XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator,
reported its first quarter 2024 financial results and highlighted
recent activities.
“We continue to build the foundation for accelerating value
creation with a disciplined approach to capital deployment,” stated
Owen Hughes, Chief Executive Officer of XOMA. “In recent
months, we’ve completed the acquisition of Kinnate, acquired
economic interests in two commercial assets, as well as in two
first-in-class Phase 3 assets, and initiated our first share
buyback program on the heels of securing the VABYSMO®
royalty-backed loan with Blue Owl. Lastly, and most
importantly, the FDA approved OJEMBA™ (tovorafenib), Day One
Biopharmaceuticals’ type II RAF inhibitor for patients with
relapsed or refractory pLGG harboring a BRAF fusion or
rearrangement or BRAF V600 mutation, ushering in an important new
treatment for children living with relapsed or refractory
pLGG.”
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 Alora Pharmaceuticals. XOMA
receives 100 percent of the DSUVIA® economics until a threshold is
achieved; thereafter, XOMA retains the 15 percent royalty
associated with DSUVIA® commercial sales. The 75 percent
royalties from Department of Defense purchases and remaining
milestone payments will be shared equally between XOMA and
Talphera. |
Kinnate Pharmaceuticals |
XOMA initiated the acquisition of
Kinnate Pharmaceuticals for $2.5879 in cash per share, plus a
non-tradeable contingent value right (CVR) representing the right
to receive 85 percent of the net proceeds from the out license or
sale of Kinnate assets effected on or before April 2, 2025, and
100% of the net proceeds received from Pierre-Fabre. |
Zevra Therapeutics |
U.S. Food and Drug Administration
(FDA) accepted the arimoclomol NDA resubmission for review and set
a Prescription Drug User Fee Act (PDUFA) action date of September
21, 2024. XOMA paid a $1 million milestone to LadRx based
upon the achievement of this milestone. |
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 $1 million milestone
payment to XOMA. |
Compugen |
Received a $1 million milestone
payment from Compugen. |
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 $9 million milestone
upon the approval and is entitled to receive mid-single digit
royalties from OJEMDA sales. |
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 U.S. rights to commercialize
Ovaprene®, a hormone-free monthly intravaginal contraceptive,
currently in Phase 3 clinical trials. XOMA also acquired a
synthetic royalty in Sildenafil Cream, 3.6%, a Phase 3-ready asset
for female sexual arousal disorder. |
Rezolute |
Dosed first patient in its Phase
3 trial of RZ358; XOMA earned a $5.0 million milestone associated
with the event. |
Anticipated 2024 Events of Note
Partner |
Event |
Zevra Therapeutics |
September 21, 2024 – FDA PDUFA
action date for arimoclomol NDA |
Takeda |
In its press release dated March
13, 2024, Takeda announced plans to initiate a global Phase 3 trial
of mezagitamab in ITP in fiscal year 2024.ii |
First Quarter 2024 Financial Results
XOMA recorded total revenues of $1.5 million for the first
quarter of 2024, which included a $1.0 million milestone payment
received from AVEO Oncology, as compared with $0.4 million in the
first quarter of 2023.
Research and development (R&D) expenses were $33,000 and
$54,000, respectively, for the first quarters of 2024 and
2023. Upon closing the Kinnate merger in the second quarter
of 2024, XOMA assumed operations of Kinnate’s pipeline, as well as
ongoing Phase 1 study, and will incur increased R&D costs until
winddown activities are complete.
General and administrative (“G&A”) expenses were $8.5
million for the first quarter of 2024, compared to $6.2 million for
the first quarter of 2023. The increase of $2.3 million was
primarily due to a $1.3 million increase in stock-based
compensation and a $0.7 million increase in consulting and legal
expenses. The increase in stock-based compensation expenses
was largely due to the appointment of Mr. Hughes as our full-time
Chief Executive Officer in January 2024.
In the first quarter of 2024, G&A expenses included $2.9
million in non-cash stock-based compensation expense, compared with
$1.6 million in the first quarter of 2023. The increase in
stock-based compensation expenses was largely due to the PSU grant
associated with the appointment of Mr. Hughes as our full-time
Chief Executive Officer in January 2024 combined with PSUs granted
in May 2023.
Interest expense in the first quarter of 2024 was $3.6 million,
representing interest related to the Blue Owl Loan established in
December 2023.
The Company reported total other income, net, of $2.0 million in
the first quarter of 2024, as compared to total other income, net,
of $0.4 million in the corresponding period of 2023. The $1.6
million increase reflects a $1.3 million increase in investment
income due to higher cash balances and higher market interest rates
on our investments, as well as the change in the market price of
Rezolute’s common stock.
Net loss for the first quarter of 2024 was $8.6 million,
compared to a net loss of $9.8 million for the first quarter of
2023.
On March 31, 2024, XOMA had cash and cash equivalents of $142.4
million (including $6.2 million in restricted cash). On
December 31, 2023, XOMA had cash and cash equivalents of $159.6
million (including $6.3 million in restricted cash). During
the first quarter of 2024, XOMA received $9.8 million in cash from
royalty and milestone payments and deployed $8 million to acquire
new royalty and milestone economic interests. Net cash used
in operating activities during the quarter was $4.9 million.
On April 15, 2024, the Company paid a total of $1.4 million in cash
dividends on the 8.625% Series A Cumulative Perpetual Preferred
Stock (Nasdaq: XOMAP) and the 8.375% Series B Cumulative Perpetual
Preferred Stock (Nasdaq: XOMAO).
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 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
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), 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 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, 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.
XOMA
CORPORATION |
|
CONDENSED
CONSOLIDATED BALANCE SHEETS |
|
(in
thousands, except share and per share amounts) |
|
|
|
|
|
|
|
March
31, |
|
December
31, |
|
|
|
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, $0.05 par value, 1,000,000 shares authorized: |
|
|
|
|
8.625% Series A cumulative, perpetual preferred stock, 984,000
shares issued and outstanding at March 31, 2024 and
December 31, 2023 |
|
49 |
|
|
|
49 |
|
|
8.375% Series B cumulative, perpetual preferred stock, 1,600 shares
issued and outstanding at March 31, 2024 and December 31,
2023 |
|
— |
|
|
|
— |
|
|
Convertible preferred stock, 5,003 issued and outstanding at
March 31, 2024 and December 31, 2023 |
|
— |
|
|
|
— |
|
|
Common stock, $0.0075 par value, 277,333,332 shares authorized,
11,636,355 and 11,495,492 shares issued and outstanding at
March 31, 2024 and December 31, 2023, respectively |
|
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 |
|
|
|
|
|
|
|
XOMA
CORPORATION |
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS |
|
(in
thousands, except share and per share amounts) |
|
|
|
|
|
|
|
Three Months
Ended March 31, |
|
|
|
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 |
|
|
|
|
|
|
|
XOMA
CORPORATION |
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS |
(in
thousands) |
|
|
|
|
|
|
|
Three Months
Ended March 31, |
|
|
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: |
Juliane Snowden |
Kathy Vincent |
XOMA |
KV Consulting &
Management |
+1-646-438-9754 |
+1-310-403-8951 |
juliane.snowden@xoma.com |
kathy@kathyvincent.com |
i
https://www.takeda.com/newsroom/newsreleases/2024/takeda-announces-positive-topline-results-from-phase-2-study-evaluating-mezagitamab-TAK-079-a-potential-best-in-class-anti-CD38-monoclonal-antibody-for-primary-immune-thrombocytopenia/
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