Full Press Release Details
Senior Vice President, Investor Relations & Corporate Communications
Travere Therapeutics Reports
Second Quarter 2022 Financial Results
SAN DIEGO, August 4, 2022 Travere Therapeutics, Inc. (NASDAQ: TVTX) today
reported its second quarter 2022 financial results and provided a corporate update.
In the second quarter, the FDA accepted for review our NDA for sparsentan for the treatment of IgA nephropathy and granted
priority review; this positions us for the first potential approval of sparsentan in November and keeps us on course to achieve our goal of making sparsentan a new treatment standard for rare kidney disorders said Eric Dube, Ph.D., president
and chief executive officer of Travere Therapeutics. Our organization is making great progress in building upon our existing commercial capabilities to prepare for a potential launch that will provide broad access to sparsentan, if approved.
In addition, we continue to advance our pipeline with the vision of strengthening our leadership position in the rare disease community. The DUPLEX Study of sparsentan in FSGS continues to progress and we look forward to reporting two-year results in the first half of next year. We are also very pleased to receive Breakthrough Therapy Designation for our pegtibatinase program in HCU. We look forward to continuing to work with regulators this
year to align on the design of a pivotal program that can enable pegtibatinase to potentially become the first disease modifying therapy for the HCU community.
Quarter Ended June 30, 2022
Net product sales for
the second quarter of 2022 were $51.0 million, compared to $54.6 million for the same period in 2021. For the six months ended June 30, 2022, net product sales were $97.4 million, compared to $102.0 million for the same
period in 2021. The difference is largely attributable to a decrease in Thiola sales partially offset by an increase in sales for the Company s bile acid products.
Research and development (R&D) expenses for the second quarter of 2022 were $59.7 million, compared to $51.8 million for the same period in
2021. For the six months ended June 30, 2022, R&D expenses were $116.3 million, compared to $99.8 million for the same period in 2021. The difference is largely attributable to increased headcount and medical affairs activities to
support the continued advancement of the sparsentan and pegtibatinase programs. On a non-GAAP adjusted basis, R&D expenses were $54.4 million for the second quarter of 2022, compared to
$48.7 million for the same period in 2021.
Selling, general and administrative (SG&A) expenses for the second quarter of 2022 were
$53.0 million, compared to $35.0 million for the same period in 2021. For the six months ended June 30, 2022, SG&A expenses were $99.8 million, compared to $71.7 million for the same period in 2021. The difference is
largely attributable to increased headcount as a result of the Company s operational growth, and commercial launch preparations. On a non-GAAP adjusted basis, SG&A expenses were $37.5 million for
the second quarter of 2022, compared to $24.0 million for the same period in 2021.
Total other expense, net, for the second quarter of 2022 was
$1.5 million, compared to $3.6 million for the same period in 2021. The difference is largely attributable to lower interest expense during the period.
Net loss for the second quarter of 2022 was $67.0 million, or $1.05 per basic share, compared to a net loss of $39.0 million, or $0.64 per basic
share for the same period in 2021. For the six months ended June 30, 2022, net loss was $143.0 million, compared to $92.9 million for the same period in 2021. On a non-GAAP adjusted basis, net
loss for the second quarter of 2022 was $41.3 million, or $0.65 per basic share, compared to a net loss of $23.3 million, or $0.39 per basic share for the same period in 2021.
As of June 30, 2022, the Company had cash, cash equivalents and marketable securities of $553.2 million.
Pegtibatinase (TVT-058)
Upcoming Investor Conference Participation
Company management will present at the 2022 Wedbush PacGrow Healthcare Virtual Conference on Tuesday, August 9, 2022 at 4:05 p.m. ET.
A live webcast will be available at https://ir.travere.com/events-presentations and an archived replay will be accessible for up to 30 days.
Conference Call Information
Travere Therapeutics will
host a conference call and webcast today, Thursday, August 4, 2022 at 8:00 a.m. ET to discuss company updates as well as second quarter 2022 financial results. To participate in the conference call, dial +1 (888)
220-8474 (U.S.) or +1 (313) 209-6544 (International), confirmation code 5371785 shortly before 8:00 a.m. ET. The webcast can be accessed at travere.com, in the Events
and Presentations section of the Investors & Media page, and will be archived for at least 30 days. A replay of the call will be available from 11:00 a.m. ET, August 4, 2022 to 11:00 a.m. ET, August 11, 2022. The replay number is
+1 (888) 203-1112 (U.S.) or +1 (719) 457-0820 (International), confirmation code 5371785.
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 income (loss) measures exclude from GAAP net
income (loss), as applicable, stock-based compensation expense, amortization and depreciation expense, revaluation of acquisition 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
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 , may , might , believes , anticipates , plans , expects ,
intends 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: the likelihood of the
FDA s potential approval of sparsentan for IgAN by the November 17, 2022 target action date or at all; the expectation around any potential future request by the FDA to hold an advisory committee meeting related to the sparsentan IgAN
application; the Company s goal of making sparsentan a new treatment standard for rare kidney disorders, if approved; the Company s expectations for a commercial launch of sparsentan for IgAN with broad access, if approved; expectations
regarding the future conduct of the ongoing PROTECT and DUPLEX studies and timing for the topline eGFR endpoint analyses; the ability to submit for traditional approval in FSGS following the completion of the DUPLEX Study and expectations regarding
the timing thereof, as well as plans for regulatory submissions of sparsentan in Europe for IgAN and FSGS and the timings thereof; references to the efficacy, safety and tolerability profile of sparsentan based on the preliminary data from the
DUPLEX and PROTECT Studies interim analyses; the Company s belief that preliminary eGFR data available at the time of the interim analysis from the PROTECT Study are indicative of a potential clinically meaningful treatment effect after
two years of treatment; the potential for sparsentan to become the first medicine approved for both FSGS and IgAN; the Company s plans for working with regulators this year to align on the design of a pivotal program that can enable
pegtibatinase to potentially become the first disease modifying therapy for the HCU; and the expectation that Breakthrough Therapy designation for pegtibatinase for HCU will confer advantages on the program. 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 Subpart H accelerated approval pathway in the United States and the conditional marketing authorization (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. 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 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 accelerated approval of sparsentan as planned; the risk that the Phase 3 DUPLEX Study of sparsentan in FSGS will not demonstrate that sparsentan is safe or effective or serve as a basis for traditional approval of
sparsentan as planned; and the risk that sparsentan will not be approved 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 for safety, regulatory or other reasons. There is no guarantee that the review process for the sparsentan IgAN NDA will remain on track for the FDA s assigned target action date, that the FDA will grant accelerated
approval of sparsentan for IgAN within the assigned target action date, or at all, or that the DUPLEX Study will support an application for traditional review or that sparsentan will be approved for FSGS. There is also no guarantee that the results
from the ongoing clinical study of pegtibatinase will be positive or that the Company will be able to align with regulators on the design of a pivotal program for pegtibatinase for HCU. The Company faces 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; risk 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. The Company faces additional risks associated with the potential impacts the
COVID-19 pandemic may have on its business, including, but not limited to (i) the Company s ability to continue its ongoing development activities and clinical trials, (ii) the timing of such
clinical trials and the release of data from those trials, (iii) the Company s and its suppliers ability to successfully manufacture its commercial products and product candidates, and (iv) the market for and sales of its
commercial products. 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, 2022 | December 31, 2021 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 179,759 | $ | 165,753 | ||||
| Marketable debt securities, at fair value | 373,414 | 387,129 | ||||||
| Accounts receivable, net | 16,689 | 15,914 | ||||||
| Inventory, net | 7,632 | 7,313 | ||||||
| Prepaid expenses and other current assets | 9,283 | 6,718 | ||||||
| Total current assets | 586,777 | 582,827 | ||||||
| Property and equipment, net | 10,080 | 11,106 | ||||||
| Operating lease right of use assets | 21,910 | 23,196 | ||||||
| Intangible assets, net | 149,920 | 148,435 | ||||||
| Other assets | 10,807 | 11,069 | ||||||
| Total assets | $ | 779,494 | $ | 776,633 | ||||
| Liabilities and Stockholders Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 11,848 | $ | 15,144 | ||||
| Accrued expenses | 82,694 | 75,180 | ||||||
| Deferred revenue, current portion | 12,503 | 16,268 | ||||||
| Business combination-related contingent consideration, current portion | 7,300 | 7,400 | ||||||
| Operating lease liabilities, current portion | 4,123 | 3,908 | ||||||
| Other current liabilities | 6,024 | 6,188 | ||||||
| Total current liabilities | 124,492 | 124,088 | ||||||
| Convertible debt | 374,690 | 226,581 | ||||||
| Deferred revenue, less current portion | 16,235 | 20,379 | ||||||
| Business combination-related contingent consideration, less current portion | 68,400 | 59,700 | ||||||
| Operating lease liabilities, less current portion | 29,359 | 31,497 | ||||||
| Other non-current liabilities | 9,605 | 12,276 | ||||||
| Total liabilities | 622,781 | 474,521 | ||||||
| Stockholders Equity: | ||||||||
| Preferred stock $0.0001 par value; 20,000,000 shares authorized; 0 issued and outstanding as of June 30, 2022 and December 31, 2021 | ||||||||
| Common stock $0.0001 par value; 200,000,000 shares authorized; 63,838,050, and 62,491,498 issued and outstanding as of June 30, 2022 and December 31, 2021, respectively | 6 | 6 | ||||||
| Additional paid-in capital | 1,036,533 | 1,068,634 | ||||||
| Accumulated deficit | (878,744 | ) | (765,966 | ) | ||||
| Accumulated other comprehensive loss | (1,082 | ) | (562 | ) | ||||
| Total stockholders equity | 156,713 | 302,112 | ||||||
| Total liabilities and stockholders equity | $ | 779,494 | $ | 776,633 |
Note: Certain adjustments / reclassifications have been made to prior periods to conform to current year
TRAVERE THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)