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Welcome to the BONESUPPORT Q1 Report 2019 [Operator Instructions] Just to remind you, this conference call is being recorded. Today, I am pleased to present, CEO, Emil Billbäck; and CFO, Håkan Johansson. Please begin your meeting.
Thank you very much, operator, and welcome, everyone, to BONESUPPORT's Quarter 1 2019 Results Call. My name is Emil Billbäck, I'm the BONESUPPORT CEO, and I'm also here with Håkan Johansson, our CFO, this morning. We will start with a presentation of about 15 minutes and run through the results of the first quarter before we will finish with question-and-answer session.Please, operator, next slide. And before starting the presentation, I would like to draw your attention to the disclaimers covering any forward-looking statements that we will make today.Slide 3, please. So I would like to begin this presentation by quickly highlighting some of the strong figures that we have released in this morning's report. Overall, quarter 1 sales were at SEK 33 million, which is up 5% versus previous year. The performance in the quarter is overall a confirmation, a confirmation that the strategic programs initiated during 2018 have put the business on the right track.The segment Europe & Rest of World grew with 41%, reaching SEK 21 million. And this strong growth is driven by broader and more frequent use of CERAMENT G and V, mainly among existing customer base. The antibiotic-eluting product grew in the quarter with 54%.In the segment North America, we also saw a strong continued progress, with sales reaching SEK 11.5 million, which is more than double the sales we saw in the previous quarter. Last year, as part of our strategic program to accelerate market penetration, we made an important decision to change our distribution setup in the U.S. so that we now can address the entire market potential, and we start to see the first sign that this strategy is really working.In terms of earnings, we have a significant improvement on the EBIT level versus previous quarter, which is of course driven by improved sales, but also an effect of our implemented cost control programs.Operationally, I would like to highlight that we're seeing strong progress, very strong progress in our market access in the U.S. And here I would especially like to highlight the GPO contract with Ascension which was signed in the quarter, giving us access to additional 151 hospitals for CERAMENT BVF.One of the key strengths of BONESUPPORT is our industry-leading clinical evidence. And in the quarter, the first study ever validating both by radiology and histology data that CERAMENT remodels into human bones was published. This study equipped our sales team with yet another unique set of arguments for positioning CERAMENT against autograft and other treatment modalities. We have established a strong innovation pipeline, which will allow us to launch a steady stream of new products over the next several years. And in this quarter, we launched a product line of BONIFY in the U.S. I will speak more about that later.Slide 4, please. I would like now to provide you with more details on the quarterly development. So this slide you will remember from previous calls, it shows the last 12 months, with the dark blue part of the bar representing Europe, Europe & Rest of World; and the light blue and the purple part of the bar is displaying sales in the U.S. And the purple part, which is visible in quarter 4 of 2018 and quarter 1 of 2019, shows the sales that we have achieved with the new distribution setup.We can see the effect on sales development when Zimmer Biomet started to have their internal challenges and couldn't keep up with the market demand for CERAMENT. And we also see the effect of Zimmer Biomet canceling their orders after BONESUPPORT terminated the agreement in May of 2018. The chart also confirms the very steady growth we have in Europe & Rest of World.We have started this year with a strong beat rate. If you look to the left of the bar chart, you can see the buildup in momentum from plus 14% in the first half of 2018 to an impressive 41% growth in quarter 1 of 2019. We believe this gives a very good confirmation that the business is on the right track.Slide 5, please. So focusing a bit more on the details of segment Europe & Rest of World. I have already mentioned the strong momentum in the segment in total and especially with the antibiotic-eluting product. And last year, we announced we will close to double the sales team in Europe, and we're almost there. We currently have 3 vacant territories, which means we have 22 salespeople on the ground and we expect soon to be 25. A key focus for the sales force expansion has been Germany and the U.K., but we have also recruited in Scandinavia and in Spain.Historically, much of the sales growth for CERAMENT has come from the indication of osteomyelitis, which is chronic bone infection. But on the strength of the top line results from CERTiFy study, we are starting to see some very encouraging momentum and sales growth in the indication trauma. As you are aware from our previous presentation, the trauma market is a significant opportunity for CERAMENT.As I have said on many previous occasions, strong clinical evidence and health economic data are cornerstones of our strategy. In the quarter 1, the first patient was enrolled in a new clinical study called SOLARIO. This study will investigate if the use of a synthetic bone graft containing antibiotics will allow shorter course of oral or intravenous antibiotics to limit the risk for antibiotic resistance, to limit the risk for side effects and to reduce costs. The SOLARIO trial is a randomized European multicenter study which is conducted in collaboration with a prestigious European Bone and Joint Infection Society. It is expected to recruit 500 patients.Traditionally, treating bone infections has required multiple procedures and hospital visits. We have previously shown in a British study on 100 patients that with CERAMENT G, chronic bone infection was eradicated on 96% of the patients, with only one single-stage treatment. And a positive outcome of the SOLARIO trial could lead, indeed, to a paradigm shift in the treatment of bone infections.Slide 6, please, operator. Turning then to North America. Sales in the quarter was SEK 11.5 million. This is up significantly from quarter 4 2018, and sales was made up of a good mix between new and legacy accounts.Since October of last year, the new distribution network is up and running, and now with 40 distributors, which together deploy more than 500 sales reps. Our former distributor, Zimmer Biomet, canceled all their orders last year when we terminated the agreement. However, they do have the right to sell any remaining product and inventory up until May 20 of this year. After this date, CERAMENT BVF will only be sold exclusively by BONESUPPORT.Our commercial team in the U.S. is making strong progress on market access. And in the quarter, we closed yet one more important GPO contract, this was with Ascension. This gives us access to additional 151 hospitals, and I expect the signing of further GPO contracts to be an important part of our future growth.In March, we launched BONIFY. This is a unique bone graft composed of 100% demineralized bone matrix, DBM. This offers osteoinductive potential to aid in the bone healing process. Osteoinductivity means that it stimulates creation of new bone. As such, BONIFY is a great complement to our CERAMENT platform, which offers osteoconductive properties and osteo-connectivity, as you know, means that it creates a scaffolding for new bone to be formed.As you can see in the pie chart, DBM is almost 1/3 of the total U.S. market for treating damaged bones. As such, BONIFY opened up great, untapped potential for us in indications and procedures where we before did not have a complete portfolio. And BONIFY is the first product coming out of our strategic partnership with MTF Biologics.Slide 7, please. Clinically, we've had a milestone in the quarter when, for the first time ever, bone remodeling of CERAMENT was verified in humans through radiology and histology data. This study is truly unique as it is the first time it has been validated that with biopsies in humans, bone remodeling has been seen from a graft substitute. The trial design was a retrospective review of 138 patients who had at least 12 months of radiographic follow-up. In the pictures to the right, you can see the early biopsy and you can see the bone-forming cells, which is called osteoblast, they're covering the surface of CERAMENT, which is marked within the #2. In the picture of the late biopsy, you can see some remaining hydroxy appetite from CERAMENT, this is #1, surrounded by a healthy regenerated bone that has been formed and that has replaced CERAMENT, and this in #2.The publication shows that the radiology and histology images matched the positive clinical outcomes in the patient series. And here's a short comment. In the first picture on the early biopsy, the CERAMENT is #1 and the osteoblast is #2, okay? I cannot enough stress how unique this study is and how important it is for our salespeople when promoting CERAMENT and explaining its unique benefits to surgeons. CERAMENT is the first bone graft substitute that has strong bone remodeling, validated by both radiology and histology examinations, which is published in a clinical paper.So with that brief update, I will now hand over to Håkan, who will cover the financial review.
Thank you, Emil. Let's move to Slide 9, please. This graph represents net sales by quarter as bars and last 12 months net sales as a line. And as you can see, net sales in the first quarter amounted to SEK 32.8 million compared with SEK 31.1 million in the same period previous year, equaling an increase of roughly 6%. The period showed continued strong growth in Europe & Rest of World and a continued gradual improvement in U.S. sales, both supported to the net sales improvement. Net sales for the last 12 months amounted to SEK 98 million compared to SEK 123 million last year, a decrease of 23%. The segment Europe & Rest of World increased with 26% and net sales in the segment North America decreased with 59% as effect of the changes made in the distribution platform that was made during 2018.Both in first quarter this year as well as in the fourth quarter 2018 shows really that Q3 2018 was actually a turning point in the execution of BONESUPPORT's commercial strategy with sales and marketing investment in both the U.S. and in European direct markets.Next slide, please. In the segment North America, sales for the period showed a decrease of 28% compared with the corresponding period last year, but at the same time, displaying a significant increase to SEK 11.5 million in the period compared to SEK 4.2 million in last quarter of 2018. The contribution from the segment was minus SEK 15.7 million compared to SEK 2 million same period last year. The increased loss relates to the lower sales and the ongoing commercial investments.Next slide, please. In the segment Europe & Rest of World, sales for the segment increased by 41% compared to the corresponding period last year and amounted to SEK 21.3 million. Sales in direct key markets accounted for 87% of the segment sales and sales of the antibiotic-eluting product, CERAMENT G and CERAMENT V, continued to show strong performance and together increased by 54% compared to the first quarter last year. The contribution from the segment was at SEK 0.9 million compared to a slight loss of SEK 0.8 million last year, an improvement despite substantial sales and marketing investments on our direct markets where we see an increase in expenses of SEK 4 million.Next slide, please. Net sales with strong growth in Europe & Rest of World as well as the gradual improvement in the U.S. means that we in the first quarter this year reached the highest level in 6 quarters. Gross margin continued to show improvement with favorable effect from product mix, with strong growth in the antibiotic-eluting products, CERAMENT G and V, but also from the improvement in U.S.The implemented cost control measures continued to follow plan and show that we can focus and allocate a move to commercial acceleration, and more data to come on the next slide. BONESUPPORT remains funded to realize its commercial strategy and to reach profitability and positive cash flow.Next slide, please. Total expenses in the quarter is up with SEK 9 million compared to the same period last year as a result of a commercial investment initiated in 2018 and with selling expenses up with SEK 13 million. R&D is remaining on a stable level and showing execution within our clinical and research activities. And administrative expenses is stabilizing on a lower level the latest 2 quarters, mainly as an effect of general cost savings and lower spend on consultants as well as lower costs for stock and [ order ] programs.And with this, I hand over back to Emil.
Thank you, HĂĄkan. So if I could ask the operator, please, to take us to Slide 15. This is my summarizing slide. Thank you. Over the last 12 months, we have undertaken several important strategic initiatives to enable and accelerate the market penetration of our products in both the U.S. and the E.U.We have established a new foundation addition, a road map for the company by delivering a clear strategy that defines priorities as well as the journey ahead. We have done what we said we would do, and the results are confirming that we are on the right path. The implemented changes have, above all, driven commercial discipline and commercial decisiveness.For the rest of the year, we expect an increasing trend quarter-by-quarter in the E.U. and in the U.S., which will lead to a significant uplift in sales for 2019. This growth is built on several pillars. With the new U.S. commercial platform, we're able to go after the full potential of CERAMENT and our market access is improving every day. In the quarter, we were very pleased to secure additional GPO agreements and we expect more to come.In Europe, our expanded sales organization will continue to grow sales by a combination of better geographic reach and increased penetration of the important indications, such as trauma. A strong sales drive in the U.S. is complementary product launches, and this quarter we launched BONIFY. This will show effect as well for the full year. And with strong clinical evidence, we believe that we have the key to transform the treatment standard for the 650,000 procedures per year addressing insufficient bone healing. The unique histology study published in this quarter is an important part of the clinical evidence that we are building. These results are supporting our quest and are paving the way for future market penetration.In our mission to transform the treatment standard, our antibiotic-eluting products play a key role. We have increased the growth continuously, reaching an impressive 54% in the latest quarter. All in all, I believe that we are well positioned to have a strong 2019. Beyond that, we have high confidence in our corporate target of an annual growth of 40%. We are funded to reach profitability and I'm confident that we can deliver significant shareholder value on the journey ahead.Slide 16, please. On this slide, you see the updated calendar of value-generating milestones, many of which I have mentioned in this presentation. This concludes my presentation. Thank you very much. And I would now like to open up for questions.
[Operator Instructions] You have the first question from Erik Cassel from ABG.
This is Erik Cassel. So my first question, you presented BONIFY in March. When are we going to start seeing sales contribution from the product?
Yes. Thanks, Erik. Thanks for the question. We're very excited about the BONIFY launch that took place on the big American Academy of Orthopaedic Surgeons, which this year was held in Las Vegas and had about 18,000 participants. We had a lot of traffic in the booth and people were excited to see this high-quality DBM product. So what happens now is that we put it in the hands of our strong sales teams and they are out promoting it. It will take a couple of months to get the, say, on the right contract and to add this to the GPOs that we're already on. So we should start to see some first sales, I would believe, around summertime and then accelerating throughout the end of the year.
Very helpful. And regarding the new GPO contract you signed during the quarter, could you add some color on how it impacted sales in Q1 and expectations going forward?
Absolutely. So all the way since the foundation, Erik, going live, which was in October 23, we have continuously won GPO contracts. And a few of these are really prestige contracts like the HCA that we announced in the previous quarter call and now the Ascension. When you win one of these contracts, there is an administration period and there is transformation period -- transition period rather. So I expect sales from Ascension to be visible maybe end of quarter 2, at a minimum, beginning of quarter 3. But that's the lead time that we usually see with these contracts.
Next question comes from Jonas Peciulis from Edison Research.
Congratulations with a good pickup in the U.S. Could you please provide a -- or give us a quick update on the FORTIFY trial? How is the enrollment ongoing? And I think the data was expected next year, if I'm correct.
Yes, thank you. So yes, for everyone's benefit, the FORTIFY trial was initiated 2017 with the ambition of providing data that will give approval of CERAMENT G, which is CERAMENT together with gentamicin in the U.S. And it was set out that enrollment would finish at the end of this year, and we're sticking to that plan. Recruitment is going well, is going according to plan. Some months better, some months worse, but overall, we're still going to plan. And we expect the data from the trial to be available in 2020 and that's also when we expect the submission to take place for FDA.
Okay, great. A follow-up question, probably a high-level question. Presuming that all will go well with this trial and data and the FDA interactions, what are your sort of plans or current thinking how to introduce this product to U.S. market because this will be a new product in the U.S. market, right? So do you think it will be as straightforward as giving your current distributors the new G and V CERAMENT? Or do you plan any more like specialized marketing activities? Just wondering what is your current thinking about how to introduce this product.
Yes. I was in the U.S., I was in Las Vegas 2 months ago for the big AAOS congress, and I must say there's an enormous interest for CERAMENT G in the U.S. from basically all available big orthopedic companies. And I expect that, that excitement comes from 2 things: one is the very strong sales success that we're seeing in Europe; and secondly, the government and health care providers' efforts in the U.S. to address antibiotic resistancy and the strong preference for treatment with local antibiotics. So this is, of course, also very encouraging for us in terms of looking at the market potential.The current plan is to provide CERAMENT G to the network of independent distributors that we have built. And that's why it was important to cancel with Zimmer Biomet to get this network established well in time before CERAMENT G, so that we have existing relationships and that we have existing account base to roll this very important product out.
Okay. Just a quick question on the CERTiFy trial data. If I may have missed, will you publish a peer-reviewed article of the data anytime soon?
Yes. Apologies, I should have mentioned that. The CERTiFy data is, of course, a very important piece of information and it has taken a little bit longer than we anticipated to get all the different centers, the 20 centers that have participated, 20 trauma centers in Germany, to get everyone to agree what should -- how the report should be written. But the manuscript is now submitted to one of the most prestigious orthopedic magazines, and we're expecting the publication to come early quarter 3.
Okay. That's great. Last one from me, also a question a bit more in general. Before the strategic shift to your own distribution network in U.S., and you mentioned that you had only partial access, market access to -- in the U.S. and I think your thinking was that was the only -- of course you could access perhaps a wider coverage. So is this happening? I know that you're mentioning that you have seen sort of incoming orders from new customers and old customers, but sort of just probably a different question about the same. So is the market access -- has the market improved compared to what's in the coverage?
Yes, thank you for that question, Jonas. I think we -- time will tell. But what I see so far, quarter 1 was strong. It has started off in a nice way and we have secured hospitals and contracts where we never before had access during Zimmer Biomet. So if I give a short answer to your question, is the strategy working? Very well, indeed.
Next question comes from Niklas Elmhammer from Carlsquare.
This is Niklas from Carlsquare, formerly Jarl Securities. Congratulations on the return to growth. I was wondering, it was relatively sort of weak both in the sales for BVF in Europe & Rest of World, at the same time you're saying that the CERTiFy results are -- they increased traction. So could you be -- maybe elaborate a bit on that? Is the -- are the CERTiFy results pushing sales finally in -- for the antibiotic-eluting products or...
Yes. Okay, thank you. Excellent question, Niklas, and I'll do my best to answer it. The CERTiFy study is a trauma study done on BVF. And what we're out is promoting that CERAMENT is now equally good alternative or equivalent to autograft. What we see in the clinical practice is that most of the surgeons have a preference to use the antibiotic product. Even if there is no sign of infection, they take it as a very convenient and cheap insurance for preventing and avoiding getting an infection. And since -- the treatment with CERAMENT G and V, local antibiotics, you get very high doses locally in the tissue but a very, very low systemic influence. It's a perfectly safe modality to use, and that's why these surgeons feel extremely confident with using this therapy. So many of the orthopedic surgeons that used to use CERAMENT BVF are switching to either CERAMENT G or CERAMENT V because they feel that it's such a unique value proposition in either eradicating possible infection or preventing infection. And it doesn't with come with any side effects, they are very generous to use it.
Okay, I understand. Also regarding the GPO contracting, you mentioned this new contract with Ascension. This is an organization that covers sort of its own set of customers as well? I mean those kind of customers who you reached with Zimmer Biomet or is this entirely new customers?
Yes, that is correct. Ascension, these hospitals we had not access to before. So it's one of these wins that we're very happy with. Ascension also has -- they're not so many hospitals, 150 only approximately, but they have a very strong compliance and very strong treatment protocols. So when they decide on a treatment modality, you have all the hospitals following. And if we wouldn't have gone -- you never say never, but most likely if we wouldn't have gone independent, Ascension would still not be customers of ours and they would use something else. And thanks to now setting up our own organization with a strong group of people working specifically on market access, we have been able to secure this new customer.
Okay. Good. One last question on expenses, they are increasing at quite a modest pace given the sequential growth. Is there anything that's special in the quarter? Or is this due to your cost-reduction efforts? And how -- could you just give us an update we could going forward, giving -- maybe increasing sales activities or R&D?
Thank you, Niklas. It's HĂĄkan here. I think that the slide that we presented showing the quarters all the way from 2017 up to the first quarter this year shows or give you some guidance on your question why you're seeing that research and development is maintained on a stable level, why you see the investments done in selling -- sales and marketing. That is gradually leveling out, given what was done in 2018. And you also see administrative expenses giving -- staying on quite a stable level for the last 2 quarters.
I think what HĂĄkan mentioned also before in his presentation is we have said goodbye to quite a lot of consultants which we felt didn't add any value because we could do better ourselves.
Next question comes from Lala Gregorek from Trinity Delta.
I have a handful of questions, basically about growth potential. There were a few comments made through the presentation where you're sort of hinting quite subtly about the various growth drivers coming through. First of all, to sort of follow back to Erik's question about GPO and the progress in the sort of lag lead time before we really start seeing sales coming through there. I wanted to ask, with respect to the programs that you currently have, are there any sort of significant orthopedic centers that are included within those because obviously that has -- that may have an impact on your sort of KOL outreach work there. Secondly, going into Europe, you'd mentioned that G and V sales have mainly been with existing prescribers. And I was wondering what the sort of traction was like with getting into the new areas. And then thirdly, with respect to the innovation pipeline, BONIFY all sounds very, very positive, but that's obviously your first new product. What sort of time frames might we see for additional products coming through [ NTB ] or even the Collagen Matrix Inc. deal that you have?
Thank you, Lala. Very insightful questions. And yes, there were a handful of them and I will do my very best to respond to them. The first one was regarding the growth potential and matching this to the GPOs. So what I should maybe clarify is that if we look at sales for the first quarter and also sales in the fourth quarter of last year, sales is coming both from GPO contracts and outside of GPO contracts. So I would say that GPO contracts covers about 70% of the U.S. market and about 30% of the U.S. market is outside of GPO. And then there are GPOs that are very strict and the member hospitals must follow a very strict protocol, like Ascension. Then there are others where it's more down to the individual physician and individual hospital. So they have different shapes and forms.The -- one of the absolutely biggest contracts in the U.S. is the HealthTrust. The HealthTrust GPO is a bit of a holy grail. And of course, we're working the best we can to possibly secure CERAMENT on this contract one day. To the composition of their hospitals, I couldn't reply with a specific number, but I can say that there are a few south and southeast major orthopedic clinics that are part of HCA and Ascension, where we previously didn't have presence. So this gives us a great hunting license, I would say. This gives us access to our salespeople, and we do believe that this will be highly visible in quarter 3 results.The next question was on Europe. And basically what you're asking is why are we telling that sales growth comes from existing customers. We do that because we see that once a clinic -- once an orthopedic clinic in Europe has started to use CERAMENT, more and more colleagues of the original surgeons who tried the product are then coming on board. This is, for us, very positive because almost every orthopedic surgeon that tries CERAMENT becomes a positive ambassador to talk to their colleagues about the product and to publish paper and eventually what we see is that a big part of the whole clinic eventually is using the product.We have been limited, in example, Germany, before we had only 4 salespeople. And since our salespeople many times participate in the surgery room, the -- our sales resource was a scarce factor, was a limiting factor. The new salespeople we hired came on board end of last year and beginning of this year. And they're starting now to also be very comfortable with our customers, to build relationships and to penetrate geographical areas where we haven't been before. So the way to read this is that for the first quarter of this year, most of the sales growth came from existing clinics where the popularity of CERAMENT makes it used more broadly. And we haven't yet seen so much sales coming out of totally new customers. But that is what we expect for later this year as a result of the new salespeople ramping up in capacity. In terms of innovation, we had the BONIFY launch and we have more to come. But also given, let's say, the competitive environment, we prefer actually not to give any timings on when those products would be available to market. But the collaboration with Collagen Matrix Inc. and MTF is continuing, as well as our own development and internal portfolio.
Next question comes from Franc Gregori from Trinity Delta.
I've been sat here listening and it's become increasingly clear that it's the quality of the clinical data that really differentiates you from other competitors out there. And that means I'm going to ask a longer-term question. We still have CERTiFy. We still have these studies to come, and that's going to be good. But if we look beyond that, what plans do you have for other clinical data? And I'm guessing that trauma would lend itself to have some clinical study and some clinical data longer term.
Yes. Thank you, Franc, absolutely. You're totally right that in an industry, I would say, where competition is laser sharp, of course we are differentiating ourselves by not only having unique benefits for the product but also having the ability to show that it's validated by strong significant clinical data. So this will continue. What we announced in this quarter, which is new, is the SOLARIO study. And this is a massive study with -- which will have 500 patients included. Needless to say, these studies are quite expensive. Both the SOLARIO study, the CERTiFy study and the FORTIFY study are enormously expensive, and I must say I'm grateful to be part of a company that is making visible choices to invest in their future so much by these studies. Those are the 3 big ones. And unfortunately, I'm not able to disclose other studies that we are planning or discussing with collaboration partners. Right now, I think we are fully busy with taking care of these 3 studies. And we should be aware that once a study is published, like CERTiFy will be published in quarter 3, it will probably take many months before our salespeople have been out in all geographies to speak about it and before all the magazine has been distributed. So it's something that we will work on for many years to come, the results on these studies. And both FORTIFY and CERTiFy are, indeed, trauma studies as you mentioned.
We have no further questions for the moment. [Operator Instructions] There are no further questions at this time. Please go ahead, speakers.
Well, thank you, everyone, for joining our quarterly call this morning. Very appreciated. Thank you for your very insightful questions. We're very happy to continue the dialogue with you. And I hope that you, just as me and HĂĄkan now, look forward to this very exciting times that BONESUPPORT is experiencing. Thank you very much, and have a good day.