UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
or
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission file number:
Xencor, Inc.
(Exact Name of Registrant as Specified in its Charter)
(State or Other Jurisdiction of Incorporation or Organization) | (I.R.S. Employer Identification No.) | |
(Address of Principal Executive Offices) | (Zip Code) |
(
(Registrant’s Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class: |
| Trading Symbol |
| Name of each exchange on which registered: |
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See definitions of “large accelerated filer”, “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
If an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13 (a) of the Exchange Act. ◻
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Securities Exchange Act of 1934). Yes
Indicate the number of shares of each of the issuer’s classes of common stock, as of the latest practicable date:
Class | Outstanding at August 1, 2019 | |
Common stock, $0.01 par value |
Xencor, Inc.
Quarterly Report on FORM 10-Q for the quarter ended June 30, 2019
Table of Contents
In this report, unless otherwise stated or the context otherwise indicates, references to “Xencor,” “the Company,” “we,” “us,” “our” and similar references refer to Xencor, Inc. The Xencor logo is a registered trademark of Xencor, Inc. This report also contains registered marks, trademarks and trade names of other companies. All other trademarks, registered marks and trade names appearing in this report are the property of their respective holders.
2
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of federal securities laws. Forward-looking statements include statements that may relate to our plans, objectives, goals, strategies, future events, future revenues or performance, capital expenditures, financing needs and other information that is not historical information. Many of these statements appear, in particular, under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations”. Forward-looking statements can often be identified by the use of terminology such as “subject to”, “believe”, “anticipate”, “plan”, “expect”, “intend”, “estimate”, “project”, “may”, “will”, “should”, “would”, “could”, “can”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy.
All forward-looking statements, including, without limitation, our examination of historical operating trends, are based upon our current expectations and various assumptions. We believe there is a reasonable basis for our expectations and beliefs, but they are inherently uncertain. We may not realize our expectations, and our beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements. The following uncertainties and factors, among others (including those set forth under “Risk Factors”), could affect future performance and cause actual results to differ materially from those matters expressed in or implied by forward-looking statements:
● | our plans to research, develop and commercialize our product candidates; |
● | our ongoing and planned clinical trials; |
● | the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; |
● | our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; |
● | our ability to identify additional products or product candidates with significant commercial potential that are consistent with our business objectives; |
● | the rate and degree of market acceptance and clinical utility of our products; |
● | the capabilities and strategy of our suppliers and vendors including key manufacturers of our clinical drug supplies; |
● | significant competition in our industry; |
● | costs of litigation and the failure to successfully defend lawsuits and other claims against us; |
● | our partners’ ability to advance drug candidates into, and successfully complete, clinical trials; |
● | our ability to receive research funding and achieve anticipated milestones under our collaborations; |
● | our intellectual property position; |
● | loss or retirement of key members of management; |
● | costs of compliance and our failure to comply with new and existing governmental regulations; |
● | failure to successfully execute our growth strategy, including any delays in our planned future growth; and |
● | our failure to maintain effective internal controls. |
The factors, risks and uncertainties referred to above and others are more fully described under the heading “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2018 and subsequent Quarterly Reports on Form 10-Q. Forward-looking statements should be regarded solely as our current plans, estimates and beliefs. You should not place undue reliance on forward-looking statements. We cannot guarantee future results, events, levels of activity, performance or achievements. We do not undertake and specifically decline any obligation to update, republish or revise forward-looking statements to reflect future events or circumstances or to reflect the occurrences of unanticipated events.
3
PART I — FINANCIAL INFORMATION
Item1. Financial Statements
Xencor, Inc.
Balance Sheets
(In thousands, except share amounts)
| June 30, |
| December 31, | |||
2019 | 2018 | |||||
(unaudited) | ||||||
Assets | ||||||
Current assets | ||||||
Cash and cash equivalents | $ | | $ | | ||
Marketable securities | | | ||||
Accounts receivable | |
| | |||
Income tax receivable | | | ||||
Prepaid expenses and other current assets | |
| | |||
Total current assets | |
| | |||
Property and equipment, net |
| |
| | ||
Patents, licenses, and other intangible assets, net | |
| | |||
Marketable securities - long term | | | ||||
Income tax receivable | | | ||||
Other assets |
| |
| | ||
Total assets | $ | | $ | | ||
Liabilities and stockholders’ equity | ||||||
Current liabilities | ||||||
Accounts payable | $ | | $ | | ||
Accrued expenses | |
| | |||
Deferred rent | — | | ||||
Lease liabilities | | — | ||||
Deferred revenue | |
| | |||
Income tax liability |
| |
| — | ||
Total current liabilities | |
| | |||
Deferred rent, net of current portion | — | | ||||
Lease liabilities, net of current portion | | — | ||||
Deferred revenue, net of current portion | | — | ||||
Total liabilities | |
| | |||
Commitments and contingencies | ||||||
Stockholders’ equity | ||||||
Preferred stock, $ | — | — | ||||
Common stock, $ | |
| | |||
Additional paid-in capital | |
| | |||
Accumulated other comprehensive income (loss) | |
| ( | |||
Accumulated deficit |
| ( |
| ( | ||
Total stockholders’ equity |
| |
| | ||
Total liabilities and stockholders’ equity | $ | | $ | |
See accompanying notes.
4
Xencor, Inc.
Statements of Comprehensive Income (Loss)
(unaudited)
(In thousands, except share and per share data)
Three Months Ended |
| Six Months Ended | ||||||||||
June 30, |
| June 30, | ||||||||||
| 2019 |
| 2018 |
| 2019 |
| 2018 | |||||
Revenue | ||||||||||||
Collaborations, licenses, milestones, and royalties | $ | | $ | — | $ | | $ | — | ||||
Operating expenses | ||||||||||||
Research and development |
| |
| |
| |
| | ||||
General and administrative |
| |
| |
| |
| | ||||
Total operating expenses |
| |
| |
| |
| | ||||
Income (loss) from operations |
| ( |
| ( |
| |
| ( | ||||
Other income (expenses) | ||||||||||||
Interest income, net |
| |
| |
| |
| | ||||
Other expense | ( | ( | ( | ( | ||||||||
Total other income, net |
| |
| |
| |
| | ||||
Net income (loss) before income taxes | ( | ( | | ( | ||||||||
Income tax expense | | — | | — | ||||||||
Net income (loss) | ( | ( | | ( | ||||||||
Other comprehensive income (loss) | ||||||||||||
Net unrealized gain (loss) on marketable securities | | | | ( | ||||||||
Comprehensive income (loss) | $ | ( | $ | ( | $ | | $ | ( | ||||
Basic net income (loss) per common share | $ | ( | $ | ( | $ | | $ | ( | ||||
Diluted net income (loss) per common share | $ | ( | $ | ( | $ | | $ | ( | ||||
Basic weighted average common shares outstanding | | | | | ||||||||
Diluted weighted average common shares outstanding | | | | |
See accompanying notes.
5
Xencor, Inc.
Statement of Stockholders’ Equity
(in thousands, except share data)
Accumulated | |||||||||||||||||
Additional | Other | Total | |||||||||||||||
Common Stock | Paid | Comprehensive | Accumulated | Stockholders’ | |||||||||||||
Stockholders’ Equity | Shares | Amount | in-Capital | Income (Loss) | Deficit | Equity | |||||||||||
Balance, December 31, 2018 | | | | ( | ( | | |||||||||||
Issuance of common stock upon exercise of stock awards | | | | — | — | | |||||||||||
Issuance of restricted stock units | | — | — | — | — | — | |||||||||||
Comprehensive income | — | — | — | | | | |||||||||||
Stock-based compensation | — | — | | — | — | | |||||||||||
Balance, March 31, 2019 | | $ | | $ | | $ | | $ | ( | $ | | ||||||
Issuance of common stock upon exercise of stock awards | | | | — | — | | |||||||||||
Issuance of common stock under the Employee Stock Purchase Plan | | — | | — | — | | |||||||||||
Comprehensive income (loss) | — | — | — | | ( | ( | |||||||||||
Stock-based compensation | — | — | | — | — | | |||||||||||
Balance, June 30, 2019 (unaudited) | | $ | | $ | | $ | | $ | ( | $ | | ||||||
Accumulated | |||||||||||||||||
Additional | Other | Total | |||||||||||||||
Common Stock | Paid | Comprehensive | Accumulated | Stockholders’ | |||||||||||||
Stockholders’ Equity | Shares | Amount | in-Capital | Income (Loss) | Deficit | Equity | |||||||||||
Balance, December 31, 2017 | | | | ( | ( | | |||||||||||
Adoption of ASC 606 | — | — | — | — | | | |||||||||||
Balance December 31, 2017 as revised | | | | ( | ( | | |||||||||||
Sale of common stock, net of issuance cost | | | | — | — | | |||||||||||
Issuance of common stock upon exercise of stock awards | | | | — | — | | |||||||||||
Comprehensive loss | — | — | — | ( | ( | ( | |||||||||||
Stock-based compensation | — | — | | — | — | | |||||||||||
Balance, March 31, 2018 | | $ | | $ | | $ | ( | $ | ( | $ | | ||||||
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 | | — | | — | — | | |||||||||||
Comprehensive income (loss) | — | — | — | | ( | ( | |||||||||||
Stock-based compensation | — | — | | — | — | | |||||||||||
Balance, June 30, 2018 | | $ | | $ | | $ | ( | $ | ( | $ | |
See accompanying notes.
6
Xencor, Inc.
Statements of Cash Flows
(unaudited)
(in thousands)
Six Months Ended | ||||||
June 30, | ||||||
| 2019 |
| 2018 | |||
Cash flows from operating activities | ||||||
Net income (loss) | $ | | $ | ( | ||
Adjustments to reconcile net income (loss) to net cash used in operating activities: | ||||||
Depreciation and amortization |
| |
| | ||
Amortization of premium and accretion of discount on marketable securities |
| ( |
| | ||
Stock-based compensation |
| |
| | ||
Abandonment of capitalized intangible assets |
| |
| | ||
Loss on disposal of assets | | — | ||||
Changes in operating assets and liabilities: | ||||||
Accounts receivable |
| |
| ( | ||
Interest receivable | ( | ( | ||||
Prepaid expenses and other assets |
| ( |
| ( | ||
Accounts payable |
| |
| ( | ||
Accrued expenses |
| ( |
| | ||
Income taxes | | ( | ||||
Deferred rent | ( | | ||||
Lease liabilities and ROU assets | | — | ||||
Deferred revenue |
| |
| — | ||
Net cash provided by (used in) operating activities |
| |
| ( | ||
Cash flows from investing activities | ||||||
Purchase of marketable securities |
| ( |
| ( | ||
Purchase of intangible assets |
| ( |
| ( | ||
Purchase of property and equipment |
| ( |
| ( | ||
Proceeds from maturities of marketable securities | | | ||||
Repayment of loan | — | | ||||
Net cash used in investing activities |
| ( |
| ( | ||
Cash flows from financing activities | ||||||
Proceeds from issuance of common stock upon exercise of stock awards |
| |
| | ||
Proceeds from issuance of common stock under the Employee Stock Purchase Plan | | | ||||
Proceeds from issuance of common stock | — | | ||||
Common stock issuance costs | — | ( | ||||
Net cash provided by financing activities |
| |
| | ||
Net increase in cash and cash equivalents |
| |
| | ||
Cash and cash equivalents, beginning of period |
| |
| | ||
Cash and cash equivalents, end of period | $ | | $ | | ||
Supplemental disclosure of cash flow information | ||||||
Cash paid during the period for: | ||||||
Interest | $ | | $ | | ||
Income taxes | $ | | $ | | ||
Supplemental disclosures of non-cash investing activities | ||||||
Unrealized gain (loss) on marketable securities, net of tax | $ | | $ | ( |
See accompanying notes.
7
Xencor, Inc.
Notes to Financial Statements
(unaudited)
June 30, 2019
1. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited interim financial statements for Xencor, Inc. (the Company, Xencor, we or us) have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information. Certain amounts in the prior period financial statements have been revised to conform to the presentation of the current period financial statements. See “Recent Accounting Pronouncements – Pronouncements Adopted in 2019.” The financial statements include all adjustments (consisting only of normal recurring adjustments) that the management of the Company believes are necessary for a fair presentation of the periods presented. The preparation of interim financial statements requires the use of management’s estimates and assumptions that affect reported amounts of assets and liabilities at the date of the interim financial statements and the reported revenues and expenditures during the reported periods. These interim financial results are not necessarily indicative of the results expected for the full fiscal year or for any subsequent interim period.
The accompanying unaudited interim financial statements and related notes should be read in conjunction with the audited financial statements and notes thereto included in the Company’s 2018 Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 26, 2019.
Use of Estimates
The preparation of interim 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. On an ongoing basis, management evaluates its estimates, including estimates related to its accrued clinical trial and manufacturing development expenses, stock-based compensation expense, intangible assets and related amortization. Significant estimates in these interim financial statements include estimates made for accrued research and development expenses, stock-based compensation expenses, intangible assets and related amortization, estimated standalone selling price of performance obligations, and recoverability of deferred tax assets.
Intangible Assets
The Company maintains definite-lived intangible assets related to certain capitalized costs of acquired licenses and third-party costs incurred in establishing and maintaining its intellectual property rights to its platform technologies and development candidates. These assets are amortized over their useful lives, which are estimated to be the remaining patent life or the contractual term of the license. The straight-line method is used to record amortization expense. The Company assesses its intangible assets for impairment if indicators are present or changes in circumstances suggest that impairment may exist. There were
The Company capitalizes certain in-process intangible assets that are abandoned when they are no longer pursued or used in current research activities. There was no material abandonment of in-process intangible assets during the six months ended June 30, 2019 or 2018.
8
Marketable Securities
The Company has an investment policy that includes guidelines on acceptable investment securities, minimum credit quality, maturity parameters, and concentration and diversification. The Company invests its excess cash primarily in marketable debt securities issued by investment grade institutions.
The Company considers its marketable debt securities to be available-for-sale. These assets are carried at fair value and the unrealized gains and losses are included in accumulated other comprehensive income (loss). Accrued interest on marketable debt securities is included in marketable securities. If a decline in the value of a marketable debt security in the Company’s investment portfolio is deemed to be other-than-temporary, the Company writes down the security to its current fair value and recognizes a loss as a charge against income. The Company reviews its portfolio of marketable debt securities, using both quantitative and qualitative factors, to determine if declines in fair value below cost are other-than-temporary.
Recent Accounting Pronouncements
Pronouncements Adopted in 2019
Effective January 1, 2019, the Company adopted Accounting Standards Codification Topic 842 (ASC 842), Leases, which requires lessees to recognize a right-of-use (ROU) asset and a lease liability for leases with terms greater than 12 months and also requires disclosures about the amount, timing and uncertainty of cash flows arising from such leases. The Company adopted ASC 842 using the optional transition method provided under ASU 2018-11, which did not require adjustments to comparative periods nor require modified disclosures in those comparative periods. Under this method, the Company adjusted its financial statements for the cumulative effect of the adoption of ASC 842 at the beginning of January 1, 2019.
At inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances. For leases with a term of one year or longer where the Company is the lessee, ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent an obligation to make lease payments arising from the lease. ROU assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. The interest rate implicit with such leases is typically not readily determined. The Company has determined the appropriate incremental borrowing rate by reference to an estimate of the current market borrowing rate for a collateralized asset over a similar term as the lease term.
The new standard impacts our reporting of the leases to our facilities in Monrovia and San Diego. Under ASC 842, tenant allowances under such operating leases are no longer tracked separately as a deferred rent liability; instead, it is integrated as part of the ROU asset. As a result, we recorded an adjustment of the cumulative effect to the beginning balance for deferred rent liability and adopted the use of ROU asset and lease liability. We recorded lease liabilities of $
Effective January 1, 2019, the Company adopted ASU No. 2018-07, Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting, which expands the scope of Topic 718 to include share-based payments issued to nonemployees for goods and services. The standard requires a modified retrospective transition approach, with a cumulative adjustment to retained earnings as of adoption date, for all liability-classified awards that have not been settled as of the adoption date and equity-classified nonemployee awards for which a measurement date has not been established. The adoption of this standard did not have any impact on the Company’s financial statements.
There have been no other material changes to the significant accounting policies previously disclosed in the Company’s 2018 Annual Report on Form 10-K.
9
2. Fair Value of Financial Instruments
Financial instruments included in the financial statements include cash equivalents, marketable securities, accounts receivable, accounts payable and accrued expenses. Marketable securities and cash equivalents are carried at fair value. The fair value of the other financial instruments closely approximates their fair value due to their short-term maturities.
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). 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. The ASC 820 hierarchy ranks the quality of reliable inputs, or assumptions, used in the determination of fair value and requires assets and liabilities carried at fair value to be classified and disclosed in one of the following three categories:
Level 1—Fair Value is determined by using unadjusted quoted prices that are available in active markets for identical assets or liabilities.
Level 2—Fair Value is determined by using inputs other than Level 1 quoted prices that are directly or indirectly observable. Inputs can include quoted prices for similar assets or liabilities in active markets or quoted prices for identical assets or liabilities in markets that are not active. Related inputs can also include those used in valuation or other pricing models, such as interest rates and yield curves that can be corroborated by observable market data.
Level 3—Fair value is determined by inputs that are unobservable and not corroborated by market data. Use of these inputs involves significant and subjective judgments to be made by the reporting entity –e.g. determining an appropriate discount factor for illiquidity associated with a given security.
The Company measures the fair value of financial assets using the highest level of inputs that are reasonably available as of the measurement date. The assets recorded at fair value are classified within the hierarchy as follows for the periods reported (in thousands):
June 30, 2019 | December 31, 2018 | |||||||||||||||||
| Total |
|
|
| Total |
|
| |||||||||||
Fair Value | Level 1 | Level 2 | Fair Value | Level 1 | Level 2 | |||||||||||||
Money Market Funds | $ | | $ | | $ | — | $ | | $ | | $ | — | ||||||
Corporate Securities | | — | | | — | | ||||||||||||
Government Securities | | — | |
| | — | | |||||||||||
$ | | $ | | $ | | $ | | $ | | $ | |
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. During the three and six months ended June 30, 2019 and 2018, there were
10
3. Net Income (Loss) Per Share
We compute basic net income (loss) per common share 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. Diluted net income (loss) per 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. The treasury stock method is used to determine the dilutive effect of the Company’s stock option grants, employee stock purchase plan (ESPP) and restricted stock units (RSUs). Potentially dilutive securities consisting of stock issuable under options, ESPP and RSUs are not included in the per common share calculation in periods where there is a net loss where the inclusion of such shares would have had an antidilutive effect.
Basic and diluted net income (loss) per common share is computed as follows (in thousands except share and per share data):
Three Months Ended |
| Six Months Ended | ||||||||||
June 30, | June 30, | |||||||||||
| 2019 |
| 2018 |
| 2019 |
| 2018 | |||||
(in thousands, except share and per share data) | ||||||||||||
Numerator: | ||||||||||||
Net income (loss) attributable to common stockholders | $ | ( | $ | ( | $ | | $ | ( | ||||
Denominator: | ||||||||||||
Weighted-average common shares outstanding used in computing basic net income (loss) |
| |
| |
| |
| | ||||
Weighted-average common shares outstanding used in computing diluted net income (loss) | | | | | ||||||||
Basic net income (loss) per common share | $ | ( | $ | ( | $ | | $ | ( | ||||
Diluted net income (loss) per common share | $ | ( | $ | ( | $ | | $ | ( |
For the three months ended June 30, 2019 and the three and six months ended June 30, 2018, all outstanding potentially dilutive securities have been excluded from the calculation of diluted net loss per common share as the effect of including such securities would have been antidilutive. For the six months ended June 30, 2019, potentially dilutive securities were included in the diluted net income per common share calculation.
The number of common stock equivalents that were included in the calculation of the weighted-average common shares outstanding used in computing diluted net income per common share consists of
The table below summarizes the number of common stock equivalents that were excluded in the calculation of the weighted-average common shares outstanding used in computing diluted net income (loss) because the inclusion of such shares would have had an antidilutive effect as follows:
Three Months Ended |
| Six Months Ended | ||||||
June 30, |
| June 30, | ||||||
| 2019 |
| 2018 |
| 2019 |
| 2018 | |
(in thousands) |
| (in thousands) | ||||||
Options to purchase common stock and RSU grants |
| |
| | — |
| |
11
4. Comprehensive Income (Loss)
Comprehensive income (loss) is comprised of net income (loss) and other comprehensive income (loss). For the three and six months ended June 30, 2019 and 2018, the only component of other comprehensive income (loss) is net unrealized gain (loss) on marketable securities. There were no material reclassifications out of accumulated other comprehensive income (loss) during the three and six months ended June 30, 2019 and 2018.
5. Marketable Securities
The Company’s marketable debt securities held as of June 30, 2019 and December 31, 2018 are summarized below:
Gross | Gross | |||||||||||
| Amortized |
| Unrealized | Unrealized |
| |||||||
June 30, 2019 | Cost | Gains | Losses | Fair Value | ||||||||
(in thousands) | ||||||||||||
Money Market Funds | $ | | $ | — | $ | — | $ | | ||||
Corporate Securities | | | ( | | ||||||||
Government Securities | | | ( | | ||||||||
$ | | $ | | $ | ( | $ | | |||||
Reported as | ||||||||||||
Cash and cash equivalents | $ | | ||||||||||
Marketable securities | | |||||||||||
Total investments | $ | | ||||||||||
Gross | Gross | |||||||||||
| Amortized |
| Unrealized | Unrealized |
| |||||||
December 31, 2018 | Cost | Gains | Losses | Fair Value | ||||||||
(in thousands) | ||||||||||||
Money Market Funds | $ | | $ | — | $ | — | $ | | ||||
Corporate Securities | | | ( | | ||||||||
Government Securities | | | ( | | ||||||||
$ | | $ | | $ | ( | $ | | |||||
Reported as | ||||||||||||
Cash and cash equivalents | $ | | ||||||||||
Marketable securities | | |||||||||||
Total investments | $ | |
12
The maturities of the Company’s marketable debt securities are as follows:
Amortized |
| Estimated | ||||
June 30, 2019 | Cost | Fair Value | ||||
(in thousands) | ||||||
Mature in one year or less | $ | | $ | | ||
Mature within two years | | | ||||
$ | | $ | |
The unrealized losses on available-for-sale investments and their related fair values as of June 30, 2019 and December 31, 2018 are as follows:
Less than 12 months | 12 months or greater | |||||||||||
June 30, 2019 | Fair value | Unrealized losses | Fair value | Unrealized losses | ||||||||
(in thousands) | ||||||||||||
Corporate Securities | $ | | $ | ( | $ | — | $ | — | ||||
Government Securities | | ( | — | — | ||||||||
$ | | $ | ( | $ | — | $ | — | |||||
Less than 12 months | 12 months or greater | |||||||||||
December 31, 2018 | Fair value | Unrealized losses | Fair value | Unrealized losses | ||||||||
(in thousands) | ||||||||||||
Corporate Securities | $ | | $ | ( | $ | | $ | ( | ||||
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.
The Company does not intend to sell these securities, and it is not more likely than not that the Company will be required to sell the securities before recovery of the amortized cost basis. Therefore, the Company did not consider these securities to be other-than-temporarily impaired as of June 30, 2019 or December 31, 2018.
6. Sale of Additional Common Stock
In March 2018, we completed the sale of
13
7. Stock Based Compensation
Our Board of Directors and the requisite stockholders previously approved the 2010 Equity Incentive Plan (the 2010 Plan). In October 2013, our Board of Directors approved the 2013 Equity Incentive Plan (the 2013 Plan) and in November 2013 our stockholders approved the 2013 Plan which became effective as of December 3, 2013. As of December 2, 2013, we suspended the 2010 Plan and
As of June 30, 2019, the total number of shares of common stock available for issuance under the 2013 Plan is
In November 2013, our Board of Directors and stockholders approved the 2013 Employee Stock Purchase Plan (ESPP), which became effective as of December 5, 2013. We have reserved a total of
During the six months ended June 30, 2019, the Company awarded
Total employee, director and non-employee stock-based compensation expense recognized for the three and six months ended June 30, 2019 and 2018 are as follows (in thousands):
Three Months Ended |
| Six Months Ended | ||||||||||
June 30, |
| June 30, | ||||||||||
| 2019 |
| 2018 |
| 2019 |
| 2018 | |||||
General and administrative | $ | | $ | | $ | | $ | | ||||
Research and development |
| |
| |
| |
| | ||||
$ | | $ | | $ | | $ | | |||||
Three Months Ended | Six Months Ended | |||||||||||
June 30, | June 30, | |||||||||||
2019 |
| 2018 | 2019 |
| 2018 | |||||||
Stock options | $ | | $ | | $ | | $ | | ||||
ESPP | | | | | ||||||||
Restricted stock units | | | | | ||||||||
$ | | $ | | $ | | $ | |
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The following table summarizes option activity under our stock plans and related information:
|
|
| Weighted |
| Weighted | ||||||
Average |
| Average | |||||||||
Number of | Exercise |
| Remaining | Aggregate | |||||||
Shares subject | Price |
| Contractual | Intrinsic | |||||||
to outstanding | (Per |
| Term | Value | |||||||
options | Share) |
| (in years) | (in thousands) | |||||||
Balances at December 31, 2018 |
| | $ | | |||||||
Options granted |
| | $ | | |||||||
Options forfeited |
| ( | $ | | |||||||
Options exercised |
| ( | $ | | |||||||
Balances at June 30, 2019 |
| | $ | | $ | | |||||
Exercisable | | $ | | $ | |
We calculate the intrinsic value as the difference between the exercise price of the options and the closing price of common stock of $
Weighted average fair value of options granted during the six-month periods ended June 30, 2019 and 2018 were $
Options | Options |
| |||||||
Three Months Ended | Six Months Ended | ||||||||
June 30, | June 30, |
| |||||||
| 2019 |
| 2018 |
| 2019 |
| 2018 |
| |
Expected term (years) |
|
| |||||||
Expected volatility | | % | | % | | % | | % | |
Risk-free interest rate | | % | | % | | % | | % | |
Expected dividend yield | — | % | — | % | — | % | — | % |
ESPP | ESPP |
| |||||||
Three Months Ended | Six Months Ended |
| |||||||
June 30, | June 30, |
| |||||||
| 2019 |
| 2018 |
| 2019 |
| 2018 |
| |
Expected term (years) |
|
|
| ||||||
Expected volatility | % | % | % | % | |||||
Risk-free interest rate |
| % | % | % | % | ||||
Expected dividend yield | — | % | — | % | — | % | — | % |
As of June 30, 2019, the unamortized compensation expense related to unvested stock options was $
15
The following table summarizes the RSU activity for the six-month period ended June 30, 2019:
Weighted | |||||
Restricted | Average Grant | ||||
Stock | Date Fair Value | ||||
Units | (Per unit) | ||||
Unvested at December 31, 2018 |
| | $ | | |
Granted |
| | | ||
Vested |
| ( | | ||
Forfeited |
| ( | | ||
Unvested at June 30, 2019 |
| | $ | |
As of June 30, 2019, the unamortized compensation expense related to unvested restricted stock units was $
8. Leases
The Company leases office and laboratory space in Monrovia, CA under a lease that continues through June 2020, with an
The Company also leases office space in San Diego, CA through July 2020 which includes an option to renew for an additional
The Company leases additional office space in San Diego, CA through August 2022, with an option to extend for an additional
Our lease agreements do not contain any residual value guarantees or restrictive covenants. As of June 30, 2019, 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 June 30, 2019 to the operating lease liabilities recorded on the balance sheet (in thousands):
Years ending December 31, | |||
For the remainder of 2019 | $ | | |
2020 |
| | |
2021 | | ||
2022 | | ||
2023 | | ||
2024 | | ||
Thereafter | | ||
Total undiscounted lease payments | | ||
Less: Imputed interest | ( | ||
Present value of lease payments | $ | | |
Lease liabilities - short-term | $ | | |
Lease liabilities - long-term | | ||
Total lease liabilities | $ | |
16
Our operating lease cost and the cash payments for operating leases for the six months ended June 30, 2019 were $
At June 30, 2019, the weighted-average remaining lease term for operating leases was
9. Commitments and Contingencies
From time to time, the Company may be subject to various litigation and related 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.
We are obligated to make future payments to third parties under in-license agreements, including sublicense fees, royalties, and payments that become due and payable on the achievement of certain development and commercialization milestones. As the amount and timing of sublicense fees and the achievement and timing of these milestones are not probable and estimable, such commitments have not been included on our balance sheet. We have also entered into agreements with third-party vendors which will require us to make future payments upon the delivery of goods and services in future periods.
10. Collaboration and Licensing Agreements
The following is a summary description of the material revenue arrangements, including arrangements that generated revenue in the six months ended June 30, 2019 and 2018.
Genentech
In February 2019, the Company entered into a collaboration and license agreement (the Genentech Agreement) with Genentech, Inc. and F. Hoffman-La Roche LTD (collectively, Genentech) for the development and commercialization of novel IL-15 collaboration products (Collaboration Products), including XmAb24306, the Company’s IL-15/IL-15Ra candidate. The Genentech Agreement became effective March 8, 2019.
Under the terms of the Genentech Agreement, Genentech received an exclusive worldwide license to XmAb24306 and other Collaboration Products, including any new IL-15 programs identified during the joint research collaboration. Genentech and Xencor will jointly collaborate on worldwide development of XmAb24306 and other Collaboration Products with Genentech maintaining all worldwide commercialization rights, subject to Xencor having an option to co-promote in the United States. Xencor has the right to perform clinical studies of Collaboration Products in combination with other therapeutic agents at its own cost, subject to certain requirements.
The term of the Genentech Agreement will continue on a program-by-program and country-by-country basis until there are
17
The Company received a $
Pursuant to the Genentech Agreement, XmAb24306 is designated as a development program and all costs incurred for developing XmAb24306 from the effective date of the Genentech Agreement are being shared with Genentech under the initial cost-sharing percentage.
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. The
The Company evaluated the Genentech Agreement under the provisions of ASU No. 2014-09, Revenue from Contracts with Customers and all related amendments (collectively, ASC 606) and also ASC 808, Collaborative Arrangements. Certain provisions of the Genentech Agreement including the cost-sharing of development programs are governed by ASC 808. We have determined that Genentech is a customer for purposes of the delivery of specific performance obligations under the Genentech Agreement and applied the provisions of ASC 606 to the transaction.
The Company evaluated the Genentech Agreement under ASC 606 and identified the following performance obligations under the Agreement: (i) the license of XmAb24306 and (ii) research services during a
The Company determined the standalone selling price of the license to be $
The Company determined that the transaction price of the Genentech Agreement at inception was $
18
The Company allocated the transaction price to each of the separate performance obligation using the relative standalone selling price with $
The Company recognized the $
For the three and six months ended June 30, 2019, we recognized $
Astellas
Effective March 29, 2019, the Company entered into a Research and License Agreement (Astellas Agreement) with Astellas Pharma Inc. (Astellas) pursuant to which the Company and Astellas will conduct a discovery program to characterize compounds and products for development and commercialization. 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.
Pursuant to the Astellas Agreement, the Company will apply its bispecific Fc technology to an antigen pair provided by Astellas to generate bispecific antibody candidates and will conduct limited testing and characterization of the bispecific candidates and return the candidates to Astellas for development and commercialization. The activities will be conducted under a research plan agreed to by both parties to the Astellas Agreement. Astellas will assume full responsibility for development and commercialization of the antibody candidate. Pursuant to the Astellas Agreement, the Company received an upfront payment of $
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. 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.
Astellas will control and benefit from the antibodies that are delivered. The Astellas Agreement provides Astellas the right to sublicense the antibody to third parties and Astellas has significant experience and capabilities in developing and commercializing clinical candidates and is capable of performing these activities from the delivered antibodies without the Company’s involvement.
The Company determined the standalone selling price of the bispecific deliverable to be $
19
The Company determined that the transaction price of the Astellas Agreement at inception was $
The Company allocated the transaction price to each of the separate performance obligations using the relative standalone selling price with $
The Company recognized the $
For the three and six months ended June 30, 2019, we recognized $
Novartis
In June 2016, the Company entered into a Collaboration and License Agreement (Novartis Agreement) with Novartis Institutes for BioMedical Research, Inc. (Novartis), to develop and commercialize bispecific and other Fc engineered antibody drug candidates using the Company’s proprietary XmAb technologies and drug candidates. Pursuant to the Novartis Agreement:
● | The Company granted Novartis certain exclusive rights to research, develop and commercialize XmAb14045 and XmAb13676, |
● | The Company will apply its bispecific technology in up to |
● | The Company will provide Novartis with a non-exclusive license to certain of its Fc technologies to apply against up to |
Under the Novartis Agreement, the Company and Novartis are co-developing XmAb14045 worldwide and sharing development costs.
In December 2018, Novartis notified us that they were returning their rights to the XmAb13676 program. Pursuant to the terms of the Novartis Agreement, the rights to the XmAb13676 program reverted to us in June 2019 and Novartis’ obligation to fund its share of XmAb13676 development costs will continue through June 2020.
We completed delivery of a Global Discovery Program in 2017 and delivery of a second Global Discovery Program in 2018.
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.
During each of the three and six months ended June 30, 2019 and 2018, there was
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Amgen Inc.
In September 2015, the Company entered into a research and license agreement (the Amgen Agreement) with Amgen Inc. (Amgen) to develop and commercialize bispecific antibody product candidates using the Company’s proprietary XmAb bispecific Fc technology. Under the Amgen Agreement, the Company granted an exclusive license to Amgen to develop and commercialize bispecific drug candidates from the Company’s preclinical program that bind the CD38 antigen and the cytotoxic T-cell binding domain CD3 (the CD38 Program). The Company also agreed to apply its bispecific technology to five previously identified Amgen provided targets (each a Discovery Program). The Company received a $
Pursuant to the Amgen Agreement, the Company applied its bispecific technology to
Amgen assumed full responsibility for development and commercialization of product candidates under each of the Discovery Programs.
During each of the three and six months ended June 30, 2019 and 2018,
MorphoSys Ag
In June 2010, the Company entered into a Collaboration and License Agreement with MorphoSys AG (MorphoSys) for a worldwide license to the Company’s patents and know-how to research, develop and commercialize our drug candidate XmAb5574 (subsequently renamed MOR208 and tafasitamab) with the right to sublicense under certain conditions. Under the agreement, the Company agreed to collaborate with MorphoSys to develop and commercialize tafasitamab. If certain developmental, regulatory and sales milestones are achieved, the Company is eligible to receive future milestone payments and royalties.
In June 2017, MorphoSys initiated a Phase 3 clinical trial under the arrangement for which the Company received a milestone payment of $
There were
Alexion Pharmaceuticals, Inc.
In January 2013, the Company entered into an option and license agreement with Alexion Pharmaceuticals, Inc. (Alexion). 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 to evaluate and advance compounds against
21
The Company is eligible to receive contractual milestones for certain regulatory and commercial achievements and is also entitled to receive royalties based on a percentage of net sales of Ultomiris sold by Alexion, its affiliates or its sub licensees, which percentage is in the low single digits. 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.
In the third quarter of 2018, Alexion completed certain regulatory submission filings for ALXN1210, and the Company received $
In the second quarter of 2019, Alexion received marketing authorization from Japan’s Ministry of Health, Labour and Welfare, and the Company earned a $
Under ASC 606, we recognize revenue for sales-based royalties upon the subsequent sale of the product. We began earning royalty revenue from the sale of Ultomiris in the United States in 2019. For the six months ended June 30, 2019, we have estimated royalty revenue of $
We recognized $
Boehringer Ingelheim International GmbH
In 2007, the Company entered into a Research Licensee and Collaboration Agreement with Boehringer Ingelheim International GmbH (BI). Under the agreement, the Company provided BI with a
INmune Bio, Inc.
In October 2017, the Company entered into a License Agreement with INmune Bio, Inc. (INmune). Under the terms of the agreement, the Company provided INmune with an exclusive license to certain rights to a proprietary protein, XPRO1595. Under the agreement the Company received an upfront payment of $
The equity interest in INmune constituted of
In 2018, INmune filed a registration statement on Form S-1 with the Securities and Exchange Commission (SEC) which was declared effective by the SEC as of December 19, 2018.
The Company did not recognize any revenue related to the agreement for the three and six months ended June 30, 2019 and 2018. There is
22
Revenue earned
The revenues recorded for the three and six months ended June 30, 2019 were earned principally from the following licensees (in millions):
Three Months Ended |
| Six Months Ended | ||||||||||
June 30, |
| June 30, | ||||||||||
2019 | 2018 |
| 2019 | 2018 | ||||||||
Alexion |
| $ | |
| $ | — | $ | |
| $ | — | |
Astellas | | — | | — | ||||||||
Genentech | |
| — | |
| — | ||||||
Total | $ | | $ | — | $ | | $ | — |
The below table summarizes the disaggregation of revenue recorded for the three and six months ended June 30, 2019 (in millions):
Three Months Ended |
| Six Months Ended | ||||||||||
June 30, |
| June 30, | ||||||||||
2019 | 2018 |
| 2019 | 2018 | ||||||||
Research collaboration |
| $ | |
| $ | — | $ | |
| $ | — | |
Milestone | |
| — | |
| — | ||||||
Licensing | — |
| — | |
| — | ||||||
Royalties | | — | | — | ||||||||
Total | $ | | $ | — | $ | | $ | — |
Remaining Performance Obligations and Deferred Revenue
Our remaining performance obligations are delivery of Global Discovery Programs under the Novartis Agreement and the conduct of research activities pursuant to research plans under the Genentech and Astellas Agreements. As of June 30, 2019 and 2018, we have deferred revenue of $
11. Income taxes
The provision for income taxes of $0.1 and $0.9 million for the three and six months ended June 30, 2019 represents the interim period tax allocation of the state alternative minimum tax based on the Company’s projected year-end effective income tax rates which cannot be offset by the Company’s net operating loss carryforwards. The Company has a federal income tax receivable of $
23
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis should be read in conjunction with our financial statements and accompanying notes included in this Quarterly Report on Form 10-Q and the financial statements and accompanying notes thereto for the fiscal year ended December 31, 2018 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K for the year ended December 31, 2018. See also “Special Note Regarding Forward-Looking Statements” included in this Quarterly Report on Form 10-Q.
Company Overview
We are a clinical-stage biopharmaceutical company focused on discovering and developing engineered monoclonal antibody and other protein therapeutics to treat severe and life-threatening diseases with unmet medical needs. We are developing a suite of clinical-stage drug candidates from our proprietary XmAb® technology platforms that are designed to treat cancer, autoimmune and allergic diseases, and other conditions. In contrast to conventional approaches to antibody design, which focus on the portion of antibodies that interact with target antigens, our protein engineering efforts and the XmAb technologies are focused on the portion of the antibody that interacts with multiple segments of the immune system and controls antibody structure. This portion, referred to as the Fc domain, is constant and interchangeable among antibodies. Our engineered Fc domains, the XmAb technology, can be readily substituted for natural Fc domains.
Our business strategy is based on the plug-and-play nature of the XmAb technology, allowing us to create new antibody drug candidates for our internal development or licensing, or to selectively license access to one or more of our XmAb technologies to pharmaceutical or biotechnology companies to use in developing their own proprietary antibodies with improved properties.
There are currently 14 antibody product candidates that are being advanced in clinical trials by us or by our partners that have been engineered with our XmAb technologies. The most recent expansion of our platform is the XmAb bispecific Fc domains, which enable the rapid design and simplified development of antibodies, and other protein structures, that bind two or more different targets simultaneously using an engineered heterodimer Fc domain. These bispecific Fc domains are used to generate a broad array of novel drug candidates.
The initial bispecific antibody candidates that we designed contain an anti-tumor associated antigen binding domain and a second binding domain targeted to CD3, an activating receptor on T cells. We are advancing three CD3 bispecific candidates through clinical development: XmAb14045, XmAb13676, and XmAb18087.
● | XmAb14045 is a bispecific antibody that targets CD123, an antigen on acute myeloid leukemia (AML) cells and leukemic stem cells, and CD3, a cytotoxic T-cell binding domain. It is being developed in collaboration with Novartis and is being evaluated in a Phase 1 study. In September 2016, we dosed the first patient in an open-label, multiple-dose, dose escalation study to assess the safety, tolerability, and preliminary anti-tumor activity of XmAb14045 in patients with relapsed or refractory AML and other CD123-expressing hematologic malignancies. We presented initial data from the study in December 2018 at the American Society of Hematology (ASH) Annual Meeting. The data presented indicated multiple complete remissions had been achieved with weekly dosing of XmAb14045 in this heavily-pretreated patient population. |
In April 2019, the FDA lifted the partial clinical hold that had been placed on the Phase 1 study of XmAb14045 in February 2019, when we received notice from the FDA placing the XmAb14045 study on partial clinical hold due to safety issues of cytokine release syndrome and pulmonary toxicities. The FDA’s decision to lift the hold followed discussion and agreement on amendments to the study protocol, including guidance on the monitoring and clinical management of cytokine release syndrome. In July 2019, we resumed enrolling patients in the trial based on the amended protocol.
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● | XmAb13676 is a bispecific antibody that targets CD20, an antigen on B-cell tumors, and CD3 for the treatment of B-cell malignancies. In February 2017, we dosed the first patient in an open-label, Phase 1, multiple-dose, dose escalation study to assess the safety, tolerability, and preliminary anti-tumor activity of XmAb13676 in patients with B-cell malignancies. This program was also partnered with Novartis pursuant to the Novartis Agreement. In December 2018, as part of a strategic realignment of their pipeline, Novartis notified us of its decision to return its rights to XmAb13676. The Novartis rights to XmAb13676 reverted to us in June 2019. We continue to develop XmAb13676 as planned and expect to present initial data from the Phase 1 study in the second half of 2019. |
● | XmAb18087 is a bispecific antibody that targets somatostatin receptor 2 (SSTR2) and the cytotoxic T-cell binding domain CD3 for the treatment of neuroendocrine tumors (NET) and gastrointestinal stromal tumors (GIST). In February 2018, we dosed the first patient in a Phase 1 study. XmAb18087 is our first CD3 bispecific to be evaluated in solid tumors. We expect to provide initial data from this study in the first half of 2020. |
We are also advancing a suite of tumor microenvironment (TME) activators that have been designed to promote tumor-selective T-cell activation by targeting multiple checkpoint or co-stimulatory receptors. We are advancing three TME activator candidates in development: XmAb20717, XmAb22841, and XmAb23104:
● | XmAb20717 simultaneously targets PD-1 and CTLA-4, both immune checkpoint receptors, and is being developed in broad oncology indications including solid tumors. In July 2018, we dosed the first patient in an open label, Phase 1 dose-escalation study to assess the safety, tolerability, and preliminary anti-tumor activity of XmAb20717 in patients with selected solid tumors. We expect to provide initial data from this study in the first half of 2020. |
● | XmAb23104 targets PD-1 and ICOS, an immune co-stimulatory receptor, and is being developed for multiple oncology indications. In May 2019, we dosed the first patient in an open-label, Phase 1, dose-escalation study to assess the safety, tolerability and preliminary anti-tumor activity of XmAb23104 in patients with selected solid tumors. |
● | XmAb22841 targets CTLA-4 and LAG-3, also an immune checkpoint receptor, and is being developed for multiple indications. We intend to advance XmAb22841 in combination with an anti-PD-1 drug to create a triple checkpoint blockade. In May 2019, we dosed the first patient in an open-label, Phase 1, dose-escalation study to assess the safety, tolerability, and preliminary anti-tumor activity of XmAb22841 in patients with selected solid tumors. |
In 2018, we expanded our bispecific Fc platform with the design of our novel cytokine candidates. These cytokines are built on our bispecific Fc domain and have potency tuned to improve therapeutic index. These candidates also incorporate our Xtend technology for longer duration of action.
● | Our first cytokine candidate is XmAb24306, an IL15/IL15-receptor alpha complex fused to a bispecific Fc domain (IL15/IL15Ra-Fc). We believe a broad combination development strategy will be critical to realize the potential of IL-15 cytokines like XmAb24306. In February 2019, we entered into the Genentech Agreement to develop and commercialize novel IL-15 cytokine therapeutics, whereby the companies will co-develop XmAb24306 and other potential IL-15 programs. |
XmAb24306 is currently in Investigational New Drug application (IND)-enabling studies, and we will support Genentech’s efforts to submit an IND for this candidate, which is currently expected in the second half of 2019.
We have also created a suite of wholly-owned compounds using our Immune Inhibitor Fc Domain.
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● | XmAb5871 uses our XmAb Immune Inhibitor Fc Domain and targets CD19 with its variable domain, which is designed to inhibit the function of B cells, an important component of the immune system. We have completed Phase 2 clinical trials for XmAb5871 in three autoimmune diseases: Systemic Lupus Erythematosus (SLE), IgG4-Related Disease (IgG4-RD), and Rheumatoid Arthritis (RA). |
We have also completed an additional Phase 1 trial for a subcutaneous formulation of XmAb5871.
We believe that the data from the studies of XmAb5871 in patients with SLE and IgG4-RD support further development in these indications and show the potential of XmAb5871 in other B-cell mediated autoimmune indications. We are seeking to partner XmAb5871 with a partner that has the infrastructure and resources to continue late-stage development of XmAb5871 and maximize the potential of this candidate for a broad set of patient populations.
● | XmAb7195 uses our Immune Inhibitor Fc Domain and is being developed for the treatment of severe asthma and allergic diseases. In May 2016, we reported complete data from the Phase 1a trial with XmAb7195 treating patients with high baseline IgE levels. In 2017, we announced data from a Phase 1b trial for XmAb7195 with a subcutaneous formulation. The data from the trial showed that subcutaneous administration of XmAb7195 was well tolerated and effective at reducing free and total IgE levels in patients in the study. The results support subcutaneous delivery for future development. We are seeking a development partner for XmAb7195. |
Licensing partnerships: We have eight partnership for the licensing of our XmAb technologies and XmAb candidates. These arrangements provide upfront payments, annual licensing fees, potential milestone payments and royalties as our partners advance compounds that incorporate our technology through clinical development. These payments provide us with multiple revenue streams that help fund development of our product candidates and usually require limited resources or efforts from us. Where possible, we structure such transactions to retain long-term value in the drug candidates through profit-split arrangements or retaining commercial rights to geographic areas. In the first half of 2019, we have entered into collaborations and licensing transactions with Genentech and Astellas for which we received upfront payments of $120.0 million and $15.0 million, respectively.
The most advanced program where we have licensed our technology is Alexion’s Ultomiris®, formerly ALXN1210. Alexion has received marketing authorizations from regulatory agencies in the U.S., Europe, and Japan for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
Examples of other antibodies which we have licensed to other pharmaceutical and biotechnology companies for further development include tafasitamab (MOR208), an antibody in Phase 3 development by our licensee MorphoSys, and AMG424, a CD38 x CD3 bispecific antibody which we licensed to Amgen. As part of our 2015 Amgen collaboration, we also created and licensed to Amgen the bispecific antibody AMG509, which is being developed for patients with prostate cancer. In 2017, MorphoSys advanced tafasitamab into a Phase 3 clinical trial and MorphoSys has indicated plans to submit a Biologics License Application (BLA) to the FDA in the second half of 2019. Amgen has started a Phase 1 study for AMG424 and also has initiated IND enabling activities for AMG509.
We have over 750 issued and pending patents worldwide to protect our XmAb technology platform and XmAb drug candidates.
Since we commenced active operations in 1998, we have devoted substantially all our resources to staffing our company, business planning, raising capital, developing our technology platforms, identifying potential product candidates, undertaking pre-clinical and IND-enabling studies and conducting clinical trials. We have no products approved for commercial sale and have not generated any revenues from product sales, and we continue to incur significant research and development expenses and other expenses related to our ongoing operations. To date, we have funded our operations primarily through the sale of stock and from payments generated from our product development partnerships and licensing arrangements.
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As of June 30, 2019, we had an accumulated deficit of $259.3 million. Substantially all of the operating losses that we have incurred resulted from expenses incurred in connection with our product candidate development programs, our research activities and general and administrative costs associated with our operations.
Results of Operations
Comparison of the Three Months Ended June 30, 2019 and 2018
The following table summarizes our results of operations for the three months ended June 30, 2019 and 2018 (in millions):
Three Months Ended |
| |||||||||
June 30, |
| |||||||||
| 2019 |
| 2018 |
| Change |
| ||||
Revenues: | ||||||||||
Research collaboration |
| $ | 14.4 | $ | — | $ | 14.4 | |||
Milestone | 4.0 | — | 4.0 | |||||||
Royalties | 1.1 | — | 1.1 | |||||||
Total revenues |
| 19.5 | — | 19.5 | ||||||
Operating expenses: | ||||||||||
Research and development | 33.3 |
| 23.3 | 10.0 | ||||||
General and administrative | 5.8 |
| 5.0 | 0.8 | ||||||
Total operating expenses | 39.1 |
| 28.3 | 10.8 | ||||||
Other income, net |
| 3.6 |
| 2.4 | 1.2 | |||||
Income (loss) before income taxes | (16.0) | (25.9) | 9.9 | |||||||
Income tax expense | — | — | — | |||||||
Net income (loss) | $ | (16.0) | $ | (25.9) | $ | 9.9 |
Revenues
Revenues recognized for the three months ended June 30, 2019 are from research collaboration revenue recognized under the Genentech and Astellas Agreements as well as milestones and royalties received from Alexion.
Research and Development Expenses
The following table summarizes our research and development expenses for the three months ended June 30, 2019 and 2018 (in millions):
Three Months Ended | |||||||||
June 30, | |||||||||
| 2019 |
| 2018 |
| Change | ||||
Product programs: | |||||||||
XmAb5871 programs |
| $ | 6.6 | $ | 5.6 | $ | 1.0 | ||
XmAb7195 programs | 0.1 |
| 0.1 |
| — | ||||
Bispecific programs: | |||||||||
CD3* | 8.5 | 5.5 | 3.0 | ||||||
Tumor micro environment (TME) activators | 6.4 | 8.3 | (1.9) | ||||||
Cytokines* | 7.3 | 1.6 | 5.7 | ||||||
Subtotal Bi-specific programs | 22.2 |
| 15.4 | 6.8 | |||||
Other, research and early stage programs | 4.4 |
| 2.2 |
| 2.2 | ||||
Total research and development expenses |
| $ | 33.3 | $ | 23.3 | $ | 10.0 |
*Net of reimbursements from our partners pursuant to agreements that include cost-sharing arrangements.
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Research and development expenses increased by $10.0 million for the three months ended June 30, 2019 over the same period in 2018 due to increases in stock-based compensation charges and additional spending on our pipeline of bispecific candidates. Increased spending in development activities for our bispecific cytokines and CD3 candidates and technologies were offset by decreased spending in our TME activator candidates.
General and Administrative Expenses
The following table summarizes our general and administrative expenses for the three months ended June 30, 2019 and 2018 (in millions):
Three Months Ended |
| |||||||||
June 30, |
| |||||||||
| 2019 |
| 2018 |
| Change |
| ||||
General and administrative |
| $ | 5.8 | $ | 5.0 |
| $ | 0.8 |
General and administrative expenses increased by $0.8 million for the three months ended June 30, 2019 over the same period in 2018 primarily due to additional spending on expenses related to personnel and professional services.
Other Income, Net
Other income, net was $3.6 million and $2.4 million for the three months ended June 30, 2019 and 2018, respectively. The increase in other income, net was primarily from higher interest income from our investments in 2019.
Comparison of the Six Months Ended June 30, 2019 and 2018
The following table summarizes our results of operations for the six months ended June 30, 2019 and 2018 (in millions):
Six Months Ended |
| |||||||||
June 30, |
| |||||||||
| 2019 |
| 2018 |
| Change |
| ||||
Revenues: | ||||||||||
Research collaboration |
| $ | 14.7 | $ | — | $ | 14.7 | |||
Milestone | 4.0 |
| — | 4.0 | ||||||
Licensing | 111.6 | — |
| 111.6 | ||||||
Royalties | 1.1 | — | 1.1 | |||||||
Total revenues |
| 131.4 | — | 131.4 | ||||||
Operating expenses: | ||||||||||
Research and development | 61.5 |
| 49.4 |
| 12.1 | |||||
General and administrative | 11.3 |
| 9.5 | 1.8 | ||||||
Total operating expenses | 72.8 |
| 58.9 | 13.9 | ||||||
Other income, net |
| 6.3 |
| 3.5 | 2.8 | |||||
Loss before income taxes | 64.9 | (55.4) | 120.3 | |||||||
Income tax expense | 0.9 | — | 0.9 | |||||||
Net loss | $ | 64.0 | $ | (55.4) | $ | 119.4 |
Revenues
Revenues recognized for the six months ended June 30, 2019 are primarily from licensing and collaboration revenue recognized under the Genentech and Astellas Agreements. Milestone and royalty revenue reflect revenue earned from Alexion in the period.
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Research and Development Expenses
The following table summarizes our research and development expenses for the six months ended June 30, 2019 and 2018 (in millions):
Six Months Ended | |||||||||
June 30, | |||||||||
| 2019 |
| 2018 |
| Change | ||||
Product programs: | |||||||||
XmAb5871 programs |
| $ | 13.2 | $ | 11.9 | $ | 1.3 | ||
XmAb7195 programs | 0.3 |
| 0.3 |
| — | ||||
Bispecific programs: | |||||||||
CD3* | 16.0 | 10.8 | 5.2 | ||||||
Tumor micro environment (TME) activators | 12.8 | 19.6 | (6.8) | ||||||
Cytokines* | 12.0 | 2.2 | 9.8 | ||||||
Subtotal Bi-specific programs | 40.8 |
| 32.6 | 8.2 | |||||
Other, research and early stage programs | 7.2 |
| 4.6 |
| 2.6 | ||||
Total research and development expenses |
| $ | 61.5 | $ | 49.4 | $ | 12.1 |
*Net of reimbursements from our partners pursuant to agreements that include cost-sharing arrangements.
Research and development expenses increased by $12.1 million for the six months ended June 30, 2019 over the same period in 2018 due to increased stock-based compensation charges and additional spending on our pipeline of bispecific candidates. Increased spending in development activities for our bispecific cytokines and CD3 candidates and technologies were offset by decreased spending in our TME activator candidates.
General and Administrative Expenses
The following table summarizes our general and administrative expenses for the six months ended June 30, 2019 and 2018 (in millions):
Six Months Ended | |||||||||
June 30, | |||||||||
| 2019 |
| 2018 |
| Change | ||||
General and administrative |
| $ | 11.3 | $ | 9.5 |
| $ | 1.8 |
General and administrative expenses increased by $1.8 million for the six months ended June 30, 2019 over the same period in 2018 primarily due to additional spending on intellectual property including patents and licenses and expenses related to personnel and professional services.
Other Income, Net
Other income, net was $6.3 million and $3.5 million for the six months ended June 30, 2019 and 2018, respectively. The increase in other income, net was primarily from higher interest income from our investments in 2019.
Cash Flows
The following table sets forth the primary sources and uses of cash for each of the periods presented below (in thousands):
Six Months Ended | |||||||||
June 30, | |||||||||
| 2019 |
| 2018 |
| Change | ||||
Net cash (used in) provided by: | |||||||||
Operating activities | $ | 90,428 | $ | (52,664) | $ | 143,092 | |||
Investing activities |
| (88,757) |
| (177,495) |
| 88,738 | |||
Financing activities | 4,640 |
| 248,923 |
| (244,283) | ||||
Net increase (decrease) in cash | $ | 6,311 | $ | 18,764 | $ | (12,453) |
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Operating Activities
Cash provided by operating activities for the six months ended June 30, 2019 increased by $143.1 million over amounts reported for the six months ended June 30, 2018 primarily due to increased income posted in the six-month period ended June 30, 2019.
Investing Activities
Investing activities consist primarily of investments in marketable securities available-for-sale, purchases of intangible assets, capitalization of patent and licensing costs and purchases of property and equipment.
Financing Activities
Net cash provided by financing activities for the six months ended June 30, 2019 decreased by $244.3 million over the same period in 2018 which reflects proceeds received from our financing in March 2018 and additional proceeds received from the exercise of stock options.
Liquidity and Capital Resources
We have financed our operations primarily through private placements of our equity and convertible notes, the public offerings of our common stock, and payments received under our product development partnerships and licensing arrangements.
On September 19, 2016, we entered into an Equity Distribution Agreement (the Distribution Agreement) with Piper Jaffray & Co (Piper Jaffray) pursuant to which we may sell from time to time, at our option, up to an aggregate of $40 million of common stock through Piper Jaffray as sales agent. The issuance and sale of these shares by Xencor under the Distribution Agreement will be pursuant to our shelf registration statement on Form S-3 (File No.333-213700) declared effective by the SEC on October 5, 2016.
To date, we have not sold any shares under the Distribution Agreement.
In March 2018, we completed the sale of 8,395,000 shares of common stock which included shares issued pursuant to our underwriters’ exercise of their over-allotment option pursuant to a follow-on financing. We received net proceeds of $245.5 million after underwriting discounts, commissions and offering expenses.
As of June 30, 2019, we had $626.1 million of cash, cash equivalents and marketable securities compared to $530.5 million at December 31, 2018. The investments in marketable securities are further described above in footnote 5 to the notes to the financial statements. We expect to continue to receive additional payments from our collaborators for research and development services rendered, additional milestone, opt-in, contingent payments and royalties. Our ability to receive milestone payments and contingent payments from our partners is dependent upon either our ability or our partners’ abilities to achieve certain levels of research and development activities and is therefore uncertain at this time.
Funding Requirements
We have not generated any revenue from product sales to date and do not expect to do so until we obtain regulatory approval of and commercialize one or more of our product candidates. As we are currently in the clinical stage of development, it will be some time before we expect to achieve this, and it is uncertain that we ever will commercialize one or more of our product candidates. We expect that we will continue to increase our operating expenses in connection with ongoing as well as additional clinical and pre-clinical development of product candidates in our pipeline.
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Although it is difficult to predict our funding requirements, based upon our current operating plan, we expect that our existing cash, cash equivalents and marketable securities and certain potential milestone payments will fund our operating expenses and capital expenditure requirements beyond 2024. We have based these estimates on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect.
Off-Balance Sheet Arrangements
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements.
Contractual Obligations and Commitments
There were no material changes outside of the ordinary course of business to our specific contractual obligations during the six months ended June 30, 2019.
Critical Accounting Policies
For a discussion on our material changes in critical accounting policies, see “Recent Accounting Pronouncements” in the notes to the financial statements included in this Quarterly Report on Form 10-Q.
ITEM 3. Quantitative and Qualitative Disclosures about Market Risk
Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates. Due to the short-term maturities of our cash equivalents and marketable securities and the low risk profile of our investments, an immediate 10% decrease in interest rates would not have a material effect on the fair market value of our portfolio. Accordingly, we would not expect our operating results or cash flows to be affected to any significant degree by the effect of a sudden change in market interest rates on our investment portfolio.
We do not believe that our cash and cash equivalents have significant risk of default or illiquidity. While we believe our cash and cash equivalents do not contain excessive risk, we cannot provide absolute assurance that in the future our investments will not be subject to adverse changes in market value. In addition, we maintain significant amounts of cash and cash equivalents at one or more financial institutions that are in excess of federally insured limits.
Inflation generally affects us by increasing our cost of labor and clinical trial costs. We do not believe that inflation has had a material effect on our results of operations during the periods presented.
ITEM 4. Controls and Procedures
Disclosure Controls and Procedures
Our management, with the supervision of our Chief Executive Officer and Chief Financial Officer (our principal executive officer and principal financial officer, respectively), evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2019. Our disclosure controls and procedures are designed to provide reasonable assurance that the information required to be disclosed in this Quarterly Report on Form 10-Q has been appropriately recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission's rules and forms, and that such information is accumulated and communicated to our management, including our principal executive and principal financial officers, to allow timely decisions regarding required disclosure. Based on that evaluation, our principal executive and principal financial officers have concluded that our disclosure controls and procedures are effective at the reasonable assurance level as of June 30, 2019.
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A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues, if any, within a company have been detected. Accordingly, our disclosure controls and procedures are designed to provide reasonable assurance, not absolute assurance, that the objectives of our disclosure control system are met and, as set forth above, our principal executive officer and principal financial officer have concluded, that based on their evaluation as of the end of the period covered by this Quarterly Report on Form 10-Q, our disclosure controls and procedures were effective to provide reasonable assurance that the objective of our disclosure control system were met.
Changes in Internal Control
There have been no changes in our internal control over financial reporting during our most recent fiscal quarter that have materially affected or are reasonably likely to materially affect our internal control over financial reporting.
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PART II — OTHER INFORMATION
ITEM 1. Legal Proceedings.
None.
ITEM 1A. Risk Factors
For information regarding certain factors that could materially affect our business, results of operations, financial condition and liquidity, see the risk factor discussion provided under “Risk Factors” in item 1A of our Annual Report on Form 10-K for the year ended December 31, 2018. See also “Special Note Regarding Forward-Looking Statements” included in this Quarterly Report on Form 10-Q. In addition to the risks set forth in our Annual Report on Form 10-K for the year ended December 31, 2018, additional risks and uncertainties not currently known to us or that we currently deem to be immaterial may also materially and adversely affect our business.
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ITEM 6. Exhibits
Exhibit | ||
Number |
| Description of Document |
3.1 | ||
3.2 | ||
4.1 | ||
4.2 | ||
10.1* | ||
31.1 | Rule 13a-14(a) Certification of Principal Executive Officer. | |
31.2 | Rule 13a-14(a) Certification of Principal Financial Officer. | |
32.1 | Section 1350 Certification of Principal Executive Officer and Principal Financial Officer. | |
101.INS | XBRL Instance Document – The instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the inline XBRL document. | |
101.SCH | XBRL Schema Document | |
101.CAL | XBRL Calculation Linkbase Document | |
101.DEF | XBRL Definition Linkbase Document | |
101.LAB | XBRL Labels Linkbase Document | |
101.PRE | XBRL Presentation Linkbase Document |
* Indicates management or compensatory plan.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
XENCOR, INC. | ||
BY: | /s/ BASSIL I. DAHIYAT | |
Bassil I. Dahiyat, Ph.D. | ||
President and Chief Executive Officer | ||
(Principal Executive Officer) | ||
BY: | /s/ JOHN J. KUCH | |
John J. Kuch | ||
Chief Financial Officer | ||
(Principal Financial Officer) | ||
Dated: August 6, 2019 |
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Exhibit 10.1
TRANSITION AND SEPARATION AGREEMENT AND RELEASE
This Transition and Separation Agreement and Release ("Agreement") is made by and between Xencor, Inc. (the "Company"), and Paul Foster ("Employee") (collectively referred to herein as the “Parties”), effective as of the date last executed below (the “Effective Date”).
WHEREAS, Employee is employed by the Company and Employee and the Company have mutually agreed to separate therefore such employment is being terminated;
NOW THEREFORE, in consideration of the mutual promises made herein, the Company and Employee hereby agree as follows:
1.Termination and Transition Period. Employee's employment will terminate October 31, 2019 (which date is expected to be during the Company’s search to hire a Chief Medical Officer), or earlier as mutually agreed upon by the Parties or otherwise provided herein (such date, the “Termination Date”). Between the date of this Agreement and the Termination Date, Employee will remain an employee of the Company to provide transition services and support (the “Transition Period”). Employee acknowledges that his employment with the Company shall irrevocably and forever end on the Termination Date and will not be resumed at any time. In addition, in the event the Parties mutually agree in writing to a thirty (30) day extension of the Termination Date (the “Extended Termination Date”), during the time period between the Termination Date and the Extended Termination Date, the Company shall pay Employee 110% of his base salary at the rate in effect as of the Termination Date, and the Employee will continue to participate in all employee benefits program sponsored by the Company and in which he was enrolled as of the Termination Date.
2.Effective Dates. Except as otherwise provided herein, this Agreement shall initially be effective on the eighth calendar day after it has been executed by the Employee (the “Initial Effective Date”), unless the Agreement has been timely and properly revoked as provided in Section 10. Upon the Employee’s re-execution of this Agreement following the Termination Date or Extended Termination Date, this Agreement shall become finally effective on the eighth calendar day after it has been re-executed by the Employee (the “Final Effective Date”), unless the Agreement has been timely and properly revoked as provided in Section 10.
3.Transition Services, Benefits, and Salary. During the time period from the Effective Date through the Termination Date or Extended Termination Date (the “Transition Period”), Employee will continue to provide services to the Company as Senior Vice President, Chief Medical Officer, following all policies and procedures of the Company as specified in the Company’s employee manual, trading policy and procedures, and compliance manual. In addition, Employee’s services will include transitioning the clinical development, biometrics, and clinical operations functions to the new Chief Medical Officer and helping that person transition into his or her role. During the Transition Period, Employee’s base salary will continue, paid on the Company’s regular payroll dates, and Employee will continue to participate in all employee benefits programs sponsored by the Company in which Employee was enrolled as of Initial Effective Date. Except as expressly provided in this Agreement or in the plan documents governing the Company’s employee benefit plans, after the Termination Date or Extended Termination Date, whichever is applicable, Employee will no longer be eligible for, receive, accrue, or participate in any benefits or benefit plans provided by the Company, including, without limitation, the Company’s 401(k) retirement plan; provided, however, that nothing in this Agreement shall waive
1
the Employee’s right to any vested amounts in the Company’s 401(k) retirement plan, which amounts shall be handled as provided in the applicable plan documents.
4.Final Wages. On the Termination Date, or the Extended Termination Date, whichever is applicable, the Company will pay Employee the unpaid portion of his annual salary and for all accrued, unused vacation time, less required tax withholdings and authorized deductions, earned through the applicable date. Employee shall submit a final expense report within five (5) business days of the Termination Date or Extended Termination Date, whichever is applicable, and any outstanding expenses will be reimbursed pursuant to the Company’s expense policy.
5.Separation Benefits. Although the Company otherwise is not obligated to do so, in exchange for Employee’s covenants and releases herein, and provided that the Employee re-executes this Agreement after the Final Effective Date and allows it to become irrevocable as specified in Section 10 below, the Company will provide Employee with the following Separation Benefits.:
a.Severance Pay. A separation payment in the gross amount of six hundred thirty thousand two hundred eighty six dollars ($630,286), less required tax withholdings and authorized deductions (“Separation Payment”), which is equal to twelve (12) months of the Employee's base salary at the rate in effect as of the Termination Date plus the Employee’s maximum eligible annual bonus. The Separation Payment will be paid to the Employee in a one-time lump-sum payment as soon as administratively practical following the Final Effective Date.
b.Healthcare Coverage. Provided that Employee timely elects COBRA health insurance continuation coverage, the Company will pay one hundred percent of the premium cost of such coverage for a period of twelve (12) months following the end of his or her coverage through the Company, or until Employee becomes eligible for group health insurance coverage offered by another employer, or until such time as Employee is no longer eligible for COBRA continuation coverage, whichever comes first (the “Coverage Payment”). In the event Employee become covered under another employer's group health plan or otherwise ceases to be eligible for COBRA, Employee must immediately notify the Company of such event. Notwithstanding the foregoing, if at any time the Company determines, in its sole discretion, that its payment of COBRA premiums on Employee’s behalf would result in a violation of applicable law (including, without limitation, Section 2716 of the Public Health Service Act), then in lieu of paying COBRA premiums on Employee’s behalf, the Company will pay Employee a fully taxable cash payment equal to the COBRA premium for that month, subject to applicable tax withholding (such amount, the “Special Severance Payment”), such Special Severance Payment to be made without regard to Employee’s payment of COBRA premiums. Employee understands and acknowledges that his receipt of the Coverage Payment or Special Severance Payment is expressly conditioned on his allowing the Agreement to become irrevocable pursuant to Section 10.
c.Equity. The Employee and the Company hereby acknowledge that, pursuant to the terms of the Company’s equity incentive plans (the "Plans") and/or under any stock option agreement between the Employee and the Company, no options or shares subject to options granted to the Employee (“Employee Options”) that are unvested as of the Termination Date shall vest or become exercisable at any time after the Termination Date.
2
Notwithstanding the foregoing, if this Agreement becomes irrevocable by Employee as of the Final Effective Date, and provided that Employee continues to be available at reasonable times and under reasonable conditions to consult through the end of the original vesting schedule of each such Employee Option, then each Employee Option that was granted to Employee prior to the date of this Agreement (1) shall continue to vest through the end of its original vesting schedule as if Employee remained in continuous service with the Company following the Final Effective Date, provided that each such Employee Option shall become fully vested and exercisable upon a Change in Control (as defined in the Company’s 2013 Equity Incentive Plan) during such time and (2) may be exercised by the Employee until its original expiration date (the “Extended Post-Termination Exercise Period”). Pursuant to the tax rules governing “incentive stock options”, the Extended Post-Termination Exercise Period may immediately cause any Employee Options to cease to qualify as “incentive stock options” and by executing this Agreement, Employee agrees to such treatment. The Employee confirms that he has read and understood the terms and conditions of the Plans and his stock option agreement(s), and understands his responsibility contained therein, including the expiration of the right to exercise any such stock options. Except for the continued vesting, potential vesting acceleration and Extended Post-Termination Exercise Period described above, nothing in this Agreement is intended to supersede or modify the terms and conditions of the Company’s Plans or any agreements issued in connection with those Plans.
d.Insider Trading. Employee understand and agrees that in the event this Agreement becomes irrevocable by Employee as of the Final Effective Date, his obligation to abide by the Company insider trading policy and/or window period policy continues and survives for a period of three (3) months after the Final Effective Date.
e.Acknowledgements. Employee understands and acknowledges that he would not be entitled to receive the Separation Benefits in this Section 5 absent the execution of the releases contained herein and his compliance with all obligations in this Agreement, and that the payment of these benefits is made strictly without the admission of any liability. In addition, Employee understands acknowledges that no Separation Benefits will be paid by the Company if Employee resigns prior to the Termination Date, fails to report to work as required during the Transition Period, fails to properly transition work duties, or revokes this Agreement prior to the Final Effective Date pursuant to Section 10.
Employee hereby acknowledges and states that Employee has read this Agreement, that this Agreement is written in language which is understandable to Employee, that Employee fully appreciates the meaning of the terms of this Agreement, and that Employee enters into this Agreement freely and voluntarily.
6.Acknowledgement of Total Compensation and Indebtedness. The Employee acknowledges and agrees that, other than the cash payment in Section 5 of this Agreement, Employee has received all compensation, benefits, or other obligations owed to him (including, but not limited to salary, bonus, or other incentive compensation), any and all obligations for monies, or other compensation or benefits that the Employee has earned or could have earned him as a result of his employment by the Company (including the termination of that employment) through the Termination Date or Extended Termination Date, whichever is applicable, including any bonus compensation.
7.Tax Consequences. The Employee acknowledges that (a) the Company has not made any representations to him about, and that he has not relied upon any statement in this Agreement or
3
otherwise, with respect to, any individual tax consequences that may arise by virtue of any payment provided under this Agreement, including, but not limited to, the applicability of Section 409A of the Internal Revenue Code, and (b) he has or will consult with his own tax advisors as to any such tax consequences.
8.Release of Claims.
a.Release. Except as otherwise expressly provided in this Agreement, the Employee, for himself or herself and his heirs, executors, administrators, assigns, affiliates, successors and agents (collectively, the "Employee's Affiliates") hereby fully and without limitation releases and forever discharges the Company, its parents, affiliates, subsidiaries, predecessors, successors, and benefit plans, agents, representatives, shareholders, owners, officers, directors, employees, consultants, attorneys, auditors, accountants, investigators, trustees, administrators, successors and assigns (collectively, the "Releasees"), both individually and collectively, from any and all rights, claims, demands, liabilities, actions, causes of action, damages, losses, costs, expenses and compensation, of whatever nature whatsoever, known or unknown, fixed or contingent, which the Employee or any of the Employee's Affiliates has or may have or may claim to have against the Releasees by reason of any matter, cause, or thing whatsoever, prior to and including the date Employee signs this Agreement ("Claims"), including, without limiting the generality of the foregoing, any Claims arising out of, based upon, or relating to the recruitment, hiring, employment, remuneration, or termination of the Employee by any of the Releasees, the Employee's tenure as an employee of the Company, and any agreement or compensation arrangement between the Employee and the Releasees to the maximum extent permitted by law. The Employee specifically and expressly releases any Claims arising out of or based on: the Dodd-Frank Act; the Sarbanes-Oxley Act of 2002; the California Fair Employment and Housing Act, as amended; Title VII of the Civil Rights Act of 1964, as amended; the Civil Rights Act of 1991, as amended; the Age Discrimination in Employment Act of 1967, as amended; the Americans with Disabilities Act of 1990; the Fair Labor Standards Act, as amended; the Worker Adjustment and Retraining Notification Act; the California Fair Employment and Housing Act, as amended; and the California Labor Code including sections 201, et seq., any other provisions of the California Labor Code; the California common law on fraud, misrepresentation, negligence, defamation, infliction of emotional distress and all as may be amended from time to time; any and all claims arising out of any other laws and regulations relating to employment or employment discrimination, including any and all claims for attorneys' fees and costs; tort, breach of contract or covenant, violation of public policy or wrongful termination; state or federal wage and hour laws; or any other state or federal law, rule or regulation dealing with the employment relationship. The only claims not released by this Agreement are claims that cannot be released as a matter of law.
Employee agrees that the release set forth in this Section shall be and remain in effect in all respects as a complete general release as to the matters released. Employee understands and agrees that this Release extinguishes all claims by Employee whether known or unknown and foreseen or unforeseen.
b.Governmental Agencies. Notwithstanding the release of claims language set forth in this Section 8, nothing in this Agreement prohibits or prevents Employee from filing a charge with or participating, testifying, or assisting in any investigation, hearing, whistleblower proceeding or other proceeding before any federal, state, or local government agency, nor does anything in this Agreement preclude, prohibit, or otherwise
4
limit, in any way, Employee’s rights and abilities to contact, communicate with, report matters to, or otherwise participate in any whistleblower program administered by any such agencies.
c.Excluded Claims. Nothing contained in this Section 8 or any other provision of this Agreement shall release or waive (i) any right that the Employee has to indemnification, advancement and/or reimbursement of expenses (including reasonable attorneys’ fees) by the Company with respect to which Employee may be eligible as provided in the Company’s Certificate of Incorporation, Bylaws and/or Delaware law, and any applicable directors and officers, errors & omissions, umbrella or general liability insurance policies, any indemnification agreements, including any employment agreement, or any other applicable source; (ii) any rights which are not waivable as a matter of law; (iii) any claims for breach of this Agreement; and (iv) claims for payment under group health coverage for medical care, dental care, and prescriptions; workers’ compensation claims; short-term disability benefit claims; or claims for physical injury, emotional injury, or pain and suffering damages arising from Title VII of the Civil Rights Act, Section 504 of the Rehabilitation Act, the Americans with Disabilities Act, retaliation claims under the ADEA, or state laws against employment discrimination.
9.Civil Code Section 1542. The Employee understands and agrees that the release of claims provided herein extends to all Claims released above whether known or unknown, suspected or unsuspected. Employee expressly waives any rights or benefits under Section 1542 of the California Civil Code, or any other equivalent statute. California Civil Code Section 1542 (or similar state statutes), provides as follows:
A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS THAT THE CREDITOR OR RELEASING PARTY DOES NOT KNOW OR SUSPECT TO EXIST IN HIS OR HER FAVOR AT THE TIME OF EXECUTING THE RELEASE AND THAT, IF KNOWN BY HIM OR HER, WOULD HAVE MATERIALLY AFFECTED HIS OR HER SETTLEMENT WITH THE DEBTOR OR RELEASED PARTY..
Employee fully understands that if any fact, with respect to any matter, covered by this Release is found hereafter to be other than or different from the facts now believed by him to be true, he expressly accepts and assumes that this Release shall be and remain effective, notwithstanding such difference in the facts.
10.Acknowledgment of Waiver of Claims under ADEA.
Employee further acknowledges that he is waiving and releasing any rights he may have under the Age Discrimination in Employment Act of 1967 (“ADEA”) and the Older Workers Benefit Protection Act (“OWBPA”) and that this waiver and release is knowing and voluntary. Employee and the Company agree that this waiver and release does not apply to any rights or claims that may arise under ADEA after the Initial Effective Date or Final Effective Date (as applicable) of this Agreement. Employee acknowledges that the consideration given for this waiver and release Agreement is in addition to anything of value to which Employee was already entitled. Employee further acknowledges that he has been advised by this writing, as required by the ADEA, that (a) he has the right to and should consult with an attorney prior to executing this Agreement (although he may execute this Agreement voluntarily earlier); (b) he has at least twenty-one (21) days within which to consider this Agreement; (c) he has seven (7) days following the execution of this
5
Agreement to revoke the Agreement by sending a written notice to the Company to the attention of General Counsel, Xencor, Inc., 111 West Lemon Avenue, 2nd Floor, Monrovia, CA 91016.
11.No Filings. The Employee warrants that as of the date of execution of this Agreement, he has not commenced, filed, participated in, offered testimony, or assisted any investigation, hearing, or whistleblower proceeding before any federal, state, or local government agency relating to the Releasees. In addition, to the maximum extent permitted by law, Employee agrees that if any lawsuits or claims, charges or complaints are made against the Company or the other Releasees with any local, state or federal agency or court, Employee shall not be entitled to recover any individual monetary relief or other individual remedies, and that, if any such agency or court ever assumes jurisdiction over any such lawsuit, claim, charge or complaint and/or any agency purports to bring any legal proceeding, in whole or in part, on behalf of the Employee based upon events occurring prior to the execution of this Agreement, the Employee will request such agency or court to withdraw from and/or to dismiss the lawsuit, claim, charge or complaint with prejudice. Employee further warrants that he has disclosed, or will disclose prior to the execution of this Agreement, any and all known or suspected violations of law. Such disclosure must include how he has firsthand knowledge of the known or suspected violation. If Employee previously reported such known or suspected violation, such disclosure must also include who the violation was previously reported to and how such violation has not been cured. The Employee also agrees that to the maximum extent allowed by law he will not induce, encourage, solicit or assist any other person or entity to file or pursue any proceeding of any kind against the Company or the other Releasees or voluntarily appear or invite a subpoena to testify in any such legal proceeding. This Section 11 shall not prohibit the Employee from challenging the validity of the ADEA release in Section 10 of this Agreement.
12.Confidentiality. The Employee acknowledges that during the course of or related to his employment with the Company he was provided access and during his continuing employment will be provided certain confidential and/or proprietary information regarding the Company and its business that is not generally known outside of the Company and that would not otherwise have been provided to him (collectively, “Confidential Information”). Confidential Information includes, without limitation, the following materials and information (whether or not reduced to writing and whether or not patentable or protected by copyright): trade secrets; inventions; processes; formulae; programs; technical data; financial information; research and product development; marketing and advertising plans and strategies; customer identities, lists, and confidential information about customers and their buying habits; confidential information about prospects, suppliers, vendors, and key employees; personal information relating to the Company’s employees; mailing and email lists; and any other confidential or proprietary information relating to the Company’s business. The Employee agrees that Confidential Information is the sole property of the Company. The Employee further agrees that he will not disclose to any person or use any such Confidential Information except as necessary for the performance of his continuing duties to the Company without the written consent of the Company’s Board of Directors. If the Employee is served with a deposition subpoena or other legal process calling for the disclosure of Confidential Information, or if he is contacted by any third person requesting such information, he will notify the Company’s General Counsel or, if none, a person serving in a similar position as soon as is reasonably practicable after receiving notice and will cooperate with the Company in preventing or minimizing the disclosure thereof. Any other agreement between the Employee and the Company for the protection of confidential and proprietary information remains in effect, and in the event that any provision of this Section 12(a) conflicts with any provision in such other agreement, the terms and provisions of the agreement providing the greatest protection to the Company shall control.
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Notwithstanding the confidentiality obligations set forth in this Section 12 or elsewhere in this Agreement, the Employee understands that, pursuant to the Defend Trade Secrets Act of 2016 (“DTSA”), the Employee will not be held criminally or civilly liable under any federal or state trade secret law for the disclosure of a trade secret that: (A) is made (i) in confidence to a federal, state, or local government official, either directly or indirectly, or to an attorney; and (ii) solely for the purpose of reporting or investigating a suspected violation of law; or (B) is made in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal. The Employee further understands that if a court of law or arbitrator determines that he misappropriated Company trade secrets willfully or maliciously, including by making permitted disclosures without following the requirements of the DTSA as detailed in this Section 12(c), then the Company may be entitled to an award of exemplary damages and attorneys' fees against him.
13.Return of Equipment and Materials. Employee shall return any and all Company files, materials, property and equipment (without retaining either electronically stored or physical copies thereof) upon the Termination Date or upon the Company’s earlier request unless otherwise provided with written permission from an authorized representative of the Company, To the extent that it is subsequently determined that Employee has failed to comply with Company policies with respect to appropriate records retention, has failed to return equipment or has otherwise destroyed, mutilated, removed, compromised or stolen any Company property of any kind, including customer and project files, the Company’s obligations to provide payment of the Separation Payment or further reimburse Employee for appropriate expenses shall terminate. To the extent Company property has been removed, damaged or destroyed Employee may be reported to law enforcement authorities for appropriate legal action.
14.Proprietary Information and Inventions Agreement and/or Non-Disclosure Agreement. Employee acknowledges, is reminded of, and affirms his agreement to abide by the terms and conditions of all previously executed Proprietary Information and Inventions Agreement and/or a Non-Disclosure Agreement (together the “Confidentiality Agreement”) between the Parties. Employee further agrees and understands that he may not disclose to any person or entity any confidential information, whether directly or indirectly, or use or misuse such information in any way. Employee shall promptly return all confidential and proprietary information in his possession to the Company on or before the Termination Date or Extended Termination Date, whichever is applicable.
15.Cooperation. As long as there is no conflict between Employee's legal interests and those of the Company, Employee agrees that he shall, to the extent reasonably requested in writing, cooperate with and serve in any capacity requested by the Company in any investigation and/or threatened or pending litigation (now or in the future) in which the Company is a party, and regarding which Employee, by virtue of his employment with the Company, has knowledge or information relevant to said investigation or litigation including, but not limited to (i) meeting with representatives of the Company to prepare for testimony and to provide truthful information regarding his knowledge, (ii) acting as the Company's representative, and (iii) providing, in any jurisdiction in which the Company requests, truthful information or testimony relevant to the investigation or litigation. Company agrees to reimburse Executive's reasonable expenses incurred for his cooperation under this Section 15.
Employee also agrees to cooperate with the Company and its counsel in connection with any matters relating to the Company in which Employee has been compelled, by subpoena or other compulsory, to testify or produce documents. Employee shall notify the Company’s General Counsel or, if none, a person serving in a similar position within 48 hours of receiving such notice
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and agrees to (i) meet with the Company's representatives and attorneys (ii) provide the attorneys with any documents requested, and (iii) prepare for any appearance with the Company's attorneys.
Employee, at his own expense, may retain his own counsel, in lieu of or in addition to, the Company's counsel. Employee's appointment of his own counsel shall in no way interfere with his obligation to cooperate with the Company as described herein.
Nothing in this Agreement shall be construed to preclude Employee from cooperating with any lawful governmental investigation.
16.No Admission of Liability. The Parties understand and acknowledge that this Agreement constitutes a compromise and settlement of all claims. No action taken by the Parties hereto, or either of them, either previously or in connection with this Agreement shall be deemed or construed to be (a) an admission of the truth or falsity of any claims heretofore made or (b) an acknowledgment or admission by either party of any fault or liability whatsoever to the other party or to any third party.
17.Governing Law. This Agreement shall be governed by the laws of the State of California, without giving effect to principles of conflict of laws.
18.Non-Disparagement. Employee agrees not to disparage the Company, its current and former officers, directors, managers, members, partners, employees, shareholders, investors, affiliates and agents, in any manner likely to be harmful to them or their business, business reputation or personal reputation, and the Company agrees to direct its officers and directors not to disparage Employee in any manner likely to be harmful to his business reputation or personal reputation. Nothing in this Section 18 or this Agreement will be interpreted or construed to prevent Employee from giving truthful testimony to any law enforcement officer, court, administrative proceeding or as part of an investigation by any federal, state, or local government agency. In addition, nothing in this Section 18 or this Agreement is intended to prohibit or restrain Employee in any manner from making disclosures that are protected under federal law or regulation or under other applicable law or regulation.
19.Authority. The Company represents and warrants that the undersigned has the authority to act on behalf of the Company and to bind the Company and all who may claim through it to the terms and conditions of this Agreement. Employee represents and warrants that he has the capacity to act on his own behalf and on behalf of all who might claim through him to bind them to the terms and conditions of this Agreement. Each Party warrants and represents that there are no liens, or claims of lien, or assignments in law or equity or otherwise of or against any of the claims or causes of action released herein.
20.No Representations. Neither party has relied upon any representations or statements made by the other party hereto which are not specifically set forth in this Agreement.
21.Arbitration. The parties hereto agree that any future dispute of any nature whatsoever between them, including, but not limited to, any claims of statutory violations, contract or tort claims, or claims regarding any aspect of this Agreement, its formation, validity, interpretation, effect, performance or breach, or any act which allegedly has or would violate any provision of this Agreement (“Arbitrable Dispute”) will be submitted to arbitration in Monrovia, California, unless the parties agree to another location, before an experienced employment arbitrator licensed to practice law in California and selected in accordance with the employment arbitration rules of Judicial Arbitration and Mediation Services, Inc. (“JAMS”), unless the parties agree to a different
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arbitrator, as the exclusive remedy for any such Arbitrable Dispute. Should any party to this Agreement hereafter institute any legal action or administrative proceeding against the other with respect to any claim waived by this Agreement or pursue any Arbitrable Dispute by any method other than said arbitration, the responding party shall be entitled to recover from the initiating party all damages, costs, expenses and attorneys’ fees incurred as a result of such action. This Section 21 shall not restrict actions for equitable relief by the Company for violation of Sections 12 and 14 of this Agreement.
22.Attorneys’ Fees. Except as otherwise provided herein, in any arbitration or other proceeding between the parties arising out of or in relation to this Agreement, including any purported breach of this Agreement, the prevailing party shall be entitled to an award of its costs and expenses, including reasonable attorneys’ fees.
23.Severability. In the event that any provision hereof becomes or is declared by a court of competent jurisdiction to be illegal, unenforceable or void, this Agreement shall continue in full force and effect without said provision. Such provision shall be modified by the court so as to be rendered enforceable, insofar as possible, and consistent with the intent of the Parties to all remaining portions of the Agreement.
24.Entire Agreement. This Agreement represents the entire agreement and understanding between the Company and Employee concerning the subject matter hereof, and supersedes and replaces any and all prior agreements and understandings, whether oral or written, concerning the subject matter hereof, except for any Confidentiality Agreement, which Employee agrees and understands shall survive the termination of his employment. Parole evidence shall be inadmissible to show agreement by and between the Parties as to any term or condition contrary to or in addition to the terms and conditions hereof. Any and all such prior agreements and understandings with respect to the subject matter herein, including agreements for compensation, including bonuses and commissions, are also hereby terminated and of no further force and effect, and Employee hereby expressly disclaims any and all rights in connection with any previous agreements, if any, whether oral or written.
25.No Oral Modification. This Agreement may only be amended in writing signed by Employee and the Chief Executive Officer of the Company.
26.Counterparts. This Agreement shall become binding when any one or more counterparts hereof, individually or taken together, shall bear the signatures of each of the Parties. This Agreement may be executed in any number of counterparts, each of which shall be deemed an original as against the Party whose signature appears thereon, but all of which taken together shall constitute but one and the same instrument. A signed copy of this Agreement delivered by facsimile, e-mail or other means of electronic transmission shall be deemed to have the same legal effect as delivery of an original signed copy of this Agreement.
27.Voluntary Execution of Agreement. This Agreement is executed voluntarily and without any duress or undue influence on the part or behalf of the Parties hereto, with the full intent of releasing all claims. Employee acknowledges that: (a) he has read this Agreement; (b) has been represented in the preparation, negotiation, and execution of this Agreement by legal counsel of his own choice or that he has voluntarily declined to seek such counsel; (c) understands the terms and consequences of this Agreement and of the releases it contains; (d) is fully aware of the legal and binding effect of this Agreement; and understands that he must re-execute this Agreement on or after the Termination Date or Extended Termination Date, whichever is applicable, for it to be effective.
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28.Assignment. This Agreement inures to the benefit of and is binding upon the Company and its successors and assigns. The Company may assign its rights under this Agreement, but the Employee’s rights under this Agreement are not assignable, except to his estate.
29.Notice. All notices, requests, demands, claims and other communications hereunder shall be in writing and shall be deemed to have been duly given (a) if personally delivered; (b) if sent by email; or (c) if mailed by overnight or by first class, certified or registered mail, postage prepaid, return receipt requested, and properly addressed as follows:
If to the Employee: Paul Foster
PO Box 8010
Rancho Santa Fe, CA 92067
Email: pfostermd@san.rr.com
If to the Company: Xencor, Inc.
111 West Lemon Avenue, 2nd Floor
Monrovia, CA 94583
Attn: General Counsel
Email: jcasciani@xencor.com
Such addresses may be changed, from time to time, by means of a notice given in the manner provided above. Notice will conclusively be deemed to have been given when personally delivered (including, but not limited to, by messenger or courier); or if given by mail, on the third day after being sent by first class, certified or registered mail; or if given by Federal Express or other similar overnight service, on the date of delivery; or if given by email during normal business hours on a business day, when confirmation of transmission is indicated by the sender’s machine; or if given by email at any time other than during normal business hours on a business day, the first business day following when confirmation of transmission is indicated by the sender’s machine. Notices, requests, demands and other communications delivered to legal counsel of any party hereto, whether or not such counsel shall consist of in-house or outside counsel, shall not constitute duly given notice to any party hereto.
IN WITNESS WHEREOF, the Parties have executed this Agreement on the respective dates set forth below.
June 21, 2019 |
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Bassil I. Dahiyat |
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Chief Executive Officer |
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Re-executed on the Extended Termination Date: |
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Exhibit 31.1
CERTIFICATION OF CHIEF PRINCIPAL OFFICER PURSUANT TO SECTION 302 OF THE
SARBANES-OXLEY ACT OF 2002
I, Bassil I. Dahiyat, Ph.D., certify that:
1. |
I have reviewed this Quarterly Report on Form 10-Q of Xencor, Inc., (the “Company”); |
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Company as of, and for, the periods presented in this report; |
4. |
The Company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act rules 13a-15(f) and 15d-15(f)) for the Company and have: |
a) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Company, including its consolidated subsidiaries, is made known to us by others within those entities particularly during the period in which this report is being prepared; |
b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
c) |
Evaluated the effectiveness of the Company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
d) |
Disclosed in this report any change in the Company’s internal control over financial reporting that occurred during the Company’s most recent fiscal quarter (the Company’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting; and |
5. |
The Company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Company’s auditors and the audit committee of the Company’s board of directors (or persons performing the equivalent functions): |
a) |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Company’s ability to record, process, summarize and report financial information; and |
b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the Company’s internal control over financial reporting. |
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/s/ BASSIL I. DAHIYAT |
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Bassil I. Dahiyat, Ph.D. |
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President & Chief Executive Officer |
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Date: August 6, 2019 |
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Exhibit 31.2
CERTIFICATION OF THE PRINCIPAL FINANCIAL OFFICER PURSUANT TO SECTION 302 OF THE
SARBANES-OXLEY ACT OF 2002
I, John J. Kuch, certify that:
1. |
I have reviewed this Quarterly Report on Form 10-Q of Xencor, Inc., (the “Company”); |
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Company as of, and for, the periods presented in this report; |
4. |
The Company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act rules 13a-15(f) and 15d-15(f) for the Company and have: |
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
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Evaluated the effectiveness of the Company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
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Disclosed in this report any change in the Company’s internal control over financial reporting that occurred during the Company’s most recent fiscal quarter (the Company’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting; and |
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The Company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Company’s auditors and the audit committee of the Company’s board of directors (or persons performing the equivalent functions): |
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Company’s ability to record, process, summarize and report financial information; and |
b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the Company’s internal control over financial reporting. |
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/s/ JOHN J. KUCH |
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John J. Kuch |
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Chief Financial Officer (Principal Financial Officer) |
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Date: August 6, 2019 |
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Exhibit 32.1
CERTIFICATION
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Bassil I. Dahiyat, Chief Executive Officer of Xencor, Inc. (the “Company”), and John J. Kuch, Chief Financial Officer of the Company, each hereby certifies that, to the best of his or her knowledge:
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The Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2019, to which this Certification is attached as Exhibit 32.1 (the “Periodic Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and |
2. |
The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Dated: August 6, 2019
IN WITNESS WHEREOF, the undersigned have set their hands hereto as of the 6th day of August 2019.
/s/ BASSIL I. DAHIYAT |
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/s/ JOHN J. KUCH |
Bassil I. Dahiyat |
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John J. Kuch |
Chief Executive Officer |
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Chief Financial Officer |
This certification accompanies the Periodic Report to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Xencor, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.