Elutia Inc. (Nasdaq: ELUT) (“Elutia”), a company pioneering
drug-eluting biomatrix products, today provided a business update
and financial results for the third quarter ended September 30,
2023.
Business Highlights:
- Successfully
completed transformation to Elutia, establishing a high growth
company dedicated to developing and marketing propriety drug
eluting biomatrices.
- Achieved a
significant 44% year-over-year increase in SimpliDerm® net sales
and an 11% year-over-year growth in CanGaroo® net sales.
- Divested
Orthobiologics business unit for initial gross proceeds of $15
million, and up to $35.0 million in total proceeds.
- Closed private
placement financing, securing initial gross proceeds of
approximately $10.5 million, and up to $26.2 million in total
proceeds.
- Completed
validation of an accelerated in-vitro elution assay for CanGarooRM
and held productive pre-submission meeting with FDA, paving the way
for 510(k) submission in 4Q23.
- Published case
report in peer-reviewed journal Heart Rhythm Case Reports
highlighting the benefits of bioenvelopes for reoperative
procedures.
“This quarter was transformational and I am
pleased that Elutia is off to a great start,” said Dr. Randy Mills,
President and Chief Executive Officer of Elutia. “Our commercial
teams delivered outstanding results, growing our proprietary
product lines, CanGaroo and SimpliDerm, by 26% year-over-year. We
were particularly excited to see SimpliDerm sales accelerate during
the quarter through our partnership with Sientra.”
"Looking ahead, we anticipate submitting our FDA
510(k) filing for CanGarooRM, the most advanced drug-eluting
biomatrix product in our pipeline, before the end of 2023. Having
completed the necessary validation studies, we recently held a
productive pre-submission meeting with the FDA, setting a positive
trajectory ahead of a decision in the first half of 2024. We
believe CanGarooRM represents our greatest near-term opportunity as
we seek to capture a significant share of the CIED envelope market
estimated at $600 million,” remarked Dr. Mills.
Dr. Mills concluded by commenting on recent
financial moves, stating, “Lastly, we completed a private placement
of stock and warrants and closed the divestiture of our
Orthobiologics business unit. These transactions immediately
fortify our balance sheet and have the potential to bring in a
total of $60 million, which we’ll use to drive topline growth,
develop best-in-class products, and retire a portion of our
outstanding debt. Having accomplished these critical steps, we
believe we are poised to deliver substantial value for our
shareholders.”
CanGarooRM Update
In the third quarter, notable progress was made
in advancing the 510(k) filing for CanGarooRM, focused on
addressing completely the issues raised in the not-substantially
equivalent letter we received in March. Our proactive approach
included a presubmission meeting with the FDA to collaboratively
chart the path forward. The FDA's primary request, the
establishment of an accelerated drug release test method, has been
successfully developed and validated. This method, simulating drug
release within 48 hours, meets the requirement of over 80% drug
release for quality control and stability testing. As a result, we
anticipate filing a fully responsive resubmission by year-end.
The market for drug-eluting cardiac device
envelopes is estimated at over $600 million annually. As only the
second entrant and the sole product offering the combined benefits
of a biological envelope and potent antibiotics, rifampin and
minocycline, we believe CanGarooRM is well-positioned to compete
effectively in this space.
Third Quarter 2023 Financial Results
Net sales for the third quarter of 2023 were
$6.1 million, compared to $5.8 million in the third quarter of
2022. Net sales of both SimpliDerm and CanGaroo performed well,
growing 44% and 11%, respectively, versus the third quarter of
2022. Net sales growth was partially offset by a decline from the
Cardiovascular business unit 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 third quarter of 2023 was
$2.8 million and gross margin was 46.4%, as compared to $2.9
million and 50.2%, 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 60.2% for the third quarter of
2023, as compared to 64.8% in the third quarter of 2022. The
decline in gross margin was primarily related to the Cardiovascular
business which declined due to the previously mentioned transition
to distributor sales versus direct sales in the prior-year
period.
Total operating expenses were $10.2 million for
the third quarter of 2023, down 14% as compared to $11.9 million in
the corresponding prior-year period.
Net loss from continuing operations was $8.5
million in the third quarter of 2023, down 23% as compared to $11.0
million in the third quarter of 2022. Net loss from continuing
operations per share in the third quarter of 2023 was $0.50 per
share, as compared to a loss of $0.81 per share in the third
quarter of 2022.
Net loss from discontinued operations was $1.2
million in the third quarter of 2023, as compared to net income of
$1.1 million in the corresponding prior-year period. Net loss from
discontinued operations per share in the third quarter of 2023 was
$0.07 per share, as compared to net income of $0.08 per share in
the third quarter of 2022.
Elutia’s cash balance as of September 30, 2023,
was $14.5 million, which includes the initial gross proceeds from
the private placement completed in September 2023 of approximately
$10.5 million but does not include proceeds from the Orthobiologics
business unit divestiture that closed in November 2023.
Conference Call
Elutia will host a conference call today at 4:30
p.m. Eastern Time / 1:30 p.m. Pacific Time to discuss its third
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 Elutia website at investors.elutia.com.
About Elutia
Elutia 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, Elutia’s mission is humanizing medicine
so patients can thrive without compromise. For more information,
visit www.Elutia.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 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 our expectations for our drug-eluting
biomatrix technology aimed at improving surgical outcomes, any
milestones or projections for our CanGaroo® and SimpliDerm®
products and the outcome of our FDA 510(k) submission for our
CanGarooRM product. 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 associated with
shifting focus to our drug-eluting biomatrix solutions in the
cardiovascular and breast reconstruction areas and away from our
now-divested Orthobiologics business; 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 the divestiture of our
Orthobiologics 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;
the possibility of adverse determinations in our FDA 510(k)
submission process; future revenues of the disposed-of
Orthobiologics business and its impact on “earn out” provisions in
the related acquisition agreement; the possibility that our stock
will be delisted from the Nasdaq Capital Market; and our
intellectual property rights, and other important factors which can
be found in the “Risk Factors” section of Elutia’s public filings
with the Securities and Exchange Commission (“SEC”), including
Elutia’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 Elutia’s
other filings with the SEC, including Elutia’s Quarterly Reports on
Form 10-Q, accessible on the SEC’s website at www.sec.gov and the
Investor Relations page of Elutia’s website at
https://investors.elutia.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 Elutia 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, Elutia 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.
Investors:Matt SteinbergFINN
Partnersmatt.steinberg@finnpartners.com
ELUTIA INC.CONDENSED CONSOLIDATED BALANCE
SHEETS(In Thousands, Except for Share and Per
Share Data) |
|
(UNAUDITED) |
|
|
September 30, |
|
December 31, |
|
|
2023 |
|
|
2022 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash |
|
$ |
14,517 |
|
|
$ |
16,989 |
|
Accounts receivable, net of credit loss reserve of $652 and $87,
respectively |
|
|
2,883 |
|
|
|
3,774 |
|
Inventory |
|
|
6,503 |
|
|
|
4,240 |
|
Receivables of FiberCel litigation costs |
|
|
7,452 |
|
|
|
13,813 |
|
Prepaid expenses and other current assets |
|
|
452 |
|
|
|
2,387 |
|
Current assets of discontinued operations |
|
|
7,320 |
|
|
|
9,496 |
|
Total current assets |
|
|
39,127 |
|
|
|
50,699 |
|
|
|
|
|
|
|
|
Property and equipment,
net |
|
|
175 |
|
|
|
245 |
|
Intangible assets, net |
|
|
12,520 |
|
|
|
15,069 |
|
Operating lease right-of-use
assets and other |
|
|
155 |
|
|
|
320 |
|
Noncurrent assets of
discontinued operations |
|
|
2,603 |
|
|
|
2,508 |
|
Total assets |
|
$ |
54,580 |
|
|
$ |
68,841 |
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Deficit |
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
2,962 |
|
|
$ |
1,374 |
|
Accrued expenses and other current liabilities |
|
|
10,723 |
|
|
|
8,830 |
|
Payables to tissue suppliers |
|
|
707 |
|
|
|
900 |
|
Current portion of revenue interest obligation |
|
|
11,053 |
|
|
|
8,990 |
|
Contingent liability for FiberCel litigation |
|
|
15,702 |
|
|
|
17,360 |
|
Current operating lease liabilities |
|
|
399 |
|
|
|
232 |
|
Current liabilities of discontinued operations |
|
|
3,190 |
|
|
|
4,929 |
|
Total current liabilities |
|
|
44,736 |
|
|
|
42,615 |
|
|
|
|
|
|
|
|
Long-term debt |
|
|
25,278 |
|
|
|
24,260 |
|
Long-term revenue interest
obligation |
|
|
5,471 |
|
|
|
5,916 |
|
Warrants and other long-term
liabilities |
|
|
7,983 |
|
|
|
127 |
|
Noncurrent liabilities of
discontinued operations |
|
|
585 |
|
|
|
956 |
|
Total liabilities |
|
|
84,053 |
|
|
|
73,874 |
|
|
|
|
|
|
|
|
Commitments and contingencies
(Note 10) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity (deficit): |
|
|
|
|
|
|
Class A Common stock, $0.001 par value, 200,000,000 shares
authorized as of September 30, 2023 and
December 31, 2022, and 18,852,930 and 11,823,445 shares
issued and outstanding, as of September 30, 2023 and
December 31, 2022, respectively |
|
|
19 |
|
|
|
12 |
|
Class B Common stock, $0.001 par value, 20,000,000 shares
authorized, as of September 30, 2023 and
December 31, 2022 and 4,313,406 issued and outstanding as
of September 30, 2023 and
December 31, 2022 |
|
|
4 |
|
|
|
4 |
|
Additional paid-in capital |
|
|
136,834 |
|
|
|
132,939 |
|
Accumulated deficit |
|
|
(166,330 |
) |
|
|
(137,988 |
) |
Total stockholders’ deficit |
|
|
(29,473 |
) |
|
|
(5,033 |
) |
Total liabilities and stockholders' deficit |
|
$ |
54,580 |
|
|
$ |
68,841 |
|
ELUTIA INC.CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS(In Thousands, Except
Share and Per Share Data) |
|
(UNAUDITED) |
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Net sales |
|
$ |
6,127 |
|
|
$ |
5,849 |
|
|
$ |
18,870 |
|
|
$ |
17,262 |
|
Cost of goods sold |
|
|
3,286 |
|
|
|
2,910 |
|
|
|
9,943 |
|
|
|
8,689 |
|
Gross profit |
|
|
2,841 |
|
|
|
2,939 |
|
|
|
8,927 |
|
|
|
8,573 |
|
Sales and marketing |
|
|
2,802 |
|
|
|
4,379 |
|
|
|
10,514 |
|
|
|
13,672 |
|
General and
administrative |
|
|
2,757 |
|
|
|
4,330 |
|
|
|
10,137 |
|
|
|
12,788 |
|
Research and development |
|
|
557 |
|
|
|
1,723 |
|
|
|
3,016 |
|
|
|
5,867 |
|
FiberCel litigation costs,
net |
|
|
4,096 |
|
|
|
1,474 |
|
|
|
7,278 |
|
|
|
1,908 |
|
Total operating expenses |
|
|
10,212 |
|
|
|
11,906 |
|
|
|
30,945 |
|
|
|
34,235 |
|
Loss from operations |
|
|
(7,371 |
) |
|
|
(8,967 |
) |
|
|
(22,018 |
) |
|
|
(25,662 |
) |
Interest expense |
|
|
1,448 |
|
|
|
1,247 |
|
|
|
4,285 |
|
|
|
3,666 |
|
Other income, net |
|
|
(312 |
) |
|
|
803 |
|
|
|
(312 |
) |
|
|
803 |
|
Loss before provision for income taxes |
|
|
(8,507 |
) |
|
|
(11,017 |
) |
|
|
(25,991 |
) |
|
|
(30,131 |
) |
Income tax expense |
|
|
12 |
|
|
|
12 |
|
|
|
36 |
|
|
|
36 |
|
Net loss from continuing operations |
|
|
(8,519 |
) |
|
|
(11,029 |
) |
|
|
(26,027 |
) |
|
|
(30,167 |
) |
Discontinued operations |
|
|
(1,228 |
) |
|
|
1,119 |
|
|
|
(2,315 |
) |
|
|
2,710 |
|
Net loss |
|
|
(9,747 |
) |
|
$ |
(9,910 |
) |
|
|
(28,342 |
) |
|
$ |
(27,457 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss from continuing
operations per share - basic and diluted |
|
$ |
(0.50 |
) |
|
$ |
(0.81 |
) |
|
$ |
(1.58 |
) |
|
$ |
(2.22 |
) |
Net loss from discontinued
operations per share - basic and diluted |
|
$ |
(0.07 |
) |
|
$ |
0.08 |
|
|
$ |
(0.14 |
) |
|
$ |
0.20 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding - basic and diluted |
|
|
17,017,610 |
|
|
|
13,660,555 |
|
|
|
16,464,262 |
|
|
|
13,618,580 |
|
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 |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2023 |
|
2022 |
|
|
2023 |
|
2022 |
|
Net sales |
|
$ |
6,127 |
|
$ |
5,849 |
|
|
$ |
18,870 |
|
$ |
17,262 |
|
Cost of goods sold |
|
|
3,286 |
|
|
2,910 |
|
|
|
9,943 |
|
|
8,689 |
|
Gross profit |
|
|
2,841 |
|
|
2,939 |
|
|
|
8,927 |
|
|
8,573 |
|
Intangible asset amortization expense |
|
|
849 |
|
|
849 |
|
|
|
2,547 |
|
|
2,547 |
|
Gross profit, excluding
intangible asset amortization |
|
$ |
3,690 |
|
$ |
3,788 |
|
|
$ |
11,474 |
|
$ |
11,120 |
|
Gross margin |
|
|
46.4 |
% |
|
50.2 |
% |
|
|
47.3 |
% |
|
49.7 |
% |
Gross margin, excluding
intangible asset amortization |
|
|
60.2 |
% |
|
64.8 |
% |
|
|
60.8 |
% |
|
64.4 |
% |
Elutia (NASDAQ:ELUT)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Elutia (NASDAQ:ELUT)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024