Full Press Release Details
MIMEDX Announces Fourth Quarter and Full Year 2022 Operating and Financial Results
Reports Highest Quarterly Net Sales Since the Fourth Quarter of 2019
Quarterly Net Sales of $74.4 million Reflect Growth of 10% with Strong Contributions from Sales to the Surgical Market
Initiated the First of Two Registrational Clinical Trials for micronized dehydrated human amnion/chorion membrane ( mDHACM ) in
the Treatment of Knee Osteoarthritis ( KOA )
Management to Host Conference Call Today, February 28, 2023, at 5:00 PM
MARIETTA, Ga., February 28, 2023 MiMedx Group, Inc. (Nasdaq: MDXG) ( MIMEDX or the
Company ), a pioneer and leader in placental biologics, today announced operating and financial results for the fourth quarter and full year 2022.
Joseph H. Capper, MIMEDX Chief Executive Officer ( CEO ), commented, The MIMEDX team closed out 2022 on a high note, delivering the highest
quarterly net sales in a couple of years. That strong momentum has continued into 2023, driven by our best-in-class product offering. These solid results and our
continued commercial execution come despite the uneven playing field in the private physician office, specifically around Medicare reimbursement. We remain optimistic that reimbursement changes in this care setting, once finalized, can add even more
momentum to our business.
Mr. Capper continued, During my first month at MIMEDX, I have been highly impressed by the experience,
industry knowledge and competitive spirit throughout the company. As I look across MIMEDX, we have an excellent platform from which to build, our Wound & Surgical business in the U.S. is performing well, we have an emerging presence with a
first-mover advantage in Japan and a robust product pipeline including our mDHACM product with its registrational trial now underway. Furthermore, with a focus on cost management and targeted complementary investments, I am confident our
business has the potential to grow significantly over time.
Recent Operating and Financial Highlights:
Key Fourth Quarter and Full
Year 2022 Financial Metrics
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
| (in thousands) | (in thousands) | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Net sales | $ | 74,375 | $ | 67,409 | $ | 267,841 | $ | 258,615 | ||||||||
| Net (loss) income | (415 | ) | 2,215 | (30,197 | ) | (10,285 | ) | |||||||||
| EBITDA 1 | 2,043 | 4,427 | (20,929 | ) | 125 | |||||||||||
| Adjusted EBITDA 1 | 7,317 | 3,609 | 3,914 | 18,726 | ||||||||||||
| Net (loss) income per common share - basic | $ | (0.02 | ) | $ | 0.01 | $ | (0.33 | ) | $ | (0.15 | ) | |||||
| Net (loss) income per common share - diluted | $ | (0.02 | ) | $ | 0.01 | $ | (0.33 | ) | $ | (0.15 | ) |
MIMEDX operates as two reportable segments: Wound & Surgical and Regenerative Medicine. A summary of the Company s performance for the three
months ended December 31, 2022 and 2021 by segment is summarized below (amounts in thousands):
| Wound & Surgical | Regenerative Medicine | Corporate & Other 2 | Consolidated | |||||||||||||
| Net sales | $ | 73,609 | $ | $ | 766 | $ | 74,375 | |||||||||
| Cost of sales | 13,335 | 1,034 | 14,369 | |||||||||||||
| Selling, general and administrative | 37,631 | 12,315 | 49,946 | |||||||||||||
| Research and development | 1,797 | 3,603 | 5,400 | |||||||||||||
| Amortization of intangible assets | 182 | 182 | ||||||||||||||
| Segment contribution | $ | 20,846 | $ | (3,603 | ) | |||||||||||
| Investigation, restatement and related | 3,406 | |||||||||||||||
| Operating income | $ | 1,072 | ||||||||||||||
| Supplemental information | ||||||||||||||||
| Depreciation expense | $ | 427 | $ | 45 | $ | 324 | $ | 796 | ||||||||
| Share-based compensation | $ | 907 | $ | 246 | $ | 715 | $ | 1,868 |
Three Months Ended December 31, 2021
| Wound & Surgical | Regenerative Medicine | Corporate & Other 2 | Consolidated | |||||||||||||
| Net sales | $ | 66,539 | $ | 11 | $ | 859 | $ | 67,409 | ||||||||
| Cost of sales | 9,558 | 3 | 1,192 | 10,753 | ||||||||||||
| Selling, general and administrative | 36,192 | 1,783 | 15,094 | 53,069 | ||||||||||||
| Research and development | 1,783 | 2,790 | 4,573 | |||||||||||||
| Amortization of intangible assets | 173 | 173 | ||||||||||||||
| Segment contribution | $ | 19,006 | $ | (4,565 | ) | |||||||||||
| Investigation, restatement and related | (4,513 | ) | ||||||||||||||
| Impairment of intangible assets | 53 | |||||||||||||||
| Operating income | $ | 3,301 | ||||||||||||||
| Supplemental information | ||||||||||||||||
| Depreciation expense | $ | 472 | $ | 33 | $ | 468 | $ | 973 | ||||||||
| Share-based compensation | $ | 1,330 | $ | 313 | $ | 1,999 | $ | 3,642 |
Segment results for the year ended December 31, 2022 and 2021 can be found
at the end of this press release.
MIMEDX reported net sales for the three months ended December 31, 2022, of $74.4 million, compared to $67.4 million for the three months ended
December 31, 2021, an increase of 10.3%. Net sales growth came from solid contributions in both the Wound & Surgical end markets.
full year 2022, MIMEDX reported net sales of $267.8 million, compared to $258.6 million in the prior year period, reflecting growth of 3.6%. MIMEDX s full year 2022 net sales also reflect growth of 10.5% across its continuing
portfolio of Advanced Wound Care products.
Gross Profit and Margin
Gross profit for the three months ended December 31, 2022, was $60.0 million, an increase of $3.4 million as compared to the prior year. For the
full year 2022, gross profit was $219.5 million, reflecting an increase of $4.2 million compared to the prior year period.
Gross margin for the
three months ended December 31, 2022, was 80.7%, compared to 84.0% for the three months ended December 31, 2021. For the full year 2022, MIMEDX reported gross margin of 82.0%, compared to 83.3% for the full year 2021.
Gross margins were negatively influenced in both the fourth quarter and for the full year 2022 by impacts from production variances, primarily due to lower
general and administrative ( SG&A ) expenses for the three months ended December 31, 2022 were $50.0 million compared to $53.1 million for the three months ended December 31, 2021. SG&A expense during the fourth
quarter 2022 included increased sales commissions and the impact of severance associated with restructuring activities. Lower compensation expense, principally due to year-end incentive adjustments, more than
offset the impact of the increased costs.
For the full year 2022, SG&A expenses totaled $208.8 million, compared to $198.4 million for the
prior year period. The increase was driven by higher travel expenses, sales commissions, bad debt expense and severance costs, all of which were partially offset by the reversal of share-based compensation expense associated with the severance
activities and lower professional service expenses.
Research and development expenses were $5.4 million for the three months ended December 31,
2022 compared to $4.6 million for the three months ended December 31, 2021. The increase was primarily driven by higher costs associated with our KOA clinical program. For the full year 2022, research and
development expenses totaled $22.8 million compared to $17.3 million in 2021. In addition to the spend related to the KOA efforts, the increase in research and development expenses for
the full year was also driven by costs associated with the launches of our recent products and higher personnel costs.
Investigation, restatement and
related expense for the three months ended December 31, 2022 was an expense of $3.4 million compared to a benefit of $4.5 million for the three months ended December 31, 2021. For the full year 2022, investigation, restatement
and related expenses totaled $12.2 million compared to $3.8 million in 2021.
Net losses for the three months and full year ended
December 31, 2022, were $0.4 million and $30.2 million, respectively, compared to net income of $2.2 million for the three months ended December 31, 2021 and a net loss of $10.3 million for the year ended
Cash and Cash Equivalents
As of December 31, 2022, the Company had $66.0 million of cash and cash equivalents compared to $87.1 million as of December 31, 2021 and
$73.2 million as of September 30, 2022. The decrease during the year ended December 31, 2022 reflects payments of accrued compensation, which included the payment of annual employee incentives, and the payment of payroll taxes, some
of which had been deferred under the Coronavirus Aid, Relief, and Economic Security Act. The decrease also reflects the initial payment to Turn Therapeutics in connection with our licensing and distribution agreement.
The Company s goal is to deliver
net sales percentage growth in the low double-digits annually.
In 2023, the Company expects to see continued growth in both the wound and surgical end
markets throughout the year, particularly in the hospital and wound care clinic sites-of-service, as well as a modest contribution from sales generated in Japan.
However, in light of the ongoing uncertainty around potential changes to the U.S. Centers for Medicare and Medicaid Services reimbursement in the private physician office setting, the Company anticipates a continued challenging environment in this site-of-service during the year.
As previously communicated, the Company has
goals to achieve a Wound & Surgical segment contribution margin at or above 30% of segment net sales and corporate expenses as a percentage of sales below 20%.
KOA Registrational Clinical Trial Details
The registrational trial for KOA, which is now underway, will study approximately 470 patients randomized into three arms: (1) a control group receiving a
single intra-articular placebo injection; (2) a treatment group receiving a single intra-articular injection of 40 mg mDHACM; and (3) a treatment group receiving a single intra-articular injection of 100 mg mDHACM. Co-primary endpoints include statistically significant improvement in Pain and Function scores at six months, as measured on the Western Ontario and McMaster Universities ( WOMAC ) Osteoarthritis Index. An
additional six month follow-up evaluation is also included in the trial protocol, developed following extensive dialogue with the United States Food & Drug Administration and in partnership with the
Company s Contract Research Organizations.
Conference Call and Webcast
MIMEDX will host a conference call and webcast to review its fourth quarter and full year 2022 results on Tuesday, February 28, 2023, beginning at 5:00
p.m., Eastern Time. The call can be accessed using the following information:
U.S. Investors: 877-407-6184
International Investors: 201-389-0877
Conference ID: 13735959
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
This press release includes forward-looking statements. Statements regarding: (i) our confidence that our business has the potential to
grow significantly over time; (ii) our optimism that reimbursement changes in the private physician office care setting, once finalized, can add momentum to our business; (iii) future sales or sales growth; (iv) our goals and
expectations for future financial results, including net sales, segment contribution margins and levels of expenses; (v) our expectations regarding a continued challenging environment in the private physician office site-of-service; (vi) our expectations regarding the timing of clinical programs and trials; (vii) our expectations regarding the timing and impact of new product
launches; and (viii) 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, the reimbursement environment 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.
MIMEDX is a pioneer and leader in placental
biologics, developing and distributing placental tissue allografts to help address unmet clinical needs in multiple sectors of healthcare, including the Advanced Wound Care market as well as in surgical recovery settings. MIMEDX is also focused on
advancing a promising late-stage pipeline opportunity targeted at decreasing pain and improving function for patients with knee osteoarthritis. Our products are derived from human placental tissues and processed using our proprietary methods,
including the Company s own 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.
Selected Unaudited Financial Information