Welcome to PolyNovo's half-year results presentation. Today we have presenting, Chairman, David Williams, Managing Director, Paul Brennan, and CFO, Jan-Marcel Gielen. Covering analysts will have the opportunity to ask questions following the presentation. I would now like to hand you over to Chairman, David Williams. Please go ahead.
Thank you, welcome everybody to this call. I don't propose to say too much. I'm going to hand it over to Paul Brennan and Jan-Marcel Gielen. We have just come from a board meeting, and I thought it might be helpful just to reflect on the progress of the company, the way I see it. As you saw, our growth in the first half in terms of sales was only 31%. I've said ad infinitum that the business is lumpy. Interestingly, while we had a soft October, November, sales in December, for example, in the U.S., were above budget. I'm not going to sit here and say that COVID is a problem. It's got small issues for us in terms of access to one-on-one meetings with surgeons. It's got small issues for us in terms of hiring new staff in the U.S.
At the same time, we can go from a soft month to an above-budget month in a heartbeat. At the same time, I've got a super confident head of the U.S. who's very happy with his forecast and with his trajectory. In this half, we've picked up 20 new clients in the U.S. alone. We're now servicing over 100 hospitals in the U.S., and in recent months, we've also signed up several GPOs, Group Purchasing Organizations, and that looks like it's going to bear some fruit for us very quickly in the next couple of months. Even when I look at today, compared with our 31% BTM sales year-on-year, it's now over 40%, and, as I said, our head of the U.S. in particular is very confident about where he's going and where his trajectory is. We've now got 22 sales staff in the U.S.
A lot of those have only recently come on, so we're not seeing the full belt of that either. It's not all U.S. If you think about what's happened, and Paul will go through some detail of this, but since September last year, we've signed up distribution arrangements in Finland, Taiwan, Benelux, and so forth, Turkey, Poland, Italy. All of those have happened since September, and many of them were in January, Turkey, Poland, February for Italy, for example. Already we're starting to see some fruit come out of that. In Benelux alone, where we didn't sign till into November, we've had four patients. In Finland, we've had 12, and so forth. As the year progresses, those sales are going to trick up and will we get to double our sales on last year? Who knows?
The business is growing strongly, and we continue to pick up new hospitals around the world. I've given the example recently of Germany, which is going particularly well, where we've got 30 hospitals we're servicing, and we've got another 30 hospitals trialing the product. As I said before, I haven't seen it yet where a surgeon trials a product and then doesn't buy the product. Quite rightly, they want to put it on a wound. They know about it, but they want to see how it comes out, and that's a two, three, four-month process, depending on what they want to see out of a particular operation. I'm pretty happy with the way it's going. I wish the sales weren't as lumpy, but as the business grows, a lot of that lumpiness will come out of the business. I think that's probably enough from me.
I think that the price, it is what it is. I keep saying to people, when we did the AGM in November, I think our share price was AUD 2.20, and then went all the way up to AUD four, and now we're back roughly, probably where we were. I would point out to those of you a bit more sophisticated that the shorts in the market at that stage were 7.5%, went down to 1.5%. I look at a lot of that action as being people covering themselves, and I look at a lot of the action now where the shorts look like they've come back up to 4.5% as driving some of the downside. I'm very happy with the progress of the company. Surgeons love it. We love it.
It's a bit volatile, but if you look at the trajectory over the last two years, there's only one direction. Welcome, everybody. I'd like to introduce you now to Paul Brennan. I'll probably put Paul and Jan-Marcel Gielen, our CFO, on the screen at the same time and let them talk to the presentation that we put up on the ASX this morning.
Good morning, everybody, and thank you for joining us today. Both Jan and I will take questions, and both of us will be presenting different parts of the deck. If we start up on slide two. Next slide. This is just giving the highlight numbers as a top line, as David's covered, we've had the increase of 31.2% in overall net BTM sale. The pleasing thing in U.S. dollars, so without any currency impacts, we've seen the U.S. increase 41% in the first half, and that's with several challenges, in the variability of the states, in their response to COVID.
The U.S. is not one market, it's 50 individual markets in effect, and they all behave slightly differently to the challenges. Overall for the group, the pleasing thing also is the decrease in outflow of net cash for the profitability, and really tracing our break-even line, which I'll speak to a little bit later. The research and development expenditure, AUD 1.28 million during the quarter, is reflective of most of the investment going on in transferring the hernia devices into a production-ready phase. Capital expenditure is coming to a close, if you like, with the factory build. We've spent AUD 2.3 million in the first half, and that now in the remaining period only has AUD 1.3 million of commitments. Cash on hand is AUD 7.6 million. When we get to the end slides, you'll see the out-flowing of cash, that AUD 7.6 million is fine by us.
We've got good cash and good revenue projections in the months ahead. If we go to slide three. We've signed 22 new accounts in the U.S. during this COVID challenge of the first half, and sales in Germany, as David has alluded to, in that DACH region, the 30 accounts with another 30 evaluations in progress. The really pleasing thing is that's a very wide clinical indication use of uptake that we're seeing in the DACH region. That is turning into relatively consistent revenue for us from our partner, PMI. We've had very strong webinar referral program, and that's bringing new accounts and increasing the credibility. The BAPRAS, which is the British Association of Plastic Surgeons conference, held recently, was classed almost embarrassingly as a Medizoll BTM show. There were surgeons from the U.S., Germany, Australia, and the U.K. all presenting their cases of BTM.
Very strong peer-to-peer referral. The first two GPOs and IDNs started in the U.S., and we've got further agreements in process at the moment. We'll have some announcements coming through in the coming months. The GPOs, Group Purchasing Organizations, have groups of hospitals within their purchasing group. That will give us a faster route to market and a smoother process for inventory management within those groups. Dr. Anthony Kaye joined us as a COO from CSL, and Anthony brings enormous production in R&D and engineering experience to the business, and he's already had a significant impact on our hernia program and the quality of the ultrasonic welding, and things have really stepped up since Anthony's come into the business and added his expertise to the team. The hernia factory build is going well, and there's been some commissioning delays in some of the machines.
We managed to overcome this with video links to our German suppliers of those machines, and for them to custom-make some cabling to enable dual control of those machines through the internet so we were able to commission them. Really good effort on our team, and thank you to all of our staff in R&D and production who were very creative and tolerant through this process. We had the U.S. FDA approve our pivotal trial, which is for the BARDA trial, and that now means that we can begin recruitment of patients program. We also have BARDA committing the $15 million to support us in that program itself. We'll now go to the next slide. With our distributors, as David alluded to, we've continued our expansion throughout Europe.
We sell direct in the U.K. and Ireland, the Republic of Ireland, and we use distributors in Finland, Taiwan, Belgium, Netherlands, Luxembourg and Greece. To achieve that in that first half, our business development manager, who's based in the U.K., has been doing a fantastic job. We've got some excellent distribution partners, and he's done the training and induction of these companies into how to sell BTM. That looks like it's going to be good business for us. We've added Turkey, Poland, and Italy since January. There will be further countries added to that before the close of this financial year. If we go to the next slide. Just wanted to highlight some of the creativity in digital processes.
For Australians on the line, you'll know that we can't travel to New Zealand, and Valerie Young, who's our sales manager, is also the territory manager for New Zealand. She had a life-size cutout made there, and she had a conferencing system put there, and she attended that conference virtually and spoke to many surgeons during that conference session and opened a couple of new accounts post the conference. We're very creative in how we sort of get ourselves around and how we involve ourselves with our customers. Might go to the next slide. Revenue has been lumpy, and that's been the reality that hospitals have varying levels of activity in elective surgery and bed access. It's been a very strange world for all of us to live in.
For those in hospitals, it's much more stressful than anything that any of us on the outside experience. I think on the sum of it, we've done very well through a very challenging period. For logistics, we've had some increasing cost in finding bellies of planes to ship things in and scheduling challenges. However, we've got significant inventory in all of our holding warehouses in all regions. Katharina and her team in logistics have done an outstanding job of staying on top of not only the production, which is excellent and very efficient, but also in getting into the markets. For the markets themselves, it's been highly variable, with how they've treated the lockdown. Suffice to say, within all regions, we've been opening new accounts.
Those new accounts mean that as the elective surgery backlog needs to be cleared, we should see a corresponding rise in demand for NovoSorb BTM. The outlook for us, I think, looks quite strong, and the vaccine rollout globally is accelerating, with the U.K. already at nearly 15 million people and having announced this morning a four-stage exit plan, in five-week blocks for the U.K. Our U.K. team are very excited because they've already signed nine NHSs and doing evaluations in several others. The demand and knowledge of NovoSorb BTM, as I was referring to the BAPRAS conference, is quite strong. We should see a good uptake in BTM in all of our markets.
On the side of that slide, you'll see webinars that have been run, and they can be viewed retrospectively on our website under the healthcare professional tab. We'll go to the next slide. For the BARDA program, we've had the IDE approved, and there was a bit of a delay in the FDA processing that because they had their own COVID challenges as well. We've now had the vendor kickoff meeting, which is all of our contractors and suppliers for running this program, and we'll be in a position to recruit patients into this trial in March, April. One of the things that's quite exciting about this program, it's gonna be done in Canada as well as the U.S.
We'll have between 20 and 25 sites involved in the program. We'll be making announcements as soon as we get the first patient recruited. We're judging NovoSorb BTM against what's called the standard of care. Whatever that institution uses within that facility to treat a full thickness burn is what BTM will be compared to within that facility, and then the aggregate rolled up, to give a comparison of NovoSorb BTM's performance, which I'm sure, given our commercial success and everything we see from our surgeons, it'll be a very positive outcome for the trial. Next slide. For our employees, we're now at 92. When we had June 30th, we were at 78. You can see that we're not going slow on the recruitment of talent into the business. Roles such as Anthony's as COO is important to us.
We're actively recruiting at the moment for a head of R&D, so that once we've got that head, we can bring in more scientists underneath. There are ads out there at the moment for further development scientists. Pleased that we've, as of a couple of days ago, contracted with a marketer, who'll be joining on that global capacity to help with product development, to make sure that we're incorporating the patient and surgeon needs within those development programs. For the U.S., we continue to expand that. We're actually at 22 sales managers at the moment and four regional sales managers, and we're making investments. As we find talent, we'll be constantly bringing them into the business, in line with driving revenue opportunities. For Australia and New Zealand, it's been quite challenging with some of the border closures, but you've seen how creative we've been.
As the vaccine now rolls out in Australia, I'm hoping that the border closures might be left behind and our team can be more mobile and more face-to-face with their customers. For the U.K. and Ireland, we have four salespeople in place there, and we'll hold that level of staffing until COVID restrictions are eased and we see some revenue bump. Next slide. For the factory, we thought you might appreciate some photos of what this new factory looks like as shareholders effectively purchase. We're quite excited that the film extrusion process is well and truly understood by us now, and the area that those machines will go in will be finished by the end of March 2021. We've been extruding film out at Universal Biosensors at Scoresby.
We've been renting some space from them, and that's been fantastic for us to get our skills and talents up to speed before the factory was ready, and we'll bring those machines in-house, and install them here at Port Melbourne by May. We're already building the finished product, to begin all the laboratory and animal study work required for building the regulatory dossier. We're quite excited about our achievements in this phase. In the forward commitment, we've got some, AUD 1.3 million of outstanding capital required and one of the items in that is a packaging machine, which is a final part payment. We're looking forward to that packaging machine. It's been significantly delayed in its build in the U.K., because of COVID. When we get that will also have significant efficiency improvements for us in our BTM space for packaging. Next slide.
For all of our inventory in the warehouses, we have plenty of inventory in all warehouses. We can supply any customer very quickly, and we've got no problems in our supply chain. We've got plenty of raw materials. We've got plenty of stock. We're in a very healthy position. Next slide. Just take us through, but I'll hand over now to Jan Gielen, and I'll rejoin you with the new products at the end. Over to you, Jan.
Great. Thanks, Paul. Just running through our financial results for the half. As mentioned, our BTM product sales are up 31% for the half. Total sales coming in at AUD 11.25 million versus last year's AUD 8.6 million.
Next slide.
My apologies. Next slide. Thank you. Total revenue coming in at AUD 12.8 million. That includes AUD 1.3 million of barter sales. Some other highlights, we had really strong sales in Q1. The Q1 was up 75% on the same time last year. Things slowed down a little bit in October and then November, as Paul mentioned, but all COVID related with restricted access to hospitals and surgeons, and we did see a reduction in elective surgery. Again, that came back strongly again in December where we actually exceeded budget in the U.S., New Zealand, and Taiwan, which was really pleasing. Looking at other markets and growth overall. The first half, we opened 35 new accounts across all our direct markets. Quite a few of those in the U.S., followed by Australia and then the U.K.
Important just to look at how we performed for the calendar year during a pandemic. We actually managed to open 109 new accounts, which is nearly double, what we did in the prior year. It's great platform growth, and holds in good stead for the year ahead. Looking at the USA, their local sales in local currency over there, we've obviously had an appreciation of the U.S. dollar against the Australian dollar. Looking at their sales for the half, they were actually up 41% on the same time last year, which is better than the 31% overall. Moving on to distributors. As David mentioned at the start of the call, really strong sales in the DACH region through our distributor, PMI, has been very pleasing.
We went to new markets in Greece, Benelux, Sweden, Finland, and Taiwan, some of those with initial stocking orders and also a number of evaluations underway. The U.K. is continuing to build on its customer base despite being in lockdown, which do have further evaluations underway. We're also pleased to say that we've had our first evaluation performed in Ireland, which is great. Next slide, please. Moving on to our operating loss and OpEx. You can see from the graph there, our operating loss is down 78.9% on the same time last year. I've excluded non-cash items in this just to give a true underlying view of what the operating loss is. The reason why it's getting to that point, which is good to see, we've obviously had revenue growth.
We've had gross margin improvement of 3.9%, which is great to see year-on-year. Cost management has been minimized, and we're actually below budget with our OpEx for the half. In terms of profitability, the U.S. and New Zealand are actually profitable on a standalone basis. You can see from the graph there from an operating perspective, we're actually close to breakeven for the half. In terms of OpEx was up 19.8%, but the major driver of that is the increase in headcount from 65 staff to 91, increasing by 40%. Obviously you get that annualized effect of prior period highs coming through. All this is planned, and was expected.
What's also pleasing to see, is corporate admin costs have remained fairly low in terms of the growth only coming up 3.4% at the same time last year. Obviously, as we expand, there are costs in entering new markets and regional operations like setting up in Ireland, but we'll continue to invest in growth and monitor our cash flow and OPEX accordingly. Next slide, please. Moving on to cash and cash flow. You can see we ended the period there with AUD 7.7 million cash on hand. Our cash burn for the half was negative AUD 1.4 million. The trend has improved the same time last year for the reasons I just pointed out on the previous slide.
In terms of CapEx, as Paul's mentioned that stage two, which is the last stage of the hernia clean room build, will be completed by May 31st . That's on track. We've got all our equipment on hand. It's just the packaging machine which will arrive soon. Then that will be complete in terms of equipment CapEx. I've put in a forecast there for the second half of AUD 1.5 million. That will be met by having that facility as well. That's covered. Next slide, please, operator. Let's move on to our P&L. I'm just looking at some highlights. What I have done at the bottom of the P&L there is just adjust it so you can see the underlying loss and backed out the non-cash items of share-based payments, which is expensive share options.
Also the unrealized Forex loss for the period, just with depreciation of the US dollar against the Australian dollar. Going through the highlights, as mentioned, product sales 31%, BARDA revenue up 25%, product sales, gross margin up 3.9%, so we enjoy a very high gross margin. Employee expenses are up 33%, 32.6%, but for reasons we know, increased headcount. The R&D spend has been down, but that's mainly due to activity, with the BARDA trial switching from feasibility, and we're transitioning to the pivotal trial. That will increase as the pivotal trial starts to recruit patients. Corporate and admin overhead up 3.4%, and the loss for the period after tax, negative AUD 3.5. Our underlying loss, and I went back to the break-even comment earlier, only just under AUD 1 million for the half. Next slide, please. Just wrapping up the finance section. Product sales, again, 31%.
We've entered new markets successfully, as Paul indicated. 109 new accounts during a pandemic, 89% growth. Great effort from my sales team. Improved margin, underlying loss near break-even. We end the period with cash on hand of AUD 7.7 million, which we feel is enough to get through and execute our plans. We have a net NAB debt facility of AUD 1.5 million. A bit of headroom there, and that will cover the CapEx for the first half. Next year will be a CapEx light year with everything in place by 30 June and paid for. Thank you, and thanks, Paul. Back to you.
Thanks, Jan. That's excellent. Next slide, please. The next one. Syntrel is the name of our hernia device, we thought we'd give you a bit of an update on the hernia progress, where we're at. There's a picture there of the actual finished device that you can see ultrasonically welded the foam together. That might sound very straightforward. Technically, that's quite an achievement. Our R&D team have been fantastic at being able to achieve this and many in our production team, who have brought many of their skills to the table, literally. We're now commercially production-ready for making this device. We're also got the opportunity to look at some partnership opportunities to see if that accelerated path to market and accelerated market penetration. It's too early to get into any detail there.
As always, our role is to look at the products we've got and maybe some variations, and look at how we can generate revenues quickly. We'll make some further announcement on hernia, by July of 2021. The next slide. The NovoSorb BTM, we've got some additional sizes there. The packaging is really what we need to move forward with this project. That's arriving and on track. For the Synpass product, for the chronic wound space in the U.S., the diabetic foot ulcers, venous leg ulcers, we're now open for recruitment for this trial, and we should have some announcements very shortly about the first patient enrolled. That's a two-year study to build the economic data for private health reimbursement of the product. Just want to emphasize, it is not a U.S. FDA requirement. It's purely a commercial requirement for the reimbursements.
We'll launch into that market segment as soon as we do have our reimbursement from those insurers. NovoSorb, other products, the plastic and reconstructive device effectively is a breast device. For technical and regulatory points of view, we'll be calling it plastic and reconstruction. We've moved that development in-house and employed a dedicated marketer to help build the product specifications and requirements, and we're recruiting some additional scientists. We anticipate that it'll be a three-year plus development path. Just caution you that, with all these things, there are a lot of unknowns as you're developing products. We'll have a more further into this process. The Beta Cell diabetes treatment, the Beta Cell group with Toby Coates in Adelaide, still say they're on track for doing a human trial in 2021. We're just standing by waiting for that.
Our role will be to supply NovoSorb BTM, and the longer term is that this would be another market segment for sales of BTM, albeit unique shapes and sizes into that segment. That's another exciting opportunity for market expansion. Next slide. For the H2 activities, want to caution, as David has highlighted already, that we do anticipate sales will be lumpy, but there is a significant pent-up demand within the hospital networks now, globally as elective surgery is, we should see that play through in demand. We'll continue to expand our R&D team and our product development pipeline. Should have our first patient enrolled in the pivotal trial in March, April. We'll have the patients in the recruitment for the chronic wound study, and we'll have further market entries into Europe and the Middle East.
That concludes the sort of formal presentation part. Now I will hand back to the moderator to take questions from the analysts.
Thank you. If you wish to ask a question, please press star one on your telephone and wait for your name to be announced. If you wish to cancel your request, please press star two. If you're on a speakerphone, please pick up the handset to ask your question. Your first question comes from Lyanne Harrison with Bank of America. Please go ahead.
Oh, hi, Paul, and hi, Jan. Thank you for taking my questions today. Can we talk a little bit in terms of, I guess, the expectations for the second half of 2021? I know, it's uncertain times because of COVID, and I know that previously you've been reluctant to talk about month-on-month trends. Given, I guess, the circumstances when you mentioned, first half 2021, the U.S., saw significant improvement there, then slower October, November, and then returning again December. Can you provide some color on what you're seeing for January and February?
Well, I don't want to get into the cycle. As soon as I answer this question, Lyanne, you and others will be asking me each month what the sales were like this month. On the agreement that it doesn't degenerate into that as in the go, you said was very good. January still showed some good performance. From what we hear in the U.S. at the moment, things are looking reasonable for February. I'm only hesitant on saying anything in close on February because the month is not closed.
Yeah
of each month is when a significant number of purchase orders come through in the administrative processes of hospitals. I don't want to crow about things that aren't invoiced and banked. Suffice to say that the team activity and what we're hearing on the ground sounds quite positive.
Okay. If I could ask, probably in a different way about, with the caseload easing, particularly in the United States and the vaccine being rolled out, how is PolyNovo placed to, I guess, ramp up its sales activity in the United States, for the second half of financial 2021?
Well, we've got sales representatives in widespread geographies, and compared to pre-COVID, in many more geographies than we had before we went into this lockdown. We've been doing significant amount of webinars and peer-to-peer engagements, and you can see that we've signed many new accounts in the past calendar year. Just in the first half, 22 new accounts. Plus we've signed GPOs. I think if you connect all those dots, it's looking positive from where I sit in PolyNovo's preparedness to be able to service the demand in the market. We've got significant inventories sitting in Kentucky. No problems or downsides from my perspective.
Okay. Thank you. Since you mentioned new customer accounts, am I right because you mentioned 35 new accounts, for first half 2021 and 109 for calendar year 2020. Is that like for like, showing that, first half of 2021 was significantly lower?
It is like for like. It represents the growth on the prior year. The 109 is 89% greater than the prior calendar year.
Yeah. Okay. If I could talk about the U.S. in particular, I guess the new 22 new customer accounts that you signed up in first half 2021. Can you talk a bit more about the extent of penetration you've got in different tranches of hospital types? Obviously burn hospitals, large general hospitals, and then now as you're working through the GPOs?
Well, there are a wide variety of hospitals, Lyanne. We only target large hospitals.
We're not after the small, rural type settings. The penetration within all of those hospitals is variable depending on the maturity of that account. Whenever you gain entry into, say, a new hospital, you'll be in either through trauma, plastics, or burns, and whichever one of those tentacles was your way in, as a salesperson, you're tasked with growing all the other departments, orthopedics, general surgery, and the rest. Depending how long the reps have been in those accounts and the networks they've established, there'll be a variable depth of penetration. There's no one answer to give. There's X% penetration in the accounts. It's territory by territory, each of those salespeople in their territories have specific goals and targets based on penetration and dollars to achieve, and they're judged and mentored and coached around those numbers weekly by their sales directors.
Okay, thank you. I guess just one final question. In terms of your new products to market, particularly the alternate sizes for BTM, what's the timeframe on that?
Well, we haven't got a hard and fast because it's gonna depend on the different markets. For the U.S., for example, as soon as I've got that packaging machine, we can roll out different sizes, as we can here in Australia and Europe. In the filing for the 510(k) covers everything from four square centimeters to 800 square centimeters. We can make any size we like within that. The thing that you need to build into that is that we've got to do stability testing, accelerated oven testing, if you like, of the packaging. That takes a couple of months.
We'd be looking at at least another four - five months before we roll out those sizes to get stability testing for the QA system, because you've already got your regulatory approval, but those regulatory approvals are on the condition that if at any point you get audited, you have that data. You morally, ethically, and commercially should not be out there selling a product until you've generated all your data. There's some normal quality processes that you've got to complete, and we'll be doing those diligently.
Okay, if we're thinking about first revenue from those new sizes to come through in first half 2022, that would be reasonable to factor that in?
That'd be reasonable.
Okay. Thank you. I'll leave it there. Thanks a lot.
Cool.
Your next question comes from Rachael Harwood with Macquarie. Please go ahead.
Yeah. Hi, Paul, Jan, and David. Thanks for taking my questions. Just so that I'm really clear, trauma and burns seem to be urgent in nature rather than elective. I'm just wondering exactly what the driver of the COVID impact is. Are you finding a lower incidence rate of people presenting to hospitals that are eligible for BTM as a result of these lockdowns, or is it more around surgeons having little time to evaluate and trial a new product?
With the trauma and burns one, yes, there is a reduced incidence directly by people staying at home. Not out doing all the silly socializing things. I mean, burns in particular, the highest cohort is 18 - 24-year-old males with alcohol in one hand and fuel in the other. It's an unfortunate reality. The elective surgery, we've got penetration within that space as well, and that's been impacted. As normal life and normal activity returns, so will the hospital activities. Some of the surgeons in some regions, like in the U.K., have been on duty as nurse assistants doing basic patient care. Normal surgery practice hasn't been happening in some of the markets that we're in.
Okay, that makes sense. I guess just following on from Lyanne's question, you mentioned some new GPOs and other accounts signed. Are you starting to see any sales come through from these accounts yet? I guess, do you expect there to be some pent-up demand that will be pulled through once hospital capacity starts to free up? How should we start thinking about this?
Yes, some of the GPOs we've got some sales have come through. Some of those accounts are ones that until we were with the GPO, we weren't allowed access and no visibility itself. We've had sales into some of the hospitals within some of those GPOs. That'll accelerate as we go forward, as their activities, et cetera, increase. Some of the other GPOs that we're signing have some good support mechanisms to help the adoption of BTM as well. We'll cover those with more granularity once we've actually finished all those processes with those GPOs.
Okay, great. That makes sense. Thanks.
That's all from me. Your next question comes from Shane Storey with Wilsons. Please go ahead.
Yeah, good morning, team. Thanks for taking my question. Perhaps we can start, I just want to look at the U.S. business in a slightly different way. Look, lumpiness aside, can you help us understand the level of sales concentration within that portfolio of U.S. accounts? By that I mean, if you look at the proportion of accounts that constitute 50% of sales, as the business stands today, what would that percentage look like? Thanks.
Yeah. My hand to Jan. We do have several very large accounts that proportionally cover quite a bit of revenue. That's going back, I suppose, to Leanne's question on penetration. Some accounts in particular are very strong for us, and others are still in maturation phases, if you like. Jan, would you like to comment on that sort of weighting?
Yeah, sure.
Maybe the Pareto 80/20 sort of rule?
Sure. Not every quarter customer will order every single month, it depends on the hospital and how they're using our product. With trauma, you'll get a series of orders, it's also episodic, that could play into it. As we penetrate those hospitals, that changes. We've seen things like that, for example, in New South Wales, where we do have a lot of concentration in other parts of indications, we do get those reorders from customers every month. There is a portion of customers, probably, they're definitely a good 20% that are big orders of BTM. Yeah, I would definitely say it's probably 70/30, it would be where that would sit. Does that answer your question, Shane?
Yeah, thanks. Yeah, it does. That's very helpful. The other question that I had, just as far as utilization and penetration is concerned, was it seems that the company's had a fairly different experience through the first and then the second kind of experiences through COVID. It seemed the first experience had more resilience. I guess the second time around, the lumpiness that we've just seen in the current period, am I right in thinking it was just more elective stuff that has kind of developed as utilization of the product has developed? It's that elective piece which has kind of fallen off, and perhaps that happened within those sort of larger accounts. Is that an accurate kind of way to think about it?
Yeah, the electives have fallen off. We've got one report from the U.S., which talks about, in effect, $20 billion of losses across the U.S. hospital networks, over that quarter. The U.S. government response to that. The impact of COVID on the second sort of phase, if you like, of the year of 2020, just as was in Australia, was much stronger than it was in the initial phases of COVID rolling out. In the initial phases, we all thought, "Well, this'll go shortly. It'll be like a flu." For anyone in Melbourne, you know we have lockdowns that tend to last a long time. The health impacts on people are severe. It has had a direct impact. We've had staff who thankfully have recovered, but we've had staff's relatives who have passed on.
The brutality of COVID in the U.S. has been quite severe with them now approaching 500,000 deaths. There just is an impact on every aspect of people's lives in the U.S. on a day-to-day basis with COVID, regardless of the political spin that's put on it in the news. On the ground, it's quite harsh. Thankfully, the vaccines are rolling out. They're starting to see an improvement. 330 million people have got a long way to go.
Thanks. Look, the last one from me, for Jan. Perhaps some guidance on the R&D expense that we can expect over the next 18 months outside the pivotal program and then kind of some clear residual sort of evidence development in hernia, the outpatient trials you called out today and the breast reconstruction project. Thank you.
Yeah, sure. Obviously, with the hernia device, you would've seen the presentation today, we've come a long way in terms of actually developing a device. In doing so, to get to that point, there's always a bigger spend, with materials and research and all the things that you need to get to that point. I guess moving forward, aside from BARDA, with breast, as Paul mentioned in other presentations, it will leverage off our hernia manufacturing process and what we've developed there. That's the whole benefit of NovoSorb and the base technology. We'll get a lot of leverage off that as we branch out and start working on other products. We do have a short list of other things we want to develop, and it just depends how that plays out and what we prioritize and I expect it to increase.
We're still working through plans on that and when and how they're going to be executed and what the cost will be.
Thanks very much.
I think the key thing, Shane, to consider there in the R&D expenses is that our revenues that we're earning, with our very high gross margins. We've got plenty of cash, and we'll manage that expenditure in line with our cash flows, and we're in a very good position.
Thank you. Once again, if you wish to ask a question, please press star one on your telephone and wait for your name to be announced. Your next question comes from Elyse Shapiro with Bell Potter. Please go ahead.
Hi, guys. Thanks for taking the question. Most of mine have already been asked, but just given the fact that we saw a lot of COVID-related delays on sales and market access and hospital entry, and now, with your additional hires ramping up the sales efforts, how many sites would you say that you're in the late stage, kind of eval process that you might expect to be signed on over the course of the next six months?
I don't think we plan on giving forward projection numbers at this point, Elyse, so I'll take that one on notice, and we'll consider that for another time.
Would you say that it's an improvement, though, over what we saw for the last half?
What I will say is that, we are bringing on more salespeople, and we're very active with GPOs, and that will also bring further accounts. I think things are looking positive and optimistic. I don't think I'm in a position to give you a hard number.
Got it. Great. Thank you.
There are no further questions at this time. I'll now hand back to Mr. Brennan for closing remarks.
Well, thank you very much, everybody, for your interest and continued support of PolyNovo. I think you'll see that we're in a reasonably good position for what's been a very difficult and trying time for everybody globally. We're continuing to expand our sales team. We're adding new accounts. We're increasing our bringing to market potential products. I think there's a lot of good energy and excitement within the business, and I'd also publicly like to thank our board for their ongoing support, guidance, and coaching for the management and indeed the individuals within the business.
Make a special call-out to Anthony Kaye, who joined us, for his fantastic contributions since he has joined, and in particular, not only our sales team, but our production team, who have turned up here every day through COVID lockdown as essential workers and maintained really high standards of personal protection and things to ensure that we had a very robust, functioning business of manufacturing BTM to supply our global partners. A big shout-out to our production team for being fantastic people who consistently put in. Thank you very much for your interest today.