are some great studies on Polynovo's website https://au.polynovo.com/case-studies/ and quick Pubmed or Google scholarly articles check will yield you dozens and dozens of case studies. 'BTM studies' is a good search to start with - be warned there are very graphic images.

Key take-aways from this podcast:

1.     Polynovo has the ability to scale without much capital 

2.     David explains that the company is playing catch up: There are so many use cases and off-label case studies that they are trying to stay on top of. They are then running small trials to provide clinical evidence so that other doctors can pick up and use the product in similar ways. (I think this is the biggest hint and divergence in growth strategy perhaps from the former MD. David wants a lot of people out on the road and fast). 

3.     No real competitors – a very interesting insight, perhaps Integra David justifies this by explaining:

a.     BTM is far cheaper

b.     The outcomes are phenomenal – surgeons want it because of this. He has still never heard of a surgeon who has tried the product and not bought it following their experience

c.     Biologics aren’t real competitors as they tend to have rejection rates that PNV just doesn’t see due to the inert nature of BTM

4.     PNV – sees a wide open market with a widening application base. 

Polynovo is a frequently discussed stock amongst financial analysts. I see quick snippets in articles or off the cuff buy, hold, sell recommendations. Frequently an analyst will sight caution with the stock due to the number of competitors in the space – then shoot off a long list of biological competitors ARX, Integra etc.. I think this is where a more nuanced understanding of the tech and the medical research can be an advantage. As David highlights – Once a surgeon has trialled a synthetic polymer they WILL NEVER  pick a product with added risk of rejection, infection and complication over another that just doesn’t have these problems. 

The statement around PNV continued growth is an interesting one. David certainly has the gift of the gab but I do admire his tenacity and vision. The scalability, diverse use cases and amazing clinical outcomes are what are keeping me invested with strong conviction.

Cheers

Nnyck777

#Bull Case
stale
Added 3 years ago

I just received another email update from David Williams. He sent around a link with Andrew Chapman from Merchant Group discussing his funds next big investments - VR1 (virtual reality exposure) SHP (food security play) PNV (Leveraging world reopening)

His fund was in PNV since 2012 and sold recently on the run up to over $3.00. Merchant sold on the basis of valuation - He states that COVID was clearly going to affect bottom line and the market was ignoring this.

Merchant is now back in at $1.70 with a massive vote of confidence for the stable board and David Williams. He states he feels very safe with the interim MD. He describes this as a massive transition phase for the company.


As the world opens up and returns to elective surgery the sales of BTM are expected to skyrocket. Plus there is a tonne of stock shorted so there is predicted to be a very quick run back to $3.00 as positions have to cover.

I will buy more in my SMSF at this price.

#ASX Announcements
stale
Added 3 years ago

What a day! Speculation is already running rife around the nature of the departure of Paul Brennan. Firstly as a long-term PNV investor my thanks for his efforts at moving this company to where it is today.......Or my animosity for holding it back when a more experienced managing director was warranted. I am not sure which. I believe PNV has a huge potential and will be a future behemoth in the health care space. Their products are becoming the gold standard for burns, wounds and ulcers.

The hernia product delays, plus the recent resignation of COO Dr. Anthony Kaye were the catalysts for Polynovo's recent share price decline. I shrugged Dr. Kaye's resignation off, the announcement stated a promotion back with CSL was the reason for his departure. However, it is now difficult to overlook teething and growing pains with this company. The COO and MD in the space of a month resigning? From the head rots the fish is usually an appropriate adage. The reality is that this has become a global company in a very short time span. David Williams the PNV Chairman is an extremely prudent business man and has a lot of his personal wealth invested in this stock. He has overseen the global growth of the green whistle and may have been frustrated with the inexperience of the now former MD in directing this business forward.

The recent asx announcement listing % growth rather than $$ values was pretty amateur hour. Interesting that this was in the same fortnight as PB's resignation.

As long as David Williams is involved I stay involved. If he exists then I will assume the ship is leaking heavily. I still do not believe this is the case. The growth through Europe and the US needs to be the focus of this business now. With the right MD and team on board I think this stock will progress faster and farther. Companies outgrow MDs. I am open to counter points so please share. For now I hold strong and see this as a buying opportunity.

Cheers

@Nnyck777

#FY21 AGM
stale
Added 3 years ago

FY 2021 AGM PNV

#Targetinggoldstandard #Morecountries #Morehospitals #Moreuses

Major take-aways from AGM:

Polynovo products entrance into new hospitals -  up 56% YOY

FY22 Q1 $8.05 million (including patchy September with US lockdown)

New countries on board Q2 Q3 and Q4:

Cyprus

Italy

Czechoslovakia

Canada

France

Sales team now following up in hospitals across multiple wards:

1.     Burns/amputations/plastics

2.     Oncology

3.     Endocrinology

Polynovo has taken 4 years to reach break-even (actually tiny profit)

Awaiting BARDA status in the US for full-thickness burns – this will be more for bragging rights as PNV will be able to officially declare itself as the Gold Standard for burn care (formerly held by Integra IDT biologic)

Increasing number of small size BTM product sales – better margins

Beta cell study in Type I diabetics about to launch

David Williams provided a good explanation about PNVs aim to enter US government stockpiles with their BTM product. 


US government is looking to stockpile products for burns treatments, in case of incidents of mass injury. BTM can easily be stockpiled and has a shelf life of 3 years (stored below 25 degrees Celsius which is standard for medical products). 

This is the other major advantage of this product over biologics which cannot be mass produced and stockpiled like BTM. 

#Scientific Community response
stale
Added 3 years ago

#Life changing products #Polynovo #Investinthingsyoubelievein

Part deux of the David Williams (of Green Whistle and Bega fame) emails  that I received this week discussed an interesting case report currently ‘in press’ in the Burns Journal. The paper is titled “The timing of delamination of biodegradable temporizing matrix prior to cultured epidermal autografting (CEA) in burn reconstruction: A case report.”

The common theme about investors and board members in this company is that they are all incredibly passionate about the product. Prior to Polynovo’s BTM product if you received 70-90% burns to your body you would in all probability die. There are more and more case studies being published showing patient’s not only surviving but thriving following this life changing treatment. It is hard not to be excited by what this company is doing. From survival rates, to aesthetics, to cutting edge tech attempting to restore pancreatic function in diabetics this company is worthy of shareholder support.

There is a veritable avalanche of publications coming out of international well respected medical journals on BTM’s (their leading products) uses. I encourage you, if you are interested in this company and if you have the stomach from some pretty intense images, to take a look and see what this company actually does. 

This latest paper published by the clever surgeons at the Department of Plastic Surgery at Vanderbilt University Medical Centre is worth a look. 

If a patient suffers extensive burns it is impossible to harvest donor skin to cover wounds.  Cultured epidermal autografting (CEA) is the only real way to produce the tissue needed. 

Step 1. PNV BTM over burns (surface film on foam keeps things safe and infection free. New vascularized dermis 'bottom layer skin' can start to grow into the foam). 

This buys you time for step 2. 

Step 2. Manufacture the CEA (graft) - top layer of skin

The question that needed answering was when to peel back the BTM top level film a day before, 2 days before, same day? 

The paper discusses a case of a poor patient who received burns to 75% of their body. One site had the BTM film peeled back the day before CEA and the other site had it peeled back just before application. So comparing a delayed vs immediate approach. 

If the immediate approach works it means less time in hospital, less burden, cost to patient and health care system and overall faster recovery for patients. 

This case study found just what was hoped immediate CEA placement after BTM delamination was just as affective with 100% take rate for the graft. This means patients can be cared for faster and recover quicker. 

A nifty little case study. Obviously needs more testing with larger sample sizes. But things are looking hopeful for patients with these really serious and extensive burns.

#Analyst/Fundie Views
stale
Added 3 years ago

#Macquarieresearchliftspolynovotooutperform

David Williams sent around a couple of interesting emails this week. I will separate the straws for ease.

Macquarie is lifting the price target of PNV to $2.85 (slightly below my $3.00 valuation). DCF methodology for Macquarie.

The growth in regions is sighted as the biggest determinant for the outperform.

US sales saw a record number of new accounts opened 1Q22 (+65% vs pcp). A good sign. The qrt was mixed with an excellent increase in sales in July and August (+56% vs pcp) however September was only up +21% vs pcp. September was the peak months of another Covid wave in the US. A lot of hospitals were significantly affected again. I suspect this was a blip.

The more impressive news was that European sales were HUGE - admittedly off a low base. Polynovo hasn't released dollar values yet just % (bit annoying) but % wise:

EU region up +204% in sales vs pcp

UK / Ireland up +327% in sales vs pcp

Aus/ NZ affected by lockdowns acknowledged down turn here.

PNV has altered forecast to match 1H22 to A$17.9 million from A$19.9 million due to COVID impact. However the growth through these tough conditions is impossible to ignore.

Upcoming major dates:

  1. PNV FY21 AGM (26 of October)
  2. Chronic wound top-line trial results CY21


#Industry/competitors
stale
Added 3 years ago

#Competition

Paul Brennan CEO was interviewed yesterday and had some very very interesting insights into Polynovos future direction. He clarified the point that burns is only 10% of the global skin market that they are after. The rest includes reconstruction, melanoma repair, diabetic foot ulcers etc....

The holy grail will be hernia which will hit the market in August FY23. The new BTM film will resorb completely within 2 years. It degrades slowly to ensure new tissue has time to strengthen to prevent future herniation. This is facilitated through a slightly different manufacturing process to skin BTM. An extra layer of film above the foam provides tensile strength and slowly resorbs in 7-8 months allowing for this transfer of strength to natural tissue. Very interesting.

Paul further clarified the benefits of the inert nature of using a foam product for repair. All biologicals including Aroa's pig product have proteins that produce a pro-inflammatory response. Biologicals already have a vascular system which the body attacks and the tissue essentially acts like an agar plate providing nourishment for bacteria, at the base of wounds to thrive. The result biologicals have a 30% rejection rate due to infection. Polynovo'a BTM has almost no rejection. 
 


 

 

##polynovo FY21 results
stale
Added 3 years ago

My Summary of PNV achievements, strategies and FY22 outlook

What does Polynovo (PNV) do?

PNV produces novel medical devices using patented bioabsorbable polymer technology Novosorb. PNV currently has 56 international patents covering their products. Its leading product is Novosorb BTM.

Novosorb BTM is used in the repair and treatment of burns and wounds and reconstruction. New products Syntrel BTM is currently undergoing studies for breast and hernia reconstruction and SynPath BTM line is used in chronic wound healing.

Novosorb BTM has been applied in a range of different demonstrated cases from new full thickness burns to old cases of scarring and regraft to wound care. 

SUMMARY of why this companies product is so ground breaking (think cochlear for skin surgeries)

 ADVANTAGES of Novosorb BTM – Synthetic resorbable polymer

Synthetic means man-made – unlike competitors that use animal products (e.g Aroa)

Resorbable means that the body can break it down to harmless by products and slowly excrete it (e.g through urine).

It is a temporary structural scaffold to allow the bodies’ own natural cells to regrow – BTM merely supports the body while is undergoes this regeneration and then the body removes the product.

Novosorb BTM has inbuilt design flexibility and biocompatibility 

Key advantages include:

1.     Reduced infection rates: The polymer product is not a food source for bacteria so BTM limits bacterial growth. It can remain in situ and any infections can be treated without product removal. Biological graft techniques are more prone to infection – bacteria spread through biological tissue more readily. This means large tissue sections have to be removed, the infection treated, then new grafts placed. 

2.     Minimizes contracture – this means shrinkage and wrinkling of post graft skin is reduced. Improves the cosmetic look  and function of the skin. Contracture of skin can lead to immobile limbs that permanently stay bent as the skin is so tight it can’t stretch and fully straighten.

3.     Can aid in generating new skin over bones and tendons – wound healing

4.     Helps to salvage limbs as the new skin growth is vascularized (has blood flow) so can keep limbs functioning and avoid amputations

COVID IMPACTS

Polynovo (PNV) acknowledges the huge impact of COVID on its FY21 growth strategy in its latest report out to market today. What has impressed me as a Strawman and IRL shareholder is PNVs very quick pivot to online strategies for growth. This was primarily done in the form of online conferences to demonstrate advantages of their BTM product. Surgeons were able to gain direct online feedback from peers around the globe who had applied the product in real life cases. 

Why I am happy with my investment:

Increasing Geographical Coverage for POLYNOVO products

 

European market

Growth for FY21 has been significant, despite COVID interrupting traditional marketing strategies.

 

PNV is predicting very strong growth to continue and new hospital accounts to increase during FY22

European breakdown

 ·      Hard hit by COVID

·      CE mark for BTM achieved just as Europe locked down- very challenging

·      Sales team in EU couldn’t get in front of hospital decision makers and doctors in traditional meet and greet methods

·      Moved to online meetings – PNV stated that they were able to have wider reach and took more  online meetings than they would have taken with traditional on road approach

·      During FY21 and FY22 Increasing sales headcount is a priority across UK EUROPE and IRELAND

·      BTM now accepted into 16 countries as of time of update

UK/IRELAND

·      Elective procedures cancelled during COVID

·      Digital strategies only due to hospital closures

·      Data published in key surgical journals 

·      BTM recently highlighted in hospital documentary

·      Now only just being allowed to meet face to face

US market

 

Business rapidly expanding in revenue and sales personnel and continued growth expected in FY22

 

US breakdown

·      36 sales team members

·      US based finance

·      Market awareness and commercial growth increasing

·      Best talent recruitment strategy adopted

·      FY 21 US organisation has more than doubled

·      New GPO agreements

·      PNV intend to take market share through continued market penetration

·      Weathered COVID well

·      Built surgeon based webinars

·      Despite challenges:     

o   49% growth in sales FY21. 

o   FYH2 sales grew by 38% above and beyond FYH1 – indicating start of COVID recovery.

o   FYQ4 21 pick up 40% more orders than in Q1

o   Added 52 additional accounts in FY21

o   More accounts in trial phase currently. These numbers are not added to reports until cash flow achieved.

·      Acknowledge that Hospital closures really did affect sales 

·      Full US coverage planned

·      Clinical and medical education planned as part of growth strategy

·      BTM becoming standard of care at many hospitals in the US 

 

Australian market

 

·      COVID impact less is Australia

·      FY21 2nd year following TGA approval in Australia 

·      Growth phase

·      2 new head counts

·      4 person sales team

 

Strategy for growth in following addressable markets in Australia 

·      Plastics and reconstructive surgeries

·      Trauma in degloving and crush injuries

·      Necrotising soft tissue infections

·      Burn centres

·      Wide excisional skin cancers

·      Congenital disorders

·      Chronic wounds (saving limbs from amputation) – targeting vascular surgeons

 

New Zealand market

·      Burns centres comprehensively used Novosorb BTM

·      Widely adopted by plastics and reconstruction teams

·      Very successful market past 3 years and widely adopted

·      White island volcano success stories

·      FY21 and FY20 similar results

·      Beat market sales expectations

Global growth

 

53% increase in global distributors sales growth in FY21

 

Australian growth

 

25% increase in Australian distributors sales growth in FY21

 

US growth

 

Up 49% in sales growth FY21 

 

2020: US $10.4M

2021: US $15.5 M

 

Net profit after tax 

 

Up 121.5%

 

2020: US $-1.2M

2021: US $0.2M

 

EBITDA (Achieved break-even / profit in FY21)

 

UP 161.1%

 

2020: US $-1.0 M

2021: US $ 0.6 M

 

Cash on hand 

US $7.69M

 

BARDA Trials

 

Pivotal Burn Trial full completion FY25 and Chronic Wound Reimbursement Trial Diabetic Foot Ulcers (completed first 10 patients and moving on to trial phase 2) continue in FY22 

 

Chronic Wound TAM

SynPath chronic wound product has predicted US $400 M market in FY23

 

PNV is investing in itself and planning for growth

New Facility and upgrade: Port Melbourne

 

·      Tripled current manufacturing footprint

·      Installed new ISO 7 clean rooms for the production of medical devices

·      Increased storage areas – aim to store and distribute from facility (some devices are temperature sensitive)

·      Duplicates BTM production sites – allows for increased demand and built in redundancy to sure up integrity of POLYNOVO supply chain 

·      New equipment already installed to support Syntrel Hernia product line

·      Initial Syntrel Hernia production runs have been done – product in testing phase 

·      New Equipment will allow for Bioresorbable Polymers to be produced in a range of different formats for multiple indications – what would take months, new equipment can produce new product line in weeks or even days to get product to market immediately. 

·      All products now completely produced in-house

 

Future TAM and product line potential is huge. 

 

PNV has become a multiple trick pony. 

 

Future Applications for PNV

Beta-cell diabetes application joint collaboration with Beta Cell Technologies Pty Ltd.

Using Novasorb BTM in alternative application forms. The plan is to infuse BTM with Pancreatic Islets in the skin for diabetes treatment. 

 

A trial is planned FY22 for applying this new technology to Type I diabetics who have had renal transplants. 

 

Novosorb BTM has potential as a drug elution delivery system. 

 

Ongoing exploration of new addressable markets and applications for this product. New facility in Melbourne will allow light-speed alteration and development of products, mass productions and delivery to market. 

 

Added Strategy as ESG responsible investment

 

PNV aligned  with ESG focused responsible ETF investments. Potential for SP growth with adoption of PNV into larger fund portfolios.

 

Aiming for carbon neutral certification by FY23

#Valuation
stale
Added 3 years ago

Latest broker notes from Macquarie Research shared by David Williams shows PNV with an Outperform Rating with a Price Target of $2.95 for the next 12 months. 

Forward projections are based on expanding BTM sales with 44 new customers in the US signed sof far in FY22.  3 GPOs signed and reports of ongoing discussion with a further 3 GPOs.

If PNV can onboard 1-3 new GPOs it would be a huge coup for the company. 

UK and Ireland 23 NHS are using BTM (flagship product). It is anticipated 70% of burn and trauma units will be using PNV's product in FY22. 

Spain France and Portugal are the next expansion frontiers and distribution is planned for FY22. 

Additionally long-term use expansion of BTM product and additional PNV products for Hernia, Wound Care and Breast reconstruction will significantly expand future TAM. 

Margins on BTM are huge and new pricing agreements are being signed for around $8.50-$9.50 per cm2.