Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and
marketing innovative surgical solutions for peripheral nerve
injuries, today reported financial results and business highlights
for the second quarter ended June 30, 2023.
Second Quarter Financial Results and
Business Highlights
- Revenue was $38.2
million during the second quarter, an increase of approximately 11%
over the second quarter of 2022.
- The Company
estimates that revenues from scheduled non-trauma procedures
represented approximately half of total revenues during the second
quarter and grew over 20% from the second quarter of 2022.
- The Company
estimates that revenues from emergent trauma procedures represented
approximately half of total revenues during the second quarter and
grew in the low single digit range versus the second quarter of
2022.
- Gross margin was
81.1% for the quarter, compared to 81.8% in the second quarter of
2022.
- Net loss of $6.7
million, or $0.16 per share, compared to net loss of $7.7 million,
or $0.18 per share in the second quarter of 2022.
- Adjusted net loss
of $1.3 million, or $0.03 per share, compared to adjusted net loss
of $2.6 million, or $0.05 per share, in the second quarter of
2022.
- Adjusted EBITDA
loss of $0.2 million, compared to an adjusted EBITDA loss of $1.6
million in the second quarter of 2022.
- The balance of all
cash and cash equivalents and investments on June 30, 2023,
was $40.8 million, as compared to $44.1 million on March 31,
2023. The net change includes capital expenditures of $3.6 million
related to the construction of the Company's new processing
facility in Dayton, OH, partially offset by $0.3 million of net
positive other operating cash flow in the quarter.
- The Company
successfully initiated the pilot launch of the Axoguard HA+ Nerve
Protector™ in the second quarter and will fully launch this
extension of its nerve protection platform later this month.
- On August 2nd the
Phase 3 RECON study was published online in The Journal of Hand
Surgery. The Company had previously announced in May of 2022 that
RECON had met its primary endpoint. The publication includes the
authors analysis of the results, which found that Avance returned a
greater degree of functional recovery than conduits and superiority
was demonstrated as gap lengths increased.
"We are encouraged by the continued momentum of
our overall business, which was led by over 20% growth of scheduled
procedures," stated Karen Zaderej, AxoGen's Chairman, CEO, and
President. "The strength of our scheduled procedures category is
delivering on the Company’s underlying goal of gaining deeper
surgeon adoption and expanded use cases of our products across our
core and active accounts."
"Emergent trauma procedures continue to
experience headwinds as hospitals prioritize resources and address
operating challenges particularly with routine trauma procedures.
We believe that these challenges are transient and that recent
clinical publications, demonstrating the clinical effectiveness,
cost, and surgical time efficiencies of allograft nerve repairs,
will support continued surgeon adoption and expansion of the trauma
category,” continued Zaderej.
- Core
Accounts totaled 347, an increase of 16% over an adjusted*
prior-year level of 299, and a decrease of 1% sequentially. Revenue
from Core Accounts continued to represent approximately 60% of
total revenue.
- Active
Accounts totaled 974, an increase of 4% over an adjusted*
prior-year level of 941, and a decrease of 1% sequentially. Revenue
from the top 10% of Active Accounts represents approximately 35% of
total revenue.
- Ended the
quarter with over 200 peer-reviewed clinical publications featuring
Axogen’s nerve repair product portfolio.
- We ended
the quarter with 115 direct sales representatives compared to 116
on March 31, 2023 and a year ago.
Update on Axogen Processing Center (APC)
and BLA Submission
The Company completed construction of the APC
and in the second quarter placed into service the warehouse and
office spaces, and now expects to begin processing tissue in the
new facility later this month. The Company will include tissue
processing information from the APC in its submission of the BLA
for Avance Nerve Graft. Additionally, the Company will be
requesting to utilize a rolling submission process with the FDA at
a pre-BLA meeting that is expected to occur early first quarter of
2024. If the FDA agrees, the Company expects to begin the
submission in the first quarter of 2024 and complete the submission
in the second quarter of 2024. The company believes this process
will support BLA approval in the first half 2025.
Axoguard HA+ Nerve Protector Launch
The Company successfully initiated the pilot
launch of the Axoguard HA+ Nerve Protector™ in the second quarter
and will fully launch this extension of its nerve protection
platform later this month. Axoguard HA+ Nerve Protector is a
proprietary nerve protection device designed to provide short- and
long-term protection for peripheral nerve injuries. The device is
comprised of a processed porcine submucosa extracellular matrix
(ECM) base layer with a hyaluronate-alginate gel coating. The gel
layer facilitates enhanced nerve gliding to aid in minimizing soft
tissue attachments, while the base layer is remodeled into a
long-term protective tissue layer. It is available in a variety of
sizes to meet patients' and surgeons' needs.
2023 Financial Guidance
Management is maintaining full-year 2023 revenue
guidance in the range of $154 million to $159 million, which
represents annual growth of 11% - 15%. The Company anticipates that
gross margin will be reduced with the transition to the new
processing facility in the third and fourth quarters and that gross
margins for the full year 2023 will be approximately 80%.
*The Company voluntarily suspended market
availability of Avive® Soft Tissue Membrane on June 1, 2021; and
therefore, no Avive revenue was recorded in 2022. Core and Active
Account metrics for prior periods were adjusted for Avive revenue.
For a reconciliation of adjusted Core and Active Account numbers,
please see our Corporate Presentation on the investors page on
www.axogeninc.com.
Conference Call
The Company will host a conference call and
webcast for the investment community today at 4:30 p.m. ET.
Investors interested in participating in the conference call by
phone may do so by dialing toll free at (877) 407-0993 or use the
direct dial-in number at (201) 689-8795. Those interested in
listening to the conference call live via the Internet may do so by
visiting the Investors page of the Company's website at
www.axogeninc.com and clicking on the webcast link.
Following the conference call, a replay will be
available in the Investors section of the Company's website at
www.axogeninc.com under Investors.
About RECON
RECON is a multicenter, prospective, randomized,
subject and evaluator blinded comparative clinical study of nerve
cuffs (manufactured conduits) and Avance® Nerve Graft, evaluating
recovery outcomes for the repair of nerve discontinuities. The
phase 3 pivotal study is designed to provide clinical evidence for
the Company’s BLA filing to transition the Company’s Avance Nerve
Graft from a section 361 tissue product to a section 351 biologic
product; and, as such was designed to test for non-inferiority
between static two-point discrimination outcomes for Avance Nerve
Graft and manufactured conduit. The study design also allows for a
sequential test for superiority of Avance Nerve Graft, following
the non-inferiority analysis.
About Avance Nerve Graft
Avance Nerve Graft is a biologically active
off-the-shelf processed human nerve allograft for bridging severed
peripheral nerves without the comorbidities associated with a
second surgical site. Avance provides structural guidance for
regenerating axons, and revascularizes and remodels into the
patient’s own tissue. It is available in a variety of lengths and
diameters.
A 2010 written agreement between the FDA and
Axogen allows the company to continue marketing Avance as a section
361 Human Cells, Tissues and Cellular and Tissue Based Product
(HCT/P) while taking the necessary steps to file a Biologics
License Application (BLA) under section 351.
In 2018 the FDA granted a Regenerative Medicine
Advance Therapy (RMAT) designation for Avance Nerve Graft. A
regenerative medicine therapy is eligible for the designation if it
is intended to treat, modify, reverse, or cure a serious or
life-threatening disease or condition, and preliminary clinical
evidence indicates that the product has the potential to address
unmet medical needs for such a disease or condition. The RMAT
designation provides access to a streamlined approval process for
regenerative medicine technologies and ensures continued informal
meetings with the FDA in support of the BLA for Avance Nerve
Graft.
About Axogen
Axogen (AXGN) is the leading Company focused
specifically on the science, development, and commercialization of
technologies for peripheral nerve regeneration and repair. Axogen
employees are passionate about helping to restore peripheral nerve
function and quality of life to patients with physical damage or
transection to peripheral nerves by providing innovative,
clinically proven, and economically effective repair solutions for
surgeons and health care providers. Peripheral nerves provide the
pathways for both motor and sensory signals throughout the body.
Every day, people suffer traumatic injuries or undergo surgical
procedures that impact the function of their peripheral nerves.
Physical damage to a peripheral nerve, or the inability to properly
reconnect peripheral nerves, can result in the loss of muscle or
organ function, the loss of sensory feeling, or the initiation of
pain.
Axogen's platform for peripheral nerve repair
features a comprehensive portfolio of products that are used across
two primary application categories: scheduled, non-trauma
procedures and emergent trauma procedures. Scheduled procedures are
generally characterized as those where a patient is seeking relief
from conditions caused by a nerve defect or surgical procedure.
These procedures include providing sensation for women seeking
breast reconstruction following a mastectomy, nerve reconstruction
following the surgical removal of painful neuromas, oral and
maxillofacial procedures, and nerve decompression. Emergent
procedures are generally characterized as procedures resulting from
injuries that initially present in an ER. These procedures are
typically referred to and completed by a specialist either
immediately or within a few days following the initial injury.
Axogen’s product portfolio includes Avance®
Nerve Graft, a biologically active off-the-shelf processed human
nerve allograft for bridging severed peripheral nerves without the
comorbidities associated with a second surgical site; Axoguard
Nerve Connector®, a porcine submucosa ECM coaptation aid for
tensionless repair of severed peripheral nerves; Axoguard Nerve
Protector®, a porcine submucosa ECM product used to wrap and
protect damaged peripheral nerves and reinforce the nerve
reconstruction while preventing soft tissue attachments; Axoguard
HA+ Nerve Protector™, a porcine submucosa ECM base layer coated
with a proprietary hyaluronate-alginate gel, a next-generation
technology designed to provide short- and long-term protection for
peripheral nerve injuries; and Axoguard Nerve Cap®, a porcine
submucosa ECM product used to protect a peripheral nerve end and
separate the nerve from the surrounding environment to reduce the
development of symptomatic or painful neuroma. The Axogen portfolio
of products is available in the United States, Canada, Germany, the
United Kingdom, Spain, South Korea, and several other
countries.
Cautionary Statements Concerning
Forward-Looking StatementsThis press
release contains “forward-looking” statements as defined in the
Private Securities Litigation Reform Act of 1995. These statements
are based on management's current expectations or predictions of
future conditions, events, or results based on various assumptions
and management's estimates of trends and economic factors in the
markets in which we are active, as well as our business plans.
Words such as “expects,” “anticipates,” “intends,” “plans,”
“believes,” “seeks,” “estimates,” “projects,” “forecasts,”
“continue,” “may,” “should,” “will,” “goals,” and variations of
such words and similar expressions are intended to identify such
forward-looking statements. Forward-looking statements include
statements about (i) fully launching Axoguard HA+ later this month,
(ii) anticipated timetable for seeking approval of the rolling BLA
submission in early first quarter of 2024, (iii) subject to
approval of the rolling submission, anticipated timetable for the
initial BLA submission in the first quarter of 2024 and completion
in the second quarter of 2024, (iv) potential BLA approval in the
first half of 2025, and (v) initial processing of tissue in the new
facility later this month, as well as statements under the
subheading "2023 Financial Guidance." Actual results or events
could differ materially from those described in any forward-looking
statements as a result of various factors, including, without
limitation, statements related to the continued impact of COVID-19,
global supply chain issues, record inflation, hospital staffing
issues, product development, product potential, expected clinical
enrollment timing and outcomes, regulatory process and approvals,
APC renovation timing and expense, financial performance, sales
growth, surgeon and product adoption, market awareness of our
products, data validation, our visibility at and sponsorship of
conferences and educational events, global business disruption
caused by Russia’s invasion of Ukraine and related sanctions, as
well as those risk factors described under Part I, Item 1A., “Risk
Factors,” of our Annual Report on Form 10-K for the most recently
ended fiscal year. Forward-looking statements are not a guarantee
of future performance, and actual results may differ materially
from those projected. The forward-looking statements are
representative only as of the date they are made and, except as
required by applicable law, we assume no responsibility to publicly
update or revise any forward-looking statements.
About Non-GAAP Financial Measures
To supplement our consolidated financial
statements, we use the non-GAAP financial measures of EBITDA, which
measures earnings before interest, income taxes, and depreciation
and amortization, and Adjusted EBITDA which further excludes
non-cash stock compensation expense and litigation and related
expenses. We also use the non-GAAP financial measures of Adjusted
Net Loss and Adjusted Net Loss Per Common Share - basic and diluted
which excludes non-cash stock compensation expense and litigation
and related expenses from Net Loss and Net Loss Per Common Share -
basic and diluted, respectively. These non-GAAP measures are not
based on any comprehensive set of accounting rules or principles
and should not be considered a substitute for, or superior to,
financial measures calculated in accordance with GAAP, and may be
different from non-GAAP measures used by other companies. In
addition, these non-GAAP measures should be read in conjunction
with our financial statements prepared in accordance with GAAP. The
reconciliations of the non-GAAP measures to the most directly
comparable financial measures calculated and presented in
accordance with GAAP should be carefully evaluated.
We use these non-GAAP financial measures for
financial and operational decision-making and as a means to
evaluate period-to-period comparisons. We believe that these
non-GAAP financial measures provide meaningful supplemental
information regarding our performance and that both management and
investors benefit from referring to these non-GAAP financial
measures in assessing our performance and when planning,
forecasting, and analyzing future periods. We believe these
non-GAAP financial measures are useful to investors because (1)
they allow for greater transparency with respect to key metrics
used by management in its financial and operational decision-making
and (2) they are used by our institutional investors and the
analyst community to help them analyze the performance of our
business, the Company’s cash available for operations, and the
Company’s ability to meet future capital expenditure and working
capital requirements.
Contact:Axogen, Inc.InvestorRelations@axogeninc.com |
|
Axogen, Inc. |
Condensed Consolidated Balance Sheets |
(unaudited) |
(In thousands, except share and per share
amounts) |
|
|
June 30,2023 |
|
December 31,2022 |
Assets |
|
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
23,219 |
|
|
$ |
15,284 |
|
Restricted cash |
|
6,252 |
|
|
|
6,251 |
|
Investments |
|
11,312 |
|
|
|
33,505 |
|
Accounts receivable, net of allowance for doubtful accounts of $595
and $650, respectively |
|
21,573 |
|
|
|
22,186 |
|
Inventory |
|
21,237 |
|
|
|
18,905 |
|
Prepaid expenses and other |
|
2,583 |
|
|
|
1,944 |
|
Total current assets |
|
86,176 |
|
|
|
98,075 |
|
Property and equipment,
net |
|
87,459 |
|
|
|
79,294 |
|
Operating lease right-of-use
assets |
|
13,958 |
|
|
|
14,369 |
|
Intangible assets, net |
|
4,048 |
|
|
|
3,649 |
|
Total assets |
$ |
191,641 |
|
|
$ |
195,387 |
|
|
|
|
|
Liabilities and
shareholders’ equity |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable and accrued expenses |
$ |
22,893 |
|
|
$ |
22,443 |
|
Current maturities of long-term lease obligations |
|
1,040 |
|
|
|
1,310 |
|
Total current liabilities |
|
23,933 |
|
|
|
23,753 |
|
|
|
|
|
Long-term debt, net of debt
discount and financing fees |
|
46,154 |
|
|
|
45,712 |
|
Long-term lease
obligations |
|
20,131 |
|
|
|
20,405 |
|
Debt derivative
liabilities |
|
4,271 |
|
|
|
4,518 |
|
Total liabilities |
|
94,489 |
|
|
|
94,388 |
|
|
|
|
|
Commitments and
contingencies - see Note 12 |
|
|
|
|
|
|
|
Shareholders’
equity: |
|
|
|
Common stock, $0.01 par value
per share; 100,000,000 shares authorized; 42,979,541 and 42,445,517
shares issued and outstanding |
|
430 |
|
|
|
424 |
|
Additional paid-in capital |
|
370,036 |
|
|
|
360,155 |
|
Accumulated deficit |
|
(273,314 |
) |
|
|
(259,580 |
) |
Total shareholders’ equity |
|
97,152 |
|
|
|
100,999 |
|
Total liabilities and shareholders’ equity |
$ |
191,641 |
|
|
$ |
195,387 |
|
|
Axogen, Inc. |
Condensed Consolidated Statements of
Operation |
(unaudited) |
(In thousands, except per share amounts) |
|
|
Three Months Ended |
|
Six Months Ended |
|
June 30,2023 |
|
June 30,2022 |
|
June 30,2023 |
|
June 30,2022 |
|
|
|
|
|
|
|
|
Revenues |
$ |
38,155 |
|
|
$ |
34,454 |
|
|
$ |
74,819 |
|
|
$ |
65,461 |
|
Cost of goods
sold |
|
7,228 |
|
|
|
6,284 |
|
|
|
13,937 |
|
|
|
11,830 |
|
Gross profit |
|
30,927 |
|
|
|
28,170 |
|
|
|
60,882 |
|
|
|
53,631 |
|
Costs and
expenses: |
|
|
|
|
|
|
|
Sales and marketing |
|
20,838 |
|
|
|
19,669 |
|
|
|
42,456 |
|
|
|
40,557 |
|
Research and development |
|
7,363 |
|
|
|
7,022 |
|
|
|
14,043 |
|
|
|
13,296 |
|
General and administrative |
|
9,628 |
|
|
|
9,403 |
|
|
|
18,627 |
|
|
|
19,021 |
|
Total costs and expenses |
|
37,829 |
|
|
|
36,094 |
|
|
|
75,126 |
|
|
|
72,874 |
|
Loss from operations |
|
(6,902 |
) |
|
|
(7,924 |
) |
|
|
(14,244 |
) |
|
|
(19,243 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
Investment income (loss) |
|
235 |
|
|
|
32 |
|
|
|
784 |
|
|
|
(15 |
) |
Interest expense |
|
(148 |
) |
|
|
(249 |
) |
|
|
(164 |
) |
|
|
(603 |
) |
Change in fair value of derivatives |
|
432 |
|
|
|
434 |
|
|
|
247 |
|
|
|
686 |
|
Other expense |
|
(277 |
) |
|
|
(33 |
) |
|
|
(357 |
) |
|
|
(40 |
) |
Total other income, net |
|
242 |
|
|
|
184 |
|
|
|
510 |
|
|
|
28 |
|
Net loss |
$ |
(6,660 |
) |
|
$ |
(7,740 |
) |
|
$ |
(13,734 |
) |
|
$ |
(19,215 |
) |
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding — basic and diluted |
|
42,862,384 |
|
|
|
41,994,618 |
|
|
|
42,719,096 |
|
|
|
41,900,000 |
|
Loss per common share — basic
and diluted |
$ |
(0.16 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.32 |
) |
|
$ |
(0.46 |
) |
|
Axogen, Inc. |
RECONCILIATION OF GAAP FINANCIAL MEASURES TO NON-GAAP
FINANCIAL MEASURES |
Three Months Ended March 31, 2023 and 2022 |
(unaudited) |
(In thousands, except per share amounts) |
|
|
Three Months Ended |
|
Six Months Ended |
|
June 30,2023 |
|
June 30,2022 |
|
June 30,2023 |
|
June 30,2022 |
|
|
|
|
|
|
|
|
Net loss |
$ |
(6,660 |
) |
|
$ |
(7,740 |
) |
|
$ |
(13,734 |
) |
|
$ |
(19,215 |
) |
Depreciation and amortization
expense |
|
871 |
|
|
|
777 |
|
|
|
1,650 |
|
|
|
1,550 |
|
Investment (income) loss |
|
(235 |
) |
|
|
(32 |
) |
|
|
(784 |
) |
|
|
15 |
|
Income tax expense |
|
240 |
|
|
|
33 |
|
|
|
318 |
|
|
|
33 |
|
Interest expense |
|
148 |
|
|
|
249 |
|
|
|
164 |
|
|
|
603 |
|
EBITDA - non
GAAP |
$ |
(5,636 |
) |
|
$ |
(6,713 |
) |
|
$ |
(12,386 |
) |
|
$ |
(17,014 |
) |
|
|
|
|
|
|
|
|
Non cash stock-based
compensation expense |
|
5,390 |
|
|
|
4,910 |
|
|
|
8,344 |
|
|
|
7,588 |
|
Litigation and related
costs |
|
— |
|
|
|
216 |
|
|
|
— |
|
|
|
483 |
|
Adjusted EBITDA - non
GAAP |
$ |
(246 |
) |
|
$ |
(1,587 |
) |
|
$ |
(4,042 |
) |
|
$ |
(8,943 |
) |
|
|
|
|
|
|
|
|
Net loss |
$ |
(6,660 |
) |
|
$ |
(7,740 |
) |
|
$ |
(13,734 |
) |
|
$ |
(19,215 |
) |
Non cash stock-based
compensation expense |
|
5,390 |
|
|
|
4,910 |
|
|
|
8,344 |
|
|
|
7,588 |
|
Litigation and related
costs |
|
— |
|
|
|
216 |
|
|
|
— |
|
|
|
483 |
|
Adjusted net loss -
non GAAP |
$ |
(1,270 |
) |
|
$ |
(2,614 |
) |
|
$ |
(5,390 |
) |
|
$ |
(11,144 |
) |
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding — basic and diluted |
|
42,862,384 |
|
|
|
41,994,618 |
|
|
|
42,719,096 |
|
|
|
41,900,000 |
|
|
|
|
|
|
|
|
|
Loss per common share
— basic and diluted |
$ |
(0.16 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.32 |
) |
|
$ |
(0.46 |
) |
Non cash stock-based
compensation expense |
|
0.13 |
|
|
|
0.12 |
|
|
$ |
0.20 |
|
|
$ |
0.18 |
|
Litigation and related
costs |
|
— |
|
|
|
0.01 |
|
|
$ |
— |
|
|
$ |
0.01 |
|
Adjusted net loss per
common share — basic and diluted - non GAAP |
$ |
(0.03 |
) |
|
$ |
(0.05 |
) |
|
$ |
(0.12 |
) |
|
$ |
(0.27 |
) |
|
Axogen, Inc. |
Condensed Consolidated Statements of Changes in
Shareholders’ Equity |
(unaudited) |
(In thousands, except share amounts) |
|
|
|
|
|
|
|
|
|
Common Stock |
|
Additional Paid-inCapital |
|
AccumulatedDeficit |
|
Total Shareholders'Equity |
|
Shares |
|
Amount |
|
|
|
Three Months Ended
June 30, 2023 |
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2023 |
42,809,994 |
|
|
$ |
428 |
|
|
$ |
363,739 |
|
|
$ |
(266,654 |
) |
|
$ |
97,513 |
|
Net loss |
— |
|
|
|
— |
|
|
|
— |
|
|
|
(6,660 |
) |
|
|
(6,660 |
) |
Stock-based compensation |
— |
|
|
|
— |
|
|
|
5,390 |
|
|
|
— |
|
|
|
5,390 |
|
Issuance of restricted and
performance stock units |
57,659 |
|
|
|
1 |
|
|
|
(1 |
) |
|
|
— |
|
|
|
— |
|
Exercise of stock options and
employee stock purchase plan |
111,888 |
|
|
|
1 |
|
|
|
908 |
|
|
|
— |
|
|
|
909 |
|
Balance at June 30,
2023 |
42,979,541 |
|
|
$ |
430 |
|
|
$ |
370,036 |
|
|
$ |
(273,314 |
) |
|
$ |
97,152 |
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June
30, 2023 |
|
|
|
|
|
|
|
|
|
|
Balance at December
31, 2022 |
42,445,517 |
|
|
$ |
424 |
|
|
$ |
360,155 |
|
|
$ |
(259,580 |
) |
|
$ |
100,999 |
|
Net loss |
— |
|
|
|
— |
|
|
|
— |
|
|
|
(13,734 |
) |
|
|
(13,734 |
) |
Stock-based compensation |
— |
|
|
|
— |
|
|
|
8,344 |
|
|
|
— |
|
|
|
8,344 |
|
Issuance of restricted and
performance stock units |
296,378 |
|
|
|
4 |
|
|
|
(4 |
) |
|
|
— |
|
|
|
— |
|
Exercise of stock options and
employee stock purchase plan |
237,646 |
|
|
|
2 |
|
|
|
1,541 |
|
|
|
— |
|
|
|
1,543 |
|
Balance at June 30,
2023 |
42,979,541 |
|
|
$ |
430 |
|
|
$ |
370,036 |
|
|
$ |
(273,314 |
) |
|
$ |
97,152 |
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30, 2022 |
|
|
|
|
|
|
|
|
|
|
Balance at March 31,
2022 |
41,972,987 |
|
|
$ |
420 |
|
|
$ |
345,538 |
|
|
$ |
(242,107 |
) |
|
$ |
103,851 |
|
Net loss |
— |
|
|
|
— |
|
|
|
— |
|
|
|
(7,740 |
) |
|
|
(7,740 |
) |
Stock-based compensation |
|
|
|
|
— |
|
|
|
4,910 |
|
|
|
— |
|
|
|
4,910 |
|
Issuance of restricted and
performance stock units |
44,054 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Exercise of stock options and
employee stock purchase plan |
117,463 |
|
|
|
— |
|
|
|
669 |
|
|
|
— |
|
|
|
669 |
|
Balance at June 30,
2022 |
42,134,504 |
|
|
$ |
420 |
|
|
$ |
351,117 |
|
|
$ |
(249,847 |
) |
|
$ |
101,690 |
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June
30, 2022 |
|
|
|
|
|
|
|
|
|
|
Balance at December
31, 2021 |
41,736,950 |
|
|
$ |
417 |
|
|
$ |
342,765 |
|
|
$ |
(230,632 |
) |
|
$ |
112,550 |
|
Net loss |
— |
|
|
|
— |
|
|
|
— |
|
|
|
(19,215 |
) |
|
|
(19,215 |
) |
Stock-based compensation |
— |
|
|
|
— |
|
|
|
7,588 |
|
|
|
— |
|
|
|
7,588 |
|
Issuance of restricted and
performance stock units |
259,341 |
|
|
|
2 |
|
|
|
(2 |
) |
|
|
— |
|
|
|
— |
|
Exercise of stock options and
employee stock purchase plan |
138,213 |
|
|
|
1 |
|
|
|
766 |
|
|
|
— |
|
|
|
767 |
|
Balance at June 30,
2022 |
42,134,504 |
|
|
$ |
420 |
|
|
$ |
351,117 |
|
|
$ |
(249,847 |
) |
|
$ |
101,690 |
|
|
Axogen, Inc. |
Condensed Consolidated Statements of Cash
Flows |
(unaudited) |
(In Thousands) |
|
|
Six Months Ended |
|
June 30,2023 |
|
June 30,2022 |
Cash flows from
operating activities: |
|
|
|
|
$ |
(13,734 |
) |
|
$ |
(19,215 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
Depreciation |
|
1,506 |
|
|
|
1,418 |
|
Amortization of right-of-use assets |
|
642 |
|
|
|
859 |
|
Amortization of intangible assets |
|
144 |
|
|
|
132 |
|
Amortization of debt discount and deferred financing fees |
|
442 |
|
|
|
442 |
|
Provision for bad debt |
|
(37 |
) |
|
|
550 |
|
Provision for inventory write-down |
|
1,052 |
|
|
|
928 |
|
Change in fair value of derivatives |
|
(247 |
) |
|
|
(686 |
) |
Investment (income) loss |
|
(578 |
) |
|
|
145 |
|
Stock-based compensation |
|
8,344 |
|
|
|
7,588 |
|
Change in operating assets and liabilities: |
|
|
|
Accounts receivable |
|
650 |
|
|
|
(2,719 |
) |
Inventory |
|
(3,384 |
) |
|
|
(3,458 |
) |
Prepaid expenses and other |
|
(639 |
) |
|
|
(1,081 |
) |
Accounts payable and accrued expenses |
|
(529 |
) |
|
|
(786 |
) |
Operating lease obligations |
|
(762 |
) |
|
|
(856 |
) |
Cash paid for interest portion of finance leases |
|
(1 |
) |
|
|
— |
|
Net cash used in
operating activities |
|
(7,131 |
) |
|
|
(16,739 |
) |
Cash flows from
investing activities: |
|
|
|
Purchase of property and equipment |
|
(8,719 |
) |
|
|
(9,086 |
) |
Purchase of investments |
|
(10,203 |
) |
|
|
(6,024 |
) |
Proceeds from sale of investments |
|
32,974 |
|
|
|
11,000 |
|
Cash payments for intangible assets |
|
(516 |
) |
|
|
(852 |
) |
Net cash from (used
in) investing activities |
|
13,536 |
|
|
|
(4,962 |
) |
Cash flows from
financing activities: |
|
|
|
Cash paid for debt portion of finance leases |
|
(12 |
) |
|
|
(1 |
) |
Proceeds from exercise of stock options and ESPP stock
purchases |
|
1,543 |
|
|
|
767 |
|
Net cash provided by
financing activities |
|
1,531 |
|
|
|
766 |
|
Net increase
(decrease) in cash, cash equivalents, and restricted
cash |
|
7,936 |
|
|
|
(20,935 |
) |
Cash, cash
equivalents, and restricted cash, beginning of period |
|
21,535 |
|
|
|
39,007 |
|
Cash, cash
equivalents, and restricted cash, end of period |
$ |
29,471 |
|
|
$ |
18,073 |
|
Supplemental
disclosures of cash flow activity: |
|
|
|
Cash paid for interest, net of
capitalized interest |
$ |
— |
|
|
$ |
— |
|
Supplemental
disclosure of non-cash investing and financing
activities: |
|
|
|
Acquisition of fixed assets in
accounts payable and accrued expenses |
$ |
1,818 |
|
|
$ |
1,817 |
|
Obtaining a right-of-use asset
in exchange for a lease liability |
$ |
268 |
|
|
$ |
700 |
|
Acquisition of intangible
assets in accounts payable and accrued expenses |
$ |
326 |
|
|
$ |
186 |
|
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