Overview
We are a patient-focused, innovative, commercial-stage, global biopharmaceutical
company with a substantial presence in both
Since our inception, we have incurred net losses and negative cash flows from
our operations. Substantially all of our losses have resulted from funding our
research and development programs and general and administrative costs
associated with our operations. Developing high quality product candidates
requires a significant investment related to our research and development
activities over a prolonged period of time, and a core part of our strategy is
to continue making sustained investments in this area. Our ability to generate
profits and to generate positive cash flow from operations over the next several
years depends upon our ability to successfully market our four commercial
products - ZEJULA, Optune, QINLOCK and NUZYRA - and our other product candidates
that we are able to successfully commercialize. We expect to continue to incur
substantial expenses related to our research and development activities. In
particular, our licensing and collaboration agreements require us to make
upfront payments upon our entry into such agreements and milestone payments upon
the achievement of certain development, regulatory and commercial milestones as
well as tiered royalties based on the net sales of the licensed products. These
upfront payments and milestone payments upon the achievement of certain
development and regulatory milestones are recorded in research and development
expense in our unaudited condensed consolidated financial statements. We did not
accrue any such payments during the three months ended
Furthermore, as we pursue our strategy of growth and development, we anticipate that our financial results will fluctuate from quarter to quarter based upon the balance between the successful marketing of our commercial products and our significant research and development expenses. We cannot predict whether or when new products or new indications for marketed products will receive regulatory approval or, if any such approval is received, whether we will be able to successfully commercialize such product(s) and whether or when they may become profitable.
Recent Developments Recent Business Developments OnJanuary 6, 2022 , we announced that the NMPA accepted the new drug application (NDA) for margetuximab, an investigational, Fc-engineered monoclonal antibody that targets HER2. The margetuximab NDA is for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease, in combination with chemotherapy. OnJanuary 12, 2022 , we announced treatment of the first patient inGreater China in the PANOVA-3 trial, a Phase 3 pivotal trial of Tumor Treating Fields in patients with pancreatic cancer. PANOVA-3 is a global, open-label, randomized Phase III trial evaluating the efficacy of TTFields administered concomitantly with gemcitabine and nab-paclitaxel as front-line treatment for patients with unresectable, locally advanced pancreatic cancer. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, local progression-free survival, objective response rate, one-year survival rate, quality of life, pain-free survival, resectability rate and toxicity. InFebruary 2022 , theCenter for Drug Evaluation (CDE) of the NMPA granted Breakthrough Therapy Designation for repotrectinib for the treatment of patients with ROS1-positive metastatic NSCLC who have not been treated with a ROS1 TKI. The breakthrough therapy designation was supported by the initial data from both global and Chinese TKI-naïve ROS1-positive NSCLC patients enrolled in the Phase I/II TRIDENT-1 study. We plan to participate in all cohorts of the global TRIDENT-1 study. 17
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In
We also continued to strengthen and expand our leadership team. On
InMarch 2022 , our shareholders approved a Share Subdivision whereby the Company subdivided each of its issued and unissued ordinary shares into ten ordinary shares, effectiveMarch 30, 2022 . The one-to-ten Share Subdivision increased the number of our ordinary shares in issue and reduced the nominal value and trading price of each ordinary share. Our Board of Directors believes that the Share Subdivision will increase the trading liquidity of the ordinary shares, lower the investment barrier, and attract more investors to trade in the ordinary shares. In connection with the Share Subdivision, the Company also effected the ADS Ratio Change, whereby the conversion ratio of our ADSs to ordinary shares changed from one ADS to one ordinary share to a new ratio of one ADS representing ten ordinary shares. The Share Subdivision and ADS Ratio Change did not result in any change to the number of outstanding ADSs of the Company. InMarch 2022 ,SEC staff conclusively identified us under the HFCAA as a "Commission-Identified Issuer" becauseDeloitte Touche Tohmatsu Certified Public Accountants LLP andDeloitte Touche Tohmatsu (together, "Deloitte"), our auditor for the financial statements included in our 2021 Annual Report, is located in a foreign jurisdiction and the PCAOB has determined that it is unable to inspect or investigate the auditor completely because of a restriction imposed by a non-U.S. authority in the auditor's local jurisdiction. InApril 2022 , the Audit Committee of our Board of Directors approved the engagement ofKPMG , an auditor located inthe United States that is subject to PCAOB inspection, as our independent registered public accounting firm for the fiscal year endingDecember 31, 2022 .KPMG will be engaged to audit our annual consolidated financial statements filed with theSEC and our internal controls over financial reporting in accordance with the Exchange Act.KPMG also will be engaged to audit our consolidated financial statements submitted toThe Hong Kong Stock Exchange in accordance with the Rules Governing the Listing of Securities of theHong Kong Stock Exchange , subject to our receipt of the requisite approvals from theHong Kong Stock Exchange and theFinancial Reporting Council of Hong Kong ("FRC"), which are expected to be administrative in nature.KPMG is in the process of concluding its standard client evaluation procedures, including obtaining approval from theHong Kong Stock Exchange to be appointed as our auditor. Upon completion of these standard procedures,KPMG will be in a position to execute an engagement letter and formally commence the engagement. For more information on the HFCAA and risks related to audits of companies with significant operations inChina , see "Item 1A. Risk Factors" in this Quarterly Report on Form 10-Q. InApril 2022 , we presented new data from its internal oncology discovery portfolio at theAmerican Association for Cancer Research (AACR) Annual Meeting 2022. Key early-stage discovery programs were featured in these presentations, including first preview of preclinical data on ZL-1218 (a novel anti-CCR8 antibody for solid tumors) in oral presentation, as well as poster presentations featured ZL-1201 (a CD47-targeting antibody for advanced hematologic malignancies and solid tumors), ZL-1211 (a Claudin18.2-specific antibody for gastric and pancreatic cancer) and ZL-2201 (a highly selective small-molecule DNA-PK inhibitor for anti-cancer therapy). InApril 2022 , we announced topline data for repotrectinib within theChina region from the previously disclosed Phase 1/2 TRIDENT-1 study dataset. We plan to discuss topline TKI-naïve data with Chinese health authority in the fourth quarter of 2022. • In TKI-naïve patients (EXP-1), in 71 total patients, there was a confirmed objective response rate (cORR) of 79% across the global trial. Ten of 11 patients responded withinChina for a cORR of 91% (95% CI: 59,100) and DOR ranged from 3.6+ to 7.5+ months with a median duration of follow-up of 3.7 months. 18
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Table of Contents • In patients previously treated with 1 TKI and platinum-based chemotherapy (EXP-2), in 26 total patients, there was a cORR of 42% across the global trial. Two of 3 patients responded withinChina for a cORR of 67% (95% CI:9,99) and DOR ranged from 3.6+ to 3.7+ months with a median duration of follow-up of 3.7 months. • In patients previously treated with two TKIs without prior chemotherapy (EXP-3), in 18 total patients, there was a cORR of 28% across the global trial. Two of 4 patients responded withinChina for a cORR of 50% (95% CI: 7,93) and DOR ranged from 1.9+ to 3.4+ months with a median duration of follow-up of 2.6 months. • In patients previously treated with 1 TKI without prior chemotherapy (EXP-4), in 56 total patients, there was a cORR of 36% across the global trial. Four of 11 patients responded withinChina for a cORR of 36% (95% CI: 11,69) and DOR ranged from 2.0+ to 3.7+ months with a median duration of follow-up of 3.1 months.
In
Recent Legal and Regulatory Developments
Provisions on
On
The Draft Archives Rules require that, in relation to the overseas securities offering and listing activities of Chinese domestic enterprises, such domestic enterprises, as well as securities companies and securities service institutions providing relevant securities services, are required to strictly comply with the relevant requirements on confidentiality and archives management, establish a sound confidentiality and archives system and take necessary measures to implement their confidentiality and archives management responsibilities.
According to the Draft Archives Rules, if during the course of an overseas offering and listing (whether listed directly or indirectly), if a Chinese domestic company needs to publicly disclose or provide, or publicly disclose or provide through its overseas listed entity, to relevant entities or individuals including securities companies, other securities service providers and overseas regulators, any documents and materials that contain relevant state secrets, government department work secrets or that have a sensitive impact (i.e., that are detrimental to national security or the public interest if divulged), the Chinese domestic company should complete the relevant approval/filing and other regulatory procedures stipulated by applicable national regulations.
In addition, the Draft Archives Rules explicitly include within the scope of its supervision overseas accounting firms that engage in auditing business related to overseas securities offering and listings of Chinese domestic enterprises. Overseas accounting firms that engage in auditing business related to overseas securities offering and listings of Chinese domestic enterprises are required to abide by corresponding procedures in accordance with relevant Chinese national regulations.
Amended China Civil Procedure Law
The Civil Procedure Law of
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Collecting and Using China-Sourced Human Genetic Resources and Derived Data
On
On
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Auxiliary Rules for the Regulations on Supervision and
OnMarch 18, 2021 , theState Council published new Regulations on Supervision andAdministration of Medical Devices , or Order 739, which became effective onJune 1, 2021 . This top-level medical device administrative regulation contains a number of important changes, the practical effects of which will be implemented in corresponding auxiliary regulations and rules. Recently, a series of regulations have been amended accordingly to support the implementation of Order 739 in terms of the production, distribution and clinical trials of medical devices.
• Measures for the Supervision and
Medical Devices
On
• Measures for the Supervision and
Medical Devices
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Table of Contents • Good Practices for Medical Device Clinical Trials
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Factors Affecting our Results of Operations
Research and Development Expenses
We believe our ability to successfully develop product candidates will be the
primary factor affecting our long-term competitiveness, as well as our future
growth and development. Developing high quality product candidates requires a
significant investment of resources over a prolonged period of time, and a core
part of our strategy is to continue making sustained investments in this area.
As a result of this commitment, our pipeline of product candidates has been
steadily advancing and expanding, with twelve late-stage clinical product
candidates being investigated as of
We have financed our activities primarily through private placements, our initial public offering on Nasdaq inSeptember 2017 , multiple follow-on offerings and a secondary listing on theHong Kong Stock Exchange inSeptember 2020 . ThroughMarch 31, 2022 , we have raised approximately$164.6 million from private equity financing and approximately$2,462.7 million in net proceeds after deducting underwriting commissions and the offering expenses payable by us from our initial public offering, follow-on offerings and secondary listing. Our operations have consumed substantial amounts of cash since inception. The net cash used in our operating activities was$87.1 million and$169.5 million , for the three months endedMarch 31, 2022 and 2021, respectively. We expect our expenditures to increase significantly in connection with our ongoing activities, particularly as we advance the clinical development of our twelve late-stage clinical product candidates, research and develop our clinical- and pre-clinical-stage product candidates and initiate additional clinical trials of, and seek regulatory approval for, these and other future product candidates. These expenditures include: • expenses incurred for contract research organizations (CROs), contract manufacture organizations (CMOs), investigators and clinical trial sites that conduct our clinical studies; • employee compensation related expenses, including salaries, benefits and equity compensation expenses; • expenses for licensors; • the cost of acquiring, developing and manufacturing clinical study materials; • facilities and other expenses, which include office leases and other overhead expenses; • costs associated with pre-clinical activities and regulatory operations; • expenses associated with the construction and maintenance of our manufacturing facilities; and • costs associated with operating as a public company.
Selling, General and Administrative Expenses
Our selling, general and administrative expenses consist primarily of personnel compensation and related costs, including share-based compensation for commercial and administrative personnel. Other selling, general and administrative expenses include product distribution and promotion costs, professional service fees for legal, intellectual property, consulting, auditing and tax services as well as other direct and allocated expenses for rent and maintenance of facilities, insurance and other supplies used in selling, general and administrative activities. We anticipate that our selling, general and administrative expenses will increase in future periods to support increases in our commercial and research and development activities and as we continue to commercialize, develop and manufacture our products and assets. These increases will likely include increased headcount, increased share-based compensation charges, increased product distribution and promotion costs, expanded infrastructure and increased costs for insurance. We also anticipate to incur additional legal, compliance, accounting and investor and public relations expenses associated with being a public company.
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Our Ability to Commercialize Our Product Candidates
As ofMarch 31, 2022 , twelve of our product candidates are in late-stage clinical development and various others are in clinical and pre-clinical development inGreater China andthe United States . Our ability to generate revenue from our product candidates is dependent on our receipt of regulatory approvals for and successful commercialization of such products, which may never occur. Certain of our product candidates may require additional pre-clinical and/or clinical development, regulatory approvals in multiple jurisdictions, manufacturing supply, substantial investment and significant marketing efforts before we generate any revenue from product sales.
Our License Arrangements
Our results of operations have been, and we expect them to continue to be,
affected by our licensing, collaboration and development agreements. We are
required to make upfront payments upon our entry into such agreements and
milestone payments upon the achievement of certain development, regulatory and
commercial milestones for the relevant products under these agreements as well
as tiered royalties based on the net sales of the licensed products. These
upfront payments and milestone payments upon the achievement of certain
development and regulatory milestones are recorded in research and development
expense in our unaudited condensed consolidated financial statements and totaled
nil and
Results of Operations
Three Months Ended
Revenues
Total revenues consist of the following:
Three months ended March 31, (in thousands) 2022 % 2021 %
Revenues:
Product revenue, net
- - Total$ 46,724 100.0$ 20,103 100.0
Product Revenue, net
Our product revenue is primarily derived from the sales of ZEJULA, Optune,
QINLOCK, and NUZYRA in mainland
Three months ended March 31, (in thousands) 2022 % 2021 % ZEJULA$ 29,597 64.2$ 12,606 62.7 Optune 12,797 27.8 7,130 35.5 QINLOCK 2,959 6.4 367 1.8 NUZYRA 742 1.6 - - Total product revenue, net$ 46,095 100.0$ 20,103 100.0 22
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Collaboration revenue
Collaboration revenue increased by
Cost of Sales
Cost of sales increased by
Research and Development Expenses
The following table sets forth the components of our research and development expenses for the respective period indicated.
Three months ended March 31, (in thousands) 2022 % 2021 %
Research and development expenses:
Personnel compensation and related costs
- - 171,282 84.0 CROs/CMOs/Investigators expenses 23,550 43.7 15,526 7.6 Other costs 5,502 10.2 4,347 2.2 Total$ 53,854 100.0$ 203,852 100.0
Research and development expenses decreased by
• a decrease of$171.3 million in licensing fees in connection with the upfront and milestone fee paid for licensing agreement due to no new licensing for the three months endedMarch 31, 2022 ; offset by • an increase of$12.1 million in personnel compensation and related costs primarily attributable to increased employee compensation costs due to headcount growth during the three months endedMarch 31, 2022 and the grants of new share options and vesting of restricted shares to certain employees, and • an increase of$8.0 million in CROs/CMOs/Investigators expenses in the three months endedMarch 31, 2022 as we advanced our drug candidate pipeline.
The following table summarizes our research and development expenses by program
for the three months ended
Three months ended March 31, (in thousands) 2022 % 2021 % Research and development expenses: Clinical programs$ 22,852 42.4$ 186,256 91.4
Pre-clinical
programs 2,565 4.8 2,500 1.2
Unallocated research and development expenses 28,437 52.8 15,096 7.4
Total$ 53,854 100.0$ 203,852 100.0 23
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Research and development expenses attributable to clinical programs decreased by$163.4 million from$186.3 million during the three months endedMarch 31, 2021 (which included the licensing fees of$171.3 million ) to$22.9 million during the three months endedMarch 31, 2022 . Research and development expenses attributable to pre-clinical programs remained relatively consistent during the three months endedMarch 31, 2022 compared to the three months endedMarch 31, 2021 . Although we manage our external research and development expenses by program, we do not allocate our internal research and development expenses by program because our employees and internal resources may be engaged in projects for multiple programs at any given time.
Selling, General and Administrative Expenses
The following table sets forth the components of our selling, general and administrative expenses for the respective period indicated.
Three months ended March 31, (in thousands) 2022 % 2021 % Selling, General and Administrative Expenses: Personnel compensation and related costs$ 38,203 67.0$ 23,412 65.3 Professional service fees 7,433 13.0 3,583 10.0 Other costs 11,355 20.0 8,843 24.7 Total$ 56,991 100.0$ 35,838 100.0
Selling, general and administrative expenses increased by
• an increase of$14.8 million in personnel compensation and related costs which was primarily attributable to increased commercial and administrative personnel costs due to headcount growth during the three months endedMarch 31, 2022 and the grants and vesting of share options and restricted shares to certain employees; • an increase of$3.9 million in professional service fees mainly attributable to our increased legal, compliance, accounting and investor and public relations expenses associated with being a public company and in connection with sales of ZEJULA, Optune, QINLOCK and NUZYRA in mainlandChina andHong Kong after our commercial launch of these four commercialized products; and • an increase of$2.5 million in other costs mainly including selling, rental, and administrative expenses primarily attributable to the commercial operation in mainlandChina ,Hong Kong , andTaiwan .
Interest Income
Interest income were
Other Expenses, Net
Other expenses decreased by
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Critical Accounting Policies and Significant Judgments and Estimates
We prepare our financial statements in conformity with
The selection of critical accounting policies, the judgments and other uncertainties affecting application of those policies and the sensitivity of reported results to changes in conditions and assumptions are factors that should be considered when reviewing our financial statements. We believe the following accounting policies involve the most significant judgments and estimates used in the preparation of our financial statements.
Revenue recognition
Description
In mainland
Judgments and Uncertainties
Rebates are offered to distributors, consistent with pharmaceutical industry practices. The estimated amount of unpaid or unbilled rebates, if any, is recorded as a reduction of revenue. Estimated rebates are determined based on contracted rates, sales volumes and level of distributor inventories. We regularly review the information related to these estimates and adjust the amount accordingly.
Sensitivity of Estimate to Change
Actual amounts of rebates ultimately paid or billed may differ from our estimates. We will reassess estimates for rebates periodically. If actual results in the future vary from our estimates, we will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known.
Research and Development Expenses
Description
Research and development expenses are charged to expense as incurred when these expenditures relate to our research and development services and have no alternative future uses.
Preclinical and clinical trial costs are a significant component of our research and development expenses. We have a history of contracting with third parties that perform various preclinical and clinical trial activities on behalf of us in the ongoing development of our product candidates. Expenses related to preclinical and clinical trials are accrued based on our estimates of the actual services performed by the third parties for the respective period.
Judgments and Uncertainties
The process of estimating our research and development expenses involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated costs incurred for the services when we have not yet been invoiced or otherwise notified of the actual costs. The majority of our service providers invoice us in arrears for services performed, on a pre-determined schedule or when contractual milestones are met; however, some require advanced payments. We make estimates of our expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us at that time.
Sensitivity of Estimate to Change
Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in us reporting expenses that are too high or too low in any particular period. To date, we have not made any material adjustments to our prior estimates of research and development expenses.
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Table of Contents Share-Based Compensation Description
Employees' share-based awards are measured at the grant date fair value of the awards and recognized as expenses (1) immediately at grant date if no vesting conditions are required; or (2) using graded vesting method over the requisite service period, which is the vesting period.
To the extent the required vesting conditions are not met resulting in the forfeiture of the share-based awards, previously recognized compensation expenses relating to those awards are reversed.
Judgments and Uncertainties
We determine the fair value of the stock options granted to employees using the
Black-Scholes option valuation model. Using this model, fair value is calculated
based on assumptions with respect to (i) expected volatility of our ADS price,
(ii) the periods of time over which grantees are expected to hold their options
prior to exercise (expected lives), (iii) expected dividend yield on our ADS,
and (iv) risk-free interest rates, which are based on quoted
Sensitivity of Estimate to Change
The assumptions used in this method to determine fair value of ordinary shares consider historical trends, macroeconomic conditions, and projections consistent with the Company's operating strategy. Changes in these estimates can have a significant impact on the determination of fair value of the stock options. If factors change or different assumptions are used, the share-based compensation expenses could be materially different for any period.
Income Taxes
Description
In accordance with the provisions of ASC 740, Income Taxes, we recognize in our financial statements the benefit of a tax position if the tax position is "more likely than not" to prevail based on the facts and technical merits of the position. Tax positions that meet the "more likely than not" recognition threshold are measured at the largest amount of tax benefit that has a greater than fifty percent likelihood of being realized upon settlement. We estimate our liability for unrecognized tax benefits which are periodically assessed and may be affected by changing interpretations of laws, rulings by tax authorities, changes and/or developments with respect to tax audits, and expiration of the statute of limitations. The ultimate outcome for a particular tax position may not be determined with certainty prior to the conclusion of a tax audit and, in some cases, appeal or litigation process.
Judgments and Uncertainties
We consider positive and negative evidence when determining whether some portion or all of our deferred tax assets will not be realized. This assessment considers, among other matters, the nature, frequency and severity of current and cumulative losses, forecasts of future profitability, the duration of statutory carry-forward periods, our historical results of operations and our tax planning strategies. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Based upon the level of our historical taxable income and projections for future taxable income over the periods in which the deferred tax assets are deductible, we believe it is more likely than not that we will not realize the deferred tax assets resulted from the tax loss carried forward in the future periods.
Sensitivity of Estimate to Change
The actual benefits ultimately realized may differ from our estimates. As each
audit is concluded, adjustments, if any, are recorded in our financial
statements in the period in which the audit is concluded. Additionally, in
future periods, changes in facts, circumstances and new information may require
us to adjust the recognition and measurement estimates with regard to individual
tax positions. Changes in recognition and measurement estimates are recognized
in the period in which the changes occur. As of
B. Liquidity and Capital Resources
We have financed our activities primarily through private placements, ourSeptember 2017 initial public offering on theNasdaq stock exchange , various follow-on offerings and ourSeptember 2020 secondary listing on theHong Kong Stock Exchange of our ordinary shares and/or ADSs. ThroughMarch 31, 2022 , we have raised approximately$164.6 million from private equity financing and approximately$2,462.7 million in net proceeds after deducting underwriting commissions and the offering expenses payable by us from our initial public offering, secondary listing and subsequent follow-on offerings. 26
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Our operations have consumed substantial amounts of cash since inception. The
net cash used in our operating activities was
As of
The following table provides information regarding our cash flows for the three
months ended
Three months ended March 31, (in thousands) 2022 2021 Net cash used in operating activities$ (87,127 ) $ (169,500 ) Net cash (used in) provided by investing activities (30,144 ) 742,005 Net cash provided by (used in) financing activities 258 (271 ) Effect of foreign exchange rate changes (130 ) (930 )
Net (decreases) increases in cash, cash equivalents and restricted cash
$ (117,143 ) $ 571,304
Net cash used in operating activities
During the three months endedMarch 31, 2022 , our operating activities used$87.1 million of cash, which resulted principally from our net loss of$82.4 million , adjusted for non-cash charges of$23.0 million , and cash used in our operating assets and liabilities of$27.7 million . During the three months endedMarch 31, 2021 , our operating activities used$169.5 million of cash, which resulted principally from our net loss of$232.9 million , adjusted for non-cash charges of$72.1 million , and cash used in our operating assets and liabilities of$8.7 million . The decrease in cash used in operating activities was primarily due to the decrease of license payments.
Net cash (used in) provided by investing activities
Net cash used in investing activities was
Net cash provided by (used in) financing activities
Net cash provided by financing activities was
C. Research and Development Activities and Expenditures, Including Patents and Licenses
Full details of our research and development activities and expenditures are provided in the "Research and Development Expenses" and "Results of Operations" sections above.
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D. Trend Information
Other than as described elsewhere in this Quarterly Report on Form 10-Q, we are not aware of any trends, uncertainties, demands, commitments or events that are reasonably likely to have a material adverse effect on our revenue, income from continuing operations, profitability, liquidity or capital resources, or that would cause our reported financial information not necessarily to be indicative of future operation results or financial condition.
Recently Issued Accounting Standards
For more information regarding recently issued accounting standards, please see "Item 8. Financial Statements and Supplementary Data-Recent accounting pronouncements" in our 2021 Annual Report.
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