AxoGen, Inc. (NASDAQ:AXGN) Q1 2022 Results Conference Call May 4, 2022 4:30 PM ET Company Participants Ed Joyce - Director, IR Karen Zaderej - Chairman, President & CEO Peter Mariani - EVP & CFO Erick DeVinney - VP of Peripheral Nerve Science & Clinical Innovation Conference Call Participants Erin Fahey - SVB Leerink Frank Pinal - Jefferies Ross Osborn - Cantor Fitzgerald Dave Turkaly - JMP Securities Operator Good day, ladies and gentlemen, and welcome to the AxoGen, Inc. Reports First Quarter Earnings Cal ...

Part I [Business](index=7&type=section&id=Item%201.%20Business) Axogen leads in peripheral nerve repair, offering a product portfolio targeting a $2.7 billion market and pursuing a Biologics License Application for its key graft [General Overview](index=7&type=section&id=General) The company develops and commercializes technologies for peripheral nerve regeneration and repair, offering a portfolio of clinically proven products - Axogen's core business is providing solutions for peripheral nerve repair, aiming to restore function and quality of life for patients[21](index=21&type=chunk) - The main product portfolio includes **Avance® Nerve Graft** (human nerve allograft), **Axoguard® products** (porcine ECM-based connector, protector, and cap), and Avive® Soft Tissue Membrane (human umbilical cord)[22](index=22&type=chunk) - The market availability of **Avive® Soft Tissue Membrane was suspended** effective June 1, 2021, pending FDA discussions regarding its regulatory classification, not due to safety issues[23](index=23&type=chunk) [Peripheral Nerve Regeneration Market Overview](index=8&type=section&id=Peripheral%20Nerve%20Regeneration%20Market%20Overview) The company estimates its total addressable market in the U.S. at approximately $2.7 billion across trauma, oral, breast, and compression segments Total Addressable Market (U.S.) | Market Segment | Estimated Size | | :--- | :--- | | **Total Addressable Market** | **$2.7 billion** | | Trauma | $1.9 billion | | Oral Maxillofacial (OMF) | $300 million | | Breast Reconstruction Neurotization | $250 million | | Upper Extremity Compression | $270 million | - The company is expanding into the surgical treatment of pain, with the market size for this segment still under evaluation[35](index=35&type=chunk) [Axogen's Product Portfolio](index=9&type=section&id=Axogen's%20Product%20Portfolio) The company's product portfolio provides a comprehensive platform for peripheral nerve repair, led by the Avance® Nerve Graft and Axoguard® product line - **Avance® Nerve Graft:** A decellularized human peripheral nerve allograft for bridging nerve gaps up to 70mm, supported by over 10 years of clinical evidence[36](index=36&type=chunk)[37](index=37&type=chunk)[39](index=39&type=chunk) - **Axoguard® Nerve Connector:** A porcine ECM tube for tensionless repair of nerve gaps up to 5mm, reducing the need for sutures at the repair site[40](index=40&type=chunk)[41](index=41&type=chunk) - **Axoguard® Nerve Protector:** A porcine ECM wrap to protect damaged nerves, reinforce repairs, and prevent soft tissue attachments[42](index=42&type=chunk)[43](index=43&type=chunk) - **Axoguard® Nerve Cap:** A porcine ECM cap designed to protect severed nerve ends and reduce the formation of painful neuromas[47](index=47&type=chunk)[48](index=48&type=chunk)[49](index=49&type=chunk) - **Avive® Soft Tissue Membrane:** Market availability was suspended on June 1, 2021, and it historically accounted for approximately **5% of revenues**[44](index=44&type=chunk) [Tissue Recovery and Processing](index=12&type=section&id=Tissue%20Recovery%20and%20Processing%20for%20Avance%20Nerve%20Graft%20and%20Avive%20Soft%20Tissue%20Membrane) The company processes human tissue using its proprietary Avance Method™ and is building a new facility to support future growth and its BLA submission - The company uses the proprietary **Avance Method™** to process human nerve tissue, preserving the essential extracellular matrix structure[54](index=54&type=chunk) - Processing is currently conducted at a facility licensed from Community Tissue Services (CTS), with the agreement terminating on **December 31, 2023**[57](index=57&type=chunk)[58](index=58&type=chunk) - Axogen is renovating a new **Axogen Processing Center (APC)** facility in Ohio to support growth and the Avance Nerve Graft BLA submission[59](index=59&type=chunk) [Manufacturing of Other Products](index=14&type=section&id=Manufacturing%20of%20Axogen%20Products%20Other%20Than%20Avance%20Nerve%20Graft%20and%20Avive%20Soft%20Tissue%20Membrane) The Axoguard® product line is manufactured exclusively by Cook Biotech under agreements extending to 2027 - The **Axoguard product line** is manufactured by Cook Biotech Incorporated under exclusive distribution and supply agreements that terminate in 2027[64](index=64&type=chunk)[65](index=65&type=chunk)[67](index=67&type=chunk) - Axogen has sufficient inventory of the Axotouch Two-Point Discriminator to support sales through 2024[68](index=68&type=chunk) [Sales and Marketing](index=15&type=section&id=Sales%20and%20Marketing) The company's commercial strategy focuses on surgeon education, clinical data expansion, and a specialized direct sales force - The company focuses on educating surgeons, including training over **three-quarters of U.S. hand and microsurgery fellows** in 2021[74](index=74&type=chunk) - As of December 31, 2021, the commercial team consisted of **115 direct sales professionals** and approximately 28 independent sales agencies in the U.S[74](index=74&type=chunk) - In 2021, approximately **88% of global product revenue** was generated through the direct sales channel[74](index=74&type=chunk) - The company is generating extensive clinical data through studies like **RANGER** (over 2,500 enrollments), **RECON** (Phase 3), and **REPOSE** (neuroma study)[71](index=71&type=chunk)[73](index=73&type=chunk) [Research and Development](index=17&type=section&id=Research%20and%20Development) R&D efforts are concentrated on expanding clinical data and developing product line extensions, with a total investment of $24.2 million in 2021 - Current development focus is on expanding clinical data and developing line extensions of Avance and Axoguard products[79](index=79&type=chunk) R&D Expense | Year | R&D Expense | | :--- | :--- | | 2021 | $24.2 million | [Competition](index=17&type=section&id=Competition) Axogen competes with traditional repair methods and off-the-shelf products from major medical technology companies - Primary competition includes traditional methods (autograft) and off-the-shelf products (hollow-tube conduits, wraps)[80](index=80&type=chunk)[81](index=81&type=chunk) - Major corporate competitors for off-the-shelf repair options are **Integra LifeSciences**, **Baxter International**, and **Stryker Corporation**[81](index=81&type=chunk) - Axogen believes its key competitive advantages include its intellectual property, regulatory expertise with the **FDA BLA process**, and its broad product portfolio[82](index=82&type=chunk)[84](index=84&type=chunk) [Intellectual Property](index=18&type=section&id=Intellectual%20Property) The company protects its technology through patents, trademarks, and exclusive licenses, anticipating 12 years of market exclusivity upon BLA approval - Axogen holds exclusive worldwide licenses from the **University of Florida Research Foundation (UFRF)** and the **University of Texas at Austin (UTA)** for Avance Nerve Graft technologies[86](index=86&type=chunk) - The company owns or is the exclusive licensee of about **30 issued U.S. patents** and over 175 international patents and applications[87](index=87&type=chunk) - U.S. patent protection for Avance Nerve Graft extends through at least September 2023; upon BLA approval, the company expects **12 years of data exclusivity**[88](index=88&type=chunk) [Government Regulations](index=19&type=section&id=Government%20Regulations) The company operates under extensive FDA regulation, managing a transition to a full Biologics License Application (BLA) for its lead product - Axoguard products are regulated as medical devices and have **510(k) clearance** from the FDA[93](index=93&type=chunk)[94](index=94&type=chunk) - Avance Nerve Graft is being transitioned from a Human Tissue product (HCT/P) to a fully licensed biologic, requiring a **Biologics License Application (BLA)**[104](index=104&type=chunk)[106](index=106&type=chunk) - The **RECON study**, a Phase 3 pivotal trial for the Avance BLA, has completed subject enrollment and follow-up[125](index=125&type=chunk) - Avance Nerve Graft received **Regenerative Medicine Advanced Therapy (RMAT) designation** from the FDA, which may streamline the approval process[114](index=114&type=chunk) - The company is subject to various healthcare laws, including **Anti-Kickback**, **False Claims**, and the **Sunshine Act**[134](index=134&type=chunk)[135](index=135&type=chunk)[238](index=238&type=chunk) [Human Capital](index=28&type=section&id=Human%20Capital) As of December 31, 2021, the company employed approximately 451 people, with a significant portion dedicated to sales and marketing Employee Breakdown (as of Dec 31, 2021) | Department | Number of Employees | | :--- | :--- | | **Total Employees** | **~451** | | Sales and Marketing | 228 | | Corporate | 79 | | Research and Development | 65 | | Operations | 56 | - No employees are represented by a labor union, and the company believes its relationship with employees is satisfactory[151](index=151&type=chunk) [Executive Officers of the Registrant](index=29&type=section&id=Executive%20Officers%20of%20the%20Registrant) The company's leadership team includes Karen Zaderej as Chairman, CEO, and President, and Peter J. Mariani as Executive Vice President and CFO - Key executive officers include **Karen Zaderej** (Chairman, CEO, President), **Peter J. Mariani** (EVP, CFO), Bradley L. Ottinger (General Counsel), and Eric A. Sandberg (Chief Commercial Officer)[156](index=156&type=chunk) [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) The company faces risks from product concentration, the COVID-19 pandemic, regulatory hurdles for its key products, and intellectual property challenges [Risks Related to the Company](index=32&type=section&id=Risks%20Related%20to%20the%20Company) Revenue is highly dependent on four products, while the COVID-19 pandemic, a history of negative cash flow, and facility dependencies pose material risks - Substantially all revenue is derived from four products: **Avance Nerve Graft**, **Axoguard Nerve Protector**, **Axoguard Nerve Connector**, and **Axoguard Nerve Cap**[172](index=172&type=chunk) - The **COVID-19 pandemic** could continue to adversely affect operations and financial results through procedure deferrals and supply chain disruptions[176](index=176&type=chunk)[177](index=177&type=chunk)[178](index=178&type=chunk) - The company is highly dependent on its facility licensed from Community Tissue Services (CTS), which expires on **December 31, 2023**[186](index=186&type=chunk) - The company has a history of not consistently generating positive cash flow and had an accumulated deficit of approximately **$230.6 million** as of December 31, 2021[182](index=182&type=chunk)[183](index=183&type=chunk) [Risks Related to the Regulatory Environment](index=38&type=section&id=Risks%20Related%20to%20the%20Regulatory%20Environment%20in%20which%20the%20Company%20Operates) Significant regulatory risks include reliance on FDA enforcement discretion for Avance, the suspension of Avive, and the uncertain outcomes of clinical trials - The **Avance Nerve Graft** is distributed under an FDA enforcement discretion policy, and failure to obtain BLA approval would have a material adverse effect[226](index=226&type=chunk)[227](index=227&type=chunk) - The market availability of **Avive Soft Tissue Membrane was voluntarily suspended** on June 1, 2021, and there is no guarantee it will return to market[220](index=220&type=chunk)[221](index=221&type=chunk) - Clinical trials, such as the **RECON study** for the Avance BLA, are long, expensive, and have uncertain outcomes that could jeopardize regulatory approval[241](index=241&type=chunk)[242](index=242&type=chunk) - The company is subject to extensive healthcare fraud and abuse laws (e.g., **Anti-Kickback Statute**, **False Claims Act**), and violations can lead to significant penalties[215](index=215&type=chunk)[237](index=237&type=chunk) [Risks Related to Intellectual Property](index=45&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) Success depends on protecting intellectual property, as key patents for the Axoguard line have expired and the company relies on exclusive licenses for Avance - Failure to protect intellectual property rights could lead to **costly litigation** and loss of competitive advantage[263](index=263&type=chunk) - The patent protection for products may expire, subjecting the company to increased competition; material U.S. patents covering the **Axoguard product line have expired**[267](index=267&type=chunk) - The company depends on maintaining exclusive licenses from the **University of Florida Research Foundation (UFRF)** and the **University of Texas at Austin (UTA)** for its Avance technology[269](index=269&type=chunk) [Risks Related to Common Stock](index=47&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) Investors face risks from high stock price volatility, a no-dividend policy, and anti-takeover provisions under Minnesota law - The price of the company's common stock (AXGN) has been and is likely to continue to be **highly volatile**[274](index=274&type=chunk) - The company **does not anticipate paying any cash dividends** in the foreseeable future, retaining earnings to finance growth[276](index=276&type=chunk) - **Anti-takeover provisions** in Minnesota law may discourage or deter acquisition bids[277](index=277&type=chunk) [Risks Related to Financing Our Business](index=48&type=section&id=Risks%20Related%20to%20Financing%20Our%20Business) The company's credit facility contains restrictive covenants, and future fundraising efforts could result in shareholder dilution - The credit facility with Oberland Capital contains **restrictive operating and financial covenants**, and a breach could lead to default[280](index=280&type=chunk)[281](index=281&type=chunk) - The company may need to raise additional funds in the future, which could **dilute shareholder interests** or be difficult to obtain on acceptable terms[284](index=284&type=chunk)[285](index=285&type=chunk) [General Risk Factors](index=49&type=section&id=General%20Risk%20Factors) The company is exposed to general risks including legal proceedings, loss of key personnel, cybersecurity threats, and potential internal control weaknesses - The company is currently a defendant in **securities class action lawsuits** and may be subject to other costly legal proceedings[286](index=286&type=chunk) - The **loss of key members** of the executive management team could adversely affect the business[290](index=290&type=chunk) - The company is dependent on internal information systems that are vulnerable to **cybersecurity attacks and breaches**[302](index=302&type=chunk)[303](index=303&type=chunk) - If the company's **internal controls over financial reporting are not effective**, it could result in unreliable financial reports[307](index=307&type=chunk)[308](index=308&type=chunk) [Properties](index=52&type=section&id=Item%202.%20Properties) Axogen leases its corporate and distribution facilities and is building its own processing center in Ohio to replace an expiring services agreement - Corporate headquarters are leased in Alachua, FL (19,000 sq ft) and a major office/lab facility is leased in Tampa, FL (75,000 sq ft)[309](index=309&type=chunk)[310](index=310&type=chunk) - A distribution facility is leased in Burleson, TX (17,500 sq ft)[312](index=312&type=chunk) - The company is renovating its own **Axogen Processing Center (APC)** facility in Vandalia, OH, to replace its current processing arrangement with CTS, which ends in 2023[314](index=314&type=chunk) [Legal Proceedings](index=53&type=section&id=Item%203.%20Legal%20Proceedings) The company is defending a securities class action lawsuit that was dismissed by the District Court but is currently under appeal - The company is a defendant in a putative **securities class action lawsuit**, Einhorn v Axogen, Inc, et al, filed in January 2019[537](index=537&type=chunk) - The District Court **dismissed the Second Amended Complaint with prejudice** on March 19, 2021; the plaintiff has appealed the dismissal to the Eleventh Circuit[537](index=537&type=chunk) - A separate stockholder derivative complaint, Bach v Zaderej, et al, was **voluntarily dismissed** by the plaintiff in November 2021[538](index=538&type=chunk) [Mine Safety Disclosures](index=53&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company - None[316](index=316&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=54&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Axogen's common stock trades on Nasdaq as "AXGN," and the company has never paid cash dividends, retaining earnings for growth - The company's common stock is traded on the Nasdaq Capital Market under the symbol **"AXGN"**[317](index=317&type=chunk) - As of February 22, 2022, there were **41,795,240 shares of common stock outstanding**[318](index=318&type=chunk) - The company has **never declared or paid cash dividends** and does not anticipate paying them in the foreseeable future[321](index=321&type=chunk) - The company did not repurchase any of its securities in the fourth quarter of 2021 and had no sales of unregistered securities in 2021[320](index=320&type=chunk) [Reserved](index=55&type=section&id=Item%206.%20Reserved) This item is intentionally left blank [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=56&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Revenues grew 13.4% to $127.4 million in 2021, though net loss widened to $27.0 million due to increased operating expenses [Results of Operations](index=57&type=section&id=Results%20of%20Operations) In 2021, revenue increased 13.4% to $127.4 million and gross margin improved, but a 14.0% rise in expenses led to a wider net loss of $27.0 million Financial Performance Comparison (2021 vs. 2020) | Metric | 2021 | 2020 | Change | | :--- | :--- | :--- | :--- | | Revenues | $127.4M | $112.3M | +13.4% | | Gross Profit | $104.4M | $90.7M | +15.1% | | Gross Margin | 82.0% | 80.8% | +1.2 p.p. | | Loss from Operations | ($25.4M) | ($23.2M) | +9.5% | | Net Loss | ($27.0M) | ($23.8M) | +13.4% | Financial Performance Comparison (2020 vs. 2019) | Metric | 2020 | 2019 | Change | | :--- | :--- | :--- | :--- | | Revenues | $112.3M | $106.7M | +5.2% | | Gross Profit | $90.7M | $89.4M | +1.5% | | Gross Margin | 80.8% | 83.7% | -2.9 p.p. | | Loss from Operations | ($23.2M) | ($31.4M) | -26.2% | | Net Loss | ($23.8M) | ($29.1M) | -18.3% | - **R&D expenses increased 35.5%** in 2021 to $24.2 million, primarily due to increased spending on the BLA for Avance Nerve Graft[337](index=337&type=chunk) [Liquidity and Capital Resources](index=61&type=section&id=Liquidity%20and%20Capital%20Resources) The company held $84.1 million in cash and investments at year-end 2021, which management believes is sufficient for at least the next 12 months Liquidity Position (as of Dec 31, 2021) | Metric | Value | | :--- | :--- | | Cash, Cash Equivalents & Investments | $84.1M | | Working Capital | $102.8M | | Current Ratio | 5.2x | Cash Flow Summary (2021) | Activity | Cash Flow | | :--- | :--- | | Operating Activities | ($13.4M) | | Investing Activities | ($23.6M) | | Financing Activities | $20.5M | - The company has a credit facility with Oberland Capital, with **$50 million drawn** as of year-end 2021[365](index=365&type=chunk)[366](index=366&type=chunk) - Significant capital expenditures are ongoing for the renovation of the APC Facility, with **$19.3 million** anticipated to be spent in 2022[364](index=364&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=63&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is primarily exposed to interest rate risk from its variable-rate debt, while credit and foreign currency risks are considered minimal - **Interest Rate Risk:** The company is exposed to interest rate changes through its Oberland debt facility, which has an interest rate floor of **9.5%**[372](index=372&type=chunk) - **Credit Risk:** Financial instruments subject to credit risk include cash balances exceeding FDIC limits (**$32.2 million** as of Dec 31, 2021) and accounts receivable[373](index=373&type=chunk)[375](index=375&type=chunk) - **Foreign Currency Exchange Risk:** Exposure is minimal as revenue from international markets is denominated in U.S. dollars[376](index=376&type=chunk) [Financial Statements and Supplementary Data](index=64&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section contains the audited consolidated financial statements, accompanying notes, and the independent auditor's report from Deloitte & Touche LLP [Report of Independent Registered Public Accounting Firm](index=65&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) Deloitte & Touche LLP issued an unqualified opinion on the financial statements and internal controls, identifying inventory valuation as a Critical Audit Matter - Deloitte & Touche LLP issued an **unqualified opinion**, stating the financial statements are presented fairly in all material respects[380](index=380&type=chunk) - The auditor also opined that the company maintained **effective internal control over financial reporting** as of December 31, 2021[380](index=380&type=chunk) - A **Critical Audit Matter** was identified related to the valuation of excess and obsolete (E&O) inventory, which involves significant management judgment[386](index=386&type=chunk)[387](index=387&type=chunk) [Consolidated Financial Statements](index=67&type=section&id=Consolidated%20Financial%20Statements) The financial statements show total assets of $208.0 million, a 2021 net loss of $27.0 million, and net cash used in operations of $13.4 million Consolidated Balance Sheet Data (in thousands) | Account | Dec 31, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | **Total Assets** | **$208,024** | **$201,381** | | Cash, Cash Equivalents & Investments | $84,086 | $103,966 | | Inventory | $16,693 | $12,529 | | Property and equipment, net | $62,881 | $38,398 | | **Total Liabilities** | **$95,474** | **$78,232** | | Long-term debt, net | $44,821 | $32,027 | | **Total Shareholders' Equity** | **$112,550** | **$123,149** | Consolidated Statement of Operations Data (in thousands, except per share) | Account | 2021 | 2020 | 2019 | | :--- | :--- | :--- | :--- | | Revenues | $127,358 | $112,300 | $106,712 | | Gross Profit | $104,427 | $90,719 | $89,363 | | Loss from Operations | ($25,416) | ($23,182) | ($31,406) | | Net Loss | ($26,985) | ($23,786) | ($29,135) | | Loss per Share | ($0.65) | ($0.60) | ($0.74) | Consolidated Statement of Cash Flows Data (in thousands) | Activity | 2021 | 2020 | 2019 | | :--- | :--- | :--- | :--- | | Net Cash Used in Operating | ($13,405) | ($9,626) | ($19,872) | | Net Cash (Used in)/Provided by Investing | ($23,649) | ($16,963) | $27,271 | | Net Cash Provided by Financing | $20,452 | $40,474 | $4,031 | [Notes to Consolidated Financial Statements](index=72&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes detail key accounting policies, debt terms, commitments for the new APC facility, and the status of ongoing legal proceedings - **Inventory:** The company recorded an inventory write-down of **$1.25 million** in 2021 related to the suspension of its Avive product[413](index=413&type=chunk) - **Long-Term Debt:** As of Dec 31, 2021, the company had **$50 million in debt outstanding** from its Oberland Facility, with a net carrying value of $44.8 million[472](index=472&type=chunk)[473](index=473&type=chunk) - **Stock-Based Compensation:** Total stock-based compensation expense was **$10.9 million** in 2021, with $19.5 million of unrecognized cost remaining[485](index=485&type=chunk) - **Commitments:** The company has significant commitments for its new APC facility, with an estimated **$19.3 million** to be spent in 2022[531](index=531&type=chunk) - **Legal Proceedings:** The company is defending a securities class action lawsuit (Einhorn v Axogen) which was dismissed by the district court but is now on appeal[537](index=537&type=chunk) [Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=96&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) There were no changes in or disagreements with accountants during the period - None[542](index=542&type=chunk) [Controls and Procedures](index=96&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2021 - Management concluded that the company's **disclosure controls and procedures were effective** as of December 31, 2021[544](index=544&type=chunk) - Management concluded that the company's **internal control over financial reporting was effective** as of December 31, 2021[547](index=547&type=chunk) - The company's independent registered public accounting firm has issued an **attestation report on the effectiveness** of management's internal control over financial reporting[549](index=549&type=chunk) [Other Information](index=97&type=section&id=Item%209B.%20Other%20Information) There is no other information to report in this section - None[549](index=549&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=97&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This section is not applicable to the company - Not applicable[549](index=549&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=98&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information regarding directors, officers, and corporate governance is incorporated by reference from the 2022 definitive proxy statement - Information regarding directors, executive officers, and corporate governance is **incorporated by reference** from the company's 2022 definitive proxy statement[551](index=551&type=chunk)[552](index=552&type=chunk) - The company has adopted a **Code of Business Conduct and Ethics**, which is posted on its website[553](index=553&type=chunk) [Executive Compensation](index=98&type=section&id=Item%2011.%20Executive%20Compensation) Information concerning executive compensation is incorporated by reference from the 2022 definitive proxy statement - Information regarding executive compensation is **incorporated by reference** from the company's 2022 definitive proxy statement[554](index=554&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=98&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information on security ownership and equity compensation plans is incorporated by reference from the 2022 definitive proxy statement - Information regarding security ownership and equity compensation plans is **incorporated by reference** from the company's 2022 definitive proxy statement[554](index=554&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=98&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information on related party transactions and director independence is incorporated by reference from the 2022 definitive proxy statement - Information regarding certain relationships, related transactions, and director independence is **incorporated by reference** from the company's 2022 definitive proxy statement[555](index=555&type=chunk) [Principal Accountant Fees and Services](index=98&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Information concerning principal accountant fees and services is incorporated by reference from the 2022 definitive proxy statement - Information regarding principal accountant fees and services is **incorporated by reference** from the company's 2022 definitive proxy statement[556](index=556&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=99&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists all exhibits filed with the report and includes Schedule II detailing valuation and qualifying accounts Schedule II – Valuation and Qualifying Accounts (in thousands) | Description | 2019 | 2020 | 2021 | | :--- | :--- | :--- | :--- | | **Allowance for Doubtful Accounts (Ending Balance)** | $1,092 | $416 | $276 | | **Valuation Allowance for Deferred Tax Assets (Ending Balance)** | $39,932 | $46,517 | $53,251 | - A comprehensive list of exhibits is provided, including articles of incorporation, bylaws, material contracts, and certifications[562](index=562&type=chunk)[566](index=566&type=chunk)[567](index=567&type=chunk) [Form 10-K Summary](index=107&type=section&id=Item%2016.%20Form%2010-K%20Summary) This section is not applicable, and no summary is provided in the report - None[572](index=572&type=chunk)

AxoGen, Inc. (NASDAQ:AXGN) Q4 2021 Earnings Conference Call February 22, 2022 4:30 PM ET Company Participants Ed Joyce - Director, IR Karen Zaderej - Chairman, President & CEO Peter Mariani - EVP & CFO Conference Call Participants David Turkaly - JMP Securities\ Erin Broderick - SVB Leerink Operator Greetings. Welcome to the AxoGen, Incorporated Fourth Quarter 2021 Conference Call. At this time, all participants are in listen-only mode. A brief question-and-answer session will follow the formal of presentat ...

AxoGen, Inc. (NASDAQ:AXGN) Q3 2021 Earnings Conference Call November 3, 2021 4:30 PM ET Company Participants Peter Mariani – Executive Vice President and Chief Financial Officer Karen Zaderej – Chairman, President and Chief Executive Officer Conference Call Participants Erin Soldatis – SVB Leerink Anthony Petrone – Jeffries Kyle Rose – Canaccord Operator Greetings, welcome to AxoGen Reports Third Quarter 2021 Financial Results Call. At this time all participants are in a listen-only mode. A question-and-ans ...

AxoGen, Inc. (NASDAQ:AXGN) Q2 2021 Earnings Conference Call August 4, 2021 4:30 PM ET Company Participants Pete Mariani – Executive Vice President and Chief Financial Officer Karen Zaderej – Chairman, Chief Executive Officer and President Conference Call Participants Brandon Folkes – Cantor Fitzgerald Anthony Petrone – Jefferies Jaime Morgan – SVB Leerink Operator Greetings, and welcome to the AxoGen, Inc. Report Second Quarter 2021 Financial Results Conference Call. At this time all participants are in a l ...