Acutus Medical, Inc. (“Acutus”) (Nasdaq: AFIB), an arrhythmia
management company focused on improving the way cardiac arrhythmias
are diagnosed and treated, today reported results for the third
quarter of 2020.
Recent Highlights:
- Reported revenue of $3.2 million in the third quarter ended
September 30, 2020, a 180% increase sequentially and a 391%
increase over the same quarter last year.
- Increased worldwide installed base of second generation AcQMap
consoles to 37 as of September 30, 2020, up from 21 at the end of
the prior quarter – bringing the total installed base of AcQMap
consoles to 49 as of September 30, 2020.
- Filled a key role with the addition of Dr. Steve Mickelson as
our Chief Translational Science Officer. Dr. Mickelsen is a
prominent figure in the emerging area of Pulsed Field
Ablation.
Vince Burgess, President & CEO of Acutus, said, “In the
third quarter we saw strong execution by our commercial team and
made considerable progress on key development and operational
fronts. Despite headwinds from COVID-19, we continued to add new
customers and aggressively upgraded existing customers to our
groundbreaking second-generation electrophysiology mapping system,
AcQMap. Bringing on a new customer in our business requires
extensive cross-functional collaboration with our customers and
many members of our internal team. The growth of our installed base
achieved this quarter demonstrates enthusiastic demand for our
technology and terrific execution from our entire team during
uniquely challenging times. As we look to the future,
we are highly confident that Acutus is well positioned for
continued growth in the years ahead.”
Third Quarter 2020 Financial
ResultsRevenue was $3.2 million for the third quarter of
2020, compared to $1.1 million for the prior quarter and $0.6
million in the third quarter last year. The improvement over the
same quarter last year was driven by increased direct sales of
Acutus disposables, sales of our AcQMap consoles, and distributor
sales through our partner Biotronik as we continue to
operationalize this foundational relationship.
Gross margin was negative 62% for the third quarter of 2020,
compared with negative 251% in the same quarter last year. The
improvement was driven by greater production volumes and
efficiencies in labor and manufacturing overhead absorption when
compared to the same period last year. Also affecting margins in
the quarter were our first ever console sales that are paid for via
long-term disposables commitment deals. These types of sales, which
will be common at Acutus going forward, allocate a portion of the
future disposables’ revenue stream and all of the console COGS at
the time of the placement. It is typical for these transactions to
result in unfavorable gross margins on the up-front placement of
the console that is more than offset by a committed, predictable
annuity stream of disposables sales in future quarters. We continue
to make significant investments in our manufacturing infrastructure
to support our aggressive launch expectations and position us to
scale in-house production as our business grows. As volumes
increase over time, and the benefit of console sales accrues, we
expect to see continuous improvements to our margin profile.
Operating expenses were $24.3 million for the third quarter of
2020, compared with $29.5 million in the same quarter last year.
The decrease was driven by a $15.0 million payment for the
acquisition and in-licensing of the force sensing product line from
Biotronik made during the third quarter of 2019. This decrease was
partially offset by the expansion of our commercial team in
conjunction with our full commercial launch, various R&D
projects related to console enhancements and catheter development
programs, and increased G&A costs incurred associated with our
initial public offering and becoming a public company.
Net loss on a GAAP basis was $31.3 million for the third quarter
of 2020 and net loss per share was $1.95 on a weighted average
basic and diluted outstanding share count of 16.1 million, compared
to $32.1 million and a net loss per share of $47.21 on a weighted
average basic and diluted outstanding share count of 0.7 million in
the same period of the prior year. Excluding non-cash stock-based
compensation expense, remeasurement of our warrant liability, and
changes in the fair value of contingent consideration, our non-GAAP
net loss for the third quarter of 2020 was $21.1 million, or $0.91
per share, compared to $30.6 million, or $1.86 per share, after
giving effect to the pro forma conversion of our convertible
preferred stock for the third quarter of 2019.
Cash, cash equivalents, marketable securities and restricted
cash were $167.0 million as of September 30, 2020, which includes
the $166.3 million net proceeds from our IPO, which closed on
August 10, 2020.
Outlook and COVID-19Due to uncertainty
surrounding the COVID-19 pandemic, Acutus Medical will not provide
financial guidance for the remainder of 2020 at this time.
Management will continue to evaluate its guidance policies and
anticipates providing an update at the time of its fourth quarter
earnings announcement, to the extent practicable, based on
available information at that time.
Non-GAAP Financial MeasuresThis press release
includes references to non-GAAP net loss and non-GAAP net loss per
share, which are non-GAAP financial measures, to provide
information that may assist investors in understanding the
Company’s financial results and assessing its prospects for future
performance. We believe these non-GAAP financial measures are
important indicators of our operating performance because they
exclude items that are non-cash accounting line items unrelated to,
and may not be indicative of, our core operating results. These
non-GAAP financial measures, as we calculate them, may not
necessarily be comparable to similarly titled measures of other
companies and may not be appropriate measures for comparing the
performance of other companies relative to the Company. These
non-GAAP financial results are not intended to represent and should
not be considered to be more meaningful measures than, or
alternatives to, measures of operating performance as determined in
accordance with GAAP. To the extent we utilize such non-GAAP
financial measures in the future, we expect to calculate them using
a consistent method from period to period. A reconciliation of each
of the most directly comparable GAAP financial measures to the
non-GAAP financial measures has been provided under the heading
“Reconciliation of GAAP results to Non-GAAP Results” in the
financial statement tables attached to this press release.
Webcast and Conference Call InformationAcutus
Medical will host a conference call to discuss the third quarter
financial results after market close on Thursday, November 12, 2020
at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference
call can be accessed live over the phone (833) 570-1131 for U.S.
callers or (914) 987-7078 for international callers, using
conference ID: 6990208. The live webinar can be accessed at
https://ir.acutusmedical.com.
About Acutus Medical,
Inc. Acutus Medical is an arrhythmia management company
focused on improving the way cardiac arrhythmias are diagnosed and
treated. Acutus is committed to advancing the field of
electrophysiology with a unique array of products and technologies
which will enable more physicians to treat more patients more
efficiently and effectively. Through internal product development,
acquisitions, and global partnerships, Acutus has established a
global sales presence delivering a broad portfolio of highly
differentiated electrophysiology products. Acutus Medical’s goal is
to provide its customers with a complete solution for
catheter-based treatment of cardiac arrhythmias in each of its
geographic markets. Founded in 2011, Acutus is based in Carlsbad,
California.
Caution Regarding Forward-Looking
StatementsThis press release includes statements that may
constitute “forward-looking” statements, usually containing the
words “believe,” “estimate,” “project,” “expect” or similar
expressions. Forward-looking statements inherently involve risks
and uncertainties that could cause actual results to differ
materially from the forward-looking statements. Factors that would
cause or contribute to such differences include, but are not
limited to, the Company's ability to continue to manage expenses
and cash burn rate at sustainable levels, continued acceptance of
the Company's products in the marketplace, the effect of global
economic conditions on the ability and willingness of customers to
purchase its systems and the timing of such purchases, competitive
factors, changes resulting from healthcare policy in the United
States, including changes in government reimbursement of
procedures, dependence upon third-party vendors and distributors,
timing of regulatory approvals, the impact of the coronavirus
(COVID-19) pandemic and our response to it, and other risks
discussed in the Company's periodic and other filings with the
Securities and Exchange Commission. By making these forward-looking
statements, the Company undertakes no obligation to update these
statements for revisions or changes after the date of this release,
except as required by law.
Investor Contact:Caroline CornerWestwicke ICRD:
415-314-1725Caroline.corner@westwicke.com
Holly WindlerM: 619-929-1275media@acutusmedical.com
Acutus Medical, Inc. and
SubsidiariesCondensed Consolidated Balance
Sheets(in thousands)
|
|
|
|
|
|
September
30, |
|
December
31, |
|
|
2020 |
|
2019 |
|
|
(unaudited) |
|
|
|
ASSETS: |
|
|
|
|
Current
assets: |
|
|
|
|
Cash and cash equivalents |
$ |
58,302 |
|
|
$ |
9,452 |
|
|
Marketable securities, short-term |
|
99,742 |
|
|
|
62,351 |
|
|
Restricted cash |
|
150 |
|
|
|
150 |
|
|
Accounts receivable |
|
1,893 |
|
|
|
263 |
|
|
Inventory |
|
10,932 |
|
|
|
8,424 |
|
|
Prepaid expenses and other current assets |
|
4,635 |
|
|
|
1,816 |
|
|
Total
current assets |
|
175,654 |
|
|
|
82,456 |
|
|
|
|
|
|
|
Marketable
securities, long-term |
|
8,789 |
|
|
|
- |
|
|
Property and
equipment, net |
|
9,940 |
|
|
|
4,427 |
|
|
Right-of-use
asset, net |
|
1,838 |
|
|
|
2,341 |
|
|
Intangible
assets, net |
|
3,780 |
|
|
|
4,110 |
|
|
Goodwill |
|
12,026 |
|
|
|
12,026 |
|
|
Other
assets |
|
482 |
|
|
|
95 |
|
|
Total assets |
$ |
212,509 |
|
|
$ |
105,455 |
|
|
|
|
|
|
|
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS'
EQUITY (DEFICIT) |
|
|
|
|
Current
liabilities: |
|
|
|
|
Accounts payable |
$ |
4,723 |
|
|
$ |
3,882 |
|
|
Accrued liabilities |
|
6,500 |
|
|
|
10,076 |
|
|
Contingent consideration, short-term |
|
4,000 |
|
|
|
8,200 |
|
|
Operating lease liabilities, short-term |
|
907 |
|
|
|
833 |
|
|
Common and preferred stock warrant liability |
|
- |
|
|
|
8,919 |
|
|
Total
current liabilities |
|
16,130 |
|
|
|
31,910 |
|
|
|
|
|
|
|
Operating
lease liabilities, long-term |
|
1,365 |
|
|
|
2,054 |
|
|
Long-term
debt |
|
38,762 |
|
|
|
38,244 |
|
|
Contingent
consideration, long-term |
|
3,600 |
|
|
|
5,700 |
|
|
Other
long-term liabilities |
|
8 |
|
|
|
- |
|
|
Total
liabilities |
|
59,865 |
|
|
|
77,908 |
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
Convertible preferred stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A
convertible preferred stock |
|
- |
|
|
|
3,059 |
|
|
Series B
convertible preferred stock |
|
- |
|
|
|
40,685 |
|
|
Series C
convertible preferred stock |
|
- |
|
|
|
74,575 |
|
|
Series D
convertible preferred stock |
|
- |
|
|
|
135,039 |
|
|
|
|
|
|
|
Stockholders' equity (deficit) |
|
|
|
|
Preferred
stock |
|
- |
|
|
|
- |
|
|
Common
stock |
|
28 |
|
|
|
1 |
|
|
Additional
paid-in capital |
|
484,162 |
|
|
|
33,252 |
|
|
Accumulated
deficit |
|
(331,613 |
) |
|
|
(259,034 |
) |
|
Accumulated
other comprehensive income (loss) |
|
67 |
|
|
|
(30 |
) |
|
Total
stockholders' equity (deficit) |
|
152,644 |
|
|
|
(225,811 |
) |
|
Total liabilities, convertible preferred stock and
stockholders' equity (deficit) |
$ |
212,509 |
|
|
$ |
105,455 |
|
|
|
|
|
|
|
Acutus Medical, Inc. and
SubsidiariesCondensed Consolidated Statements of
Operations and Comprehensive Loss(in thousands, except
share and per share amounts)(Unaudited)
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
|
Revenue |
|
$ |
3,173 |
|
|
$ |
646 |
|
|
$ |
5,890 |
|
|
$ |
2,167 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and operating expenses: |
|
|
|
|
|
|
|
|
|
|
Cost of products sold |
|
|
5,141 |
|
|
|
2,267 |
|
|
|
10,998 |
|
|
|
6,878 |
|
|
|
Research and development |
|
|
8,343 |
|
|
|
5,865 |
|
|
|
24,492 |
|
|
|
15,489 |
|
|
|
Research and development - license acquired |
|
|
- |
|
|
|
15,000 |
|
|
|
- |
|
|
|
15,000 |
|
|
|
Selling, general and administrative |
|
|
15,833 |
|
|
|
7,978 |
|
|
|
35,193 |
|
|
|
18,998 |
|
|
|
Change in fair value of contingent consideration |
|
|
118 |
|
|
|
700 |
|
|
|
(1,466 |
) |
|
|
700 |
|
|
|
Total costs
and operating expenses |
|
|
29,435 |
|
|
|
31,810 |
|
|
|
69,217 |
|
|
|
57,065 |
|
|
|
Loss
from operations |
|
|
(26,262 |
) |
|
|
(31,164 |
) |
|
|
(63,327 |
) |
|
|
(54,898 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
Change in fair value of warrant liability and embedded
derivative |
|
|
(3,683 |
) |
|
|
(3 |
) |
|
|
(5,555 |
) |
|
|
(608 |
) |
|
|
Loss on debt extinguishment |
|
|
- |
|
|
|
(49 |
) |
|
|
- |
|
|
|
(1,447 |
) |
|
|
Interest income |
|
|
23 |
|
|
|
525 |
|
|
|
393 |
|
|
|
733 |
|
|
|
Interest expense |
|
|
(1,366 |
) |
|
|
(1,394 |
) |
|
|
(4,090 |
) |
|
|
(20,905 |
) |
|
|
Total other
expense, net |
|
|
(5,026 |
) |
|
|
(921 |
) |
|
|
(9,252 |
) |
|
|
(22,227 |
) |
|
|
Net
loss |
|
$ |
(31,288 |
) |
|
$ |
(32,085 |
) |
|
$ |
(72,579 |
) |
|
$ |
(77,125 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income (loss) |
|
|
|
|
|
|
|
|
|
|
Unrealized (loss) gain on marketable securities |
|
|
(9 |
) |
|
|
40 |
|
|
|
(50 |
) |
|
|
47 |
|
|
|
Foreign currency translation adjustment |
|
|
78 |
|
|
|
(45 |
) |
|
|
147 |
|
|
|
(57 |
) |
|
|
Comprehensive loss |
|
$ |
(31,219 |
) |
|
$ |
(32,090 |
) |
|
$ |
(72,482 |
) |
|
$ |
(77,135 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
common share, basic and diluted |
|
$ |
(1.95 |
) |
|
$ |
(47.21 |
) |
|
$ |
(12.36 |
) |
|
$ |
(115.66 |
) |
|
|
Weighted
average shares outstanding, basic and diluted |
|
|
16,080,467 |
|
|
|
679,591 |
|
|
|
5,870,861 |
|
|
|
666,823 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Acutus Medical, Inc. and
SubsidiariesCondensed Consolidated Statements of
Cash Flows(in thousands)(Unaudited)
|
|
|
Nine Months Ended September 30, |
|
|
|
|
2020 |
|
2019 |
|
|
Cash
flows from operating activities |
|
|
|
|
|
|
Net loss |
|
$ |
(72,579 |
) |
|
$ |
(77,125 |
) |
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
Depreciation expense |
|
|
1,754 |
|
|
|
1,676 |
|
|
|
Amortization of intangible assets |
|
|
330 |
|
|
|
125 |
|
|
|
Stock-based compensation expense |
|
|
9,272 |
|
|
|
2,174 |
|
|
|
Amortization of premiums/(accretion of discounts) on marketable
securities, net |
|
|
113 |
|
|
|
(100 |
) |
|
|
Amortization of debt issuance costs |
|
|
518 |
|
|
|
17,438 |
|
|
|
Amortization of right-of-use assets |
|
|
507 |
|
|
|
470 |
|
|
|
Research and development - license acquired |
|
|
- |
|
|
|
15,000 |
|
|
|
Gain on disposal of property and equipment |
|
|
- |
|
|
|
(1 |
) |
|
|
Loss on debt extinguishment |
|
|
- |
|
|
|
1,447 |
|
|
|
Change in fair value of warrant liability and embedded
derivative |
|
|
5,555 |
|
|
|
608 |
|
|
|
Change in fair value of contingent consideration |
|
|
(1,466 |
) |
|
|
700 |
|
|
|
Changes in operating assets and liabilities, net of effect from
business combination: |
|
|
|
|
|
Accounts receivable |
|
|
(1,630 |
) |
|
|
(697 |
) |
|
|
Inventory |
|
|
(1,865 |
) |
|
|
(3,829 |
) |
|
|
Prepaid expenses and other current assets |
|
|
(2,729 |
) |
|
|
(306 |
) |
|
|
Other assets |
|
|
(387 |
) |
|
|
(8 |
) |
|
|
Accounts payable |
|
|
753 |
|
|
|
2,873 |
|
|
|
Accrued liabilities |
|
|
1,423 |
|
|
|
9,268 |
|
|
|
Operating lease liabilities |
|
|
(615 |
) |
|
|
(536 |
) |
|
|
Other long-term liabilities |
|
|
8 |
|
|
|
- |
|
|
|
Net cash
used in operating activities |
|
|
(61,038 |
) |
|
|
(30,823 |
) |
|
|
|
|
|
|
|
|
|
Cash
flows from investing activities |
|
|
|
|
|
|
Purchases of available-for-sale marketable securities |
|
|
(108,528 |
) |
|
|
(68,735 |
) |
|
|
Sales of available-for-sale marketable securities |
|
|
17,095 |
|
|
|
- |
|
|
|
Maturities of available-for-sale marketable securities |
|
|
45,000 |
|
|
|
11,550 |
|
|
|
Purchases of property and equipment |
|
|
(7,822 |
) |
|
|
(683 |
) |
|
|
Purchase of research and development license |
|
|
- |
|
|
|
(10,000 |
) |
|
|
Cash paid, net of cash acquired for the Rhythm Xience
Acquisition |
|
|
- |
|
|
|
(3,000 |
) |
|
|
Net cash
used in investing activities |
|
|
(54,255 |
) |
|
|
(70,868 |
) |
|
|
|
|
|
|
|
|
|
Cash
flows from financing activities |
|
|
|
|
|
|
Proceeds from issuance of debt and warrants |
|
|
- |
|
|
|
77,000 |
|
|
|
Repayment of debt |
|
|
- |
|
|
|
(15,000 |
) |
|
|
Payment of issuance and extinguishment costs related to debt |
|
|
- |
|
|
|
(2,332 |
) |
|
|
Payment of contingent consideration |
|
|
(2,636 |
) |
|
|
- |
|
|
|
Proceeds from issuance of convertible preferred stock, net of
issuance costs |
|
|
- |
|
|
|
66,567 |
|
|
|
Proceeds from issuance of common stock upon IPO, net of issuance
costs |
|
|
166,286 |
|
|
|
- |
|
|
|
Proceeds from stock options exercises |
|
|
350 |
|
|
|
76 |
|
|
|
Net cash
provided by financing activities |
|
|
164,000 |
|
|
|
126,311 |
|
|
|
|
|
|
|
|
|
|
Effect of
exchange rate changes on cash, cash equivalents and restricted
cash |
|
|
143 |
|
|
|
(50 |
) |
|
|
|
|
|
|
|
|
|
Net change
in cash, cash equivalents and restricted cash |
|
|
48,850 |
|
|
|
24,570 |
|
|
|
Cash, cash
equivalents and restricted cash, at the beginning of the
period |
|
|
9,602 |
|
|
|
9,775 |
|
|
|
Cash, cash equivalents and restricted cash, at the end of
the period |
|
$ |
58,452 |
|
|
$ |
34,345 |
|
|
|
|
|
|
|
|
|
Acutus Medical, Inc. and
SubsidiariesReconciliation of GAAP Results to
Non-GAAP Results(in thousands, except share and per share
data)(Unaudited)
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
|
GAAP net loss |
|
$ |
(31,288 |
) |
|
$ |
(32,085 |
) |
|
$ |
(72,579 |
) |
|
$ |
(77,125 |
) |
|
|
Stock-based compensation |
|
|
6,374 |
|
|
|
812 |
|
|
|
9,272 |
|
|
|
2,174 |
|
|
|
Change in fair value of contingent consideration |
|
|
118 |
|
|
|
700 |
|
|
|
(1,466 |
) |
|
|
700 |
|
|
|
Change in fair value of warrant liability and embedded
derivative |
|
|
3,683 |
|
|
|
3 |
|
|
|
5,555 |
|
|
|
608 |
|
|
|
Non-GAAP net
loss |
|
$ |
(21,113 |
) |
|
$ |
(30,569 |
) |
|
$ |
(59,218 |
) |
|
$ |
(73,643 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator |
|
|
|
|
|
|
|
|
Weighted
average shares of common stock outstanding used in GAAP per share
calculations |
|
|
16,080,467 |
|
|
|
679,591 |
|
|
|
5,870,861 |
|
|
|
666,823 |
|
|
|
Adjustments
to reflect the assumed conversion of convertible preferred stock
(1) |
|
|
7,205,624 |
|
|
|
15,712,489 |
|
|
|
13,373,360 |
|
|
|
11,290,142 |
|
|
|
Shares used
in non-GAAP per share calculations |
|
|
23,286,091 |
|
|
|
16,392,080 |
|
|
|
19,244,221 |
|
|
|
11,956,965 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net
loss per share |
|
$ |
(1.95 |
) |
|
$ |
(47.21 |
) |
|
$ |
(12.36 |
) |
|
$ |
(115.66 |
) |
|
|
Non-GAAP net
loss per share |
|
$ |
(0.91 |
) |
|
$ |
(1.86 |
) |
|
$ |
(3.08 |
) |
|
$ |
(6.16 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Assumes the
conversion of outstanding shares of convertible preferred stock
into shares of common stock as if such conversion had occurred at
the beginning of the period or their issuance dates, if later. |
Acutus Medical (NASDAQ:AFIB)
Historical Stock Chart
From Mar 2024 to Apr 2024
Acutus Medical (NASDAQ:AFIB)
Historical Stock Chart
From Apr 2023 to Apr 2024