UNITED STATES
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FORM
CURRENT REPORT
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| Item 2.02 | Results of Operations and Financial Condition. |
On May 5, 2021, Quanterix Corporation (“Quanterix”) issued a press release announcing its financial results for the first quarter ended March 31, 2021 (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 May 5, 2021. |
| 104 | Cover Page Interactive 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/ John Fry | |
| John Fry | ||
| General Counsel and Secretary | ||
Date: May 5, 2021
Exhibit 99.1
Quanterix Corporation Releases Operating Results for First Quarter 2021
Q1 GAAP revenue including grant revenue $27.2M; Q1 non-GAAP revenue $24.9M, an increase of 58% versus prior year
Billerica, Mass. – May 5, 2021 — Quanterix Corporation (NASDAQ: QTRX), a company helping to transform healthcare with digital protein biomarker technology enabling precision health, today announced financial results for the three months ending March 31, 2021.
“We made productive advances on our strategic and operational priorities during the first quarter 2021,” said Chairman, Chief Executive Officer and President, Quanterix, Kevin Hrusovsky. “The precision health ecosystem continues to catalyze interest and adoption from healthcare payors, government agencies, academia, and pharmaceutical companies as they make tangible advances in developing drug therapies for Alzheimer’s, Parkinson’s, Multiple Sclerosis, traumatic brain injury, COVID-19, infectious diseases and cancers. We are rapidly innovating our technology and expanding our assay menu with a priority focus on early detection plasma biomarkers for Alzheimer’s and neuro-degeneration to keep pace with today’s research demands and deliver on the promise of non-invasive biomarkers to fuel breakthroughs in diagnostics and drug development.”
First Quarter 2021 Financial Highlights
Key financial results for the first quarter of 2021 are shown below:
| · | Q1 GAAP total revenue, which includes grant revenue of $2.3M, was $27.2M versus prior year Q1 of $15.7M; |
| · | Q1 non-GAAP total revenue was $24.9M versus prior year Q1 of $15.7M, an increase of 58%; |
| · | Q1 GAAP product revenue was $18.2M versus prior year Q1 of $9.8M, an increase of 86%; |
| · | Q1 GAAP service and other revenue was $6.4M versus prior year Q1 of $5.8M, an increase of 11% |
| · | Q1 GAAP gross margin was 60.1%; Q1 non-GAAP gross margin was 58.5% versus prior year Q1 of 48.5%, an increase of 1,000 bps. |
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.
First Quarter Business Highlights
| · | Received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for Quanterix’ Simoa® SARS-CoV-2 N Protein Antigen Test that can be run on the Simoa HD-X Analyzer®. |
| · | Released the SARS-CoV-2 N Protein Antigen Advantage Assay tailored for Research Use, enabling scientists to measure viral load and immune response in a variety of sample matrices, including blood obtained by minimally invasive capillary (finger prick) sample. |
| · | Record Instrument placement revenue of $7.0M, an increase of 86%, and consumables revenue of $11.3m, an increase of 86%. |
| · | Simoa played a key role in research to detect the COVID-19 virus in serum/plasma, dried blood microsamples (DBS) and saliva samples, including a Nature Communications study validating non-invasive antigen detection methods as an important complement to current PCR-based nasal and nasopharyngeal (NP) swab samples. |
| · | Continued to experience significant demand for phosphorylated tau at threonine 181 (pTau181) assays for the study of Alzheimer’s Disease (AD) pathology and Neuro Multiplex assays associated with many neurodegenerative diseases. |
| · | Simoa neurology assays and technologies continue to support various Alzheimer’s drug development programs globally, focusing on detecting signs of precognitive impairment early in the disease cascade with blood biomarkers. |
| · | Established a joint Simoa laboratory with WuXi AppTec in China to improve access to Quanterix’ industry leading biomarker testing and development offerings across China and the APAC market. |
| · | Successfully raised approximately $270M in net proceeds through a follow-on offering in February, further strengthening our balance sheet with growth capital. |
| · | Participated in important industry events aimed at addressing public health challenges created by the COVID-19 pandemic, including the Precision Medicine World Conference (PMWC) 2021 COVID-19 Conference and the Precision Medicine Leadership Summit hosted in connection with Powering Precision Health. |
| · | Invited to discuss the Powering Precision Health movement, rebuilding public trust in science and leadership of the industry-wide proteomics revitalization disrupting healthcare on Health Care Rounds Podcast and Mendelspod. |
| · | Welcomed Laurie Olson, a seasoned industry executive and former Pfizer executive leadership team member, to our board as we continue to scale the business and capitalize on the market opportunity ahead. |
| · | Simoa technology was highlighted in 110 new publications in the first quarter 2021, bringing total Simoa-specific inclusions to more than 1,200 publications. |
Conference Call
In conjunction with this announcement, Quanterix Corporation will host a conference call on May 5 at 4:30 p.m., EDT. Individuals interested in listening to the conference call may do so by dialing (800) 697-5978 for domestic callers, or (630) 691-2750 for international callers. Please reference the following conference ID: 9220 612#. A live webcast will also be available at: https://edge.media-server.com/mmc/p/ta24ja4s
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 | Q1 2021 | Q1 2020 | ||||||
| Product Revenue | 18,248 | 9,833 | ||||||
| Service and Other Revenue | 6,409 | 5,762 | ||||||
| Collaboration and License Revenue | 261 | 132 | ||||||
| Development Revenue | 2,291 | 0 | ||||||
| Total Revenue | 27,209 | 15,727 | ||||||
| Cost of Product Revenue | 7,480 | 6,186 | ||||||
| Cost of Services Revenue | 3,380 | 2,728 | ||||||
| Gross Profit | 16,349 | 6,813 | ||||||
| Gross Margin % | 60.1 | % | 43.3 | % | ||||
| Research and Development | 6,683 | 4,268 | ||||||
| Selling, General and Administrative | 19,455 | 14,273 | ||||||
| Total Operating Expenses | 26,138 | 18,541 | ||||||
| Loss From Operations | -9,789 | -11,728 | ||||||
| Interest (Expense) Income, net | -163 | 161 | ||||||
| Other Expense, net | -194 | -167 | ||||||
| Tax | 42 | 124 | ||||||
| Net Loss | -10,104 | -11,610 | ||||||
Weighted average shares outstanding was 34.4 million for Q1 2021 and 28.2 million for Q1 2020.
Quanterix Balance Sheet
| in '000 USD | At 3/31/21 | At 12/31/20 | ||||||
| Cash and Cash Equivalents | 442,672 | 181,584 | ||||||
| Accounts Receivable | 14,936 | 17,184 | ||||||
| Inventory | 17,044 | 14,856 | ||||||
| Prepaid Expenses and Other | 7,791 | 5,981 | ||||||
| Total Current Assets | 482,443 | 219,605 | ||||||
| Restricted Cash | 1,400 | 1,000 | ||||||
| Property and Equipment, Net | 14,183 | 13,912 | ||||||
| Intangible Assets, Net | 12,464 | 13,716 | ||||||
| Goodwill | 9,933 | 10,460 | ||||||
| Right-of-Use Assets | 11,870 | 11,995 | ||||||
| Other Non-Current Assets | 373 | 357 | ||||||
| Total Assets | 532,666 | 271,045 | ||||||
| Accounts Payable & Accrued Expenses | 19,121 | 22,421 | ||||||
| Deferred Revenue | 6,420 | 5,421 | ||||||
| Current Portion of Long Term Debt | 7,694 | 7,673 | ||||||
| Lease Liabilities | 1,271 | 1,234 | ||||||
| Other Current Liabilities | 1,985 | 3,054 | ||||||
| Total Current Liabilities | 36,491 | 39,803 | ||||||
| Deferred Revenue, Net of Current Portion | 776 | 577 | ||||||
| Lease Liabilities, Net of Current Portion | 21,552 | 21,891 | ||||||
| Other Non-Current Liabilities | 2,378 | 2,649 | ||||||
| Total Liabilities | 61,197 | 64,920 | ||||||
| Total Stockholders’ Equity | 471,469 | 206,125 | ||||||
| Total Liabilities and Stockholders’ Equity | 532,666 | 271,045 | ||||||
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 and non-GAAP gross margin. 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.
Reconciliation of non-GAAP Financials
(In thousands)
| 2021 | 2020 | |||||||
| Three months ended | ||||||||
| March 31 | ||||||||
| Total revenue | $ | 27,209 | $ | 15,727 | ||||
| Grant revenue (Note 1) | $ | (2,291 | ) | — | ||||
| Non-GAAP revenue | $ | 24,918 | $ | 15,727 | ||||
| Gross profit | $ | 16,349 | $ | 6,813 | ||||
| Grant revenue (Note 1) | $ | (2,291 | ) | — | ||||
| Acquisition-related purchase accounting charges (Note 2) | $ | 520 | $ | 820 | ||||
| Non-GAAP gross profit | $ | 14,578 | $ | 7,633 | ||||
| GAAP gross margin % | 60.1 | % | 43.3 | % | ||||
| Non-GAAP gross margin % | 58.5 | % | 48.5 | % | ||||
| GAAP total operating expenses | $ | 26,138 | $ | 18,541 | ||||
| Grant research and development expenses (Note 3) | $ | (1,763 | ) | — | ||||
| Acquisition-related purchase accounting charges (Note 4) | $ | (20 | ) | $ | (20 | ) | ||
| Non-GAAP total operating expenses | $ | 24,355 | $ | 18,521 | ||||
| GAAP loss from operations | $ | (9,789 | ) | $ | (11,728 | ) | ||
| Non-GAAP loss from operations | $ | (9,777 | ) | $ | (10,888 | ) | ||
Note 1: During the three months ended March 31, 2021, we recognized $2.3 million in revenue in connection with our workplan 2 award under the National Institute of Health Rapid Acceleration of Diagnostics Program.
Note 2: During the three months ended March 31, 2021, we incurred $138 thousand of acquisition-related amortization of inventory valuation and $382 thousand of acquisition-related amortization of intangible assets adjustments in connection with our acquisition of UmanDiagnostics. During the three months ended March 31, 2020, we incurred $438 thousand of acquisition-related amortization of inventory valuation and $382 thousand of acquisition-related amortization of intangible assets in connection with our acquisition of UmanDiagnostics.
Note 3: During the three months ended March 31, 2021, we incurred $1.8 million in research and development expenses in connection with our workplan 2 award under the National Institute of Health Rapid Acceleration of Diagnostics Program.
Note 4: During each of the the three months ended March 31, 2021 and 2020, we incurred $20 thousand of acquisition-related amortization of intangible assets adjustments in connection with our acquisition of UmanDiagnostics.
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