Accelerate Diagnostics reports Q3 2018 financial results
TUCSON, Ariz., Nov. 6, 2018 /PRNewswire/ -- Accelerate Diagnostics, Inc. today announced financial results for the quarter ending September 30, 2018. The company reported a 40% increase in U.S. instruments placed under commercial contract, and revenue for the quarter of $1.3 million, an increase of 64% from the prior year quarter. Worldwide, revenue-generating instruments combined with those under evaluation agreements grew to 458 instruments.
"We're happy to report solid commercial growth this quarter, having enabled more hospitals than ever before to tailor antibiotic use specifically for individual patients much earlier," said Lawrence Mehren, president and chief executive officer. "Despite a challenge for capital sales, we continue to drive clinical adoption through new acquisition options and a streamlined process. We believe the emerging clinical and economic outcome data, combined with strong customer advocacy, are compelling indicators of what is to come."
During the third quarter, clinicians from the University of Arkansas for Medical Sciences presented independent clinical outcome data showing a 3-day reduction in hospital length of stay for patients with bacteremia after implementing the Accelerate Pheno(TM) system.(1)
The company also announced it recently engaged with the U.S. Food and Drug Administration (FDA) and proposed a plan to address variability in the quantitative reference method used to compare the performance of its new test for severe bacterial pneumonia. New pre-clinical data obtained by the company in preparation of the clinical trial showed high variability in quantitative culture methods commonly used in clinical laboratories.
"We have found that the way laboratories perform cultures on lower respiratory tract specimens varies significantly across institutions, informed by local epidemiology, patient mix and treatment models," said Dr. Romney Humphries, chief scientific officer of Accelerate Diagnostics. "This variability, however, means the results are not translatable from one site to another, and there is no true gold standard result." Based on the need for further collaboration with the Agency, additional development, and related trial preparation, the company now expects to start the clinical trial in Q1 of 2019.
Mr. Mehren, together with Steve Reichling, chief financial officer, will host a conference call to review the financial results, commercial progress, and development updates at 4:15 p.m. Eastern Time on November 6, 2018.
Third quarter 2018 results
-- Revenue-generating placements in the U.S. increased by 40%.
-- Net sales of $1.3 million for the third quarter and $3.8 million year to
date, compared to $828 thousand and $2.0 million for the same respective
periods in the prior year.
-- Gross margin realized was 49.8% for the quarter and 50.9% year to date.
-- Selling, general, and administrative expenses for the quarter were $12.2
million and $41.8 million year to date as compared to $11.6 million and
$33.6 million from the respective same periods in the prior year. These
year-over-year increases were driven by higher personnel and customer
evaluation-related costs for evaluations in the U.S. and EMEA regions.
-- Research and development costs for the quarter were $7.9 million and
$20.7 million year to date as compared to $6.4 million and $16.2 million
from the respective same periods in the prior year. These year-over-year
increases are the result of additional investments in the preparation
for respiratory clinical trials and expanded scientific affairs
activity.
-- Net loss of $22.1 million in the third quarter and $66.1 million year to
date, or $0.41 and $1.21 per share on weighted average basic shares
outstanding of 54.1 million and 54.6 million shares, respectively. This
net loss includes $3.5 million in non-cash stock-based compensation
expense in the third quarter and $12.5 million year to date.
-- Net cash used in the quarter was $16.8 million and $50 million year to
date, ending the quarter with total cash, investments, and cash
equivalents from all activities of $181 million.
Full financial results for the quarter ending September 30, 2018 will be filed on Form 10-Q through the Securities and Exchange Commission's (SEC) website at http://www.sec.gov.
(1 )Dare R, McCain K, Lusardi K et al. Impact of Accelerate Pheno(TM) Rapid Blood Culture Detection System on Laboratory and Clinical Outcomes in Bacteremic Patients. Presented as an oral presentation at ID Week(TM) 2018.
Audio Webcast and Conference Call
Listen to an audio webcast of the call by visiting the events section of the company's investor relations website at ir.axdx.com. A replay of the audio webcast will be available until November 26, 2018.
To participate in the conference call, dial +1.877.883.0383 and enter the conference ID: 0396861
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 access code 10124532 until November 26, 2018.
About Accelerate Diagnostics, Inc.
Accelerate Diagnostics, Inc. (Nasdaq: AXDX), is an in vitro diagnostics company dedicated to providing solutions for the global challenges of antibiotic resistance and sepsis. The Accelerate Pheno(TM) system and Accelerate PhenoTest(TM) 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 about 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, such as those, among others, about our projections as to when certain key business milestones may be achieved, the potential of our products or technology, the growth of the market, our estimates as to the size of our market opportunity and potential pricing, our competitive position and estimates of time reduction to results, and our future development plans and growth strategy. 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 1, 2018, and in any other reports that we file with the Securities and Exchange Commission from time to time. 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.
ACCELERATE DIAGNOSTICS, INC.
CONDENSED CONSOLIDATED
BALANCE SHEET
(in thousands, except share data)
September 30, December 31,
2018 2017
---
Unaudited
ASSETS
Current assets:
Cash and cash
equivalents $
61,622 $
28,513
Investments 118,982 80,648
Trade accounts
receivable 1,440 1,946
Inventory 9,406 8,063
Prepaid expenses 940 850
Other current assets 494 468
Total current assets 192,884 120,488
Property and
equipment, net 7,412 4,890
Intellectual property,
net 119 134
Other non-current
assets 241
Total assets $
200,656 $
125,512
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $
1,559 $
2,080
Accrued liabilities 3,518 3,636
Accrued interest 191
Deferred revenue and
income 202 1,071
Total current
liabilities 5,470 6,787
Other long term
liabilities 26 21
Convertible notes 117,754
Total liabilities $
123,250 $
6,808
Commitments and contingencies
Stockholders' equity:
Preferred shares, $0.001 par value;
5,000,000 preferred
shares authorized and
none outstanding as
of September 30, 2018
and December 31, 2017 -
Common stock, $0.001 par value;
75,000,000 common
shares authorized December 31, 2017
with 54,196,876
shares issued and
outstanding on
September 30, 2018
and 75,000,000 common
shares authorized
with 55,673,810
shares issued and
outstanding on 54 56
Contributed capital 430,734 360,620
Treasury Stock (45,067)
Accumulated deficit (308,156) (241,972)
Accumulated other
comprehensive loss (159)
Total stockholders'
equity 77,406 118,704
Total liabilities and
stockholders' equity $
200,656 $
125,512
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 Nine Months Ended
September 30, September 30, September 30, September 30,
2018 2017 2018 2017
---
Net sales $
1,355 $
828 $
3,848 $
2,058
Cost of sales 680 191 1,889 352
Gross profit 675 637 1,959 1,706
Costs and expenses:
Research and development 7,891 6,351 20,734 16,166
Sales, general and
administrative 12,153 11,601 41,835 33,589
Total costs and expenses 20,044 17,952 62,569 49,755
Loss from operations (19,369) (17,315) (60,610) (48,049)
Other income (expense):
Interest expense (3,357) (6,720)
Foreign currency exchange
(loss) (133) (40) (331) (73)
Interest income 908 323 1,983 612
Other income, (expense),
net - 2 (25) (3)
Total other income
(expense), net (2,582) 285 (5,093) 536
Net loss before income
taxes (21,951) (17,030) (65,703) (47,513)
Provision for income
taxes (147) (45) (432) (220)
Net loss $
(22,098) $
(17,075) $
(66,135) $
(47,733)
Basic and diluted net
loss per share $
(0.41) $
(0.31) $
(1.21) $
(0.89)
Weighted average shares
outstanding 54,145 55,316 54,591 53,603
Other comprehensive loss:
Net loss $
(22,098) $
(17,075) $
(66,135) $
(47,733)
Net unrealized (loss)
gain on available-for-
sale investments 1 (7) (54) (4)
Foreign currency
translation adjustment (26) 91 (105) 295
Comprehensive loss $
(22,123) $
(16,991) $
(66,294) $
(47,442)
See accompanying notes to condensed
consolidated financial statements.
ACCELERATE DIAGNOSTICS, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS
(Unaudited)
(in thousands)
Nine Months Ended
September 30, September 30,
2018 2017
---
Cash flows from operating activities:
Net loss $
(66,135) $
(47,733)
Adjustments to reconcile net loss to net cash
used in operating activities:
Depreciation 1,734 1,595
Amortization of intangible
assets 15 9
Amortization of investment
discount (413) 298
Equity-based compensation 12,476 10,970
Amortization of debt
discount and issuance costs 4,529
Loss on disposal of property
and equipment 540 3
(Increase) decrease in assets:
Accounts receivable 506 (1,077)
Inventory (5,206) (7,079)
Prepaid expense and other 55 (392)
Other current assets (26) (277)
Other non-current assets (241)
Increase (decrease) in liabilities:
Accounts payable (524) 359
Accrued liabilities (18) 780
Accrued Interest 191
Deferred revenue and income (918) 46
Deferred compensation 5
Net cash used in operating
activities (53,430) (42,498)
Cash flows from investing activities:
Purchases of equipment (842) (2,055)
Purchases of available-for-
sale securities (115,634) (68,423)
Sales of available-for-
sale securities 3,000 9,522
Maturity of available-for-
sale securities 74,496 30,049
Net cash used in investing
activities (38,980) (30,907)
Cash flows from financing activities:
Issuance of common stock net
of issuance costs 477 83,741
Exercise of options and
warrants 3,710 4,562
Proceeds from issuance of
convertible note 171,500
Prepayment of forward stock
repurchase transaction (45,069)
Payment of debt issuance
costs (4,992)
Net cash provided by
financing activities 125,596 88,303
Effect of exchange rate on
cash: (77) 289
Increase in cash and cash
equivalents 33,109 15,187
Cash and cash equivalents,
beginning of period 28,513 19,244
Cash and cash equivalents,
end of period $
61,622 $
34,431
Non-cash investing activities:
Transfer of instruments from
inventory to property and
equipment $
4,061
$
Supplemental cash flow information:
Interest paid $
2,001
$
Income taxes paid $
435
$
See accompanying notes to
consolidated financial statements.
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SOURCE Accelerate Diagnostics, Inc.
