Financial Data and Key Metrics Changes - Aziyo Biologics reported Q3 2021 revenue of $11.5 million, a 3% decrease from $11.8 million in Q3 2020 and a 5.6% decrease from $12.2 million in Q2 2021 [23] - Year-to-date total revenues exceeded $36 million, representing a 21% increase over the same period in 2020 [7] - Gross margin for Q3 2021 was 32.1%, down from 47.1% in Q3 2020 and 46.2% in Q2 2021 [27] - Total operating expenses for Q3 2021 were $10.7 million, a 30% increase from $8.2 million in Q3 2020 [28] - Net loss for Q3 2021 was $8.3 million, compared to a net loss of $6.7 million in Q3 2020 [29] Business Line Data and Key Metrics Changes - Net sales of core products were $8.6 million in Q3 2021, down from $10.3 million in Q3 2020, while non-core products saw an increase to $2.9 million from $1.4 million [24] - The decline in core products was primarily due to a decrease in the orthopedic and spinal repair business following the discontinuation of FiberCel sales by its distributor [24] - Sales of CanGaroo and SimpliDerm showed growth, offsetting some declines in other areas [25] Market Data and Key Metrics Changes - Increased sales of CanGaroo in Europe were attributed to the launch of a new expanded label allowing hydration in gentamicin solution prior to implantation [12] - The company experienced improved productivity from its U.S. direct sales force, with higher utilization in existing accounts and new account openings [11] Company Strategy and Development Direction - Aziyo plans to scale its commercial organization and advance CanGaroo RM, a next-generation product with antibiotics, with an expected FDA filing in Q1 2022 [8] - The company aims to generate clinical data and expand market access for SimpliDerm, with ongoing clinical studies and publications planned for 2022 [14] - In the orthopedic and spine business, Aziyo anticipates onboarding additional partners and launching new viable bone matrices [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating challenges posed by COVID-19 and highlighted strong performance in CanGaroo and SimpliDerm despite headwinds [36] - The outlook for Q4 2021 includes expectations for core product sales to remain similar to Q3 results, with growth anticipated in 2022 driven by CanGaroo RM and additional partnerships [31] Other Important Information - The company is participating in a patient support program related to the FiberCel recall, aiming to support affected patients [9] - Aziyo has implemented new screening and testing procedures to enhance product safety, which are expected to set new industry standards [18] Q&A Session Summary Question: Impact of COVID-19 on Q3 performance - Management noted that despite COVID-19 disruptions, CanGaroo and SimpliDerm performed well, with a larger order from a non-core customer contributing to Q3 sales [36] Question: Guidance for Q4 sales - Management indicated that Q4 sales would likely see a step down due to the non-recurrence of a large order and ongoing challenges in the viable bone matrix business [39] Question: Growth expectations for CanGaroo and SimpliDerm - Management refrained from providing specific growth percentages but expressed optimism about the potential for both products in 2022 [41] Question: M&A strategy - Management stated that while they are exploring tuck-in acquisitions, they remain focused on organic growth opportunities within their existing product lines [50] Question: FiberCel's impact on core business growth - Management confirmed that excluding FiberCel, there was sequential growth in the core business, driven by CanGaroo and SimpliDerm [54]

PART I – FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements) Unaudited financials report Q3 net loss of **$8.3 million** and nine-month loss of **$15.8 million**, raising substantial doubt about going concern - The company has identified conditions that raise substantial doubt about its ability to continue as a going concern within one year, citing recurring net losses, an accumulated deficit of **$96.0 million**, and uncertainty regarding future cash flows to meet operating needs[44](index=44&type=chunk)[46](index=46&type=chunk) Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $22,543 | $39,150 | | Total current assets | $39,254 | $59,707 | | Total assets | $59,903 | $82,810 | | **Liabilities & Equity** | | | | Total current liabilities | $22,510 | $26,779 | | Total liabilities | $52,044 | $61,979 | | Accumulated deficit | $(96,027) | $(80,259) | | Total stockholders' equity | $7,859 | $20,831 | Condensed Consolidated Statements of Operations Highlights (in thousands) | Metric | Three Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2021 | | :--- | :--- | :--- | | Net sales | $11,485 | $36,529 | | Gross profit | $3,689 | $15,632 | | Loss from operations | $(6,976) | $(15,270) | | Net loss | $(8,316) | $(15,768) | | Net loss per share | $(0.81) | $(1.54) | Condensed Consolidated Statements of Cash Flows Highlights (Nine Months Ended Sep 30, in thousands) | Activity | 2021 | 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(9,059) | $(8,258) | | Net cash used in investing activities | $(344) | $(525) | | Net cash (used in) provided by financing activities | $(7,503) | $7,837 | | **Net decrease in cash and restricted cash** | **$(16,906)** | **$(946)** | [Management's Discussion and Analysis of Financial Condition and Results Of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20Of%20Operations) Management discusses the FiberCel recall's impact, leading to Medtronic agreement termination, revenue decline, and substantial doubt about going concern - In June 2021, the company issued a voluntary recall for a single donor lot of FiberCel after post-surgical infections, including tuberculosis, were reported, leading to Medtronic suspending all purchases and subsequently moving to terminate the distribution agreement in October 2021[154](index=154&type=chunk)[161](index=161&type=chunk) - The termination of the FiberCel agreement with Medtronic may negatively affect future revenues and creates uncertainty about the company's ability to comply with its debt covenants, contributing to substantial doubt about its ability to continue as a going concern[154](index=154&type=chunk)[155](index=155&type=chunk)[216](index=216&type=chunk) Q3 2021 vs Q3 2020 Performance (in thousands) | Metric | Q3 2021 | Q3 2020 | Change (%) | | :--- | :--- | :--- | :--- | | Net Sales | $11,485 | $11,774 | (2.5)% | | Gross Profit | $3,689 | $5,541 | (33.4)% | | Gross Margin | 32.1% | 47.1% | (15.0) pps | | Loss from Operations | $(6,976) | $(2,691) | 159.2% | | Net Loss | $(8,316) | $(6,731) | 23.5% | Nine Months 2021 vs 2020 Performance (in thousands) | Metric | YTD 2021 | YTD 2020 | Change (%) | | :--- | :--- | :--- | :--- | | Net Sales | $36,529 | $30,216 | 20.9% | | Gross Profit | $15,632 | $14,540 | 7.5% | | Gross Margin | 42.8% | 48.1% | (5.3) pps | | Loss from Operations | $(15,270) | $(9,636) | 58.5% | | Net Loss | $(15,768) | $(16,469) | (4.3)% | [Quantitative and Qualitative Disclosures About Market Risk](index=46&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Primary market risk stems from variable interest rates, though a **10%** change is not material, with credit risk concentrated in one institution and one customer - The company's main market risk is interest rate risk from its variable-rate debt, but management states a **10%** rate change would not materially impact financial statements[257](index=257&type=chunk) - Credit risk is present, with cash held at a single institution and one customer accounting for **10%** or more of accounts receivable as of September 30, 2021[258](index=258&type=chunk)[259](index=259&type=chunk) [Controls and Procedures](index=47&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2021, with no material changes to internal control over financial reporting - Based on an evaluation as of the end of the reporting period, the company's management concluded that disclosure controls and procedures were effective[266](index=266&type=chunk) - There were no changes in internal control over financial reporting during the nine months ended September 30, 2021, that have materially affected, or are reasonably likely to materially affect, internal controls[267](index=267&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=47&type=section&id=Item%201.%20Legal%20Proceedings) The company faces **41 lawsuits** related to the FiberCel recall, alleging tuberculosis infections, with potential material financial impact - As of November 5, 2021, **forty-one lawsuits** have been filed against the company in multiple states related to the FiberCel recall, alleging patients contracted tuberculosis after implantation[128](index=128&type=chunk) - The company states that it is not possible to estimate a range of probable loss from the FiberCel litigation at this time, but acknowledges that the loss could have a material effect on its financial position and results of operations[130](index=130&type=chunk) [Risk Factors](index=47&type=section&id=Item%201A.%20Risk%20Factors) Significant risks include FiberCel recall consequences, reputational damage, substantial litigation, Medtronic agreement termination, and substantial doubt about going concern - The FiberCel recall and subsequent negative publicity could harm the company's brand image, decrease confidence in its products, and adversely affect its ability to retain customers and partners[272](index=272&type=chunk) - The company faces significant litigation risk from the FiberCel recall, with **41 lawsuits** filed, and an unfavorable outcome could result in substantial damages and materially harm the business[304](index=304&type=chunk)[319](index=319&type=chunk) - The termination of the FiberCel distribution agreement by Medtronic, a significant commercial partner, could adversely affect business, financial condition, and results of operations[276](index=276&type=chunk)[277](index=277&type=chunk) - The company has identified conditions and events, including operating losses and the impact of the FiberCel recall, that raise substantial doubt about its ability to continue as a going concern without raising additional capital[281](index=281&type=chunk)[282](index=282&type=chunk)[284](index=284&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=61&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities were reported during the period - None reported[357](index=357&type=chunk) [Defaults Upon Senior Securities](index=61&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported during the period - None reported[357](index=357&type=chunk) [Mine Safety Disclosures](index=61&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[357](index=357&type=chunk) [Other Information](index=61&type=section&id=Item%205.%20Other%20Information) No other information was reported for the period - None reported[357](index=357&type=chunk) [Exhibits](index=62&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including required certifications by the Principal Executive and Financial Officers

Start Time: 16:30 January 1, 0000 5:10 PM ET Aziyo Biologics, Inc. (AZYO) Q2 2021 Earnings Conference Call August 09, 2021, 16:30 PM ET Company Participants Ronald Lloyd - President and CEO Matthew Ferguson - CFO Leigh Salvo - IR, Gilmartin Group LLC Conference Call Participants Matthew O’Brien - Piper Sandler Joshua Jennings - Cowen and Company David Rescott - Truist Securities Brandon Folkes - Cantor Fitzgerald Operator Ladies and gentlemen, thank you for standing by. Welcome to Aziyo Biologics Q2 2021 E ...

Table of Contents Title of each class Trading Symbol(s) Name of each exchange on which registered Class A Common Stock, par value $0.001 per share AZYO The Nasdaq Global Market UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the trans ...

Aziyo Biologics, Inc. (AZYO) Q1 2021 Results Earnings Conference Call May 4, 2021 4:30 PM ET Company Participants Leigh Salvo - Investor Relations, Gilmartin Group LLC Ronald Lloyd - President and Chief Executive Officer Matthew Ferguson - Chief Financial Officer Conference Call Participants Matthew O'Brien - Piper Sandler Neil Chatterji - Cowen and Company David Rescott - Truist Securities Operator Welcome to the Aziyo Biologics Q1 2021 Earnings Call. My name is Ajen and I'll be your operator for today's c ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ____________________________________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 or ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-39577 ____________________________________________________ Aziyo Biologics ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2020 or ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For transition period from to Commission File Number: 001-39577 Aziyo Biologics, Inc. (Exact name of registrant as specified in its charter) Delaware 47-4790334 (State or other jurisdiction of i ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ____________________________________________________ ____________________________________________________ (Mark One) x Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended September 30, 2020 or ¨ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For transition period from to Commission File Number: 001-39577 _______________ ...