Travere Therapeutics, Inc. (NASDAQ:TVTX) Q1 2023 Earnings Conference Call May 4, 2023 4:30 PM ET Company Participants Naomi Eichenbaum - VP, IR Eric Dube - President, CEO and Director Jula Inrig - Chief Medical Officer Christopher Cline - CFO Peter Heerma - Chief Commercial Officer William Rote - SVP, Research and Development Conference Call Participants Maury Raycroft - Jefferies Greg Harrison - Bank of America Joseph Schwartz - SVB Securities Leon Wang - Barclays Liisa Bayko - Evercore ISI Laura Chico - W ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 _________________________________ FORM 10-Q _________________________________ ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 001-36257 TRAVERE THERAPEUTICS, INC. (Exact name o ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2022 ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Commission File Number: 001-36257 TRAVERE THERAPEUTICS, INC. (Exact Name of Registrant as specified in its Charter) Delaware 27-4842691 (State or other jurisdiction of incorporation or organization) (I.R.S. E ...

Travere Therapeutics Corporate Overview November 2022 © 2022 Travere Therapeutics, Inc. Forward-Looking Statements 2 This presentation contains forward-looking statements, including statements about our prospects, products, growth projections, competitive position, potential regulatory filings and agency actions, and the anticipated development, timing, data readouts and therapeutic scope of programs in our clinical pipeline. These forward- looking statements may be accompanied by such words as "anticipate, ...

Travere Therapeutics, Inc. (NASDAQ:TVTX) Q3 2022 Earnings Conference Call October 27, 2022 4:30 PM ET Company Participants Naomi Eichenbaum - Vice President, Investor Relations Eric Dube - President and Chief Executive Officer Jula Inrig - Chief Medical Officer Peter Heerma - Chief Commercial Officer Chris Cline - Chief Financial Officer William Rote - Senior Vice President of Research and Development Conference Call Participants Maurice Raycroft - Jefferies Greg Harrison - Bank of America Tim Lugo - Willia ...

Financial Data and Key Metrics Changes - For Q2 2022, total revenue was reported at $54.2 million, consisting of approximately $51 million in net product sales and $3.2 million in collaboration revenue, compared to $54.6 million in net product sales for the same period in 2021 [31] - The company reported a GAAP net loss of $67 million for Q2 2022, with a non-GAAP net loss of $41.3 million after adjusting for noncash expenses and income tax [31][32] - Cash and cash equivalents at the end of Q2 2022 stood at $553.2 million, which is expected to support operations into 2024 [33] Business Line Data and Key Metrics Changes - The sparsentan program is on track for a potential approval for IgA nephropathy by the PDUFA target action date of November 17, 2022, while the FSGS program is pursuing traditional approval based on 2-year eGFR slope data [7][11] - The pegtibatinase program received breakthrough therapy designation from the FDA, indicating significant unmet need and promising data [12][22] Market Data and Key Metrics Changes - The company is preparing for the launch of sparsentan for IgA nephropathy, with strong engagement from the nephrology community and patient advocacy groups [16][27] - The bile acid portfolio, led by Cholbam, performed well during the quarter, with expectations for growth in the second half of the year [24] Company Strategy and Development Direction - The company aims to position sparsentan as a foundational therapy for IgA nephropathy and FSGS, focusing on medical education and engagement with nephrologists [13][30] - The strategy includes applying for conditional marketing authorization of sparsentan for IgA nephropathy in Europe, with a review decision anticipated in the second half of 2023 [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential approval of sparsentan for IgA nephropathy and the ability to submit a supplemental NDA for FSGS based on supportive data from the DUPLEX study [11][36] - The company is focused on ensuring broad access to sparsentan, with plans to price it competitively to achieve its vision of making it a new treatment standard [72] Other Important Information - The company completed its recruitment of the field force to support the potential launch of sparsentan, with team members having significant nephrology experience [26] - The company anticipates increases in R&D and SG&A expenses as it prepares for the potential launch of sparsentan [32][33] Q&A Session Summary Question: What 2-year data from DUPLEX was the FDA able to look at? - The FDA reviewed a descriptive look at the composite of all available eGFR data for the sparsentan arm and the irbesartan treatment arm, without breaking it down by duration in the study [42] Question: Are you expecting the initial patient bolus to start sparsentan post-approval? - Initial uptake is expected to be strong once physicians gain experience with sparsentan, despite the conservative nature of nephrologists as prescribers [46] Question: Has the FDA quantified what the threshold is for FSGS approval? - The FDA has not set a specific threshold but acknowledged the high bar for accelerated approval due to the challenges in studying FSGS [50] Question: Can you elaborate on the heterogeneity of the FSGS patients enrolled in DUPLEX? - The trial enrolled a wide spectrum of FSGS patients, including those with primary FSGS and genetic patients, representing the largest trial of FSGS patients to date [59] Question: Have you thought about pricing to balance patient benefit with value? - The company has not disclosed specific pricing yet but is studying the burden of disease and the value proposition of sparsentan [70][72]

PART I – FINANCIAL INFORMATION [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) Financial statements for Q2 2022 reveal increased liabilities from new convertible debt, a wider net loss due to higher operating expenses, and significant cash usage in operations offset by financing activities [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets slightly increased to $779.5 million, while total liabilities significantly rose to $622.8 million due to convertible debt, leading to a decrease in stockholders' equity Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | June 30, 2022 (unaudited) | December 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $179,759 | $165,753 | | Total current assets | $586,777 | $582,827 | | **Total assets** | **$779,494** | **$776,633** | | Total current liabilities | $124,492 | $124,088 | | Convertible debt | $374,690 | $226,581 | | **Total liabilities** | **$622,781** | **$474,521** | | **Total stockholders' equity** | **$156,713** | **$302,112** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Q2 2022 saw total revenue of $54.2 million and a net loss of $67.0 million, a wider loss than Q2 2021, driven by increased R&D and SG&A expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2022 | Q2 2021 | YTD 2022 | YTD 2021 | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $54,167 | $54,617 | $102,654 | $102,024 | | Research and development | $59,681 | $51,807 | $116,292 | $99,753 | | Selling, general and administrative | $52,979 | $34,965 | $99,767 | $71,743 | | Operating loss | ($65,451) | ($35,315) | ($131,581) | ($82,864) | | **Net loss** | **($67,032)** | **($39,012)** | **($143,003)** | **($92,879)** | | Net loss per share (basic & diluted) | ($1.05) | ($0.64) | ($2.26) | ($1.59) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly increased to $92.1 million, offset by $114.7 million from financing, resulting in a $14.0 million net cash increase Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Cash Flow Category | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($92,126) | ($19,978) | | Net cash used in investing activities | ($5,931) | ($177,513) | | Net cash provided by financing activities | $114,744 | $196,056 | | **Net increase (decrease) in cash** | **$14,006** | **($1,484)** | | **Cash and cash equivalents, end of period** | **$179,759** | **$83,288** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail business, accounting policies, revenue, collaborations, and debt, highlighting product sales, the Vifor Pharma collaboration, and significant convertible debt restructuring - The company is a biopharmaceutical firm focused on rare diseases, with key clinical programs for sparsentan (FSGS and IgAN), pegtibatinase (HCU), and Chenodal (CTX) Approved products include Chenodal, Cholbam, and Thiola/Thiola EC[28](index=28&type=chunk)[30](index=30&type=chunk)[35](index=35&type=chunk) Net Product Sales by Category (in thousands) | Product Category | Q2 2022 | Q2 2021 | YTD 2022 | YTD 2021 | | :--- | :--- | :--- | :--- | :--- | | Bile acid products | $25,534 | $24,974 | $50,609 | $46,938 | | Tiopronin products | $25,416 | $29,643 | $46,784 | $55,086 | | **Total net product sales** | **$50,950** | **$54,617** | **$97,393** | **$102,024** | - Under the September 2021 license agreement with Vifor Pharma for sparsentan, the company received a **$55.0 million** upfront payment For the three and six months ended June 30, 2022, the company recognized **$3.2 million** and **$5.3 million**, respectively, in license and collaboration revenue[61](index=61&type=chunk)[66](index=66&type=chunk) - In March 2022, the company issued **$316.3 million** of **2.25%** Convertible Senior Notes due 2029 Concurrently, it repurchased **$207.1 million** of its **2.50%** Convertible Senior Notes due 2025, resulting in a **$7.6 million** loss on early extinguishment of debt[97](index=97&type=chunk)[108](index=108&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses pipeline updates, including sparsentan's NDA Priority Review, and financial results showing decreased product sales and increased operating expenses, while affirming sufficient liquidity for the next 12 months [Pipeline and Approved Products](index=25&type=section&id=Pipeline%20and%20Approved%20Products) The pipeline is led by sparsentan, with an IgAN NDA under Priority Review and traditional approval planned for FSGS, alongside positive Phase 1/2 results for pegtibatinase and existing approved products - The FDA accepted and granted **Priority Review** for the New Drug Application (NDA) of sparsentan for IgAN, with a PDUFA target action date of **November 17, 2022**[140](index=140&type=chunk) - Following FDA feedback, the company no longer plans to seek accelerated approval for sparsentan in FSGS and will instead file for traditional approval after the DUPLEX study completes in the **first half of 2023**[141](index=141&type=chunk) - Pegtibatinase (TVT-058) for HCU demonstrated **positive topline results** in its Phase 1/2 COMPOSE Study, showing **dose-dependent reductions** in total homocysteine (tHcy) The company is engaging with regulators on next steps for a pivotal program[144](index=144&type=chunk)[145](index=145&type=chunk) - A generic version of the 100 mg original formulation of Thiola became available in **May 2021**, which has impacted sales of the company's Tiopronin products[152](index=152&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) Net product revenues decreased by $3.7 million in Q2 2022, mainly from lower Tiopronin sales, while operating expenses significantly rose due to increased R&D and SG&A for pipeline advancement and launch preparations Net Product Sales Change (in thousands) | Product | Q2 2022 vs Q2 2021 Change | YTD 2022 vs YTD 2021 Change | | :--- | :--- | :--- | | Bile acid products | $560 | $3,671 | | Tiopronin products | ($4,227) | ($8,302) | | **Total net product revenues** | **($3,667)** | **($4,631)** | - R&D expenses increased by **$7.9 million** in Q2 2022 and **$16.5 million** in H1 2022 compared to the prior year periods, due to increased headcount and external costs for the sparsentan and pegtibatinase programs[160](index=160&type=chunk) - SG&A expenses rose by **$18.0 million** in Q2 2022 and **$28.0 million** in H1 2022 year-over-year, largely due to increased headcount for operational growth and commercial launch preparations[162](index=162&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2022, the company held $553.2 million in cash and investments, deemed sufficient for over 12 months, bolstered by $306.4 million from convertible notes and $20.1 million from an ATM equity offering - The company believes its available cash and short-term investments of **$553.2 million** as of June 30, 2022, are sufficient to fund operations **beyond the next 12 months**[135](index=135&type=chunk)[168](index=168&type=chunk) - In H1 2022, the company sold **701,600 shares** under its ATM Agreement for gross proceeds of **$20.1 million** As of June 30, 2022, **$19.5 million** remained eligible for sale under the ATM program[173](index=173&type=chunk) - The company has future contingent cash payment obligations related to the Ligand License Agreement for sparsentan (**up to $114.1 million** in milestones) and a new collaboration with PharmaKrysto for a cystinuria program (**up to $16.0 million** in milestones)[176](index=176&type=chunk)[177](index=177&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its $553.2 million investment portfolio, with a 100 basis point change estimated to impact its value by $1.7 million - The company's main market risk is interest rate sensitivity on its **$553.2 million** portfolio of cash equivalents and marketable debt securities[203](index=203&type=chunk) - A hypothetical **100 basis point (1%)** change in interest rates would impact the investment portfolio's value by approximately **$1.7 million**[203](index=203&type=chunk) [Item 4. Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2022, with no significant changes to internal control over financial reporting during the quarter - Based on an evaluation as of the end of the quarter, the CEO and CFO concluded that the company's disclosure controls and procedures were **effective** at the reasonable assurance level[206](index=206&type=chunk) - **No significant changes** to internal control over financial reporting occurred during the quarter ended June 30, 2022, that have materially affected or are likely to materially affect such controls[207](index=207&type=chunk) PART II – OTHER INFORMATION [Item 1. Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company faces routine legal matters, none expected to be materially adverse, though a French authority claim for Kolbam sales reimbursement from 2015-2020 has an unestimable potential liability - In October 2021, French authorities sought reimbursement for a portion of Kolbam sales in France from 2015-2020 The company **cannot estimate the potential liability** at this time[116](index=116&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including clinical trial failures, regulatory approval uncertainty, manufacturing dependence, generic competition, financial indebtedness, and operational challenges like data security and business disruptions - Clinical trials for key candidates like sparsentan and pegtibatinase may **fail to demonstrate safety and efficacy**, which could prevent or delay regulatory approval[210](index=210&type=chunk) - The company faces **generic competition** for its products; a generic version of the 100 mg Thiola tablet was approved in May 2021, which has **negatively impacted sales**[244](index=244&type=chunk)[298](index=298&type=chunk) - The company is **dependent on third-party manufacturers**, who are often **sole-source suppliers**, for its products Any disruption could **adversely impact commercialization and supply**[254](index=254&type=chunk)[300](index=300&type=chunk) - The company's indebtedness of approximately **$385 million** as of March 31, 2022, could **adversely affect its financial condition and ability to fund operations**[393](index=393&type=chunk) - The business is subject to stringent and evolving data privacy and security regulations (e.g., GDPR, CCPA), and a failure to comply or a data breach could result in **significant penalties and reputational harm**[364](index=364&type=chunk)[372](index=372&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=58&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred during the reporting period - None[405](index=405&type=chunk) [Item 3. Defaults Upon Senior Securities](index=58&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported during the period - None[406](index=406&type=chunk) [Item 4. Mine Safety Disclosures](index=58&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This disclosure item is not applicable to the company's operations - Not applicable[407](index=407&type=chunk) [Item 5. Other Information](index=58&type=section&id=Item%205.%20Other%20Information) No other material information was reported for the period - None[408](index=408&type=chunk) [Item 6. Exhibits](index=59&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate governance documents, an equity incentive plan, and CEO/CFO certifications - The exhibits include CEO and CFO certifications pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act, as well as Inline XBRL data files[410](index=410&type=chunk)

Travere Therapeutics, Inc. (NASDAQ:TVTX) Q1 2022 Earnings Conference Call May 5, 2022 4:30 PM ET Company Participants Chris Cline – Senior Vice President-Investor Relations Eric Dube – Chief Executive Officer Jula Inrig – Chief Medical Officer Peter Heerma – Chief Commercial Officer Laura Clague – Chief Financial Officer Bill Rote – Senior Vice President-Research & Development Conference Call Participants Carter Gould – Barclays Mary Kate Davis – Bank of America Liisa Bayko – Evercore ISI Maury Raycroft – J ...

| | UNITED STATES | | --- | --- | | | SECURITIES AND EXCHANGE COMMISSION | | | WASHINGTON, D.C. 20549 | | | _________________________________ | | | FORM 10-Q | | | _________________________________ | | ☑ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | | | For the quarterly period ended March 31, 2022 | | | or | | ☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | | | For the transition period from ___________ to ________ ...

Travere Therapeutics Corporate Overview March 2022 © 2021 Travere Therapeutics, Inc. Forward-Looking Statements 2 This presentation contains forward-looking statements, including statements about our prospects, products, growth projections, competitive position, potential regulatory filings and agency actions, and the anticipated development, timing, data readouts and therapeutic scope of programs in our clinical pipeline. These forward- looking statements may be accompanied by such words as "anticipate," " ...