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Fluidigm Announces Third Quarter 2021 Financial Results
Источник: Nasdaq GlobeNewswire / 08 ноя 2021 15:02:00 America/Chicago
Board Undertaking Review of Range of Value-Enhancing Opportunities
SOUTH SAN FRANCISCO, Calif., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Fluidigm Corporation (Nasdaq: FLDM), an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, today announced financial results for the third quarter ended September 30, 2021.
“We saw a very active third quarter and made progress with our ambitious plan to commercially scale two new instrument systems,” said Chris Linthwaite, President and CEO. “Core demand for our products was healthy, but we were unable to fulfill all orders for our products during the quarter, largely due to supply chain issues. Our backlog of unfilled orders stands at more than $9 million, which is almost twice as much as our historic average. We expect to work through these pending orders over the next few quarters. Demand in the APAC region was impacted by tax permit issues in China and COVID-related shutdowns in Japan.
“We were pleased to deliver the first production units of the Olink® Signature Q100 benchtop instrument system and anticipate an increase in deliveries in Q4 for this product, as well as for our new CyTOF® XT platform,” continued Linthwaite.
Strategic Review
Fluidigm also announced today that its Board of Directors is undertaking a review of various options, with the assistance of outside financial, operating and legal advisors, to maximize stockholder value, including with regard to strategic alternatives, cost and capital structure, and operations and supply chain. There can be no assurance that the evaluation of these options will result in Fluidigm taking any particular action, and there can be no assurance as to the outcome or timing of this process. Fluidigm has not set a timetable for completion of the process and does not intend to disclose developments related to the Board’s process unless and until the Board determines that further disclosure is appropriate or required.
Recent Highlights
Mass Cytometry
Innovation:
- Introduced Maxpar® OnDemand Antibodies (as part of our IMC™ Summit: Uncovering Spatial Biology), an option that more than doubles our current catalog offerings for metal-conjugated antibodies for Imaging Mass Cytometry™ (IMC).
- Sold ten of our new CyTOF XT™ systems since launch, with two additional instruments in backlog.
Partnerships:
- Announced a new phase of a collaboration agreement with Visiopharm®. New software developed in collaboration with Visiopharm enables native reading of data files from the Hyperion™ Imaging System to simplify and accelerate workflow.
- Executed a collaboration agreement with the Karolinska Institutet to accelerate customer adoption of our new CyTOF XT instrument.
Beachheads:
- Announced that Imaging Mass Cytometry is being utilized in studies led by researchers at Weill Cornell Medicine to identify molecular links between African ancestry and aggressive forms of breast and prostate cancer and investigate these as a source of racial disparities in cancer outcomes, further expanding use cases and highlighting IMC as a valuable tool in oncology drug development.
- Announced publication of new data further validating the potential of mass cytometry, the basis of Fluidigm® proprietary CyTOF technology. A Nature Communications article outlined a study evaluating key inflammatory pathways in pregnant women infected with SARS-CoV-2, the virus that causes COVID-19, illustrating the flexibility of CyTOF technology in gaining health insights.
- At quarter end, over 175 clinical trials were underway using CyTOF technology.
- Total publications and preprints involving CyTOF technology exceeded 1,740, including 130 publications and preprints for Imaging Mass Cytometry, as of the end of Q3 2021.
Microfluidics
Innovation:
- Launching this week, our next-generation Biomark™ microfluidics platform, delivering significant innovation and industry-leading advantages in speed, throughput, flexibility and cost while supporting broader market penetration.
- Our agreement with the National Institutes of Health (the RADx program) was extended into the fourth quarter of 2021. Our next milestone includes an FDA Emergency Use Authorization submission leveraging a new sample-to-answer IFC format as part of a COVID-19 testing kit. This submission specifies a test with a sample type that extracts RNA from nasal samples.
Partnerships:
- Saw strong demand for orders of the Olink Signature Q100 system designed and manufactured by Fluidigm, showcasing how strategic partnerships can support our Vision 2025 strategic growth plan.
Beachheads:
- A leading contract research organization (CRO) customer secured a large contract for a saliva-based COVID-19 testing program for a large network of public schools using Fluidigm microfluidics technology.
Third Quarter 2021 Financial Results
Total revenue was $28.5 million for the quarter ended September 30, 2021, compared with $39.9 million for the third quarter of 2020. Base product and service revenue (excluding COVID-19 testing revenue) was $25.6 million, compared to $25.1 million during the same period last year. Base revenue included $6.0 million in service revenue. Total revenue also included $0.6 million of other revenue.
GAAP net loss for the quarter was $13.8 million, compared with a GAAP net loss of $6.0 million for the third quarter of 2020.
Non-GAAP net loss was $5.4 million for the quarter, compared with non-GAAP net income of $2.5 million for the third quarter of 2020.
Cash and cash equivalents and restricted cash as of September 30, 2021, totaled $30.3 million, compared to $31.9 million as of June 30, 2021, and undrawn capacity on our revolver was $10.3 million at the end of the quarter.
A reconciliation of GAAP to non-GAAP financial measures can be found in the tables of this news release.
Supplemental Financial Information updated through September 30, 2021, has been posted on our website concurrent with this release.
Fiscal 2021 Guidance
Fluidigm is revising its previously stated full-year total revenue guidance as various factors have affected our business and business outlook in the near term. These factors include current supply chain constraints, new outbreaks of COVID-19 infections and the impact on access to labs and research institutions, and ongoing uncertainty regarding resolution of tax permit issues in China.
($ in millions) 2020 2021
ActualsPrevious
GuidanceCurrent
GuidanceProduct & Service Revenue Base business $100.1 $120 – $122 $107 – $109 COVID-19 Testing Revenue $22.4 $10– $13 $12 – $13 Total Product & Service Revenue $122.5 $130 – $135 $119 – $122 Other Revenue $15.6 $4 – $5 $4 – $5 Total Revenue $138.1 $134 – $140 $123 – $127 Year-over-year growth Base business (14)% 20% – 22% 7% – 9% COVID-19 Testing Revenue NM (55)% – (42)% (46)% – (42)% Total Product & Service Revenue 5% 6% – 10% (2)% – (0)% Total Revenue 18% (3)% – 1% (11)% – (8)% - GAAP net loss of $63 million to $66 million.
- Non-GAAP net loss of $37 million to $40 million.
Q4 2021 Guidance
- Base product and service revenue (excluding COVID-19 testing revenue) of approximately $30 million to $32 million, or a year-over-year growth of approximately (3)% to 3%.
- COVID-19 testing revenue of approximately $1 million to $2 million, a year-over-year decline of $7.4 million to $8.4 million.
- Total product and service revenue of approximately $31 million to $34 million, or a year-over-year decline of approximately 16 percent to 23 percent. Product and service revenue in Q4 2020 included approximately $9.4 million of COVID-19 testing revenue.
- Total revenue of approximately $31 million to $34 million.
Conference Call Information
Fluidigm will host a conference call today, November 8, 2021, at 1:30 p.m. PT, 4:30 p.m. ET, to discuss third quarter 2021 financial results and operational progress. Individuals interested in listening to the conference call may do so by dialing the following:US domestic callers: (877) 556-5248
Outside US callers: (720) 545-0029
Please reference Conference ID: 5579013A live webcast of the conference call will be available online from the Investor Relations page of the company’s website at Events & Presentations. The link will not be active until 1:15 p.m. PT, 4:15 p.m. ET, on November 8, 2021. The webcast will be archived on the Fluidigm Investor Relations page at investors.fluidigm.com.
Statement Regarding Use of Non-GAAP Financial Information
Fluidigm has presented certain financial information in accordance with U.S. GAAP and also on a non-GAAP basis for the three-month periods ended September 30, 2021, and September 30, 2020, as well as guidance for non-GAAP net loss for fiscal 2021. Management believes that non-GAAP financial measures, taken in conjunction with GAAP financial measures, provide useful information for both management and investors by excluding certain non-cash and other expenses that are not indicative of the company’s core operating results. Management uses non-GAAP measures to compare the company’s performance relative to forecasts and strategic plans and to benchmark the company’s performance externally against competitors. Our estimates of forward-looking non-GAAP net loss excludes estimates for stock-based compensation expense and depreciation and amortization; loss on disposal of property and equipment; future changes relating to developed and acquired technologies; other intangible assets; and income taxes, among other items, certain of which are presented in the tables accompanying our earnings release. A reconciliation of adjusted guidance measures to corresponding GAAP measures is not available on a forward-looking basis without unreasonable effort due to the uncertainty regarding certain expenses that may be incurred in the future. The time and amount of certain material items needed to estimate non-GAAP financial measures are inherently unpredictable or outside of our control. Material changes to any of these items could have a significant effect on guidance and future GAAP results. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of the company’s operating results as reported under U.S. GAAP. Fluidigm encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. Reconciliations between GAAP and non-GAAP operating results are presented in the accompanying tables of this release.
Use of Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, among others, statements regarding new product introductions and launch plans, anticipated benefits under collaborations and agreements with third parties, access to new customers and markets, the adoption of Fluidigm technology and products for translational and clinical research, the impact of the COVID-19 pandemic, exploration of options to maximize stockholder value, and revenue and net loss guidance for future periods. Forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from currently anticipated results, including but not limited to risks relating to the potential adverse effects of the coronavirus pandemic on our business and operating results; the possible loss of key employees, customers, or suppliers; customers and prospective customers continuing to curtail or suspend activities utilizing our products; our ability and/or the ability of the research institutions utilizing our products and technology to obtain and maintain Emergency Use Authorization from the FDA and any other requisite authorizations or approvals to use our products and technology for diagnostic testing purposes; potential changes in the priorities of government agencies; challenges inherent in developing, manufacturing, launching, marketing, and selling new products; reliance on sales of capital equipment for a significant proportion of revenues in each quarter; seasonal variations in customer operations; unanticipated increases in costs or expenses; risks related to our cash management plans and financing alternatives uncertainties in contractual relationships; reductions in research and development spending or changes in budget priorities by customers; Fluidigm research and development and distribution plans and capabilities; interruptions or delays in the supply of components or materials for, or manufacturing of, Fluidigm products; potential product performance and quality issues; risks associated with international operations; intellectual property risks; and competition. Information on these and additional risks and uncertainties and other information affecting Fluidigm's business and operating results is contained in its Annual Report on Form 10-K for the year ended December 31, 2020, and in its other filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Fluidigm disclaims any obligation to update these forward-looking statements except as may be required by law.
About Fluidigm
Fluidigm (Nasdaq:FLDM) focuses on the most pressing needs in translational and clinical research, including cancer, immunology, and immunotherapy. Using proprietary CyTOF and microfluidics technologies, we develop, manufacture, and market multi-omic solutions to drive meaningful insights in health and disease, identify biomarkers to inform decisions, and accelerate the development of more effective therapies. Our customers are leading academic, government, pharmaceutical, biotechnology, plant and animal research, and clinical laboratories worldwide. Together with them, we strive to increase the quality of life for all. For more information, visit fluidigm.com.
Fluidigm, the Fluidigm logo, Biomark, CyTOF, CyTOF XT, Hyperion, Imaging Mass Cytometry, IMC and Maxpar are trademarks and/or registered trademarks of Fluidigm Corporation or its affiliates in the United States and/or other countries. All other trademarks are the sole property of their respective owners. Fluidigm products are provided for Research Use Only. Not for use in diagnostic procedures.Available Information
We use our website (fluidigm.com), investor site (investors.fluidigm.com), corporate Twitter account (@fluidigm), Facebook page (facebook.com/Fluidigm), and LinkedIn page (linkedin.com/company/fluidigm-corporation) as channels of distribution of information about our products, our planned financial and other announcements, our attendance at upcoming investor and industry conferences, and other matters. Such information may be deemed material information, and we may use these channels to comply with our disclosure obligations under Regulation FD. Therefore, investors should monitor our website and our social media accounts in addition to following our press releases, SEC filings, public conference calls, and webcasts.Contacts:
Investors:
Peter DeNardo
415 389 6400
IR@fluidigm.comMedia:
Mark Spearman
Senior Director, Corporate Communications
650 243 6621
mark.spearman@fluidigm.comFLUIDIGM CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share amounts) (Unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Revenue: Product revenue $ 21,937 $ 29,210 $ 69,292 $ 65,596 Service revenue 6,016 6,131 18,929 16,457 Product and service revenue 27,953 35,341 88,221 82,053 Other revenue (1) 551 4,520 4,095 11,483 Total revenue 28,504 39,861 92,316 93,536 Costs and expenses: Cost of product revenue 13,327 12,773 37,720 31,896 Cost of service revenue 1,508 1,769 5,465 4,531 Cost of product and service revenue 14,835 14,542 43,185 36,427 Research and development 9,209 8,128 29,403 25,275 Selling, general and administrative 24,072 22,655 75,928 65,966 Total costs and expenses 48,116 45,325 148,516 127,668 Loss from operations (19,612 ) (5,464 ) (56,200 ) (34,132 ) Interest expense (968 ) (885 ) (2,751 ) (2,682 ) Surplus funding from NIH contract 5,000 — 5,000 — Other income (expense), net 315 107 534 (248 ) Loss before income taxes (15,265 ) (6,242 ) (53,417 ) (37,062 ) Income tax benefit 1,422 243 3,609 2,068 Net loss $ (13,843 ) $ (5,999 ) $ (49,808 ) $ (34,994 ) Net loss per share, basic and diluted $ (0.18 ) $ (0.08 ) $ (0.66 ) $ (0.49 ) Shares used to compute net loss per share, basic and diluted 76,301 72,486 75,494 71,294 Notes: (1) Other revenue includes product development, license, royalty and grant revenue. FLUIDIGM CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands) (Unaudited) September 30,
2021December 31,
2020 (1)ASSETS Current assets: Cash and cash equivalents (2) $ 29,309 $ 68,520 Accounts receivable, net 13,732 25,423 Inventories, net 24,498 19,689 Prepaid expenses and other current assets (2) 5,926 4,031 Total current assets 73,465 117,663 Property and equipment, net 28,913 17,531 Operating lease right-of-use assets, net 37,698 38,114 Other non-current assets (2) 4,692 4,680 Developed technology, net 30,992 40,206 Goodwill 106,428 106,563 Total assets $ 282,188 $ 324,757 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 10,786 $ 9,220 Accrued compensation and related benefits 8,286 13,787 Operating lease liabilities, current 2,873 2,973 Other accrued liabilities 8,188 11,882 Deferred grant income, current 4,299 2,912 Deferred revenue, current 12,858 13,475 Total current liabilities 47,290 54,249 Term loan, net 9,993 — Convertible notes, net 54,051 54,224 Deferred tax liability, net 7,229 8,697 Operating lease liabilities, non-current 38,170 38,178 Deferred revenue, non-current 6,034 7,990 Deferred grant income, non-current 19,130 21,036 Other non-current liabilities 954 1,333 Total liabilities 182,851 185,707 Total stockholders' equity 99,337 139,050 Total liabilities and stockholders' equity $ 282,188 $ 324,757 Notes: (1) Derived from audited consolidated financial statements (2) Cash, cash equivalents and restricted cash consist of: Cash and cash equivalents $ 29,309 $ 68,520 Restricted cash (included in other current assets and other non-current assets) 1,016 1,016 Total cash, cash equivalents and restricted cash $ 30,325 $ 69,536 FLUIDIGM CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (In thousands) (Unaudited) Nine Months Ended September 30, 2021 2020 OPERATING ACTIVITIES Net loss $ (49,808 ) $ (34,994 ) Stock-based compensation expense 11,738 10,358 Amortization of developed technology 8,944 8,929 Loss on disposal of property and equipment 6 191 Depreciation and amortization 2,744 2,988 Other non-cash items 2,357 2,971 Changes in assets and liabilities, net (13,040 ) (2,127 ) Net cash used in operating activities (37,059 ) (11,684 ) INVESTING ACTIVITIES Acquisition, net of cash acquired — (5,154 ) Proceeds from NIH Contract 2,000 11,151 Proceeds from sales and maturities of investments — 36,810 Purchases of property and equipment (12,801 ) (2,010 ) Net cash provided by (used in) investing activities (10,801 ) 40,797 FINANCING ACTIVITIES Proceeds from term loan 10,000 — Proceeds from issuance of common stock from at-the-market offering, net of commissions — 20,226 Repayment of long-term debt (501 ) — Proceeds from (payments for) employee equity programs, net (802 ) 708 Payment of debt and equity issuance costs (35 ) (509 ) Net cash provided by financing activities 8,662 20,425 Effect of foreign exchange rate fluctuations on cash and cash equivalents (13 ) 86 Net increase (decrease) in cash, cash equivalents and restricted cash (39,211 ) 49,624 Cash, cash equivalents and restricted cash at beginning of period 69,536 23,736 Cash, cash equivalents and restricted cash at end of period $ 30,325 $ 73,360 Cash, cash equivalents and restricted cash consist of: Cash and cash equivalents $ 29,309 $ 72,345 Restricted cash (included in prepaid and other current assets, and other non-current assets) 1,016 1,015 Total cash, cash equivalents and restricted cash $ 30,325 $ 73,360 FLUIDIGM CORPORATION RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (In thousands, except per share amounts) (Unaudited) ITEMIZED RECONCILIATION BETWEEN GAAP AND NON-GAAP NET LOSS Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Net loss (GAAP) $ (13,843 ) $ (5,999 ) $ (49,808 ) $ (34,994 ) Stock-based compensation expense 4,320 4,358 11,738 10,358 Amortization of developed technology (a) 2,979 2,993 8,944 8,929 Depreciation and amortization 893 972 2,744 2,988 Interest expense (b) 968 885 2,751 2,682 Loss on disposal of property and equipment 5 43 6 191 Loss on extinguishment of debt — — 9 — Benefit from acquisition related income taxes (c) (742 ) (742 ) (2,226 ) (2,226 ) Net income (loss) (Non-GAAP) $ (5,420 ) $ 2,510 $ (25,842 ) $ (12,072 ) Shares used in net loss per share calculation - basic and diluted (GAAP and Non-GAAP) 76,301 72,486 75,494 71,294 Net loss per share - basic and diluted (GAAP) $ (0.18 ) $ (0.08 ) $ (0.66 ) $ (0.49 ) Net income (loss) per share - basic and diluted (Non-GAAP) $ (0.07 ) $ 0.03 $ (0.34 ) $ (0.17 ) ITEMIZED RECONCILIATION BETWEEN GAAP AND NON-GAAP PRODUCT AND SERVICE MARGIN Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Product and service gross profit (GAAP) $ 13,118 $ 20,799 $ 45,036 $ 45,626 Amortization of developed technology (a) 2,800 2,800 8,400 8,400 Depreciation and amortization (d) 348 419 1,161 1,215 Stock-based compensation expense (d) 188 133 414 312 Product and service gross profit (Non-GAAP) $ 16,454 $ 24,151 $ 55,011 $ 55,553 Product and service margin percentage (GAAP) 46.9 % 58.9 % 51.0 % 55.6 % Product and service margin percentage (Non-GAAP) 58.9 % 68.3 % 62.4 % 67.7 % ITEMIZED RECONCILIATION BETWEEN GAAP AND NON-GAAP OPERATING EXPENSES Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Operating expenses (GAAP) $ 33,281 $ 30,783 $ 105,331 $ 91,241 Stock-based compensation expense (e) (4,132 ) (4,225 ) (11,324 ) (10,046 ) Depreciation and amortization (e) (723 ) (746 ) (2,127 ) (2,302 ) Loss on disposal of property and equipment (e) (5 ) (43 ) (6 ) (191 ) Operating expenses (Non-GAAP) $ 28,421 $ 25,769 $ 91,874 $ 78,702 ITEMIZED RECONCILIATION BETWEEN GAAP AND NON-GAAP LOSS FROM OPERATIONS Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Loss from operations (GAAP) $ (19,612 ) $ (5,464 ) $ (56,200 ) $ (34,132 ) Stock-based compensation expense 4,320 4,358 11,738 10,358 Amortization of developed technology (a) 2,979 2,993 8,944 8,929 Depreciation and amortization (e) 893 972 2,744 2,988 Loss on disposal of property and equipment (e) 5 43 6 191 Income (loss) from operations (Non-GAAP) $ (11,415 ) $ 2,902 $ (32,768 ) $ (11,666 ) (a) Represents amortization of developed technology in connection with the DVS and InstruNor acquisitions (b) Represents interest expense, primarily on convertible debt and the term loan (c) Represents the tax impact on the purchase of intangible assets in connection with the DVS acquisition (d) Represents expense associated with cost of product revenue (e) Represents expense associated with research and development and selling, general and administrative activities
- Introduced Maxpar® OnDemand Antibodies (as part of our IMC™ Summit: Uncovering Spatial Biology), an option that more than doubles our current catalog offerings for metal-conjugated antibodies for Imaging Mass Cytometry™ (IMC).