EMA accepted for review the Conditional Marketing Authorization application for sparsentan for IgAN in Europe; review decision expected in second half of 2023
New PDUFA target action date for sparsentan in IgAN set for February 17, 2023
Net product sales of $50.8 million for the third quarter of 2022
SAN DIEGO, Oct. 27, 2022 (GLOBE NEWSWIRE) — Travere Therapeutics, Inc. (NASDAQ: TVTX) today reported its third quarter 2022 financial results and provided a corporate update.
“During the third quarter we continued to execute towards our vision of being a leader in the global rare disease community,” said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics. “Our IgA nephropathy and FSGS programs continue to advance with the goal of positioning sparsentan to become the first and only dual-acting, non-immunosuppressive treatment option for people living with rare kidney disorders. With the new PDUFA target action date confirmed in the U.S. and the acceptance of the CMA application in Europe in the third quarter, we are well positioned for potential approvals of sparsentan for the treatment of IgA nephropathy in both the U.S. and Europe next year. In the U.S., we have already built upon our strong commercial foundation to establish a field team with extensive nephrology experience. Additionally, we continue to look forward to the upcoming readout of our DUPLEX Study of sparsentan in FSGS in the first half of next year, as well as the potential to advance pegtibatinase into a pivotal trial for HCU in 2023.”
Quarter Ended September 30, 2022
Net product sales for the third quarter of 2022 were $50.8 million, compared to $54.2 million for the same period in 2021. For the nine months ended September 30, 2022, net product sales were $148.2 million, compared to $156.2 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 third quarter of 2022 were $59.3 million, compared to $48.4 million for the same period in 2021. For the nine months ended September 30, 2022, R&D expenses were $175.5 million, compared to $148.2 million for the same period in 2021. The difference is largely attributable to the continued advancement of the Company’s sparsentan and pegtibatinase programs, including increased headcount and medical affairs activities. On a non-GAAP adjusted basis, R&D expenses were $54.0 million for the third quarter of 2022, compared to $45.2 million for the same period in 2021.
Selling, general and administrative (SG&A) expenses for the third quarter of 2022 were $57.5 million, compared to $36.1 million for the same period in 2021. For the nine months ended September 30, 2022, SG&A expenses were $157.3 million, compared to $107.8 million for the same period in 2021. The difference is largely attributable to commercial launch preparations, including additional field-based headcount. On a non-GAAP adjusted basis, SG&A expenses were $45.4 million for the third quarter of 2022, compared to $25.5 million for the same period in 2021.
Total other expense, net, for the third quarter of 2022 was $1.4 million, compared to $3.9 million for the same period in 2021. The difference is largely attributable to increased interest income and lower interest expense during the period.
Net loss for the third quarter of 2022 was $69.7 million, or $1.09 per basic share, compared to a net loss of $35.6 million, or $0.59 per basic share for the same period in 2021. For the nine months ended September 30, 2022, net loss was $212.7 million, compared to $128.5 million for the same period in 2021. On a non-GAAP adjusted basis, net loss for the third quarter of 2022 was $48.9 million, or $0.76 per basic share, compared to a net loss of $7.9 million, or $0.13 per basic share for the same period in 2021.
As of September 30, 2022, the Company had cash, cash equivalents and marketable securities of $506.3 million.
Program Updates
Sparsentan – IgAN
Sparsentan – FSGS
Pegtibatinase (TVT-058)
Conference Call Information
Travere Therapeutics will host a conference call and webcast today, Thursday, October 27, 2022 at 4:30 p.m. ET to discuss company updates as well as third quarter 2022 financial results. To participate in the conference call, dial +1 (888) 394-8218 (U.S.) or +1 (323) 794-2551 (International), confirmation code 3327353 shortly before 4:30 p.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 90 days.
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 February 17, 2023 target action date or at all; EMA’s potential approval of sparsentan for IgAN during the second half of 2023 or at all; the Company’s goal of goal of positioning sparsentan to become the first and only dual-acting, non-immunosuppressive treatment option for people living with rare kidney disorders, if approved; the Company’s expectations for a commercial launch of sparsentan for IgAN, 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 a potential regulatory submission of sparsentan in Europe for FSGS and the timing 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 ability to engage with regulators to establish next steps for the design of a pivotal development program to ultimately support potential approvals of pegtibatinase for the treatment of HCU; and the potential for pegtibatinase to become the first disease modifying therapy for people living with HCU;. 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 extended target action date, that the FDA will grant accelerated approval of sparsentan for IgAN within the extended 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.
Contact:
Investors: Naomi Eichenbaum Vice President, Investor Relations 888-969-7879 IR@travere.com |
Media: Nivi Nehra Vice President, Corporate Communications 888-969-7879 mediarelations@travere.com |
TRAVERE THERAPEUTICS, INC. | |||||||
CONSOLIDATED BALANCE SHEETS | |||||||
(in thousands, except share amounts) | |||||||
September 30, 2022 | December 31, 2021 | ||||||
Assets | (unaudited) | ||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 151,337 | $ | 165,753 | |||
Marketable debt securities, at fair value | 354,989 | 387,129 | |||||
Accounts receivable, net | 12,670 | 15,914 | |||||
Inventory, net | 7,297 | 7,313 | |||||
Prepaid expenses and other current assets | 8,549 | 6,718 | |||||
Total current assets | 534,842 | 582,827 | |||||
Property and equipment, net | 9,557 | 11,106 | |||||
Operating lease right of use assets | 21,253 | 23,196 | |||||
Intangible assets, net | 149,469 | 148,435 | |||||
Other assets | 11,094 | 11,069 | |||||
Total assets | $ | 726,215 | $ | 776,633 | |||
Liabilities and Stockholders’ Equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 14,010 | $ | 15,144 | |||
Accrued expenses | 88,383 | 75,180 | |||||
Deferred revenue, current portion | 11,383 | 16,268 | |||||
Business combination-related contingent consideration, current portion | 7,300 | 7,400 | |||||
Operating lease liabilities, current portion | 4,233 | 3,908 | |||||
Other current liabilities | 5,723 | 6,188 | |||||
Total current liabilities | 131,032 | 124,088 | |||||
Convertible debt | 375,117 | 226,581 | |||||
Deferred revenue, less current portion | 12,919 | 20,379 | |||||
Business combination-related contingent consideration, less current portion | 68,900 | 59,700 | |||||
Operating lease liabilities, less current portion | 28,267 | 31,497 | |||||
Other non-current liabilities | 9,304 | 12,276 | |||||
Total liabilities | 625,539 | 474,521 | |||||
Stockholders’ Equity: | |||||||
Preferred stock $0.0001 par value; 20,000,000 shares authorized; 0 issued and outstanding as of September 30, 2022 and December 31, 2021 | — | — | |||||
Common stock $0.0001 par value; 200,000,000 shares authorized; 64,150,510, and 62,491,498 issued and outstanding as of September 30, 2022 and December 31, 2021, respectively | 6 | 6 | |||||
Additional paid-in capital | 1,048,767 | 1,068,634 | |||||
Accumulated deficit | (948,400 | ) | (765,966 | ) | |||
Accumulated other comprehensive loss | 303 | (562 | ) | ||||
Total stockholders’ equity | 100,676 | 302,112 | |||||
Total liabilities and stockholders’ equity | $ | 726,215 | $ | 776,633 |
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, | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
(unaudited) | |||||||||||||||
Net product sales: | |||||||||||||||
Bile acid products | $ | 25,420 | $ | 24,353 | $ | 76,029 | $ | 71,291 | |||||||
Tiopronin products | 25,370 | 29,821 | 72,154 | 84,907 | |||||||||||
Total net product sales | 50,790 | 54,174 | 148,183 | 156,198 | |||||||||||
License and collaboration revenue | 2,706 | 14,043 | 7,967 | 14,043 | |||||||||||
Total revenue | 53,496 | 68,217 | 156,150 | 170,241 | |||||||||||
Operating expenses: | |||||||||||||||
Cost of goods sold | 1,675 | 1,592 | 5,864 | 4,888 | |||||||||||
Research and development | 59,256 | 48,407 | 175,548 | 148,160 | |||||||||||
Selling, general and administrative | 57,519 | 36,065 | 157,286 | 107,808 | |||||||||||
Change in fair value of contingent consideration | 3,180 | 13,864 | 17,167 | 23,960 | |||||||||||
Total operating expenses | 121,630 | 99,928 | 355,865 | 284,816 | |||||||||||
Operating loss | (68,134 | ) | (31,711 | ) | (199,715 | ) | (114,575 | ) | |||||||
Other income (expenses), net: | |||||||||||||||
Interest income | 2,101 | 360 | 3,161 | 1,757 | |||||||||||
Interest expense | (2,892 | ) | (4,899 | ) | (8,379 | ) | (15,072 | ) | |||||||
Loss on early extinguishment of debt | — | — | (7,578 | ) | — | ||||||||||
Other income (expense), net | (586 | ) | 654 | 102 | (223 | ) | |||||||||
Total other expense, net | (1,377 | ) | (3,885 | ) | (12,694 | ) | (13,538 | ) | |||||||
Loss before income tax provision | (69,511 | ) | (35,596 | ) | (212,409 | ) | (128,113 | ) | |||||||
Income tax provision | (145 | ) | (43 | ) | (250 | ) | (405 | ) | |||||||
Net loss | $ | (69,656 | ) | $ | (35,639 | ) | $ | (212,659 | ) | $ | (128,518 | ) | |||
Per share data: | |||||||||||||||
Basic and diluted net loss per common share | $ | (1.09 | ) | $ | (0.59 | ) | $ | (3.34 | ) | $ | (2.17 | ) | |||
Basic and diluted weighted average common shares outstanding | 64,033,759 | 60,803,045 | 63,604,962 | 59,230,881 |
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, | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
GAAP operating loss | $ | (68,134 | ) | $ | (31,711 | ) | $ | (199,715 | ) | $ | (114,575 | ) | |||
R&D operating expense | (59,256 | ) | (48,407 | ) | (175,548 | ) | (148,160 | ) | |||||||
Stock compensation | 3,393 | 2,630 | 10,245 | 8,477 | |||||||||||
Amortization & depreciation | 1,906 | 614 | 3,817 | 1,188 | |||||||||||
Subtotal non-GAAP items | 5,299 | 3,244 | 14,062 | 9,665 | |||||||||||
Non-GAAP R&D expense | (53,957 | ) | (45,163 | ) | (161,486 | ) | (138,495 | ) | |||||||
SG&A operating expense | (57,519 | ) | (36,065 | ) | (157,286 | ) | (107,808 | ) | |||||||
Stock compensation | 5,433 | 4,356 | 19,404 | 13,713 | |||||||||||
Amortization & depreciation | 6,672 | 6,250 | 19,961 | 18,369 | |||||||||||
Subtotal non-GAAP items | 12,105 | 10,606 | 39,365 | 32,082 | |||||||||||
Non-GAAP SG&A expense | (45,414 | ) | (25,459 | ) | (117,921 | ) | (75,726 | ) | |||||||
Change in fair value of contingent consideration | 3,180 | 13,864 | 17,167 | 23,960 | |||||||||||
Subtotal non-GAAP items | 20,584 | 27,714 | 70,594 | 65,707 | |||||||||||
Non-GAAP operating loss | $ | (47,550 | ) | $ | (3,997 | ) | $ | (129,121 | ) | $ | (48,868 | ) | |||
GAAP net loss | $ | (69,656 | ) | $ | (35,639 | ) | $ | (212,659 | ) | $ | (128,518 | ) | |||
Non-GAAP operating loss adjustments | 20,584 | 27,714 | 70,594 | 65,707 | |||||||||||
Income tax provision | 145 | 43 | 250 | 405 | |||||||||||
Non-GAAP net loss | $ | (48,927 | ) | $ | (7,882 | ) | $ | (141,815 | ) | $ | (62,406 | ) | |||
Per share data: | |||||||||||||||
Basic and diluted net loss per common share | $ | (0.76 | ) | $ | (0.13 | ) | $ | (2.23 | ) | $ | (1.05 | ) | |||
Basic and diluted weighted average common shares outstanding | 64,033,759 | 60,803,045 | 63,604,962 | 59,230,881 | |||||||||||
Note: Certain adjustments / reclassifications have been made to prior periods to conform to current year presentation.
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