KORU Medical Systems
Q3 2021
Craig-Hallum Conference
November 16, 2021
1
Forward-Looking Statements / Non-GAAP Measures
This presentation contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995 regarding our growth drivers, expanding our market potential and clinical trial opportunities, among others. Forward-looking statements are neither historical facts nor assurances of future performance and are based only on our current beliefs, expectations and assumptions. Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements.
Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: impact of COVID-19; introduction of competitive products; availability of insurance reimbursement; changes in U.S. Food and Drug Administration regulations; changes to health care policies; success of our research and development efforts; our ability to raise capital if or when needed; acceptance of and demand for new and existing products; expanded market acceptance of the FREEDOM Syringe Infusion System; our ability to obtain required governmental approvals; success in enforcing and obtaining patents; continued performance by principal suppliers; continued customer preference to work through distributors; continued service of key personnel and attracting and maintaining new personnel; the costs, duration and ultimate outcome of litigation; and general economic and business conditions, as well as those risks and uncertainties included under the captions "Risk Factors" in our Annual Report on Form 10-Kfor the year ended December 31, 2020, which is available on the SEC website at www.sec.govand on our website atwww.korumedical.com/investors. Any forward-lookingstatement made by us is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-lookingstatement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Non-GAAP Adjusted EBITDA
Adjusted EBITDA excludes from net loss: income tax expense, depreciation and amortization, interest income, net, reorganization charges, discontinued product expense, litigation expense, manufacturing initiative expenses, and stock-based compensation expense.
Non-GAAP Measures
This presentation includes the non-GAAP financial measure of "Adjusted EBITDA" that is not in accordance with, nor an alternate to, generally accepted accounting principles and may be different from non-GAAP measures used by other companies. In addition, this non-GAAP measure is not based on any comprehensive set of accounting rules or principles. Non-GAAP financial measures should not be considered a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. They are limited in value because they exclude charges that have a material effect on our reported results and, therefore, should not be relied upon as the sole financial measures to evaluate our financial results. The non-GAAP financial measure is meant to supplement, and to be viewed in conjunction with, GAAP financial results. A reconciliation of our non-GAAP measure is included in an attachment to this press release.
2
Allowing Chronically-Ill Patients to Self-Administer Subcutaneous Therapy in their Homes
- Manufacture and sell innovative, easy-to-use mechanical infusion system
- Leading share position in growing SCIg drug therapy (Hizentra®, Hizentra Prefilled Syringes, Xembify®, Cuvitru®, Cutaquig®) to patients suffering from chronic primary immune deficiency disorders: Primary Immunodeficiency (PIDD) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- Capitalizing on accelerating shift from institutional care to lower-costhome and alternative site settings
- Pursuing TAM expansion with 70 targeted large volume (>10ml) new drug therapies
- Well-capitalizedwith no debt, simple capital structure
- Attractive economics: high product loyalty with low churn; recurring revenue via razor / razor blade model; strong operating leverage and cash flow potential as company grows.
18.2% Revenue
CAGR
(2016-2020)
60% Gross Margin Anticipated in 2022
3
Recent Q3 2021 Highlights
Three key leadership team hires including Vice President of Quality Assurance,
Vice President of Sales, and Vice President of BioPharma Business Development
Received FDA 510(k) clearance for CSL Hizentra 20 mL prefilled syringe with the Freedom Edge Syringe Infusion System
Collaboration with Gilero to acceleration innovation
Third consecutive quarter of positive sequential growth
Announced Strategic Plan Update for December 2, 2021
4
Building the Next Phase of Value Creation at KORU Medical
Leveraging Our Core Strengths Today to Drive Growth Tomorrow
Increase Core SCIg Penetration
- Innovation Focus on Comfort and Convenience
- Win SCIg Prefilled Syringe
- Focus on New Patient Starts
• Clinical Thought Leadership
Geographic Expansion
• Expand to new markets - Germany, France and Japan
- Accelerate growth in line with pharma partners
Extend to Novel Therapies
• Focus in Large Volume >10ml
- Support from Pre-Clinical to Commercialization
Building the Foundation
- Build a Strong Team
- Innovate
- Quality First
- Operational Excellence
5
Attachments
- Original document
- Permalink
Disclaimer
Repro Med Systems Inc. published this content on 16 November 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 16 November 2021 12:56:11 UTC.