EX-99 2 ex_99-1.htm PRESS RELEASE DATED MARCH 2, 2022

 

EXHIBIT 99.1

 

KORU MEDICAL SYSTEMS ANNOUNCES 2021 Q4 AND FULL YEAR FINANCIAL RESULTS

 

CHESTER, NY – 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.

 

Highlights:

 

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.

 

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Non-GAAP Measures

 

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.

 

Investor Contact:

 

Greg Chodaczek

347-620-7010

investor@korumedical.com

 

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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  

 

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REPRO MED SYSTEMS, INC.

BALANCE SHEETS

 

    December 31,   December 31,  
    2021   2020  
               
ASSETS              
               
CURRENT ASSETS              
Cash and cash equivalents   $ 25,334,889   $ 27,315,286  
Accounts receivable less allowance for doubtful accounts of $24,271 and $24,469 for December 31, 2021, and December 31, 2020, respectively     3,592,886     2,572,954  
Inventory     6,106,338     6,829,772  
Other receivables     718,220      
Prepaid expenses and other     1,568,821     807,780  
TOTAL CURRENT ASSETS     37,321,154     37,525,792  
Property and equipment, net     1,106,445     1,167,623  
Intangible assets, net of accumulated amortization of $263,729 and $199,899 at December 31, 2021 and December 31, 2020, respectively     808,813     843,587  
Operating lease right-of-use assets     95,553     236,846  
Deferred income tax assets, net     1,941,254     125,274  
Other assets     19,812     19,812  
TOTAL ASSETS   $ 41,293,031   $ 39,918,934  
               
LIABILITIES AND STOCKHOLDERS’ EQUITY              
               
CURRENT LIABILITIES              
Accounts payable   $ 1,227,533   $ 624,920  
Accrued expenses     2,709,704     2,610,413  
Note Payable     508,583      
Deferred Revenue     90,000      
Accrued payroll and related taxes     160,603     287,130  
Finance lease liability – current         2,646  
Operating lease liability – current     95,553     141,293  
TOTAL CURRENT LIABILITIES     4,791,976     3,666,402  
Operating lease liability, net of current portion         95,553  
TOTAL LIABILITIES     4,791,976     3,761,955  
Commitments and contingencies              
STOCKHOLDERS’ EQUITY              
Common stock, $0.01 par value, 75,000,000 shares authorized, 48,044,162 and 46,680,119 shares issued; 44,623,660 and 43,259,617 shares outstanding at December 31, 2021, and December 31, 2020, respectively     480,441     466,801  
Additional paid-in capital     40,774,245     35,880,986  
Treasury stock, 3,420,502 shares at December 31, 2021 and December 31, 2020, at cost     (3,843,562 )   (3,843,562 )
Retained earnings     (910,069 )   3,652,754  
TOTAL STOCKHOLDERS’ EQUITY     36,501,055     36,156,979  
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY   $ 41,293,031   $ 39,918,934  

 

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REPRO MED SYSTEMS, INC.

STATEMENTS OF CASH FLOWS

 

    For the Years Ended
December 31,
 
    2021   2020  
CASH FLOWS FROM OPERATING ACTIVITIES              
Net Loss   $ (4,562,823 ) $ (1,212,063 )
Adjustments to reconcile net (loss) to net cash used in operating activities:              
Stock-based compensation expense     2,707,554     1,618,732  
Stock-based litigation settlement expense         1,285,102  
Depreciation and amortization     463,130     418,595  
Gain on disposal of fixed assets     (1,009 )   (16,591 )
Deferred income taxes     (1,815,980 )   62,967  
Provision for doubtful accounts         (8,176 )
Abandonment of intangible assets         41,919  
Changes in operating assets and liabilities:              
(Increase)/Decrease in accounts receivable     (1,019,932 )   669,743  
Decrease/(Increase) in inventory     723,434     (4,441,295 )
Increase in other receivables     (718,220 )    
Increase in prepaid expenses and other assets     (761,041 )   (420,614 )
Increase in accounts payable     602,613     52,264  
(Decrease)/Increase in accrued payroll and related taxes     (126,527 )   96,865  
Increase in deferred revenue     90,000      
Increase in accrued expenses     99,291     1,313,801  
Decrease in accrued tax liability         (204,572 )
NET CASH USED IN OPERATING ACTIVITIES     (4,319,510 )   (743,323 )
               
CASH FLOWS FROM INVESTING ACTIVITIES              
Purchases of property and equipment     (346,178 )   (920,604 )
Purchases of intangible assets     (29,056 )   (140,548 )
Proceeds from disposal of property and equipment     9,065     25,000  
NET CASH USED IN INVESTING ACTIVITIES     (366,169 )   (1,036,152 )
               
CASH FLOWS FROM FINANCING ACTIVITIES              
Proceeds from issuance of equity     1,261,251     26,728,486  
Common stock issuance settlement of litigation     938,094      
Purchase of treasury stock         (3,499,358 )
Borrowings from indebtedness     924,389     4,976,508  
Payments on indebtedness     (415,806 )   (4,976,508 )
Payments on finance lease liability     (2,646 )   (5,296 )
NET CASH PROVIDED BY FINANCING ACTIVITIES     2,705,282     23,223,832  
               
NET (DECREASE)/INCREASE IN CASH AND CASH EQUIVALENTS     (1,980,397 )   21,444,357  
CASH AND CASH EQUIVALENTS, BEGINNING OF YEAR     27,315,286     5,870,929  
CASH AND CASH EQUIVALENTS, END OF YEAR   $ 25,334,889   $ 27,315,286  
               
Supplemental Information              
Cash paid during the years for:              
Interest   $ 13,241   $ 27,736  
Income taxes   $ 1,903   $ 321,983  
Schedule of Non-Cash Operating, Investing and Financing Activities:              
Issuance of common stock as compensation   $ 433,654   $ 240,960  
Issuance of common stock as settlement for litigation   $ 938,094   $ 938,094  

 

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REPRO MED SYSTEMS, INC.

SUPPLEMENTAL INFORMATION

(UNAUDITED)

 

The following table summarizes our net revenues for the three and twelve months ended December 31, 2021 and 2020:

 

  Three Months
Ended December 31,
  Change from Prior Year
  2021   2020   $   %
Net Revenues                    
Domestic $ 5,004,192   $ 3,176,504   $ 1,827,687   $ 57.5% 
International   1,261,731     828,575     433,156     52.3% 
Novel Therapies   224,584     52,141     172,444     330.7% 
Total $ 6,490,507   $ 4,057,220   $ 2,433,287   $ 60.0% 

 

 

  Twelve Months
Ended December 31,
  Change from Prior Year
  2021   2020   $   %
Net Revenues                    
Domestic $ 19,045,512   $ 18,895,923   $ 149,589   $ 0.8% 
International   3,856,972     3,368,519     488,453     14.5% 
Novel Therapies   587,691     1,912,006     (1,324,315 )   (69.3%)
Total $ 23,490,175   $ 24,176,448   $ 686,273   $ (2.8%)

 

 

A reconciliation of one of our non-GAAP measures is below:

 

Reconciliation of Reported
Net Revenues to Non-GAAP
Net Revenues
  Three Months Ended
December 31,
  Change from Prior Year  
    2021   2020   $   %  
Reported Net Revenues   $ 6,490,507   $ 4,057,220   $ 2,433,287 ) 60.0%  
   Early Order/Inventory Stocking         1,031,000     (1,031,000 ) 100.0%  
Non-GAAP Adjusted Net Revenues   $ 6,490,507   $ 5,088,220   $ 1,402,287   27.6%  

 

 

Reconciliation of Reported
Net Revenues to Non-GAAP
Net Revenues
  Twelve Months Ended
December 31,
  Change from Prior Year  
    2021   2020   $   %  
Reported Net Revenues   $ 23,490,175   $ 24,176,448   $ (686,273 ) (2.8%)  
   Early Order/Inventory Stocking         (304,000 )   304,000   100.0%  
Non-GAAP Adjusted Net Revenues   $ 23,490,175   $ 23,872,448   $ (382,273 ) (1.6%)  

 

Early Order/Inventory Stocking. For the quarter, we included the effect of an early order and covid related inventory stocking in calculating our non-GAAP measure. We had an early order from our largest distributor in the three months ended September 30, 2020, which would have otherwise been placed in the three months ended December 31, 2020, as well as higher purchases in the first half of the year that we believe would have been made in the second half of 2020, had it not been for the pandemic. For the twelve months ended December 31, 2020, we excluded what we believe to have been inventory stocking purchased in the first half of the year, had it not been for the pandemic.

 

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A reconciliation of two of our non-GAAP measures is below:

 

    Three Months Ended     Twelve Months Ended
Reconciliation of GAAP Net Loss   December 31,     December 31,
to Non-GAAP Adjusted EBITDA:   2021     2020     2021   2020
GAAP Net Loss   $ (1,068,358 )   $ (834,628 )   $ (4,562,823 ) $ (1,212,063 )
Tax (Benefit)/Expense     (375,837 )     (298,400 )     (1,801,618 )   17,800  
Depreciation and Amortization     113,308       120,794       463,130     418,595  
Interest Expense/(Income), Net     3,800       (18,705 )     (13,083 )   (42,395 )
Reorganization Charges           95,700       1,192,618     95,700  
Discontinued Product Expenses           (459 )         70,859  
Litigation Expenses           466           2,447,213  
Manufacturing Initiative Expenses     1,883       51,723       239,216     246,527  
Stock-based Compensation Expense     739,922       607,592       2,707,554     1,618,732  
Non-GAAP Adjusted EBITDA   $ (585,282 )   $ (275,917 )   $ (1,775,006 ) $ 3,660,968  

 

 

    Three Months Ended     Twelve Months Ended
Reconciliation of Reported Diluted EPS   December 31,     December 31,
to Non-GAAP Adjusted Diluted EPS*:   2021     2020     2021   2020
Reported Diluted Earnings Per Share   $ (0.02 )   $ (0.02 )   $ (0.10 ) $ (0.03 )
Reorganization Charges                 0.03      
Discontinued Product Expense                      
Litigation Expenses                     0.06  
Manufacturing Initiative Expenses                     0.01  
Stock-based Compensation Expense                 0.01      
Tax (Expense) Adjustment                 (0.01 )   (0.02 )
Non-GAAP Adjusted Diluted Earnings Per Share   $ (0.02 )   $ (0.02 )   $ (0.07 ) $ 0.02  

 

*Numbers presented are rounded to the nearest whole cent

 

Reorganization Charges. We have excluded the effect of reorganization charges in calculating our non-GAAP measures. We incurred significant expenses in connection with the departure and replacement of our chief executive officer and the recruiting of two new board members, which we would not have otherwise incurred in periods presented as part of our continuing operations.

 

Discontinued Product Expense. We have excluded the effect of expenses related to a discontinued product line in calculating our non-GAAP measures. We did not incur any related expense in 2021.

 

Litigation. We have excluded litigation expenses in calculating our non-GAAP measures. Litigation expenses in 2020 included professional fees associated with our litigation with EMED, which discontinued as a result of the settlement on May 20, 2020.

 

Manufacturing Initiative Expenses. We have excluded the effect of expenses related to creating manufacturing efficiencies, in calculating our non-GAAP measures. We incurred expenses in connection with these initiatives which we would not have otherwise incurred in periods presented as part of our continuing operations. We expect to incur related expenses for the next six to nine months.

 

Stock-based Compensation Expense. We have excluded the effect of stock-based compensation expense in calculating our non-GAAP measures. We record non-cash compensation expense related to grants of options for executives, employees and consultants, and grants of common stock to our board of directors and our CEO. Depending upon the size, timing and the terms of the grants, the non-cash compensation expense may vary significantly but will recur in future periods. Adjusted EBITDA for the twelve months ended December 31, 2021 included stock-based compensation expense of $0.4 million related to the departure and replacement of our chief executive officer. This expense is the only amount included in Stock-based Compensation Expense in calculating Adjusted Diluted EPS.

 

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