MIMEDX Announces Third Quarter 2022 Operating and Financial Results
MiMedx Group reported third quarter net sales of $67.7 million, a 7.3% increase compared to the prior year. This growth was driven by the Surgical Recovery market and initial contributions from new products, AMNIOEFFECT™ and AXIOFILL™. However, the company also faced challenges, including a net loss of $8.4 million, up from $2.3 million the previous year. Operating expenses increased to $53.5 million, reflecting higher sales commissions and travel costs. Looking ahead, MiMedx anticipates fourth quarter sales of $73 to $76 million.
- Third quarter net sales increased to $67.7 million, a 7.3% growth year-over-year.
- Introduced new products AMNIOEFFECT™ and AXIOFILL™, enhancing the Surgical Recovery product line.
- Reimbursement approval secured for EPIFIX® in Japan, expanding market access.
- Expect fourth quarter 2022 net sales in the range of $73 to $76 million, reflecting 8% to 15% growth.
- Net loss increased to $8.4 million, compared to $2.3 million loss in the same period last year.
- Adjusted EBITDA loss of $0.7 million, down from a gain of $7.0 million in the prior year.
- Operating expenses rose to $53.5 million, resulting from increased commissions and severance costs.
Third Quarter Net Sales of
Introducing Wound & Surgical and Regenerative Medicine Segment Reporting to Highlight Trends Within Each Business Unit
Third Quarter Growth Led by Surgical Recovery with Initial Contributions from AMNIOEFFECT™ and AXIOFILL™
Management to Host Conference Call on Wednesday, November 2, 2022, at 5:00 PM ET
MARIETTA, Ga., Nov. 02, 2022 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”), a transformational placental biologics company, today announced operating and financial results for the third quarter 2022, which ended September 30, 2022.
Todd Newton, MIMEDX interim Chief Executive Officer ("CEO"), commented, “The third quarter 2022 represented the first year-over-year growth in net sales in six quarters and included several important achievements that we expect to build upon. In September, we launched two new products tailored for the Surgical Recovery market, AXIOFILL™ and AMNIOEFFECT™; secured reimbursement approval in Japan for our EPIFIX® product; and the first patients in Japan were treated with our product. Also, we made recent progress toward our goal of commencing patient enrollment in our registrational study for the treatment of knee osteoarthritis.”
Mr. Newton continued, “However, there is no denying that we must also focus on becoming profitable. The executive team and I have set goals to continue delivering year-over-year revenue growth, while at the same time generating profitability. We are now forming detailed plans across the organization to realize our goals. Beginning this quarter, we are reporting our financial results by segment to better highlight the underlying revenue trends, cost structure and progress against the growth and profitability initiatives we are implementing. We clearly have much to do and I look forward to reporting back to shareholders on these initiatives.”
Recent Operating and Financial Highlights:
- Reported third quarter net sales of
$67.7 million , an increase of7.3% . - Appointed Todd Newton interim CEO.
- Obtained reimbursement approval from the Japanese Ministry of Health, Labour and Welfare for the use of EPIFIX to treat refractory or hard-to-heal lower extremity diabetic and venous ulcers.
- Launched AMNIOEFFECT, a tri-layer PURION® processed human tissue allograft offering superior handling characteristics for surgeons when addressing certain surgical wounds.
- Launched AXIOFILL, a versatile human placental-derived particulate product that can be used as a particulate or paste in large, complex or irregular surgical wounds.
- Advanced engagement with the U.S. Food and Drug Administration (“FDA”) for the Company’s next knee osteoarthritis (“KOA”) registrational study with its micronized dehydrated human amnion chorion membrane (“mdHACM”) product. This engagement included the filing with FDA of its proposed study protocol, amendments to its chemistry, manufacturing, and controls (“CMC”) activities, and holding a Type B RMAT meeting with FDA to review and discuss the plans.
- Appointed Matt Notarianni Head of Investor Relations.
- Introduced segment reporting of financial results for Wound & Surgical and Regenerative Medicine business units, with the aim of providing additional insights into the growth, expense profile and cash generation of our business units.
Key Third Quarter 2022 Financial Metrics
- Net sales of
$67.7 million for third quarter 2022, compared to$63.1 million for the prior year period. - Net loss of
$8.4 million for third quarter 2022, compared to a net loss of$2.3 million for the prior year period. - Adjusted EBITDA1 loss of
$0.7 million for third quarter 2022, compared to a gain of$7.0 million for the prior year period.
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
(in thousands) | (in thousands) | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
Net sales | $ | 67,689 | $ | 63,074 | $ | 193,466 | $ | 191,206 | |||||||
Net loss | (8,426 | ) | (2,339 | ) | (29,783 | ) | (12,500 | ) | |||||||
EBITDA1 | (6,097 | ) | 41 | (22,971 | ) | (4,302 | ) | ||||||||
Adjusted EBITDA1 | (724 | ) | 7,022 | (3,402 | ) | 15,117 | |||||||||
Net loss per common share - basic | $ | (0.09 | ) | $ | (0.04 | ) | $ | (0.31 | ) | $ | (0.15 | ) | |||
Net loss per common share - diluted | $ | (0.09 | ) | $ | (0.04 | ) | $ | (0.31 | ) | $ | (0.15 | ) |
- EBITDA and Adjusted EBITDA are non-GAAP financial measures. See “Reconciliation of Non-GAAP Measures” for a reconciliation of EBITDA and Adjusted EBITDA to Net loss, located in “Selected Unaudited Financial Information” of this release.
Segment Information
MIMEDX operates as two reportable segments: Wound & Surgical and Regenerative Medicine. A summary of the Company’s performance for the three months ended September 30, 2022 and three months ended September 30, 2021 by segment is summarized below (amounts in thousands):
Three Months Ended September 30, 2022
Wound & Surgical | Regenerative Medicine | Corporate & Other | Consolidated | ||||||||||
Net sales | $ | 66,873 | $ | — | $ | 816 | $ | 67,689 | |||||
Cost of sales | 11,159 | — | 1,029 | 12,188 | |||||||||
Selling, general and administrative expense | 35,531 | — | 17,944 | 53,475 | |||||||||
Research and development expense | 1,680 | 4,273 | — | 5,953 | |||||||||
Amortization of intangible assets | — | — | 175 | 175 | |||||||||
Segment contribution | $ | 18,503 | $ | (4,273 | ) | ||||||||
Investigation, restatement and related expense | 3,001 | ||||||||||||
Operating loss | $ | (7,103 | ) | ||||||||||
Supplemental information | |||||||||||||
Depreciation expense | $ | 451 | $ | 36 | $ | 344 | $ | 831 | |||||
Share-based compensation | $ | 1,945 | $ | 347 | $ | 80 | $ | 2,372 |
Note: Net sales in Corporate & Other reflect the Company's only sales of Dental products, from a contract under which sales will terminate in 2023.
Three Months Ended September 30, 2021
Wound & Surgical | Regenerative Medicine | Corporate & Other | Consolidated | ||||||||||
Net sales | $ | 62,138 | $ | 76 | $ | 860 | $ | 63,074 | |||||
Cost of sales | 8,924 | 16 | 1,189 | 10,129 | |||||||||
Selling, general and administrative expense | 32,104 | 1,285 | 12,900 | 46,289 | |||||||||
Research and development expense | 1,423 | 2,945 | — | 4,368 | |||||||||
Amortization of intangible assets | — | — | 193 | 193 | |||||||||
Segment contribution | $ | 19,687 | $ | (4,170 | ) | ||||||||
Investigation, restatement and related expense | 3,170 | ||||||||||||
Operating loss | $ | (1,075 | ) | ||||||||||
Supplemental information | |||||||||||||
Depreciation expense | $ | 511 | $ | 34 | $ | 378 | $ | 923 | |||||
Share-based compensation | $ | 1,435 | $ | 322 | $ | 2,054 | $ | 3,811 |
Note: Net sales in Corporate & Other reflect the Company's only sales of Dental products, from a contract under which sales will terminate in 2023.
Net Sales
MIMEDX reported net sales for the three months ended September 30, 2022, of
Gross Profit and Margin
Gross profit for the three months ended September 30, 2022, was
Gross margin for the three months ended September 30, 2022, was
Operating Expenses
Selling, general and administrative expenses for the three months ended September 30, 2022 were
Research and development expenses were
Investigation, restatement and related expenses for the three months ended September 30, 2022 were
Net loss for the three months ended September 30, 2022, was
Cash and Cash Equivalents
As of September 30, 2022, the Company had
Outlook for Q4:22 and 2022
The Company expects net sales for the fourth quarter 2022 to be in a range of
Conference Call and Webcast
MIMEDX will host a conference call and webcast to review its third quarter 2022 results on Wednesday, November 2, 2022, beginning at 5:00 p.m., Eastern Time. The call can be accessed using the following information:
Webcast: Click here
U.S. Investors: 877-407-6184
International Investors: 201-389-0877
Conference ID: 13733025
A replay of the webcast will be available for approximately 30 days on the Company’s website at www.mimedx.com following the conclusion of the event.
Important Cautionary Statement
This press release includes forward-looking statements. Statements regarding: (i) future sales or sales growth; (ii) our 2022 financial outlook and expectations for future financial results, including net sales and levels of selling, general and administrative expense; (iii) our expectations regarding the timing of clinical programs and trials; (iv) our expectations regarding the timing and impact of new product launches; and (v) the effectiveness of amniotic tissue as a therapy for any particular indication or condition. Additional forward-looking statements may be identified by words such as "believe," "expect," "may," "plan," “goal,” “outlook,” "potential," "will," "preliminary," and similar expressions, and are based on management's current beliefs and expectations.
Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause actual results to differ from expectations include: (i) future sales are uncertain and are affected by competition, access to customers, patient access to healthcare providers, and many other factors; (ii) the status, timing, results and expected results of the Company’s clinical trials and planned regulatory submissions, and our expectations regarding our ability to potentially accelerate the timing of any trial or regulatory submission, depend on a number of factors including favorable trial results, patient access, and our ability to manufacture in accordance with Current Good Manufacturing Practices (“CGMP”) and appropriate CMC; (iii) the Company may change its plans due to unforeseen circumstances, or delays in analyzing and auditing results, and may delay or alter the timeline for future trials, analyses, or public announcements; (iv) our access to hospitals and health care provider facilities could be restricted as a result of the ongoing COVID-19 pandemic or other factors; (v) the results of scientific research are uncertain and may have little or no value; (vi) our ability to sell our products in other countries depends on a number of factors including adequate levels of reimbursement, market acceptance of novel therapies, and our ability to build and manage a direct sales force or third party distribution relationship; (vii) the effectiveness of amniotic tissue as a therapy for particular indications or conditions is the subject of further scientific and clinical studies; and (viii) we may alter the timing and amount of planned expenditures for research and development based on the results of clinical trials and other regulatory developments. The Company describes additional risks and uncertainties in the Risk Factors section of its most recent annual report and quarterly reports filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and the Company assumes no obligation to update any forward-looking statement.
About MIMEDX
MIMEDX is a transformational placental biologics company, developing and distributing placental tissue allografts with patent-protected, proprietary processes for multiple sectors of healthcare. As a pioneer in placental tissue engineering, we have both a commercial business, focused on addressing the needs of patients with acute and chronic non-healing wounds, and a promising late-stage pipeline targeted at decreasing pain and improving function for patients with degenerative musculoskeletal conditions. We derive our products from human placental tissues and process these tissues using our proprietary methods, including the PURION® process. We employ Current Good Tissue Practices, Current Good Manufacturing Practices, and terminal sterilization to produce our allografts. MIMEDX has supplied over two million allografts, through both direct and consignment shipments. For additional information, please visit www.mimedx.com.
Contact:
Matt Notarianni
Investor Relations
470.304.7291
mnotarianni@mimedx.com
Selected Unaudited Financial Information
MiMedx Group, Inc. | ||||||
Condensed Consolidated Balance Sheets | ||||||
(in thousands) Unaudited | ||||||
September 30, 2022 | December 31, 2021 | |||||
ASSETS | ||||||
Current assets: | ||||||
Cash and cash equivalents | $ | 73,217 | $ | 87,083 | ||
Accounts receivable, net | 40,830 | 40,353 | ||||
Inventory | 13,976 | 11,389 | ||||
Prepaid expenses | 4,679 | 6,146 | ||||
Income tax receivable | 756 | 743 | ||||
Other current assets | 2,582 | 2,809 | ||||
Total current assets | 136,040 | 148,523 | ||||
Property and equipment, net | 7,912 | 9,165 | ||||
Right of use asset | 3,728 | 4,696 | ||||
Goodwill | 19,976 | 19,976 | ||||
Intangible assets, net | 4,992 | 5,383 | ||||
Other assets | 150 | 186 | ||||
Total assets | $ | 172,798 | $ | 187,929 | ||
LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS’ (DEFICIT) EQUITY | ||||||
Current liabilities: | ||||||
Accounts payable | $ | 8,820 | $ | 7,385 | ||
Accrued compensation | 24,090 | 23,595 | ||||
Accrued expenses | 10,986 | 9,812 | ||||
Other current liabilities | 1,962 | 1,565 | ||||
Total current liabilities | 45,858 | 42,357 | ||||
Long term debt, net | 48,475 | 48,127 | ||||
Other liabilities | 5,491 | 4,869 | ||||
Total liabilities | 99,824 | 95,353 | ||||
Convertible preferred stock | 92,494 | 92,494 | ||||
Total stockholders' (deficit) equity | (19,520 | ) | 82 | |||
Total liabilities, convertible preferred stock, and stockholders’ (deficit) equity | $ | 172,798 | $ | 187,929 |
MiMedx Group, Inc. | |||||||||||||||
Condensed Consolidated Statements of Operations | |||||||||||||||
(in thousands) Unaudited | |||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
Net sales | $ | 67,689 | $ | 63,074 | $ | 193,466 | $ | 191,206 | |||||||
Cost of sales | 12,188 | 10,129 | 33,947 | 32,530 | |||||||||||
Gross profit | 55,501 | 52,945 | 159,519 | 158,676 | |||||||||||
Operating expenses: | |||||||||||||||
Selling, general and administrative | 53,475 | 46,289 | 158,838 | 145,291 | |||||||||||
Research and development | 5,953 | 4,368 | 17,429 | 12,770 | |||||||||||
Investigation, restatement and related | 3,001 | 3,170 | 8,771 | 8,304 | |||||||||||
Amortization of intangible assets | 175 | 193 | 519 | 647 | |||||||||||
Operating loss | (7,103 | ) | (1,075 | ) | (26,038 | ) | (8,336 | ) | |||||||
Other expense, net | |||||||||||||||
Interest expense, net | (1,270 | ) | (963 | ) | (3,566 | ) | (3,806 | ) | |||||||
Other expense, net | — | — | (1 | ) | (3 | ) | |||||||||
Loss before income tax provision | (8,373 | ) | (2,038 | ) | (29,605 | ) | (12,145 | ) | |||||||
Income tax provision expense | (53 | ) | (301 | ) | (178 | ) | (355 | ) | |||||||
Net loss | $ | (8,426 | ) | $ | (2,339 | ) | $ | (29,783 | ) | $ | (12,500 | ) | |||
Net loss available to common shareholders | $ | (10,096 | ) | $ | (3,913 | ) | $ | (34,667 | ) | $ | (17,039 | ) | |||
Net loss per common share - basic | $ | (0.09 | ) | $ | (0.04 | ) | $ | (0.31 | ) | $ | (0.15 | ) | |||
Net loss per common share - diluted | $ | (0.09 | ) | $ | (0.04 | ) | $ | (0.31 | ) | $ | (0.15 | ) | |||
Weighted average common shares outstanding - basic | 113,448,251 | 110,717,073 | 112,650,713 | 110,136,517 | |||||||||||
Weighted average common shares outstanding - diluted | 113,448,251 | 110,717,073 | 112,650,713 | 110,136,517 |
MiMedx Group, Inc. | |||||||
Condensed Consolidated Statements of Cash Flows | |||||||
(in thousands) Unaudited | |||||||
Nine Months Ended September 30, | |||||||
2022 | 2021 | ||||||
Cash flows from operating activities: | |||||||
Net loss | $ | (29,783 | ) | $ | (12,500 | ) | |
Adjustments to reconcile net loss to net cash flows (used in) provided by operating activities: | |||||||
Share-based compensation | 10,798 | 11,115 | |||||
Depreciation | 2,549 | 3,390 | |||||
Bad debt expense | 2,817 | — | |||||
Amortization of intangible assets | 519 | 647 | |||||
Amortization of deferred financing costs | 348 | 943 | |||||
Non-cash lease expenses | 931 | 724 | |||||
Accretion of asset retirement obligation | 69 | 57 | |||||
(Gain) loss on fixed asset disposal | (17 | ) | 236 | ||||
Increase (decrease) in cash resulting from changes in: | |||||||
Accounts receivable | (3,295 | ) | (1,113 | ) | |||
Inventory | (2,586 | ) | (835 | ) | |||
Prepaid expenses | 1,467 | 3,527 | |||||
Income taxes | (13 | ) | 9,420 | ||||
Other assets | (287 | ) | 1,990 | ||||
Accounts payable | 1,090 | (828 | ) | ||||
Accrued compensation | 495 | 2,085 | |||||
Accrued expenses | 1,724 | (16,768 | ) | ||||
Other liabilities | 905 | (840 | ) | ||||
Net cash flows (used in) provided by operating activities | (12,269 | ) | 1,250 | ||||
Cash flows from investing activities: | |||||||
Purchases of equipment | (847 | ) | (2,893 | ) | |||
Patent application costs | (128 | ) | (263 | ) | |||
Proceeds from sale of equipment | 24 | — | |||||
Principal payments from note receivable | — | 75 | |||||
Net cash flows used in investing activities | (951 | ) | (3,081 | ) | |||
Cash flows from financing activities: | |||||||
Stock repurchased for tax withholdings on vesting of restricted stock | (1,191 | ) | (4,751 | ) | |||
Proceeds from exercise of stock options | 574 | 1,404 | |||||
Principal payments on finance lease | (29 | ) | (27 | ) | |||
Net cash flows used in financing activities | (646 | ) | (3,374 | ) | |||
Net change in cash | (13,866 | ) | (5,205 | ) | |||
Cash and cash equivalents, beginning of period | 87,083 | 95,812 | |||||
Cash and cash equivalents, end of period | $ | 73,217 | $ | 90,607 |
MiMedx Group, Inc.
Segment Reporting for the Nine Months Ended September 30, 2022
(in thousands) Unaudited
Wound & Surgical | Regenerative Medicine | Corporate & Other | Consolidated | ||||||||||
Net sales | $ | 191,297 | $ | — | $ | 2,169 | $ | 193,466 | |||||
Cost of sales | 31,126 | — | 2,821 | 33,947 | |||||||||
Selling, general and administrative expense | 108,256 | — | 50,582 | 158,838 | |||||||||
Research and development expense | 6,068 | 11,361 | — | 17,429 | |||||||||
Amortization of intangible assets | — | — | 519 | 519 | |||||||||
Segment contribution | $ | 45,847 | $ | (11,361 | ) | ||||||||
Investigation, restatement and related expense | 8,771 | ||||||||||||
Operating loss | $ | (26,038 | ) | ||||||||||
Supplemental information | |||||||||||||
Depreciation expense | $ | 1,364 | $ | 120 | $ | 1,065 | $ | 2,549 | |||||
Share-based compensation | $ | 5,609 | $ | 910 | $ | 4,279 | $ | 10,798 |
MiMedx Group, Inc.
Segment Reporting for the Nine Months Ended September 30, 2021
(in thousands) Unaudited
Wound & Surgical | Regenerative Medicine | Corporate & Other | Consolidated | ||||||||||
Net sales | $ | 172,401 | $ | 16,584 | $ | 2,221 | $ | 191,206 | |||||
Cost of sales | 25,646 | 3,652 | 3,232 | 32,530 | |||||||||
Selling, general and administrative expense | 87,392 | 11,127 | 46,772 | 145,291 | |||||||||
Research and development expense | 4,080 | 8,690 | — | 12,770 | |||||||||
Amortization of intangible assets | — | — | 647 | 647 | |||||||||
Segment contribution | $ | 55,283 | $ | (6,885 | ) | ||||||||
Investigation, restatement and related expense | 8,304 | ||||||||||||
Operating loss | $ | (8,336 | ) | ||||||||||
Supplemental information | |||||||||||||
Depreciation expense | $ | 1,172 | $ | 213 | $ | 2,005 | $ | 3,390 | |||||
Share-based compensation | $ | 3,827 | $ | 1,147 | $ | 6,141 | $ | 11,115 |
Reconciliation of Non-GAAP Measures
In addition to our GAAP results, we provide certain non-GAAP metrics 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. Company management uses these Non-GAAP measurements 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.
EBITDA is intended to provide a measure of the Company’s operating performance as it eliminates the effects of financing and capital expenditures. EBITDA consists of GAAP net loss excluding: (i) depreciation, (ii) amortization of intangibles, (iii) interest expense, net, and (iv) income tax provision. Adjusted EBITDA is intended to provide a 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 that may be irregular, one-time, or non-recurring from EBITDA. This enables us to identify underlying trends in our business that could otherwise be masked by such items. Adjusted EBITDA consists of GAAP net loss excluding: (i) depreciation, (ii) amortization of intangibles, (iii) interest expense, net, (iv) income tax provision, (v) costs incurred in connection with the Audit Committee Investigation and Restatement (as defined in our most recent Annual Report on Form 10-K), and (vi) share-based compensation.
A reconciliation of GAAP net loss to EBITDA and Adjusted EBITDA appears in the table below (in thousands):
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
Net loss | $ | (8,426 | ) | $ | (2,339 | ) | $ | (29,783 | ) | $ | (12,500 | ) | |||
Net margin | (12.4)% | (3.7)% | (15.4)% | (6.5)% | |||||||||||
Non-GAAP Adjustments: | |||||||||||||||
Depreciation expense | 831 | 923 | 2,549 | 3,390 | |||||||||||
Amortization of intangible assets | 175 | 193 | 519 | 647 | |||||||||||
Interest expense, net | 1,270 | 963 | 3,566 | 3,806 | |||||||||||
Income tax provision expense, net | 53 | 301 | 178 | 355 | |||||||||||
EBITDA | (6,097 | ) | 41 | (22,971 | ) | (4,302 | ) | ||||||||
EBITDA margin | (9.0)% | 0.1 | % | (11.9)% | (2.2)% | ||||||||||
Additional Non-GAAP Adjustments | |||||||||||||||
Costs incurred in connection with Audit Committee Investigation and Restatement | 3,001 | 3,170 | 8,771 | 8,304 | |||||||||||
Share-based compensation | 2,372 | 3,811 | 10,798 | 11,115 | |||||||||||
Adjusted EBITDA | $ | (724 | ) | $ | 7,022 | $ | (3,402 | ) | $ | 15,117 | |||||
Adjusted EBITDA margin | (1.1)% | 11.1 | % | (1.8)% | 7.9 | % |
FAQ
What were MiMedx's net sales for the third quarter of 2022?
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