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|Item 2.02||Results of Operations and Financial Condition.|
On August 14, 2023, Aziyo Biologics, Inc. (the “Company” or “Aziyo”) issued a press release announcing its results for the second quarter ended June 30, 2023. A copy of the Company’s press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
|Item 9.01||Financial Statements and Exhibits|
|99.1||Press Release of Aziyo Biologics, Inc., dated August 14, 2023|
|104||Cover Page Interactive Data File (formatted as an Inline XBRL document)|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|AZIYO BIOLOGICS, INC.|
|Date: August 14, 2023||By:||/s/ Matthew Ferguson|
|Chief Financial Officer|
Aziyo Biologics Reports Second Quarter 2023 Financial Results - Transformation Continues to Drug-Eluting Biomatrix Company
Negotiating multiple LOIs to divest Orthopedic business
CanGaroo® RM 510(k) resubmission to the FDA remains on track
SimpliDerm® quarterly net sales up 32% year-over-year
Successful transfer of Cardiovascular product distribution to LeMaitre Vascular
SILVER SPRING, Md., Aug. 14, 2023 — Aziyo Biologics, Inc. (Nasdaq: AZYO) (“Aziyo”), a company that develops and commercializes biologic products to improve compatibility between medical devices and the patients who need them, today provided a business update and reported financial results for the second quarter ended June 30, 2023.
“Our strategy to transform Aziyo into a high growth drug-eluting biomatrix product company continues to move forward," said Dr. Randy Mills, President and Chief Executive Officer of Aziyo Biologics. “We are in discussions with several interested parties to divest our Orthopedic business and have made significant progress in preparing our resubmission of CanGaroo RM for 510(k) clearance with the FDA. Furthermore, SimpliDerm had a strong quarter with sales up 32%, and we are pleased with higher sales volume of our Cardiovascular segment following our product distribution agreement with LeMaitre Vascular.”
“Regarding the voluntary recall of our viable bone matrix products, we continue to work closely with the FDA and the CDC to fully investigate the matter. Patients are at the center of everything we do at Aziyo and their safety will continue to be our foremost priority,” added Dr. Mills.
Second Quarter 2023 Financial Results
Net sales for the second quarter of 2023 were $10.3 million, compared to $12.6 million in the second quarter of 2022. The decrease was primarily due to the viable bone matrix recall and market withdrawal in July 2023, which resulted in the reversal of $3.0 million of second quarter revenue.
While the voluntary recall and market withdrawal of the Company’s viable bone matrix products negatively impacted the Orthopedic segment, the Women’s Health segment and its SimpliDerm product experienced 32% growth in the second quarter of 2023 compared to the corresponding prior-year period. Device Protection revenue during the second quarter was relatively consistent compared to the prior-year period, and net sales from the Cardiovascular segment declined due to the commencement of the Company’s distribution agreement with LeMaitre Vascular, which resulted in increased sales volume but at distributor transfer pricing rather than the previous end-user pricing.
Gross profit for the second quarter of 2023 was $1.0 million and gross margin was 9.5%, as compared to $4.9 million and 38.8%, respectively, in the corresponding prior-year period. Gross margin, excluding intangible asset amortization (a measure not presented in accordance with U.S. generally accepted accounting principles (“GAAP”)) was 17.8% for the second quarter of 2023, as compared to 45.5% in the second quarter of 2022. The decline in gross margin was due to the impact of the viable bone matrix recall and market withdrawal, which decreased second quarter gross profit by $5.0 million and gross margin by 35%.
Total operating expenses were $10.1 million for the second quarter of 2023, as compared to $13.1 million in the corresponding prior-year period.
Net loss was $10.6 million in the second quarter of 2023, as compared to $9.4 million in the corresponding prior year period. Net loss per share in the second quarter of 2023 was $0.65 per share, as compared to a loss of $0.69 per share in the second quarter of 2022.
Aziyo’s cash balance as of June 30, 2023, was $9.3 million.
Aziyo will host a conference call today at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to discuss its second quarter 2023 financial results and performance.
Individuals interested in listening to the conference call are required to register online. Participants are recommended to register at least 15 minutes before the start of the call. A live and archived webcast of the event and the accompanying presentation materials will be available on the “Investors” section of the Aziyo website at https://investors.aziyo.com/.
About Aziyo Biologics
Aziyo develops and commercializes biologic products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Aziyo’s mission is to humanize medical devices to improve patient outcomes. For more information, visit www.Aziyo.com.
This press release contains “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, as amended. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including any statements and information concerning the effectiveness of our products, the ability to expand availability of our products as a result of our distribution arrangements with LeMaitre Vascular and Sientra, the potential success of our distribution arrangements with LeMaitre Vascular and Sientra, our expectations regarding the potential disposition of our Orthopedics business and our expectations relating to the FDA regulatory process for the CanGaroo RM Antibacterial Envelope. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect our business, strategy, operations or financial performance, and actual results may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, and other important factors that may cause actual results, performance or achievements to differ materially from those contemplated or implied in this press release, including, but not limited to, risks regarding the ability to successfully execute or realize the anticipated benefits under our distribution arrangements with LeMaitre Vascular and Sientra; our inability to generate sufficient revenue to achieve or sustain profitability; adverse changes in economic conditions and instability and disruption of credit markets; our ability to continue as a going concern; our ability to successfully execute or achieve expected benefits from a divestiture of our Orthopedics business; our products and our ability to enhance, expand, develop and commercialize our product offerings; the impact on our business of the recall of a single lot of our FiberCel product and the discontinuation of its sales by our distribution partner; consequences of our recall of a single lot of one of our viable bone matrix products and market withdrawal of all of our viable bone matrix products; our dependence on our commercial partners; the impact of the bankruptcy of Surgalign Holdings, Inc., a significant customer of the Company, on our future revenues; physician awareness of the distinctive characteristics, and acceptance by the medical community, of our products; the ability to obtain regulatory approval or other marketing authorizations; and our intellectual property rights, and other important factors which can be found in the “Risk Factors” section of Aziyo’s public filings with the Securities and Exchange Commission (“SEC”), including Aziyo’s Annual Report on Form 10-K for the year ended December 31, 2022, as such factors may be updated from time to time in Aziyo’s other filings with the SEC, including, Aziyo’s Quarterly Reports on Form 10-Q, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Aziyo’s website at https://investors.aziyo.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Aziyo in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Aziyo expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
AZIYO BIOLOGICS, INC.
CONSOLIDATED BALANCE SHEET DATA
(Unaudited, in thousands)
|June 30, 2023||December 31, 2022|
|Accounts receivable, net||6,317||6,830|
|Receivables of FiberCel litigation costs||8,876||13,813|
|Prepaid expense and other assets||2,363||3,015|
|Total current assets||36,126||50,699|
|Property and equipment, net||1,467||1,403|
|Intangible assets, net||13,370||15,069|
|Operating lease right-of-use assets, and other||1,366||1,670|
|Liabilities and Stockholders' Deficit|
|Accounts payable and accrued expenses and other current liabilities||$||17,411||$||15,583|
|Current portion of long-term debt and revenue interest obligation||10,366||8,990|
|Contingent liability for FiberCel litigation||14,470||17,360|
|Current operating lease liabilities||620||682|
|Total current liabilities||42,867||42,615|
|Long-term revenue interest obligation||5,601||5,916|
|Long-term operating lease liabilities||711||956|
|Other long-term liabilities||351||127|
|Stockholders' equity (deficit):|
|Additional paid-in capital||134,439||132,939|
|Total stockholders' equity (deficit)||(22,128||)||(5,033||)|
|Total liabilities and stockholders' equity||$||52,329||$||68,841|
AZIYO BIOLOGICS, INC.
CONSOLIDATED STATEMENT OF OPERATIONS
(Unaudited, in thousands, except share and per share data)
|Three months ended June 30,||Six months ended June 30,|
|Cost of goods sold||9,316||7,740||16,035||14,954|
|Sales and marketing||3,618||5,406||8,974||10,224|
|General and administrative||4,005||4,711||7,684||8,736|
|Research and development||1,171||2,617||2,974||4,889|
|FiberCel litigation costs||1,271||346||3,182||434|
|Total operating expenses||10,065||13,080||22,814||24,283|
|Loss from operations||(9,085||)||(8,182||)||(15,503||)||(15,104||)|
|Loss before provision of income taxes||(10,609||)||(9,386||)||(18,571||)||(17,523||)|
|Provision for income taxes||12||12||24||24|
|Net loss attributable to common stockholders||(10,621||)||(9,398||)||(18,595||)||(17,547||)|
|Net loss per share attributable to common stockholders - basic and diluted||$||(0.65||)||$||(0.69||)||$||(1.15||)||$||(1.29||)|
|Weighted average common shares outstanding - basic and diluted||16,223,919||13,620,196||16,208,905||13,597,243|
Non-GAAP Financial Measures
This press release presents our gross margin, excluding intangible asset amortization. We calculate gross margin, excluding intangible asset amortization, as gross profit, excluding amortization expense relating to intangible assets we acquired in our acquisition of all of the commercial assets of CorMatrix Cardiovascular, Inc. in 2017, divided by net sales.
We present gross margin, excluding intangible asset amortization, because we believe that it provides meaningful supplemental information regarding our operating performance by removing the impact of amortization expense, which is not indicative of our overall operating performance. We believe this provides our management and investors with useful information to facilitate period-to-period comparisons of our operating results. Our management uses this metric in assessing the health of our business and our operating performance, and we believe investors’ understanding of our operating performance is similarly enhanced by our presentation of this metric.
Gross margin, excluding intangible asset amortization, is a supplemental measure of our performance, is not defined by or presented in accordance GAAP, has limitations as an analytical tool and should not be considered in isolation or as an alternative to our GAAP gross margin, gross profit or any other financial performance measure presented in accordance with GAAP. In addition, other companies, including companies in our industry, may use other measures to evaluate their performance, which could reduce the usefulness of this non-GAAP financial measure as a tool for comparison.
The following table presents a reconciliation of our gross margin, excluding intangible asset amortization, to the most directly comparable GAAP financial measure, which is our GAAP gross margin (in thousands).
|Three months ended June 30,||Six months ended June 30,|
|Intangible asset amortization expense||849||849||1,698||1,698|
|Gross profit, excluding intangible asset amortization||$||1,829||$||5,747||$||9,009||$||10,877|
|Gross margin percentage, excluding intangible asset amortization||17.8||%||45.5||%||38.6||%||45.1||%|