0001503274 false 0001503274 2022-03-01 2022-03-01 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): March 1, 2022

 

QUANTERIX CORPORATION

(Exact name of registrant as specified in its charter)

 

Delaware 001-38319 20-8957988
(State or other jurisdiction
of incorporation)
(Commission File Number) (IRS Employer
Identification No.)

 

900 Middlesex Turnpike
Billerica, MA
01821
(Address of principal executive offices) (zip code)

 

Registrant’s telephone number, including area code: (617) 301-9400

 

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))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). 

 

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. ¨

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class  Trading symbol(s)  Name of each exchange on which registered
Common Stock, $0.001 par value per share  QTRX  The Nasdaq Global Market

 

 

 

 

 

 

Item 2.02Results of Operations and Financial Condition.

 

On March 1, 2022, Quanterix Corporation (“Quanterix” or, the “Company”) issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2021 and providing a business update (the “Earnings Release”). A copy of the Earnings Release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.

 

Item 5.02Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

On March 1, 2022, Quanterix announced its executive leadership succession plan designed to leverage the Company’s strong foundation for growth. Effective April 25, 2022, Chairman and Chief Executive Officer Kevin Hrusovsky will become Executive Chairman of the Board of Directors, and President of Quanterix and Diagnostics Masoud Toloue will succeed Mr. Hrusovsky as Chief Executive Officer and join Quanterix’ Board of Directors. Mr. Hrusovsky will focus on key strategic initiatives, Board evolution and important customer, partner and investor relationships, while transitioning CEO responsibilities to Dr. Toloue.

 

Additional information about Dr. Toloue, age 41, can be found in the Current Report on Form 8-K filed by the Company on May 11, 2021 (File No. 001-38319) which is incorporated herein by reference. A copy of the Press Release announcing the succession plan is filed as Exhibit 99.2 hereto and is incorporated herein by reference. An amendment will be filed to this Form 8-K when the Company has finalized the terms of Mr. Hrusovsky’s and Dr. Toloue’s arrangements with the Company.

 

Item 8.01Other Events

 

On March 1, 2022, Quanterix also announced it has entered into a collaboration with Eli Lilly and Company (“Lilly”) to advance the diagnosis, monitoring and treatment of Alzheimer’s disease. As part of the collaboration, Quanterix will receive a non-exclusive, world-wide license to Lilly’s proprietary P-tau217 antibody technology for potential near-term use in research use only products and services, and future in vitro diagnostic applications. The parties have also entered into a collaboration agreement, which establishes a framework for future projects focused on the development of Simoa® immunoassays. As part of this agreement, Lilly will fund $11 million of development with the Quanterix Accelerator group this year. A copy of the Press Release announcing the collaboration with Lilly is filed as Exhibit 99.3 hereto and is incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit
No.
 
  Description  
99.1   Earnings Release dated March 1, 2022.
99.2   Press Release dated March 1, 2022.
99.3   Press Release dated March 1, 2022.
104   Cover Page Interactive Data File (embedded within the inline XBRL document)

 

The matters reported under Items 5.02 and 8.01 of this Current Report on Form 8-K (including Exhibits 99.2 and 99.3) are being filed pursuant to such items. The matters reported under Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1) are being furnished pursuant to such item and 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 they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

 

 

 

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: March 1, 2022

 

 

 

 

Exhibit 99.1

 

 

 

Quanterix Corporation Releases Operating Results for Fourth Quarter and Full Year 2021

 

Company strengthens balance sheet ending FY with GAAP total revenue growth increase of 28% led by strong performance in neuro-related studies and applications

 

Executive leadership succession plan effective April 25, 2022, to build on the Company's foundation for growth

 

Billerica, Mass. – March 1, 2022 Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, today announced financial results for the fourth quarter and twelve months ending December 31, 2021.

 

“We‘ve reached an important inflection point with the achievement of several key milestones, namely, our license and collaboration agreements with Eli Lilly, FDA Breakthrough Device Designation for plasma pTau-181 for Alzheimer’s disease (AD), and ending a strong 2021 with another record quarter. We have nearly $400 million on our balance sheet and the recruitment of several key executives that strengthen both RUO and diagnostics potential,” said Kevin Hrusovsky, Chairman and Chief Executive Officer, Quanterix. “With our new agreements in place, we now have access to Lilly’s marquis P-tau217 antibody technology for AD and a collaboration framework for future projects across all disease categories. As we build our franchise in 2022, we look forward to partnering with other bio-pharmaceuticals, payors, researchers, and investors to unlock the massive opportunity for asymptomatic medicine using precision health proteomics.”

 

For more information on the new agreements with Lilly to advance diagnosis and treatment of Alzheimer’s disease, please see the press release issued today.

 

Quanterix also announced the Company’s executive leadership succession plan. Effective April 25, 2022, President Masoud Toloue will succeed Chairman & Chief Executive Officer Kevin Hrusovsky as CEO and join Quanterix’ Board of Directors. Hrusovsky will move into an active Executive Chairman role, continuing to serve on the Board and support key strategic initiatives and important customer, partner and investor relationships. For more information on the succession plan, please see the full release issued today.

 

Fourth Quarter 2021 Financial Highlights

 

Key financial results for the fourth quarter of 2021 are shown below:

 

Q4 GAAP total revenue, which includes grant revenue of $1.0M, was $30.3M versus prior year Q4 of $26.1M, which included grant revenue of $4.5M, an increase of 16%;

 

Q4 non-GAAP total revenue was $29.3M versus prior year Q4 of $21.6M, an increase of 35%;

 

Q4 GAAP product revenue was $23.5M versus prior year Q4 of $15.7M, an increase of 49%;

 

Q4 GAAP service and other revenue was $5.7M versus prior year Q4 of $5.5M, an increase of 3%;

 

Q4 GAAP gross margin was 53.7% versus prior year Q4 of 57.6%; and

 

Q4 non-GAAP gross margin was 53.5% versus prior year Q4 of 50.8%.

 

 

 

 

Full Year 2021 Financial Highlights

 

Key financial results for FY 2021 are shown below:

 

FY GAAP total revenue, which includes grant revenue of $5.2M, was $110.6M versus prior year FY of $86.4M; which included one-time license revenue of $11.2M and grant revenue of $6.4M, an increase of 28%;

 

FY non-GAAP total revenue was $105.3M versus prior year FY of $68.8M, an increase of 53%;

 

FY GAAP product revenue was $81.1M versus prior year FY of $44.0M, an increase of 84%;

 

FY GAAP service and other revenue was $23.6M versus prior year FY of $24.1M, a decrease of 2%;

 

FY GAAP gross margin was 55.8% versus prior year FY of 55.8%; and

 

FY non-GAAP gross margin was 55.4% versus prior year FY of 49.2%.

 

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

 

The Company strengthened its balance sheet by successfully raising $287.5 million in gross proceeds through a follow-on offering completed in Q1. Quanterix had $399.0 million in cash, cash equivalents and restricted cash on the balance sheet as of December 31, 2021.

 

Quanterix’ Simoa phospho-Tau 181 (pTau-181) blood test was granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) as an aid in diagnostic evaluation of Alzheimer’s disease.

 

The FDA expanded the Emergency Use Authorization (EUA) label for Quanterix’ Simoa SARS-CoV-2 N Protein Antigen Test to include testing with nasal swab and saliva samples, and for asymptomatic serial testing with nasal swab samples. The expanded label established this test as the first antigen test authorized for use with saliva samples.

 

Quanterix’ Simoa HD-X technology and assays were used to measure pTau217 using antibodies developed by Eli Lilly and Company for its Phase 2 TRAILBLAZER-ALZ study, which was presented by Lilly at the Alzheimer’s Association International Conference (AAIC) 2021.

 

Following the FDA approval of ADUHELM™, Biogen conducted biomarker studies on Phase 3 EMERGE and ENGAGE trial samples, utilizing Quanterix’ Simoa HD-X to measure plasma pTau-181. Dr. Oskar Hansson from University of Lund reported preliminary data showing a dose-dependent reduction in plasma pTau-181 levels following treatment with ADUHELM, which correlated with decreases in brain amyloid as measured by PET scan and a slowing of cognitive decline across four independent assessment tools.

 

Instrument installations increased by 32% in 2021 to 708 at year-end, with many HD-X instruments being used for neuro-related applications.

 

Quanterix’ Simoa technology powered the largest and most diverse global investigation in the role of plasma neurofilament light (NfL) for dementia diagnosis, published in Nature Communications. The research marks the most robust effort to date to assess the use of NfL in blood to screen for neurodegeneration as a cause of cognitive symptoms, to differentiate among neurodegenerative disorders and distinguish psychiatric disorders, and to derive age-related concentration cutoffs that may help to maximize plasma NfL’s usefulness in a clinical setting.

 

Data presented at the 2021 Clinical Trials on Alzheimer’s Disease (CTAD) conference described a prototype Simoa plasma pTau-231 assay and its potential role in detecting Alzheimer’s disease pathology. This emerging biomarker allows for detection even earlier in the disease continuum, when patients are asymptomatic and not yet exhibiting brain pathology in PET imaging studies.

 

 

 

 

The Company welcomed Masoud Toloue, with a high growth track record from PerkinElmer, to the position of President of Quanterix and Diagnostics. The Company subsequently accounced its executive transition plan as noted above. The Company also appointed Michael Doyle, a strong financial executive with deep public company experience, to the position of Chief Financial Officer and Treasurer. Laurie Olson, a seasoned industry executive who brings more than three decades of experience in commercial and corporate strategy from Pfizer, Inc., joined Quanterix’ Board of Directors.

 

Quanterix was named a finalist for the Deloitte Fast 500 list, which ranks the fastest-growing technology, media, telecommunications and life sciences companies based in North America. The annual ranking is based on percentage revenue growth over the Company’s last three fiscal years.

 

Academic publication pull-through performance continued to be strong. Quanterix’ Simoa technology was highlighted in a record 465 new publications in 2021, bringing total Simoa-specific inclusions to over 1,585.

 

Conference Call

 

In conjunction with this announcement, Quanterix Corporation will host a conference call on March 1, 2022 at 8:30 a.m. EST. 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: 5230769.

 

A live webcast will also be available at: https://edge.media-server.com/mmc/p/udpgv5ou. You may also access the live webcast by visiting the News & Events page within the Investors section of the Quanterix website at www.quanterix.com. The webcast will be available on the Company’s website for one year following completion of the call.

 

 

 

 

Financial Highlights (in thousands)

 

Quanterix Income Statement                
                 
in '000 USD  Q4 2021   Q4 2020   YTD 2021   YTD 2020 
Product Revenue   23,476    15,732    81,062    44,017 
Service and Other Revenue   5,674    5,498    23,629    24,129 
Collaboration and License Revenue   162    408    648    11,809 
Development Revenue   975    4,493    5,217    6,422 
Total Revenue   30,287    26,131    110,556    86,377 
                     
Cost of Product Revenue   9,916    7,961    34,149    25,950 
Cost of Services Revenue   4,110    3,120    14,679    11,245 
Cost of collaboration and license revenue   0    0    0    1,000 
Gross Profit   16,261    15,050    61,728    48,182 
Gross Margin %   53.7%   57.6%   55.8%   55.8%
                     
Research and Development   7,734    6,217    27,978    20,174 
Selling, General and Administrative   28,423    18,766    92,336    59,592 
Total Operating Expenses   36,157    24,983    120,314    79,766 
                     
Loss From Operations   -19,896    -9,933    -58,586    -31,584 
Interest Income (Expense), net   15    -166    -403    -273 
Other (Expense) Income, net   -213    155    1,265    -49 
Tax   68    123    36    376 
Net Loss   -20,026    -9,821    -57,688    -31,530 

 

Weighted average shares outstanding was 36.7 million for Q4 2021 and 36.0 million for YTD 2021.

 

 

 

 

Quanterix Balance Sheet        
         
in '000 USD  At 12/31/21   At 12/31/20 
Cash and Cash Equivalents   396,465    181,584 
Accounts Receivable   23,786    17,184 
Inventory   22,190    14,856 
Prepaid Expenses and Other   6,514    5,981 
Total Current Assets   448,955    219,605 
Restricted Cash   2,577    1,000 
Property and Equipment, Net   17,960    13,912 
Intangible Assets, Net   10,534    13,716 
Goodwill   9,632    10,460 
Right-of-Use Assets   11,491    11,995 
Other Non-Current Assets   378    357 
Total Assets   501,527    271,045 
           
Accounts Payable & Accrued Expenses   28,947    22,421 
Deferred Revenue   6,361    5,421 
Current Portion of Long Term Debt   0    7,673 
Lease Liabilities   1,428    1,234 
Other Current Liabilities   241    3,054 
Total Current Liabilities   36,977    39,803 
Deferred Revenue, Net of Current Portion   1,099    577 
Lease Liabilities, Net of Current Portion   20,464    21,891 
Other Non-Current Liabilities   2,035    2,649 
Total Liabilities   60,575    64,920 
           
Total Stockholders’ Equity   440,952    206,125 
           
Total Liabilities and Stockholders’ Equity   501,527    271,045 
           
    0    0 

 

 

 

 

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   2021   2020 
   Three months ended   Twelve months ended 
   December 31   December 31 
Total revenue  $30,287   $26,131   $110,556   $86,377 
     Grant revenue (Note 1)  $(975)  $(4,493)  $(5,217)  $(6,422)
     License agreement revenue (Note 2)  $-   $-   $-   $(11,200)
Non-GAAP revenue  $29,312   $21,638   $105,339   $68,755 
                     
Gross profit  $16,261   $15,050   $61,728   $48,182 
     Grant revenue (Note 1)  $(975)  $(4,493)  $(5,217)  $(6,422)
     License agreement revenue (Note 2)  $-   $-   $-   $(11,200)
Acquisition-related purchase accounting charges (Note 3)  $382   $433   $1,804   $2,251 
     Cost of license revenue (Note 4)  $-   $-   $-   $1,000 
Non-GAAP gross profit  $15,668   $10,990   $58,315   $33,811 
GAAP gross margin %   53.7%   57.6%   55.8%   55.8%
Non-GAAP gross margin %   53.5%   50.8%   55.4%   49.2%
                     
GAAP total operating expenses  $36,157   $24,983   $120,314   $79,766 
     Grant research and development expenses (Note 5)  $-   $(2,322)  $(3,355)  $(3,625)
Acquisition-related purchase accounting charges (Note 6)  $(20)  $(20)  $(80)  $(81)
Non-GAAP total operating expenses  $36,137   $22,641   $116,879   $76,060 
                     
GAAP loss from operations  $(19,896)  $(9,933)  $(58,586)  $(31,584)
Non-GAAP loss from operations  $(20,469)  $(11,651)  $(58,564)  $(42,249)

 

Note 1: During the three months ended December 31, 2021, we recognized $1.0 million in revenue in connection with our workplan 2 award under the National Institute of Health Rapid Acceleration of Diagnostics Program. During the twelve months ended December 31, 2021, we recognized $5.2 million in revenue in connection with our workplan 2 award under the National Institute of Health Rapid Acceleration of Diagnostics Program. During the three months ended December 31, 2020, we recognized $4.5 million in revenue in connection with our workplan 1 and workplan 2 awards under the National Institute of Health Rapid Acceleration of Diagnostics Program. During the twelve months ended December 31, 2020, we recognized $6.4 million in revenue in connection with our workplan 1 and workplan 2 awards under the National Institute of Health Rapid Acceleration of Diagnostics Program.
Note 2: During the twelve months ended December 31, 2020, we recognized $10.0 million in license revenue in connection with a non-exclusive license agreement with Abbott Laboratories. Also, during the twelve months ended December 31, 2020, we recognized $1.2 million of previously deferred license revenue as a result of entering into the license agreement with Abbott Laboratories.
Note 3: During the three months ended December 31, 2021, we incurred $382 thousand of acquisition-related amortization of intangible assets adjustments in connection with our acquisition of UmanDiagnostics. During the twelve months ended December 30, 2021, we incurred $274 thousand of acquisition-related amortization of inventory valuation and $1,530 thousand of acquisition-related amortization of intangible assets adjustments in connection with our acquisition of UmanDiagnostics. During the three months ended December 31, 2020, we incurred $51 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 twelve months ended December 31, 2020, we incurred $722 thousand of acquisition-related amortization of inventory valuation and $1,529 thousand of acquisition-related amortization of intangible assets adjustments in connection with our acquisition of UmanDiagnostics.
Note 4: During the twelve months ended December 31, 2020, we incurred $1.0 million in license fees in connection with our non-exclusive license agreement with Abbott Laboratories.
Note 5: During the twelve months ended December 31, 2021, we incurred $3.4 million in research and development expenses in connection with our workplan 2 award under the National Institute of Health Rapid Acceleration of Diagnostics Program. During the three months ended December 31, 2020, we incurred $2.3 million in research and development expenses in connection with our workplan 1 and workplan 2 awards under the National Institute of Health Rapid Acceleration of Diagnostics Program. During the twelve months ended December 31, 2020, we incurred $3.6 million in research and development expenses in connection with our workplan 1 and workplan 2 awards under the National Institute of Health Rapid Acceleration of Diagnostics Program.
Note 6: During the three and twelve months ended December 31, 2021, we incurred $20 thousand and $80 thousand, respectively, of acquisition-related amortization of intangible assets adjustments in connection with our acquisition of UmanDiagnostics. During three and twelve months ended December 31, 2020, we incurred $20 thousand and $81 thousand, respectively, 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.

 

Contacts

 

Media Contact: 

 

PAN Communications 

Paige Romine, 321-652-8370 

pan.quanterix@pancomm.com

 

Investor Relations Contact: 

 

Stephen Hrusovsky 

(774) 278-0496 

shrusovsky@quanterix.com 

 

 

 

Exhibit 99.2

 

 

 

Quanterix Announces Executive Leadership Succession Plan

 

Masoud Toloue, President of Quanterix and Diagnostics, to Become CEO and Join Board of Directors

 

Kevin Hrusovsky, Chairman and CEO of Quanterix, to Assume Role as Executive Chairman of the Board

 

Moves are Designed to Propel the Precision Health Vision and Catalyze the Next Chapter of Growth and Impact

 

BILLERICA, Mass.—Mar. 1, 2022 -- Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, today announced its executive leadership succession plan designed to leverage the Company’s strong foundation for growth. Effective April 25, 2022, Chairman and Chief Executive Officer Kevin Hrusovsky will become Executive Chairman of the Board and President Masoud Toloue will succeed Hrusovsky as CEO and join Quanterix’ Board of Directors. Hrusovsky will focus on key strategic initiatives, Board evolution and important customer, partner and investor relationships, while transitioning CEO responsibilities to Toloue.

 

Hrusovsky said, “With Masoud firmly established, our recent and planned hires, and Quanterix’ collaborations with Eli Lilly, Abbott and Siemens, this is the right time for this transition. Masoud is the perfect leader for our next phase of growth, and with our experienced Board of Directors, we are poised to realize the massive promise of precision health. Our incredible team of employees, customers, investors, partners and David Walt, our inspiring founder of Quanterix and Illumina and Quanterix Board member, are all instrumental in shaping our next chapter as the Company supports ‘asymptomatic’ medicine targeting the eradication of today’s most lethal diseases.”

 

Toloue has served as President of Quanterix and Diagnostics since June 2021 and has spent considerable time with Hrusovsky meeting key customers, partners and investors. He brings a wealth of industry experience and a track record for fostering disruptive innovation and high growth while at PerkinElmer, where he most recently served as Senior Vice President, Diagnostics. Prior to PerkinElmer, Toloue founded and led Bioo Scientific’s next generation sequencing business, which was acquired by PerkinElmer in 2016. He also co-founded and led Genohub, which he transformed from a supplier of next generation sequencing matching technology to a leading platform provider for managing sequencing projects globally. He holds a doctoral degree in molecular cell biology from the University at Buffalo and was a postdoctoral fellow in biochemistry at The University of Texas Health Science Center at San Antonio.

 

Hrusovsky joined Quanterix in 2014 and quickly transformed the company into a leading company in proteomics. Revenues have grown to over $100m, a successful IPO in 2017 and $700m in capital raises have put the company into a leadership position. Quanterix is very well positioned to make the promise of earlier, non-invasive disease interception across multiple diseases a reality. The recent FDA approval of emergency use authorizations (EUAs) for asymptomatic COVID detection and its grant of Breakthrough Device Designation for the Company’s plasma pTau-181 Alzheimer’s test are just a couple of examples of how Quanterix has shaped the industry under Hrusovsky’s leadership. Quanterix is also a leader in Powering Precision Health, a non-profit collaborative, that is a model for fostering collaboration across academia, industry, and the financial community to inspire healthcare disruption.

 

Toloue said, “I would like to thank Kevin and the Board for this incredible opportunity to lead Quanterix. We are witnessing first-hand the power our people, science and strategic vision are having on the future of healthcare through extreme collaboration by unlocking innovative solutions for earlier disease detection, better prognoses, and enhanced treatment methods in neurology, immunology and infectious disease.”

 

Martin D. Madaus, Ph.D, lead Independent Director of the Quanterix Board, said, “Kevin’s and Masoud’s upcoming transitions represent an important opportunity for Quanterix to leverage its strong momentum to realize the next phase of growth and impact. We are tremendously grateful for Kevin’s contributions and for the opportunity afforded by this transition as Masoud is a perfect fit at right time to lead Quanterix.”

 

 

 

 

 

 

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: 

Sard Verbinnen & Co 

Chris Kittredge/Emily Claffey/Warren Rizzi 

Quaternix-svc@sardverb.com

 

PAN Communications 

Paige Romine, 321-652-8370 

pan.quanterix@pancomm.com

 

Investor Relations Contact: 

Stephen Hrusovsky 

ir@quanterix.com

 

###

 

 

 

 

Exhibit 99.3

 

 

 

Quanterix Announces New Agreements with Lilly to Advance Alzheimer’s Disease Diagnosis and Treatment

 

License agreement provides Quanterix access to Lilly’s P-tau217 antibody technology, creating pathway for plasma-based biomarkers for use in Alzheimer’s disease

 

Establishes framework for future collaboration and supports development of Quanterix tests to advance diagnosing and treating life-threatening diseases

 

Billerica, Mass. – March 1, 2022 Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, today announced it has entered into a collaboration with Eli Lilly and Company (Lilly) to advance the diagnosis, monitoring and treatment of Alzheimer’s disease. As part of the collaboration, Quanterix will receive a non-exclusive, world-wide license to Lilly’s proprietary P-tau217 antibody technology for potential near-term use in research use only products and services, and future in vitro diagnostic applications. The parties have also entered into a collaboration agreement, which establishes a framework for future projects focused on the development of Simoa® immunoassays. As part of this agreement, Lilly will fund $11 million of development with the Quanterix Accelerator group this year. The other financial terms were not disclosed.

 

These new agreements represent a commitment to advance blood-based biomarkers into routine clinical use. Plasma biomarkers have recently emerged as potential tools to speed clinical trial enrollment, improve clinical trial outcomes, eliminate the invasive techniques required to monitor drug efficacy and lower clinical trial costs. The initial collaboration under the agreements is expected to be focused on P-tau217, a blood-based biomarker that has shown diagnostic promise for early Alzheimer’s detection.

 

For Alzheimer’s disease, current diagnostic testing techniques, including PET imaging and lumbar punctures, are often difficult to obtain, more invasive and late. Both Quanterix and Lilly see the compelling value of plasma-based diagnostic tools to broaden access to testing, facilitate earlier Alzheimer’s disease diagnosis, identify candidates for emerging therapeutics and monitor disease progression with a simple blood test. These tests can help address the urgent need of patients, their families, physicians and the broader healthcare system.

 

“We’re thrilled to collaborate with Lilly in developing innovative diagnostics solutions to revolutionize the diagnosis and treatment of Alzheimer’s,” said Kevin Hrusovsky, Chairman and Chief Executive Officer, Quanterix and Founder of Powering Precision Health. “Our collaboration leverages Lilly’s advanced antibody technology with the ultra-sensitive Simoa technology, which we believe has the potential to identify Alzheimer’s early in the pathology, potentially before the onset of severe symptoms – a concept we call ‘neurodiagnostic therapy.’ We believe this collaboration has the potential to advance the field of Alzheimer’s research, treatment and diagnostics”

 

“Lilly has a long-standing commitment to patients and their families globally suffering from Alzheimer's disease and other forms of dementia,” said Mark Mintun, Lilly Senior Vice President, Research and Development – Neuroscience, and President of Avid Radiopharmaceuticals. “We’re excited about continuing our collaboration with Quanterix and combining Lilly’s P-tau217 and Quanterix’ Simoa technologies to propel the development of plasma-based biomarkers to facilitate Alzheimer’s disease diagnosis and enable access to treatment.”

 

 

 

 

 

 

Last year, Lilly presented new data from the Phase 2 TRAILBLAZER-ALZ study at the Alzheimer’s Association International Conference generated through Quanterix’ highly sensitive Simoa technology. The study utilized the Simoa HD-X platform and assays developed by Quanterix using Lilly’s proprietary antibody technology to measure P-tau217, and reported a significant reduction in plasma levels of phosphorylated tau protein after treatment with donanemab, its investigational therapy for Alzheimer’s disease.

 

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.

 

Contacts

 

Media Contact:

PAN Communications

Paige Romine, 321-652-8370

quanterix@pancomm.com