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T2 Biosystems(TTOO) - 2021 Q3 - Earnings Call Transcript
2021-11-04 23:31
T2 Biosystems, Inc. (NASDAQ:TTOO) Q3 2021 Results Earnings Conference Call November 4, 2021 4:30 PM ET Company Participants Philip Taylor - Investor Relations. John Sperzel - Chairman & CEO John Sprague - CFO Conference Call Participants Operator Good afternoon, and welcome to the T2 Biosystems Third Quarter 2021 Earnings Conference Call. [Operator Instructions]. Please note, this event is being recorded. I would now like to turn the conference over to, Philip Taylor, Investor Relations. Please go ahead. Ph ...
T2 Biosystems(TTOO) - 2021 Q3 - Quarterly Report
2021-11-04 20:05
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36571 T2 Biosystems, Inc. (Exact name of registrant as specified in its charter) Delaware 20-4827488 (State or other jurisd ...
T2 Biosystems(TTOO) - 2021 Q2 - Quarterly Report
2021-08-09 20:17
PART I FINANCIAL INFORMATION [Item 1. Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) The unaudited financial statements for T2 Biosystems, Inc. as of June 30, 2021, report a net loss of $23.1 million, total assets of $78.9 million, and liabilities of $69.9 million, with significant going concern doubt [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2021, total assets were $78.9 million, total liabilities $69.9 million, and stockholders' equity $9.0 million, with increased cash and notes payable Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $32,708 | $16,793 | | Total current assets | $63,859 | $53,584 | | Total assets | $78,898 | $79,078 | | **Liabilities & Equity** | | | | Total current liabilities | $9,345 | $9,800 | | Notes payable | $46,487 | $45,235 | | Total liabilities | $69,889 | $70,352 | | Total stockholders' equity | $9,009 | $8,726 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Total revenue for H1 2021 increased to $13.7 million, driven by product sales, resulting in a net loss of $23.1 million, an improvement from the prior year Statement of Operations Summary (in thousands) | Metric | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | Total revenue | $13,650 | $5,097 | | - Product revenue | $8,328 | $2,086 | | - Contribution revenue | $5,322 | $3,000 | | Total costs and expenses | $34,132 | $27,497 | | Loss from operations | $(20,482) | $(22,400) | | Net loss | $(23,135) | $(25,634) | | Net loss per share | $(0.15) | $(0.27) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was $19.3 million, offset by $14.9 million from investing and $20.3 million from financing, leading to a $15.9 million cash increase Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(19,305) | $(28,231) | | Net cash provided by (used in) investing activities | $14,948 | $(9,370) | | Net cash provided by financing activities | $20,272 | $53,097 | | **Net increase in cash, cash equivalents and restricted cash** | **$15,915** | **$15,496** | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail business, accounting policies, and financial arrangements, highlighting substantial doubt about going concern, BARDA contract revenue, CRG term loan, and equity offerings - The company has concluded that **substantial doubt exists about its ability to continue as a going concern** for at least 12 months from the issuance of the financial statements, as management's plans to raise sufficient funding or reduce expenditures are considered less than probable[33](index=33&type=chunk) - The company has a milestone-based contract with BARDA, initially valued at **$6.0 million** with a potential value up to **$69.0 million**, with revenue from this contract being **$5.3 million** for the first six months of 2021[125](index=125&type=chunk)[127](index=127&type=chunk) - The company has a Term Loan Agreement with CRG, which requires maintaining a minimum cash balance of **$5.0 million** and meeting certain revenue targets, which were met as of June 30, 2021[31](index=31&type=chunk)[97](index=97&type=chunk) - In July 2021, shareholders approved an increase in authorized common stock from **200 million to 400 million shares**[137](index=137&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses significant revenue growth from the T2SARS-CoV-2 panel, reiterating substantial doubt about going concern due to historical losses and the need for future funding - The company is an in vitro diagnostics leader in the rapid detection of sepsis-causing pathogens using its proprietary T2MR technology, with key products including **T2Dx Instrument, T2Candida, T2Bacteria, and the T2SARS-CoV-2 Panel**[143](index=143&type=chunk) - The company has never been profitable, with an accumulated deficit of **$446.1 million** as of June 30, 2021, and future operations depend on raising additional capital[151](index=151&type=chunk) - Management has concluded that **substantial doubt exists about the company's ability to continue as a going concern** for at least one year, as plans to secure funding or reduce spending are not considered probable[156](index=156&type=chunk) [Results of Operations](index=33&type=section&id=Results%20of%20Operations) Total revenue for H1 2021 increased 168% to $13.7 million, driven by product and contribution revenue, while net loss improved to $23.1 million Comparison of Results for the Six Months Ended June 30 (in thousands) | Line Item | 2021 | 2020 | Change | Change (%) | | :--- | :--- | :--- | :--- | :--- | | **Total revenue** | **$13,650** | **$5,097** | **$8,553** | **167.8%** | | Product revenue | $8,328 | $2,086 | $6,242 | 299.2% | | Contribution revenue | $5,322 | $3,000 | $2,322 | 77.4% | | **Total costs and expenses** | **$34,132** | **$27,497** | **$6,635** | **24.1%** | | Cost of product revenue | $10,621 | $6,971 | $3,650 | 52.4% | | Research and development | $10,064 | $8,566 | $1,498 | 17.5% | | Selling, general and administrative | $13,447 | $11,960 | $1,487 | 12.4% | | **Loss from operations** | **$(20,482)** | **$(22,400)** | **$1,918** | **-8.6%** | | **Net loss** | **$(23,135)** | **$(25,634)** | **$2,499** | **-9.7%** | - The increase in product revenue for H1 2021 was driven primarily by higher consumables revenue of **$5.8 million**, mainly from the T2SARS-CoV-2 Panel which launched in Q3 2020[190](index=190&type=chunk) - The increase in R&D expenses was driven by higher lab/facility expenses (**$0.6 million**), IT support (**$0.5 million**), and payroll (**$0.3 million**), largely related to the BARDA agreement[194](index=194&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2021, the company held $32.7 million in cash, raised $20.0 million from equity offerings, but faces substantial doubt about its going concern ability - The company had an accumulated deficit of **$446.1 million** as of June 30, 2021[200](index=200&type=chunk) - On March 31, 2021, the company entered into a new Sales Agreement with Canaccord to sell up to **$75.0 million** of common stock, having sold shares for net proceeds of **$20.0 million** by June 30, 2021[204](index=204&type=chunk) - The company's Term Loan with CRG requires maintaining a **$5.0 million** minimum cash balance, and while compliance is expected, assurances cannot be provided without additional funding[213](index=213&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=40&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, T2 Biosystems is exempt from providing quantitative and qualitative disclosures about market risk - As a smaller reporting company, T2 Biosystems is not required to provide information for this item[234](index=234&type=chunk) [Controls and Procedures](index=40&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2021, with no material changes to internal control over financial reporting - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of June 30, 2021[236](index=236&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, the company's internal controls[237](index=237&type=chunk) PART II OTHER INFORMATION [Legal Proceedings](index=41&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal claims or actions that would adversely affect its financial condition or operations - There are currently no claims or legal actions that would have a material adverse effect on the company's financial condition or results of operations[240](index=240&type=chunk) [Risk Factors](index=41&type=section&id=Item%201A.%20Risk%20Factors) No material changes have occurred to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2020 - No material changes have occurred to the risk factors disclosed in the Annual Report on Form 10-K for the year ended December 31, 2020[241](index=241&type=chunk) [Other Items (Items 2, 3, 4, 5)](index=41&type=section&id=Other%20Items%20(Items%202,%203,%204,%205)) Items 2, 3, 4, and 5 report no unregistered equity sales, no defaults on senior securities, no mine safety disclosures, and no other information - Item 2 (Unregistered Sales of Equity Securities), Item 3 (Defaults Upon Senior Securities), Item 4 (Mine Safety Disclosures), and Item 5 (Other Information) are all reported as 'None' or 'Not applicable'[242](index=242&type=chunk)[243](index=243&type=chunk)[244](index=244&type=chunk)[245](index=245&type=chunk)
T2 Biosystems(TTOO) - 2021 Q2 - Earnings Call Transcript
2021-08-06 03:35
T2 Biosystems, Inc. (NASDAQ:TTOO) Q2 2021 Earnings Conference Call August 5, 2021 4:30 PM ET Company Participants Greg Chodaczek - Managing Director, Gilmartin Group John Sperzel - Chairman & CEO John Sprague - CFO Conference Call Participants Operator Greetings, and welcome to the T2 Biosystems Second Quarter 2021 Earnings Conference Call. [Operator Instructions]. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Greg Chodaczek, Managing Director o ...
T2 Biosystems(TTOO) - 2021 Q1 - Quarterly Report
2021-05-13 18:52
[PART I FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) [Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20%28unaudited%29) Unaudited Q1 2021 financial statements reveal increased revenue, ongoing net losses, and a stockholders' deficit, raising substantial doubt about going concern Condensed Consolidated Balance Sheets (in thousands) | | March 31, 2021 (in thousands) | December 31, 2020 (in thousands) | | :--- | :--- | :--- | | **Total current assets** | $44,587 | $53,584 | | **Total assets** | $70,052 | $79,078 | | **Total current liabilities** | $10,401 | $9,800 | | **Total liabilities** | $70,618 | $70,352 | | **Total stockholders' (deficit) equity** | ($566) | $8,726 | Condensed Consolidated Statements of Operations (in thousands) | | Three Months Ended March 31, 2021 (in thousands) | Three Months Ended March 31, 2020 (in thousands) | | :--- | :--- | :--- | | **Total revenue** | $6,956 | $2,545 | | Product revenue | $4,650 | $1,045 | | Contribution revenue | $2,306 | $1,500 | | **Loss from operations** | ($9,702) | ($13,561) | | **Net loss** | ($10,660) | ($14,949) | | **Net loss per share** | ($0.07) | ($0.22) | Condensed Consolidated Statements of Cash Flows (in thousands) | | Three Months Ended March 31, 2021 (in thousands) | Three Months Ended March 31, 2020 (in thousands) | | :--- | :--- | :--- | | **Net cash used in operating activities** | ($8,708) | ($14,740) | | **Net cash provided by (used in) investing activities** | $2,553 | ($67) | | **Net cash provided by financing activities** | $53 | $40,097 | - Management has concluded that **substantial doubt** exists about the Company's ability to continue as a **going concern** for at least 12 months from the financial statement issuance date due to a history of net losses, cash outflows, and reliance on future funding not considered probable[29](index=29&type=chunk) - The company's T2SARS-CoV-2 Panel, a COVID-19 molecular diagnostic test, received **Emergency Use Authorization (EUA)** from the FDA in August 2020[20](index=20&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2021 performance, highlighting significant revenue growth driven by product sales, while reiterating substantial doubt about the company's ability to continue as a going concern Results of Operations (in thousands) | | Three Months Ended March 31, 2021 (in thousands) | Three Months Ended March 31, 2020 (in thousands) | Change (in thousands) | | :--- | :--- | :--- | :--- | | **Total revenue** | $6,956 | $2,545 | $4,411 | | Cost of product revenue | $5,790 | $4,671 | $1,119 | | Research and development | $4,665 | $4,780 | ($115) | | Selling, general and administrative | $6,203 | $6,655 | ($452) | | **Loss from operations** | ($9,702) | ($13,561) | $3,859 | | **Net loss** | ($10,660) | ($14,949) | $4,289 | - Product revenue increased by **$3.6 million**, primarily driven by **$3.3 million** in higher consumables sales from the T2SARS-CoV-2 Panel, which began selling in Q3 2020[173](index=173&type=chunk) - The company again states that conditions raise **substantial doubt** about its ability to continue as a **going concern** for one year, as its plans to raise sufficient funding or reduce expenditures are considered less than probable[149](index=149&type=chunk)[193](index=193&type=chunk) - In March 2021, the company entered into a new Sales Agreement with Canaccord Genuity LLC for an **'at the market' offering** to sell up to **$75.0 million** of common stock[184](index=184&type=chunk) - Net cash used in operating activities decreased to **$8.7 million** in Q1 2021 from **$14.7 million** in Q1 2020, primarily due to a lower net loss and favorable changes in working capital, including a significant increase in accounts payable[196](index=196&type=chunk)[197](index=197&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company, as a smaller reporting company, is not required to provide the information requested under this item - As a **smaller reporting company**, T2 Biosystems is **not required** to provide quantitative and qualitative disclosures about market risk[211](index=211&type=chunk) [Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including CEO and CFO, affirmed the effectiveness of disclosure controls and procedures as of March 31, 2021, with no material changes to internal control over financial reporting - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were **effective** as of March 31, 2021[214](index=214&type=chunk) - There were **no changes** to the company's internal control over financial reporting during the quarter that **materially affected**, or are reasonably likely to materially affect, its internal controls[215](index=215&type=chunk) [PART II OTHER INFORMATION](index=39&type=section&id=PART%20II%20OTHER%20INFORMATION) [Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) The company states that it is not currently involved in any legal proceedings that would have a material adverse effect on its financial condition or results of operations - There are currently **no claims or legal actions** that would have a **material adverse effect** on the company's results of operations or financial condition[218](index=218&type=chunk) [Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) This section refers to risk factors detailed in the Annual Report on Form 10-K, confirming no material changes to previously disclosed risks - There have been **no material changes** from the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2020[219](index=219&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the reporting period - The company reported **'None'** for this item[220](index=220&type=chunk) [Defaults Upon Senior Securities](index=39&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company for the reporting period - The company reported this item as **'Not applicable.'**[221](index=221&type=chunk) [Mine Safety Disclosures](index=39&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - The company reported this item as **'Not applicable.'**[222](index=222&type=chunk) [Other Information](index=39&type=section&id=Item%205.%20Other%20Information) The company reported no other information required to be disclosed under this item - The company reported **'None'** for this item[223](index=223&type=chunk) [Exhibits, Financial Statement Schedules](index=40&type=section&id=Item%206.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists exhibits filed with the Form 10-Q, including amendments to the BARDA contract and CRG Term Loan Agreement, plus required officer certifications - Key exhibits filed include an amendment to the **BARDA contract**, an amendment to the **CRG Term Loan Agreement**, and required **CEO/CFO certifications**[225](index=225&type=chunk)
T2 Biosystems(TTOO) - 2021 Q1 - Earnings Call Transcript
2021-05-06 23:17
T2 Biosystems, Inc. (NASDAQ:TTOO) Q1 2021 Earnings Conference Call May 6, 2021 4:30 PM ET Company Participants Philip Taylor - Investor Relations, Gilmartin Group John Sperzel - President and Chief Executive Officer John Sprague - Chief Financial Officer Conference Call Participants Stephanie Yan - Canaccord Genuity Ben Haynor - Alliance Global Partners Operator Good day and welcome to the T2 Biosystems First Quarter 2021 Earnings Conference Call. Today's conference is being recorded. At this time, I would ...
T2 Biosystems(TTOO) - 2020 Q4 - Annual Report
2021-03-31 20:07
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the year ended December 31, 2020 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36571 T2 Biosystems, Inc. (Exact name of registrant as specified in its charter) Delaware 20-4827488 (State or other jurisdiction of incorpora ...
T2 Biosystems(TTOO) - 2020 Q4 - Earnings Call Transcript
2021-03-05 01:38
T2 Biosystems, Inc. (NASDAQ:TTOO) Q4 2020 Earnings Conference Call March 4, 2021 4:30 PM ET Company Participants Philip Taylor - Investor Relations, Gilmartin Group John Sperzel - President and CEO John Sprague - Chief Financial Officer Conference Call Participants Westley Dupray - SVB Leerink Max Masucci - Canaccord Genuity Mark Massaro - BTIG Ben Haynor - Alliance Global Partners Operator Greetings. Welcome to T2 Biosystems Fourth Quarter and Full Year 2020 Earnings Conference Call. At this time, all part ...
T2 Biosystems(TTOO) - 2020 Q3 - Quarterly Report
2020-11-05 20:57
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36571 For the quarterly period ended September 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 T2 Biosystems, Inc. (Exact name of registrant as specified in its charter) Delaware 20-4827488 (State or other jurisd ...
T2 Biosystems(TTOO) - 2020 Q3 - Earnings Call Transcript
2020-11-05 01:18
T2 Biosystems, Inc. (NASDAQ:TTOO) Q3 2020 Earnings Conference Call November 4, 2020 4:30 PM ET Company Participants Philip Taylor - Gilmartin Group John Sperzel - President and CEO John Sprague - CFO Conference Call Participants Max Masucci - Canaccord Genuity Puneet Souda - SVB Leerink Mark Massaro - BTIG Steve Brozak - WBB Securities Ben Haynor - Alliance Global Operator Greetings and welcome to the T2 Biosystems Third Quarter 2020 Earnings Conference Call. At this time, all participants are in a listen-o ...