INTEGRA LIFESCIENCES HOLDINGS CORP 10-Q

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion and analysis of the Company's financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and the related notes thereto appearing elsewhere in this report and our consolidated financial statements for the year ended December 31, 2022 included in our Annual Report on Form 10-K. We have made statements in this report that constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”). All statements other than statements of historical fact contained in this Quarterly Report on Form 10-Q (this “Quarterly Report”), including statements regarding our future results of operations and financial position, business strategy and plans, objectives of management for future operations and current expectations or forecasts of future results, are forward-looking statements. These forward-looking statements are subject to a number of risks, uncertainties and assumptions about the Company and other matters that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. These statements involve known and unknown risks, uncertainties, and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Our forward-looking statements may include statements related to our growth and growth strategies, developments in the markets for our products and services, financial results, development launches and effectiveness, research and development strategy, regulatory approvals, competitive strengths, the potential or anticipated direct or indirect impact of the Coronavirus pandemic on our business, results of operations, and/or financial condition, restructuring and cost-saving initiatives, intellectual property rights, litigation and tax matters, governmental proceedings and investigations, mergers and acquisitions, divestitures, market acceptance of our products and services, accounting estimates, financing activities, ongoing contractual obligations, working capital adequacy, value of our investments, our effective tax rate, our expected returns to shareholders, and sales efforts. In some cases, these forward-looking statements may be identified by forward-looking words such as “believe,” “may,” “might,” “could,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “seek,” “plan,” “expect,” “should,” “would” and similar words and expressions in this report. Forward-looking statements in this Quarterly Report include, but are not limited to, statements regarding our ability to drive long-term shareholder value, development and future launches of products and continued or future acceptance of products and services in our segments; our ability to navigate and mitigate any on-going or future impact associated with economic disruptions, including supply chain constraints and inflation; expected timing for completion of research studies relating to our products; market positioning and performance of our products; divestitures and the potential benefits thereof; the costs and benefits of integrating previous acquisitions; anticipated timing for Food and Drug Administration (“FDA”) in the U.S., as well as for non-U.S. regulatory approval of new products; statements regarding the issues causing the voluntary removal of the Company’s CereLink ICP Monitor System and the Company’s voluntary recall of all products manufactured at its Boston facility; the potential effects of the process deviations identified at the Boston manufacturing facility; the anticipated impact of the voluntary removal and recall and manufacturing stoppage on the Company’s business; the Company’s ability to address in a timely manner the product-related issues discussed herein and re-initiate sales of Cerelink and resume manufacturing activities at its Boston facility; our future financial performance; increased presence in new markets, including markets outside the U.S.; changes in the market and our market share; acquisitions and investment initiatives, including the timing of regulatory approvals as well as integration of acquired companies into our operations; the resolution of tax matters; the effectiveness of our development activities in reducing patient care costs and hospital stay lengths; our approach towards cost containment; our expectations regarding healthcare costs; general economic conditions; and the potential impact of our compliance with governmental regulations and accounting guidance. On September 12, 2023, a securities class action complaint, captioned Pembroke Pines Firefighters & Police Officers Pension Fund v. Integra LifeSciences Holdings Corporation , No. 23-cv-20321 (D.N.J.), was filed by a purported stockholder of the Company in the United States District Court for the District of New Jersey (the “Pembroke Litigation”) against the Company and certain of the Company’s current and former executive officers. The Pembroke Litigation, filed on behalf of a putative class of stockholders who purchased or acquired the Company’s common stock between March 11, 2019 and May 22, 2023, inclusive, alleges violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 promulgated thereunder, on the basis of purportedly materially false and misleading statements and omissions relating to certain quality systems issues identified by the U.S. Food and Drug Administration at the Company’s Boston, Massachusetts manufacturing facility, the Company’s efforts to remediate those issues, and the Company’s forecasts for certain products in its Tissue Technologies segment. The complaint seeks, among other things, compensatory damages, attorneys’ fees, expert fees, and other costs. The Company believes that it has strong defenses to the allegations in the Pembroke Litigation, as we intend to defend the matter vigorously. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, results of operations, financial condition, and/or cash flows. These forward-looking statements speak only as of the date of this Quarterly Report and are subject to a number of risks, uncertainties and assumptions described in the “Risk Factors” section and elsewhere in our Annual Report on Form 10-K for the year ended 34 Table of Contents " December 31, 2022. As forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. One must carefully consider forward-looking statements and understand that such forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, and involve a variety of risks and uncertainties, known and unknown, including, among others, those discussed in the sections entitled “Government Regulation and Compliance” within “Item 1. Business” and “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by applicable law. GENERAL Integra LifeSciences is a world leader in medical technologies and products that transform surgical, neurologic and regenerative care to help restore patients’ lives. Our mission is to innovate treatment pathways to advance patient outcomes and set new standards of care. Founded in 1989 with the acquisition of an engineered collagen technology platform used to repair and regenerate tissue, Integra LifeSciences Holdings Corporation common stock trades on the Nasdaq Global Select Market (“Nasdaq”) under the symbol “IART.” Integra has developed numerous product lines from this technology for applications ranging from burn and deep tissue wounds to the repair of dura mater in the brain, as well as nerves and tendons. We have expanded our base regenerative technology business to include surgical instruments, neurosurgical products and advanced wound care through global acquisitions and product development to meet the evolving needs of our customers and enhance patient care. We manufacture and sell medical technologies and products in two reportable business segments: Codman Specialty Surgical ("CSS") and Tissue Technologies ("TT"). The CSS segment, which represents approximately two-thirds of our total revenue, consists of market-leading technologies and instrumentation used for a wide range of specialties, such as neurosurgery, neurocritical care and otolaryngology. We are the world leader in neurosurgery and one of the top three providers in instruments used in precision, specialty, and general surgical procedures. Our TT segment generates about one-third of our overall revenue and focuses on three main areas: complex wound surgery, surgical reconstruction, and peripheral nerve repair. We have key manufacturing and research facilities located in California, Indiana, Maryland, Massachusetts, New Jersey, Ohio, Puerto Rico, Tennessee, Utah, France, Germany, Ireland and Switzerland. We source most of our handheld surgical instruments and sealant products through specialized third-party vendors. Following the completion of our strategic refresh, we refocused our strategies around five pillars. Of these five pillars, we have identified three core growth drivers: innovating for outcomes, growing internationally, and broadening our impact on care pathways. We have enabled by two key levers: driving operational and customer excellence and cultivating a high-performance culture. As outlined in greater detail below, we believe these five pillars will enable us to realize and advance our integrated growth strategy. Innovating for Outcomes. An important part of Integra’s growth strategy is introducing new products to strengthen and expand our portfolio. Additionally, we seek clinical evidence to support regulatory approval and strong reimbursement of our product portfolio around the world, including new indications for existing technologies. On December 6, 2022, we completed the acquisition of Surgical Innovation Associates, Inc. (“SIA”), which develops, markets and sells DuraSorb, a resorbable synthetic matrix for plastic and reconstructive surgery. This acquisition advances our global strategy in breast reconstruction, expanding plans to access the U.S. market where SIA is pursuing pre-market approval for use in implant-based breast reconstruction ("IBBR"). As part of our commitment to implant-based breast reconstruction strategy and innovating new treatment pathways, in June 2023 we completed enrollment in the DuraSorb U.S. investigational device exemption (IDE) clinical study for two-stage breast reconstruction. We also continued to advance the development of pioneering neurosurgical technologies with the expansion of our product offerings. In early 2023, the CUSA® Clarity Bone Tip was launched in U.S., which is used when controlled fragmentation, emulsification and aspiration of bone is necessary. This follows the CUSA® Clarity extended laparoscopic tip, launched in the U.S. in late 2022 to enhance the benefits of ultrasonic ablation to minimally invasive laparoscopic liver surgery. Growing International. Over the years, we have been significantly expanding our global footprint through investments in our commercial organization, expansion and development of international markets and new product introductions. Several new products were introduced in 2023, including MicroMatrix® and Certas Plus® Programmable Valve which were launched in Europe, and CUSA Clarity Laparoscopic ("Lap") tip which was launched in Australia, New Zealand, Japan, Canada, South Africa and Israel. In addition, DuraGen Secure received approval in Japan, while DuraGen Plus was approved in China. Broadening Impact on Care Pathways. Integra seeks ways to develop products and technologies that impact the lives of patients, starting with the journey that a patient takes from diagnosis and treatment planning to surgery and postoperative care. Integra is well-established in acute care in the hospital setting and plans to leverage that strong position to grow in this segment and shape treatment pathways into preoperative care and additional sites of care. 35 Table of Contents " Driving Operations and Customer Excellence. Integra has been making investments to build more responsive and scalable processes, enhance the reliability of our supply chain, and drive productivity initiatives to further supply and lower costs. Additionally, we continue to invest in technologies, systems and processes to enhance the customer experience. In 2023, we continue to invest in our capacity expansion. This includes ongoing projects of transferring our Boston manufacturing to a new location in Braintree, MA., validating manufacturing processes in our 109 facility in Plainsboro, and increasing cleanroom capacity in our Memphis location. In 2022, certain transactional back-office finance and customer service activities were outsourced to enhance customer quality, build scale for future growth, and capture cost efficiencies. Cultivating a High-Performance Culture. Creating a culture focused on empowerment and agility and building a diverse and inclusive workplace are cornerstones of our people strategy. These efforts resulted in Integra being named in several best workplace lists globally in 2023, including Integra China being recognized as a Great Place to Work in Greater China. Additionally, we have been making great strides in advancing our environmental, social and governance ("ESG") agenda to drive sustainability across the organization and recently published our second annual ESG report in the third quarter of 2023. Clinical and Product Development Activities Integra continues to invest in collecting clinical evidence to support our existing products and new product launches, and to ensure that we obtain market access for broader and more cost-effective solutions. In 2022, we made progress to several enhancements to our CUSA Clarity Tissue Ablation System. The extended laparoscopic tip was launched in the U.S. to enhance laparoscopic liver procedures. In addition, a single-sided bone tip received 510(k) clearance. In early 2023, we had our commercial launch with initial surgeries successfully completed. We continue to update our CUSA Clarity platform by incorporating new ultrasonic handpiece and integrated electrosurgical capabilities. We launched a modified 23 kHz CUSA Electrosurgery Module (CEM) for Clarity handpieces that can be used with additional electrosurgery generators in August 2023. In 2023, we continued to advance the early-stage technology platforms we acquired in 2019. Through the acquisition of Arkis Biosciences, Inc. ("Arkis") we added a platform technology, CerebroFlo® external ventricular drainage ("EVD"), catheter with Endexo® technology, a permanent additive designed to reduce the potential for catheter obstruction due to thrombus formation. The CerebroFlo EVD Catheter has demonstrated an average of 99% less thrombus accumulation onto its surface, in vitro, compared to a market leading EVD catheter. Our work to combine our Bactiseal® antimicrobial technology with the Endexo anti-occlusive technology continues to progress for both a silicone-based hydrocephalus and EVD project. In 2023, we continued to advance our innovation from the Rebound Therapeutics Corporation ("Rebound Therapeutics"), which was acquired in 2019. Rebound Therapeutics specializes in single-use medical device, known as the Aurora Surgiscope, which is the only tubular retractor system designed for cranial surgery with an integrated access channel, camera and lighting. In the third quarter of 2021, we conducted a limited clinical launch of the Aurora Surgiscope for use in minimally invasive neurosurgery as well as ini tiated a registry called MIRROR to collect data on early surgical intervention using this same technology platform for blood evacuation. In 2022, we launched the Aurora® Evacuator with Coagulation device in the U.S., designed to be used in conjunction with our Aurora Surgiscope to safely address and evacuate fluid in the brain. Additionally, the 9 mm Surgiscope 510(k) was submitted to the FDA in August 2023 and is currently under review, with clearance and launch expected in Q4 2023 or Q1 2024. We are focused on the development of core clinical applications in our electromechanical technologies portfolio. In June 2022, we launched the Neutus® EVD system, our first EVD in China. The Neutus EVD system is manufactured in China by Shanghai Haoju Medical Technology Co., Ltd. under an exclusive distribution arrangement. The device is used in the management of CSF and is highly complementary to our Bactiseal® catheter and advanced intercranial pressure monitoring products. We launched our CereLink ICP Monitor System in the U.S. and Europe direct markets. Refer below to the information appearing in the "FDA Matters" section for additional information on the voluntary recall of the CereLink ICP Monitor System. Within our TT segment, in 2022, we launched NeuraGen 3D Nerve Guide Matrix, a resorbable implant for repair of peripheral nerve discontinuities and engineered to create an optimized environment for nerve regeneration. In the third quarter of 2021, we filed the PMA application for a specific indication for Surgimend® in the use of post-mastectomy breast reconstruction, for which we hope to obtain FDA approval in 2025. On December 6, 2022, we completed the acquisition of SIA, which develops, markets and sells DuraSorb®, a resorbable synthetic matrix for plastic and reconstructive surgery. This acquisition advances our global strategy in breast reconstruction, expanding plans to access the U.S. market where SIA is pursuing pre-market approval for use in IBBR. In 2023, the Company received 510(k) clearance for MicroMatrix® Flex As part of our ongoing efforts to remain compliant, the Company continues to work towards European Union Medical Device Regulation ("EU MDR") certifications. In 2023 the Company has received EU MDR certification in the CSS segment for Hakim Programmable Valves. Additionally, the Company has received EU MDR certification in the TT segment for IDRT and BioPatch. 36 Table of Contents " FDA Matters On August 18, 2022, we, after consultation with the FDA and other regulatory authorities outside of the United States, initiated an immediate voluntary global product removal of all CereLink intracranial pressure monitors as a result of customer reports about monitors whose pressure readings were out of range. We believe that the out-of-range readings are principally caused by a combined interaction of electrical noise (originating from sources such as electrical components in the device, other devices set up near the CereLink Monitor, and the hospital power grid) and an electrical potential difference between the patient and monitor. These out-of-range readings have occurred at a low incidence rate and at a limited number of sites; however, out of an abundance of caution, we removed all CereLink monitors from the field. We submitted a traditional application for 510(k) to the FDA on September 15, 2023 which includes design changes to remedy the issue. We plan to resume shipments of CereLink monitors in the U.S. following receipt of 510(k) clearance. Shipments resumed in international markets with a limited release in Q3 2023. As of September 30, 2023, we maintained a $1.3 million provision for product returns, and a $0.8 million rework accrual. On March 7, 2019, TEI Biosciences, Inc. ("TEI"), one of our wholly-owned subsidiaries, received a Warning Letter (the “2019 Warning Letter”), dated March 6, 2019, from the FDA. The 2019 Warning Letter related to quality systems issues at TEI's manufacturing facility located in Boston, Massachusetts. The Boston facility manufactures extracellular bovine matrix products. The letter resulted from an inspection held at that facility in October and November 2018 and did not identify any new observations that were not already provided in the Form 483 that followed the inspection. We submitted our initial response to the 2019 Warning Letter on March 28, 2019 and provide regular progress reports to the FDA as to its corrective actions. On October 28, 2021, the FDA initiated an inspection of the facility and at the conclusion of the inspection, issued an FDA Form 483 on November 12, 2021 (the "2021 Form 483"). We provided an initial response to the inspection observations. On March 1, 2023, the FDA commenced an inspection of the Boston facility, and issued an FDA Form 483 at the conclusion of this inspection (the “2023 Form 483”). On July 19, 2023, TEI received a Warning Letter, dated July 17, 2023, from the FDA related to quality system issues at the TEI Boston facility (the “2023 Warning Letter”). The 2023 Warning Letter did not identify any new observations that had not already been provided in the 2023 Form 483. The Company has submitted an initial response to the FDA for both the 2023 Form 483 and the 2023 Warning Letter. We are committed to resolving the matters identified in the Warning Letters and Form 483s and are continuing our significant efforts to remediate the observations. Although the Warning Letters and the Form 483s do not restrict our ability to manufacture or ship products or require the recall of any products, in May 2023, after consultation with the FDA, the Company initiated a voluntary recall of products manufactured in the Boston facility distributed between March 1, 2018 and May 22, 2023, and extended the temporary halt of manufacturing at the facility to implement additional detection and quality controls. Following implementation of such controls, the Company expects to resume manufacturing at its Boston facility by late in the fourth quarter of 2023. Additionally, the Warning Letters do not restrict the Company’s ability to seek FDA 510(k) clearance of products, but premarket approval applications for Class III devices to which the quality system regulation violations are reasonably related will not be approved until the violations have been addressed We cannot give any assurances that the FDA will be satisfied with our response to the issues identified by the FDA or as to the expected date of the resolution of such issues. Until the issues cited by the FDA are resolved to the FDA’s satisfaction, the FDA may initiate additional regulatory action without further notice. Any adverse regulatory action, depending on its magnitude, may restrict us from effectively manufacturing, marketing and selling our products and could have a material adverse effect on our business, financial condition and results of operations. Revenues of products manufactured in the Boston facility for the year ended December 31, 2022 were approximately 5.3% of consolidated revenues. In the nine months ended September 30, 2023, due to the Boston recall, the Company recorded a $19.7 million provision for product returns, as a reduction of net revenue. Of this amount, $9.0 million was credited to customers in the nine months ended September 30, 2023. The Company also recorded a $24.6 million write off of inventory that was no longer able to be sold. Optimization and Integration Activities As a result of our ongoing acquisition strategy and significant growth in recent years, we have undertaken cost-saving initiatives to consolidate manufacturing operations, distribution facilities and transfer activities, eliminate duplicative positions, realign various sales and marketing activities, and expand and upgrade production capacity for our regenerative technology products. These efforts are expected to continue and while we expect a positive impact from ongoing restructuring, integration, and manufacturing transfer and expansion activities, such results remain uncertain. In support of our continued focus on product margins we closed a manufacturing facility located in France in 2022, and transferred production to our existing Switzerland facility. In addition to closing the manufacturing facility, we outsourced certain transactional back-office finance and customer service activities to enhance customer quality, build scale for future growth, and capture cost efficiencies. 37 Table of Contents " RESULTS OF OPERATIONS Executive Summary Net income for the three and nine months ended September 30, 2023 was $19.5 million and $47.9 million, or $0.24 and $0.59 per diluted share respectively, as compared to $49.9 million and $127.6 million or $0.60 and $1.53 per diluted share for the three and nine months ended September 30, 2022. The decrease in net income for the three and nine months ended September 30, 2023, was primarily driven by impacts from the Boston recall. This includes inventory write-offs of $24.6 million and a provision for product returns of $19.7 million for the nine months ended September 30, 2023. Special Charges Income before taxes includes the following special charges : Three Months Ended September 30, Nine Months Ended September 30, Dollars in thousands 2023 2022 2023 2022 Acquisition, divestiture and integration-related charges $ 5,832 $ (13,842) $ 18,056 $ (19,552) Structural optimization charges 5,893 10,112 15,022 24,604 EU medical device regulation 13,490 13,208 34,172 32,970 Boston recall expenses (1) 5,636 — 33,687 — Total $ 30,851 $ 9,478 $ 100,937 $ 38,022 (1) This includes inventory write-offs and idle capacity charges. The items reported above are reflected in the condensed consolidated statements of operations as follows: Three Months Ended September 30, Nine Months Ended September 30, Dollars in thousands 2023 2022 2023 2022 Cost of goods sold $ 11,223 $ 4,198 $ 50,437 $ 13,859 Research and development 5,448 5,723 13,878 15,528 Selling, general and administrative 14,302 877 37,371 12,440 Gain from Sale of Business — (644) — (644) Other income (122) (676) (749) (3,161) Total $ 30,851 $ 9,478 $ 100,937 $ 38,022 We typically define special charges as items for which the amounts and/or timing of such expenses may vary significantly from period to period, depending upon our acquisition, divestiture, integration and restructuring activities, and for which the amounts are non-cash in nature, and for which the amounts are not expected to recur at the same magnitude. We believe that given our ongoing strategy of seeking acquisitions, our continuing focus on rationalizing our existing manufacturing and distribution infrastructure and our continuing review of various product lines in relation to our current business strategy, some of the special charges discussed above could recur with similar materiality in the future. We believe that the separate identification of these special charges provides important supplemental information to investors regarding financial and business trends relating to our financial condition and results of operations. Investors may find this information useful in assessing comparability of our operating performance from period to period, against the business model objectives that management has established, and against other companies in our industry. We provide this information to investors so that they can analyze our operating results in the same way that management does and to use this information in their assessment of our core business and valuation of Integra. 38 Table of Contents " Revenues and Gross Margin The Company's revenues and gross margin on product revenues were as follows: Three Months Ended September 30, Nine Months Ended September 30, Dollars in thousands 2023 2022 2023 2022 Segment Net Sales Codman Specialty Surgical $ 268,205 $ 249,796 $ 787,371 $ 754,967 Tissue Technologies 114,216 135,395 357,163 404,677 Total revenues $ 382,421 $ 385,191 $ 1,144,534 1,159,644 Cost of goods sold 164,076 148,445 486,292 439,418 Gross margin on total revenues $ 218,345 $ 236,746 $ 658,242 $ 720,226 Gross margin as a percentage of total revenues 57.1 % 61.5 % 57.5 % 62.1 % Three Months Ended September 30, 2023 as Compared to Three Months Ended September 30, 2022 Revenues For the three months ended September 30, 2023, total revenues decreased by $2.8 million to $382.4 million from $385.2 million for the same period in 2022. This decrease was primarily driven by the impact of the Boston recall, which was comprised of $6.8 million of return reserve recorded, as well as a decline in revenue of $20.5 million. The decrease was also inclusive of a favorable foreign currency impact of $1.0 million on revenues, as well as a $4.4 million decrease that impacts both domestic and international revenues related to the divestiture of the TWC business. This also includes an increase of $2.9 million related to the SIA Acquisition. Excluding the impacts of these items, domestic revenues increased by $11.2 million, or 4.3% as compared to the prior year period. International revenues increased by $14.5 million or 14.9% as compared to the prior period. The increase in domestic revenues was primarily driven by our Instruments and Neurosurgery portfolios. The increase in international revenues was primarily driven by increases in our APAC region including China, Japan, and Australia. In the CSS segment, revenues were $268.2 million which was an increase of $18.4 million, or 7.4% as compared to the prior-year period , inclusive of a $0.9 million favorable foreign currency impact on revenue. Excluding the impact of foreign exchange, Neurosurgery portfolio grew mid single digits primarily due to sales in Dural Access, Neuro Monitoring and CSF Management. Sales in our instruments portfolio increased mid single digits as compared to the same period in the prior year. In the TT segment, revenues were $114.2 million which was a decrease of $21.2 million, or 15.6% from the prior-year period. This decrease is primarily driven by the impact of the Boston recall of $6.8 million additional return reserve and $20.5 million decline in revenue. The decrease is also inclusive of a $0.1 million favorable foreign currency impact on revenue, a $4.4 million decrease that impacts both domestic and international revenues related to the divestiture of the TWC business, and an increase of $2.9 million related to the SIA Acquisition. Excluding the impact of these items, the TT segment increased high single digits as compared to the same period in the prior year, attributable to strong sales in MicroMatrix®, Cytal®, Gentrix® and amniotics. Gross Margin Gross margin was $218.3 million for the three months ended September 30, 2023, a decrease of $18.4 million from $236.7 million for the sa me period in 2022. Gross margin as a percentage of revenues was 57.1% for the three months ended September 30, 2023 and 61.5% f or the sa me period in 2022. The decrease in gross margin percentage was primarily associated with the Boston recall, which includes a provision for product returns of $6.8 million and idle capacity at the Boston facility of $5.1 million for the three months ended September 30, 2023. Operating Ex penses The following is a summary of operating expenses as a percent of total revenues: Three Months Ended September 30, 2023 2022 Research and development 7.0 % 6.4 % Selling, general and administrative 42.3 % 37.3 % Intangible asset amortization 0.8 % 0.8 % Total operating expenses 50.1 % 44.5 % 39 Table of Contents " Total operating expenses, which consist of research and development, selling, general and administrative, and amortization expenses, increased by $20.1 million, or 11.7% to $191.8 million in the three months ended September 30, 2023, compared to $171.7 million in the same period in 2022. The increase in operating expenses compared to the prior year is primarily a result of the SIA Acquisition combined with higher spend in selling activities as a percentage of revenue. Research and Development Research and development expenses for the three months ended September 30, 2023 increased by $1.9 million as compared to the same period in the prior year. This increase in spending resulted from additional spending related to the SIA Acquisition, new product development and clinical studies. Selling, General and Administrative Selling, general and administrative costs for the three months ended September 30, 2023 increased by $18.1 million as compared to the same period in the prior year driven primarily due to increased costs associated with SIA Acquisition and higher spend in commercial selling activities. Prior year expenses included a reduction in the fair value of contingent consideration for ACell of $13.1 million. Intangible Asset Amortization Amortization expense (exclu din g amounts reported in cost of product revenues for technology-based intangible assets) for the three months ended September 30, 2023 was $3.2 million compared to $3.1 million for the same period in the prior year. Non-Operating Income and Expenses The following is a summary of non-operating income and expenses: Three Months Ended September 30, Dollars in thousands 2023 2022 Interest income $ 4,607 $ 3,264 Interest expense (13,062) (12,809) Gain (loss) from the sale of business — 644 Other income, net 471 2,648 Total non-operating income and expense $ (7,984) $ (6,253) Interest Income Interest income for the three months ended September 30, 2023 increased by $1.3 million as compared to the same period in the prior year due to higher interest rates. Interest Expense Interest expense for the three months ended September 30, 2023 increased by $0.3 million as compared to the same period in the prior year. Other Income, net Other income, net for the three months ended September 30, 2023 decreased by $2.2 million compared to the same period in the prior year. The decrease is primarily driven by lower Transition Service Agreement ("TSA") income from our recent divestitures. Income Taxes Three Months Ended September 30, Dollars in thousands 2023 2022 Income before income taxes $ 18,609 $ 58,796 Income tax (benefit) expense (888) 8,881 Effective tax rate (4.8) % 15.1 % Our effective income tax rates for the three months ended September 30, 2023 and 2022 were (4.8)% and 15.1%, respectively. For the three months ended September 30, 2023, the primary drivers of the lower tax rate relate to a reduction to book income in higher-taxed jurisdictions and a $3.3 million benefit related to the filing of the prior year tax returns. 40 Table of Contents " The effective tax rate may vary from period to period depending on, among other factors, the geographic and business mix of taxable earnings and losses, tax planning and settlements with various taxing authorities. We consider these factors and others, including the Company's history of generating taxable earnings, in assessing our ability to realize tax assets on a quarterly basis. Additionally, changes to income tax laws and regulations, in any of the tax jurisdictions in which we operate, could impact the effective tax rate. Various governments, both U.S. and non-U.S., are increasingly focused on tax reform and revenue-raising legislation. Further, legislation in foreign jurisdictions may be enacted, in response to the base erosion and profit-shifting project begun by the Organization for Economic Cooperation and Development ("OECD"). The OECD recently finalized major reform of the international tax system with respect to implementing a global minimum tax rate. Such changes in U.S. and non-U.S. jurisdictions could have an adverse effect on the Company’s effective tax rate. While it is often difficult to predict the outcome or the timing of the resolution of a particular matter with the various federal, state, and foreign tax authorities, we believe that our reserves reflect the most probable outcome of known tax contingencies. Settlement of a particular issue would usually require the use of cash. A favorable resolution would be recognized as a reduction to our annual effective tax rate in the year of resolution. Our tax reserves are presented in the balance sheet within other liabilities, except for amounts relating to items that we expect to pay in the coming year, which would be classified as current income taxes payable. Nine Months Ended September 30, 2023 as Compared to Nine Months Ended September 30, 2022 Revenues and Gross Margin For the nine months ended September 30, 2023, total revenues decreased by $15.1 million to $1,144.5 million from $1,159.6 million for the same period in 2022. This decrease was primarily driven by the impact of the Boston recall, which was comprised of $19.7 million of return reserve recorded, as well as a decline in revenue of $42.4 million. The decrease was also inclusive of an unfavorable foreign currency impact of $7.7 million on revenues, as well as a $16.3 million decrease that impacts both domestic and international revenues related to the divestiture of the TWC business. This also includes an increase of $7.2 million related to the SIA Acquisition. Excluding the impacts of these items, domestic revenues increased by $36.8 million, or 4.7% as compared to the prior year period. International revenues increased by $30.2 million or 9.8% as compared to the prior period. The increase in domestic revenues was primarily driven by increases in our Instruments and Neurosurgery portfolio. The increase in international revenues was primarily driven by our APAC region including China, Japan, and Australia. In the CSS Segment, revenues were $787.4 million an increase of $32.4 million, or 4.3% from the prior period, inclusive of a $7.2M unfavorable foreign currency impact on revenue. Excluding the impact of foreign exchange, Neurosurgery portfolio grew mid single digits primarily due to sales in Dural Access, CSF Management, and Advanced Energy. Sales in our instruments portfolio increased high single digits as compared to the same period in the prior year. In the TT segment, revenues w ere $357.2 million, a decrease of $47.5 million, or 11.7% from the prior-year period, inclusive of a $0.5 million unfavorable foreign currency impact on revenue, a $16.3 million decrease that impacts both domestic and international revenues related to the divestiture of the TWC business, and of $7.2 million related to the SIA Acquisition. This also includes the impact of the Boston recall of $19.7 million return reserve and $42.4 million decline in revenue. Excluding the impact of these items, the TT segment increased high single digits as compared to the same period in the prior year, attributable to strong sales in MicroMatrix®, Cytal®, Gentrix® and amniotics. Gross Margin Gross margin was $658.2 million for the nine months ended September 30, 2023, a decrease of $62.0 million from $720.2 million for the same period last year. Gross margin as a percentage of total revenue decreased to 57.5% for the nine months ended September 30, 2023 from 62.1% in the same period last year. The decrease in gross margin percentage was primarily associated with the Boston recall, which includes inventory write-offs of $24.6 million, a provision for product returns of $19.7 million, and idle capacity at the Boston facility of $9.0 million for the nine months ended September 30, 2023. Operating Expenses The following is a summary of operating expenses as a percent of total revenues: Nine Months Ended September 30, 2023 2022 Research and development 7.0 % 6.4 % Selling, general and administrative 43.1 % 40.0 % Intangible asset amortization 0.8 % 0.9 % Total operating expenses 50.9 % 47.4 % 41 Table of Contents " Total operating expenses, which consist of selling, general and administrative expenses, research and development expenses, and amortization expenses, increased by $33.6 million, or 6.1% to $582.8 million in the nine months ended September 30, 2023, compared to $549.1 million in the same period in 2022. Research and Development Research and development expenses for the nine months ended September 30, 2023 increased by $5.5 million as compared to the same period in the prior year. This increase in spending resulted from additional spending related to the SIA Acquisition, new product development and clinical studies. Selling, General and Administrative Selling , general and administrative costs increased by $29.1 million as compared to the same period in the prior year driven primarily due to increased costs associated with SIA Acquisition and higher spend in commercial selling activities. Prior year expenses included a reduction in the fair value of contingent consideration for ACell of $13.1 million. Intangible Asset Amortization A mortization expense (excludin g amounts reported in cost of product revenues for technology-based intangible assets) for the nine months ended September 30, 2023 was $9.3 million compared to $10.3 million for the same period in prior year. We expect total annual amortization expense to be approximately $20.7 million for the remainder of 2023, $82.2 million in 2024, $82.1 million in 2025, $82.0 million in 2026, $80.0 million in 2027, $78.5 million in 2028 and $477.1 million thereafter. Non-Operating Income and Expenses The following is a summary of non-operating income and expenses: Nine Months Ended September 30, Dollars in thousands 2023 2022 Interest income $ 12,653 $ 6,606 Interest expense (37,626) (36,700) Gain from the sale of business — 644 Other income, net 1,705 8,056 Total non-operating income and expense $ (23,268) $ (21,394) Interest Income Interest income for the nine months ended September 30, 2023 increased by $6.0 million as compared to the same period last year due to higher interest rates. Interest Expense Interes t expense for the nine months ended September 30, 2023 increased by $0.9 million as compared to the same period last year. Other Income, net Othe r income, net for the nine months ended September 30, 2023, decreased by $6.4 million primarily due to lower Transition Service Agreement ("TSA") income from our recent divestitures. Income Taxes Nine Months Ended September 30, Dollars in thousands 2023 2022 Income before income taxes $ 52,211 $ 149,686 Income tax (benefit) expense 4,304 22,082 Effective tax rate 8.2 % 14.8 % The Company’s effective income tax rates for the nine months ended September 30, 2023 and 2022 were 8.2% and 14.8%, r espectively. For the nine months ended September 30, 2023, the primary drivers of the lower tax rate relate to a reduction to book income in higher-taxed jurisdictions and a $3.8 million benefit related to the filing of the prior year tax returns. The lower rate from the nine months ended September 30, 2022 was primarily due to a $5.5 million benefit related to excess tax benefits from stock compensation. 42 Table of Contents " GEOGRAPHIC PRODUCT REVENUES AND OPERATIONS We attribute revenues to geographic areas based on the location of the customer. Total revenue by major geographic area consisted of the following: Three Months Ended September 30, Nine Months Ended September 30, Dollars in thousands 2023 2022 2023 2022 United States $ 269,838 $ 282,016 $ 817,622 $ 832,714 Europe 41,524 38,301 120,040 128,907 Asia Pacific 48,777 42,774 146,956 133,856 Rest of World 22,282 22,100 59,916 64,167 Total Revenues $ 382,421 $ 385,191 $ 1,144,534 $ 1,159,644 We generate significant revenues outside the U.S., a portion of which are U.S. dollar-denominated transactions conducted with customers that generate revenue in currencies other than the U.S. dollar. As a result, currency fluctuations between the U.S. dollar and the currencies in which those customers do business could have an impact on the demand for our products in foreign countries. Local economic conditions, regulatory compliance or political considerations, the effectiveness of our sales representatives and distributors, local competition and changes in local medical practice all may combine to affect our sales into markets outside the U.S. Domestic revenues decreased by $12.2 million for the three months ended September 30, 2023 compared to the same period last year. European sales increased by $3.2 million for the three months ended September 30, 2023 compared to the same period last year. Sales to customers in Asia Pacific increased by $6.0 million for the three months ended September 30, 2023. Sales to customers in the the Rest of World for the three months ended September 30, 2023 increased by $0.2 million compared to the same period last year . The international revenues were impacted by $1.0 million of favorable foreign exchange impact, with the larger impact in Europe. The decrease in global revenues is primarily the result of the Boston recall which affected both Domestic and International markets. Sales in China, Japan, and Australia led to continued growth in our Asia Pacific market. Domestic revenues decreased by $15.1 million for the nine months ended September 30, 2023 compared to the same period last year. European sales decreased by $8.9 million for the nine months ended September 30, 2023 compared to the same period last year. Sales to customers in Asia Pacific increased by $13.1 million million for the nine months ended September 30, 2023. Sales to customers in the Rest of World for the nine months ended September 30, 2023 decreased by $4.3 million million compared to the same period last year. LIQUIDITY AND CAPITAL RESOURCES Working Capital The Company's working capital as of September 30, 2023 and December 31, 2022 was $671.5 million and $840.6 million, respectively. Working capital consists of total current assets less total current liabilities as presented in the consolidated balance sheets. Cash and Marketable Securities The Company had cash and cash equivalents totaling approximately $273.7 million and $456.7 million at September 30, 2023 and December 31, 2022 respectively, which are valued based on Level 1 measurements in the fair value hierarchy. At September 30, 2023, our non-U.S. subsidiaries held approximately $247.7 million of cash and cash equivalents that are available for use outside the U.S. The Company asserts that it has the ability and intends to indefinitely reinvest the undistributed earnings from its foreign operations unless there is no material tax cost to remit the earnings into the U.S.. Cash Flows Nine Months Ended September 30, Dollars in thousands 2023 2022 Net cash provided by operating activities $ 81,205 $ 179,135 Net cash used in investing activities (36,949) (3,760) Net cash used in financing activities (223,035) (154,254) Effect of exchange rate fluctuations on cash (4,150) (22,632) 43 Table of Contents " Cash Flows Provided by Operating Activities Operating cash flows for the nine months ended September 30, 2023 decreased by $97.9 million compared to the same period in 2022. Within operating cash flows, n et income less non-cash adjustments decreased for the nine months ended September 30, 2023 by approximately $55.9 million as compared to the same period in 2022 primarily due to low er revenues attributable to the Boston recall along with higher selling expenses. The changes in assets and liabilities for the nine months ended September 30, 2023 , net of business acquisitions, decreased cash flows by $91.7 million , mainly attributable to increases in inventory, other current assets, and decreases in accrued expenses and other current liabilities due to reduced payments processed during the year. The changes in assets and liabilities for the nine months ended September 30, 2022, net of business acquisitions, decreased cash flows by $49.7 million , primarily due to increases in inventory to support increased sales. Cash Flows Used in Investing Activities Uses of cash from investing activities for the nine months ended September 30, 2023 related to $42.3 million paid for capital expenditures to support operations improvement initiatives at a number of our manufacturing facilities and other information technology investments. Sources of cash from investing activities for the nine months ended September 30, 2023 were $5.4 million in proceeds from settlement of our net investment hedges. Uses of cash from investing activities during the nine months ended September 30, 2022 related to $27.9 million paid for capital expenditures to support operations improvement initiatives at a number of our manufacturing facilities and other information technology investments as well as the final $4.7 million payment related to the final developmental milestone for Rebound Therapeutics Corporation. Sources of cash from investing activities during the nine months ended September 30, 2022 included proceeds from the sale of the TWC business of $24.0 million. The proceeds from the sale of the TWC business of $27.8 million is presented net of cash transferred of $3.5 million and other transaction fees. Additionally, the Company also received $4.9 million proceeds on cross-currency swaps designated as net investment hedge. Cash Flows Used in Financing Activities Uses of cash from financing activities in the nine months ended September 30, 2023 related to the repurchase of shares of treasury stock of $275.0 million under the January and August 2023 accelerated share repurchase agreements, as well as repayments of $85.9 million under our Senior Credit Facility and Securitization Facility. We also had $7.6 million in payment of debt issuance costs. In addition, the Company had $5.5 million in cash taxes paid for net equity settlements. Sources of cash from financing activities for the nine months ended September 30, 2023 were $146.9 million borrowing under our Senior Credit Facility and Securitization Facility and $4.1 million proceeds from the exercise of stock options. Uses of cash from financing activities in the nine months ended September 30, 2022 related to the repurchase of treasury stock of $125.0 million under the 2022 accelerated share repurchase agreement, repayments of $40.8 million under our Senior Credit Facility and Securitization Facility. In addition, we had $24.3 million in cash taxes paid for net equity settlements. Sources of cash from financing activities for the nine months ended September 30, 2022 were $34.3 million borrowing under our Senior Credit Facility and Securitization Facility and $1.6 million proceeds from the exercise of stock options. Amended and Restated Senior Credit Agreement, Convertible Senior Notes, Securitization and Related Hedging Activities See Note 6. Debt , to the Notes to Unaudited Condensed Consolidated Financial Statements (Part I, Item 1 of this Quarterly Report) for a discussion of our Amended and Restated Senior Credit Agreement, the 2025 Notes and Securitization Facility and Note 7, Derivative Instruments , to the Notes to Unaudited Condensed Consolidated Financial Statements (Part I, Item 1 of this Quarterly Report) for discussion of our hedging activities. We are forecasting that sales and earnings for the next twelve months will be sufficient to remain in compliance with our financial covenants under the terms of the March 2023 Amendment to the Senior Credit Facility. 44 Table of Contents " Share Repurchase Plan On August 15, 2023, the Company entered into a $125.0 million accelerated share repurchase ("August 2023 ASR") and received 2.3 million shares of the Common stock at inception of the August 2023 ASR, which represented approximately 80% of the expected total shares under the August 2023 ASR. On October 18, 2023 the early exercise provision was exercised by the August 2023 ASR counterparty. The Company received an additional 0.9 million shares determined using the volume-weighted average price of the Company's common stock during the term of the August 2023 ASR. On January 26, 2023, the Company entered into a $150.0 million accelerated share repurchase ("January 2023 ASR") and received 2.1 million shares of the common stock at inception of the January 2023 ASR, which represented approximately 80% of the expected total shares under the January 2023 ASR. The settlement of the ASR agreement was completed in two separate transactions on April 26, 2023 and May 4, 2023, where the Company received an additional 0.30 million and 0.31 million shares respectively, determined using the volume-weighted average price of the Company's common stock during the term of the January 2023 ASR. On January 12, 2022, we entered into a $125.0 million accelerated share repurchase ("2022 ASR") and received 1.48 million shares of our common stock at inception of the 2022 ASR, which represented approximately 80% of the expected total shares under the 2022 ASR. On March 24, 2022, the early exercise provision under the 2022 ASR was exercised by 2022 ASR counterparty. Upon settlement of the 2022 ASR on March 24, 2022, we received an additional 0.46 million shares determined using the volume-weighted average price of our common stock during the term of the 2022 ASR. See Note 11. Treasury Stock, to the Notes to Unaudited Condensed Consolidated Financial Statements (Part I, Item 1 of this Quarterly Report) for further details. Dividend Policy We have not paid any cash dividends on our common stock since our formation. Our Senior Credit Facility limits the amount of dividends that we may pay. Any future determinations to pay cash dividends on our common stock will be at the discretion of the Board and will depend upon our financial condition, results of operations, cash flows and other factors deemed relevant by the Board. Capital Resources We believe that our cash and available borrowings under the Senior Credit Facility are sufficient to finance our operations and capital expenditures for the foreseeable future. Our future capital requirements will depend on many factors, including the growth of our business, the timing and introduction of new products and investments, strategic plans and acquisitions, among others. Additional sources of liquidity available to us include short term borrowings and the issuance of long term debt and equity securities. Off-Balance Sheet Arrangements We do not have any off–balance sheet financing arrangements during the nine months ended September 30, 2023 that have or are reasonably likely to have, a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to our interests. Contractual Obligations and Commitments We will continue to have cash requirements to support seasonal working capital needs and capital expenditures, to pay interest, to service debt, and to fund acquisitions. As part of our ongoing operations, we enter into contractual arrangements that obligate us to make future cash payments. Our primary obligations include principal and interest payments on the revolving portion and t erm loan component of the Senior Credit Facility, Securitization Facility and 2025 Notes. See Note 6. Debt , to the Notes to Unaudited Consolidated Financial Statements (Part I, Item 1 of this Quarterly Report) for details. We also lease some of our manufacturing facilities and office buildings which have future minimum lease payments associated. See Note 10. Leases and Related Party Leases , to the Notes to Unaudited Consolidated Financial Statements (Part I, Item 1 of this Quarterly Report) for a schedule of our future minimum lease payments. Amounts related to our other obligations, including employment agreements and purchase obligations were not material. The Company has contingent consideration obligations related to prior and current year acquisitions and future pension contribution obligations. See Note 9. Retirement Plans , and Note 16. Commitments and Contingencies , to the Notes to Unaudited Condensed Consolidated Financial Statements (Part I, Item 1 of this Quarterly Report) for details. The associated obligations are not fixed. We also have a liability for uncertain tax benefits including interest and penalties. We cannot make a reliable estimate of the period in which the uncertain tax benefits may be realized. 45 Table of Contents " OTHER MATTERS Critical Accounting Estimates We based the discussion and analysis of our financial condition and results of operations upon our consolidated financial statements, which have been prepared in conformity with GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amount of assets and liabilities, the disclosure of contingent liabilities, and the reported amounts of revenues and expenses. The critical accounting estimates discussed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 did not materially change in the nine months ended September 30, 2023. Recently Issued Accounting Standards Information regarding new accounting pronouncements is included in Note 1. Basis of Presentation , to the Notes to Unaudited Condensed Consolidated Financial Statements (Part I, Item 1 of this Quarterly Report), and is applicable to the current period’s unaudited condensed consolidated financial statements.