KORU Medical Systems, Inc.

Greetings and welcome to Coru Medical System's first quarter 2022 earnings conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Greg Horacek, 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 31st, 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. You will find additional disclosure regarding these non-GAAP measures, including reconciliation 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 4th, 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 Kover Medical Systems, and Karen Fisher, Kover Medical's Chief Financial Officer. Linda, please go ahead.

Thank you, Greg. Good afternoon, everyone, and thank you for joining us today. Before we begin, I want to express a heartfelt thank you to the CORO team for their dedication and passion in delivering another strong quarter in our mission to improve the quality of life for patients self-administering infusion therapy in the home. During today's call, we will use slides to support our commentary. I will begin with a brief overview of financial results before turning to a business update. I will then turn the call over to Karen to discuss the quarterly financials before ending with updates to our 2022 guidance. Karen and I will then be happy to open the call up for Q&A. Before jumping into Q1 highlights, a few comments on our progress and vision as a leading drug delivery provider. Our Freedom Infusion System is being used today by over 25,000 patients to subcutaneously infuse large volume drugs in a home setting, supporting a growing trend to healthcare delivery in the home. With our label expansions, we continue to increase our penetration into the sub-QIG total addressable market population of over 300 million. We continue to expand our pharmaceutical partnerships with our on-label indications now totaling 12, with our announcement of another new label addition this week. As a market leader and provider, we deliver our pumps and disposables into the home through our specialty pharmacy partners as we continue to strengthen our relationships with them. And as the overall market for sub-Q development continues to expand, we are extending our leadership position into new drug categories. With further agreements and pipeline expansion that I will discuss today, we are driving closer to the $1.3 billion total addressable market. Turning to our first quarter results, we reported net revenues of $6.2 million for the first quarter of 2022. This represents a 15% increase year over year and marks the company's second consecutive quarter of double-digit growth. Our domestic core business led our growth with a 13.2% increase. The strong quarter in our U.S. business is indicative of our continued implementation of our strategic plan to outpace the underlying market growth. The overall SCIG drug market also saw an uptick in growth from 1% in Q4 to 7% in Q1. We believe these trends signal market recovery as patients return to their regular cadence of therapy, and we see increases in patient diagnosis as concerns over the pandemic subside. Net revenues were down 8.6% year-over-year for International Core due to ordering patterns at a few of our smaller distributors. Novel therapies revenues increased to over $350,000 for the first quarter as we began to recognize pre-commercialization revenues from our pharmaceutical pipeline deal expansion. We are very pleased with our solid start to the year. In December of 21, we rolled out a strategic plan, and I will now turn our focus to providing a Q1 update. The five-year plan strategic initiatives include increasing core SCIG penetration, extending to novel therapies, and continuing to build our foundation to support growth. In our efforts to increase penetration in our core business, the U.S. business nearly doubled the pace of the overall SCIG drug market growth, driven by a 40% increase in our pumps as an indicator of new patient starts. One of the biggest areas of progress has been the expansion of our label with four new drug device additions over the last five months, and in particular, the pre-fill syringe clearance in November. This has assisted an expansion of pre-fills in the market in Q4 of 3.4% to 5% penetration in Q1. In support of expansion in our international business, we are also pleased to announce the signing of a distributor agreement with DIA Expert, a leading provider in the German market of products and services for patients administering therapy in the home. In our novel therapies business, we continue to see an uptick in our pipeline with one new non-IG deal signed this quarter and five total deals in the last two quarters. We are also pleased to announce a scope expansion of an innovation development agreement signed last quarter and for which we have begun to recognize revenues for milestone completion this quarter. In support of all of these initiatives, we continue to build a stronger foundation for growth at CORU. We are on track to move our new building location to Marlowe, New Jersey on June the 1st. We have built out our executive team with the hiring of a new Chief Technology Officer Brian Case, who brings us 20-plus years of experience in technology and product development. And finally, the final phase of our outsourced manufacturing is on track for Q3 implementation in support of expanding our core business margin to the 60% plus range. I'm now going to dive a little deeper into our expanded label indications. Our label expansion is critical as it does two things. First, it enables us to work pre-launch with our pharmaceutical partners in ensuring a safe and effective drug delivery device experience for patients. Second, with a broad label, we make it easier for our specialty pharmacy accounts to service patients with an FDA-cleared platform. So two key highlights on this slide. First is the pace of label expansion. We have seen four new indications in the past five months indicating an uptick in both new drugs and sub-Q delivery and our efforts. Second, the two new clearances we announced this week expand our use of the KORU Freedom Edge infusion system outside of IG. The pump is now clear to deliver Empaveli, marketed by Apellis in the United States, and branded as Aspaveli and marketed by Sobe outside the United States. Mpavelli and Aspavelli are prescription drugs used to treat PNH, a rare blood disease. The total U.S. addressable market population is approximately 1,500 patients with about 150 new diagnoses each year. With their treatment occurring twice per week, this could expand Quora's total addressable market by approximately 2 to 3 million. The most critical part of this new indication is that we establish our platform outside of IG as a proof point as we look toward the future and further solidifying Koro Medical as a leader in high volume subcutaneous drug delivery. Turning towards a pre-filled syringe market, this represents a significant opportunity in an early stage fast growing market. Pre-filled syringes are rapidly capturing market share and represent 5% of the total FCIG grams infused today, up from 3.4% in the prior quarter, and driven by expanded efforts from our label expansion for pre-filled syringes in November. Pre-filled syringes offer a distinct advantage to patients by removing five steps from the infusion process. 20 ml format, this provides us an excellent opportunity to capitalize on this growth. We have focused on commercialization with a specific effort on new patient adoption and conversion. We also have coordinated efforts with our partners as they roll out their marketing strategies. We look forward to continued work with our pharmaceutical and specialty pharmacy partners to increase pre-filled penetration and simplify the lives of our patients. To date, we have focused our strategic efforts on our U.S. core and novel therapies businesses. However, having just returned from a multi-country European tour, I'm excited to announce progress on our strategy to expand geographically in our international business. Germany is one of the largest SCIG markets where we did not participate. It has a large population, high utilization of SCIG, and double-digit growth. After a thorough search, we have signed an exclusive distribution agreement with DIAXPERT. We chose DIAXPERT based on several key capabilities. 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 CORU'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 Coru Medical's new Chief Technology Officer. As previously discussed, investing in innovation is a significant strategic growth area for Coru 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 consumable sales outperforming a rebounding sub-QIG market growth at 7%. As we expand our novel therapies pipeline, we are also excited to report novel therapy sales were $355,000 for the three 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 SEIG 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 sub-Q 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 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 to build out our internal innovation capabilities, as well as consulting fees to support accelerated product development efforts through our previously announced agreement with Galero. RAQA 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 six cents per diluted share compared to net loss of 1.3 million or a negative three cents 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 pre-approved 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 to $27 million, previously $26 to $27 million. due to the Q1 U.S. market growth, which is approaching our high single-digit range prior communicated for the year, and 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 in unfavorable 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 one-time 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 five months and our first clearance outside of IG with MPavelli and Aspavelli. 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 CORU team, and I will now turn the call over for Q&A.

Thank you. At this time, we will be conducting a question and answer session. If you would like to ask a question, Please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for questions. Our first question is from Alex Nowak with Craig Hallam Capital Group. Please go ahead.

Good afternoon, everyone. This is Chase on for Alex. So to start from me, penetration for pre-filled syringes is great to see. Have you seen any impact to overall sub-Q 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 ads and pump orders for you guys would be helpful. Thanks.

So, hi, Chase. Great question. We are very encouraged by the pre-fill growth that we see this year, and we are seeing that it is impacting sub-Q patient starts, although there's a lot of things that affect it. We did see a half a point improvement from Q4 in overall sub-Q 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 one, and a significant part of that growth was attributable to our Freedom Edge, which is the pump that's specifically cleared for indication with pre-filled syringes. So we see pre-fills. We're thrilled as being the only unlabeled 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.

Very helpful. Thanks. And then with the CTO announcement, any update on the new pump development? 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?

Yeah, so first, just let me say we're thrilled to have someone of Brian's caliber on board 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. Clearly, innovation, as you see in our spending results, is a huge focus of our efforts as we move forward. That's really in support of capturing a lot more drug opportunity that we see in the overall pipeline. Our short-term activities will be focused on what I would call comfort and convenience. You'll see improvements both to our Freedom Edge platform. what I would call a second-generation freedom platform that is more specifically geared to pre-fills. And then, of course, in parallel to all of that, we have our next-generation pump and many, many new things we're planning for that next-generation pump. So think about the three themes I like to talk about, comfort, convenience, connected. You'll start to see the beginning of that pipeline roll out by 2020. 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.

You know, and then just concerning what you're hearing from the specialty pharmacies, as pre-fields have started to roll out here, you know, have you heard some feedback about potentially addressing some of, you know, previous pushbacks with switching to sub-Q and How do you think things are trending in the specialty pharmacy?

Yeah, 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, there has Entra has helped because it allows the patient to just put the pre-fill 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's in a 20, 40, or 60, that patients still at times have to draw up from the pre-filled 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 pre-fill pipeline. so that we can bring an even better patient experience to the marketplace. But overall, I would say, you know, 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 pre-fills have outperformed our early expectations on this product.

Great. Thanks for the questions. I'll hop back in the queue here. Thank you, Chase.

Thank you. Our next question is from Jason Bednar with Piper Center. Please go ahead.

Hey, good afternoon. Thanks for taking the questions. This is Joe on for Jason. Yeah, so my question, so back in Q4 and obviously reiterated today, you guys mentioned the novel therapies pipeline and investments in Europe and internationally as levers to pull, you know, 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, you know, the odds we can actually get back to 20% growth moving forward with these levers. Thanks.

Thanks, Joe. Great question. So maybe just, I'm going to build us 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 what we saw happen in first quarter, you know, I talked about a 7% average on the quarter, but it looked like a 3% growth in January, a 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. You know, we've just inked it. We've got training to do, you know, 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 we'll look at three things. Number one is can the U.S. market grow double digits this year? 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 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 pre-fills. Pre-fills at 5% is encouraging to us, and again, A pre-fill customer is a core root customer. So we grow our position from 70% of the market to 100% when it's a pre-fill 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. Thank you. And then just one more from me. So congrats on the recent 510K approval from Pavely. Great to see for the business, obviously. Can you just talk a little bit about how we should be thinking about contribution from this approval looking forward and to what extent patients may have already been using it off-label with the Freedom Edge pump?

Yeah, so I can't speak to off-label indication, although we know that the Coru pump was approved. 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 Appellus 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 are trying to convert, we see the opportunity overall this year somewhere between 100 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 Freedom Edge pump with Aspavelli and Ampavelli.

Thanks a lot. I really appreciate it.

Great. Thanks, Joe.

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 Thave for closing remarks.

Thank you, everyone, for listening in today, and I want to say thank you to the entire CORU 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.