AngioDynamics Inc. (NASDAQ: ANGO) Q2 2021 earnings call dated Jan. 07, 2021
Corporate Participants:
Jim Clemmer — President and Chief Executive
Stephen A. Trowbridge — Executive Vice President and Chief Financial
Analysts:
Jayson T. Bedford — Raymond James — Analyst
Matthew I. Mishan — KeyBanc Capital Markets — Analyst
Bill J. Plovanic — Canaccord Genuity — Analyst
Presentation:
Operator
Good morning, and welcome to the AngioDynamics Fiscal Year 2021 Second Quarter Earnings Call. [Operator Instructions]
The news release detailing the fiscal 2021 second quarter results crossed the wire earlier this morning and is available on the company’s website. This conference call is also being broadcast live over the Internet at Investors section of the company’s website at www.angiodynamics.com. And the webcast replay of the call will be available at the same site approximately one hour after the end of today’s call.
Before we begin, I would like to caution listeners that during the course of this conference call, the company will make projections or forward-looking statements regarding future events, including statements about expected revenue, adjusted earnings and gross margins for fiscal year 2021. Management encourages you to review the company’s past and future filings with the SEC, including without limitation, the company’s Forms 10-Q and 10-K, which identify specific factors that may cause the actual results or events to differ materially from those described in the forward-looking statements.
The slide package offering insight into the company’s financial results is also available on the Investors section of the company’s website under Events and Presentations. This presentation should be read in conjunction with the press release discussing the company’s operating results and financial performance during this morning’s conference call.
I’d now like to turn the call over to Jim Clemmer, AngioDynamics’ President and Chief Executive Officer. Mr. Clemmer?
Jim Clemmer — President and Chief Executive
Thank you, Rob, and good morning, everyone, and thank you for joining us for AngioDynamics fiscal 2021 second quarter earnings call. Joining me on today’s call is Steve Trowbridge, AngioDynamics, Executive Vice President and the Chief Financial Officer who will provide a detailed analysis of our second quarter financial performance.
I’m very pleased with our second quarter performance. We delivered strong revenue growth while continuing to invest in our key technology platforms; Auryon, AngioVac and NanoKnife, all delivered strong performances during the quarter, resulting in second quarter revenue of $72.8 million, growing 4% year-over-year. Additionally, we continue to balance near-term cash and expense management with strategic investment in our long-term growth initiatives and were pleased to deliver an adjusted EPS of $0.01 for the second quarter.
The COVID-19 pandemic continues to impact both the AngioDynamics team and our customers. However, we observed improvements in certain geographies throughout the quarter as hospitals and local governments continue to navigate the pandemic. We’re very excited that there have been several positive developments in the global fight against COVID-19, including the approval of several vaccines. However, we expect headwinds to continue to impact our markets through the back half of our fiscal year and do not anticipate a full return to pre-COVID levels of demand in the near-term.
I am extremely proud of the resilience our team has shown over the past several months as we continue to navigate this unprecedented global crisis. We have established a very solid momentum through the first half of our fiscal year while continuing to make progress on our key growth initiatives. I am excited about the upcoming product launches we have planned throughout calendar year 2021, including the planned release of our new multi-purpose mechanical aspiration thrombectomy device, which I will discuss in more detail later on our call.
As we’ve discussed about in recent quarters, we are focused on driving growth across our three key technology platforms through internal R&D, M&A and clinical and regulatory pathway expansion. Auryon was the most recent acquisition and continues to perform well and in line with our expectations for the year. We successfully launched our Auryon atherectomy system during the quarter, and we have seen strong customer interest in this new product. We reported Auryon-related revenue of $2.1 million in the quarter, bringing our fiscal year first half revenue to $3.2 million. And we continue to anticipate Auryon revenue in the range of $7 million to $10 million for the full fiscal year.
While like last quarter, M&A was not an area of focused spending in the quarter. It will continue to play an important role in our transformation in the future. We continue to pause any M&A activity until we are comfortable that the COVID pandemic is behind us, at which time, we will resume our disciplined approach of identifying appropriate M&A targets and assessing strategic opportunities.
In terms of internal R&D, we continue to invest for growth. And during the second quarter, we saw continued strength from our AngioVac platform, which grew 24% year-over-year. We are also very excited about the upcoming launch of our multi-purpose mechanical aspiration thrombectomy device, another product resulting from our focused internal research and development.
We have continued to see strong momentum in our NanoKnife platform with strong disposable sales in the quarter, building off the strong capital sales last fiscal year as well as the increased visibility into the uniqueness of this technology provided by the comprehensive DIRECT study. On that note, our sponsored clinical studies, DIRECT and PATHFINDER, remain a primary focus and continue to require flexibility in the current environment.
As of today, we have 26 DIRECT study sites that have secured IRB approval, three additional sites since the update we provided you on our first quarter earnings call. We are pleased with a significant number of leading hospitals that have signed on to participate in this important study. Moving forward, we anticipate shifting efforts from additional site initiation to patient screening and enrollment. As can be expected, screening activity has been challenging in the current environment due to COVID-related protocols at many hospitals.
Our PATHFINDER Auryon Registry study has nine sites initiated and enrolling subjects. As of today, we are about 75% of the way toward our enrollment target, and we expect enrollment to be completed by the end of the third quarter. The vast majority of sites participating in PATHFINDER are office-based laboratories. To date, these OBLs are not experiencing the same type of significant COVID-related delays as hospitals.
Finally, with respect to reimbursement, we would like to highlight CMS’ final decision to provide for and increase Medicare payment of IRE, which is NanoKnife’s method of action in the hospital out-patient setting. This is a significant milestone for the technology. As we previously discussed, IRE received tissue-agnostic CPT3 codes. These codes now have payment associated with them in the hospital out-patient setting, at least on par with other ablation technologies. And we believe that the advantages of IRE in the newly established reimbursement levels will drive adoption in the out-patient setting, a setting that is very well utilized in Europe by specialties like urologists and interventional radiologists.
With that, I’d like to turn the call over to Steve Trowbridge, our Executive Vice President and Chief Financial Officer to review the quarter in more detail.
Stephen A. Trowbridge — Executive Vice President and Chief Financial
Thanks, Jim. Good morning, everyone. Before I begin, I’d like to point you to the presentation on our Investor Relations website summarizing the key items associated with our quarterly results. As I’ve done in each of the last two quarters, I’d note that with respect to the second quarter and our business moving forward, we will continue to provide slightly more intra-quarter detail than we would in a normal operating environment.
Our net sales for the second quarter of fiscal 2021 increased 4% year-over-year to $72.8 million. As I stated last quarter, our same customer analysis of our business has indicated that volumes remained below pre-COVID levels. And assuming the recovery continues along its current trajectory, we do expect this to remain a factor throughout the course of fiscal 2021. Our second quarter results reflected less severe declines than the 10% to 15% decline we discussed on last quarter’s call. But we are still keeping a close eye on the third quarter and currently expect that the third quarter is likely to see a more pronounced impact from COVID-related headwinds.
As has been true in our recent quarters, the ongoing pandemic has impacted each of our three businesses in varying ways. Our VA and VIT businesses performed the strongest during the quarter as the number of procedures improved from the COVID lows we saw in the second half of last fiscal year, but still remained below pre-COVID levels. Our oncology business also performed well during the quarter, but did face a difficult comparison on the capital side.
Our total VIT business increased 8.8% year-over-year, driven by AngioVac sales growth of 24%. I know that this is the first quarter that comp against the launch of our Gen 3 platform, so while in absolute terms the growth rate appears lower than previous quarters, the trajectory of this business remains quite strong and unchanged. our VIT business also benefited from $2.1 million in sales related to Auryon. We officially announced the commercial launch of Auryon in September, and the early response from the marketplace has been positive. As we stated in the past, we anticipate this product will represent an increasing part of our VIT business moving forward with sequential quarterly improvement throughout the rest of this year.
For our VIT business, this growth was driven by AngioVac and Auryon was somewhat offset by a 10.6% decline in venous sales, resulting from a decline in the number of elective procedures being performed due to the COVID-19 pandemic. This impact is consistent with what we have seen in the previous two quarters, and we anticipate these headwinds will continue throughout the remainder of fiscal ’21.
Vascular access revenue increased 5% during the quarter. Growth in this business was driven by growth in PICCs and midlines for the third straight quarter as well as growth in ports and dialysis. Our strong second quarter performance was partly attributable to the fact that the headwinds we faced as a result of the COVID-19 pandemic were less severe than we had expected, but again, we expect the more pronounced impact during the third quarter given elevated cases across the country and the globe.
Revenue from our oncology business declined 7% during the quarter. This decline was the result of lower NanoKnife capital sales on a year-over-year basis when compared to the second fiscal quarter of last year, during which we saw strong capital sales, driven by the release of our NanoKnife 3.0. We were very pleased that NanoKnife probe sales grew 30% in the quarter, led by 76% growth in the United States. This strong probe growth is driven in large part by the increased installed base resulting from the strong capital sales we reported in previous quarters, giving us further confidence in our ability to drive growth in probes through an increasingly large installed base.
Moving down the income statement. Our gross margin for the second quarter of fiscal 2021 was 55.2%, a decrease of 410 basis points compared to a year ago, but an increase of 430 basis points sequentially from our first quarter. The decline was split fairly evenly between Auryon start-up costs and planned under absorption in our manufacturing facility. As we’ve discussed in the past, this decline was anticipated given the ongoing focus on employee safety and predictability.
In addition, we reported an inventory reduction during the quarter of $3.2 million, resulting in a year-to-date reduction of $10.3 million. As previously noted, our plans will have an impact on our full year gross margin as we assess the shape and timing of the COVID-19 recovery, but we continue to expect to finish the year with quarterly gross margin running closer to pre-COVID levels.
Our research and development expenses during the second quarter of fiscal ’21 were $9.7 million or 13.3% of sales compared to $7.8 million or 11.1% of sales a year ago. We remain focused on strategically investing in R&D in order to improve our key technology platforms, while remaining thoughtful about our investments given the COVID environment. Staying true to this plan, we expect to accelerate our investment in anticipation of the launch of our new multi-purpose mechanical aspiration thrombectomy device in calendar 2021 with opportunities for additional investment in the back half of fiscal ’21. This investment is included in our R&D guidance. And while we reserve the right to pull back on these investments if the environment changes meaningfully, for fiscal ’21, we anticipate that R&D spend will come in at the higher end of our previously provided range of between $35 million and $40 million as we’ve accelerated certain investments on the heels of our first half performance.
SG&A expense for the second quarter of fiscal ’21 decreased slightly from the previous year to $29.4 million, representing 40.4% of sales compared to $31.1 million, representing 44.4% of sales a year ago. We are continually assessing controllable discretionary spend with an eye toward cash management while maintaining investment in our key technologies. We now anticipate our full year SG&A spending to come in toward the lower end of our previously provided range of between $123 million and $127 million.
Our adjusted net income for the second quarter of fiscal ’21 was $0.6 million for earnings of $0.01 per share compared to adjusted net income of $2.2 million or $0.06 per share in the second quarter of last year. Adjusted EBITDA in the second quarter of fiscal ’21 was $5.2 million compared to $6.4 million in the second quarter of fiscal 2020.
Turning to our balance sheet. In the second quarter of fiscal ’21, we began the quarter with roughly $47.9 million in cash and cash equivalents and we generated $11.5 million of cash from operating activities. During the second quarter, we had capital expenditures of $1.4 million. As of November 30, 2020, we had $58 million in cash and cash equivalents and $40 million in debt outstanding. Subsequent to the end of our second fiscal quarter, we repaid $10 million of our outstanding debt, and now have $30 million in debt outstanding at the time of this call.
Turning now to guidance. Based upon what we are currently seeing, we continue to anticipate fiscal year 2021 net sales will be in the range of $278 million to $284 million and full year adjusted earnings per share to be in the range of $0.00 to $0.05. While we obviously had a strong second quarter, we do expect to see a sequential decline in third quarter revenue as a result of the typical seasonality in our business and reflecting our current thinking around the impacts of the COVID-19 pandemic on our third quarter results. Historically, we have seen a 1% to 3% sequential decline in revenue from our second fiscal quarter to our third fiscal quarter. Overall, we are pleased with our strong performance in the second quarter despite continued headwinds from COVID-19. We will remain committed to growing our key technology platforms, and we’ll continue to invest to support new product launches and product updates for 2021 and beyond.
With that, I’ll turn it back to Jim.
Jim Clemmer — President and Chief Executive
Thanks, Steve. I am pleased with our balanced approach of managing expenses in cash, while continuing to strategically invest in our three key technology platforms; AngioVac, Auryon and NanoKnife. I believe this approach will position us to achieve profitable long-term growth as the effects of the COVID-19 pandemic begin to subside.
Before moving on to the question-and-answer session, I want to take the opportunity to highlight one of our key areas of investment during the quarter; our new multi-purpose mechanical aspiration thrombectomy device. Over the course of the past 18 months, we have discussed with you our desire to expand our offerings in the mechanical thrombectomy space with an off-circuit device. And today, we are excited to announce the planned release of this device in calendar year ’21, which will expand our AngioVac platform and open up a significantly larger piece of the addressable market in the moderately complex area. You can see on Page 12 of our investor presentation.
We anticipate filing a 510(k) in the first half of calendar year ’21, and expect to receive clearance in the second half of calendar year ’21, followed by a commercial launch. As many of you know, this is a large and rapidly growing market where physicians are becoming increasingly comfortable with choosing mechanical thrombectomy to treat DVT cases, and we look forward to providing them another choice in the treatment of their patients. Our new device will be a unique design, which has been guided by the well respected key opinion leaders on our medical advisory board. And we believe once physicians experience the intuitive and thoughtful design of this product, they want to have this device in their arsenal. What you’ll see over the coming 36 months are extensions to this product family through the introduction of new sizes as well as the clinical and regulatory initiatives necessary to secure an indication for pulmonary embolism, positioning us to enter additional sizable addressable markets.
To provide you with some context in that regard, our current AngioVac system serves a market that is made up of approximately 15,000 cases annually, while our new multi-purpose mechanical aspiration thrombectomy device will be aimed at a DVT market that sees over 200,000 cases treated annually, and eventually, the PE indication, which sees over 150,000 cases treated annually. This is a significant increase in the size of the addressable market. And we believe the design of our platform positions us well to take share in what is on already growing market. Innovation drives outcomes and outcomes drive growth, and that is what this industry is built upon. We are really excited to be bringing this new product to market.
As I mentioned earlier, in our remarks, I am pleased with our performance during the quarter and thrilled about the future here at AngioDynamics as we continue to execute on our transformation. Our quarterly performance underscores the long-term growth potential of our key technology platforms. We still have a lot of work ahead of us, but I am encouraged by the progress we have continued to make against our long-term goals. I would like to thank the incredible AngioDynamics team once again for their commitment and dedication as we continue to deliver innovative solutions that improve the lives and treatment of patients worldwide.
With that, I’d like to turn the call back to the operator for questions. Rob?
Questions and Answers:
Operator
Thank you. [Operator Instructions] Our first question is from the line of Jayson Bedford with Raymond James. Please proceed with your questions.
Jayson T. Bedford — Raymond James — Analyst
Good morning, guys, and Happy New Year to you. So I guess just a few questions. First on the quarter, do you think there was any benefit from catch up at all in fiscal 2Q here?
Jim Clemmer — President and Chief Executive
So Jayson, it’s Jim. Maybe a little. We tried to measure that closely. There might have been a little bit in the beginning of the quarter. I don’t think there was a lot, Jayson, because we also measured closely what we call same-store sales as well. And there is still a decline as to what we would have expected based upon prior year. So I think I know what you’re looking for. There may have been a little bit of effect, but I don’t think it was measurable.
Jayson T. Bedford — Raymond James — Analyst
Okay. And then if there is any way you can compare the trends you saw in fiscal 2Q, which ended in November? And may be the trends you’re seeing or you saw in December, I’m just kind of curious as to kind of the step-up if there is a difference here with the severity of COVID ramping?
Jim Clemmer — President and Chief Executive
So Jayson, I’ll give you what’s going on in the field and Steve can give you some numbers to highlight that. But again, we’re hearing from our customers as probably many of our peer companies are that they are very concerned and they are limiting some care and they are limiting our access. So that has been in effect. We’ve seen that some customers have asked us to stand down. Some of the out-patient centers that we serve have actually shutdown temporarily given the COVID.
And Steve, what do you think from the numbers side?
Stephen A. Trowbridge — Executive Vice President and Chief Financial
Yeah. Look, we’re keeping an eye on it. As we’ve said in the prepared remarks, there is no doubt that it is a — an impact globally. Quite frankly, we expected a little bit more of an impact in our Q2. We’ve got the odd Q2, September, October, November. We are pleased with how we came through that. We’re keeping an eye on our Q3. As I did say, we’ll give a little bit more intra-quarter detail than we have in the past. Probably, I was expecting a little bit more of a pronounced impact in December than we actually saw. So our trajectory so far have been holding relatively consistent. We like what we’re seeing, but we’re keeping an eye on it because there is no doubt that you’re seeing increased stress in the system throughout the U.S. and globally.
Jayson T. Bedford — Raymond James — Analyst
Okay, that’s helpful. On the new multi-purpose mechanical aspiration device, will you have some data at launch?
Jim Clemmer — President and Chief Executive
So this is a 510(k) device. And so it’s not requiring a lot of clinical data for clearance. As we’ve shown with our other product launches, we are absolutely committed to creating a foundation of data to support those launches. And so I would expect that we’re going to continue to do the same thing and that may take the form of registry, it may take the form of other studies. We’ll support the launch with data, but we see this as an extension that is going to be building off of the strong use cases and data that we have with the current AngioVac platform moving into that less complex DVT section that is off-circuit. And then we’ll be continuing to support that product launch with the collection, assessment and generation of clinical data as we move forward.
Jayson T. Bedford — Raymond James — Analyst
Okay. And maybe Steve or Jim, will you build a separate sales team for this or will it go through the existing team?
Jim Clemmer — President and Chief Executive
So Jayson, I think two years ago, we kind of — we shifted some of the priorities in our sales bags. So what we’ll do today is it will still be sold by the same sales team that sells the AngioVac product today, and we’ll add selling resources there. So we look to expand that team. But the current AngioVac sales force will take this product to market to our customers.
Stephen A. Trowbridge — Executive Vice President and Chief Financial
Jayson, we’ve talked about the different spectrum of treatment and we’ve talked about the very complex where AngioVac currently plays. On the other end of the spectrum, you’ve got the less complex where you may do catheter-directed thrombolysis and then you’ve got that middle section, which is really what we’re looking to go after with this new product launch. The call point is all the same. So the physicians — the same physicians that are doing those procedures are the ones that are typically doing this.
Now there may be some cardiothoracic surgeons that are focusing more on the right heart procedures that current Angio has, and this may be a product that may be more indicative of an IR. But the call points that we’re currently going after are all the same. So it’s going to fit right into that same sales force with the additional investment that Jim talked about.
Jayson T. Bedford — Raymond James — Analyst
Okay, that’s helpful. And I’ll ask one and then I’ll let someone else jump in. You mentioned earlier on — excuse me, Jim, product launches throughout ’21 outside of the new aspiration device. What else are you looking to launch this year?
Jim Clemmer — President and Chief Executive
Yeah. So the most impactful is the aspiration device. We have some other products, Jayson, that we’re looking at in our vascular access business. There is extension to our dialysis catheter line we’re looking to launch this year, which is really important. That business has been, as you’ve seen, you’ve known our company for years, it’s been really well run combination of the new products we’ve added in the VA business and just really good management by that team has helped.
And Jayson, we’re also — you and I have talked and we talked to our investors about our interest in expanding NanoKnife into other organs eventually. Now that we have here the DIRECT study, which is — we’re trying to prove that it’s the right product for pancreas treatment. And we’ve talked about prostate being the next organ that we’re interested in. And so, Jayson, what you’ll see from us, and I’ll give more details in the near future. But last year, the FDA released new guidance on focal therapy in prostate, which really aligns well with the technology and the mechanism of action of NanoKnife. And we’ve seen some — a lot of physicians and urologists outside of the U.S. utilize this product for successful treatment.
So now we’re looking at — now we’re engaged with the FDA in discussions as to what it will take to gain an indication. We’d like to have NanoKnife on label for prostate. When we do that, Jayson, you’ll probably see us launching maybe some different products and set-ups that are geared towards servicing that urologist to treat the unique need of focal therapy in a prostate case. So that’s something we’re excited about. We’ll give you more details soon on that.
Jayson T. Bedford — Raymond James — Analyst
Okay, that’s helpful. Thank you.
Operator
The next question comes from the line of Matthew Mishan with KeyBanc Capital Markets. Please proceed with your questions.
Matthew I. Mishan — KeyBanc Capital Markets — Analyst
Hey, good morning, guys. Just for the new mechanical thrombectomy device. What is the technology differentiation that you’re migrating down from AngioVac to the wider market? And specifically, how do you think this device can improve the patient outcomes?
Jim Clemmer — President and Chief Executive
So a couple of things, Matt. We can both answer. Really when you look at how successful AngioVac has been and really the product we launched in November of ’19, the newest version. A lot of the physicians that have adopted this product have asked us, boy, this works really well for a few reasons. It’s very special. And as you’ve seen in our deck, we showed the uniqueness of the product. And there’s really a couple of unique factors, one of which is on-circuit, allows the perfusion of blood, keep the patient healthy during a complex procedure. But number two, the vortex funnel tip allows us to really pull massive clot burden into the device out of the patient’s body. And they love that feature, so they’ve asked us to design a product now off-circuit so they can utilize more cases that don’t require the complexity of the perfusion circuit, and that’s really what we’ve done.
So when we can share with you the device and design, you’ll see we’ve taken kind of the best features of that vortex funnel tip and how that works to full mass clot burdens with a really uniquely designed tool on the other end, which gives physicians control that they’ve asked for. Control of the process and procedure, utilizing the amount of torque and pull that we can give to remove clot, yet giving the physicians the control they aspire to have. So that’s really — it’s kind of a blend of technologies, and that’s what we’re excited about. The medical advisory board has guided us in this. Physicians are excited by what AngioVac can do and what this new off-circuit product can do in their hands to treat less burden — less aggressive clot.
Stephen A. Trowbridge — Executive Vice President and Chief Financial
Yeah. The control that Jim talked about, Matt, is really important. So we understand this market. We’ve learned a lot. We know where the current AngioVac product plays. And Jim mentioned the funnel tip, which is proprietary to AngioVac, which is a huge advantage that allows a much greater clot burden to come out.
One of the big advantages of the current AngioVac system is the minimization of blood loss because we’ve got that re-infusion circuit. But as Jim said, it’s a very complex procedure and it requires additional specialties, it requires perfusion. So we’re looking at a product, we’re listening to our customers and we think that it’s important to provide that funnel tip to go after the big clot burden that take away the complexity of adding perfusion, but still give the physicians the control to know that when they’re going after a clot, they have the ability to limit blood loss while going after that clot burden. We think that’s the benefit that we’re going to provide.
Matthew I. Mishan — KeyBanc Capital Markets — Analyst
Excellent. Of the $2.1 million for Auryon, how much of that was recurring revenue and how much of that was the initial placements?
Stephen A. Trowbridge — Executive Vice President and Chief Financial
Yeah. So that’s all recurring. As we’ve said, this is the — we’ve been spending a little bit more time with the OBLs as opposed to the hospital-based setting just given the current environment. The marketplace there, as we’ve mentioned, has been to place lasers pursuant to use agreements and then have the recurring revenue with the catheters. And that’s all of what we saw in Q2.
Matthew I. Mishan — KeyBanc Capital Markets — Analyst
Is the expectation that the $2.1 million recurring increases sequentially from here or is there some level of like inventory build looks like initial stocking?
Stephen A. Trowbridge — Executive Vice President and Chief Financial
Yeah. We mentioned, we expect to see sequential increasing throughout this year with the Auryon sales. As we come out at the beginning of the quarter, we said we expect to see 7 to 10. We’re very comfortable with the pace that we’re seeing. And that implies some sequential increases, and that’s what we’d like to see.
Matthew I. Mishan — KeyBanc Capital Markets — Analyst
Okay.
Jim Clemmer — President and Chief Executive
Yeah. Matt, we’re measuring the cases performed each week very carefully. And we’ve added, if you remember back we made the acquisition, there was one commercial person that came in the Eximo acquisition, the great scientist in Israel with their one commercial person. We now have over 30 people dedicated to this business on a commercial side, whether they’re selling, marketing or field clinical support specialists in our customers each day. So we’re making sure that each week that goes by we have the capability that ramps up, provide that support to our customers. So we expect sequential usage to keep growing.
Matthew I. Mishan — KeyBanc Capital Markets — Analyst
Okay. And last question. When do you think you’ll be able to give an update or milestone for the NanoKnife trials outside of the number of sites registered?
Stephen A. Trowbridge — Executive Vice President and Chief Financial
Yeah. So it’s a good question and we’re continually assessing where we are on that. So the one statistic we have given is the number of sites, and we gave that this quarter with 26 coming up from 23. We had talked about timing of our expectations of enrollment of the registry side of that study. And that indicated that as COVID hit, we certainly saw a delay and a push out and probably a restarting of that clock. And we had always talked about two and a half years is our expectation for enrolling the registry side of the study, but felt that COVID did impact that and we were restarting that clock kind of the — during our first quarter of this year. And I think that that’s fair to say that we’re not seeing that same full pause, right? So we’re a quarter plus into that two and a half year expectation as we’re seeing the enrollment go.
Matthew I. Mishan — KeyBanc Capital Markets — Analyst
All right. Thank you.
Jim Clemmer — President and Chief Executive
Thanks, Matt.
Stephen A. Trowbridge — Executive Vice President and Chief Financial
Thanks, Matt.
Operator
Our next question comes from the line of Bill Plovanic with Canaccord Genuity. Please proceed with your questions.
Bill J. Plovanic — Canaccord Genuity — Analyst
Great, thanks. Good morning. Can you hear me okay?
Jim Clemmer — President and Chief Executive
Hi, Bill. Good morning. Thanks.
Stephen A. Trowbridge — Executive Vice President and Chief Financial
Hi, Bill.
Bill J. Plovanic — Canaccord Genuity — Analyst
Thanks. So just a couple of questions, just to start out on the AngioVac product, it’s pretty strong growth year-over-year. How much of that do you think is COVID-related versus — or new account-related or any color would be greatly appreciated?
Stephen A. Trowbridge — Executive Vice President and Chief Financial
Yeah. We don’t think that that’s COVID-related. I mean, as we talked about earlier, kind of mid last year when the COVID pandemic was first hitting, there was some discussion in the medical community about increased clotting. But the AngioVac cases that we’re seeing, we don’t feel that they’re COVID-related. We feel that this is pretty good run rate for the overall DVT market, in thrombectomy market. We actually are bringing new cases on, so we have some new customers that are signing on and we’re increasing new users in with our current base as well. So we’ve been pretty pleased with that performance.
Bill J. Plovanic — Canaccord Genuity — Analyst
Okay, thanks. And then in terms of the mechanical product, just looking at the timeline, so it looks like this will be a launch — approval and launch late this calendar year, and I’m looking at Slide 12 of the chart. And I’m just — so that’s first, just to clarify that. And then secondly, trying to understand what’s the difference between Gen 1 and Gen 2. If you can help us out with that?
Jim Clemmer — President and Chief Executive
Sure, Bill. So what you’ll see — again, as I said in my prepared remarks, we expect to file for the 510(k) in the first half of calendar year. And as you see in the chart, you’re correct. We expect approval second half clearance. So Gen 1 will be a larger board device. General 2, we’ll start to introduce smaller sizes, enabling us to go deeper into the body and access other DVT. So we’d expand the market, that’s what the chart here shows. So we intend to have over time different sizes to make sure physicians can access different parts of the body and treat different areas of DVT and ultimately again working on a PE indication. We think the product is really, really well designed to really be a really good products for PE over time. So we’ll do the clinical and regulatory work necessary to seek that indication.
Stephen A. Trowbridge — Executive Vice President and Chief Financial
Yeah. I think, the…
Bill J. Plovanic — Canaccord Genuity — Analyst
Okay. And then just…
Stephen A. Trowbridge — Executive Vice President and Chief Financial
I’m sorry, Bill. One of the defining elements of this market is that we know that there is not a one size fits all solution. AngioVac in its current form has a great role to play. We like the space that we’re playing in there. We show that in the slide deck. We’re moving into an area that we think is a bigger market. There are some other customer — competitors in there. They’ve done a good job. They’ve got products. Physicians will have a number of products in their tool bag and we think that this is going to be a great product to add to that. But you don’t have to displace everything out there. This is not a one size fits all and there is plenty of room in this really attractive growing market for a number of solutions, and we think we’ve got a really good one here.
Bill J. Plovanic — Canaccord Genuity — Analyst
Okay. And then two more questions, just one clarity on mechanical product. As you talk about control, would that be some sort of automated aspiration associated with it or would it be manual?
Jim Clemmer — President and Chief Executive
So it’s a manual piece, Bill. It really allows the physicians. Where the physicians helped us design, they really asked us. They said, look, we’re really good at this. Give us a tool that enables us to utilize our skill here. That’s what we did. So we designed it really on their guidance. So there will be no automation, it’s a fully mechanical devices that they’ll utilize their hands and their skill.
Bill J. Plovanic — Canaccord Genuity — Analyst
Okay. And then just the last question was a bigger picture volume-related. I think, Steve, you mentioned you were a bit pleasantly surprised at the amount of COVID impact in December. And just as we think about that, as you think about kind of moving into your fiscal third quarter, there is two impacts; your seasonality which is typically down 1% to 3% and there is the COVID impact. I mean, how is we’re through December and in January, and it seems like it’s less — it seems — and not to put words in your mouth, but it’s more of a stable environment where from it it’s down whatever it’s 5% to 10% top normal volumes, but that seems to be kind of stable the last couple of months. Is that what I’m hearing? If you could just clarify — help clarify that for me from a broader volume standpoint.
Stephen A. Trowbridge — Executive Vice President and Chief Financial
Yeah. Bill, I think your characterization is absolutely fair. As we said, we’re very keenly keeping an eye on what’s going on in the broader environment. There is no secret that you’re seeing increased cases. There is no secret that you are seeing in pockets stress being put on the system. But as we talked about when we came out with guidance at the end of our first quarter, the way that we saw this happening and our expectations for the market is that you will see a lot of these peaks coming up, but it’s going to be a little bit more geographically isolated and it’s going to be more specific to certain areas don’t have stress, they will come down, other areas will be okay.
We’re not seeing full across the board shutdowns like we saw back in the March-April timeframe. That has held consistent. That is what we’re seeing. That’s what we expect to see going forward for the rest of our fiscal year here as well as those little flare-ups in different geographies and stress is coming around, but more isolated.
So as of so far, yes, we are not back to pre-COVID levels. We are still seeing the resilience and stability. We may be moving into a little different time period as we get to the end of January and February with some of these increased cases that we’re seeing in the U.S. But as what we’re seeing now, I think the way that you’ve characterized it is exactly right.
Bill J. Plovanic — Canaccord Genuity — Analyst
Great. Thanks for taking my questions.
Stephen A. Trowbridge — Executive Vice President and Chief Financial
Thanks, Bill.
Operator
Thank you. At this time we have reached the end of the question-and-answer session. And I will turn the call over to Jim Clemmer for closing remarks.
Jim Clemmer — President and Chief Executive
Thanks, Rob. We at AngioDynamics are pleased with our performance. We understand the global complexity that everybody is facing dealing with COVID. Our customers are under stress and pressure and our people are as well. We worked really hard to maintain safety and security of our people and our workforce. Our folks in our operations and quality team have done an amazing job. They are working to produce our products that produce lifesaving ability for physicians to utilize for care.
So we’re really committed to making sure we can get through this pandemic, keep our people safe and secure and make sure our customers are getting access to the products they need. We’re also really excited about our future, and we shared some of that today about our new multi-purpose mechanical thrombectomy product. We’ll have other products coming out of our R&D pipeline soon. We’re very pleased with our quarter. We’re looking forward to the future. Thank you for joining us again today.
Operator
[Operator Closing Remarks]