Full Press Release Details
Biologics Reports Second Quarter 2023 Financial Results - Transformation Continues to Drug-Eluting Biomatrix Company
multiple LOIs to divest Orthopedic business
RM 510(k) resubmission to the FDA remains on track
quarterly net sales up 32% year-over-year
transfer of Cardiovascular product distribution to LeMaitre Vascular
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.
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."
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
Quarter 2023 Financial Results
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
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.
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%.
operating expenses were $10.1 million for the second quarter of 2023, as compared to $13.1 million in the corresponding prior-year period.
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.
cash balance as of June 30, 2023, was $9.3 million.
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.
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/.
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.
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 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | $ | 9,296 | $ | 16,989 | ||||
| Accounts receivable, net | 6,317 | 6,830 | ||||||
| Inventory | 9,274 | 10,052 | ||||||
| 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 | ||||||
| Total assets | $ | 52,329 | $ | 68,841 | ||||
| Liabilities and Stockholders' Deficit | ||||||||
| Current liabilities: | ||||||||
| 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 debt | 24,927 | 24,260 | ||||||
| Long-term revenue interest obligation | 5,601 | 5,916 | ||||||
| Long-term operating lease liabilities | 711 | 956 | ||||||
| Other long-term liabilities | 351 | 127 | ||||||
| Total liabilities | 74,457 | 73,874 | ||||||
| Stockholders' equity (deficit): | ||||||||
| Common stock | 16 | 16 | ||||||
| Additional paid-in capital | 134,439 | 132,939 | ||||||
| Accumulated deficit | (156,583 | ) | (137,988 | ) | ||||
| 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, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Net sales | $ | 10,296 | $ | 12,638 | $ | 23,346 | $ | 24,133 | ||||||||
| Cost of goods sold | 9,316 | 7,740 | 16,035 | 14,954 | ||||||||||||
| Gross profit | 980 | 4,898 | 7,311 | 9,179 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| 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 | ) | ||||||||
| Interest expense | 1,524 | 1,204 | 3,068 | 2,419 | ||||||||||||
| Loss before provision of income taxes | (10,609 | ) | (9,386 | ) | (18,571 | ) | (17,523 | ) | ||||||||
| Provision for income taxes | 12 | 12 | 24 | 24 | ||||||||||||
| Net loss | (10,621 | ) | (9,398 | ) | (18,595 | ) | (17,547 | ) | ||||||||
| 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 |
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.
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.
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.
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, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Net sales | $ | 10,296 | $ | 12,638 | $ | 23,346 | $ | 24,133 | ||||||||
| Gross profit | 980 | 4,898 | 7,311 | 9,179 | ||||||||||||
| 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 | 9.5 | % | 38.8 | % | 31.3 | % | 38.0 | % | ||||||||
| Gross margin percentage, excluding intangible asset amortization | 17.8 | % | 45.5 | % | 38.6 | % | 45.1 | % |