false
0000727207
0000727207
2024-01-07
2024-01-07
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
UNITED STATES
SECURITIES AND EXCHANGE
COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT
REPORT
Pursuant to Section 13
or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) |
January 7, 2024 |
Accelerate
Diagnostics, Inc.
(Exact name of registrant
as specified in its charter)
Delaware
(State
or other jurisdiction of incorporation)
001-31822 |
|
84-1072256 |
(Commission File Number) |
|
(IRS Employer Identification No.) |
3950
South Country Club Road, Suite 470,
Tucson, Arizona |
|
85714 |
(Address of principal executive offices) |
|
(Zip Code) |
(520)
365-3100
(Registrant’s
telephone number, including area code)
Not Applicable
(Former
name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b)
of the Act:
Title
of each class |
Trading
Symbol |
Name
of each exchange on which
registered |
Common
Stock, $0.001 par value per share |
AXDX |
The
Nasdaq Stock Market LLC
(The Nasdaq Capital Market) |
Indicate by check mark whether the registrant is
an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the
Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 2.02. | Results of Operations and Financial Condition. |
On January 7, 2024, Accelerate
Diagnostics, Inc. (the “Company”) issued a press release announcing certain preliminary results for the quarter and year ending
December 31, 2023. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference in its entirety.
In accordance with General
Instruction B.2 for Form 8-K, the information in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes
of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities
of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange
Act, except as expressly set forth by specific reference in such filing.
Item 9.01. |
Financial Statements and Exhibits. |
(d) Exhibits.
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
ACCELERATE DIAGNOSTICS, INC. |
|
(Registrant) |
Date: January 8, 2024 |
|
|
/s/ David Patience |
|
David Patience |
|
Chief Financial Officer |
Exhibit 99.1
Accelerate Diagnostics Announces Certain Preliminary
Fourth Quarter and Full-Year 2023 Results
TUCSON, Ariz., January 7, 2024 -- Accelerate Diagnostics, Inc.
(Nasdaq: AXDX) (Accelerate), an in vitro diagnostics company dedicated to providing services that improve patient outcomes and
lower healthcare costs through the rapid diagnosis of serious infections, today announced certain preliminary, unaudited results for
the quarter and year ended December 31, 2023.
“In 2023, we made significant progress with the development
of our next-generation rapid Antimicrobial Susceptibility Testing system, Accelerate WaveTM. We continue to advance this important
development program and remain on plan to begin our clinical trials in the second quarter of 2024,” commented Jack Phillips,
President and CEO of Accelerate Diagnostics, Inc. “In addition, we continue to expand and secure our Pheno®
customer base, with an upgrade path to Wave adoption. Based on consistent customer feedback, Wave is anticipated to set
the new standard for rapid, same-shift, susceptibility testing,” Mr. Phillips continued.
2023 Fourth Quarter Operational Results
| § | Notable
Wave program achievements during the quarter included: |
| § | Completed
Wave system integration. |
| § | Significantly
advanced AST performance of gram-negative positive blood culture menu for approximately 250
bug-drug combinations and running approximately 3,000 unique strains of gram-negative organisms
with average time-to-results below 4.5 hours. |
| § | Completed
extensive reviews with U.S. and EMEA customers to validate Wave’s product specifications
and menu roll-out strategy. Approximately 90% of customers have expressed interest in adopting
Accelerate Wave for both rapid positive blood culture and isolated colony testing given unique
perceived benefits compared to existing and emerging automated susceptibility platforms. |
| § | In
the US, added six new contracted Pheno instruments during the quarter, ending the quarter
with 340 clinically live Pheno revenue-generating instruments and another 71 contracted Pheno
instruments in the process of being implemented. |
| § | Executed
a collaboration and quality agreement with Bruker Corporation for the Accelerate ArcTM
system, made significant progress towards completing the U.S. clinical trial and anticipate
submission to the FDA during the first quarter of 2024. |
Preliminary 2023 Full Year Results
| § | Secured
approximately 65% of current U.S. Pheno customers to multi-year contracts for rapid
susceptibility testing, reflecting customers’ commitment to Accelerate rapid AST technology
and interest in Wave. |
| § | Preliminary
revenue was approximately $12.1 million for the year, compared to $12.8 million in the prior
year. While year-over-year revenues for consumable products increased by approximately 5%,
overall annual revenue was down year-over-year due to a challenging capital sales environment
in all our sales regions. |
| § | Ended
the year with approximately $13.4 million in cash and cash equivalents, representing net
cash used in the fourth quarter of approximately $7.8 million. This reflects a continued
reduction in operating cash use over the prior quarters of 2023, following cost cutting measures
implemented throughout 2023. |
The preliminary results set forth above are unaudited, are based on
management’s initial review of Accelerate’s results as of and for the year ended December 31, 2023, and are subject
to revisions based upon Accelerate’s year-end closing procedures and the completion of the external audit of Accelerate’s
year-end financial statements. Actual results may differ materially from these preliminary unaudited results as a result of the completion
of year-end closing procedures, final adjustments and other developments arising between now and the time that Accelerate’s financial
results are finalized. In addition, these preliminary unaudited results are not a comprehensive statement of Accelerate’s financial
results for the year ended December 31, 2023, should not be viewed as a substitute for full, audited financial statements, prepared
in accordance with generally accepted accounting principles, and are not necessarily indicative of the Company’s results for any
future period. Accordingly, investors are cautioned not to place undue reliance on these preliminary unaudited results.
Accelerate expects to announce full-year 2023 financial results in
advance of its earnings conference call in March 2024.
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 “ACCELERATE ARC” and “ACCELERATE WAVE”
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, such as, among others: the company’s anticipated results for the quarter and year ended
December 31, 2023; the company’s future development plans and growth strategy, including plans and objectives relating to
its future operations, products and performance; projections as to when certain key business milestones may be achieved; expectations
regarding the potential or benefits of the company’s products and technologies; expectations regarding the company’s customer
base and demand for its products; projections of future demand for the company’s products; the company’s continued investment
in new product development to both enhance its existing products and bring new ones to market; the company’s expectations relating
to current supply chain impacts and inflationary pressures; the company’s expectations regarding its commercial partnerships, such
as with Bruker Corporation, including anticipated benefits from such collaboration; the company’s intentions and plans relating
to clinical trials and regulatory approvals, including the company’s anticipated submission to the FDA during the first quarter
of 2024 for the Accelerate Arc system; and the company’s liquidity and capital requirements, including the company’s plan
to continue to focus on cash burn reductions. Actual results or developments may differ materially from those projected or implied in
these forward-looking statements due to significant risks and uncertainties, including, but not limited to: volatility throughout the
global economy and the related impacts to the businesses of the company’s suppliers and customers, whether due to customer demand
fluctuations, supply chain constraints and inflationary pressures or otherwise; difficulties in resolving the company’s continuing
financial condition and ability to obtain additional capital to meet its financial obligations; and the company’s ability to obtain
any regulatory approvals. Other important factors that could cause the company’s actual results to differ materially from those
in its forward-looking statements include those discussed in the company’s filings with the Securities and Exchange Commission
(the “SEC”), including in the “Risk Factors” sections of the company’s most recently filed periodic reports
on Form 10-K and Form 10-Q and subsequent filings with the SEC. 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.
###
For further information: Investor Inquiries & Media Contact:
Laura Pierson, Accelerate Diagnostics, +1 520 365-3100, investors@axdx.com
Source: Accelerate Diagnostics Inc.
v3.23.4
Cover
|
Jan. 07, 2024 |
Cover [Abstract] |
|
Document Type |
8-K
|
Amendment Flag |
false
|
Document Period End Date |
Jan. 07, 2024
|
Entity File Number |
001-31822
|
Entity Registrant Name |
Accelerate
Diagnostics, Inc.
|
Entity Central Index Key |
0000727207
|
Entity Tax Identification Number |
84-1072256
|
Entity Incorporation, State or Country Code |
DE
|
Entity Address, Address Line One |
3950
South Country Club Road
|
Entity Address, Address Line Two |
Suite 470
|
Entity Address, City or Town |
Tucson
|
Entity Address, State or Province |
AZ
|
Entity Address, Postal Zip Code |
85714
|
City Area Code |
520
|
Local Phone Number |
365-3100
|
Written Communications |
false
|
Soliciting Material |
false
|
Pre-commencement Tender Offer |
false
|
Pre-commencement Issuer Tender Offer |
false
|
Title of 12(b) Security |
Common
Stock, $0.001 par value per share
|
Trading Symbol |
AXDX
|
Security Exchange Name |
NASDAQ
|
Entity Emerging Growth Company |
false
|
X |
- DefinitionBoolean flag that is true when the XBRL content amends previously-filed or accepted submission.
+ References
+ Details
Name: |
dei_AmendmentFlag |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionFor the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.
+ References
+ Details
Name: |
dei_DocumentPeriodEndDate |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:dateItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.
+ References
+ Details
Name: |
dei_DocumentType |
Namespace Prefix: |
dei_ |
Data Type: |
dei:submissionTypeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionAddress Line 1 such as Attn, Building Name, Street Name
+ References
+ Details
Name: |
dei_EntityAddressAddressLine1 |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionAddress Line 2 such as Street or Suite number
+ References
+ Details
Name: |
dei_EntityAddressAddressLine2 |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- Definition
+ References
+ Details
Name: |
dei_EntityAddressCityOrTown |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCode for the postal or zip code
+ References
+ Details
Name: |
dei_EntityAddressPostalZipCode |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the state or province.
+ References
+ Details
Name: |
dei_EntityAddressStateOrProvince |
Namespace Prefix: |
dei_ |
Data Type: |
dei:stateOrProvinceItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionA unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityCentralIndexKey |
Namespace Prefix: |
dei_ |
Data Type: |
dei:centralIndexKeyItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionIndicate if registrant meets the emerging growth company criteria.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityEmergingGrowthCompany |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCommission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.
+ References
+ Details
Name: |
dei_EntityFileNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:fileNumberItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTwo-character EDGAR code representing the state or country of incorporation.
+ References
+ Details
Name: |
dei_EntityIncorporationStateCountryCode |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarStateCountryItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityRegistrantName |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityTaxIdentificationNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:employerIdItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionLocal phone number for entity.
+ References
+ Details
Name: |
dei_LocalPhoneNumber |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 13e -Subsection 4c
+ Details
Name: |
dei_PreCommencementIssuerTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 14d -Subsection 2b
+ Details
Name: |
dei_PreCommencementTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTitle of a 12(b) registered security.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b
+ Details
Name: |
dei_Security12bTitle |
Namespace Prefix: |
dei_ |
Data Type: |
dei:securityTitleItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the Exchange on which a security is registered.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection d1-1
+ Details
Name: |
dei_SecurityExchangeName |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarExchangeCodeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Section 14a -Number 240 -Subsection 12
+ Details
Name: |
dei_SolicitingMaterial |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTrading symbol of an instrument as listed on an exchange.
+ References
+ Details
Name: |
dei_TradingSymbol |
Namespace Prefix: |
dei_ |
Data Type: |
dei:tradingSymbolItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Securities Act -Number 230 -Section 425
+ Details
Name: |
dei_WrittenCommunications |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
Accelerate Diagnostics (NASDAQ:AXDX)
Graphique Historique de l'Action
De Mai 2024 à Juin 2024
Accelerate Diagnostics (NASDAQ:AXDX)
Graphique Historique de l'Action
De Juin 2023 à Juin 2024