Raised up to
Received
Added third commercial asset to XOMA’s portfolio with the acquisition of economic interests in DSUVIA® (sufentanil sublingual tablet) in
Closed 2023 with two partners’ New Drug Applications (NDA) submitted to the
“Over the course of 2023, we continued to build the foundation for future growth, spearheaded by the
Key Fourth Quarter Events
Partner | Event |
Day One Biopharmaceuticals |
|
Zevra Therapeutics | Resubmitted the arimoclomol NDA with FDA |
Medexus | Pediatric label expansion application for IXINITY® accepted for review by FDA |
Rezolute |
|
AstraZeneca | Launched and dosed first patient in rilvegostomig Phase 3 study |
LG Chem (AVEO Oncology) | Launched ficlatuzumab Phase 3 study |
Organon | Announced intent to terminate ebopiprant License Agreement |
Anticipated 2024 Events of Note
Partner | Event |
Day One Biopharmaceuticals | |
Zevra Therapeutics | |
Medexus | FDA decision regarding IXINITY® pediatric label expansion |
Financial Results
XOMA recorded total revenues of
General and administrative (“G&A”) expenses were
In the fourth quarter of 2023, G&A expenses included
XOMA received cash payments of approximately
XOMA incurred one-time arbitration settlement costs of
For the year ended
Other income, net was
In 2023, net loss for the fourth quarter and year ended
On
Subsequent Events
On
On
On
On
About
XOMA is a biotechnology royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of improving human health. XOMA acquires the potential future economics associated with pre-commercial and commercial therapeutic candidates that have been licensed to pharmaceutical or biotechnology companies. When XOMA acquires the future economics, the seller receives non-dilutive, non-recourse funding they can use to advance their internal drug candidate(s) or for general corporate purposes. The Company has an extensive and growing portfolio of assets (asset defined as the right to receive potential future economics associated with the advancement of an underlying therapeutic candidate). For more information about the Company and its portfolio, please visit www.xoma.com.
Forward-Looking Statements/Explanatory Notes
Certain statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding the timing and amount of potential commercial payments to XOMA and other developments related to VABYSMO® (faricimab-svoa), IXINITY® [coagulation factor IX (recombinant)], DSUVIA® (sufentanil sublingual tablet), tovorafenib, and arimoclomol; the potential out-licensing of ebopiprant to an external partner for further development; the anticipated timings of regulatory filings and approvals related to assets in XOMA’s portfolio; the potential of XOMA’s portfolio of partnered programs and licensed technologies generating substantial milestone and royalty proceeds over time; and XOMA’s cash sufficiency forecast. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” “expect,” “may,” “will”, “would,” “could” or “should,” the negative of these terms or similar expressions. These forward-looking statements are not a guarantee of XOMA’s performance, and you should not place undue reliance on such statements. These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry, including those related to the fact that our product candidates subject to out-license agreements are still being developed, and our licensees may require substantial funds to continue development which may not be available; we do not know whether there will be, or will continue to be, a viable market for the products in which we have an ownership or royalty interest; if the therapeutic product candidates to which we have a royalty interest do not receive regulatory approval, our third-party licensees will not be able to market them; and the impact to the global economy as a result of the COVID-19 pandemic. Other potential risks to XOMA meeting these expectations are described in more detail in XOMA's most recent filing on Form 10-Q and in other filings with the
EXPLANATORY NOTE: Any references to “portfolio” in this press release refer strictly to milestone and/or royalty rights associated with a basket of drug products in development. Any references to “assets” in this press release refer strictly to milestone and/or royalty rights associated with individual drug products in development.
As of the date of this press release, all assets in XOMA’s milestone and royalty portfolio, except VABYSMO® (faricimab-svoa), IXINITY® [coagulation factor IX (recombinant)], DSUVIA® (sufentanil sublingual tablet), are investigational compounds. Efficacy and safety have not been established. There is no guarantee that any of the investigational compounds will become commercially available.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||
(in thousands, except per share amounts) | ||||||||
Year Ended | ||||||||
2023 | 2022 | |||||||
Revenues: | ||||||||
Revenue from contracts with customers | $ | 2,650 | $ | 4,150 | ||||
Revenue recognized under units-of-revenue method | 2,108 | 1,877 | ||||||
Total revenues | 4,758 | 6,027 | ||||||
Operating expenses: | ||||||||
Research and development | 143 | 153 | ||||||
General and administrative | 25,606 | 23,191 | ||||||
Impairment charges | 15,828 | - | ||||||
Arbitration settlement costs | 4,132 | - | ||||||
Amortization of intangible assets | 897 | 97 | ||||||
Total operating expenses | 46,606 | 23,441 | ||||||
Loss from operations | (41,848 | ) | (17,414 | ) | ||||
Other income (expense) | ||||||||
Interest expense | (569 | ) | - | |||||
Other income (expense), net | 1,586 | 295 | ||||||
Loss before income tax | $ | (40,831 | ) | $ | (17,119 | ) | ||
Income tax benefit | - | 15 | ||||||
Net loss and comprehensive loss | $ | (40,831 | ) | $ | (17,104 | ) | ||
Net loss and comprehensive loss attributable to common stockholders, basic and diluted | $ | (46,303 | ) | $ | (22,576 | ) | ||
Basic and diluted net loss per share attributable to common stockholders | $ | (4.04 | ) | $ | (1.98 | ) | ||
Weighted average shares used in computing basic and diluted net loss per share attributable to common stockholders | 11,471 | 11,413 | ||||||
CONSOLIDATED BALANCE SHEETS | ||||||||
(in thousands, except share and per share amounts) | ||||||||
2023 | 2022 | |||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 153,290 | $ | 57,826 | ||||
Short-term restricted cash | 160 | - | ||||||
Short-term equity securities | 161 | 335 | ||||||
Trade and other receivables, net | 1,004 | 1 | ||||||
Short-term royalty and commercial payment receivables | 14,215 | 2,366 | ||||||
Prepaid expenses and other current assets | 483 | 725 | ||||||
Total current assets | 169,313 | 61,253 | ||||||
Long-term restricted cash | 6,100 | - | ||||||
Property and equipment, net | 25 | 7 | ||||||
Operating lease right-of-use assets | 378 | 29 | ||||||
Long-term royalty and commercial payment receivables | 57,952 | 63,683 | ||||||
Intangible assets, net | - | 15,150 | ||||||
Other assets - long term | 533 | 260 | ||||||
Total assets | $ | 234,301 | $ | 140,382 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 653 | $ | 524 | ||||
Accrued and other liabilities | 2,768 | 2,918 | ||||||
Contingent consideration under RPAs, AAAs and CPPAs | 7,000 | 75 | ||||||
Operating lease liabilities | 54 | 34 | ||||||
Unearned revenue recognized under units-of-revenue method | 2,113 | 1,899 | ||||||
Preferred stock dividend accrual | 1,368 | 1,368 | ||||||
Current portion of long-term debt | 5,543 | - | ||||||
Total current liabilities | 19,499 | 6,818 | ||||||
Unearned revenue recognized under units-of-revenue method – long-term | 7,228 | 9,550 | ||||||
Long-term operating lease liabilities | 335 | - | ||||||
Long-term debt | 118,518 | - | ||||||
Total liabilities | 145,580 | 16,368 | ||||||
Stockholders’ equity: | ||||||||
Preferred Stock, | ||||||||
8.625% Series A cumulative, perpetual preferred stock, 984,000 shares issued and outstanding at | 49 | 49 | ||||||
8.375% Series B cumulative, perpetual preferred stock, 1,600 shares issued and outstanding at | — | — | ||||||
Convertible preferred stock, 5,003 issued and outstanding at | — | — | ||||||
Common stock, | 86 | 86 | ||||||
Additional paid-in capital | 1,311,809 | 1,306,271 | ||||||
Accumulated deficit | (1,223,223 | ) | (1,182,392 | ) | ||||
Total stockholders’ equity | 88,721 | 124,014 | ||||||
Total liabilities and stockholders’ equity | $ | 234,301 | $ | 140,382 | ||||
CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||
(in thousands) | |||||||
Year Ended | |||||||
2023 | 2022 | ||||||
Cash flows from operating activities: | |||||||
Net loss | $ | (40,831 | ) | $ | (17,104 | ) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Stock-based compensation expense | 9,099 | 3,608 | |||||
Impairment charges | 15,828 | — | |||||
Change in fair value of contingent consideration under RPAs, AAAs, and CPPAs | (75 | ) | — | ||||
Common stock contribution to 401(k) | 123 | 85 | |||||
Amortization of intangible assets | 897 | 97 | |||||
Depreciation | 3 | 7 | |||||
Accretion of long-term debt | 34 | — | |||||
Non-cash lease expense | 119 | 170 | |||||
Change in fair value of equity securities | 174 | 439 | |||||
Changes in assets and liabilities: | |||||||
Trade and other receivables, net | (1,003 | ) | 208 | ||||
Prepaid expenses and other assets | 219 | (71 | ) | ||||
Accounts payable and accrued liabilities | (523 | ) | 1,845 | ||||
Income taxes payable | — | (91 | ) | ||||
Operating lease liabilities | (114 | ) | (195 | ) | |||
Unearned revenue recognized under units-of-revenue method | (2,108 | ) | (1,877 | ) | |||
Net cash used in operating activities | (18,158 | ) | (12,879 | ) | |||
Cash flows from investing activities: | |||||||
Payments of consideration under RPAs, AAAs and CPPAs | (14,650 | ) | (8,000 | ) | |||
Receipts under RPAs, AAAs and CPPAs | 13,956 | 3,026 | |||||
Payment for IP acquired under the ObsEva IP Acquisition Agreement | — | (15,247 | ) | ||||
Purchase of property and equipment | (17 | ) | — | ||||
Net cash used in investing activities | (711 | ) | (20,221 | ) | |||
Cash flows from financing activities: | |||||||
Proceeds from issuance of long-term debt | 130,000 | — | |||||
Debt issuance costs and loan fees | (4,253 | ) | — | ||||
Payment of preferred stock dividends | (5,472 | ) | (5,472 | ) | |||
Proceeds from exercise of options and other share-based compensation | 466 | 2,419 | |||||
Taxes paid related to net share settlement of equity awards | (148 | ) | (1,398 | ) | |||
Net cash provided by (used in) financing activities | 120,593 | (4,451 | ) | ||||
Net increase (decrease) in cash, cash equivalents and restricted cash | 101,724 | (37,551 | ) | ||||
Cash, cash equivalents at the beginning of the period | 57,826 | 95,377 | |||||
Cash, cash equivalents and restricted cash at the end of the period | $ | 159,550 | $ | 57,826 | |||
Supplemental Cash Flow Information: | |||||||
Cash paid for taxes | $ | — | $ | 76 | |||
Right-of-use assets obtained in exchange for operating lease liabilities | $ | 468 | $ | — | |||
Non-cash investing and financing activities: | |||||||
Issuance of common stock warrants in connection with long-term debt | $ | 1,470 | $ | — | |||
Accrued issuance costs in connection with issuance of long-term debt | $ | 501 | $ | — | |||
Preferred stock dividend accrual | $ | 1,368 | $ | 1,368 | |||
Estimated fair value of contingent consideration under the LadRx Agreements | $ | 1,000 | $ | — | |||
Accrued transaction costs in connection with ObsEva IP Acquisition | $ | — | $ | 122 | |||
Accrual of contingent consideration under the Affitech CPPA | $ | 6,000 | $ | — | |||
Investor contact: Juliane Snowden XOMA +1-646-438-9754 juliane.snowden@xoma.com | Media contact: +1-310-403-8951 kathy@kathyvincent.com |
Source:
2024 GlobeNewswire, Inc., source