Attached files
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| 8-K - FORM 8-K - Accelerate Diagnostics, Inc | tm217489d1_8k.htm |
Exhibit 99.1
Accelerate Diagnostics Reports Fourth Quarter and Full-Year 2020 Financial Results
TUCSON, Ariz., February 23, 2021 -- 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.
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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, +1.412.902.6506 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® 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, 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.
###
For further information: Investor Inquiries & Media Contact: Laura Pierson, Accelerate Diagnostics, +1 520 365-3100, investors@axdx.com
Source: Accelerate Diagnostics Inc.
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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 85,000,000 common shares authorized with 54,708,792 shares issued and outstanding on December 31, 2019 | 58 | 55 | ||||||
| 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 | ||||
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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 available-for-sale investments | (2 | ) | 193 | 23 | ||||||||
| Foreign currency translation adjustment | 151 | (102 | ) | (172 | ) | |||||||
| Comprehensive loss | $ | (78,059 | ) | $ | (84,214 | ) | $ | (88,475 | ) | |||
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ACCELERATE DIAGNOSTICS, INC.
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
(in thousands)
| Shares | Common Stock Amount | Contributed Capital | Accumulated Deficit | Treasury stock | Accumulated Other Comprehensive Income (Loss) | Total Stockholders’ Equity (Deficit) | ||||||||||||||||||||||
| Balances, January 1, 2018 | 55,674 | $ | 56 | $ | 360,620 | $ | (241,972 | ) | $ | — | $ | — | $ | 118,704 | ||||||||||||||
| Net loss | — | — | — | (88,326 | ) | — | — | (88,326 | ) | |||||||||||||||||||
| Exercise of options and restricted stock awards issued | 382 | — | 3,749 | — | — | — | 3,749 | |||||||||||||||||||||
| Issuance of common stock under employee purchase plan | 35 | — | 583 | — | — | — | 583 | |||||||||||||||||||||
| Unrealized gain on available-for-sale securities | — | — | — | — | — | 23 | 23 | |||||||||||||||||||||
| Foreign currency translation adjustment | — | — | — | — | — | (172 | ) | (172 | ) | |||||||||||||||||||
| Repurchase of common stock under Prepaid Forward contract | (1,859 | ) | (2 | ) | — | — | (45,067 | ) | — | (45,069 | ) | |||||||||||||||||
| Issuance of convertible note | — | — | 53,283 | — | — | — | 53,283 | |||||||||||||||||||||
| Cumulative impact of accounting change | — | — | — | (50 | ) | — | — | (50 | ) | |||||||||||||||||||
| Equity-based compensation | — | — | 14,650 | — | — | — | 14,650 | |||||||||||||||||||||
| Balances, December 31, 2018 | 54,232 | 54 | 432,885 | (330,348 | ) | (45,067 | ) | (149 | ) | 57,375 | ||||||||||||||||||
| Net loss | — | — | — | (84,305 | ) | — | — | (84,305 | ) | |||||||||||||||||||
| Issuance of common stock | 56 | — | 1,000 | — | — | — | 1,000 | |||||||||||||||||||||
| Exercise of options and restricted stock awards issued | 396 | 1 | 5,364 | — | — | — | 5,365 | |||||||||||||||||||||
| Issuance of common stock under employee purchase plan | 25 | — | 458 | — | — | — | 458 | |||||||||||||||||||||
| Unrealized gain on available-for-sale securities | — | — | — | — | — | 193 | 193 | |||||||||||||||||||||
| Foreign currency translation adjustment | — | — | — | — | — | (102 | ) | (102 | ) | |||||||||||||||||||
| Equity-based compensation | — | — | 12,637 | — | — | — | 12,637 | |||||||||||||||||||||
| Balances, December 31, 2019 | 54,709 | 55 | 452,344 | (414,653 | ) | (45,067 | ) | (58 | ) | (7,379 | ) | |||||||||||||||||
| Net loss | — | — | — | (78,208 | ) | — | — | (78,208 | ) | |||||||||||||||||||
| Exercise of options and restricted stock awards issued | 2,858 | 3 | 6,059 | — | — | — | 6,062 | |||||||||||||||||||||
| Issuance of common stock under employee purchase plan | 41 | — | 359 | — | — | — | 359 | |||||||||||||||||||||
| Unrealized loss on available-for-sale securities | — | — | — | — | — | (2 | ) | (2 | ) | |||||||||||||||||||
| Foreign currency translation adjustment | — | — | — | — | — | 151 | 151 | |||||||||||||||||||||
| Cumulative impact of accounting change | — | — | — | (105 | ) | — | — | (105 | ) | |||||||||||||||||||
| Equity-based compensation | — | — | 16,310 | — | — | — | 16,310 | |||||||||||||||||||||
| Balances, December 31, 2020 | $ | 57,608 | $ | 58 | $ | 475,072 | $ | (492,966 | ) | $ | (45,067 | ) | $ | 91 | $ | (62,812 | ) | |||||||||||
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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 issuance costs | 11,168 | 9,969 | 6,849 | |||||||||
| Realized loss on available-for-sale securities | 3 | — | — | |||||||||
| Loss on disposal of property and equipment | 785 | 837 | 678 | |||||||||
| Contributions to deferred compensation plan | (357 | ) | — | — | ||||||||
| (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 securities | — | 14,500 | 3,000 | |||||||||
| Maturities of marketable securities | 61,901 | 88,867 | 98,416 | |||||||||
| Net cash provided by (used in) investing activities | 13,606 | 52,811 | (20,138 | ) | ||||||||
| Cash flows from financing activities: | ||||||||||||
| Proceeds from issuance of common stock | 362 | 1,458 | 583 | |||||||||
| Proceeds from exercise of options and warrants | 6,059 | 5,365 | 3,749 | |||||||||
| Proceeds from issuance of convertible note | — | — | 171,500 | |||||||||
| Proceeds from debt | 5,578 | — | — | |||||||||
| Payment of debt | (366 | ) | — | — | ||||||||
| Prepayment of forward stock repurchase transaction | — | — | (45,069 | ) | ||||||||
| Payment of debt issuance costs | — | — | (4,992 | ) | ||||||||
| Net cash provided by financing activities | 11,633 | 6,823 | 125,771 | |||||||||
| Effect of exchange rate on cash | (78 | ) | (86 | ) | (130 | ) | ||||||
| Increase (decrease) in cash and cash equivalents | (25,233 | ) | (5,246 | ) | 37,747 | |||||||
| Cash and cash equivalents, beginning of period | 61,014 | 66,260 | 28,513 | |||||||||
| Cash and cash equivalents, end of period | $ | 35,781 | $ | 61,014 | $ | 66,260 | ||||||
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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 and equipment | $ | 1,525 | $ | 3,361 | $ | 4,767 | ||||||
| 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.
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