Welcome to the Avinger Second Quarter 2024 Results Call. At this time, all participants are on a listen-only mode. Later we’ll conduct a question-and-answer session. I'll now turn the call over to your host, Matt Kreps, Investor Relations. You may begin..

Thank you, and thank you all for joining us on today's call. I would like to welcome you to Avinger's second quarter 2024 conference call. Joining us today are Avinger's CEO, Jeff Soinski; and Principal Financial Officer Nabeel Subainati. Earlier today, we released financial results for the quarter ended June 30, 2024.

A copy of the release is posted on the Avinger website under Investor Relations.

Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995.

Any statements contained in this call that are not statements of historical fact should be deemed to be forward-looking statements.

All forward-looking statements, including without limitation, our future financial expectations and expected timing for commercial launch of products and filings with the FDA are based upon our current estimates and various assumptions.

These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements.

For a list and description of the risks and uncertainties associated with our business, please see our Form 10-K and 10-Q filings with the Securities and Exchange Commission.

Avinger disclaims any intention or obligation except as required by law to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. Also, today's presentation will include reference to non-GAAP financial measures, such as adjusted EBITDA.

A reconciliation of these non-GAAP financial measures to the most comparable GAAP financial measures is available within the earnings release, which can be found on Avinger's website. And with that, I'd like to now turn the call over to Jeff..

Thank you, Matt. Good afternoon and thank you all for joining us. The second quarter marked significant progress for Avinger's therapeutic programs as well as a meaningful shift in our operating structure as we move our company forward.

Following the March announcement of our new strategic partner -- partnership with Zylox-Tonbridge, which provided a substantial investment in Avinger and opens a pathway for the introduction of our image-guided devices to the Greater China market, we further improved our balance sheet in the second quarter.

In May, we announced the conversion of $11 million of debt held by CRG in the shares of a new series of convertible preferred stock, which increased stockholders' equity by the same amount. In June, we announced the public offering providing up to $24 million in growth financing.

The financing included $6 million upfront at closing with up to an additional $18 million available based upon the exercise in full of coronary clinical milestone-linked warrants. In June, we also implemented an operating cost savings program that reduced our head count by approximately 24%.

This cost reduction program streamlines the operating cost of our peripheral business as we emphasize our field sales team's support of existing peripheral device users and allows us to increase focus on our coronary product development program.

We expect the full effect of the cost reductions to be seen in the second half of 2024 with both improved gross margin and reduced operating costs anticipated in the period. Turning to some of the key operating accomplishments in the quarter.

We continued to make exciting progress on our first coronary product as we prepare for filing an IDE submission with the FDA. We are in the process of completing Phase 3 verification and validation studies and initial clinical site selection for our proprietary CTO crossing device.

Pending successful completion of the remaining testing, we anticipate filing an IDE application with the FDA by the end of the third quarter.

This is a critical step for Avinger since FDA approval of our IDE submission would allow Avinger to initiate the first human clinical study for this groundbreaking new device and brings us one step closer to making our proprietary image-guided system available to physicians treating this challenging and complex condition in the coronary arteries.

We believe our first coronary device provides the opportunity to redefine a large and underserved market. Crossing chronic total occlusions in the coronary arteries today is typically a complex, time-consuming and expensive procedure with a clinically documented high failure rate.

By leveraging our proprietary image-guided technology, we believe, we can provide physicians with a superior, simplified and more successful solution for crossing coronary CTOs.

We have deployed our technologies into a low-profile four French catheter design that combines real-time OCT guidance with the precise control and steerability needed to facilitate an antegrade approach, which we expect to significantly reduce procedure times and improve crossing success rates.

Like our peripheral catheters, our coronary device incorporates the precise measurement capability to help physicians properly size balloons or stents prior to placement, which is critical for optimal outcomes.

We expect our unique image-guided system to allow physicians to cross coronary CTOs with less reliance on specialty wires support catheters and reentry devices while also limiting x-ray radiation exposure and usage of iodine-containing contrast dye, which can pose significant health risks to physicians and patients.

Based on multiple animal and cadaver heart studies completing during our development process and extensive experience with our OCT-guided therapy in the peripheral arteries, we are confident our combination of onboard image guidance and precise control within the vessel will support a robust safety profile during clinical practice.

We expect adoption of our coronary CTO crossing system to benefit from existing reimbursement dynamics. Following FDA clearance, our coronary device will immediately access existing high-value reimbursement codes for CTO crossing in the coronary arteries.

We also expect our image-guided system to access existing reimbursement codes for coronary OCT diagnostic imaging with the same device. This is a key differentiator from the peripheral markets, where discrete reimbursement codes for CTO crossing and diagnostic OCT imaging are not currently available.

In addition to attractive reimbursement dynamics, we expect our coronary CTO crossing system to allow for reduced crossing time, less contrast media usage and require the use of fewer accessory devices, all of which would result in significant cost savings for the hospital system.

We're excited to advance this revolutionary product through the clinical and regulatory process and look forward to providing further updates on our progress in the coming quarters.

While we've reduced head count and streamlined operations for our peripheral business, we have taken steps to ensure our image-guided catheters remain available to treat patients with clinically-challenging peripheral artery disease.

We've maintained a field presence in existing sales territories and are focusing our clinical specialists and sales reps on supporting current users, while seeking growth opportunities within or in close proximity to existing accounts.

Underscoring our commitment to the clinical importance of our image-guided approach, earlier this week we announced an important new addition to our leadership team. Dr. Tom Davis, a practicing interventional cardiologist and one of the preeminent leaders in the treatment of vascular disease has joined Avinger as Chief Medical Officer. Dr.

Davis serves as Director of Cardiovascular Research at St. John Hospital and Medical Center in Detroit Michigan and has served on several scientific advisory boards for interventional device development. Dr.

Davis has authored numerous publications, presented extensively on the podium at clinical conferences and participated as an investigator or a principal investigator in multiple clinical trials for new endovascular technologies including several of Avinger's clinical studies. We're excited to have Dr.

Davis joined the team and look forward to working closely with him on clinical strategy and medical affairs initiatives to advance our clinical and product development programs and drive awareness of Avinger's image-guided therapies in the broader medical community.

We've also made important progress in the commercialization of our new peripheral products, along with the introduction of our new Tigereye ST crossing catheter in the second half of 2023.

We've completed the limited launch phase of our new Pantheris LV peripheral atherectomy catheter and are building product inventory for full commercial launch in the coming weeks.

Our new Pantheris LV, image-guided atherectomy system is designed to streamline the atherectomy procedure and in combination with our Lightbox 3 imaging console expand the mainstream appeal of our image-guided platform. LV stands for large vessel.

And consistent with its name Pantheris LV is ideal for the treatment of the larger arteries above and behind the knee, where the majority of PAD procedures are performed today.

Pantheris LV does not require a balloon for plaque apposition and operates at significantly higher rotational speeds than our current atherectomy offerings with variable speeds up to 3000 RPMs.

Based on our learnings from limited launch and the clinical outcomes, we see physicians delivering with the streamlined new device, we're excited to get Pantheris LV into the hands of more physicians through the commercial launch process. Before I close, I'd also like to provide a quick update on our strategic partnership with Zylox-Tonbridge.

As a reminder, Zylox is a fully integrated medical device company and a leader in the peripheral vascular and neurovascular markets in China. Zylox has developed and launched numerous products into the Greater China market, operates an extensive sales and marketing network and maintains a state-of-the-art manufacturing facility in Hangzhou, China.

Since closing Zylox's $7.5 million first tranche investment in March, we worked closely with Zylox's operating teams to support their efforts in gaining regulatory approval to sell Avinger's peripheral products in the Greater China region, as well as establishing their own manufacturing capability for our products.

We could not be more impressed with the professionalism of the Zylox organization and are excited to support their goal of commercializing our image-guided catheters in the China market in 2025. As previously disclosed, sales of Avinger products in the Zylox territory will be royalty bearing to Avinger.

And following regulatory approval, Avinger will sell finished goods to Zylox, until their self-manufactured products are available for sale in China.

In addition, once Zylox has qualified their own manufacturing capability and been successfully registered as a manufacturer of Avinger's products with the US FDA, Avinger will have the option to source finished product from Zylox.

We believe this could provide the opportunity for Avinger to reduce cost of goods sold, improve gross margin and reduce facility and related overhead expense in the future. At this point, I'd like to turn the call over to Nabeel Subainati, our Principal Financial Officer and Accounting Officer to take us through the financial results.

I'll then return for Q&A.

Nabeel?.

Thank you, Jeff. Total revenue was $1.8 million for the second quarter of 2024, compared with $1.9 million in the first quarter of 2024 and $2 million in the second quarter of 2023, reflecting the impact of reduced field sales head count in the last month of the quarter.

Gross margin for the second quarter of 2024 was 20%, compared with 18% in the first quarter of 2024 and 30% in the second quarter of 2023. The change in gross margin primarily reflects lower production activity during the quarter, as we continue to optimize inventory levels while conserving cash expenditures.

Operating expenses for the second quarter of 2024 were $4.5 million compared with $5.4 million in the first quarter of 2024 and $4.3 million in the second quarter of 2023. In June, we reduced our head count by approximately 24%, as we refocused our peripheral business activities.

Severance and other separation costs associated with this action were included in the second quarter, so we expect to see the benefit of these cost reductions starting in the third quarter of this year, with both improved gross margin and reduced operating expenses anticipated in the second half of 2024.

Net loss and comprehensive loss for the second quarter of 2024 was $4.4 million compared with $5.5 million in the first quarter of 2024 and $4.2 million in the second quarter of 2023.

Adjusted EBITDA as defined under our non-GAAP financial measures provided in today's press release was a loss of $3.8 million compared to a loss of $3.9 million in the first quarter of 2024 and a loss of $3.4 million in the second quarter of 2023.

For more information regarding non-GAAP financial measures, please see non-GAAP financial measures and the reconciliation of non-GAAP measures to the nearest GAAP measure provided in the tables in today's press release.

We continue to take steps to improve our balance sheet in the second quarter with cash and cash equivalents totaling $8.8 million as of June 30.

In May, we announced the conversion of $11 million or approximately 80% of CRG debt into shares of a new series of convertible preferred stock, reducing the outstanding principal amount of debt to $2.6 million with no principal payments required until 2027. The debt conversion resulted in an $11 million increase in stockholders' equity.

In June 2024, we announced a public offering valued at up to $24 million in total proceeds, including $6 million of upfront and up to an additional $18 million of aggregate gross proceeds upon the exercise in full of coronary clinical milestone-linked warrants. At this point, I'd like to turn the call back to Jeff for Q&A..

Thanks, Nabeel.

The second quarter has been busy for Avinger, as we refocused our peripheral business and reduced our operating cost structure, advanced our coronary CTO program towards IDE filing, supported Zylox commercialization efforts for entry into the vast and growing Greater China market and prepared our new Pantheris LV atherectomy catheter for full commercial launch.

As Nabeel highlighted, we also took important steps to improve our balance sheet and increase stockholders' equity during the quarter. We believe, we're well positioned going into the second half of the year and look forward to reporting our continued progress in the coming months. At this point, we'd be happy to take your questions..

[Operator Instructions] Our first question comes from RK from H.C. Wainwright. Please state your question..

Good afternoon, Jeff and Nabeel. So in the prepared remarks, you were talking about cost reduction and trying to lower some of the personnel.

I'm just trying to understand, is the reduction in personnel anything to do with the Zylox-Tonbridge collaboration? And what I'm trying to ask is, if at all you lose any revenues by decreasing the force here? Can you make that happen more and more than that by the collaboration with Zylox?.

Thanks for the question, RK. So first of all, the reduction in force and as we discussed we reduced about 24% of our head count with head count being our biggest operating expense in the actions we took in early June. None of that reduction was related to Zylox. We did an assessment, as we talked about at the time.

Where would our investment be required and where did the Board and the company want to focus our investment in the second half of the year with so many critical milestones and activities coming up related to our coronary program.

And so we took a step back in the peripheral business in terms of headcount, reducing about a third of the sales and marketing expense for that part of our organization. So that's where the majority of reductions were.

We also made some other reductions across the operations, manufacturing group and even in G&A to run the company even leaner in these financial markets as we move forward. We certainly are careful to maintain a full operating structure as a medical device manufacturer and marketer.

We are maintaining a field presence in all of our existing territories, although a reduced presence in some territories, Where we did make a reduction at the senior leadership level in sales, we've maintained two very experienced regional sales directors, one for the North and one for the south to guide those activities.

So none of this was related to Zylox. We do believe that Zylox provides significant opportunity for us as they access a brand-new market, a huge market with a very large sales and marketing infrastructure in place, both their own and distributors throughout the Greater China region.

We don't anticipate significant revenue from that until sometime well into 2025 as they get their regulatory approval. But we do think that will be -- definitely provide upside to our total revenue base as they start to come online and sell the products.

The other thing that the Zylox transaction brings to us is while we are maintaining a full manufacturing capability here in the United States, they are in the process of establishing and we're helping them establish their own manufacturing capability.

Not only for eventual supply to the China market, but under our agreements with Zylox, we have the opportunity to purchase product from them, finished goods on a cost-plus basis, which could provide the opportunity for us to significantly reduce our cost of goods, improve our gross margins and also reduce our overall operating -- our overhead expense.

So a lot of elements of this deal that could be very positive to us. We do expect in the back half of the year, because we have reduced our team, some softening of revenue on the peripheral side.

But we think that's the right strategic decision as we focus resources on the very high opportunity coronary area and continue to support our Zylox relationship..

Okay. Thanks for the all that color. On the Zylox relationship, when do you think Zylox will be able to start filing applications with the Chinese regulatory bodies so that you can get some product through the sales channels? I know you said sometime in 2025, I did hear that, but I'm just trying to understand where things are as we speak..

Yes. So there are really two primary activities that Zylox is leading, and we're supporting them. One is to prepare for regulatory registration of our products as imported products in China. And as you're probably aware, China NMPA, which is the Chinese FDA has very stringent and rigorous requirements.

And there is a complete battery of verification and validation testing that has to be done, it's called type testing in China. We're well along -- or Zylox is well along in that process.

And once that is completed -- and they've also been performing a lot of work, again, with our support on preparing the appropriate documentation for a regulatory filing.

So once that is completed and we certainly don't want to speak for them on a timing basis, they would be in a position to file, we think, a very robust package with the NMPA, which would support the kind of time frames that they've guided to, which is a 2025 potential launch. And I would expect that to be sometime in the second half of 2025.

But again, it's not something that we're in control of..

And then on the Pantheris LV, the limited launch that you have right now.

When can that get turned into your full commercial launch?.

Yes. So that -- so as you know, we've been in the market with the Pantheris LV product for a while now. We've had some wonderful case experience and learned a lot about the device, identified it a couple of areas, where we wanted to make some minor areas for improvement prior to commercial launch.

Those have all now been completed and released, and we're in the process of finalizing inventory builds for transition to full commercial launch, which we would expect to happen in the very near term..

On the cardiovascular catheter, you said, you're getting ready to file the IDE. So let's say, you file the IDE in the fourth quarter.

How long after that can you start the study? And in terms of your initial conversations with potential clinics that can do the IDE for you, where does that -- where do those conversations stand now?.

Yes. So first of all, to answer your first question, assuming filing of the IDE in the near term here as we talked about, we would plan and assume of course out of our control but typically, four to six months for IDE clearance, which would put us into the early part of 2025.

While we're waiting for IDE clearance we would be contracting with and preparing for the – certainly, the pilot part of our study where we would first go into five to 10 patients, and then the expansion into the full clinical study. We have already identified several clinical sites. We've been in discussion with those sites.

And our IDE filing will include the initial sites that we're planning on. So, that's how far along, we are in those discussions.

And I will say, there's a lot of enthusiasm with the physicians, not only who have been involved with the development of this product as part of our advisory board, but also other physicians who've learned about it, who we've shared information with and interest and participate in something that could be so really groundbreaking for this market.

As you know RK, this is an extraordinarily challenging condition to treat. And it is no exaggeration to say that physicians will take four to five hours, under fluoroscopy using many devices and accessory devices and oftentimes not having a successful outcome.

And so, if we can help these positions make this more efficient reduce the X-ray radiation, reduce the contrast media burden on the patient and most of all, have a safe and successful crossing of that coronary CTO in a much less invasive fashion, I think we really can make a huge difference in the standard of care.

So -- and I think physicians see that too. So assuming that we file on the time frames, we expect assuming we get the clearance on the time frames we expect, I would assume that we would be in the clinic in the first part of 2025 -- first half of 2025.

And while we are defining the number of patients required for our IDE filing, we do not see this as a large study in terms of number of patients required. And as we've discussed previously, there's only a 30-day follow-up required for a CTO crossing device in the coronary arteries.

So we would hope that we could get the study enrolled in a relatively efficient time frame and be in a position to file a 510(k) based upon the clinical data in 2026. Those are the time frames that we're operating against. And as I said, this has become a primary focus and certainly a priority of the company..

Thank you. Thanks for taking all my questions here..

Thank you, RK.

At this time, we have no further questions. I'll now turn the call back over to Mr. Jeff Soinski..

Well, thank you again, for joining our call this afternoon. We very much appreciate your interest in our company, and look forward to reporting our further progress in the coming quarters..

This concludes today's conference call. Thank you for attending..