Xencor Reports Fourth Quarter and Full Year 2021 Financial Results
Xencor, a clinical-stage biopharmaceutical company, reported its financial results for Q4 and FY 2021, highlighting significant advancements in its drug portfolio. The company initiated Phase 2 trials for vudalimab in prostate cancer and established a collaboration with Janssen. Revenues surged to $154 million in Q4, compared to $42 million in Q4 2020, while full-year revenues reached $275 million, up from $123 million. Net income for 2021 was $82.6 million, a turnaround from a net loss of $69.3 million in 2020. Xencor expects to maintain cash reserves of $500-$550 million by the end of 2022.
- Revenues for Q4 2021 were $154 million, up from $41.9 million in Q4 2020.
- Full-year revenues increased to $275.1 million from $122.7 million in 2020.
- Net income for 2021 was $82.6 million, a significant improvement from a net loss of $69.3 million.
- Strong financial position with $664.1 million cash as of December 31, 2021.
- Research and development expenses rose to $192.5 million for FY 2021, compared to $169.8 million in 2020.
-- Management to Host Conference Call at
“In 2021, we made significant decisions to advance our portfolio of internal XmAb® drug candidates — the initiation of Phase 2 trials in prostate cancer with vudalimab, the entry into our second collaboration with Janssen, focused on plamotamab and additional CD28 bispecifics, as well as the decision to stop a Phase 1 program, vibecotamab. We are focused on using our resources on the most promising clinical-stage programs and on the next wave of additional reduced-potency cytokines, CD28 T cell engagers and 2+1 CD3 T cell engagers,” said
Recent Portfolio Highlights
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Vudalimab (PD-1 x CTLA-4): In
November 2021 ,Xencor presented updated expansion cohort data from the Phase 1 study of vudalimab in patients with multiple types of advanced solid tumors at the SITC Annual Meeting. The results from the study indicate vudalimab was generally well tolerated and demonstrated activity in advanced prostate cancer, ovarian cancer, and multiple other tumor types and have informed Phase 2 development plans. The Company is currently enrolling a Phase 2 study in patients with metastatic castration-resistant prostate cancer (mCRPC), where vudalimab is being evaluated as a monotherapy or in combination with chemotherapy or a PARP inhibitor depending on the tumor’s molecular subtype. The Company plans to present initial data from the study in the second half of 2022. A second Phase 2 study will begin this year, evaluating vudalimab monotherapy in patients with advanced pelvic tumors, including clinically defined high-risk mCRPC and certain gynecologic malignancies.
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Plamotamab (CD20 x CD3): In
December 2021 ,Xencor presented updated dose-escalation data from the Phase 1 study of plamotamab at the ASH Annual Meeting. Expansion cohorts are actively recruiting patients with DLBCL and FL and are dosing using the recommended Phase 2 regimen to further evaluate the safety and efficacy of plamotamab monotherapy. In 2022, subcutaneous administration of plamotamab will be incorporated into the study, and the Company plans to present data from the expansion cohorts in the second half of the year. The Company is currently opening clinical sites for the potentially registration-enabling Phase 2 study, evaluating plamotamab in combination with tafasitamab and lenalidomide, in patients with relapsed or refractory DLBCL.
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XmAb564 (IL2-Fc): XmAb564 is a potency-reduced IL2-Fc fusion protein targeting regulatory T cells, and it is being developed for patients with autoimmune disease.
Xencor is conducting a Phase 1 study to evaluate the safety and tolerability of a single dose of XmAb564, administered subcutaneously in healthy adult volunteers. The Company plans to present tolerability, durability and biomarker data from the study in 2022 and plans to initiate a multiple-ascending dose study in select patient populations.
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XmAb306 (IL15/IL15Rα-Fc): XmAb306 is a potency-reduced IL15/IL15Rα-Fc fusion protein targeting NK and T cells for the treatment of patients with cancer, which
Xencor is co-developing withGenentech , a member of the Roche Group. InNovember 2021 ,Xencor announced that XmAb306 promoted high levels of sustained NK cell expansion and evidence of peripheral effector T cell proliferation, in an ongoing Phase 1 dose-escalation study of XmAb306 in patients with advanced solid tumors. Additional studies of XmAb306 in combination with other therapeutic agents are being planned.
- Preclinical Data Presentations: New data from four preclinical-stage programs, including Xencor’s IL-12-Fc cytokine program (XmAb662), PD-L1 x CD28 bispecific antibody program, TGFβR2 bispecific antibody platform, and bispecific NK cell engager platform, were presented at the SITC Annual Meeting.
Progress Across Partnered Programs and New Partnerships
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Vir Biotechnology, Inc.: In 2021,
Xencor recognized in royalty revenue under the Company’s agreement with Vir. Sotrovimab, an antibody that targets the SARS-CoV-2 virus and incorporates Xencor’s Xtend Fc domain for longer duration of action, is made available by Vir and its partner$52.2 million Glaxo Wellcome UK Limited andGlaxoSmithKline Biologicals S.A. under an emergency use authorization (EUA) from theU.S. FDA for the treatment of mild-to-moderate COVID-19 in high-risk adults and pediatric patients. Sotrovimab has also been granted a marketing authorization in theEuropean Union , approved via Japan’s Special Approval for Emergency Pathway inJapan , and granted conditional, provisional, or temporary authorizations for the early treatment of COVID in 15 other countries.
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Janssen Biotech, Inc. : In the fourth quarter of 2021, Janssen selected a CD28 bispecific antibody candidate under theNovember 2020 collaboration agreement, and the Company earned a milestone payment. The first collaboration between Janssen and$5.0 million Xencor is focused on the discovery of XmAb bispecific antibodies against CD28, an immune co-stimulatory receptor on T cells, and an undisclosed prostate tumor target, for the potential treatment of patients with prostate cancer. Under the agreement, the Company has a right to access select, predefined agents from Janssen’s portfolio of clinical-stage drug candidates and commercialized medicines to evaluate potential combination therapies in prostate cancer with agents in the Company's own pipeline, subject to some limitations. Janssen has the same right withXencor's portfolio to evaluate potential combination therapies in prostate cancer.
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Amgen Inc.: Amgen is enrolling patients with mCRPC in a Phase 1 study evaluating AMG 509 (STEAP1 x CD3), an XmAb 2+1 bispecific antibody. The XmAb 2+1 multivalent format enables higher binding capability for STEAP1 expressing cells. In
February 2022 , Amgen presented encouraging, preliminary data highlighting AMG 509’s pharmacodynamic activity of maximum prostate specific antigen (PSA) decline among 30 patients in the study, which provides an early signal of activity and potential validation for the capabilities of the XmAb 2+1 bispecific antibody format.
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Zenas BioPharma Ltd. : InNovember 2021 ,Xencor entered into a second product license agreement with Zenas and granted Zenas the exclusive worldwide rights to develop and commercialize obexelimab, which uses the XmAb Immune Inhibitor Fc Domain and targets CD19 with its variable domains, to inhibit the function of B cells.Xencor received a warrant to acquire additional equity in Zenas and is eligible to receive up to in milestone payments and tiered, mid-single digit to mid-teen percent royalties upon commercialization of obexelimab, dependent on geography.$470 million
Financial Results for the Fourth Quarter and Full Year Ended
Cash, cash equivalents, receivables and marketable debt securities totaled
Revenues for the fourth quarter ended
Research and development expenses for the fourth quarter ended
General and administrative expenses for the fourth quarter ended
Non-cash, share based compensation expense for the year ended
Net income for the fourth quarter ended
The total shares outstanding were 59,355,558 as of
Financial Guidance
Based on current operating plans,
Conference Call and Webcast
The live call may be accessed by dialing (877) 359-9508 for domestic callers or +1 (224) 357-2393 for international callers and referencing conference ID number 5290676. A live webcast of the conference call will be available online from the Investors section of the Company's website at www.xencor.com. The webcast will be archived on the company's website for 30 days.
About
Forward-Looking Statements
Certain statements contained in this press release may constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include statements that are not purely statements of historical fact, and can generally be identified by the use of words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” and similar terms, or by express or implied discussions relating to Xencor’s business, including, but not limited to, statements regarding planned presentations of clinical data, planned additional clinical trials, the quotations from
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|||||
Condensed Balance Sheets |
|||||
(in thousands) |
|||||
|
|||||
|
2021 |
|
|
2020 |
|
Assets | |||||
Current assets | |||||
Cash and cash equivalents | $ |
143,480 |
$ |
163,544 |
|
Short-term marketable debt securities |
|
153,767 |
|
434,156 |
|
Equity securities |
|
36,860 |
|
5,303 |
|
Accounts receivable |
|
66,384 |
|
11,443 |
|
Contract asset |
|
— |
|
12,500 |
|
Other current assets |
|
23,877 |
|
10,726 |
|
Total current assets |
|
424,368 |
|
637,672 |
|
Property and equipment, net |
|
28,240 |
|
21,682 |
|
Intangible assets, net |
|
16,493 |
|
15,977 |
|
Long-term marketable debt securities |
|
300,465 |
|
1,030 |
|
Equity securities - noncurrent |
|
31,262 |
|
16,071 |
|
Long-term notes receivable |
|
5,000 |
|
— |
|
Right of use asset |
|
31,730 |
|
10,600 |
|
Other assets |
|
653 |
|
212 |
|
Total assets | $ |
838,211 |
$ |
703,244 |
|
Liabilities and stockholders’ equity | |||||
Current liabilities | |||||
Accounts payable and accrued liabilities | $ |
33,444 |
$ |
26,557 |
|
Current portion of deferred revenue |
|
37,294 |
|
92,615 |
|
Current portion of lease liability |
|
— |
|
1,889 |
|
Total current liabilities |
|
70,738 |
|
121,061 |
|
Lease liability, less current portion |
|
33,969 |
|
9,739 |
|
Total liabilities |
|
104,707 |
|
130,800 |
|
Stockholders’ equity |
|
733,504 |
|
572,444 |
|
Total liabilities and stockholders’ equity | $ |
838,211 |
$ |
703,244 |
|
|||||||||||||||
Condensed Statements of Comprehensive Income (Loss) |
|||||||||||||||
(in thousands, except share and per share data) |
|||||||||||||||
Three months ended |
Year ended |
||||||||||||||
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
|
(unaudited) | |||||||||||||||
Revenues | $ |
154,016 |
|
$ |
41,854 |
|
$ |
275,111 |
|
$ |
122,694 |
|
|||
Operating expenses: | |||||||||||||||
Research and development |
|
50,988 |
|
|
47,949 |
|
|
192,507 |
|
|
169,802 |
|
|||
General and administrative |
|
11,375 |
|
|
7,603 |
|
|
38,837 |
|
|
29,689 |
|
|||
Total operating expenses |
|
62,363 |
|
|
55,552 |
|
|
231,344 |
|
|
199,491 |
|
|||
Income (loss) from operations |
|
91,653 |
|
|
(13,698 |
) |
|
43,767 |
|
|
(76,797 |
) |
|||
Other income (expense), net |
|
(18,592 |
) |
|
7 |
|
|
38,864 |
|
|
7,464 |
|
|||
Net income (loss) |
|
73,061 |
|
|
(13,691 |
) |
|
82,631 |
|
|
(69,333 |
) |
|||
Other comprehensive income (loss) | |||||||||||||||
Net unrealized loss on marketable securities |
|
(1,435 |
) |
|
(493 |
) |
|
(1,584 |
) |
|
(1,087 |
) |
|||
Comprehensive income (loss) | $ |
71,626 |
|
$ |
(14,184 |
) |
$ |
81,047 |
|
$ |
(70,420 |
) |
|||
Net income (loss) per share: | |||||||||||||||
Basic net income (loss) per share | $ |
1.25 |
|
$ |
(0.24 |
) |
$ |
1.42 |
|
$ |
(1.21 |
) |
|||
Fully diluted net income (loss) per share | $ |
1.21 |
|
$ |
(0.24 |
) |
$ |
1.37 |
|
$ |
(1.21 |
) |
|||
Weighted average number of shares used in computing net income (loss), basic |
|
58,277,543 |
|
|
57,573,955 |
|
|
58,379,641 |
|
|
57,212,737 |
|
|||
Weighted average number of shares used in computing net income (loss), fully diluted |
|
60,338,462 |
|
|
57,573,955 |
|
|
60,495,455 |
|
|
57,212,737 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20220223006054/en/
cliles@xencor.com
Media Contact
619-849-6005
jason@canalecomm.com
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