Don Pettigrew
Analyst · Craig-Hallum Capital Group. 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. We see the CIDP market opportunity evolving in similar fashion PIDD as such we're focused on supporting treatment conversions from IVIg therapy to subcu IG therapy. We believe that PIDD and CIDP offers significant growth opportunities. And at present nearly 20 times our annual revenue in the US alone. We also recognize that our Freedom System is a platform technology with potentially broader applications and significant long-term growth opportunities. To this end, we're pursuing partnerships with pharma manufacturers outside of the IG space to support the increasing trends towards subcutaneous drug delivery for a variety of disease states. We also believe that COVID-19 has placed emphasis on the benefits and perhaps necessity of home healthcare to protect the most vulnerable among us. I like to use the analogy of the growing adoption of Telehealth when discussing the potential for at home subcu IG. In recent report by McKinsey & Company stated that in 2019 just 11% of patients used Telehealth to replace cancelled or in person health care business. Today 46% of patients are utilizing Telehealth with adjunct driven by the pandemic. Physicians and other healthcare professionals are now seeing 50 to 175 times the number of patients via Telehealth than they did before the pandemic. This type of rapid adoption reflects how quickly behavior can change and more importantly begin evolving into a standard of care. It also shows in my opinion, how sometimes the obvious solution to any problem is the most difficult to see. We continue to manage the business towards our strategic planned goals of $50 million run rate by year end 2022. Improving our operating efficiencies to drive us towards our 70% gross margin goal and generating 20% plus organic revenue growth for each year. As previously discussed, we're focused on reducing COGS as a compliment to rise in sales as a means to achieve greater manufacturing efficiencies. Our success is due in large part to an attractive economic model. Most of the patients that use the Freedom Integrated Infusion System are managing chronic conditions. In other words, their therapy is required for the rest of their lives. We have experienced minimal patient churn once the patient begins using the Freedom System they typically stick with it because our products are used in conjunction with prescribed drugs such as Hizentra and Xembify. Our sales and marketing expenditures are modest compared to other healthcare companies. On Slide 4, with that background let's move onto the overview of the second quarter. We had a strong second quarter with increases across several metrics. We completed a successful offering that generated net proceeds of nearly $27 million and we settled longstanding litigation with a competitor. Our stock was also added to Russell 3000 Index in June. Moving to Slide 5, our $7.7 million in net sales was a record for any quarter in our history with increases across our product portfolio. Our baseline annual sales growth target is 20% with upside from clinical trial sales and anticipated increasing adoption of subcu IG therapy. We certainly experienced each of these in the second quarter with continued contribution from clinical trial activity and sales growth that aligned with industry trends both of which we expect will continue. The unique aspect of this quarter sales was increased purchasing activity from specialty pharmacies likely in anticipation of higher demand for at home infusion therapy due to the pandemic. It is difficult to determine at what level this COVID-related buying activity will continue for the balance of the year. However, we expect that our 2020 sales will align with our previously announced financial goals which are part of our strategic plan. Gross profit rose by more than 41%. You'll see that we reported net loss of $1.1 million which is almost entirely due to the one-time non-cash litigation settlement with our competitor, excluding these costs we operated profitably. Settling this matter has eliminated future associated litigation expenses which totaled $3.4 million in 2019 and will allow us to allocate more of our resources to managing the business. Adjusted EBITDA rose more than 18% to $1.8 million. Slide 6, we believe that our Freedom Integrated Infusion System has provided us with first mover advantages and chronically ill patients with the way to assume control over their lives and treatment of their disease, while delivering improved patient compliance, enhanced outcomes and tangible quality of life benefits. We view this as a unique value proposition in these challenging times. Our pumps are easy to use, cost effective, low maintenance and enable patients to self-administer their therapy at home. It takes just three simple steps to initiate and infusion. Our Precision Flow Rate Tubing is available in a wide variety of configurations and a wide array of HIgH-Flo Safety Needles Sets are safe, comfortable and can promote faster infusions. Today there are several subcu IG products available that can be used with our Freedom System. Hizentra from CSL Behring, Cuvitru from Takeda and newest entrant, Xembify from Grifols and cutaquig from Octapharma. We're supporting each of these manufacturers in their commercialization activities via training, sales and product support and education. We expect to benefit as sales of these products increase driven by treatment conversion for IVIg to subcu IG and anticipation by speciality pharmacies at the adoption of at home infusion therapy will continue to gain acceptance among patients, physicians and payers. We believe that a large factor of this growing acceptance are the meaningful benefits that subcu IG offers patients when compared to IVIg. With respect to Xembify which was launched in December, 2019 we believe that this product is still in the early stages of adoption because it's expected to have a very positive impact on subcu IG availability. Slide 7, we believe that the foundation we're creating will allow us to expand our commercial applications and drive our growth. We intend to meet growing demand for subcu IG therapy for current indications and PIDD and CIDP, some of that driven by patient preference changes due to COVID-19. As we've pointed out in prior calls, Grifols is the market leader in the IVIg market and we feel they're focused on their subcu formulation validates the more widely preferred and prescribed modality of subcu infusion versus IV infusion. While we're aware of some plasma collection disruption driven by COVID especially as it relates to centers near college campuses we're seeing a significant ramp up of new collection centers, incentives to returning donors and awareness campaigns. Longer term, Grifols, CSL Behring and Takeda have articulated plans to increase their global plasma collection and manufacturing capacity over the next several years. With respect to awareness just last week President Trump issued a National Call To Action and hosted a roundtable at Red Cross headquarters to encourage plasma collection including convalescent plasma to treat COVID. The President stated that with the help of various government supported initiatives nearly 50,000 COVID patients have been treated with convalescent plasma. On the roundtable members was Paul Perreault, CEO of CSL Limited which manufactures Hizentra. Mr. Perreault talked about the promise hyper immune plasma therapy which is a treatment consisting of isolated antibodies from people who have recovered from COVID-19. He also stressed the importance of plasma donors not just for COVID treatment but in general because plasma is used to treat other rare diseases this includes PIDD and CIDP. Mr. Perreault went to state that working jointly with the NIH, the major plasma manufacturers who've designed a clinical trial that will be enrolling individuals in the month of August to investigate the efficacy hyper immune therapy and the treatment of COVID-19. We're very interested in helping to support our drug manufacturing partners in whatever we can to help advances important initiative. We'll pursue international expansion with respect to PIDD and CIDP. International sales were 16% of our total net sales in 2019. We believe that the simplicity of the FREEDOM60 provides an attractive alternative to legacy infusion devices that are popular in Europe. We expect growth outside the US will have similar dynamics to those we've experienced in the US. To this end, we plan to leverage our relationships with pharma manufacturers to introduce our products in conjunction with their sales efforts. Slide 8, as you can see on this slide we're focused on supporting drug development activities. Our Freedom System is currently involved in multiple clinical trials associated with the potential expansion of IG and development of subcutaneous therapies for other disease states. This includes recently completed Phase III trial in hematology that met its primary efficacy endpoint. We expect to drug launch sometime in 2021. While we cannot be specific for competitive reasons, our current program development opportunity includes drugs from over 100 companies in over 10 therapeutic areas with at least 10 future candidates we believe have high potential. In addition to hematology, we've identified market opportunities at several other disease states. We estimate these programs have a total addressable market of approximately 40 million patients. Our Freedom System is a proven, simple and cost-effective delivery device that we believe positions KORU to be the partner of choice for certain drug manufacturers. As they pursue the development and commercialization of new therapies. Slide 9, as we continue to grow and evolve with the company. We also seek to hire and retain the best and brightest talent for our organization. In July, we were pleased to announce the appointment of Josh Bennett to the newly created position of Vice President, Global Commercialization. Josh brings 20 years of healthcare management and consulting experience to KORU medical including Baxter Healthcare where he focused on product and market development for various medical devices, pharmaceuticals and biologics. Josh brings a broad and proven record of building marketing programs and creating new sales channels domestically and internationally through chronic development, commercialization and M&A. He joined us at the perfect time as we accelerate our pursuit of identifying new and adjacent market opportunities. Expanding the therapeutic and pharmaceutical applications of our Freedom Integrated Infusion System and leveraging the significant advantages of self-administered at home infusion therapy. I would now like to turn things over to Karen Fisher, our Chief Financial Officer for a review of the quarter. Karen?