Greetings and welcome to the KORU Medical's Systems Second Quarter 2020 Financial Results Conference Call. [Operator Instructions] As a reminder this conference is being recorded. It is now my pleasure to introduce to your host, Devin Sullivan, Senior Vice President of Equity Group. Thank you, Mr. Sullivan. You may now begin.

Thank you, Mercel [ph] and good morning. Thank you all for joining us for KORU Medical Systems second quarter 2020 financial results conference call. Our speakers for today's call are Don Pettigrew, President and Chief Executive Officer and Karen Fisher, Chief Financial Officer. During this call, we will discuss our business outlook and make forward-looking statements. These comments are based on our predictions and expectations as of today. Actual events or results could differ materially due to several risks and uncertainties including those mentioned in the associated slide presentation and our most recent filings with the SEC, along with the associated press releases. We assume no obligation to update any forward-looking statements. The associated slide presentation is posted to the Investor Relations section of our website, www.korumedical.com today. 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 slide presentation accompanying this webcast and our filings with the SEC, each of which are posted on our website, you will find additional disclosure regarding these non-GAAP measures, including reconciliations of these measures with comparable GAAP measures. Our strategic plan goals incorporate the trends that we've seen today and what we believe today to be appropriate assumptions. Our results are inherently unpredictable and may be materially affected by many factors, including the introduction of competitive products, the availability of insurance reimbursement, the success of our research and development efforts, acceptance of and demand for new and existing products, expanded market acceptance of the Freedom System, the cost duration and ultimate outcomes of litigation, general economic and business conditions in the United States and abroad, the impact of COVID-19 and other factors described in our filings with the SEC. Therefore, our actual results could differ materially from the goals set forth in our plan. For the benefit of those of you listening to the replay, this call was held and recorded on Wednesday, August 5th, 2020 at approximately 9 AM Eastern Time. Since then, the company may have made additional comments related to the topics discussed. Please reference the company's most recent press releases and filings with the SEC. With that said, I'd now like to turn the call over to Don Pettigrew, President and CEO of KORU Medical Systems. Don, please go ahead.

Thank you, Devin. Good morning, everyone and appreciate you join us today. Hopefully, most of you have power this morning. I want to start by acknowledging KORU Medical's production staff for their continuing commitment to our company. I'm very proud of our team and the remarkable fortitude they're demonstrating in helping us navigate through the COVID crisis as well maintaining our manufacturing supply chain and serving the thousands of patients who rely on our products. I want to make sure you're aware of the safe harbor statement regarding forward-looking statement and non-GAAP financial measures on Slide 2, which I'll solidify [ph] in my remarks today. Now let's start with the Slide 3, before we begin discussing our results for the second quarter and for the benefit of any new investors and attendance. I thought it would be helpful to provide a brief summary of our business so that our results and initiatives can be viewed with a deeper understanding and appropriate context. Our primary end market is Primary Immunodeficiency Diseases or PIDD which consist of more than 350 chronic disorders of the immune system. We've seen estimates regarding or the undiagnosed PIDD patient population as high as 500,000 in the US. At present, we estimate just 70,000 patients have been diagnosed and are currently receiving IG therapy. Off those, 40,000 are currently receiving a therapy intravenously which we refer to as IVIg and 30,000 are receiving their therapy subcutaneously or SCIg. The majority of these SCIg patients are utilizing KORU Medical's Freedom Integrated Infusion System. We're also addressing patient suffering from CIDP, a neurological disorder. This is a smaller patient population than PIDD of approximately 25,000 patients. CIDP has been on the market dominated by IVIg therapy. But that changed in 2018 when Hizentra was approved to treat CIDP subcutaneously.…

Thank you, Don. Good morning, everyone. Beginning on Slide 10, net sales rose 44.1% to $7.7 million in the second quarter from $5.3 million in last year's Q2, with growth across our infusion product line. We believe this is driven by continued demand increases and included clinical trials as well as increased purchasing to support the trends towards at home infusion therapy and in response to the uncertainties created by COVID-19. Gross profit in Q2 rose 41.3% to $4.9 million from $3.5 million in Q2, 2019 primarily due to increased sales volume. Gross margin was 63.7% in Q2, 2020 as compared to 65% in Q2, 2019 mostly due to an increase in overtime cost related to COVID-19 absenteeism. Gross margin was 65.4% when adjusted for this overtime. Total operating expenses for Q2, 2020 increased to $5.9 million from $3.4 million in last year's second quarter. Selling, general and administrative expenses were $3.2 million or 41.5% of net sales compared to $2.1 million or 38.3% of net sales in Q2, 2019. The increase is primarily due to the impact of her hires in the second half of last year from severance, a bonus for employee service during COVID-19 pandemic, increased consulting, distributor fees and other miscellaneous administrative costs. These were all partially offset by lower trade show and travel expenses due to the COVID-19 related travel restrictions. Higher litigation cost in Q2, 2020 consisted of $2.2 million non-cash, stock-based expense associated with the negotiation of and entry into a litigation settlement agreement with a competitor in May, 2020. We expect future expenses related to the competitor litigation will discontinue because of the settlement. Litigation expenses in Q2, 2019 were $1.1 million. Our adjusted EBITDA rose 18.1% to $1.8 million from Adjusted EBITDA of $1.5 million in Q2. Net loss for Q2, 2020 was $1.1 million or $0.03 per share and included the $2.2 million litigation settlement expense. Net income in Q2, 2019 was $78,000 or $0.00 per diluted share. On Slide 11, moving to our balance sheet. We ended the quarter with $38.1 million of cash, a $32.2 million increase from December 31, 2019. [Indiscernible] all the increases was due to $26.5 million of net proceeds from the recent capital raise along with $3.5 million draw against the company line of credit. Cash provided by operations contributed $2.7 million net of an increase in inventory as we build to meet demand. We ended the quarter with 43.9 million of basic shares outstanding and a diluted share count of 48.1 million. Here on Slide 12, you can see the reconciliation of net income to adjusted EBITDA along with the metric that comprises calculation. I'll now turn it back over to Don.

Thank you, Karen. Thank you all again for your continuing interest in KORU Medical. We can now open the call up for questions.

[Operator Instructions] your first question comes from the line of Alex Nowak with Craig-Hallum Capital Group. Please go ahead.

Don, I was just curious. So how is the supply IG for pharmacy? I mean it certainly seems like a lot of people are trying to switch to subcu IG right now. So is subcu IG drug supplied all constrained within the quarter?

So we hear supply is high as it's ever been Alex. But we're also hearing about some allocation going on at this point. So my understanding is that especially pharmacies are really trying to manage the transition from IV to subcu IG. But for the most part supply is as good as it's ever been and we feel that the addition of Xembify to the market has had a positive and profound impact on total subcu supply.

And staying on that, we've typically found that positions and really patients, they typically don't switch from IV to subcu especially if they're doing well on an IV therapy. But with COVID, are you hearing that more patients and physicians are now willing to actually switch a patient over?

It's a good question. We are hearing that in a lot of cases due to COVID patients just can't get into seated [ph] position, they can't get into an acute setting or an IV center or home infusion center. So they might not even have the option. So we're aware of initiatives by specialty pharmacies to actively encourage and push patients from IVIg to subcu IG and we're also aware of the increased awareness from the patient perspective of this option for subcu therapy. So we're starting to hear more about patients actually requesting to move to subcu IG.

Okay, understood. And then on the pipeline that you laid out. It includes more than 10 high potential future candidates. Are these are all chronic diseases that would have economics for patients similar to the PIDD market or these are more acute illness and they're just going to have different economics for patient?

Yes, so it's a mix, but most of them have similar dynamics in terms of the razor/razorblade model. So we feel most of these are chronic diseases and when similar dynamics to what we experienced with PIDD and CIDP.

Okay, got it. And just last question from me on the clinical trial that you mentioned with Grifols, CSL and Takeda for a plasma to treat COVID. Is the FREEDOM60 pumps being used in that trial?

So the trial is being defined and patients are being enrolled in August, to be clear for convalescent plasma. These are for the most sick COVID patients that will typically be delivered in a hospital setting. So while we don't see this as opportunity for our Freedom Integrated Infusion System. We see the increased awareness of IG as well as the increased supply of IG being used for the Freedom System. With that Alex, we're looking to actively support studies that potentially look at subcu IG for treatment of COVID-19 as well.

Okay, understood. Thank you. Congrats on the results.

Thanks for the questions.

The next question comes from the line of Matthew O'Brien with Piper Sandler. Please go ahead.

Just a [indiscernible] Don for a little bit finer point around what you're seeing from a metric perspective. In terms of the interest level of subcu side versus IVIg, due to COVID. Can you talk about the number of people that are enquiring versus what you typically see? The number of people that maybe are training virtually. Just maybe help us kind of illuminate benefits that you're seeing as a result of the virus.

Thanks for the question, Matt. So we're very close to our specialty pharmacies and we're helping to support with education items and training items for these specialty pharmacies to promote the movement of patients to subcu IG. What we're finding is things such as remote training, we're finding initiatives from these specialty pharmacies to better educate and get these patients do their treatment at home. But in terms of upside, we see this as building upside. This is not an immediate impact. We see this as a long-term sustainable impact. But it's very real and we are there to support our specialty pharmacies in that conversion.

Okay and do you have any, give the visibility into number of patients? Maybe typically you know 100 in the funnel just given what's going on, you're at 110, 120 versus what you typically see? Is there any way to kind of quantify to give that kind of visibility?

You know what we do see is, we look at the - for example like CSL Behring and Hizentra and a look at a percent of their IG sales that are attributed to subcu IG and we see about a percent growth of that market share for quarter. So that is a very good metric that kind of supports the movement from IVIg to subcu IG.

Got it. Okay. And then just to close up the plasma disruption commentary. What would have to go on for you to be impacted in terms of your ability to supply the market because that's always a little bit of x factor, it's difficult to get your head around?

Yes so one thing I think a lot of are not aware of is, the plasma supply historically has been very low versus demand. And if demand is increased, these specialties pharmacies really try to manage the allocation of their IV product versus their subcu product and we see a significant increase in preference in prescription rates from physicians for subcu IG. So the other thing to note is the supply of IG has been better than it ever has and the manufacturing process takes from seven to 12 months. So any major disruption to your point, you would probably see a supply challenge in 2021. But that assumes that you're not seeing ramp up efforts or awareness campaign to make up for lost times and we're seeing the opposite right now, with new collection centers, the awareness campaign etc.

Okay, that's helpful. Just two more from me. You know I've got [indiscernible] distributors out there and I think you said in the last call, that there was some maybe pull forward buying that you saw maybe in Q1. Is there any events for inventory levels in the channel or just one-time purchases or anything to call out in Q2 here that's just beyond, what you're seeing on that clinical trial or even demand side of things?

So the underlying fundamentals of our business remain the same and if anything continue to promote acceleration into the subcu business which is good for us. But in terms of distribution, usually that's driven by increased demand from especially the larger specialty pharmacies. And while we see a continued underlying demand of 20% plus growth. What we see is the anticipated increase in the subcu IG patient population and see specialty pharmacies preparing for that.

Got it, okay. That's helpful. Last one from me. Don, I know you're limited as far as what you can on the drug partnership side and you talked a little bit more about hematology specifically. But can you just give us a sense or maybe a little bit of update as far as the partnerships? How some of those are progressing? Are some getting to the point where you could start to talk about them more, maybe later this year or even into next year? I mean should we expect another update on a new drug, later this year or is it more 2021 event, where we get an update on one or two drugs? Just any developments you can call out there on the partnership side?

Yes, I appreciate the question and understand the interest. Right now we have, we're engaged in clinical trials from Phase I to Phase III and in different states and as they start to get through Phase III and we start get closer than commercialization line. We will communicate that. But right now there's nothing else I would communicate in terms of expected upside from clinical trials outside of what I've communicated with hematology.

Got it. Thanks so much.

Thank you, Matt.

Your next question comes from the line of with [Indiscernible] from H.C. Wainwright. Please go ahead.

This is [indiscernible] dialing in for Ram Selvaraju. How are you doing?

Good. How are you?

Yes, I'm doing great. Just a couple from me. So what are your thoughts on the HIgH-Flo Super26 needle launch? Can you provide more clarity in terms of timeline, pricing and whether this would cannibalize the revenue of existing needle set?

Yes, so we announced in 2019 the 5, 10-K clearance for our Super26 Safety Needle Set. This is essentially a product line extension. There is a growing preference in the market for faster infusion. So this is in response to a patient and physician preference for these faster infusions. Our strategy has been to get the clinical trial data, which we've done in a limited fashion. We're trying to collect a large patient population which has been delayed by COVID-19. But we still plan to launch in Q4, 2020. But this is a product line extension. There's the potential for a small premium. But we're not expecting materially impact to our revenues.

Okay, that's really helpful. And in terms of pricing, so our understanding is that, every PIDD patient brings a recurring revenue of $750 per year for the company and in the case of CIDP for about $1,500. So how should we be thinking about the revenue per patient in new indications that you're currently working on? I may be jumping the gun little bit here, but is there a chance for the revenue per patient may go higher than $1,500 in the new indications that you're working on?

It's a very good question and has everything to do with frequency of therapy. So in the case of CIDP patient, they will be administering two to three times a week versus once a week for a PIDD patient. A lot of the therapies we are pursuing have very similar dynamics. Some of them slightly lower frequency of administration and some have more frequent administration. But for the most part we're looking to stay in the same frequencies.

Okay. I think that's it from me. Thank you so much.

Thanks for the questions.

Your next question comes from the line of Kyle Rose with Canaccord Genuity. Please go ahead.

Great, thank you for squeezing me in here. So lots been asked, Don so I want to ask a bit more of a higher level question. You've obviously brought on a lot of talent particularly focused on partnerships in future development. Maybe help us frame out how your conversations with pharma manufacturers have trended over the last four to five months from a COVID perspective? Obviously, there's a lot of focus on shifting to the subcu space in IG specifically. But when you had those conversations, how have development priorities and timeline shifted from a pharma manufacturer perspective with respect to the broader trend of subcu in moving to the home? And then kind of the other part of that question is, does COVID impact any of those development timeline that you have ongoing, due to difficulty running trials, analyzing data, things of that sort given just the socially distance aspect here.

Thanks, Kyle. So for the most part, we look at our pharma manufacturers. There's been a net positive effect with our connection with these manufacturers. So COVID-19 has met more availability. So we spent a lot of time with WebEx training and things like that and connecting with their sales and marketing folks. So it's really been trying to support the current business. With that said, we know there's interest in expanding these therapies beyond PIDD and CIDP and areas such as secondary immunodeficiency. So we're engaged in discussions in support where we can, any trials around these indication expansions. With that said, the COVID-19 impact we have seen a delay in certain initiatives including some clinical trials that we hope to start accelerating again. But for the most part we feel that's been the biggest impact of COVID-19.

Okay, great. And then when you think about the new drug launches in IG and in subcu in particular over the course of the last 12 to 18 months. How do you view the overall size of the market versus far as more our sales and marketing dollars in the pharma perspective? Is it driving growth in the diagnosis rate of PIDD or is it really just more of a near term share shift of IV into subcu?

The answer is both. Before kind of the trend. There was a growing trend of movement of IV to subcu patients already. But similar to the Telehealth analogy I gave, you're seeing an accelerated push towards that based on what seems to be obvious and logical. So in terms of the size of the subcu market and new entries into it. We look at like Xembify from Grifols is having like I mentioned an immediate a profound impact on the supply of IG. So as I kind of touched earlier on another question. We think that increasing supply will help promote awareness and prescriptions of subcu IG. We also mention that the latest NIH estimates have roughly 500,000 patients that are undiagnosed in the US, which is a larger number than we've communicated in the past. So we feel the addressable market has an increase and a large part of that is based on some new info available as well as better awareness on subcu IG.

Okay, that's very helpful. And then just question is, you had these long-term targets in place for a period of time now. When you look at just overall executions since you put those targets in place in growing of magnitudes of what the implied long-term growth rate is there? I guess I'm just trying to understand how you still think about long-term guidance as far as 2023 revenue level and the implied growth along the way. And then if you're not going to make a change now maybe, help us understand what type of event would need to happen in order for you to maybe expand that guidance or give us a different long-term view?

Yes, so the guidance remains the same. Of existing the year 2022 with $50 million run rate as well as getting to 70% margins. But doing so with year-over-year growth of 20% plus. With that said, changes in that trajectory would really come from new products, expanded indication and adjacent market expansion as well. But for the most part, that's an organic number and as we identify additional drug opportunities that would have the most immediate or the largest impact on the guidance we provided.

Okay, great. Thank you for taking the questions.

You bet, thanks Kyle.

There are no further questions at this time. I would like to turn the floor back over to management for closing comments. Thank you.

All right. Thanks everybody for the questions. I want to close once again by thanking KORU Medical's production staff for their continuing dedication and all our stakeholders for their support. We have several events planned for the fall and look forward to interacting with you. Next week we'll be participating virtually at the Canaccord Growth Conference. Thank you again for your time and attention. I hope you all have a wonderful day.

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