Zymeworks Inc
For the period ended Jun 30, 2024. Filed Aug 1, 2024.
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Jun 30, 2024 · Filed Aug 1, 2024
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Notes to the Interim Condensed Consolidated Financial Statements
(Expressed in thousands of U.S. dollars except share and per share data)
- Nature of Operations
Zymeworks Inc. together with its subsidiaries (collectively the “Company” or “Zymeworks”) is a clinical-stage biopharmaceutical company dedicated to the development of next-generation multifunctional biotherapeutics. Zymeworks BC Inc. (“Zymeworks BC”), (previously known as “Zymeworks Inc.”) was incorporated on September 8, 2003 under the laws of the Canada Business Corporations Act. On October 22, 2003, the Company was registered as an extra-provincial company under the Company Act (British Columbia). On May 2, 2017, the Company continued under the Business Corporations Act (British Columbia).
Since its inception, the Company has devoted substantially all of its resources to research and development activities, including developing its therapeutic platforms and identifying and developing potential product candidates by undertaking preclinical studies and clinical trials. The Company supports these activities through general and administrative support, as well as by raising capital, conducting business planning and protecting its intellectual property.
On October 13, 2022, the Company completed an internal reorganization transaction resulting in a Delaware incorporated entity becoming the listed company (the “Redomicile Transactions”). Prior to the Redomicile Transactions, the shares of Zymeworks BC Inc. (formerly known as Zymeworks Inc.) were publicly listed. Unless the context otherwise requires or otherwise expressly states, all references in the accompanying consolidated financial statements to “Zymeworks,” the “Company,” “we,” “us” and “our” (i) for periods until completion of the Redomicile Transactions, refer to Zymeworks BC Inc. and its subsidiaries and (ii) for periods after completion of the Redomicile Transactions, refer to Zymeworks Inc. (formerly known as Zymeworks Delaware Inc.) and its subsidiaries.
To effect the Redomicile Transactions, the Company conducted a share exchange, pursuant to which holders of the Company’s common shares exchanged their common shares in the Company for shares of common stock of Zymeworks Inc. (formerly known as Zymeworks Delaware Inc.) or, at their election with respect to all or a portion of their common shares in the Company and subject to applicable eligibility criteria and an overall cap, exchangeable shares (the “Exchangeable Shares”) in the capital of a newly formed indirect subsidiary of Zymeworks Inc. A special meeting of Company security holders was held on October 7, 2022 to approve the Redomicile Transactions. The Redomicile Transactions were governed by a transaction agreement dated July 14, 2022, as restated and amended on August 18, 2022 (the “Restated and Amended Transaction Agreement”), by and among the Company and its direct or indirect subsidiaries Zymeworks Inc., Zymeworks CallCo ULC (“CallCo”) and Zymeworks ExchangeCo Ltd., (“ExchangeCo”) including a plan of arrangement included as Exhibit A to the Restated and Amended Transaction Agreement (the “Plan of Arrangement”).
- Summary of Significant Accounting Policies
Basis of Presentation
The accompanying interim condensed consolidated financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) for interim financial information. Accordingly, these financial statements do not include all the information and footnotes required for complete financial statements and should be read in conjunction with the audited consolidated financial statements of the Company and the accompanying notes thereto for the year ended December 31, 2023.
These unaudited interim condensed consolidated financial statements reflect all adjustments, consisting solely of normal recurring adjustments, which, in the opinion of management, are necessary for a fair presentation of results for the interim periods presented. The results of operations for the three and six months ended June 30, 2024 and 2023 are not necessarily indicative of results that can be expected for a full year. These unaudited interim condensed consolidated financial statements follow the same significant accounting policies as those described in the notes to the audited consolidated financial statements of the Company for the year ended December 31, 2023.
All amounts expressed in the interim condensed consolidated financial statements of the Company and the accompanying notes thereto are expressed in thousands of U.S. dollars, except for share and per share data and where otherwise indicated. References to “$” are to U.S. dollars and references to “C$” are to Canadian dollars.
Certain prior period amounts have been reclassified for consistency with the current period presentation. These reclassifications had no effect on the reported results of operations.
Use of Estimates
The preparation of interim condensed consolidated financial statements in accordance with U.S. GAAP requires the Company to make estimates and judgments in certain circumstances that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, the Company evaluates its estimates, most notably those related to revenue recognition including estimated timing of completion of performance obligations required to meet revenue recognition criteria, accrual of expenses including clinical and preclinical study expense accruals, stock-based compensation, valuation allowance for deferred taxes, measurement of contingent consideration liabilities, and other contingencies. Management bases its estimates on historical experience and on various other assumptions that it believes to be reasonable under the circumstances. Actual results could differ from these estimates.
- Recent Accounting Pronouncements
Recent accounting pronouncements not yet adopted
The Company has reviewed recent accounting pronouncements and concluded that they are either not applicable to the business, or that no material effect is expected on the consolidated financial statements as a result of future adoption.
- Net loss per share
Net loss per share for the three and six months ended June 30, 2024 and 2023 was as follows:
| Three Months EndedJune 30, | Six Months EndedJune 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Numerator: | ||||
| Net loss attributable to common stockholders: | ||||
| Basic | $(37,686) | $(51,152) | $(69,339) | $(75,505) |
| Adjustment for change in fair value of liability classified stock options | (51) | (49) | (201) | (109) |
| Diluted | $(37,737) | $(51,201) | $(69,540) | $(75,614) |
| Denominator: | ||||
| Weighted-average common stock outstanding: | ||||
| Basic | 76,392,593 | 67,281,028 | 76,303,713 | 67,011,664 |
| Adjustment for dilutive effect of liability classified stock options | 3,624 | 3,483 | 18,228 | 3,130 |
| Diluted | 76,396,217 | 67,284,511 | 76,321,941 | 67,014,794 |
| Net loss per common share – basic | $(0.49) | $(0.76) | $(0.91) | $(1.13) |
| Net loss per common share – diluted | $(0.49) | $(0.76) | $(0.91) | $(1.13) |
Weighted average number of shares of common stock used in the basic and diluted earnings per share calculations include Exchangeable Shares and the pre-funded warrants issued in connection with the Company’s June 2019 and January 2020 offerings and December 2023 private placement as the warrants were exercisable at any time for nominal cash consideration. The Company’s potentially dilutive securities, which include stock options and RSUs, have been excluded from the computation of diluted net loss per share for the three and six months ended June 30, 2024 as the effect would be to reduce the net loss per share.
- Cash, Cash Equivalents and Marketable Securities
The following table summarizes the Company’s marketable securities as of June 30, 2024:
| June 30, 2024 | |||
|---|---|---|---|
| Amortized Cost | Unrealized Loss | Fair Value | |
| Short-term marketable securities: | |||
| Contractual maturity of one year or less: | |||
| Guaranteed investment certificates (“GICs”) | $87,341 | $— | $87,341 |
| U.S. Treasury notes | 68,887 | (155) | 68,732 |
| Corporate debt securities | 103,450 | (340) | 103,110 |
| 259,678 | (495) | 259,183 | |
| Long-term marketable securities: | |||
| Contractual maturity of one to three years: | |||
| U.S. Treasury notes | 7,731 | (17) | 7,714 |
| Corporate debt securities | 53,871 | (653) | 53,218 |
| Contractual maturity of three to four years: | |||
| Corporate debt securities | 4,942 | (80) | 4,862 |
| 66,544 | (750) | 65,794 | |
| $326,222 | $(1,245) | $324,977 | |
The following table summarizes the Company’s marketable securities as of December 31, 2023:
| December 31, 2023 | |||
|---|---|---|---|
| Amortized Cost | Unrealized Gain (Loss) | Fair Value | |
| Short-term marketable securities: | |||
| Contractual maturity of one year or less: | |||
| GICs | $75,066 | $— | $75,066 |
| U.S. Treasury notes | 46,416 | 136 | 46,552 |
| Corporate debt securities | 94,900 | 252 | 95,152 |
| 216,382 | 388 | 216,770 | |
| Long-term marketable securities: | |||
| Contractual maturity of one to three years: | |||
| Corporate debt securities | 70,181 | (321) | 69,860 |
| Contractual maturity of three to four years: | |||
| Corporate debt securities | 12,081 | (11) | 12,070 |
| 82,262 | (332) | 81,930 | |
| $298,644 | $56 | $298,700 | |
The following tables present information about the Company’s assets that are measured at fair value on a recurring basis, and indicate the fair value hierarchy of the valuation techniques used to determine such fair value:
| June 30,2024 | December 31,2023 | |||||||
|---|---|---|---|---|---|---|---|---|
| Level 1 | Level 2 | Level 3 | Total | Level 1 | Level 2 | Level 3 | Total | |
| Cash and cash equivalents: | ||||||||
| Cash | $3,261 | $23,126 | ||||||
| Cash equivalents: | ||||||||
| Money market funds | $19,408 | $— | $— | $19,408 | $64,247 | $— | $— | $64,247 |
| GICs | 48,294 | — | — | 48,294 | 70,184 | — | — | 70,184 |
| $67,702 | $— | $— | $70,963 | $134,431 | $— | $— | $157,557 | |
| Marketable securities: | ||||||||
| GICs | $87,341 | $— | $— | $87,341 | $75,066 | $— | $— | $75,066 |
| U.S. Treasury notes | 76,446 | — | — | 76,446 | 46,552 | — | — | 46,552 |
| Corporate debt securities | — | 161,190 | — | 161,190 | — | 177,082 | — | 177,082 |
| $163,787 | $161,190 | $— | $324,977 | $121,618 | $177,082 | $— | $298,700 | |
| Total | $231,489 | $161,190 | $— | $395,940 | $256,049 | $177,082 | $— | $456,257 |
- IPR&D and Goodwill
Acquired IPR&D
In-process research and development assets (“IPR&D”) acquired in the 2016 Kairos Therapeutics Inc. (“Kairos”) business combination are classified as indefinite-lived intangible assets and are not currently being amortized. During the three months ended June 30, 2024, we determined that the fair value of IPR&D, which was estimated using an income approach, was less than its carrying value. Accordingly, the Company recorded an impairment charge of $17,287. The carrying value of IPR&D, net of impairment, was $341 at June 30, 2024 (December 31, 2023: $17,628). The impairment was a result of the Company's decision to discontinue the zanidatamab zovodotin clinical development program which utilized the acquired technology represented by the IPR&D assets.
Goodwill
The Company performed its most recent annual impairment test of goodwill as of December 31, 2023. As part of the evaluation of the recoverability of goodwill, the Company identified onlyone reporting unit to which the total carrying amount of goodwill has been assigned. As at December 31, 2023, the Company performed a qualitative assessment for its annual impairment test of goodwill after concluding that it was not more likely than not that the fair value of the reporting unit was less than its carrying value. Consequently, a quantitative impairment test was not required. The Company concluded that there wereno impairment indicators related to goodwill as of June 30, 2024.
- Liabilities
Accounts payable and accrued liabilities consisted of the following:
| June 30,2024 | December 31,2023 | |
|---|---|---|
| Trade payables | $1,733 | $6,212 |
| Accrued research and development expenses | 36,096 | 26,661 |
| Employee compensation and vacation accruals | 3,937 | 6,153 |
| Fair value of liability classified stock options | 304 | 960 |
| Accrued legal and professional fees | 1,397 | 3,707 |
| Liability for contingent consideration (note 13) | — | 1,570 |
| Other | 953 | 729 |
| Total | $44,420 | $45,992 |
Other long-term liabilities consisted of the following:
| June 30,2024 | December 31,2023 | |
|---|---|---|
| Liability for contingent consideration (note 13) | $— | $308 |
| Liability from in-licensing agreements | 747 | 747 |
| Finance lease liability (note 11) | 33 | 92 |
| Other | 449 | 554 |
| Total | $1,229 | $1,701 |
- Stockholders’ Equity
a. Equity Offerings
2023 Private Placement
On December 28, 2023, the Company completed a private placement pursuant to which the Company sold 5,086,521 pre-funded warrants to purchase 5,086,521 shares of common stock at $9.8299 per pre-funded warrant. The Company received gross proceeds of $50,000 and net proceeds were $49,862, after expenses.
2023 ATM financing
On June 16, 2023, the Company sold 3,350,000 shares of common stock pursuant to the Company’s at-the-market sale program, at $8.12 per common share. Net proceeds were $26,233 after underwriting commissions and offering expenses.
b. Authorized Share Capital and Preferred Stock
The Company’s authorized share capital consists of 1,000,000,000 shares of stock, consisting of (i)900,000,000 shares of common stock, par value $0.00001 per share, and (ii)100,000,000 shares of preferred stock, par value $0.00001 per share.
In connection with the Plan of Arrangement, the Company issued to Computershare Trust Company of Canada, a trust company existing under the laws of Canada (the “Share Trustee”), one share of the Company’s preferred stock, par value $0.00001 per share, which has certain variable voting rights in proportion to the number of Exchangeable Shares outstanding (the “Special Voting Preferred Stock”), enabling the Share Trustee to exercise voting rights for the benefit of the Exchangeable Shareholders.
Immediately prior to the completion of the Redomicile Transactions, there were 61,699,387 Zymeworks BC common shares issued and outstanding. In connection with the consummation of the Plan of Arrangement,60,274,854 shares of Common Stock and 1,424,533 Exchangeable Shares were issued to former Zymeworks BC shareholders. As of June 30, 2024, there were 570,637 Exchangeable Shares held by former Zymeworks BC shareholders (December 31, 2023:651,219). The Company will issue shares of its common stock as consideration when a holder of Exchangeable Shares calls for Exchangeable Shares to be retracted by ExchangeCo, when ExchangeCo redeems Exchangeable Shares from the holder, or when CallCo purchases Exchangeable Shares from the Exchangeable Shareholder under CallCo’s overriding call rights. These Exchangeable Shares and the Special Voting Preferred Stock, when taken together, are similar in substance to the Company’s common stock.
c. Pre-Funded Common Share Warrants
In connection with the public offerings completed on June 24, 2019, January 27, 2020, January 31, 2022 and private placement completed on December 28, 2023 (note 8a), the Company issued a total of 13,668,482 pre-funded warrants which granted holders of warrants the right to purchase up to 13,668,482 common shares of the Company, at an exercise price of $0.0001 per share.
The pre-funded warrants are exercisable by the holders at any time on or after the original issue date. The pre-funded warrants do not expire unless they are exercised or settled in accordance with the pre-funded warrant agreement. As the pre-funded warrants meet the condition for equity classification, proceeds from issuance of the pre-funded warrants, net of any transaction costs, are recorded in additional paid-in capital. Upon exercise of the pre-funded warrants, the historical costs recorded in additional paid-in capital along with exercise price collected from holders will be recorded in common shares.
On August 23, 2022, October 25, 2022, October 27, 2022 and October 19, 2023, a total of 8,581,961 pre-funded warrants were exercised in exchange for issuance of 8,581,868 common shares. As a result of the December 28, 2023 private placement, as of June 30, 2024, there were 5,086,521 pre-funded warrants outstanding (December 31, 2023:5,086,521).
d. Stock-Based Compensation
As of June 30, 2024,4,903,136 shares of common stock were available for future award grants under the New Plan (December 31, 2023:4,594,639 shares of common stock).
On January 5, 2022, the board of directors approved the Zymeworks Inc. Inducement Stock Option and Equity Compensation Plan (the “Inducement Plan”) and reserved 750,000 of the Company’s common shares for issuance pursuant to equity awards granted thereunder. As of June 30, 2024,50,000 shares of common stock were available for future award grants under this plan (December 31, 2023:50,000).
RSUs
The following table summarizes the Company’s RSU activity under the New Plan since December 31, 2023:
| Number of RSUs | Weighted-average grantdate fair value($) | |
|---|---|---|
| Outstanding, December 31, 2023 | 771,413 | 8.63 |
| Granted | 957,750 | 10.56 |
| Vested and settled | (224,104) | 8.65 |
| Forfeited | (137,220) | 11.10 |
| Outstanding, June 30, 2024 | 1,367,839 | 9.73 |
As of June 30, 2024, there was $6,399 of unamortized RSU expense that will be recognized over a weighted average period of 1.49 years.
Stock Options
The following table summarizes the Company’s stock options granted in Canadian dollars under the Original Plan and the New Plan:
| Numberof Options | Weighted-AverageExercise Price(C$) | Weighted-AverageExercise Price($) | Weighted-AverageContractualTerm(years) | Aggregateintrinsic value(C$) | Aggregateintrinsic value($) | |
|---|---|---|---|---|---|---|
| Outstanding, December 31, 2023 | 1,489,478 | 19.59 | 14.39 | 5.50 | 2,987 | 2,255 |
| Granted | — | — | — | |||
| Exercised | (136,946) | 10.97 | 8.12 | |||
| Forfeited | (93,744) | 23.89 | 17.56 | |||
| Outstanding, June 30, 2024 | 1,258,788 | 20.21 | 14.84 | 5.07 | 1,288 | 942 |
The following table summarizes the Company’s stock options granted in U.S. dollars under the New Plan and the Inducement Plan:
| Numberof Options | Weighted-AverageExercise Price($) | Weighted-AverageContractualTerm(years) | Aggregateintrinsic value($) | |
|---|---|---|---|---|
| Outstanding, December 31, 2023 | 6,069,242 | 12.97 | 7.67 | 9,213 |
| Granted | 2,174,800 | 10.48 | ||
| Exercised | (221,011) | 7.61 | ||
| Forfeited | (405,426) | 11.70 | ||
| Outstanding, June 30, 2024 | 7,617,605 | 12.49 | 7.81 | 2,637 |
During the six months ended June 30, 2024, the Company received cash proceeds of $2,876 from stock options exercised.
The stock options outstanding at June 30, 2024 expire at various dates from July 1, 2024 to June 9, 2034.
The estimated fair values of options granted to officers, directors, employees and consultants are amortized over the relevant vesting periods. Stock-based compensation expense for equity classified instruments, RSUs, as well as the financial statement impact of the amortization and periodic revaluation of liability classified instruments, are recorded in research and development expense and general and administration expense as follows:
| Three Months Ended June 30, | Six Months Ended June 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Research and development expense | $2,381 | $(1,085) | $4,306 | $(640) |
| General and administrative expense | 2,107 | 1,411 | 3,641 | 3,143 |
The amounts above include stock-based compensation expense relating to RSUs of $1,636 and $2,658 for the three and six months ended June 30, 2024 (2023: $1,088 and $1,743).
The estimated fair value of stock options granted under the New Plan was determined using the Black-Scholes option pricing model with the following weighted-average assumptions:
| Six Months Ended June 30, | ||
|---|---|---|
| 2024 | 2023 | |
| Dividend yield | 0% | 0% |
| Expected volatility | 64.9% | 67.7% |
| Risk-free interest rate | 4.08% | 3.80% |
| Expected average life of options | 6.04 years | 6.05 years |
The weighted-average Black-Scholes option pricing assumptions for liability classified stock options outstanding at June 30, 2024 and 2023 are as follows:
| June 30,2024 | June 30,2023 | |
|---|---|---|
| Dividend yield | 0% | 0% |
| Expected volatility | 43.4% | 79.3% |
| Risk-free interest rate | 3.90% | 4.50% |
| Expected average option term | 0.61 years | 1.68 years |
| Number of liability classified stock options outstanding | 353,694 | 512,155 |
At June 30, 2024, the unamortized compensation expense related to unvested options was $12,909. The remaining unamortized compensation expense as of June 30, 2024 will be recognized over a weighted-average period of 1.71 years.
- Research, Collaboration and Licensing Agreements
Revenue recognized from the Company’s strategic partnerships. which includes amounts from Jazz Pharmaceuticals Ireland Limited or Jazz Pharmaceuticals, Inc. (subsidiaries of Jazz Pharmaceuticals plc, collectively referred to as “Jazz”) is summarized as follows:
| Three Months EndedJune 30, | Six Months EndedJune 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Jazz: | ||||
| Development support payments | $1,109 | $21,924 | $3,175 | $48,066 |
| Drug supply for ongoing studies | 3,983 | 4,640 | 10,201 | 9,393 |
| Other drug supply | 5,746 | — | 7,324 | 3,528 |
| Credit for program amendments | — | (20,100) | — | (20,100) |
| BeiGene: | ||||
| Milestone revenue | 8,000 | — | 8,000 | — |
| Drug supply | 405 | — | 405 | 187 |
| Development support payments | — | 34 | — | 220 |
| Research support and other payments from other partners | — | 504 | 168 | 1,286 |
| $19,243 | $7,002 | $29,273 | $42,580 | |
Since December 31, 2023, there have not been any material changes to the key terms of our collaboration and license agreements.
In June 2024, the Company recognized $8,000 of milestone revenue from BeiGene in relation to the acceptance by the CDE of the NMPA in China of the BLA for zanidatamab for second-line treatment of HER2-positive BTC.
Contract Assets and Liabilities
As at June 30, 2024, contract assets from research, collaboration and licensing agreements werenil (December 31, 2023: nil) and contract liabilities were $38,461 (December 31, 2023: $36,640). As at June 30, 2024 and December 31, 2023, $5,520 and $3,699 respectively, of the contract liabilities is classified as short-term. Contract liabilities relate to deferred revenue from the BeiGene and Jazz agreements.
- Other income (expense), net
Other income (expense), net, consists of the following:
| Three Months EndedJune 30, | Six Months EndedJune 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Foreign exchange gain (loss), net | $61 | $(439) | $346 | $(895) |
| Other | 53 | 230 | 72 | 199 |
| $114 | $(209) | $418 | $(696) | |
- Leases
The lease for our Vancouver location, which we entered into in January 2019, has an initial term expiring in February 2032, withtwo five-year extension options. In addition, the Company leases office spaces in Bellevue, Washington and in Redwood City, California with lease terms expiring between December 2024 and May 2027. None of the optional extension periods have been included in the determination of the right-of-use assets or the lease liabilities for operating leases as the Company did not consider it reasonably certain that the Company would exercise any such options.
The Company also leases office equipment under capital lease agreements.
The balance sheet classification of the Company’s lease liabilities was as follows:
| June 30,2024 | December 31,2023 | |
|---|---|---|
| Operating lease liabilities: | ||
| Current portion | $2,839 | $4,261 |
| Long-term portion | 17,192 | 22,369 |
| Total operating lease liabilities | 20,031 | $26,630 |
| Finance lease liabilities: | ||
| Current portion included in other current liabilities | 24 | 30 |
| Long-term portion included in other long-term liabilities | 33 | 92 |
| Total finance lease liabilities | 57 | 122 |
| Total lease liabilities | $20,088 | $26,752 |
| Weighted average remaining lease term: | ||
| Operating leases | 7.0 years | 6.7 years |
| Weighted average discount rate: | ||
| Operating leases in U.S. dollars | 5.2% | 3.6% |
| Operating leases in Canadian dollars | 4.8% | 4.8% |
Cash paid for amounts included in the measurement of operating lease liabilities for the three and six months ended June 30, 2024 was $881 and $2,222, respectively, and were included in net cash used in operating activities in the consolidated statement of cash flows. In addition, on April 4, 2024, the Company terminated its long-term facility lease in Seattle, pursuant to which the Company paid $6,075 as a termination fee.
As of June 30, 2024, the maturities of the Company’s operating lease liabilities were as follows:
| Operatingleases | |
|---|---|
| Within 1 year | $3,702 |
| 1 to 2 years | 3,416 |
| 2 to 3 years | 3,284 |
| 3 to 4 years | 3,085 |
| 4 to 5 years | 2,990 |
| Thereafter | 7,015 |
| Total operating lease payments | 23,492 |
| Less: | |
| Imputed interest | (3,461) |
| Operating lease liabilities | $20,031 |
The cost components of the operating leases were as follows for the three and six months ended June 30, 2024 and 2023:
| Three Months EndedJune 30, | Six Months EndedJune 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Lease expenses: | ||||
| Operating lease expense | $552 | $678 | $974 | $1,335 |
| Variable lease expense | 603 | 449 | 1,021 | 835 |
| Termination of long-term facility lease in Seattle, net | 1,033 | — | 1,033 | — |
| $2,188 | $1,127 | $3,028 | $2,170 | |
- Financial Instruments
The Company evaluates financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level of classification each reporting period. This determination requires the Company to make subjective judgments as to the significance of inputs used in determining fair value and where such inputs lie within the fair value hierarchy.
Fair Value Measurements
The Company measures certain financial instruments and other items at fair value.
To determine fair value, the Company uses a fair value hierarchy that prioritizes the inputs, assumptions and valuation techniques used to measure fair value. The three levels of the fair value hierarchy are as follows:
Level 1 inputs are unadjusted quoted market prices for identical instruments available in active markets.
Level 2 inputs are inputs other than Level 1 prices, such as prices for a similar asset or liability that are observable either directly or indirectly. If the asset or liability has a contractual term, the input must be observable for substantially the full term. An example includes quoted market prices for similar assets or liabilities in active markets.
Level 3 inputs are unobservable inputs for the asset or liability and will reflect management’s assessment about market assumptions that would be used to price the asset or liability.
Assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurements. Changes in the observability of valuation inputs may result in a reclassification of levels for certain securities within the fair value hierarchy.
The Company’s financial instruments consist of cash and cash equivalents, short-term and long-term investments in marketable and other securities, accounts receivable, accounts payable and accrued liabilities, contingent consideration, finance and operating lease obligations, and other long-term liabilities.
The carrying values of cash and cash equivalents, accounts receivable and accounts payable and accrued liabilities approximate their fair values due to the near-term maturities of these financial instruments. All marketable securities are classified as available- for-sale and are recorded at fair value. As at June 30, 2024, long-term investments in equity securities of private entities are accounted for as available for sale at their fair values. Other long-term liabilities for contingent consideration related to business acquisitions are recorded at fair value on the acquisition date and are adjusted quarterly for changes in fair value. Changes in the fair value of contingent consideration liabilities can result from changes in anticipated milestone payments and changes in assumed discount periods and rates. These inputs are unobservable in the market and therefore categorized as level 3 inputs as defined above.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to a concentration of credit risk consist primarily of cash and cash equivalents, short-term and long-term marketable securities and accounts receivable. Cash and cash equivalents and investments in marketable securities are invested in accordance with the Company’s cash investment policy with the primary objective being the preservation of capital and maintenance of liquidity. The cash investment policy includes guidelines on the quality of financial instruments and defines allowable investments that the Company believes minimizes the exposure to concentration of credit risk. The Company limits its exposure to credit loss by placing its cash and cash equivalents and investments with high credit quality financial institutions.
At June 30, 2024, the maximum exposure to credit risk for accounts receivable was $32,081,67% of which was from Jazz (December 31, 2023: $19,477) and all accounts receivable are due within the next 12 months. As at June 30, 2024 and December 31, 2023, the Company has recognized nominal amounts of provision for expected credit losses in relation to accounts receivable.
Liquidity Risk
Liquidity risk is the risk that the Company will encounter difficulty in meeting the obligations associated with its financial liabilities that are settled by delivering cash or another financial asset. The Company’s short-term cash requirements are primarily to settle its financial liabilities, which consist primarily of accounts payable and accrued liabilities falling due within 45 days and current portion of lease obligations falling due within the next 12 months, with medium term requirements to invest in property and equipment and research and development. The Company’s principal sources of liquidity to settle its financial liabilities are cash, cash equivalents, short-term and long-term investments, collection of accounts receivable relating to research collaboration and license agreements and additional public equity offerings as required. The Company believes that these principal sources of liquidity are sufficient to fund its operations for at least the next 12 months.
Foreign Currency Risk
The Company incurs certain operating expenses in currencies other than the U.S. dollar and accordingly is subject to foreign exchange risk due to fluctuations in exchange rates. The Company does not use derivative instruments to hedge exposure to foreign exchange risk and therefore assumes the risk of future gains or losses in its consolidated statements of (loss) income. At June 30, 2024, the Company’s net monetary liabilities denominated in Canadian dollars were $727 (C$995).
The operating results and financial position of the Company are reported in U.S. dollars in the Company’s interim condensed consolidated financial statements. The fluctuation of the U.S. dollar relative to the Canadian dollar and other foreign currencies will have an impact on the reported balances for net assets, net loss and stockholders’ equity in the Company’s interim condensed consolidated financial statements.
- Commitments and Contingencies
Commitments
The Company has entered into research collaboration agreements with strategic partners in the ordinary course of operations that may include contractual milestone payments related to the achievement of pre-specified research, development, regulatory and commercialization events and indemnification provisions, which are common in such agreements. Pursuant to the agreements, the Company is obligated to make research and development and regulatory milestone payments upon the occurrence of certain events and royalty payments based on net sales. The maximum amount of potential future indemnification is unlimited, however, the Company currently holds commercial and product liability insurance that limits the Company’s liability and may enable it to recover a portion of any future amounts paid. Historically, the Company has not made any indemnification payments under such agreements and believes that the fair value of these indemnification obligations is minimal. Accordingly, the Company has not recognized any liabilities relating to indemnification obligations for any period presented in the interim condensed consolidated financial statements.
In connection with the Company’s 2016 Kairos acquisition, the Company may be required to make future payments of up to an aggregate of C$8,500, consisting of (i) a C$2,500 payment when the first patient is dosed in the first Phase 2 trial and (ii) a C$6,000 payment when the first patient is dosed in the first Phase 3 trial, to CDRD Ventures Inc. (“CVI”) upon the direct achievement of certain development milestones for products incorporating certain Kairos intellectual property (such as zanidatamab zovodotin or other product candidates using our ZymeLink technology). In addition, CVI is eligible to receive low single-digit royalty payments from the Company on the net sales of such products. For out-licensed products and technologies incorporating certain Kairos intellectual property, the Company may also be required to pay CVI a mid-single digit percentage of certain future revenue. As of June 30, 2024, the contingent consideration had an estimated fair value ofnil, which has been recorded within liabilities (note 7) on the Company’s consolidated balance sheet (December 31, 2023: $1,878). The contingent consideration was calculated using a probability weighted assessment of the likelihood of the milestones being met, a probability adjusted discount rate that reflects the stage of the development and time to complete the development. Contingent consideration is a financial liability and measured at its fair value at each reporting period, with any changes in fair value from the previous reporting period recorded within research and development expenses in the statement of loss and comprehensive loss.
The following table presents the changes in fair value of the Company’s liability for contingent consideration:
| Liability atthe beginningof the period | Increase / (decrease) infair value ofliability forcontingentconsideration | Amounts paid or transferred to payables | Liability at endof the period | |
|---|---|---|---|---|
| Three months ended June 30, 2024 | $1,178 | $(1,178) | $— | $— |
| Six months ended June 30, 2024 | $1,878 | $(1,878) | $— | $— |
The following tables present information about the Company’s liability for contingent consideration measured at fair value on a recurring basis, and indicate the fair value hierarchy of the valuation technique used to determine such fair value:
| December 31,2023 | Level 1 | Level 2 | Level 3 | |
|---|---|---|---|---|
| Liability for contingent consideration | $1,878 | $— | $— | $1,878 |
| Total | $1,878 | $— | $— | $1,878 |
The Company used the following assumptions to estimate fair value of contingent consideration liability as of June 30, 2024 and December 31, 2023:
| June 30,2024 | December 31,2023 | |
|---|---|---|
| Weighted assessment of the likelihood of the milestones | 0.0% | 33.5% |
| Weighted average estimated period for achievement of milestones | 0 | 0.92 years |
| Discount rate | 17.0% | 17.0% |
Contingencies
From time to time, the Company may be subject to various legal proceedings and claims related to matters arising in the ordinary course of business. The Company does not believe it is currently subject to any material matters where there is at least a reasonable possibility that a material loss may be incurred.
- Subsequent Event
On August 1, 2024, the board of directors of the Company authorized a share repurchase program (the “Share Repurchase Program”) under which the Company may repurchase up to $60,000 of the Company’s common stock. The shares may be repurchased from time to time in open market transactions, or other means in accordance with Rule 10b5-1 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Rule 10b-18 of the Exchange Act. The timing, number of shares repurchased, and prices paid for the shares under this program will depend on general business and market conditions as well as corporate and regulatory limitations, prevailing stock prices, and other considerations. The Share Repurchase Program may be suspended or discontinued at any time and does not obligate the Company to acquire any amount of common stock.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.