TUCSON, Ariz., May 6, 2021 /PRNewswire/ -- Accelerate
Diagnostics, Inc. (Nasdaq: AXDX) today announced financial results
for the first quarter for the period ended March 31, 2021.
"First quarter financial results were consistent with our
expectations," commented Jack Phillips, Chief Executive
Officer of Accelerate Diagnostics, Inc. "We also progressed
key commercial and product development programs during the
quarter."
First Quarter 2021 Highlights
- Added 2 contracted instruments and brought 12 instruments live
in the U.S. in the quarter.
- Ended the first quarter with 274 U.S. clinically live and
revenue-generating instruments, with another 111 U.S. contracted
instruments in the process of being implemented and not yet
revenue-generating.
- Net sales were $2.5 million,
compared to $2.3 million in the first
quarter of 2020, or an 8% increase. Instrument revenue
declined while consumable revenue grew by 16%.
- Gross margin was 36% for the quarter, compared to 45% in the
first quarter of 2020. The decline in gross margins resulted
from ongoing pandemic-related impacts to manufacturing costs and
other factors.
- Selling, general, and administrative (SG&A) costs for the
quarter were $14.0 million, compared
to $12.9 million from the same
quarter of the prior year. SG&A costs for the quarter excluding
non-cash stock-based compensation were $8.0
million, compared to $9.9
million from the same quarter of the prior year. This
decrease was the result of the ongoing benefits from cost-cutting
efforts put in place during 2020.
- Research and development (R&D) costs for the quarter were
$6.9 million, compared to
$5.8 million from the same quarter of
the prior year. R&D costs excluding non-cash stock-based
compensation expense for the quarter were $4.1 million, compared to $4.7 million from the quarter of the prior year.
This decrease was the result of improved internal efficiencies and
lower external study-related costs.
- Net loss was $24.2 million in the
first quarter, resulting in $0.41 net
loss per share. Net loss excluding non-cash stock-based
compensation expense for the first quarter was $15.4 million.
- Net cash used in the quarter was $12.3
million, and the company ended the quarter with total cash,
investments, and cash equivalents of $66.7
million.
- Closed on the first of three equal $10.7M tranches of previously announced
financing.
Full financial results for the quarter ending March 31, 2021 will be filed on Form 10-Q through
the Securities and Exchange Commission's (SEC) website at
http://www.sec.gov.
Audio Webcast and Conference Call
The company will host a conference call at 4:30PM ET today to review its first quarter
financial results, To listen to the 2021 first quarter
financial results call by phone, +1.877.883.0383 and enter Elite
Entry Number: 4747452. International participants may dial
+1.412.902.6506. Please dial in 10–15 minutes prior to the start of
the conference. A replay of the call will be available by telephone
at +1.877.344.7529 (U.S.) or +1.412.317.0088 (International) using
the replay code 10154554 until May 27,
2021.
This conference call will also be webcast and can be accessed
from the company's website at ir.axdx.com. A replay of the audio
webcast will be available until August 6,
2021.
Use of Non-GAAP Financial Measures
This press release contains certain financial measures that are
not recognized measures under accounting principles generally
accepted in the United States of
America ("GAAP"), which include SG&A, R&D, and Net
income (loss) amounts excluding stock-based compensation
expenses.
Our management and board of directors use expenses excluding the
cost of stock-based compensation to understand and evaluate our
operating performance and trends, to prepare and approve our annual
budget and to develop short-term and long-term operating and
financing plans. Accordingly, we believe that expenses excluding
the cost of stock-based compensation provides useful information
for investors in understanding and evaluating our operating results
in the same manner as our management and our board of directors.
Expenses excluding the cost of stock-based compensation is a
non-GAAP financial measure and should be considered in addition to,
not as superior to, or as a substitute for, SG&A expenses,
R&D expenses, and net income (loss) reported in accordance with
GAAP. The following tables present a reconciliation of SG&A
expenses, R&D expenses and net income (loss) excluding
stock-based compensation to comparable GAAP measures for the
periods indicated:
|
Three Months
Ended
March 31,
(in thousands)
|
|
2021
|
2020
|
Sales, general and
administrative
|
$14,029
|
$12,943
|
Non-cash equity-based
compensation as a component of sales, general and
administrative
|
5,992
|
3,005
|
Sales, general and
administrative less non-cash equity-based compensation
|
$8,037
|
$9,938
|
|
|
|
|
|
Three Months
Ended
March 31,
(in thousands)
|
|
2021
|
2020
|
Research and
development
|
$6,895
|
$5,842
|
Non-cash equity-based
compensation as a component of research and development
|
2,746
|
1,123
|
Research and
development less non-cash equity-based compensation
|
$4,149
|
$4,719
|
|
|
|
|
|
Three Months
Ended
March 31,
(in thousands)
|
|
2021
|
Net loss
|
$24,239
|
Non-cash equity-based
compensation as a component of net loss
|
8,839
|
Net loss less
non-cash equity-based compensation
|
$15,400
|
About Accelerate Diagnostics, Inc.
Accelerate Diagnostics, Inc. is an in vitro diagnostics
company dedicated to providing solutions for the global challenges
of antibiotic resistance and sepsis. The Accelerate
Pheno® system and Accelerate PhenoTest® BC
kit combine several technologies aimed at reducing the time
clinicians must wait to determine the most optimal antibiotic
therapy for deadly infections. The FDA cleared system and kit fully
automate the sample preparation steps to report phenotypic
antibiotic susceptibility results in approximately 7 hours direct
from positive blood cultures. Recent external studies indicate the
solution offers results 1–2 days faster than existing methods,
enabling clinicians to optimize antibiotic selection and dosage
specific to the individual patient days earlier.
The "ACCELERATE DIAGNOSTICS" and "ACCELERATE PHENO" and
"ACCELERATE PHENOTEST" and diamond shaped logos and marks are
trademarks or registered trademarks of Accelerate Diagnostics,
Inc.
For more information about the company, its products and
technology, or recent publications, visit axdx.com.
Forward-Looking Statements
Certain of the statements made in this press release are forward
looking or may have forward looking implications. Actual results or
developments may differ materially from those projected or implied
in these forward-looking statements. Information about the risks
and uncertainties faced by Accelerate Diagnostics is contained in
the section captioned "Risk Factors" in the company's most recent
Annual Report on Form 10-K, filed with the Securities and Exchange
Commission on March 2, 2021, and in any other reports that the
company files with the Securities and Exchange Commission. The
company's forward-looking statements could be affected by general
industry and market conditions. Except as required by federal
securities laws, the company undertakes no obligation to update or
revise these forward-looking statements to reflect new events,
uncertainties or other contingencies.
Source: Accelerate Diagnostics Inc.
ACCELERATE
DIAGNOSTICS, INC.
|
CONDENSED
CONSOLIDATED
|
BALANCE
SHEETS
|
(in thousands, except
share data)
|
|
|
March
31,
|
December
31,
|
|
2021
|
2020
|
|
Unaudited
|
|
ASSETS
|
Current
assets:
|
|
|
Cash and cash
equivalents
|
$
|
42,726
|
|
$
|
35,781
|
|
Investments
|
23,954
|
|
32,488
|
|
Trade accounts
receivable
|
1,976
|
|
1,550
|
|
Inventory
|
9,785
|
|
9,216
|
|
Prepaid
expenses
|
1,891
|
|
1,172
|
|
Other current
assets
|
1,479
|
|
1,780
|
|
Total current
assets
|
81,811
|
|
81,987
|
|
Property and
equipment, net
|
5,825
|
|
6,135
|
|
Right of use
assets
|
3,007
|
|
3,183
|
|
Other non-current
assets
|
2,025
|
|
2,120
|
|
Total
assets
|
$
|
92,668
|
|
$
|
93,425
|
|
|
LIABILITIES AND
STOCKHOLDERS' DEFICIT
|
Current
liabilities:
|
|
|
Accounts
payable
|
$
|
1,917
|
|
$
|
1,290
|
|
Accrued
liabilities
|
3,221
|
|
2,991
|
|
Accrued
interest
|
191
|
|
1,262
|
|
Deferred
revenue
|
357
|
|
376
|
|
Current portion of
long-term debt
|
1,127
|
|
553
|
|
Current operating
lease liability
|
551
|
|
497
|
|
Total current
liabilities
|
7,364
|
|
6,969
|
|
Non-current operating
lease liability
|
2,900
|
|
3,063
|
|
Other non-current
liabilities
|
453
|
|
335
|
|
Long-term
debt
|
4,108
|
|
4,659
|
|
Convertible
notes
|
144,207
|
|
141,211
|
|
Total
liabilities
|
$
|
159,032
|
|
$
|
156,237
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
Stockholders'
deficit:
|
|
|
Preferred shares,
$0.001 par value;
|
|
|
5,000,000 preferred
shares authorized and none outstanding as of March 31, 2021 and
December 31, 2020
|
—
|
|
—
|
|
Common stock, $0.001
par value;
|
|
|
85,000,000 common
shares authorized with 59,561,357 shares issued and outstanding on
March 31, 2021 and 85,000,000 common shares authorized with
57,607,939 shares issued and outstanding on December 31,
2020
|
60
|
|
58
|
|
Contributed
capital
|
495,857
|
|
475,072
|
|
Treasury
stock
|
(45,067)
|
|
(45,067)
|
|
Accumulated
deficit
|
(517,205)
|
|
(492,966)
|
|
Accumulated other
comprehensive income (loss)
|
(9)
|
|
91
|
|
Total stockholders'
deficit
|
(66,364)
|
|
(62,812)
|
|
Total liabilities and
stockholders' deficit
|
$
|
92,668
|
|
$
|
93,425
|
|
|
See accompanying
notes to condensed consolidated financial statements.
|
ACCELERATE
DIAGNOSTICS, INC.
|
CONDENSED
CONSOLIDATED
|
STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS
|
Unaudited
|
(in thousands, except
per share data)
|
|
|
Three Months
Ended
|
|
March
31,
|
March
31,
|
|
2021
|
2020
|
Net
sales
|
$
|
2,518
|
|
$
|
2,342
|
|
|
|
|
Cost of
sales
|
1,621
|
|
1,287
|
|
Gross
profit
|
897
|
|
1,055
|
|
|
|
|
Costs and
expenses:
|
|
|
Research and
development
|
6,895
|
|
5,842
|
|
Sales, general and
administrative
|
14,029
|
|
12,943
|
|
Total costs and
expenses
|
20,924
|
|
18,785
|
|
|
|
|
Loss from
operations
|
(20,027)
|
|
(17,730)
|
|
|
|
|
Other income
(expense):
|
|
|
Interest
expense
|
(4,090)
|
|
(3,749)
|
|
Foreign currency
exchange loss
|
(159)
|
|
(128)
|
|
Interest
income
|
43
|
|
380
|
|
Other expense,
net
|
(6)
|
|
(82)
|
|
Total other expense,
net
|
(4,212)
|
|
(3,579)
|
|
|
|
|
Net loss before
income taxes
|
(24,239)
|
|
(21,309)
|
|
Provision for income
taxes
|
—
|
|
—
|
|
Net loss
|
$
|
(24,239)
|
|
$
|
(21,309)
|
|
|
|
|
Basic and diluted net
loss per share
|
$
|
(0.41)
|
|
$
|
(0.39)
|
|
Weighted average
shares outstanding
|
58,520
|
|
54,837
|
|
|
|
|
Other
comprehensive loss:
|
|
|
Net loss
|
$
|
(24,239)
|
|
$
|
(21,309)
|
|
Net unrealized (loss)
gain on debt securities available-for-sale
|
(19)
|
|
223
|
|
Foreign currency
translation adjustment
|
(81)
|
|
(15)
|
|
Comprehensive
loss
|
$
|
(24,339)
|
|
$
|
(21,101)
|
|
|
See accompanying
notes to condensed consolidated financial statements.
|
ACCELERATE
DIAGNOSTICS, INC.
|
CONDENSED
CONSOLIDATED
|
STATEMENTS OF CASH
FLOWS
|
Unaudited
|
(in
thousands)
|
|
|
Three Months
Ended
|
|
March
31,
|
March
31,
|
|
2021
|
2020
|
Cash flows from
operating activities:
|
|
|
Net loss
|
$
|
(24,239)
|
|
$
|
(21,309)
|
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
Depreciation and
amortization
|
659
|
|
755
|
|
Amortization of
investment discount
|
49
|
|
(4)
|
|
Equity-based
compensation
|
8,839
|
|
4,199
|
|
Amortization of debt
discount and issuance costs
|
2,996
|
|
2,674
|
|
Loss on disposal of
property and equipment
|
—
|
|
432
|
|
Contributions to
deferred compensation plan
|
(112)
|
|
—
|
|
(Increase) decrease
in assets:
|
|
|
Accounts
receivable
|
(401)
|
|
(9)
|
|
Inventory and
instruments in property and equipment
|
(683)
|
|
(1,735)
|
|
Prepaid expense and
other
|
(292)
|
|
(1,011)
|
|
Increase (decrease)
in liabilities:
|
|
|
Accounts
payable
|
575
|
|
968
|
|
Accrued liabilities,
and other
|
183
|
|
(1,475)
|
|
Accrued
interest
|
(1,048)
|
|
(1,071)
|
|
Deferred revenue and
income
|
(19)
|
|
(85)
|
|
Deferred
compensation
|
118
|
|
74
|
|
Net cash used in
operating activities
|
(13,375)
|
|
(17,597)
|
|
|
|
|
Cash flows from
investing activities:
|
|
|
Purchases of
equipment
|
—
|
|
(438)
|
|
Purchase of
marketable securities
|
(7,307)
|
|
(21,582)
|
|
Maturities of
marketable securities
|
15,829
|
|
16,664
|
|
Net cash provided by
(used in) investing activities
|
8,522
|
|
(5,356)
|
|
|
|
|
Cash flows from
financing activities:
|
|
|
Proceeds from
issuance of common stock
|
10,746
|
|
111
|
|
Proceeds from
exercise of options
|
1,109
|
|
1,318
|
|
Net cash provided by
financing activities
|
11,855
|
|
1,429
|
|
|
|
|
Effect of exchange
rate on cash
|
(57)
|
|
(3)
|
|
|
|
|
Increase (decrease)
in cash and cash equivalents
|
6,945
|
|
(21,527)
|
|
Cash and cash
equivalents, beginning of period
|
35,781
|
|
61,014
|
|
Cash and cash
equivalents, end of period
|
$
|
42,726
|
|
$
|
39,487
|
|
|
See accompanying
notes to condensed consolidated financial statements.
|
ACCELERATE
DIAGNOSTICS, INC.
|
CONDENSED
CONSOLIDATED
|
STATEMENTS OF CASH
FLOWS (CONTINUED)
|
Unaudited
|
(in
thousands)
|
|
|
Three Months
Ended
|
|
March
31,
|
March
31,
|
|
2021
|
2020
|
Non-cash investing
activities:
|
|
|
Net transfer of
instruments from inventory to property and equipment
|
$
|
306
|
|
$
|
1,282
|
|
Supplemental cash
flow information:
|
|
|
Interest
paid
|
$
|
2,144
|
|
$
|
2,144
|
|
Income taxes paid,
net of refunds
|
$
|
—
|
|
$
|
26
|
|
|
See accompanying
notes to condensed consolidated financial statements.
|
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SOURCE Accelerate Diagnostics, Inc.