KORU Medical Systems, Inc. (NASDAQ: KRMD) ("KORU Medical" or
the "Company"), a leading medical technology company focused on
development, manufacturing, and commercialization of innovative and
patient-centric large volume subcutaneous infusion solutions, today
reported financial results for the fourth quarter and full year
ended December 31, 2023. The Company also issued guidance for the
full year 2024.
Recent Highlights
- Fourth quarter 2023 net revenues of $7.2 million, a 2% decrease
from the prior year; Full year 2023 net revenues of $28.5 million,
a 2% increase over the prior year
- Full year 6.7% Core business growth (U.S. and International)
driven by overall SCIg market growth, share gains and expansion in
new geographies
- Fourth quarter gross margin of 60.3%, reflecting year-over-year
improvement of 470 basis points; Full year gross margin of 58.6%,
reflecting year-over-year improvement of 350 basis points
- Positive cash flow of $0.7 million in the fourth quarter of
2023, ending the year with a cash balance of $11.5 million
- Entered 3 Novel Therapies collaborations during 2023 and
announced 2 new collaborations in the first quarter of 2024
- Recorded a non-cash valuation allowance against deferred tax
assets of $6.0 million. Net loss for the year, which included this
allowance, was ($13.7) million, or ($0.30) per share. Adjusted
EBITDA was ($6.0) million, or ($0.13) per share vs. ($6.1) million
or ($0.14) in the prior year.
- Signed a $10 million credit facility with HSBC USA to replace
an expired $3.5 million revolver agreement; the credit facility
will be reserved for strategic growth capital
- Issued full year 2024 net revenues guidance of $31.2-$32.2
million, representing 10-13% growth
“I am proud of the KORU team for delivering a solid end to 2023,
led by performance in our Core business. Entry into multiple
geographic markets drove international sales, and in the US, we hit
a key milestone with the FDA clearance and launch of the 50mL
prefill pump platform, which we anticipate will be a significant
growth driver in 2024. Additionally, we saw double-digit growth in
our end-user specialty pharmacy sales, reflective of share gains
and a growing Ig market,” said Linda Tharby, KORU Medical's
President and CEO. “Within our Novel Therapies business, we
recently announced collaborations for two late-stage therapies. On
the operational side, we increased gross margins, were cash flow
positive in the fourth quarter and finished the year with a
significantly lower cash burn than the prior year. We are excited
by the momentum we are carrying into 2024; we remain focused on the
execution of our Vision 2026 strategy, and positioning KORU for
growth, profitability and value creation for our customers and
shareholders.”
2023 Fourth Quarter Financial Results
Three Months Ended December
31,
Change from Prior Year
% of Total
2023
2022
$
%
2023
2022
Net Revenues
Domestic Core
$
5,565,349
$
5,314,836
$
250,513
4.7
%
77.4
%
72.4
%
International Core
1,315,036
1,221,540
93,496
7.7
%
18.3
%
16.6
%
Novel Therapies
305,547
808,305
(502,758
)
(62.2
%)
4.3
%
11.0
%
Total
$
7,185,932
$
7,344,681
$
(158,749
)
(2.2
%)
Total net revenues decreased $0.2 million, or 2.2%, for the
three months ended December 31, 2023, as compared with the same
period last year. Domestic Core net revenues increased by 4.7%
year-over-year, driven by growth in pumps and consumables, due to
competitive share gain in new accounts. International Core net
revenues increased by 7.7%, driven by strong SCIg volume and growth
in several OUS geographies as we continue to expand into new
markets. Novel Therapies net revenues declined by 62%
year-over-year, primarily driven by the completion of a large
milestone for a pharmaceutical NRE agreement in 2022.
Gross profit increased $0.3 million or 6.2% for the three months
ended December 31, 2023, as compared with the same period last
year. Gross profit stated as a percentage of net revenues increased
to 60.3% for the fourth quarter of 2023 compared to 55.5% in the
fourth quarter of 2022. The increase was primarily driven by
production efficiencies from the completion of an outsourced
manufacturing initiative and consolidation of our manufacturing
sites. Allowing for a one-time inventory adjustment for a product
discontinuation, adjusted gross margin for the fourth quarter of
2023 was 63.1%. A reconciliation of adjusted gross margin to the
most directly comparable GAAP measure is provided at the end of
this press release.
Total operating expenses for the fourth quarter of 2023 were
$6.7 million, an increase of $0.1 million or 1.6%, compared to $6.6
million in the prior year period. The increase was driven primarily
by the hiring of our new Chief Commercial Officer to lead our Core
business growth strategy, partially offset by efficiencies in
insourcing R&D.
Net loss for the fourth quarter of 2023 was $7.5 million, or
$(0.16) per diluted share, compared to a net loss of $2.0 million,
or ($0.04) per diluted share for the same period of 2022. Net loss
included a tax valuation allowance of $6.0 million for the fourth
quarter of 2023. Adjusted EBITDA for the quarter was ($1.0
million), or ($0.02) per diluted share versus ($1.6 million), or
($0.04) in the prior year. A reconciliation of adjusted EBITDA and
adjusted diluted EPS to the most directly comparable GAAP measures
is provided at the end of this press release.
2023 Full Year Financial Results
Years Ended December
31,
Change from Prior Year
% of Total
2023
2022
$
%
2023
2022
Net Revenues
Domestic Core
$
22,446,519
$
21,205,204
$
1,241,315
5.9
%
78.7
%
76.0
%
International Core
4,596,097
4,164,714
431,383
10.4
%
16.1
%
14.9
%
Novel Therapies
1,475,050
2,526,119
(1,051,069
)
(41.6
%)
5.2
%
9.1
%
Total
$
28,517,666
$
27,896,037
$
621,629
2.2
%
Total net revenues increased $0.6 million, or 2.2%, for the year
ended December 31, 2023, as compared with the same period last
year. Domestic Core growth of 5.9% was driven by volume growth in
pumps and consumables attributed to share gains. International Core
growth of 10.4% was driven by increased volume across several EU
markets and the entry into multiple new geographic markets. The
growth in Core offset a 41.6% year-over-year decline in Novel
Therapies net revenues, primarily driven by the completion of a
large milestone for a pharmaceutical NRE agreement in 2022.
Gross profit increased $1.3 million or 8.7% for the year ended
December 31, 2023, compared to the same period in 2022. Gross
profit as a percentage of net revenues increased to 58.6% compared
to 55.1% from the prior year. The increase was driven by
improvements in manufacturing productivity and product mix.
Allowing for a one-time inventory adjustment for a product
discontinuation, adjusted gross margin for the year ended 2023 was
59.6%. A reconciliation of adjusted gross margin to the most
directly comparable GAAP measure is provided at the end of this
press release.
Selling, general and administrative expenses decreased $0.2
million, or 1.2%, during the year ended December 31, 2023, compared
to the same period last year, primarily driven by lower executive
restructuring costs partially offset by an increase of new hires in
commercial business development and medical affairs.
Research and development expenses increased $0.8 million, or
15.9%, during the year ended December 31, 2023, compared with the
same period last year, primarily due to compensation and expenses
to support new hires focused on new product development.
Net loss for the full year 2023 was $13.7 million, or $(0.30)
per diluted share, compared to a net loss of $8.7 million, or
$(0.19) per diluted share for the same period of 2022. Net loss
included a tax valuation allowance of $6.0 million for the full
year 2023. Adjusted EBITDA for the full year was ($6.0) million, or
($0.13) per diluted share versus ($6.1) million or ($0.14) in the
prior year. A reconciliation of adjusted EBITDA and adjusted
diluted EPS to the most directly comparable GAAP measures is
provided at the end of this press release.
Cash and cash equivalents were $11.5 million as of December 31,
2023, reflecting positive cash flow of $0.7 million in the fourth
quarter and a reduction of cash burn to $5.9 million in 2023 from
$8 million in 2022.
Subsequent Events
The Company has entered into a $5M revolving credit facility and
a $5M term loan facility with HSBC Bank USA, which replaced a $3.5M
revolving credit facility with a regional bank that expired in
August of 2023. This new debt facility provides KORU Medical with
additional capital flexibility to support a reserve for growth and
strategic opportunities.
The Company has received an assessment report from its notified
body in the EU, BSI, stating that, following BSI’s review of
technical documentation submitted by the Company in connection with
a prior audit nonconformance, a recommendation for continued
certification cannot be made. The Company has filed an appeal to
this determination. Management believes that the Company’s appeal
will be successful in limiting the scope of the suspension to have
minimal impact on the Company’s revenues, if any.
Assumptions and Guidance for Full Year 2024
KORU Medical's guidance for the full year 2024 reflects numerous
assumptions that could affect its business, based on the
information management has as of this date. Management will discuss
its outlook and several of its assumptions on its fourth quarter
2023 earnings call.
KORU Medical expects:
- Full year 2024 net revenue between $31.2 and $32.2 million,
representing growth in the range of 10% to 13%
- SCIg market growth of mid-to-high single digits
- Three new Novel Therapies collaborations
- Prefilled syringe market penetration of approximately
20%-25%
- Gross margin between 59% and 61% for the full year 2024
- Geographic expansion into lower ASP markets
- Supply chain inflationary pricing pressure
- Production line start-up in Q4 for new product
introduction
- 2024 year-end cash balance greater than $8.0 million
- Operating expenses of approximately $23.5- $24.0 million,
exclusive of stock compensation expense
- Cash flow breakeven in the fourth quarter of 2024 and cash flow
positive for full year 2025
- Ending cash balance is exclusive of the new $10 million credit
facility, which will be reserved for strategic growth capital
opportunities
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 13, 2024, at 4:30 PM ET.
To participate in the call, please dial (844) 826-3035
(domestic) or (412) 317-5195 (international) and provide conference
ID: 6447448. The live webcast will be available on the IR Calendar
on the News/Events page of the Investors section of KORU Medical's
website.
Non-GAAP Measures
This press release includes the non-GAAP financial measures
"adjusted gross margin,” "adjusted diluted EPS" and “adjusted
EBITDA” 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 develops, manufactures, and commercializes
innovative and patient-centric large volume subcutaneous infusion
solutions that improve quality of life for patients around the
world. The FREEDOM Syringe Infusion System (“the FREEDOM 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, financial guidance and expected operating performance
for fiscal 2024. 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 "guidance", "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 SCIg market growth, prefilled syringe penetration, plasma
supply, clinical trial activity and success, the Company’s EU
certification, the shift to increased healthcare delivery in the
home, new patient diagnoses, customer ordering patterns, global
health crises, innovation and competition, labor and supply price
increases, inflationary impacts, labor supply, 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, 2023
which is on file with the SEC and 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 13, 2024. 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.
KORU MEDICAL SYSTEMS,
INC.
BALANCE SHEETS
December 31,
December 31,
2023
2022
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$
11,482,240
$
17,408,257
Accounts receivable less allowance for
doubtful accounts of $24,777 and $21,459 for December 31, 2023, and
December 31, 2022, respectively
4,045,211
3,558,884
Inventory
3,481,301
6,404,867
Other receivables
28,889
972,396
Prepaid expenses and other
1,218,288
1,457,232
TOTAL CURRENT ASSETS
20,255,929
29,801,636
Property and equipment, net
3,837,657
3,886,975
Intangible assets, net of accumulated
amortization of $390,341 and $325,872 at December 31, 2023 and
December 31, 2022, respectively
754,361
787,182
Operating lease right-of-use assets
3,514,055
3,786,545
Deferred income tax assets, net allowance
for non-realization of deferred tax assets of $6,002,777 and zero
for December 31, 2023 and December 31, 2022, respectively
—
3,967,480
Other assets
98,970
102,625
TOTAL ASSETS
$
28,460,972
$
42,332,443
LIABILITIES AND STOCKHOLDERS’
EQUITY
CURRENT LIABILITIES
Accounts payable
$
975,193
$
2,391,799
Accrued expenses
1,711,427
2,889,941
Note Payable
314,344
433,295
Other liabilities
512,520
257,337
Accrued payroll and related taxes
462,941
542,399
Finance lease liability – current
109,540
98,335
Operating lease liability – current
368,313
345,834
TOTAL CURRENT LIABILITIES
4,454,278
6,958,940
Finance lease liability, net current
portion
316,623
394,283
Operating lease liability, net of current
portion
3,336,300
3,653,257
TOTAL LIABILITIES
8,107,201
11,006,480
Commitments and contingencies (Refer to
Note 8)
STOCKHOLDERS’ EQUITY
Common stock, $0.01 par value, 75,000,000
shares authorized, 49,089,864 and 48,861,891 shares issued;
45,669,362 and 45,441,389 shares outstanding at December 31, 2023,
and December 31, 2022, respectively
490,899
488,619
Additional paid-in capital
47,018,707
44,252,117
Treasury stock, 3,420,502 shares at
December 31, 2023 and December 31, 2022, at cost
(3,843,562
)
(3,843,562
)
Retained Deficit
(23,312,273
)
(9,571,211
)
TOTAL STOCKHOLDERS’ EQUITY
20,353,771
31,325,963
TOTAL LIABILITIES AND STOCKHOLDERS’
EQUITY
$
28,460,972
$
42,332,443
See accompanying Notes to Financial
Statements.
KORU MEDICAL SYSTEMS,
INC.
STATEMENTS OF
OPERATIONS
Three Months Ended
Twelve Months Ended
December 31,
December 31,
2023
2022
2023
2022
NET REVENUES
$
7,185,932
$
7,344,681
$
28,517,666
$
27,896,037
Cost of goods sold
2,854,987
3,266,535
11,809,384
12,527,051
Gross Profit
4,330,946
4,078,146
16,708,282
15,368,986
OPERATING EXPENSES
Selling, general and administrative
5,012,646
4,761,173
20,365,617
20,606,507
Research and development
1,287,515
1,640,732
5,742,254
4,956,215
Depreciation and amortization
228,340
187,658
870,390
587,137
Total Operating Expenses
6,528,501
6,589,563
26,978,261
26,149,859
Net Operating Loss
(2,197,555
)
(2,511,417
)
(10,269,979
)
(10,780,873
)
Non-Operating (Expense)/Income
(Loss)/Gain on currency exchange
7,418
(977
)
(5,124
)
(39,874
)
Loss on disposal of fixed assets, net
—
—
(59,807
)
—
Interest (expense)/income, net
169,230
101,008
561,328
145,587
TOTAL OTHER (EXPENSE)/INCOME
176,648
100,031
496,397
105,713
LOSS BEFORE INCOME TAXES
(2,020,907
)
(2,411,386
)
(9,773,582
)
(10,675,160
)
Income Tax Benefit/(Expense)
(5,445,123
)
434,659
(3,967,480
)
2,014,018
NET LOSS
$
(7,466,029
)
$
(1,976,727
)
$
(13,741,062
)
$
(8,661,142
)
NET LOSS PER SHARE
Basic
$
(0.16
)
$
(0.04
)
$
(0.30
)
$
(0.19
)
Diluted
$
(0.16
)
$
(0.04
)
$
(0.30
)
$
(0.19
)
WEIGHTED AVERAGE NUMBER OF COMMON SHARES
OUTSTANDING
Basic
45,669,691
45,372,132
45,601,346
45,002,074
Diluted
45,669,691
45,372,132
45,601,346
45,002,074
KORU MEDICAL SYSTEMS,
INC.
STATEMENTS OF CASH
FLOWS
For the Years Ended December
31,
2023
2022
CASH FLOWS FROM OPERATING ACTIVITIES
Net Loss
$
(13,741,062
)
$
(8,661,142
)
Adjustments to reconcile net loss to net
cash used in operating activities:
Stock-based compensation expense
2,768,870
3,079,427
Depreciation and amortization
870,390
587,137
Loss on disposal of fixed assets
59,807
—
Deferred income taxes
(2,035,297
)
(2,026,226
)
Allowance for non-realization of deferred
tax asset
6,002,777
—
ROU landlord credit
(21,988
)
212,546
Changes in operating assets and
liabilities:
(Increase)/Decrease in accounts
receivable
(486,327
)
34,002
Decrease/(Increase) in inventory
2,923,566
(298,529
)
Decrease/(Increase) in other
receivables
943,507
(254,176
)
Decrease in prepaid expenses and other
assets
242,599
28,776
(Decrease)/Increase in accounts
payable
(1,416,606
)
1,164,266
(Decrease)/Increase in accrued payroll and
related taxes
(79,458
)
381,796
Increase in other liabilities
255,183
167,337
(Decrease)/Increase in accrued
expenses
(1,178,514
)
180,237
NET CASH USED IN OPERATING ACTIVITIES
(4,892,553
)
(5,404,549
)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchases of property and equipment
(782,949
)
(2,761,056
)
Purchases of intangible assets
(31,648
)
(40,512
)
NET CASH USED IN INVESTING ACTIVITIES
(814,597
)
(2,801,568
)
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from issuance of equity
—
406,623
Borrowings from indebtedness
565,172
783,799
Payments on indebtedness
(684,123
)
(859,087
)
Finance lease ROU asset
(33,461
)
—
Payments on finance lease liability
(66,455
)
(51,850
)
NET CASH (USED IN) PROVIDED BY FINANCING
ACTIVITIES
(218,867
)
279,485
NET DECREASE IN CASH AND CASH
EQUIVALENTS
(5,926,017
)
(7,926,632
)
CASH AND CASH EQUIVALENTS, BEGINNING OF
YEAR
17,408,257
25,334,889
CASH AND CASH EQUIVALENTS, END OF YEAR
$
11,482,240
$
17,408,257
Supplemental Information
Cash paid during the years for:
Interest
$
50,832
$
28,490
Income taxes
$
3,160
$
—
Schedule of Non-Cash Operating, Investing
and Financing Activities:
Issuance of common stock as
compensation
$
446,349
$
513,082
See accompanying Notes to Financial
Statements.
KORU MEDICAL SYSTEMS,
INC.
SUPPLEMENTAL
INFORMATION
(UNAUDITED)
A reconciliation 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:
2023
2022
2023
2022
GAAP Net Loss
$
(7,466,029
)
(1,976,727
)
$
(13,741,062
)
$
(8,661,142
)
Tax (Benefit)/Expense
(557,654
)
(434,659
)
(2,035,297
)
(2,014,018
)
Valuation Allowance for DTA
6,002,777
—
6,002,777
—
Depreciation and Amortization
228,340
187,658
870,390
587,137
Interest (Income), Net
(169,230
)
(101,009
)
(561,328
)
(145,587
)
Reorganization Charges
329,869
—
329,869
765,433
Manufacturing Initiative Expenses
—
184,343
55,361
293,229
Product Discontinuance
280,000
—
280,000
—
Stock-based Compensation Expense
389,256
588,654
2,768,869
3,079,426
Adjusted EBITDA
$
(962,671
)
$
(1,551,740
)
$
(6,030,421
)
$
(6,095,522
)
Three Months Ended
Twelve Months Ended
Reconciliation of Reported Diluted
EPS
December 31,
December 31,
to Non-GAAP Adjusted Diluted
EPS:
2023
2022
2023
2022
Reported Diluted Earnings Per Share
$
(0.16
)
$
(0.04
)
$
(0.30
)
$
(0.19
)
Tax (Benefit)/Expense
(0.01
)
(0.01
)
(0.04
)
(0.05
)
Valuation Allowance for DTA
0.13
—
0.13
—
Depreciation and Amortization
—
—
0.02
0.01
Interest (Income)/Expense, Net
—
—
(0.01
)
—
Reorganization Charges
0.01
—
0.01
0.02
Manufacturing Initiative Expenses
—
—
—
—
Product Discontinuance
—
—
—
—
Stock-based Compensation Expense
0.01
0.01
0.06
0.07
Adjusted Diluted Earnings Per Share
$
(0.02
)
$
(0.04
)
$
(0.13
)
$
(0.14
)
Three Months Ended
Twelve Months Ended
Reconciliation of GAAP Gross Profit
to
December 31,
December 31,
Adjusted Gross Margin
2023
2022
2023
2022
Reported Gross Profit stated as a
percentage of Net Revenues (Gross Margin)
60.3
%
55.6
%
58.6
%
55.1
%
Product Discontinuance
2.8
%
0.0
%
1.0
%
0.0
%
Adjusted Gross Profit stated as a
percentage of Net Revenues (Adjusted Gross Margin)
63.1
%
55.6
%
59.6
%
55.1
%
*Numbers presented are rounded to the nearest whole cent and
percentage
Reorganization Charges. We have excluded the effect of
reorganization charges in calculating our non-GAAP measures. In
2022 and 2023 we incurred severance expenses related to the
reorganization of the leadership team, which we would not have
otherwise incurred in periods presented as part of continuing
operations.
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.
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 expenses related to
grants of options and restricted shares for executives, employees
and consultants, and grants of shares to our board of directors.
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.
Allowance for nonrealization of deferred tax assets (DTA). We
have excluded the effect of recording a full valuation allowance on
our deferred tax assets in the fourth quarter ended 2023 in the
amount of $6.0 million to illustrate the impact on net loss and
earnings per share.
Product Discontinuation. We have excluded the effect of
disposing of a non-launched inventoried product that has no value
in our core business product portfolio.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240313563140/en/
Investor Contact: Louisa Smith
investor@korumedical.com
KORU Medical Systems (NASDAQ:KRMD)
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KORU Medical Systems (NASDAQ:KRMD)
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De Jan 2024 à Jan 2025