Ligand Pharmaceuticals Incorporated (Nasdaq: LGND)
today reported financial results for the three and twelve months
ended December 31, 2024, and provided an operating forecast and
business update. Ligand management will host a conference call and
webcast today beginning at 8:30 a.m. Eastern time to discuss this
announcement and answer questions.
“We achieved significant revenue growth in 2024
driven by strong momentum across our major commercial programs,”
said Todd Davis, CEO of Ligand. “Three of our portfolio products
with blockbuster sales potential, Verona’s Ohtuvayre, Travere’s
Filspari and Merck’s Capvaxive, received FDA approvals in 2024 and
are at an early stage in their growth trajectories. Moreover, the
important addition of Recordati’s Qarziba to our portfolio last
year highlights the expertise of our investment team. Looking ahead
to 2025, we anticipate multiple value-creating milestones,
including the potential for a strategic transaction and subsequent
launch of the recently approved ZELSUVMI™ by mid-2025. We believe
we are well positioned and capitalized to execute on our broad
pipeline of potential investment opportunities to drive significant
future growth and create long-term shareholder value.”
Fourth Quarter 2024 Financial
Results
Total revenues and other income for the fourth
quarter of 2024 were $42.8 million, compared with $28.1 million for
the same period in 2023, with the 52% increase driven primarily by
royalty revenue. Royalties for the fourth quarter of 2024 were
$34.8 million, compared with $22.5 million for the same period in
2023, with the 55% increase primarily attributable to royalties
earned on Ligand’s recently acquired royalty asset, Qarziba, and an
increase in sales of Travere Therapeutics’ Filspari. Captisol®
sales were $7.9 million for the fourth quarter of 2024, compared
with $3.9 million for the same period in 2023, with the increase
due to timing of customer orders. Contract revenue and other income
was $0.1 million for the fourth quarter of 2024, compared with $1.7
million for the same period in 2023, with the difference due to the
timing of partner milestone events.
Cost of Captisol was $2.8 million for the fourth
quarter of 2024, compared with $1.6 million for the same period in
2023, with the change due to an increase in Captisol sales.
Amortization of intangibles was $8.3 million for the fourth
quarters of both 2024 and 2023. Research and development expenses
were $4.4 million for the fourth quarter of 2024, compared with
$5.5 million for the same period in 2023. General and
administrative expenses were $25.6 million for the fourth quarter
of 2024, compared with $16.0 million for the same period in 2023,
with the increase primarily attributable to higher employee-related
expenses and increased operating costs associated with incubating
the Pelthos Therapeutics business. Fair value adjustment to partner
program derivatives was $7.2 million for the fourth quarter of 2024
primarily due to the discontinued development of certain Agenus
partnered programs.
GAAP net loss was $31.1 million, or $1.64 per
share for the fourth quarter of 2024, compared with net income of
$18.2 million, or $1.03 per diluted share, for the same period in
2023. GAAP net loss for the fourth quarter of 2024 included loss of
23.9 million from our short-term investments. Core adjusted net
income from continuing operations for the fourth quarter of 2024
was $25.2 million, or $1.27 per diluted share, compared with $18.6
million, or $1.05 per diluted share, for the same period in 2023.
Core adjusted net income excluded gains from the sale of Viking
Therapeutics common stock in the fourth quarter of 2023. We did not
sell any shares of Viking Therapeutics common stock in the fourth
quarter of 2024. The increase in core adjusted net income was
driven primarily by the 55% increase in royalty revenue. See the
table below for a reconciliation of net income (loss) from
continuing operations to core adjusted net income from continuing
operations.
As of December 31, 2024, Ligand had cash, cash
equivalents and short-term investments of $256.2 million which
included $40.2 million in Viking Therapeutics common stock.
Full Year 2024 Financial
Results
Total revenues and other income for full year
2024 were $167.1 million, compared with $131.3 million for full
year 2023. Royalties for full year 2024 were $108.8 million,
compared with $85.0 million for full year 2023, with the increase
primarily attributable to royalties earned on Qarziba and an
increase in royalties on Filspari. Captisol sales were $30.9
million for full year 2024, compared with $28.4 million for full
year 2023, with the change due to the timing of customer orders.
Contract revenue and other income was $27.5 million for full year
2024, compared with $18.0 million for full year 2023, with the
increase driven by milestone payments of $19.2 million earned
from Verona Pharma upon the approval and commercial launch of
Ohtuvayre.
Cost of Captisol was $11.1 million for full year
2024, compared with $10.5 million for full year 2023, with the
increase due to higher Captisol sales. Amortization of intangibles
was $33.0 million for full year 2024, compared with $33.7 million
for full year 2023. Research and development expenses were $21.4
million for full year 2024, compared with $24.5 million for full
year 2023, with the decrease primarily attributable to lower
employee-related expenses and lab supplies resulting from the
Pelican Technology Holdings spin-off in September 2023. The
decrease was partially offset by additional costs associated with
incubating the Pelthos Therapeutics business. General and
administrative expenses were $78.7 million for full year 2024,
compared with $52.8 million for full year 2023. This increase was
primarily driven by higher stock-based compensation expenses
associated with certain executive departures in addition to
investments made in building out the Company’s business development
and investment team. Additionally, costs associated with incubating
the Pelthos Therapeutics business contributed to the increase.
Financial royalty asset impairment was $30.6 million for the full
year 2024 primarily due to the impairment loss related to the
discontinuation of Takeda’s soticlestat program. Fair value
adjustment to partner program derivatives was $15.1 million for the
full year 2024 primarily due to the discontinuation of certain
Agenus partnered programs. These programs may be relicensed at a
later date, and Ligand would retain its economic interest upon any
relicense activity.
GAAP net loss from continuing operations was
$4.0 million, or $0.22 per share, for full year 2024, compared with
net income of $53.8 million, or $3.03 per diluted share, for full
year 2023. GAAP net loss for full year 2024 included a $30.6
million decrease in the carrying value of the Company’s
investments, primarily in connection with Takeda’s soticlestat, and
a $38.6 million decrease in Ligand’s investment in Primrose Bio.
Adjusted net income from continuing operations for full year 2024
was $156.0 million, or $8.25 per diluted share, compared with net
income of $107.4 million, or $6.09 per diluted share, for full year
2023. Excluding the impact of gains from sales of Viking
Therapeutics common stock, core adjusted net income from continuing
operations for full year 2024 was $108.5 million, or $5.74 per
diluted share, compared with net income of $71.7 million, or $4.06
per diluted share, for full year 2023. See the table below for a
reconciliation of net income (loss) from continuing operations to
core adjusted net income from continuing operations.
2025 Financial Guidance
Ligand is reaffirming the 2025 financial
guidance introduced at its Investor Day on December 10, 2024. The
Company continues to expect 2025 royalty revenue ranging from $135
million to $140 million, revenue from sales of Captisol ranging
from $35 million to $40 million and contract revenue ranging from
$10 million to $20 million. These revenue components result in a
total revenue forecast of $180 million to $200 million. Ligand
notes that with total revenue of $180 million to $200 million,
adjusted earnings per diluted share2 are anticipated to range from
approximately $6.00 to $6.25.
Fourth Quarter 2024 and Recent Business
Highlights
New Royalty Investment
On February 25, 2025, Ligand announced that it
closed a royalty financing agreement with Castle Creek Biosciences,
a late-stage cell and gene therapy company, to support Castle
Creek’s planned D-Fi (FCX-007) Phase 3 clinical study. D-Fi is an
injectable autologous gene-modified cell therapy in development for
the treatment of dystrophic epidermolysis bullosa (DEB), a
devastating, painful, and debilitating rare genetic skin disorder.
D-Fi has been granted Orphan Drug Designation from the U.S. Food
and Drug Administration (FDA). Ligand led a $75 million investment
in D-Fi by committing $50 million to the syndicated round. An
additional $25 million was secured from a syndicate of
co-investors. In return for the $75 million investment, investors
will receive a high- single digit royalty which is shared on a
pro-rated basis; therefore Ligand will net a mid-single digit
royalty.
Portfolio Updates
Ohtuvayre
- On January 7,
2025, Verona reported that more than 3,500 unique healthcare
professionals (HCPs) have prescribed Ohtuvayre and over 16,000
prescriptions were filled of which approximately one-third were
patient refills in 2024. Verona received FDA approval on June 26,
2024 and Ohtuvayre became commercially available in August
2024.
- Ohtuvayre’s
product specific J-code, J7601, became effective on January 1,
2025.
- In November
2024, Verona completed enrollment in a Phase 2 dose-ranging trial
with glycopyrrolate, a long-acting muscarinic antagonist (LAMA),
supporting a fixed-dose combination with ensifentrine for the
maintenance treatment of COPD via a nebulizer. Results are expected
to support initiation of a Phase 2b trial with a fixed dose
combination of ensifentrine with glycopyrrolate in the third
quarter of 2025.
- Verona continues
to enroll subjects in a Phase 2 trial to assess the efficacy and
safety of nebulized ensifentrine in patients with non-cystic
fibrosis bronchiectasis (NCFBE).
Filspari
- On February 11,
2025, Travere announced completion of its Type C meeting with the
FDA and plans to submit a supplemental New Drug Application (sNDA)
seeking traditional approval of Filspari for focal segmental
glomerulosclerosis (FSGS). The sNDA will be based on existing data
from the Phase 3 DUPLEX and Phase 2 DUET studies of Filspari and is
expected to be submitted around the end of the first quarter of
2025.
- On January 30,
2025, Travere’s partner, Renalys Pharma announced completion of
patient enrollment in its registrational Phase 3 clinical trial of
sparsentan for IgAN in Japan.
- In the fourth
quarter of 2024, Travere received 693 new patient start forms
(PSFs), an increase of 37% from the prior quarter, driven by growth
amongst new and repeat prescribers following full approval by the
FDA on September 5, 2024.
- The FDA recently
accepted Travere’s sNDA requesting modification of the liver
monitoring REMS requirement for Filspari in IgAN and assigned a
PDUFA target action date of August 28, 2025.
- CSL Vifor
launched Filspari for the treatment of IgAN in Germany, Austria,
and Switzerland and recently received approval for Filspari in the
UK.
Capvaxive
- On January 31,
2025, Merck announced that the Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Agency (EMA) recommended
the approval of Capvaxive (Pneumococcal 21-valent Conjugate
Vaccine) for active immunization for the prevention of invasive
disease and pneumonia caused by Streptococcus pneumoniae in
individuals 18 years of age and older. The CHMP’s recommendation
will now be reviewed by the European Commission (EC) for marketing
authorization in the European Union (EU), Iceland, Liechtenstein
and Norway, and a final decision is expected during the second
quarter of 2025.
Qtorin Rapamycin
- On January 10,
2025, Palvella Therapeutics announced the publication of results
from the Phase 2 clinical trial of Qtorin 3.9% rapamycin anhydrous
gel (Qtorin rapamycin) for the treatment of microcystic lymphatic
malformations (MLM) in the Journal of Vascular Anomalies.
- Palvella is
currently enrolling approximately 40 subjects in SELVA, a 24-week,
Phase 3, single-arm, baseline-controlled trial of Qtorin rapamycin
for the treatment of MLMs.
- The FDA has
granted Breakthrough Therapy Designation, Fast Track Designation,
and Orphan Drug Designation to Qtorin rapamycin for the treatment
of MLMs. Additionally, the SELVA study is supported by an Orphan
Products Grant from the FDA’s Office of Orphan Products
Development.
- On January 8,
2025, Palvella announced the first patients were dosed in TOIVA, a
multicenter, Phase 2 clinical trial designed to evaluate the safety
and efficacy of Qtorin rapamycin for the treatment of cutaneous
venous malformations (cutaneous VMs).
- The Phase 2
TOIVA study is a single-arm, open-label, baseline-controlled
clinical trial of Qtorin rapamycin administered topically once
daily for the treatment of cutaneous VMs. The Phase 2 study is
expected to enroll approximately 15 participants, ages six and
older, at leading vascular anomaly centers across the United
States.
Other Program Updates
- On January 30,
2025, Takeda announced the decision to discontinue its soticlestat
(TAK-935) development program. This decision follows the June 2024
announcement that the soticlestat Phase 3 SKYLINE study in Dravet
syndrome (DS) and Phase 3 SKYWAY study in Lennox-Gastaut Syndrome
(LGS) missed their primary endpoints. Subsequently, Takeda
discontinued the soticlestat LGS development program and engaged
with the FDA around the totality of evidence for soticlestat
treatment for DS. The FDA informed Takeda that the current clinical
data package would not be sufficient to demonstrate substantial
evidence of effectiveness to support a New Drug Application (NDA)
for soticlestat in DS.
- On January 30,
2025, Sanofi announced the EMA acceptance of the regulatory
submission for Tzield in children and adolescents to delay the
onset of stage 3 type 1 diabetes (T1D) as well as for the early
intervention of stage 3 T1D. Tzield is currently approved in the US
to delay the onset of stage 3 T1D. Sanofi expects a decision in the
second half of 2025.
- On January 10,
2025, Primrose Bio announced a collaboration with Serum Institute
of India Pvt. Ltd. (“SIIPL”) to develop a novel multi-antigen
vaccine for infections that affect millions of people globally.
Both companies will contribute towards the design of the vaccine
with Primrose Bio fully responsible for developing manufacturing
strains using its Pfenex Expression Technology and SIIPL
responsible for further development and commercialization.
- On December 16,
2024, the FDA granted SQ Innovation Inc., Tentative Approval for
Lasix ONYU for the home treatment of fluid overload in congestive
heart failure. Captisol is a key part of the Lasix ONYU novel
high-concentration formulation of furosemide 80mg/2.67mL (30mg/mL),
and Ligand is entitled to milestone payments, royalties and revenue
from material sales. Tentative Approval indicates that Lasix ONYU
has met the regulatory standards for quality, safety and efficacy
required for approval in the United States. Full approval was
precluded because the FDA had granted market exclusivity in the
United States for a competing product until October 2025. SQ
Innovation will seek full approval in the United States after the
expiration of the regulatory exclusivity period. Lasix ONYU now
expects the first products to be available on the market by the end
of 2025.
- On December 13,
2024, CASI Pharmaceuticals, the exclusive marketer of Evomela in
China, received a termination letter from Acrotech, which holds
exclusive worldwide rights to Evomela. The letter alleges that CASI
materially breached the license agreement between Acrotech and CASI
failed to cure that breach. CASI may continue to distribute and
sell Evomela in China for a reasonable wind down period, not to
exceed 24 months.
- On November 19,
2024, Viking Therapeutics presented the final results of its Phase
2b VOYAGE trial of oral small molecule VK2809 in biopsy-confirmed
non-alcoholic steatohepatitis (NASH; also referred to as metabolic
dysfunction associated steatohepatitis, MASH) at the 75th Liver
Meeting® 2024. At the 52-week mark, the drug reduced liver fat
content by an average of 37% to 55% compared to baseline, with all
treatment arms showing statistically significant improvements
compared to placebo.
- On October 28,
2024, Xi’an Xintong Pharmaceuticals Research Co., Ltd was informed
that the China National Medical Products Administration (NMPA)
approved Xinshumu (pradefovir), an oral medication for adult
patients with chronic hepatitis B (HBV). Ligand is entitled to
milestone payments and a 9% royalty on worldwide net sales of
Xinshumu.
Adjusted Financial Measures
Ligand reports adjusted net income from
continuing operations, adjusted net income per diluted share and
adjusted earnings per diluted share in addition to, not as a
substitute for, and does not consider such measures superior to,
financial measures calculated in accordance with GAAP. The Company
also reports a core calculation for each of the foregoing measures
which excludes any realized gain from sales of Viking Therapeutics
common stock. Additionally, adjusted earnings per diluted share is
a key component of the financial metrics utilized by the Company’s
board of directors to measure, in part, management’s performance
and determine significant elements of management’s compensation.
The Company’s financial measures under GAAP include share-based
compensation expense, amortization of debt-related costs,
amortization related to acquisitions and intangible assets, changes
in contingent liabilities, mark-to-market adjustments for amounts
relating to its equity investments in public companies, excess tax
benefit from share-based compensation, transaction costs, income
tax effect of adjusted reconciling items and others that are listed
in the itemized reconciliations between GAAP and non-GAAP adjusted
financial measures included at the end of this press release. A
reconciliation of forward-looking non-GAAP adjusted earnings per
diluted share to the most directly comparable GAAP measures is not
available without unreasonable effort, as certain items cannot be
reasonably predicted because of their high variability, complexity
and low visibility. Specifically, non-cash adjustments that could
be made for changes in contingent liabilities, changes in the
market value of its investments in public companies, share-based
compensation expense and the effects of any discrete income tax
items, directly impact the calculations of our adjusted earnings
per diluted share, which we expect to have a significant impact on
our future GAAP financial results.
Conference Call
Ligand management will host a conference call
and webcast today beginning at 8:30 a.m. Eastern time (5:30 a.m.
Pacific time) to discuss this announcement and answer questions. To
participate via telephone, please dial (800) 715-9871 (North
America toll-free number) using the conference ID 8755336.
International participants outside of Canada may use the toll
number (646) 307-1963 and use the same conference ID. To
participate via live or replay webcast, a link is available at
www.ligand.com.
About Ligand
Pharmaceuticals
Ligand is a biopharmaceutical company enabling
scientific advancement through supporting the clinical development
of high-value medicines. Ligand does this by providing financing,
licensing our technologies or both. Our business model seeks to
generate value for stockholders by creating a diversified portfolio
of biotech and pharmaceutical product revenue streams that are
supported by an efficient and low corporate cost structure. Our
goal is to offer investors an opportunity to participate in the
promise of the biotech industry in a profitable and diversified
manner. Our business model is based on funding programs in mid- to
late-stage drug development in return for economic rights,
purchasing royalty rights in development stage or commercial
biopharmaceutical products and licensing our technology to help
partners discover and develop medicines. We partner with other
pharmaceutical companies to attempt to leverage what they do best
(late-stage development, regulatory management and
commercialization) in order to generate our revenue. We operate two
infrastructure-light royalty generating technology IP platform
technologies. Our Captisol® platform technology is a chemically
modified cyclodextrin with a structure designed to optimize the
solubility and stability of drugs. Our NITRICIL™ platform
technology facilitates tunable dosing, permitting an adjustable
drug release profile to allow proprietary formulations that target
a broad range of indications. We have established multiple
alliances, licenses and other business relationships with the
world’s leading pharmaceutical companies including Amgen, Merck,
Pfizer, Jazz, Gilead Sciences and Baxter International. For more
information, please visit www.ligand.com. Follow Ligand on X
@Ligand_LGND.
We use our investor relations website and X as a
means of disclosing material non-public information and for
complying with our disclosure obligations under Regulation FD.
Investors should monitor our website and our X account, in addition
to following our press releases, SEC filings, public conference
calls and webcasts.
Forward-Looking Statements
This news release contains forward-looking
statements, as defined in Section 21E of the Securities Exchange
Act of 1934, by Ligand that involve risks and uncertainties and
reflect Ligand’s judgment as of the date of this release. All
statements, other than statements of historical fact, could be
deemed to be forward-looking statements. In some instances, words
such as “plans,” “believes,” “expects,” “anticipates,” and “will,”
and similar expressions, are intended to identify forward-looking
statements. Readers are cautioned not to place undue reliance on
these forward-looking statements, which reflect our good faith
beliefs (or those of the indicated third parties) and speak only as
of the date hereof. These forward-looking statements include,
without limitation, statements regarding: Ligand’s ability to
expand its portfolio with life sciences royalty opportunities; the
timing of clinical and regulatory events of Ligand’s partners,
including the expected commercial launch of ZELSUVMI or any other
product; the timing of the initiation or completion of preclinical
studies and clinical trials by Ligand and its partners; the timing
of product launches by Ligand or its partners; and guidance
regarding projected 2025 financial results. Actual events or
results may differ from Ligand’s expectations due to risks and
uncertainties inherent in Ligand’s business, including, without
limitation: Ligand relies on collaborative partners for milestone
payments, royalties, materials revenue, contract payments and other
revenue projections and may not receive expected revenue; Ligand
may not receive expected revenue from Captisol material sales;
Ligand and its partners may not be able to timely or successfully
advance any product(s) in its internal or partnered pipeline or
receive regulatory approval and there may not be a market for the
product(s) even if successfully developed and approved; Ligand may
not achieve its guidance for 2025; Ligand faces competition in
acquiring royalties and locating suitable royalties to acquire;
Ligand may not be able to create future revenues and cash flows
through the acquisition of royalties or by developing innovative
therapeutics; products under development by Ligand or its partners
may not receive regulatory approval; the total addressable market
for our partners’ products may be smaller than estimated; Ligand
faces competition with respect to its technology platforms which
may demonstrate greater market acceptance or superiority; Ligand is
currently dependent on a single source sole supplier for Captisol
and failures by such supplier may result in delays or inability to
meet the Captisol demands of its partners; Ligand’s partners may
change their development focus and may not execute on their sales
and marketing plans for marketed products for which Ligand has an
economic interest; Ligand’s collaboration partners may become
insolvent; Ligand’s and its partners’ products may not be proved to
be safe and efficacious and may not perform as expected and
uncertainty regarding the commercial performance of such products;
Ligand or its partners may not be able to protect their
intellectual property and patents covering certain products and
technologies may be challenged or invalidated; Cyber-attacks or
other failures in telecommunications or information technology
systems could result in information theft, data corruption and
significant disruption to Ligand’s business operations; Ligand’s
partners may terminate any of its agreements or development or
commercialization of any of its products; Ligand and its partners
may experience delays in the commencement, enrollment, completion
or analysis of clinical testing for its product candidates, or
significant issues regarding the adequacy of its clinical trial
designs or the execution of its clinical trials, challenges, costs
and charges associated with integrating acquisitions with Ligand’s
existing businesses; Ligand may not be able to successfully
commercialize Pelthos’ berdazimer gel (10.3%) program and may not
be able to outlicense or sell Pelthos’ other programs or assets
(including the NITRICIL technology platform) acquired during the
2023 Novan acquisition or may be unable to execute a strategic
transaction involving Pelthos; Ligand may not be able to
successfully implement its strategic growth plan and continue the
development of its proprietary programs; restrictions under
Ligand’s credit agreement may limit its flexibility in operating
its business and a default under the agreement could result in a
foreclosure of the collateral securing such obligations; and
changes in general economic conditions, including as a result of
war, conflict, epidemic diseases, or the new presidential
administration in the U.S., and ongoing or future litigation could
expose Ligand to significant liabilities and have a material
adverse effect on the Company. The failure to meet expectations
with respect to any of the foregoing matters may reduce Ligand’s
stock price. Additional information concerning these and other risk
factors affecting Ligand can be found in prior press releases
available at www.ligand.com as well as in Ligand’s public periodic
filings with the Securities and Exchange Commission available at
www.sec.gov. Ligand disclaims any intent or obligation to update
these forward-looking statements beyond the date of this release,
including the possibility of additional license fees and milestone
revenues we may receive. This caution is made under the safe harbor
provisions of the Private Securities Litigation Reform Act of
1995.
Other Disclaimers and
Trademarks
The information in this press release regarding
certain third-party products and programs, including Capvaxive, a
Merck product, Filspari, a Travere Therapeutics product, Ohtuvayre,
a Verona Pharma product, Qtorin rapamycin, a Palvella Therapeutics
product candidate, Lasix ONYU, an SQ Innovation product candidate,
Xinshumu, a Xi'an Xintong product, VK2809, a Viking Therapeutics
product candidate, Evomela, a CASI Pharmaceuticals product, and
soticlestat, a Takeda product candidate, comes from information
publicly released by the owners of such products and programs.
Ligand is not responsible for, and has no role in, the development
of such products or programs.
Ligand owns or has rights to trademarks and
copyrights that it uses in connection with the operation of its
business including its corporate name, logos and websites. Other
trademarks and copyrights appearing in this press release are the
property of their respective owners. The trademarks Ligand owns
include Ligand, Captisol, NITRICIL and ZELSUVMI. Solely for
convenience, some of the trademarks and copyrights referred to in
this press release are listed without the ®, © and ™ symbols, but
Ligand will assert, to the fullest extent under applicable law, its
rights to its trademarks and copyrights.
Contacts
Investors: Melanie
Hermaninvestors@ligand.com (858) 550-7761
Media: Kellie Walshmedia@ligand.com (914)
315-6072
|
[Tables Follow] |
|
|
LIGAND PHARMACEUTICALS
INCORPORATEDCONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(Unaudited, in thousands, except per share
amounts) |
|
|
|
Three Months Ended December 31, |
|
Year Ended December 31, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Revenues and other income: |
|
|
|
|
|
|
|
|
Revenue from intangible royalty assets |
|
$ |
27,817 |
|
|
$ |
22,463 |
|
|
$ |
95,329 |
|
|
$ |
83,910 |
|
Income from financial royalty assets |
|
|
6,990 |
|
|
|
23 |
|
|
|
13,444 |
|
|
|
1,049 |
|
Royalties |
|
|
34,807 |
|
|
|
22,486 |
|
|
|
108,773 |
|
|
|
84,959 |
|
Captisol |
|
|
7,916 |
|
|
|
3,922 |
|
|
|
30,883 |
|
|
|
28,372 |
|
Contract revenue and other income |
|
|
89 |
|
|
|
1,693 |
|
|
|
27,477 |
|
|
|
17,983 |
|
Total revenues and other income |
|
|
42,812 |
|
|
|
28,101 |
|
|
|
167,133 |
|
|
|
131,314 |
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
Cost of Captisol |
|
|
2,837 |
|
|
|
1,641 |
|
|
|
11,074 |
|
|
|
10,512 |
|
Amortization of intangibles |
|
|
8,258 |
|
|
|
8,338 |
|
|
|
32,959 |
|
|
|
33,654 |
|
Research and development |
|
|
4,425 |
|
|
|
5,488 |
|
|
|
21,425 |
|
|
|
24,537 |
|
General and administrative |
|
|
25,605 |
|
|
|
15,992 |
|
|
|
78,654 |
|
|
|
52,790 |
|
Financial royalty assets impairment |
|
|
4,081 |
|
|
|
— |
|
|
|
30,572 |
|
|
|
— |
|
Fair value adjustments to partner program derivatives |
|
|
7,243 |
|
|
|
— |
|
|
|
15,055 |
|
|
|
— |
|
Total operating costs and expenses |
|
|
52,449 |
|
|
|
31,459 |
|
|
|
189,739 |
|
|
|
121,493 |
|
Gain on sale of Pelican |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(2,121 |
) |
Operating income (loss) from continuing operations |
|
|
(9,637 |
) |
|
|
(3,358 |
) |
|
|
(22,606 |
) |
|
|
11,942 |
|
Non-operating income and expenses: |
|
|
|
|
|
|
|
|
Gain from short-term investments |
|
|
(23,899 |
) |
|
|
16,025 |
|
|
|
75,024 |
|
|
|
46,365 |
|
Interest income, net |
|
|
1,048 |
|
|
|
1,562 |
|
|
|
5,018 |
|
|
|
7,055 |
|
Other non-operating expense, net |
|
|
(6,712 |
) |
|
|
2,868 |
|
|
|
(54,918 |
) |
|
|
(1,702 |
) |
Total non-operating (expenses) income, net |
|
|
(29,563 |
) |
|
|
20,455 |
|
|
|
25,124 |
|
|
|
51,718 |
|
Income before income tax from continuing operations |
|
|
(39,200 |
) |
|
|
17,097 |
|
|
|
2,518 |
|
|
|
63,660 |
|
Income tax benefit (expense) |
|
|
8,112 |
|
|
|
1,091 |
|
|
|
(6,550 |
) |
|
|
(9,841 |
) |
Net income (loss) from continuing operations |
|
|
(31,088 |
) |
|
|
18,188 |
|
|
|
(4,032 |
) |
|
|
53,819 |
|
Net loss from discontinued operations |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(1,665 |
) |
Net income (loss): |
|
$ |
(31,088 |
) |
|
$ |
18,188 |
|
|
$ |
(4,032 |
) |
|
$ |
52,154 |
|
|
|
|
|
|
|
|
|
|
Basic net income (loss) from continuing operations per share |
|
$ |
(1.64 |
) |
|
$ |
1.04 |
|
|
$ |
(0.22 |
) |
|
$ |
3.11 |
|
Basic net loss from discontinued operations per share |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
(0.10 |
) |
Basic net income (loss) per share |
|
$ |
(1.64 |
) |
|
$ |
1.04 |
|
|
$ |
(0.22 |
) |
|
$ |
3.02 |
|
Shares used in basic per share calculation |
|
|
18,974 |
|
|
|
17,466 |
|
|
|
18,290 |
|
|
|
17,298 |
|
|
|
|
|
|
|
|
|
|
Diluted net income (loss) from continuing operations per share |
|
$ |
(1.64 |
) |
|
$ |
1.03 |
|
|
$ |
(0.22 |
) |
|
$ |
3.03 |
|
Diluted net loss from discontinued operations per share |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
(0.09 |
) |
Diluted net income (loss) per share |
|
$ |
(1.64 |
) |
|
$ |
1.03 |
|
|
$ |
(0.22 |
) |
|
$ |
2.94 |
|
Shares used in diluted per share calculation |
|
|
18,974 |
|
|
|
17,676 |
|
|
|
18,290 |
|
|
|
17,757 |
|
|
LIGAND PHARMACEUTICALS
INCORPORATEDCONDENSED CONSOLIDATED BALANCE
SHEETS(unaudited, in thousands) |
|
|
|
December 31, 2024 |
|
December 31, 2023 |
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash, cash equivalents and short-term investments |
|
$ |
256,165 |
|
$ |
170,309 |
Accounts receivable, net |
|
|
38,376 |
|
|
32,917 |
Inventory |
|
|
14,114 |
|
|
23,969 |
Income tax receivable |
|
|
4,073 |
|
|
6,395 |
Other current assets |
|
|
18,831 |
|
|
3,839 |
Total current assets |
|
|
331,559 |
|
|
237,429 |
|
|
|
|
|
Goodwill and other intangible assets, net |
|
|
371,898 |
|
|
402,976 |
Long-term portion of financial royalty assets, net |
|
|
185,024 |
|
|
62,291 |
Noncurrent derivative assets |
|
|
10,583 |
|
|
3,531 |
Property and equipment, net |
|
|
15,133 |
|
|
15,607 |
Operating lease right-of-use assets |
|
|
6,907 |
|
|
6,062 |
Finance lease right-of-use assets |
|
|
2,766 |
|
|
3,393 |
Equity method investment in Primrose Bio |
|
|
— |
|
|
12,595 |
Other investments |
|
|
10,908 |
|
|
36,726 |
Deferred income taxes, net |
|
|
72 |
|
|
214 |
Other assets |
|
|
6,924 |
|
|
6,392 |
Total assets |
|
$ |
941,774 |
|
$ |
787,216 |
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
33,139 |
|
$ |
14,894 |
Income tax payable |
|
|
1,199 |
|
|
— |
Deferred revenue |
|
|
1,278 |
|
|
1,222 |
Current contingent liabilities |
|
|
206 |
|
|
256 |
Current operating lease liabilities |
|
|
1,266 |
|
|
403 |
Current finance lease liabilities |
|
|
24 |
|
|
7 |
Total current liabilities |
|
|
37,112 |
|
|
16,782 |
|
|
|
|
|
Long-term contingent liabilities |
|
|
3,475 |
|
|
2,942 |
Long-term operating lease liabilities |
|
|
5,815 |
|
|
5,755 |
Deferred income taxes, net |
|
|
32,524 |
|
|
31,622 |
Other long-term liabilities |
|
|
32,409 |
|
|
29,202 |
Total liabilities |
|
|
111,335 |
|
|
86,303 |
|
|
|
|
|
Total stockholders' equity |
|
|
830,439 |
|
|
700,913 |
Total liabilities and stockholders' equity |
|
$ |
941,774 |
|
$ |
787,216 |
|
LIGAND PHARMACEUTICALS
INCORPORATEDADJUSTED FINANCIAL
MEASURES(Unaudited, in thousands, except per share
amounts) |
|
|
|
Three months ended December 31, |
|
Year ended December 31, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
|
|
|
|
|
|
|
Net income (loss) from continuing operations |
|
$ |
(31,088 |
) |
|
$ |
18,188 |
|
|
$ |
(4,032 |
) |
|
$ |
53,819 |
|
Adjustments: |
|
|
|
|
|
|
|
|
Share-based compensation expense |
|
|
7,524 |
|
|
|
5,721 |
|
|
|
41,089 |
|
|
|
25,743 |
|
Non-cash interest expense (1) |
|
|
786 |
|
|
|
81 |
|
|
|
2,724 |
|
|
|
240 |
|
Amortization of intangible assets |
|
|
8,258 |
|
|
|
8,338 |
|
|
|
32,959 |
|
|
|
33,654 |
|
Amortization of financial royalty assets (2) |
|
|
3,824 |
|
|
|
(23 |
) |
|
|
10,811 |
|
|
|
(1,049 |
) |
Change in contingent liabilities (3) |
|
|
(310 |
) |
|
|
(397 |
) |
|
|
683 |
|
|
|
(265 |
) |
Pelthos operating loss |
|
|
4,386 |
|
|
|
5,183 |
|
|
|
20,879 |
|
|
|
5,520 |
|
Transaction costs |
|
|
— |
|
|
|
(210 |
) |
|
|
— |
|
|
|
3,078 |
|
Loss (gain) from short-term investments |
|
|
23,899 |
|
|
|
(16,025 |
) |
|
|
(75,024 |
) |
|
|
(46,365 |
) |
Realized gain (loss) from short-term investments |
|
|
(21 |
) |
|
|
7,180 |
|
|
|
59,897 |
|
|
|
44,377 |
|
Gain on sale of Pelican |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(2,121 |
) |
Provision for current expected credit losses on financial royalty
assets |
|
|
(852 |
) |
|
|
405 |
|
|
|
(4,315 |
) |
|
|
3,595 |
|
Impairment of financial royalty assets (4) |
|
|
4,081 |
|
|
|
— |
|
|
|
30,572 |
|
|
|
924 |
|
Decrease in investments in Primrose Bio (5) |
|
|
1,245 |
|
|
|
1,761 |
|
|
|
38,609 |
|
|
|
1,829 |
|
Loss (gain) from derivative assets |
|
|
12,478 |
|
|
|
(250 |
) |
|
|
27,133 |
|
|
|
(250 |
) |
Other (6) |
|
|
3,627 |
|
|
|
94 |
|
|
|
7,701 |
|
|
|
780 |
|
Income tax effect of adjusted reconciling items above |
|
|
(12,478 |
) |
|
|
816 |
|
|
|
(34,158 |
) |
|
|
(9,144 |
) |
Discrete tax expense related to increase in unrecognized tax
benefits (7) |
|
|
— |
|
|
|
(7,206 |
) |
|
|
426 |
|
|
|
(7,206 |
) |
Excess tax benefit (shortfall) from share-based compensation
(8) |
|
|
(139 |
) |
|
|
757 |
|
|
|
87 |
|
|
|
228 |
|
Adjusted net income from continuing
operations |
|
$ |
25,220 |
|
|
$ |
24,413 |
|
|
$ |
156,041 |
|
|
$ |
107,387 |
|
Realized gain from sales of VKTX stock, net of tax |
|
|
— |
|
|
|
(5,780 |
) |
|
|
(47,563 |
) |
|
|
(35,720 |
) |
Core adjusted net income from continuing
operations |
|
$ |
25,220 |
|
|
$ |
18,633 |
|
|
$ |
108,478 |
|
|
$ |
71,667 |
|
|
|
|
|
|
|
|
|
|
Diluted per-share amounts attributable to common
shareholders: |
|
|
|
|
|
|
|
|
Diluted net income (loss) per share from continuing operations |
|
$ |
(1.64 |
) |
|
$ |
1.03 |
|
|
$ |
(0.22 |
) |
|
$ |
3.03 |
|
Adjustments: |
|
|
|
|
|
|
|
|
Share-based compensation expense |
|
|
0.38 |
|
|
|
0.32 |
|
|
|
2.17 |
|
|
|
1.46 |
|
Non-cash interest expense (1) |
|
|
0.04 |
|
|
|
— |
|
|
|
0.14 |
|
|
|
0.01 |
|
Amortization of intangible assets |
|
|
0.41 |
|
|
|
0.47 |
|
|
|
1.74 |
|
|
|
1.91 |
|
Amortization of financial royalty assets (2) |
|
|
0.19 |
|
|
|
— |
|
|
|
0.57 |
|
|
|
(0.06 |
) |
Change in contingent liabilities (3) |
|
|
(0.02 |
) |
|
|
(0.02 |
) |
|
|
0.04 |
|
|
|
(0.02 |
) |
Pelthos operating loss |
|
|
0.22 |
|
|
|
0.29 |
|
|
|
1.10 |
|
|
|
0.31 |
|
Transaction costs |
|
|
— |
|
|
|
(0.01 |
) |
|
|
— |
|
|
|
0.17 |
|
Loss (gain) from short-term investments |
|
|
1.20 |
|
|
|
(0.91 |
) |
|
|
(3.97 |
) |
|
|
(2.63 |
) |
Realized gain (loss) from short-term investments |
|
|
— |
|
|
|
0.41 |
|
|
|
3.17 |
|
|
|
2.52 |
|
Gain on sale of Pelican |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(0.12 |
) |
Provision for current expected credit losses on financial royalty
assets |
|
|
(0.04 |
) |
|
|
0.02 |
|
|
|
(0.23 |
) |
|
|
0.21 |
|
Impairment of financial royalty assets (4) |
|
|
0.21 |
|
|
|
— |
|
|
|
1.62 |
|
|
|
0.05 |
|
Decrease in investments in Primrose Bio (5) |
|
|
0.06 |
|
|
|
0.10 |
|
|
|
2.04 |
|
|
|
0.10 |
|
Loss from derivative assets |
|
|
0.63 |
|
|
|
(0.01 |
) |
|
|
1.43 |
|
|
|
(0.01 |
) |
Other (6) |
|
|
0.19 |
|
|
|
0.01 |
|
|
|
0.42 |
|
|
|
0.05 |
|
Income tax effect of adjusted reconciling items above |
|
|
(0.63 |
) |
|
|
0.05 |
|
|
|
(1.80 |
) |
|
|
(0.49 |
) |
Discrete tax expense related to increase in unrecognized tax
benefits (7) |
|
|
— |
|
|
|
(0.41 |
) |
|
|
0.02 |
|
|
|
(0.41 |
) |
Excess tax benefit (shortfall) from share-based compensation
(8) |
|
|
(0.01 |
) |
|
|
0.04 |
|
|
|
— |
|
|
|
0.01 |
|
Adjustment for shares excluded due to anti-dilution effect on GAAP
net loss |
|
|
0.08 |
|
|
|
— |
|
|
|
0.01 |
|
|
|
— |
|
Adjusted diluted net income per share from continuing
operations |
|
$ |
1.27 |
|
|
$ |
1.38 |
|
|
$ |
8.25 |
|
|
$ |
6.09 |
|
Realized gain from sales of VKTX stock, net of tax |
|
|
— |
|
|
|
(0.33 |
) |
|
|
(2.51 |
) |
|
|
(2.03 |
) |
Core adjusted diluted net income per share from continuing
operations |
|
$ |
1.27 |
|
|
$ |
1.05 |
|
|
$ |
5.74 |
|
|
$ |
4.06 |
|
|
|
|
|
|
|
|
|
|
GAAP - weighted average number of common shares - diluted |
|
|
18,974 |
|
|
|
17,676 |
|
|
|
18,290 |
|
|
|
17,757 |
|
Shares excluded due to anti-dilutive effect on GAAP net loss |
|
|
931 |
|
|
|
— |
|
|
|
619 |
|
|
|
— |
|
Diluted effect of the 2023 Notes (9) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(119 |
) |
Adjusted weighted average number of common shares - diluted |
|
|
19,905 |
|
|
|
17,676 |
|
|
|
18,909 |
|
|
|
17,638 |
|
(1) Amounts represent (a) non-cash interest
expense in connection with the royalty and milestone payments
purchase agreement assumed as part of the Novan asset acquisition
in September 2023; and (b) non-cash debt related costs that are
calculated in accordance with the authoritative accounting guidance
for our revolving credit facility and convertible debt instruments
that were settled in cash.
(2) Amounts represent the adjustments to the
effective interest income recognized to total contractual payments
recognized in the period.
(3) Amounts represent changes in fair value of
contingent consideration related to CyDex and Metabasis
transactions.
(4) Amounts represent the impairment of
financial royalty assets primarily related to the discontinuation
of Takeda’s soticlestat program.
(5) In June 2024, Primrose Bio announced a
Series B preferred share offering. Management applies the
measurement alternative for its investment in the Series A
preferred shares of Primrose Bio. Management concluded the Series B
financing was a relevant transaction for determining an observable
price change and revalued its Series A investment resulting in a
downward adjustment of $25.8 million in the price of the Series A
shares during the fiscal year 2024. The unrealized loss on the
Series A preferred shares was an indicator that the losses in
common shares (equity method investment) are other than temporary.
As a result, management recorded a $5.8 million impairment charge
to its equity method investment in addition to Ligand's share of
the net loss of Primrose Bio recognized during fiscal year
2024.
(6) Amounts primarily relate to loss on other
investment and restructuring costs.
(7) Amounts represent discrete tax benefit
related to the release of FIN48 reserves associated with certain
R&D tax credits during the fourth quarter of 2023 due to the
lapse of applicable statute of limitation.
(8) Excess tax benefits from share-based
compensation are recorded as a discrete item within the provision
for income taxes on the consolidated statements of operations as a
result of the adoption of an accounting pronouncement (ASU 2016-09)
on January 1, 2017. Prior to the adoption, the amount was
recognized in additional paid-in capital on the consolidated
statement of stockholders’ equity.
(9) Excluding the impact from the adoption of
accounting pronouncement (ASU 2020-06) on January 1, 2022 as the
Company intended to settle the principal balance in cash. Under the
standard, the Company is required to reflect the dilutive effect of
the 2023 Notes by application of the if-converted method. The 2023
Notes were fully paid off on May 15, 2023, the debt maturity
date.
________________________________________________________1 A
reconciliation of forward-looking non-GAAP adjusted earnings per
diluted share to the most directly comparable GAAP measure is not
available without unreasonable effort, as certain items cannot be
reasonably predicted because of their high variability, complexity
and low visibility. Specifically, non-cash adjustments that could
be made for changes in contingent liabilities, changes in the
market value of investments in public companies, share-based
compensation expense and the effects of any discrete income tax
items, directly impact the calculation of our adjusted earnings per
diluted share.
2 A reconciliation of forward-looking non-GAAP
adjusted earnings per diluted share to the most directly comparable
GAAP measure is not available without unreasonable effort, as
certain items cannot be reasonably predicted because of their high
variability, complexity and low visibility. Specifically, non-cash
adjustments that could be made for changes in contingent
liabilities, changes in the market value of investments in public
companies, share-based compensation expense and the effects of any
discrete income tax items, directly impact the calculation of our
adjusted earnings per diluted share.
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