UNITED STATES
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FORM
CURRENT REPORT
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| Item 2.02 | Results of Operations and Financial Condition. |
On March 2, 2021, Quanterix Corporation (“Quanterix”) issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2020 (the “Earnings Release”). A copy of the Earnings Release is furnished as Exhibit 99.1 and is incorporated herein by reference.
The information in this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (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 or the Exchange Act, except as expressly set forth by specific reference in such a filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. | Description |
| 99.1 | Earnings Release dated March 2, 2021. |
| 104 | Cover Page lnteractive Data File (embedded within the Inline XBRL document). |
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 thereunto duly authorized.
| QUANTERIX CORPORATION | ||
| By: | /s/ Amol Chaubal | |
| Amol Chaubal | ||
| Chief Financial Officer | ||
Date: March 2, 2021
Exhibit 99.1
Quanterix Corporation Releases Operating Results for Fourth Quarter and Full Year 2020
Q4 GAAP revenue including Grant Revenue $26.1M; Q4 non-GAAP revenue $21.6M, an increase of 36% versus prior year
Billerica, Mass. – March 2, 2021 — Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, today announced financial results for the fourth quarter and 12 months ended December 31, 2020.
“Responding to the pandemic crisis as well as advances in therapies to treat Alzheimer’s has accelerated our leadership of precision health and the proteomics revolution,” said Chairman, Chief Executive Officer and President, Quanterix, Kevin Hrusovsky. “There is a strong demand for ultra-sensitive protein analytical tools to support disease studies, diagnostics and drug development as the COVID focus shifts from battling the acute virus to the long-hauler impact of the virus on organ and overall human health (CNS, Cardiac, Respiratory, Immunology, etc). We enter 2021 on strong footing as we scale Quanterix to support this unprecedented opportunity.”
Fourth Quarter 2020 Financial Highlights
Key financial results for the four quarter of 2020 are shown below:
| · | Q4 GAAP total revenue, which includes Grant Revenue, was $26.1M versus prior year Q4 of $15.9M; | |
| · | Q4 non-GAAP total revenue was $21.6M versus prior year Q4 of $15.9M, an increase of 36%; | |
| · | Q4 GAAP product revenue was $15.7M versus prior year Q4 of $11.4M, an increase of 38%; | |
| · | Q4 GAAP service and other revenue was $5.5M versus prior year Q4 of $4.3M, an increase of 28% |
Full Year 2020 Financial Highlights
Key financial results for FY 2020 are shown below:
| · | FY GAAP total revenue, which includes one-time License Revenue and Grant Revenue, was $86.4M versus prior year FY of $56.7M; | |
| · | FY non-GAAP total revenue was $68.8M versus prior year FY of $56.7M, an increase of 21%; | |
| · | FY GAAP product revenue was $44.0M versus prior year FY of $40.5M, an increase of 9%; | |
| · | FY GAAP service and other revenue was $24.1M versus prior year FY of $16.1M, an increase of 50% |
For additional information on the non-GAAP financial measures included in this press release, please see “Use of Non-GAAP Financial Measures” and “Reconciliation of Non-GAAP Financials” below.
Fourth Quarter and Full Year Business Highlights
| · | Awarded an $18.2M contract with the NIH through its RADx initiative to accelerate the continued development and scale-up of a novel SARS-CoV-2 antigen test. | |
| · | Received FDA Emergency Use Authorizations for novel SARS-COV-2 antigen test (after year-end) and for semi-quantitative antibody test, underscoring our longstanding science-first mentality and deep dedication to the highest standards of quality and scientific rigor across our business. |
| · | Leveraging the unparalleled ultra-sensitivity of Simoa, enabled several leading researchers globally, including at the NIH, to begin tackling leading-edge COVID challenges, such as establishing potential for blood based anti-viral endpoints for new drug therapies and understanding the long-term complications of COVID-19. | |
| · | Expanded our differentiated Neurology menu to include tau phosphorylated at threonine 181 (pTau-181), a highly specific biomarker for the study of Alzheimer’s disease pathology, in cerebral spinal fluid (CSF), serum and plasma as well as launched Neuro Multiplex assays associated with many neurodegenerative diseases. Our biomarker portfolio is now supporting leading Alzheimer’s programs globally and a growing body of research, including work published recently in The Lancet Neurology. This work suggests that blood pTau-181 levels could prove critical to predicting Alzheimer’s disease progression and differentiating the disease from other neurodegenerative disorders, marking a critical step toward AD early detection, clinical trial advancements, improved patient triaging and asymptomatic screening. | |
| · | Novartis’ multiple sclerosis (MS) drug KESIMPTA® (ofatumumab), which utilized Nf-L as secondary endpoint, was approved by the FDA. | |
| · | Quanterix’ Simoa technology was highlighted in a record 443 new publications in 2020, bringing total Simoa-specific inclusions to over 1,120. Also, was invited to present at several marquis symposiums showcasing our Precision Health vision and potential to catalyze asymptomatic medicine. | |
| · | Instrument installed base increased by 34% in 2020 to 535, despite access challenges posed by COVID-19. This includes 93 HD-X placements with over 50% new installations and 84 new SR-X and SP-X placements. | |
| · | Solidified Simoa’s technological leadership by achieving a 100x sensitivity improvement in a pilot of the digital enzyme-linked immunosorbent assay (ELISA) that powers the Company’s HD-X™ and SR-X™ Ultra-Sensitive Biomarker Detection Systems. | |
| · | Entered into a non-exclusive royalty-bearing license agreement with Abbott Laboratories, to grant Abbott access to Quanterix’ portfolio of bead-based technology patents for use in in-vitro diagnostic (IVD) applications. | |
| · | Realized multi-category revenue opportunities with one of the largest multi-national, healthcare payor groups, with execution of multiple population surveillance studies, creating beachhead for our vision for the future of precision medicine, where early and non-invasive disease detection has the potential to transform life and healthcare costs. | |
| · | Successfully raised ~$385 million in gross proceeds across 2020 and early-2021 through our follow-on offerings, further strengthening our balance sheet with growth capital. | |
| · | William Geist joined Quanterix as Chief Operating Officer to help us sustain and grown our strong momentum across numerous digital biomarker platforms. |
Conference Call
In conjunction with this announcement, Quanterix Corporation will host a conference call on March 2 at 4:30 p.m., EDT. Individuals interested in listening to the conference call may do so by dialing (833) 686-9351 for domestic callers, or (612) 979-9890 for international callers. Please reference the following conference ID: 4438067. A live webcast will also be available at: https://edge.media-server.com/mmc/p/tbpi32nd. The webcast will be available on the Company’s website, https://www.quanterix.com, for one year following completion of the call.
Financial Highlights
| Quanterix Income Statement | ||||||||||||||||
| in '000 USD | Q4 2020 | Q4 2019 | YTD 2020 | YTD 2019 | ||||||||||||
| Product Revenue | 15,732 | 11,431 | 44,017 | 40,491 | ||||||||||||
| Service and Other Revenue | 5,498 | 4,302 | 24,129 | 16,059 | ||||||||||||
| Collaboration and License Revenue | 408 | 184 | 11,809 | 184 | ||||||||||||
| Development Revenue | 4,493 | 0 | 6,422 | 0 | ||||||||||||
| Total Revenue | 26,131 | 15,917 | 86,377 | 56,734 | ||||||||||||
| Cost of Product Revenue | 7,961 | 6,684 | 25,950 | 20,900 | ||||||||||||
| Cost of Services Revenue | 3,120 | 2,368 | 11,245 | 8,998 | ||||||||||||
| Cost of License Revenue | 0 | 0 | 1,000 | 0 | ||||||||||||
| Gross Profit | 15,050 | 6,865 | 48,182 | 26,836 | ||||||||||||
| Gross Margin % | 57.6 | % | 43.1 | % | 55.8 | % | 47.3 | % | ||||||||
| Research and Development | 6,217 | 4,398 | 20,174 | 16,190 | ||||||||||||
| Selling, General and Administrative | 18,766 | 13,953 | 59,592 | 52,246 | ||||||||||||
| Total Operating Expenses | 24,983 | 18,351 | 79,766 | 68,436 | ||||||||||||
| Loss From Operations | -9,933 | -11,486 | -31,584 | -41,600 | ||||||||||||
| Interest Income (Expense), net | -166 | 282 | -273 | 627 | ||||||||||||
| Other Income (Expense), net | 155 | 139 | -49 | -10 | ||||||||||||
| Tax | 123 | 107 | 376 | 187 | ||||||||||||
| Net Loss | -9,821 | -10,958 | -31,530 | -40,796 | ||||||||||||
Weighted average shares outstanding was 31.7 million for Q4 2020 and 28.6 million for YTD 2020
| Quanterix Balance Sheet | ||||||||
| in '000 USD | At 12/31/20 | At 12/31/19 | ||||||
| Cash and Cash Equivalents | 181,584 | 109,155 | ||||||
| Accounts Receivable | 17,184 | 10,906 | ||||||
| Inventory | 14,856 | 10,463 | ||||||
| Prepaid Expenses and Other | 5,981 | 2,137 | ||||||
| Total Current Assets | 219,605 | 132,661 | ||||||
| Restricted Cash | 1,000 | 1,026 | ||||||
| Property and Equipment, Net | 13,912 | 12,047 | ||||||
| Intangible Assets, Net | 13,716 | 14,307 | ||||||
| Goodwill | 10,460 | 9,353 | ||||||
| Right-of-Use Assets | 11,995 | 0 | ||||||
| Other Non-Current Assets | 357 | 557 | ||||||
| Total Assets | 271,045 | 169,951 | ||||||
| Accounts Payable & Accrued Expenses | 22,421 | 14,845 | ||||||
| Deferred Revenue | 5,421 | 4,697 | ||||||
| Current Portion of Long Term Debt | 7,673 | 75 | ||||||
| Lease Liabilities | 1,234 | 0 | ||||||
| Other Current Liabilities | 3,054 | 216 | ||||||
| Total Current Liabilities | 39,803 | 19,833 | ||||||
| Deferred Revenue, Net of Current Portion | 577 | 466 | ||||||
| Long Term Debt, Net of Current Portion | 0 | 7,587 | ||||||
| Lease Liabilities, Net of Current Portion | 21,891 | 0 | ||||||
| Other Non-Current Liabilities | 2,649 | 13,407 | ||||||
| Total Liabilities | 64,920 | 41,293 | ||||||
| Total Stockholders’ Equity | 206,125 | 128,658 | ||||||
| Total Liabilities and Stockholders’ Equity | 271,045 | 169,951 | ||||||
Use of Non-GAAP Financial Measures
To supplement the Company’s financial statements presented on a GAAP basis, the Company has provided certain non-GAAP financial measures, including non-GAAP revenue. Management uses these non-GAAP measures to evaluate the Company’s operating performance in a manner that allows for meaningful period-to-period comparison and analysis of trends in its business. Management believes that such measures are important in comparing current results with prior period results and are useful to investors and financial analysts in assessing the Company’s operating performance. The non-GAAP financial information presented here should be considered in conjunction with, and not as a substitute for, the financial information presented in accordance with GAAP. Investors are encouraged to review the reconciliation of these non-GAAP measures to their most directly comparable GAAP financial measures set forth below.
About Quanterix
Quanterix is a company that’s digitizing biomarker analysis with the goal of advancing the science of precision health. The company’s digital health solution, Simoa, has the potential to change the way in which healthcare is provided today by giving researchers the ability to closely examine the continuum from health to disease. Quanterix’ technology is designed to enable much earlier disease detection, better prognoses and enhanced treatment methods to improve the quality of life and longevity of the population for generations to come. The technology is currently being used for research applications in several therapeutic areas, including oncology, neurology, cardiology, inflammation and infectious disease. The company was established in 2007 and is located in Billerica, Massachusetts. For additional information, please visit https://www.quanterix.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release are based on Quanterix’ expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause Quanterix’ actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Quanterix’ filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as required by law, Quanterix assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
Media Contact:
PAN Communications
Staci Didner, (407) 734-7325
quanterix@pancomm.com
Investor Relations Contact:
Stephen Hrusovsky
(774) 278-0496
shrusovsky@quanterix.com