EX-99.2 3 acclarentacquisitioninve.htm EX-99.2 acclarentacquisitioninve
ACQUISTION OF ACCLARENT, A LEADER IN ENT SURGICAL INTERVENTIONS DECEMBER 13, 2023 Exhibit 99.2


 
Legal Information 2 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties and reflect the Company's judgment as of the date of this presentation. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements. Some of these forward-looking statements may contain words like “will,” “believe,” “may,” “can,” “could,” “would,” “might,” “project,” “possible,” “should,” “expect,” “intend,” “plan,” “anticipate,” “target,” or “continue,” the negative of these words, other terms of similar meaning or they may use future dates. Forward-looking statements contained in this presentation include, but are not limited to, statements regarding the planned completion of the Company's proposed acquisition of Acclarent, Inc. ("Acclarent"), the expected strategic and financial benefits of the proposed acquisition, including future financial performance and operating results, Integra’s business’s plans, objectives, expectations and intentions and the expected timing of completion of the proposed acquisition. Statements of past performance, efforts, or results about which assumptions or inferences may be made can also be forward-looking statements and are not indicative of future performance or results. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Such risks and uncertainties include, but are not limited to, the following: the successful closing of the proposed acquisition; the ability to obtain required regulatory approvals for the proposed acquisition (including the approval of antitrust authorities and the Israel Innovation Authority necessary to complete the proposed acquisition), the timing of obtaining such approvals and the risk that such approvals may result in the imposition of conditions, including with respect to divestitures required by antitrust authorities, that could materially adversely affect Integra, the Acclarent ear, nose and throat ("ENT") business and the expected benefits of the proposed acquisition; the risk that a condition to closing of the proposed acquisition may not be satisfied on a timely basis or at all; the State of Israel's on-going war against Hamas, and the potential for the continuation or escalation of such conflict to disrupt the operations and employees of Acclarent located in the State of Israel and make it more difficult for the Company to realize the intended benefits of the acquisition; the effects of disruption caused by the proposed acquisition making it more difficult for Integra to execute its operating plan effectively or to maintain relationships with employees, vendors and other business partners; Integra’s ability to successfully integrate the Acclarent ENT business and other acquired businesses; the difficulty of predicting the timing or outcome of product development efforts and regulatory agency approvals or actions, if any; physicians’ willingness to adopt and third-party payers’ willingness to provide reimbursement for Integra’s and Acclarent ENT business’s existing, recently launched and planned products; difficulties or delays in manufacturing; the Company's ability to remediate quality systems violations; the availability and pricing of third party sourced products and materials; macroeconomic conditions, including inflation, disruptions to the global supply chain, fluctuations in currency exchange rates, weakness in general economic conditions and recessions; global macroeconomic and political conditions, including acts of terrorism or outbreak of war, hostilities, civil unrest and other political or security disturbances, including the war in Ukraine and the State of Israel's on-going war against Hamas and any escalations of that conflict; the Company's ability to increase product sales and gross margins, and control non-product costs; the Company’s ability to achieve anticipated growth rates, margins and scale and execute its strategy generally; the amount and timing of divestiture, acquisition and integration-related costs; the geographic distribution of where the Company generates its taxable income; new U.S. and foreign government laws and regulations, and changes in existing laws, regulations and enforcement guidance, which affect areas of our operations including, but not limited to, those affecting the health care industry, including the EU Medical Devices Regulation; and the economic, competitive, governmental, technological, and other risk factors and uncertainties identified under the heading “Risk Factors” included in Item 1A of Integra's Annual Report on Form 10-K for the year ended December 31, 2022 and information contained in subsequent filings with the Securities and Exchange Commission. These forward-looking statements are made only as of the date hereof, and the Company undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events, or otherwise. Industry and Market Data This presentation has been prepared by the Company and includes market data and other statistical information from third-party sources. Although the Company believes these third-party sources are reliable as of their respective dates, none of the Company or any of its respective representatives make any representation or warranty with respect to the accuracy of such information. Use of Projections This presentation contains certain financial forecast information including revenues, earnings per share, and return on invested capital. Such financial forecast information constitutes forward-looking information and is for informational purposes only and should not be relied upon as necessarily being indicative of future results. The assumptions and estimates underlying such financial forecast information are inherently uncertain and are subject to a wide variety of significant business, economic, competitive and other risks and uncertainties. Actual results may differ materially from the results contemplated by the financial forecast information contained in this presentation, and inclusion of such information in this presentation should not be regarded as a representation by any person that the results reflected in such forecasts will be achieved. The Company’s independent auditors have not audited, reviewed, compiled or performed any procedures with respect to the projections for the purpose of their inclusion in this presentation, and, accordingly, they have not expressed an opinion or provided any other form of assurance with respect thereto for the purpose of this presentation.


 
International Portfolio and Channel Higher Revenue Growth, Higher Margin Growth Breadth/Depth in Care Pathway Adjacencies S T R AT E G I C F I LT E R S F I N A N C I A L F I LT E R S Accretive to Growth and/or Earnings ≥10% ROIC by Year 5     TBD Strategic and Accretive Approach to M&A Acclarent acquisition provides a unique opportunity to build scale and capture a leadership position in the complementary ENT device segment while delivering value to shareholders 3


 
Acquisition Overview & Strategic Rationale Strategic Rationale Acclarent Business Description 2022 revenue ~$110 million, HSD Growth; gross margin in line with company average; U.S. sales only • Pioneered balloon sinus dilation to treat patients suffering from chronic sinus disease; developed first dilation system to address persistent eustachian tube dysfunction; leadership position in each category • Developed advanced surgical navigation platform for sinus and skull base surgery, including electromagnetic instrument tracking; robust R&D capabilities in hardware/software design, digital/AI applications development • US-based direct sales force with deep clinical knowledge, strong KOL relationships, professional education focus • Primary headquarters in Irvine, CA. R&D in Irvine, CA and in Haifa, Israel. Outsourced product manufacturing Key Deal Terms Purchase price $275M at closing and an additional $5 million upon the achievement of certain regulatory milestones Adj. EPS expected to be neutral in 2024; accretive in the first full year (2025) ROIC to exceed 10% by year 5 (2028) • Acquisition structured as a stock purchase agreement • Subject to the satisfaction of customary conditions; transaction expected to close by the second quarter of 2024 • Transition Service Agreement and Transition Manufacturing Agreement for up to 4 years ENT specialty device category is a natural adjacency for CSS • Attractive category; >$1B U.S. opportunity, 5-6% CAGR1 • Anatomical adjacency to neurosurgery, including access to brain tumors through skull base approaches • Opportunity to accelerate Integra’s current MicroFrance® ENT instruments (~$20M US, MSD CAGR2), with a focused channel Enables Integra to successfully access the ENT device segment with immediate relevant scale and accretive growth • Expanded footprint enables Integra to reach all ENT sites of care (hospital, ASC, office/clinic) via direct ENT sales channel • Enables internal development of ENT products using Integra technology and follow-on M&A 1Triangulated from third-party and internal reports 42MSD CAGR 2019-2023E 4


 
5 1 MAYFIELD is a registered trademark of SM USA, Inc. and is used by Integra under license; ENT: Ear, Nose, and Throat Transformative leader in Neuro -access, -surgery, -monitoring Leading provider of specialty instruments solutions DuraGen®/DuraSeal® | CUSA® | MAYFIELD1 | Certas® Plus BACTISEAL® | CereLink® | ISOCOOL® | Integra® Duo | MicroFrance® Codman Specialty Surgical Outcomes leader in complex wound reconstruction Leading innovator in surgical/breast reconstruction Tissue Technologies Support Segments and Private Label Regenerative Technologies Integra Dermal Matrices | NeuraGen® | NeuraWrap™ PriMatrix® | MicroMatrix® UBM | SurgiMend® Macroporous TCC-EZ® Total Contact Cast System Announcing the acquisition of the Acclarent ENT business to be integrated into Integra’s Codman Specialty Surgical division Integra Overview (NASDAQ: IART) Restoring Patient Lives through Technologies that Transform Surgical, Neurologic & Regenerative Care


 
HAWK 6 Codman Specialty Surgical Overview Acclarent acquisition propels Integra to a leadership position in ENT 3% – 5% Market CAGR INSTRUMENTS Neuro and Specialty Instrumentation 2% – 3% Market CAGR Expansion to >$6B TAM1 • 3% – 5% Market CAGR • >$1B Revenue2 $0.2B2 Jarit® • Surgical Lighting Systems Dural Access & Repair $0.3B2 DuraGen Dural Graft DuraSeal Dural Sealant Hydrocephalus $0.2B2 Certas Plus Programmable Valves • BACTISEAL® Catheters Neuro Monitoring $0.1B2 CereLink ICP Monitor and Sensors Advanced Energy $0.2B2 CUSA Tissue Ablation Aurora® Surgiscope ENT $0.1B3 TruDi® • RELIEVA SPINPLUS® NAV • Acclarent AERA®•MicroFrance® NEUROSURGERY and ENT Brain Lesion Surgery with MIS Expansion Traumatic Brain Injury (TBI) Hydrocephalus ENT Note: Market size and growth from third party market reports and internal estimates; 1 TAM for ENT is US only; 2 TTM revenue as of 9/30/23; 3TTM revenue as of 12/31/22; MIS: Minimally Invasive Surgery; ICP: Intracranial Pressure


 
7 ENT is a natural & complementary adjacency to Neurosurgery & Instruments Entering a higher growth segment where focused innovation and channels win NEURO- SURGERY INSTRUMENTSENT • Highly specialized market where focus wins • Disease states driven by patient demographics and advancements in diagnostics and imaging • Surgeons influence buying decisions • Stable market with consistent demand • Portfolio breadth including specialty instruments enables scale and drives broad customer relationships • Focused segment with high degree of specialization and surgeon preference • Disease states with high prevalence and unmet clinical needs • Neurosurgery & ENT anatomically adjacent in skull base procedures • Expands R&D capabilities, fuels innovation • Pull-through of existing Integra MicroFrance ENT instrumentation portfolio KEY ADJACENCIES


 
8 1Triangulated from third-party and internal reports, numbers may not add up due to rounding 2 2022-2025 ENT Market growth CAGR 3 Other segments include Energy, RF, Cryoablation, Endoscopy / Video, and Nasal Stents Note: HSD = High single digit growth; MSD = Mid-single-digit growth; LSD = Low single-digit growth Attractive ENT market  Disease states with high prevalence and unmet clinical needs (e.g. chronic rhinosinusitis, nasal airway obstruction, eustachian tube dysfunction, and skull base tumors)  Focused category with high degree of specialization and surgeon preference  Increasing adoption of navigation technologies and shift towards minimally invasive, navigated procedures  Continued expansion of new indications and payor coverage Why Integra & Acclarent will win in ENT  Strong brand equity from creating the ENT balloon category  Heritage in sinus balloon technology with strong innovation pipeline and expanding clinical areas such as eustachian tube  Expansion within higher growth segments such as navigation and navigated instruments with differentiated product offering  Best-in-class ENT sales channel – expands footprint into outpatient, ASC, and office sites of care  Pull-through of existing MicroFrance ENT offerings  Synergistic R&D and portfolio capabilities to fuel innovation US 2022 $1B Market Size and MSD CAGR Immediate relevant scale in attractive and complementary ENT market Acclarent is positioned to accelerate penetration in higher growth segments $0.2 LSD Sinus Balloons $0.1 MSD Eustachian Tube & Airway Balloons $0.3 MSD Shavers & Drills $0.2 HSD Navigation Systems $0.1 MSD Instruments $0.4 Other Segments3 ~$1.1B1 5-6%2 Expanding Presence MSD / HSD Growth, Current Share <5% Acclarent Legacy Leadership Position Higher Growth Segments


 
Differentiated recent NPIs and complete suite of navigation products Positioned for continued portfolio expansion in higher growth segments 9 TruDi® Navigation System is designed to provide consistent accuracy, a simple workflow, and advanced software functionality.1,2 1. ACCLARENT® ENT Navigation System Instructions for Use. UG-2000-00 02A 11.2018. 2. Acclarent, Inc. IOM005058 Rev. B, 02/12/2019 Fast Anatomical Mapping (FAM) Real-time imaging tool that documents surgical changes to the anatomy TruSeg™ TruDi® uses artificial intelligence to apply automatic segmentation to pre-defined anatomical structures TruPath™ Calculates and presents the shortest, valid path between 2 points specified by the physician TruDi® enables the use of a full suite of differentiated, navigated disposables for sinus and skull base surgical procedures (balloons, shavers, and other instruments) RELIEVA SPINPLUS® NAV Balloon Sinuplasty System Disposable Patient Tracker TruDi® Shaver Blade TruDi® Probe Navigation Instrument


 
Building upon heritage and leading position in balloon technology Driving category growth by creating new standards of care; supported by clinical evidence and expanding market access 10 The Acclarent AERA® Eustachian Tube Dilation (ETD) System is the first device specifically designed to dilate the Eustachian tube for patients with persistent tube dysfunction Clinical evidence demonstrating safety and efficacy and expanding market access Acclarent AERA® is backed by a prospective, multicenter, randomized clinical trial to demonstrate:1 1. Poe D, Anand V, Dean M, et al. (2017). Balloon dilation of the Eustachian tube for dilatory dysfunction: A randomized controlled trial.Laryngoscope. Sep 20. doi: 10.1002/lary.26827.Laryngoscope. Sep 20. doi: 10.1002/lary.26827.2010;120(7):1411-1416 99.7% technical success in dilating the Eustachian tube 51.8% vs. 13.9% higher rate of tympanogram normalization compared to control subjects treated with medical management alone 56.1% vs. 8.5% improvement in the quality-of-life measure from the Eustachian Tube Dysfunction Questionnaire (ETDQ-7) A) Balloon Catheter Insertion B) Balloon Inflation Eustachian Tube Balloon Dilation


 
Strong business foundation to support sustainable growth 11 Expanding Portfolio & Strong Innovation Pipeline  TruDi enhancements: including augmented reality and AI capabilities  New products to invigorate core platforms such as navigated accessories  AREA® Eustachian Tube – potential for indication expansion Advanced Innovation Capabilities & Culture  Established R&D capabilities spanning core technologies and advancing digital solutions  Strong culture and history of breakthrough innovation Established Commercial Footprint & Presence  Proficient and complementary sales channel  Strong brand equity and category leadership Fueling Organic & Inorganic Opportunities  Scale enables future opportunities to extend and complement ENT market presence and/or supplement portfolio with differentiated technologies


 
Acclarent acquisition propels Integra to a leadership position in ENT & Neurosurgery ENT provides a natural and complementary adjacency to Neurosurgery 12 1 Highly complementary with neuro commercial, portfolio and R&D capabilities • Anatomical adjacency to neurosurgery, including access to brain tumors with skull base approaches • Foundational commercial capabilities and scale for future organic and inorganic growth • Pull-through of existing Integra MicroFrance ENT portfolio • Expands R&D capabilities to fuel innovation across CSS technology platforms 2 Attractive growth and value profile • Adds $1B to CSS TAM growing MSD • HSD sales CAGR and accretive to LRP growth rate • 2022 revenue ~$110M; gross margin in line with company average • Transaction expected to be neutral to adj. EPS in 2024; accretive to adj. EPS in 2025; ROIC > 10% by Year 5 • Close expected by the second quarter of 2024 3 Enables Integra’s CSS division to effectively address the attractive ENT device segment with established commercial scale, strong brand recognition, differentiated portfolio, and robust innovation pipeline