Full Press Release Details
Aziyo Biologics Reports Third Quarter
2020 Financial Results
SILVER SPRING, Md. - November 19, 2020 -
Aziyo Biologics, Inc. (Nasdaq: AZYO), a commercial-stage regenerative medicine company focused on creating the next generation
of differentiated products and improving outcomes in patients undergoing surgery, today reported
financial results for the three and nine months ended September 30, 2020.
results reflect the strong performance of our Core Products, which showed year-over-year growth in sales over 30%," said
Ron Lloyd, Chief Executive Officer. "Following our initial public offering in October, we are now better positioned financially
and operationally to deliver on the opportunity we have in three large markets within regenerative medicine: implantable electronic
devices, orthopedic and spine repair, and soft tissue reconstruction. Today, we are addressing this estimated $3 billion market
with a comprehensive and growing portfolio of next-generation products driven by an expanding commercial team and partnerships
with industry leaders.
we're especially excited about our strong pipeline of anticipated new product launches, including a growing platform opportunity
with CanGaroo to potentially reduce complications associated with a range of implantable electronic devices," concluded Lloyd.
Net sales for the third
quarter of 2020 were $11.8 million, an increase of 6%, compared to the third quarter of 2019. The increase was driven primarily
by growth of the company's proprietary Core Products, which delivered sales of $10.3 million, a 31% increase over Q3 2019.
Gross profit for the
third quarter of 2020 was $5.5 million and gross margin was 47%, as compared to 50% in the corresponding prior-year period. Gross
margin, excluding intangible asset amortization (a non-GAAP financial measure) was 54% for the third quarter of 2020, as compared
to 57% in the third quarter of 2019. The decrease in gross margin in Q3 2020 primarily resulted from a two-week shutdown of the
company's main production facility, resulting in plant costs being charged directly to cost of goods sold during this shutdown
period rather than being a component of inventory, which allowed for the early completion of maintenance activities that would
otherwise take place closer to year-end.
Total operating expenses
were $8.2 million for the third quarter of 2020, as compared to $7.4 million in the corresponding prior year period, an increase
of 11%. The increase was driven primarily by investments in research and development and increased general and administrative expenses
in anticipation of the company's initial public offering.
Net loss was $6.7 million
in the third quarter of 2020, as compared to $3.1 million in the corresponding period of the prior year. Loss per share
in the third quarter of 2020, which includes the accretion of deemed dividends to the preferred stockholders, was $15.79 per share,
compared to a loss of $4.81 per share in the third quarter of 2019.
Cash and cash equivalents
were $1.6 million as of September 30, 2020. However, following the end of the third quarter of 2020, Aziyo completed its initial
public offering, raising approximately $43.0 million of net proceeds, after deducting underwriting fees and other expenses.
Aziyo will host a conference
call at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time on Thursday November 19, 2020 to discuss its third quarter 2020 financial
results. The call may be accessed through an operator by calling (833) 665-0667 for domestic callers and (914) 987-7319 for international
callers using conference ID number 7952289. A live and archived webcast of the event will be available at https://investors.aziyo.com/.
About Aziyo Biologics
Aziyo Biologics is a commercial-stage regenerative medicine
company focused on creating the next generation of differentiated products and improving outcomes in patients undergoing surgery,
concentrating on patients receiving implantable medical devices. Since its founding in 2015, the Company has created a portfolio
of commercial-stage products used in cardiovascular, orthopedic, and reconstructive specialties. For more information, visit www.Aziyo.com.
Forward-Looking Statements
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 are based on management's current assumptions and
expectations of future events and trends, which affect or may affect the Company's 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. All statements contained in this press release that do not relate to matters of historical fact should be considered
forward-looking statements, including statements and information concerning the Company's anticipated financial performance;
possible or assumed future results of operations, including descriptions of the Company's revenues, profitability, outlook
and overall business strategy; expectations regarding the Company's operational position, opportunities and deliverables,
goals, strategies, priorities and initiatives, including the expansion of the Company's commercial team and partnerships;
and expectations regarding the Company's pipeline and anticipated new product launches, including platform opportunities
with CanGaroo and the potential results thereof. Forward-looking statements are inherently subject to risks and uncertainties,
some of which cannot be predicted or quantified. Factors that could cause actual results to differ materially from those contemplated
in this press release can be found in the Risk Factors section of Aziyo's public filings with the Securities and Exchange
Commission ("SEC"), including Aziyo's 424(b)(4) filed on October 8, 2020 in connection with the company's
initial public offering, as updated in Aziyo's Quarterly Report on Form 10-Q for the quarterly period ended September 30,
2020 to be filed with the SEC, and as such factors may be updated from time to time in Aziyo's other filings with the SEC,
which are accessible on the SEC's website at www.sec.goc and the Investor Relations page of Aziyo's website
at www.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. Except to the extent required by law, the Company undertakes
no obligation to update or review any estimate, projection, or forward-looking statement. Actual results may differ from those
set forth in this press release due to the risks and uncertainties inherent in the Company's business.
Leigh Salvo or Caroline Paul
AZIYO BIOLOGICS, INC.
CONSOLIDATED BALANCE SHEET DATA
(Unaudited, in thousands)
| Assets | September 30, 2020 | December 31, 2019 | ||||||
| Current assets: | ||||||||
| Cash | $ | 1,644 | $ | 2,590 | ||||
| Accounts receivable, net | 7,096 | 7,229 | ||||||
| Inventory | 9,788 | 7,190 | ||||||
| Prepaid expense and other assets | 3,685 | 1,437 | ||||||
| Total current assets | $ | 22,213 | $ | 18,446 | ||||
| Property and equipment, net | 1,140 | 988 | ||||||
| Intangible assets, net | 22,714 | 25,262 | ||||||
| Other assets | 76 | 76 | ||||||
| Total assets | $ | 46,143 | $ | 44,772 | ||||
| Liabilities, Convertible Preferred Stock and Stockholders' Deficit | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 13,542 | $ | 8,955 | ||||
| Current portion of long-term debt and revenue interest obligation | 5,640 | 4,442 | ||||||
| Revolving line of credit | 5,866 | 4,227 | ||||||
| Deferred revenue and other current liabilities | 537 | 650 | ||||||
| Total current liabilities | 25,585 | 18,274 | ||||||
| Long-term debt | 21,201 | 19,612 | ||||||
| Long-term revenue interest obligation | 16,667 | 16,596 | ||||||
| Deferred revenue and other long-term liabilities | 1,001 | 952 | ||||||
| Total liabilities | 64,454 | 55,434 | ||||||
| Convertible preferred stock | 56,593 | 44,449 | ||||||
| Stockholders' deficit: | ||||||||
| Common stock | 1 | 1 | ||||||
| Additional paid-in capital | - | 1,826 | ||||||
| Accumulated deficit | (74,905 | ) | (56,938 | ) | ||||
| Total stockholders' deficit | (74,904 | ) | (55,111 | ) | ||||
| Total liabilities, convertible preferred stock and stockholders' deficit | $ | 46,143 | $ | 44,772 |
AZIYO BIOLOGICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited, in thousands, except share and per share data)
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Net sales | $ | 11,774 | $ | 11,138 | $ | 30,216 | $ | 30,847 | ||||||||
| Cost of goods sold | 6,233 | 5,595 | 15,676 | 15,972 | ||||||||||||
| Gross profit | 5,541 | 5,543 | 14,540 | 14,875 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Sales and marketing | 4,174 | 4,435 | 12,471 | 11,592 | ||||||||||||
| General and administrative | 3,195 | 2,448 | 8,894 | 6,741 | ||||||||||||
| Research and development | 863 | 507 | 2,811 | 1,742 | ||||||||||||
| Total operating expenses | 8,232 | 7,390 | 24,176 | 20,075 | ||||||||||||
| Loss from operations | (2,691 | ) | (1,847 | ) | (9,636 | ) | (5,200 | ) | ||||||||
| Interest expense | 1,465 | 1,249 | 4,248 | 3,935 | ||||||||||||
| Other expense, net | 2,567 | - | 2,567 | - | ||||||||||||
| Loss before provision of income taxes | (6,723 | ) | (3,096 | ) | (16,451 | ) | (9,135 | ) | ||||||||
| Provision for income taxes | 8 | 8 | 18 | 21 | ||||||||||||
| Net loss | (6,731 | ) | (3,104 | ) | (16,469 | ) | (9,156 | ) | ||||||||
| Accretion of Convertible Preferred Stock | 3,510 | - | 3,510 | - | ||||||||||||
| Net loss attributable to common stockholders | $ | (10,241 | ) | $ | (3,104 | ) | $ | (19,979 | ) | $ | (9,156 | ) | ||||
| Net loss per share attributable to common stockholders - | ||||||||||||||||
| basic and diluted | $ | (15.79 | ) | $ | (4.81 | ) | $ | (30.82 | ) | $ | (14.19 | ) | ||||
| Weighted average common shares outstanding - basic and diluted | 648,436 | 645,142 | 648,331 | 645,142 |
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. Gross margin, excluding intangible asset amortization, is a supplemental measure
of our performance, is not defined by or presented in accordance with U.S. generally accepted accounting principles, ("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. 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.
Although we use gross margin, excluding intangible
asset amortization, as described above, this metric has limitations as an analytical tool and should not be considered in isolation
or as a substitute for financial information 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 September 30, | Nine months ended September 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Net sales | $ | 11,774 | $ | 11,138 | $ | 30,216 | $ | 30,847 | ||||||||
| Gross profit | 5,541 | 5,543 | 14,540 | 14,875 | ||||||||||||
| Intangible asset amortization expense | 849 | 849 | 2,548 | 2,548 | ||||||||||||
| Gross profit, excluding intangible asset amortization | $ | 6,390 | $ | 6,392 | $ | 17,089 | $ | 17,424 | ||||||||
| Gross margin | 47 | % | 50 | % | 48 | % | 48 | % | ||||||||
| Gross margin percentage, excluding intangible asset amortization | 54 | % | 57 | % | 57 | % | 56 | % |