Travere Therapeutics, Inc. (NASDAQ: TVTX) today reported its fourth
quarter and full year 2024 financial results and provided a
corporate update.
“Our strong execution in 2024 made it a
remarkable year for Travere and the patients we serve. The ongoing
commercial launch of FILSPARI outperformed benchmarks and the
recent full approval has reinforced physicians’ confidence in
choosing FILSPARI as a foundational therapy for IgAN,” said Eric
Dube, Ph.D., president and chief executive officer of Travere
Therapeutics. “We enter 2025 with strong momentum and a clear
focus. With FILSPARI’s differentiated profile as the only medicine
that has been shown to provide superior preservation of kidney
function in a head-to-head trial and can replace historical
foundational therapy, we remain committed to reaching more patients
at risk of IgAN progression. Following our recent FDA engagement
for FILSPARI in FSGS, we are on track to complete our sNDA
submission around the end of the first quarter and are preparing to
be ready for a successful launch, if approved. Additionally, we
continue to optimize our manufacturing for pegtibatinase and will
be preparing to restart enrollment in the pivotal program next
year. These strategic priorities will position us to drive a
lasting positive impact for our patients and stakeholders.”
Financial Results for Continuing
Operations for the Quarter and Year Ended December 31,
2024
The following financial results discussion
compares Travere’s continuing operations. All periods unless
otherwise specified have been adjusted to exclude discontinued
operations related to the divestiture of the bile acid product
portfolio completed on August 31, 2023.
Net product sales for the fourth quarter of 2024
were $73.5 million, compared to $39.9 million for the same period
in 2023. For the full year 2024, net product sales were $226.7
million, compared to $127.5 million for the same period in 2023.
The increase is attributable to growth in sales of FILSPARI,
including a full twelve months of sales in 2024, following the
February 2023 launch.
Research and development (R&D) expenses for
the fourth quarter of 2024 were $62.1 million, compared to $59.7
million for the same period in 2023. For the full year 2024,
R&D expenses were $217.5 million, compared to $245.0 million
for the same period in 2023. The decrease is largely attributable
to previously announced restructuring initiatives and lower costs
associated with the development of sparsentan as our Phase 3
programs advance towards completion, offset by an increase in costs
associated with the development of pegtibatinase following the
December 2023 initiation of the Phase 3 HARMONY Study. On a
non-GAAP adjusted basis, R&D expenses were $58.6 million for
the fourth quarter and $203.3 million for the full year 2024,
compared to $55.3 million and $220.4 million for the same periods
in 2023.
Selling, general, and administrative (SG&A)
expenses for the fourth quarter of 2024 were $69.5 million,
compared to $63.6 million for the same period in 2023. For the full
year 2024, SG&A expenses were $264.1 million, compared to
$265.5 million for the same period in 2023. On a non-GAAP adjusted
basis, SG&A expenses were $51.6 million for the fourth quarter
and $197.8 million for the full year 2024, compared to $49.7
million and $199.5 million for the same periods in 2023.
Total other income, net for the fourth quarter
of 2024 was $0.4 million, compared to $5.7 million for the same
period in 2023. Total other income, net for the full year 2024 was
$3.3 million, compared to $12.0 million in the same period in 2023.
The difference is largely attributable to a non-cash charge to
other expense during the second quarter related to the Renalys
Pharma collaboration entered into in 2024, and a decrease in
interest income.
As of December 31, 2024, the Company had cash,
cash equivalents, and marketable securities of $370.7 million. This
includes net proceeds of $134.7 million from a common stock
offering completed in November 2024.
Program Updates
FILSPARI®
(sparsentan) – IgAN
- On September 5, 2024, the U.S. Food
and Drug Administration (FDA) granted full approval to FILSPARI to
slow kidney function decline in adults with primary IgAN who are at
risk of disease progression.
- In the fourth quarter of 2024, the
Company received 693 new patient start forms (PSFs) driven by
growth amongst both new and repeat prescribers following full
approval.
- Fourth quarter 2024 net product
sales of FILSPARI totaled $49.6 million; full year 2024 net product
sales of FILSPARI totaled $132.2 million.
- The FDA assigned a PDUFA target
action date of August 28, 2025, to the Company’s supplemental New
Drug Application (sNDA) requesting modification of liver monitoring
for FILSPARI in IgAN.
- In 2025, the Company anticipates
final publication of the updated Kidney Disease Improving Global
Outcomes (KDIGO) clinical guidelines for IgAN. The draft guidelines
published in August 2024 recommended FILSPARI as a foundational
kidney-targeted therapy and lowered the targeted proteinuria level
for all IgAN patients to under 0.5 g/day or ideally complete
remission (under 0.3 g/day).
- In 2025, the Company expects the
ongoing SPARTAN Study to be expanded to include post-kidney
transplant patients with recurring IgAN and has plans to initiate a
new open label study of FILSPARI in post kidney-transplant patients
with recurrent IgAN or FSGS.
- In 2025, the Company anticipates
presenting additional data from its ongoing clinical studies to
further support FILSPARI as foundational therapy in treating
patients with IgAN.
- The Company’s collaborator, CSL
Vifor, has launched FILSPARI for the treatment of IgAN in Germany,
Austria and Switzerland.
- In 2025, the Company and CSL Vifor
anticipate the current conditional marketing authorization (CMA)
for FILSPARI for the treatment of IgAN in Europe will be converted
to full approval. The Company expects to receive a $17.5 million
milestone payment from CSL Vifor upon conversion of the CMA to full
approval, and the Company remains eligible to receive additional
milestone payments related to market access and sales-based
achievements.
- The Company’s partner, Renalys
Pharma, Inc., recently completed enrollment in its registrational
Phase 3 clinical trial of sparsentan for the treatment of IgAN in
Japan and expects topline results in the second half of 2025.
FILSPARI®
(sparsentan) – FSGS
- Following its Type C meeting with
the FDA, the Company is on track to submit an sNDA for an FSGS
indication around the end of the first quarter of 2025.
- The sNDA submission will be based
on the results from Phase 3 DUPLEX and Phase 2 DUET studies of
FILSPARI in FSGS, two of the largest interventional clinical trials
conducted in FSGS to-date.
- If approved, FILSPARI would be the
first and only approved medicine indicated for FSGS, a rare kidney
disorder and a leading cause of kidney failure.
Pegtibatinase (TVT-058) – Classical
HCU
- The Company is continuing to make
progress on the necessary process improvements in manufacturing
scale-up and is on track to restart enrollment in the Phase 3
HARMONY Study in 2026.
Conference Call Information
Travere Therapeutics will host a conference call
and webcast today, February 20, 2025, at 4:30 p.m. ET to discuss
company updates as well as fourth quarter and full year 2024
financial results. To participate in the conference call, dial +1
(800) 549-8228 (U.S.) or +1 (646) 564-2877 (International),
conference ID 25215 shortly before 4:30 p.m. ET. The webcast can be
accessed on the Investor page of Travere’s website at
ir.travere.com/events-presentations. Following the live webcast, an
archived version of the call will be available for 30 days on the
Company’s website.
Use of Non-GAAP Financial
Measures
To supplement Travere’s financial results and
guidance presented in accordance with U.S. generally accepted
accounting principles (GAAP), the Company uses certain non-GAAP
adjusted financial measures in this press release and the
accompanying tables. The Company believes that these non-GAAP
financial measures are helpful in understanding its past financial
performance and potential future results. They are not meant to be
considered in isolation or as a substitute for comparable GAAP
measures and should be read in conjunction with the consolidated
financial statements prepared in accordance with GAAP. Travere’s
management regularly uses these supplemental non-GAAP financial
measures internally to understand, manage and evaluate its business
and make operating decisions. In addition, Travere believes that
the use of these non-GAAP measures enhances the ability of
investors to compare its results from period to period and allows
for greater transparency with respect to key financial metrics the
Company uses in making operating decisions.
Investors should note that these non-GAAP
financial measures are not prepared under any comprehensive set of
accounting rules or principles and do not reflect all of the
amounts associated with the Company’s results of operations as
determined in accordance with GAAP. Investors should also note that
these non-GAAP financial measures have no standardized meaning
prescribed by GAAP and, therefore, have limits in their usefulness
to investors. In addition, from time to time in the future the
Company may exclude other items, or cease to exclude items that it
has historically excluded, for purposes of its non-GAAP financial
measures; because of the non-standardized definitions, the non-GAAP
financial measures as used by the Company in this press release and
the accompanying tables may be calculated differently from, and
therefore may not be directly comparable to, similarly titled
measures used by the Company’s competitors and other companies.
As used in this press release, (i) the
historical non-GAAP net loss measures exclude from GAAP net loss,
as applicable, stock-based compensation expense, amortization and
depreciation expense, and income tax; (ii) the historical non-GAAP
SG&A expense measures exclude from GAAP SG&A expenses, as
applicable, stock-based compensation expense, and amortization and
depreciation expense; (iii) the historical non-GAAP R&D expense
measures exclude from GAAP R&D expenses, as applicable,
stock-based compensation expense, and amortization and depreciation
expense.
About Travere
Therapeutics
At Travere Therapeutics, we are in rare for
life. We are a biopharmaceutical company that comes together every
day to help patients, families and caregivers of all backgrounds as
they navigate life with a rare disease. On this path, we know the
need for treatment options is urgent – that is why our global team
works with the rare disease community to identify, develop and
deliver life-changing therapies. In pursuit of this mission, we
continuously seek to understand the diverse perspectives of rare
patients and to courageously forge new paths to make a difference
in their lives and provide hope – today and tomorrow. For more
information, visit travere.com.
FILSPARI®
(sparsentan) U.S. Indication
FILSPARI (sparsentan) is indicated to slow
kidney function decline in adults with primary immunoglobulin A
nephropathy (IgAN) who are at risk for disease progression.
IMPORTANT SAFETY
INFORMATION
BOXED WARNING: HEPATOTOXICITY AND
EMBRYO-FETAL TOXICITY
Because of the risks of hepatotoxicity
and birth defects, FILSPARI is available only through a restricted
program called the FILSPARI REMS. Under the FILSPARI REMS,
prescribers, patients and pharmacies must enroll in the
program.
Hepatotoxicity
Some Endothelin Receptor Antagonists
(ERAs) have caused elevations of aminotransferases, hepatotoxicity,
and liver failure. In clinical studies, elevations in
aminotransferases (ALT or AST) of at least 3-times the Upper Limit
of Normal (ULN) have been observed in up to 3.5% of
FILSPARI-treated patients, including cases confirmed with
rechallenge.
Measure transaminases and bilirubin
before initiating treatment and monthly for the first 12 months,
and then every 3 months during treatment. Interrupt treatment and
closely monitor patients who develop aminotransferase elevations
more than 3x ULN.
FILSPARI should generally be avoided in
patients with elevated aminotransferases (>3x ULN) at baseline
because monitoring for hepatotoxicity may be more difficult and
these patients may be at increased risk for serious
hepatotoxicity.
Embryo-Fetal Toxicity
FILSPARI can cause major birth defects
if used by pregnant patients based on animal data. Therefore,
pregnancy testing is required before the initiation of treatment,
during treatment and one month after discontinuation of treatment
with FILSPARI. Patients who can become pregnant must use effective
contraception before the initiation of treatment, during treatment,
and for one month after discontinuation of treatment with
FILSPARI.
Contraindications
FILSPARI is contraindicated in patients who are
pregnant. Do not coadminister FILSPARI with angiotensin receptor
blockers (ARBs), ERAs, or aliskiren.
Warnings and Precautions
-
Hepatotoxicity: Elevations in ALT or AST of
at least 3-fold ULN have been observed in up to 3.5% of
FILSPARI-treated patients, including cases confirmed with
rechallenge. While no concurrent elevations in bilirubin
>2-times ULN or cases of liver failure were observed in
FILSPARI-treated patients, some ERAs have caused elevations of
aminotransferases, hepatotoxicity, and liver failure. To reduce the
risk of potential serious hepatotoxicity, measure serum
aminotransferase levels and total bilirubin prior to initiation of
treatment and monthly for the first 12 months, then
every 3 months during treatment.
Advise patients with symptoms suggesting
hepatotoxicity (nausea, vomiting, right upper quadrant pain,
fatigue, anorexia, jaundice, dark urine, fever, or itching) to
immediately stop treatment with FILSPARI and seek medical
attention. If aminotransferase levels are abnormal at any time
during treatment, interrupt FILSPARI and monitor as
recommended.
Consider re-initiation of FILSPARI only when
hepatic enzyme levels and bilirubin return to pretreatment values
and only in patients who have not experienced clinical symptoms of
hepatotoxicity. Avoid initiation of FILSPARI in patients with
elevated aminotransferases (>3x ULN) prior to drug initiation
because monitoring hepatotoxicity in these patients may be more
difficult and these patients may be at increased risk for serious
hepatotoxicity.
- Embryo-Fetal
Toxicity: FILSPARI can cause fetal harm when
administered to a pregnant patient and is contraindicated during
pregnancy. Advise patients who can become pregnant of the potential
risk to a fetus. Obtain a pregnancy test prior to initiation of
treatment with FILSPARI, monthly during treatment, and one month
after discontinuation of treatment. Advise patients who can become
pregnant to use effective contraception prior to initiation of
treatment, during treatment, and for one month after
discontinuation of treatment with FILSPARI.
- FILSPARI
REMS: Due to the risk of hepatotoxicity and
embryo-fetal toxicity, FILSPARI is available only through a
restricted program called the FILSPARI REMS. Prescribers, patients,
and pharmacies must be enrolled in the REMS program and comply with
all requirements (www.filsparirems.com).
-
Hypotension: Hypotension has been observed in
patients treated with ARBs and ERAs. There was a greater incidence
of hypotension-associated adverse events, some serious, including
dizziness, in patients treated with FILSPARI compared to
irbesartan. In patients at risk for hypotension, consider
eliminating or adjusting other antihypertensive medications and
maintaining appropriate volume status. If hypotension develops,
despite elimination or reduction of other antihypertensive
medications, consider a dose reduction or dose interruption of
FILSPARI. A transient hypotensive response is not a
contraindication to further dosing of FILSPARI, which can be given
once blood pressure has stabilized.
- Acute Kidney
Injury: Monitor kidney function periodically. Drugs
that inhibit the renin-angiotensin system (RAS) can cause kidney
injury. Patients whose kidney function may depend in part on the
activity of the RAS (e.g., patients with renal artery stenosis,
chronic kidney disease, severe congestive heart failure, or volume
depletion) may be at particular risk of developing acute kidney
injury on FILSPARI. Consider withholding or discontinuing therapy
in patients who develop a clinically significant decrease in kidney
function while on FILSPARI.
-
Hyperkalemia: Monitor serum potassium
periodically and treat appropriately. Patients with advanced kidney
disease, taking concomitant potassium-increasing drugs (e.g.,
potassium supplements, potassium-sparing diuretics), or using
potassium-containing salt substitutes are at increased risk for
developing hyperkalemia. Dosage reduction or discontinuation of
FILSPARI may be required.
- Fluid
Retention: Fluid retention may occur with ERAs, and
has been observed in clinical studies with FILSPARI. FILSPARI has
not been evaluated in patients with heart failure. If clinically
significant fluid retention develops, evaluate the patient to
determine the cause and the potential need to initiate or modify
the dose of diuretic treatment then consider modifying the dose of
FILSPARI.
Most common adverse reactions
The most common adverse reactions (≥5%) are
hyperkalemia, hypotension (including orthostatic hypotension),
peripheral edema, dizziness, anemia, and acute kidney injury.
Drug interactions
- Renin-Angiotensin System
(RAS) Inhibitors and ERAs: Do not coadminister
FILSPARI with ARBs, ERAs, or aliskiren due to increased risks of
hypotension, syncope, hyperkalemia, and changes in renal function
(including acute renal failure).
- Strong and Moderate CYP3A
Inhibitors: Avoid concomitant use of FILSPARI with
strong CYP3A inhibitors. If a strong CYP3A inhibitor cannot be
avoided, interrupt FILSPARI treatment. When resuming treatment with
FILSPARI, consider dose titration. Monitor blood pressure, serum
potassium, edema, and kidney function regularly when used
concomitantly with moderate CYP3A inhibitors. Concomitant use with
a strong CYP3A inhibitor increases sparsentan exposure which may
increase the risk of FILSPARI adverse reactions.
- Strong CYP3A
Inducers: Avoid concomitant use with a strong CYP3A
inducer. Concomitant use with a strong CYP3A inducer decreases
sparsentan exposure which may reduce FILSPARI efficacy.
- Antacids and Acid Reducing
Agents: Administer FILSPARI 2 hours before or after
administration of antacids. Avoid concomitant use of acid reducing
agents (histamine H2 receptor antagonist and PPI proton pump
inhibitor) with FILSPARI. Sparsentan exhibits pH-dependent
solubility. Antacids or acid reducing agents may decrease
sparsentan exposure which may reduce FILSPARI efficacy.
- Non-Steroidal
Anti-Inflammatory Agents (NSAIDs), Including Selective
Cyclooxygenase-2 (COX-2) Inhibitors: Monitor for
signs of worsening renal function with concomitant use with NSAIDs
(including selective COX-2 inhibitors). In patients with volume
depletion (including those on diuretic therapy) or with impaired
kidney function, concomitant use of NSAIDs (including selective
COX-2 inhibitors) with drugs that antagonize the angiotensin II
receptor may result in deterioration of kidney function, including
possible kidney failure.
- CYP2B6, 2C9, and 2C19
Substrates: Monitor for efficacy of concurrently
administered CYP2B6, 2C9, and 2C19 substrates and consider dosage
adjustment in accordance with the Prescribing Information.
Sparsentan decreases exposure of these substrates, which may reduce
efficacy related to these substrates.
- P-gp and BCRP
Substrates: Avoid concomitant use of sensitive
substrates of P-gp and BCRP with FILSPARI. Sparsentan may increase
exposure of these transporter substrates, which may increase the
risk of adverse reactions related to these substrates.
- Agents Increasing Serum
Potassium: Monitor serum potassium frequently in
patients treated with FILSPARI and other agents that increase serum
potassium. Concomitant use of FILSPARI with potassium-sparing
diuretics, potassium supplements, potassium-containing salt
substitutes, or other drugs that raise serum potassium levels may
result in hyperkalemia.
Please see the
full Prescribing
Information, including BOXED WARNING, for
additional Important Safety Information.
Forward-Looking Statements
This press release contains “forward-looking
statements” as that term is defined in the Private Securities
Litigation Reform Act of 1995. Without limiting the foregoing,
these statements are often identified by the words “on-track,”
“positioned,” “look forward to,” “will,” “would,” “may,” “might,”
“believes,” “anticipates,” “plans,” “expects,” “intends,”
“potential,” or similar expressions. In addition, expressions of
strategies, intentions or plans are also forward-looking
statements. Such forward-looking statements include, but are not
limited to, references to: continued progress with the FILSPARI
launch in IgAN; plans and expectations regarding the submission of
an sNDA for FILSPARI in FSGS, expectations regarding the timing and
outcome thereof, and statements regarding preparations for a
successful launch in FSGS, if approved; statements regarding the
potential for FILSPARI to be the first and only approved medicine
indicated for FSGS; statements regarding FILSPARI’s potential to
replace the historical standard of care in IgAN as a new
foundational therapy and to reach more patients at risk of IgAN
progression; statements regarding manufacturing for pegtibatinase
and the Company’s ability to restart enrollment in the Phase 3
HARMONY Study in 2026; statements regarding the Company’s sNDA
requesting modification of liver monitoring for FILSPARI in IgAN
and expectations regarding the timing and outcome thereof;
expectations regarding the conversion of the current conditional
marketing authorization (CMA) for FILSPARI for the treatment of
IgAN in Europe to full approval; expectations regarding milestone
payments and the potential achievement and timing thereof;
expectations regarding the SPARTAN Study and the other studies
described herein; expectations regarding Renalys Pharma’s
registrational Phase 3 clinical trial of sparsentan for the
treatment of IgAN in Japan; expectations regarding the KDIGO
guidelines; and statements regarding financial metrics and
expectations related thereto. Such forward-looking statements are
based on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change
any of them, and could cause actual outcomes and results to differ
materially from current expectations. No forward-looking statement
can be guaranteed. Among the factors that could cause actual
results to differ materially from those indicated in the
forward-looking statements are risks and uncertainties related to
the Company’s planned submission of an sNDA for FILSPARI in FSGS,
including the timing and outcome thereof. There is no guarantee
that the FDA will accept the sNDA for filing, grant priority review
of the sNDA or grant approval of FILSPARI for FSGS. The Company
also faces risks related to its business and finances in general,
the success of its commercial products, risks and uncertainties
associated with its preclinical and clinical stage pipeline, risks
and uncertainties associated with the regulatory review and
approval process, risks and uncertainties associated with
enrollment of clinical trials for rare diseases, and risks that
ongoing or planned clinical trials may not succeed or may be
delayed for safety, regulatory or other reasons. Specifically, the
Company faces risks associated with the ongoing commercial launch
of FILSPARI in IgAN, the timing and potential outcome of its and
its partners’ clinical studies, market acceptance of its commercial
products including efficacy, safety, price, reimbursement, and
benefit over competing therapies, risks related to the challenges
of manufacturing scale-up, risks associated with the successful
development and execution of commercial strategies for such
products, including FILSPARI, and risks and uncertainties related
to the new administration and matters related to the funding and
staffing of government agencies including the FDA. The Company also
faces the risk that it will be unable to raise additional funding
that may be required to complete development of any or all of its
product candidates, including as a result of macroeconomic
conditions; risks relating to the Company’s dependence on
contractors for clinical drug supply and commercial manufacturing;
uncertainties relating to patent protection and exclusivity periods
and intellectual property rights of third parties; risks associated
with regulatory interactions; and risks and uncertainties relating
to competitive products, including current and potential future
generic competition with certain of the Company’s products, and
technological changes that may limit demand for the Company’s
products. The Company also faces additional risks associated with
global and macroeconomic conditions, including health epidemics and
pandemics, including risks related to potential disruptions to
clinical trials, commercialization activity, supply chain, and
manufacturing operations. You are cautioned not to place undue
reliance on these forward-looking statements as there are important
factors that could cause actual results to differ materially from
those in forward-looking statements, many of which are beyond our
control. The Company undertakes no obligation to publicly update
any forward-looking statement, whether as a result of new
information, future events, or otherwise. Investors are referred to
the full discussion of risks and uncertainties, including under the
heading “Risk Factors”, as included in the Company’s most recent
Form 10-K, Form 10-Q and other filings with the Securities and
Exchange Commission.
|
TRAVERE THERAPEUTICS, INC. AND SUBSIDIARIES |
CONSOLIDATED BALANCE SHEETS |
(in thousands, except share amounts) |
|
|
|
|
|
|
|
December 31, 2024 |
|
December 31, 2023 |
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
58,535 |
|
|
$ |
58,176 |
|
Marketable debt securities, at fair value |
|
|
312,166 |
|
|
|
508,675 |
|
Accounts receivable, net |
|
|
27,116 |
|
|
|
21,179 |
|
Inventory |
|
|
6,200 |
|
|
|
9,410 |
|
Prepaid expenses and other current assets |
|
|
12,685 |
|
|
|
19,335 |
|
Total current assets |
|
|
416,702 |
|
|
|
616,775 |
|
Long-term inventory |
|
|
35,656 |
|
|
|
31,494 |
|
Property and equipment,
net |
|
|
5,336 |
|
|
|
7,479 |
|
Operating lease right-of-use
assets |
|
|
14,295 |
|
|
|
18,061 |
|
Intangible assets, net |
|
|
103,974 |
|
|
|
104,443 |
|
Other assets |
|
|
18,162 |
|
|
|
10,661 |
|
Total assets |
|
$ |
594,125 |
|
|
$ |
788,913 |
|
Liabilities and
Stockholders' Equity |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
23,534 |
|
|
$ |
41,675 |
|
Accrued expenses |
|
|
86,028 |
|
|
|
118,991 |
|
Convertible debt, current portion |
|
|
68,678 |
|
|
|
— |
|
Deferred revenue, current portion |
|
|
2,815 |
|
|
|
7,096 |
|
Operating lease liabilities, current portion |
|
|
5,405 |
|
|
|
4,909 |
|
Other current liabilities |
|
|
14,291 |
|
|
|
5,237 |
|
Total current liabilities |
|
|
200,751 |
|
|
|
177,908 |
|
Convertible debt, less current portion |
|
|
310,310 |
|
|
|
377,263 |
|
Operating lease liabilities, less current portion |
|
|
17,191 |
|
|
|
22,612 |
|
Other non-current liabilities |
|
|
6,796 |
|
|
|
10,320 |
|
Total liabilities |
|
|
535,048 |
|
|
|
588,103 |
|
|
|
|
|
|
Stockholders'
Equity: |
|
|
|
|
Preferred stock $0.0001 par value; 20,000,000 shares authorized; no
shares issued and outstanding as of December 31, 2024 and 2023 |
|
|
— |
|
|
|
— |
|
Common stock $0.0001 par value; 200,000,000 and 200,000,000 shares
authorized; 87,452,835 and 75,367,117 issued and outstanding as of
December 31, 2024 and 2023, respectively |
|
|
9 |
|
|
|
7 |
|
Additional paid-in capital |
|
|
1,506,315 |
|
|
|
1,327,881 |
|
Accumulated deficit |
|
|
(1,447,167 |
) |
|
|
(1,125,622 |
) |
Accumulated other comprehensive loss |
|
|
(80 |
) |
|
|
(1,456 |
) |
Total stockholders' equity |
|
|
59,077 |
|
|
|
200,810 |
|
Total liabilities and stockholders' equity |
|
$ |
594,125 |
|
|
$ |
788,913 |
|
Note: Certain adjustments / reclassifications have been
made to prior periods to conform to current year
presentation. |
TRAVERE THERAPEUTICS, INC. AND SUBSIDIARIES |
CONSOLIDATED STATEMENT OF OPERATIONS |
(in thousands, except share and per share
data) |
|
|
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
(unaudited) |
|
|
|
|
Net product sales: |
|
|
|
|
|
|
|
|
FILSPARI |
|
$ |
49,644 |
|
|
$ |
14,699 |
|
|
$ |
132,222 |
|
|
$ |
29,208 |
|
Tiopronin products |
|
|
23,902 |
|
|
|
25,217 |
|
|
|
94,485 |
|
|
|
98,329 |
|
Total net product sales |
|
|
73,546 |
|
|
|
39,916 |
|
|
|
226,707 |
|
|
|
127,537 |
|
License and collaboration
revenue |
|
|
1,241 |
|
|
|
5,143 |
|
|
|
6,468 |
|
|
|
17,701 |
|
Total revenue |
|
|
74,787 |
|
|
|
45,059 |
|
|
|
233,175 |
|
|
|
145,238 |
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
2,553 |
|
|
|
4,564 |
|
|
|
7,744 |
|
|
|
11,450 |
|
Research and development |
|
|
62,067 |
|
|
|
59,746 |
|
|
|
217,496 |
|
|
|
244,990 |
|
Selling, general and administrative |
|
|
69,501 |
|
|
|
63,588 |
|
|
|
264,119 |
|
|
|
265,542 |
|
In-process research and development |
|
|
— |
|
|
|
— |
|
|
|
65,205 |
|
|
|
— |
|
Restructuring |
|
|
1,403 |
|
|
|
11,394 |
|
|
|
2,438 |
|
|
|
11,394 |
|
Total operating expenses |
|
|
135,524 |
|
|
|
139,292 |
|
|
|
557,002 |
|
|
|
533,376 |
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(60,737 |
) |
|
|
(94,233 |
) |
|
|
(323,827 |
) |
|
|
(388,138 |
) |
|
|
|
|
|
|
|
|
|
Other income (expense),
net: |
|
|
|
|
|
|
|
|
Interest income |
|
|
3,795 |
|
|
|
7,152 |
|
|
|
17,817 |
|
|
|
21,768 |
|
Interest expense |
|
|
(2,817 |
) |
|
|
(2,821 |
) |
|
|
(11,182 |
) |
|
|
(11,334 |
) |
Other (expense) income, net |
|
|
(581 |
) |
|
|
1,374 |
|
|
|
(3,318 |
) |
|
|
1,594 |
|
Total other income, net |
|
|
397 |
|
|
|
5,705 |
|
|
|
3,317 |
|
|
|
12,028 |
|
|
|
|
|
|
|
|
|
|
Loss from continuing
operations before income tax provision |
|
|
(60,340 |
) |
|
|
(88,528 |
) |
|
|
(320,510 |
) |
|
|
(376,110 |
) |
Income tax benefit (provision)
on continuing operations |
|
|
72 |
|
|
|
(68 |
) |
|
|
(120 |
) |
|
|
(223 |
) |
|
|
|
|
|
|
|
|
|
Loss from continuing
operations, net of tax |
|
|
(60,268 |
) |
|
|
(88,596 |
) |
|
|
(320,630 |
) |
|
|
(376,333 |
) |
Income (loss) from
discontinued operations, net of tax |
|
|
4 |
|
|
|
(1,577 |
) |
|
|
(915 |
) |
|
|
264,934 |
|
Net loss |
|
$ |
(60,264 |
) |
|
$ |
(90,173 |
) |
|
$ |
(321,545 |
) |
|
$ |
(111,399 |
) |
|
|
|
|
|
|
|
|
|
Per share
data |
|
|
|
|
|
|
|
|
Basic and diluted: |
|
|
|
|
|
|
|
|
Net loss per common share |
|
$ |
(0.73 |
) |
|
$ |
(1.18 |
) |
|
$ |
(4.08 |
) |
|
$ |
(1.50 |
) |
Weighted average common shares outstanding |
|
|
83,105,184 |
|
|
|
76,474,560 |
|
|
|
78,888,861 |
|
|
|
74,267,418 |
|
Note: Certain adjustments / reclassifications have been
made to prior periods to conform to current year
presentation. |
TRAVERE THERAPEUTICS, INC. AND SUBSIDIARIES |
RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED
INFORMATION |
(in thousands, except share and per share
data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
GAAP operating
loss |
|
$ |
(60,737 |
) |
|
$ |
(94,233 |
) |
|
$ |
(323,827 |
) |
|
$ |
(388,138 |
) |
|
|
|
|
|
|
|
|
|
R&D operating expense |
|
|
(62,067 |
) |
|
|
(59,746 |
) |
|
|
(217,496 |
) |
|
|
(244,990 |
) |
|
|
|
|
|
|
|
|
|
Stock compensation |
|
|
3,426 |
|
|
|
3,426 |
|
|
|
14,178 |
|
|
|
17,284 |
|
Amortization &
depreciation |
|
|
— |
|
|
|
997 |
|
|
|
— |
|
|
|
7,261 |
|
Subtotal non-GAAP items |
|
|
3,426 |
|
|
|
4,423 |
|
|
|
14,178 |
|
|
|
24,545 |
|
Non-GAAP R&D expense |
|
|
(58,641 |
) |
|
|
(55,323 |
) |
|
|
(203,318 |
) |
|
|
(220,445 |
) |
|
|
|
|
|
|
|
|
|
SG&A operating
expense |
|
|
(69,501 |
) |
|
|
(63,588 |
) |
|
|
(264,119 |
) |
|
|
(265,542 |
) |
|
|
|
|
|
|
|
|
|
Stock compensation |
|
|
5,789 |
|
|
|
3,070 |
|
|
|
22,735 |
|
|
|
28,389 |
|
Amortization &
depreciation |
|
|
12,093 |
|
|
|
10,855 |
|
|
|
43,555 |
|
|
|
37,671 |
|
Subtotal non-GAAP items |
|
|
17,882 |
|
|
|
13,925 |
|
|
|
66,290 |
|
|
|
66,060 |
|
Non-GAAP SG&A expense |
|
|
(51,619 |
) |
|
|
(49,663 |
) |
|
|
(197,829 |
) |
|
|
(199,482 |
) |
|
|
|
|
|
|
|
|
|
Subtotal non-GAAP items |
|
|
21,308 |
|
|
|
18,348 |
|
|
|
80,468 |
|
|
|
90,605 |
|
Non-GAAP operating
loss |
|
$ |
(39,429 |
) |
|
$ |
(75,885 |
) |
|
$ |
(243,359 |
) |
|
$ |
(297,533 |
) |
|
|
|
|
|
|
|
|
|
GAAP net
loss |
|
$ |
(60,264 |
) |
|
$ |
(90,173 |
) |
|
$ |
(321,545 |
) |
|
$ |
(111,399 |
) |
Non-GAAP operating loss adjustments |
|
|
21,308 |
|
|
|
18,348 |
|
|
|
80,468 |
|
|
|
90,605 |
|
Income tax (benefit) provision |
|
|
(72 |
) |
|
|
68 |
|
|
|
120 |
|
|
|
223 |
|
Non-GAAP net
loss(1) |
|
$ |
(39,028 |
) |
|
$ |
(71,757 |
) |
|
$ |
(240,957 |
) |
|
$ |
(20,571 |
) |
|
|
|
|
|
|
|
|
|
Per share
data |
|
|
|
|
|
|
|
|
Basic and diluted: |
|
|
|
|
|
|
|
|
Non-GAAP net loss per common
share |
|
$ |
(0.47 |
) |
|
$ |
(0.94 |
) |
|
$ |
(3.05 |
) |
|
$ |
(0.28 |
) |
Weighted average common shares
outstanding |
|
|
83,105,184 |
|
|
|
76,474,560 |
|
|
|
78,888,861 |
|
|
|
74,267,418 |
|
(1) Non-GAAP net loss includes income from discontinued
operations but excludes non-GAAP adjustments for the effect of
discontinued operations. |
Note: Certain adjustments / reclassifications have been
made to prior periods to conform to current year
presentation. |
Contact:Investors:888-969-7879ir@travere.com |
Media:888-969-7879mediarelations@travere.com |
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