Xencor Reports First Quarter 2020 Financial Results
-- Management to Host Conference Call at
“Xencor’s XmAb® technologies enable us, and our partners, to create antibodies and cytokines with enhanced properties and potential new mechanisms of therapeutic action. Today, our clinical-stage XmAb bispecific antibodies and cytokines include five wholly owned candidates, two being co-developed with partners and three being developed by our partners,” said
Recent Business and Clinical Highlights
COVID-19 Business Update:
- Clinical Studies: The pandemic did not disrupt enrollment to Xencor’s six ongoing clinical studies during the first quarter of 2020. Clinical studies in oncology remain a high priority for patients, their families and their physicians; however, Xencor’s planned study initiations for vibecotamab and plamotamab and enrollment in its ongoing studies will likely be adversely affected in subsequent periods, as many clinical sites have delayed study initiations and have postponed enrollment in regions with significant numbers of COVID-19 cases.
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Workforce and Research Operations: In mid-March,
Xencor implemented measures to protect the health and safety of its employees, including a requirement for all non-laboratory employees to work remotely and a reduction of onsite laboratory staff density by implementing alternating shifts and reorganizing research facilities.
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Licensing and Partnerships:
Xencor is monitoring potential impacts to partnership revenues, which are primarily milestone payments and royalties. If the pandemic affects the sales or clinical and regulatory progress of partnered programs, Xencor’s revenue could be adversely affected in the future.
In addition, Xencor’s partners Alexion Pharmaceuticals and Vir Biotechnology each announced in April plans to initiate clinical studies evaluating antibodies that incorporate its Xtend™ Fc technology to treat patients with COVID-19.
XmAb20717: XmAb20717 is a PD-1 x CLTA-4 bispecific antibody targeting two immune checkpoint receptors and is engineered to selectively activate the tumor microenvironment (TME). XmAb20717 is being evaluated in an ongoing Phase 1 study, which is enrolling patients with advanced non-small cell lung cancer, renal cell carcinoma, prostate cancer and other cancers without approved checkpoint therapies to expansion cohorts, and the study continues to enroll patients in additional dose-escalation cohorts. An expansion cohort for patients with melanoma is fully enrolled.
- Phase 1 studies evaluating Xencor’s additional TME activators, XmAb22841 (CTLA-4 x LAG-3) and XmAb23104 (PD-1 x ICOS), are enrolling patients with select advanced solid tumors into dose-escalation cohorts.
XmAb24306: In March,
Preclinical Programs:
Select Partnered Programs: Xencor’s partners expand the use of XmAb technology by providing late-stage development capabilities, successful track records of developing or commercializing programs or have programs for potential combination with Xencor’s bispecific antibody or cytokine programs. Additionally, the plug-and-play nature of XmAb technologies enables selective access for licensees with limited effort or resources by
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Tafasitamab (MorphoSys): In March, MorphoSys announced that the
U.S. Food and Drug Administration (FDA) accepted MorphoSys’ Biologics License Application (BLA) and granted priority review for tafasitamab in combination with lenalidomide for the treatment of patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL), andXencor received a milestone payment of$12.5 million . Tafasitamab was initially developed byXencor and incorporates an XmAb Cytotoxic Fc Domain to enhance its anti-tumor activity. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date ofAugust 30, 2020 , andXencor is eligible to receive an additional$25 million regulatory milestone payment related to DLBCL and royalties on net sales in the high-single to low-double digit percentages.
- AMG 509 (Amgen): AMG 509 is Amgen’s STEAP1 x CD3 XmAb 2+1 bispecific antibody, developed under Xencor’s Amgen collaboration. Amgen is developing AMG 509 for patients with prostate cancer and Ewing sarcoma. Preclinical data were presented during Session I of the AACR Virtual Annual Meeting in April. Amgen is recruiting patients in a Phase 1 study of AMG 509 in patients with metastatic castration-resistant prostate cancer (mCRPC).
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Anti-HIV Antibodies (Gilead Sciences): In January,
Xencor and Gilead Sciences entered into a license agreement under which Gilead has been granted access to Xencor’s Xtend extended half-life and Cytotoxic XmAb Fc technologies to develop and commercialize elipovimab (GS-9722), which is currently being evaluated in a Phase 1 clinical study for HIV, and options for up to three additional anti-HIV antibodies. Gilead has since exercised the three options.Xencor has received$13.5 million in upfront and option payments.
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Anti-COVID-19 Antibodies (Vir Biotechnology): In March,
Xencor and Vir Biotechnology entered into a second license agreement, under which Vir has non-exclusive access to Xencor’s Xtend Fc technology to extend the half-life of novel antibodies that Vir is investigating as potential treatments for patients with COVID-19. Vir has announced plans to proceed directly into a Phase 2 study within the coming months.Xencor is eligible to receive royalties on the net sales of approved products in the mid-single digit percent range.
First Quarter Ended
Cash, cash equivalents and marketable securities totaled
Total revenue for the first quarter ended
Research and development expenditures for the first quarter ended
General and administrative expenses for the first quarter ended
Non-cash, stock-based compensation expense for the first quarter ended
Net loss for the first quarter ended
The total shares outstanding were 57,001,253 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 6686425. A live webcast of the conference call will be available online from the Investors section of
About
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are forward-looking statements within the meaning of applicable securities laws, including, but not limited to, the quotations from
Condensed Balance Sheets | |||||
(in thousands) | |||||
|
|||||
|
2020 |
|
|
2019 |
|
(unaudited) | |||||
Assets | |||||
Current assets | |||||
Cash and cash equivalents |
$ |
73,808 |
$ |
50,312 |
|
Short-term marketable securities |
|
497,841 |
|
479,470 |
|
Equity securities |
|
2,253 |
— | ||
Accounts receivable |
|
6,825 |
|
21,574 |
|
Income tax receivable |
|
904 |
|
502 |
|
Other current assets |
|
6,476 |
|
6,547 |
|
Total current assets |
|
588,107 |
|
558,405 |
|
Property and equipment, net |
|
16,799 |
|
15,805 |
|
Long-term marketable securities |
|
38,232 |
|
71,526 |
|
Intangible assets, net |
|
14,637 |
|
14,421 |
|
Right of use asset |
|
8,877 |
|
9,380 |
|
Income tax receivable | — |
|
402 |
||
Other assets |
|
311 |
|
311 |
|
Total assets |
$ |
666,963 |
$ |
670,250 |
|
Liabilities and stockholders’ equity | |||||
Current liabilities | |||||
Accounts payable and accrued liabilities |
$ |
17,605 |
$ |
19,184 |
|
Current portion of deferred revenue |
|
46,176 |
|
45,205 |
|
Current portion of lease liability |
|
2,136 |
|
2,169 |
|
Total current liabilities |
|
65,917 |
|
66,558 |
|
Lease liability, less current portion |
|
8,041 |
|
8,565 |
|
Deferred revenue, less current portion | — |
|
1,926 |
||
Total liabilities |
|
73,958 |
|
77,049 |
|
Stockholders’ equity |
|
593,005 |
|
593,201 |
|
Total liabilities and stockholders’ equity |
$ |
666,963 |
$ |
670,250 |
The 2019 balance sheet was derived from the 2019 annual financial statements included in the Form 10-K that was filed on |
Condensed Statements of Comprehensive Income (Loss) | |||||||||
(in thousands, except share and per share data) | |||||||||
Three months ended |
|||||||||
2020 |
|
2019 |
|||||||
(unaudited) | |||||||||
Revenues |
$ |
|
32,385 |
|
$ |
|
111,939 |
||
Operating expenses: | |||||||||
Research and development |
33,943 |
|
28,183 |
||||||
General and administrative |
7,219 |
|
5,512 |
||||||
Total operating expenses |
41,162 |
|
33,695 |
||||||
Income (loss) from operations |
(8,777 |
) |
78,244 |
||||||
Other income, net |
703 |
|
2,701 |
||||||
Income (loss) before income taxes |
(8,074 |
) |
80,945 |
||||||
Income tax expense | — |
900 |
|||||||
Net income (loss) |
(8,074 |
) |
80,045 |
||||||
Other comprehensive income (loss) | |||||||||
Net unrealized gain (loss) on marketable securities |
(105 |
) |
1,316 |
||||||
Comprehensive income (loss) |
$ |
|
(8,179 |
) |
$ |
|
81,361 |
||
Net income (loss) per share: | |||||||||
Basic net income (loss) per share |
$ |
|
(0.14 |
) |
$ |
|
1.42 |
||
Diluted net income (loss) per share |
$ |
|
(0.14 |
) |
$ |
|
1.38 |
||
Weighted-average number of common shares used in net income (loss) per share applicable to common stockholders - basic |
56,946,714 |
|
56,302,967 |
||||||
Weighted-average number of common shares used in net income (loss) per share applicable to common stockholders - diluted |
56,946,714 |
|
58,009,878 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20200507006007/en/
626-737-8118
cliles@xencor.com
Media Contact
619-849-6005
jason@canalecomm.com
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