Full Press Release Details
KORU MEDICAL SYSTEMS ANNOUNCES 2021 Q4 AND
FULL YEAR FINANCIAL RESULTS
- March 2, 2022 - Repro Med Systems, Inc. dba KORU Medical Systems (NASDAQ: KRMD) ("KORU Medical"
or the "Company"), a leading medical technology company focused on the development, manufacturing, and commercialization
of innovative and easy-to-use specialty infusion solutions that improve quality of life for patients, today reported financial results
for the fourth quarter and full year ended December 31, 2021.
| Fourth quarter net revenues of $6.5 million, compared to $4.1 million in Q4 2020, 60% growth as reported, 27.6% growth when adjusted for customer inventory stocking impacting Q4 2020 | |
| Fourth quarter year-over-year revenue growth was driven by positive momentum across all three businesses, including increased pump placements and consumables growth in the U.S., higher consumables in Europe, and a strengthened novel therapies pipeline | |
| Full year net revenues of $23.5 million, compared to $24.2 million last year, with core revenue growth offset by lower novel therapies revenues due to a large clinical trial order in 2020 | |
| Expanded on label indications with three new 510(k) clearances, including use of the FreedomEdge infusion pump to deliver Hizentra 20 mL prefilled syringes, and use of the FREEDOM60 Infusion System with two additional SCIg drugs, Cutaquig and Xembify | |
| Announced five-year strategic plan to achieve significant expansion of pipeline value through extending leading position in subcutaneous (SC) IG therapy to new subcutaneous drug therapies, multiple new product introductions and $60 million in revenues by 2026 |
"We are very pleased to finish 2021 with a strong fourth quarter.
Driven by the efforts of our team, KORU Medical has seen momentum in all three areas of our business - domestic and international
core business and novel therapies," said Linda Tharby, KORU Medical's CEO. "During the fourth quarter, we hit several
key milestones, including three new 510(k) clearances, increased pump placements in our U.S. business, and four new agreements in our
novel therapies pipeline. In addition, we announced our new strategic plan, including milestones that will drive accelerated revenue growth,
margin improvement, and expansion of our total addressable market. We look forward to continued execution of our plan and driving long-term
growth and value for our patients, customers, employees, and shareholders."
2021 Fourth Quarter Financial Results
| Three Months Ended December 31, | Change from Prior Year | |||||||||||
| 2021 | 2020 | $ | % | |||||||||
| Domestic Core | 5,004,192 | 4,207,504 | 796,688 | 18.9% | ||||||||
| International Core | 1,261,731 | 828,575 | 433,156 | 52.3% | ||||||||
| Novel Therapies | 224,584 | 52,141 | 172,443 | 330.7% | ||||||||
| Non-GAAP Adjusted Net Revenues | $ | 6,490,507 | $ | 5,088,220 | $ | 1,402,287 | 27.6% |
*This table represents Non-GAAP adjusted net revenues. See reconciliation
to GAAP table below.
Net revenues for the fourth quarter of 2021 were $6.5 million,
compared with $4.1 million in the prior-year period, a 60% increase. Adjusting for net inventory stocking of $1.0 million last
year, net revenues grew 27.6%, reflecting growth in all areas of the Company's business; domestic core growth driven by pumps
and consumables, international driven by consumables and increased novel therapies revenues from expansion of its pipeline.
Gross margin was 59.0% for the fourth quarter of 2021, an increase from
prior year of 56.6%. The majority of the increase was driven by a mid-year price increase.
Total operating expenses for the fourth quarter of 2021 were $5.9 million,
compared to $3.5 million for the same period in 2020. The increase in operating expenses
is due to strategic investments in commercialization, quality and regulatory, and research and development.
Net loss for the fourth quarter of 2021 was $1.1
million, or $(0.02) per diluted share, compared with a net loss of $0.8 million, or $(0.02) per diluted share for the same period in 2020.
Non-GAAP adjusted EBITDA for the fourth quarter of 2021 was $(0.6) million, compared with $(0.3) million in the fourth quarter of 2020.
On a non-GAAP basis, adjusted diluted earnings per share was $(0.02) per diluted share in both periods.
2021 Full Year Financial Results
Net revenues for 2021 were $23.5 million, 2.8%
lower compared with $24.2 million in the prior year. On an adjusted basis, net revenues were lower by 1.6%. The shortfall was driven by
lower year-over-year novel therapies revenues due to a large clinical trial order in 2020. Domestic core net revenues for 2021 were 0.8%
higher than last year mostly driven by price in the second half of the year and international core net revenues were up 14.5% compared
to the previous year, driven by growth in key customers.
Gross margin was 58.6% in 2021 compared to 61.8%
in 2020. The decrease was primarily driven by the delay in the transition to a secondary manufacturing source.
Total operating expenses increased 28.5%, or $4.6
million compared to last year. The increase was primarily driven by investments associated with building the Company's leadership
and extended team, commercialization and regulatory efforts, and research and development.
Net loss for the full year 2021 was $4.6 million, or $(0.10) per diluted
share, compared with a net loss of $1.2 million, or $(0.03) per diluted share for the same period in 2020. Non-GAAP adjusted EBITDA for
the full year 2021 was $(1.8) million, compared with $3.7 million for the same period in 2020. On a non-GAAP basis, adjusted diluted earnings
per share was $(0.07) for the full year 2021, compared with $0.02 diluted earnings per share for the same period in 2020.
The Company ended the year with $25.3 million of cash and believes it has
sufficient resources to execute its strategic plan over the next several years.
Assumptions and Outlook for Full Year Fiscal 2022
KORU Medical's outlook for fiscal year 2022 reflects numerous assumptions
that could affect its business, based on the information management has as of this date, which includes assumptions regarding the continued
recovery from the COVID-19 pandemic related to new SCIg patient starts, plasma supply, clinical trial activity, and supply chain impacts.
Management will discuss its outlook and several of its assumptions on its fourth fiscal quarter 2021 earnings call.
For fiscal year 2022, KORU Medical expects the subcutaneous immunoglobulin
(SCIg) market to recover and grow high single digits. Assuming this market growth holds, the Company expects revenue growth in the low
to mid double digits, or $26.0 to $27.0 million on a full year basis. Gross margin will be impacted by the supplier transition, which
the Company estimates will be completed in the third quarter of 2022 and expects to exit the year at a 60% run rate. The Company expects
operating expenses to increase to roughly $27.0 to $28.0 million for full year 2022 in support of the strategic plan, including investments
in building the team, research and development and commercialization efforts supporting new product introductions, novel therapies pipeline
expansion, and SCIg market penetration.
Conference Call and Webcast Details
The Company will host a live conference
call and webcast to discuss these results and provide a corporate update on Wednesday, March 2, 2022, at 4:30 PM ET.
To participate in the call, please
dial (877) 407-0784 (domestic) or (201) 689-8560 (international) and provide conference ID 13726808. The live webcast will be available
on the Events & Presentations page of the Investors section of KORU Medical's website.
This press release includes the non-GAAP
financial measures of "Adjusted Net Revenues," "Adjusted EBITDA" and "Adjusted Diluted EPS" that are
not in accordance with, nor an alternate to, generally accepted accounting principles and may be different from non-GAAP measures used
by other companies. These non-GAAP measures are 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 KORU Medical's reported results and, therefore,
should not be relied upon as the sole financial measures to evaluate the Company's financial results. Non-GAAP financial measures
are meant to supplement, and to be viewed in conjunction with, GAAP financial results. Reconciliations of the Company's non-GAAP
measures are included at the end of this press release.
About KORU Medical Systems
KORU Medical Systems develops, manufactures, and commercializes innovative
and easy-to-use specialty infusion solutions that improve quality of life for patients around the world. The FREEDOM Syringe Infusion
System currently includes the FREEDOM60 and FreedomEdge Syringe Infusion Drivers, Precision Flow Rate
Tubing and HIgH-Flo Subcutaneous Safety Needle Sets . These devices are used for infusions administered
in the home and alternate care settings. For more information, please visit www.korumedical.com.
Forward-looking Statements
This press release contains forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. All statements that are not historical fact
are forward-looking statements, including, but not limited to, expected financial outlook and operating performance for fiscal 2022, expected
market growth and availability of resources to execute the strategic plan. Forward-looking statements discuss the Company's current
expectations and projections relating to its financial position, results of operations, plans, objectives, future performance and business.
Forward-looking statements can be identified by words such as "outlook", "expect", "plan", "believe"
and "will". Actual results may differ materially from the results predicted and reported results should not be considered
as an indication of future performance. The potential risks and uncertainties that could cause actual results to differ from the results
predicted include, among others, uncertainties associated with the shift to increased healthcare delivery in the home, new patient diagnoses,
customer ordering patterns, COVID-19, innovation and competition, and those risks and uncertainties included under the captions "Risk
Factors" in our Annual Report on Form 10-K for the year ended December 31, 2021, which is on file with the SEC and is available
on our website at www.korumedical.com/investors and on the SEC website at www.sec.gov. All information provided in this release and in
the attachments is as of March 2, 2022. Undue reliance should not be placed on the forward-looking statements in this press release, which
are based on information available to us on the date hereof. We undertake no duty to update this information unless required by law.
REPRO MED SYSTEMS, INC.
STATEMENTS OF OPERATIONS
| Three Months Ended | Twelve Months Ended | ||||||||||||
| December 31, | December 31, | ||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||
| NET REVENUES | $ | 6,490,507 | $ | 4,057,220 | $ | 23,490,175 | $ | 24,176,448 | |||||
| Cost of goods sold | 2,658,718 | 1,759,946 | 9,720,597 | 9,240,362 | |||||||||
| Gross Profit | 3,831,789 | 2,297,274 | 13,769,578 | 14,936,086 | |||||||||
| OPERATING EXPENSES | |||||||||||||
| Selling, general and administrative | 4,881,709 | 2,988,795 | 17,862,314 | 12,028,309 | |||||||||
| Litigation | - | - | - | 2,447,213 | |||||||||
| Research and development | 949,930 | 352,116 | 2,473,669 | 1,296,754 | |||||||||
| Depreciation and amortization | 113,308 | 120,794 | 463,130 | 418,595 | |||||||||
| Total Operating Expenses | 5,944,947 | 3,461,706 | 20,799,113 | 16,190,871 | |||||||||
| Net Operating Loss | (2,113,158 | ) | (1,164,432 | ) | (7,029,535 | ) | (1,254,785 | ) | |||||
| Non-Operating (Expense)/Income | |||||||||||||
| (Loss)/Gain on currency exchange | (7,144 | ) | 12,699 | (28,905 | ) | 1,536 | |||||||
| Gain on disposal of fixed assets, net | - | - | 1,009 | 16,591 | |||||||||
| Other Income | 679,907 | - | 679,907 | - | |||||||||
| Interest (expense)/income, net | (3,800 | ) | 18,705 | 13,083 | 42,395 | ||||||||
| TOTAL OTHER (EXPENSE)/INCOME | 668,963 | 31,404 | 665,094 | 60,522 | |||||||||
| LOSS BEFORE INCOME TAXES | (1,444,195 | ) | (1,133,028 | ) | (6,364,441 | ) | (1,194,263 | ) | |||||
| Income Tax Benefit/(Expense) | 375,837 | 298,400 | 1,801,618 | (17,800 | ) | ||||||||
| NET LOSS | $ | (1,068,358 | ) | $ | (834,628 | ) | $ | (4,562,823 | ) | $ | (1,212,063 | ) | |
| NET LOSS PER SHARE | |||||||||||||
| Basic | $ | (0.02 | ) | $ | (0.02 | ) | $ | (0.10 | ) | $ | (0.03 | ) | |
| Diluted | $ | (0.02 | ) | $ | (0.02 | ) | $ | (0.10 | ) | $ | (0.03 | ) | |
| WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING | |||||||||||||
| Basic | 44,571,079 | 43,732,728 | 44,385,032 | 41,929,736 | |||||||||
| Diluted | 44,571,079 | 43,732,728 | 44,385,032 | 41,929,736 |