2 unchanged sentences
Audited Financial Statements for the Years Ended December 31, 2021, 2020 and 2019:
−Removed: Report of Independent Registered Public Accounting Firm
+Added: Report of Independent Registered Public Accounting Firm (PCAOB ID:
Balance Sheets
30 unchanged sentences
Management’s identification of the performance obligations requires significant judgment, including whether the performance obligations are distinct and capable of being distinct, which requires management to evaluate whether the customer can benefit from the good or service on its own, or together with other resources readily available to the customer.
−Removed: Management applies significant judgment in determining the revenue recognition for these collaboration and licensing contracts including the identification of and accounting for all performance obligations and the calculation of the standalone selling price (SSP) for each identified performance obligation.
+Added: Management applies significant judgment in determining the revenue recognition for these collaboration and licensing contracts including the identification of and accounting for all performance obligations and the calculation of the stand-alone selling price (SSP) for each identified performance obligation.
The Company’s estimate of SSP for each performance obligation within these customer contracts requires management to consider many factors, including
7 unchanged sentences
● As each contract has multiple performance obligations, we also tested the allocation of the transaction price to each performance obligation based upon the SSP.
−Removed: We have served as the Company’s auditor since 2015.
/s/ RSM US LLP
+Added: We have served as the Company’s auditor since 2015.
Los Angeles, California
31 unchanged sentences
Cash and cash equivalents
−Removed: Marketable securities
−Removed: Equity securities
+Added: Marketable debt securities
+Added: Marketable equity securities
Accounts receivable
−Removed: Income tax receivable
Contract asset
3 unchanged sentences
Patents, licenses, and other intangible assets, net
−Removed: Marketable securities - long term
−Removed: Equity securities - long term
−Removed: Income tax receivable
+Added: Marketable debt securities - long term
+Added: Marketable equity securities - long term
+Added: Notes receivable - long term
Right of use asset
7 unchanged sentences
Lease liabilities, net of current portion
−Removed: Deferred revenue, net of current portion
Total liabilities
24 unchanged sentences
Interest income, net
−Removed: Other income (expense)
+Added: Other income (expense), net
+Added: Gain on equity securities, net
Total other income, net
13 unchanged sentences
Stockholders’ Equity
+Added: Income (Loss)
Balance, December 31, 2018
−Removed: Sale of common stock, net of issuance cost
Issuance of common stock upon exercise of stock awards
Issuance of common stock under the Employee Stock Purchase Plan
−Removed: Comprehensive loss
+Added: Issuance of restricted stock units
+Added: Comprehensive income
Stock-based compensation
3 unchanged sentences
Issuance of restricted stock units
−Removed: Comprehensive income
+Added: Comprehensive loss
Stock-based compensation
Balance, December 31, 2020
+Added: Sale of common stock
Issuance of common stock upon exercise of stock awards
1 unchanged sentence
Issuance of restricted stock units
−Removed: Comprehensive loss
+Added: Comprehensive income
Stock-based compensation
8 unchanged sentences
Depreciation and amortization
−Removed: Amortization of premium on marketable securities
+Added: Amortization of premium (accretion of discount) on marketable securities
Stock-based compensation
1 unchanged sentence
Loss on disposal of assets
−Removed: Loss (gain) on sale of marketable securities available-for-sale
+Added: Gain on sale of marketable securities available-for-sale
Equity received in connection with license agreement
+Added: Equity received in connection with sale of financial assets
Cash redemption of equity received in connection with license agreement
−Removed: Change in fair value of equity security
+Added: Change in fair value of equity securities
+Added: Equity securities impairment
Changes in operating assets and liabilities:
Accounts receivable
−Removed: Interest receivable
+Added: Interest receivable from marketable debt securities
Prepaid expenses and other current assets
4 unchanged sentences
Deferred rent
−Removed: Income tax payable
Lease liabilities and ROU assets
7 unchanged sentences
Purchase of property and equipment
−Removed: Proceeds from repayment of loan receivable
+Added: Purchase of convertible note
+Added: Exercise of stock options
Net cash provided by (used in) investing activities
3 unchanged sentences
Proceeds from issuance of common stock
−Removed: Common stock issuance costs
Net cash provided by financing activities
−Removed: Net increase in cash and cash equivalents
+Added: Net (decrease) increase in cash and cash equivalents
Cash and cash equivalents , beginning of year
8 unchanged sentences
(we, us, our, or the Company) was incorporated in California in 1997 and reincorporated in Delaware in September 2004.
−Removed: We are a clinical-stage biopharmaceutical company focused on discovering and developing engineered monoclonal antibody and cytokine therapeutics to treat patients with cancer and autoimmune diseases who have unmet medical needs.
+Added: We are a clinical-stage biopharmaceutical company focused on discovering and developing engineered monoclonal bispecific antibody and cytokine therapeutics to treat patients with cancer and autoimmune diseases who have unmet medical needs.
We create our product candidates using our proprietary XmAb technology platforms, which focus on the portion of an antibody that interacts with multiple segments of the immune system, referred to as the Fc domain, which is constant and interchangeable among antibodies.
4 unchanged sentences
Use of Estimates
−Removed: The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes.
−Removed: Significant estimates include useful lives of long-lived assets, the periods over which certain revenues and expenses will be recognized including collaboration revenue recognized from non-refundable upfront licensing payments, the amount of non-cash compensation costs related to share-based payments to employees and non-employees and the period over which these costs are expensed.
+Added: The preparation of financial statements in conformity with GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, other comprehensive gain (loss) and the related disclosures.
+Added: On an ongoing basis, management evaluates its estimates, including estimates related to its accrued clinical trial and manufacturing development expenses, stock-based compensation expense, evaluation of intangible assets, investments, leases and other assets for evidence of impairment, fair value measurements, and contingencies.
+Added: Significant estimates in these financial statements include estimates made for royalty revenue, accrued research and development expenses, stock-based compensation expenses, intangible assets, incremental borrowing rate for right-of-use asset and lease liability, estimated standalone selling price of performance obligations, estimated time for completing delivery of performance obligations under certain arrangements, the likelihood of recognizing variable consideration, the carrying value of equity instruments without a readily determinable fair value, and recoverability of deferred tax assets.
Recent Accounting Pronouncements
1 unchanged sentence
Effective January 1, 2021, the Company adopted ASU No.
−Removed: 2016-13, Financial Instruments – Credit Losses (Topic 326):
−Removed: Measurement of Credit Losses on Financial Instruments, as well as ASU No, 2018-19, Codification Improvements to Topic 326, Financial Instruments – Credit Losses.
−Removed: The standard amends guidance on reporting credit losses for assets held at amortized cost basis and also provides an available-for-sale (AFS) debt security impairment model that is a modified version of the other-than-temporary-impairment (OTTI) model.
−Removed: The AFS debt security impairment model no longer allows consideration of the length of time during which the fair value has been less than its amortized cost when determining whether a credit loss exists.
−Removed: The adoption of this standard did not have any impact on the Company’s financial statements.
−Removed: Effective January 1, 2020, the Company adopted ASU No.
−Removed: 2018-13, Fair Value Measurement (Topic 820):
−Removed: Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement, which modifies the disclosures for transfers between Level 1 and Level 2 of the fair value hierarchy, modifies the Level 3 disclosure requirements for non-public entities and requires additional disclosure for Level 3 fair value hierarchy.
−Removed: The adoption of this standard did not have any impact on the Company’s financial statements.
−Removed: Effective January 1, 2020, the Company adopted ASU No.
−Removed: 2018-18, Collaborative Arrangements (Topic 808):
−Removed: Clarifying the Interaction Between Topic 808 and Topic 606, which provides guidance on how to assess whether certain transactions between collaborative arrangement participants should be accounted for within the revenue recognition standard.
−Removed: The adoption of this standard did not have any impact on the Company’s financial statements.
−Removed: Pronouncements not yet effective
−Removed: In December 2019, the FASB issued ASU No.
2019-12, Income Taxes (Topic 740):
−Removed: Simplifying the Accounting for Income Taxes , which is effective for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years.
−Removed: The standard removes specific exceptions to the general principles in Topic 740 and simplifies the accounting for income taxes.
−Removed: The Company does not anticipate that the standard will have a significant impact on its financial statements.
−Removed: In January 2020, the FASB issued ASU No.
+Added: Simplifying the Accounting for Income Taxes , which removes specific exceptions to the general principles in Topic 740 and simplifies the accounting for income taxes.
+Added: The adoption of this standard did not have a significant impact on the Company’s financial statements.
+Added: Effective January 1, 2021, the Company adopted ASU No.
2020-01, which clarifies that a company should consider observable transactions that require a company to either apply or discontinue the equity method of accounting under Topic 323, Investment – Equity Method and Joint Ventures , for the purposes of applying the measurement alternative in accordance with Topic 321, Investments – Equity Securities immediately before applying or upon discontinuing the equity method.
−Removed: The amendment is effective for fiscal years beginning after December 15, 2020.
−Removed: The Company does not anticipate that the standard will have a significant impact on its financial statements.
−Removed: In October 2020, the FASB issued ASU No.
+Added: The adoption of this standard did not have a significant impact on the Company’s financial statements.
+Added: Effective January 1, 2021, the Company adopted ASU No.
2020-10, Codification Improvements , which amends a variety of topics in the Accounting Standards Codification to improve consistency and clarify guidance.
−Removed: The amendment is effective for fiscal years beginning after December 15, 2020.
−Removed: The Company is currently evaluating the amendment and does not anticipate that it will have an impact on its financial statements.
+Added: The adoption of this standard did not have a significant impact on the Company’s financial statements.
+Added: Pronouncements not yet effective
+Added: There are accounting standards that have been issued by the Financial Accounting Standards Board (FASB) but are not yet effective.
+Added: The standards are not expected to have a material impact on our results of operations, financial conditions, or cash flows.
Revenue Recognition
3 unchanged sentences
The licensing agreements also include royalties on sales of any commercialized products by our partners.
−Removed: We recognize revenue through the five-step process in accordance with ASC 606 Revenue Recognition when control of the promised goods or services is transferred to our customers in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services.
+Added: We recognize revenue through the five-step process in accordance with Accounting Standards Codification (ASC) 606, Revenue from Contracts with Customers , when control of the promised goods or services is transferred to our customers in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services.
Deferred Revenue
3 unchanged sentences
The total amounts reported as deferred revenue were $ 37.3 million and $ 92.6 million at December 31, 2021 and 2020, respectively.
+Added: Accounts Receivable
+Added: Accounts receivable primarily consists of royalty and milestone revenues receivable from our license and collaboration agreements, as well as receivables arising from cost-sharing development activities.
+Added: We did not record allowance for doubtful accounts at December 31, 2021 or 2020, as we expect to collect all receivables within the terms, which are generally between 30 and 60 days .
Research and Development Expenses
1 unchanged sentence
Research and development costs are expensed as incurred.
−Removed: These costs consist primarily of salaries and benefits, including associated stock-based compensation, laboratory supplies, facility costs, and applicable overhead expenses of personnel directly involved in the research and development of new technology and products, as
−Removed: well as fees paid to other entities that conduct certain research development activities on our behalf.
−Removed: We estimate preclinical study and clinical trial expenses based on the services performed pursuant to the contracts with research institutions and clinical research organizations that conduct and manage preclinical studies and clinical trials on our behalf based on the actual time and expenses incurred by them.
+Added: These costs consist primarily of salaries and benefits, including associated stock-based compensation, laboratory supplies, facility costs, and applicable overhead expenses of personnel directly involved in the research and development of new technology and products, as well as fees paid to other entities that conduct certain research and development activities on our behalf.
+Added: We estimate preclinical study and clinical trial expenses based on the services performed pursuant to the contracts with research institutions and clinical research organizations that conduct and manage preclinical studies and clinical trials on our behalf based on the actual time and expenses they incurred.
Further, we accrue expenses related to clinical trials based on the level of patient enrollment and activity according to the related agreement.
4 unchanged sentences
We consider cash equivalents to be only those investments which are highly liquid, readily convertible to cash and which mature within three months from the date of purchase.
−Removed: Marketable and Equity Securities
+Added: Marketable Debt and Equity Securities
The Company has an investment policy that includes guidelines on acceptable investment securities, minimum credit quality, maturity parameters, and concentration and diversification.
10 unchanged sentences
If the Company sells an investment, any realized gains or losses on the sale of the securities will be recognized within other income (expense) in the Statement of Comprehensive Income (Loss) in the period of sale.
−Removed: The Company also has an investment in an equity security without a readily determinable fair value, where the Company elects the measurement alternative to record at its initial cost minus impairment, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer.
+Added: The Company also has investments in equity securities without a readily determinable fair value, where the Company elects the measurement alternative to record at their initial cost minus impairment, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer.
Concentrations of Risk
7 unchanged sentences
Amounts on deposit in excess of federally insured limits at December 31, 2021 and 2020 approximated $ 143.2 million and $ 163.3 million, respectively.
−Removed: We have payables with one service provider that represent 49 % of our total payables and with two service providers that represented 48 % of our total payables at December 31, 2020 and 2019, respectively.
−Removed: We rely on three critical suppliers for the manufacture of our drug product for use in our clinical trials.
−Removed: While we believe that there are alternative vendors available, a change in manufacturing vendors could cause a delay in the availability of drug product and result in a delay of conducting and completing our clinical trials.
+Added: We have payables with four service providers that represent 64 % of our total payables and with one service provider that represented 49 % of our total payables at December 31, 2021 and 2020, respectively.
+Added: We rely on four critical suppliers for the manufacture of our drug product for use in our clinical trials.
+Added: While we believe that there are
+Added: alternative vendors available, a change in manufacturing vendors could cause a delay in the availability of drug product and result in a delay of conducting and completing our clinical trials.
No other vendor accounted for more than 10% of total payables at December 31, 2021 or 2020.
+Added: We have receivables with two service providers that represent 84 % and 88 % of our total receivables at December 31, 2021 and 2020, respectively.
+Added: The receivables are related to royalty revenues from our licensing and collaboration agreements.
+Added: No other customer accounted for more than 10% of total receivables at December 31, 2021 or 2020.
Fair Value of Financial Instruments
1 unchanged sentence
Marketable debt securities and cash equivalents are carried at fair value.
+Added: The fair value of a financial instrument is the amount that would be received in an asset sale or paid to transfer a liability in an orderly transaction between unaffiliated market participants.
The fair value of the other financial instruments closely approximate their fair value due to their short maturities.
−Removed: The Company accounts for recurring and non-recurring fair value measurements in accordance with FASB Accounting Standards Codification (ASC) 820, Fair Value Measurements and Disclosures (ASC 820).
+Added: The Company accounts for recurring and non-recurring fair value measurements in accordance with FASB ASC 820, Fair Value Measurements and Disclosures .
ASC 820 defines fair value, establishes a fair value hierarchy for assets and liabilities measured at fair value, and requires expanded disclosure about fair value measurements.
13 unchanged sentences
Government Securities
−Removed: Equity Securities with Readily Determinable Fair Value
−Removed: Equity Securities without Readily Determinable Fair Value
December 31, 2020
2 unchanged sentences
Government Securities
−Removed: The Company holds equity securities without readily determinable fair value as of December 31, 2020.
−Removed: The Company elects the measurement alternative to record at its initial cost minus impairment, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer.
+Added: Our policy is to record transfers of assets between Level 1 and Level 2 at their fair values as of the end of each reporting period, consistent with the date of the determination of fair value.
+Added: During the years ended December 31, 2021 and 2020, there were no transfers between Level 1 and Level 2.
Property and Equipment
15 unchanged sentences
We review our intellectual property on a regular basis to determine if there are changes in the estimated useful life of issued patents and if any capitalized costs for unissued patents should be abandoned.
−Removed: Capitalized patent costs related to abandoned patent filings are charged off in the period of the decision to abandon.
+Added: Capitalized patent costs related to
+Added: abandoned patent filings are charged off in the period of the decision to abandon.
During 2021, 2020, and 2019, we abandoned previously capitalized patent and licensing related charges of $ 0.9 million, $ 0.5 million, and $ 0.2 million, respectively.
38 unchanged sentences
We recorded stock-based compensation and expense for stock-based awards to employees, directors, and consultants of approximately $ 37.0 million, $ 31.6 million, and $ 31.9 million for the years ended December 31, 2021, 2020, and 2019, respectively.
−Removed: Included in the 2020, 2019, and 2018 balances for total compensation expense is $ 0.8 million, $ 0.7 million and $ 0.7 million, respectively, relating to our ESPP.
Net Income (Loss) Per Share
+Added: Basic net income (loss) per common share is computed by dividing the net income (loss) attributable to common stockholders by the weighted-average number of common shares outstanding during the period without consideration of common stock equivalents.
+Added: Diluted net income (loss) per common share is computed by dividing the net income (loss) attributable to common stockholders by the weighted-average number of common stock equivalents outstanding for the period.
+Added: Potentially dilutive securities consisting of stock issuable pursuant to outstanding options and restricted stock units (RSUs), and stock issuable pursuant to the 2013 Employee Stock Purchase Plan (ESPP) are not included in the per common share calculation in periods when the inclusion of such shares would have an anti-dilutive effect.
+Added: Basic and diluted net income (loss) per common share is computed as follows:
Basic net income (loss) per common share is computed by dividing the net income or loss by the weighted-average number of common shares outstanding during the period.
−Removed: Potentially dilutive securities were included
−Removed: in the diluted net income per common share calculation for 2019.
−Removed: We included 1,923,310 options to purchase shares of common stock and 13,131 shares of RSUs in the calculation of the weighted-average common shares outstanding used in computing diluted net income per common share.
−Removed: We excluded 1,022,623 shares of options and RSUs from the calculation for 2019 because the inclusion of such shares would have had an antidilutive effect.
−Removed: In 2020 and 2018, we excluded all options and awards from the calculations because we reported net losses in the periods, and the inclusion of such shares would have had an antidilutive effect.
+Added: Potentially dilutive securities were included in the diluted net income per common share calculation for 2021 and 2019.
+Added: In 2020, we excluded all options and awards from the calculations because we reported net losses in the period, and the inclusion of such shares would have had an antidilutive effect.
Year Ended December 31,
5 unchanged sentences
Weighted average number of common shares outstanding used in computing basic net income (loss) per common share
−Removed: Dilutive effect of employee stock options and ESPP
+Added: Dilutive effect of employee stock options, RSUs, and ESPP
Weighted-average number of common shares outstanding used in computing diluted net income (loss) per common share
Diluted net income (loss) per common share
+Added: For the year ended December 31, 2021, we excluded 1,196,268 shares of options and RSUs from the calculation of diluted net income per common share because the inclusion of such shares would have had an anti-dilutive effect.
+Added: For the year ended December 31, 2020, all outstanding potentially dilutive securities were excluded from the calculation as the effect of including such securities would have been anti-dilutive.
+Added: For the year ended December 31, 2019, we excluded 1,022,623 shares of options and RSUs from the calculation because the inclusion of such shares would have had an anti-dilutive effect.
Segment Reporting
3 unchanged sentences
Comprehensive income (loss) is comprised of net income (loss) and other comprehensive income (loss).
−Removed: For the years ended December 31, 2020 and 2019, the only component of other comprehensive income (loss) is net unrealized gains on marketable debt securities.
+Added: For the years ended December 31, 2021, 2020, and 2019, the only component of other comprehensive income (loss) is net unrealized gain (loss) on marketable debt securities.
There were no material reclassifications out of accumulated other comprehensive loss during the year ended December 31, 2021.
−Removed: Marketable Securities
+Added: Marketable Debt and Equity Securities
The Company’s marketable debt securities held as of December 31, 2021 and 2020 are summarized below:
18 unchanged sentences
Mature in one year or less
−Removed: Mature after one year through five years
+Added: Mature within two years
The unrealized losses on available-for-sale investments and their related fair values as of December 31, 2021 and 2020 are as follows:
14 unchanged sentences
Corporate Securities
+Added: Government Securities
The unrealized losses from the listed securities are due to a change in the interest rate environment and not a change in the credit quality of the securities.
−Removed: For the year ended December 31, 2020, the Company received shares of Aimmune common stock and MiRagen common stock in connection with the Aimmune and MiRagen Agreements (both as defined below).
−Removed: Aimmune common stock was redeemed for cash within the same year;
−Removed: MiRagen common stock is classified as equity securities with a readily determinable fair value at December 31, 2020.
−Removed: For the year ended December 31, 2020, the Company also received equity of a private company in connection with a licensing agreement.
−Removed: The Company elects measurement alternative to carry the investment at cost minus impairment, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer.
−Removed: There has not been any impairment or observable price changes related to this investment.
−Removed: We did not hold any equity securities in our investment portfolio during the year ended December 31, 2019.
−Removed: Net gains and losses during the year ended December 31, 2020 and 2019 consist of the following:
+Added: The Company’s equity securities include securities with a readily determinable fair value.
+Added: These investments are carried at fair value with changes in fair value recognized each period and reported within other income (expense).
+Added: Equity securities with a readily determinable fair value and their fair values (in thousands) as of December 31, 2021 and 2020 are as follows:
+Added: December 31, 2021
+Added: December 31, 2020
+Added: Astria Common Stock
+Added: INmune Common Stock
+Added: Viridian Common Stock
+Added: The Company also has investments in equity securities without a readily determinable fair value.
+Added: The Company elects the measurement alternative to record these investments at their initial cost and evaluate such investments at each reporting period for evidence of impairment, or observable price changes in orderly transactions for the identical or a similar investment of the same issuer.
+Added: During the year ended December 31, 2021, the Company recorded an impairment charge of $ 0.8 million related to the Astria preferred stock.
+Added: Equity securities without a readily determinable fair value and their carrying values (in thousands) as of December 31, 2021 and 2020 are as follows:
+Added: Carrying Value
+Added: Carrying Value
+Added: December 31, 2021
+Added: December 31, 2020
+Added: Astria Preferred Stock
+Added: Zenas Preferred Stock
+Added: In 2018, the Company received equity shares in Quellis Biosciences, Inc.
+Added: (Quellis) in connection with a licensing transaction.
+Added: The Company recorded the Quellis equity as securities without a readily determinable fair value, and the investment was recorded at its original cost.
+Added: In 2021, Quellis merged into Catabasis Pharmaceuticals, Inc.
+Added: (Catabasis), and the Company received 259,206 shares of common stock and 3,928 shares of preferred stock in Catabasis in exchange for its Quellis equity.
+Added: In June 2021, 3,581 shares of the Catabasis preferred stock were exchanged for 3,580,539 shares of Catabasis common stock.
+Added: The total 3,839,745 shares of the Catabasis common stock have a readily determinable fair value.
+Added: In August 2021, Catabasis effected a reverse stock split of its shares of common stock at a ratio of 1 :6, and in September 2021, Catabasis changed its name to Astria Therapeutics, Inc.
+Added: The adjustment in the fair value of the Astria common stock has been recorded in unrealized gain (loss) on equity securities for the year ended December 31, 2021.
+Added: The Company records its investment in the shares of Astria preferred stock as an equity interest without a readily determinable fair value.
+Added: The Company elected to record the original 3,928 shares of preferred stock at their initial cost of $ 12.1 million and to review the carrying value for impairment or other changes in carrying value at each reporting period.
+Added: After the conversion of 3,581 shares of Astria preferred stock to common stock in June 2021, the Company owned 347 shares of preferred stock and continued to carry the shares at their original cost of $ 1.1 million.
+Added: The Company subsequently recorded impairment charges of $ 0.8 million related to its investment in Astria’s preferred stock.
+Added: In 2017, the Company received 1,585,000 shares of common stock of INmune Bio, Inc.
+Added: (INmune) and an option to acquire an additional 10 % of INmune’s outstanding shares of common stock in connection with a licensing transaction.
+Added: The Company also received an option to acquire 108,000 shares of INmune common stock in connection with a designee appointed by us serving on the board of directors of INmune.
+Added: The Company initially recorded its equity interest, including its option to acquire additional equity in INmune, at cost pursuant to ASC 323, Investments – Equity Method and Joint Ventures .
+Added: In June 2021, the Company entered into an Option Cancellation Agreement with INmune and received $ 15.0 million in proceeds and an additional 192,533 shares of INmune common stock in exchange for the option to acquire 10 % of INmune.
+Added: During the three-month period ended June 30, 2021, the Company determined that it should no longer account for its investment in INmune under the equity method.
+Added: In September 2021, the Company exercised its option to purchase 108,000 shares of INmune common stock for $ 0.8 million and the Company recorded a gain of $ 0.9 million on the purchase.
+Added: The 1,885,533 shares of INmune common stock have a readily determinable fair value, and the adjustment in the fair value of the shares of INmune common stock was recorded in gain (loss) on equity securities for the year ended December 31, 2021.
+Added: In December 2020, the Company received 322,407 shares of common stock of Viridian Therapeutics, Inc.
+Added: (Viridian) in connection with the Viridian Agreement (defined below).
+Added: In December 2021, the Company received an additional 394,737 shares of common stock of Viridian in connection with the Second Viridian Agreement (defined below).
+Added: The shares of Viridian common stock are classified as equity securities with a readily determinable fair value and the adjustment in the fair value of the shares of Viridian common stock was recorded in gain (loss) on equity securities for the year ended at December 31, 2021.
+Added: In 2020, the Company received an equity interest in Zenas BioPharma Limited (Zenas), in connection with the Zenas Agreement (defined below).
+Added: The Company elected the measurement alternative to carry the Zenas equity at cost minus impairment, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer.
+Added: In 2021, the Company received a warrant to receive equity from Zenas in connection with the Second Zenas Agreement (defined below).
+Added: During the year ended December 31, 2021, there have not been any impairment or observable price changes related to this investment.
+Added: Unrealized gains and losses recognized on equity securities (in thousands) during the year ended December 31, 2021 and 2020 consist of the following:
Year Ended December 31,
1 unchanged sentence
net gains recognized on equity securities redeemed
−Removed: Unrealized losses recognized on equity securities
+Added: Unrealized gain (losses) recognized on equity securities
Sale of Additional Common Stock
−Removed: In March 2018, we completed the sale of 8,395,000 shares of commons stock which included shares we issued pursuant to our underwriters’ exercise of their over-allotment option pursuant to a follow-on financing.
−Removed: We received net proceeds of $245.5 million, after underwriters’ discounts and offering expenses.
+Added: Under the terms of the Stock Purchase Agreement (defined below), Johnson & Johnson Innovation, JJDC, Inc.
+Added: (JJDC), purchased $ 25.0 million of newly issued unregistered shares of the Company’s common stock, priced at a 30 -day volume-weighted average price of $ 33.4197 per share as of October 1, 2021.
+Added: The Company issued 748,062 shares of common stock to JJDC on November 12, 2021.
+Added: The issued shares are subject to customary resale restrictions pursuant to Rule 144 of the Securities Act of 1933.
Property and Equipment
4 unchanged sentences
Leasehold and tenant improvements
+Added: Total gross carrying amount
Less accumulated depreciation and amortization
+Added: Total property and equipment, net
Depreciation expense related to property and equipment in 2021, 2020, and 2019 was $ 6.3 million, $ 4.7 million, and $ 3.4 million, respectively.
8 unchanged sentences
Stock-based compensation
+Added: Change in state rate
Net change in valuation allowance
−Removed: Income tax provision (benefit)
+Added: Income tax provision
The tax effect of temporary differences that give rise to a significant portion of the deferred tax assets and liabilities at December 31, 2021 and 2020 is presented below (in thousands):
3 unchanged sentences
Unrealized loss on securities
+Added: Capitalized lease assets
Accrued compensation
18 unchanged sentences
The Company’s net deferred income tax asset is not more likely than not to be realized due to the lack of sufficient sources of future taxable income and cumulative losses that have resulted over the years.
−Removed: During the year ended December 31, 2020, the valuation allowance increased by $ 28.6 million.
+Added: During the year ended December 31, 2021, the valuation allowance decreased by $ 12.4 million.
The Company’s tax years starting in 2017 through 2020 remain open to potential examination by the U.S.
3 unchanged sentences
Our federal net operating loss carryforwards expire starting in 2026, state net operating loss carryforwards expire starting in 2035, and federal tax credit carryforwards began to expire in 2019.
−Removed: A total of $ 0.03 million in federal tax credits expired in 2019, and an additional $ 0.3 million will expire over the next five years if not utilized.
+Added: A total of $ 0.5 million in federal tax credits will expire over the next four years if not utilized.
Utilization of our net operating loss and tax credit carryforwards are subject to a substantial annual limitation under Section 382 of the Code due to the fact that we have experienced ownership changes.
12 unchanged sentences
As of December 31, 2021, the Company has awarded 1,124,487 RSUs to certain employees pursuant to the 2013 Plan.
−Removed: Vesting of these awards will be in three equal annual installments and is contingent on continued employment terms.
+Added: Vesting of these awards will be annually over equal installments, either a two or three-year vesting period, and is contingent on continued employment terms.
The fair value of these awards is determined based on the intrinsic value of the stock on the date of grant and will be recognized as stock-based compensation expense over the requisite service period.
5 unchanged sentences
We have reserved a total of 581,286 shares of common stock for issuance under the ESPP.
−Removed: Unless otherwise determined by our Board, beginning on January 1, 2014, and continuing until the expiration of the ESPP, the total number shares of common stock available for issuance under the ESPP will automatically increase annually on January 1 by the lesser of (i) 1 % of the total number of issued and outstanding shares of common stock as of December 31 of the immediately preceding year, or (ii) 621,814 shares of common stock.
+Added: Unless otherwise determined by our Board, beginning on January 1, 2014, and continuing until the expiration of the ESPP, the total number shares of common stock available for issuance under the ESPP will automatically increase annually on January 1 by the lesser of (i) 1 % of the total number of issued and outstanding shares of common stock as of December 31 of the
+Added: immediately preceding year, or (ii) 621,814 shares of common stock.
On January 1, 2014, the total number of shares of common stock available for issuance under the ESPP was automatically increased by 313,545 shares, which is included in the number of shares reserved for issuance above.
72 unchanged sentences
The expected stock price volatility for our stock options for the years ended December 31, 2021, 2020, and 2019 was determined using a blended volatility by examining the historical volatility for industry peer companies and the volatility of our stock from the effective date that our shares were publicly traded on a national stock exchange.
−Removed: For the year ended December 31, 2018, expected stock volatility was determined by examining the historical volatilities for industry peers and adjusting for differences in our life cycle and financing leverage.
−Removed: Industry peers consist of several public companies in the biopharmaceutical industry.
We determined the average expected life of stock options based on the anticipated time period between the measurement date and the exercise date by examining the option holders’ past exercise patterns.
13 unchanged sentences
The remaining unamortized compensation expense will be recognized over the next 1.95 years.
−Removed: The Company leases office and laboratory space in Monrovia, CA under a lease that expired in June 2020.
−Removed: In April 2020 and in September 2020, the Company entered into amendments to the lease to extend the term of the lease under the original terms through October 2020.
−Removed: In November 2020, the Company entered into an amended lease for the space, which includes a 62-month term with an option to renew for an additional five years at then market rates.
−Removed: In July 2017, the Company entered into an amended lease agreement for additional space in the same building with a lease that continues through September 2022, also with an option to renew for an additional five years .
−Removed: The Company assesses that it is likely to exercise both options of the lease term extensions.
−Removed: The Company also leased office space in San Diego, CA through July 2020 which included an option to renew for an additional five years .
−Removed: The lease expired and the Company did not exercise its option to extend the lease.
−Removed: The Company leases additional office space in San Diego, CA through August 2022, with an option to extend for an additional five years .
−Removed: The Company assesses that it is unlikely to exercise the option to extend the lease term.
+Added: The Company leases office and laboratory space in Monrovia, California under a lease that expires in December 2025 with an option to renew for an additional five years at then market rates.
+Added: In July 2017, under a separate lease agreement, the Company entered into a lease for additional space in the same building with a lease that continues through September 2022, also with an option to renew for an additional five years .
+Added: The Company has assessed that it is unlikely to exercise either of the lease term extension options.
+Added: The Company leases additional office space in San Diego, California through August 2022, with an option to extend for an additional five years .
+Added: The Company has assessed that it is unlikely to exercise the option to extend the lease term.
+Added: In June 2021, the Company entered into an Agreement of Lease (the Halstead Lease) relating to 129,543 rentable square feet, for laboratory and office space, in Pasadena, California, where the Company intends to move its corporate headquarters in the second half of 2022.
+Added: The term of the Halstead Lease will become effective in two phases.
+Added: The first phase commences on July 1, 2022 and encompasses 83,083 square feet while the second phase commences no later than September 30, 2026 and encompasses an additional 46,460 square feet.
+Added: The term of the Halstead Lease is 13 years from the first phase commencement date.
+Added: The Company received delivery of the first phase premises on July 1, 2021 and is scheduled to complete construction of office, laboratory, and related improvements in the second half of 2022.
+Added: The Halstead Lease provides the Company with improvement allowances of up to $ 17,032,015 and $ 3,252,000 in connection with the Phase 1 and Phase 2 building improvements, respectively.
+Added: The initial base monthly rent is $ 386,335.95 , or $ 4.65 per square foot, and includes increases of three percent annually.
+Added: The Company will also be responsible for its proportionate share of operating expenses, tax expense, and utility costs.
+Added: In July 2021, the Halstead Lease was amended to clarify the start date of the new lease as August 1, 2022 and to amend other provisions of the Halstead Lease to reflect the new start date of the lease.
+Added: For the year ended December 31, 2021, ROU assets obtained in exchange for new operating lease liabilities are $ 29.7 million.
+Added: In June 2021, the Company entered into an 18-month lease for a 7,020 -square-foot office space in Monrovia, California.
+Added: The lease began on August 1, 2021, and the initial base monthly rent is $ 15,000.00 .
+Added: The Company received delivery of the premises on July 19, 2021.
+Added: For the year ended December 31, 2021, ROU assets obtained in exchange for new operating lease liabilities are $ 0.3 million.
The Company’s lease agreements do not contain any residual value guarantees or restrictive covenants.
−Removed: As of December 31, 2020, the Company did not have additional operating leases that have not yet commenced.
The following table reconciles the undiscounted cash flows for the operating leases at December 31, 2021 to the operating lease liabilities recorded on the balance sheet (in thousands):
1 unchanged sentence
Total undiscounted lease payments
+Added: Tenant allowance
Imputed interest
Present value of lease payments
−Removed: Lease liabilities - short-term
Lease liabilities - long-term
−Removed: Total lease liabilities
−Removed: The following table summarizes lease costs and cash disclosures for the years ended December 31, 2020 and 2019 (in thousands):
+Added: The following table summarizes lease costs, cash, and other disclosures for the years ended December 31, 2021, 2020, and 2019 (in thousands):
Operating lease cost
3 unchanged sentences
the measurement of lease liabilities
−Removed: Rent expense for the year ended December 31, 2018 was $ 2.5 million.
−Removed: The 2020 lease amendments to the Monrovia, CA lease are lease modifications.
−Removed: Non-cash activities involving right of use assets related to the lease modification were $ 3.1 million.
−Removed: At December 31, 2020 and 2019, the weighted-average remaining lease terms for operating leases were 7.4 years and 5.5 years, respectively, and the weighted average discount rates for operating leases were both 5.5 %.
+Added: Weighted-average remaining lease term
+Added: —operating leases (in years)
+Added: Weighted-average discount rate
+Added: —operating leases
Commitments and Contingencies
14 unchanged sentences
The revenue reported for each agreement has been adjusted to reflect the adoption of ASC 606 for each period presented.
−Removed: Janssen Biotech, Inc.
−Removed: In November 2020, the Company entered into a Collaboration and License Agreement (the Janssen Agreement) with Janssen Biotech, Inc.
−Removed: (Janssen) pursuant to which Xencor and Janssen will conduct research and development activities to discover novel CD28 bispecific antibodies for the treatment of prostate cancer.
−Removed: Janssen and Xencor will conduct joint research activities for up to a three-year period to discover XmAb bispecific antibodies against CD28 and against an undisclosed prostate tumor-target with Janssen maintaining exclusive worldwide rights to develop and commercialize Licensed Products identified from the research activities.
−Removed: Under the Janssen Agreement, the Company will conduct research activities and apply its bispecific Fc technology to antibodies targeting prostate cancer provided by Janssen.
−Removed: Upon completion of the research activities Janssen will have a candidate selection option to advance an identified candidate for development and commercialization.
−Removed: The activities will be conducted under a research plan agreed to by both parties.
−Removed: Janssen will assume full responsibility for development and commercialization of the CD28 bispecific antibody candidate.
−Removed: Pursuant to the Janssen Agreement, the Company received an upfront payment of $ 50.0 million and is eligible to receive up to $ 662.5 million in milestones which include $ 161.9 million in development milestones, $ 240.6 million in regulatory milestones and $ 260.0 million in sales milestones.
−Removed: If commercialized, the Company is eligible to receive royalties on net sales that range from the high-single to low-double digit percentages.
−Removed: Pursuant to the Janssen Agreement, upon development of a bispecific candidate by Janssen through proof of concept, we have the right to opt-in to fund 20 % of development costs and to perform 30 % of detailing efforts in the U.S.
−Removed: If we exercise this right, we will be eligible to receive tiered royalties in the low-double digit to mid-teen percentage range.
−Removed: We evaluated the Janssen Agreement under ASC 606 and identified the performance obligation under the Agreement to be delivery of CD28 bispecific antibodies to Janssen from the research activities outlined in the research
−Removed: The Company determined that the license to the bispecific antibodies is not a separate performance obligation because it is not capable of being distinct, the license to the antibodies cannot be separated from the underlying antibodies.
−Removed: Janssen will benefit from delivery of the bispecific antibodies upon completion of the research activities.
−Removed: The Company determined that the transaction price of the Janssen Agreement at inception was $ 50.0 million consisting of the upfront payment.
−Removed: The potential milestones are not included in the transaction price as these are contingent on future events and the Company would not recognize these in revenue until it is not probable that these would not result in significant reversal of revenue amounts in future periods.
−Removed: The candidate selection option payment is substantive and is a separate performance obligation.
−Removed: The Company will re-assess the transaction price at each reporting period and when event outcomes are resolved or changes in circumstances occur.
−Removed: The Company allocated the transaction price to the single performance obligation, delivery of CD28 bispecific antibodies to Janssen.
−Removed: The Company will recognize the $ 50.0 million transaction price as it satisfies its performance obligation to deliver CD28 bispecific antibodies to Janssen.
−Removed: The Company will recognize revenue related to the performance obligation over the expected period of time to complete and deliver the CD28 bispecific antibodies to Janssen using the expected input method which considers an estimate of the Company’s efforts to complete the research activities outlined in the Janssen Agreement.
−Removed: No revenue was recognized under this arrangement for the year ended December 31, 2020, and there is $ 50.0 million in deferred revenue as of December 31, 2020 related to our obligation to complete research activities and deliver CD28 bispecific antibodies under the Janssen Agreement.
Aimmune Therapeutics, Inc.
13 unchanged sentences
The Company determined that the transaction price is to be allocated to the performance obligations.
−Removed: The Aimmune Agreement includes variable consideration for potential future milestones and royalties that are contingent on future success factors for the XmAb7195 program.
+Added: The Aimmune Agreement includes variable consideration for potential future milestones and royalties that are contingent on future
+Added: success factors for the XmAb7195 program.
The Company used the “most likely amount” method to determine the variable consideration.
4 unchanged sentences
The license to XmAb7195 was transferred to Aimmune at inception of the Aimmune Agreement, and the XmAb7195 data were transferred to Aimmune in March 2020.
+Added: No revenue was recognized for the year ended December 31, 2021;
the Company recognized $ 9.6 million of revenue related to the agreement for the year ended December 31, 2020.
+Added: There is no deferred revenue as of December 31, 2021 or 2020 related to this agreement.
+Added: Alexion Pharmaceuticals, Inc.
+Added: In January 2013, the Company entered into an option and license agreement with Alexion Pharmaceuticals, Inc.
+Added: Under the terms of the agreement, the Company granted to Alexion an exclusive research license, with limited sublicensing rights, to make and use our Xtend technology.
+Added: Alexion exercised its rights to include our technology in ALXN1210, which is now marketed as Ultomiris.
+Added: The Company is eligible to receive contractual milestones for certain commercial achievements, and the Company is also entitled to receive royalties based on a percentage of net sales of such products sold by Alexion, its affiliates, or its sub licensees, which percentage is in the low single digits.
+Added: Alexion’s royalty obligations continue on a product-by-product and country-by-country basis until the expiration of the last-to-expire valid claim in a licensed patent covering the applicable product in such country.
+Added: In 2019, Alexion completed certain regulatory submissions for Ultomiris, and the Company received a total of $ 8.0 million in milestone payments.
+Added: During 2019, the Company also recorded royalty revenue of $ 5.0 million in connection with reported net sales of Ultomiris by Alexion.
+Added: In 2020, the Company received $ 10.0 million for the achievement of certain sales milestones of Ultomiris in 2020 and also recorded royalty revenue of $ 16.2 million on net sales.
+Added: In 2021, the Company recorded royalty revenue of $ 22.2 million on net sales.
+Added: The total revenue recognized under this arrangement was $ 22.2 million, $ 26.2 million, and $ 13.0 million for the years ended December 31, 2021, 2020, and 2019, respectively.
+Added: As of December 31, 2021, there is a receivable of $ 10.8 million, and there is no deferred revenue related to this agreement.
+Added: In September 2015, the Company entered into a research and license agreement (the Amgen Agreement) with Amgen Inc.
+Added: (Amgen) to develop and commercialize bispecific antibody product candidates using the Company’s proprietary XmAb® bispecific Fc technology.
+Added: The Company also agreed to apply its bispecific technology to five previously identified Amgen provided targets (each a Discovery Program).
+Added: Amgen has advanced one of the discovery programs into clinical development.
+Added: The Company is eligible to receive up to $ 255.0 million in future development, regulatory and sales milestones in total for the program and is eligible to receive royalties on any global net sales of products.
+Added: In the third quarter of 2019, a $ 5.0 million milestone was recognized in connection with a development milestone for a Discovery Program.
+Added: During the year ended December 31, 2019, the Company recognized $ 5.0 million in revenue under this arrangement.
+Added: No revenue was recognized for the year ended December 31, 2021, or 2020.
+Added: As of December 31, 2021, there was no deferred revenue related to the arrangement.
+Added: Astellas Pharma Inc.
+Added: Effective March 29, 2019, the Company entered into a Research and License Agreement (Astellas Agreement) with Astellas Pharma Inc.
+Added: (Astellas) pursuant to which the Company and Astellas conducted a discovery program to characterize compounds and products for development and commercialization.
+Added: Under the Astellas Agreement, Astellas was granted a worldwide exclusive license, with the right to sublicense products in the field created by the research activities.
+Added: Pursuant to the Astellas Agreement, the Company applied its bispecific Fc technology to research antibodies provided by Astellas to generate bispecific antibody candidates and returned the candidates to Astellas for further development and commercialization.
+Added: Astellas will assume full responsibility for development and commercialization of the antibody candidate.
+Added: Pursuant to the Astellas Agreement, the Company received an upfront payment of $ 15.0 million and is eligible to receive up to $ 240.0 million in milestones, which include $ 32.5 million in development milestones, $ 57.5 million in regulatory milestones and $ 150.0 million in sales milestones.
+Added: If commercialized, the Company is eligible to receive royalties on net sales that range from the high-single to low-double digit percentages.
+Added: Astellas has advanced an antibody that was delivered into development, and we received a milestone related to the candidate in 2020.
+Added: The Company recognized the $ 13.6 million of revenue in 2019 and recognized $ 2.5 million related to the milestone in 2020.
+Added: The $ 1.4 million allocated to the research activities was recognized as the research services were completed.
+Added: No revenue was recognized for the year ended December 31, 2021.
+Added: We recognized $ 3.5 million and $ 14.0 million of revenue under this arrangement for the years ended December 31, 2020 and 2019, respectively.
+Added: There is no deferred revenue as of December 31, 2021.
+Added: Astria Therapeutics, Inc.
+Added: In May 2018, the Company entered into an agreement with Quellis, pursuant to which the Company provided Quellis a non-exclusive license to its Xtend Fc technology to apply to an identified antibody.
+Added: Quellis is responsible for all development and commercialization activities.
+Added: The Company received an equity interest in Quellis and is eligible to receive up to $ 66.0 million in milestones, which include $ 6.0 million in development milestones, $ 30.0 million in regulatory milestones and $ 30.0 million in sales milestones.
+Added: In addition, the Company is eligible to receive royalties in the mid-single digit percentage range on net sales of approved products.
+Added: In January 2021, Quellis merged into Catabasis, and the Company received common stock and preferred stock of Catabasis in exchange for its equity in Quellis.
+Added: The Company recognized an increase in the fair value of its equity interest for the exchange of shares, which was recorded as unrealized gain for the three months ended March 31, 2021.
+Added: In June 2021, a portion of the Company’s preferred stock in Catabasis was converted to common stock, which was recorded at its fair value as of June 30, 2021.
+Added: The remaining Catabasis preferred stock is carried at its original cost and is reviewed for impairment or other changes at each reporting period.
+Added: In August 2021, Catabasis effected a reverse stock split of its shares of common stock at a ratio of 1 :6, and in September 2021, Catabasis changed its name to Astria.
+Added: The Company recorded an impairment charge of $ 0.8 million for its investment in Astria preferred stock for the year ended December 31, 2021.
+Added: The Company recognized unrealized gain of $ 4.5 million related to its equity interest in Astria for the year ended December 31, 2021.
There is no deferred revenue as of December 31, 2021 related to this agreement.
+Added: Bristol-Myers Squibb Company
+Added: In May 2021, the Company entered into a Technology License Agreement (the BMS Agreement ) with Bristol-Myers Squibb Company (BMS) pursuant to which the Company provided a non-exclusive license to its Xtend technology to extend the half-life of antibodies that specifically bind to SARS-CoV-2.
+Added: Under the terms of the BMS Agreement, BMS is responsible for all research, development, regulatory and commercial activities for antibodies, and the Company is eligible to receive royalties on net sales of approved products in the low-single digit percentage range.
+Added: BMS initiated a Phase 2 study with a licensed antibody to treat patients with COVID-19 in the third quarter of 2021.
+Added: No revenue was recognized for the year ended December 31, 2021.
+Added: There is no deferred revenue as of December 31, 2021 related to this agreement.
+Added: Genentech, Inc., and F.
+Added: Hoffmann-La Roche Ltd.
In February 2019, the Company entered into a collaboration and license agreement (the Genentech Agreement) with Genentech, Inc.
2 unchanged sentences
Genentech and Xencor will jointly collaborate on worldwide development of XmAb306 and potentially other Collaboration Products.
+Added: The two-year research term expired in March 2021.
The Company received a $ 120.0 million upfront payment and is eligible to receive up to an aggregate of $ 160.0 million in clinical milestone payments for XmAb306 and up to $ 180.0 million in clinical milestone payments for each new Collaboration Product.
3 unchanged sentences
Pursuant to the Genentech Agreement, XmAb306 is designated as a development program and all costs incurred for developing both XmAb306 is being shared with Genentech under the initial cost-sharing percentage.
−Removed: Under the Genentech Agreement, the Company and Genentech will conduct joint research activities for a two-year period to identify and discover additional IL-15 candidates developed from the Company’s cytokine and bispecific technologies.
−Removed: The two-year research term may be extended an additional year if both parties agree.
−Removed: The Company and Genentech are each responsible for their own costs in conducting the research activities.
−Removed: The Company is eligible for clinical milestone payments for new Collaboration Products identified from the research efforts.
The Company evaluated the Genentech Agreement under the provisions of ASU No.
3 unchanged sentences
The Company identified the following performance obligations under the Genentech Agreement:
−Removed: (i) the license of XmAb306 and (ii) research services during a two-year period to identify up to potentially nine additional IL-15 candidates, each a separate research program and a separate performance obligation.
−Removed: The Company determined that the license and each of the potential research programs are separate performance obligations because they are capable of being distinct and are distinct in the context of the Genentech Agreement.
+Added: (i) the license of XmAb306 and (ii) research services during a two-year period, which expired in March 2021, to identify additional IL-15 candidates, each a separate research program and a separate performance obligation.
+Added: The Company determined that the license and each of the potential research programs are separate performance obligations because they were capable of being distinct in the context of the Genentech Agreement.
The license to XmAb306 has standalone functionality as Genentech has exclusive worldwide rights to the program, including the right to sublicense to third parties.
Upon the transfer of the license of XmAb306, Genentech could develop and commercialize XmAb306 without further assistance from the Company.
−Removed: The Company determined that the research services for each potential additional IL-15 candidate and research program were separate standalone performance obligations.
−Removed: The Genentech Agreement provides an outline of an integrated research plan for the programs to be conducted by the two companies, and the research activities are separate and distinct from the license to XmAb306.
−Removed: In October 2020, an additional program was declared a Collaboration Program under the Agreement, and the Company completed its performance obligation for that specific research program as the program and licensed rights were transferred to Genentech.
+Added: The Company determined that the research services for a potential additional IL-15 candidate and research program were separate standalone performance obligations.
+Added: The Genentech Agreement provided an outline of an integrated research plan for the programs to be conducted by the two companies, and the research activities were separate and distinct from the license to XmAb306.
+Added: In October 2020, an additional program was declared a Collaboration Program under the Agreement, and the Company completed its performance obligation for that specific
+Added: research program as the program and licensed rights were transferred to Genentech.
The Company determined the standalone selling price of the license to be $ 114.4 million using the adjusted market assessment approach considering similar collaboration and license agreements and transactions.
−Removed: The standalone selling price for the research activities for all nine of the potential IL-15 programs to be performed during the research term was determined to be $ 8.5 million using the expected cost approach which was derived from the Company’s experience and information from providing similar research activities to other parties.
−Removed: The Company determined that the transaction price of the Genentech Agreement at inception was $ 120.0 million consisting of the upfront payment.
+Added: The standalone selling price for the research activities to be performed during the research term was determined to be $ 8.5 million using the expected cost approach which was derived from the Company’s experience and information from providing similar research activities to other parties.
+Added: The Company determined that the transaction price of the Genentech Agreement at inception was $ 120.0 million consisting of the upfront payment, and allocated the transaction price to each of the separate performance obligations using the relative standalone selling price with $ 111.7 million allocated to the license to XmAb306, $ 4.1 million allocated to the additional program and $ 4.2 million allocated to the research services.
+Added: The Company recognized the $ 111.7 million allocated to the license when it satisfied its performance obligation and transferred the license to Genentech in March 2019, and the $ 8.3 million allocated to the research activities was recognized over a period of time through the end of the research term or the time that a program is delivered to Genentech.
+Added: The research term expired in the first half of 2021, and the balance in deferred revenue related to the Genentech Agreement was recognized as the Company is no longer required to render services.
+Added: A total of $ 2.5 million, $ 3.5 million, and $ 2.2 million of revenue related to the research activities was recognized for the years ended December 31, 2021, 2020, and 2019, respectively.
+Added: For the years ended December 31, 2021, 2020, and 2019, we recognized $ 2.5 million, $ 3.5 million, and $ 113.9 million of income, respectively from the Genentech Agreement.
+Added: As of December 31, 2021, there is a $ 2.2 million payable related to cost-sharing development activities during the fourth quarter of 2021.
+Added: There is no deferred revenue as of December 31, 2021.
+Added: Gilead Sciences, Inc.
+Added: In January 2020, the Company entered into a Technology License Agreement (the Gilead Agreement) with Gilead Sciences, Inc.
+Added: (Gilead), in which the Company provided Gilead an exclusive license to its Cytotoxic Fc and Xtend Fc technologies for an initial identified antibody and options for up to three additional antibodies directed to the same molecular target.
+Added: Gilead is responsible for all development and commercialization activities for all target candidates.
+Added: The Company received an upfront payment of $ 6.0 million and is eligible to receive up to $ 67.0 million in milestones, which include $ 10.0 million in development milestones, $ 27.0 million in regulatory milestones and $ 30.0 million in sales milestones for each product incorporating the antibodies selected.
+Added: In addition, the Company is eligible to receive royalties in the low-single digit percentage range on net sales of approved products.
+Added: In the second quarter of 2020, Gilead exercised options on three additional antibody compounds, and in April 2020, we received a total of $ 7.5 million in payment of the three options.
+Added: The total transaction price is $ 13.5 million which includes the upfront payment of $ 6.0 million and the option fee payment of $ 7.5 million which was contractually due with the exercise of the three options by Gilead.
+Added: The milestone payments are variable consideration to which the Company applied the “most likely amount” method and concluded at inception of the Gilead Agreement it is unlikely that the Company will collect such payments.
+Added: The milestone payments were not included in the transaction price, and the Company will review this conclusion and update at each reporting period.
+Added: No revenue was recognized for the year ended December 31, 2021.
+Added: The Company recognized $ 13.5 million of revenue related to the Gilead Agreement for the year ended December 31, 2020.
+Added: There is no deferred revenue as of December 31, 2021 related to this agreement.
+Added: INmune Bio, Inc.
+Added: In October 2017, the Company entered into a License Agreement (the INmune Agreement) with INmune.
+Added: Under the terms of the INmune Agreement, the Company provided INmune with an exclusive license to certain rights to a proprietary protein, XPro1595.
+Added: In connection with the agreement the Company received 1,585,000 shares of INmune common stock and an option to acquire additional shares of INmune.
+Added: The Company also received an option to acquire 108,000 shares of INmune common stock with a designee appointed by us serving on the board of directors of INmune.
+Added: The option had a six-year term from the date of the INmune Agreement and provided the Company the option to purchase up to 10 % of the fully diluted outstanding shares of INmune common stock for $ 10.0 million.
+Added: The Company initially recorded its equity interest in INmune, including its option to acquire additional INmune shares, at cost pursuant to ASC 323.
+Added: In June 2021, the Company entered into the First Amendment to License Agreement (the Amended INmune Agreement) and an Option Cancellation Agreement (the Option Agreement) with INmune.
+Added: The Amended INmune Agreement modified certain diligence provisions in the INmune Agreement with no change in total consideration or performance obligations.
+Added: The Option Agreement provided for the sale of the option to INmune for the total consideration of $ 18.3 million which includes $ 15.0 million in cash and $ 3.3 million in additional shares of INmune common stock, which represented an additional 192,533 shares of INmune common stock.
+Added: The Company recorded a realized gain of $ 18.3 million according to ASC 860, Transfer and Servicing , and recorded the additional investment of 192,533 shares of INmune common stock according to ASC 321, Investments – Equity Securities .
+Added: During the three months ended June 30, 2021, the Company determined that it should no longer record its investment in INmune under the equity method and recorded its investment in INmune pursuant to ASC 321.
+Added: The Company adjusted the carrying value of this investment by recognizing an unrealized gain of $ 27.8 million as other income for the three months ended June 30, 2021.
+Added: In September 2021, the Company exercised its option to purchase 108,000 shares of INmune common stock for $ 0.8 million.
+Added: The Company recognized an unrealized gain of $ 2.0 million, which consists of $ 1.1 million of fair value of the option and $ 0.9 million gain on the purchase, as other income for the three months ended September 30, 2021.
+Added: For the year ended December 31, 2021, the Company recorded $ 15.1 million of unrealized gain and $ 18.3 million of realized gain related to its investment in INmune.
+Added: No revenue was recognized for the year ended December 31, 2021, 2020, or 2019.
+Added: At the inception of the INmune Agreement in 2017, INmune was a related party as a result of the Company's significant influence with respect to its investment in INmune, as determined under ASC 323.
+Added: The Company did not have any amounts due to or from INmune at December 31, 2021 or 2020.
+Added: At June 30, 2021, the Company determined that it no longer has a significant influence in INmune and that INmune is no longer a related party.
+Added: Janssen Biotech, Inc.
+Added: Janssen Agreement
+Added: In November 2020, the Company entered into a Collaboration and License Agreement (the Janssen Agreement) with Janssen Biotech, Inc.
+Added: (Janssen) pursuant to which Xencor and Janssen will conduct research and development activities to discover novel CD28 bispecific antibodies for the treatment of prostate cancer.
+Added: Janssen and Xencor will conduct joint research activities for up to a three-year period to discover XmAb bispecific antibodies against CD28 and against an undisclosed prostate tumor-target with Janssen maintaining exclusive worldwide rights to develop and commercialize Licensed Products identified from the research activities.
+Added: Under the Janssen Agreement, the Company will conduct research activities and apply its bispecific Fc technology to antibodies targeting prostate cancer provided by Janssen.
+Added: Upon completion of the research activities Janssen will have a candidate selection option to advance an identified candidate for development and commercialization.
+Added: The activities will be conducted under a research plan agreed to by both parties.
+Added: Janssen will assume full responsibility for development and commercialization of the CD28 bispecific antibody candidate.
+Added: Pursuant to the Janssen Agreement, the Company received an upfront payment of $ 50.0 million and is eligible to receive up to $ 662.5 million in milestones which include $ 161.9 million in development milestones, $ 240.6 million in regulatory milestones and $ 260.0 million in sales milestones.
+Added: If commercialized, the Company is eligible to receive royalties on net sales that range from the high-single to low-double digit percentages.
+Added: Pursuant to the Janssen Agreement, upon development of a bispecific candidate by Janssen through proof of concept, we have the right to opt-in to fund 20 % of development costs and to perform 30 % of detailing efforts in the U.S.
+Added: If we exercise this right, we will be eligible to receive tiered royalties in the low-double digit to mid-teen percentage range.
+Added: We evaluated the Janssen Agreement under ASC 606 and identified the performance obligation under the Agreement to be delivery of CD28 bispecific antibodies to Janssen from the research activities outlined in the research plan.
+Added: The Company determined that the license to the bispecific antibodies is not a separate performance obligation because it is not capable of being distinct, the license to the antibodies cannot be separated from the underlying antibodies.
+Added: Janssen will benefit from delivery of the bispecific antibodies upon completion of the research activities.
+Added: The Company determined that the transaction price of the Janssen Agreement at inception was $ 50.0 million consisting of the upfront payment.
The potential milestones are not included in the transaction price as these are contingent on future events and the Company would not recognize these in revenue until it is not probable that these would not result in significant reversal of revenue amounts in future periods.
+Added: The candidate selection option payment is substantive and is a separate performance obligation.
The Company will re-assess the transaction price at each reporting period and when event outcomes are resolved or changes in circumstances occur.
−Removed: The Company allocated the transaction price to each of the separate performance obligations using the relative standalone selling price with $ 111.7 million allocated to the license to XmAb306, $ 4.1 million allocated to the additional program and $ 4.2 million allocated to the research services.
−Removed: The Company recognized the $ 111.7 million allocated to the license when it satisfied its performance obligation and transferred the license to Genentech in March 2019.
−Removed: The license was transferred upon the effective date of the Genentech Agreement, and the $ 8.3 million allocated to the research activities is being recognized over a period of time through the end of the research term or the time that a program is delivered to Genentech.
−Removed: A total of $ 3.5 million and $ 2.2 million of revenue related to the research activities was recognized for the years ended December 31, 2020 and December 31, 2019, respectively.
−Removed: For the years ended December 31, 2020 and December 31, 2019, we recognized $ 3.5 million and $ 113.9 million of income, respectively from the Genentech Agreement.
−Removed: As of December 31, 2020, there is a $ 3.2 million payable related to cost-sharing development activities during the fourth quarter of 2020.
−Removed: There is $ 2.5 million in deferred revenue as of December 31, 2020 which reflects our obligation to perform research services during the remaining research term.
−Removed: Effective March 29, 2019, the Company entered into a Research and License Agreement (Astellas Agreement) with Astellas Pharma Inc.
−Removed: (Astellas) pursuant to which the Company and Astellas will conduct a discovery program to characterize compounds and products for development and commercialization.
−Removed: Under the Astellas Agreement, Astellas was granted a worldwide exclusive license, with the right to sublicense products in the field created by the research activities.
−Removed: Pursuant to the Astellas Agreement, the Company applied its bispecific Fc technology to research antibodies provided by Astellas to generate bispecific antibody candidates and returned the candidates to Astellas for further development and commercialization.
−Removed: The activities were conducted under a research plan agreed to by both parties to the Astellas Agreement.
−Removed: Astellas will assume full responsibility for development and commercialization of the antibody candidate.
−Removed: Pursuant to the Astellas Agreement, the Company received an upfront payment of $ 15.0 million and is eligible to receive up to $ 240.0 million in milestones, which include $ 32.5 million in development milestones, $ 57.5 million in regulatory milestones and $ 150.0 million in sales milestones.
+Added: The Company allocated the transaction price to the single performance obligation, delivery of CD28 bispecific antibodies to Janssen.
+Added: The Company will recognize the $ 50.0 million transaction price as it satisfies its performance obligation to deliver CD28 bispecific antibodies to Janssen.
+Added: The Company will recognize revenue related to the performance obligation over the expected period of time to complete and deliver the CD28 bispecific antibodies to Janssen using the expected input method which considers an estimate of the Company’s efforts to complete the research activities outlined in the Janssen Agreement.
+Added: In November 2021, the Company completed its performance obligations under the research activities and delivered CD28 bispecific antibodies to Janssen.
+Added: In December 2021, Janssen selected a bispecific CD28 candidate for further development, and we received a milestone of $ 5.0 million.
+Added: For the year ended December 31, 2021 the Company recognized as revenue the $ 50.0 million transaction price in connection with the completion of the research activities and the $ 5.0 million milestone for selection of an antibody candidate by Janssen.
+Added: Second Janssen Agreement
+Added: On October 1, 2021, the Company entered into a second Collaboration and License Agreement (the Second Janssen Agreement) with Janssen pursuant to which the Company granted Janssen an exclusive worldwide license to develop, manufacture, and commercialize plamotamab, the Company’s CD20 x CD3 development candidate, and pursuant to which Xencor and Janssen will conduct research and development activities to discover novel CD28 bispecific antibodies.
+Added: The parties will conduct joint research activities for up to a two-year period to discover XmAb bispecific antibodies against CD28 and undisclosed B cell tumor-targets with Janssen receiving exclusive worldwide rights, subject to certain Xencor opt-in rights, to develop, manufacture and commercialize pharmaceutical products that
+Added: contain one or more of such discovered antibodies (CD28 Licensed Antibodies).
+Added: The Agreement became effective on November 5, 2021.
+Added: Pursuant to the Second Janssen Agreement, the Company received an upfront payment of $ 100.0 million and is eligible to receive up to $ 1,187.5 million in milestones which include $ 289.4 million in development milestones, $ 378.1 million in regulatory milestones and $ 520.0 million in sales milestones.
+Added: Under the terms of the Stock Purchase Agreement, Johnson & Johnson Innovation, JJDC, Inc.
+Added: (JJDC), agreed to purchase $ 25.0 million of newly issued unregistered shares of the Company’s common stock, priced at a 30 -day volume-weighted average price of $ 33.4197 per share as of October 1, 2021.
+Added: The Company issued JJDC 748,062 shares of its common stock which had a fair market value of $ 28.9 million when the shares were transferred.
+Added: The Company will collaborate with Janssen on further clinical development of plamotamab with Janssen and share development costs with Janssen paying 80 % and the Company paying 20 % of certain development costs.
+Added: The Company is generally responsible for conducting research activities under the Second Janssen Agreement, and Janssen is generally responsible for all development, manufacturing, and commercialization activities for CD28 Licensed Antibodies that are advanced.
+Added: Under the Second Janssen Agreement, the Company granted Janssen an exclusive worldwide right to its plamotamab program and the Company will conduct research activities and apply its CD28 bispecific Fc technology to antibodies targeting B-cells.
+Added: Upon completion of the research activities Janssen will have options to advance up to four identified candidates for development and commercialization.
+Added: The activities will be conducted under a research plan agreed to by both parties.
+Added: Janssen will assume full responsibility for development and commercialization of the CD28 bispecific antibody candidate.
If commercialized, the Company is eligible to receive royalties on net sales that range from the high-single to low-double digit percentages.
−Removed: We evaluated the Astellas Agreement under ASC 606 and identified the performance obligations under the Agreement to be (i) delivery of bispecific antibodies to Astellas from the antigen provided by Astellas and (ii) research activities against the bispecific antibodies as outlined in the research plan.
−Removed: The Company determined the standalone selling price of the bispecific deliverable to be $ 17.1 million and the standalone selling price for the research activities to be performed was determined to be $ 1.4 million.
−Removed: The Company determined that the transaction price of the Astellas Agreement is $ 17.5 million consisting of the upfront payment and an initial milestone of $ 2.5 million for Astellas initiating an IND enabling study.
−Removed: The additional milestones are not included in the transaction price as these are contingent on future events, and the Company would not recognize these in revenue until it is not probable that these would not result in significant reversal of revenue amounts in future periods.
+Added: The Company evaluated the Second Janssen Agreement under the provisions of ASC 606.
+Added: We have determined that Janssen is a customer for purposes of the delivery of specific performance obligations under the Second Janssen Agreement and applied the provisions of ASC 606 to the transaction.
+Added: The Company identified the following performance obligations under the Second Janssen Agreement:
+Added: (i) the license to the plamotamab program, and
+Added: (ii) research services during a two-year period to create up to four CD28 bispecific candidates targeting B-cell antigens.
+Added: The Company determined that the license and the research services are separate performance obligations because they are capable of being distinct and are distinct in the context of the Second Janssen Agreement.
+Added: The license to plamotamab has standalone functionality as Janssen has exclusive worldwide rights to the program, including the right to sublicense to third parties.
+Added: Janssen has significant experience and capabilities in developing and commercializing drug candidates similar to plamotamab, and Janssen is capable of performing these activities without the Company’s involvement.
+Added: Upon the transfer of the license of plamotamab and the related data and materials, Janssen could develop and commercialize plamotamab without further assistance from the Company.
+Added: The Company determined that the research services for potential CD28 candidates was a separate standalone performance obligation.
+Added: The Second Janssen Agreement provides an outline of an integrated research plan for the programs to be conducted by the two companies, and the research activities are separate and distinct from the license to plamotamab.
+Added: The Company determined the standalone selling price of the license to be $ 58.5 million using the adjusted market assessment approach considering similar collaboration and license agreements and transactions.
+Added: The standalone selling price for the research services to be performed during the research term was determined to be $ 37.6 million using the market approach which was derived from the Company’s experience and information from providing similar research services.
+Added: The Company determined that the transaction price of the Second Janssen Agreement at inception was $ 96.1 million consisting of the $ 100.0 million upfront payment reduced by the $ 3.9 million discount on the proceeds received from the sale of Company common stock to Janssen.
+Added: The potential milestones are not included in the transaction price as these are contingent on future events and the Company would not recognize these in revenue until it is not probable that these would not result in significant reversal of revenue amounts in future periods.
The Company will re-assess the transaction price at each reporting period and when event outcomes are resolved or changes in circumstances occur.
−Removed: The Company allocated the transaction price to each of the separate performance obligations using the relative standalone selling price with $ 16.1 million allocated to delivery of the bispecific antibodies and the remainder of $ 1.4 million was allocated to the research activities.
−Removed: The Company recognized the $ 13.6 million allocated to the bispecific antibodies when it satisfied its performance obligation to Astellas in 2019 and recognized $ 2.5 million related to the milestone in 2020.
−Removed: The $ 1.4 million allocated to the research activities was recognized as the research services were completed.
−Removed: We recognized $ 3.5 million and $ 14.0 million of revenue under this arrangement for the years ended December 31, 2020 and December 31, 2019, respectively.
−Removed: There is a $ 2.5 million contract asset recorded at December 31, 2020 related to a milestone.
−Removed: There is zero and $ 1.0 million in deferred revenue as of December 31, 2020 and December 31, 2019, respectively.
+Added: The Company allocated the transaction price to each of the separate performance obligations using the relative standalone selling price with $ 58.5 million allocated to the license to the plamotamab program and $ 37.6 allocated to the research services.
+Added: The Company recognized the $ 58.5 million allocated to the license when it satisfied its performance obligation and transferred the license to Janssen in November 2021.
+Added: The license was transferred upon the effective date of the Second Janssen Agreement and when the Company subsequently transferred certain data related to the program to Janssen.
+Added: The $ 37.6 million allocated to the research services is being recognized over a period of time through the end of the research term that services are rendered as we determine that the input method is the appropriate approach to recognize income for such services.
+Added: A total of $ 0.3 million of revenue related to the research services was recognized in the year ended December 31, 2021.
+Added: The Company recognized $ 113.8 million of revenue related to the two Janssen agreements for the year ended December 31, 2021.
+Added: No revenue was recognized under this arrangement for the year ended December 31, 2020.
+Added: There is $ 37.3 million in deferred revenue as of December 31, 2021 related to our obligation to complete research activities and deliver CD28 bispecific antibodies under the Second Janssen Agreement.
+Added: In June 2010, the Company entered into a Collaboration and License Agreement with MorphoSys AG (MorphoSys), which was subsequently amended in March 2012 and in 2020.
+Added: The agreement provides MorphoSys with an exclusive worldwide license to the Company’s patents and know-how to research, develop, and commercialize the Company’s XmAb5574 product candidate (subsequently renamed MOR208 and tafasitamab) with the right to sublicense under certain conditions.
+Added: If certain developmental, regulatory, and sales milestones are achieved, the Company is eligible to receive future milestone payments and royalties.
+Added: The Company recognized a total of $ 12.5 million of milestone revenue related to clinical studies and $ 5.9 million of royalty revenue on net sales of Monjuvi for the year ended December 31, 2021.
+Added: The Company recognized a total of $ 37.5 million of milestone revenue related to regulatory submission and approval of Monjuvi in the U.S, and royalties of $ 1.5 million on net sales of Monjuvi for the year ended December 31, 2020.
+Added: There was no revenue recognized under this arrangement for the year ended December 31, 2019.
+Added: As of December 31, 2021, the Company has no deferred revenue related to this agreement and has recorded a receivable of $ 1.9 million for royalties due.
+Added: Novartis Institute for Biomedical Research, Inc.
In June 2016, the Company entered into a Collaboration and License Agreement (Novartis Agreement) with Novartis Institutes for BioMedical Research, Inc.
7 unchanged sentences
In November 2019, the Company and Novartis amended the Agreement, and Novartis paid the Company $ 1.4 million in settlement of its projected remaining cost-sharing due for the plamotamab program.
−Removed: We completed delivery of a Global Discovery Program in 2017 and delivery of a second Global Discovery Program in 2018.
+Added: In August 2021, Novartis notified the Company it was terminating its rights with respect to the vibecotamab program, which will be effective in February 2022.
+Added: Under the Novartis Agreement, Novartis is responsible for its share of vibecotamab development costs through August 2022.
+Added: We completed delivery of two Global Discovery Programs under the Agreement.
In December 2019, Novartis dosed a patient in a Phase 1 study with an undisclosed bispecific antibody that is a Global Discovery Program, and we received a $ 10.0 million milestone payment.
−Removed: Novartis will assume full responsibility for development and commercialization of each product candidate under each of the Global Discovery Programs.
+Added: Novartis will assume full responsibility for development and commercialization of this Global Discovery Program.
Under ASC 606, revenue is recognized at the time that the Company’s performance obligation for each Global Discovery is completed upon delivery of each discovery program to Novartis.
−Removed: The Company delivered a discovery program to Novartis in 2017 and recognized $ 20.1 million of revenue in the period of delivery.
−Removed: In the third quarter of 2018, the Company delivered a second discovery program to Novartis and recognized an additional $ 20.0 million of revenue.
−Removed: In the third quarter of 2019, Novartis received notice of approval for an investigational new study (IND) from the Food and Drug Administration (FDA) for an application submitted for a Global Discovery Program, and we recognized $ 10.0 million of revenue.
+Added: The Company delivered two discovery programs to Novartis and recognized $ 40.1 million of revenue in the period that each program was delivered.
+Added: In the third quarter of 2019, we received a $ 10.0 million milestone related to development activity for a Global Discovery Program, and we recognized $ 10.0 million of revenue.
+Added: The Company’s obligations to provide research services under the Agreement for additional Global Discovery Programs expired in 2021, and we recognized $ 40.1 million of research revenue from deferred revenue.
+Added: In June 2021, Novartis selected an Fc candidate and received a non-exclusive license to the Company’s Fc technology.
+Added: Novartis will assume full responsibility for development and commercialization of the licensed Fc product candidate.
+Added: The Company is eligible to receive development, clinical, and sales milestones and royalties on net sales of approved products for the licensed Fc candidate.
+Added: During the year-ended December 31, 2021, Novartis advanced the Fc candidate into development and initiated clinical studies and the Company recognized $ 3.0 million of revenue related to the milestones.
During the year ended December 31, 2021 and 2019, the Company recognized $ 43.1 million and $ 10.0 million of revenue, respectively.
No revenue was recognized during the year ended December 31, 2020.
−Removed: There is a receivable of $ 0.9 million and $ 12.2 million as of December 31, 2020 and December 31, 2019, respectively, related to the arrangement, and we have recorded $ 40.1 million in deferred revenue as of December 31, 2020 related to the arrangement.
−Removed: In September 2015, the Company entered into a research and license agreement (the Amgen Agreement) with Amgen Inc.
−Removed: (Amgen) to develop and commercialize bispecific antibody product candidates using the Company’s proprietary XmAb® bispecific Fc technology.
−Removed: Under the Amgen Agreement, the Company granted an exclusive license to Amgen to develop and commercialize bispecific drug candidates from the Company’s preclinical CD38 Program.
−Removed: The Company also agreed to apply its bispecific technology to five previously identified Amgen provided targets (each a Discovery Program).
−Removed: The Company received a $ 45.0 million upfront payment and milestones totaling $ 15.5 million from Amgen and is eligible to receive up to $ 255.0 million in future development, regulatory and sales milestones in total for programs in development and is eligible to receive royalties on any global net sales of products.
−Removed: Amgen will assume full responsibility for development and commercialization of product candidates under each of the Discovery Programs.
−Removed: The Company evaluated the Amgen Agreement under ASC 606 and determined that it is a customer and that delivery of the CD38 Program and each of the five Discovery Programs represent the performance obligations under the contract.
−Removed: The Company determined the transaction price at inception is the $ 45.0 million upfront payment to be allocated to the performance obligations.
−Removed: The Amgen Agreement includes variable consideration for potential future milestones and royalties that were contingent on future success factors for development programs.
−Removed: The Company used the “most likely” method to determine the variable consideration.
−Removed: In 2019, the Company recognized a $ 5.0 million milestone related to one of the Discovery Programs.
−Removed: No other development, regulatory or sales milestones or royalties were included in the transaction price.
−Removed: The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.
−Removed: The Company completed performance obligations under the Amgen Agreement.
−Removed: In the third quarter of 2019, a $ 5.0 million milestone was recognized in connection with a development milestone for a Discovery Program.
−Removed: During the years ended December 31, 2019 and 2018, the Company recognized $ 5.0 million and $ 0.6 million in revenue, respectively, under this arrangement.
−Removed: No revenue was recognized for the year ended December 31, 2020.
−Removed: As of December 31, 2020, there was no deferred revenue related to the arrangement.
−Removed: In June 2010, the Company entered into a Collaboration and License Agreement with MorphoSys AG (MorphoSys), which was subsequently amended in March 2012 and in 2020.
−Removed: The agreement provides MorphoSys with an exclusive worldwide license to the Company’s patents and know-how to research, develop, and commercialize the Company’s XmAb5574 product candidate (subsequently renamed MOR208 and tafasitamab) with the right to sublicense under certain conditions.
−Removed: If certain developmental, regulatory, and sales milestones are achieved, the Company is eligible to receive future milestone payments and royalties.
−Removed: The Company recognized a total of $ 37.5 million of milestone revenue related to regulatory submission and approval of MorphoSys’ tafasitamab in the U.S., now Monjuvi, and royalties of $ 1.5 million on net sales of Monjuvi for the year ended December 31, 2020.
−Removed: There were no revenues recognized under this arrangement for the years ended December 31, 2019 and 2018.
−Removed: As of December 31, 2020, the Company has no deferred revenue related to this agreement and has recorded a receivable of $ 1.2 million for royalties due.
−Removed: Alexion Pharmaceuticals, Inc.
−Removed: In January 2013, the Company entered into an option and license agreement with Alexion Pharmaceuticals, Inc.
−Removed: Under the terms of the agreement, the Company granted to Alexion an exclusive research license, with limited sublicensing rights, to make and use our Xtend technology.
−Removed: Alexion exercised its rights to include our technology in ALXN1210, which is now marketed as Ultomiris.
−Removed: The Company is eligible to receive contractual milestones for certain development, regulatory and commercial achievements, and the Company is also entitled to receive royalties based on a percentage of net sales of such products sold by Alexion, its affiliates or its sub licensees, which percentage is in the low single digits.
−Removed: Alexion’s royalty obligations continue on a product-by-product and country-by-country basis until the expiration of the last-to-expire valid claim in a licensed patent covering the applicable product in such country.
−Removed: In 2018, Alexion completed certain regulatory submissions and regulatory approvals for Ultomiris, and the Company received $ 20.0 million in milestone payments.
−Removed: In 2019, Alexion completed certain regulatory submissions for Ultomiris, and the Company received a total of $ 8.0 million in milestone payments.
−Removed: During 2019, the Company also recorded royalty revenue of $ 5.0 million in connection with reported net sales of Ultomiris by Alexion.
−Removed: In 2020, the Company received $ 10.0 million for the achievement of certain sales milestones of Ultomiris in 2020 and also recorded royalty revenue of $ 16.2 million on net sales.
−Removed: The total revenue recognized under this arrangement was $ 26.2 million, $ 13.0 million, and $ 20.0 million for the years ended December 31, 2020, 2019, and 2018, respectively.
−Removed: As of December 31, 2020, there is a receivable of $ 8.8 million, and there is no deferred revenue related to this agreement.
−Removed: Gilead Sciences, Inc.
−Removed: In January 2020, the Company entered into a Technology License Agreement (the Gilead Agreement) with Gilead Sciences, Inc.
−Removed: (Gilead), in which the Company provided Gilead an exclusive license to its Cytotoxic Fc and Xtend Fc technologies for an initial identified antibody and options for up to three additional antibodies directed to the
−Removed: same molecular target.
−Removed: Gilead is responsible for all development and commercialization activities for all target candidates.
−Removed: The Company received an upfront payment of $ 6.0 million and is eligible to receive up to $ 67.0 million in milestones, which include $ 10.0 million in development milestones, $ 27.0 million in regulatory milestones and $ 30.0 million in sales milestones for each product incorporating the antibodies selected.
−Removed: In addition, the Company is eligible to receive royalties in the low-single digit percentage range on net sales of approved products.
−Removed: In the second quarter of 2020, Gilead exercised options on three additional antibody compounds, and in April 2020, we received a total of $ 7.5 million in payment of the three options.
−Removed: The Company evaluated the Gilead Agreement under the revenue recognition standard ASC 606 and identified the following performance obligations that it deemed to be distinct at the inception of the contract:
−Removed: ● non-exclusive license to its Cytotoxic Fc and Xtend Fc technologies;
−Removed: ● options for four exclusive commercial licenses to incorporate the licensed technologies on approved target compounds.
−Removed: The Company considered the licenses as functional intellectual property as Gilead has the right to use the technologies at the time that the Company transfers such rights.
−Removed: Each of the four options is considered a separate performance obligation as the arrangement does not confer material rights to the options without payment of the option exercise fee.
−Removed: Gilead will benefit from each option upon exercise of each of the four options and payment of each option fee as Gilead has access to each technology at inception of the arrangement and the rights are transferred upon payment of each option fee.
−Removed: The total transaction price is $ 13.5 million which includes the upfront payment of $ 6.0 million and the option fee payment of $ 7.5 million which was contractually due with the exercise of the three options by Gilead.
−Removed: The milestone payments are variable consideration to which the Company applied the “most likely amount” method and concluded at inception of the Gilead Agreement it is unlikely that the Company will collect such payments.
−Removed: The milestone payments were not included in the transaction price, and the Company will review this conclusion and update at each reporting period.
−Removed: The Company allocated $ 3.5 million of the transaction price to the licenses to the cytotoxic Fc and Xtend Fc technologies and recognized income for the licenses at inception of the arrangement when Gilead began benefiting access to them.
−Removed: The Company allocated $ 2.5 million to the initial option exercise which was effective at inception of the arrangement and payment of the upfront amount, and the Company allocated $ 7.5 million to the three remaining options which became effective in April 2020 when Gilead paid the option fees.
−Removed: The Company recognized $ 13.5 million of revenue related to the Gilead Agreement for the year ended December 31, 2020.
−Removed: There is no deferred revenue as of December 31, 2020 related to this agreement.
+Added: There is a receivable of $ 0.6 million as of December 31, 2021 related to the arrangement, and there is no deferred revenue as of December 31, 2021 related to the arrangement.
Omeros Corporation
3 unchanged sentences
In addition, the Company is eligible to receive royalties in the mid-single digit percentage range on net sales of approved products.
−Removed: The Company evaluated the Omeros Agreement under the revenue recognition standard ASC 606 and identified the following performance obligations that it deemed to be distinct at the inception of the contract:
−Removed: ● non-exclusive license to its Xtend Fc technologies;
−Removed: ● options for four exclusive commercial licenses to incorporate the licensed technologies on approved target compounds.
−Removed: The Company considered the license as functional intellectual property as Omeros has the right to use the technology at the time that the Company transfers such rights.
−Removed: Each of the four options is considered a separate performance obligation as the arrangement does not confer material rights to the options without payment of the option exercise fee.
−Removed: Omeros will benefit from each option upon exercise of each of the four options and payment of each option fee as Omeros has access to each technology at inception of the arrangement and the rights are transferred upon payment of each option fee.
−Removed: The total transaction price is $ 5.0 million, which includes the upfront payment.
−Removed: The milestone payments are variable consideration to which the Company applied the “most likely amount” method and concluded at inception of the Omeros Agreement it is unlikely that the Company will collect such payments.
−Removed: The milestone payments were not included in the transaction price and the Company will review this conclusion and update at each reporting period.
−Removed: The Company allocated $ 2.0 million of the transaction price to the licenses to the Xtend Fc technology and recognized income for the licenses at inception of the arrangement when Omeros began benefiting access to it.
−Removed: The Company allocated $ 3.0 million to the initial option exercise which was effective at inception of the arrangement.
The Company recognized $ 5.0 million of revenue related to the Omeros Agreement for the year ended December 31, 2020.
+Added: There was no revenue recognized for the year ended December 31, 2021.
There is no deferred revenue as of December 31, 2021 related to this agreement.
−Removed: MiRagen Therapeutics, Inc./Viridian Therapeutics, Inc.
−Removed: In December 2020, we entered into a Technology License Agreement (MiRagen Agreement) with MiRagen Therapeutics, Inc.
−Removed: (MiRagen), in which we provided MiRagen a non-exclusive license to our Xtend Fc technology and an exclusive license to apply our Xtend Fc technology to antibodies targeting IGF-1R.
−Removed: MiRagen subsequently changed its name to Viridian Therapeutics, Inc.
+Added: Vir Biotechnology, Inc.
+Added: In 2019, the Company entered into a Patent License Agreement (the Vir Agreement) with Vir Biotechnology (Vir) pursuant to which the Company provided a non-exclusive license to its Xtend technology for up to two targets.
+Added: Under the terms of the Vir Agreement, the Company received a total of $ 1.5 million in upfront and milestone payments and is eligible to receive additional milestones of $ 154.5 million which include $ 4.5 million of development milestones, $ 30.0 million of regulatory milestones and $ 120.0 million of sales milestones.
+Added: In addition, the Company is eligible to receive royalties on the net sales of approved products in the low-single digits.
+Added: Vir initiated a Phase 1 study with a licensed antibody in 2019, and in the second quarter of 2020, it initiated a Phase 1 study with a second licensed antibody.
+Added: In March 2020, the Company entered into a second Patent License Agreement (the Second Vir Agreement) with Vir pursuant to which the Company provided a non-exclusive license to its Xtend technology to extend the half-life of novel antibodies Vir is investigating as potential treatments for patients with COVID-19.
+Added: Under the terms of the Second Vir Agreement, Vir is responsible for all research, development, regulatory and commercial activities for the antibody, and the Company is eligible to receive royalties on the net sales of approved products in the mid-single digit percentage range.
+Added: In May 2021, the FDA granted emergency use authorization (EUA) to Vir’s COVID-19 antibody, sotrovimab (VIR-7831), for the treatment of mild-to-moderate COVID-19 in high-risk adult and pediatric patients.
+Added: In December 2021, the European Union, and several other countries authorized sotrovimab for the treatment of mild-to-moderate COVID-19 in high-risk adult and pediatric patients.
+Added: Vir and its marketing partner, GSK, began recording sales for sotrovimab beginning in June 2021.
+Added: In 2021, we recognized royalty revenue of $ 52.2 million related to this agreement.
+Added: In February 2021, the Company entered into the Vir Amendment No.
+Added: 1 to the Vir Agreement and the Vir Amendment No.
+Added: 1 to the Second Vir Agreement (collectively, the Vir Amendments), in each case, pursuant to which the Company provided a non-exclusive license to additional Fc technology for the targets previously identified in the Vir Agreement and the Second Vir Agreement, respectively.
+Added: If Vir incorporates additional Fc technologies in the identified targets, the Company is eligible to receive additional royalties on net sales of approved products from low to mid-single digit range.
+Added: The Company determined that the Second Vir Agreement and the Vir Amendments were modifications of the original Vir Agreement, and that the transfer of the license occurred at inception of the Vir Agreement.
+Added: The total consideration under the arrangement did not change with the Second Vir Agreement or the Amendments as the Company will potentially receive additional royalty revenue which is variable consideration and is not included in the transaction price.
+Added: In June 2021, Vir announced its plan to initiate a Phase 2 study for VIR-3434 and subsequently completed dosing of the first patient in such study in July 2021.
+Added: The Company recorded a $ 0.5 million contract asset in connection with this milestone event, and the payment was received in August 2021.
+Added: The Company recognized $ 52.7 million, $ 0.3 million, and $ 0.8 million of revenues related to the agreement for the years ended December 31, 2021, 2020, and 2019, respectively.
+Added: There is no deferred revenue as of December 31, 2021 related to this agreement.
+Added: As of December 31, 2021, the Company has recorded a receivable of $ 45.0 million for royalties due related to this agreement.
+Added: Viridian Therapeutics, Inc.
+Added: In December 2020, we entered into a Technology License Agreement (Viridian Agreement) with Viridian Therapeutics, Inc.
+Added: (Viridian), in which we provided Viridian a non-exclusive license to our Xtend Fc technology and an exclusive license to apply our Xtend Fc technology to antibodies targeting IGF-1R.
Viridian is responsible for all development and commercialization activities.
We received an upfront payment of 322,407 shares of Viridian common stock valued at $ 6.0 million and are eligible to receive up to $ 55.0 million in milestones, which include $ 10.0 million in development milestones, $ 20.0 million in regulatory milestones and $ 25.0 million in sales milestones.
−Removed: We are also eligible to receive royalties in the mid-single digit percentage range on net sales of approved products.
−Removed: The Company evaluated the MiRagen Agreement under the revenue recognition standard ASC 606 and identified the following performance obligation that it deemed to be distinct at the inception of the contract:
+Added: eligible to receive royalties in the mid-single digit percentage range on net sales of approved products.
+Added: The Company evaluated the Viridian Agreement under the revenue recognition standard ASC 606 and identified the following performance obligation that it deemed to be distinct at the inception of the contract:
● non-exclusive license to its Xtend Fc technologies
−Removed: The Company considered the license as functional intellectual property as MiRagen has the right to use the technology at the time that the Company transfers such rights.
−Removed: The total transaction price is $ 6.0 million, which includes the upfront payment of 322,407 MiRagen shares at their fair value at the date of the Agreement.
−Removed: The milestone payments are variable consideration to which the Company applied the “most likely amount” method and concluded at inception of the MiRagen Agreement it is unlikely that the Company will collect such payments.
+Added: The Company considered the license as functional intellectual property as Viridian has the right to use the technology at the time that the Company transfers such rights.
+Added: The total transaction price is $ 6.0 million, which includes the upfront payment of 322,407 Viridian shares at their fair value at the date of the Agreement.
+Added: The milestone payments are variable consideration to which the Company applied the “most likely amount” method and concluded at inception of the Viridian Agreement it is unlikely that the Company will collect such payments.
The milestone payments were not included in the transaction price, and the Company will review this conclusion and update at each reporting period.
−Removed: The Company allocated $ 6.0 million of the transaction price to the licenses to the Xtend Fc technology and recognized income for the licenses at inception of the arrangement when MiRagen began benefiting access to it.
−Removed: The Company recognized $ 6.0 million of revenue related to the MiRagen Agreement for the year ended December 31, 2020.
+Added: The Company allocated $ 6.0 million of the transaction price to the licenses to the Xtend Fc technology and recognized income for the licenses at inception of the arrangement when Viridian began benefiting access to it.
+Added: In December 2021, we entered into a second Technology License Agreement (Second Viridian Agreement) with Viridian for a non-exclusive license to certain antibody libraries developed by us.
+Added: Under the Second Viridian Agreement, Viridian received a one-year research license to review the antibodies and the right to select up to three antibodies for further development.
+Added: Viridian is responsible for all further development of the selected antibodies.
+Added: We received an upfront payment of 394,737 shares of Viridian common stock valued at $ 7.5 million and are eligible to receive up to $ 24.75 million in milestones, which include $ 1.75 million in development milestones, $ 3.0 million in regulatory milestones and $ 20.0 million in sales milestones in addition to royalties on net sales of approved products under the Second Viridian Agreement.
+Added: The Company evaluated the Second Viridian Agreement under the revenue recognition standard ASC 606 and identified the following performance obligation that it deemed to be distinct at the inception of the contract:
+Added: ● non-exclusive license to certain antibody libraries created by the Company
+Added: The Company considered the license as functional intellectual property as Viridian has the right to use the materials and license at the time that the Company transfers such rights.
+Added: The total transaction price is $ 7.5 million, which includes the upfront payment of 394,737 Viridian shares at their fair value at the date of the Agreement.
+Added: The milestone payments are variable consideration to which the Company applied the “most likely amount” method and concluded at inception of the Viridian Agreement it is unlikely that the Company will collect such payments.
+Added: The milestone payments were not included in the transaction price, and the Company will review this conclusion and update at each reporting period.
+Added: The Company allocated $ 7.5 million of the transaction price to the licenses to the antibody libraries and recognized income for the licenses at inception of the arrangement when Viridian received the materials and began accessing them.
+Added: The Company recognized $ 7.5 million and $ 6.0 million of revenue related to the Viridian Agreement for the year ended December 31, 2021 and 2020, respectively.
There is no deferred revenue as of December 31, 2021 related to this agreement.
−Removed: Private Biotech Company License Agreement
−Removed: In November 2020, the Company entered into a License Agreement with a newly formed, privately held biotechnology company (Private BioCo) pursuant to which the Company granted Private BioCo exclusive worldwide rights to develop and commercialize to three preclinical-stage Fc-engineered drug candidates:
+Added: Zenas BioPharma Limited
+Added: In November 2020, the Company entered into a License Agreement (Zenas Agreement) with Zenas BioPharma Limited (Zenas) pursuant to which the Company granted Zenas exclusive worldwide rights to develop and
+Added: commercialize to three preclinical-stage Fc-engineered drug candidates:
XmAb6755, Xpro9523, and XmAb10171.
−Removed: Under the Agreement, Private BioCo will be responsible for all further development and commercialization activities for XmAb6755, XPro9523 and XmAb10717.
−Removed: The Company received a 15 % equity interest in Private BioCo with a fair value of $ 16.1 million, and the Company is eligible to receive royalties on net sales of approved products in the mid-single digit to mid-teen percentage range.
−Removed: Under the License Agreement, Private BioCo received exclusive worldwide rights to manufacture, develop and commercialize XmAb6755, XPro9523 and XmAb10717.
−Removed: They also received the rights to all data, information and research materials related to the three preclinical stage programs.
−Removed: The Company evaluated the License Agreement under the revenue recognition standard ASC 606 and identified the following performance obligations that it deemed to be distinct at the inception of the contract:
+Added: Under the Zenas Agreement, Zenas will be responsible for all further development and commercialization activities for XmAb6755, Xpro9523, and XmAb10171.
+Added: The Company received a 15 % equity interest in Zenas with a fair value of $ 16.1 million, and the Company is eligible to receive royalties on net sales of approved products in the mid-single digit to mid-teen percentage range.
+Added: Under the Zenas Agreement, Zenas received exclusive worldwide rights to manufacture, develop and commercialize XmAb6755, Xpro9523, and XmAb10171.
+Added: Zenas also received the rights to all data, information, and research materials related to the three preclinical stage programs.
+Added: The Company evaluated the Zenas Agreement under the revenue recognition standard ASC 606 and identified the following performance obligations that it deemed to be distinct at the inception of the contract:
● exclusive license to the XmAb6755, Xpro9523, and XmAb10171 drug candidates;
● rights to material, data, and information that the Company had accumulated in connection with conducting preclinical activities for each of the three programs and intellectual property filings and information.
−Removed: The Company considered the licenses as functional intellectual property as Private BioCo has the right to use each of XmAb6755, XPro9523 and XmAb10717 at the time that the Company transfers such rights.
−Removed: The rights to the preclinical programs’ data are not considered to be separate from the license to programs as Private BioCo cannot benefit from the license without the supporting data and documentation.
−Removed: The total transaction price is $ 16.1 million, which includes the upfront payment of 15 % of the equity of Private BioCo at its fair value at the date of the Agreement.
−Removed: The License Agreement includes variable consideration for potential future royalties that were contingent on future success factors for the licensed programs.
+Added: The Company considered the licenses as functional intellectual property as Zenas has the right to use each of XmAb6755, Xpro9523 and XmAb10171 at the time that the Company transfers such rights.
+Added: The rights to the preclinical programs’ data are not considered to be separate from the license to programs as Zenas cannot benefit from the license without the supporting data and documentation.
+Added: The total transaction price is $ 16.1 million, which includes the upfront payment of 15 % of the equity of Zenas at its fair value at the date of the Zenas Agreement.
+Added: The Zenas Agreement includes variable consideration for potential future royalties that were contingent on future success factors for the licensed programs.
The Company used the “most likely amount” method to determine the variable consideration.
1 unchanged sentence
The Company will re-evaluate the transaction price in each reporting period as uncertain events are resolved or other changes in circumstances occur.
−Removed: The Company determined the transaction price at inception of the License Agreement and allocated it to the performance obligation, delivery of the XmAb6755, XPro9523 and XmAb10717 licenses.
+Added: The Company determined the transaction price at inception of the Zenas Agreement and allocated it to the performance obligation, delivery of the XmAb6755, Xpro9523, and XmAb10171 licenses.
The Company completed delivery of its performance obligations in December 2020.
−Removed: The licenses to XmAb6755, XPro9523, and XmAb10717 were transferred to Private BioCo at inception of the Agreement, and the related research data and documentation was transferred to Private BioCo in December 2020.
−Removed: The Company recognized $ 16.1 million of revenue related to the agreement for the year ended December 31, 2020.
−Removed: There is no deferred revenue as of December 31, 2020 related to this agreement.
−Removed: INmune Bio, Inc.
−Removed: In October 2017, the Company entered into a License Agreement with INmune Bio, Inc.
−Removed: Under the terms of the agreement, the Company provided INmune with an exclusive license to certain rights to a proprietary protein, XPro1595.
−Removed: Under the agreement the Company received an upfront payment of $ 100,000 , 1,585,000 shares of INmune common stock and an option to purchase an additional 10 % interest of the fully diluted shares of INmune for $ 10.0 million.
−Removed: The Company is eligible to receive a percentage of sublicensing revenue received for XPro1595 and also royalties in the mid-single digit percent range on the sale of approved products.
−Removed: In 2018, INmune filed a registration statement on a Form S-1 with the Securities and Exchange Commission (SEC) which was declared effective by the SEC on December 19, 2018.
−Removed: Under ASC 606, the Company determined that the performance obligation under the agreement was the license to XPro1595, and performance occurred at the effective date of the agreement.
−Removed: The total consideration under the agreement was determined to be $ 100,000 as the equity interest, and the option at inception of the Agreement had an insignificant fair value.
−Removed: The Company recognized $ 100,000 as revenue related to the agreement for the year ended December 31, 2017 and did not recognize any revenue related to the agreement for the years ended December 31, 2020, 2019, or 2018.
−Removed: There is no deferred revenue as of December 31, 2020 related to this agreement.
−Removed: The INmune shares are recorded at cost on the Company’s balance sheet as of December 31, 2020.
−Removed: Vir Biotechnology, Inc.
−Removed: In 2019, the Company entered into a Patent License Agreement (the Vir Agreement) with Vir Biotechnology (Vir) pursuant to which the Company provided a non-exclusive license to its Xtend technology for up to two targets.
−Removed: Under the terms of the Vir Agreement, the Company received an upfront payment and is eligible to receive total milestones of $ 155.0 million which include $ 5.0 million of development milestones, $ 30.0 million of regulatory milestones and $ 120.0 million of sales milestones.
−Removed: In addition, the Company is eligible to receive royalties on the net sales of approved products in the low-single digits.
−Removed: The Company evaluated the Vir Agreement and determined that the single performance obligation was access to a non-exclusive license to certain patents of the Company which were transferred to Vir upon execution of the Vir Agreement in July 2019.
−Removed: Vir initiated a Phase 1 study with a licensed antibody in 2019, and in the second quarter of 2020, it initiated a Phase 1 study with a second licensed antibody.
−Removed: In March 2020, the Company entered into a second Patent License Agreement (the Second Vir Agreement) with Vir pursuant to which the Company provided a non-exclusive license to its Xtend technology to extend the half-life of novel antibodies Vir is investigating as potential treatments for patients with COVID-19.
−Removed: Under the terms of the Second Vir Agreement, Vir is responsible for all research, development, regulatory and commercial activities for the antibody, and the Company is eligible to receive royalties on the net sales of approved products in the mid-single digit percentage range.
−Removed: Vir initiated a Phase 3 study with a licensed antibody to treat patients with COVID-19 in 2020.
−Removed: The Company determined that the Second Vir Agreement was a modification of the original agreement, and the transfer of the license occurred at inception of the Vir Agreement.
−Removed: The total consideration under the arrangement did not change with the Second Vir Agreement as the Company will potentially receive additional royalty revenue which is variable consideration and is not included in the transaction price.
−Removed: The Company recognized $ 0.3 million and $ 0.8 million of license and milestone revenue related to the agreement for the years ended December 31, 2020 and 2019, respectively.
+Added: The licenses to XmAb6755, Xpro9523, and XmAb10171 were transferred to Zenas at inception of the Zenas Agreement, and the related research data and documentation was transferred to Zenas in December 2020.
+Added: In November 2021, the Company entered into a second License Agreement (Second Zenas Agreement) with Zenas, in which we licensed the exclusive worldwide rights to develop and commercialize the Company’s obexelimab (XmAb5871) drug candidate.
+Added: Under the Second Zenas Agreement, Zenas will be responsible for all further development and commercialization activities for obexelimab.
+Added: The Company received a warrant to acquire additional equity in Zenas with a fair value of $ 14.9 million, and the Company is eligible to receive royalties on net sales of approved products in the mid-single digit to mid-teen percentage range.
+Added: We are also eligible to receive up to $ 470.0 million based on the achievement of certain clinical development, regulatory and commercialization milestones and are eligible to receive tiered, mid-single digit to mid-teen percent royalties upon commercialization of obexelimab, dependent on geography.
+Added: Zenas will have sole responsibility for advancing the research, development, regulatory and commercial activities of obexelimab worldwide.
+Added: The Company evaluated the Second Zenas Agreement under the revenue recognition standard ASC 606 and identified the following performance obligations that it deemed to be distinct at the inception of the contract:
+Added: ● exclusive license to the obexelimab drug candidate;
+Added: ● rights to material, data, and information that the Company had accumulated in connection with conducting clinical activities for the program and intellectual property filings and information.
+Added: The Company considered the license as functional intellectual property as Zenas has the right to use obexelimab at the time that the Company transfers such rights.
+Added: The rights to the obexelimab program data are not considered to be separate from the license to program as Zenas cannot benefit from the license without the supporting data and documentation.
+Added: The total transaction price is $ 14.9 million, which includes the upfront payment of a warrant to acquire up to 15 % of the equity of Zenas in connection with a future financing at its fair value at the date of the Second Zenas Agreement.
+Added: The Second Zenas Agreement includes variable consideration for potential future royalties that were contingent on future success factors for the licensed programs.
+Added: The Company used the “most likely amount” method to determine the variable consideration.
+Added: None of the royalties were included in the transaction price.
+Added: The Company will re-evaluate the transaction price in each reporting period as uncertain events are resolved or other changes in circumstances occur.
+Added: The Company determined the transaction price at inception of the Second Zenas Agreement and allocated it to the performance obligation, delivery of the obexelimab license.
+Added: The Company completed delivery of its performance obligations in December 2021.
+Added: The licenses to obexelimab were transferred to Zenas at inception of the Second Zenas Agreement, and the related research data and documentation was transferred to Zenas in December 2021.
+Added: The Company recognized $ 14.9 million and $ 16.1 million of revenue related to the two Zenas Agreements for the years ended December 31, 2021 and 2020, respectively.
There is no deferred revenue as of December 31, 2021 related to this agreement.
1 unchanged sentence
The $ 275.1 million, $ 122.7 million, and $ 156.7 million of revenue recorded for the years ended December 31, 2021, 2020, and 2019, respectively, were earned principally from the following licensees (in millions):
−Removed: MiRagen/Viridian
−Removed: Private BioCo
The table below summarizes the disaggregation of revenue recorded for the years ended December 31, 2021, 2020, and 2019 (in millions):
Research collaboration
−Removed: A portion of our revenue is earned from collaboration partners outside the United States.
−Removed: revenue is denominated in U.S.
−Removed: A breakdown of our revenue from U.S.
−Removed: sources for the years ended December 31, 2020, 2019 and 2018 is as follows (in millions):
Remaining Performance Obligations and Deferred Revenue
−Removed: Our remaining performance obligations are delivery of two additional Global Discovery Programs under the Novartis Agreement and conducting research activities pursuant to research plans under the Genentech and Janssen Agreements.
+Added: The Company’s remaining performance obligation as of December 31, 2021 is conducting research activities pursuant to research plans under the Second Janssen Agreement.
As of December 31, 2021 and 2020, we have deferred revenue of $ 37.3 million and $ 92.6 million, respectively.
−Removed: All of the deferred revenue was classified as short term as of December 31, 2020 as our obligations to perform research services are due on demand when requested by Novartis, Genentech and Janssen under the respective Agreements.
−Removed: As of December 31, 2019, $ 45.2 million of deferred revenue was classified as current liabilities as our
−Removed: obligations to perform services are due on demand when requested by Novartis and Astellas under the Novartis and Astellas Agreements, respectively.
−Removed: A total of $ 1.9 million of deferred liability is classified as long-term for the obligation to perform research services to Genentech under the Genentech Agreement after one year .
+Added: The Company completed its performance obligations for research activities pursuant to the Astellas Agreement in the second quarter of 2020.
+Added: The Company’s obligation to perform research services for Genentech and to deliver additional Global Discovery Programs under the Novartis Agreement ended upon expiration of the respective research terms for each agreement in the second quarter of 2021.
+Added: All of the deferred revenue was classified as short term as of December 31, 2021 and 2020, respectively, as the Company’s obligations to perform research services are due on demand when requested by Novartis, Genentech, and Janssen under the respective Agreements.
We have a 401(k) plan covering all full-time employees.
5 unchanged sentences
Employer contributions made for the years ended December 31, 2021, 2020, and 2019 were $ 1.1 million, $ 0.8 million, and $ 0.6 million, respectively.
−Removed: Condensed Quarterly Financial Data (unaudited)
−Removed: The following table contains selected unaudited financial data for each quarter of 2020 and 2019.
−Removed: The unaudited information should be read in conjunction with the Company’s financial statements and related notes included elsewhere in this Annual Report.
−Removed: The Company believes that the following information reflects all normal recurring adjustments necessary for a fair presentation of the information for the periods presented.
−Removed: The operating results for any quarter are not necessarily indicative of results for any future period.
−Removed: Quarterly Financial Data (in thousands, except per share data):
−Removed: 2020 Quarter Ended
−Removed: September 30,
−Removed: Total revenue
−Removed: Loss from operations
−Removed: Basic net loss per common share
−Removed: Diluted net loss per common share
−Removed: 2019 Quarter Ended
−Removed: September 30,
−Removed: Total revenue
−Removed: Income (loss) from operations
−Removed: Net income (loss)
−Removed: Basic net income (loss) per common share
−Removed: Diluted net income (loss) per common share
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
1 unchanged sentence
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.