Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2020
or
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission file number: 001-36182
Xencor, Inc.
(Exact Name of Registrant as Specified in its Charter)
Delaware
20-1622502
(State or Other Jurisdiction of Incorporation
or Organization)
(I.R.S. Employer Identification No.)
111 West Lemon Avenue, Monrovia, CA
91016
(Address of Principal Executive Offices)
(Zip Code)
(626) 305-5900
(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:
Common Stock, par value $0.01 per share
XNCR
NASDAQ
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. Yes ⌧ No ◻
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). Yes ⌧ No ◻
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.
Large accelerated filer ⌧ Accelerated filer ◻ Non-accelerated filer ◻ Smaller reporting company ☐ Emerging growth company ☐
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 ☐ No ☒
Indicate the number of shares of each of the issuer’s classes of common stock, as of the latest practicable date:
Class
Outstanding at July 30, 2020
Common stock, $0.01 par value
57,242,886
Quarterly Report on FORM 10-Q for the Quarter Ended June 30, 2020
Page
SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS
3
PART I.
FINANCIAL INFORMATION
5
Item 1.
Financial Statements
Balance Sheets as of June 30, 2020 (unaudited) and December 31, 2019
Statements of Comprehensive Income (Loss) for the Three and Six Months Ended June 30, 2020 and 2019 (unaudited)
6
Statement of Stockholders’ Equity for the Three and Six Months Ended June 30, 2020 and 2019 (unaudited)
7
Statements of Cash Flows for the Six Months Ended June 30, 2020 and 2019 (unaudited)
8
Notes to Financial Statements (unaudited)
9
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
26
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
37
Item 4.
Controls and Procedures
38
PART II.
OTHER INFORMATION
39
Legal Proceedings
Item 1A.
Risk Factors
Item 6.
Exhibits
41
Signatures
42
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. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements should not be read as a guarantee of future performance or results and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time those statements are made and/or management’s good faith belief as of that time with respect to future events, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth below under Part II, Item 1A, “Risk Factors” in this Quarterly Report. These statements, which represent our current expectations or beliefs concerning various future events, may contain words such as “may,” “will,” “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate” or other words indicating future results. Such statements may include, but are not limited to, statements concerning the following:
These forward-looking statements should, therefore, be considered in light of various important factors, including but not limited to, the following:
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, 2019 and this Quarterly Report on Form 10-Q. Forward-looking statements should be regarded solely as our current plans, estimates and beliefs. 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.
4
PART I — FINANCIAL INFORMATION
Item1. Financial Statements
Balance Sheets
(In thousands, except share amounts)
June 30,
December 31,
2020
2019
(unaudited)
Assets
Current assets
Cash and cash equivalents
$
109,534
50,312
Marketable securities
474,114
479,470
Equity securities
2,611
—
Accounts receivable
8,925
21,574
Income tax receivable
804
502
Prepaid expenses and other current assets
7,398
6,547
Total current assets
603,386
558,405
Property and equipment, net
16,239
15,805
Patents, licenses, and other intangible assets, net
15,162
14,421
Marketable securities - long term
1,145
71,526
402
Other assets
8,788
9,691
Total assets
644,720
670,250
Liabilities and stockholders’ equity
Current liabilities
Accounts payable
10,513
10,189
Accrued expenses
9,157
8,995
Lease liabilities
2,094
2,169
Deferred revenue
44,685
45,205
Total current liabilities
66,449
66,558
Lease liabilities, net of current portion
7,626
8,565
Deferred revenue, net of current portion
1,926
Total liabilities
74,075
77,049
Commitments and contingencies
Stockholders’ equity
Preferred stock, $0.01 par value: 10,000,000 authorized shares; -0- issued and outstanding shares at June 30, 2020 and December 31, 2019
Common stock, $0.01 par value: 200,000,000 authorized shares at June 30, 2020 and December 31, 2019; 57,214,253 issued and outstanding at June 30, 2020 and 56,902,301 issued and outstanding at December 31, 2019
572
569
Additional paid-in capital
908,084
887,873
Accumulated other comprehensive income
1,483
1,161
Accumulated deficit
(339,494)
(296,402)
Total stockholders’ equity
570,645
593,201
Total liabilities and stockholders’ equity
See accompanying notes.
Statements of Comprehensive Income (Loss)
(In thousands, except share and per share data)
Three Months Ended
Six Months Ended
Revenue
Collaborations, licenses, milestones, and royalties
13,089
19,485
45,474
131,424
Operating expenses
Research and development
43,458
33,299
77,401
61,481
General and administrative
7,231
5,758
14,449
11,270
Total operating expenses
50,689
39,057
91,850
72,751
Income (loss) from operations
(37,600)
(19,572)
(46,376)
58,673
Other income (expenses)
Interest income, net
2,090
3,615
5,129
6,501
Other income (expense), net
492
(27)
(1,845)
(212)
Total other income, net
2,582
3,588
3,284
6,289
Net income (loss) before income tax expense
(35,018)
(15,984)
(43,092)
64,962
Income tax expense
50
950
Net income (loss)
(16,034)
64,012
Other comprehensive income
Net unrealized gain on marketable securities
427
1,284
322
2,600
Comprehensive income (loss)
(34,591)
(14,750)
(42,770)
66,612
Basic net income (loss) per common share
(0.61)
(0.28)
(0.76)
1.14
Diluted net income (loss) per common share
1.10
Basic weighted average common shares outstanding
57,059,610
56,399,255
57,003,162
56,351,377
Diluted weighted average common shares outstanding
58,042,819
Statement of Stockholders’ Equity
(in thousands, except share data)
Accumulated
Additional
Other
Total
Common Stock
Paid-in
Comprehensive
Stockholders’
Stockholders’ Equity
Shares
Amount
Capital
Income (Loss)
Deficit
Equity
Balance, December 31, 2019
56,902,301
Issuance of common stock upon exercise of stock awards
79,930
1
1,470
1,471
Issuance of restricted stock units
19,022
Comprehensive loss
(105)
(8,074)
(8,179)
Stock-based compensation
6,512
Balance, March 31, 2020
57,001,253
570
895,855
1,056
(304,476)
593,005
181,856
3,273
3,275
2,800
Issuance of common stock under the Employee Stock Purchase Plan
28,344
725
8,231
Balance, June 30, 2020
57,214,253
Balance, December 31, 2018
56,279,542
563
845,366
(971)
(323,277)
521,681
58,536
666
667
11,311
Comprehensive income
1,316
80,045
81,361
5,856
Balance, March 31, 2019
56,349,389
564
851,888
345
(243,232)
609,565
143,504
3,238
3,239
36,505
734
9,303
Balance, June 30, 2019
56,529,398
565
865,163
1,629
(259,266)
608,091
Statements of Cash Flows
(in thousands)
Cash flows from operating activities
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
Depreciation and amortization
2,816
2,003
Accretion of discount on marketable securities
(838)
(1,876)
14,743
15,159
Abandonment of capitalized intangible assets
167
90
Equity received in connection with license agreement
(4,589)
Change in fair value of equity security
1,978
Loss on disposal of assets
Gain on sale of marketable securities available for sale
(153)
Changes in operating assets and liabilities:
12,649
122
Interest receivable
914
(154)
Prepaid expenses and other assets
(843)
(932)
324
5,197
162
(3,436)
Income taxes
91
1,604
Lease liabilities and right of use (ROU) assets
(110)
(65)
(2,446)
8,699
Net cash provided by (used in) operating activities
(18,222)
90,428
Cash flows from investing activities
Purchase of marketable securities
(302,319)
(244,499)
Purchase of intangible assets
(1,467)
(2,164)
Purchase of property and equipment
(2,695)
(1,867)
Proceeds from maturities of marketable securities
378,454
159,773
Net cash provided by (used in) investing activities
71,973
(88,757)
Cash flows from financing activities
Proceeds from issuance of common stock upon exercise of stock awards
4,746
3,906
Proceeds from issuance of common stock under the Employee Stock Purchase Plan
Net cash provided by financing activities
5,471
4,640
Net increase in cash and cash equivalents
59,222
6,311
Cash and cash equivalents, beginning of period
26,246
Cash and cash equivalents, end of period
32,557
Supplemental disclosure of cash flow information
Cash paid during the period for:
Interest
11
150
Supplemental disclosures of non-cash investing activities
Unrealized gain on marketable securities
Notes to Financial Statements
June 30, 2020
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. 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 2019 Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 25, 2020.
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 royalties and accrued research and development expenses, stock-based compensation expenses, intangible assets and related amortization, estimated standalone selling price of performance obligations, the likelihood of recognizing variable consideration, 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 no impairment charges recorded for the three and six months ended June 30, 2020 and 2019.
The Company capitalizes certain in-process intangible assets that are then 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 three and six months ended June 30, 2020 and 2019.
Marketable and Equity Securities
The Company has an investment policy that includes guidelines on acceptable investment securities, minimum credit quality, maturity parameters, and concentration and diversification. 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 and 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. These assets are carried at fair value and any impairment losses and recoveries related to the underlying issuer’s credit standing are recognized within other income (expense), while non-credit related impairment losses and recoveries are recognized within accumulated other comprehensive income (loss). There were no impairment losses or recoveries recorded for the three and six months ended June 30, 2020 and 2019. Accrued interest on marketable debt securities is included in marketable securities’ carrying value. Each reporting period, the Company reviews its portfolio of marketable debt securities, using both quantitative and qualitative factors, to determine if each security’s fair value has declined below its amortized cost basis.
The Company also has an investment in an equity security that is carried at fair value with changes in fair value recognized within other income (expense). For equity securities with a readily determinable fair value, the Company remeasures these equity investments at each reporting period until such time that the investment is sold or disposed. If the Company sells an investment, any realized gains and losses on the sale of the securities will be recognized within other income (expense) in the Statement of Comprehensive Income (Loss) in the period of sale.
Recent Accounting Pronouncements
Pronouncements Adopted in 2020
Effective January 1, 2020, the Company adopted ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, as well as ASU No, 2018-19, Codification Improvements to Topic 326, Financial Instruments – Credit Losses. The standard amends guidance on reporting credit losses for assets held at amortized cost basis and also provides an available-for-sale (AFS) debt security impairment model that is a modified version of the other-than-temporary-impairment (OTTI) model. The AFS debt security impairment model no longer allows consideration of the length of time during which the fair value has been less than its amortized cost when determining whether a credit loss exists. The adoption of this standard did not have any impact on the Company’s financial statements.
Effective January 1, 2020, the Company adopted ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement, which modifies the disclosures for transfers between Level 1 and Level 2 of the fair value hierarchy, modifies the Level 3 disclosure requirements for non-public entities and requires additional disclosure for Level 3 fair value hierarchy. The adoption of this standard did not have any impact on the Company’s financial statements.
Effective January 1, 2020, the Company adopted ASU No. 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction Between Topic 808 and Topic 606, which provides guidance on how to assess whether certain transactions between collaborative arrangement participants should be accounted for within the revenue recognition standard. The adoption of this standard did not have any impact on the Company’s financial statements.
Pronouncements Not Yet Effective
In December 2019, the Financial Accounting Standards Board (FASB) issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes, which is effective for fiscal years beginning on and after December 15, 2020, and interim periods within those fiscal years. The standard removes specific exceptions to the general principles in Topic 740 and simplifies the accounting for income taxes. The Company does not anticipate that the standard will have a significant impact on its financial statements.
10
In January 2020, the FASB issued ASU No. 2020-01, which clarifies that a company should consider observable transactions that require a company to either apply or discontinue the equity method of accounting under Topic 323, Investment – Equity Method and Joint Ventures, for the purposes of applying the measurement alternative in accordance with Topic 321 immediately before applying or upon discontinuing the equity method. The amendment is effective for fiscal years beginning after December 15, 2020. The Company does not anticipate that the standard will have a significant impact on its financial statements.
There have been no other material changes to the significant accounting policies previously disclosed in the Company’s 2019 Annual Report on Form 10-K.
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):
December 31, 2019
Fair Value
Level 1
Level 2
Money Market Funds
103,231
32,009
Corporate Securities
267,542
281,751
Government Securities
207,717
269,245
Equity Securities with Readily Determinable Fair Value
581,101
105,842
475,259
583,005
550,996
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, 2020 and 2019, there were no transfers between Level 1 and Level 2. The Company does not have any Level 3 assets or liabilities.
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 when the inclusion of such shares would have an antidilutive effect.
Basic and diluted net income (loss) per common share is computed as follows (in thousands except share and per share data):
(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)
Effect of dilutive securities
1,691,442
Weighted-average common shares outstanding used in computing diluted net income (loss)
For the three and six months ended June 30, 2020, and the three months ended June 30, 2019, 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 consisting of 1,173,829 shares of stock awards are excluded from the calculation for the same period because the inclusion of such shares would have had an antidilutive effect.
4. Comprehensive Income
Comprehensive income is comprised of net income (loss) and other comprehensive income (loss). For the three and six months ended June 30, 2020 and 2019, the only component of other comprehensive income is net unrealized gain on marketable securities. There were no material reclassifications out of accumulated other comprehensive income (loss) during the three and six months ended June 30, 2020 and 2019.
12
5. Marketable and Equity Securities
The Company’s marketable debt securities held as of June 30, 2020 and December 31, 2019 are summarized below:
Gross
Amortized
Unrealized
Cost
Gains
Losses
266,756
786
207,010
710
(3)
576,997
1,496
578,490
Reported as
Total investments
281,586
195
(30)
268,239
1,006
581,834
1,201
The maturities of the Company’s marketable debt securities are as follows:
Estimated
Mature in one year or less
472,639
Mature within two years
1,127
473,766
13
The unrealized losses on available-for-sale investments and their related fair values as of June 30, 2020 and December 31, 2019 are as follows:
Less than 12 months
12 months or greater
Fair value
losses
49,973
46,303
(24)
13,992
(6)
The unrealized losses from the listed securities are primarily due to a change in the interest rate environment and not a change in the credit quality of the securities.
In connection with the Aimmune Agreement (as defined below) which we entered in February 2020, the Company received shares of Aimmune common stock which are classified as equity securities with a readily determinable fair value as of June 30, 2020. The Company recorded $0.3 million of unrealized gain and $2.0 million of unrealized loss related to these securities in other income (expense) during the three and six months ended June 30, 2020. We did not hold any equity securities in our investment portfolio during the year ended December 31, 2019.
6. Stock Based Compensation
Our Board of Directors (the Board) and the requisite stockholders previously approved the 2010 Equity Incentive Plan (the 2010 Plan). In October 2013, the Board 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 no additional awards may be granted under the 2010 Plan. Any shares of common stock covered by awards granted under the 2010 Plan that terminate after December 2, 2013 by expiration, forfeiture, cancellation or other means without the issuance of such shares will be added to the 2013 Plan reserve.
As of June 30, 2020, the total number of shares of common stock available for issuance under the 2013 Plan is 12,116,313, which includes 2,684,456 shares of common stock that were available for issuance under the 2010 Plan as of the effective date of the 2013 Plan. Unless otherwise determined by the Board, beginning January 1, 2014, and continuing until the expiration of the 2013 Plan, the total number of shares of common stock available for issuance under the 2013 Plan will automatically increase annually on January 1 of each year by 4% of the total number of issued and outstanding shares of common stock as of December 31 of the immediate preceding year. Pursuant to approval by the Board, the total number of shares of common stock available for issuance under the 2013 Plan was increased by 1,138,046 shares on January 1, 2020. As of June 30, 2020, a total of 10,327,214 shares of common stock subject to options have been granted under the 2013 Plan.
14
In November 2013, the Board and our stockholders approved the 2013 Employee Stock Purchase Plan (ESPP), which became effective as of December 5, 2013. We have reserved a total of 581,286 shares of common stock for issuance under the ESPP. Unless otherwise determined by the Board, beginning on January 1, 2014, and continuing until the expiration of the ESPP, the total number of shares of common stock available for issuance under the ESPP will automatically increase annually on January 1 by the lesser of (i) 1% of the total number of issued and outstanding shares of common stock as of December 31 of the immediately preceding year, or (ii) 621,814 shares of common stock. Pursuant to approval by our Board of Directors, there was no increase in the number of authorized shares in the ESPP from 2015 to 2020. As of June 30, 2020, we have issued a total of 445,621 shares of common stock under the ESPP.
During the six months ended June 30, 2020, the Company awarded 305,794 Restricted Stock Units (RSUs) to certain employees. Vesting of these awards is in three equal annual installments and is contingent on continued service to the Company. The fair value of these awards is determined based on the intrinsic value of the stock on the date of grant and will be recognized as stock-based compensation expense over the requisite service period. As of June 30, 2020, we have granted a total of 411,293 shares of common stock subject to RSUs.
Total employee, director and non-employee stock-based compensation expense recognized for the three and six months ended June 30, 2020 and 2019 are as follows (in thousands):
2,804
2,008
5,095
3,862
5,427
7,295
9,648
11,297
Stock options
6,667
8,946
12,549
14,470
ESPP
213
407
413
Restricted stock units
1,351
1,787
276
The following table summarizes option activity under our stock plans and related information:
Weighted
Average
Number of
Exercise
Remaining
Aggregate
Shares Subject
Price
Contractual
Intrinsic
to Outstanding
(Per
Term
Value
Options
Share)
(in years)
Balances at December 31, 2019
7,174,319
24.03
7.32
Options granted
1,433,699
32.10
Options forfeited
(115,261)
31.28
Options exercised
(261,786)
18.13
Balances at June 30, 2020
8,230,971
25.52
7.33
65,362
Exercisable
4,587,110
20.28
6.10
58,544
We calculate the intrinsic value as the difference between the exercise price of the options and the closing price of common stock of $32.39 per share as of June 30, 2020.
15
Weighted-average fair value of options granted during the six-month periods ended June 30, 2020 and 2019 were $16.44 and $20.74 per share, respectively. There were 1,700,583 options granted during the six-month period ended June 30, 2019. We estimated the fair value of each stock option using the Black-Scholes option-pricing model based on the date of grant of such stock option with the following weighted average assumptions for the three and six months ended June 30, 2020 and 2019:
Expected term (years)
5.7
5.9
6.2
6.0
Expected volatility
56.1
%
61.3
54.3
Risk-free interest rate
0.41
2.07
0.84
2.43
Expected dividend yield
0.5 - 2.0
50.8 - 62.6
55.0 - 71.4
0.18 - 1.65
1.47 - 2.70
As of June 30, 2020, the unamortized compensation expense related to unvested stock options was $59.4 million. The remaining unamortized compensation expense will be recognized over the next 2.8 years. As of June 30, 2020, the unamortized compensation expense under our ESPP was $1.3 million. The remaining unamortized expense will be recognized over the next 1.4 years.
The following table summarizes the RSU activity for the six-month period ended June 30, 2020:
Restricted
Average Grant
Stock
Date Fair Value
Units
(Per unit)
Unvested at December 31, 2019
90,006
34.66
Granted
305,794
31.64
Vested
(21,822)
31.91
Forfeited
(7,311)
31.47
Unvested at June 30, 2020
366,667
32.37
As of June 30, 2020, the unamortized compensation expense related to unvested RSUs was $10.2 million. The remaining unamortized expense will be recognized over the next 2.3 years.
7. Leases
The Company leases office and laboratory space in Monrovia, CA under a lease that expires September 30, 2020; the original lease was a 66-month lease that expired June 2020. In April 2020, the Company entered into an amendment to the lease to extend the term of the lease under the original terms through September 2020. In July 2017, the Company entered into a lease agreement for additional space in the same building with a lease that continues through September 2022, with an option to renew for an additional five years. The Company assesses that it is likely to exercise the option of the lease term extension.
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The Company also leases office space in San Diego, CA that expired July 2020. The lease includes an option to renew for an additional five years and the Company did not exercise the option to extend this lease.
The Company leases additional office space in San Diego, CA through August 2022, with an option to extend for an additional five years. The Company assesses that it is unlikely to exercise the option to extend the lease term.
The Company’s lease agreements do not contain any residual value guarantees or restrictive covenants. As of June 30, 2020, the Company did not have additional operating leases that have not yet commenced.
The following table reconciles the undiscounted cash flows for the operating leases at June 30, 2020 to the operating lease liabilities recorded on the balance sheet (in thousands):
Years ending December 31,
For the remainder of 2020
1,297
2021
2,583
2022
2,203
2023
1,347
2024
1,366
2025
1,212
Thereafter
1,238
Total undiscounted lease payments
11,246
Less: Imputed interest
(1,526)
Present value of lease payments
9,720
Lease liabilities - short-term
Lease liabilities - long-term
Total lease liabilities
The following table summarizes lease costs and cash disclosures for the three and six months ended June 30, 2020 (in thousands):
Operating lease cost
648
650
1,299
Variable lease cost
47
59
57
Total lease costs
686
697
1,356
Cash paid for amounts included in
the measurement of lease liabilities
566
344
1,123
854
The amendment to the Monrovia, CA lease is a lease modification. Non-cash activities involving ROU assets related to the lease modification were $0.1 million for three and six months ended June 30, 2020.
At June 30, 2020, the weighted-average remaining lease term for operating leases was 5.2 years, and the weighted-average discount rate for operating leases is 5.5%
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8. 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.
The Company is 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 the Company’s balance sheet. The Company has 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.
9. Collaboration and Licensing Agreements
The following is a summary description of the material revenue arrangements, including arrangements that generated revenue in the three and six months ended June 30, 2020 and 2019.
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 (also named RG6323), 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 the Company will jointly collaborate on worldwide development of XmAb24306 and potentially other Collaboration Products with Genentech maintaining all worldwide commercialization rights, subject to the Company having an option to co-promote in the United States. The Company 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 Company received a $120.0 million upfront payment and is eligible to receive up to an aggregate of $160.0 million in clinical milestone payments for each Collaboration Product that advances to Phase 3 clinical trials. The Company is also eligible to receive 45% share of net profits for sales of XmAb24306 and other Collaboration Products, while also sharing in net losses at the same percentage rate. The parties will jointly share in development and commercialization costs for all programs designated as a development program under the Genentech Agreement at the same percentage rate, while Genentech will bear launch costs entirely. The initial 45% profit-cost share percent is subject to ratchet down at the Company’s discretion and convertible to a royalty under certain restrictions.
Pursuant to the Genentech Agreement, XmAb24306 is designated as a development program and all costs incurred for developing XmAb24306 from March 8, 2019, the effective date of the Genentech Agreement, are being shared with Genentech under the initial cost-sharing percentage of 45%.
Pursuant to 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 two-year research term may be extended an additional year if both parties agree. The Company and Genentech are each responsible for their own costs in conducting the research activities. The Company is eligible for clinical milestone payments for new Collaboration Products identified from the research efforts.
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The Company recognized the $111.7 million allocated to the license when it satisfied its performance obligation and transferred the license to Genentech in March 2019. A total of $8.3 million of the transaction price was allocated to the research activities and is being recognized over a period of time through the end of the research term that services are rendered. A total of $0.8 million and $1.5 million of revenue related to the research activities was recognized in the three- and six-month periods ended June 30, 2020, respectively.
For the three months ended June 30, 2020 and 2019, the Company recognized $0.8 million and $0.6 million of income, respectively, from the Genentech Agreement. For the six months ended June 30, 2020 and 2019, the Company recognized $1.5 million and $112.5 million of income, respectively. As of June 30, 2020, there is a $1.3 million payable related to cost-sharing development activities during the second quarter of 2020 for the XmAb24306 program. There is $4.6 million in deferred revenue as of June 30, 2020 which reflects the Company’s obligation to perform research services during the remaining research term.
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 research antibodies 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 $15.0 million and is eligible to receive up to $240.0 million in milestones which include $32.5 million in development milestones, $57.5 million in regulatory milestones and $150.0 million in sales milestones. If commercialized, the Company is eligible to receive royalties on net sales that range from the high-single to low-double digit percentages.
The Company recognized the $13.6 million allocated to the bispecific antibodies when it satisfied its performance obligation and transferred the bispecific antibodies to Astellas in June 2019. The $1.4 million allocated to the research activities is being recognized as the research services are being completed over the period of time the Company expects to complete the activities under the research plan. The Company completed the remaining activities under the research plan during the second quarter of 2020.
For the three months ended June 30, 2020 and 2019, the Company recognized $0.7 million and $13.8 million of revenue related to the arrangement, respectively. For the six months ended June 30, 2020 and 2019, the Company recognized $0.9 million and $13.8 million of revenue, respectively. There is no deferred revenue as of June 30, 2020 related to the arrangement.
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. The Company received an upfront payment of $150.0 million and is eligible to receive additional development, regulatory and sales milestones.
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Pursuant to the Novartis Agreement:
Under the Novartis Agreement, the Company and Novartis are co-developing vibecotamab worldwide and sharing development costs.
In December 2018, Novartis notified the Company it was terminating its rights with respect to the plamotamab program, which became effective June 2019.
The Company has completed delivery of two target pair antibodies under the Agreement and in December 2019 Novartis initiated a Phase 1 study with one of the target pair antibodies.
No revenue was recognized during the three and six months ended June 30, 2020 and 2019. As of June 30, 2020, there is a receivable of $1.0 million related to cost-sharing of development activities for the second quarter of 2020 for the vibecotamab program, and $40.1 million in deferred revenue related to the obligation to deliver two additional Global Discovery Programs to Novartis under the arrangement.
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 the rights to our CD38 x CD3 preclinical program and developed AMG 424. Amgen also applied our bispecific Fc technology to create AMG 509, a STEAP1 x CD3 XmAb 2+1 bispecific antibody. The Company has received a total of $60.5 million in upfront payments and milestone payments and is eligible to receive up to $255.0 million in future development, regulatory and sales milestone payments in total for the STEAP1 x CD3 program and is eligible to receive royalties on any global net sales of products.
In May 2020, Amgen notified the Company that it was terminating its rights with respect to the CD38 x CD3 program, including AMG 424, which termination became effective July 2020. Under the terms of the Agreement, the rights to the AMG 424 program revert to the Company in connection with the termination.
No revenue was recognized under the arrangement during the three and six months ended June 30, 2020 or 2019. As of June 30, 2020, there is no deferred revenue related to the arrangement.
MorphoSys AG
In June 2010, the Company entered into a Collaboration and License Agreement with MorphoSys AG (MorphoSys), which was subsequently amended. Under the agreement, we granted MorphoSys an exclusive worldwide license to the Company’s patents and know-how to research, develop and commercialize the XmAb5574 product candidate (subsequently renamed MOR208 and tafasitamab) with the right to sublicense under certain conditions. If certain developmental, regulatory and sales milestones are achieved, the Company is eligible to receive future milestone payments and royalties.
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In February 2020, the U.S. Food and Drug Administration (FDA) accepted MorphoSys’ Biologics License Application (BLA) for tafasitamab and the Company received a milestone payment of $12.5 million. The Company recognized the payment as revenue in the period that the milestone event occurred.
On July 31, 2020, the FDA approved MorphoSys’ BLA for tafasitamab (now Monjuvi®). In connection with the approval, the Company will receive a milestone payment of $25.0 million. The Company will recognize the payment as revenue in the period that the milestone event occurs.
No revenue was recognized under this arrangement for the three months ended June 30, 2020. The Company recognized $12.5 million of milestone revenue for the six months ended June 30, 2020. No revenue was recognized under this arrangement for the three and six months ended June 30, 2019. As of June 30, 2020, there is no deferred revenue related to this agreement.
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 the Company’s Xtend technology to evaluate and advance compounds. Alexion exercised its rights to one target program, ALXN1210, which is now marketed as Ultomiris®.
The Company is eligible to receive contractual milestones for certain 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 sublicensees, 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.
Under ASC 606, the Company recognizes revenue for sales-based royalties upon the subsequent sale of the product. We began earning royalty revenue from the sale of Ultomiris in 2019.
The Company recognized $3.8 million and $1.1 million of royalty revenue under this arrangement for the three months ended June 30, 2020 and 2019, respectively. The Company also recognized $4.0 million of milestone revenue for the three months ended June 30, 2019. The Company recognized total revenue of $7.2 million and $5.1 million for the six months ended June 30, 2020 and 2019, respectively. As of June 30, 2020, there is a receivable of $7.4 million related to royalties due under the arrangement. There is no deferred revenue related to this agreement.
INmune Bio, Inc.
In October 2017, the Company entered into a License Agreement (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 $100,000, 1,585,000 shares of INmune common stock and an option to acquire additional shares of INmune. The Company is also eligible to receive a percentage of sublicensing revenue received for XPRO1595 and royalties in the mid-single digit percent range on the sale of approved products.
The option has a six-year term from the date of the Agreement and provides the Company the option to purchase up to 10% of the fully diluted outstanding shares of INmune for $10.0 million. The Company has recorded its equity interest in INmune at cost pursuant to ASC 323. The Company did not record its share of the net loss from INmune during the three and six months ended June 30, 2020 or 2019, respectively, as the carrying value of this investment has been reduced to zero.
The Company did not recognize any revenue related to the agreement for the three and six months ended June 30, 2020 and 2019. There is no deferred revenue as of June 30, 2020 related to this agreement.
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Vir Biotechnology, Inc.
In the third quarter of 2019, the Company entered into a Patent License Agreement (the VirBio Agreement) with Vir Biotechnology (VirBio) pursuant to which the Company provided a non-exclusive license to its Xtend technology for up to two targets. Under the terms of the VirBio Agreement, the Company received an upfront payment and is eligible to receive total milestones of $155.25 million which include $5.25 million of development milestones, $30.0 million of regulatory milestones and $120.0 million of sales milestones. In addition, the Company is eligible to receive royalties on the net sales of approved products in the low single digit percent range.
The Company evaluated the VirBio Agreement and determined that the single performance obligation was access to a non-exclusive license to certain patents of the Company which were transferred to VirBio upon execution of the VirBio Agreement in July 2019.
VirBio initiated a Phase 1 study with a licensed antibody in 2019 and in the second quarter of 2020 it initiated a Phase 1 study with a second licensed antibody.
In March 2020, the Company entered into a second Patent License Agreement (the Second VirBio Agreement) with VirBio pursuant to which the Company provided a non-exclusive license to its Xtend technology to extend the half-life of novel antibodies VirBio is investigating as potential treatments for patients with SARS-CoV-2, which causes COVID-19. Under the terms of the Second VirBio Agreement, VirBio is responsible for all research, development, regulatory and commercial activities for the antibody, and the Company is eligible to receive royalties on the net sales of approved products in the mid-single digit percent range.
The Company determined that the Second VirBio Agreement was a modification of the original agreement and the transfer of the license occurred at inception of the VirBio Agreement. The total consideration under the arrangement did not change with the Second VirBio Agreement as the Company will potentially receive additional royalty revenue which is variable consideration and is not included in the transaction price.
The Company recognized $0.3 million milestone revenue for the three and six months ended June 30, 2020. The Company did not recognize revenue related to the agreement for the three and six months ended June 30, 2019. There is no deferred revenue as of June 30, 2020 related to this agreement.
Aimmune Therapeutics, Inc.
On February 4, 2020, the Company entered into a License, Development and Commercialization Agreement (the Aimmune Agreement) with Aimmune Therapeutics, Inc. (Aimmune) pursuant to which the Company granted Aimmune an exclusive worldwide license to XmAb7195, which was renamed AIMab7195. Under the Aimmune Agreement, Aimmune will be responsible for all further development and commercialization activities for XmAb7195. The Company received an upfront payment of $5.0 million and 156,238 shares of Aimmune common stock with an aggregate value of $4.6 million on the closing date. Under the Aimmune Agreement, the Company is also eligible to receive up to $385.0 million in milestones, which include $22.0 million in development milestones, $53.0 million in regulatory milestones and $310.0 million in sales milestones, and tiered royalties on net sales of approved products from high-single to mid-teen percent range.
Under the Aimmune Agreement, Aimmune received exclusive worldwide rights to manufacture, develop and commercialize XmAb7195. They also received the rights to all data, information and research materials related to the XmAb7195 program.
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The Company evaluated the Aimmune Agreement under the revenue recognition standard ASC 606 and identified the following performance obligations that it deemed to be distinct at the inception of the contract:
The Company considered the licenses as functional intellectual property as Aimmune has the right to use XmAb7195 at the time that the Company transfers such rights. The rights to the XmAb7195 data are not considered to be separate from the license to XmAb7195 as Aimmune cannot benefit from the license without the supporting data and documentation.
The Company determined the transaction price at inception is $9.6 million which consists of the $5.0 million upfront payment and the 156,238 shares of Aimmune common stock which had a value of $4.6 million on the closing date. The Company determined that the transaction price is to be allocated to the performance obligations. The Aimmune Agreement includes variable consideration for potential future milestones and royalties that were contingent on future success factors for the XmAb7195 program. The Company used the “most likely amount” method to determine the variable consideration. None of the development, regulatory or sales milestones or royalties were included in the transaction price. The Company will re-evaluate the transaction price in each reporting period as uncertain events are resolved or other changes in circumstances occur.
The Company determined the transaction price at inception of the Aimmune Agreement and allocated it to the performance obligation, delivery of the XmAb7195 license.
The Company completed delivery of its performance obligations in March 2020. The license to XmAb7195 was transferred to Aimmune at inception of the Aimmune Agreement, and the XmAb7195 data was transferred to Aimmune in March 2020.
No revenue was recognized in the three months ended June 30, 2020. The Company recognized $9.6 million of revenue related to the agreement for the six months ended June 30, 2020. There is no deferred revenue as of June 30, 2020 related to this agreement.
Gilead Sciences, Inc.
In January 2020, the Company entered into a Technology License Agreement (the Gilead Agreement) with Gilead Sciences, Inc. (Gilead), in which the Company provided an exclusive license to its Cytotoxic Fc and Xtend Fc technologies for an initial identified antibody and options for up to three additional antibodies directed to the same molecular target. The Company retains the right to grant licenses for other antibodies directed to the target, subject to the Company’s approval. Gilead is responsible for all development and commercialization activities for all target candidates. The Company received an upfront payment of $6.0 million and is eligible to receive up to $67.0 million in milestones, which include $10.0 million in development milestones, $27.0 million in regulatory milestones and $30.0 million in sales milestones for each product incorporating the antibodies selected. In addition, the Company is eligible to receive royalties in the low-single digit percentage range on net sales of approved products.
In March 2020, Gilead exercised options on two additional antibody compounds and in April 2020 it exercised the option on the third antibody available under the Gilead Agreement. In April 2020, we received a total of $7.5 million in payment of the three options.
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The Company evaluated the Gilead Agreement under the revenue recognition standard ASC 606 and identified the following performance obligations that it deemed to be distinct at the inception of the contract:
The Company considered the licenses as functional intellectual property as Gilead has the right to use the technologies at the time that the Company transfers such rights. Each of the four options is considered a separate performance obligation as the arrangement does not confer material rights to the options without payment of the option exercise fee. Gilead will benefit from each option upon exercise of each of the four options and payment of each option fee as Gilead has access to each technology at inception of the arrangement and the rights are transferred upon payment of each option fee.
The total transaction price is $13.5 million which includes the upfront payment of $6.0 million and the option fee payment of $7.5 million which was contractually due with the exercise of the three options by Gilead. The milestone payments are variable consideration to which the Company applied the “most likely amount” method and concluded at inception of the Gilead Agreement it is unlikely that the Company will collect such payments. The milestone payments were not included in the transaction price and the Company will review this conclusion and update at each reporting period.
The Company allocated $3.5 million of the transaction price to the licenses to the cytotoxic Fc and Xtend Fc technologies and recognized income for the licenses at inception of the arrangement when Gilead began benefiting access to them. The Company allocated $2.5 million to the initial option exercise which was effective at inception of the arrangement and payment of the upfront amount and the Company allocated $7.5 million to the three remaining options which became effective in April 2020 when Gilead paid the option fees.
The Company recognized $7.5 million and $13.5 million of revenue related to the Gilead Agreement for the three and six months ended June 30, 2020, respectively. There is no deferred revenue as of June 30, 2020 related to this agreement.
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Revenue earned
The revenues recorded for the three and six months ended June 30, 2020 were earned principally from the following licensees (in millions):
Aimmune
9.6
Alexion
3.8
5.1
7.2
0.7
13.8
0.9
0.8
0.6
1.5
112.5
Gilead
7.5
13.5
MorphoSys
12.5
Vir Biotechnology
0.3
13.1
19.5
45.5
131.4
The table below summarizes the disaggregation of revenue recorded for the three and six months ended June 30, 2020 (in millions):
Research collaboration
14.4
2.4
14.7
Milestone
4.0
12.8
Licensing
23.1
111.6
Royalties
1.1
Remaining Performance Obligations and Deferred Revenue
The Company’s remaining performance obligations are delivery of two Global Discovery Programs under the Novartis Agreement and conducting research activities pursuant to research plans under the Genentech Agreement. We have completed the remaining research activities pursuant to the research plan under the Astellas Agreement in the three-month period ended June 30, 2020. As of June 30, 2020 and 2019, the Company has deferred revenue of $44.7 million and $48.8 million, respectively. As of June 30, 2020, all deferred revenue is classified as current liabilities as the Company’s obligations to perform services are due on demand when requested by Novartis under the Novartis Agreement and the Company’s obligation to perform research services to Genentech will end upon expiration of the research term within one year. As of June 30, 2019, $45.5 million was classified as current liabilities for the same reason, and $3.3 million of the deferred revenue liability was classified as long-term for the portion of obligations to perform research services to Genentech after one year.
10. Income taxes
On March 27, 2020, the president signed the Coronavirus Aid, Relief and Economic Security (CARES) Act. The legislation provides several changes to corporation income taxes including:
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The Company reviewed the new legislation and determined that certain provisions would provide income tax benefits:
There was no provision for income taxes for the three and six months ended June 30, 2020. The provision for income taxes of $0.9 million for the 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 $0.8 million at June 30, 2020 related to refundable alternative minimum tax credits. As of June 30, 2020, the Company’s deferred income tax assets, consisting primarily of net operating loss and tax credit carryforwards, have been fully offset by a valuation allowance.
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, 2019 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, 2019. 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 cytokine therapeutics to treat patients with cancer and autoimmune diseases who have unmet medical needs. We are developing a suite of clinical-stage drug candidates from our proprietary XmAb® technology platforms. In contrast to conventional approaches to antibody design, which focus on the segment of antibodies that interact with target antigens, our protein engineering efforts and the XmAb technologies are focused on the Fc domain, the part of an antibody that interacts with multiple segments of the immune system and controls antibody structure. The Fc domain is constant and interchangeable among antibodies, and our engineered Fc domains, the XmAb technology, can be readily substituted for natural Fc domains. We use our protein engineering capabilities to increase our understanding of protein structure and interactions and to design new XmAb technologies and development candidates with improved properties.
Our business strategy is based on the plug-and-play nature of the XmAb technology, allowing us to create new antibody and cytokine 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.
COVID-19
We are closely monitoring the pandemic caused by the novel coronavirus SARS-CoV-2 which causes the disease COVID-19, and are evaluating its impact on all aspects of our business including how it will affect our partners, collaborations, and our research and development operations. While the pandemic did not significantly disrupt our
business during the six months ended June 30, 2020, the evolving nature of the pandemic prevents us from reasonably predicting how the pandemic will affect our financial condition, results of operations and cash flows due to numerous uncertainties. These uncertainties include the scope, severity and duration of the pandemic, the actions taken to contain the pandemic or mitigate its impacts and the direct and indirect economic effects of the pandemic
and containment measures, among others. Many states, including California, where we are headquartered and where our principal place of business is located, and cities therein have instituted quarantines, restrictions, rules and guidelines that affect the continued operation of businesses. Other countries and states where we conduct manufacturing of our drug product, testing activities and clinical sites where patients are enrolled in our clinical trials have enacted similar restrictions that could affect our ability to conduct our drug candidate development and clinical operations.
The potential impacts on our business, revenue, clinical studies and research and development activities of the COVID-19 pandemic include:
Our ability to continue to earn revenue from these and other partnerships is dependent on the partners’ ability to generate sales of products, such as our royalties from Ultomiris, and the ability of our partners to continue to advancing their programs through regulatory approval and the ability of our partners to advance our partnered programs into later stages of development, which provide us with potential milestone payments. If the COVID-19 pandemic continues for an extended period and adversely affect the sales or clinical, development and regulatory progress of partnered programs, the amount of revenue we could earn would be adversely affected.
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Wholly Owned and Co-Developed Drug Candidates
There are currently 17 antibody and cytokine drug candidates that are being advanced in clinical trials, by us or by our partners, that have been engineered with our XmAb technologies, and we expect additional candidates currently in later stages of preclinical development to enter the clinic within the next year. 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 can bind two or more different targets simultaneously. We recently expanded the functionality, selectivity and potency tuning of the bispecific platform with the design of our 2+1 bispecific format. These bispecific Fc domains are used to generate a broad array of novel drug candidates.
CD3 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. The goal of the “CD3 bispecific” is to recruit or activate T cells against tumor cells expressing the antigen target.
We are currently conducting Phase 1 studies for three CD3 bispecific antibody candidates: vibecotamab, plamotamab and tidutamab.
XmAb 2+1 bispecific antibodies. We use the modularity of our XmAb Fc technology to build bispecific antibodies in a variety of formats to best suit therapeutic uses. Recently we created CD3 bispecific antibodies with 2 binding domains to the tumor target (bivalent binding) and 1 binding domain to CD3, a format called 2+1 bispecific antibody. The 2+1 bispecific antibodies can be more tumor specific, because bivalent binding preferentially targets tumor cells with high density target expression, potentially sparing any normal tissue expressing the target at low density. Also, bivalent binding broadens the range of potency tuning for improving efficacy and tolerability. We believe that the selectivity of the 2 +1 format is particularly useful for antibodies against solid tumor targets, which can have poor tolerability because such targets are often expressed on a range of normal tissues, including critical organs.
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The 2+1 format was used for the design of AMG509, a bispecific antibody that we developed under our Amgen collaboration. AMG509 is a STEAP1 x CD3 XmAb 2+1 bispecific antibody for which Amgen is currently enrolling a Phase 1 trial and is being developed for patients with prostate cancer and Ewing sarcoma.
At the American Association for Cancer Research (AACR) Virtual Annual Meeting in June, we presented preclinical data from three 2+1 bispecific programs targeting renal cell carcinoma, prostate cancer and ovarian cancer which included XmAb30819, ENPP3 x CD3, our initial bispecific development program using the 2+1 format and targeting ENPP3 x CD3.
ENPP3 is an underexplored tumor antigen overexpressed on RCCs. In preclinical models, XmAb30819 bound preferentially to tumor cells compared to normal cells and selectively and effectively recruited T cells to kill tumor cells. Additional data demonstrated a strong reversal of tumor growth in human-cell engrafted mouse models of disease. A study in non-human primates demonstrated XmAb30819 was well-tolerated with expected pharmacodynamics and an antibody like half-life. We are conducting IND-enabling studies with XmAb30819 and expect to file an IND and initiate Phase 1 studies for this candidate in 2021.
TME activator candidates: 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. These TME activator candidates use our bispecific Fc domain and incorporate our Xtend technology for longer half-life. We are currently conducting Phase 1 studies for three TME activator candidates: XmAb20717, XmAb22841 and XmAb23104:
In May 2020, we presented initial dose-escalation data from the study. In the first six dose-escalation cohorts, XmAb20717 was generally well-tolerated in heavily pretreated patients with advanced solid tumors. We observed dose-dependent increases in T cell activation biomarkers, and within the highest dose cohort (10 mg/kg), a patient with melanoma, who was treated previously with checkpoint therapy (pembrolizumab), achieved a confirmed complete response. Additionally, a patient at the 6 mg/kg dose level with microsatellite instability-high (MSI-H) colorectal cancer, who had progressive disease after 10 months of treatment with pembrolizumab and prior treatment with both nivolumab and ipilimumab, achieved stable disease, and as of the presentation of data, had continued on treatment at cycle 14 (392 days).
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Cytokine candidates: Our cytokine drug candidates are built on our bispecific Fc domain and have their potency tuned to improve therapeutic index. These candidates also incorporate our Xtend technology for longer half-life.
Licensing Partnerships
An important part of our business strategy is to leverage the value of our Fc technologies and drug candidates with partnerships and collaborations. We have eleven partnerships for the licensing of our XmAb technologies and drug candidates. These arrangements provide upfront payments, annual licensing fees, potential milestone payments and royalties as our partners advance XmAb technologies and drug candidates through clinical development and commercialize products that gain regulatory approval. These payments provide us with multiple revenue streams that help fund development of our product candidates, and the partnerships 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 U.S. commercial rights.
In 2020, we entered into licensing transactions with Aimmune and Gilead for which we received total payments of $9.6 million and $13.5 million, respectively. In 2020, we have also extended our licensing partnership with VirBio whereby VirBio will have non-exclusive access to Xtend Fc technology to extend the half-life of antibodies that VirBio is investigating as potential treatments for patients with COVID-19, the disease caused by the novel coronavirus SARS-CoV-2.
In July 2020, we entered into a Collaboration and License Agreement (Atreca Agreement) with Atreca, Inc. (Atreca), to research, develop and commercialize novel CD3 bispecific antibodies as potential therapeutics in oncology. Under the Atreca Agreement, the companies will engage in a three-year research program in which Atreca will provide antibodies against novel tumor targets through its discovery platform from which we will engineer XmAb bispecific antibodies that also bind to the CD3 receptor on T cells. Up to two joint programs are eligible to be mutually selected for further development and commercialization, with each partner sharing 50 percent of costs and profits. Each company has the option to lead development, regulatory and commercialization activities for one of the joint programs. In addition, the agreement allows each partner the option to pursue up to two programs independently, with a mid-to high-single digit percent royalty payable on net sales to the other partner.
The most advanced program where we have licensed our technology is Alexion’s Ultomiris®, a complement inhibitor antibody, to allow for a longer duration of action, less frequent dosing and reduced patient burden of therapy compared to Alexion’s previous generation therapy, Soliris®. Alexion is approved for marketing in the U.S., Europe and Japan for the treatment of adult patients with the rare blood disease paroxysmal nocturnal hemoglobinuria (PNH) and is also approved in the U.S. and Europe for the treatment of patients with atypical hemolytic uremic syndrome (aHUS). In March 2020, Alexion announced it was initiating a Phase 3 study of Ultomiris in treating patients with severe COVID-19, adults who are hospitalized with severe pneumonia or acute respiratory distress syndrome (ARDS).
Examples of other partnerships and collaborations in which we have licensed XmAb technologies and candidates to other biopharmaceutical companies for further development include those with MorphoSys, Amgen, Novartis, Gilead and VirBio:
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Amgen also licensed the rights to our CD38 x CD3 preclinical program and developed AMG 424 which was enrolling a Phase 1 study in patients with multiple myeloma. In May 2020, Amgen notified us they were terminating the CD38 x CD3 program, including AMG 424, which termination became effective July 2020. Under the terms of the agreement, the rights to the CD38 program including AMG 424 revert to us. We are working with Amgen to review the AMG 424 development data and determine potential next steps for the program.
In March 2020, we entered into a second non-exclusive license with VirBio to use our Xtend technology to extend the half-life of VIR-7831 and VIR-7832, novel antibodies that VirBio is investigating as potential treatments for patients with COVID-19, the disease caused by the novel coronavirus SARS-CoV-2. VirBio plans to commence a Phase 2/3 clinical study for VIR-7831 within the coming months.
We have over 1,000 issued and pending patents worldwide to protect our XmAb technology platform and XmAb drug candidates.
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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.
As of June 30, 2020, we had an accumulated deficit of $339.5 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, 2020 and 2019
The following table summarizes our results of operations for the three months ended June 30, 2020 and 2019 (in millions):
Change
Revenues:
(12.9)
(3.7)
2.7
Total revenues
(6.4)
Operating expenses:
43.5
33.3
10.2
5.8
1.4
50.7
39.1
11.6
Other income, net
2.6
3.6
(1.0)
Loss before income tax expense
(35.0)
(16.0)
(19.0)
Net loss
Revenues
Revenues for the three months ended June 30, 2020 are primarily from royalty revenue from our Alexion collaboration and licensing revenue recognized from our Gilead collaboration. Revenue for the three months ended June 30, 2019 is primarily from our research collaboration revenue from our Genentech and Astellas collaborations and milestone revenue received from our Alexion collaboration.
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Research and Development Expenses
The following table summarizes our research and development expenses for the three months ended June 30, 2020 and 2019 (in millions):
Product programs:
Obexelimab (XmAb5871)
1.0
5.4
(4.4)
Bispecific programs:
CD3 programs:
Vibecotamab (XmAb14045)*
3.1
3.7
(0.6)
Plamotamab (XmAb13676)
9.3
3.3
Tidutamab (XmAb18087)
2.9
XmAb30819, ENPP3 x CD3
1.9
Total CD3 programs
18.0
9.9
8.1
Tumor micro environment (TME) activators:
XmAb20717
6.8
2.8
XmAb23104
2.1
1.6
XmAb22841
2.2
Total TME activators
12.7
8.0
4.7
Cytokine programs:
XmAb24306*
2.0
(3.1)
XmAb27564
Total cytokine programs
6.7
0.5
Subtotal bispecific programs
37.4
24.1
13.3
Other, research and early stage programs
1.3
Total research and development expenses
*Includes net payments to, and reimbursements from our partners pursuant to agreements that include cost-sharing arrangements.
Research and development expenses increased by $10.2 million for the three months ended June 30, 2020 over the same period in 2019 primarily due to increased spending on our plamotamab and XmAb20717 programs as we continue to advance these programs in dose escalation clinical studies. Spending also increased on our XmAb27564 and XmAb30819 programs as we initiate manufacturing campaigns and IND enabling studies. Spending also increased in our earlier research stage studies. These increases were partially offset by reduced spending on our XmAb24306 and obexelimab programs.
General and Administrative Expenses
The following table summarizes our general and administrative expenses for the three months ended June 30, 2020 and 2019 (in millions):
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General and administrative expenses increased by $1.4 million for the three months ended June 30, 2020 over the same period in 2019 primarily due to increased general and administrative staffing and spending on professional fees.
Other Income, Net
Other income was $2.6 million and $3.6 million for the three months ended June 30, 2020 and 2019, respectively. The decrease in other income was primarily due to lower interest income earned from our marketable securities.
Comparison of the Six Months Ended June 30, 2020 and 2019
The following table summarizes our results of operations for the six months ended June 30, 2020 and 2019 (in millions):
(12.3)
8.8
(88.5)
6.1
(85.9)
77.4
61.5
15.9
11.3
91.8
72.8
19.0
6.3
(3.0)
Income (loss) before income tax expense
(43.0)
64.9
(107.9)
(0.9)
64.0
(107.0)
Revenues for the six months ended June 30, 2020 are primarily from royalty revenue from our Alexion collaboration and licensing revenue recognized from our collaborations with Gilead and Aimmune. Revenues recognized for the six months ended June 30, 2019 are primarily from licensing and collaboration revenue recognized under the Genentech and Astellas arrangements.
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The following table summarizes our research and development expenses for the six months ended June 30, 2020 and 2019 (in millions):
11.9
(10.0)
6.5
(0.8)
16.4
5.2
11.2
6.9
5.6
31.9
17.3
14.6
12.1
4.1
23.3
8.9
9.8
(5.8)
6.6
1.2
10.6
11.0
(0.4)
65.8
42.7
9.7
Research and development expenses increased by $15.9 million for the six months ended June 30, 2020 over the same period in 2019 primarily due to increased spending on our plamotamab, XmAb20717 and XmAb22841 programs as we continue to advance these programs in dose escalation clinical studies. Spending also increased on our XmAb27564 and XmAb30819 programs as we initiate manufacturing campaigns and IND enabling studies and activities. Spending also increased in our earlier research stage studies. These increases were partially offset by reduced spending on the XmAb24306 and obexelimab programs.
The following table summarizes our general and administrative expenses for the six months ended June 30, 2020 and 2019 (in millions):
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General and administrative expenses increased by $3.1 million for the six months ended June 30, 2020 over the same period in 2019 primarily due to increased general and administrative staffing and spending on professional fees.
Other income was $3.3 million and $6.3 million for the six months ended June 30, 2020 and 2019, respectively. The decrease in other income was primarily from the $2.3 million unrealized loss recognized in the first quarter related to our Aimmune common stock and also a reduction in earnings from investments due to lower interest rates during the period.
Cash Flows
The following table sets forth the primary sources and uses of cash for each of the periods presented below (in thousands):
Net cash (used in) provided by:
Operating activities
(108,650)
Investing activities
160,730
Financing activities
831
Net increase in cash
52,911
Operating Activities
Cash used in operating activities for the six months ended June 30, 2020 was $18.2 million while cash provided by operating activities for the six months ended June 30, 2019 was $90.4 million. This is primarily due to upfront and milestone payments received from collaborations in the six-month period ended June 30, 2019 in excess of operating costs incurred in each period.
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, 2020 increased by $0.8 million over the same period in 2019 which reflects 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.
As of June 30, 2020, we had $587.4 million of cash, cash equivalents and marketable and equity securities compared to $601.3 million at December 31, 2019. The investments in marketable securities are further described above in footnote 5 in the Notes to Financial Statements in Item 1 of Part I of this Quarterly Report on Form 10-Q. 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.
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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 preclinical development of product candidates in our pipeline.
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 into 2024. We have based these estimates on assumptions that may prove to be wrong, and the COVID-19 pandemic could materially alter these estimates which would cause us to 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, 2020.
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. In connection with the COVID-19 pandemic the financial markets were materially affected and all classes of public corporate debt were subject to increased risk. We are closely monitoring the changes in the market with our financial advisors and are adjusting our investment holdings in connection with the risk caused by the COVID-19 pandemic.
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
As required by Rule 13a-15(b) and Rule 15d-15(b) of the Exchange Act, 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 the design and operation of our disclosure controls and procedures (as defined in Exchange Act Rule 13a-15(b) and 15d-15(e)) as of June 30, 2020. 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, 2020.
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 were no changes in our internal control over financial reporting that occurred during the six months ended June 30, 2020 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. Beginning March 17, 2020, a majority of our business, accounting and financial reporting employees began working remotely due to the COVID-19 pandemic. Since that time, we have not experienced any material impact to our internal controls over financial reporting. We are continually monitoring and assessing the COVID-19 situation on our internal controls to minimize the impact to their design and operating effectiveness.
PART II — OTHER INFORMATION
ITEM 1. Legal Proceedings.
None.
ITEM 1A. Risk Factors
You should carefully consider the factors discussed in Part 1, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2019, which could materially affect our business, financial position, or future results of operations. 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, 2019, 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. In light of the rapid spread of SARS-CoV-2, which causes coronavirus disease 2019 (COVID-19), we are updating and supplementing our risk factors described in our Annual Report on Form 10-K for the year ended December 31, 2019 to include the following new risk factor.
Risks Relating To Our Business and to the Discovery, Development, Regulatory Approval of Our Product Candidates and other Legal Compliance Matters
The COVID-19 pandemic and the future outbreak of other highly infectious or contagious diseases, could materially and adversely impact or disrupt our business and our financial condition, results of operations, cash flows and performance.
On March 11, 2020, the World Health Organization (WHO) declared the rapid spread of COVID-19 a global pandemic, and on March 19, the Governor of the State of California, where we are headquartered and where our principal place of business is located, implemented a mandatory stay at home order for residents working in non-critical businesses.
An epidemic or pandemic disease outbreak, including the COVID-19 pandemic, could cause significant disruptions to our business operations, business operations of our partners, on whom we rely for potential revenue, and product development collaborations; operations of our third-party manufacturers and contract research organizations (CROs), on which we rely to conduct our clinical trials; and to our clinical trials, including as a result of significant restrictions or bans on travel into and within the countries in which our manufacturers produce our product candidates or where we conduct our clinical trials. Such disruptions could impede, delay, limit or prevent our employees and CROs from continuing research and development activities.
Although the COVID-19 pandemic has not materially affected our clinical development for the period ended June 30, 2020, certain of our clinical programs have seen slower enrollment and there have also been delays in initiating new studies as a result of the COVID-19 pandemic. These delays are not seen across all our trials and is specific to certain trials enrolling at certain sites. In the future, the COVID-19 pandemic could further adversely affect our and our partners’ ability to enroll and recruit patients in current and future clinical trials. Our success is dependent on our ability and the ability of our partners to advance our wholly-owned and partnered development programs into later stages of clinical development. Many pharmaceutical and biotechnology companies have indicated that their clinical trials will be delayed and enrollment of current and ongoing trials will suffer as a result of the COVID-19 pandemic. Completion of our ongoing clinical and preclinical studies or commencement of new clinical trials could be impeded, delayed, limited or prevented by the effects of the COVID-19 pandemic and related restrictions including negative effects on the production, delivery or release of our product candidates to our clinical trial sites, as participation by our clinical trial investigators, patients or other critical staff, which to could delay data collection, analysis and other related activities, any of which could cause delay or denial of regulatory approval of our product candidates. The delay and impact on enrollment cannot be determined at this time and will depend on the length and severity of the COVID-19 pandemic. Continued delays on our clinical and preclinical studies or trials will increase our costs and expenses and seriously harm our operations and financial condition, which will adversely affect our business.
The COVID-19 pandemic could also potentially affect the business of the FDA as well as other health regulatory authorities, which could result in delays in our communications with these authorities and ultimately in our ability for us and our partners to have drug products approved.
The COVID-19 pandemic and mitigation measures also have had and may continue to have an adverse impact on global economic conditions which could have an adverse effect on our business and financial condition, including impairment of our ability to raise capital when needed. The trading prices for biopharmaceutical companies’ stock, including our common shares have been highly volatile as a result of the COVID-19 pandemic. In addition, a recession, depression or other sustained adverse market event resulting from the COVID-19 pandemic could materially and adversely affect our business and the value of our common shares.
The COVID-19 pandemic could potentially affect our partnerships and collaborations which provide us with revenue and non-dilutive payments in the form of upfront payments, milestone payments, royalties and cost-sharing of co-development programs. If our partners’ and collaborators’ operations are severely affected by the COVID-19 pandemic, it will adversely affect our future potential revenue from such partners and collaborators.
We have required most of our employees, including all of our administrative employees, to work remotely, restricted on-site staff to only those employees that must perform essential activities that must be completed on-site and limited the number of staff allowed in our laboratory and offices. These changes may negatively impact productivity, or disrupt, delay, or otherwise adversely impact our business. In addition, this could increase our cyber security risk, create data accessibility concerns, and make us more susceptible to communication disruptions, any of which could adversely impact our business operations. When we reopen our facilities, we could encounter delays in connection with implementing precautionary measures to mitigate the risk of exposing our facilities and employees to COVID-19.
The COVID-19 pandemic could adversely affect our supply chain for our research, development and clinical programs. We rely on third party vendors for research supplies, development activities including manufacturing of drug product for our clinical studies and testing of drug material. If any of the vendors in our supply chain of products or services are severely affected from the COVID-19 pandemic, it will adversely affect our ability to continue our research and development activities and also continue our clinical trial activities.
The COVID-19 pandemic continues to rapidly evolve. Its ultimate impact on our business operations is highly uncertain and subject to change that will depend on future developments, which cannot be accurately predicted, including the duration of the COVID-19 pandemic, additional or modified government actions, new information that will emerge concerning the severity and impact of COVID-19 and the actions taken to address its impact in the short and long term, among others. We do not yet know the full extent of potential delays or impacts on our business, our clinical trials, our research programs, healthcare systems or the global economy. We will continue to monitor the situation closely.
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ITEM 6. Exhibits
Exhibit
Number
Description of Document
Amended and Restated Certificate of Incorporation of the Company (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K, filed with the SEC on December 11, 2013).
3.2
Amended and Restated Bylaws of the Company (incorporated by reference to Exhibit 3.2 to the Company’s Current Report on Form 8-K, filed with the SEC on December 11, 2013).
Form of Common Stock Certificate of the Company (incorporated by reference to Exhibit 4.1 to the Company’s Registration Statement on Form S-1, as amended (File No. 333-191689), originally filed with the SEC on October 25, 2013).
4.2
Third Amended and Restated Investor Rights Agreement, dated June 26, 2013, among the Company and certain of its stockholders incorporated by reference to Exhibit 4.2 to the Company’s Registration Statement on Form S-1, as amended (File No. 333-191689), originally filed with the SEC on October 11, 2013).
10.1
Third Amendment to Lease, dated April 30, 2020, by and between the Company and 111 Lemon Investors LLC
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
Inline 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
Inline XBRL Schema Document
101.CAL
Inline XBRL Calculation Linkbase Document
101.DEF
Inline XBRL Definition Linkbase Document
101.LAB
Inline XBRL Labels Linkbase Document
101.PRE
Inline XBRL Presentation Linkbase Document
104
104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
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)
/s/ JOHN J. KUCH
John J. Kuch
Chief Financial Officer
(Principal Financial Officer)
Dated: August 4, 2020