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Watchlist
Account
MiMedx Group
MDXG
#6975
Rank
$0.57 B
Marketcap
๐บ๐ธ
United States
Country
$3.86
Share price
-0.52%
Change (1 day)
-45.56%
Change (1 year)
๐งฌ Biotech
Categories
Market cap
Revenue
Earnings
Price history
P/E ratio
P/S ratio
More
Price history
P/E ratio
P/S ratio
P/B ratio
Operating margin
EPS
Stock Splits
Shares outstanding
Fails to deliver
Cost to borrow
Total assets
Total liabilities
Total debt
Cash on Hand
Net Assets
Annual Reports (10-K)
MiMedx Group
Quarterly Reports (10-Q)
Financial Year FY2023 Q2
MiMedx Group - 10-Q quarterly report FY2023 Q2
Text size:
Small
Medium
Large
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
10-Q
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the
Quarterly Period Ended
June 30, 2023
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _____________________to______________________
Commission File Number
001-35887
MIMEDX GROUP, INC.
(Exact name of registrant as specified in its charter)
Florida
26-2792552
(State or other jurisdiction of incorporation or organization)
(I.R.S. Employer Identification No.)
1775 West Oak Commons Ct NE
Marietta
,
GA
30062
(Address of principal executive offices)
(Zip Code)
(
770
)
651-9100
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, par value $0.001 per share
MDXG
The Nasdaq Stock Market
Securities registered pursuant to Section 12(g) of the Act: None.
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes
x
No
¨
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Yes
x
No
¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
¨
Accelerated filer
x
Non-accelerated filer
¨
Smaller reporting company
☐
Emerging growth company
☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
¨
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes ☐ No
x
There were
116,109,125
shares of the registrant’s common stock, par value $0.001 per share, outstanding as of July 27, 2023.
Table of Contents
Part I FINANCIAL INFORMATION
Item 1
Financial Statements (Unaudited)
Condensed Consolidated Balance Sheets
6
Condensed Consolidated Statements of Operations
7
Condensed Consolidated Statements of Stockholders’ (Deficit) Equity
8
Condensed Consolidated Statements of Cash Flows
10
Notes to the Condensed Consolidated Financial Statements
11
Item 2
Management’s Discussion and Analysis of Financial Condition and Results of Operations
27
Item 3
Quantitative and Qualitative Disclosures About Market Risk
38
Item 4
Controls and Procedures
38
Part II OTHER INFORMATION
Item 1
Legal Proceedings
39
Item 1A
Risk Factors
39
Item 2
Unregistered Sales of Equity Securities and Use of Proceeds
39
Item 3
Defaults upon Senior Securities
39
Item 4
Mine Safety Disclosures
39
Item 5
Other Information
39
Item 6
Exhibits
40
Signatures
40
3
Explanatory Note and Important Cautionary Statement Regarding Forward-Looking Statements
As used herein, the terms “
MIMEDX
,” the “
Company
,” “
we
,” “
our
” and “
us
” refer to MiMedx Group, Inc., a Florida corporation, and its consolidated subsidiaries as a combined entity, except where it is clear that the terms mean only MiMedx Group, Inc.
Certain statements made in this Quarterly Report on Form 10-Q (this “
Quarterly Report
”) are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the
“Securities Act”
), and Section 21E of the Securities Exchange Act of 1934, as amended. All statements relating to events or results that may occur in the future are forward-looking statements, including, without limitation, statements regarding the following:
•
our strategic focus and current business priorities, and our ability to implement these priorities, including as a result of our no longer being able to market our micronized products and certain other products;
•
our expectations regarding future revenue growth, margins, and cash flows;
•
our expectations regarding our ability to fund our ongoing operations and future operating costs and the sufficiency of our liquidity and existing capital resources to implement our current business priorities;
•
the advantages of our products and development of new products;
•
our expectations regarding the size of potential markets for our products and any growth in such markets;
•
our expectations regarding the regulatory pathway for our products;
•
our expectations regarding ongoing regulatory obligations and oversight and the changing nature thereof impacting our products, research and clinical programs, and business, including those relating to patient privacy;
•
our expectations regarding costs relating to compliance with regulatory requirements, including those arising from maintaining current Good Tissue Practice compliance;
•
the likelihood, timing, and scope of possible regulatory approval and commercial launch of new products;
•
our expectations regarding government and other third-party coverage and reimbursement for our existing and new products;
•
our belief in the sufficiency of our intellectual property rights in our technology;
•
our expectations regarding our ability to procure sufficient supplies of human tissue to manufacture and process our products;
•
our expectations regarding future income tax liability;
•
our expectations regarding the outcome of pending litigation and investigations;
•
our expectations regarding the ongoing and future effects arising from the investigation conducted by the Audit Committee (the “
Audit Committee
”) of our Board of Directors (the “
Board
”) that concluded in May 2019 relating to allegations regarding certain sales and distribution practices at the Company and certain other matters (the “
Investigation
” or the “
Audit Committee Investigation
”), the restatement of our consolidated financial statements previously filed in our Annual Report for the year ended December 31, 2016, as well as selected unaudited condensed consolidated financial data as of and for the years ended December 31, 2015 (Restated) and 2014 (Restated), which reflected adjustments to our previously filed consolidated financial statements as of and for the years ended December 31, 2015 and 2014 (collectively, the “
Restatement
”), and related litigation;
•
the ongoing and future effects arising from the COVID-19 pandemic (“
Covid-19
”) and possible other future health emergencies on our business, employees, suppliers and other third parties with whom we do business, and our responses intended to mitigate such effects;
•
demographic and market trends; and
•
our ability to compete effectively.
Forward-looking statements generally can be identified by words such as “expect,” “will,” “change,” “intend,” “seek,” “target,” “future,” “plan,” “continue,” “potential,” “possible,” “could,” “estimate,” “may,” “anticipate,” “to be” and similar expressions.
4
These statements are based on numerous assumptions and involve known and unknown risks, uncertainties and other factors that could significantly affect the Company’s operations and may cause the Company’s actual actions, results, financial condition, performance or achievements to differ materially from any future actions, results, financial condition, performance or achievements expressed or implied by any such forward-looking statements. Factors that may cause such a difference include, without limitation, those discussed under the heading “
Risk Factors
” in our Annual Report on Form 10-K for the year ended December 31, 2022 (our “
2022 Form 10-K
”), filed with the Securities and Exchange Commission (“
SEC
”) on February 28, 2023 and those discussed in Part II, Item 1A, Risk Factors, if any.
Unless required by law, the Company does not intend, and undertakes no obligation, to update or publicly release any revision to any forward-looking statements, whether as a result of the receipt of new information, the occurrence of subsequent events, a change in circumstances or otherwise. Each forward-looking statement contained in this Quarterly Report is specifically qualified in its entirety by the aforementioned factors. Readers are advised to carefully read this Quarterly Report in conjunction with the important disclaimers set forth above prior to reaching any conclusions or making any investment decisions and not to place undue reliance on forward-looking statements, which speak only as of the date of the filing of this Quarterly Report with the SEC.
Estimates and Projections
This Quarterly Report includes certain estimates, projections and other statistical data. These estimates and projections reflect management’s best estimates based upon currently available information and certain assumptions we believe to be reasonable as of the date of this Quarterly Report. These estimates are inherently uncertain, subject to risks and uncertainties, many of which are not within our control, have not been reviewed by our independent auditors and may be revised as a result of management’s further review. In addition, these estimates and projections are not a comprehensive statement of our financial results, and our actual results may differ materially from these estimates and projections due to developments that may arise between now and the time the results are final. There can be no assurance that the estimates will be realized, and our results may vary significantly from the estimates, including as a result of unexpected issues in our business and operations. Accordingly, you should not place undue reliance on such information. Projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk.
5
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
MIMEDX GROUP, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share data)
(unaudited)
June 30,
2023
December 31,
2022
ASSETS
Current assets:
Cash and cash equivalents
$
68,652
$
65,950
Accounts receivable, net
48,963
43,084
Inventory
16,815
13,183
Prepaid expenses
3,683
8,646
Other current assets
3,110
3,335
Total current assets
141,223
134,198
Property and equipment, net
7,261
7,856
Right of use asset
2,742
3,400
Goodwill
19,441
19,976
Intangible assets, net
5,565
5,852
Other assets
146
148
Total assets
$
176,378
$
171,430
LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable
$
8,150
$
8,847
Accrued compensation
21,602
21,852
Accrued expenses
12,645
11,024
Other current liabilities
2,063
1,834
Total current liabilities
44,460
43,557
Long term debt, net
48,838
48,594
Other liabilities
3,252
4,773
Total liabilities
$
96,550
$
96,924
Commitments and contingencies (Note 13)
Convertible preferred stock Series B; $
0.001
par value;
100,000
shares authorized, issued and outstanding at June 30, 2023 and December 31, 2022
$
92,494
$
92,494
Stockholders' deficit
Preferred stock Series A; $
0.001
par value;
5,000,000
shares authorized,
0
issued and outstanding at June 30, 2023 and December 31, 2022
$
—
$
—
Common stock; $
0.001
par value;
250,000,000
shares authorized,
116,109,125
issued and outstanding at June 30, 2023 and
187,500,000
shares authorized,
113,705,447
issued and outstanding at December 31, 2022
116
114
Additional paid-in capital
182,907
173,804
Accumulated deficit
(
195,689
)
(
191,906
)
Total stockholders' deficit
(
12,666
)
(
17,988
)
Total liabilities, convertible preferred stock, and stockholders’ deficit
$
176,378
$
171,430
See notes to unaudited condensed consolidated financial statements
6
MIMEDX GROUP, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
(unaudited)
Three Months Ended June 30,
Six Months Ended June 30,
2023
2022
2023
2022
Net sales
$
81,257
$
66,883
$
152,933
$
125,777
Cost of sales
13,583
11,823
26,002
21,759
Gross profit
67,674
55,060
126,931
104,018
Operating expenses:
Selling, general and administrative
51,925
55,793
104,202
105,363
Research and development
8,497
5,512
14,993
11,476
Restructuring (Note 16)
3,256
—
3,256
—
Investigation, restatement and related
1,017
3,218
4,690
5,770
Amortization of intangible assets
191
173
380
345
Operating income (loss)
2,788
(
9,636
)
(
590
)
(
18,936
)
Other expense, net
Interest expense, net
(
1,630
)
(
1,170
)
(
3,184
)
(
2,295
)
Other expense, net
(
32
)
—
(
32
)
(
1
)
Income (loss) before income tax provision
1,126
(
10,806
)
(
3,806
)
(
21,232
)
Income tax provision benefit (expense)
74
(
62
)
23
(
125
)
Net income (loss)
$
1,200
$
(
10,868
)
$
(
3,783
)
$
(
21,357
)
Net loss available to common shareholders (Note 9)
$
(
528
)
$
(
12,496
)
$
(
7,194
)
$
(
24,571
)
Net loss per common share - basic
$
(
0.00
)
$
(
0.11
)
$
(
0.06
)
$
(
0.22
)
Net loss per common share - diluted
$
(
0.00
)
$
(
0.11
)
$
(
0.06
)
$
(
0.22
)
Weighted average common shares outstanding - basic
115,866,371
112,867,912
115,136,646
112,245,334
Weighted average common shares outstanding - diluted
115,866,371
112,867,912
115,136,646
112,245,334
See notes to unaudited condensed consolidated financial statements
7
MIMEDX GROUP, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ (DEFICIT) EQUITY
(in thousands, except share data)
(unaudited)
Common Stock Issued
Additional Paid-In
Treasury Stock
Accumulated
Shares
Amount
Capital
Shares
Amount
Deficit
Total
Balance at March 31, 2023
115,380,542
$
115
$
178,829
334
$
(
1
)
$
(
196,889
)
$
(
17,946
)
Share-based compensation expense
—
—
4,060
—
—
—
4,060
Exercise of stock options
4,334
—
20
—
—
—
20
Issuance of restricted stock
724,249
1
(
16
)
(
4,485
)
15
—
—
Restricted stock shares canceled/forfeited
—
—
14
4,151
(
14
)
—
—
Net income
—
—
—
—
—
1,200
1,200
Balance at June 30, 2023
116,109,125
$
116
$
182,907
—
$
—
$
(
195,689
)
$
(
12,666
)
Common Stock Issued
Additional Paid-In
Treasury Stock
Accumulated
Shares
Amount
Capital
Shares
Amount
Deficit
Total
Balance at March 31, 2022
113,525,178
$
114
$
165,490
172,768
$
(
840
)
$
(
172,198
)
$
(
7,434
)
Share-based compensation expense
—
—
4,428
—
—
—
4,428
Exercise of stock options
84,096
—
143
(
25,904
)
128
—
271
Issuance of restricted stock
—
—
(
723
)
(
148,696
)
723
—
—
Restricted stock shares canceled/forfeited
—
—
14
2,835
(
14
)
—
—
Net loss
—
—
—
—
—
(
10,868
)
(
10,868
)
Balance at June 30, 2022
113,609,274
$
114
$
169,352
1,003
$
(
3
)
$
(
183,066
)
$
(
13,603
)
Common Stock Issued
Additional Paid-In
Treasury Stock
Accumulated
Shares
Amount
Capital
Shares
Amount
Deficit
Total
Balance at December 31, 2022
113,705,447
$
114
$
173,804
—
$
—
$
(
191,906
)
$
(
17,988
)
Share-based compensation
—
—
8,405
—
—
—
8,405
Employee stock purchase plan
235,419
—
680
—
—
—
680
Issuance of restricted stock
2,163,925
2
(
195
)
(
62,255
)
193
—
—
Restricted stock shares canceled/forfeited
—
—
193
62,255
(
193
)
—
—
Exercise of stock options
4,334
—
20
—
—
—
20
Net loss
—
—
—
—
—
(
3,783
)
(
3,783
)
Balance at June 30, 2023
116,109,125
$
116
$
182,907
—
$
—
$
(
195,689
)
$
(
12,666
)
8
Common Stock Issued
Additional Paid-In
Treasury Stock
Accumulated
Shares
Amount
Capital
Shares
Amount
Deficit
Total
Balance at December 31, 2021
112,703,926
$
113
$
165,695
778,710
$
(
4,017
)
$
(
161,709
)
$
82
Share-based compensation expense
—
—
8,426
—
—
—
8,426
Exercise of stock options
84,096
—
(
829
)
(
150,238
)
1,266
—
437
Issuance of restricted stock
821,252
1
(
3,960
)
(
880,749
)
3,959
—
—
Restricted stock shares canceled/forfeited
—
—
20
3,502
(
20
)
—
—
Shares repurchased for tax withholding
—
—
—
249,778
(
1,191
)
—
(
1,191
)
Net loss
—
—
—
—
—
(
21,357
)
(
21,357
)
Balance at June 30, 2022
113,609,274
$
114
$
169,352
1,003
$
(
3
)
$
(
183,066
)
$
(
13,603
)
See notes to unaudited condensed consolidated financial statements
9
MIMEDX GROUP, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
Six Months Ended June 30,
2023
2022
Cash flows from operating activities:
Net loss
$
(
3,783
)
$
(
21,357
)
Adjustments to reconcile net loss to net cash flows provided by (used in) operating activities:
Share-based compensation
8,405
8,426
Impairment of clinical trial assets
2,130
—
Depreciation
1,401
1,718
Non-cash lease expenses
658
610
Impairment of goodwill
535
—
Amortization of intangible assets
380
345
Bad debt expense
289
2,391
Amortization of deferred financing costs
245
229
Accretion of asset retirement obligation
43
46
Gain on fixed asset disposal
—
(
15
)
Increase (decrease) in cash resulting from changes in:
Accounts receivable
(
6,170
)
301
Inventory
(
3,633
)
(
1,993
)
Prepaid expenses
2,832
2,061
Other assets
226
(
353
)
Accounts payable
(
130
)
442
Accrued compensation
(
345
)
(
6,316
)
Accrued expenses
1,218
740
Other liabilities
(
574
)
(
503
)
Net cash flows provided by (used in) operating activities
3,727
(
13,228
)
Cash flows from investing activities:
Purchases of equipment
(
932
)
(
498
)
Patent application costs
(
93
)
(
103
)
Proceeds from sale of equipment
—
24
Net cash flows used in investing activities
(
1,025
)
(
577
)
Cash flows from financing activities:
Proceeds from exercise of stock options
20
437
Principal payments on finance lease
(
20
)
(
22
)
Stock repurchased for tax withholdings on vesting of restricted stock
—
(
1,191
)
Net cash flows used in financing activities
—
(
776
)
Net change in cash
2,702
(
14,581
)
Cash and cash equivalents, beginning of period
65,950
87,083
Cash and cash equivalents, end of period
$
68,652
$
72,502
See notes to unaudited condensed consolidated financial statements
10
MIMEDX GROUP, INC.
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2023 AND 2022
1.
Nature of Business
MiMedx Group, Inc. (together with its subsidiaries, except where the context otherwise requires, “
MIMEDX
,” or the “
Company
”) is a pioneer and leader in placental biologics focused on addressing the needs of patients with acute and chronic non-healing wounds. All of the Company’s products sold in the United States are regulated by the United States Food & Drug Administration (“
FDA
”). The Company’s business is focused primarily on the United States of America but the Company is pursuing opportunities for international expansion, with specific focus on the sale of its placental tissue products in Japan.
During the three and six months ended June 30, 2023, the Company operated as
two
defined, internal business units: Wound & Surgical and Regenerative Medicine. On June 20, 2023, the Company announced that it would disband its Regenerative Medicine business unit, the primary function of which was to obtain FDA approval to market the Company’s micronized dehydrated amnion chorion membrane (“
mDHACM
”) injectable product to reduce pain and restore function in patients suffering from Knee Osteoarthritis (“
KOA
”) in the United States. The Company also announced a suspension of its associated Knee Osteoarthritis clinical trial program.
2.
Significant Accounting Policies
Please see Note 2,
Significant Accounting Policies
, to the Company’s Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 (the “
2022 Form 10-K
”), filed with the Securities and Exchange Commission (“
SEC
”) on February 28, 2023 for a description of all significant accounting policies.
Basis of Presentation
These unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“
GAAP
”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments considered necessary for a fair presentation of the results of operations for the periods presented have been included. The operating results for the three and six months ended June 30, 2023 and 2022 are not necessarily indicative of the results that may be expected for the full fiscal year. The balance sheet as of December 31, 2022 was derived from the audited consolidated financial statements at that date, but does not include all of the information and footnotes required by GAAP for complete financial statements.
These unaudited condensed consolidated financial statements should be read in conjunction with the historical consolidated financial statements of the Company included in the 2022 Form 10-K.
Reclassifications
Decrease in cash resulting from changes in income taxes of $
0.1
million for the six months ended June 30, 2022, which was separately presented in the unaudited condensed consolidated statement of cash flows in previously-issued financial statements, is included as part of increases and decreases in cash resulting from changes in other assets in the unaudited condensed consolidated statement of cash flows included as part of these financial statements.
Principles of Consolidation
The consolidated financial statements include the accounts of MiMedx Group, Inc. and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated upon consolidation.
Use of Estimates
GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported consolidated statements of operations during the reporting period. Actual results could differ from those estimates. Significant estimates include estimated useful lives and potential impairment of property and equipment, estimates of impairment for goodwill and intangible assets, estimates of loss for contingent liabilities, estimate of allowance for doubtful accounts, management’s assessment of the Company’s ability to continue as a going concern, estimate of fair value and the probable achievement of share-based payments, estimates of returns and allowances, and valuation of deferred tax assets.
11
Share-Based Compensation
The Company grants share-based awards to employees and members of the Company’s Board of Directors (the “
Board
”). Awards to employees and the Board are generally made annually. Grants are issued outside of the annual cadence for certain new hires, promotions, and other events.
The amount of expense to be recognized is determined by the fair value of the award using inputs available as of the grant date. The fair value of non-option share awards that are not subject to a market condition is the value of the common stock on the grant date. For non-option share awards that are subject to a market condition, the fair value of the common stock on the grant date is adjusted to reflect the value of the market condition, generally using a path-dependent pricing model, such as a Monte Carlo simulation.
The fair value of stock option grants is estimated using an option pricing model, as appropriate based on the terms of the grant. Use of a valuation model requires management to make certain assumptions with respect to selected model inputs, which generally follows the inputs to a Black-Scholes option pricing model. Absent the availability of an option market with similar terms to the awarded options, the Company infers an expectation for volatility using the historical volatility of daily price changes in its share price for a period equal to the contractual or expected term of the option, as applicable, subject to adjustment for price activity associated with certain events which are not expected to recur during the relevant term. The expected term is derived based on the Company’s expectations for option exercise by the recipients. The Company uses U.S. Treasury yields with a maturity similar to the expected or contractual term, as applicable, as the basis for its risk-free interest rate assumption. The Company has never declared a dividend on its common stock and, therefore, assumes a dividend yield of
0
%.
Expense is recognized over the requisite service period to achieve a vesting condition associated with an award, which can either be explicitly defined by the award, implied by its terms, or derived from potential market movements. In situations where multiple vesting conditions must be achieved, the longest service period is used as a basis for expense recognition. Derived service periods associated with market conditions are accelerated if such market conditions are met prior to the initially-assessed derived service period, but are not deferred if the market conditions are not met prior to the end of the initially-assessed derived service period.
For awards with only service-based vesting conditions, the Company recognizes share-based compensation expense on a straight-line basis through the vesting date of the last tranche of the award. For awards which vest based on more than service conditions, the Company recognizes share-based compensation expense using a graded-vesting method, treating each tranche as if it were a separately-granted award and recognizing expense through the vesting date of each individual tranche. In each scenario, the Company recognizes share-based compensation expense to the extent that the associated service and performance conditions are considered probable to occur. Determinations of probability are made each reporting period and the Company uses available evidence considered relevant for evaluating the performance conditions. The Company recognizes the cumulative effect of changes in the probability of occurrence in the period of re-evaluation. The probability of occurrence and ultimate resolution of a market condition is not considered in expense recognition. Consequently, the Company could recognize expense for awards that do not ultimately vest.
Basic and Diluted Net Income (Loss) Per Common Share
Basic net income (loss) per common share is calculated as net income (loss) available to common stockholders divided by the weighted average common shares outstanding for the applicable period. Net income (loss) available to common stockholders is calculated by adjusting net income (loss) for periodic accumulated dividends on the Company’s Series B Convertible Preferred Stock (“
Series B Preferred Stock
”). This amount is divided by the weighted average common shares outstanding during the period.
Weighted average common shares outstanding is calculated as shares of the Company outstanding adjusted for the portion of the period for which they are outstanding. Unvested non-option share awards are excluded from the calculation of weighted average common shares outstanding until they have vested. Unexercised stock options are excluded from the calculation of weighted average common shares outstanding until they are exercised. Shares issuable pursuant to the Company’s Employee Stock Purchase Plan (“
ESPP
”) are included for the minimum number of shares issuable beginning at the point in time that all contingencies for share issuance are resolved.
Diluted net income (loss) per common share adjusts basic net income (loss) per common share for convertible securities, options, equity incentive awards, and other share-based payment awards which have yet to vest and vest only on the satisfaction of a service condition. Equity incentive awards and options that are subject to a performance or market condition are included only if the performance or market condition would be satisfied if the end of the applicable period were the end of the
12
performance period. In any case, these adjustments are reflected in the calculation of diluted net income (loss) per common share to the extent that they reduce basic net income (loss) per common share.
The Company uses the if-converted method to calculate the dilutive effect of the Series B Preferred Stock and other convertible securities to the extent they are outstanding. The if-converted method assumes that convertible securities are converted at the later of the issuance date and the beginning of the period. If the hypothetical conversion of convertible securities, and the consequential avoidance of any accumulated preferred dividends, would decrease basic net income (loss) per common share, these effects are incorporated in the calculation of diluted net income (loss) per common share, adjusted for the portion of the period the securities were outstanding.
The Company uses the treasury stock method to calculate the dilutive effect of options, non-option share awards, and certain other share-based payments. The treasury stock method assumes that the proceeds from exercise are used to repurchase common shares at the weighted average market price during the period, increasing the denominator for the net effect of shares issued upon exercise less hypothetical shares repurchased.
Shares issuable pursuant to the ESPP are included in the calculation of diluted net loss per common share to the extent that such shares would be issued based on the share price at the conclusion of the period, to the extent such shares are not already included in the calculation of weighted average common shares outstanding.
Recently Adopted Accounting Pronouncements
In March 2020, the Financial Accounting Standards Board issued Accounting Standards Update (“
ASU
”) 2020-04, “
Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting.
” ASU 2020-04 provides temporary expedients to accounting guidance for certain contract modifications and hedging arrangements to ease financial reporting burdens as a result of market transitions from certain reference rates, including the London Interbank Offered Rate (“
LIBOR
”). The updates are effective immediately and may be applied prospectively to contract modifications made and hedging relationships entered into or evaluated on or before December 31, 2024.
In June 2023, the Company entered into Amendment No. 2 (the “
Second Amendment
”) to the loan agreement, dated as of June 30, 2020, by and among the Company, Hayfin Services, LLP (“
Hayfin
”), an affiliate of Hayfin Capital Management LLP, and certain other parties, (as amended, the “
Hayfin Loan Agreement
”), pursuant to which the reference rate used to determine the interest rate was changed from LIBOR to the Secured Overnight Financing Rate (“
SOFR
”). Because the only terms of the Second Amendment that affected the Company’s contractual cash flows were related to the changes in the reference rate, the Company adopted the optional guidance prescribed by Topic 848 to this transaction. The adoption of ASU 2020-04 and its application to the Second Amendment did not materially impact the Company’s unaudited condensed consolidated financial statements as of or for the three or six months ended June 30, 2023.
Recently Issued Accounting Pronouncements Not Yet Adopted
All ASUs issued and not yet effective for the three and six months ended June 30, 2023, and through the date of this report, were assessed and determined to be either not applicable or are expected to have minimal impact on the Company’s financial position and results of operations.
13
3.
Accounts Receivable, Net
Accounts receivable, net, consisted of the following (in thousands):
June 30, 2023
December 31, 2022
Accounts receivable, gross
$
51,159
$
46,867
Less: allowance for doubtful accounts
(
2,196
)
(
3,783
)
Accounts receivable, net
$
48,963
$
43,084
Activities related to the Company’s allowance for doubtful accounts for the three months ended June 30, 2023 and 2022 were as follows (in thousands):
2023
2022
Balance at April 1
$
3,601
$
1,386
Bad debt expense
349
2,168
Write-offs
(
1,754
)
(
83
)
Balance at June 30
$
2,196
$
3,471
Activities related to the Company’s allowance for doubtful accounts for the six months ended June 30, 2023 and 2022 were as follows (in thousands):
2023
2022
Balance at January 1
$
3,783
$
1,187
Bad debt expense
289
2,391
Write-offs
(
1,876
)
(
107
)
Balance at June 30
$
2,196
$
3,471
4.
Inventory
Inventory consisted of the following (in thousands):
June 30, 2023
December 31, 2022
Raw materials
$
875
$
810
Work in process
7,885
6,855
Finished goods
8,055
5,518
Inventory
$
16,815
$
13,183
5.
Property and Equipment, Net
Property and equipment, net, consisted of the following (in thousands):
June 30, 2023
December 31, 2022
Laboratory and clean room equipment
$
17,211
$
16,422
Furniture and equipment
15,223
15,016
Leasehold improvements
9,328
9,190
Construction in progress
1,649
1,983
Asset retirement cost
944
983
Finance lease right-of-use asset
189
189
Property and equipment, gross
44,544
43,783
Less: accumulated depreciation and amortization
(
37,283
)
(
35,927
)
Property and equipment, net
$
7,261
$
7,856
Depreciation expense for the three and six months ended June 30, 2023 and 2022 is summarized in the table below (in thousands):
14
Three Months Ended June 30,
Six Months Ended June 30,
2023
2022
2023
2022
Depreciation expense
$
687
$
858
$
1,401
$
1,718
Depreciation expense is allocated amongst cost of sales, research and development expense, and selling, general, and administrative expense on the unaudited condensed consolidated statements of operations.
6.
Goodwill and Intangible Assets, Net
Goodwill
The following table provides a summary of goodwill activity for the three months ended June 30, 2023 (amounts in thousands):
Wound & Surgical
Regenerative Medicine
Goodwill
Balance as of March 31, 2023
$
19,441
$
535
$
19,976
Impairment of goodwill
—
(
535
)
(
535
)
Balance as of June 30, 2023
$
19,441
$
—
$
19,441
The following table provides a summary of goodwill activity for the six months ended June 30, 2023:
Wound & Surgical
Regenerative Medicine
Goodwill
Balance as of December 31, 2022
$
19,441
$
535
$
19,976
Impairment of goodwill
—
(
535
)
(
535
)
Balance as of June 30, 2023
$
19,441
$
—
$
19,441
There was
no
goodwill activity during either the three or six months ended June 30, 2022.
Impairment of Regenerative Medicine Business Unit
On June 20, 2023, the Company announced the disbanding of its Regenerative Medicine business unit and the suspension of its Knee Osteoarthritis clinical trial program. As a result of this event, the Company evaluated goodwill associated with the Regenerative Medicine reporting unit for potential impairment. The Company estimated fair value for the reporting unit using the income approach; specifically, a discounted cash flow method. As a result of this assessment, management concluded that the carrying value of the reporting unit exceeded its carrying value by an amount that exceeded its goodwill balance. Accordingly, the Company recognized an impairment loss for the full amount of the goodwill ascribed to the Regenerative Medicine reporting unit. The impairment loss is included as a component of restructuring expense in the unaudited condensed statement of operations for the three and six months ended June 30, 2023.
15
Intangible Assets, Net
Intangible assets, net, are summarized as follows (in thousands):
June 30, 2023
December 31, 2022
Gross Carrying Amount
Accumulated Amortization
Net Carrying Amount
Gross Carrying Amount
Accumulated Amortization
Net Carrying Amount
Amortized intangible assets
Patents and know-how
$
9,968
$
(
7,461
)
$
2,507
$
9,923
$
(
7,106
)
$
2,817
Licenses
1,000
(
29
)
971
1,000
(
4
)
$
996
Total amortized intangible assets
$
10,968
$
(
7,490
)
$
3,478
$
10,923
$
(
7,110
)
$
3,813
Unamortized intangible assets:
Tradenames and trademarks
$
1,008
$
1,008
$
1,008
$
1,008
Patents in Process
1,079
1,079
1,031
1,031
Total intangible assets
$
13,055
$
5,565
$
12,962
$
5,852
Expected future amortization of intangible assets as of June 30, 2023, is as follows (in thousands):
Year ending December 31,
Estimated
Amortization
Expense
2023 (excluding the six months ended June 30, 2023)
$
379
2024
759
2025
364
2026
210
2027
209
Thereafter
1,557
Total amortized intangible assets
$
3,478
7.
Accrued Expenses
Accrued expenses consisted of the following (in thousands):
June 30, 2023
December 31, 2022
Legal and settlement costs
$
5,239
$
4,447
Commissions to sales agents
2,958
2,941
Accrued group purchasing organization fees
716
638
Estimated sales returns
810
659
Accrued rebates
630
707
Accrued contract termination costs
567
—
Accrued travel
414
566
Accrued clinical trials
90
90
Other
1,221
976
Accrued expenses
$
12,645
$
11,024
8.
Long Term Debt, Net
16
Hayfin Loan Agreement
On June 30, 2020, the Company entered into the Hayfin Loan Agreement, which Hayfin funded on July 2, 2020, providing the Company with a senior secured term loan in an aggregate amount of $
50.0
million (the “
Term Loan
”). The Term Loan matures on June 30, 2025 (the “
Maturity Date
”).
On June 15, 2023, the Company entered into the Second Amendment to the Hayfin Loan Agreement to change the LIBOR reference rate under the Hayfin Loan Agreement from LIBOR to SOFR. Prior to the Second Amendment, interest on any borrowings under the Hayfin Loan Agreement was based on LIBOR, subject to a floor of
1.5
% (the “
Floor
”), plus a margin of
6.75
% per annum (the “
Margin
”). Subsequent and pursuant to the Second Amendment, interest on any borrowings is based on SOFR, plus a fallback provision of
0.15
%, subject to the Floor, plus the Margin. The Term Loan carried an interest rate of
12.1
% as of June 30, 2023.
As of June 30, 2023, the Company was in compliance with all applicable financial covenants under the Hayfin Loan Agreement. A breach of a financial covenant in the Hayfin Loan Agreement, if uncured or unable to be cured, would likely result in an event of default that could trigger the lender’s remedies, including acceleration of the entire principal balance of the loan as well as any applicable prepayment premiums.
The balances of the Term Loan as of June 30, 2023 and December 31, 2022 were as follows (in thousands):
June 30, 2023
December 31, 2022
Outstanding principal
$
50,000
$
50,000
Deferred financing costs
(
1,007
)
(
1,219
)
Original issue discount
(
155
)
(
187
)
Long term debt, net
$
48,838
$
48,594
Interest expense related to the Term Loan, included in interest expense, net in the unaudited condensed consolidated statements of operations, was as follows (amounts in thousands):
Three Months Ended June 30,
Six Months Ended June 30,
2023
2022
2023
2022
Stated interest
$
1,505
$
1,043
$
2,956
$
2,074
Amortization of deferred financing costs
108
101
212
199
Accretion of original issue discount
17
16
33
30
Interest expense
$
1,630
$
1,160
$
3,201
$
2,303
A summary of principal payments due on the Term Loan, by year, from June 30, 2023 through maturity are as follows (in thousands):
Year ending December 31,
Principal
2023 (excluding the six months ended June 30, 2023)
$
—
2024
—
2025
50,000
2026
—
2027
—
Thereafter
—
Outstanding principal
$
50,000
As of June 30, 2023, the fair value of the Term Loan was $
47.9
million. This valuation was calculated based on a series of Level 2 and Level 3 inputs, including a discount rate based on the credit risk spread of debt instruments of similar risk character in reference to U.S. Treasury instruments with similar maturities, with an incremental risk premium for risk factors specific to the Company. Fair value was calculated by discounting the remaining cash flows associated with the Term Loan to June 30, 2023 using this discount rate.
17
9.
Net Income (Loss) Per Common Share
Net income (loss) per common share is calculated using two methods: basic and diluted.
Basic Net Income (Loss) Per Common Share
The following table provides
a reconciliation of net loss to net loss available to common stockholders and calculation of basic net loss per common share for each of the three and six months ended June 30, 2023 and 2022 (in thousands, except share and per share amounts):
Three Months Ended June 30,
Six Months Ended June 30,
2023
2022
2023
2022
Net income (loss)
$
1,200
$
(
10,868
)
$
(
3,783
)
$
(
21,357
)
Accumulated dividends on Series B Preferred Stock
1,728
1,628
3,411
3,214
Net loss available to common stockholders
$
(
528
)
$
(
12,496
)
$
(
7,194
)
$
(
24,571
)
Weighted average common shares outstanding
115,866,371
112,867,912
115,136,646
112,245,334
Basic net loss per common share
$
(
0.00
)
$
(
0.11
)
$
(
0.06
)
$
(
0.22
)
Diluted Net Income (Loss) Per Common Share
The following table sets forth the computation of diluted net loss per common share (in thousands, except share and per share amounts):
Three Months Ended June 30,
Six Months Ended June 30,
2023
2022
2023
2022
Net loss available to common stockholders
$
(
528
)
$
(
12,496
)
$
(
7,194
)
$
(
24,571
)
Adjustments:
Accumulated dividends on Series B Convertible Preferred Stock
1,728
1,628
3,411
3,214
Less: antidilutive adjustments
(
1,728
)
(
1,628
)
(
3,411
)
(
3,214
)
Total adjustments
—
—
—
—
Numerator
$
(
528
)
$
(
12,496
)
$
(
7,194
)
$
(
24,571
)
Weighted average shares outstanding
115,866,371
112,867,912
115,136,646
112,245,334
Adjustments
Potential common shares
30,996,553
29,199,666
30,273,154
29,102,650
Less: antidilutive potential common shares (a)
(
30,996,553
)
(
29,199,666
)
(
30,273,154
)
(
29,102,650
)
Total adjustments
—
—
—
—
Weighted average shares outstanding adjusted for potential common shares
115,866,371
112,867,912
115,136,646
112,245,334
Diluted net loss per common share
$
(
0.00
)
$
(
0.11
)
$
(
0.06
)
$
(
0.22
)
(a) Weighted average common shares outstanding for the calculation of diluted net loss per common share does not include the following adjustments for potential common shares below because their effects were determined to be antidilutive for the periods presented.
Three Months Ended June 30,
Six Months Ended June 30,
2023
2022
2023
2022
Series B Convertible Preferred Stock
29,997,271
28,262,957
29,559,946
27,850,916
Restricted stock unit awards
943,659
487,708
674,215
635,997
Restricted stock awards
34,244
295,107
24,572
444,511
Performance stock unit awards
16,189
61,488
11,486
30,914
Outstanding stock options
5,190
92,406
65
140,312
Employee stock purchase plan
—
—
2,870
—
Potential common shares
30,996,553
29,199,666
30,273,154
29,102,650
18
10.
Equity
Series B Convertible Preferred Stock
The Company has not declared or paid any dividends on the Series B Preferred Stock since issuance. Dividends accumulated but not paid as of June 30, 2023 were $
17.2
million. As this amount has not been declared, the Company has not recorded this amount on its unaudited condensed consolidated balance sheet as of June 30, 2023.
Based on accumulated dividends as of June 30, 2023, the Series B Preferred Stock was convertible into an aggregate of
30,445,997
shares of the Company’s common stock as of that date.
Equity Incentive Awards
The Company has issued restricted stock awards (“
RSAs
”), restricted stock unit awards (“
RSUs
”), and performance stock unit awards (“
PSUs
”, together with RSAs and RSUs, collectively, the
“Equity Incentive Awards”
) to its employees. The following is summary information for Equity Incentive Awards for the six months ended June 30, 2023.
As of June 30, 2023, there was $
31.6
million of unrecognized share-based compensation expense related to the Equity Incentive Awards. This expense is expected to be recognized over a weighted-average period of
2.38
years, which approximates the remaining vesting period of these grants.
The table below summarizes activity of unvested Equity Incentive Awards by award type from January 1, 2023 through June 30, 2023.
RSA
RSU
PSU
Number of
Shares
Weighted-Average Grant Date
Fair Value
Number of
Shares
Weighted-Average Grant Date
Fair Value
Number of
Shares
Weighted-Average Grant Date
Fair Value
Unvested at January 1, 2023
122,755
$
6.13
4,774,971
$
6.28
241,072
$
4.62
Granted
—
—
3,156,544
4.59
3,689,427
3.72
Vested
—
—
(
2,226,180
)
6.17
—
—
Forfeited
(
62,255
)
5.73
(
628,833
)
6.03
(
59,524
)
4.62
Unvested at June 30, 2023
60,500
$
6.56
5,076,502
$
5.31
3,870,975
$
3.76
Stock Options
A summary of stock option activity for the six months ended June 30, 2023 is presented below:
Number of
Shares
Weighted-
Average
Exercise
Price
Weighted-
Average
Remaining
Contractual
Term
(in years)
Aggregate
Intrinsic
Value
Outstanding at January 1, 2023
933,894
$
6.46
Granted
3,600,000
3.70
Exercised
(
4,334
)
5.84
Vested options expired
(
378,133
)
5.73
Outstanding at June 30, 2023
4,151,427
4.13
6.40
9,257,661
Exercisable at June 30, 2023
551,427
$
6.96
0.77
$
75,977
As of June 30, 2023, there was $
5.9
million of unrecognized share-based compensation expense related to Stock Options. This expense is expected to be recognized over a weighted-average period of
2.29
years.
CEO Performance Grant
On January 27, 2023, the Board of Directors appointed Joseph H. Capper to serve as Chief Executive Officer. The Company entered into a Letter Agreement with Mr. Capper that included, among other things, a grant of
3,300,000
PSUs (the “
CEO Performance PSUs
”) and a non-qualified stock option (the “
CEO Performance Option
”, collectively with the CEO
19
Performance PSUs, the “
CEO Performance Grant
”) for
3,600,000
shares of the Company’s common stock. In addition to continued employment with the Company, the occurrence and extent of vesting of each component of the CEO Performance Grant is dependent upon the Company’s operating and share price performance: the CEO Performance PSUs vest on the basis of achieved revenue growth, while the CEO Performance Option vests on the basis of share price appreciation.
CEO Performance PSUs
The CEO Performance PSUs vest in a single tranche on the earlier of the filing date of the Company’s 2026 Annual Report on Form 10-K and March 15, 2027. The occurrence and extent of vesting depends on the Company’s compound annual growth rate (“
CAGR
”) achieved with respect to its revenue growth between the year ended December 31, 2022 and the year ending December 31, 2026. The PSUs may vest with respect to
50
% to
200
% of the granted number of PSUs, depending on the extent of CAGR achievement. Failure to achieve the CAGR associated with
50
% of achievement would result in no vesting.
Management determined the probable level of vesting using internally-developed forecasts for the relevant period representing the Company’s best estimate for revenue, with a factor applied to calculate the highest level of CAGR evaluated to be probable of occurring based on that estimate. The Company recognized $
0.4
million and $
0.7
million of expense related to the CEO Performance PSUs during the three and six months ended June 30, 2023, respectively.
CEO Performance Option
The CEO Performance Option grants Mr. Capper the right to purchase up to
3,600,000
shares of common stock for $
3.70
per share. The CEO Performance Option vests based on the satisfaction of service and market conditions. Mr. Capper may vest in
25
% of the CEO Performance Option on each of the first four anniversary dates of the date of grant provided that he remains employed by the Company and provided that specified share price goals are achieved at any point between the date of grant and January 31, 2027. There are three separate share price goals associated with the CEO Performance Option. If specified share price goals are met at one level, one-third of the option may vest, at a second level, a further one-third may vest, and at a third level, the full amount of the option may vest. Satisfaction of the share price goals is based on the average of the closing price of the Company’s common stock during any
20
consecutive trading days through January 31, 2027 exceeding the stipulated share price goal. The CEO Performance Option expires on February 1, 2030.
The Company estimated the fair value of the awards using a Monte Carlo simulation using the following assumptions:
Assumption
Stock price on grant date
$
3.70
Exercise price
$
3.70
Risk-free interest rate
3.58
%
Expected volatility (annualized)
75.00
%
Dividend yield
—
%
Weighted average grant date fair value
$
1.93
The risk-free interest rate was derived based on the U.S. Treasury Yield curve in effect at the date of grant for maturities of similar periods to the contractual term. The expected volatility was estimated principally based on the Company’s historical daily stock price movements for a term similar in length to the contractual term. The dividend yield was based on the Company’s history of dividends on its common stock. The fair value was determined using an expected term which reflects the anticipated holding and post-vesting behavior pattern, calculated for each individual simulation.
The total grant date fair value of the CEO Performance Option was $
7.0
million. The fair value associated with each tranche of the award will be recognized, straight-line, over the associated requisite service period for that tranche, subject to acceleration if the market condition is met prior to the end of the derived service period. Failure to meet the market condition for an award does not result in reversal of previously-recognized expense, so long as the service is provided for the duration of the required service period. The Company recognized $
0.7
million and $
1.2
million of expense related to the CEO Performance Option during the three and six months ended June 30, 2023, respectively.
11.
Income Taxes
The effective tax rates for the Company were (
6.6
)% and (
0.6
)% for the three months ended June 30, 2023 and 2022, respectively. The effective tax rates for the Company were
0.6
% and (
0.6
)% for the six months ended June 30, 2023 and 2022, respectively.
There were no material discrete items affecting the effective tax rate in any period.
20
12.
Supplemental Disclosure of Cash Flow and Non-cash Investing and Financing Activities
Selected cash payments, receipts, and non-cash activities are as follows (in thousands):
Six Months Ended June 30,
2023
2022
Cash paid for interest
$
2,960
$
2,080
Cash paid for income taxes
210
184
Non-cash activities:
Issuance of shares pursuant to employee stock purchase plan
680
—
Purchases of equipment in accounts payable
252
255
Right of use assets arising from operating lease liabilities
—
(
37
)
13.
Commitments and Contingencies
Nordic Agreement
In June 2022, the Company entered into a collaboration agreement (the “
Nordic Agreement
”) with Nordic Bioscience Clinical Development A/S (“
NBCD
”) to provide full operational support for the Company’s KOA clinical trial program. Under the terms of the Nordic Agreement, the Company was obligated to pay $
10.2
million upon the achievement of specified milestones over the course of the clinical trial.
On June 23, 2023, the Company submitted notice to NBCD to immediately suspend all trial activities and terminate the Nordic Agreement. Pursuant to the Nordic Agreement, the Company is obligated to reimburse NBCD for services performed through the effective termination date and for noncancelable obligations reasonably incurred prior to that date. If the Company has prepaid NBCD for services performed, the Company is entitled to reimbursement to the extent that such funds have not been consumed. In addition, the Company and NBCD have certain regulatory obligations for all trial participants enrolled in the study prior to the suspension of clinical trial activities. Refer to Note 16, “
Restructuring,
” for additional discussion.
Turn Agreement
On December 7, 2022, the Company acquired certain intellectual property rights pursuant to a Platform Intellectual Property License Agreement (the “
Turn Agreement
”) with Global Health Solutions, Inc. (d.b.a. Turn Therapeutics; “
Turn
”). The Turn Agreement provided the Company with an exclusive, worldwide, sub-licensable license to use Turn’s proprietary antimicrobial technology platform (PermaFusion®) to develop antimicrobial product line extensions and new products. In addition, the Turn Agreement granted the Company the commercial rights to Turn’s placental collagen matrix product, FleX™ AM (“
Flex
”), contingent upon Turn’s receipt of FDA 510(k) clearance and other conditions. The Turn Agreement provided for a potential milestone payment by the Company of $
9.6
million upon Turn’s receipt of 510(k) clearance for FleX. As of June 30, 2023, FleX has not received 510(k) clearance.
Litigation and Regulatory Matters
In the ordinary course of business, the Company and its subsidiaries may be a party to pending and threatened legal, regulatory, and governmental actions and proceedings (including those described below). In view of the inherent difficulty of predicting the outcome of such matters, particularly where the plaintiffs or claimants seek very large or indeterminate damages or where the matters present novel legal theories or involve a large number of parties, the Company generally cannot predict what the eventual outcome of the pending matters will be, what the timing of the ultimate resolution of these matters will be, or what the eventual recovery, loss, fines or penalties related to each pending matter may be. The Company’s unaudited condensed consolidated balance sheet as of June 30, 2023 reflects the Company’s current best estimate of probable losses associated with these matters, including costs to comply with various settlement agreements, where applicable. For more information regarding the Company’s legal proceedings, refer to Note 16, “
Commitments and Contingencies
” in the 2022 Form 10-K.
The Company has not accrued for any potential losses related to legal matters as of June 30, 2023. The Company paid $
0.2
million toward the resolution of legal matters involving the Company during the six months ended June 30, 2023.
The following is a description of certain litigation and regulatory matters to which the Company is a party:
21
Securities Class Action
On January 16, 2019, the United States District Court for the Northern District of Georgia entered an order consolidating
two
purported securities class actions (MacPhee v. MiMedx Group, Inc., et al. filed February 23, 2018 and Kline v. MiMedx Group, Inc., et al. filed February 26, 2018). The order also appointed Carpenters Pension Fund of Illinois (“
CPFI
”) as lead plaintiff. On May 1, 2019, CPFI filed a consolidated amended complaint, naming as defendants the Company, Michael J. Senken, Parker H. “Pete” Petit, William C. Taylor, Christopher M. Cashman and Cherry Bekaert & Holland LLP. The amended complaint (the “
Securities Class Action Complaint
”) alleged violations of Section 10(b) of the Securities Exchange Act of 1934, as amended (the “
Exchange Act
”), Rule 10b-5 promulgated thereunder, and Section 20(a) of the Exchange Act. It asserted a class period of March 7, 2013 through June 29, 2018. Following the filing of motions to dismiss by the various defendants, CPFI was granted leave to file an amended complaint. CPFI filed its amended complaint against the Company, Michael J. Senken, Parker H. Petit, William C. Taylor, and Cherry Bekaert & Holland (Christopher Cashman was dropped as a defendant) on March 30, 2020. The defendants filed motions to dismiss on May 29, 2020. On March 25, 2021, the Court granted defendants’ respective motions to dismiss, finding that CPFI lacked standing to bring the underlying claims and also could not establish loss causation because it sold all of its shares in the Company prior to any corrective disclosures, and dismissed the case. On April 22, 2021, CPFI filed a motion for reconsideration of the dismissal and for leave to amend to add a new plaintiff to attempt to cure the standing and loss causation issues. On January 28, 2022, the Court denied CPFI’s motion to reconsider and motion to substitute class representative. On February 25, 2022, CPFI filed a Notice of Appeal in the 11th Circuit Court of Appeals. On July 10, 2023, the Court of Appeals affirmed the District Court’s dismissal of the case and the denial of the motion for leave to amend. On July 31, 2023, CPFI filed a petition for rehearing
en banc
, which remains pending.
Welker v. MiMedx, et. al.
On November 4, 2022, Troy Welker and Min Turner, former option holders of the Company, brought a lawsuit in Fulton County State Court against the Company, former directors Terry Dewberry and Charles Evans, and former officers Parker H. “Pete” Petit, William C. Taylor, and Michael Senken alleging violations of the Georgia Racketeer Influenced and Corrupt Organizations (“
RICO
”) Act against all defendants, and conspiracy to violate the Georgia RICO Act and breach of fiduciary duty against the individual defendants. The Company is defending against the allegations and removed the case to the United States District Court for the Northern District of Georgia. Plaintiffs filed a motion to remand back to state court, which was granted. The Company has filed its answer and a motion to dismiss, which is currently pending.
Former Employee Litigation and Related Matters
On January 12, 2021, the Company filed suit in the Circuit Court of the Eleventh Judicial District in and for Miami-Dade County, Florida (MiMedx Group, Inc. v. Petit, et. al.) against its former CEO, Parker H. “Pete” Petit, and its former COO, William C. Taylor, seeking a determination of its rights and obligations under indemnification agreements with Petit and Taylor following a federal jury’s guilty verdict against Petit for securities fraud and Taylor for conspiracy to commit securities fraud. The Company is seeking a declaratory judgment that it is not obligated to indemnify or advance expenses to Petit and Taylor in connection with certain cases to which Petit and Taylor are parties and also seeking to recoup amounts previously paid on behalf of Petit and Taylor in connection with such cases. On April 22, 2021, Petit and Taylor filed an answer and asserted counterclaims against the Company alleging breach of their indemnification agreements, breach of the covenant of good faith and fair dealing with respect to their indemnification agreements, and seeking a declaration that the Company remains obligated to indemnify and advance fees in connection with certain cases. Petit and Taylor simultaneously also filed a motion seeking to compel the Company to advance and reinstate its payments of Petit and Taylor’s legal expenses. The Company opposed Petit and Taylor’s motion and a hearing was set for June 23, 2021. At the joint request of the parties, the hearing was cancelled to allow the parties to attend a mediation to attempt a resolution of this matter; such mediation was held on August 11, 2021.
Following the mediation, the Company and Mr. Taylor reached an agreement to settle the matter between them. Negotiations with Mr. Petit are ongoing.
Other Matters
Under the Florida Business Corporation Act and agreements with its current and former officers and directors, the Company is obligated to indemnify its current and former officers and directors who are made party to a proceeding, including a proceeding brought by or in the right of the corporation, with certain exceptions, and to advance expenses to defend such matters. The Company has already borne substantial costs to satisfy these indemnification and expense advance obligations and may continue to do so in the future. Costs incurred pursuant to these agreements are included in investigation, restatement and related expense in the unaudited condensed consolidated statements of operations.
In addition to the matters described above, the Company is a party to a variety of other legal matters that arise in the ordinary course of the Company’s business, none of which are deemed to be individually material at this time. Due to the inherent
22
uncertainty of litigation, there can be no assurance that the resolution of any particular claim or proceeding would not have a material adverse effect on the Company’s business, results of operations, financial position or liquidity.
14.
Revenue
Net Sales by Site of Service
The Company has
three
sites of service for its products (1) Hospital settings and wound care clinics, which are stable reimbursement settings in which products are used for surgical applications, (2) Private offices, which generally represents doctors and practitioners with independent operations, and (3) Other, which includes federal facilities, international sales, and other sites of service.
Below is a summary of net sales by site of service (in thousands):
Three Months Ended June 30,
Six Months Ended June 30,
2023
2022
2023
2022
Hospital
$
46,588
$
39,926
$
88,758
$
75,907
Private Office
23,750
19,039
45,237
35,196
Other
10,919
7,918
18,938
14,674
Total
$
81,257
$
66,883
$
152,933
$
125,777
The Company did not have significant foreign operations or a single external customer from which 10% or more of revenues were derived during the three or six months ended June 30, 2023 or 2022.
Net Sales by Product
The Company has
two
primary classes of products: (1) Advanced Wound Care, or Section 361, products, consisting of its tissue and cord sheet allograft products as well as certain particulate products regulated under Section 361, and (2) Section 351 products, consisting of the Company’s micronized and certain other particulate products. Advanced Wound Care is further disaggregated between the Company’s Tissue/Other and Cord products.
Below is a summary of net sales by class of product (in thousands):
Three Months Ended June 30,
Six Months Ended June 30,
2023
2022
2023
2022
Advanced Wound Care
Tissue/Other
$
75,490
$
60,274
$
141,261
$
113,126
Cord
5,748
5,889
11,187
11,486
Total Advanced Wound Care
81,238
66,163
152,448
124,612
Section 351
(1)
19
720
485
1,165
Total
$
81,257
$
66,883
$
152,933
$
125,777
(1) Revenue recognized from collections relating to revenue transactions for which performance obligations were fulfilled prior to October 1, 2019, the date at which the Company changed its pattern of revenue recognition, for the three and six months ended June 30, 2022 of $
0.1
million, which were separately presented in previously-issued financial statements, are presented as part of Section 351 in the table above.
15.
Segment Information
The Company had
two
reportable segments during the three and six months ended June 30, 2023: Wound & Surgical and Regenerative Medicine.
•
Wound & Surgical
focuses on the Advanced Wound Care and Surgical Recovery markets through the sale of the Company’s portfolio of products and product development to serve these primary end markets. Its platform technologies include tissue allografts derived from human placental membrane (EPIFIX®, AMNIOFIX®, and AMNIOEFFECT®), tissue allografts derived from human umbilical cord (EPICORD® and AMNIOCORD®), and a particulate extracellular matrix derived from human placental disc (AXIOFILL®). This segment is also responsible for international sales of the Company’s Section 351 products.
23
•
Prior to June 20, 2023,
Regenerative Medicine
focused solely on Regenerative Medicine technologies, specifically progressing the Company’s placental biologics platform towards registration as an FDA-approved biological drug. mDHACM was the lead product candidate in its late-stage pipeline targeted at achieving FDA approval for an indication to help decrease pain and improve function in patients suffering from Knee Osteoarthritis. On June 20, 2023, the Company announced a plan to disband the Regenerative Medicine business unit and suspended its Knee Osteoarthritis clinical trial program. Regenerative Medicine was not deemed to be abandoned as of June 30, 2023 as the Company has continuing run-off operations pursuant to certain regulatory requirements.
The accounting policies of the segments were the same as the Company’s accounting policies. See Note 2, “
Significant Accounting Policies
,” included in the 2022 Form 10-K.
The Company evaluated the performance of its segments and allocated resources based on segment contribution, defined as net sales less (i) cost of sales, (ii) selling, general and administrative expense, (iii) research and development expense, (iv) amortization of intangible assets, and (v) restructuring. The only components which comprised income (loss) before income tax provision that were not included in operating income (loss) were interest expense, net and other expense, net.
The Company did not allocate any assets to the reportable segments. No asset information was reported or disclosed to the chief operating decision maker in the financial information for each segment.
Net sales and segment contribution by each reportable segment for the three months ended June 30, 2023 were as follows (in thousands):
Wound & Surgical
Regenerative Medicine
Corporate & Other
Consolidated
Net sales
$
80,461
—
$
796
$
81,257
Cost of sales
12,736
—
847
13,583
Selling, general and administrative expense
38,500
—
13,425
51,925
Research and development expense
1,632
6,865
—
8,497
Restructuring
—
3,256
—
3,256
Amortization of intangible assets
—
—
191
191
Segment contribution
$
27,593
$
(
10,121
)
Investigation, restatement and related expense
1,017
Operating income
$
2,788
Supplemental information
Depreciation expense
$
395
$
72
$
220
$
687
Share-based compensation
$
1,845
$
(
193
)
$
2,408
$
4,060
Net sales and segment contribution by each reportable segment for the three months ended June 30, 2022 were as follows (in thousands):
Wound & Surgical
Regenerative Medicine
Corporate & Other
Consolidated
Net sales
$
66,094
$
—
$
789
$
66,883
Cost of sales
10,838
—
985
11,823
Selling, general and administrative expense
38,681
—
17,112
55,793
Research and development expense
2,408
3,104
—
5,512
Amortization of intangible assets
—
—
173
173
Segment contribution
$
14,167
$
(
3,104
)
Investigation, restatement and related expense
3,218
Operating loss
$
(
9,636
)
Supplemental information
Depreciation expense
$
459
$
39
$
360
$
858
Share-based compensation
$
1,896
$
302
$
2,230
$
4,428
24
Net sales and segment contribution by each reportable segment for the six months ended June 30, 2023 were as follows (in thousands):
Wound & Surgical
Regenerative Medicine
Corporate & Other
Consolidated
Net sales
$
151,090
—
$
1,843
$
152,933
Cost of sales
24,068
—
1,934
26,002
Selling, general and administrative expense
76,166
—
28,036
104,202
Research and development expense
3,154
11,839
—
14,993
Restructuring
—
3,256
—
3,256
Amortization of intangible assets
—
—
380
380
Segment contribution
$
47,702
$
(
15,095
)
Investigation, restatement and related expense
4,690
Operating loss
$
(
590
)
Supplemental information
Depreciation expense
$
784
$
135
$
482
$
1,401
Share-based compensation
$
3,228
$
259
$
4,918
$
8,405
Net sales and segment contribution by each reportable segment for the six months ended June 30, 2022 were as follows (in thousands):
Wound & Surgical
Regenerative Medicine
Corporate & Other
Consolidated
Net sales
$
124,423
$
—
$
1,354
$
125,777
Cost of sales
19,967
—
1,792
21,759
Selling, general and administrative expense
72,725
—
32,638
105,363
Research and development expense
4,358
7,118
—
11,476
Amortization of intangible assets
—
—
345
345
Segment contribution
$
27,373
$
(
7,118
)
Investigation, restatement and related expense
5,770
Operating loss
$
(
18,936
)
Supplemental information
Depreciation expense
$
914
$
84
$
720
$
1,718
Share-based compensation
$
3,661
$
564
$
4,201
$
8,426
16.
Restructuring
On June 20, 2023, the Company announced that it was suspending all activities associated with its knee osteoarthritis clinical trial program and disbanding its Regenerative Medicine business unit (the “
Restructuring
”). This was the result of the Company’s decision to focus on its Wound & Surgical business to drive profitability and cash flows. The Company anticipates that activities related to the Restructuring will materially conclude in the second half of 2023. Expenses associated with the Restructuring are recognized as the associated liabilities are incurred in an amount equal to the fair value to settle the liability.
Severance
As part of the Restructuring, the Company separated from certain employees whose primary responsibilities were toward the advancement of the Company’s knee osteoarthritis clinical trial program. The Company offered an aggregate of severance arrangements of $
2.1
million to separated employees. This amount was recognized as part of research and development expense on the unaudited condensed consolidated statements of operations for the three and six months ended June 30, 2023, as these arrangements were determined not to qualify for accounting as a one-time separation benefit under ASC 420. This amount is reflected in accrued compensation on the unaudited condensed consolidated balance sheet as of June 30, 2023.
Impairments
25
On June 23, 2023, the Company provided notice to NBCD of the termination of the Nordic Agreement. As part of the Restructuring, the Company no longer anticipated that it would receive any benefits pursuant to the clinical trial program. Accordingly, it recognized an impairment of clinical trial assets related to the Nordic Agreement and all pass-through vendors of $
2.1
million during the three and six months ended June 30, 2023. This amount is reflected as part of restructuring expense on the unaudited condensed consolidated statements of operations for the three and six months ended June 30, 2023.
In addition, the Company recorded goodwill impairment for $
0.5
million, reflecting all goodwill assigned to the Regenerative Medicine reporting unit. This amount is reflected as part of restructuring expense on the unaudited condensed consolidated statements of operations for the three and six months ended June 30, 2023. See Note 6,
“
Goodwill and Intangible Assets, Net
,” for further information regarding the impairment of goodwill due to the disbanding of the Company’s Regenerative Medicine business unit.
Contract Termination Costs
The Company anticipates that it will incur $
0.6
million in expenses to wind-down certain contracts related to the knee osteoarthritis clinical trial program. This amount generally reflects the Company’s expectation for its obligation to carry out the protocol for the patients enrolled in the trial prior to the suspension of activities and close-out costs related to the trial. This amount is reflected as part of accrued expenses on the unaudited condensed consolidated balance sheet as of June 30, 2023 and as part of restructuring expense on the unaudited condensed consolidated statements of operations for the three and six months ended June 30, 2023. The Company had not paid any of these amounts as of June 30, 2023.
17.
Subsequent Events
Hiring of Chief Financial Officer
On July 5, 2023, the Company announced that Doug Rice was appointed to serve as Chief Financial Officer of the Company, effective that day. Mr. Rice’s compensation included, among other things, a grant of
162,000
PSUs,
97,200
RSUs, and
94,000
stock options (“
Options
”), as a material inducement to his hiring.
The PSUs vest based on a
three-year
performance period ending on December 31, 2025 based upon the achievement of specified performance conditions, subject to Mr. Rice’s continued employment, except in the case of Mr. Rice’s death or disability. The awards can vest between
50
% and
150
% of the original PSUs, depending on actual performance. Vesting is limited to
100
% of the award in the event that certain share price conditions are not achieved.
The RSUs will vest in three equal tranches on each of the first three anniversary dates of the grant date, provided Mr. Rice remains in continuous service with the Company.
The Options will vest in four equal tranches on each of the first four anniversary dates of the grant date, subject to Mr. Rice’s continued employment. The Options expire
seven years
after vesting.
26
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Overview
MIMEDX is a pioneer and leader in placental biologics, focused on addressing the needs of patients with acute and chronic non-healing wounds. All of our products sold in the United States are regulated by the U.S. Food & Drug Administration (“
FDA
”).
We have two classes of products: (1) Advanced Wound Care products, or Section 361 products, consisting of our tissue and cord sheet allograft products, as well as certain particulate products regulated under Section 361, and (2) Section 351 products, consisting of our micronized and certain other particulate products, which, prior to May 31, 2021, the date the FDA’s period of enforcement discretion ended, were used to treat a variety of clinical conditions, including both advanced wound care and musculoskeletal applications. Our Advanced Wound Care products includes two product categories: Tissue/Other and Cord products. We apply Current Good Tissue Practices (“
CGTP
”) and Current Good Manufacturing Practice (“
CGMP
”) standards in addition to terminal sterilization to produce our allografts.
During the three and six months ended June 30, 2023, we operated under two defined internal business units: Wound & Surgical and Regenerative Medicine.
The Wound & Surgical business focuses on the Advanced Wound Care and Surgical Recovery markets through sales of our existing product portfolio and product development to serve these primary end markets. This business unit is responsible for substantially all sales of our Advanced Wound Care products, as well as the sale of our Section 351 products internationally.
The Regenerative Medicine business was focused on progressing the Company’s placental biologics platform. Micronized dehydrated human amnion chorion membrane (“
mDHACM
”) was our injectable placental biologic product candidate targeted at achieving FDA approval to help decrease pain and improve function in patients suffering from knee osteoarthritis (
“KOA”
). On June 20, 2023, we announced a plan to disband our Regenerative Medicine business unit and the suspension of our KOA clinical trial program. We do not intend to pursue FDA approval for mDHACM at this time. The Regenerative Medicine business unit was not deemed to be abandoned as of June 30, 2023 as the Company has continuing run-off operations pursuant to certain regulatory requirements. We anticipate that such operations will materially conclude in the second half of 2023.
This discussion, which presents our results for the three and six months ended June 30, 2023 and 2022, should be read in conjunction with our financial statements and accompanying notes in this Form 10-Q and the financial statements and accompanying notes thereto and Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022.
Results of Operations
Three Months Ended June 30, 2023 Compared to the Three Months Ended June 30, 2022
Total Company
27
Three Months Ended June 30,
(in thousands)
2023
2022
$ Change
% Change
Net sales
$
81,257
$
66,883
$
14,374
21.5
%
Cost of sales
13,583
11,823
1,760
14.9
%
Gross profit
67,674
55,060
12,614
22.9
%
Selling, general and administrative
51,925
55,793
(3,868)
(6.9)
%
Research and development
8,497
5,512
2,985
54.2
%
Restructuring
3,256
—
3,256
—
%
Investigation, restatement and related
1,017
3,218
(2,201)
(68.4)
%
Amortization of intangible assets
191
173
18
10.4
%
Interest expense, net
(1,630)
(1,170)
(460)
39.3
%
Income tax provision benefit (expense)
74
(62)
136
nm
Net income (loss)
$
1,200
$
(10,868)
$
12,068
nm
Net Sales
We recorded net sales for the three months ended June 30, 2023 of $81.3 million, a $14.4 million, or 21.5%, increase compared to the three months ended June 30, 2022, in which we recognized net sales of $66.9 million. Net sales in all care settings had one fewer shipping day during the three months ended June 30, 2023 compared to the same period in 2022.
Our sales by care setting were as follows (amounts in thousands):
Three Months Ended June 30,
Change
2023
2022
$
%
Hospital
$
46,588
$
39,926
$
6,662
16.7
%
Private Office
23,750
19,039
4,711
24.7
%
Other
10,919
7,918
3,001
37.9
%
Total
$
81,257
$
66,883
$
14,374
21.5
%
Net sales in the Hospital care setting were $46.6 million for the three months ended June 30, 2023, a $6.7 million or 16.7% increase compared to $39.9 million for the three months ended June 30, 2022. The increase was primarily driven by sales of our new products that we introduced during the third quarter of 2022.
Net sales in the Private Office care setting grew by $4.7 million, or 24.7%, to $23.8 million for the three months ended June 30, 2023, compared to $19.0 million for the three months ended June 30, 2022. The increase reflects general increases in sales volume, driven by strong commercial execution.
Net sales in Other care settings increased by $3.0 million, or 37.9%, year-over-year. The increase was the result of the addition of new customers and sales of EPIFIX in Japan during the quarter.
Cost of Sales and Gross Profit Margin
Cost of sales for the three months ended June 30, 2023 and 2022 was $13.6 million and $11.8 million, respectively, an increase of $1.8 million, or 14.9%. Increases in cost of sales were driven by increases in sales volume noted above.
Gross profit margin for the three months ended June 30, 2023 was 83.3% compared to 82.3% for the three months ended June 30, 2022. Increases in gross profit margin were driven by continued execution on yield improvement projects, as well as year-over-year changes in sales mix, driven by execution in higher-margin care settings.
28
Selling, General and Administrative Expense
Selling, general and administrative (“
SG&A
”) expense for the three months ended June 30, 2023 was $51.9 million, compared to $55.8 million for the three months ended June 30, 2022, a decrease of $3.9 million, or 6.9%. The decrease in SG&A expense was due to decreases in professional service costs, personnel costs, and bad debt expense. The decrease in professional service expenses reflects $2.1 million in consulting and advisory expenses incurred in 2022 related to a withhold the vote campaign launched by a shareholder. There was no similar activity during 2023. The decrease in personnel costs reflect the results of our cost reduction efforts which began during the third quarter of 2022. Finally, the decrease in bad debt expense was the result of the deterioration of credit for certain specific customers in 2022. These decreases were offset by increases in commissions due to higher sales volumes.
Research and Development Expense
Our research and development expense increased by $3.0 million, or 54.2%, to $8.5 million for the three months ended June 30, 2023, compared to $5.5 million for the three months ended June 30, 2022. The increase reflects severance expenses of $2.1 million related to the disbanding of our Regenerative Medicine business unit. Prior to this disbanding, we incurred greater expenses related to our clinical trial activities, which also contributed to the increase. As a result of the disbanding of our Regenerative Medicine business unit and the suspension of our KOA clinical trial program, we anticipate that research and development expense will decrease in future quarters.
Restructuring Expense
Restructuring expense of $3.3 million for the three months ended June 30, 2023 reflects certain charges related to the disbanding of our Regenerative Medicine business unit, including write-downs of prepaid clinical trial assets of $2.1 million, charges for the wind-down of our KOA clinical trial program of $0.6 million, and impairment of goodwill of $0.5 million.
Investigation, Restatement and Related Expense
Investigation, restatement and related expense for the three months ended June 30, 2023 was $1.0 million compared to $3.2 million for the three months ended June 30, 2022. The decrease was primarily attributable to a decrease in legal fees advanced on behalf of a former officer, year-over-year.
Amortization of Intangible Assets
Amortization expense related to intangible assets was $0.2 million for each of the three months ended June 30, 2023 and 2022.
Interest Expense, Net
Interest expense, net was $1.6 million for the three months ended June 30, 2023 compared to $1.2 million for the three months ended June 30, 2022, an increase of $0.5 million, or 39.3%. The increase was the result of year-over-year increases in the London Interbank Offered Rate (“
LIBOR
”), which was the reference rate on our outstanding debt during both periods.
Income Tax Provision Benefit (Expense)
The effective tax rates for the Company were (6.6)% and (0.6)% for the three months ended June 30, 2023 and June 30, 2022, respectively. There were no material discrete items affecting the effective tax rate in either period.
Wound & Surgical
Three Months Ended June 30,
(in thousands)
2023
2022
$ Change
% Change
Net sales
$
80,461
$
66,094
$
14,367
21.7
%
Cost of sales
12,736
10,838
1,898
17.5
%
Selling, general and administrative expense
38,500
38,681
(181)
(0.5)
%
Research and development expense
1,632
2,408
(776)
(32.2)
%
Segment contribution
$
27,593
$
14,167
$
13,426
94.8
%
Our Wound & Surgical business recorded $80.5 million of net sales for the three months ended June 30, 2023, a $14.4 million, or 21.7%, increase compared to the $66.1 million we recorded for the three months ended June 30, 2022. The increase in net
29
sales was driven primarily by strong commercial execution in the Private Office care setting, sales of our new products, addition of new customers in the Other care setting, and sales of EPIFIX in Japan.
Cost of sales for the three months ended June 30, 2023 was $12.7 million, a $1.9 million, or 17.5%, increase compared to the $10.8 million recognized for the three months ended June 30, 2022. The increase was driven by increases in sales volumes, offset in part by year-over-year changes in sales mix.
SG&A expense was $38.5 million for the three months ended June 30, 2023, a $0.2 million, or 0.5%, decrease compared to the three months ended June 30, 2022, during which we incurred $38.7 million of expenses. The decrease was driven by year-over-year decreases in personnel costs and bad debt expense. The decrease in personnel costs reflects the results of our cost reduction efforts which began in the third quarter of 2022. The decrease in bad debt expense was the result of the deterioration of credit for certain specific customers in 2022. These decreases were offset by increases in commissions resulting from increases in sales volume.
Research and development expense was $1.6 million for the three months ended June 30, 2023, compared to $2.4 million for the three months ended June 30, 2022. The decrease reflects fewer product development costs, year-over-year, driven by the timing of our product launches.
Segment contribution margin for Wound & Surgical was 34.3% for the three months ended June 30, 2023, compared to 21.4% for the three months ended June 30, 2022.
Regenerative Medicine
Three Months Ended June 30,
(in thousands)
2023
2022
$ Change
% Change
Research and development expense
$
6,865
$
3,104
$
3,761
nm
Restructuring
3,256
—
3,256
nm
Segment contribution
$
(10,121)
$
(3,104)
$
(7,017)
nm
On June 20, 2023, we announced a plan to disband our Regenerative Medicine business unit and the suspension of our KOA clinical trial program. As a result of these actions, we incurred severance expense for former employees of $2.1 million.
Research and development expense was $6.9 million for the three months ended June 30, 2023, compared to $3.1 million for the three months ended June 30, 2022, an increase of $3.8 million. In addition to the severance expenses referenced above, we incurred greater expenses related to our clinical trial activities during the three months ended June 30, 2023.
Restructuring reflects certain charges related to the disbanding of our Regenerative Medicine business unit, including write-downs of prepaid clinical trial assets of $2.1 million, charges for the wind-down of our KOA clinical trial program of $0.6 million, and impairment of goodwill of $0.5 million.
Corporate
SG&A expense for the Corporate function was $13.4 million, or 16.5% of total net sales, for the three months ended June 30, 2023, compared to $17.1 million for the three months ended June 30, 2022, reflecting 25.6% of total net sales. The decrease in SG&A expense was primarily due to year-over-year decreases in professional services costs, primarily resulting from a withhold the vote campaign launched by a shareholder during 2022. There was no similar activity in 2023.
Six Months Ended June 30, 2023 Compared to the Six Months Ended June 30, 2022
Total Company
30
Six Months Ended June 30,
(in thousands)
2023
2022
$ Change
% Change
Net sales
$
152,933
$
125,777
$
27,156
21.6
%
Cost of sales
26,002
21,759
4,243
19.5
%
Gross profit
126,931
104,018
22,913
22.0
%
Selling, general and administrative
104,202
105,363
(1,161)
(1.1)
%
Research and development
14,993
11,476
3,517
30.6
%
Restructuring
3,256
—
3,256
—
%
Investigation, restatement and related
4,690
5,770
(1,080)
(18.7)
%
Amortization of intangible assets
380
345
35
10.1
%
Interest expense, net
(3,184)
(2,295)
(889)
38.7
%
Other expense, net
(32)
(1)
(31)
nm
Income tax provision benefit (expense)
23
(125)
148
nm
Net loss
$
(3,783)
$
(21,357)
$
17,574
(82.3)
%
Net Sales
We recorded net sales for the six months ended June 30, 2023 of $152.9 million, a $27.2 million, or 21.6%, increase compared to the six months ended June 30, 2022, for which we recorded net sales of $125.8 million. Net sales for the six months ended June 30, 2023 in all sites of service benefited from the alleviation of the Omicron wave of the Covid-19 Pandemic, which adversely impacted sales during the six months ended June 30, 2022. There was an equal number of shipping days in each period.
Our sales by care setting were as follows (amounts in thousands):
Six Months Ended June 30,
Change
2023
2022
$
%
Hospital
$
88,758
$
75,907
$
12,851
16.9
%
Private Office
45,237
35,196
10,041
28.5
%
Other
18,938
14,674
4,264
29.1
%
Total
$
152,933
$
125,777
$
27,156
21.6
%
Net sales in the Hospital care setting were $88.8 million for the six months ended June 30, 2023, a $12.9 million or 16.9% increase compared to $75.9 million for the six months ended June 30, 2022. The increase was primarily driven by sales of our new products that we introduced during the third quarter of 2022.
Net sales in the Private Office care setting grew by $10.0 million, or 28.5%, to $45.2 million for the six months ended June 30, 2023, compared to $35.2 million for the six months ended June 30, 2022. The increase reflects general increases in sales volume, driven by strong commercial execution resulting from a prioritization of this site of service.
Net sales in Other care settings increased by $4.3 million, or 29.1%, year-over-year. The increase was primarily driven by our new products, addition of new customers in certain sites of service and sales of EPIFIX in Japan.
Cost of Sales and Gross Profit Margin
Cost of sales for the six months ended June 30, 2023 was $26.0 million, an increase of $4.2 million, or 19.5%, compared to $21.8 million for the six months ended June 30, 2022. Increases in cost of sales were driven by increases in sales volume noted above.
Gross profit margin for six months ended June 30, 2023 was 83.0% and 82.7% for the six months ended June 30, 2023 and 2022, respectively.
Selling, General and Administrative Expense
31
SG&A expense for the six months ended June 30, 2023 decreased by $1.8 million, or 1.7%, to $104.2 million, compared to $105.4 million for the six months ended June 30, 2022. The decrease was driven by decreases in professional services expenses, personnel costs and bad debt expense. The decrease in professional services expenses reflects $2.1 million in consulting and advisory expenses incurred in 2022 related to a withhold the vote campaign launched by a shareholder. There was no similar activity during 2023. The decrease in personnel costs reflects the results of our cost reduction efforts that began in the third quarter of 2022. Finally, the decrease in bad debt expense was the result of the deterioration of credit for certain specific customers in 2022.
The decrease was offset by increases in sales commissions, driven by increases in sales volumes. In addition, we incurred greater travel expenses, reflecting the removal of travel restrictions that were in place during the six months ended June 30, 2022 due to the Covid-19 Pandemic.
Research and Development Expense
Our research and development expenses increased by $3.5 million, or 30.6%, to $15.0 million for the six months ended June 30, 2023, compared to $11.5 million for the six months ended June 30, 2022. The increase reflects severance expenses of $2.1 million related to the disbanding of our Regenerative Medicine business unit. Prior to this disbanding, we incurred greater personnel costs and clinical trial expenses to support clinical activities, which also contributed to the increase.
Investigation, Restatement and Related Expense
Investigation, restatement and related expenses for the six months ended June 30, 2023 decreased by $1.1 million, or 18.7%, to $4.7 million compared to $5.8 million for the six months ended June 30, 2022. The decrease was attributable to a decrease in legal fees advanced on behalf of a former officer.
Amortization of Intangible Assets
Amortization expense increased from $0.3 million for the six months ended June 30, 2022 to $0.4 million for the six months ended June 30, 2023.
Restructuring Expense
Restructuring expense of $3.3 million for the six months ended June 30, 2023 reflects certain charges related to the disbanding of our Regenerative Medicine business unit, including write-downs of prepaid clinical trial assets of $2.1 million, charges for the wind-down of our KOA clinical trial program of $0.6 million, and impairment of goodwill of $0.5 million.
Interest Expense, Net
Interest expense, net was $3.2 million for the six months ended June 30, 2023 compared to $2.3 million for the six months ended June 30, 2022. The increase was the result of year-over-year increases in LIBOR, which was the reference rate on our outstanding debt during both periods.
Income Tax Provision Benefit (Expense)
The effective tax rates for the Company were 0.6% and (0.6)% for the six months ended June 30, 2023 and 2022, respectively. There were no material discrete items affecting the effective tax rate in either period. Net operating losses incurred during both periods were offset by a valuation allowance.
Wound & Surgical
Six Months Ended June 30,
(in thousands)
2023
2022
$ Change
% Change
Net sales
$
151,090
$
124,423
$
26,667
21.4
%
Cost of sales
24,068
19,967
4,101
20.5
%
Selling, general and administrative expense
76,166
72,725
3,441
4.7
%
Research and development expense
3,154
4,358
(1,204)
(27.6)
%
Segment contribution
$
47,702
$
27,373
$
20,329
74.3
%
32
Our Wound & Surgical business recorded $151.1 million of net sales for the six months ended June 30, 2023, a $26.7 million, or 21.4%, increase compared to the $124.4 million we recorded for the six months ended June 30, 2022. Net sales for the six months ended June 30, 2023 benefited from the alleviation of the Omicron wave of the Covid-19 Pandemic, which adversely impacted sales during the six months ended June 30, 2022. The increase in net sales was driven primarily by strong commercial execution in the Private Office care setting, sales of our new products, addition of new customers in the Other care setting, and sales of EPIFIX in Japan.
Cost of sales for the six months ended June 30, 2023 was $24.1 million, a $4.1 million, or 20.5%, increase compared to the $20.0 million recognized for six months ended June 30, 2022. Cost of sales increased due to increases in sales volumes.
SG&A expense was $76.2 million for the six months ended June 30, 2023, a $3.4 million, or 4.7%, increase over the six months ended June 30, 2022, during which we incurred $72.7 million of expenses. The increase was driven by increases in commissions, driven by sales volumes. In addition, we incurred greater travel expenses, reflecting the removal of travel restrictions that were in place during the six months ended June 30, 2022 due to the Covid-19 Pandemic. These effects were offset by year-over-year decreases in personnel costs, which reflects the results of our cost reduction efforts that began in the third quarter of 2022, and in bad debt expense, which was the result of the deterioration of credit for certain specific customers in 2022.
Research and development expense was $3.2 million for the six months ended June 30, 2023, compared to $4.4 million for the six months ended June 30, 2022, a decrease of $1.2 million, or 27.6%. The decrease reflects less product development costs during 2023, specifically as we were readying product launches in the third quarter of 2022.
Regenerative Medicine
Six Months Ended June 30,
(in thousands)
2023
2022
$ Change
% Change
Research and development expense
$
11,839
$
7,118
$
4,721
66.3
%
Restructuring
3,256
—
3,256
nm
Segment contribution
$
(15,095)
$
(7,118)
$
(7,977)
nm
On June 20, 2023, we announced a plan to disband our Regenerative Medicine business unit and the suspension of our KOA clinical trial program. As a result of these actions, we incurred severance expense for former employees of $2.1 million.
Research and development expense was $11.8 million for the six months ended June 30, 2023, compared to $7.1 million for the six months ended June 30, 2022, an increase of $4.7 million. In addition to the one-time expenses referenced above, we incurred greater personnel costs and clinical trial expenses to support clinical activities during the three months ended June 30, 2023.
Restructuring expense reflects certain charges related to the disbanding of our Regenerative Medicine business unit, including write-downs of prepaid clinical trial assets of $2.1 million, charges for the wind-down of our KOA clinical trial program of $0.6 million, and impairment of goodwill of $0.5 million.
Corporate
SG&A expense for the Corporate function was $28.0 million, or 18.3% of total net sales, for the six months ended June 30, 2023, compared to $32.6 million for the six months ended June 30, 2022, reflecting 25.9% of total net sales. The decrease in SG&A expense was primarily due to year-over-year decreases in professional services costs related to a withhold the vote campaign launched by a shareholder during 2022.
Non-GAAP Financial Measures
In addition to our GAAP results, we provide certain Non-GAAP measures including Earnings Before Interest, Taxes, Depreciation and Amortization (“
EBITDA
”), and Adjusted EBITDA. We believe that the presentation of these measures provides important supplemental information to management and investors regarding our performance. These measurements are not a substitute for GAAP measurements, and the manner in which we calculate such metrics may not be identical to the manner in which other companies calculate and present similar metrics. Company management uses these Non-GAAP measures as aids in monitoring our ongoing financial performance from quarter-to-quarter and year-to-year on a regular basis and for benchmarking against comparable companies.
33
EBITDA and Adjusted EBITDA
In addition to our GAAP results, we provide the following Non-GAAP measures: Earnings Before Interest, Taxes, Depreciation and Amortization (“
EBITDA
”) and Adjusted EBITDA. These measurements are not, and should not be used, as a substitute for GAAP measures. Company management uses these Non-GAAP measures as aids in monitoring our ongoing financial performance on a regular basis and for benchmarking against comparable companies.
EBITDA is intended to provide a measure of our operating performance as it eliminates the effects of financing and capital expenditures. EBITDA consists of GAAP net income or loss excluding: (i) depreciation, (ii) amortization of intangibles, (iii) interest expense, net, and (iv) income tax provision.
Adjusted EBITDA is intended to provide an enduring, normalized view of EBITDA and our broader business operations that we expect to experience on an ongoing basis by removing certain non-cash items and items which may be irregular, one-time, or non-recurring from EBITDA. This includes share-based compensation, which is predominantly settled in shares. This enables us to identify underlying trends in our business that could otherwise be masked by such items.
Adjusted EBITDA consists of GAAP net income or loss excluding: (i) depreciation, (ii) amortization of intangibles, (iii) interest expense, (iv) income tax provision, (v) investigation, restatement and related expenses, (vi) share-based compensation, and (vii) expenses related to the disbanding of our Regenerative Medicine business unit.
Expenses related to the disbanding of our Regenerative Medicine business unit include (i) write-downs of our prepaid clinical trial assets, (ii) charges associated with the wind-down of contracts associated with our KOA clinical trial program, (iii) severance expenses incurred which were directly attributable to the disbanding, and (iv) impairment of goodwill.
Management also assesses EBITDA margin and Adjusted EBITDA margin to provide an additional layer of context to the Company’s profitability; indicating our ability to convert our sales into sustainable operating results. EBITDA margin is calculated as EBITDA divided by GAAP net sales. Similarly, Adjusted EBITDA margin is calculated as Adjusted EBITDA divided by GAAP net sales.
A reconciliation of GAAP net loss to EBITDA and Adjusted EBITDA appears in the table below (in thousands):
Three Months Ended June 30,
Six Months Ended June 30,
2023
2022
2023
2022
Net income (loss)
$
1,200
$
(10,868)
$
(3,783)
$
(21,357)
Net margin
1.5
%
(16.2)
%
(2.5)
%
(17.0)
%
Non-GAAP Adjustments:
Depreciation expense
687
858
1,401
1,718
Amortization of intangible assets
191
173
380
345
Interest expense, net
1,630
1,170
3,184
2,295
Income tax provision
(74)
62
(23)
125
EBITDA
3,634
(8,605)
1,159
(16,874)
EBITDA margin
4.5
%
(12.9)
%
0.8
%
(13.4)
%
Additional Non-GAAP Adjustments
Costs incurred in connection with Audit Committee Investigation and Restatement
1,017
3,218
4,690
5,770
Share-based compensation
4,060
4,428
8,405
8,426
Expenses related to disbanding of Regenerative Medicine business unit
5,391
—
5,391
—
Adjusted EBITDA
$
14,102
$
(959)
$
19,645
$
(2,678)
Adjusted EBITDA margin
17.4
%
(1.4)
%
12.8
%
(2.1)
%
34
Discussion of Cash Flows
Operating Activities
Net cash provided by operating activities during the six months ended June 30, 2023 was $3.7 million, compared to cash used of $13.2 million for the six months ended June 30, 2022. The change was primarily the result of year-over-year increases in net sales, which drove increases in collections from customers, as well as year-over-year decreases in operating expenses.
Investing Activities
Net cash used for investing activities during the six months ended June 30, 2023 was $1.0 million, compared to $0.6 million for the six months ended June 30, 2022. This increase reflects a $0.4 million year-over-year increase in capital expenditures.
Financing Activities
We did not have meaningful cash flows from financing activities during the six months ended June 30, 2023. Cash used in financing activities was $0.8 million during the six months ended June 30, 2022. We ceased withholding shares to satisfy employee tax obligations upon vesting of equity awards in 2022. Accordingly, we did not have any cash paid for tax withholdings during the six months ended June 30, 2023, compared to $1.2 million for the six months ended June 30, 2022. This effect was offset by $0.4 million of cash receipts from option exercises in the six months ended June 30, 2022, compared to immaterial proceeds from option exercises during 2023.
Liquidity and Capital Resources
Our business requires capital for our operating activities, including costs associated with the sale of product through direct and indirect sales channels, the conduct of research and development activities, compliance costs, and legal and consulting fees in connection with ongoing litigation and other matters.
As of June 30, 2023, we had $68.7 million of cash and cash equivalents, total current assets of $141.2 million and total current liabilities of $44.5 million, reflecting a current ratio of 3.2.
We are currently paying our obligations in the ordinary course of business.
We anticipate cash requirements related to the following items within one year of the date of the filing of this Quarterly Report:
•
investments to advance and expand our existing product portfolio;
•
expenditures required to achieve necessary regulatory approval and establish operations in new markets deemed strategically important toward the enhancement of our global footprint;
•
costs to wind-down certain contracts associated with our KOA clinical trial program; and
•
severance payments related to certain former members of management and other employees.
We have analyzed our ability to address these commitments and potential liabilities for the 12 months extending from the date of the filing of this Quarterly Report. After completing this analysis, which included a review of expectations of revenue, margins, and expenses, we believe that our existing cash and cash from operations will be sufficient to meet our obligations as they come due.
Term Loan
On June 30, 2020, we entered into a Loan Agreement with, among others, Hayfin Services, LLP, (“
Hayfin
”) an affiliate of Hayfin Capital Management, LLP (as amended, the “
Hayfin Loan Agreement
”), under which Hayfin provided us with a senior secured term loan of $50 million (the “
Term Loan
”). The Term Loan matures on June 30, 2025 (the “
Maturity Date
”).
No principal payments are due on the Term Loan until the Maturity Date. Interest is payable on the Term Loan for principal outstanding quarterly through the Maturity Date. Pursuant to Amendment No. 2 to the Loan Agreement entered into in June 2023, interest on any borrowings under the Term Loan is equal to the Secured Overnight Finance Rate (“
SOFR
”), plus a fallback provision of 0.15%, subject to a floor of 1.5%, plus a margin of 6.75%. An additional 3.0% margin would be applied to the interest rate upon the occurrence of an Event of Default, as defined in the Hayfin Loan Agreement. As of June 30, 2023, the Term Loan carried an interest rate of 12.1%.
35
The Hayfin Loan Agreement contains certain financial covenants, including a Minimum Consolidated Total Net Sales covenant, tested quarterly, and a Minimum Liquidity covenant, tested monthly (each as defined). In addition, the Hayfin Loan Agreement includes certain negative covenants and events of default customary for facilities of this type. Upon the occurrence of such events of default, all outstanding loans under the Hayfin Loan Agreement may be accelerated or the lenders’ commitments terminated. The Hayfin Loan Agreement also specifies mandatory prepayments based on a percentage of Excess Cash Flow (as defined in the Hayfin Loan Agreement, if such is generated), as well as upon the occurrence of other events specified in the Hayfin Loan Agreement.
As of June 30, 2023, we were in compliance with all financial covenants under the Hayfin Loan Agreement. A breach of a financial covenant in the Hayfin Loan Agreement, if uncured or unable to be cured, would likely result in an event of default that could trigger the lenders’ remedies, including acceleration of the entire principal balance of the loan as well as any applicable prepayment premiums.
Series B Preferred Stock
We have 100,000 shares of Series B Preferred Stock outstanding as of June 30, 2023.
The Series B Preferred Stock accumulates dividends at a rate of 6.0% per annum. Dividends are declared at the sole discretion of our Board of Directors. Dividends, if declared, are paid in cash at the end of each quarter based on dividend amounts that accumulate beginning on the last payment date through the day prior to the end of each quarter. In lieu of paying a dividend, we may elect to accrue the dividend owed to shareholders. Dividend balances accumulate at the prevailing dividend rate for each dividend period during which they are outstanding.
Each share of Series B Preferred Stock, including any accrued and unpaid dividends, is convertible into our common stock at any time at the option of the holder at a conversion price of $3.85 per common share. The Series B Preferred Stock converts automatically at any time after July 2, 2023, provided that the common stock has traded at $7.70 or higher (i) for 20 out of 30 consecutive trading days, and (ii) on such date of conversion.
If we undergo a change of control, we will have the option to repurchase some or all then-outstanding shares of Series B Preferred Stock for cash in an amount equal to the liquidation preference and any accumulated and unpaid dividends. If we do not exercise this right, holders of the Series B Preferred Stock will have the option to (1) require us to repurchase any or all of our then-outstanding shares of Series B Preferred Stock in an amount equal to the liquidation preference plus unpaid dividends, or (2) convert the Series B Preferred stock into common stock and receive its pro rata consideration thereunder.
We have not declared or paid any cash dividends on our Series B Preferred Stock since issuance. Dividends accumulated but not paid as of June 30, 2023 were $17.2 million. The Series B Preferred Stock was convertible into 30,445,997 shares of common stock as of June 30, 2023.
Share Repurchases
We did not repurchase any shares of our common stock during the three months ended June 30, 2023. The timing and amount of future repurchases, if any, will depend upon our stock price, economic and market conditions, regulatory requirements, and other corporate considerations. We may initiate, suspend or discontinue purchases at any time.
Contractual Obligations
Except as described below and as previously disclosed in our Quarterly Report for the three months ended March 31, 2023, there were no significant changes to our contractual obligations during the six months ended June 30, 2023 from those disclosed in the section Item 7, “
Management’s Discussion and Analysis of Financial Condition and Results from Operations
”, in our 2022 Form 10-K.
Nordic Agreement
In June 2022, we entered into a collaboration agreement (the “
Nordic Agreement
”) with Nordic Bioscience Clinical Development A/S (“
NBCD
”) to provide full operational support for our KOA clinical trial program. Under the terms of the Nordic Agreement, we were obligated to pay $10.2 million upon the achievement of specified milestones over the course of the clinical trial. Pursuant to the Nordic Agreement, we are obligated to reimburse NBCD for services performed through the effective termination date and for non-cancelable obligations reasonably incurred prior to that date. If we have prepaid NBCD for services performed, we are entitled to reimbursement to the extent that such funds have not been consumed. In addition, we have certain regulatory obligations for all trial participants enrolled in the study prior to the suspension of clinical trial activities.
36
Critical Accounting Estimates
In preparing financial statements, we follow accounting principles generally accepted in the United States, which require us to make certain estimates and apply judgments that affect our financial position and results of operations. We regularly review our accounting policies and financial information disclosures. A summary of critical accounting estimates in preparing the financial statements was provided in our 2022 Form 10-K.
In addition, during the period covered by this Quarterly Report, we identified the following critical accounting estimates which were not material to the 2022 Form 10-K.
Share-Based Compensation Expense
Description
We measure stock options and other stock-based awards granted to employees based on their fair value on the date of the grant and recognize the assessed fair value as share-based compensation expense, straight-line, over the requisite service period to achieve the award based on the vesting requirements, to the extent that the achievement of performance conditions associated with such awards, as applicable, are determined to be “probable.”
Judgments and Uncertainties
Share-based payment arrangements are measured at fair value on the grant date. The fair value of equity incentive awards, which are usually shares of our common stock, are generally measured at the last trading price on the grant date.
The fair value of stock options is calculated using an appropriate valuation technique. The valuation technique generally requires us to make certain assumptions, including (1) the fair value of the common stock, (2) the expected volatility of our stock price, (3) the expected term of the award, (4) the risk-free interest rate, and (5) expected dividends. Our expectation for volatility is generally based on historical daily share price movements, with certain adjustments for abnormal share price activity associated with events which are not expected to recur during the expected term. The expected term of the award requires us to make assumptions regarding the post-vesting behavior of the recipients, which is based off available evidence. Our assumption for the risk-free rate is derived from prevailing U.S. Treasuries with similar terms to the award on the grant date. Our assumption for dividends is derived from our own dividend history.
To the extent that any such awards are subject to a market condition, the resolution of the market condition is reflected in the fair value of the grant date. Further, the requisite service period associated with an award containing a market condition must derive the service period over which the market condition is expected to be met. Fair value and derived service periods are generally determined using a Monte Carlo simulation.
Subsequent to the determination of fair value, we recognize expense to the extent we evaluate that performance conditions associated with share-based payment arrangements are probable of occurring. In certain cases where the extent of vesting is based on the extent of achievement, we are required to determine the extent to which achievement is probable. We determine probable performance based on actual performance to date, internally-developed budgets and forecasts for periods covered by the relevant performance condition, and other evidence deemed relevant to this determination. We re-evaluate our probability assessments at least quarterly, with any revisions reflected as a cumulative adjustment to expense. Because of the cumulative nature of adjustments, during any period in which we re-evaluate probability, the adjustments could significantly impact our results of operations.
Sensitivity of Estimate to Change
During the six months ended June 30, 2023, we granted stock options with a fair value on the grant date of $7.0 million. This estimate was determined using a Monte Carlo simulation using the following inputs:
Assumption
Stock price on grant date
$
3.70
Exercise price
$
3.70
Risk-free interest rate
3.58
%
Expected volatility (annualized)
75.00
%
Dividend yield
—
%
Weighted average grant date fair value
$
1.93
37
The granted stock options reflected an expected term based on our expectations for exercise activity. Changes in any of these assumptions could result in a revised estimate of fair value of the granted stock options, which would impact the amount of expense recognized over the requisite service period, and could materially affect the total fair value or the amount of expense recognized in a particular period.
In addition, cumulative expense recognized for unvested performance stock unit awards was $0.9 million as of June 30, 2023. This is based on determinations regarding probable resolution or the extent of probable resolution of relevant performance conditions to earn such awards. If it is subsequently determined that the performance conditions associated with these awards are no longer probable of being met, or performance conditions which were determined to be probable of occurring do not actually occur, we could reverse up to this amount of expense in the period such determination is made. Furthermore, if probable levels of achievement are later determined to be greater, or actual achievement exceeds the level of achievement assessed as probable, we could record increases to expense to reflect this level of achievement. The amount of any incremental expense recognition or reversal will depend on the magnitude and timing of such change in estimate.
Recent Accounting Pronouncements
For the effect of recent accounting pronouncements, see Note 2,
“
Significant Accounting Policies
”, to the unaudited condensed consolidated financial statements contained herein.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
We are exposed to risks associated with changes in interest rates that could adversely affect our results of operations and financial condition. We do not hedge against interest rate risk.
The interest rate on our Term Loan is determined quarterly based on the 3-month SOFR rate, subject to a floor of 1.5%. As of June 30, 2023, the interest rate on our Term Loan was 12.1%. A 100 basis point change in SOFR, to the extent that such change would not cause SOFR to be below the 1.5% floor, would change our interest expense by $0.5 million on an annualized basis.
During the three and six months ended June 30, 2023, we incurred $0.5 million and $0.9 million in incremental interest expense compared to the equivalent periods in the prior year resulting from increases in the relevant reference rate during the intervening period.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended, or the Exchange Act) as of the end of the period covered by this report. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures as of the end of the period covered by this report were effective at a reasonable assurance level in ensuring that information required to be disclosed by us in reports that we file or submit under the Exchange Act (i) is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and (ii) accumulated and communicated to management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely discussions regarding required disclosure. We believe that a control system, no matter how well designed and operated, cannot provide absolute assurance that the objectives of the control system are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected.
Changes in Internal Control over Financial Reporting
There was no change in our internal control over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) of the Exchange Act) that occurred during the fiscal quarter ended June 30, 2023 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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PART II – OTHER INFORMATION
Item 1. Legal Proceedings
The Company and its subsidiaries are parties to numerous claims and lawsuits arising in the ordinary course of its business activities, some of which involve claims for substantial amounts. The ultimate outcome of these suits cannot be ascertained at this time. The description of our securities class action and the
Welker v. MiMedx, et. Al case
contained in
Note 13,
“Commitments and Contingencies
,
” to the unaudited condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report, is incorporated herein by reference.
Item 1A. Risk Factors
There have been no material changes to the Company’s risk factors included in its 2022 Form 10-K.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
(a) None.
(b) None.
(c) None.
Item 3. Defaults Upon Senior Securities
Not applicable.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
Not applicable.
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Item 6. Exhibits
Exhibit
Number
Description
3.1*
Articles of Amendment to the Restated Articles of Incorporation of MiMedx Group, Inc., effective June 13, 2023 (
incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on June 20, 202
3).
10.1*
Amended and Restated MiMedx Group, Inc. 2016 Equity and Cash Incentive Plan (
incorporated by reference to Exhibit 10.5 to the Registrant’s Current Report on Form 8-K filed on June 20, 2023
).
10.2#
Amendment No. 2 to Loan Agreement dated as of June 15, 2023
, which amends that certain Loan Agreement dated as of June 30, 2020 by and among MiMedx Group, Inc., certain subsidiaries of MiMedx Group, Inc. parties thereto, the Lenders from time to time party hereto, Hayfin Services LLP, as administrative agent for the Lenders and as collateral agent for the Secured Parties.
31.1 #
Certification of Chief Executive Officer
pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2 #
Certification of Chief Financial Officer
pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1 #
Certification of Chief Executive Officer
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2 #
Certification of Chief Financial Officer
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS #
XBRL Instance Document
101.SCH #
XBRL Taxonomy Extension Schema Document
101.CAL #
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF #
XBRL Taxonomy Extension Definition Linkbase Document
101.LAB #
XBRL Taxonomy Extension Label Linkbase Document
101.PRE #
XBRL Taxonomy Extension Presentation Linkbase Document
*
Previously filed and incorporated herein by reference
#
Filed or furnished herewith
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
August 1, 2023
MIMEDX GROUP, INC.
By:
/s/ Doug Rice
Doug Rice
Chief Financial Officer and Principal Financial Officer
40