XOMA Reports Third Quarter 2023 Financial Results and Highlights Upcoming Events Expected to Drive Shareholder Value
07 Novembre 2023 - 1:30PM
XOMA Corporation (Nasdaq: XOMA), the biotech royalty aggregator,
reported its third quarter 2023 financial results and highlighted
recent portfolio activities expected to drive long-term shareholder
value.
“Our existing royalty portfolio continues to mature, driven by
increasing cash receipts of VABYSMO® and IXINITY® and the
advancement of several assets, most notably the New Drug
Application (NDA) filing of tovorafenib by Day One
Biopharmaceuticals,” stated Owen Hughes, Executive Chairman of
XOMA. “With additional regulatory and development milestones
forthcoming by year-end, we believe a solid foundation for future
growth is upon us.”
Key Third Quarter Events |
|
Partner |
Event |
Day One Biopharmaceuticals |
Tovorafenib NDA filed in mid-September |
Zevra
Therapeutics |
Zevra confirmed arimoclomol
NDA to be filed in 4Q |
Medexus |
Pediatric label expansion accepted for review - 1H 2024
decision |
|
Financial ResultsXOMA recorded total revenues
of $0.8 million for the third quarter of 2023 and $0.5 million for
the third quarter of 2022. The increase for the three months
ended September 30, 2023, as compared to the same period in 2022,
was primarily due to $0.2 million of milestone revenue earned under
XOMA’s license agreement with Janssen.
General and administrative (“G&A”) expenses were $6.4
million for the third quarter of 2023, compared to $4.8 million for
the third quarter of 2022. The additional $1.6 million during
the third quarter of 2023 reflects an increase in stock-based
compensation expenses of $1.9 million, partially offset by a
decrease of $0.6 million for legal and consulting costs.
In the third quarter of 2023, G&A expenses included $2.7
million in non-cash stock-based compensation expense, compared with
$0.8 million in the third quarter of 2022. The increase in
the 2023 period reflects $1.1 million of stock-based compensation
expense related to the issuance of performance-based stock unit
awards and $0.9 million related to stock options granted to our new
executives at the beginning of 2023. During the quarter, XOMA
received approximately $6.6 million from royalties and milestone
payments. XOMA’s net cash used in operations in the third
quarter of 2023 was $2.1 million, as compared with $3.7 million
during the third quarter of 2022.
Other income, net was $0.3 million for the third quarter of 2023
and $0.2 million in the corresponding quarter of 2022. The
increase in other income, net between quarters is primarily due to
an increase in investment income.
Net loss for the third quarter of 2023 was $5.5 million,
compared to net loss of $4.2 million for the third quarter of
2022.
On September 30, 2023, XOMA had cash of $33.5 million. In
September 2023, XOMA received a $4.9 million cash payment from
Roche representing XOMA’s 0.5% royalty interest related to VABYSMO®
sales during the first six months of 2023. The payment was
recorded in the Company’s condensed consolidated balance sheet as
of September 30, 2023, as a reduction of short-term royalty and
commercial payment receivables. On October 16, 2023, the
Company paid total cash dividends of $1.4 million on the 8.625%
Series A Cumulative Perpetual Preferred Stock (Nasdaq: XOMAP) and
on the 8.375% Series B Cumulative Perpetual Preferred Stock
(Nasdaq: XOMAO). The Company ended December 31, 2022, with
cash of $57.8 million. Based upon the cash flows XOMA expects
to receive from VABYSMO® and IXINITY® sales in addition to its
current cash position, the Company continues to believe its current
cash position will be sufficient to fund XOMA’s operations for
multiple years.
Subsequent EventsOn October 30, 2023, XOMA
earned a $5 million milestone related to the FDA’s acceptance of
Day One Biopharmaceuticals’ NDA for tovorafenib as a monotherapy in
relapsed or progressive pediatric low-grade glioma. The FDA
assigned a Prescription Drug User Fee Act target date of April 30,
2024.
On October 23, 2023, Organon notified XOMA Corporation of its
termination of the License Agreement pertaining to the development
of ebopiprant, an investigational, orally active, selective
prostaglandin F2α (PGF2α) receptor antagonist being evaluated as a
potential treatment for preterm labor by reducing inflammation and
uterine contractions. Based on the existing human clinical
data generated by ObsEva SA and the lack of adequate treatments to
treat preterm labor, XOMA will seek to out-license ebopiprant in
order to address this critical unmet need.
About XOMA CorporationXOMA 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 with more than
70 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
NotesCertain 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)], 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 Securities and Exchange Commission. Consider such risks
carefully when considering XOMA's prospects. Any
forward-looking statement in this press release represents XOMA's
beliefs and assumptions only as of the date of this press release
and should not be relied upon as representing its views as of any
subsequent date. XOMA disclaims any obligation to update any
forward-looking statement, except as required by applicable
law.
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) and
IXINITY® [coagulation factor IX (recombinant)], are investigational
compounds. Efficacy and safety have not been
established. There is no guarantee that any of the
investigational compounds will become commercially available.
XOMA CORPORATION |
|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS |
|
(unaudited) |
|
(in thousands, except per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
Revenues: |
|
|
|
|
|
|
|
|
Revenue from contracts with customers |
$ |
225 |
|
|
$ |
25 |
|
|
$ |
1,350 |
|
|
$ |
3,300 |
|
|
Revenue recognized under units-of-revenue method |
|
605 |
|
|
|
426 |
|
|
|
1,575 |
|
|
|
1,241 |
|
|
Total revenues |
|
830 |
|
|
|
451 |
|
|
|
2,925 |
|
|
|
4,541 |
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
25 |
|
|
|
29 |
|
|
|
118 |
|
|
|
125 |
|
|
General and administrative |
|
6,368 |
|
|
|
4,794 |
|
|
|
18,341 |
|
|
|
15,620 |
|
|
Royalty purchase agreement asset impairment |
|
- |
|
|
|
- |
|
|
|
1,575 |
|
|
|
- |
|
|
Arbitration settlement costs |
|
- |
|
|
|
- |
|
|
|
4,132 |
|
|
|
- |
|
|
Amortization of intangible assets |
|
224 |
|
|
|
- |
|
|
|
673 |
|
|
|
- |
|
|
Total operating expenses |
|
6,617 |
|
|
|
4,823 |
|
|
|
24,839 |
|
|
|
15,745 |
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(5,787 |
) |
|
|
(4,372 |
) |
|
|
(21,914 |
) |
|
|
(11,204 |
) |
|
|
|
|
|
|
|
|
|
|
Other income (expense), net: |
|
|
|
|
|
|
|
|
Other income (expense), net |
|
278 |
|
|
|
194 |
|
|
|
1,192 |
|
|
|
76 |
|
|
Net loss and comprehensive loss |
$ |
(5,509 |
) |
|
$ |
(4,178 |
) |
|
$ |
(20,722 |
) |
|
$ |
(11,128 |
) |
|
Less: accumulated dividends on Series A and Series B preferred
stock |
|
(1,368 |
) |
|
|
(1,368 |
) |
|
|
(4,104 |
) |
|
|
(4,104 |
) |
|
Net loss and comprehensive loss attributable to common
stockholders, basic and diluted |
$ |
(6,877 |
) |
|
$ |
(5,546 |
) |
|
$ |
(24,826 |
) |
|
$ |
(15,232 |
) |
|
Basic and diluted net loss per share attributable to common
stockholders |
$ |
(0.60 |
) |
|
$ |
(0.48 |
) |
|
$ |
(2.17 |
) |
|
$ |
(1.34 |
) |
|
Weighted average shares used in computing basic and diluted net
loss per share attributable to common stockholders |
|
11,473 |
|
|
|
11,447 |
|
|
|
11,466 |
|
|
|
11,400 |
|
|
|
XOMA CORPORATION |
|
CONSOLIDATED BALANCE SHEETS |
|
(in thousands, except share and per share
amounts) |
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
|
ASSETS |
(unaudited) |
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
$ |
33,472 |
|
|
$ |
57,826 |
|
|
Short-term equity securities |
|
214 |
|
|
|
335 |
|
|
Trade and other receivables, net |
|
43 |
|
|
|
1 |
|
|
Short-term royalty and commercial payment receivables |
|
- |
|
|
|
2,366 |
|
|
Prepaid expenses and other current assets |
|
776 |
|
|
|
725 |
|
|
Total current assets |
|
34,505 |
|
|
|
61,253 |
|
|
Property and equipment, net |
|
5 |
|
|
|
7 |
|
|
Operating lease right-of-use assets |
|
- |
|
|
|
29 |
|
|
Long-term royalty and commercial payment receivables |
|
74,696 |
|
|
|
63,683 |
|
|
Intangible assets, net |
|
14,477 |
|
|
|
15,150 |
|
|
Other assets - long term |
|
411 |
|
|
|
260 |
|
|
Total assets |
$ |
124,094 |
|
|
$ |
140,382 |
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
$ |
728 |
|
|
$ |
524 |
|
|
Accrued and other liabilities |
|
2,160 |
|
|
|
2,918 |
|
|
Contingent consideration under RPAs, AAAs and CPPAs |
|
4,000 |
|
|
|
75 |
|
|
Operating lease liabilities |
|
- |
|
|
|
34 |
|
|
Unearned revenue recognized under units-of-revenue method |
|
2,078 |
|
|
|
1,899 |
|
|
Preferred stock dividend accrual |
|
1,368 |
|
|
|
1,368 |
|
|
Total current liabilities |
|
10,334 |
|
|
|
6,818 |
|
|
Unearned revenue recognized under units-of-revenue method –
long-term |
|
7,796 |
|
|
|
9,550 |
|
|
Total liabilities |
|
18,130 |
|
|
|
16,368 |
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
Preferred Stock, $0.05 par value, 1,000,000 shares authorized: |
|
|
|
|
8.625% Series A cumulative, perpetual preferred stock, 984,000
shares issued and outstanding at September 30, 2023 and December
31, 2022 |
|
49 |
|
|
|
49 |
|
|
8.375% Series B cumulative, perpetual preferred stock, 1,600 shares
issued and outstanding at September 30, 2023 and December 31,
2022 |
|
— |
|
|
|
— |
|
|
Convertible preferred stock, 5,003 issued and outstanding at
September 30, 2023 and December 31, 2022 |
|
— |
|
|
|
— |
|
|
Common stock, $0.0075 par value, 277,333,332 shares authorized,
11,472,808 and 11,454,025 shares issued and outstanding at
September 30, 2023 and December 31, 2022, respectively |
|
86 |
|
|
|
86 |
|
|
Additional paid-in capital |
|
1,308,943 |
|
|
|
1,306,271 |
|
|
Accumulated deficit |
|
(1,203,114 |
) |
|
|
(1,182,392 |
) |
|
Total stockholders’ equity |
|
105,964 |
|
|
|
124,014 |
|
|
Total liabilities and stockholders’ equity |
$ |
124,094 |
|
|
$ |
140,382 |
|
|
|
XOMA CORPORATION |
CONSOLIDATED STATEMENTS OF CASH FLOWS |
(unaudited) |
(in thousands) |
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
2023 |
|
|
|
2022 |
|
Cash flows from operating activities: |
|
|
|
|
|
Net loss |
$ |
(20,722 |
) |
|
$ |
(11,128 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
Stock-based compensation expense |
|
6,450 |
|
|
|
2,620 |
|
Royalty purchase agreement asset impairment |
|
1,575 |
|
|
|
— |
|
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 |
|
673 |
|
|
|
— |
|
Depreciation |
|
2 |
|
|
|
7 |
|
Non-cash lease expense |
|
115 |
|
|
|
127 |
|
Change in fair value of equity securities |
|
121 |
|
|
|
330 |
|
Changes in assets and liabilities: |
|
|
|
|
|
Trade and other receivables, net |
|
(42 |
) |
|
|
193 |
|
Prepaid expenses and other assets |
|
(202 |
) |
|
|
(343 |
) |
Accounts payable and accrued liabilities |
|
(554 |
) |
|
|
596 |
|
Income taxes payable |
|
— |
|
|
|
(91 |
) |
Operating lease liabilities |
|
(120 |
) |
|
|
(144 |
) |
Unearned revenue recognized under units-of-revenue method |
|
(1,575 |
) |
|
|
(1,241 |
) |
Net cash used in operating activities |
|
(14,231 |
) |
|
|
(8,989 |
) |
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
Payments of consideration under RPAs, AAAs and CPPAs |
|
(14,650 |
) |
|
|
(8,000 |
) |
Receipts under RPAs, AAAs and CPPAs |
|
8,428 |
|
|
|
3,026 |
|
Net cash used in investing activities |
|
(6,222 |
) |
|
|
(4,974 |
) |
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
Payment of preferred stock dividends |
|
(4,104 |
) |
|
|
(4,104 |
) |
Proceeds from exercise of options and other share-based
compensation |
|
208 |
|
|
|
2,373 |
|
Taxes paid related to net share settlement of equity awards |
|
(5 |
) |
|
|
(1,398 |
) |
Net cash used in financing activities |
|
(3,901 |
) |
|
|
(3,129 |
) |
|
|
|
|
|
|
Net decrease in cash, cash equivalents and restricted cash |
|
(24,354 |
) |
|
|
(17,092 |
) |
Cash, cash equivalents and restricted cash at the beginning of the
period |
|
57,826 |
|
|
|
95,377 |
|
Cash, cash equivalents and restricted cash at the end of the
period |
$ |
33,472 |
|
|
$ |
78,285 |
|
|
|
|
|
|
|
Supplemental Cash Flow Information: |
|
|
|
|
Cash paid for taxes |
$ |
— |
|
|
$ |
95 |
|
Right-of-use assets obtained in exchange for operating lease
liabilities |
$ |
85 |
|
|
$ |
— |
|
Non-cash investing and financing activities: |
|
|
|
|
Preferred stock dividend accrual |
$ |
1,368 |
|
|
$ |
1,368 |
|
Estimated fair value of contingent consideration under the LadRx
Agreements |
$ |
1,000 |
|
|
$ |
— |
|
Accrual of contingent consideration under the Affitech CPPA |
$ |
3,000 |
|
|
$ |
— |
|
|
Investor contact: |
Media
contact: |
Juliane Snowden |
Kathy Vincent |
XOMA |
KV Consulting & Management |
+1-646-438-9754 |
+1-310-403-8951 |
juliane.snowden@xoma.com |
kathy@kathyvincent.com |
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