PR Newswire | Feb 23, 2021 04:16PM EST

Results

02/23 15:15 CST

Accelerate Diagnostics Reports Fourth Quarter and Full-Year 2020 Financial Results TUCSON, Ariz., Feb. 23, 2021

TUCSON, Ariz., Feb. 23, 2021 /PRNewswire/ -- Accelerate Diagnostics, Inc. (Nasdaq: AXDX) today announced financial results for the fourth quarter and full year ended December 31, 2020.

"We were pleased with the improvement in our go-live execution over the course of 2020, which drove a material increase in our live instruments in the fourth quarter and led to a 63% increase in our revenue-generating installed base during the year," commented Jack Phillips, Chief Executive Officer of Accelerate Diagnostics, Inc. "We also saw modest improvements in the demand environment during the quarter, although new instrument placements continued to be challenged due to pandemic-related headwinds, including limited salesforce access to potential customer sites and hospital decision-makers' strong focus on COVID-19. Entering 2021, we are optimistic about an improving hospital selling environment as we leverage our improved sales and implementation processes and plan to bring our exciting new product launches to market."

Fourth Quarter 2020 Highlights

* Added 21 contracted instruments in the quarter and brought 45 instruments live in the U.S. * Ended the fourth quarter with 268 U.S. live revenue-generating instruments, with another 133 U.S. contracted Pheno instruments not yet live. * Net sales of $3.1 million, compared to $3.5 million in the fourth quarter of 2019, or a 10% decline, due to an international capital deal in the fourth quarter of 2019 that did not repeat in the current year. * Gross margin was 37% for the quarter, compared to 44% in the fourth quarter of 2019. This decrease was the result of pandemic-related effects on manufacturing, restructuring charges in EMEA, and dilution due to capital deals in the quarter. * Selling, general, and administrative expenses for the quarter were $11.2 million, compared to $13.6 million in the fourth quarter of 2019. This decrease was driven by pandemic-related reductions in sales and marketing spend related to travel and trade shows. * Research and development (R&D) costs for the quarter were $5.1 million, compared to $6.2 million in the fourth quarter of 2019. This decrease was the result of increased efficiencies and lower external study spend. * Net loss was $18.9 million in the fourth quarter, or $0.33 per share, which included $4.2 million in non-cash stock-based compensation expense. * Net cash used in the quarter was $9.2 million, and the company ended the quarter with total cash, investments, and cash equivalents of $68.3 million.

2020 Full Year Highlights

* Net sales were $11.2 million for the year as compared to $9.3 million from the same period in the prior year, or 20% growth. * Gross margin was 40% for the year, compared to 47% for the prior year. This decrease was the result of pandemic-related effects on manufacturing, restructuring charges in EMEA, and dilution due to capital deals during the year. * Selling, general, and administrative expenses were $46.9 million for the year, compared to $51.9 million in 2019. This decrease was driven by pandemic-related reductions in sales and marketing spend related to travel and trade shows. * Research and development (R&D) costs were $21.3 million year-to-date, compared to $25.4 million in 2019. This decrease was the result of increased efficiencies and lower external study spend. * Net loss was $78.2 million for the year, or $1.40 per share, which included $16.5 million in non-cash stock-based compensation expense. * Net cash used was $40.2 million, and the company ended the quarter with total cash, investments, and cash equivalents of $68.3 million.

Full financial results for the year ending December 31, 2020 will be filed on Form 10-K 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 fourth quarter and full year 2020 results. To listen to the 2020 fourth quarter and full year 2020 financial results call by phone, +1.877.883.0383 and enter the conference ID: 9000762. 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 10151395 until March 16, 2021.

This conference call will also be webcast and can be accessed from the "Investors" section of the company's website at axdx.com/investors. A replay of the audio webcast will be available until May 24, 2021.

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(r) system and Accelerate PhenoTest(r) 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, such as, among others, Mr. Phillips statements regarding our optimism that our selling environment will improve in 2021, and our plan to bring new products to market. 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 February 27, 2020, 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.

CONSOLIDATED

BALANCE SHEETS

(in thousands, except share data)



December 31,

2020 2019

ASSETS

Current assets:

Cash and cash equivalents $35,781 $61,014

Investments 32,488 47,437

Trade accounts receivable 1,550 3,222

Inventory 9,216 8,059

Prepaid expenses 1,172 955

Other current assets 1,780 1,165

Total current assets 81,987 121,852

Property and equipment, net 6,135 7,905

Right of use assets 3,183 3,917

Other non-current assets 2,120 750

Total assets $93,425 $134,424



LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities:

Accounts payable $1,290 $2,351

Accrued liabilities 2,991 3,828

Accrued interest 1,262 1,262

Deferred revenue 376 271

Current portion of long-term debt 553 -

Current operating lease liability 497 450

Total current liabilities 6,969 8,162

Non-current operating lease liability 3,063 3,579

Other non-current liabilities 335 19

Long-term debt 4,659 -

Convertible notes 141,211 130,043

Total liabilities 156,237 141,803



Commitments and contingencies



Stockholders' equity (deficit):

Preferred shares, $0.001 par value;

5,000,000 preferred shares authorized and none - - outstanding as of December 31, 2020 and 2019

Common stock, $0.001 par value;

85,000,000 common shares authorized with 57,607,939 shares issued and outstanding on December 31, 2020 and 58 55 85,000,000 common shares authorized with 54,708,792 shares issued and outstanding on December 31, 2019

Contributed capital 475,072 452,344

Treasury stock (45,067) (45,067)

Accumulated deficit (492,966)(414,653)

Accumulated other comprehensive loss 91 (58)

Total stockholders' equity (deficit) (62,812) (7,379)

Total liabilities and stockholders' equity (deficit) $93,425 $134,424







ACCELERATE DIAGNOSTICS, INC.

CONSOLIDATED

STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except per share data)



Years Ended December 31,

2020 2019 2018

Net sales $11,165 $9,297 $5,670



Cost of sales 6,706 4,897 3,187

Gross profit 4,459 4,400 2,483



Costs and expenses:

Research and development 21,255 25,345 27,638

Sales, general and administrative 46,904 51,886 55,214

Total costs and expenses 68,159 77,231 82,852



Loss from operations (63,700) (72,831) (80,369)



Other income (expense):

Interest expense (15,550) (14,256) (10,113)

Foreign currency exchange gain (loss) 252 (124) (450)

Interest and dividend income 855 2,809 2,845

Other expense, net (60) (14) (28)

Total other expense, net (14,503) (11,585) (7,746)



Net loss before income taxes (78,203) (84,416) (88,115)

Benefit (provision) for income taxes (5) 111 (211)

Net loss $(78,208)$(84,305)$(88,326)



Basic and diluted net loss per share $(1.40) $(1.55) $(1.62)

Weighted average shares outstanding 56,010 54,506 54,494



Other comprehensive loss:

Net loss $(78,208)$(84,305)$(88,326)

Net unrealized (loss) gain on (2) 193 23 available-for-sale investments

Foreign currency translation adjustment 151 (102) (172)

Comprehensive loss $(78,059)$(84,214)$(88,475)







ACCELERATE DIAGNOSTICS, INC.

CONSOLIDATED

STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT)

(in thousands)



Accumulated Common Total ContributedAccumulated Treasury Other Shares Stock Deficit Stockholders' Capital stock Comprehensive Amount Equity (Deficit) Income (Loss)

Balances, January 55,674 $56 $ 360,620$(241,972)$- $ - $ 118,704 1, 2018

Net loss - - - (88,326) - - (88,326)

Exercise of options and 382 - 3,749 - - - 3,749 restricted stock awards issued

Issuance of common stock under 35 - 583 - - - 583 employee purchase plan

Unrealized gain on available-for-sale- - - - - 23 23 securities

Foreign currency translation - - - - - (172) (172) adjustment

Repurchase of common stock under(1,859) (2) - - (45,067) - (45,069) Prepaid Forward contract

Issuance of - - 53,283 - - - 53,283 convertible note

Cumulative impact of accounting - - - (50) - - (50) change

Equity-based - - 14,650 - - - 14,650 compensation

Balances, December54,232 54 432,885 (330,348) (45,067) (149) 57,375 31, 2018

Net loss - - - (84,305) - - (84,305)

Issuance of common56 - 1,000 - - - 1,000 stock

Exercise of options and 396 1 5,364 - - - 5,365 restricted stock awards issued

Issuance of common stock under 25 - 458 - - - 458 employee purchase plan

Unrealized gain on available-for-sale- - - - - 193 193 securities

Foreign currency translation - - - - - (102) (102) adjustment

Equity-based - - 12,637 - - - 12,637 compensation

Balances, December54,709 55 452,344 (414,653) (45,067) (58) (7,379) 31, 2019

Net loss - - - (78,208) - - (78,208)

Exercise of options and 2,858 3 6,059 - - - 6,062 restricted stock awards issued

Issuance of common stock under 41 - 359 - - - 359 employee purchase plan

Unrealized loss on available-for-sale- - - - - (2) (2) securities

Foreign currency translation - - - - - 151 151 adjustment

Cumulative impact of accounting - - - (105) - - (105) change

Equity-based - - 16,310 - - - 16,310 compensation

Balances, December$57,608$58 $ 475,072$(492,966)$(45,067)$ 91 $ (62,812) 31, 2020







ACCELERATE DIAGNOSTICS, INC.

CONSOLIDATED

STATEMENT OF CASH FLOWS

(in thousands)



Years Ended December 31,

2020 2019 2018

Cash flows from operating activities:

Net loss $(78,208)$(84,305)$(88,326)

Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation and amortization 2,997 2,602 2,561

Amortization of investment discount 99 (427) (621)

Equity-based compensation expense 16,464 12,618 14,422

Amortization of debt discount and 11,168 9,969 6,849 issuance costs

Realized loss on available-for-sale 3 - - securities

Loss on disposal of property and 785 837 678 equipment

Contributions to deferred compensation (357) - - plan

(Increase) decrease in assets:

Accounts receivable 1,592 (1,362) 86

Inventory (1,356) (3,655) (4,223)

Prepaid expense and other assets (2,087) (752) (250)

Increase (decrease) in liabilities:

Accounts payable (1,006) 988 (748)

Accrued liabilities (909) (1,327) 1,426

Accrued interest - - 1,262

Deferred revenue and income 105 54 (904)

Deferred compensation 316 (34) 32

Net cash used in operating activities (50,394) (64,794) (67,756)

Cash flows from investing activities:

Purchases of equipment (1,362) (330) (998)

Purchase of marketable securities (46,933) (50,226) (120,556)

Proceeds from sales of marketable - 14,500 3,000 securities

Maturities of marketable securities 61,901 88,867 98,416

Net cash provided by (used in) investing 13,606 52,811 (20,138) activities

Cash flows from financing activities:

Proceeds from issuance of common stock 362 1,458 583

Proceeds from exercise of options and 6,059 5,365 3,749 warrants

Proceeds from issuance of convertible - - 171,500 note

Proceeds from debt 5,578 - -

Payment of debt (366) - -

Prepayment of forward stock repurchase - - (45,069) transaction

Payment of debt issuance costs - - (4,992)

Net cash provided by financing activities11,633 6,823 125,771



Effect of exchange rate on cash (78) (86) (130)



Increase (decrease) in cash and cash (25,233) (5,246) 37,747 equivalents

Cash and cash equivalents, beginning of 61,014 66,260 28,513 period

Cash and cash equivalents, end of period $35,781 $61,014 $66,260







ACCELERATE DIAGNOSTICS, INC.

CONSOLIDATED

STATEMENT OF CASH FLOWS (CONTINUED)

(in thousands)



Years Ended December 31,

2020 2019 2018

Non-cash investing activities:

Transfer of instruments from inventory to property $1,525$3,361$4,767and equipment

Supplemental cash flow information:

Interest paid $4,288$4,288$2,001

Income taxes paid, net of refunds $43 $41 $651



See accompanying notes to consolidated financial statements.

View original content to download multimedia: http://www.prnewswire.com/news-releases/accelerate-diagnostics-reports-fourth-quarter-and-full-year-2020-financial-results-301233831.html

SOURCE Accelerate Diagnostics, Inc.