Opsens Inc. (OTCQX:OPSSF) Q2 2022 Earnings Conference Call April 13, 2022 11:00 AM ET
Company Participants
Robert Blum – Lytham Partners, IR
Louis Laflamme – President and CEO
Robin Villeneuve – Chief Financial Officer
Conference Call Participants
Rahul Sarugaser – Raymond James
Justin Keywood – Stifel GMP
Scott McAuley – Paradigm Capital
Nicholas Cortellucci – MPartners
Sahil Dhingra – RBC Capital Markets
Operator
Good day. And welcome to the OpSens Reports Second Quarter of Fiscal Year 2022 Financial Results. All participants will be in listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions]
Please note, this event is being recorded. I would now like to turn the conference over to Robert Blum with Lytham Partners.
Robert Blum
All right. Good morning. Thank you, Scott. Good morning, everyone, and thank you all for joining us today for the OpSens second quarter fiscal year 2022 conference call for the period ending February 28, 2022.
With us on the call represent the company today are Louis Laflamme, OpSens President and Chief Executive Officer; and Robin Villeneuve, OpSens Chief Financial Officer. At the conclusion of today’s prepared remarks, we will open the call for a question-and-answer session.
Before we begin with prepared remarks just couple of comments. Today’s call will contain forward-looking statements that are based on current assumptions and subject to risks and uncertainties that could cause actual results to differ materially from those projected and the company undertakes no obligation to update these statements, except as required by law.
Information about these risks and uncertainties are included in the company’s filings, as well as periodic filings with regulators in Canada and the United States, which you can find on SEDAR and the OpSens website.
Today’s discussion will also include adjusted financial measures, which are non-IFRS measures. These should be considered as a supplement to and not a substitute for IFRS financial measures.
Finally, today’s event is being recorded and will be available for replay through both the webcast and conference call dial-in information provided in the press release.
With that said, let me turn the call over to Louis Laflamme, President and Chief Executive Officer for OpSens. Louis, please proceed.
Louis Laflamme
Thank you, Robert, and good morning to all of you. We are excited to speak with you today again to discuss the developments within the business. Let me also take a minute to greet the French speaking audience. [Foreign Language]
Similar to last quarter, the challenges brought on by the Omicron variant continue to impact sales in the second quarter as procedure volumes decrease and we encountered supply chain disruption that limited our ability to ship certain orders.
Fortunately, with the Omicron variant subsiding in North America, we have seen an increase in activity recently and are expecting an increase in revenue in the third quarter compared to the most recent second quarter. This is consistent with what I mentioned last quarter, as we remain very optimistic that the second half of fiscal year 2022 will show resumption in revenue growth.
I will expand more up on the growth trends we are seeing as we now set about half way through the third quarter, as well as the initiatives we are taking to further expand and then our sales organization to now take advantage of these new trends in the market. Bottomline, we see continued commercial adoption for our products, despite the slowdown in overall hospital related procedures and supply chain challenges in the last few quarters.
On the development side of our business, we remain equally optimistic to the prospects we communicated last quarter as we remain on track for an anticipated approval in mid-2022 for Canada and the second half of 2022 in the U.S. for our next-generation medical guidewire, which we are calling SavvyWire.
As a reminder, in November last year, we completed the 20-patient in-man clinical safety and efficacy study utilizing the SavvyWire, with all patients successfully treated without any adverse effects related to the product. We then submitted our clinical package for 510(k) clearance to the U.S. FDA approval without Canada and submitted more recently for CE Mark as well. We are responding to what we believe are normal courses of questions at this time and did not foresee any change to our estimated timeline for approval.
These submissions were clearly significant milestone for the team here at Opsens, but the ultimate goal is clearance and commercialization. I will expand a bit more on this in a moment, as we feel we are now closer than ever to entering the massive and rapidly growing TAVR market with what we believe is the key innovative product for TAVR procedure evolution, which will drive future revenue and strategic value for Opsens.
Another key development was the signing of our four-year extension of the supply agreement we have with Abiomed to continue supplying OpSens’ Sensor Technology for Abiomed’s Impella heart pump through April 2028. We are extremely pleased by this development as it validates our fiber optic sensor technology and continues to provide us with a strong and predictable base of revenue and growth.
So with those three high level points, let’s jump into a few more specifics. Starting with the OptoWire. As you saw in the press release, sales within our coronary artery disease business or what we refer to as FFR and dPR were $4.6 million during the second quarter, compared to $6.1 million in the year ago quarter. The results were impacted by supply chain disruption and by the lower number of procedures in the hospitals due to the Omicron variant wave, which hit hard in December and ran through mid-February. However, as I mentioned a moment ago, the tide appears to have turn and we have seen an increase in activity recently, which should bode well for the current third quarter and the second half of the year.
As we look at the sales around the world, there were certainly bright spots, as we were able to mitigate the impact in a few key areas. In particular, EMEA was up 9% compared to the second quarter of a year ago and up 13% sequentially. As you recall, the variant rolled through this region earlier than in others, which helped, but more importantly, the team has done a tremendous job of improving the performance of distributors in the region to enhance educational activities. I believe the work that has been accomplished in the last few months should bode well for continued improvement in this region.
In Canada, similar to what I mentioned last quarter, was a variant impacted procedure volumes. Those impacts were offset by a multiyear contract we received where we were selected as the main coronary pressure guidewire for the eastern part of the province of Quebec. This has been a nice growth driver for us and with the hopeful return of normalized procedure volume should only elevate our performance in Canada.
The impact was most felt in the U.S. and Japan. In Japan, the impact was primarily due to supply chain disruption that prohibited our ability to obtain certain components for deliveries in Japan. However, we expect reversals of these trends in Q3 and into Q4 to finish the year on a strong note.
Taking a step back, as you may recall, when the pandemic first hit, we reduce the number of employees dedicated to business development in the field, particularly in the United States, as access to cath labs and hospital were restricted by sanitary measures.
We have remained cautious since that time and have managed our business prudently. While we could have ramped up the hiring of additional salespeople earlier, we wanted to try and see the proverbial light at the end of the tunnel before jumping all the way in.
Well, we feel the time is right now to launch a more aggressive expansion of our sales organization. As such, we have started accelerating hiring for these positions in the past few weeks to intensify our sales force in North America.
Additionally, we brought on Board a new Chief Commercial Officer, Brad Davis to lead our global commercialization strategy, and more specifically, expand our U.S. commercials operation.
Brad was formerly Vice President, Global Marketing and Health Care Economics & Reimbursement at Cardiovascular Systems or CSI. During his nearly seven-year tenure at CSI, the company tripled coronary atherectomy revenue and grew peripheral atherectomy revenue faster than the market to achieve U.S. atherectomy market share leadership, while expanding into new product categories.
Prior to CSI, Brad held numerous commercial roles of increasing responsibility at Guidant and Boston Scientific. I believe Brad’s 21 years of sales, marketing and strategy experience will prove to be instrumental in growing our commercial OptoWire operation and even more so as we look to commercialize our SavvyWire later this year.
So with Brad have held leadership of our sales team, the hiring of a new sales professionals in the U.S. and with a hopeful return of more normalized procedure volumes, I believe we are well-positioned to have a strong second half of fiscal 2022.
One final point I will make on our commercialization efforts is that we continue to make progress with our GPO relationships. We are making good progress with the two current GPO we have signed thus far and believe we are making strong progress in adding to this going forward. I hope to have more news for you on this shortly.
Transitioning to our business partnerships for a moment where several companies are integrating Opsens sensors into their products used in medical application as I mentioned at the beginning. I am excited to have signed a four-year extension of our agreements with Abiomed.
Overall, sales to OEM were $2.4 million in Q2 2022, compared to $1.8 million in Q2 2021, with the vast majority of those sales going to Abiomed. We are pleased to continue this long-term mutually beneficial relationship and look forward to many successful years of working together.
Let’s us now transition to our Industrial segment, which leverage our fiber optic sensing technology and knowledge by offering key solutions in optical temperature, pressure, strain and other critical parameters for various industries, including aerospace, nuclear and power electronics.
For the quarter revenue was approximately $1 million, compared to $979,000 in the year ago quarter. Looking forward, the long-term opportunity in this segment continues to get more attractive, as we are working on an increasing number of potentially significant projects, where Opsens proprietary fiber optic sensing components could be integrated into these critical projects, including the international EUREKA network project, the International Thermonuclear Experimental Reactor or ITER project, fuel monitoring for aerospace and many others. The team at Opsens solution continues to do a great job and I look forward to the continued success in leveraging our fiber optic sensing technology to a wide variety of commercial applications.
With that overview on our commercial base operation, let’s jump into our lead development program for TAVR. During the second quarter, we made substantial progress, completing the 20 patients in-man clinical study, utilizing the SavvyWire in November and soon after submitting our package for U.S., Canada and EMEA clearances. Our team is diligently addressing this round of typical questions from the regulatory authorities. We believe we remain on track for approval later this year.
To those newer to the company, the SavvyWire is our new intelligent pre-shaped structural guidewire with integrated pressure monitoring aimed at improving procedural efficiency and clinical outcomes by allowing multiple steps over the same device without exchange. The device has been designed to support the minimalist TAVR approach, which has been growing among structural heart physicians.
With the SavvyWire, physicians can expect to diagnose and implant the valve over the same device, while getting continuous and accurate hemodynamic measurements. The introduction of this novel and advanced guidewire that adds the ability to both deliver the valve, while allowing continues hemodynamic pressure measurement during the procedure is considered to be a significant benefit in the medical community, especially given the rapid growth in TAVR procedures.
The press and medical buzz around the guidewire have been tremendous, which we believe augurs well for our commercialization efforts. As a reminder, recently at a few high profile industry events positive data was presented at TCT 2021 in November, where SavvyWire was featured in four presentation by leading medical specialists, including Dr. Genereux, who presented for the first time clinical data validating the robustness of the OpSens’ pressure measurement in assessing pressure gradient before and after TAVR procedure compared to the different diagnostic modalities.
Additionally, world renowned cardiologist including Dr. Rodes-Cabau at the Quebec Heart and Lung Institute, Dr. Thomas Modine from CHU Bordeaux from France, Dr. Hemal Gada from UPMM — UPMC Pinnacle and Dr. Réda Ibrahim from Montreal Heart Institute, all discussed the benefit of the SavvyWire.
While we await the agency’s clearance, we are advancing commercial preparations to ensure a successful product launch. This includes ramping up our manufacturing capabilities and developing a strong sales and marketing strategy. Brad Davis experience here has been tremendous. We look forward to communicating more with you in the future on the status of the FDA, Health Canada and EMEA clearances for the SavvyWire.
Before I turn it over to Robin for a more detailed review of the financial, let me quickly summarize. While the pandemic has had many turns and bumps along the way, which have impacted our business, we are seeing increased volumes over the past month or so, which we believe bodes well for the back half of the year.
The supply chain disruption we encountered which impacted our sales primarily to Japan appeared to be resolved and we are expecting normalize shipments in the upcoming quarters. As a result, we have ramped up our sales and marketing activities, and brought on Board key individuals to help lead the commercialization, not just about OptoWire, but SavvyWire as well. Again, we think Q3 is setting up to find growth again.
Our Industrials team continues to do a great job as we gear up for some exciting projects in the coming years and with the signing of a four-year extension with Abiomed the stability of that base of business remains in place for many more years.
And with TAVR study completed, our 510(k) submission with the FDA and the filing with Health Canada, we are closer than ever to commercializing our disruptive new SavvyWire technology later this year. We feel confident to sign at least one additional GPO contracts in the coming weeks.
And finally, what I think is always something important to point out, our balance sheet remains strong, allowing us to execute on our strategies to drive value creation going forward. As always, I want to thank all of our employees for their hard work and dedication, we have accomplished several important milestones and development and we see many more opportunities ahead.
Let me now turn the call over to Robin for a further review of the financial results. Robin?
Robin Villeneuve
Thank you, Louis, and thanks to everyone joining us on the call. As Louis hit on a few of these items, I will try to add additional details where I can. The company reported sales of $8.1 million during the second quarter. This was broken down as $4.6 million in our coronary artery disease lines of business, $2.4 million in optical medical systems, which is mainly our agreement with Abiomed for integration of our pressure sensor into their Impella pump, and $1 million in our Industrial segment.
When you look at gross margins, margins were stable at 51.5% in 2022, compared to 51.7% last year. We continue to believe we will see year-over-year increase in gross margin percentage due to higher sales volume and the related economies of scale combined with enhanced productivity.
From an operating expenses standpoint, as planned, overall operating expenses increased by $2.1 million during the second quarter of fiscal 2022 compared to the second quarter of fiscal 2021. The increase is largely explained by our investments in sales and marketing, as we are ramping up our sales efforts to continue growing market shares in the U.S. along with increases in our R&D and general and administrative costs pertaining to higher headcount stock options expensive and professional fees.
As we explained, we are making additional investments in sales and marketing, and research and development over the coming quarters to capitalize on the opportu0nities to accelerate growth of our OptoWire and to prepare the commercialization of our SavvyWire.
EBITDA which we defined as net income less plus tax, financial expenses, depreciation of PP&E and right-of-use-assets, amortization of intangible assets and stock-based compensation costs was negative $1.4 million in the second quarter of 2022, compared to a positive $0.9 million in the second quarter of 2021. The decrease is mainly due to higher operating expenses of $2.1 million, as previously explained.
Looking at net income, we are reporting a net loss of $2.4 million in the second quarter of 2022, compared with a net income of $41,000 in the year ago second quarter. That net loss is due to our investments to capitalize on business opportunities with additional spending in sales and marketing, R&D and others, our operating expenses increasing $2.1 million, as I mentioned earlier.
Finally, on the balance sheet, we ended February 28, 2022, with $30.9 million in cash and cash equivalents. The company prepaid the entire balance of the term loan in the amount of $5.8 million in September 2021.
With that, I will turn the call over to Louis.
Louis Laflamme
Thank you, Robin. Thank you to all our investors for their continued interest and support of Opsens. We are working hard every day to capitalize on the opportunities ahead of us to position Opsens for long-term success.
Operator, let me now turn the call over to any questions.
Question-and-Answer Session
Operator
[Operator Instructions] Our first question comes from Rahul Sarugaser from Raymond James. Please go ahead.
Rahul Sarugaser
Thank you. Good morning, Louis, Robin. Thanks for taking my questions as always. So my first question is, of course, we recognize that this quarter was squarely set during the Omicron spike. So we’ve seen the softness across the sector. I guess my question really is, as you are now ramping your sales and marketing organization for TAVR, which we estimate conservatively with assuming approvals with the launched in early next year. Given that we have the remainder of 2022, how do you see the strengthened sales and marketing team affecting your legacy sales of OptoWire for the remainder of the year?
Louis Laflamme
Yeah. Well, good morning. First, thanks a lot for the question, Rahul. And again, I mean, we see a lot of potential with OptoWire — with the OptoWire. So, of course, as you know, SavvyWire is important for our strategy to be more relevant for doctors, hospital and GPOs and having a second product in our portfolio.
But today, we feel that with the volumes that are coming back to a more normal situation in hospitals, there is a lot of opportunities for us to grow in all of our markets with additional resources.
And in particular in U.S. we see potential, I mean, new hirings are having right now, I would say, quicker impact than what we had in the past. So we are confident that and already we saw this in Q3. We can show better performance in U.S., obviously, for EMEA and Canada remains strong and we are expecting a rebound in Japan, where, as you saw, it was from a revenue standpoint a difficult second quarter.
So, overall, to your question, we think that, I mean, the investment we are doing today is really strategic, because there is opportunities to capture much more market share in U.S. and all over the world.
Rahul Sarugaser
Perfect. Thanks. Thanks for color, Louis. So my second question is now focusing specifically on the clinical timelines associated with the TAVR application. You had said that, you don’t expect any changes, so what we had originally anticipated based on your previous comments that how Canada late Q — late calendar Q2, FDA late a calendar Q3, are these timelines in fact what you’re looking at is there — is a possibility for that to be flipped given sort of the way the FDA has been moving recently with medical devices?
Louis Laflamme
I would say, it’s always a challenge to speculate on this, but what we can see that is really factual is that, communications have been really positive, really fair, quite practical from all those agencies. So we feel that we are — we have been making good progress and doing the demonstration that [Technical Difficulty]
Operator
Our next question comes from Justin Keywood from Stifel GMP. Please go ahead
Louis Laflamme
I was not finished with the answer.
Operator
Oh! Okay.
Louis Laflamme
But from a Health Canada standpoint, they have done a lot of work when we did the request to perform the first in-man. So, because of that, we think they are already well advanced and validating the safety of the SavvyWire, so back end of first half of calendar year 2022 make sense. And in U.S. there was a good interactions and we don’t change our timeline, where we’ve been talking about September, October timeframe and we are still going after this. So I’m now ready to receive the question from Justin, assuming that Rahul has completed his question.
Operator
Okay. The next question is from Justin Keywood from Stifel GMP. Please go ahead.
Justin Keywood
Hi. Good morning. Thanks for taking my call. On the comments of the Omicron variant impacting procedures, but also the comment on supply chain disruptions leading to some software sales. How would you bucket ties those two headwinds as far as the impact? Are they equally impact of or is one more than the other?
Louis Laflamme
I would think that they were both equally. In terms of dollar value the impact was probably similar for both. The — we had customers in North America where their monthly volume went from, let’s say, something like 60 or 70 units a month to 20 during this period of Omicron spike and not because patient were not willing to get at the hospital, it wasn’t hard, because the staff of the hospital were sick. So there was — it was not, obviously, in our hospital like this, but there was a good amount of volume that has been impacted because of this.
And in Japan, obviously, the supply disruption had an impact that was more than $1.3 million. So in a normal situation, we think we would have achieved similar growth than what we had in the past and are looking forward to find the growth again in Q3 and Q4.
Justin Keywood
That’s helpful. I think it’s well understood the impact from the variants and we’ve heard this from a number of customers selling or companies selling into the hospital, but on the supply chain impact, what gives you confidence that this will normalize, as we’re hearing that, there could be some constraints going through for the rest of the year?
Louis Laflamme
Well, there — it has been from our standpoint everything was much closer to normal in March, and so far, April is going fine. So I don’t expect, I don’t foresee any additional significant issues like we had. There is still different normal thing that we have to work out. But similar to what we had in unusual operations. So we think there was a specific situation that happened during Q2, but we are confident that the supply chain that we have is really strong to meet the customer’s demand.
Justin Keywood
Okay. Understood. And then on the OpEx, understood that there’s a increased sales hires ahead of the potential SavvyWire approval. Is this level of OpEx, is that what we should expect in the near-term or is there additional investments to be made?
Louis Laflamme
When we look at the third quarter, you can expect to see administration expenses being down, just because there was a certain stock option, which is a non-cash expense impact in Q2, which we won’t have in Q3.
For sales and marketing, you can expect to see an increase by between $500,000 to $750,000 and this is a combination of hiring of new human resources and also, I mean, the — we will have the EuroPCR event, which is the biggest cardiovascular conference in Europe.
So we’ll have this during the month of May and Opsens is going to invest a good amount of resources, because, I mean, there is some — you will have some presentation about the SavvyWire concept, you will also have some the OptoWire will be well displayed there and we feel it’s a good investment to do because even if we have been doing great in Europe, there is opportunities to do much better since we think the OptoWire is clearly the best special guidewire for coronary artery disease.
So you can expect to see us further increase in sales and marketing. And from R&D standpoint, it will be similar. We have a great team in place that is going after short-term innovations that are well aware by the market, but also working on some long-term project that will be we think disruptive and highly value creators for the company.
Justin Keywood
Okay. Thank you for taking my questions.
Louis Laflamme
Real pleasure.
Operator
Our next question comes from Scott McAuley from Paradigm Capital. Please go ahead.
Scott McAuley
Good morning, gentlemen. Thanks for taking the question. Just to briefly kind of circle back on the supply chain, just in terms of your availability of materials and also impact on inflation, either on kind of your costs of goods and/or shipping things like that. Are you seeing any impact from these? Are you expecting any kind of on the balance of the year or are you pretty confident in the process moving forward and your costs moving forward?
Louis Laflamme
I would say the inflation did not have an impact substantially on our cost. We have seen, okay, different, no small increases, but I would say that, the biggest driver that we have for the cost of goods sold in our case is the yield that we get into production. So — and we are working on this, doing multiple actions to improve our performance.
So on the inflation, I would say, it seems to be under control. We have a good partnership with our suppliers. So it’s going well on that side. The availability of raw material is the element that has been impacting the Q2 results. But, again, we feel that there was a punctual event and so far Q3 has been going well.
Scott McAuley
That’s great. Thanks for that detail. And switching over to the SavvyWire, obviously, kind of working to lay the groundwork for that commercialization hopefully upon approval? It kind of how are you expecting those sales to ramp, like, are you thinking day one on FDA approval, you’re hoping to have some customers who will be purchasing and using this — the product? Are you kind of expecting that to take kind of a few quarters to materially impact kind of your revenues?
Louis Laflamme
I would say the, I’m sure we already have, I mean, interest from people that would like to use the SavvyWire will still be — we have to grow in a very systematic manner there. From a regulatory standpoint, it’s important to do a limited market release. We also think that it’s really useful to fine tune out all the marketing strategy, everything in the cath lab to make sure that it’s going well. So you can expect that it will take few quarters before having a really massive revenues coming from the SavvyWire. This being said, we want to grow as fast as we can.
So to respond to your question is that, of course, we are not going to sell through all hospital that are making the request on day one, we’ll go gradually with few centers. But the plan is still to be fairly aggressive.
I mean, we are putting in place right now a team to capitalize on these very significant commercial opportunities in front of us. So we’ll try to go as fast as possible, but you need to plan for a certain number of months before getting substantial revenues.
Scott McAuley
Absolutely. That’s great. And just lastly for me, I think, you’d mentioned briefly on the previous call around publication of the SavvyWire data that you have today. Is that still something you’re planning for and kind of the near-term or is that something you’re hoping y, if and when it’s approved, to have it published around then to kind of bolster that sales and marketing efforts?
Louis Laflamme
Yeah. We are confident that before the next earnings call, we should have a couple of papers that will be published on the SavvyWire. Again, the interest from the community around this concept is really good.
Scott McAuley
That’s great. That’s all my questions for now. Thanks a lot, guys.
Louis Laflamme
Thank you.
Operator
[Operator Instructions] Our next question comes from Nicholas Cortellucci from MPartners. Please go ahead.
Nicholas Cortellucci
Hey, Louis, Robin. How’s going on?
Louis Laflamme
Good morning, Nick. It’s going well and you?
Nicholas Cortellucci
Great. My first question was that, I think, the last normalized environment we kind of saw was Q3 of last year, where you guys posted some really solid growth, $9.2 million revenues, 59% gross margin. Do you think that quarter was a good analogy for what we’re going to see through the second half of this year?
Louis Laflamme
I mean, let’s say, I’ll take the — with the current demand that we get from our customers, if we would not have the supply disruption in Q2, would have done better than Q3. So I think Q3 is an indication where — I mean, Q3 of last year is an indication where there is good demand for the OptoWire. We think we have further developed our sales channels and the install base of the monitor. So certainly will trend toward that direction.
Nicholas Cortellucci
Perfect. Okay. And then my other question was about the GPO contracts. When do you think we’re going to start to see the impact of those on the topline?
Louis Laflamme
Yeah. Well, again, the volume of procedures were down in U.S. during the Q2 2022. So obviously, you don’t perceive necessarily the impact of GPOs. But we think they will have an impact in Q3 and we are really positive about the relationships we are developing with those organizations.
Nicholas Cortellucci
Perfect. That makes sense. Thanks for answering my question guys.
Louis Laflamme
Thank you, Nick.
Operator
Our next question comes from Sahil Dhingra from RBC Capital Markets. Please go ahead.
Sahil Dhingra
Hi. This is Sahil for Doug Miehm. Thank you for taking my questions.
Louis Laflamme
Yeah.
Sahil Dhingra
My first one is on Japan. So you have said that supply chain disruption is normalized now. But the COVID cases there are although down from the peak are still elevated versus last year. So do you still think the revenues would be — would bounce back to normal levels?
Louis Laflamme
Yeah. We are confident that, I mean, the OptoWire users continued in Japan even if we don’t see this in our revenues. So the partner there use the some of the inventory, really they have to make sure that the customers were not impacted by this situation and in Japan, that’s a country where there is a lot of interest around FFR and we are confident that the demand will be there for the next quarters and the future years.
Sahil Dhingra
Okay. Thank you. That is helpful. And in terms of the recovery in procedure volumes in the month of March, can you quantify that? Is it back to pre-pandemic levels?
Louis Laflamme
I think it’s not back at 100%, but we certainly saw and different customers rebound for at least 20% of procedures, if you compare that with the Q2 marks.
Sahil Dhingra
Okay. Thank you. And my last question is on the approval timeline in Europe for SavvyWire, by when can we expect that?
Louis Laflamme
On that I would prefer to respond maybe in the next conference call. Right now, I would say, that we think it’s 2022 event, but we have to be [ph] a more precise.
Sahil Dhingra
Okay. Thank you.
Operator
This concludes our question-and-answer session. I would now like to turn the conference back over to management for any closing remarks.
Louis Laflamme
Many thanks to everyone to — for participating on our — on today’s call. We look forward to hopefully speaking with all of you again shortly.
Operator
The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.
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