PolyNovo Limited (PNV) Earnings Call Transcript & Summary

Welcome to PolyNovo's FY '21 Results Presentation. Today, we have presenting Chairman, David Williams; Managing Director, Paul Brennan; and CFO, Jan Gielen. [Operator Instructions] I would now like to hand you over to Chairman, David Williams.

Well, thank you, and thank you all for attending. I would say there's close to 200 online. I'm going to hand you over very shortly. I've got a little to say to -- Paul, our Managing Director, and he's going to run you through some exciting list of all the things that we've done this year from new staff to new products and new jurisdictions, new factory and all of that sort of stuff. But before I get there, you'll notice that I'm wearing a red jacket and a tie today. And I'm doing that on purpose because this is no ordinary results presentation which you think have turned up for. It's a red-letter day for our company, and what I want to do is point you squarely -- not so much to distract you from what Paul is going to say because that's all very useful, but I want to point you squarely at the financial result, which is a reported profit but if you scratch and take out items, the share-based payments in particular and the unrealized FX losses and so forth, we have just turned a profit for the first time, no flash in the pan. We are now profitable. And I want to just emphasize to you how important that is to us as a Board, but how important it is to you as shareholders and how important it is to the company in itself and especially to our staff. This is a situation where most start-ups never get to. You go into a start-up -- and I was just thinking last night, when I went into seek -- 15 years ago, long before it was listed and all I saw year after year was costs. And at 1 year, I remember thinking, "Geez, I must be spending $20 million on outside broadcasting, outside billboards and so forth." And then -- but my focus is all on cost. When is the next capital raising coming? How much more cost? When will they ever turn a profit? And then over time, you start to see the revenues creep up and creep up until I get to a point where you think, "You know what? This might happen." And this might actually crash through and then it will turn to just cash dropping out of the system. And that's really where we've got today, and that's why it's a red-letter day for us. And I want people to -- not only recognizing that and acknowledge that, and it obviously has implications for whether we need more capital and all those [ nuff-nuffs ] will be going on about that. But let's put that aside for the moment. But I want you to understand that what we're really doing here is we've got a fantastic product. We've got more or less stable cash costs. Of course, they're going to go up because we're going to put more support staff on, and we're going to put more salespeople on and so forth. But we're only putting those salespeople on because they can generate more sales and more cash for the business. So we see this as the beginning of making this significantly cash flow positive. And that's the most exciting part of it. So when I look at our results this year where we got hit a bit because of COVID and we -- guess what, we only grew 49% in the U.S. in U.S. dollars, for example, woe is me, instead of some people's expected 100% but with half of hospitals shut with lack of access to surgeons, still magnificent growth. But the thing I want to emphasize to you is that in this -- exactly this time last year, we had 18 staff in the U.S. We've now got 36. We've got another 4 to be appointed, and we're going as quickly as we can to get to 50 people. That is what is going to make this significantly cash flow positive going forward. And on top of that -- and you'll get these messages out of Paul's explanation today, is what's happening in the U.K. We're back in operating theaters. What's happening in Sweden? We've just opened, What's happening in Taiwan? We just had our first order. All of the new jurisdictions we've got, the new stuff we're putting out in Ireland, the new stuff we're putting out in the U.K., the new stuff we're putting out in the U.S. is -- just means that we've jumped over the cost line, and this is a -- that's why I think this is a really important day for the company. This is not like another start-up. We just didn't invent a product, and you got to sit back there and worry whether we can get it into oncology surgeons or whether we can get it into a company that analyzes of blood or whatever it is. We've got a solid product. We've got relatively stable now costs. I mean relative to revenue, that is. And we've got significant increases in revenue and significant increases in our ability to generate revenues by building the infrastructure and other jurisdictions, by building the sales force in the U.S. and even by building it in Australia. I've made the example before that when we started with our [ young ] saleswoman, Valerie Young, and she finally got to $1 million in sales. And then we said, "Well, we're only touching the service on the hospital. So put somebody else on." So we put somebody on Sydney. Then we're doing $2 million in sales. Now we've got somebody just new in Brisbane. We've got a [ half-timer ] in Perth. You can see easily that in Australia alone and New Zealand, we could easily have 5 people. And that means we can have 7 in California, for example. So that's where we're heading. And that's why I'm super excited today to say that we're delivering on what we've got. And just on the issue of cash, I mean we're obviously just tipped over. I don't want to yell too loudly about the profit because we've just tipped over the sort of cost line but it is profitable when you take out those [ non-funding ]. And the people who are looking at cash, if you look carefully again at the release, we had $7 million, I think, in December. We got $7 million now. I think it went up by $100,000, which would reflect what you would expect. It's suddenly you've got most of your CapEx done. We've built the factory. Okay, we've still got some clinical trials and so on and so forth, but this is a pretty exciting day for us and it should be a pretty exciting day for you. I might have some more to say later on, but I think it's better that I pass over to Paul and let him go through the sort of minutiae but with a focus on what are always things he's going to tell you about today doing to the number of people we've got on the road and, therefore, our ability to get to surgeons and to get them using the product. Thank you for coming, and maybe I'll see you at question time. Paul, I'll hand to you.

Cheers. Thanks a lot, David, and welcome, everybody. And as David said, this is a very exciting period for us as we do enter our profitability phase, and I'll cover that now. So I'm on Slide 2 of the slide deck if people are following offline. Despite COVID and the restrictions that happened, just draw your attention that we did grow the U.S. business by 49% in U.S. dollars, for U.S. dollar comparison, over last year. Our European distributor markets grew at 53%, and our Australian business grew 25%. Now all of that is in the face of restricted travel, border closures, hospital access being denied. We didn't take the path of many of furloughing staff. We actually grew our staff. We pivoted very quickly to a digital marketing platform. We established a wide range of webinars, enabling peer-to-peer referral of case outcomes and -- to expand our reach into other institutions. And that led to new account acquisitions, which was also topped off by signing 3 U.S. GPOs. And then we've also managed to complete our [ Premier ] factory, albeit delayed through many COVID impacts from various flows, whether they be builders or machines or engineers who are commissioning those machines. And we've actually manufactured over 1,300 fully packaged commercial standard central hernia devices to begin a large animal study and some other studies that we'll be doing. So it shows that we do have capacity, and we've done all of that while managing cash flow, investing aggressively in our sales team growth and to drive revenue and turn a profit. So as David says, quite a significant day for all. Moving on to Slide 3, which is the dashboard. I think this just calls out in a very succinct form for you to look at the 49% growth in the U.S. business, overall NovoSorb in Australian dollars going up 33.8% across the group. And the group revenue is growing by 32%. BARDA revenue grew. We are now open in recruitment in 5 hospitals within the U.S. That's going out as we do the contracting, et cetera, in those sites to 25 sites in the U.S. and 5 in Canada. Our employee growth during the pandemic has been, I think, nothing short of spectacular, from 78 in 2020 to -- at the end of June being 106. And today, we're north of 110. So we've continued to invest not only in salespeople but also some of the support services with HR, finance, expanding our QA team, expanding our production facility, our team for NovoSorb BTM and also expanding into R&D the resources to accelerate concurrent product development. Our cash on hand has risen. Albeit small, it shows very nice -- and I'll leave. I won't steal all the time under -- he has some beautiful graphs there to show the trajectory of cash flows, which will put to bed any concerns about our ability to service our growth in FY '22. Significant decrease in both capital expenditure and the cash outflows is highlighted there. Slide 4 identifies the geographies and gives a little snapshot of each. And beside each of those are QR codes, and you'll see these throughout our annual report, which will be in glossy format on our website and published within a week. And each of these QR codes take you to a video of our sales directors of each of these regions. And what we were doing in this is so you can hear, if you like, from the horse's mouth what it feels like on the ground. What are our teams facing? And how are they conquering the market? It's very easy from a distance or a helicopter to be critical of sales performance, why haven't we given 100%. COVID has touched us in many ways, including some of our staff having lost family members during the pandemic. So for the United States, the business over there itself is actually profitable. We've heavily invested in expanding that team, and we'll continue to expand that team throughout FY '22 to generate high gross margin revenues. In South Africa, our partners, Ascendis Medical, have been doing a fairly good job in what is a very underfunded public health system, and they've achieved some fairly spectacular surgical outcomes on some very needy, poor people. And we're limited in our private health access there through the health reimbursement system, but we continue to work with Ascendis on building that. And they've restructured their team. And they now have 14 people in their team who take BTM out into the field on a daily basis. Our European business has seen significant growth throughout this year, and I think you'd all agree that we've been quite rapid in our geographic expansion throughout Europe. I'd like to call out David Hollis, who you'll meet through video on this QR code, who's done an outstanding job for us in our business development, and we'll continue to invest in expanding that European development team to support our distributors and bring on more geographies. And we definitely have some other geographies that will be coming on shortly in Europe. For the U.K. and Ireland. The U.K. in particular has been very heavily impacted by COVID and very restricted in access. Pleasingly, I mean you would have all seen their Freedom Day. However, since that Freedom Day, we have had an increase in face-to-face engagements with surgeons. Our team are now in the operating theaters with those surgeons doing cases. We're in 70% of the bench units now in the U.K. and our face-to-face conferences have restarted in U.K. and Europe. And we're attending several of those in the coming months. I'll move on to Slide 5 now, which is further geographies of the Middle East, which has been very much a hiatus for us during COVID with restricted travel and access, but we see good potential to bring on some Middle Eastern markets in FY '22. For Asia, we entered the Taiwan market through a distributor arrangement, and that has been very good for us. We've had surgeries done in 5 major hospitals there, good outcomes. And unlike some other countries in the world, it's a very well-sophisticated, developed health system within Taiwan. However, the patients actually buy our product. So there is subsidy reimbursement within the actual hospitals themselves, but there is a copayment from patients who believe in NovoSorb BTM, which is nice. In Australia, we've grown the business very well, 25%. And I'm sorry everybody on this call living in Australia knows that travel has been rather difficult, and we're all in severe lockdowns at the moment. However, we've stayed engaged with our customers on a regular basis, and we've continued to see the growth within the Australian business. And as David said, we've put a person now in Perth, and Penny is doing a wonderful job for us, new to the organization and building on the foundations laid by Valerie in WA. We've also brought Chloe on in Victoria/Tasmania, and she's been doing an excellent job. And we've got Lyndall in New South Wales and Lewis in Queensland. Lyndall in New South Wales has covered a vast geography. And I think the important thing I'll cover with Australia will come in the SKU mix a little bit later. For New Zealand, we're very well penetrated in the New Zealand market, and we continue to see that business grow strongly. And there's a lot of peer-to-peer referral. And we've made a couple of visits to New Zealand in the past year. And we see that after we get through this current lockdown and vaccinations improve, we'll be able to access New Zealand more frequently. But the New Zealand business is a very strong business for us. And when you look at the raw numbers, you might say it's 5% behind last year. But in 2020, it was the White Island volcano tragedy which did add significantly to revenue. So in lieu of not having a repeat disaster like that and thank god there hasn't been, we've still managed to grow the business significantly within the New Zealand market. So I'm very pleased with the performance in New Zealand. Slide 6 just calls out our geographic expansion throughout FY '21. And you'll see the list of countries and the dates in which we entered those. The reason that we've used distributors in these countries is to gain speed but it's also that it's a profitable route to market for us. It's a low-cost entry strategy. We made good gross margin on those sales, and we're able to reinvest that money in the expansion of our direct business markets. So these markets are contributing significantly to our ability to reinvest in the further expansion of our U.S. business in particular, which is a large market and a highly profitable market. I'll now move on to geographical highlights on Slide 8 and give you time to catch up there for the highlights for the U.S.A. NovoSorb grew in sales by 49% year-on-year, and our U.S. team have been fantastic in their tenacity and their diligence and their creativity in reaching out to customers. We distribute through Owens & Minor, and we are able to service customers throughout the U.S. on an overnight basis. When there are crises though, our team are there. And even with COVID and all the restrictions and the fear of all those activities, our teams were there on the front line whenever there was a disaster and people were needing support with BTM. We've won new accounts throughout the financial year. And we've increased our sales reps from 18 to 36. At the half year, we said that our ambition was to get to 30 salespeople on the ground in the U.S. by the end of June, and we exceeded that. And I'm very pleased about that because, as David has referred to very often, when we bring on a salesperson, they generate positive revenue very quickly. And so our ability to expand the sales revenues within the U.S. are also tied to our ability to expand the sales team. Now there are some of you who say, "Well, maybe you've underinvested and you could have gone harder." Doubling a sales team means a lot of resources go into supporting those salespeople, recruitment for one, training, bringing them up to speed, introducing them to accounts. The resource support that we've now got within our system is significant. We have online training facilities. We have induction facilities. We're improving our IT infrastructure so that by November, all of the digital equipment that our team in the U.S. is using will be the same and be mirrored off a central cloud server. We've added significantly to the roles that support, whether they be clinical, marketing or human resources or finance in the U.S. team. We have expanded our reach into Canada, and we have done surgeries on multiple children in the Canadian market through an exemption scheme process. They have a different regulatory requirement, and I'm pleased to say that we are well down our path on accreditation on what's called MDSAP process. We've commenced the BARDA pivotal trial, and there will be 30 centers across the U.S. and Canada. And the enthusiasm we've had from centers wanting to join has been quite outstanding. Surgeons are passionate about joining our trial. They see the value of BTM. Many of the surgeons joining the trial have used BTM in other indications and really want to dive into supporting us with getting the burn PMA approval. We commenced the SynPath chronic wound reimbursement trial. Now 10 patients were [ blended ] in that initial phase, and we took them through to full healing or closure of their diabetic foot ulcers. And I'm pleased to say that 10 patients, all, had closure within 7 weeks. Our final report of that study will be handed to us by the CRO at the end of September. And that informs us on the next step, which is a 100-patient randomized controlled trial to develop more health economic data to support an insurance submission for reimbursement. I just want to emphasize, we already have FDA approval for these indications. This is a financial reimbursement through health insurers. We signed 3 GPOs, IDNs during the period, and we've got ongoing discussions with more. These are live discussions and contracting arrangements. And we are putting dedicated resources into what is essentially a GPO team within our sales team. And we've developed and executed very well on the digital strategies. Slide 9 for Australia. We grew revenues by 25% but importantly the volume by 35%. Now with 35% growth in volume, what that's telling you and us is that the small sizes, 10x10 and 10x20, are really picking up in our sales volume in Australia. And this is directly attributable to its use in elective surgeries and smaller chronic wounds and reconstructive things like melanomas, excision, wide excisions and repairs. We've got quite a healthy private hospital sales channel now, and our team have done a really good job of building our non-burn indication use, and that's being reflected in our SKU mix. And just for everybody's benefit, our SKU mix of 20x40s is now only 49% of our revenue base, whereas many years ago, it was a dominant revenue base. So that will give you an indication that we are significantly growing our non-burn indications globally. As I've covered, we've appointed additional salespeople, and we've had excellent campaigns within Australia. We'll now move on to Slide 10, which is the highlights of U.K. and Ireland. NovoSorb has been sold to 23 NHSs within the U.K. Now that is outstanding. The volumes have not been high due to COVID, which had -- the U.K. has been severely restricted. We also put on a salesperson in Ireland. And very quickly, the Irish business has taken off at a good rate. We've got good access to accounts throughout Ireland, and we're seeing that as a very strong driver of business in that region. We're in 70% of the burn centers throughout the U.K. And our issue now is to drive further penetration within those accounts. So it's about achieving a bigger capture of the burns that come in and also penetration into other departments. Just for emphasis, in the U.K., we did not enter through the burns indication, rather through multi-trauma as the predominant sales route. And we've maintained our staff through COVID lockdown, which has been important for maintaining customer relationships but also the knowledge within the business, and that's a significant asset for us carrying forward in our growth trajectory for FY '22 in the U.K. and Ireland. The direct sales team there are gaining momentum, and they are in actual operating rooms. We also were featured on the BBC StoryWorks team, where they highlighted John Weeks, who is the first patient who was treated with NovoSorb BTM, and very good interviews with the Royal Adelaide team within that documentary as well, including Professor John Greenwood, who's since retired but still remains a very good supporter of PolyNovo and a colleague for all of us. And Marcus Wagstaff has been fantastic in his support of us in our clinical trials and ongoing support across all of our regions as we train people all over the world. But those BBC documentaries, I commend them to you and I encourage you seek them out. There are links on our website where you can see some of these. Now the next slide, Slide 11, distributor markets. You can see the markets that we entered, and we did that in a very short time. And when you appoint a distributor, not only do you have to assess that distributor for fit and drive and momentum of how it's going to add to PolyNovo's business but how we integrate to theirs. And what is their reach within the market? What's the skill set of their teams? Can they service our brand as we want our brand to be represented in market? And we've had a phenomenal success with a 53% growth in sales there and wide expansion. We're at work now on France, Portugal and Spain, and we'll enter those markets this financial year. And when we have substance to report on those, we'll obviously be informing the market. To support our distributors throughout Europe, we're also opening a distribution center in Belgium, called Movianto. And that 3PL partner will enable us to service small orders on a frequent basis to these businesses throughout Europe who are going to be building their business quickly. And that cuts costs from operating from Australia to each individual country. It also enables us to be highly responsive in volume supply whenever they have peaks in demand. And we already have stock in that Belgium warehouse today. So as soon as the European holidays are over in September, that will be an invaluable support for our business expansion. I'll now move on to new product development and Slide 13 on Syntrel. And during FY '21, we completed the factory. It is now commissioned. It's fully manufacturing finished goods and devices, fully packed, sterilized, labeled, branded, finished. It's been a mountain of work. Our internal team have been pushed, and they have really dug deep and delivered an extraordinary outcome. When you think that our customized machines being made in Germany and then shipped over here, and the engineers from Germany have been unable to come and commission those machines, our teams have worked tirelessly to find waste to commission those machines with video links and building data cables so that the Germans could control those machines and pass on that knowledge to us so that we have a much deeper in-house skill set now on how to control these machines and manufacture products. The ultrasonic welding -- and you can see a picture of one of the devices on the slide. The skills that we've now built within our team on ultrasonic welding are very exciting. One of our team members, [ Alex ], has done a phenomenal job, and we're now going to be commissioning a different style of ultrasonic welding head that -- it will give the same weld, but it will give us 10x the speed of what we're currently doing. So even though this product hasn't reached commercial sale yet, we're already at the point of looking at how we reduce waste, how we increase volume capacity, the throughput of the factory and how we drive down cost of goods. And that will continue as a work in progress. The large animal study has started in the U.S., and that's in pigs and that's looking at the toxicology, biocompatibility and the resorption rate. There is some banter out there that this is BTM. This is not BTM. It's nothing like BTM. The only component shared with BTM is the NovoSorb foam. There is no glue bonding the film to the foam. It's done by ultrasonic welds. And that film is a completely different formula of NovoSorb, expressed as a solid then melted and extruded as a film. So what we are doing in this large animal study is demonstrating the resorption rate and speed of the film breakdown. And this film will now enable us to make a plethora of other devices that can be used throughout the body where the film is going to be providing strength. And so this step is a significant move for us in that, yes, it supports the hernia product but it's also going to underpin future product developments that are in progress. We anticipate filing with the U.S. FDA in March of '23 for our Syntrel VP device. But in the meantime, we're also accelerating now the next round of products that are coming into the Syntrel family for the rectus muscle space, which will be a slightly different formatted product. Move on to Slide 14 now. With NovoSorb BTM, we'll be launching additional sizes, 2x2s and 5x5s. The first market for these is actually going to be the U.K. with a launch scheduled for September, October. The products have been manufactured, just going through the final QA processes before they can be shipped, We'll also be launching a 20x20 product, and that's to service some reimbursement requirements in some markets where effectively, if we sold the 20x40, you wouldn't get paid for the extra material provided. And so we're providing a size that goes to the maximum of the reimbursement codes. For the EU, Australia, New Zealand, we'll also be launching the smaller sizes to address chronic wound use. Other markets will flow after that. And the SynPath product in the next column is going to be using some of those smaller sizes. And we're, as I covered, doing that reimbursement trial. And the next phase is doing the randomized controlled trial, RCT. We're hoping to have that reimbursement in late '23, early '24, and that will open up a market with a TAM of $400 million. NovoSorb in other devices is an accelerating area for us. We've recruited new and additional scientists into our team as well as some lab assistant support staff to ensure that the scientists are doing high-value work. And we've also employed marketing people to service the R&D team in outreach to end users and surgeons and to help build the design profiles of those. We'll be doing some work on breast, and we'll be communicating time lines on that probably by the half year as to the development time lines. Now the beta cell use of BTM in the treatment of type 1 diabetes, the Beta Cell Group in Adelaide are ready now to do human trials and just waiting for COVID restriction lifts to get started on those trials, and they have funding from the Juvenile Diabetes Foundation. It looks like a very exciting prospect for patients. They will be using patients who have had renal transplants because they're already immunosuppressed, and that takes out one variable factor in the trial program. So you'll see some more news on that when we get that from our Beta Cell team that will continue to support them with the supply of product. In FY '22, our strategies remain to be very resilient against COVID. We'll continue our expansion throughout Europe and other geographies. We'll continue to invest in our R&D team expansion. We want concurrent product development and not sequential product development so that we can bring more of these exciting NovoSorb devices to market sooner. We'll execute on our BARDA pivotal trial. We'll launch those small NovoSorb BTM products in those markets, and we'll continue to do our clinical trial to build the reimbursement evidence for the SynPath product in the U.S. We're also recruiting patients into a Flinders University trial on venous -- arterial leg ulcers rather. And this has been prompted by the Flinders University team getting healing in toes and limbs where the arterial perfusion is so low, they thought that the only option was an amputation and yet they're getting closed with NovoSorb BTM. So this study will be looking at what's the mode of action, what's going on in these limbs that enables them to heal inside NovoSorb BTM and they can't heal in any other products that they've been using. So this is a quite exciting development for us to partner with them to look at what's a physiological difference of NovoSorb in these very difficult ulcers. We'll continue to support clinical publications of NovoSorb BTM, and please see the website. We have them published on a regular basis. And in the last few months, I think there's been about 8. So keeping up with publications is a bit of a challenge. There's a lot out there, and they're truly exciting. And what's rewarding for all of our staff is seeing that our product is actually improving somebody's life. So you may look at the tagline as an investor and think, well, that's just a pretty tagline, but all of you are actually having a hand in contributing to a real person's life in their long-term outcome and improvement. The COVID-19 on Slide 17. I think that we all know where the world has been. It's been a very ugly place and Sydney's having a mild taste of what most of Europe and the U.S. experienced for an extended period of 2020. But as vaccinations have increased, so we're seeing the liberation of some of these markets. So for example, Florida is still getting 12,000 new COVID cases a day. It's a disease clogging hospitals in the southern states of the nonvaccinated. Those who are vaccinated are not turning up in hospitals. So as the vaccination rates and motivations improve, we'll see the capacity and flow-through of hospitals hopefully returning back to what they were pre-COVID. But that will still take some time. If you look on my LinkedIn page, there's a very impassioned plea from the trauma surgeon at Lakes in Louisiana outlining the challenges that they face. But across the U.S., we're seeing significant improvement in face-to-face interaction, and hospital access for patients to have procedures done as well. The U.K., Ireland have high vaccination rates and hospitals are picking up their cadence on elective surgery and other trauma surgeries. Maintaining our surgeon engagement in Australia will continue, and we'll see fluctuations in elective surgery rates. As you can see, we've got several hundred healthcare workers out of our health system here in Victoria today because of COVID and the need to isolate. So as we do see vaccinations pick up in the 16- to 39-year-olds and seen hopefully down to 12-year-olds, I think we'll see a liberation of the Australian market as well in capacity to service non-COVID hospital requirements. Move on to Slide 18 with inventory status. Catherina Lim and or supply and demand team have done an extraordinary job for us throughout the last financial year, and I'd like to call them out. We airfreight our product around the world. There aren't as many planes to have bellies to fly product around the world. It's -- the reality is Australia has been isolated. We found alternate routes. We've delivered products on time. We've got a good stockpile of products in all of the markets listed there, and we have been able to service every customer on time regardless of where they are in the world. So I'm very pleased that for our brand, we committed that we would be there for our patients and our surgeons, and we have been and will continue to be. We've got significant forward inventories in all of these hubs ready to go. Other matters, Slide 20, the BARDA trial. I think we've covered that already. Suffice it to say that it's in progress now and we've got an excellent working relationship with BARDA, and that program is very strong. Slide 21, capital works. When you have a look at our annual report, there is an actual factory QR code where you can see inside our new facility. There's a couple of pictures on here to give you a snapshot, but the capacity we now have to synthesize large volumes of polymer in new labs, extrude film, make micros-spheres of hard polymers, ultrasonically weld, increase cutting capacity on a new high-tech cutting machine and also automated packaging where the machine actually was installed on Monday this week. So within the next month, we'll have that fully commissioned by a QA team, a very significant milestone. So the CapEx committed in the year ahead is only $390,000, So you can see a dramatic fall away in capital investment. That's not to say that we're moving away from future investments. It's that we've now built this capacity to service all the things we need for the next few years. And it's small-ticket items from here on that we need to do. Correct me. On the slide here, there is some actual virtual tour which you can feel free to take. We won't take you through that now. Anthony Kaye will talk to you -- our COO, in that tour. And Anthony has bought a lot of value and support to our team since he joined us in November last year. Slide 23 speaks to the expansion of the team that -- from 78 to 110 recruiting and inducting and onboarding all of those people with COVID restriction and using video systems and all the rest has been a challenge, but we've been up to it. And I'm pleased that we have aggressively invested in the expansion of our teams. And that is driving our revenues and puts us in a very good positive cash generation position for FY '22. The U.S. will remain a large focus for us, and we'll continue to recruit and invest into that market as we will in the U.K. The research and development teams have expanded, and we've recruited some spectacular talent into that team. And I'd also like to highlight that there have been several people in that R&D team who, through the hernia project, have shown enormous personal growth and really stepped up to the plate when we've been very challenged with gaining outside consultants to come in. They filled those breaches and done a spectacular job. So particularly Berkay and [ Jimmy ] that I'd call out there is really doing a lot, and Jason, who's been a very good addition to our team. Moving on to Slide 24 for the diversity of our team. I'm very proud of our Australian team at -- people walk in to our office and they're surprised at the true multicultural reach of our team and the spread of male and female representation at all levels within our management group. Globally, we've still got some way to go in increasing our diversity, but we take diversity very seriously as a business. It brings outside mindsets, gives us good insights in communication and capability into multiple markets. And it also makes life them and work a lot more interesting. So we'll continue to invest in this, and we do have a positive affirmation diversity policy in place for our U.S. business. Moving on to Slide 25, our ESG initiatives. We're developing a very comprehensive carbon offset plan, and our desire is to be carbon-neutral by the end of FY '23. We've got very little water use. We've got small carbon output, but that's measured. And we've had a comprehensive waste program in place. There'll be a lot more detail on our programs within the annual report, and we're increasing our IT infrastructure with the first move to all-encrypted, cloud-based server system, which happened last weekend, and the integration of a lot of our IT software, driving out the use of paper and print in a lot of our processes and that drive will continue. So stay tuned to our ESG. It is a very live and strong feature of our business moving forward. I'd now like to hand over to Jan Gielen, our CFO, to run through the financial highlights. And Jan, over to you.

Great. Thanks, Paul. Just to touch on highlights that have already been presented by David and Paul. We'll run through them again. Great result in what was a challenging year for all of us and for most businesses. Total revenue up for PolyNovo by 32%, comprising of BTM product sales up 34% and BARDA revenue up 18%. Total BTM sales of $25.5 million versus last year's $9.1 million. And we achieved a fantastic growth in the second half with BTM sales up 27% on the first half, demonstrating a good cadence in the business and great momentum and the impact of the sales reps that they've put on, particularly in the U.S., starting to come through in the numbers. Just to further demonstrate that even further, we ended the quarter with a record month, $3.3 million in sales. And that gives us a really great run rate coming into FY '22. Looking across the markets. And the U.S., as mentioned, has grown by 49% in local currency. And again, the second half demonstrating some great momentum with 38% growth on the first half. Australia has done really well, considering the numerous lockdowns we're all enduring, growing by 25%. Distributor sales, particularly in Europe -- and I'm calling out our distributor PMI who has done a fantastic job, getting great results in the DACH region. They service Germany, Switzerland and Austria, and we've given them other regions to service as well, including Benelux, so doing a great result there and really driving that number. We've had first sales in Finland, Italy and Taiwan and further sales in South Africa and India. And as the Belgium 3PL comes online in the 1st of September, we expect to see a lot more ordering activity from our distributors who've been ready for that to come online. So looking forward to reporting back on that at the half. In addition to that, 99 new customers are in all direct markets, 44 of those in the U.S., fantastic result considering it's hard to get into hospitals, It has been particularly in the U.S. during the peak of the pandemic. So it's a great achievement by our sales team finding out -- finding different ways to access customers and introduce our product. And our digital marketing strategy is clearly working there. And touching on distributors, 7 new distributors signed for the period, covering 9 markets. So most of those in Europe and obviously including Taiwan. Moving on to other operating results. So operating expenses, I've carved out the share-based payments, unrealized ForEx loss. So you can see the underlying result. Of course, it's going to go up. We're investing in growing the business. Operating expenses have gone up by 26%. But you can see the head count there going up by 36%, 78 to 106 staff, and that's what we expected the cost base to go up as we invest in the business. In addition to that, we've entered 8 additional EU markets by signing the 6 new distributors. Some initial costs in getting all that in place but as Paul mentioned earlier, it's a low-cost revenue model and all the gross margin pretty much does drop straight through the bottom line. So you'd expect no further additional setup costs because they are set up and looking forward to enjoying the profits that come from those arrangements. Other reasons cost increased, we've expanded our regional operations in the U.S. and Australia just with the general business expansion. And as mentioned earlier by Paul and David, the U.S. sales teams increased to 36. This time last year, it was only 18 staff. So it's a great way to start the year with a big sales team on board in the U.S. like that. What's the net impact? We've had a small profit excluding noncash items, so $259,000; EBITDA excluding noncash items, $635,000. And there's a reconciliation on Page 30 as to how we get to that. So we broke even during FY '21. And we got there through strong revenue growth during a pandemic, and we've managed our costs effectively as well, so a really pleasing result. Looking at cash flow. Cash on hand ended 0.4% up from the half, which is a great result. So our cash burn was only $250,000. On an accounting basis, we've broken even and made a small profit for the year. On top of that, our CapEx investment has dropped off now that the factory is built, the facility, and we've got all the equipment on site. We've just got some committed CapEx just to fix up the remaining contractors' invoices over the next couple of months, and that adds to just under $400,000. So cash is in a great position. The business is doing well in terms of breaking even. We've got a great run rate coming into this year and expect to see this business start to turn a continual profit and improve cash flows even further. Just a summary of the overall result there. And as mentioned earlier, I've got a reconciliation at the bottom there. So you can see how we get from the net loss after tax to our underlying profit, excluding noncash items. So product sales up 34%; revenue overall up 32%, including BARDA. Pleasingly, gross margin on sales up 3%. We've got higher throughput from the facility. The operations team and our COO, Anthony, do a fantastic job on sweating the assets and looking for efficiency going through our operations and manufacturing, and it's great to see coming through the numbers. Employee-related expenses up, as mentioned before, because of the increased head count. Corporate admin and overhead expenses up slightly, 10%, but not going to grow at the same rate as sales. We are starting to see those economies of scale, and it's coming through in the net result being underlying profit. R&D spend were up 55%. So we've expanded the team. We've put on a director of R&D. We've got the DFU trial underway, the hernia animal study underway and also investing in other tissue technologies. Net loss after tax of $4.6 million does include $2.6 million in share-based payments, meaning expensing of share options. It's not a cash payment, just so you know. It's just an accounting thing. So net result after all that, underlying profit of, yes, $260,000, so a great result. So just to sum up, as David mentioned at the start of the call, achieving breakeven is a significant company milestone. Great to have achieved that this year. We've entered a lot of new markets successfully. We've improved our gross margin. Our cash is stable and will grow in this half as we generate cash flows, a really great result for the year all things considered. Looking to the future, FY '22, we'll continue doing what we've been doing since we entered the U.S. market 3, 4 years ago, and then reinvest our cash flows to grab market share, enter new markets and invest in developing new products. So look, I think at this point, we'll hand it over to Q&A time. So we've got about 7 covering analysts that are going to ask some questions today. So I'll hand that over to the operator to introduce them. Thank you.

[Operator Instructions] Your first question comes from Lyanne Harrison with Bank of America.

Congratulations on getting that good momentum in the second half of 2021. So if I could focus, I guess, on the U.S. market now, I guess what we're seeing is increasing COVID rates, as you spoke about, in some of the southern states. In terms of, I guess, the restrictions in place with hospitals, are you still getting good access to the hospitals? And secondly, in terms volumes of surgery and the like, would you say that that's more driven by, I guess, the lockdown restrictions or limits on movement across the United States as opposed to actually being able to access hospitals?

Lyanne, thanks for your comments and the question. We had a very strong July as well, backing up June out of the U.S., showing growing momentum. August is still going strong for us. The U.S. isn't having lockdowns as such. People are traveling fairly freely. The -- where they've got some chokeholds or bottlenecks is in some of the traumas where ICU beds are congested. So that surgeon or professor of trauma in Lakes in Louisiana highlighted that many of her patients would now spend days in an ER on a gurney rather than getting treatment as quickly as they should have because the ICU bed might be for the COVID patient. So overall, our access to hospitals is still fairly good and show an improvement, and travel has improved. Some hospitals still have restricted access as a precaution of bringing COVID into the institution. But within those, the sales teams are able to meet with the surgeons in coffee shops or offsite. So there are still those interactions happening, and we see the U.S. getting freer each month, not going the other way.

And if I could just, I guess, continue on the United States. Obviously, you've added a fair few new salespeople into your team. Can you give us some color in terms of what's the focus for them in the next 6 months, whether it's targeting new customers or increasing the depths of penetration amongst existing customers?

Yes. To use the American vernacular, I need to chew gum and walk at some time. So I want both. It's not a matter of being greedy. It's just the reality that we've got a lot of headroom for growth in new accounts, but also that the fast growth of revenue can also come from your existing accounts. So they're not mutually exclusive of each other. You could take an area just big hospitals, say LSU in Louisiana. Yes, we've got a large volume of the burn business there, and we've got increasing levels of trauma business in LSU, but it's also then reaching out into the general surgery community there, what's the necrotizing fasciitis, hidradenitis, reconstructive or melanoma excision or a general surgeon who might do a minor trauma that could use BTM. So our teams are doing both, and what they're tasked to do is to do both. Now for the GPO growth, we are putting people into that strategic driving team to support the sales and marketing activity in opening up a faster rate of GPO penetrations. So you'll see both new accounts and penetration increasing in FY '22.

Okay. And if I can move on then to the U.K. So you mentioned that you're looking to, I guess, launch the new sizing in the U.K. first compared to other markets. Can you give us a sense -- obviously, there was a fairly large opportunity in the U.K. with respect to wounds and the like. Can you give us a sense of what the lost revenue might be given that you're shifting from bigger sizes to smaller sizes in that market versus the expectation of higher volumes?

Yes. I don't think we're going to see a lot of revenue, quite the opposite. Where, say, a 10x10 -- taking your theory of -- where they wouldn't buy a 10x10 but they'll now 5x5 and we will go a 10x10 sale, it's that they're using them now on a limited number of patients who potentially could be accessing it. And some of that is because of price. So offering the 5x5 is actually expanding the breadth and scope of the number of patients we can service. And that's coming from those surgeons who say, "Well, that's been fantastic on these patients. But I'd actually use it on all of these other smaller ones that I'm currently not using these types of products on." So I think we'll see a good revenue drive from our 5x5s and 2x2s versus a loss of revenue from 10x10s. And bear in mind, we've got a low penetration of the U.K. market at the moment. So those other SKUs will continue to grow, as will our penetration in the burns unit sort of capturing more of the actual large-size burns as well.

And just one last question. Obviously, getting good exit rates in the United States for '21. How does that compare to, I guess, your other markets? So -- and what you factor in being, I guess, Europe, U.K. and other regions for, I guess, June, the last quarter to June '21, and then what you're seeing to date.

Europe is actually picking up their speed with surgical activities quite aggressively. So I think we'll continue to see good strong growth in Europe. The U.K. has been a bit of a lag compared to the U.S. in the scale and volume of that acceleration, but that's now starting to pick up pace. You'll see that the English are back to international travel and going to the soccer and then having the brawl on a street afterwards, but the actual NHS throughputs are starting to increase and the elective surgery rates are improving. For Australia, we are on a very good growth. And even last month, where Sydney was in lockdown, we had very strong sales in New South Wales. So I think the underlying demand for the product is going to be there when you've got products who can't be delayed. They need the product, surgeons or service, but it is very much a watching brief in Australia for the next 3 months as we get the vaccination numbers up as to see what is the impact of elective surgery as our hospitals are following health care workers, which is problematic.

Your next question comes from Rachael Harwood with Macquarie.

First question is just on GPOs. So how are your sales through GPOs progressing? And then just to clarify, are those 3 GPOs new? Or does that include Premier and then other previously announced figures?

No. They're the -- Rachael, thanks. So the already announced GPOs and they brought quite a few new accounts to us in the time that we've been with them, not a large volume to date. But that's one of those things that is gaining pace and why we're going to be investing more in the GPO servicing team as a sort of subgroup team. Each salesperson will continue to service all the accounts in their area. But from a head office interaction and reporting process, we'll have some more resources in the business. We've already set up a system within our ERP system to track GPO sales and monitor those growth rates and trajectories, and that's building well. At the moment, we'll see further acceleration of that in FY '22 as it matures.

Yes. Great. And then just a question on pricing. Are you seeing any changes in pricing either in direct sales or through the GPOs or distributors at all?

Yes. We had some small increase in the average selling price. So as a blanket for the U.S., for example, it used to be $8.50. It's now nearing $9 as the total average per square centimeter. There are some accounts and some SKUs that have got higher growth rates than that. We'll be taking a managed approach to how we increase pricing over the coming couple of years as we have given commitments to our customers in the past that we wouldn't raise prices in the first couple of years because that was an entry-level strategy of our competitors at various times, which has left a lot of accounts weary about swapping to something that they see as good, new, bringing them a saving only to then get hit with savage price increases once that's institutionalized. So we've been taking those up gradually with new accounts and also with our GPOs. We've put a nice floor in there that gives us a price rise and assist in the margin increase as well.

That's great. And then just last question from me. Just -- I think you touched on it briefly, but can you maybe just expand on how you're seeing elective procedures recovering and any regions particularly still impacted by COVID? And then do you expect some of these southern states hit with the Delta strain to be affected in FY '22?

Yes. I think COVID is going to be fluid. Guessing through that crystal ball is difficult. I can't give a conclusive undertone of knowledge on what's going to happen. But from what we do see is that where vaccination rates are high, things seem to be relatively normal. Some of the southern states where vaccination rates haven't been as high, there is some ICU bed congestion. And there are some websites that you can find -- that will give you a daily tracking of ICU bed occupancy rate throughout the U.S. And some of those southern states are impacted, but we've weathered that storm in the past. And I think the difference is that in FY '21, you could class the world as COVID-reactive. We didn't really know what we're dealing with as a community. We used lockdowns and stayed home and stopped a lot of businesses. Now with vaccinations, that's more COVID-resilient. So if you look at Europe and the U.S., then people are traveling quite widely and freely. People are taking family holidays to Florida. Now there are 12,000 new cases a day in Florida, but you don't see people wanting to go on a family holiday to Sydney at the moment with 1,000 cases a day. So I think the difference is that there will be intermittent hiccups and congestions, but overall, the market is improving as COVID becomes normalized within how we manage it. It's managing rather than avoiding.

Your next question comes from Elyse Shapiro with Bell Potter.

Just looking at the sales force, obviously grew to 36, and I think David mentioned in his initial remarks adding 4 more. How many -- I guess what's the goal? How many would you like to get to?

Well, I think it's a matter of that there's no point just giving numbers of, "We're going to be at X number." We will continue to invest in the expansion of the sales team throughout the year to drive sales and drive new geographical reaches and to the earlier point of deeper penetration of accounts. This financial year, we'll probably be somewhere close to 50 by the end of the financial year. But the caveat on that is we may well go above that. If we see an opportunity to invest more and receive more revenues, then we'll keep going. So it's not a hard in stones, set number. It's going to be as we can drive and recruit, we will. And pleasingly, the Board has never said we shouldn't be recruiting, quite the opposite. They're sort of giving us their imprimatur to go forward and recruit and drive sales and revenues that there's self-funding. So we'll continue with that strategy, and we've managed the cash flows very well. And we think that we've got good cash flows coming in and good growth that will underpin that ability to aggressively grow our team to somewhere around the 50 mark this financial year and possibly more.

Got it. And with that to see, are you targeting kind of certain geographies or certain types of hospitals that you maybe weren't covering as well before?

Yes, it's a mix. So there are some new geographies. Like Nevada, for example, is one and Utah. But it's also, to David's point earlier, about should we have 7 in California? Today, we've got 3 in California but we're expanding that more. So as sales team -- as salespeople have smaller geographical territories, they're unable to penetrate deeper. One of the other things we're bringing on is what's called the sales associates. And some of these sales associates will be working with some of our territory managers so that they can maintain and penetrate an account, freeing their territory manager to go and conquer new ones. So there's a multitude of strategies on sales expansion that are going on within the business, but all [ drive out ] where we can realize revenue in very quick time.