InspireMD Inc (NSPR) 2021 Q3 法說會逐字稿

Greetings. Welcome to InspireMD Third Quarter 2021 Earnings Call. (Operator Instructions) Please note, this conference is being recorded.

I will now turn the conference over to David Holmes with LifeSci Advisors. Thank you. You may begin.

Thank you, Sherry, and good morning, everyone. Thank you for joining us for the InspireMD Third Quarter 2021 Financial Results and Corporate Update Conference Call. Joining us today from InspireMD are Marvin Slosman, Chief Executive Officer; and Craig Shore, Chief Financial Officer.

During this call, management will be making forward-looking statements, including statements that address InspireMD's expectations for future performance and operational results, particularly in light of the COVID-19 pandemic. Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements. For more information about these risks, please refer to the risk factors described in InspireMD's most recently filed periodic reports on Form 10-K and Form 10-Q filed with the U.S. Securities and Exchange Commission and InspireMD's press release that accompanies this call, particularly the cautionary statements made in it.

This call contains time-sensitive information that is accurate only as of today, November 9, 2021. Except as required by law, InspireMD disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call.

It is now my pleasure to turn the call over to Marvin Slosman, Chief Executive Officer. Marvin, please go ahead.

Thank you, David. Good morning, and thank you all for joining the third quarter 2021 call. Also joining me today is Craig Shore, our Chief Financial Officer.

I'd like to begin with the reiteration of our mission at InspireMD, which is to establish CGuard EPS as the standard of care solution to change the way carotid artery disease is managed and strokes are prevented. The CGuard carotid stent system enables this change through its unique design and proprietary MicroNet mesh protection, which has yielded an unmatched and growing body of clinical evidence in real-world practice as well as ongoing clinical studies.

We serve equally all physician specialists treating carotid artery disease with focus on the stent system and patient outcomes. We create greater awareness of the advantages of CGuard as a first-line option to a broad physician base. As well as advanced new delivery systems and accessory solutions, we believe we can enable the conversion of this surgically dominated $5 billion global total addressable market to a less invasive endovascular standard of care.

The third quarter of 2021 proved meaningful in our quest to deliver on our growing body of evidence, further differentiating CGuard from all other first-generation and dual-layered stents in the market with the publication in JACC of a randomized trial comparing CGuard EPS against Abbott's first-generation open-cell Acculink, with clear differentiation and a statistically significant reduction of approximately 80% in periprocedural cerebral embolization in favor of CGuard. We will further discuss the results in this breakthrough publication later.

Additionally, we continue to build market demand for CGuard while gaining traction in our company objectives of global expansion, commercial growth and development of pipeline offerings. Commercial business grew for the quarter, 24% year-over-year in CGuard sales and for the 9 months year-to-date increased 45% over the same period in 2020. During the quarter, we sold 1,709 devices, an increase of 21% as compared to the third quarter of 2020, with scheduled procedures to normalized levels in most of our served markets.

In France, we've received the anticipated reimbursement approval to combine with our previously announced clinical approval for CGuard from the French National Authority for Health and have subsequently launched CGuard into the French market with 18 cases completed in the first week post approval. These key commercial inflection points of expansion into new markets have also accelerated our plans to advance our direct sales efforts in selective strategic locations to capture higher average sales price and enable greater control of the sales process to drive growth, as we have demonstrated previously in the United Kingdom and now France.

Strategy in Asia continues with talks in Japan amongst distributor partners interested in representing CGuard. As we noted previously and consistent with our agreement in China several months ago, we believe the Asian market offers an accelerated opportunity for CGuard as the existing standard of care for procedural intervention is predominantly endovascular-focused and less surgically dominated. Additionally, with the advanced enrollment in our C-Guardians FDA trial and greater U.S. physician experience with CGuard, we're planning to establish a U.S. base of business, including addition of commercial leadership and operational infrastructure.

Speaking of the U.S. C-Guardians trial, we've completed over 10% of the enrollment to date, led by our global principal investigator, Dr. Chris Metzger, at Ballad Health System in Eastern Tennessee. As we launched the trial in the U.S. with the top carotid stenting leaders, we're encouraged by the growing foundation of awareness and credibility through the utilization of CGuard with investigator experience, positioning us for a successful and accelerated post-approval commercial launch.

In reference to the prior-mentioned publication of the randomized trial comparing CGuard to the Abbott Acculink stent, trial compared CGuard EPS against the first-generation Abbott Acculink in a CAS-related ipsilateral cerebral embolism study measured by DW-MRI following CAS and found a dramatic 4.5-fold reduction in periprocedural cerebral embolism in favor of CGuard. Most significantly, this reduction in procedural events was reflected in both volume and number of lesions in favor of CGuard, consistent with the MicroNet covered prevention, delivering cerebral protection both during and following CAS.

The ability of our MicroNet mesh to prevent the migration of thrombus in the lumen of the vessel following CAS remains the foundational advantage of CGuard against all other stent alternatives, and this important publication adds further evidence to the advantages of our stent plan. Though the study was not powered to show statistical significance of clinical outcomes, there were 2 observed ipsilateral strokes, which occurred in the Abbott Acculink arm, but no neurological events occurred with the CGuard arm, further suggesting the value of post-procedural protection from the MicroNet mesh.

Our investment in our pipeline of innovation continues with new advanced tools to enable more test procedures. Our progress with the previous-mentioned new delivery systems continues with anticipated approval in 2022, which we believe will facilitate greater accelerated growth in overall global market demand and will significantly address the conversion of surgical procedures to endovascular stenting.

To summarize, the quarter reflects our priority of execution and growth, which will continue to drive our objective of establishing CGuard carotid stent system as the foundational enabler of endovascular conversions from open surgery. We chart a new course for how CAD is managed and stroke is prevented with our clinically proven CGuard EPS system. Demonstrating superior clinical outcomes for patients compared to alternative carotid stent types, conventional or next-generation double-layer stents as well as invasive surgical procedures, such as endarterectomy, we are encouraged by our progress and mission as we continue to invest in our future to leverage and unlock their tremendous potential to change the way carotid artery disease is managed and stroke is prevented.

With that, I'll turn the call over to Craig, who will review the first quarter financials. Craig?

Thank you, Marvin, and to everyone for joining today. Here are some key financial highlights for the third quarter ended September 30, 2021. The Total revenue for the quarter was $1.071 million, an increase of 9% compared to $980,000 during the 3 months ended September 30, 2020. CGuard EPS had revenue of $1.031 million, an increase of 24% from $833,000 for the same period last year.

This sales increase was mainly due to procedures with CGuard EPS, which are generally scheduled for nonemergency cases, began this quarter to return to normal levels in additional territories as compared to the 3 months ended September 30, 2020, when procedures with CGuard EPS were still somewhat postponed as hospitals shifted resources to patients affected by COVID-19. This increase in sales of CGuard EPS was partially offset by a decrease of 73% in sales of MGuard EPS from $147,000 during the 3 months ended September 30, 2020, to $40,000 during the 3 months ended December 30, 2021.

For the 3 months ended September 30, 2021, we had a gross profit of $92,000 compared to $298,000 during the 3 months ended September 30, 2020. This decrease in gross profit resulted from $136,000 increase in material and labor costs, mainly due to an increase in sales volume as well as a short-term increase in production cost per unit, an increase of write-offs of $66,000 due to component supply issues, a $57,000 increase in new employee training costs and an increase of $38,000 in miscellaneous expenses during the 3 months ended September 30, 2021.

This decrease was partially offset by $91,000 increase in revenue, mainly due to the increases in sales volume previously stated. Gross margin decreased to 9% during the 3 months ended September 30, 2021, from 30% during the 3 months ended September 30, 2020, driven by the reasons just stated.

Total operating expenses for the quarter ended September 30, 2021, were $4.123 million, an increase of 65% compared to $2.493 million for the same period in 2020. This increase was primarily due to increases of $700,000 in expenses related to the commencement of the C-Guardians FDA study, $400,000 in salary expenses and related accruals due to additional resources, mainly in our product development and sales infrastructure; $151,000 in development expenses associated with CGuard EPS new delivery system and accessory solutions; $147,000 in share-based compensation related to expenses due to the recognition of grants made from August 31, 2020; $102,000 in sales and marketing expenses associated with expansion of existing and new markets; $81,000 of directors' and officers' liability insurance expense due to increased premiums caused by recent trends in the overall industry; and $41,000 in miscellaneous expense.

Net loss for the third quarter of 2021 totaled $4.071 million or $0.53 per basic and diluted share, compared to a net loss of $2.233 million or $0.96 per basic and diluted share for the same period in 2020. The average amount of shares outstanding used for the earnings per share calculation were 7,739,463 in Q3 2021 and 2,325,619 in Q3 2020, both adjusted to reflect the 1 for 15 reverse split affected by us on April 26, 2021. As of September 30, 2021, cash, cash equivalents and short-term bank deposits were $37.1 million compared to $12.6 million as of December 31, 2020.

With that, I'd like to now turn the call over for questions. Operator, please go ahead.

(Operator Instructions) Our first question is from Ben Haynor with Alliance Global Partners.

Congrats on all the progress. First off for me, just on the C-Guardians trial, can you talk a little bit about how the other sites are on track for opening enrollment? Kind of when do you expect all the sites to be up and running?

Yes. Ben, thanks for the question. So we have 4 sites currently that are approved and up and ready to enroll. The process, as you may be aware, is a bit complicated in terms of getting all the contracts in place and getting everything set. Plan to have another 4 sites completed by the end of the year. So in total, I think we'll be looking at somewhere around 7 or 8 sites total by the end of the year for enrollment purposes. So progressing during that process, and then it will be a part of going ahead and getting cases done.

Got it. And then on the SIBERIA data, that looks great, obviously. Have you gotten any feedback from clinicians since the publication that you can discuss?

Yes, nothing solid other than the fact that it's a recent publication in JACC, and we certainly are trying to promote that in our commercial organization. But most recently, we just attended the TCT, and VEITH is actually next week as well.

So we're hopeful that both the outreach as well as just the overall absorption of this by the industry and by physicians will be very positive. And this was certainly an important trial and result for us because it was a randomized event head-to-head with the Abbott Acculink stent. So we're really pleased with the information, and look forward to using it to advance our storyline and clinical data.

Makes sense. And is there anything that surprised you coming out of that in terms of the performance? I mean it looks pretty fantastic to me. Just curious on whether there's any surprise from your end?

Yes. I think, Ben, the great part of the result is the fact that it continues to reinforce what we've observed from the very beginning from the trials that have taken place, investigator-initiated trials. As you know, we've got about 1,500 patients enrolled in these efforts. And it just continues to reiterate the performance of CGuard just in a different context, head to head with the Abbott Acculink stent. But no surprises, which is actually quite good because it shows the consistency of performance of the stent in previous work as well.

Okay. That makes a lot of sense. And then you're up and running in France. Can you talk a little bit about what the -- kind of what the ASPs look like there? I know you're at roughly $600 overall, but kind of where are those at in France? And then maybe talk a little bit more about the Asian opportunity as you see it developing.

Yes. So the French market in terms of reimbursement is somewhere around $800 for reimbursement in this particular category. Our objective there, obviously, was to go on a direct sales model for obvious reasons, which gives us the full benefit of the ASP, but also allows us to control the market. So in that particular case, it made good sense to make the transition to a direct sales effort in France.

In terms of Asia, I think your second question was Asia. We've got 3 interested distributor partners in Japan right now, all of which are quite interested and are in the process of trying to sort out what is best in terms of our approach, which partner relationship and so forth. But it's nice to have 3 very strong options in the Japanese market as it's a very significant play for us. So we're encouraged by that, and we'll continue to negotiate the best option.

Got it. And then any other color that you can share on the 2 new delivery systems that you mentioned earlier?

Yes. I'm anxious to talk about that. It's a little bit premature. We're just sort of rounding the edges in terms of regulatory strategy and pathway and commercial pathway. And I'm certainly hopeful that in the near future, we're going to be able to talk more openly about what those delivery systems mean to our overall commercial strategy. But coming soon is the way I would frame that. But we're making great progress.

Okay. Stay tuned. I know it's one of my favorite questions.

I want you to keep asking it. Stay tuned. We're getting there.

There are no more questions at this time. I would like to turn the conference back over to Marvin Slosman for closing remarks.

Thanks very much. I'd like to thank everyone for taking the time to join the call today. Of course, InspireMD is fundamentally a stronger company today than ever before. We're really encouraged about our future, and I'm very proud of the extraordinary efforts of our expanding team in creating an exciting future for the company. Thank you.

Thank you. This does conclude today's conference. You may disconnect your lines at this time, and thank you for your participation.