Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $32.9 million, an 18% increase from $27.9 million in Q1 2024, primarily driven by growth in the biologics product family [5][13] - Net income for Q1 2025 was $58,000, compared to a net loss of $4.4 million in Q1 2024, indicating a significant turnaround [16] - Adjusted EBITDA for Q1 2025 was $3 million, compared to an adjusted EBITDA loss of $1 million in the same period last year [16] Business Line Data and Key Metrics Changes - The biologics product family experienced year-over-year growth, while spinal implant sales declined by 10% or $1.2 million [13] - The company launched two new products, Trivium and FiberX, aimed at rejuvenating its core demineralized bone offerings [8] - The gross margin for Q1 2025 was 61.5%, slightly down from 62.1% in Q1 2024, affected by inventory disposal charges [14] Market Data and Key Metrics Changes - The company received royalties from licensing its Simply Max Q code, with CMS extending local coverage determination for skin substitutes to December 31, 2025, potentially increasing royalty income [10] - The company anticipates mid double-digit revenue growth in its biologics product family for 2025, while hardware revenue is expected to remain flat to modestly down [11] Company Strategy and Development Direction - The company has completed the vertical integration of its biologics products, positioning itself as a diversified, vertically integrated biologics company [7] - The focus for 2025 is on self-sustainability, profitability, and cash generation, with targeted growth opportunities and cost-cutting initiatives [11] - The company plans to rationalize its hardware product lines to optimize cash management [11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's strategic direction and the removal of a restrictive investor rights agreement, which is expected to benefit shareholders [6] - The company remains cautious about potential changes in government policies affecting revenue, particularly regarding royalties [23] - Management expects steady revenue growth throughout the year, with cash flow from operations anticipated to improve in Q4 2025 [28] Other Important Information - The company has added processing capacity at its Belgrade facility to support growing production needs [10] - The company has $5.4 million in cash and cash equivalents, with net accounts receivable at $23.5 million and inventory at $38.8 million as of March 31, 2025 [18] Q&A Session Summary Question: What are the assumptions for incremental minimum payments and royalties from the Amneal deals? - Management has not included additional minimums under the royalty agreement and assumes full manufacturing under the manufacturing license agreement for the remainder of 2025 [21][22] Question: Can you walk through the different drivers for growth in the biologics side? - Key drivers include growth from Amneal and VBM, with a focus on transitioning customers to the new Cortera line [24][25] Question: How should we think about EBITDA and cash flow through the rest of the year? - Cash flow from operations is expected to be tighter in Q3 but improve in Q4, with steady revenue growth anticipated [28] Question: How do you foresee sales and marketing expenses for the rest of the year? - Sales and marketing expenses are expected to increase in Q2 and beyond, aligning more closely with Q4 of the previous year [35] Question: Is there potential for margin improvement with in-house production? - Management indicated that bringing production in-house will lead to margin improvements, particularly for products like Trivium and Fibrex [37][40]

Part I: Financial Information [Financial Statements](index=7&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) The company reported a net income of **$58 thousand** in Q1 2025, a significant turnaround from a **$4.4 million** net loss in Q1 2024, driven by an **18%** revenue increase and a post-quarter change in majority ownership [Condensed Consolidated Financial Statements](index=7&type=section&id=Condensed%20Consolidated%20Financial%20Statements) Q1 2025 financial statements reflect a shift to profitability with a net income of **$58 thousand**, positive operating cash flow of **$1.3 million**, and a slight increase in total assets to **$95.8 million** Condensed Consolidated Balance Sheet Data (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $5,032 | $6,199 | | Total current assets | $69,144 | $67,116 | | Total Assets | $95,833 | $93,837 | | Total current liabilities | $29,581 | $28,581 | | Total Liabilities | $51,956 | $50,874 | | Total Stockholders' Equity | $43,877 | $42,963 | Condensed Consolidated Statements of Operations (in thousands, except per share data) | Account | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Total Revenue | $32,904 | $27,873 | | Gross Profit | $20,243 | $17,302 | | Income (Loss) from Operations | $1,063 | $(3,470) | | Net Income (Loss) | $58 | $(4,400) | | Basic & Diluted EPS | $0.00 | $(0.03) | Condensed Consolidated Statements of Cash Flows (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $1,278 | $(5,755) | | Net cash used in investing activities | $(1,143) | $(674) | | Net cash (used in) provided by financing activities | $(919) | $5,179 | | Net change in cash | $(786) | $(1,299) | [Notes to Financial Statements](index=12&type=section&id=Notes%20to%20Financial%20Statements) Notes reveal a significant revenue shift with **$3.6 million** in new licensing revenue, continued debt covenant compliance, and a major post-quarter ownership change where Nantahala Capital Management acquired a **49.1%** stake Revenue by Product Line (in thousands) | Product Line | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Orthobiologics | $18,074 | $15,416 | | Spinal implant | $11,210 | $12,457 | | License revenue | $3,620 | $— | | **Total revenue** | **$32,904** | **$27,873** | - A new license agreement includes a **$1.5 million** upfront fee and guaranteed quarterly minimum royalties, though future minimums beyond Q1 2025 were constrained due to uncertainty regarding a CMS policy change[52](index=52&type=chunk) - As of March 31, 2025, the company had **$5.7 million** available under its revolving line of credit and was in compliance with all debt covenants[59](index=59&type=chunk) - Subsequent to the quarter end, in April 2025, OrbiMed sold its entire **~73.1 million share stake**, with Nantahala Capital Management increasing its ownership to **49.1%** of the company's outstanding common stock as the lead purchaser[79](index=79&type=chunk)[83](index=83&type=chunk) [Management's Discussion and Analysis (MD&A)](index=23&type=section&id=ITEM%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management attributes Q1 2025 revenue growth of **18%** to orthobiologics and new licensing, leading to an operating income of **$1.1 million** and sufficient liquidity to fund operations through at least May 2026 [Business Overview and Strategy](index=23&type=section&id=Business%20Overview%20and%20Strategy) The company focuses on developing and marketing regenerative medicine and medical devices, pursuing growth through new products, expanded distribution, adjacent market penetration, and strategic acquisitions - The company's four key growth initiatives are: - Introduce new products (e.g., Trivium™) - Expand distribution network - Penetrate adjacent markets - Leverage growth platform with technology and strategic acquisitions[88](index=88&type=chunk) - Recent license agreements for SimpliGraft® and SimpliMax™ products are subject to revenue recognition risks related to potential changes in CMS reimbursement policies, which have been delayed to January 1, 2026[91](index=91&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Q1 2025 total revenue grew **18%** to **$32.9 million** driven by orthobiologics and new licensing, while gross margin slightly decreased to **61.5%** and operating expenses notably declined, shifting to operating income - Total revenue increased **18%** year-over-year to **$32.9 million**, driven by orthobiologics sales and **$3.6 million** in new licensing revenue[93](index=93&type=chunk) - Gross margin decreased by **60 basis points** to **61.5%**, primarily due to inventory write-offs and sales mix changes[94](index=94&type=chunk) - Sales and marketing expenses decreased by **10%** (**$1.3 million**), mainly from a **$0.8 million** reduction in agent commissions and a **$0.7 million** decrease in compensation expense due to reduced headcount[96](index=96&type=chunk) - General and administrative expenses decreased by **3%** (**$0.3 million**) due to reduced accounting and consultant fees[95](index=95&type=chunk) [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity, including **$5.4 million** cash and **$5.7 million** available credit, is deemed sufficient to meet cash requirements through at least May 2026, supported by **$1.3 million** in Q1 2025 operating cash flow - The company believes its **$5.4 million** in cash as of March 31, 2025, along with operating cash flows and available credit, will be sufficient to meet cash requirements through at least **May 2026**[109](index=109&type=chunk) - Net cash from operating activities was **$1.3 million** in Q1 2025, a significant improvement from a **$5.8 million** use of cash in Q1 2024, primarily due to achieving net income versus a net loss[101](index=101&type=chunk) - As of March 31, 2025, the company had **$11.3 million** outstanding on its revolving line of credit, with **$5.7 million** of availability[106](index=106&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) As a smaller reporting company, Xtant Medical is not required to provide the information for this item - The company is not required to provide this information as it qualifies as a smaller reporting company[113](index=113&type=chunk) [Controls and Procedures](index=27&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Management concluded that disclosure controls and procedures were not effective as of March 31, 2025, due to a previously identified material weakness in internal control over financial reporting - Based on their evaluation, the principal executive officer and principal financial officer concluded that as of March 31, 2025, the company's disclosure controls and procedures were not effective[115](index=115&type=chunk) - The ineffectiveness is attributed to a material weakness in the company's internal control over financial reporting[115](index=115&type=chunk) Part II: Other Information [Legal Proceedings](index=28&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) The company is subject to various legal claims arising in the ordinary course of business and believes it has adequately accrued for probable and estimable contingent liabilities - The company is subject to potential liabilities from various claims and legal actions arising in the ordinary course of business[71](index=71&type=chunk)[117](index=117&type=chunk) - Management believes it has adequately accrued for contingent liabilities where loss is probable and reasonably estimable, and does not expect the ultimate resolution of claims to have a material adverse effect[71](index=71&type=chunk) [Other Information](index=28&type=section&id=ITEM%205.%20OTHER%20INFORMATION) Effective May 12, 2025, Mark A. Schallenberger was appointed COO with an annual base salary of **$461,760** and a **75%** target bonus, with no Rule 10b5-1 trading plan changes reported - Effective May 12, 2025, Mark A. Schallenberger was appointed as the company's Chief Operating Officer[122](index=122&type=chunk) - Mr. Schallenberger's compensation was increased to an annual base salary of **$461,760** and a target annual bonus of **75%** of base salary[124](index=124&type=chunk) [Other Items (Risk Factors, Unregistered Sales, Defaults, Mine Safety)](index=28&type=section&id=Other%20Items) As a smaller reporting company, Item 1A (Risk Factors) information is not required, and other items including unregistered sales, defaults, and mine safety disclosures were not applicable - As a smaller reporting company, information regarding Risk Factors (Item 1A) is not required[118](index=118&type=chunk) - Items concerning Unregistered Sales of Equity Securities, Defaults Upon Senior Securities, and Mine Safety Disclosures were not applicable[119](index=119&type=chunk)[120](index=120&type=chunk)[121](index=121&type=chunk)

Core Insights - Xtant Medical Holdings, Inc. reported a positive net income of $58,000 for Q1 2025, a significant improvement from a net loss of $4.4 million in Q1 2024, indicating a turnaround in financial performance [4][9] - The company achieved an 18% year-over-year revenue growth, reaching $32.9 million, driven by increased sales in orthobiologics and licensing revenue [2][3] - Xtant Medical has raised its revenue guidance for the full year 2025 to between $127 million and $131 million, reflecting an expected growth of 8% to 12% [10] Financial Highlights - Revenue for Q1 2025 was $32.9 million, compared to $27.9 million in Q1 2024, marking an 18% increase [3][9] - Gross margin decreased slightly to 61.5% from 62.1% year-over-year, primarily due to charges for excess and obsolete inventory [3][9] - Operating expenses decreased to $19.2 million in Q1 2025 from $20.8 million in Q1 2024, mainly due to reduced compensation and commission expenses [4][9] Cash Flow and EBITDA - The company generated $1.3 million in operating cash flow in Q1 2025, a turnaround from cash used in operations of $5.8 million in the prior year [2][9] - Non-GAAP adjusted EBITDA for Q1 2025 was $3.0 million, compared to an adjusted EBITDA loss of $1.0 million in Q1 2024 [5][9] Product Development - Xtant Medical launched Trivium™, a next-generation demineralized bone matrix allograft, which is expected to enhance the company's orthobiologics portfolio and drive future growth [2][9] Corporate Developments - The company completed a secondary private sale of existing shares by OrbiMed Advisors LLC, enhancing corporate governance flexibility by terminating the investor rights agreement with OrbiMed [9]

BELGRADE, Mont., May 6, 2025 /PRNewswire/ -- Xtant Medical Holdings, Inc. (NYSE American: XTNT), a global medical technology company focused on surgical solutions for the treatment of spinal, orthopedic and woundcare disorders, today announced that it will release its financial results for the first quarter ended March 31, 2025, after the close of the financial markets on Monday, May 12, 2025. Sean Browne, President and Chief Executive Officer, and Scott Neils, Chief Financial Officer, will host a conferenc ...

Core Viewpoint - Xtant Medical Holdings, Inc. has launched Trivium™, a next-generation demineralized bone matrix allograft aimed at improving bone grafting procedures through advanced technology and design [1][4]. Product Features - Trivium is designed with intertwined structures and interconnected porosity to enhance cell attachment and tissue ingrowth, creating an optimal healing environment [2]. - The product features superior moldability and handling characteristics, allowing for precise placement in various surgical applications [2]. - Trivium is processed using the proprietary BacteRinse® method, which preserves native bone morphogenetic proteins (BMPs) to ensure the delivery of essential bioavailable growth factors for bone repair [3]. Company Commitment - The launch of Trivium reflects Xtant Medical's commitment to innovation in regenerative medicine, providing surgeons with a reliable solution for diverse surgical needs [4]. - The product is now available through the company's nationwide distribution network of independent agents [4]. Company Overview - Xtant Medical Holdings, Inc. focuses on the design, development, and commercialization of orthobiologics and spinal implant systems, aiming to facilitate spinal fusion in complex procedures [5].

Stock Transaction and Ownership Changes - The Company completed a stock transaction on April 15, 2025, selling approximately 73.1 million shares at a price of $0.42 per share, totaling approximately $30.7 million[6][12]. - Following the transaction, Nantahala Capital Management, LLC acquired 57.0 million shares, resulting in Nantahala holding 49.1% of the Company's issued and outstanding common stock[7][12]. - The transaction resulted in a change of control, with Nantahala becoming the largest stockholder and effectively controlling the Company[12]. - The Company amended its credit agreements to increase the ownership threshold for a Change in Control from 40% to 49.9%[7]. - Nantahala's significant ownership may prevent other stockholders from influencing corporate decisions, potentially affecting the market price of the common stock[20]. - The Company is no longer classified as a "controlled company" under NYSE American standards due to the change in stock ownership[16]. - The transaction led to the termination of the Investor Rights Agreement with ROS Acquisition and ORO II, effective immediately[9]. - Nantahala's ownership concentration may discourage unsolicited acquisition proposals, impacting the Company's strategic options[20]. - The Company has entered into a Registration Rights Agreement with several purchasers, which may influence future stockholder dynamics[23]. Financial Performance and Projections - The Company disclosed preliminary, unaudited revenue for the quarter ended March 31, 2025, in connection with the transaction announcement[10]. - The Company anticipates a preliminary revenue growth of 18% to 19% for the first quarter of 2025[23]. - The Company warns that future sales of shares may lead to a material adverse impact on the trading price of the Common Stock, especially given its low trading volume[22]. - The Company is obligated to file a Resale Registration Statement, which will allow these shares to be available for resale, potentially impacting future capital raising efforts[21]. - The Company has filed several amendments to its credit agreements, indicating ongoing financial restructuring efforts[23]. Risks and Regulatory Compliance - The Company cautions that forward-looking statements involve risks and uncertainties that could lead to actual results differing materially from expectations[22]. - The Company is at risk of delisting from NYSE American if the trading price of its Common Stock falls to abnormally low levels[21]. - The Company emphasizes the importance of reviewing its SEC filings for a comprehensive understanding of risks and uncertainties[22]. - The Chief Financial Officer, Scott Neils, signed the report, indicating official acknowledgment of the financial disclosures[26].

Core Viewpoint - Xtant Medical Holdings, Inc. is focusing on a strategic shift towards higher-margin orthobiologics, supported by new product launches and a recent secondary private sale of shares, which enhances its operational flexibility and aligns with long-term healthcare-focused investors [1][2][3]. Group 1: Strategic Developments - The completion of a secondary private sale of 73.1 million shares by OrbiMed Advisors LLC to existing and new stockholders, led by Nantahala Capital Management LLC, marks a significant change in ownership structure [1]. - The termination of the investor rights agreement with OrbiMed allows Xtant greater strategic and operational flexibility moving forward [2]. - The company aims to prioritize profitability and self-sustainability as part of its long-term growth strategy, with a focus on expanding its orthobiologics offerings [3]. Group 2: Financial Performance - Xtant Medical expects to report Q1 2025 revenue between $32.8 million and $33.1 million, reflecting an 18% to 19% increase compared to Q1 2024 [4]. - The growth in revenue is primarily driven by orthobiologics and licensing revenue, indicating a successful transition towards higher-margin products [4]. Group 3: Future Outlook - The company plans several new product launches that will expand its offerings beyond spinal solutions, which is anticipated to accelerate growth in 2025 and beyond [3]. - Nantahala Capital Management expresses confidence in Xtant's innovative biologics and implant solutions, which address a growing need in the healthcare sector for regenerative and cost-effective surgical solutions [3].

Financial Data and Key Metrics Changes - The company reported record fourth-quarter revenue of $31.5 million, a 12% increase from $28.1 million in Q4 2023, and full-year revenue of $117.3 million, representing a 28% increase from $91.3 million in 2023 [16][24] - Gross margin for Q4 2024 was 50.8%, down from 61% in Q4 2023, primarily due to inventory write-offs and reduced production throughput [17][18] - Adjusted EBITDA for Q4 2024 was $438,000, compared to an adjusted EBITDA loss of $695,000 in Q4 2023 [22] Business Line Data and Key Metrics Changes - The biologics business grew by 21% year-over-year, while hardware sales declined by 10% [7][17] - The decline in hardware sales was attributed to a strong previous year and ongoing EU supply chain issues [8] - The company plans to launch four new biologics products in 2025, including a growth factor product and upgraded DBM-based products [9][10] Market Data and Key Metrics Changes - The company anticipates mid-double-digit revenue growth in the biologics segment for 2025, while hardware revenue is expected to decline modestly [14] - The international business faced challenges due to supply chain issues in the EU, impacting sales [8] Company Strategy and Development Direction - The company is focusing on achieving self-sustainability and prioritizing profitability over revenue growth [13] - Cost-cutting measures have led to a reduction in operating expenses by approximately $5 million, including a headcount reduction of over 13% [4][19] - The company is rationalizing old hardware lines to optimize offerings and improve cash management [6][14] Management's Comments on Operating Environment and Future Outlook - Management acknowledged 2024 as a challenging year due to the integration of Surgiline businesses but expressed optimism about becoming a leaner and more efficient organization [3] - The company expects to see improvements in gross margins as new products are introduced and sales channels expand [44] - Management highlighted the importance of reliable supply for OEM partners to capitalize on demand [60] Other Important Information - The company had $6.2 million in cash and cash equivalents as of December 31, 2024, with net accounts receivable of $20.7 million and inventory of $38.6 million [29] - The company does not anticipate needing to raise additional capital in 2025 due to projected revenue growth and cost savings [15] Q&A Session Summary Question: Insights on Biologics growth and DBM launch - Management indicated that the growth in the biologics segment was primarily driven by white label products, with expectations for a more balanced contribution from Xtant branded products in 2025 [33][35] Question: 2025 guidance assumptions - Management discussed expectations for seasonality in sales and indicated that operating expenses would see improvements, particularly in general and administrative costs [53][54] Question: Potential for outperformance in 2025 - Management noted that any delays in the local coverage determination (LCD) could positively impact revenue, particularly in the wound care segment [58][60] Question: Cost savings impact on P&L - Management confirmed that cost savings measures were already being reflected in Q4 2024 results and would continue to impact the first quarter of 2025 [70][71]

Xtant Medical Holdings, Inc. (NYSE:XTNT) Q4 2024 Results Conference Call March 6, 2025 4:30 PM ET Company Participants Brett Maas - Hayden IR Sean Browne - President & Chief Executive Officer Scott Neils - Chief Financial Officer Conference Call Participants Chase Knickerbocker - Craig-Hallum Sean Browne Good afternoon, everyone. I am pleased to announce record fourth-quarter revenue of $31.5% million and for the full year, $117.3% million. This is our first full quarter. A consistent year-over-year compari ...

Financial Agreements and Acquisitions - In Q4 2024, Xtant Medical entered a license agreement for the SimpliMax™ product, receiving a one-time cash payment of $1.5 million and expected minimum royalty payments of $3.75 million in 2025[21]. - A manufacture and license agreement for the SimpliGraft product was established, with an upfront payment of $1.5 million and minimum purchase obligations totaling $3.9 million in 2025[22]. - Xtant Medical acquired Surgalign SPV for $17 million, gaining rights to the Coflex and CoFix product lines approved by the FDA for lumbar spinal stenosis treatment[24]. - The acquisition of Surgalign Holdings' assets included a broad portfolio of spinal hardware implants and biologics, funded with $5 million in cash[25]. - The company acquired RTI Surgical's nanOss production operations for $2 million, along with a low single-digit royalty on future sales[26]. - Recent license agreements generated a one-time cash payment of $1.5 million, with potential quarterly royalty payments starting in 2025[143]. - The company acquired Surgalign SPV and other assets in 2023, aiming to enhance product offerings through strategic acquisitions[147]. Product Development and Market Strategy - Xtant Medical's strategic focus includes introducing new biologics products and leveraging its distribution network to penetrate adjacent markets[19]. - The company plans to launch new products in 2025, including FibreX and OsteoFactor Pro, aimed at enhancing bone regeneration[32]. - New product offerings include SimpliGraft, SimpliMax, OsteoVive Plus, and the Cortera Spinal Fixation System, aimed at increasing future revenues[128]. - The company expects its private label and OEM business to grow, but this segment typically has lower gross margins compared to independent agent sales[142]. Regulatory Compliance and Challenges - The company is ISO 13485 and MDSAP certified, ensuring compliance with quality management systems for medical devices[52]. - The company’s products are regulated as human cellular and tissue products (HCT/Ps) and have received 510(k) clearances from the FDA[53]. - The FDA's 510(k) review process typically takes three to nine months, with no assurance of clearance[63]. - The FDA may require the company to conduct post-market surveillance studies for products marketed under PMA, which could delay commercialization[176]. - The company is subject to extensive regulatory requirements, including obtaining FDA clearances or approvals for new products, which can be costly and time-consuming[170]. - Compliance with the Federal Physician Payments Sunshine Act requires the company to report annual payments to physicians and teaching hospitals[184]. - The company must comply with the EU Medical Devices Regulation 2017/745 to market products in the European Economic Area (EEA)[191]. - The company is required to perform post-market clinical follow-up studies to evaluate the safety and performance of previously approved products[196]. Financial Performance and Risks - As of December 31, 2024, the company has an accumulated deficit of $259.5 million and incurred a net loss of $16.4 million during the year[113]. - The company may seek additional financing through equity or debt, which could dilute current stockholders' interests[115]. - The company faces significant risks related to its high level of indebtedness, which could adversely affect its financial condition and operating results[119]. - The company has focused on four key growth initiatives: introducing new products, expanding distribution networks, penetrating adjacent markets, and leveraging technology and strategic acquisitions[128]. - The company may need to curtail operations significantly if it fails to raise additional funds or generate sufficient cash flow[117]. - The company has a minimum liquidity covenant of $5.0 million, which it has struggled to comply with in recent years[116]. Workforce and Employee Relations - As of December 31, 2024, Xtant had 232 employees, with 217 being full-time, including 90 in operations and 42 in sales and marketing[86]. - The company’s total workforce consists of 49% female and 39% racially or ethnically diverse employees[87]. - The average tenure of employees is approximately 4 years, while management team members have an average tenure of about 7 years[88]. - The company has no employee unions and maintains good relations with its employees[89]. - The company emphasizes employee safety and wellness, implementing multiple safety programs and health initiatives[92][93]. - The company has a robust learning management system for employee development and training[99]. Market Conditions and Competitive Landscape - The orthopedic biomaterials market is expected to grow, with increasing demand for products that aid in healing and bone tissue augmentation[27]. - Recent changes in CMS reimbursement policies may impact revenue from the SimpliMax™ and SimpliGraft products, with potential revenue reductions anticipated[23]. - The overall escalating cost of medical products is leading to increased pressures on the healthcare industry to reduce costs, which may affect Xtant's product demand[81]. - International reimbursement systems vary significantly, impacting Xtant's ability to achieve market acceptance in foreign markets[82]. - The company anticipates a shift towards more outpatient procedures in ambulatory surgical centers, which may reduce product prices and margins due to lower facility fee reimbursements compared to hospitals[166]. Operational Challenges and Supply Chain Issues - The company has faced delays in product launches, including OsteoVivePlus and Cortera Spinal Fixation System, due to validation and supplier issues[133]. - In 2023, the company experienced a shortage of stem cells, which adversely affected revenues in the first half of fiscal 2024[135]. - Manufacturing biologics products is complex and time-consuming, leading to operational challenges and missed revenue opportunities in 2023[136]. - The company relies heavily on human donors and placentas for its biologics business, with limited availability impacting revenue and operations[137]. - Persistent inflation and supply chain disruptions have resulted in increased costs and delayed product launches, affecting profit margins[139]. Legal and Liability Risks - The company may incur material liabilities from product liability claims, which may exceed insurance coverage[160]. - The potential for product recalls due to design or manufacturing failures could adversely affect demand and revenue[161]. - The company is subject to product liability litigation, which could harm its financial condition if it results in substantial damage awards[210]. - The FDA has the authority to inspect facilities and enforce compliance, which could lead to recalls or other enforcement actions if violations are found[214]. International Operations and Compliance - The company operates in 33 countries, exposing it to political, economic, and social instability risks[151]. - Compliance with international trade regulations is costly and may result in significant penalties for non-compliance[151]. - Regulatory approvals for marketing products outside the U.S. are costly and time-consuming, and failure to obtain them could adversely affect the business[189]. - The company faces risks from reliance on a limited number of third-party suppliers, which could disrupt operations if not managed properly[157]. Miscellaneous Risks - The company faces risks related to fluctuations in foreign currency exchange rates, particularly with the Euro, Swiss franc, and British pound against the U.S. dollar[164]. - The company’s ability to deduct interest on indebtedness is limited to business interest income and 30% of adjusted taxable income, which has become more restrictive since 2022[165]. - The company is exposed to increasing criminal prosecutions for noncompliance with HIPAA and state data privacy laws[185]. - Negative publicity regarding tissue recovery methods could reduce demand for biologics products[154].