MIMEDX Announces Second Quarter 2021 Operating and Financial Results
MiMedx Group, Inc. (MDXG) reports Q2 2021 net sales of $68.2 million, a 27% increase from Q2 2020's $53.6 million. Adjusted net sales reached $67.9 million, up 30.6%. The net loss decreased to $1.8 million from $8.5 million in the prior year. Gross profit margin declined to 81.3% due to higher expenses, including a 43.6% rise in selling, general, and administrative costs. The company is on track to release topline results for its musculoskeletal pipeline by late summer and anticipates steady adjusted net sales for 2021.
- Net sales increased 27% to $68.2 million compared to Q2 2020.
- Net loss significantly reduced to $1.8 million from $8.5 million the previous year.
- Adjusted net sales rose 30.6% year-over-year.
- Expanded sales force by 10% to enhance market presence.
- Gross profit margin decreased to 81.3% from 84.7% due to higher production costs.
- Selling, general, and administrative expenses increased by 43.6% to $53.6 million.
- Adjusted EBITDA fell to $2.8 million, significantly lower than $10.2 million in the prior year.
Second Quarter Net Sales Increase
On Track to Deliver Topline Results for Late-Stage Musculoskeletal Pipeline in Late Summer
Company to Host Conference Call on August 4, 2021, at 8:30 AM ET
MARIETTA, Ga., Aug. 03, 2021 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”), an industry leader in utilizing amniotic tissue as a platform for regenerative medicine, today announced the filing of its second quarter 2021 Form 10-Q for the period ended June 30, 2021.
Timothy R. Wright, MIMEDX Chief Executive Officer, commented, “Our expanded commercial team is working aggressively toward the goal of achieving above-market growth for our Advanced Wound Care business, and executing on multiple initiatives that reinforce the differentiation of our products and convey the clinical and economic value of our brands. As the only data-driven amniotic tissue allograft to have complete national commercial coverage for the treatment of Diabetic Foot Ulcers, we continue to leverage our expansive reimbursement coverage and invest in medical education programs that are designed to raise awareness on the appropriate and timely use of our Advanced Wound Care products. It is imperative that we continue to grow this base business to support patients in need.”
Mr. Wright continued, “I applaud the team for their efforts to exercise strong leadership and exceptional customer service throughout the end of the period of Enforcement Discretion. Our proactive and continued dialogue with the U.S. Food and Drug Administration (FDA) enabled us to mitigate customer disruption, dispel misinformation, and partner with customers throughout the transition. Backed by years of clinical, tissue engineering, and manufacturing knowledge about the science of amniotic tissue, MIMEDX is well-positioned to advance into a more rigorously regulated biologics pathway, and we are making significant progress on the critical steps necessary for a complete and potentially successful Biologics License Application (BLA). We remain on track to share topline results for our Plantar Fasciitis and Knee Osteoarthritis programs by late summer and review these data with the FDA."
Second Quarter 2021 and Recent Operating Highlights:
- Announced a collaborative agreement with the Wake Forest Institute for Regenerative Medicine (WFIRM) to develop and advance scientific evidence in support of safe and effective clinical therapies
- Received regulatory approval to commercialize PURION® processed EPIFIX® in Japan
- Announced the publication of a peer-reviewed study in the Journal of Investigative Dermatology Innovations addressing the potential benefit of MIMEDX PURION® processed dehydrated Human Amnion/Chorion Membrane (dHACM) to combat complications stemming from excessive fibrosis, a pathological process central to a number of serious unmet medical needs
- Added to the Russell 2000® and Russell 3000® Indexes
- Notified by the FDA that the Company's Investigational New Drug (IND) for the use of AMNIOFIX® Injectable (mdHACM) in Surgical Incisions was accepted as filed
- Expanded sales force headcount by ten percent
- MIMEDX Board member Cato T. Laurencin, M.D., Ph.D. awarded the NAACP's highest honor for his contributions to emerging medical sciences that advance human healing
Key Second Quarter 2021 Financial Metrics
- Net sales of
$68.2 million for second quarter 2021, compared to$53.6 million for the year prior - Adjusted net sales1, which excludes impacts of the change in the Company’s methods for recognizing revenue, of
$67.9 million for second quarter 2021, compared to$51.9 million for the prior year period - Net loss of
$1.8 million for second quarter 2021, compared to a net loss of$8.5 million for the prior year period - Adjusted EBITDA2 of
$2.8 million for second quarter 2021, compared to$10.2 million for the prior year period
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||
(in thousands) | (in thousands) | ||||||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||||||
Net sales | $ | 68,165 | $ | 53,647 | $ | 128,132 | $ | 115,383 | |||||||||||
Adjusted net sales1 | 67,852 | 51,941 | 127,521 | 109,182 | |||||||||||||||
Net loss | (1,779 | ) | (8,466 | ) | (10,161 | ) | (13,287 | ) | |||||||||||
EBITDA2 | 1,108 | (4,172 | ) | (4,343 | ) | (16,133 | ) | ||||||||||||
Adjusted EBITDA2 | 2,837 | 10,241 | 7,570 | 13,355 | |||||||||||||||
Net loss per common share - basic | $ | (0.03 | ) | $ | (0.08 | ) | $ | (0.12 | ) | $ | (0.12 | ) | |||||||
Net loss per common share - diluted | $ | (0.03 | ) | $ | (0.08 | ) | $ | (0.12 | ) | $ | (0.12 | ) | |||||||
- Adjusted Net Sales is a non-GAAP financial measure. See “Reconciliation of GAAP Net Sales to Adjusted Net Sales and Reconciliation of GAAP Net Income to EBITDA and Adjusted EBITDA” for a reconciliation of Adjusted Net Sales to Net Sales, located in “Selected Unaudited Financial Information” of this release.
- EBITDA and Adjusted EBITDA are non-GAAP financial measures. See “Reconciliation of GAAP Net Sales to Adjusted Net Sales and Reconciliation of GAAP Net Income to EBITDA and Adjusted EBITDA” for a reconciliation of EBITDA and Adjusted EBITDA to Net loss, located in “Selected Unaudited Financial Information” of this release.
MIMEDX reported net sales for the three months ended June 30, 2021, of
Adjusted net sales for the three months ended June 30, 2021, which excludes cash collected on the remaining contracts outstanding at the time of the change in the Company's revenue recognition methodology, were
MIMEDX has two primary classes of products: (1) Advanced Wound Care, or Section 361, products, consisting of its sheet allograft products, and (2) Section 351 products, consisting of the Company’s micronized and particulate products. Advanced Wound Care is further disaggregated between the Company’s Tissue/Other and Cord products. A summary of the Company's revenue, including revenue derived from its Section 351 products, is included in the table below (amounts in thousands):
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||||||
Advanced Wound Care | |||||||||||||||||||
Tissue/Other | $ | 53,408 | $ | 42,528 | $ | 99,977 | $ | 87,134 | |||||||||||
Cord | 5,886 | 3,263 | 10,846 | 7,160 | |||||||||||||||
Total Advanced Wound Care | 59,294 | 45,791 | 110,823 | 94,294 | |||||||||||||||
Section 351 | 8,558 | 6,150 | 16,698 | 14,888 | |||||||||||||||
Other1 | 313 | 1,706 | 611 | 6,201 | |||||||||||||||
Total | $ | 68,165 | $ | 53,647 | $ | 128,132 | $ | 115,383 | |||||||||||
- “Other” represents cash collections on the Remaining Contracts. Remaining Contracts are those contracts for which performance obligations have been satisfied as of September 30, 2019, but for which the criteria required for revenue recognition had not been met and would not be met until the ultimate collection of cash. For all practicable purposes, the Company is not able to allocate these revenues to different product groups.
Gross profit margin for the three months ended June 30, 2021, was
Selling, general and administrative expenses for the three months ended June 30, 2021, increased
Research and development expenses were
Investigation, restatement and related expenses for the three months ended June 30, 2021, was a benefit of
Net loss for the three months ended June 30, 2021, was
Adjusted EBITDA for the three months ended June 30, 2021, was
As of June 30, 2021, the Company had
Enforcement Discretion
In November 2017, the FDA developed the regenerative medicine policy framework to support innovations in regenerative medicine therapies, including human cells, tissues, and cellular and tissue-based products (HCT/Ps). As a result of the COVID-19 public health emergency, the FDA extended the Enforcement Discretion policy for certain HCT/Ps that do not raise reported safety concerns or potential significant safety concerns, from November 2020 to May 31, 2021. On April 21, 2021, the FDA reaffirmed that the period of Enforcement Discretion would not be extended and would therefore end on May 31, 2021.
Outlook for 2021
The Company expects that adjusted net sales for 2021 will be consistent with the prior year. This reflects the end of the period of Enforcement Discretion on May 31, 2021, and is in line with the expected impact previously disclosed in the Company’s 2021 Outlook, within the Company’s Annual Report on Form 10-K for the year ended December 31, 2020.
Conference Call and Webcast
MIMEDX will host a conference call and webcast to review its second quarter 2021 results on Wednesday, August 4, 2021, beginning at 8:30 am, Eastern Time. The call can be accessed using the following information:
Webcast: https://edge.media-server.com/mmc/p/2gfy7rx3
U.S. Investors: 877-359-9508
International Investors: 224-357-2393
Conference ID: 8777681
A replay of the webcast will be available for approximately thirty 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) the status, timing, 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 and eventual BLA approvals; (iii) the timing of our disclosure of clinical trial results; (iv) the results of future scientific studies; (v) expectations regarding our ability to sell EPIFIX in other countries, (vi) the effectiveness of amniotic tissue as a therapy for any particular indication or condition, and (vii) future increases in research and development spending. 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, 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 CGMP and appropriate chemistry and manufacturing controls; (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) the results of scientific research are uncertain and may have little or no value; (v) 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; (vi) the effectiveness of amniotic tissue as a therapy for particular indications or conditions is the subject of further scientific and clinical studies; and (vii) 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 an industry leader in utilizing amniotic tissue as a platform for regenerative medicine, developing and distributing placental tissue allografts with patent-protected, proprietary processes for multiple sectors of healthcare. As a pioneer in placental biologics, we have both a base 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.
Contacts:
Investors:
Jack Howarth
Investor Relations
404.360.5681
jhowarth@mimedx.com
Media:
Hilary Dixon
Corporate & Strategic Communications
770.651.9307
hdixon@mimedx.com
Selected Unaudited Financial Information
MiMedx Group, Inc. | |||||||||
Condensed Consolidated Balance Sheets | |||||||||
(in thousands) Unaudited | |||||||||
June 30, 2021 | December 31, 2020 | ||||||||
ASSETS | |||||||||
Current assets: | |||||||||
Cash and cash equivalents | $ | 85,007 | $ | 95,812 | |||||
Accounts receivable, net | 37,243 | 35,423 | |||||||
Inventory | 10,137 | 10,361 | |||||||
Prepaid expenses | 3,350 | 5,605 | |||||||
Income tax receivable | 10,138 | 10,045 | |||||||
Other current assets | 1,816 | 3,371 | |||||||
Total current assets | 147,691 | 160,617 | |||||||
Property and equipment, net | 10,273 | 11,437 | |||||||
Right of use asset | 3,144 | 3,623 | |||||||
Goodwill | 19,976 | 19,976 | |||||||
Intangible assets, net | 5,750 | 6,004 | |||||||
Other assets | 313 | 375 | |||||||
Total assets | $ | 187,147 | $ | 202,032 | |||||
LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS’ DEFICIT | |||||||||
Current liabilities: | |||||||||
Accounts payable | $ | 10,563 | $ | 8,765 | |||||
Accrued compensation | 21,257 | 18,467 | |||||||
Accrued expenses | 17,073 | 30,460 | |||||||
Other current liabilities | 1,678 | 1,470 | |||||||
Total current liabilities | 50,571 | 59,162 | |||||||
Long term debt, net | 47,905 | 47,697 | |||||||
Other liabilities | 3,314 | 3,755 | |||||||
Total liabilities | 101,790 | 110,614 | |||||||
Convertible preferred stock | 92,494 | 91,568 | |||||||
Total stockholders' deficit | (7,137 | ) | (150 | ) | |||||
Total liabilities, convertible preferred stock, and stockholders’ deficit | $ | 187,147 | $ | 202,032 | |||||
MiMedx Group, Inc. | |||||||||||||||||||
Condensed Consolidated Statements of Operations | |||||||||||||||||||
(in thousands) Unaudited | |||||||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||||||
Net sales | $ | 68,165 | $ | 53,647 | $ | 128,132 | $ | 115,383 | |||||||||||
Cost of sales | 12,760 | 8,198 | 22,401 | 18,223 | |||||||||||||||
Gross profit | 55,405 | 45,449 | 105,731 | 97,160 | |||||||||||||||
Operating expenses: | |||||||||||||||||||
Selling, general and administrative | 53,599 | 37,329 | 99,003 | 84,270 | |||||||||||||||
Investigation, restatement and related | (2,062 | ) | 11,446 | 5,134 | 27,038 | ||||||||||||||
Research and development | 4,063 | 2,259 | 8,402 | 4,910 | |||||||||||||||
Amortization of intangible assets | 215 | 271 | 454 | 542 | |||||||||||||||
Operating loss | (410 | ) | (5,856 | ) | (7,262 | ) | (19,600 | ) | |||||||||||
Interest expense, net | (1,371 | ) | (2,574 | ) | (2,844 | ) | (4,961 | ) | |||||||||||
Other expense, net | (3 | ) | (9 | ) | (2 | ) | (3 | ) | |||||||||||
Loss before income tax provision | (1,784 | ) | (8,439 | ) | (10,108 | ) | (24,564 | ) | |||||||||||
Income tax provision benefit (expense) | 5 | (27 | ) | (53 | ) | 11,277 | |||||||||||||
Net loss | $ | (1,779 | ) | $ | (8,466 | ) | $ | (10,161 | ) | $ | (13,287 | ) | |||||||
Net loss available to common stockholders | $ | (3,276 | ) | $ | (8,466 | ) | $ | (13,126 | ) | $ | (13,287 | ) | |||||||
Net loss per common share - basic | $ | (0.03 | ) | $ | (0.08 | ) | $ | (0.12 | ) | $ | (0.12 | ) | |||||||
Net loss per common share - diluted | $ | (0.03 | ) | $ | (0.08 | ) | $ | (0.12 | ) | $ | (0.12 | ) | |||||||
Weighted average common shares outstanding - basic | 110,276,636 | 108,119,461 | 109,841,428 | 108,081,625 | |||||||||||||||
Weighted average common shares outstanding - diluted | 110,276,636 | 108,119,461 | 109,841,428 | 108,081,625 |
MiMedx Group, Inc. | |||||||||
Condensed Consolidated Statements of Cash Flows | |||||||||
(in thousands) Unaudited | |||||||||
Six Months Ended June 30, | |||||||||
2021 | 2020 | ||||||||
Cash flows from operating activities: | |||||||||
Net loss | $ | (10,161 | ) | $ | (13,287 | ) | |||
Adjustments to reconcile net loss to net cash flows used in operating activities: | |||||||||
Share-based compensation | 7,304 | 7,783 | |||||||
Depreciation | 2,467 | 2,928 | |||||||
Amortization of intangible assets | 454 | 542 | |||||||
Amortization of deferred financing costs | 833 | 1,441 | |||||||
Non-cash lease expenses | 480 | 486 | |||||||
Accretion of asset retirement obligation | 37 | — | |||||||
Loss on fixed asset disposal | 236 | 1 | |||||||
Increase (decrease) in cash resulting from changes in: | |||||||||
Accounts receivable | (1,820 | ) | 2,230 | ||||||
Inventory | 224 | (1,460 | ) | ||||||
Prepaid expenses | 2,254 | 3,819 | |||||||
Income taxes | (93 | ) | (10,682 | ) | |||||
Other assets | 1,387 | 821 | |||||||
Accounts payable | 2,794 | 3,236 | |||||||
Accrued compensation | 2,790 | (518 | ) | ||||||
Accrued expenses | (13,752 | ) | (12,109 | ) | |||||
Other liabilities | (514 | ) | (609 | ) | |||||
Net cash flows used in operating activities | (5,080 | ) | (15,378 | ) | |||||
Cash flows from investing activities: | |||||||||
Purchases of equipment | (2,346 | ) | (1,421 | ) | |||||
Principal payments from note receivable | 45 | — | |||||||
Patent application costs | (200 | ) | (151 | ) | |||||
Net cash flows used in investing activities | (2,501 | ) | (1,572 | ) | |||||
Cash flows from financing activities: | |||||||||
Proceeds from exercise of stock options | 1,359 | 298 | |||||||
Stock repurchased for tax withholdings on vesting of restricted stock | (4,563 | ) | (2,330 | ) | |||||
Principal payments on finance lease | (20 | ) | — | ||||||
Deferred financing cost | — | (23 | ) | ||||||
Repayment of term loans | — | (11,875 | ) | ||||||
Proceeds from term loans | — | 10,000 | |||||||
Net cash flows used in financing activities | (3,224 | ) | (3,930 | ) | |||||
Net change in cash | (10,805 | ) | (20,880 | ) | |||||
Cash and cash equivalents, beginning of period | 95,812 | 69,069 | |||||||
Cash and cash equivalents, end of period | $ | 85,007 | $ | 48,189 | |||||
Reconciliation of GAAP Net Sales to Adjusted Net Sales and Reconciliation of GAAP Net Income to EBITDA and Adjusted EBITDA
In addition to our GAAP results, we provide certain non-GAAP metrics including Adjusted Net Sales, 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. Adjusted Net Sales is intended to allow one to understand the trend, if any, in sales and to facilitate comparison of sales amounts in periods that used different revenue recognition methods. 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; most significantly those expenses related to the Audit Committee Investigation and Restatement. This also 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 loss excluding: (i) depreciation, (ii) amortization of intangibles, (iii) interest expense, (iv) income tax provision, (v) (benefits) costs incurred in connection with the Audit Committee Investigation and Restatement, (vi) the effect of the Company’s change in revenue recognition on net loss, and (vii) share-based compensation.
A reconciliation of GAAP net sales to Adjusted Net Sales appears in the table below (in thousands):
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||||||
Net sales | $ | 68,165 | $ | 53,647 | $ | 128,132 | $ | 115,383 | |||||||||||
Effect of change in revenue recognition | (313 | ) | (1,706 | ) | (611 | ) | (6,201 | ) | |||||||||||
Adjusted net sales | $ | 67,852 | $ | 51,941 | $ | 127,521 | $ | 109,182 | |||||||||||
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, | |||||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||||
Net loss | $ | (1,779 | ) | $ | (8,466 | ) | $ | (10,161 | ) | $ | (13,287 | ) | ||||||
Net margin | (2.6 | ) | % | (15.8 | ) | % | (7.9 | ) | % | (11.5 | ) | % | ||||||
Non-GAAP Adjustments: | ||||||||||||||||||
Depreciation expense | 1,306 | 1,422 | 2,467 | 2,928 | ||||||||||||||
Amortization of intangible assets | 215 | 271 | 454 | 542 | ||||||||||||||
Interest expense, net | 1,371 | 2,574 | 2,844 | 4,961 | ||||||||||||||
Income tax provision (benefit) expense, net | (5 | ) | 27 | 53 | (11,277 | ) | ||||||||||||
EBITDA | 1,108 | (4,172 | ) | (4,343 | ) | (16,133 | ) | |||||||||||
EBITDA margin | 1.6 | % | (7.8 | ) | % | (3.4 | ) | % | (14.0 | ) | % | |||||||
Additional Non-GAAP Adjustments | ||||||||||||||||||
(Benefits) costs incurred in connection with Audit Committee Investigation and Restatement | (2,062 | ) | 11,446 | 5,134 | 27,038 | |||||||||||||
Effect of change in revenue recognition | (269 | ) | (1,467 | ) | (525 | ) | (5,333 | ) | ||||||||||
Share-based compensation | 4,060 | 4,434 | 7,304 | 7,783 | ||||||||||||||
Adjusted EBITDA | $ | 2,837 | $ | 10,241 | $ | 7,570 | $ | 13,355 | ||||||||||
Adjusted EBITDA margin | 4.2 | % | 19.1 | % | 5.9 | % | 11.6 | % | ||||||||||
Adjusted EBITDA, % of Adjusted Net Sales | 4.2 | % | 19.7 | % | 5.9 | % | 12.2 | % |
FAQ
What were MiMedx's Q2 2021 earnings results?
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