Greetings, and welcome to KORU Medical Systems Third Quarter 2022 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Hannah Jeffrey, from Gilmartin Group. Thank you, and over to you..

Thank you, Ezekiel, and good afternoon, everyone. Earlier today, KORU Medical Systems released financial results for the third quarter ended September 30, 2022. A copy of the press release is available on the company's website. During this call, we will make certain forward-looking statements regarding our business plans and other matters.

These comments are based on our predictions and expectations as of today. Actual events or results could differ materially due to many risks and uncertainties, including those mentioned in the associated press release and our most recent filings with the SEC. We assume no obligation to update any forward-looking statements.

I encourage listeners to have our press release in front of you, which includes our financial results as well as commentary on the quarter. During the call, management will discuss certain non-GAAP financial measures in our press release and accompanying investor presentation and our filings with the SEC, each of which are posted on our website.

You will find additional disclosure regarding those non-GAAP measures, including reconciliations of these measures with comparable GAAP measures, in our press release and accompanying investor presentation and those filings.

For the benefit of those listening to the replay, this call was held and recorded on Wednesday, November 9, 2022, at approximately 4:30 p.m. Eastern Time. Since then, the company may have made additional comments related to the topics discussed. And please reference the company's most recent press release and filings with the SEC.

Joining us on today's call is Linda Tharby, President and CEO of KORU Medical Systems; Tom Adams, KORU Medical's Interim Chief Financial Officer; and Josh Bennett, VP of Strategy and Business Development. Linda, please go ahead..

Thank you, Hannah. Good afternoon, everyone, and thank you for joining us today. We are very pleased with our results this quarter as we continue to make progress against our strategic objectives across all 3 of our businesses.

We are making impactful strides as a leader in large-volume subcutaneous drug delivery, and we are very excited by our advancements to enhance the quality of life for our patients while improving therapeutic benefit and overall health care system costs. All of this is not possible without the efforts of our KORU Medical Systems team.

I want to begin by thanking them and our shareholders for their continued support. During today's call, we will use slides to support our commentary. I will begin with the business update of the third quarter. I will then turn the call over to Tom to discuss the quarterly financials, before ending with updates to our 2022 guidance.

After concluding our prepared remarks, Tom, Josh and I will then be happy to open the call up for Q&A. The third quarter marked another period of growth for the company, with strong performance across several key milestones.

Q3 '22 revenue of $7.8 million and 28.5% growth marked our fourth consecutive double-digit growth quarter, and we saw strength across all of our businesses. We continued to see great progress and momentum in our novel therapies business.

During the quarter, we entered 4 new clinical drug collaborations in Phase II, including 2 announced yesterday with Kira Pharmaceuticals, and we had 1 of our drugs progress to Phase III. We now have 23 total commercialized and collaboration deals. This includes 14 novel therapy collaborations and 9 on-label drug indications. In our U.S.

core business, our growth of 16% outpaced the underlying subcutaneous immunoglobulin, or SCIg, market as we executed on strong sales and marketing programs and were also aided by the backorder clearance. Our international business saw 46.8% growth off a relatively small base, with growth in several countries.

On gross margin, we ended the quarter at 55.7%, up from 51.1% in Quarter 2, driven by great efforts from our operations team, an improving supply chain and improvements in manufacturing efficiency. We also continued to build our executive team, hiring a new Vice President of Medical Affairs, Brent Rutland.

Brent's experience base is well aligned with our strategy, and his expertise will advance clinical evidence generation in support of our product pipeline, provide valuable insight to our drug therapy candidates and help develop important key opinion leader relationships.

And finally, driven by the confidence of our novel therapies business and a growing core business, we are raising our guidance range to $27.5 million to $28 million. Before providing more detail on the quarter, I want to spend a few moments on our strategy and capability to enable the growing shift from the hospital to the home.

Our Freedom system is the market leader in large-volume subcutaneous, or subcu, drug delivery, which we classify as above 10 ml.

With the use of our system and our value-added services, we empower patients to manage their weekly, biweekly or monthly therapies independently from their homes, versus a nurse-assisted visit to a hospital or infusion center.

The Freedom system is attractive to pharmaceutical companies, as it is a market-proven system that offers them a clear pathway to the clinic and commercialization.

We have FDA clearance and regulatory approval in over 25 countries, commercial readiness with 9 on-label SC drug indications and a simple, fully mechanical system that can be customized for rapid deployment. Our core SC business comes from our FDA-cleared drug therapies for use with our pump.

The majority of this business comes from the growing SCIg market, where patients receive our reusable pump at the start of their therapy and the disposable consumables are delivered to their home once per month, generating approximately $750 per year in recurring revenue per patient.

As a market leader, we support over 30,000 patients globally who require SC therapy infusions at least once per week. This segment is currently the largest part of our revenue and represents a $480 million global opportunity, with over 600,000 patients with PIDD, CIDP or PNH, the majority of which are on IV therapy.

The second area of our business is our novel therapies business, where we work with pharmaceutical companies to provide services, innovation and product for their clinical trial process as they are moving their IV drugs to a subcu formulation or are working to introduce new SC drugs to the market.

We have identified a significant pipeline of opportunities within novel therapies across multiple drug classes and phases, currently estimated at over a $2 billion total addressable market, or TAM.

The company has closed 14 pharmaceutical collaborations, including an FDA approval for 1 new novel therapy drug, and has 6 new drug therapy areas represented in our pipeline. This progress diversifies our portfolio and demonstrates the viability of large-volume drug delivery in the home across multiple therapies.

We are excited by the growth and momentum in both our core SCIg business and by our novel therapies pipeline and by the opportunity it presents, a $2.5 billion TAM, as the market for at-home subcu delivery continues to expand.

We see the market for subcu delivery continues to grow for a number of reasons that are supported with an increasing number of studies. First is the therapeutic benefit of subcu versus IV therapy, which has been well studied in the Ig space and we are seeing further studies of this in other drug classes.

The proven therapeutic benefits include the delivery of consistent Ig levels over time, leading to fewer adverse reactions and infections. The second is a preference for SC over IV therapy; this one from a recent oncology study showing 85% patient preference.

And finally are the cost savings of 33% to 52% associated with multiple-drug therapies being administered outside of the hospital, supported by a UnitedHealth Group study.

We believe that the therapeutic benefits, combined with patient preference and associated cost savings, will continue to drive increasing numbers of pharmaceutical companies and patients towards SC therapy. Turning back to our third quarter, we saw significant progress in execution of our strategic initiatives.

Within our commercial SCIg market, we are working to ensure we win new patient starts, win prefilled syringes and expand geographically. For new patient starts, we continue to see the company's growth outpacing the growth of the underlying U.S. SCIg market.

Our domestic core growth for the third quarter was 16.2% and 12.8% year-to-date, outpacing an SCIg market that is growing just over 6% year-to-date. This growth is driven by execution on our sales and marketing programs, including value-added services and label expansions.

Second, the prefilled market remains the fastest growing part of the SCIg market, and KORU remains uniquely qualified to capitalize on this growing market with our Freedom Infusion System, the only pump with FDA 510(k) clearance for a prefilled syringe indication.

For the third quarter of 2022, the prefilled market has grown 244% year-over-year and now accounts for 11.5% of the overall SCIg market. Lastly, our ex-U.S. business grew 46.8% this quarter, as we saw growth across several European markets in both our pumps and consumables as we continued to increase our focus in this area.

Given the growth being driven by prefilled syringes, or PFS, I want to dive deeper into the progress made during the quarter. As I mentioned above, the prefilled syringe market is currently the fastest growing segment within the SCIg market. While still considered early stage, we believe prefilled syringes offer significant opportunity.

Since receiving the only FDA clearance with a pump specifically for prefilled syringe indication in Q4 2021, the market penetration has nearly tripled, ending the third quarter of 2022 with an 11.5% prefilled syringe penetration.

We believe PFS will continue to be the preferred format over vial administration, as from the patient's perspective a prefilled syringe eliminates approximately 25% of the steps from the process. In a recent study, 97% of patients reported satisfaction with prefills for their convenience and ease of administration.

While offering significant patient value due to the elimination of the vial transfer step, prefilled syringes today satisfy only about 1/3 of the total market opportunity, according to patient dosing requirements. Prefilled syringes today are offered in a 5-, 10- and 20-ml format.

Thus, we continue to work with our pharma partners to pursue additional indications and innovation opportunities related to prefills to serve a greater part of the Ig market. Moving to our novel therapies business, we have made strong progress executing our strategy to extend our leadership position in SCIg to broader novel therapy drugs.

This business works with pharmaceutical companies to use our Freedom system in clinical trials required for drug approval and launch, and the system is often customized to the requirements of each drug.

Revenue in this business includes devices sold for use in trials and nonrecurring engineering and technical services to customize and validate our platform for use with each drug. We expanded our collaborations in the quarter, winning 4 new indications in neurology, nephrology, hematology and respiratory, all in Phase II.

This includes the 2 agreements with Kira Pharmaceuticals we announced yesterday. Additionally, a previous program advanced from Phase II to Phase III. This brings our total collaborations to 14, including 1 novel therapy drug which was approved in the first quarter of this year, Apellis' Empaveli. We have expanded our total portfolio to 7 drug classes.

We also have 10 to 15 additional opportunities we are pursuing in our pipeline that span from Phase II to Phase III and are both reformulations and new indications and new molecules. Each of these collaborations represents a drug for a specific indication, spanning Ig and non-Ig drugs.

We're making progress because of the value we provide to pharmaceutical companies. Drug companies want a device that has an approved regulatory pathway, is patient-friendly with consistent training support, able to be marketed globally and can get them into the clinic quickly.

Our ability to meet these needs as evidenced by the 30,000-plus global patients using the Freedom system successfully creates confidence that KORU can deliver. And the flexible design of our system, adaptable to volume and needs of each medication, allows us to enter the clinic quickly, a key priority in the drug development process.

Now I would like to take a closer look at those close collaborations and lay out additional details about their potential.

Before turning to the specific metrics, I want to remind everyone that these drugs are either in development or seeking new indications and each indication will have an individualized path through the clinic, regulatory and commercialization processes.

In total, our 9 on-label SC indications and 14 active collaborations include over 2.8 million potential patients and a TAM of roughly $2.5 billion. The total addressable market of each collaboration is based on many factors.

The ones we consider in our TAM model include each drug's potential patient population, expected treatment frequency or how often they dose and an average selling price of our Freedom pump and consumables. As an example, the oncology drug in Phase II has a patient population of 800,000, but a less frequent dosing expectancy and a higher ASP.

We have not discounted our TAM for clinical risk, but have provided the phase of each of our drug collaborations. Our strategic plan does not rely on every collaboration to make it through to commercialization. However, each indication represents an additional patient opportunity for the company.

We remain confident that novel therapies will accelerate our growth and will continue to expand. We plan to update this pipeline quarterly to show the novel therapies' progression and are extremely excited about the potential.

We remain on track to achieve our strategic goals based on continued positive engagement by pharma and ongoing collaborations in our pipeline. I will now turn the call over to Tom for a discussion of our Q3 financials..

Thank you, Linda, and good afternoon, everyone. I'm excited to report our fourth consecutive quarter of double-digit net sales growth, ending the third quarter with net sales of $7.8 million, a 28.5% increase from $6 million for the same period last year.

This increase was driven by strength across all 3 business segments, with each reporting double-digit growth. Net revenues for the third quarter included $300,000 of backorder from Q2, which accounted for 5% of the overall revenue growth in the period.

Our domestic core business grew by 16.2%, or $823,000, and was primarily driven by increased volume growth ahead of SCIg market growth and label expansions, including prefilled syringes. Domestic core also benefited from clearing of $300,000, or 6% of domestic growth, of backorders from the second quarter of 2022.

International net sales were $1.1 million for the 3 months ended September 30, up 46.8% compared with the same period last year, due to volume growth in several European markets. Novel therapy sales were approximately $760,000 for the quarter, an increase of $547,000 over prior year, or a 252% increase.

Higher novel therapy sales related to services performed for innovation, development agreement and increases in clinical trial product sales to pharmaceutical customers.

The following slide shows a sequential view of margin improvement from last quarter as well as a bridge of gross margin and related impacts that we saw in the quarter versus the prior year.

Starting on the left side, recalling that in Q2 our gross margin was impacted by supply chain issues and higher manufacturing variance amortization impact in the quarter, we saw sequential quarterly improvement of 460 basis points this quarter driven by supply chain improvements, which resulted in improved manufacturing productivity.

On the right side, total gross margin for the quarter was 55.7% and was lower than prior year by 220 basis points. The decline in the gross margin percent was primarily caused by higher manufacturing costs associated with labor and materials.

In addition, our NRE service revenue mix, while contributing positively to gross profit, showed a decline in gross margin as a percentage of sales. Price and product mix contributed a small offset of the overall margin decline.

Total cash used for the first 3 quarters was approximately $9 million, primarily driven by net losses in operating activities of $6.7 million and $2.5 million of investing activities.

Of these drivers, we estimate approximately $3.7 million of onetime impacts, including our headquarters relocation, executive severance and inventory build for supply chain disruptions due to a prior announced manufacturing transition to our outsource partner.

We expect in the last quarter of the year to reduce the cash usage by planning for lower net losses due to higher sales, gross margin improvements and lower operating expenses in line with our guidance. In addition, we expect lower working capital driven by a reduction in trade accounts receivable balances and lower inventory.

And finally, incoming cash from state-filed employee retention credits and leasehold improvement reimbursements are expected in the final quarter. As a result of our second half projections, we expect our ending cash to be a minimum of $16 million.

Finally, as indicated in the appendix, our net loss for the third quarter of 2022 was $1.2 million, or a negative $0.03 per diluted share, compared to a net loss of $1.1 million, or a negative $0.02 per diluted share, for the same period of 2021. The net loss included a tax benefit of $300,000 for the third quarter of 2022.

On a non-GAAP basis, adjusted diluted earnings per share was a negative $0.03, compared to a negative $0.02 in the same period of 2021. I will now turn the call back to Linda for guidance and closing comments..

SCIg market growth in the high single digits; plasma supply; clinical trial activity and expansion of the novel therapies pipeline; inflationary impacts, including labor and supply price increases; supply chain and labor shortage impacts; timely receipt of other receivable tax credits; and planned inventory reductions by year-end '22.

For full year 2022, we are raising our revenue guidance to $27.5 million to $28 million, previously $27 million to $27.5 million, based primarily on the strength of our novel therapies pipeline and continued growth in the U.S SCIg market. We are confirming our guide to a 55% to 60% gross margin to exit the year.

We expect stability and less disruption in our supply chain, and we are managing our NRE margin variability. We have lowered our operating expense range to $26.5 million to $27 million, previously $27 million to $28 million, in line with our latest projections.

And finally, we expect our cash position to reflect a year-end balance of a minimum of $16 million. We anticipate continued improvement from the first half of the year burn rate, where we had significant onetime investing activities for our headquarters relocation and experienced lower gross margins driven by supply disruptions.

In addition to higher sales and improved gross margin per our forecast, we expect lower working capital from both reduced AR and inventory. In addition, we expect cash from our filed employee retention credit and tenant improvement reimbursements. In closing, we are making significant progress in advancing our strategic priorities.

We have achieved our fourth consecutive quarter of double-digit growth and are making continued progress within the novel therapies pipeline. Our core domestic and international businesses are also reporting strong growth. We continue to be resilient in the face of multiple supply chain challenges and are showing gross margin improvements.

Our team is motivated and capable of executing on our strategic plan. We are excited by our progress to date and look forward to continuing to build our position as a leading drug delivery player empowering patients and building value for our shareholders. I will now turn the call over for Q&A..

[Operator Instructions] Our first question is from the line of Alex Nowak, from Craig-Hallum..

Linda, you've been at KORU now for 18 months, and you've taken this business from growing pretty much in line with the market to growing well above at SCIg, plus a bunch of other stuff on the international side, novel therapies.

But on Ig, what is really the biggest driver of that success? Is it restructured pharma contracts? Prefill? New approvals there? Changed sales force? Just trying to understand what's with the strength, the real core strength in the Ig franchise..

Great question, Alex, and thanks for joining us today. So you hit a number of topics in your question. So let me start with we really focus first on rebuilding, and we have a very strong team now, a full sales team. We put in new key account management. We surrounded them with value-added services, with nursing services that we hired into the channel.

So not only do we bring a high-quality product to our patient base, but value-added services that we surround them with, including all of our full training services and online training services is critically important. And then you look at our sales and marketing progress and programs. We focus in a couple of key areas. First is on-label indications.

That was the first priority we went after. And here in the U.S., we added 4 new label indications over the course of the last year, which really helps our specialty pharma partners be able to promote only 1 platform. They also see our novel therapies pipeline.

And for these specialty pharmacy customers, bringing them new patients is how their business model works. So they're very appreciative of all the work that we're doing in that area. And then finally, prefilled syringes. Having the only pump that is approved for a prefill indication is critically important.

We see today that prefilled syringes are driving the majority of the growth in overall SCIg. And while a portion of that is being taken away from vial administration, we see it also penetrating the overall market. So it's a great team, it's focusing on our pipeline and value-added services and then executing against those programs every single day.

And then we just have really focused in on key accounts and ensuring that we're getting in there and negotiating agreements with these accounts. So a long way to go, but we are very pleased with our progress in the U.S. business..

That's great. And really appreciate outlining the pipeline here around novel therapies. There's a lot of drugs on here, most of them Phase II, a couple of them are Phase III. I was hoping we could get a little bit more granular on the indications.

And maybe just take one of the Phase IIs and take one of the Phase IIIs, and could you give us a little more detail what sort of drug class it is, where it could be used? Just to give, I think, us an idea on how the pump can be used beyond just the Ig market like it is today..

Sure. So maybe I'll start, and then I'm going to hand the call over to Josh, who really leads up this whole new business area for us.

But I would say, as you indicate, first of all, this is our first time showing the pipeline in this level of granularity by indication that we're working on, by drug therapy class, and we'll continue to take feedback from our investor base to get better at this, certainly every single quarter. But we're really proud of the progress.

So maybe I'll start with one, which is the oncology piece that I talked about. Oncology, as we think about this one, this could start, as I've mentioned earlier, with alternate-site delivery of oncology drugs with patients in clinic today.

Instead of the nurse using a push methodology with the syringe, they're using the KORU pump to free up patient time. Obviously, a tremendous patient population, but a less frequent dosing administration. The Kira indications, perhaps I'll hand it over to Josh.

He can talk about Kira and some of the indications there, and maybe, Josh, you could use one other opportunity in the pipeline..

Sure. Alex, thanks for the question. So I think, as Linda mentioned, we're very excited about what we see in the pipeline and the strength of some of these opportunities. And think about Kira, specifically, what's exciting about what they're doing is they're a fantastic partner. They have a unique asset in KP-104.

And it's addressing multiple conditions, multiple indications, with significant unmet needs. So that one is an example we size as a total opportunity of at least 150,000 patients in the U.S., with an opportunity to be quite a bit bigger when we look outside the U.S.

We're also very encouraged by the opportunities that are not yet translated into deals that we are actively pursuing. The pace of those has increased dramatically this year as folks are becoming more aware of KORU as a great option for large-volume subcu therapy. And those span Phase II, Phase III trials as well as new drugs and reformulations.

So we think when we look across the whole pipeline, this $2 billion TAM on top of the $0.5 billion we have in our core business really did encourage us on our ability to create value over time..

And maybe just, obviously, many of these, we can't get into a lot of detail because they are covered under confidentiality with our pharma partners. The other piece I would just mention is we also have a large number in immunology, so in our core business, where we continue to work on geographic expansion, new device indications and reformulations.

And that's very exciting because it's nearer term for us and gets us ever closer to that $480 million TAM..

And if we go back a year ago, last December, at the Analyst Day, the goal was to get 1 new drug commercialized in 5 years. You now have 4 years left, but you've got 14 drugs in the pipeline.

Confident that you hit that target?.

I think we already did. We had our first non-Ig drug launch, although on a smaller indication, in Quarter 1 of 2022. So I would say our confidence level is high. And we anticipate doing another Investor Day toward the end of Q1 of '23 or early in Q2, and I think we'll have a lot of exciting news to report.

We've been working hard in this novel therapy space. The company has -- I entered a company with just a great franchise of patient base, great relationships with specialty pharmacy. And we really needed to get out there and have people understand who KORU was and what we offered.

And this year, we presented at 2 of the largest drug delivery conferences and attended all 3. And the feedback and response and now people really understand that there's a system out there that can deliver volumes of drugs subcutaneously is very encouraging, and we have a lot of interest. So it's exciting..

Our next question is from the line of Kyle Rose from Canaccord Genuity..

This is Caitlin on for Kyle. Just on novel therapies, it appears as though you've increased the potential TAM to $2 billion from what you previously indicated.

Can you kind of explain what's built into that larger TAM?.

So thanks for the question, Caitlin. And I'll start, and then I'll hand it over to Josh. So when we reported the $1 billion pipeline last year and total addressable market opportunity, I think there were two major differences. First of all, I don't think we were fully aware of the opportunity in front of us.

So we used a fairly high discount factor in terms of the overall number of drugs that would be available to us. And second, it had a lot of the risk factors entered in. So it was discounted for things like clinical risk, drug success, competitive risk, et cetera.

What we're showing you here is a full total addressable market, versus a fully discounted one. I think that one probably more addressed the full commercialized opportunity, but it didn't address what we're now seeing, which is a larger pipeline of potential opportunities..

And Caitlin, the only thing I'd add to what Linda said is we're really encouraged by the size of some of the opportunities being a bit larger than what we assumed last year. We'll always have a mix in our pipeline of things that are a little bit smaller and things that are a little bit larger.

But our confidence in the size of each drug opportunity has increased..

Got it.

And just on the prefill market, when can you expect to kind of offer these smaller prefill syringe sizes?.

Okay. So good question, Caitlin. What's offered today are the smaller sizes, which is 5-, 10- and 20-ml. Most patients dose above a 50-ml.

And I can't speak to when, due to confidentiality reasons and competitive reasons, but I would say we're working aggressively at the next size formulations for prefills, given the success we're seeing in the market and the patient uptake..

Our next question is from the line of Jason Bednar from Piper Sandler..

Linda and Tom, this is Joe on for Jason. Congrats on the nice quarter and the solid progress here. Just wanted to start on the gross margin guide. So it offers a large range, with less than 2 months left in the year.

And we're just wondering, do you feel comfortable more the upper or lower end of that range? And what could lead you to finish on either end of that range?.

Joe, thanks for the question. As you can see, the gross margin has improved from Q2 to Q3 by about 460 basis points.

As we get into Q4 here, part of it is our product versus with respect to our products for our core domestic business and the mix of service revenues for our novel therapies business, which we've been really calling out all year that mix. So it's dependent on work completed on the NRE service aspect of that.

I would say from a projection standpoint, we're right in that midpoint of that margin call, and that's where we expect to be. Now obviously, there's things that happen. We're ensuring that our supply chain continues to have stability and that we're watching our labor costs, et cetera. So that's where we plan to land the quarter..

Okay. Got it. And then following up on kind of a prefill question that was asked prior, we're wondering with the penetration of the prefill market where could that go over the next couple of years.

Or do we see the trajectory of that range start to moderate at any level over time?.

So great question, Joe. So of course we're going to look at analogs that we see in other markets, such as vaccines, et cetera. But we believe that once the larger sizes are introduced and our new innovation in this area is introduced, we believe that over the next 5-year range that this will be more than half the market..

Okay. Got it. And just one more from us on regards to 2023 Street numbers. So the Street is modeling 15% growth for '23. Obviously, KORU has been doing better than that year-to-date.

Is this a good starting point as we look out to next year? Are there any factors you think the Street should be considering in their models that aren't really being contemplated at this moment?.

We're not going to comment right now a lot on '23. We're just in the process now of working with our board on our full '23 plan and getting approval for that. But I'm just going to come back to the fundamental drivers that we need to think about for our market and our business.

So number one is novel therapies pipeline and the strength, which we talked a lot about that today, and we feel quite confident about that. The U.S. SCIg market has continued to grow. We saw it retract a little bit, which we -- generally, we see the quarters go up and down, but calling that market probably for next year in the low-double-digit range.

So that's going to be really important, and we feel quite good about that. And then the third piece that we always think about is our international expansion for next year. You'll see us come out more aggressively on our international expansions for next year..

Ladies and gentlemen, we have reached the end of the question-and-answer session, and I would like to turn the call back to Linda Tharby for closing remarks..

All right. So I would like to close with saying thank you again to the KORU team for a great quarter. Thanks to our investors for listening in today. Thanks to the analysts for the great questions. And we're appreciative to our entire team for a fantastic quarter, and we look forward to reporting next quarter. Take care..

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation..