Earned
XOMA is entitled to receive a mid-single digit royalty on OJEMDA™ sales
Expanded the commercial royalty and milestone portfolio with the acquisitions of economic interests in DSUVIA® (sufentanil sublingual tablet) and XACIATO™ (clindamycin phosphate) vaginal gel 2%, as well as two Phase 3 assets
Launched XOMA’s first stock repurchase program for up to
“We continue to build the foundation for accelerating value creation with a disciplined approach to capital deployment,” stated
Key First Quarter Events
Partner | Event |
Talphera | XOMA added another commercial asset to its royalty portfolio with an economic interest in DSUVIA®, which is marketed by |
XOMA initiated the acquisition of | |
Zevra Therapeutics | |
Medexus | FDA approved the pediatric label expansion application for IXINITY® [coagulation factor IX (recombinant)]. |
Takeda | Reported positive topline results from Phase 2 study evaluating mezagitamab (TAK-079), a potential best-in-class anti-CD38 monoclonal antibody for primary immune thrombocytopenia (ITP).i |
LG Chem (AVEO Oncology) | Dosed the first patient in the ficlatuzumab Phase 3 study, resulting in a |
Compugen | Received a |
Subsequent Events
Partner | Event |
Day One Biopharmaceuticals | FDA approved Day One’s OJEMDA™ (tovorafenib) for use in pediatric patients with pediatric low-grade glioma (pLGG). XOMA earned a |
Daré Bioscience | XOMA added economic interests to three best- or first-in-category assets to its portfolio. XACIATO™ vaginal gel 2% is commercially available and marketed by Organon. Bayer holds the |
Rezolute | Dosed first patient in its Phase 3 trial of RZ358; XOMA earned a |
Anticipated 2024 Events of Note
Partner | Event |
Zevra Therapeutics | |
Takeda | In its press release dated |
First Quarter 2024 Financial Results
XOMA recorded total revenues of
Research and development (R&D) expenses were
General and administrative (“G&A”) expenses were
In the first quarter of 2024, G&A expenses included
Interest expense in the first quarter of 2024 was
The Company reported total other income, net, of
Net loss for the first quarter of 2024 was
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 or follow the Company on LinkedIn.
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), OJEMDA™ (tovorafenib), XACIATO™ (clindamycin phosphate) vaginal gel 2%, IXINITY® [coagulation factor IX (recombinant)], DSUVIA® (sufentanil sublingual tablet), and arimoclomol; the potential occurrences of the events listed under “Anticipated 2024 Events of Note”; the anticipated timings of regulatory filings and approvals related to assets in XOMA’s portfolio; and the potential of XOMA’s portfolio of partnered programs and licensed technologies generating substantial milestone and royalty proceeds over time. 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, the commercial assets in XOMA’s milestone and royalty portfolio are VABYSMO® (faricimab-svoa), OJEMDA™ (tovorafenib), XACIATO™ (clindamycin phosphate) vaginal gel 2%, IXINITY® [coagulation factor IX (recombinant)], and DSUVIA® (sufentanil sublingual tablet). All other assets in the milestone and royalty portfolio are investigational compounds. Efficacy and safety have not been established. There is no guarantee that any of the investigational compounds will become commercially available.
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
(in thousands, except share and per share amounts) | ||||||||
2024 | 2023 | |||||||
ASSETS | (unaudited) | |||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 136,225 | $ | 153,290 | ||||
Short-term restricted cash | 160 | 160 | ||||||
Short-term equity securities | 413 | 161 | ||||||
Trade and other receivables, net | 3 | 1,004 | ||||||
Short-term royalty and commercial payment receivables | 9,819 | 14,215 | ||||||
Prepaid expenses and other current assets | 270 | 483 | ||||||
Total current assets | 146,890 | 169,313 | ||||||
Long-term restricted cash | 6,016 | 6,100 | ||||||
Property and equipment, net | 40 | 25 | ||||||
Operating lease right-of-use assets | 364 | 378 | ||||||
Long-term royalty and commercial payment receivables | 65,577 | 57,952 | ||||||
Other assets - long term | 533 | 533 | ||||||
Total assets | $ | 219,420 | $ | 234,301 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 1,515 | $ | 653 | ||||
Accrued and other liabilities | 1,299 | 2,768 | ||||||
Contingent consideration under RPAs, AAAs and CPPAs | 3,000 | 7,000 | ||||||
Operating lease liabilities | 55 | 54 | ||||||
Unearned revenue recognized under units-of-revenue method | 2,159 | 2,113 | ||||||
Preferred stock dividend accrual | 1,368 | 1,368 | ||||||
Current portion of long-term debt | 6,144 | 5,543 | ||||||
Total current liabilities | 15,540 | 19,499 | ||||||
Unearned revenue recognized under units-of-revenue method – long-term | 6,692 | 7,228 | ||||||
Long-term operating lease liabilities | 319 | 335 | ||||||
Long-term debt | 114,528 | 118,518 | ||||||
Total liabilities | 137,079 | 145,580 | ||||||
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, | 87 | 86 | ||||||
Additional paid-in capital | 1,314,036 | 1,311,809 | ||||||
Accumulated deficit | (1,231,831 | ) | (1,223,223 | ) | ||||
Total stockholders’ equity | 82,341 | 88,721 | ||||||
Total liabilities and stockholders’ equity | $ | 219,420 | $ | 234,301 | ||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||
(in thousands, except share and per share amounts) | ||||||||
Three Months Ended | ||||||||
2024 | 2023 | |||||||
Revenues: | ||||||||
Revenue from contracts with customers | $ | 1,000 | $ | - | ||||
Revenue recognized under units-of-revenue method | 490 | 437 | ||||||
Total revenues | 1,490 | 437 | ||||||
Operating expenses: | ||||||||
Research and development | 33 | 54 | ||||||
General and administrative | 8,461 | 6,196 | ||||||
Arbitration settlement costs | - | 4,132 | ||||||
Amortization of intangible assets | - | 225 | ||||||
Total operating expenses | 8,494 | 10,607 | ||||||
Loss from operations | (7,004 | ) | (10,170 | ) | ||||
Other income (expense) | ||||||||
Interest expense | (3,551 | ) | - | |||||
Other income (expense), net | 1,960 | 357 | ||||||
Net loss and comprehensive loss | $ | (8,595 | ) | $ | (9,813 | ) | ||
Less: accumulated dividends on Series A and Series B preferred stock | (1,368 | ) | (1,368 | ) | ||||
Net loss and comprehensive loss attributable to common stockholders, basic and diluted | $ | (9,963 | ) | $ | (11,181 | ) | ||
Basic and diluted net loss per share attributable to common stockholders | $ | (0.86 | ) | $ | (0.98 | ) | ||
Weighted average shares used in computing basic and diluted net loss per share attributable to common stockholders | 11,580 | 11,460 | ||||||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||
(in thousands) | |||||||
Three Months Ended | |||||||
2024 | 2023 | ||||||
Cash flows from operating activities: | |||||||
Net loss | $ | (8,595 | ) | $ | (9,813 | ) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Stock-based compensation expense | 2,856 | 1,570 | |||||
Common stock contribution to 401(k) | 118 | 123 | |||||
Amortization of intangible assets | — | 225 | |||||
Depreciation | 2 | 1 | |||||
Accretion of long-term debt discount and debt issuance costs | 306 | — | |||||
Non-cash lease expense | 14 | 47 | |||||
Change in fair value of equity securities | (252 | ) | 24 | ||||
Changes in assets and liabilities: | |||||||
Trade and other receivables, net | 1,001 | (5 | ) | ||||
Prepaid expenses and other assets | 213 | 269 | |||||
Accounts payable and accrued liabilities | (105 | ) | 3,122 | ||||
Operating lease liabilities | (15 | ) | (50 | ) | |||
Unearned revenue recognized under units-of-revenue method | (490 | ) | (437 | ) | |||
Net cash used in operating activities | (4,947 | ) | (4,924 | ) | |||
Cash flows from investing activities: | |||||||
Payments of consideration under RPAs, AAAs and CPPAs | (15,000 | ) | (9,600 | ) | |||
Receipts under RPAs, AAAs and CPPAs | 7,771 | 2,366 | |||||
Purchase of property and equipment | (17 | ) | — | ||||
Net cash used in investing activities | (7,246 | ) | (7,234 | ) | |||
Cash flows from financing activities: | |||||||
Principal payments – debt | (3,616 | ) | — | ||||
Debt issuance costs and loan fees paid in connection with long-term debt | (581 | ) | — | ||||
Payment of preferred stock dividends | (1,368 | ) | (1,368 | ) | |||
Repurchases of common stock | (13 | ) | — | ||||
Proceeds from exercise of options and other share-based compensation | 1,956 | — | |||||
Taxes paid related to net share settlement of equity awards | (1,334 | ) | — | ||||
Net cash used in financing activities | (4,956 | ) | (1,368 | ) | |||
Net decrease in cash, cash equivalents and restricted cash | (17,149 | ) | (13,526 | ) | |||
Cash, cash equivalents and restricted cash at the beginning of the period | 159,550 | 57,826 | |||||
Cash, cash equivalents and restricted cash at the end of the period | $ | 142,401 | $ | 44,300 | |||
Supplemental Cash Flow Information: | |||||||
Cash paid for interest | $ | 3,780 | $ | — | |||
Non-cash investing and financing activities: | |||||||
Accrual of contingent consideration under the Affitech CPPA | $ | 3,000 | $ | — | |||
Preferred stock dividend accrual | $ | 1,368 | $ | 1,368 |
Investor contact: | Media contact: |
XOMA | |
+1-646-438-9754 | +1-310-403-8951 |
juliane.snowden@xoma.com | kathy@kathyvincent.com |
Source:
2024 GlobeNewswire, Inc., source