Travere Therapeutics, Inc. (NASDAQ: TVTX) today reported its second
quarter 2023 financial results and provided a corporate update.
"We are very pleased with the initial months of
the FILSPARI launch in IgAN and are encouraged by the positive
feedback we are receiving from both patients and prescribers," said
Eric Dube, Ph.D., president and chief executive officer of Travere
Therapeutics. "We have fully deployed our sales force, activated
our patient and prescriber support systems, and we continue to
expand awareness of FILSPARI among healthcare professionals through
engagement at major medical meetings and at the local level. With
respect to measuring demand and access, our two key indicators of
early launch success, we saw strong growth in patient start forms
and we continued to advance broader access to FILSPARI for eligible
patients through sound progress with our payer engagement efforts.
Beyond the launch, we continued to execute across our pipeline.
Notably, we are well positioned for upcoming engagement with the
FDA to evaluate a potential regulatory path forward for sparsentan
in FSGS and following the recent exciting results from the
pegtibatinase program, we are working to initiate a pivotal study
later this year. Furthermore, we were pleased to recently enter
into the agreement to sell our bile acid product portfolio which
will allow us to further focus our efforts on delivering new
treatment standards, as well as strengthen our financial
foundation.”
Financial Results for the Quarter Ended
June 30, 2023
Net product sales for the second quarter of 2023
were $57.0 million, compared to $51.0 million for the same period
in 2022. For the six months ended June 30, 2023, net product sales
were $107.3 million, compared to $97.4 million for the same period
in 2022. The increase is primarily attributable to sales from the
ongoing launch of FILSPARI.
Research and development (R&D) expenses for
the second quarter of 2023 were $69.4 million, compared to $59.7
million for the same period in 2022. For the six months ended June
30, 2023, R&D expenses were $129.3 million, compared to $116.3
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 $62.4 million for the second
quarter of 2023, compared to $54.4 million for the same period in
2022.
Selling, general, and administrative (SG&A)
expenses for the second quarter of 2023 were $74.0 million,
compared to $53.0 million for the same period in 2022. For the six
months ended June 30, 2023, SG&A expenses were $146.3 million,
compared to $99.8 million for the same period in 2022. The
difference is largely attributable to the onboarding of the
FILSPARI field team and supporting staff, as well as launch related
activities following the accelerated approval of FILSPARI in
February 2023. On a non-GAAP adjusted basis, SG&A expenses were
$55.6 million for the second quarter of 2023, compared to $37.5
million for the same period in 2022.
Total other income, net, for the second quarter
of 2023 was $2.0 million, compared to total other expense, net, of
$1.5 million for the same period in 2022. The difference is largely
attributable to an increase in interest income during the
period.
Net loss for the second quarter of 2023 was
$85.6 million, or $1.13 per basic share, compared to a net loss of
$67.0 million, or $1.05 per basic share for the same period in
2022. For the six months ended June 30, 2023, net loss was $172.0
million, compared to $143.0 million for the same period in 2022. On
a non-GAAP adjusted basis, net loss for the second quarter of 2023
was $58.2 million, or $0.77 per basic share, compared to a net loss
of $41.3 million, or $0.65 per basic share for the same period in
2022.
As of June 30, 2023, the Company had cash, cash
equivalents, and marketable securities of $491.3 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:
- 417 new patient
start forms (PSFs) received in the second quarter; a total of 563
PSFs have been received in the first four and a half months since
the accelerated approval of FILSPARI.
- Net product
sales of $3.5 million during the second quarter, totaling $6.5
million in net product sales since the beginning of the
launch.
- At the 60th ERA
Congress, the Company presented nine abstracts including the
interim analysis from the ongoing Phase 3 PROTECT Study evaluating
FILSPARI versus an active comparator in IgAN, as well as a new
analysis of the UK RaDaR Registry estimating the delay in time to
kidney failure or death based on proteinuria reduction in IgAN,
which was designated among the 10 best-ranked abstracts of 2023
ERA.
- 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.
- In late third
quarter or early fourth quarter of 2023, the Company expects to
report topline results from the two-year confirmatory endpoints in
the ongoing Phase 3 PROTECT Study, which are designed to support
traditional approval of sparsentan in IgAN.
Sparsentan - FSGS
- The Company
remains on-track to engage with regulators to explore a potential
path forward for a supplemental New Drug Application (sNDA) for
sparsentan for the treatment of focal segmental glomerulosclerosis
(FSGS) in the U.S. Together with its collaborator CSL Vifor, the
Company also plans to engage with the EMA 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 IgA nephropathy.
Pegtibatinase (TVT-058) –
HCU
- In May 2023, the
Company reported positive topline results from cohort 6 of the
Phase 1/2 COMPOSE Study, 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.
Additional detailed study results from COMPOSE will be presented at
the Society for the Study of Inborn Errors of Metabolism
Annual Symposium (SSIEM), Jerusalem, Israel, August 29-September
1.
- Following the
positive results from cohort 6, the Company is engaging with
regulators on the design of a potential pivotal Phase 3 clinical
trial. The pivotal study, which is anticipated to utilize tHcy
reduction as the primary endpoint to support registration, is
expected to initiate by the end of 2023.
Bile Acid Product Portfolio – Cholbam®
and Chenodal®
- In July 2023,
the Company announced that it has entered into a definitive
agreement with Mirum Pharmaceuticals for the sale of its bile acid
product portfolio that includes Cholbam (cholic acid) and Chenodal
(chenodiol), two medications addressing rare diseases in high-need
settings.
- Under the terms
of the definitive agreement, Mirum will purchase Travere’s bile
acid product portfolio for up to $445 million, consisting of $210
million upfront and up to $235 million in potential sales-based
milestone payments. The transaction is expected to close in the
third quarter of 2023, subject to regulatory clearance and
customary closing conditions.
Conference Call Information
Travere Therapeutics will host a conference call
and webcast today, Thursday, August 3, 2023, at 4:30 p.m. ET to
discuss company updates as well as second quarter 2023 financial
results. To participate in the conference call, dial +1 (888)
394-8218 (U.S.) or +1 (323) 794-2551 (International), confirmation
code 2448893 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, revaluation of business combination related
contingent consideration 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 ultimately become the future
foundational treatment for patients with IgAN; the timing and
achievement of additional development and regulatory milestones;
the advancement of the Company’s pipeline throughout the year;
expectations regarding the future conduct of the ongoing PROTECT
Study and timing for the topline eGFR endpoint analyses; references
to the efficacy, safety and tolerability profile of sparsentan
based on the preliminary data from the PROTECT Study interim
analysis; the Company’s plan and timing for engaging with
regulators to explore a potential path for a regulatory submission
of sparsentan for FSGS; 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 successfully close the
sale of its bile acid product portfolio on the anticipated timeline
or at all, to successfully transition the business to the acquiror,
and to receive the potential sales-based milestone payments from
the sale. 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, including the traditional
and Subpart H accelerated approval pathways in the United States
and the CMA pathway in the European Union, 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 Phase 3 PROTECT
Study of sparsentan in IgAN will not demonstrate that sparsentan is
safe or effective or serve as the basis for further approval of
sparsentan as planned; 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; the risk
that sparsentan will not be approved further for efficacy, safety,
regulatory or other reasons; and for each of the Company’s
programs, risk associated with enrollment of clinical trials for
rare diseases and risk that ongoing or planned clinical trials may
not succeed or may be delayed or abandoned for safety, regulatory,
program assessment or other reasons. There is no guarantee that the
Company will be able to establish a pathway to a potential
submission of sparsentan for FSGS based on the results from the
DUPLEX Study, that the FDA and/or EMA will support an application
for sparsentan in FSGS, or that sparsentan will be approved for
FSGS. There is no guarantee that the FDA will grant traditional
approval of sparsentan for IgAN. There is also no guarantee that
the Company will be able to align with regulators on the design of,
or ultimately proceed with, a pivotal program for pegtibatinase for
HCU. The Company also faces the risk that its cash runway will not
extend as far as anticipated and 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. With respect to the proposed sale of
the Company’s bile acid product portfolio, the Company faces the
risk that the sale will not close on the planned timeline or at all
due to a delay or failure to obtain regulatory approval or for any
other reason; the possible occurrence of any event, change or other
circumstance or condition that could give rise to the termination
of the purchase agreement for the proposed transaction; the
incurrence of significant transaction costs whether or not the
proposed transaction is consummated; the potential for litigation
relating to the proposed transaction; the risk that disruptions
from the proposed transaction will harm the Company’s business,
including current plans and operations; potential adverse reactions
or changes to business relationships resulting from the
announcement or completion of the proposed transaction; and the
risk that the Company will not receive some or all of the potential
sales-based milestone payments under the purchase
agreement. 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, 2023 |
|
December 31, 2022 |
Assets |
(unaudited) |
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
70,874 |
|
|
$ |
61,688 |
|
Marketable debt securities, at fair value |
|
420,463 |
|
|
|
388,557 |
|
Accounts receivable, net |
|
20,397 |
|
|
|
16,646 |
|
Inventory, net |
|
18,765 |
|
|
|
6,922 |
|
Prepaid expenses and other current assets |
|
11,556 |
|
|
|
12,624 |
|
Total current
assets |
|
542,055 |
|
|
|
486,437 |
|
|
|
|
|
Property and equipment,
net |
|
8,570 |
|
|
|
9,049 |
|
Operating lease right of use
assets |
|
19,559 |
|
|
|
21,000 |
|
Intangible assets, net |
|
154,456 |
|
|
|
145,038 |
|
Other assets |
|
11,789 |
|
|
|
11,061 |
|
Total
assets |
$ |
736,429 |
|
|
$ |
672,585 |
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
$ |
19,915 |
|
|
$ |
17,290 |
|
Accrued expenses |
|
88,749 |
|
|
|
95,742 |
|
Deferred revenue, current portion |
|
10,244 |
|
|
|
11,976 |
|
Business combination-related contingent consideration, current
portion |
|
6,900 |
|
|
|
7,000 |
|
Operating lease liabilities, current portion |
|
4,663 |
|
|
|
4,433 |
|
Other current liabilities |
|
5,240 |
|
|
|
5,722 |
|
Total current
liabilities |
|
135,711 |
|
|
|
142,163 |
|
Convertible debt |
|
376,403 |
|
|
|
375,545 |
|
Deferred revenue, less current
portion |
|
6,788 |
|
|
|
10,931 |
|
Business combination-related
contingent consideration, less current portion |
|
67,200 |
|
|
|
64,200 |
|
Operating lease liabilities,
less current portion |
|
25,106 |
|
|
|
27,510 |
|
Other non-current
liabilities |
|
8,736 |
|
|
|
9,385 |
|
Total
liabilities |
|
619,944 |
|
|
|
629,734 |
|
|
|
|
|
Stockholders'
Equity: |
|
|
|
Preferred stock $0.0001 par
value; 20,000,000 shares authorized; 0 issued and outstanding as of
June 30, 2023 and December 31, 2022 |
|
— |
|
|
|
— |
|
Common stock $0.0001 par
value; 200,000,000 shares authorized; 74,971,807, and 64,290,570
issued and outstanding as of June 30, 2023 and December 31, 2022,
respectively |
|
7 |
|
|
|
6 |
|
Additional paid-in capital |
|
1,306,517 |
|
|
|
1,059,975 |
|
Accumulated deficit |
|
(1,186,184 |
) |
|
|
(1,014,223 |
) |
Accumulated other comprehensive loss |
|
(3,855 |
) |
|
|
(2,907 |
) |
Total stockholders'
equity |
|
116,485 |
|
|
|
42,851 |
|
Total liabilities and
stockholders' equity |
$ |
736,429 |
|
|
$ |
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 June 30, |
|
Six Months Ended June 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
(unaudited) |
|
|
|
|
Net product sales: |
|
|
|
|
|
|
|
Bile acid products |
$ |
27,501 |
|
|
$ |
25,534 |
|
|
$ |
53,606 |
|
|
$ |
50,609 |
|
Tiopronin products |
|
26,050 |
|
|
|
25,416 |
|
|
|
47,224 |
|
|
|
46,784 |
|
FILSPARI |
|
3,461 |
|
|
|
— |
|
|
|
6,465 |
|
|
|
— |
|
Total net product sales |
|
57,012 |
|
|
|
50,950 |
|
|
|
107,295 |
|
|
|
97,393 |
|
License and collaboration
revenue |
|
2,685 |
|
|
|
3,217 |
|
|
|
9,395 |
|
|
|
5,261 |
|
Total revenue |
|
59,697 |
|
|
|
54,167 |
|
|
|
116,690 |
|
|
|
102,654 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Cost of goods sold |
|
1,990 |
|
|
|
2,051 |
|
|
|
7,115 |
|
|
|
4,189 |
|
Research and development |
|
69,411 |
|
|
|
59,681 |
|
|
|
129,324 |
|
|
|
116,292 |
|
Selling, general and administrative |
|
74,037 |
|
|
|
52,979 |
|
|
|
146,282 |
|
|
|
99,767 |
|
Change in fair value of contingent consideration |
|
1,840 |
|
|
|
4,907 |
|
|
|
8,596 |
|
|
|
13,987 |
|
Total operating expenses |
|
147,278 |
|
|
|
119,618 |
|
|
|
291,317 |
|
|
|
234,235 |
|
|
|
|
|
|
|
|
|
Operating loss |
|
(87,581 |
) |
|
|
(65,451 |
) |
|
|
(174,627 |
) |
|
|
(131,581 |
) |
|
|
|
|
|
|
|
|
Other income (expenses),
net: |
|
|
|
|
|
|
|
Interest income |
|
5,128 |
|
|
|
782 |
|
|
|
8,774 |
|
|
|
1,060 |
|
Interest expense |
|
(2,911 |
) |
|
|
(2,972 |
) |
|
|
(5,851 |
) |
|
|
(5,487 |
) |
Other (expense) income, net |
|
(201 |
) |
|
|
662 |
|
|
|
(114 |
) |
|
|
688 |
|
Loss on extinguishment of debt |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(7,578 |
) |
Total other income (expense), net |
|
2,016 |
|
|
|
(1,528 |
) |
|
|
2,809 |
|
|
|
(11,317 |
) |
|
|
|
|
|
|
|
|
Loss before income tax
provision |
|
(85,565 |
) |
|
|
(66,979 |
) |
|
|
(171,818 |
) |
|
|
(142,898 |
) |
|
|
|
|
|
|
|
|
Income tax provision |
|
(65 |
) |
|
|
(53 |
) |
|
|
(143 |
) |
|
|
(105 |
) |
|
|
|
|
|
|
|
|
Net loss |
$ |
(85,630 |
) |
|
$ |
(67,032 |
) |
|
$ |
(171,961 |
) |
|
$ |
(143,003 |
) |
|
|
|
|
|
|
|
|
Per share
data: |
|
|
|
|
|
|
|
Basic and diluted net loss per common share |
$ |
(1.13 |
) |
|
$ |
(1.05 |
) |
|
$ |
(2.38 |
) |
|
$ |
(2.26 |
) |
Basic and diluted weighted average common shares outstanding |
|
76,001,801 |
|
|
|
63,638,385 |
|
|
|
72,109,573 |
|
|
|
63,387,009 |
|
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, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
GAAP operating
loss |
$ |
(87,581 |
) |
|
$ |
(65,451 |
) |
|
$ |
(174,627 |
) |
|
$ |
(131,581 |
) |
|
|
|
|
|
|
|
|
R&D operating expense |
|
(69,411 |
) |
|
|
(59,681 |
) |
|
|
(129,324 |
) |
|
|
(116,292 |
) |
|
|
|
|
|
|
|
|
Stock compensation |
|
4,616 |
|
|
|
3,684 |
|
|
|
9,097 |
|
|
|
6,852 |
|
Amortization &
depreciation |
|
2,420 |
|
|
|
1,625 |
|
|
|
4,814 |
|
|
|
1,911 |
|
Subtotal non-GAAP items |
|
7,036 |
|
|
|
5,309 |
|
|
|
13,911 |
|
|
|
8,763 |
|
Non-GAAP R&D expense |
|
(62,375 |
) |
|
|
(54,372 |
) |
|
|
(115,413 |
) |
|
|
(107,529 |
) |
|
|
|
|
|
|
|
|
SG&A operating
expense |
|
(74,037 |
) |
|
|
(52,979 |
) |
|
|
(146,282 |
) |
|
|
(99,767 |
) |
|
|
|
|
|
|
|
|
Stock compensation |
|
6,988 |
|
|
|
8,953 |
|
|
|
16,271 |
|
|
|
13,971 |
|
Amortization &
depreciation |
|
11,482 |
|
|
|
6,483 |
|
|
|
18,634 |
|
|
|
13,289 |
|
Subtotal non-GAAP items |
|
18,470 |
|
|
|
15,436 |
|
|
|
34,905 |
|
|
|
27,260 |
|
Non-GAAP SG&A expense |
|
(55,567 |
) |
|
|
(37,543 |
) |
|
|
(111,377 |
) |
|
|
(72,507 |
) |
|
|
|
|
|
|
|
|
Change in fair value of
contingent consideration |
|
1,840 |
|
|
|
4,907 |
|
|
|
8,596 |
|
|
|
13,987 |
|
Subtotal non-GAAP items |
|
27,346 |
|
|
|
25,652 |
|
|
|
57,412 |
|
|
|
50,010 |
|
Non-GAAP operating
loss |
$ |
(60,235 |
) |
|
$ |
(39,799 |
) |
|
$ |
(117,215 |
) |
|
$ |
(81,571 |
) |
|
|
|
|
|
|
|
|
GAAP net
loss |
$ |
(85,630 |
) |
|
$ |
(67,032 |
) |
|
$ |
(171,961 |
) |
|
$ |
(143,003 |
) |
Non-GAAP operating loss adjustments |
|
27,346 |
|
|
|
25,652 |
|
|
|
57,412 |
|
|
|
50,010 |
|
Income tax provision |
|
65 |
|
|
|
53 |
|
|
|
143 |
|
|
|
105 |
|
Non-GAAP net
loss |
$ |
(58,219 |
) |
|
$ |
(41,327 |
) |
|
$ |
(114,406 |
) |
|
$ |
(92,888 |
) |
|
|
|
|
|
|
|
|
Per share
data: |
|
|
|
|
|
|
|
Basic and diluted net loss per common share |
$ |
(0.77 |
) |
|
$ |
(0.65 |
) |
|
$ |
(1.59 |
) |
|
$ |
(1.47 |
) |
Basic and diluted weighted average common shares outstanding |
|
76,001,801 |
|
|
|
63,638,385 |
|
|
|
72,109,573 |
|
|
|
63,387,009 |
|
|
|
|
|
|
|
|
|
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 |
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