MiMedx(MDXG)
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MiMedx(MDXG) - 2022 Q1 - Quarterly Report
2022-05-02 16:00
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 March 31, 2022 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 26-27925 ...
MiMedx Group (MDXG) Presents at the Canaccord Genuity Musculoskeletal Conference - Slideshow
2022-03-27 11:01
| --- | --- | --- | |---------------------------------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | A TRANSFORMATIONAL | | | | PLACENTAL BIOLOGICS COMPANY | | | | Canaccord Genuity | | | | | | | | 2022 Musculoskeletal Conference | | | | | | | | March 22, 2022 | | | DISCLAIMER & CAUTIONARY STATEMENTS This presentation includes forward-looking statements. Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against ...
MiMedx(MDXG) - 2021 Q4 - Earnings Call Transcript
2022-03-01 02:30
MiMedx Group, Inc. (NASDAQ:MDXG) Q4 2021 Earnings Conference Call February 28, 2022 5:00 PM ET Company Participants Jack Howarth - Senior Vice President, Investor Relations Tim Wright - Chief Executive Officer Pete Carlson - Chief Financial Officer Rohit Kashyap - Executive Vice President and Chief Commercial Officer Robert Stein - Executive Vice President, Research and Development Conference Call Participants Carl Byrnes - Northland Capital Markets Swayampakula Ramakanth - H.C. Wainwright John Vandermosten ...
MiMedx(MDXG) - 2021 Q4 - Annual Report
2022-02-27 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 ☐ 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) (State or other jurisdiction of incorporation ...
MiMedx(MDXG) - 2021 Q3 - Earnings Call Transcript
2021-11-03 19:45
Call Start: 08:30 January 1, 0000 9:32 AM ET MiMedx Group, Inc. (NASDAQ:MDXG) Q3 2021 Earnings Conference Call November 3, 2021 08:30 ET Company Participants Alexandra Haden - General Counsel & Secretary Tim Wright - Chief Executive Officer Pete Carlson - Chief Financial Officer Rohit Kashyap - Executive Vice President & Chief Commercial Officer Conference Call Participants Carl Byrnes - Northland Capital Markets Swayampakula Ramakanth - H.C. Wainwright John Vandermosten - Zacks Small Cap Research Eiad Asba ...
MiMedx(MDXG) - 2021 Q3 - Quarterly Report
2021-11-01 16:00
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 September 30, 2021 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 26-2 ...
MiMedx(MDXG) - 2021 Q2 - Earnings Call Transcript
2021-08-04 18:27
Financial Data and Key Metrics Changes - In Q2 2021, net sales increased by 27% year-over-year to $68.2 million, primarily driven by the Advanced Wound Care business [6][32] - Adjusted net sales, excluding the impact of revenue recognition changes, grew by 31% [6][33] - Gross profit margin was 81.3%, down from 84.7% in the same period last year, impacted by inventory reserves and increased manufacturing costs [35][36] - Net loss for Q2 2021 was $1.8 million, compared to a net loss of $8.5 million in the same period a year ago [41] Business Line Data and Key Metrics Changes - Advanced Wound Care products saw a 29% growth, driven by EPICORD Expandable and the EPIFIX portfolio [34] - Sales of Section 351 products increased by 44% compared to the prior year, which were significantly impacted by the pandemic [34] Market Data and Key Metrics Changes - The company achieved its goal of increasing the sales force by 10%, now totaling 289 customer-facing sales professionals [8] - The easing of COVID restrictions allowed for more effective sales and medical education programs [9][10] Company Strategy and Development Direction - The company is focused on expanding its Advanced Wound Care business and enhancing its product offerings [5][12] - A collaboration with Wake Forest University Institute for Regenerative Medicine aims to advance scientific evidence for clinical therapies [11] - Regulatory approval for EPIFIX in Japan is underway, with potential to reach 100,000 patients annually once reimbursement is established [13][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to adapt to potential COVID spikes and maintain sales momentum [10][73] - The company is optimistic about its pipeline, with key milestones expected in the coming months for clinical trials [22][26] Other Important Information - The company was added to the Russell 3000 and Russell 2000 indexes and anticipates being added to the NASDAQ Biotech Index in Q4 2021 [42] - The company is preparing for a potential BLA filing for its amniotic tissue products, which would be a significant milestone [24][27] Q&A Session Summary Question: Concerns about core products and 351 classification - Management does not believe EPICORD products will be affected by Enforcement Discretion due to their manufacturing and promotional methods [49][50] Question: Status of CGMP for processing facilities - One facility received a VAI, and the company is awaiting further updates from the FDA [51][52] Question: Drivers for EPICORD revenue growth - EPICORD Expandable allows targeting deeper wounds, providing a unique treatment option [58][59] Question: Impact of Enforcement Discretion on demand - The company is educating customers on viable alternatives and believes it can capture market share from competitors affected by Enforcement Discretion [62][65] Question: International product approvals beyond Japan - Current focus is on EPIFIX for wound applications in Japan, with future assessments for AMNIOFIX [74] Question: Timing for R&D day - Late fall is anticipated for the R&D day, depending on FDA meeting outcomes [67][68] Question: Processing time for trial results - The company is being thorough in its analysis, which may take longer due to the size of the studies [81][82] Question: Evidence of AMNIOFIX's regenerative properties - Preclinical studies show growth factors in AMNIOFIX that may modulate wound healing processes [89][90]
MiMedx(MDXG) - 2021 Q2 - Quarterly Report
2021-08-02 16:00
Part I [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201%20Financial%20Statements%20(Unaudited)) The unaudited financial statements for Q2 2021 show decreased total assets, improved net sales, and a reduced net loss, impacted by a $1.0 million inventory write-down [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2021, total assets decreased to $187.1 million, driven by lower cash, while total liabilities also decreased, resulting in an increased stockholders' deficit Condensed Consolidated Balance Sheet Highlights | Account | June 30, 2021 ($ thousands) | December 31, 2020 ($ thousands) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $85,007 | $95,812 | | Total current assets | $147,691 | $160,617 | | Total assets | $187,147 | $202,032 | | **Liabilities & Equity** | | | | Total current liabilities | $50,571 | $59,162 | | Long term debt, net | $47,905 | $47,697 | | Total liabilities | $101,790 | $110,614 | | Total stockholders' deficit | $(7,137) | $(150) | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q2 2021, net sales increased 27.1% to $68.2 million, and net loss significantly narrowed to $1.8 million, primarily due to reduced investigation-related expenses Q2 and H1 2021 vs 2020 Performance | Metric | Q2 2021 ($ thousands) | Q2 2020 ($ thousands) | Six Months 2021 ($ thousands) | Six Months 2020 ($ thousands) | | :--- | :--- | :--- | :--- | :--- | | Net sales | $68,165 | $53,647 | $128,132 | $115,383 | | Gross profit | $55,405 | $45,449 | $105,731 | $97,160 | | Operating loss | $(410) | $(5,856) | $(7,262) | $(19,600) | | Investigation, restatement and related | $(2,062) | $11,446 | $5,134 | $27,038 | | Net loss | $(1,779) | $(8,466) | $(10,161) | $(13,287) | | Net loss per share - basic/diluted | $(0.03) | $(0.08) | $(0.12) | $(0.12) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For H1 2021, net cash used in operating activities significantly improved to $5.1 million, with overall cash and equivalents decreasing by $10.8 million to $85.0 million Six Months Ended June 30 Cash Flow Summary | Activity | 2021 ($ thousands) | 2020 ($ thousands) | | :--- | :--- | :--- | | Net cash flows used in operating activities | $(5,080) | $(15,378) | | Net cash flows used in investing activities | $(2,501) | $(1,572) | | Net cash flows used in financing activities | $(3,224) | $(3,930) | | **Net change in cash** | **$(10,805)** | **$(20,880)** | | Cash and cash equivalents, end of period | $85,007 | $48,189 | [Notes to the Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the cessation of Section 351 product marketing, a $1.0 million inventory write-down, significant debt and preferred stock obligations, and legal accruals - The FDA's period of enforcement discretion for Section 351 products ended on May 31, 2021. The company stopped marketing these products, which accounted for **$8.6 million** in sales for Q2 2021 and **$16.7 million** for H1 2021[27](index=27&type=chunk) - The company fully reserved **$1.0 million** of its Section 351 product inventory during Q2 2021 due to the end of the FDA's enforcement discretion[65](index=65&type=chunk) - The company has a **$50 million** senior secured term loan with Hayfin, maturing in 2025, with an interest rate of **8.3%** as of June 30, 2021[70](index=70&type=chunk)[72](index=72&type=chunk) - The company has **$100 million** of Series B Convertible Preferred Stock outstanding, which pays a cumulative dividend (**6.0%** per annum after June 30, 2021) and is convertible at **$3.85** per common share. As of June 30, 2021, accumulated but unpaid dividends were **$4.1 million**[92](index=92&type=chunk)[93](index=93&type=chunk)[99](index=99&type=chunk) - As of June 30, 2021, the company has accrued **$4.5 million** related to legal proceedings and paid **$6.5 million** toward legal matters in the first six months of 2021[111](index=111&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=32&type=section&id=Item%202%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q2 2021 net sales growth driven by volume and Advanced Wound Care, the impact of Section 351 product cessation, increased operating expenses, and sufficient liquidity for the next 12 months [Results of Operations](index=34&type=section&id=Results%20of%20Operations) Q2 2021 net sales increased 27.1%, but gross margin declined due to an inventory write-down, while SG&A and R&D expenses rose significantly Q2 2021 vs Q2 2020 Results of Operations | Line Item | Q2 2021 ($ thousands) | Q2 2020 ($ thousands) | $ Change ($ thousands) | % Change | | :--- | :--- | :--- | :--- | :--- | | Net sales | $68,165 | $53,647 | $14,518 | 27.1% | | Gross profit | $55,405 | $45,449 | $9,956 | 21.9% | | Selling, general and administrative | $53,599 | $37,329 | $16,270 | 43.6% | | Investigation, restatement and related | $(2,062) | $11,446 | $(13,508) | (118.0)% | | Research and development | $4,063 | $2,259 | $1,804 | 79.9% | | Net loss | $(1,779) | $(8,466) | $6,687 | (79.0)% | - Adjusted Net Sales (excluding revenue from 'Remaining Contracts') increased **30.6%** in Q2 2021 year-over-year, driven by **29.5%** growth in Advanced Wound Care products[144](index=144&type=chunk)[145](index=145&type=chunk) - The increase in SG&A for Q2 2021 was driven by the restoration of full salaries, reduced travel costs in the prior period due to COVID-19, **$3.8 million** in proxy contest costs, and higher sales commissions[148](index=148&type=chunk)[149](index=149&type=chunk) [Non-GAAP Financial Measures](index=38&type=section&id=Non-GAAP%20Financial%20Measures) Non-GAAP measures show Q2 2021 Adjusted Net Sales increased to $67.9 million, while Adjusted EBITDA decreased to $2.8 million due to higher operating expenses Reconciliation of GAAP Net Loss to Adjusted EBITDA | Metric | Q2 2021 ($ thousands) | Q2 2020 ($ thousands) | Six Months 2021 ($ thousands) | Six Months 2020 ($ thousands) | | :--- | :--- | :--- | :--- | :--- | | Net loss | $(1,779) | $(8,466) | $(10,161) | $(13,287) | | EBITDA | $1,108 | $(4,172) | $(4,343) | $(16,133) | | **Adjusted EBITDA** | **$2,837** | **$10,241** | **$7,570** | **$13,355** | | Adjusted EBITDA margin | 4.2% | 19.1% | 5.9% | 11.6% | Reconciliation of GAAP Net Sales to Adjusted Net Sales | Metric | Q2 2021 ($ thousands) | Q2 2020 ($ thousands) | Six Months 2021 ($ thousands) | Six Months 2020 ($ thousands) | | :--- | :--- | :--- | :--- | :--- | | 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** | [Liquidity and Capital Resources](index=40&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2021, the company had $85.0 million in cash, deemed sufficient for 12 months, and was in compliance with its $50 million term loan covenants, while preferred stock dividends accumulated - The company had **$85.0 million** of cash and cash equivalents as of June 30, 2021, and believes this is sufficient to meet operational needs for the next 12 months[191](index=191&type=chunk)[192](index=192&type=chunk) - The Hayfin Term Loan has financial covenants requiring a Maximum Total Net Leverage Ratio (**4.5x** through Q2 2021, **4.0x** thereafter) and Minimum Liquidity of **$10 million**. The company was in compliance as of June 30, 2021[198](index=198&type=chunk) - The Series B Preferred Stock dividend rate increased from **4.0%** to **6.0%** per annum after June 30, 2021. As of June 30, 2021, accumulated but unpaid dividends were approximately **$4.1 million**[202](index=202&type=chunk)[205](index=205&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=42&type=section&id=Item%203%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As of June 30, 2021, the company reported no material market risk exposure due to the absence of market risk sensitive instruments - The company states it had no material market risk exposure as of June 30, 2021[211](index=211&type=chunk) [Item 4. Controls and Procedures](index=42&type=section&id=Item%204%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were not effective as of June 30, 2021, due to unremediated material weaknesses in internal control over financial reporting - The CEO and CFO concluded that disclosure controls and procedures were not effective as of June 30, 2021, due to previously identified and unremediated material weaknesses in internal control over financial reporting[213](index=213&type=chunk)[214](index=214&type=chunk) Part II [Item 1. Legal Proceedings](index=44&type=section&id=Item%201%20Legal%20Proceedings) The company is involved in numerous legal proceedings, including a securities class action, ongoing government investigations, and litigation with former executives - The company is party to numerous claims and lawsuits arising from its business activities. For detailed information, refer to Note 12 of the financial statements[218](index=218&type=chunk)[110](index=110&type=chunk) [Item 1A. Risk Factors](index=44&type=section&id=Item%201A%20Risk%20Factors) The company has amended and added several risk factors, including challenges in international expansion, potential FDA reclassification of products, and risks associated with clinical trials and manufacturing capacity - New Risk: Clinical trials are lengthy, expensive, and have uncertain outcomes. Delays or failures could prevent commercialization of new products[236](index=236&type=chunk) - New Risk: The ability to consistently manufacture biologic products is critical. Current facilities may be inadequate if the planned BLA for knee osteoarthritis is approved, requiring significant capital investment and expertise[239](index=239&type=chunk)[241](index=241&type=chunk) - Amended Risk: The company's umbilical cord-derived products (EPICORD, AMNIOCORD) could be determined by the FDA to not meet the requirements for regulation solely under Section 361, which would require pre-market approval and adversely impact revenue[229](index=229&type=chunk) - Amended Risk: International expansion, such as the recent EPIFIX approval in Japan, faces risks including difficulty in obtaining acceptable reimbursement pricing from government bodies like the JMHLW[220](index=220&type=chunk)[223](index=223&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=48&type=section&id=Item%202%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During Q2 2021, the company repurchased 127,046 common shares at an average price of $10.59, solely for tax withholding obligations on restricted stock vesting Q2 2021 Share Repurchases | Period | Total Shares Purchased | Average Price Paid per Share ($) | | :--- | :--- | :--- | | April 2021 | 121,613 | $10.63 | | May 2021 | 5,433 | $9.70 | | June 2021 | 0 | $— | | **Total for Quarter** | **127,046** | **$10.59** | [Item 3. Defaults Upon Senior Securities](index=48&type=section&id=Item%203%20Defaults%20upon%20Senior%20Securities) As of June 30, 2021, the company had accumulated $4,054,921 in unpaid dividends on its Series B Preferred Stock, electing accumulation over cash payment - As of June 30, 2021, the company had accumulated unpaid dividends of **$4,054,921** on its Series B Preferred Stock[245](index=245&type=chunk) [Item 5. Other Information](index=48&type=section&id=Item%205%20Other%20Information) On May 27, 2021, shareholders approved a bylaw amendment to implement proxy access, allowing eligible shareholders to nominate directors under specific conditions - The company amended its bylaws to provide for proxy access, allowing eligible shareholders (owning at least **3%** for **3 years**) to nominate directors[247](index=247&type=chunk) [Item 6. Exhibits](index=49&type=section&id=Item%206%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate documents, agreements, and certifications
MiMedx(MDXG) - 2021 Q1 - Earnings Call Transcript
2021-04-29 21:30
Financial Data and Key Metrics Changes - MiMedx reported a 4% growth in adjusted net sales for Q1 2021, driven by the Wound Care business, with adjusted net sales reaching $59.7 million, an increase of 4.2% from the previous year [11][45] - Net sales for Q1 2021 were $60.0 million, compared to $61.7 million for the same period in 2020, reflecting a decline due to changes in revenue recognition methodology [44][45] - Gross margin improved slightly to 83.9% in Q1 2021 from 83.8% in Q1 2020 [46] - Net loss increased to $8.4 million in Q1 2021 from a net loss of $4.8 million in Q1 2020 [50] Business Line Data and Key Metrics Changes - The Wound Care business was a significant contributor to the growth, particularly due to the recently launched EpiCord Expandable product [11][12] - Selling, general and administrative expenses decreased by 3.8% to $45.2 million, attributed to lower travel expenses due to COVID-19 restrictions [46] - Research and development expenses increased to $4.3 million in Q1 2021 from $2.8 million in the same period last year, reflecting planned investments in clinical research [47] Market Data and Key Metrics Changes - The company noted that sales of marginized and particulate products represented approximately 14% of net sales for the three months ended March 31, 2021 [53] - The FDA's end of enforcement discretion is expected to impact sales, with the company anticipating adjusted net sales for 2021 to be consistent with the previous year [54] Company Strategy and Development Direction - MiMedx is focused on pipeline acceleration, expanding patient access to wound care products, and advancing its innovative pipeline of musculoskeletal therapies [58] - The company is exploring inorganic growth opportunities but emphasizes a focus on organic growth at this time [41][42] - The addition of Dirk Stevens as Senior Vice President of Quality Assurance and Regulatory Affairs is aimed at enhancing quality standards and regulatory compliance [35][36] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's ability to achieve above-market growth rates despite the challenges posed by the end of enforcement discretion [71] - The company is committed to ensuring patient access to its products and is working with the FDA on expanded access under a cost recovery model [82] - Management highlighted the importance of ongoing dialogue with the FDA and the positive feedback received regarding their compliance efforts [75][86] Other Important Information - The company has completed the final patient visits for its Phase III studies on AmnioFix injectable for plantar fasciitis and Achilles tendonitis, with top-line results expected in the summer [19][22] - MiMedx is planning to file its first Biologics License Application (BLA) in the first half of 2022 for plantar fasciitis [27][75] Q&A Session Summary Question: Clarification on Year-over-Year Sales Decline - The decline in year-over-year sales was due to a change in revenue recognition methodology, not lost contracts [66][68] Question: Mitigation Strategies for Sales Loss - The company is focusing on expanding its sheet products and deploying its medical education team to communicate value propositions effectively [70][71] Question: FDA Approval Requirements for AmnioFix Injectable - Key steps include completing the analysis of the Phase III trial, meeting with the FDA, and ensuring the manufacturing facility meets GMP standards [73][75] Question: Impact of Enforcement Discretion Ending - Sales will continue until May 31, 2021, after which normal sales will stop without an approved BLA [79][81] Question: Market Size for Chronic Cutaneous Ulcers - The market for chronic cutaneous ulcers is expected to be significant, potentially larger than existing markets for diabetic foot ulcers and venous leg ulcers [93][96]
MiMedx(MDXG) - 2021 Q1 - Quarterly Report
2021-04-27 16:00
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 March 31, 2021 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 26-27925 ...