Travere Therapeutics, Inc. (NASDAQ: TVTX) today reported its second
quarter 2024 financial results and provided a corporate update.
“The second quarter represents our most
successful quarter to date for the FILSPARI launch in the U.S. We
again achieved new highs in patient start forms and revenue driven
by more nephrologists upgrading the standard of care to FILSPARI
for their patients. This strong performance is particularly timely
as we finalize our preparations to be ready for full approval in
IgAN with the upcoming PDUFA target action date next month,” said
Eric Dube, Ph.D., president and chief executive officer of Travere
Therapeutics. “Additionally, we are continuing to make progress in
bringing FILSPARI to patients globally. Our partner CSL Vifor
remains on track to initiate the launch of FILSPARI in Europe
shortly, and Renalys Pharma recently dosed the first patient in
their registrational trial to support regulatory submissions in
Japan. We also continue our work to identify a potential regulatory
pathway for sparsentan in FSGS, and we are advancing the Phase 3
program for pegtibatinase with the goal of delivering the first
disease modifying therapy for classical homocystinuria.”
Financial Results for Continuing
Operations for the Quarter Ended June 30, 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 second quarter of 2024
were $52.2 million, compared to $29.5 million for the same period
in 2023. The change is primarily attributable to increased sales
from the ongoing commercial launch of FILSPARI.
Research and development (R&D) expenses for
the second quarter of 2024 were $54.3 million, compared to $66.5
million for the same period in 2023. For the six months ended June
30, 2024, R&D expenses were $103.8 million, compared to $124.7
million for the same period in 2023. The decrease is largely
attributable to our previously announced restructuring initiatives
and a decline in costs associated with the development of
sparsentan as our Phase 3 programs advance towards completion. On a
non-GAAP adjusted basis, R&D expenses were $50.6 million for
the second quarter of 2024, compared to $59.5 million for the same
period in 2023.
Selling, general, and administrative (SG&A)
expenses for the second quarter of 2024 were $64.8 million,
compared to $68.2 million for the same period in 2023. For the six
months ended June 30, 2024, SG&A expenses were $129.0 million,
compared to $134.2 million for the same period in 2023. The
decrease is primarily driven by our restructuring and other cost
saving initiatives. On a non-GAAP adjusted basis, SG&A expenses
were $48.3 million for the second quarter of 2024, compared to
$49.7 million for the same period in 2023.
Total other expense, net, for the second quarter
of 2024 was $1.9 million, compared to total other income, net, of
$2.1 million for the same period in 2023. The difference is
primarily attributable to a non-cash charge to other expense during
the second quarter related to the Renalys Pharma collaboration
announced earlier in 2024.
Net loss including discontinued operations for
the second quarter of 2024 was $70.4 million, or $0.91 per basic
share, compared to a net loss of $85.6 million, or $1.13 per basic
share for the same period in 2023. For the six months ended June
30, 2024, net loss including discontinued operations was $206.5
million, compared to $172.0 million for the same period in 2023. On
a non-GAAP adjusted basis, net loss including discontinued
operations for the second quarter of 2024 was $50.1 million, or
$0.65 per basic share, compared to a net loss of $60.1 million, or
$0.79 per basic share for the same period in 2023.
As of June 30, 2024, the Company had cash, cash
equivalents, and marketable securities of $325.4 million.
Program Updates
FILSPARI®
(sparsentan) – IgAN
- On February 17, 2023, the U.S. Food and Drug Administration
(FDA) granted accelerated approval to FILSPARI to reduce
proteinuria in adults with primary IgAN at risk of rapid disease
progression, generally a urine protein-to-creatinine ratio (UPCR)
≥1.5 g/g. FILSPARI became commercially available the week of
February 27, 2023. Commercial progress in the ongoing launch has
resulted in:
- 521 new patient start forms (PSFs) received in the second
quarter of 2024; a total of 2,484 PSFs have been received since the
accelerated approval of FILSPARI.
- Net product sales of $27.1 million during the second quarter,
totaling $76.2 million in net product sales since the beginning of
the launch.
- In May 2024 the FDA granted Priority Review of the Company’s
supplemental New Drug Application (sNDA) to convert FILSPARI from
accelerated approval to full approval for the treatment of IgAN in
the U.S. The FDA assigned a PDUFA target action date of September
5, 2024.
- In the second quarter, the European Commission granted
conditional marketing authorization (CMA) to FILSPARI for the
treatment of adults with primary IgAN with a urine protein
excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75
g/g). The CMA is granted for all member states of the European
Union, as well as in Iceland, Liechtenstein and Norway. The first
launch of FILSPARI in Europe by its commercial partner, CSL Vifor,
is expected soon. The Company expects to receive a $17.5 million
milestone payment from CSL Vifor upon conversion of the CMA to full
approval, as well as an additional milestone payment in 2025 upon
achievement of market access milestones in certain countries.
- In July 2024, the Company’s partner Renalys Pharma announced
the first patient was dosed in its registrational Phase 3 clinical
trial of sparsentan for the treatment of IgAN in Japan. Topline
results are expected in the second half of 2025 to support a
submission for approval to Japanese regulators.
- At the National Kidney Foundation (NKF) Spring Clinical
Meetings and the 61st European Renal Association (ERA) Congress in
the second quarter, the Company presented abstracts including data
demonstrating:
- Treatment with FILSPARI resulted in a slower rate of kidney
function decline compared to irbesartan, despite irbesartan being
associated with a slower rate of kidney function decline than real
world standard of care treatment in the RaDaR or NefIgArd studies
in IgAN
- Patients with IgAN treated with FILSPARI over two years had one
of the slowest annual rates of kidney function decline seen in
Phase 3 clinical trials in IgAN
- FILSPARI as a first-line treatment in patients newly diagnosed
with IgAN was effective in reducing proteinuria and controlling
blood pressure
- In 2024, the Company anticipates inclusion of FILSPARI into the
draft Kidney Disease Improving Global Outcomes (KDIGO) Clinical
Practice Guideline for the Management of Glomerular Diseases.
FILSPARI®
(sparsentan) – FSGS
- In 2024, the
Company is conducting additional analyses of FSGS data with plans
to engage with regulators to evaluate potential regulatory pathways
for a sparsentan FSGS indication.
Pegtibatinase (TVT-058) – Classical
HCU
- In December 2023, the Company initiated the pivotal Phase 3
HARMONY Study to support the potential approval of pegtibatinase
for the treatment of HCU. The HARMONY Study is a global,
randomized, multi-center, double-blind, placebo-controlled Phase 3
clinical trial designed to evaluate the efficacy and safety of
pegtibatinase as a novel treatment to reduce total homocysteine
(tHcy) levels. In the beginning of 2024, the first patients were
dosed in the HARMONY Study and topline results are expected in
2026.
- During the second quarter of 2024, the Company initiated the
ENSEMBLE Study, a Phase 3b, open-label, long-term extension, that
will evaluate the ongoing efficacy and long-term safety of
pegtibatinase in participants with HCU following their completion
of the Phase 1/2 COMPOSE Study or the HARMONY Study. ENSEMBLE
includes an optional protein tolerance modification sub-study that
will evaluate if eligible participants can increase their natural
dietary protein intake and maintain an acceptable level of
metabolic control while receiving pegtibatinase.
Conference Call Information
Travere Therapeutics will host a conference call
and webcast today, Thursday, August 1, 2024, at 4:30 p.m. ET to
discuss company updates as well as second quarter 2024 financial
results. To participate in the conference call, dial +1 (888)
256-1007 (U.S.) or +1 (323) 701-0225 (International), confirmation
code 3391866 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.
About FILSPARI (sparsentan)
FILSPARI (sparsentan) is a once-daily, oral
medication designed to selectively target two critical pathways in
the disease progression of IgAN (endothelin-1 and angiotensin II)
and is the first and only non-immunosuppressive therapy approved
for the treatment of this condition. FILSPARI is a prescription
medicine indicated to reduce proteinuria in adults with primary
IgAN at risk of rapid disease progression, generally a UPCR ≥1.5
g/g.
FILSPARI (sparsentan) U.S.
Indication
FILSPARI is an endothelin and angiotensin II
receptor antagonist indicated to reduce proteinuria in adults with
primary immunoglobulin A nephropathy (IgAN) at risk of rapid
disease progression, generally a UPCR ≥1.5 g/g.
This indication is granted under accelerated
approval based on reduction in proteinuria. It has not been
established whether FILSPARI slows kidney function decline in
patients with IgAN. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
a confirmatory clinical trial.
FILSPARI (sparsentan) 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 2.5% 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 Upper Limit of Normal (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), endothelin
receptor antagonists (ERAs), or aliskiren.
Warnings and Precautions
Hepatotoxicity:
Hepatotoxicity: Elevations in ALT or AST of at
least 3-fold ULN have been observed. To reduce the risk of
potential serious hepatotoxicity, measure serum aminotransferase
levels and total bilirubin prior to initiation of treatment,
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.
Embryo-Fetal Toxicity: FILSPARI
can cause fetal harm. Advise patients who can become pregnant of
the potential risk to a fetus. Obtain a pregnancy test and advise
patients who can become pregnant to use effective contraception
prior to, during, and one month after discontinuation of FILSPARI
treatment.
FILSPARI REMS: FILSPARI is
available only through a restricted program under a REMS called the
FILSPARI REMS.
Important requirements
include:
- Prescribers must be certified with the FILSPARI REMS by
enrolling and completing training.
- All patients must enroll in the FILSPARI REMS prior to
initiating treatment and comply with monitoring requirements.
- Pharmacies that dispense FILSPARI must be certified with the
FILSPARI REMS and must dispense only to patients who are authorized
to receive FILSPARI.
Further information is available at
www.filsparirems.com or 1-833-513-1325.
Please see Full Prescribing Information
for FILSPARI here.
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 our strategies, intentions or plans are
also forward-looking statements. Such forward-looking statements
include, but are not limited to, references to: statements
regarding the continuing commercial launch of FILSPARI and trends
related thereto; statements regarding the potential for FILSPARI to
receive full approval for the treatment of IgAN in the U.S. and the
anticipated timing thereof; statements that the Company is
well-positioned for the September 5, 2024 PDUFA target action date;
statements related to the anticipated launch of FILSPARI for the
treatment of IgAN in certain European markets and the anticipated
timing thereof; statements relating to clinical studies, including
but not limited to the anticipated timing for topline data for the
Phase 3 HARMONY Study and topline data from Renalys Pharma’s study
in Japanese patients with IgA nephropathy; statements regarding
plans to engage with the FDA on potential regulatory pathways for
sparsentan in FSGS and the anticipated timing and outcome thereof;
statements regarding the potential for pegtibatinase to become the
first disease modifying therapy for HCU; statements regarding
future milestone payments; and the potential inclusion of FILSPARI
into the KDIGO guidelines. 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 associated
with the regulatory review and approval process, as well as risks
and uncertainties associated with the Company’s business and
finances in general, the success of its commercial products and
risks and uncertainties associated with the Company’s preclinical
and clinical stage pipeline. Specifically, the Company faces risks
associated with the ongoing commercial launch of FILSPARI, market
acceptance of its commercial products including efficacy, safety,
price, reimbursement, and benefit over competing therapies, as well
as risks associated with the successful development and execution
of commercial strategies for such products, including FILSPARI. The
risks and uncertainties the Company faces with respect to its
preclinical and clinical stage pipeline include risk that the
Company’s clinical candidates will not be found to be safe or
effective and that current or anticipated future clinical trials
will not proceed as planned. Specifically, the Company faces risks
related to the timing and potential outcome of the studies
described herein, and the timing and potential outcome of the FDA’s
review of the Company’s sNDA submission for full approval of
FILSPARI in IgAN. There is no guarantee that regulators will grant
full approval of sparsentan for IgAN or FSGS. 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. |
CONSOLIDATED BALANCE SHEETS |
(in thousands, except share amounts) |
|
|
|
|
|
June 30, 2024 |
|
December 31, 2023 |
Assets |
(unaudited) |
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
32,291 |
|
|
$ |
58,176 |
|
Marketable debt securities, at fair value |
|
293,105 |
|
|
|
508,675 |
|
Accounts receivable, net |
|
24,466 |
|
|
|
21,179 |
|
Inventory |
|
5,976 |
|
|
|
9,410 |
|
Prepaid expenses and other current assets |
|
13,139 |
|
|
|
19,335 |
|
Total current
assets |
|
368,977 |
|
|
|
616,775 |
|
|
|
|
|
Long-term inventory |
|
37,004 |
|
|
|
31,494 |
|
Property and equipment,
net |
|
6,580 |
|
|
|
7,479 |
|
Operating lease right of use
assets |
|
16,467 |
|
|
|
18,061 |
|
Intangible assets, net |
|
105,174 |
|
|
|
104,443 |
|
Other assets |
|
16,919 |
|
|
|
10,661 |
|
Total
assets |
$ |
551,121 |
|
|
$ |
788,913 |
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
$ |
25,843 |
|
|
$ |
41,675 |
|
Accrued expenses |
|
79,641 |
|
|
|
118,991 |
|
Deferred revenue, current portion |
|
5,378 |
|
|
|
7,096 |
|
Operating lease liabilities, current portion |
|
5,163 |
|
|
|
4,909 |
|
Other current liabilities |
|
5,243 |
|
|
|
5,237 |
|
Total current
liabilities |
|
121,268 |
|
|
|
177,908 |
|
Convertible debt |
|
378,125 |
|
|
|
377,263 |
|
Deferred revenue, less current
portion |
|
— |
|
|
|
1,835 |
|
Operating lease liabilities,
less current portion |
|
19,938 |
|
|
|
22,612 |
|
Other non-current
liabilities |
|
16,643 |
|
|
|
8,485 |
|
Total
liabilities |
|
535,974 |
|
|
|
588,103 |
|
|
|
|
|
Stockholders'
Equity: |
|
|
|
Preferred stock $0.0001 par value; 20,000,000 shares authorized; 0
issued and outstanding as of June 30, 2024 and December 31,
2023 |
|
— |
|
|
|
— |
|
Common stock $0.0001 par
value; 200,000,000 shares authorized; 76,456,562, and 75,367,117
issued and outstanding as of June 30, 2024 and December 31, 2023,
respectively |
|
8 |
|
|
|
7 |
|
Additional paid-in capital |
|
1,348,865 |
|
|
|
1,327,881 |
|
Accumulated deficit |
|
(1,332,092 |
) |
|
|
(1,125,622 |
) |
Accumulated other comprehensive loss |
|
(1,634 |
) |
|
|
(1,456 |
) |
Total stockholders'
equity |
|
15,147 |
|
|
|
200,810 |
|
Total liabilities and
stockholders' equity |
$ |
551,121 |
|
|
$ |
788,913 |
|
Note: Certain adjustments / reclassifications have been
made to prior periods to conform to current year
presentation. |
|
|
|
|
|
|
|
|
TRAVERE THERAPEUTICS, INC. |
CONSOLIDATED STATEMENTS OF OPERATIONS |
(in thousands, except share and per share
data) |
(unaudited) |
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
|
(unaudited) |
|
|
|
|
Net product sales: |
|
|
|
|
|
|
|
Tiopronin products |
$ |
25,051 |
|
|
$ |
26,050 |
|
|
$ |
45,201 |
|
|
$ |
47,224 |
|
FILSPARI |
|
27,125 |
|
|
|
3,461 |
|
|
|
46,959 |
|
|
|
6,465 |
|
Total net product sales |
|
52,176 |
|
|
|
29,511 |
|
|
|
92,160 |
|
|
|
53,689 |
|
License and collaboration
revenue |
|
1,940 |
|
|
|
2,685 |
|
|
|
3,330 |
|
|
|
9,395 |
|
Total revenue |
|
54,116 |
|
|
|
32,196 |
|
|
|
95,490 |
|
|
|
63,084 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Cost of goods sold |
|
2,061 |
|
|
|
1,452 |
|
|
|
3,565 |
|
|
|
5,597 |
|
Research and development |
|
54,330 |
|
|
|
66,492 |
|
|
|
103,750 |
|
|
|
124,654 |
|
Selling, general and administrative |
|
64,776 |
|
|
|
68,203 |
|
|
|
128,999 |
|
|
|
134,153 |
|
In-process research and development |
|
— |
|
|
|
— |
|
|
|
65,205 |
|
|
|
— |
|
Restructuring |
|
653 |
|
|
|
— |
|
|
|
912 |
|
|
|
— |
|
Total operating expenses |
|
121,820 |
|
|
|
136,147 |
|
|
|
302,431 |
|
|
|
264,404 |
|
|
|
|
|
|
|
|
|
Operating loss |
|
(67,704 |
) |
|
|
(103,951 |
) |
|
|
(206,941 |
) |
|
|
(201,320 |
) |
|
|
|
|
|
|
|
|
Other (expense) income,
net: |
|
|
|
|
|
|
|
Interest income |
|
4,420 |
|
|
|
5,128 |
|
|
|
10,452 |
|
|
|
8,774 |
|
Interest expense |
|
(2,788 |
) |
|
|
(2,843 |
) |
|
|
(5,588 |
) |
|
|
(5,693 |
) |
Other (expense) income, net |
|
(3,495 |
) |
|
|
(201 |
) |
|
|
(3,257 |
) |
|
|
(114 |
) |
Total other (expense) income, net |
|
(1,863 |
) |
|
|
2,084 |
|
|
|
1,607 |
|
|
|
2,967 |
|
|
|
|
|
|
|
|
|
Loss from continuing
operations before income tax provision |
|
(69,567 |
) |
|
|
(101,867 |
) |
|
|
(205,334 |
) |
|
|
(198,353 |
) |
Income tax provision on
continuing operations |
|
(85 |
) |
|
|
(65 |
) |
|
|
(276 |
) |
|
|
(143 |
) |
|
|
|
|
|
|
|
|
Loss from continuing
operations, net of tax |
|
(69,652 |
) |
|
|
(101,932 |
) |
|
|
(205,610 |
) |
|
|
(198,496 |
) |
(Loss) income from
discontinued operations, net of tax |
|
(757 |
) |
|
|
16,302 |
|
|
|
(860 |
) |
|
|
26,535 |
|
Net loss |
$ |
(70,409 |
) |
|
$ |
(85,630 |
) |
|
$ |
(206,470 |
) |
|
$ |
(171,961 |
) |
|
|
|
|
|
|
|
|
Per share
data: |
|
|
|
|
|
|
|
Net loss per common share |
$ |
(0.91 |
) |
|
$ |
(1.13 |
) |
|
$ |
(2.67 |
) |
|
$ |
(2.38 |
) |
Weighted average common shares outstanding |
|
77,500,245 |
|
|
|
76,001,801 |
|
|
|
77,318,369 |
|
|
|
72,109,573 |
|
Note: Certain adjustments / reclassifications have been
made to prior periods to conform to current year
presentation. |
|
TRAVERE THERAPEUTICS, INC. |
RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED
INFORMATION |
(in thousands, except share and per share
data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
GAAP operating
loss |
$ |
(67,704 |
) |
|
$ |
(103,951 |
) |
|
$ |
(206,941 |
) |
|
$ |
(201,320 |
) |
|
|
|
|
|
|
|
|
R&D operating expense |
|
(54,330 |
) |
|
|
(66,492 |
) |
|
|
(103,750 |
) |
|
|
(124,654 |
) |
|
|
|
|
|
|
|
|
Stock compensation |
|
3,774 |
|
|
|
4,616 |
|
|
|
7,431 |
|
|
|
9,097 |
|
Amortization &
depreciation |
|
— |
|
|
|
2,420 |
|
|
|
— |
|
|
|
4,814 |
|
Subtotal non-GAAP items |
|
3,774 |
|
|
|
7,036 |
|
|
|
7,431 |
|
|
|
13,911 |
|
Non-GAAP R&D expense |
|
(50,556 |
) |
|
|
(59,456 |
) |
|
|
(96,319 |
) |
|
|
(110,743 |
) |
|
|
|
|
|
|
|
|
SG&A operating
expense |
|
(64,776 |
) |
|
|
(68,203 |
) |
|
|
(128,999 |
) |
|
|
(134,153 |
) |
|
|
|
|
|
|
|
|
Stock compensation |
|
6,147 |
|
|
|
6,988 |
|
|
|
12,247 |
|
|
|
16,271 |
|
Amortization &
depreciation |
|
10,340 |
|
|
|
11,482 |
|
|
|
20,220 |
|
|
|
18,634 |
|
Subtotal non-GAAP items |
|
16,487 |
|
|
|
18,470 |
|
|
|
32,467 |
|
|
|
34,905 |
|
Non-GAAP SG&A expense |
|
(48,289 |
) |
|
|
(49,733 |
) |
|
|
(96,532 |
) |
|
|
(99,248 |
) |
|
|
|
|
|
|
|
|
Subtotal non-GAAP items |
|
20,261 |
|
|
|
25,506 |
|
|
|
39,898 |
|
|
|
48,816 |
|
Non-GAAP operating
loss |
$ |
(47,443 |
) |
|
$ |
(78,445 |
) |
|
$ |
(167,043 |
) |
|
$ |
(152,504 |
) |
|
|
|
|
|
|
|
|
GAAP net
loss |
$ |
(70,409 |
) |
|
$ |
(85,630 |
) |
|
$ |
(206,470 |
) |
|
$ |
(171,961 |
) |
Non-GAAP operating loss adjustments |
|
20,261 |
|
|
|
25,506 |
|
|
|
39,898 |
|
|
|
48,816 |
|
Income tax provision |
|
85 |
|
|
|
65 |
|
|
|
276 |
|
|
|
143 |
|
Non-GAAP net
loss (1) |
$ |
(50,063 |
) |
|
$ |
(60,059 |
) |
|
$ |
(166,296 |
) |
|
$ |
(123,002 |
) |
|
|
|
|
|
|
|
|
Per share
data: |
|
|
|
|
|
|
|
Net loss per common share |
$ |
(0.65 |
) |
|
$ |
(0.79 |
) |
|
$ |
(2.15 |
) |
|
$ |
(1.71 |
) |
Weighted average common shares outstanding |
|
77,500,245 |
|
|
|
76,001,801 |
|
|
|
77,318,369 |
|
|
|
72,109,573 |
|
|
(1)
Non-GAAP net income (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 |
|
|
|
Travere Therapeutics (NASDAQ:TVTX)
Gráfica de Acción Histórica
De Sep 2024 a Oct 2024
Travere Therapeutics (NASDAQ:TVTX)
Gráfica de Acción Histórica
De Oct 2023 a Oct 2024