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The number of beneficial owners is substantially greater than the number of record holders because a large portion of our common stock is held of record through brokerage firms in “street name.”
−Removed: Equity Compensation Plan Information
−Removed: The table below provides information about our common stock that, as of December 31, 2021, may be issued upon the exercise of options and the vesting of RSUs under the following equity compensation plans (which are all our equity compensation plans;
−Removed: provided, however, that new equity awards may only be issued under the 2015 Omnibus Incentive Plan and the 2021 Inducement Plan):
−Removed: 2015 Omnibus Incentive Plan (the “2015 Plan”)
−Removed: Stock Option Plan (the “2008 Plan”)
−Removed: 2021 Inducement Equity Incentive Plan (the "2021 Inducement Plan”)
−Removed: Non-statutory Stock Option Agreement (Inducement Award) between Badrul Chowdhury and Savara Inc.
−Removed: dated November 26, 2019
−Removed: Plan Category
−Removed: Number of securities to be issued upon exercise of outstanding options, warrants and rights
−Removed: Weighted-average exercise price of outstanding options, warrants and rights
−Removed: Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a))
−Removed: Equity compensation plans
−Removed: approved by security holders
−Removed: Equity compensation plans
−Removed: not approved by security holders
−Removed: (1) The weighted average exercise price does not take into account the shares issuable upon vesting of outstanding
−Removed: RSUs, which have no exercise price.
−Removed: (2) Includes 4,864,881 shares issuable upon the exercise of outstanding options granted under the 2015 Plan, 997,375
−Removed: shares issuable upon the vesting of RSUs granted under the 2015 Plan, and 198,960 shares issuable upon the
−Removed: exercise of outstanding options granted under the 2008 Plan.
−Removed: (3) Includes 300,000 shares issuable upon the exercise of options granted to Dr.
−Removed: Chowdhury under his inducement award
−Removed: agreement, 855,000 shares issuable upon the exercise of outstanding options granted under the 2021 Inducement
−Removed: Plan, and 275,000 shares issuable upon the vesting of RSUs granted under the 2021 Inducement Plan.
Unregistered Sales of Equity Securities
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or “us”) is a clinical-stage biopharmaceutical company focused on rare respiratory diseases.
−Removed: Our lead program, molgramostim nebulizer solution (“molgramostim”), is an inhaled granulocyte-macrophage colony-stimulating factor in Phase 3 development for autoimmune pulmonary alveolar proteinosis (“aPAP”).
+Added: Our lead program, molgramostim, is an inhaled granulocyte-macrophage colony-stimulating factor in Phase 3 development for autoimmune pulmonary alveolar proteinosis (“aPAP”).
Previously, our pipeline included molgramostim for nontuberculous mycobacterial (NTM) lung infection in both non-cystic fibrosis (“CF”) and CF patients, vancomycin hydrochloride inhalation powder (“vancomycin”) for persistent methicillin-resistant Staphylococcus aureus (“MRSA”) lung infection in people living with CF and inhaled liposomal ciprofloxacin (“Apulmiq”) for non-CF bronchiectasis.
−Removed: Savara, together with its wholly-owned subsidiaries, which includes Aravas Inc., Savara ApS, Drugrecure A/S, and Savara Australia Pty.
−Removed: Limited, operate in one segment with its principal office in Austin, Texas.
+Added: Savara, together with its wholly-owned subsidiaries, which include Aravas Inc.
+Added: and Savara ApS operate in one segment with its principal office in Austin, Texas as of December 31, 2022.
Since inception, we have devoted substantially all of our efforts and resources to identifying and developing our product candidates, recruiting personnel, and raising capital.
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The continuing COVID-19 global pandemic poses risks to our business.
−Removed: As we commence enrollment of our additional Phase 3 trial for the use of molgramostim for the treatment of aPAP, there remains a general uncertainty regarding the impact of COVID-19 on the aPAP patient population and physicians.
+Added: As we commence enrollment of our additional Phase 3 trial for the use of molgramostim for the treatment of aPAP, there remains a general uncertainty regarding the impact of COVID-19 on the aPAP patient population and availability of physicians.
Patients suffering from aPAP lung disease are prone to underlying lung conditions and are often treated by infectious disease specialists and pulmonologists.
−Removed: These treating physicians are on the front lines in addressing this global pandemic and must now, understandably, focus their attention on COVID-19.
+Added: These treating physicians are on the front lines in addressing this global pandemic and have had to, understandably, focus their attention on COVID-19.
Further, if an aPAP patient enrolled in the study were to contract COVID-19, they may need to discontinue their participation.
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our third-party service providers, manufacturers, and suppliers may experience similar circumstances which could negatively impact our supply chain and progress of our development pipeline;
−Removed: COVID-19 and related safety concerns have and could delay recruitment of our clinical trials.
+Added: COVID-19 and related safety concerns could delay recruitment of our clinical trials.
The COVID-19 pandemic remains extremely fluid and we are continuing to re-assess the impact on our operations by monitoring the spread of COVID-19, emerging COVID-19 variants, and the actions implemented to combat the virus in various regions throughout the world.
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The CARES Act
−Removed: In response to the COVID-19 pandemic, many governments are taking measures to provide aid and economic stimulus.
+Added: In response to the COVID-19 pandemic, many governments have taken measures to provide aid and economic stimulus.
These measures include deferring the due dates of tax payments or other changes to their income and non-income-based tax laws.
−Removed: The Coronavirus Aid, Relief, and Economic Security Act (the "CARES Act”), which was enacted on March 27, 2020 in the U.S., includes many measures to assist companies, including temporary changes to income and non-income-based tax laws.
−Removed: Additionally, the CARES Act provides for non-income tax provisions, such as allowing payments of the employer share of Social Security payroll taxes that would otherwise be due from the date of enactment through December 31, 2020 to be paid over the following two years.
−Removed: Other provisions will allow eligible employers subject to closure due to the COVID-19 pandemic to receive a 50% credit on qualified wages against their employment taxes each quarter with any excess credits eligible for refunds.
−Removed: On August 8, 2020, former President Trump issued a COVID-19 relief executive order (“EO”) intending to help alleviate the hardships experienced by American workers as a result of the pandemic.
−Removed: The EO focuses on four key areas of relief including the deferral of payroll tax obligations for certain workers.
−Removed: The Consolidated Appropriations Act extended and expanded the availability of the CARES Employee Retention credit through June 30, 2021.
−Removed: Subsequently, the American Rescue Plan Act of 2021 (“ARP”), enacted on March 11, 2021, extended and expanded the availability of the CARES Employee Retention credit through December 31, 2021;
−Removed: however, certain provisions apply only after December 31, 2020.
+Added: The Coronavirus Aid, Relief, and Economic Security Act (the "CARES Act”), which was enacted on March 27, 2020 in the United States, includes many measures to assist companies, including temporary changes to income and non-income-based tax laws.
+Added: Additionally, a COVID-19 relief executive order was issued by former President Trump August 8, 2020 ("EO") and the American Rescue Plan Act of 2021 ("ARP") was enacted on March 11, 2021
We have assessed the provisions of the CARES Act, EO, and ARP and do not believe the measures mentioned above materially impact us or are relevant to our tax reporting.
−Removed: However, we are continuing to assess these and other provisions of the CARES Act and ARP and any potential additional federal stimulus packages with regards to their impact on our tax reporting as well as any provisions which may benefit us or our employees.
+Added: However, we are continuing to assess these and other provisions of the CARES Act, EO and ARP and any potential additional federal stimulus packages with regards to their impact on our tax reporting as well as any provisions which may benefit us or our employees.
Critical Accounting Policies and Estimates
−Removed: Our management’s discussion and analysis of financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the U.S.
+Added: Our management’s discussion and analysis of financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States.
The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses.
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Refer to Note 2.
−Removed: Summary of Significant Accounting Policies in the notes to our consolidated financial statements in this Annual Report for additional discussion.
+Added: Summary of Significant Accounting Policies in the notes to our consolidated financial statements in this annual report on Form 10-K for additional discussion.
Accrued Research and Development Expenses
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Business Combinations
−Removed: We account for business combinations in accordance with Accounting Standards Codification (“ASC”) Topic 805, Business Combinations , and as further defined by Accounting Standards Update (“ASU”) 2017-01, Business Combinations (Topic 805) , which requires the purchase price to be measured at fair value.
+Added: We account for business combinations, when applicable, in accordance with Accounting Standards Codification (“ASC”) Topic 805, Business Combinations , and as further defined by Accounting Standards Update (“ASU”) 2017-01, Business Combinations (Topic 805) , which requires the purchase price to be measured at fair value.
When the purchase consideration consists entirely of shares of our common stock, we calculate the purchase price by determining the fair value, as of the acquisition date, of shares issued in connection with the closing of the acquisition and, if the transaction involves contingent consideration based on achievement of milestones or earn-out events, the probability-weighted fair value, as of the acquisition date, of shares issuable upon the occurrence of future events or conditions pursuant to the terms of the agreement governing the business combination.
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In accordance with ASC Topic 350, Intangibles –
−Removed: Goodwill and Other , our IPR&D and goodwill, when applicable, is determined to have indefinite lives and, therefore, is not amortized.
+Added: Goodwill and Other , our IPR&D and goodwill, when present, is determined to have indefinite lives and, therefore, is not amortized.
Instead, it is tested for impairment annually and between annual tests if we become aware of an event or a change in circumstances that would indicate the carrying value may be impaired.
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In previous years, due to a lack of Level 1 or Level 2 inputs, the Multi-Period Excess Earnings Method (“MPEEM”), which is a form of the income approach, was used to estimate the fair value of acquired IPR&D when performing a quantitative assessment.
−Removed: Under the MPEEM, the fair value of an intangible asset is
−Removed: equal to the present value of the asset’s projected incremental after-tax cash flows (excess earnings) remaining after deducting the market rates of return on the estimated value of contributory assets (contributory charge) over its remaining useful life.
+Added: Under the MPEEM, the fair value of an intangible asset is equal to the present value of the asset’s projected incremental after-tax cash flows (excess earnings) remaining after deducting the market rates of return on the estimated value of contributory assets (contributory charge) over its remaining useful life.
We evaluate potential impairment of our acquired IPR&D annually on September 30, utilizing a qualitative approach and determining if it was more-likely-than not that the fair value was impaired.
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To date, we have not generated any product revenue from our product candidates.
−Removed: Milestone Revenue
−Removed: With respect to the license agreement related to molgramostim, which includes certain milestone payments to be remunerated to us by the licensee, we identify the performance obligations, determine the transaction price, allocate the contract transaction price to the performance obligations, and recognize the revenue when (or as) the performance obligation is satisfied.
−Removed: We identify the performance obligations included within the license agreement and evaluate which performance obligations are distinct.
−Removed: The milestone payments are a form of variable consideration as the payments are contingent upon achievement of a substantive event.
−Removed: The milestone payments are estimated and included in the transaction price when we determine, under the variable consideration constraint, that it is probable that there will not be a significant reversal of cumulative revenue recognized in future periods.
−Removed: The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which we recognize revenue as or when the performance obligations under the contract are satisfied.
−Removed: At the end of each subsequent reporting period, we re-evaluate the probability of achievement of such milestones and any related constraint, and if necessary, adjust the estimate of the overall transaction price.
Share-based Compensation Expenses
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(in thousands)
−Removed: Milestone revenue
Operating expenses:
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Loss from operations
−Removed: Other expense, net
−Removed: Milestone Revenue
−Removed: We recognized $0.3 million in revenue during the year ended December 31, 2020 related to the prior achievement and receipt of a milestone payment in October 2018 pursuant to a license agreement.
−Removed: The license agreement was terminated during the third quarter of 2020 causing all performance obligations to have been satisfied, which resulted in the recognition of revenue.
−Removed: There was no such revenue recorded during the year ended December 31, 2021 .
+Added: Other income (expense), net
Research and Development
Research and development expenses decreased $1.1 million, or 3.8%, to $27.9 million for the year ended December 31, 2022 from $29.0 million for the year ended December 31, 2021.
−Removed: The decrease is largely attributable to $5.4 million of acquisition costs for the acquisition of an inhaled liposomal ciprofloxacin product candidate (the “Licensed Product”) in March 2020 and a $6.9 million decrease in CMC and clinical operations activities associated with the wind down of our vancomycin study.
−Removed: This is partially offset by a $6.4 million increase in costs associated with molgramostim for the treatment of aPAP related to the startup and progression of the IMPALA-2 trial.
+Added: The decrease is primarily related to the termination of our vancomycin study during the year ended December 31, 2020 with the study close-out completed in the year ended December 31, 2021.
General and Administrative
General and administrative expenses decreased $1.4 million, or 11.5%, to $10.9 million for the year ended December 31, 2022 from $12.4 million for the year ended December 31, 2021.
−Removed: The decrease is primarily due to the recognition of a one-time non-recurring charge of $0.8 million for non-cash stock-based compensation and approximately $1.5 million of paid and accrued severance payments to former members of executive management during the year ended December 31, 2020.
−Removed: Other Expense, Net
−Removed: Other expense, net, increased $1.2 million to $1.5 million for the year ended December 31, 2021 from $0.3 million for the year ended December 31, 2020.
−Removed: The change is primarily related to a reduction in investment income of approximately $0.8 million, which is included in the Interest expense, net line item on the consolidated statement of operations in this Annual Report.
−Removed: This reduction is primarily due to lower interest rates.
−Removed: Additionally, Foreign currency exchange (loss) gain decreased to a loss by $0.3 million due to a change in foreign currency exchange rates.
+Added: The decrease is primarily due to the reduction of personnel and overhead costs from the closure of our Denmark office and Danish activities.
+Added: Other Income (Expense), Net
+Added: Other income (expense), net increased $2.2 million to $0.7 million income for the year ended December 31, 2022 from $1.5 million expense for the year ended December 31, 2021.
+Added: The change is primarily related to a significant increase in net interest income generated by our short-term financial instrument investments of approximately $2.2 million resulting from a substantial increase in interest rates during the second half of 2022, which is included in the Interest expense, net line item on the consolidated statement of operations in this annual report on Form 10-K.
Liquidity and Capital Resources
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As discussed in Note 7.
−Removed: Debt Facility in the notes to the consolidated financial statements included in this Annual Report, we entered into a loan and security agreement with Silicon Valley Bank during the year ended December 31, 2017, which was amended a fourth time in March 2021, under which we have drawn a total of $25 million.
+Added: Debt Facility in the notes to the consolidated financial statements included in this annual report on Form 10-K, we entered into a loan and security agreement with Silicon Valley Bank during the year ended December 31, 2017, which was subsequently amended and then amended and restated in April 2022.
+Added: As of December 31, 2022, the outstanding amount of the secured loan was $26.1 million.
+Added: On March 10, 2023, the FDIC took control and was appointed receiver of Silicon Valley Bank.
+Added: As such, the Company is monitoring the impact on its loan and security agreement with Silicon Valley Bank.
Common Stock Sales Agreement
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Wainwright & Co., LLC (“Wainwright”), as sales agent, which was amended by Amendment No.
−Removed: 1 to the Common Stock Sales Agreement on June 29, 2018 (the “Wainwright Sales Agreement”), pursuant to which the Company may offer and sell, from time to time, through Wainwright, shares of Savara’s common stock, par value $0.001 per share, having an aggregate offering price of not more than $60 million, in addition to the $2.3 million in shares sold prior to the Amendment.
+Added: 1 to the Common Stock Sales Agreement on June 29, 2018 (the “Wainwright Sales Agreement”), pursuant to which the Company may offer and sell, from time to time, through Wainwright, shares of Savara’s common stock, par value $0.001 per share (“Shares”), having an aggregate offering price of not more than $60 million, in addition to the $2.3 million in Shares sold prior to the Amendment.
On July 2, 2021, the Company delivered written notice to Wainwright that it was terminating the Wainwright Sales Agreement effective July 12, 2021.
Evercore Sales Agreement
−Removed: On July 6, 2021, the Company entered into a Common Stock Sales Agreement with Evercore Group L.L.C., (“Evercore”), as sales agent (the “Sales Agreement”), pursuant to which the Company may offer and sell, from time to time, through Evercore, shares of Savara’s common stock, par value $0.001 per share (the “Shares”), having an aggregate offering price of not more than $60 million.
+Added: On July 6, 2021, the Company entered into a Common Stock Sales Agreement with Evercore Group L.L.C., (“Evercore”), as sales agent (the “Sales Agreement”), pursuant to which the Company may offer and sell, from time to time, through Evercore, Shares, having an aggregate offering price of not more than $60 million.
The Agreement was effective on July 16, 2021 (“New Registration Statement”), the date the Company’s shelf registration agreement on Form S-3, as filed with the SEC on July 6, 2021, was declared effective by the SEC.
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The Company has no obligation to sell any of the Shares and may at any time suspend sales under the Sales Agreement or terminate the Sales Agreement.
−Removed: During the year ended December 31, 2021 , we did not sell any shares of common stock under either the Wainwright Sales Agreement or the Evercore Sales Agreement.
−Removed: During the year ended December 31, 2020, we sold 942,825 shares of common stock under the Wainwright Sales Agreement for net proceeds of approximately $2.3 million.
+Added: During the years ended December 31, 2022 and 2021, we did not sell any shares of common stock under the Evercore Sales Agreement.
Recent Public Offering
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Stockholders’
−Removed: Equity in the notes to the consolidated financial statements included in this Annual Report.
+Added: Equity in the notes to the consolidated financial statements included in this annual report on Form 10-K.
Since 2017, we have completed four public offerings with combined net proceeds, after deducting the underwriting discounts and commissions and offering expenses, of approximately $257.6 million.
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Cash used in operating activities
−Removed: Cash (used in) provided by investing activities
+Added: Cash provided by (used in) investing activities
Cash provided by financing activities
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Cash flows from operating activities
−Removed: Cash used in operating activities for the year ended December 31, 2021 was $40.1 million, consisting of a net loss of $43.0 million, a $1.8 million decrease in Accounts payable and Accrued expenses and other current liabilities mostly relating to the wind down or completion of our non-aPAP trials during 2020, and a $1.0 million increase in Prepaid and
−Removed: other current assets associated with prepaid research and development costs for our IMPALA-2 trial.
+Added: Cash used in operating activities for the year ended December 31, 2022 was $34.6 million, consisting of a net loss of $38.2 million, which was partially offset by non-cash charges of $2.6 million, mainly comprised of amortization of right-of-use assets, depreciation, amortization of debt issuance costs, and stock-based compensation, and further offset by a net increase in assets and liabilities of $1.0 million.
+Added: The change in our net operating assets and liabilities was primarily due to a decrease in accrued liabilities mostly related to research and development costs for molgramostim and a decrease related to a cessation of residual costs of the wind-down of the vancomycin phase 3 trial.
+Added: Cash used in operating activities for the year ended December 31, 2021 was $40.1 million, consisting of a net loss of $43.0 million, a $1.8 million decrease in Accounts payable and Accrued expenses and other current liabilities mostly relating to the wind-down or completion of our non-aPAP trials during 2020, and a $1.0 million increase in Prepaid expenses and other current assets associated with prepaid research and development costs for our IMPALA-2 trial.
This was partially offset by approximately $5.8 million of non-cash charges (comprised primarily of depreciation and amortization including right-of-use assets, amortization on premium to short-term investments, amortization of debt issuance costs, and stock-based compensation).
−Removed: Cash used in operating activities for the year ended December 31, 2020 was $39.8 million, consisting of a net loss of $49.6 million, which was partially offset by (1) non-cash, share-based compensation expense of $5.1 million and (2) other non-cash charges related to amortization and depreciation of $0.7 million.
−Removed: In addition, the net loss was impacted by the write-off of acquired in-process research and development of $5.4 million related to the asset acquisition in the first quarter of 2020 of Apulmiq.
−Removed: The cash paid for the acquisition is reflected in cash flows from investing activities for the year ended December 31, 2020.
Cash flows from investing activities
Cash used in or provided by investing activities for the years ended December 31, 2022 and 2021 was primarily the result of net sale and maturities of short-term investments.
−Removed: In addition, we paid $3.2 million in the first quarter of 2020 related to the acquisition of Apulmiq.
Cash flows from financing activities
+Added: There was minimal cash used in financing activities for the year ended December 31, 2022.
Cash provided by financing activities for the year ended December 31, 2021 was $120.8 million, which was primarily related to $122.2 million in net proceeds from the public issuance of common stock and pre-funded warrants and $2.5 million in net proceeds from the exercise of warrants.
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Stockholders’
−Removed: Equity in the notes to the consolidated financial statements included in this Annual Report.
−Removed: Cash provided by financing activities for the year ended December 31, 2020 was $3.7 million, which was primarily related to net proceeds of $2.3 million related to the sales of our common stock through “at the market offerings”
−Removed: under the Sales Agreement and $1.8 million of net proceeds related to the exercise of certain milestone warrants issued in a private placement offering of our common stock in December 2019.
−Removed: These proceeds were partially offset by the payment of $0.5 million related to the end of period charge following the Third Amendment of our debt facility with Silicon Valley Bank in January 2020.
+Added: Equity in the notes to the consolidated financial statements included in this annual report on Form 10-K.
Future Funding Requirements
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Although we have sufficient capital to fund our planned activities, including those discussed in Note 10.
−Removed: Commitments - Manufacturing and Other of the consolidated financial statements in this Annual Report, we may need to raise additional capital to further fund the development of, and seek regulatory approvals for, our product candidate and to begin commercialization of any approved product.
+Added: Commitments –
+Added: Manufacturing and Other of the consolidated financial statements in this annual report on Form 10-K, we may need to raise additional capital to further fund the development of, and seek regulatory approvals for, our product candidate and to begin commercialization of any approved product.
The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our clinical development efforts.
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For a summary of the contingent milestone payments and commitments, refer to Note 10.
−Removed: Commitments - Manufacturing and Other , of the consolidated financial statements in this Annual Report.
+Added: Commitments –
+Added: Manufacturing and Other , of the consolidated financial statements in this annual report on Form 10-K.
Other Contracts
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Recent Accounting Pronouncements
−Removed: Summary of Significant Accounting Policies - Recent Accounting Pronouncements , of the consolidated financial statements in this Annual Report milestone for a discussion of recent accounting pronouncements and their effect, if any, on us.
+Added: Summary of Significant Accounting Policies –
+Added: Recent Accounting Pronouncements , of the consolidated financial statements in this annual report on Form 10-K milestone for a discussion of recent accounting pronouncements and their effect, if any, on us.
Quantitative and Qualitati ve Disclosures About Market Risk.
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A hypothetical 1% change in interest rates during any of the periods presented would not have had a material impact on our audited consolidated financial statements.
−Removed: Additionally, our investment securities are fixed income instruments denominated and payable in U.S.
−Removed: dollars and have short-term maturities, typically less than twelve months, and typically carry credit ratings of “A”
+Added: Additionally, our investment securities are fixed income instruments denominated and payable in United States dollars and have short-term maturities, typically less than twelve months, and typically carry credit ratings of “A”
at a minimum by two of three nationally recognized statistical rating organizations, specifically Moody’s, Standard & Poor’s or Fitch.
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We have ongoing operations in Denmark and pay those vendors in local currency (Danish Krone) or Euros.
−Removed: We seek to limit the impact of foreign currency fluctuations through the use of derivative instruments, and short-term foreign currency forward exchange contracts not designated as hedging instruments.
We did not recognize any significant exchange rate losses during the years ended December 31, 2022 and 2021.
A 10% change in the Krone-to-dollar or Euro-to-dollar exchange rate on December 31, 2022 would not have had a material effect on our results of operations or financial condition.
−Removed: We also have interest rate exposure as a result of our Loan Agreement, as amended, with Silicon Valley Bank.
−Removed: As of December 31, 2021, the outstanding gross principal amount of the secured term loan was $25.0 million.
−Removed: The loan bears interest at the prime rate reported in The Wall Street Journal, plus a spread of 3.00%.
+Added: We also have interest rate exposure as a result of our Loan Agreement with Silicon Valley Bank.
+Added: As of December 31, 2022, the outstanding amount of the secured term loan was $26.1 million.
+Added: The loan bears interest at a floating rate equal to the greater of (i) 3% or (ii) the prime rate reported in The Wall Street Journal, minus a spread of 0.5%.
Changes in the prime rate may therefore affect our interest expense associated with our secured term loan.
If a 10% change in interest rates from the interest rates on December 31, 2022 were to have occurred, this change would not have had a material effect on the value of our investment portfolio or on our interest expense obligations with respect to outstanding borrowed amounts.
+Added: On March 10, 2023, the FDIC took control and was appointed receiver of Silicon Valley Bank.
+Added: At the time Silicon Valley Bank entered into receivership, a large number of pharmaceutical and biotechnology companies held cash deposits with Silicon Valley Bank.
+Added: Department of the Treasury, Federal Reserve Board, and FDIC stated that all depositors of Silicon Valley Bank would have access to all of their money one business day following the date of closure;
+Added: we and other depositors with Silicon Valley Bank received such access on March 13, 2023.
+Added: Additionally, Treasury Secretary Janet L.
+Added: Yellen, Federal Reserve Chair Jerome H.
+Added: Powell and FDIC Chairman Martin J.
+Added: Gruenberg have announced that all bank depositors, including deposits in excess of the FDIC Limit, with SVB will be fully protected.
+Added: However, uncertainty and liquidity concerns in the broader financial services industry remain.
+Added: Department of the Treasury, Federal Reserve Board, and FDIC have announced a program to provide up to $25 billion of loans to financial institutions secured by such government securities held by financial institutions to mitigate the risk of potential losses on the sale of such instruments.
+Added: However, widespread demands for customer withdrawals or other needs of financial institutions for immediate liquidity may exceed the capacity of such program.
+Added: There is no guarantee that the U.S.
+Added: Department of Treasury, Federal Reserve Board, and FDIC will provide access to uninsured funds in the future in the event of the closure of other banks or financial institutions in a timely fashion or at all.
+Added: The financing uncertainty that pharmaceutical and biotechnology companies may now face as a result of Silicon Valley Bank’s entry into receivership may cause significant volatility with respect to pharmaceutical and biotechnology company stocks, which in turn could negatively impact the trading price of our common stock.
Inflation generally affects us by increasing our cost of labor and clinical trial costs.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.