Travere Therapeutics, Inc. (NASDAQ: TVTX) today reported its first
quarter 2024 financial results and provided a corporate update.
“We are off to an excellent start to 2024. We
are reporting new highs in both demand and revenue for FILSPARI in
IgAN during the first quarter, with continuing strong trends into
the second quarter. Additionally, the FDA recently granted Priority
Review to our sNDA seeking the conversion of accelerated approval
of FILSPARI to full approval for IgAN in the U.S., and FILSPARI
recently received conditional marketing authorization for IgAN in
Europe. Our strong performance and achievement of these key
regulatory milestones furthers our confidence in being able to
deliver significant growth in 2024 and beyond,” said Eric Dube,
Ph.D., president and chief executive officer of Travere
Therapeutics. “Additionally, we remain on track with the other
priorities to expand our growth, including dosing the first
patients with HCU in our pivotal program designed to deliver
pegtibatinase as the only disease modifying therapy for HCU. We
also continue to review our data from the DUPLEX Study and engage
with the nephrology community to facilitate our planned engagement
with FDA on potential regulatory pathways for sparsentan in
FSGS.”
Financial Results for Continuing
Operations for the Quarter Ended March 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 first quarter of 2024
were $40.0 million, compared to $24.2 million for the same period
in 2023. The difference is attributable to an increase in sales
from the ongoing commercial launch of FILSPARI.
Research and development (R&D) expenses for
the first quarter of 2024 were $49.4 million, compared to $58.2
million for the same period in 2023. The reduction in expense is
largely attributable to decreased personnel costs and lower
development costs related to FILSPARI as the Phase 3 programs
advance towards completion. On a non-GAAP adjusted basis, R&D
expenses were $45.8 million for the first quarter of 2024, compared
to $51.3 million for the same period in 2023.
Selling, general, and administrative (SG&A)
expenses for the first quarter of 2024 were $64.2 million, compared
to $66.0 million for the same period in 2023. The reduction in
expense is largely attributable to a decrease in personnel and
support costs. On a non-GAAP adjusted basis, SG&A expenses were
$48.2 million for the first quarter of 2024, compared to $49.5
million for the same period in 2023.
The Company recognized a $65 million IPR&D
milestone expense during the first quarter of 2024 as a result of
achieving the first patient dosed in the pivotal HARMONY Study of
pegtibatinase in HCU. The milestone payment is expected to occur in
the second quarter of 2024.
Total other income, net, for the first quarter
of 2024 was $3.5 million, compared to $0.9 million for the same
period in 2023. The difference is largely attributable to an
increase in interest income during the period.
Net loss including discontinued operations for
the first quarter of 2024 was $136.1 million, or $1.76 per basic
share, compared to a net loss of $86.3 million, or $1.27 per basic
share for the same period in 2023. On a non-GAAP adjusted basis,
net loss including discontinued operations for the first quarter of
2024 was $116.2 million, or $1.51 per basic share, compared to a
net loss of $62.9 million, or $0.92 per basic share for the same
period in 2023.
As of March 31, 2024, the Company had cash, cash
equivalents, and marketable securities of $441.0 million. During
the first quarter of 2024, the Company had non-recurring cash use
of approximately $61 million related to the previously announced
strategic restructuring, first quarter compensation expense,
delivery of inventory and transfer of receivables related to the
divestiture of the bile acid product portfolio. The Company
continues to anticipate that operating cash use will decline
throughout 2024.
Program Updates and Anticipated
Milestones
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:
- 511 new patient start forms (PSFs)
received in the first quarter of 2024; as of March 31, 2024, a
total of 1,963 PSFs had been received since approval.
- Net product sales of $19.8 million
during the first quarter, bringing the total to $49.0 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 April 2024, the Company and its
commercial partner CSL Vifor announced the European Commission
granted conditional marketing authorization (CMA) for 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 Company
expects to receive a $17.5 million milestone payment from CSL Vifor
upon conversion of the CMA to full approval, and the Company
anticipates receiving an additional milestone payment in 2025 upon
achievement of market access milestones in certain countries. The
first launch of FILSPARI by CSL Vifor is expected in the second
half of 2024. With the CMA approval, the Company expects to pay a
$5.8 million milestone to Ligand Pharmaceuticals in the second
quarter of 2024.
- In January 2024, the Company
announced that it had entered into an exclusive licensing agreement
with Renalys Pharma, Inc., to bring sparsentan to patients in Japan
and other countries in Asia. Following successful meetings with the
Pharmaceuticals and Medical Devices Agency (PMDA), Renalys Pharma
announced in April 2024 that it has submitted an Investigational
New Drug (IND) Application for a Phase 3 clinical trial in Japan.
The Phase 3 study will be a multicenter, open-label, single arm
study in Japanese patients with IgA nephropathy, and is planned to
confirm the efficacy and safety of sparsentan in approximately 30
Japanese patients. Topline data from the study are expected in the
second half of 2025.
- At the World Congress of Nephrology
(April 13-16), the Company presented five abstracts, including a
late-breaking oral presentation on subgroup analyses of the Phase 3
PROTECT Study of FILSPARI in IgAN, demonstrating a consistent
treatment benefit in absolute eGFR change across baseline urine
protein-to-creatinine ratio subgroups.
- Presentations also included
preliminary findings from the SPARTAN Study which demonstrated an
approximate 80 percent reduction in proteinuria and stable eGFR out
to 36 weeks in newly diagnosed patients with IgAN, as well as the
early clinical experience from the PROTECT open-label extension
illustrating that the addition of sodium-glucose cotransporter-2
inhibitors (SGLT2i) to ongoing FILSPARI treatment is generally
well-tolerated with additive benefit on proteinuria reduction in
patients with IgAN.
- At the American Nephrology Nurses
Association (ANNA) National Symposium (April 14-17), the Company
presented four abstracts on the additional insights from the HONUS
trial, including health-related quality of life (HRQoL) data and
the humanistic burden experienced by patients with IgAN and
FSGS.
- 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.
Sparsentan – Focal Segmental
Glomerulosclerosis (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 – 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. The trial is expected to enroll
approximately 70 patients with a diagnosis of classical HCU and
tHcy levels ≥50 μM while maintaining their standard-of-care
treatment. The primary endpoint is relative geometric mean change
in plasma tHcy levels from baseline compared to weeks 6 through 12.
Durability of treatment response through 24 weeks of treatment will
also be measured as a secondary endpoint. Topline results from the
HARMONY Study are expected in 2026.
- During the first quarter of 2024,
the Company dosed the first patient in the Phase 3 HARMONY
Study.
- The Company is nearing initiation
of 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 will
include an optional protein tolerance modification sub-study that
will evaluate if patients can increase their natural dietary
protein intake and maintain an acceptable level of metabolic
control while receiving pegtibatinase.
- At the Society for Inherited
Metabolic Disorders (SIMD) annual meeting (April 14-17) and Genetic
Metabolic Dieticians International (GMDI) conference (April 17-20),
the Company presented eight abstracts covering the previously
reported positive results from cohort 6 in the placebo-controlled
Phase 1/2 COMPOSE Study, the trial design of the pivotal Phase 3
HARMONY Study, insights on the development of an innovative tool
used for dietary management and monitoring in the Phase 3 HARMONY
Study and open-label extension ENSEMBLE Study, as well as economic
and clinical burdens of classical HCU in the U.S., and the
association between homocysteine and clinical outcomes in patients
with classical HCU.
Conference Call Information
Travere Therapeutics will host a conference call
and webcast today, Monday, May 6, 2024, at 4:30 p.m. ET to discuss
company updates as well as first quarter 2024 financial results. To
participate in the conference call, dial +1 (888) 224-1005 (U.S.)
or +1 (323) 794-2575 (International), confirmation code 2471523
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.
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: statements regarding the continuing
commercial launch of FILSPARI and trends related thereto; the
potential for FILSPARI to receive full approval for the treatment
of IgAN in the U.S. and the anticipated timing thereof; 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 the
potential to deliver significant growth in 2024 and beyond;
statements regarding plans to engage with the FDA on potential
regulatory pathways for sparsentan in FSGS and the anticipated
timing thereof; statements regarding the potential for
pegtibatinase to become the only 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) |
|
|
|
|
|
|
|
March 31, 2024 |
|
December 31, 2023 |
Assets |
|
(unaudited) |
|
|
Current
assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
43,251 |
|
|
$ |
58,176 |
|
Marketable debt securities, at fair value |
|
|
397,793 |
|
|
|
508,675 |
|
Accounts receivable, net |
|
|
22,731 |
|
|
|
21,179 |
|
Inventory |
|
|
4,532 |
|
|
|
9,410 |
|
Prepaid expenses and other current assets |
|
|
12,769 |
|
|
|
19,335 |
|
Total current
assets |
|
|
481,076 |
|
|
|
616,775 |
|
|
|
|
|
|
Long-term inventory |
|
|
37,774 |
|
|
|
31,494 |
|
Property and equipment,
net |
|
|
6,943 |
|
|
|
7,479 |
|
Operating lease right of use
assets |
|
|
17,271 |
|
|
|
18,061 |
|
Intangible assets, net |
|
|
101,182 |
|
|
|
104,443 |
|
Other assets |
|
|
19,301 |
|
|
|
10,661 |
|
Total
assets |
|
$ |
663,547 |
|
|
$ |
788,913 |
|
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
|
Current
liabilities: |
|
|
|
|
Accounts payable |
|
$ |
16,725 |
|
|
$ |
41,675 |
|
Accrued expenses |
|
|
139,580 |
|
|
|
118,991 |
|
Deferred revenue, current portion |
|
|
6,460 |
|
|
|
7,096 |
|
Operating lease liabilities, current portion |
|
|
5,036 |
|
|
|
4,909 |
|
Other current liabilities |
|
|
5,428 |
|
|
|
5,237 |
|
Total current
liabilities |
|
|
173,229 |
|
|
|
177,908 |
|
Convertible debt |
|
|
377,693 |
|
|
|
377,263 |
|
Deferred revenue, less current
portion |
|
|
888 |
|
|
|
1,835 |
|
Operating lease liabilities,
less current portion |
|
|
21,287 |
|
|
|
22,612 |
|
Other non-current
liabilities |
|
|
16,379 |
|
|
|
8,485 |
|
Total
liabilities |
|
|
589,476 |
|
|
|
588,103 |
|
|
|
|
|
|
Stockholders'
Equity: |
|
|
|
|
Preferred stock $0.0001 par value; 20,000,000 shares authorized; 0
issued and outstanding as of March 31, 2024 and December 31,
2023 |
|
|
— |
|
|
|
— |
|
Common stock $0.0001 par
value; 200,000,000 shares authorized; 76,108,829, and 75,367,117
issued and outstanding as of March 31, 2024 and December 31, 2023,
respectively |
|
|
8 |
|
|
|
7 |
|
Additional paid-in capital |
|
|
1,337,638 |
|
|
|
1,327,881 |
|
Accumulated deficit |
|
|
(1,261,683 |
) |
|
|
(1,125,622 |
) |
Accumulated other comprehensive loss |
|
|
(1,892 |
) |
|
|
(1,456 |
) |
Total stockholders'
equity |
|
|
74,071 |
|
|
|
200,810 |
|
Total liabilities and
stockholders' equity |
|
$ |
663,547 |
|
|
$ |
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 March 31, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
(unaudited) |
Net product sales: |
|
|
|
|
Tiopronin products |
|
$ |
20,150 |
|
|
$ |
21,174 |
|
FILSPARI |
|
|
19,834 |
|
|
|
3,004 |
|
Total net product sales |
|
|
39,984 |
|
|
|
24,178 |
|
License and collaboration
revenue |
|
|
1,390 |
|
|
|
6,710 |
|
Total revenue |
|
|
41,374 |
|
|
|
30,888 |
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
Cost of goods sold |
|
|
1,504 |
|
|
|
4,145 |
|
Research and development |
|
|
49,420 |
|
|
|
58,162 |
|
Selling, general and administrative |
|
|
64,223 |
|
|
|
65,950 |
|
In-process research and development |
|
|
65,205 |
|
|
|
— |
|
Restructuring |
|
|
259 |
|
|
|
— |
|
Total operating expenses |
|
|
180,611 |
|
|
|
128,257 |
|
|
|
|
|
|
Operating loss |
|
|
(139,237 |
) |
|
|
(97,369 |
) |
|
|
|
|
|
Other income (expenses),
net: |
|
|
|
|
Interest income |
|
|
6,032 |
|
|
|
3,646 |
|
Interest expense |
|
|
(2,800 |
) |
|
|
(2,850 |
) |
Other income, net |
|
|
238 |
|
|
|
87 |
|
Total other income, net |
|
|
3,470 |
|
|
|
883 |
|
|
|
|
|
|
Loss from continuing
operations before income tax provision |
|
|
(135,767 |
) |
|
|
(96,486 |
) |
Income tax provision on
continuing operations |
|
|
(191 |
) |
|
|
(78 |
) |
|
|
|
|
|
Loss from continuing
operations, net of tax |
|
|
(135,958 |
) |
|
|
(96,564 |
) |
(Loss) income from
discontinued operations, net of tax |
|
|
(103 |
) |
|
|
10,233 |
|
Net loss |
|
$ |
(136,061 |
) |
|
$ |
(86,331 |
) |
|
|
|
|
|
Per share
data: |
|
|
|
|
Net loss per common share |
|
$ |
(1.76 |
) |
|
$ |
(1.27 |
) |
Weighted average common shares outstanding |
|
|
77,136,493 |
|
|
|
68,174,099 |
|
|
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 March 31, |
|
|
|
2024 |
|
|
|
2023 |
|
GAAP operating
loss |
|
$ |
(139,237 |
) |
|
$ |
(97,369 |
) |
|
|
|
|
|
R&D operating expense |
|
|
(49,420 |
) |
|
|
(58,162 |
) |
|
|
|
|
|
Stock compensation |
|
|
3,657 |
|
|
|
4,481 |
|
Amortization &
depreciation |
|
|
— |
|
|
|
2,394 |
|
Subtotal non-GAAP items |
|
|
3,657 |
|
|
|
6,875 |
|
Non-GAAP R&D expense |
|
|
(45,763 |
) |
|
|
(51,287 |
) |
|
|
|
|
|
SG&A operating
expense |
|
|
(64,223 |
) |
|
|
(65,950 |
) |
|
|
|
|
|
Stock compensation |
|
|
6,100 |
|
|
|
9,283 |
|
Amortization &
depreciation |
|
|
9,880 |
|
|
|
7,152 |
|
Subtotal non-GAAP items |
|
|
15,980 |
|
|
|
16,435 |
|
Non-GAAP SG&A expense |
|
|
(48,243 |
) |
|
|
(49,515 |
) |
|
|
|
|
|
Subtotal non-GAAP items |
|
|
19,637 |
|
|
|
23,310 |
|
Non-GAAP operating
loss |
|
$ |
(119,600 |
) |
|
$ |
(74,059 |
) |
|
|
|
|
|
GAAP net income
(loss) |
|
$ |
(136,061 |
) |
|
$ |
(86,331 |
) |
Non-GAAP operating loss adjustments |
|
|
19,637 |
|
|
|
23,310 |
|
Income tax provision |
|
|
191 |
|
|
|
78 |
|
Non-GAAP net income
(loss)(1) |
|
$ |
(116,233 |
) |
|
$ |
(62,943 |
) |
|
|
|
|
|
Per share
data: |
|
|
|
|
Net loss per common share |
|
$ |
(1.51 |
) |
|
$ |
(0.92 |
) |
Weighted average common shares outstanding |
|
|
77,136,493 |
|
|
|
68,174,099 |
|
|
(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: |
Media: |
888-969-7879 |
888-969-7879 |
ir@travere.com |
mediarelations@travere.com |
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