Investor Presentation
August 2020
NASDAQ: KRMD
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. Forward-looking statements can be identified by words such as : "expect," "plan," "goals," "believe," "intend," "see," "feel," and "future," and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding our long-term growth potential and sustainability, our strategic growth initiatives and long-term financial goals, issues expected with U.S. plasma supply, expected increase in IG supply, and the potential impact of COVID-19 in the market. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they 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; and general economic and business conditions. Any forward-looking statement 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-looking statement, 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 income (loss): tax expense, depreciation and amortization, interest income/expense, net, reorganizations charges, discontinued product expenses, litigation, stock-based settlement expense, manufacturing initiative expenses, and stock option 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.
NASDAQ: KRMD | New Life, New Beginnings -2- |
KORU MEDICAL SYSTEMS
PUT TING THE PATIENT FIRST WITH EASY - TO - USE HOME INFUSION SOLUTIONS
KORU Medical Systems manufactures and sells the Freedom Integrated Infusion System that allows
chronically-ill patients to self-administersubcutaneous infusion therapy in their homes
Supporting the Migration | Pursuing Multiple | Clinical Trial |
to At-Home Healthcare | Growth Pathways | Activity |
Benefitting from | Lowering Costs; | Strong Financial |
Delivering Improved | ||
Secular Growth Trends | Performance | |
Outcomes | ||
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MAKING AT HOME TREATMENT A REALITY
PEACE OF MIND DURING UNCERTAIN TIMES
NASDAQ: KRMD | New Life, New Beginnings -4- |
KORU'S POSITIONING
LEVERAGING OUR CORE STRENGTHS TODAY TO DRIVE GROWTH TOMORROW
Significant Market Share and Growth Potential
Differentiated
Technology
Strong Pharma
Relationships
Premium Customer
Retention
Unique Value Proposition Across The Care Continuum
Growing Adoption and | Expanded Indications for |
Opportunity in Current | Existing Therapies (e.g. |
Space (Ig) | Secondary Immunodeficiency) |
Expand Outside the | Support Drug Development |
United States | for New Disease States |
NASDAQ: KRMD | New Life, New Beginnings -5- |
PIDD: $427.5 M U.S. ADDRESSABLE MARKET
E XC LU D E S OT H E R D I S E A S E S TAT E S A N D S E C O N DA R Y I M M U N E D E F I C I E N C Y D I S E A S E S I N T E R N AT I O N A L M A R K E T O P P O R T U N I T Y ~ 2 x - 3 x U . S . A D D R E S SA B L E M A R K E T
PIDD
400+ immune diseases
Chronic Condition
$750
Annual Recurring Revenue
Per PIDD Patient
CIDP
Expanded Indication 25,000 U.S. Patients
UNDERPENETRATED U.S. PIDD MARKET = COMPELLING GROWTH OPPORTUNITY
500,000
Undiagnosed U.S.
PIDD Population
70,000
Diagnosed and Receiving
Ig Therapy
24,000
Receiving SCIg Therapy using
KORU's Freedom System
$1,500 | 5% | 46,000 |
Annual Recurring Revenue Per Patient | ||
(Assumes 2 treatments per week) | Total | Potential Patient Conversions |
Market Penetration | (Diagnosed ) to KORU's Freedom System | |
PIDD patient population data fromhttps://www.cslbehring.com/patients/find-your-disease/immunodeficiency-and-autoimmune-diseases | ||
CIDP patient population (2018) from | https://www.ajmc.com/journals/supplement/2018/examining-therapies-cidp/chronic-infammatory-demyelinating-polyneuropathy-considerations-for-diagnosis- | |
NASDAQ: KRMDmanagement-and-population-health.. |
Other figures are KORU Medical estimates.
546,000
Patient Capture
Opportunity
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SCIg ENABLES IMPROVED PATIENT OUTCOMES AND QUALITY OF LIFE ( 1 )
1
2
3
4
SCIg Offers Meaningful Benefits to Patients
Self-administer at home without the need for a nurse
Infuse under the skin, not through a vein
Freedom to go about daily activities with minimal interruption
Consistent serum levels…which we believe enables patients to feel better, longer
Subcutaneous and Intravenous Serum Ig Level
SCIg promotes consistent serum levels throughout the entire treatment period, which we believe enables patients to feel better, longer while supporting improved patient compliance.
NASDAQ: KRMD | (1) P&T Product Profiler - Hizentra Vol. 35, Issue 8 / August 2010 Section 2 / adapted from Berger 2004. Available at | New Life, New Beginnings -7- |
www.ptcommunity.com/ptjournal/fulltext/Profiler_Hizentra/Profiler_Hizentra.pdf. |
MARKET OVERVIEW
PLASMA SUPPLY IS RAMPING AS DEMAND RISES FOR Ig AND SCIg THERAPY
Global Ig Market (1)
($ in billions)
$18.4
$10.8
20182025
Total Available Market
Total U.S. Plasma Collections (3)
(in millions) | 53.5 | ||||||||
48.7 | |||||||||
42.4 | |||||||||
38.3 | |||||||||
35.5 | |||||||||
29.4 | 32.6 | ||||||||
26.2 | |||||||||
23.6 | |||||||||
19.8 | |||||||||
2010 | 2011 | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 | 2018 | 2019 |
Global Home Infusion Therapy Market | ||||
+7% CAGR to $41.6 B by 2027 (2) | ||||
(1) | Fortune Business Insights. | Plans to reach 370 approved | 20 new U.S. plasma | Intends to increase plasma supply |
plasma collection centers by | collection centers opened | and manufacturing capacity | ||
www.fortunebusinessinsights.com/press-release/immunoglobulins-market-9134 | ||||
(2) | Grand View Research, February 2020 | 2024 globally | in 1H FY 2020 | by >65% over the next five years |
(3) | https://www.pptaglobal.org/images/Data/Plasma_Collection/Total_Yearly_Collections_ | Form 20-F for FY ended 12/31/19 | Press release, 2/12/20 | Fourth quarter earnings slides, 5/13/20 |
2008-2019.pdf | ||||
NASDAQ: KRMD | New Life, New Beginnings -8- |
HIZENTRA®
Team Sales Approach
KORU Medical leverages CSL Behring's
large sales organization to educate and influence physicians, patients and SPs about the advantages of subcutaneous infusion with the Freedom60®
NASDAQ: KRMD
Source:www.hizentra.com
KORU Medical's Freedom60® is featured
atwww.hizentra.comand in a
national advertising campaign for
Hizentra® SCIg therapy
New Life, New Beginnings -9-
XEMBIFY® by Grifols: Launched December 2019
- New SCIg treatment introduced by Grifols
- Grifols is a leading producer of plasma medicines
- Validates therapeutic shift from IVIg to SCIg
- Grifols anticipates increasing global plasma donation centers
- Significant long-term growth potential for KORU
Source: www.sec.gov/Archives/edgar/data/1438569/000110465920043470/tm1919375d1-20f.htm. | |
NASDAQ: KRMD | New Life, New Beginnings -10- |
NEW THERAPIES REPRESENT SIGNIFICANT MARKET
EXPANSION POTENTIAL
Current Development Programs
Total Addressable Market = ~40M Patients (1)
Secondary | Hematology | Pulmonology | Nephrology | Rheumatic & |
Immunodeficiency | Autoimmune Diseases | |||
Additional Opportunities
>10 Therapeutic Areas (1) (2) >10 High Potential Future Candidates (1) (2)
(1) Based on management analysis; (2) Inclusive of current development programs
NASDAQ: KRMD | New Life, New Beginnings -11- |
DIAGNOSES OF PRIMARY IMMUNODEFICIENCIES (PI) IMPROVE LIVES AND LOWERS COSTS
- A study by The Jeffrey Modell Foundation (2017) examined the economic burden of chronic immunodeficiency diseases
- Retrospective analysis of 1,388 patients undiagnosed with PI for at least 5 years
- Increased incidence of pneumonia, sinusitis, bronchitis, and otitis
- Higher rate of hospitalization, outpatient visits and outpatient drug utilization
Chronic Patients Necessitate Treatment
Payor economics more favorable after diagnosis
$85,782
Decline in
Annual Treatment Costs
Per Patient
After Diagnosis of PI
(before Ig treatment)
Source:www.ajmc.com/journals/supplement/2019/examining-the-application-immunoglobulin/managing-cost-of-care-and-healthcare-utilization-in-patients-using-immunoglobulin-agents
NASDAQ: KRMD | New Life, New Beginnings -12- |
AT-HOME INFUSION: THE SAVINGS OPPORTUNITY ( 1 )
"For certain administered specialty drugs, treatment at home can improve patients' physical and mental well-being and reduce disruption of work schedules
and family responsibilities, all without increasing the
likelihood of adverse drug events or side effects."
UNITEDHEALTH GROUP®
Reducing Specialty Drug Costs / September 2019
(1) UnitedHealth Group®: Reducing Specialty Drug Costs / September 2019.
NASDAQ: KRMD
Monthly Cost of Immune Deficiency Drugs for
Privately Insured Individuals, 2018
Hospitals | Physician Offices | Patients' Home | ||
$12,18044%
SAVINGS
$6,736 | for 6 Months |
of Treatment | |
$6,828 | |
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KORU IMPROVES THE DELIVERY OF CARE
PHYSICIAN/PATIENTS/SPECIALTY PHARMACIES ARE PRODUCT DECISION MAKERS KORU AND PHARMA ARE THE PRIMARY INFLUENCERS ON THESE DECISION MAKERS
Hospital / | Immunologist | Infusion Therapy | SP | Self-Administer | Infusion Resupply | |||||
Physician Visits | Diagnosis | Prescribed | Distributors | At Home | Direct to Patient | |||||
- Chronic conditions in need of therapy
- Expanding trend of physicians prescribing subcutaneous immunoglobulin
- Proven solution
- Increasing drug development for subcutaneous delivery
- Freedom pump is the market-leading mechanical subcutaneous delivery solution
- High margin, recurring revenue stream
NASDAQ: KRMD | New Life, New Beginnings -14- |
EXECUTING AGAINST OUR STRATEGIC GROWTH INITIATIVES
TO BECOME THE PREFERRED DRUG DELIVERY PARTNER FOR SPECIFIC INFUSION THERAPIES IN SELECT MARKETS
Phase 1
Growth & Market Capture
2019 - 2020
- Maintain baseline business
- Penetration of PIDD and CIDP
- Pharma reps
- Home infusion sales reps
- Distributors
- New product development/launch
- New indications
- Government partnership
- OUS development
- Pharma collaboration
- Funnel of clinical trials
- Margin improvement
NASDAQ: KRMD
Phase 2 | Phase 3 | |||
Expand & Innovate | Accelerated Growth | |||
2020 - 2021 | 2021 and Beyond | |||
• Continued execution of Phase 1 | • Continued Phase 1 and 2 execution | |||
• | New products | • New drugs and indications | ||
• | Expanded indications | • | Post-acute care growth | |
• | Post-acute care | • | Global expansion | |
• | European expansion | • | Market share gains |
GROWTH CAPITAL WILL HELP FUND THE NEXT TWO PHASES
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Q2 2020 FINANCIAL SUMMARY ( $ in MMs)
Net Sales
+44.1%
$7.7
$5.3
Gross Profit / Margin | Net Income (Loss) | ||||
+41.3% | Included $2.2 M | ||||
non-cash litigation | |||||
$4.9 | settlement expense |
$3.5 | $0.1 |
Adjusted EBITDA *
+18.1%
$1.8
$1.5
Q2 '19 | Q2 '20 |
65% 64%
Q2 '19 | Q2 '20 |
Q2 '19
$(1.1)
Q2 '20
Q2 '19 | Q2 '20 |
*Adjusted EBITDA excludes from net income (loss): tax expense, depreciation and amortization, interest expense (income), net, reorganization charges, discontinued product expenses, litigation, manufacturing initiative expenses, and stock option expense.
NASDAQ: KRMD | New Life, New Beginnings -16- |
Q2 2020 FINANCIAL SUMMARY | ( $ in MMs) | |||||||
Three Months | Three Months | Year Over | ||||||
Ended | Ended | |||||||
Year Change | ||||||||
6/30/20 | 6/30/19 | |||||||
Net Sales | $ | 7.7 | $ | 5.3 | 44.1% | |||
Gross Profit | $ | 4.9 | $ | 3.5 | 41.3% | |||
Gross Margin | 63.7% | 65.0% | (130) bps | |||||
Total Operating Expenses | $ | 5.9 | $ | 3.4 | 72.7% | |||
Net (Loss) / Income | $ | (1.1) | $ | 0.1 | $ 1.0 M | |||
Non-GAAP Adjusted EBITDA* | $ | 1.8 | $ | 1.5 | 18.1% | |||
*Adjusted EBITDA excludes from net income (loss): tax expense, depreciation and amortization, interest expense (income), net, reorganization charges, discontinued product expenses, litigation, manufacturing initiative expenses, and stock option expense.
NASDAQ: KRMD | New Life, New Beginnings -17- |
BALANCE SHEET AND CAPITAL STRUCTURE
$38.1 M
Cash & Cash Equivalents
at June 30, 2020
$3.5 M
Line of Credit
$2.5 M
Equipment Financing
Line of Credit
48.1 M
Diluted Shares Outstanding
at June 30, 2020
NASDAQ: KRMD
June 30, | December 31, | |||
($ in millions) | 2020 | 2019 | ||
Cash & Cash Equivalents | $ | 38.1 | $ | 5.9 |
Current Assets | $ | 45.3 | $ | 11.9 |
Total Assets | $ | 47.7 | $ | 13.9 |
Total Liabilities | $ | 8.4 | $ | 2.7 |
Shareholders' Equity | $ | 39.2 | $ | 11.2 |
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RECONCILIATION
Reconciliation of GAAP Net Income to Non-GAAP Adjusted EBITDA
Three Months Ended | Six Months Ended |
June 30, | June 30, | |||||||
2020 | 2019 | 2020 | 2019 | |||||
GAAP Net (Loss)/Income | $ | (1,076,038) | $ | 78,183 | $ | (626,610) | $ | (7,207) |
Tax Expense | 30,919 | 24,683 | 172,847 | 2,584 | ||||
Depreciation/Amortization | 94,940 | 86,169 | 182,164 | 169,820 | ||||
Interest Expense/(Income), Net | 5,002 | (18,243) | (14,028) | (35,723) | ||||
Reorganization Charges | - | - | - | 354,926 | ||||
Discontinued Product Expenses | (31,581) | - | 77,977 | - | ||||
Litigation* | 2,346,914 | 1,124,947 | 2,446,072 | 1,617,462 | ||||
Manufacturing Initiative Expenses | 25,957 | - | 135,759 | - | ||||
Stock Option Expense | 363,851 | 194,765 | 664,817 | 316,640 | ||||
Non-GAAP Adjusted EBITDA | $ | 1,759,964 | $ | 1,490,504 | $ | 3,038,998 | $ | 2,418,502 |
*2020 included $2.2 million of non-cash,stock-based settlement expense.
NASDAQ: KRMD | New Life, New Beginnings -19- |
THANK YOU
NEW LIFE, NEW BEGINNINGS
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Repro Med Systems Inc. published this content on 11 August 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 12 August 2020 08:42:12 UTC