Travere Therapeutics, Inc. (NASDAQ: TVTX) today reported its third
quarter 2023 financial results and provided a corporate update.
“During the third quarter we continued to lay
the foundation for FILSPARI to become a new treatment standard in
IgA nephropathy - as evidenced by quarterly growth in new patient
start forms and an increase in new and repeat prescribers.
Furthermore, our payer engagement efforts have resulted in
broadening high-quality access and we made enhancements to our
Travere Total Care services to provide patients with additional
education and support,” said Eric Dube, Ph.D., president and chief
executive officer of Travere Therapeutics. "At the recent ASN
Kidney Week meeting, we showcased our leadership in rare kidney
disease with 11 abstracts and the presentation of the Phase 3
PROTECT Study results, which were simultaneously published in The
Lancet. The data clearly convey that FILSPARI has the potential to
delay progression to kidney failure and to provide cumulative
benefit over time for patients living with IgAN. From a regulatory
perspective, we remain on track to provide updates in the fourth
quarter for both sparsentan programs as we seek sNDA submissions
for traditional approval in IgAN and FSGS. We also successfully
completed our end of Phase 2 meeting for our pegtibatinase program
for classical homocystinuria, paving the way for a pivotal study
initiation by year-end. As we close out the year, we look forward
to executing on several exciting opportunities to build further
momentum in our launch and to advance our pipeline.”
Financial Results for Continuing
Operations for the Quarter Ended September 30, 2023
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.
Net product sales for the third quarter of 2023
were $33.9 million, compared to $25.4 million for the same period
in 2022. For the nine months ended September 30, 2023, net product
sales were $87.6 million, compared to $72.2 million for the same
period in 2022. The increase is primarily attributable to sales
from the ongoing commercial launch of FILSPARI.
Research and development (R&D) expenses for
the third quarter of 2023 were $60.6 million, compared to $57.1
million for the same period in 2022. For the nine months ended
September 30, 2023, R&D expenses were $185.2 million, compared
to $169.2 million for the same period in 2022. The difference is
largely attributable to the continued advancement of the Company’s
pegtibatinase clinical program, including clinical trial expenses
and manufacturing, as well as increased headcount. On a non-GAAP
adjusted basis, R&D expenses were $53.8 million for the third
quarter of 2023, compared to $51.9 million for the same period in
2022.
Selling, general, and administrative (SG&A)
expenses for the third quarter of 2023 were $67.8 million, compared
to $52.4 million for the same period in 2022. For the nine months
ended September 30, 2023, SG&A expenses were $202.0 million,
compared to $140.4 million for the same period in 2022. The
difference is largely attributable to commercial launch related
activities following the accelerated approval of FILSPARI in
February 2023, as well as legal fees. On a non-GAAP adjusted basis,
SG&A expenses were $51.8 million for the third quarter of 2023,
compared to $43.5 million for the same period in 2022.
Total other income, net, for the third quarter
of 2023 was $3.4 million, compared to total other expense, net, of
$1.3 million for the same period in 2022. The difference is largely
attributable to an increase in interest income during the
period.
Net income including discontinued operations for
the third quarter of 2023 was $150.7 million, or $1.97 per basic
share, compared to a net loss of $69.7 million, or $1.09 per basic
share for the same period in 2022. For the nine months ended
September 30, 2023, net loss including discontinued operations was
$21.2 million, compared to $212.7 million for the same period in
2022. On a non-GAAP adjusted basis, net income including
discontinued operations for the third quarter of 2023 was $173.5
million, or $2.27 per basic share, compared to a net loss of $55.3
million, or $0.86 per basic share for the same period in 2022.
As of September 30, 2023, the Company had cash,
cash equivalents, and marketable securities of $634.6 million.
Program Updates
FILSPARI®
(sparsentan) – IgAN / FSGS
- 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:
- 430 new patient start forms (PSFs)
received in the third quarter; a total of 990 PSFs have been
received in the first seven and a half months since the accelerated
approval of FILSPARI.
- Net product sales of $8.0 million
during the third quarter, bringing the total to $14.5 million in
net product sales since the beginning of the launch.
- In September
2023, the Company reported topline results from the two-year
confirmatory endpoints from the Phase 3 PROTECT Study of FILSPARI
in IgAN. FILSPARI demonstrated long-term kidney function
preservation and achieved a clinically meaningful difference in
estimated glomerular filtration rate (eGFR) total and chronic slope
versus the active control irbesartan, narrowly missing statistical
significance in eGFR total slope while achieving statistical
significance in eGFR chronic slope for purposes of regulatory
review in the EU. FILSPARI was generally well-tolerated and the
overall safety profile in the study was consistent between
treatment groups, supporting long-term use.
- At the American
Society of Nephrology Kidney Week 2023 (November 2-5), the Company
presented 11 total abstracts, including late-breaking high-impact
oral presentations of the Phase 3 PROTECT Study of FILSPARI in IgAN
and Phase 3 DUPLEX Study of sparsentan in FSGS.
- Select data from
the PROTECT Study included:
- Treatment with
FILSPARI resulted in one of the slowest rates of kidney function
decline in an IgAN trial of its kind (-2.7 and -2.9
ml/min/1.73m2/year with chronic and total eGFR slope,
respectively).
- The absolute
overall change in kidney function from baseline to the end of the
study for patients treated with FILSPARI was -5.8 mL/min/1.73m2
compared to -9.5 mL/min/1.73m2 with irbesartan. This translates
into a 3.7 ml/min/1.73m2 higher eGFR at two years with FILSPARI
compared to irbesartan. This beneficial effect on preserving kidney
function was durable post washout.
- Treatment effects
on eGFR slope were consistent across baseline eGFR and proteinuria,
supporting the potential for FILSPARI as a foundational treatment
option across different stages of disease.
- When imbalances
between treatment arms were factored into pre-specified eGFR
analyses (early treatment discontinuations and higher rates of
rescue immunosuppression, both of which occurred more in the
irbesartan arm) the beneficial effects of FILSPARI on kidney
function preservation were strengthened.
- Treatment with
FILSPARI demonstrated lower rates of the composite endpoint of 40%
decline in eGFR, kidney failure or death compared to
irbesartan.
- More patients
treated with FILSPARI achieved complete remission of proteinuria of
less than 0.3 grams compared to those treated with irbesartan (31%
vs 11%).
- Select data from
the DUPLEX Study included:
- Treatment with
sparsentan demonstrated a clinically meaningful and durable
reduction in proteinuria, with FSGS patients achieving a 50%
reduction from baseline, compared to a 32% reduction with the
active control irbesartan.
- Sparsentan
showed a consistent and sustained achievement of complete remission
of proteinuria in 18.5% of patients on sparsentan vs. 7.5% for
irbesartan.
- The combined
hard endpoints of confirmed 50% reduction in eGFR, end-stage renal
disease or death, trended in favor of sparsentan with fewer
patients progressing to kidney failure.
- Additional
presentations at ASN included data supporting the potential use of
sparsentan as a first-line treatment (SPARTAN), potential for use
in combination with SGLT2 inhibitors, and pediatric proteinuric
glomerular diseases (EPPIK), as well as insights into patient
quality of life and the impact of proteinuria on kidney survival in
rare kidney diseases.
- In November
2023, results from the Phase 3 PROTECT Study of FILSPARI in IgAN
were published in The Lancet, and results from the Phase 3 DUPLEX
Study of sparsentan in FSGS were published in The New England
Journal of Medicine.
- The Company
remains on-track to provide a regulatory update in the fourth
quarter regarding the expected submission of a supplemental New
Drug Application (sNDA) for full approval of FILSPARI for IgAN in
the U.S.
- The Company,
together with its collaborator CSL Vifor, anticipates a review
opinion by the Committee for Medicinal Products for Human Use
(CHMP) on the potential approval of the Conditional Marketing
Authorization (CMA) application for sparsentan for the treatment of
IgAN in Europe around year-end. If approved, sparsentan would
receive CMA in all member states of the European Union, as well as
in Iceland, Liechtenstein, and Norway.
- The Company
remains on-track to provide a regulatory update in the fourth
quarter regarding the potential path forward for an sNDA for
sparsentan for the treatment of FSGS in the U.S. Together with its
collaborator CSL Vifor, the Company also plans to engage with the
European Medicines Agency to determine the potential for a
subsequent variation to the CMA of sparsentan for the treatment of
FSGS, subject to a review decision on the pending application for
CMA of sparsentan in IgAN.
Pegtibatinase (TVT-058) –
HCU
- In May 2023, the
Company reported positive topline results from cohort 6 of the
Phase 1/2 COMPOSE Study (n=5) of pegtibatinase in classical
homocystinuria (HCU), showing that treatment with 2.5mg/kg of
pegtibatinase resulted in rapid and sustained reductions in total
homocysteine (tHcy), with a 67.1% mean relative reduction in tHcy
from baseline. All patients achieved a mean tHcy below the
clinically meaningful threshold of 100uM, as well as maintenance of
mean tHcy below the threshold of 100 μM, over weeks 6 to 12. Some
patients achieved tHcy below 50 μM, including one patient with a
lower tHcy level at baseline achieving normalization of tHcy.
- At the Society
for the Study of Inborn Errors of Metabolism (SSIEM) Annual
Symposium 2023, the Company presented six abstracts, including
additional positive clinical data from cohort 6 of the Phase 1/2
COMPOSE Study. Additional presentations included analyses on the
Company’s prospective HCU natural history study, the prevalence of
HCU, the burden of HCU from the patient perspective, the clinical
burden of HCU, as well as the relationship between tHcy and
clinical outcomes, which was recognized as one of the highest
ranked posters at SSIEM.
- During the third
quarter of 2023, the Company successfully completed its end of
Phase 2 meeting with the FDA and remains on track to initiate a
pivotal study by the end of 2023. The Phase 3 study is expected to
utilize tHcy reduction as the primary endpoint to support potential
registration.
Thiola EC® and Thiola®
(tiopronin)
- The Company and its licensor,
Mission Pharmacal Company (Mission), have entered into agreements
with each of Par Pharmaceutical Inc. (Par) and Amneal EU, Limited
(Amneal) in order to settle patent invalidity and infringement
disputes related to the patent granted to Mission (to which the
Company has a license) covering the treatment of cystinuria by
administering Thiola EC with food (US Patent No. 11,458,104), and
providing for an expected license entry date of April 1, 2026 for
Par and Amneal’s generic versions of Thiola EC (100mg and
300mg).
Bile Acid Product Portfolio – Cholbam®
and Chenodal®
- In September
2023, the Company announced the successful completion of the sale
of its bile acid product portfolio that includes Cholbam (cholic
acid) and Chenodal (chenodiol), to Mirum Pharmaceuticals. In
connection with the closing of the sale, Travere received an
upfront payment of $210 million from Mirum, and remains eligible to
receive up to $235 million in potential sales-based milestone
payments.
Conference Call Information
Travere Therapeutics will host a conference call
and webcast today, Tuesday, November 7, 2023, at 4:30 p.m. ET to
discuss company updates as well as third quarter 2023 financial
results. To participate in the conference call, dial +1 (888)
394-8218 (U.S.) or +1 (323) 994-2093 (International), confirmation
code 9612207 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
TOXICITYBecause
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.
HepatotoxicitySome
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
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 our
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; the potential for FILSPARI to become a new treatment
standard in IgAN and a foundational treatment option across
different stages of disease; the timing and achievement of
additional development and regulatory milestones; the advancement
of the Company’s pipeline throughout the year; the Company’s plans
and timing for engaging with regulators; the Company’s potential
initiation of a pivotal Phase 3 trial of pegtibatinase in patients
with HCU by year-end 2023; and the Company’s ability to receive the
potential sales-based milestone payments from the sale of its bile
acid product portfolio. 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, 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 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 the risk that the results of the
Phase 3 PROTECT Study of sparsentan in IgAN will not be deemed
sufficient by the FDA to serve as the basis for an sNDA submission
for traditional approval of sparsentan, and the risk that the
results from the Phase 3 DUPLEX Study of sparsentan in FSGS will
not serve as a basis for a regulatory submission for approval of
sparsentan for FSGS. 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; 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; and the risk that the Company will not receive some or
all of the potential sales-based milestone payments under the
purchase agreement for the sale of its bile acid product portfolio.
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) |
|
|
|
|
|
September 30, 2023 |
|
December 31, 2022 |
Assets |
(unaudited) |
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
144,244 |
|
|
$ |
61,688 |
|
Marketable debt securities, at fair value |
|
490,399 |
|
|
|
388,557 |
|
Accounts receivable, net |
|
14,570 |
|
|
|
16,646 |
|
Inventory |
|
20,773 |
|
|
|
4,523 |
|
Prepaid expenses and other current assets |
|
16,244 |
|
|
|
12,033 |
|
Current assets of discontinued operations |
|
— |
|
|
|
2,990 |
|
Total current
assets |
|
686,230 |
|
|
|
486,437 |
|
|
|
|
|
Property and equipment,
net |
|
7,996 |
|
|
|
9,049 |
|
Operating lease right of use
assets |
|
18,806 |
|
|
|
21,000 |
|
Intangible assets, net |
|
106,903 |
|
|
|
97,073 |
|
Other assets |
|
12,915 |
|
|
|
10,684 |
|
Non-current assets of
discontinued operations |
|
— |
|
|
|
48,342 |
|
Total
assets |
$ |
832,850 |
|
|
$ |
672,585 |
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
$ |
24,736 |
|
|
$ |
17,290 |
|
Accrued expenses |
|
95,712 |
|
|
|
95,742 |
|
Deferred revenue, current portion |
|
8,959 |
|
|
|
11,976 |
|
Operating lease liabilities, current portion |
|
4,782 |
|
|
|
4,433 |
|
Other current liabilities |
|
5,244 |
|
|
|
5,722 |
|
Current liabilities of discontinued operations |
|
— |
|
|
|
7,000 |
|
Total current
liabilities |
|
139,433 |
|
|
|
142,163 |
|
Convertible debt |
|
376,833 |
|
|
|
375,545 |
|
Deferred revenue, less current
portion |
|
4,574 |
|
|
|
10,931 |
|
Operating lease liabilities,
less current portion |
|
23,863 |
|
|
|
27,510 |
|
Other non-current
liabilities |
|
8,381 |
|
|
|
9,385 |
|
Non-current liabilities of
discontinued operations |
|
— |
|
|
|
64,200 |
|
Total
liabilities |
|
553,084 |
|
|
|
629,734 |
|
|
|
|
|
Stockholders'
Equity: |
|
|
|
Preferred stock $0.0001 par value; 20,000,000 shares authorized; 0
issued and outstanding as of September 30, 2023 and December 31,
2022 |
|
— |
|
|
|
— |
|
Common stock $0.0001 par
value; 200,000,000 shares authorized; 75,111,517, and 64,290,570
issued and outstanding as of September 30, 2023 and December 31,
2022, respectively |
|
7 |
|
|
|
6 |
|
Additional paid-in capital |
|
1,318,861 |
|
|
|
1,059,975 |
|
Accumulated deficit |
|
(1,035,449 |
) |
|
|
(1,014,223 |
) |
Accumulated other comprehensive loss |
|
(3,653 |
) |
|
|
(2,907 |
) |
Total stockholders'
equity |
|
279,766 |
|
|
|
42,851 |
|
Total liabilities and
stockholders' equity |
$ |
832,850 |
|
|
$ |
672,585 |
|
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 September 30, |
|
Nine Months Ended September 30, |
|
2023 |
|
2022 |
|
2023 |
|
|
2022 |
|
(unaudited) |
|
|
|
|
Net product sales: |
|
|
|
|
|
|
|
Tiopronin products |
$ |
25,888 |
|
|
$ |
25,369 |
|
|
$ |
73,112 |
|
|
$ |
72,154 |
|
FILSPARI |
|
8,044 |
|
|
|
— |
|
|
|
14,509 |
|
|
|
— |
|
Total net product sales |
|
33,932 |
|
|
|
25,369 |
|
|
|
87,621 |
|
|
|
72,154 |
|
License and collaboration
revenue |
|
3,163 |
|
|
|
2,706 |
|
|
|
12,558 |
|
|
|
7,967 |
|
Total revenue |
|
37,095 |
|
|
|
28,075 |
|
|
|
100,179 |
|
|
|
80,121 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Cost of goods sold |
|
1,289 |
|
|
|
1,114 |
|
|
|
6,886 |
|
|
|
3,552 |
|
Research and development |
|
60,590 |
|
|
|
57,145 |
|
|
|
185,244 |
|
|
|
169,246 |
|
Selling, general and administrative |
|
67,801 |
|
|
|
52,420 |
|
|
|
201,954 |
|
|
|
140,434 |
|
Total operating expenses |
|
129,680 |
|
|
|
110,679 |
|
|
|
394,084 |
|
|
|
313,232 |
|
|
|
|
|
|
|
|
|
Operating loss |
|
(92,585 |
) |
|
|
(82,604 |
) |
|
|
(293,905 |
) |
|
|
(233,111 |
) |
|
|
|
|
|
|
|
|
Other income (expenses),
net: |
|
|
|
|
|
|
|
Interest income |
|
5,842 |
|
|
|
2,101 |
|
|
|
14,616 |
|
|
|
3,161 |
|
Interest expense |
|
(2,821 |
) |
|
|
(2,829 |
) |
|
|
(8,513 |
) |
|
|
(8,156 |
) |
Other income (expense), net |
|
335 |
|
|
|
(586 |
) |
|
|
220 |
|
|
|
102 |
|
Loss on extinguishment of debt |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(7,578 |
) |
Total other income (expense), net |
|
3,356 |
|
|
|
(1,314 |
) |
|
|
6,323 |
|
|
|
(12,471 |
) |
|
|
|
|
|
|
|
|
Loss from continuing
operations before income tax provision |
|
(89,229 |
) |
|
|
(83,918 |
) |
|
|
(287,582 |
) |
|
|
(245,582 |
) |
Income tax provision on
continuing operations |
|
(12 |
) |
|
|
(145 |
) |
|
|
(155 |
) |
|
|
(250 |
) |
|
|
|
|
|
|
|
|
Loss from continuing
operations, net of tax |
$ |
(89,241 |
) |
|
$ |
(84,063 |
) |
|
$ |
(287,737 |
) |
|
$ |
(245,832 |
) |
Income from discontinued
operations, net of tax |
|
239,976 |
|
|
|
14,407 |
|
|
|
266,511 |
|
|
|
33,173 |
|
Net income (loss) |
$ |
150,735 |
|
|
$ |
(69,656 |
) |
|
$ |
(21,226 |
) |
|
$ |
(212,659 |
) |
|
|
|
|
|
|
|
|
Per share
data: |
|
|
|
|
|
|
|
Net income (loss) per common share |
$ |
1.97 |
|
|
$ |
(1.09 |
) |
|
$ |
(0.29 |
) |
|
$ |
(3.34 |
) |
Weighted average common shares outstanding |
|
76,305,603 |
|
|
|
64,033,759 |
|
|
|
73,523,620 |
|
|
|
63,604,962 |
|
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 September 30, |
|
Nine Months Ended September 30, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
GAAP operating loss |
$ |
(92,585 |
) |
|
$ |
(82,604 |
) |
|
$ |
(293,905 |
) |
|
$ |
(233,111 |
) |
|
|
|
|
|
|
|
|
R&D operating expense |
|
(60,590 |
) |
|
|
(57,145 |
) |
|
|
(185,244 |
) |
|
|
(169,246 |
) |
|
|
|
|
|
|
|
|
Stock compensation |
|
4,372 |
|
|
|
3,372 |
|
|
|
13,372 |
|
|
|
10,182 |
|
Amortization &
depreciation |
|
2,447 |
|
|
|
1,906 |
|
|
|
7,261 |
|
|
|
3,817 |
|
Subtotal non-GAAP items |
|
6,819 |
|
|
|
5,278 |
|
|
|
20,633 |
|
|
|
13,999 |
|
Non-GAAP R&D expense |
|
(53,771 |
) |
|
|
(51,867 |
) |
|
|
(164,611 |
) |
|
|
(155,247 |
) |
|
|
|
|
|
|
|
|
SG&A operating
expense |
|
(67,801 |
) |
|
|
(52,420 |
) |
|
|
(201,954 |
) |
|
|
(140,434 |
) |
|
|
|
|
|
|
|
|
Stock compensation |
|
6,949 |
|
|
|
5,216 |
|
|
|
22,730 |
|
|
|
18,664 |
|
Amortization &
depreciation |
|
9,032 |
|
|
|
3,682 |
|
|
|
21,785 |
|
|
|
10,590 |
|
Subtotal non-GAAP items |
|
15,981 |
|
|
|
8,898 |
|
|
|
44,515 |
|
|
|
29,254 |
|
Non-GAAP SG&A expense |
|
(51,820 |
) |
|
|
(43,522 |
) |
|
|
(157,439 |
) |
|
|
(111,180 |
) |
|
|
|
|
|
|
|
|
Subtotal non-GAAP items |
|
22,800 |
|
|
|
14,176 |
|
|
|
65,148 |
|
|
|
43,253 |
|
Non-GAAP operating
loss |
$ |
(69,785 |
) |
|
$ |
(68,428 |
) |
|
$ |
(228,757 |
) |
|
$ |
(189,858 |
) |
|
|
|
|
|
|
|
|
GAAP net income
(loss) |
$ |
150,735 |
|
|
$ |
(69,656 |
) |
|
$ |
(21,226 |
) |
|
$ |
(212,659 |
) |
Non-GAAP operating loss adjustments |
|
22,800 |
|
|
|
14,176 |
|
|
|
65,148 |
|
|
|
43,253 |
|
Income tax provision |
|
12 |
|
|
|
145 |
|
|
|
155 |
|
|
|
250 |
|
Non-GAAP net income
(loss) (1) |
$ |
173,547 |
|
|
$ |
(55,335 |
) |
|
$ |
44,077 |
|
|
$ |
(169,156 |
) |
|
|
|
|
|
|
|
|
Per share
data: |
|
|
|
|
|
|
|
Net income (loss) per common share |
$ |
2.27 |
|
|
$ |
(0.86 |
) |
|
$ |
0.60 |
|
|
$ |
(2.66 |
) |
Weighted average common shares outstanding |
|
76,305,603 |
|
|
|
64,033,759 |
|
|
|
73,523,620 |
|
|
|
63,604,962 |
|
|
|
|
|
|
|
|
|
(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:Naomi EichenbaumVice
President, Investor
Relations888-969-7879 ir@travere.com |
Media:Nivi NehraVice President,
Corporate
Communications888-969-7879 mediarelations@travere.com |
Travere Therapeutics (NASDAQ:TVTX)
Gráfico Histórico do Ativo
De Mai 2024 até Jun 2024
Travere Therapeutics (NASDAQ:TVTX)
Gráfico Histórico do Ativo
De Jun 2023 até Jun 2024