3 unchanged sentences
in thousands, except share and per share amounts)
−Removed: September 30,
Current assets:
12 unchanged sentences
Lease liability
−Removed: Total long term liabilities
+Added: m liabilities
Total liabilities
1 unchanged sentence
Preferred stock, par value $ 0.0001 per share authorized:
−Removed: 5,000,000 shares at September 30, 2020 and December 31, 2019;
−Removed: 1,969,797 shares issued and outstanding at September 30, 2020 and December 31, 2019
+Added: 5,000,000 shares at March 31, 2021 and December 31, 2020;
+Added: 1,969,797 shares issued and outstanding at March 31, 2021 and December 31, 2020
Common stock, par value $ 0.0001 per share authorized:
−Removed: 200,000,000 at September 30, 2020 and December 31, 2019;
−Removed: 15,466,451 and 15,429,154 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively
+Added: 200,000,000 at March 31, 2021 and December 31, 2020;
+Added: 16,063,199 and 15,508,146 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively
Additional paid-in-capital
−Removed: Accumulated other comprehensive gain
+Added: Accumulated other comprehensive gain (loss)
Accumulated deficit
5 unchanged sentences
in thousands, except share and per share amounts)
−Removed: Three Months Ended September 30,
−Removed: Nine Months Ended September 30,
+Added: Three Months Ended March 31,
Total revenues
12 unchanged sentences
in thousands)
−Removed: Three Months Ended September 30,
−Removed: Nine Months Ended September 30,
+Added: Three Months Ended March 31,
Other comprehensive income (loss):
5 unchanged sentences
in thousands, except share and per share amounts)
−Removed: Preferred stock
comprehensive
1 unchanged sentence
stockholders’
+Added: Preferred stock
Balance at December 31, 2020
−Removed: Compensation expense related to stock options for services
−Removed: Unrealized gain on marketable securities
−Removed: Balance at March 31, 2020
−Removed: Exercise of common stock options
−Removed: Compensation expense related to stock options for services
−Removed: Unrealized gain on marketable securities
−Removed: Balance at June 30, 2020
+Added: Issuance of common shares in equity offering, excluding to related parties, net of transaction costs
Exercise of common stock options
1 unchanged sentence
Unrealized loss on marketable securities
−Removed: Balance at September 30, 2020
+Added: Balance at March 31, 2021
Balance at December 31, 2019
−Removed: Exercise of common stock options
Compensation expense related to stock options for services
1 unchanged sentence
Balance at March 31, 2020
−Removed: Exercise of common stock options
−Removed: Compensation expense related to stock options for services
−Removed: Unrealized gain on marketable securities
−Removed: Balance at June 30, 2019
−Removed: Exercise of common stock options
−Removed: Compensation expense related to stock options for services
−Removed: Unrealized loss on marketable securities
−Removed: Balance at September 30, 2019
See accompanying notes to condensed consolidated financial statements.
2 unchanged sentences
in thousands)
−Removed: Nine Months Ended September 30,
+Added: Three Months Ended
Cash flows from operating activities:
5 unchanged sentences
Accounts payable
−Removed: Accrued expenses
+Added: Accrued expense
Accrued interest, net of interest received on maturity of investments
4 unchanged sentences
Purchases of property and equipment, net of disposals
−Removed: Net cash provided by investing activities
+Added: Net cash provided by (used in) investing activities
Cash flows from financing activities:
−Removed: Proceeds from the exercise of common stock options
+Added: Proceeds from issuances of stock, excluding related parties, net of transaction costs
+Added: Proceeds from the exercise of common stock options, net of transaction costs
Net cash provided by financing activities
−Removed: Net increase in cash and cash equivalents
+Added: Net increase (decrease) in cash and cash equivalents
Cash and cash equivalents at beginning of period
Cash and cash equivalents at end of period
−Removed: Supplemental disclosure of cash flow information:
−Removed: Obtaining a right-of-use
−Removed: asset in exchange for a lease liability
See accompanying notes to condensed consolidated financial statements.
2 unchanged sentences
Organization, Business, and Basis of Presentation
−Removed: Organization and Business
+Added: rganization and Business
Madrigal Pharmaceuticals, Inc.
4 unchanged sentences
fatty liver disease (“NAFLD”).
−Removed: The Company initiated two Phase 3 studies of resmetirom in NASH in 2019.
−Removed: The Company previously completed Phase 2 studies of resmetirom in NASH in May of 2018 and Heterozygous Familial Hypercholesterolemia in February of 2018.
+Added: The Company initiated two Phase 3 studies of resmetirom in NASH in 2019 that are ongoing.
+Added: The Company previously completed Phase 2 studies of resmetirom in NASH in May of 2018 and Heterozygous Familial Hypercholesterolemia (“HeFH”) in February of 2018.
Basis of Presentation
7 unchanged sentences
Principle of Consolidation
−Removed: The consolidated financial statements include the financial statements of the Compan y
−Removed: and its wholly owned subsidiaries.
+Added: The consolidated financial statements include the financial statements of the Company and its wholly owned subsidiaries.
All significant intercompany balances have been eliminated in consolidation.
15 unchanged sentences
debt securities for amortization of premiums and accretion of discounts to maturity.
−Removed: The Company includes such amortization and accretion as a component of interest income, net.
+Added: The Company includes such amortization and accretion as a component of interest income.
Realized gains and losses and declines in value, if any, that the Company judges to be other-than-temporary on available-for-sale
−Removed: securities are reported as a
−Removed: component of interest income, net.
+Added: securities are reported as a component of interest income.
To determine whether an other-than-temporary impairment exists, the Company considers whether it intends to sell the debt security and, if the Company does not intend to sell the debt security, it considers available evidence to assess whether it is more likely than not that it will be required to sell the security before the recovery of its amortized cost basis.
−Removed: During the nine months ended September 30, 2020 and 2019, the Company determined it did not have any securities that were other-than-temporarily impaired.
+Added: During the three months ended March 31, 2021 and 2020, the Company determined it did not have any securities that were other-than-temporarily impaired.
Marketable securities are stated at fair value, including accrued interest, with their unrealized gains and losses included as a component of accumulated other comprehensive income or loss, which is a separate component of stockholders’ equity.
1 unchanged sentence
Realized gains and losses are determined on the specific identification method.
−Removed: During the nine months ended September 30, 2020 and 2019, the Company did not have any realized gains or losses on marketable securities.
+Added: During the three months ended March 31, 2021 and 2020, the Company did not have any realized gains or losses on marketable securities.
Fair Value of Financial Instruments
10 unchanged sentences
These inputs include reported trades of and broker-dealer quotes on the same or similar securities, issuer credit spreads, benchmark securities and other observable inputs.
−Removed: As of September 30, 2020, the Company’s financial assets valued based on Level 1 inputs consisted of cash and cash equivalents in a money market fund, its financial assets valued based on Level 2 inputs consisted of high-grade corporate and government agency bonds and commercial paper, and it had no financial assets valued based on Level 3 inputs.
−Removed: During the nine months ended September 30, 2020 and 2019, the Company did not have any transfers of financial assets between Levels 1 and 2.
−Removed: As of September 30, 2020 and December 31, 2019, the Company did not have any financial liabilities that were recorded at fair value on a recurring basis on the balance sheet.
+Added: As of March 31, 2021, the Company’s financial assets valued based on Level 1 inputs consisted of cash and cash equivalents in a money market fund, its financial assets valued based on Level 2 inputs consisted of high-grade corporate and government agency bonds and commercial paper, and it had no financial assets valued based on Level 3 inputs.
+Added: During the three months ended March 31, 2021 and 2020, the Company did not have any transfers of financial assets between Levels 1 and 2.
+Added: As of March 31, 2021 and December 31, 2020, the Company did not have any financial liabilities that were recorded at fair value on a recurring basis on the balance sheet.
Research and Development Costs
10 unchanged sentences
The Company uses the Black-Scholes option pricing model to determine the grant date fair value as management believes it is the most appropriate valuation method for its option grants.
−Removed: The Black-Scholes model requires inputs
−Removed: for risk-free interest rate, dividend yield, volatility and expected lives of the options.
+Added: The Black-Scholes model requires inputs for risk-free interest rate, dividend yield, volatility and expected lives of the options.
The expected lives for options granted represent the period of time that options granted are expected to be outstanding.
19 unchanged sentences
Basic and Diluted Loss Per Common Share
−Removed: Basic net loss per share is computed using the weighted average number of common shares outstanding during the period, excluding restricted stock that has been issued but is not yet vested.
+Added: Basic net loss per share is computed using the weighted average number of common shares outstanding during the period, excluding any restricted stock that has been issued but is not yet vested.
Diluted net loss per common share is computed using the weighted average number of common shares outstanding and the weighted average dilutive potential common shares outstanding using the treasury stock method.
−Removed: However, for the nine months ended September 30, 2020 and 2019, diluted net loss per share is the same as basic net loss per share because the inclusion of weighted average shares of unvested restricted common stock, common stock issuable upon the exercise of stock options, and common stock issuable upon the conversion of preferred stock would be anti-dilutive.
+Added: However, for the three months ended March 31, 2021 and 2020, diluted net loss per share is the same as basic net loss per share because the inclusion of weighted average shares of unvested restricted common stock, common stock issuable upon the exercise of stock options, and common stock issuable upon the conversion of preferred stock would be anti-dilutive.
The following table summarizes outstanding securities not included in the computation of diluted net loss per common share, as their inclusion would be anti-dilutive:
−Removed: Nine Months Ended September 30,
+Added: Three Months Ended March 31,
Common stock options
1 unchanged sentence
Recent Accounting Pronouncements
−Removed: In June 2016, the FASB issued ASU 2016-13,
−Removed: “Financial Instruments—Credit Losses (Topic 326):
−Removed: Measurement of Credit Losses on Financial Instruments,” which requires all or a portion of the amortized cost basis of a financial asset to be written off when it is deemed uncollectible.
−Removed: For public business entities that do not qualify as a smaller reporting company, ASU 2016-13
−Removed: is effective for annual and interim reporting periods beginning after December 15, 2019.
−Removed: The Company adopted ASU 2016-13
−Removed: effective January 1, 2020.
−Removed: There was no significant impact from the adoption.
Liquidity and Uncertainties
1 unchanged sentence
Food and Drug Administration and other government regulations.
−Removed: The Company has incurred losses since inception, including approximately $ 143.1 million for the nine months ended September 30, 2020, resulting in an accumulated deficit of approximately $ 366.3 million as of September 30, 2020.
+Added: The Company has incurred losses since inception, including approximately $ 52.5 million for the three months ended March 31, 2021, resulting in an accumulated deficit of approximately $ 478.0 million as of March 31, 2021.
Management expects to incur losses for the foreseeable future.
To date, the Company has funded its operations primarily through proceeds from sales of the Company’s common and Series A Convertible Preferred Stock.
−Removed: The Company believes that its cash, cash equivalents and marketable securities at September 30, 2020 will be sufficient to fund operations past one year from the issuance of these financial statements.
+Added: The Company believes that its cash, cash equivalents and marketable securities at March 31, 2021 will be sufficient to fund operations past one year from the issuance of these financial statements.
To meet its future capital needs, the Company intends to raise additional capital through debt or equity financings, collaborations, partnerships or other strategic transactions.
4 unchanged sentences
A summary of cash, cash equivalents and available-for-sale
−Removed: marketable securities held by the Company as of September 30, 2020 and December 31, 2019 is as follows (in thousands):
−Removed: September 30, 2020
+Added: marketable securities held by the Company as of March 31, 2021 and December 31, 2020 is as follows (in thousands):
+Added: March 31, 2021
Cash and cash equivalents:
1 unchanged sentence
Money market funds (Level 1)
−Removed: Corporate debt securities due within 3 months of date of purchase (Level 2)
Total cash and cash equivalents
8 unchanged sentences
Money market funds (Level 1)
−Removed: Corporate debt securities due within 3 months of date of purchase (Level 2)
Total cash and cash equivalents
1 unchanged sentence
Corporate debt securities due within 1 year of date of purchase (Level 2)
−Removed: Corporate debt securities due within 1 to 2 years of date of purchase
+Added: government and government sponsored entities due within 1 year of date of purchase (Level 2)
+Added: Corporate debt securities due within 1 to 2 years of date of purchase (Level 2)
Total cash, cash equivalents and marketable securities
Accrued Liabilities
−Removed: Accrued liabilities as of September 30, 2020 and December 31, 2019 consisted of the following (in thousands):
−Removed: September 30,
+Added: Accrued liabilities as of March 31, 2021 and December 31, 2020 consisted of the following (in thousands):
Contract research organization costs
5 unchanged sentences
Each common stockholder is entitled to one vote for each share of common stock held.
+Added: The common stock will vote together with all other classes and series of stock of the Company as a single class on all actions to be taken by the Company’s stockholders.
Each share of common stock is entitled to receive dividends, as and when declared by the Company’s board of directors.
2 unchanged sentences
The Series A Preferred Stock has a par value of $ 0.0001 per share and is convertible into shares of the common stock at a one -to-one
−Removed: ratio, subject certain limitations and to adjustment provisions as provided in the Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock, that the Company filed with the Secretary of State of the State of Delaware on June 21, 2017 (the “Series A Certificate”).
+Added: ratio, subject to adjustment as provided in the Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock, that the Company filed with the Secretary of State of the State of Delaware on June 21, 2017 (the “Series A Certificate”).
The terms of the Series A Preferred Stock are set forth in the Series A Certificate.
+Added: Each share of the Series A Preferred Stock is convertible into shares of Common Stock following notice that may be given at the holder’s option.
Upon any liquidation, dissolution or winding-up
2 unchanged sentences
Shares of the Series A Preferred Stock will generally have no voting rights, except as required by law.
−Removed: Shares of the Series A Preferred Stock will be entitled to receive dividends before shares of any other class or series of capital stock of the Company (other than dividends in the form of the Common Stock) generally equal to the dividend payable on each share of the Common Stock, on an as-converted
+Added: Shares of the Series A Preferred Stock will be entitled to receive dividends before shares of any other class or series of capital stock of the Company (other than dividends in the form of the Common Stock) equal to the dividend payable on each share of the Common Stock, on an as-converted
+Added: At-The-Market
+Added: Issuance Sales Agreement
+Added: In November 2020, the Company entered into an at-the-market
+Added: sales agreement (the “2020 Sales Agreement”), with Cowen and Company, LLC (“Cowen”), pursuant to which the Company may, from time to time, issue and sell shares of its common stock.
+Added: The Company is not obligated to make any sales of its common stock under the 2020 Sales Agreement.
+Added: Any shares sold will be sold pursuant to the effective shelf registration statement on Form S-3,
+Added: (the “Registration Statement”), and the prospectus supplement to the Registration Statement.
+Added: The Sales Agreement authorizes an aggregate offering of up to $ 200 million in shares of our common stock, from time to time, at the Company’s option, through Cowen as its sales agent.
+Added: Sales of common stock through Cowen may be made by any method that is deemed an “at-the-market”
+Added: offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including by means of ordinary brokers’ transactions at market prices, in block transactions or as otherwise agreed by the Company and Cowen.
+Added: Subject to the terms and conditions of the 2020 Sales Agreement, Cowen will use commercially reasonable efforts consistent with its normal trading and sales practices to sell the common stock based upon the Company’s instructions (including any price, time or size limits or other customary parameters or conditions the Company may impose).
+Added: The 2020 Sales Agreement may be terminated by the Company at any time upon 10 days’ notice.
+Added: As of March 31 2021, 590,410 shares have been sold under the 2020 Sales Agreement for an aggregate of approximately $ 72.8 million in gross proceeds.
+Added: Net proceeds to the Company were approximately $ 71.0 million after deducting commissions and other transaction costs.
+Added: Of those shares sold, 550,803 were sold in the first quarter of 2021, and 39,607 were sold in 2020.
+Added: Approximately $ 127.2 million remained reserved under the Company’s shelf registration statement and the applicable prospectus supplement for possible future issuance under the 2020 Sales Agreement.
Stock-based Compensation
4 unchanged sentences
The administration of the 2015 Stock Plan is under the general supervision of the Compensation Committee of the Board of Directors.
−Removed: The terms of stock options awarded under the 2015 Stock Plan, in general, are determined by the Compensation Committee, provided the exercise price per share generally shall not be set at less than the fair market value of a share of the common stock on the date of grant and the term shall not be greater than ten years
−Removed: from the date the option is granted.
−Removed: As of September 30, 2020, the Company had options outstanding to purchase 1,810,753 shares of its common stock, which includes options outstanding under its 2006 Stock Plan.
−Removed: As of September 30, 2020, 965,282 shares were available for future issuance.
−Removed: The following table summarizes stock option activity during the nine months ended September 30, 2020:
−Removed: average exercise
+Added: The terms of stock options awarded under the 2015 Stock Plan, in general, are determined by the Compensation Committee, provided the exercise price per share generally shall not be set at less than the fair market value of a share of the common stock on the date of grant and the term shall not be greater than ten years from the date the option is granted.
+Added: As of March 31, 2021, the Company had options outstanding to purchase 2,193,915 shares of its common stock, which includes options outstanding under its 2006 Stock Plan.
+Added: As of March 31, 2021, 575,782 shares were available for future issuance.
+Added: The following table summarizes stock option activity during the three months ended March 31, 2021:
+Added: exercise price
Outstanding at January 1, 2021
1 unchanged sentence
Options exercised
−Removed: Options cancelled
−Removed: Outstanding at September 30, 2020
−Removed: Exercisable at September 30, 2020
−Removed: The total cash received by the Company as a result of stock option exercises was $ 0.5 million and $ 0.2 million, respectively, for the nine months ended September 30, 2020 and 2019.
−Removed: The weighted-average grant date fair values, based on the Black-Scholes option model, of options granted during the nine months ended September 30, 2020 and 2019 were $ 65.65 and $ 91.65 , respectively.
+Added: Outstanding at March 31, 2021
+Added: Exercisable at March 31, 2021
+Added: The total cash received by the Company as a result of stock option exercises was $ 0.5 million and $ 0 million, respectively, for the three months ended March 31, 2021 and 2020.
+Added: The weighted-average grant date fair values, based on the Black-Scholes option model, of options granted during the three months ended March 31, 2021 and 2020 were $ 85.17 and $ 68.71 , respectively.
Stock-Based Compensation Expense
−Removed: Stock-based compensation expense during the nine months ended September 30, 2020 and 2019 was as follows (in thousands):
−Removed: Three Months Ended September 30,
−Removed: Nine Months Ended September 30,
+Added: Stock-based compensation expense during the three months ended March 31, 2021 and 2020 was as follows (in thousands):
+Added: Three Months Ended March 31,
Stock-based compensation expense by type of award:
Stock options
−Removed: Restricted stock
Total stock-based compensation expense
3 unchanged sentences
Total stock-based compensation expense included in net loss
−Removed: Unrecognized stock-based compensation expense on stock options as of September 30, 2020 was $ 41.1 million with a weighted average remaining period of 2.7 years.
+Added: Unrecognized stock-based compensation expense on stock options as of March 31, 2021 was $ 61.1 million with a weighted average remaining period of 3.05 years.
Commitments and Contingencies
4 unchanged sentences
A single-digit royalty payment range is based on net sales of products developed from resmetirom, subject to certain reductions.
−Removed: Except as described above, the Company has not achieved any additional product development or regulatory milestones and had no Licensed Product sales for the nine months ended September 30, 2020 and 2019.
+Added: The Company has not achieved any additional product development or regulatory milestones and had no Licensed Product sales for the three months ended March 31, 2021 and 2020.
The Company has entered into customary contractual arrangements and letters of intent in support of its Phase 3 clinical trials.
Subsequent Event
−Removed: In November 2020, the Company is entering
−Removed: into an at-the-market
−Removed: sales agreement (the “2020 Sales Agreement”), with Cowen and Company, LLC (“Cowen”), pursuant to which the Company may, from time to time, issue and sell shares of its common stock.
−Removed: The Company is not obligated to make any sales of its common stock under the 2020 Sales Agreement.
−Removed: Any shares sold will be sold pursuant to an effective shelf registration statement on Form S-3,
−Removed: (the “Registration Statement”), and a prospectus supplement that will be
−Removed: filed pursuant to the Registration Statemen t.
−Removed: The Sales Agreement will authorize
−Removed: an aggregate offering price of up to $ 200 million in shares of our common stock, from time to time, at the Company’s option, through Cowen as its sales agent.
−Removed: Sales of common stock through Cowen may be made by any method that is deemed an “at-the-market”
−Removed: offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including by means of ordinary brokers’ transactions at market prices, in block transactions or as otherwise agreed by the Company and Cowen.
−Removed: Subject to the terms and conditions of the 2020 Sales Agreement, Cowen will use commercially reasonable efforts consistent with its normal trading and sales practices to sell the common stock based upon the Company’s instructions (including any price, time or size limits or other customary parameters or conditions the Company may impose).
−Removed: The 2020 Sales Agreement may be terminated by the Company at any time upon 10 days ’ notice.
−Removed: SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
−Removed: This Quarterly Report on Form 10-Q
−Removed: contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, that are based on our beliefs and assumptions and on information currently available to us, but are subject to factors beyond our control.
−Removed: Forward-looking statements include but are not limited to statements or references concerning:
−Removed: our clinical trials;
−Removed: research and development activities;
−Removed: the timing and results associated with the future development of our lead product candidate, MGL-3196
−Removed: (resmetirom);
−Removed: our primary and secondary study endpoints for resmetirom and the potential for achieving such endpoints and projections;
−Removed: optimal dosing levels for resmetirom;
−Removed: projections regarding potential future NASH resolution, safety, fibrosis treatment, cardiovascular effects, lipid treatment or biomarker effects with resmetirom;
−Removed: the predictive power of liver fat reduction on NASH resolution with fibrosis reduction or improvement;
−Removed: the achievement of enrollment objectives concerning patient number, safety database and/or timing for our studies;
−Removed: potential NASH or NAFLD patient risk profile benefits with resmetirom;
−Removed: our possible or assumed future results of operations and expenses, business strategies and plans, capital needs and financing plans, trends, market sizing, competitive position, industry environment and potential growth opportunities, among other things.
+Added: Since the end of the first quarter, through May 4
+Added: , 2021, the Company has sold 521,426 shares under the 2020 Sales Agreement (described in Note 6) for an aggregate of approximately $ 62.6 million in gross proceeds.
+Added: Net proceeds to the Company were approximately $ 61.9 million after deducting commissions and other transaction costs.
+Added: Approximately $ 64.6 million remained reserved under the Company’s shelf registration statement and the applicable prospectus supplement for possible future issuance under the 2020 Sales Agreement.
+Added: CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
+Added: This Quarterly Report on Form
+Added: includes forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, that are based on our beliefs and assumptions and on information currently available to us, but are subject to factors beyond our control.
Forward-looking statements:
2 unchanged sentences
and can be identified by terms such as “allow,” “anticipates,” “be,” “believes,” “continue,” “could,” “demonstrates,” ”design,” “estimates,” “expects,” “forecasts,” “future,” “hopeful,” “goal,” “intends,” “may,” “might,” “plans,” “potential,” “predicts,” ”predictive,” “projects,” “seeks,” “should,” “will,” “will achieve,” “would” or similar expressions and the negatives of those terms.
+Added: In particular, forward-looking statements contained in or incorporated by reference to this Quarterly Report relate to, among other things,
+Added: Anticipated or estimated future results, including the risks and uncertainties associated with our future operating performance and financial position,
+Added: Our possible or assumed future results of operations and expenses, business strategies and plans, capital needs and financing plans, market trends, competitive position, industry environment and potential growth opportunities,
+Added: Our clinical trials, research and development activities, and the timing and results associated with the future development of our lead product candidate,
+Added: (resmetirom), including sector leadership,
+Added: The timing and completion of projected 2021 clinical milestone events, including enrollment, top-line data and open label projections,
+Added: Our primary and secondary study endpoints for resmetirom, and the potential for achieving such endpoints and projections, including
+Added: non-alcoholic
+Added: steatohepatitis (“NASH”) resolution, safety, fibrosis treatment, cardiovascular effects and lipid treatment with resmetirom,
+Added: Optimal dosing levels for resmetirom and projections regarding potential NASH or nonalcoholic fatty liver disease (“NAFLD”) patient benefits with resmetirom,
+Added: The predictive power of resmetirom liver fat reduction on NASH resolution with fibrosis reduction or improvement, and potential NASH or NAFLD patient risk profile benefits with resmetirom,
+Added: Market demand for and acceptance of our products,
+Added: Research, development and commercialization of new products,
+Added: Obtaining and maintaining regulatory approvals, including, but not limited to, potential regulatory delays or rejections,
+Added: Risks associated with meeting the objectives of our clinical studies, including, but not limited to our ability to achieve enrollment objectives concerning patient numbers (including an adequate safety database) and/or timing for our studies, any delays or failures in enrollment, the occurrence of adverse safety events, and the risks of successfully conducting trials that are substantially larger than our past trials,
+Added: Risks related to our ability to accomplish our business development objectives and realize the anticipated benefit of any such transactions, and
+Added: Assumptions underlying any of the foregoing.
+Added: We caution you that the foregoing list may not include all of the forward-looking statements made in this Quarterly Report.
Although management presently believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements.
13 unchanged sentences
Securities and Exchange Commission for more detailed information regarding these risks and uncertainties and other factors that may cause actual results to differ materially from those expressed or implied.
−Removed: We specifically discuss these risks and uncertainties in greater detail in the “Risk Factors” sections appearing in Part I, Item 1A of our Annual Report on Form 10-K
−Removed: for the year ended December 31, 2019, filed with the SEC on February 26, 2020, and Part II, Item 1A of the Quarterly Report on Form 10-Q
−Removed: for the period ended June 30, 2020, filed with the SEC on August 6, 2020, as well as in our other filings with the SEC.
+Added: We specifically discuss these risks and uncertainties in greater detail in the section appearing in Part I, Item 1A of our Annual Report on Form 10-K
+Added: for the year ended December 31, 2020, filed with the SEC on February 25, 2021, as well as in our other filings with the SEC.
+Added: You should read this Quarterly Report, and the other documents that we file or have filed with the SEC, with the understanding that our actual future results may be materially different from the results expressed or implied by these forward-looking statements.
+Added: Moreover, we operate in an evolving environment.
+Added: New risks and uncertainties emerge from time to time and it is not possible for our management to predict all risks and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual future results to be materially different from those expressed or implied by any forward-looking statements.
+Added: Except as required by applicable law or the rules of the NASDAQ Stock Market, or NASDAQ, we assume no obligation to update any forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
+Added: We qualify all of our forward-looking statements by these cautionary statements.
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.