Greetings, and welcome to KORU Medical Systems' First 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, Greg Chodaczek, Managing Director. Please go ahead, sir..

Thank you, Peter, and good afternoon, everyone. Earlier today, KORU Medical Systems released financial results for the first quarter ended March 31, 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 our 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 the website.

If you find -- you will find additional disclosure regarding these 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, May 4, 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 releases and filings with the SEC.

Joining us on the call today is Linda Tharby, President and Chief Executive Officer of KORU Medical Systems; and Karen Fisher, KORU Medical's Chief Financial Officer. Linda, please go ahead..

first is the scale to serve the German market; second is their track record of success; and third, is a best-in-class capability to deliver clinical training and patient care owned over many years serving diabetes patients in the home. We expect commercial activities to begin in Q2.

This geographic expansion is also relevant to our Novel Therapies business as KORU's broad regulatory approval and distribution is a differentiated offering to pharmaceutical companies. Moving to our Novel Therapies business.

During the first quarter, Novel Therapies was driven by revenue associated with the support of feasibility work for the aforementioned innovation agreement. We encouraged that Novel Therapies continues to play a more prominent role in our strategy and believe there is room for broad application beyond immunology as evidenced by our recent successes.

We continue to expand our pipeline, and we are currently pursuing over 18 opportunities for new drug candidates for our pump. This quarter, we are pleased to announce that we have signed one additional deal outside of Ig in the hematology area and have expanded the scope of a prior signed innovation deal with an Ig manufacturer.

We have dedicated significant time to expand our engagement regarding Novel Therapies pipeline, and we are beginning to see the results, both in signed deals and pre-commercialization revenues. In conjunction with the progress on the initiatives discussed above, we are continually building out our team, including a strengthened executive team.

I'm pleased to highlight another addition. In late April, we announced that we hired Brian Case, an R&D veteran with over 20 years of experience as KORU Medical's new Chief Technology Officer. As previously discussed, investing in innovation is a significant strategic growth area for KORU as we build out our Novel Therapies pipeline.

Brian will lead technology and product development and innovation as the company defines and executes its innovation strategy. Near-term innovation goals include line extensions, new product introductions and a next-generation system. And Brian will be instrumental to our long-term business success.

I will now turn the call over to Karen for a discussion of our Q1 financials..

Thank you, Linda, and good afternoon, everybody. I'm pleased to report our second consecutive quarter of double-digit net sales growth, ending the first quarter of 2022 with net sales of $6.2 million a 15% increase from $5.4 million from the same period last year.

Results were driven by domestic core growth of over 13% year-over-year with higher pumps and consumables sales outperforming a rebounding subcu Ig market growth at 7%.

As we expand our Novel Therapies pipeline, we are also excited to report Novel Therapies sales were $355,000 for the 3 months ended March 31, 2022, a $300,000 increase from the same period of 2021, primarily due to recognition of initial NRE revenues from an innovation milestone achievement for a large SCIg customer, which is expected to continue to generate NRE revenues through 2022 and clinical and commercialization revenues in the years following.

International core was down 8.6% year-over-year due to quarterly buying pattern changes on a few smaller customers. As Linda mentioned previously, we are excited to report that we have a signed distribution agreement in Germany.

With reimbursement, a great distribution partner and a large subcu patient base in Germany, we are excited about this expanded opportunity in Europe. Gross profit increased by $400,000 or 12.1% in the first quarter of 2022, while gross margin decreased by 150 basis points to 58%.

While we are excited to record the higher NRE revenues from the customization effort described earlier, this revenue had a dilutive impact to gross margin for the quarter.

Also contributing to lower margin was higher manufacturing costs in our core business from increasing raw material costs and labor costs that were partially offset by increased price and mix. Total operating expenses were $6.7 million for the quarter of 2022, an increase of $1.3 million for the same period last year.

The majority of the increase came from R&D expenses, which drove just over half of the increase or approximately $800,000 in the first quarter of 2022 compared to the same period last year.

The increase was driven primarily by higher salary and related costs as we build out our internal innovation capabilities as well as consulting fees to support accelerated product development efforts through our previously announced agreement with Gilero.

Our EQA drove 30% of the incremental spend over prior year in support of our expanded label indications and our EU MDR registrations. The remainder of our SG&A expenses were driven by new hires to support commercialization and business development.

Net loss for the first quarter of 2022 was $2.5 million or negative $0.06 per diluted share compared to a net loss of $1.3 million or a negative $0.03 per diluted share in the first quarter of 2021. The loss was driven by our investments to execute on our strategic initiatives as we just described.

As you can see from the previous slide, our use of funds remains focused on driving innovation and growth and on strengthening our foundation, including a Q1 investment in our new location. We used $2.7 million in cash in the quarter, which includes $700,000 for leasehold improvements, manufacturing and office equipment for our new location.

We have preapproved financing arrangements in the amount of $1 million, which we will execute in Q2 upon commissioning of the assets. Additionally, we expect to receive cash for build-out credits under our new lease of $200,000, and we're still waiting for our ERC credit of $700,000, which we recorded a receivable for at 12/31/2021.

The company ended the quarter with $22.6 million of cash, and we were well capitalized to continue to execute on our strategic plan. I will now turn the call back to Linda for guidance and closing comments..

Thank you, Karen. Turning to our expectations for fiscal 2022. As a reminder, our outlook is rooted in several key drivers, underlying market growth, continued recovery from COVID-19 pandemic, plasma supply, clinical trial activity and supply chain impact.

For full year 2022, we are tightening our revenue guidance to the top end of the range at $26.5 million to $27 million, previously $26 million to $27 million, due to the Q1 U.S. market growth, which is approaching our high single-digit range prior communicated for the year an expansion in our novel therapies pipeline.

The company reiterates its guidance to exit the year at a 60% gross margin run rate. Additionally, Q1 2022 supply chain disruption impacts, which are not expected to recur, have resulted non-favorable manufacturing and variances in Q1 which will be recognized in the second quarter of 2022 as we turn our inventory.

And finally, we reiterate our operating expense range in support of our strategic plan. We anticipate higher sequential Q2 expenses due to onetime building move expenses. In closing, our first quarter represents a very strong start to 2022. We are making great progress in advancing our strategic priorities.

We have met our second quarter of double-digit growth. We are progressing our label expansions with our fourth FDA clearance in 5 months, and our first clearance outside of Ig with EMPAVELI and Aspaveli.

We are expanding our Novel Therapies pipeline in both clinical trial and innovation agreements as a leading indicator of longer-term commercial opportunity, and we are beginning to build out our international strategy as we continue to build a strong team.

We are pleased with our ability to execute against our strategic plan to date as we work towards our longer-term vision of becoming a broad drug delivery player. Thank you again to the KORU team. And I will now turn the call over for Q&A..

[Operator Instructions]. Our first question is from Alex Nowak with Craig-Hallum Capital Group..

This is Chase on for Alex. So to start from me, penetration for prefilled syringes is great to see. Have you seen any impact to overall subcu penetration of the Ig market yet in your data? And any color on what you may be seeing as a result of this concerning new patient adds and pump orders for you guys would be helpful..

So Chase, great question. We are very encouraged by the prefilled growth that we see this year. And we are seeing that it is impacting subcu patient starts. Although there is a lot of things that affect it, we did see a 0.5 point improvement from Q4 in overall subcu penetration into the marketplace. So that was encouraging for us.

And then obviously, you saw the pump number that was recorded a 40% growth in quarter 1 and a significant part of that growth was attributable to our FreedomEdge, which is the pump that's specifically cleared for indication with prefilled syringes. So we see prefills, we're thrilled as being the only on-label indication.

We see it as a market opportunity with only 5% penetration with a lot of headroom for growth for us this year and the years following..

No, very helpful.

And then with the CTO announcement, any update on the new pump developments? Any other products in the works besides the new pump we should know about? Any color on how you're thinking about the pipeline strategically as the new CTO starts rolling here?.

Yes. So first, just let me say, we're thrilled to have someone of Brian's caliber onboard with the team. He has experience in developing many different pumps for different applications over the course of his career and both from technology, from in-licensing opportunities. So we've got a very experienced player in Brian.

So clearly, we -- innovation, as you see in our spending results is a huge focus of our efforts as we move forward. And that's really in support of capturing a lot more drug opportunity that we see in the overall pipeline. So our short-term activities will be focused on what I would call comfort and convenience.

You'll see improvements both to our FreedomEdge platform, what I would call, a second-generation Freedom platform that is more specifically geared to prefills. And then, of course, in parallel for all of that, our next-generation pump. And many, many new things we're planning for that next-generation pump.

So think about the 3 themes I like to talk about comfort, convenience, connected. You'll start to see the beginning of that pipeline rollout by certainly, next year at that time in the form of line extensions, then we'll go into some new products from there and then into our next-gen pump..

And then just concerning what you're hearing from the specialty pharmacies, as prefilled have started to roll out here, have you heard some feedback about potentially addressing some of previous pushbacks with switching to subcu? And how do you think things are trending in the specialty pharmacy?.

So great question, and we have done a lot of work actually our head of sales now is in meetings with all of them at one of our biggest conferences.

But to date, we certainly have heard that the clearance of the 20 ml from CSL that Hizentra has helped because it allows the patient to just put the prefilled syringe directly into our pump, which is fantastic.

I think the challenges that we hear today are obviously with the 5 and 10 formats and the fact that not everybody is in a 20, 40 or 60 that patients still at times have to draw up from the prefilled syringe into another syringe to put into the pump. So that's a little bit of additional work.

So we're looking forward to CSL building out their prefilled pipeline so that we can bring an even better patient experience to the marketplace. But overall, I would say we're working on our clinicals today. We're working on training a lot of new pharmacies and patients on the therapy.

And I would say expectations for prefills have outperformed our early expectations on this product..

Our next question is from Jason Bednar with Piper Sandler..

This is Joe on for Jason. Yes. So my question, so back in Q4, and obviously, reiterated today, you guys mentioned the Novel Therapies pipeline and investments in Europe and internationally is levers -- levers to pull to return to 20% growth.

So we're curious how we should be thinking about future developments of the Novel Therapies pipeline as well as progress in Europe? Obviously, particularly with the announced distribution agreement in Germany is impacting the top line in 2022 and beyond. And then the odds that we can actually get back to 20% growth moving forward with these levers..

Thanks, Joe. Great question. So maybe just I'm going to build this back to getting to the 15%, which obviously moving to the high end of our guidance, we're getting more comfortable with, and then I'll talk about the pathway to the 20%, which is what we're all aiming for. So clearly, the rebound in the U.S.

market is going to be the biggest thing that drives us back to that 15% plus growth range and the -- what we saw happen in first quarter, I talked about a 7% average on the quarter, but it looked like a 3% growth in January, 7% growth in February and a 10% growth in March. So that's very encouraging to us.

Beyond that, obviously, novel therapies and what we have in our pipeline for novel therapies. I mentioned the fact that we've expanded the scope of an innovation agreement we signed in Q4. That's very encouraging to us and then finally, the Germany deal, well, it's early.

We've just inked that we've got training to do, don't get the product into the hands of all their representatives in the marketplace, we see that as an opportunity. So to go from 15% to 20%, I would say it's -- we'll look at 3 things. Number one is, can the U.S. market grow double digits this year? If we see the U.S.

market grow double digits on a quarter-on-quarter, year-on-year basis, that's going to be very encouraging. Combined with our opportunity to complete that innovation agreement on time and get some incremental deals signed for Novel Therapies.

And then finally, I would say that international expansions beyond Germany, so we're focused on other markets as well will also be a positive to getting us to that 20% growth. So I see multiple -- I guess the other thing I would mention is prefills, prefills at 5% is encouraging to us. And again, a prefill customer is a KORU customer.

So we grow our position from 70% of the market to 100% when it's a prefill customer. So I guess what I'm describing is multiple shots on goal to get from the 15% to 20%. And I think we just need a little bit more time to see the market come back. A little bit more time to expand on Novel Therapies pipeline.

But you see us with all those proof points, we're recording each quarter that we're getting closer to those numbers..

That's really helpful. And then just one more for me. So congrats on the recent 510(k) approval for EMPAVELI, great to see for the business, obviously.

Can you just talk a little bit about how we should be thinking about the contribution from this approval looking forward? And to what extent patients may have already been using it off-label with the FreedomEdge pump?.

Yes. So I can't speak to off-label indication, although we know that the KORU pump was preferred in their clinical trials that they did early on for the approval. So we assume that pharmacists would have -- and doctors would have kept some of those patients on the pump.

So overall, and if we look at the numbers that Apellis is reporting, I'm going to talk about the U.S. market overall, we see the potential. And remember, we have competition out there from electronic pumps on this platform. And of the 150 new patients or so that start every year and the patient base we're trying to convert.

We see the opportunity overall this year somewhere between 100,000 and 200,000 this year for Apellis. That number is already in the numbers that I would have prior communicated. So if they do better, and we know they're reporting right now, and I hope they are, obviously, we'll see that come through in our numbers.

But I think this label indication is going to be a tremendous lift for us to now go and be able to promote the FreedomEdge pump with Aspaveli and EMPAVELI..

Thank you. 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..

Thank you, everyone, for listening in today. And I want to say thank you to the entire KORU team, again, for a fantastic start to 2022..

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