Travere Therapeutics : Corporate Overview – May 2024

Travere Therapeutics Corporate Overview

May 2024

Forward-Looking Statements

contains forward-looking statements, including but not limited to statements about: continued progress with the FILSPARI launch; the anticipated and outcome of the FDA's review of our sNDA submission for FILSPARI in IgAN; the potential for FILSPARI and pegtibatinase to become new treatment standards in IgAN and HCU; additional development and regulatory milestones, including expected data from additional studies; statements regarding plans to engage with the FDA on potential regulatory pathways for sparsentan in FSGS and the anticipated timing thereof; the advancement of our pipeline throughout the year; expectations regarding the Phase 3 HARMONY Study and the other studies described herein, including anticipated timing for topline data; the potential inclusion of FILSPARI in the KDIGO guidelines; statements regarding potential future milestone and royalty payments; statements regarding potential changes to treatment paradigms; statements regarding estimates of potential addressable market sizes; and statements regarding financial metrics and expectations related

thereto. These forward-looking statements may be accompanied by such words as "anticipate," "believe," "estimate," "expect," "forecast," "intend," "may," "plan,"

"project," "schedule," "target," "will," and other words and terms of similar meaning. You should not place undue reliance on these statements.

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with the regulatory review and approval process, as well as risks and uncertainties associated with our business and finances in general, success of our commercial products, and risks and uncertainties associated with our preclinical and clinical stage pipeline. Specifically, we face risks associated with the ongoing commercial launch of FILSPARI, market acceptance of our 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 we face with respect to our preclinical and clinical stage pipeline include risk that our 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, we face risks related to the timing and potential outcome of our Phase 3 HARMONY Study and the other studies described herein, and the timing and potential outcome of the FDA's review of our sNDA submission for full approval of FILSPARI in IgAN. There is no guarantee that regulators will grant full approval of sparsentan for IgAN or FSGS. We also face the risk that we will not receive some or all of the potential future milestone and/or royalty payments described herein, the risk that our cash runway might not last as long as currently anticipated and the risk that we will be unable to raise additional funding that may be required to complete development of any or all of our product candidates, including as a result of macroeconomic conditions; risks relating to our dependence on contractors for clinical drug supply and commercial manufacturing; uncertainties relating to patent protection and exclusivity periods and intellectual property rights of third parties; risks associated with regulatory interactions; and risks and uncertainties relating to competitive products, including current and potential future generic competition with certain of our products, and technological changes that may limit demand for our products. We also face 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, and the other risks and uncertainties that are described in the Risk Factors section of our most recent annual or quarterly report and in other reports we have filed with the SEC.

These statements are based on our current beliefs and expectations and speak only as of the date of this presentation. We do not undertake any obligation to publicly update any forward-looking statements.

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© 2024 Travere Therapeutics, Inc.

rare for life.

Travere Therapeutics, we are a biopharmaceutical company that comes together every day to help patients, families,

caregivers of all backgrounds as they navigate life with a rare disease. On this path, know the need for treatment options is

urgent - that is why our global team works the rare disease community to identify, develop, and deliver life-changing therapies.

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Travere Has

a Vital Role in

Rare Kidney and

Rare Metabolic

Diseases

	30k-50k
	addressable
>$10B	IgAN patients
	in U.S.
Market Size
	7k-10k
	addressable	15k-30k
	HCU patients
	addressable
	globally*	FSGS patients

In U.S.*

With two future potential treatment standards for rare kidney and metabolic disorders in global markets projected to exceed $10B, we are breaking down barriers in treating diseases with historically little innovation

Through further clinical development and commercial execution, we will solidify our position as a leader in rare kidney and metabolic diseases

Continue diversifying our growth through external innovation and applying our expertise developing therapies through to successful commercialization

* If approved

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Pipeline of Potential First-in-Class Programs

Targeting Rare Kidney and Metabolic Diseases

PROGRAM		THERAPEUTIC AREA	PRECLINICAL	PHASE 1	PHASE 2	PHASE 3	APPROVED	COMMERCIAL

FILSPARI®

(sparsentan)1,2IgAN

Sparsentan3FSGS

PegtibatinaseHCU (TVT-058)

ALGSALGS

Collaboration

Thiola EC® and	Cystinuria
Thiola® (tiopronin)
IgAN: IgA nephropathy; FSGS: focal segmental glomerulosclerosis; HCU: classical homocystinuria; ALGS: Alagille syndrome 1On February 17, 2023, the FDA granted approval of sparsentan under the
accelerated approval pathway for the reduction of proteinuria in IgA nephropathy (IgAN) for adults at risk of rapid disease progression. CSL Vifor has exclusive commercial rights for sparsentan in
Europe, Australia, and New Zealand. Renalys Pharma has exclusive commercial rights for sparsentan in Japan, South Korea, Taiwan, and Southeast Asian nations. 2In May 2024, the FDA granted
Priority Review for the sNDA to convert FILSPARI from accelerated approval to full approval for the treatment of IgAN in the U.S., with a PDUFA target action date of September 5, 2024. 3On May 1,
2023, the Company announced the topline results from the two-year primary efficacy endpoint in the pivotal phase 3 DUPLEX Study of sparsentan in FSGS, as described in the Corporate Press
Release (https://ir.travere.com/news-releases/news-release-details/travere-therapeutics-announces-topline-results-two-year-primary).	5

© 2024 Travere Therapeutics, Inc.

Expected Key Milestones Driving Our Mission to Deliver Life- Changing Therapies to People Living with Rare Disease

Dec '23 | HCU	Dec '23 | IgAN	Feb '24 | IgAN	Mar '24 | IgAN
Initiation of Phase 3	UpToDate guidelines	Positive CHMP opinion on	sNDA submission to convert
study of pegtibatinase	updated for FILSPARI® use	the conditional EU approval	FILSPARI accelerated approval
in HCU		of sparsentan for IgAN1	to full approval in U.S.

• Regular

updates on

2023 4Q23

Sep '24 | IgAN

PDUFA target action date

for full approval of

FILSPARI for IgAN in U.S.

2024	1Q24	Continued launch of FILSPARI
	P3 enrollment of PegT
H2 '24 | IgAN		May '24 | IgAN	Apr '24 | IgAN
		EC grants
First launch of FILSPARI for	FDA grants Priority Review of sNDA to	2Q24
conditional
convert to FILSARI to full approval in
IgAN in European markets		marketing
			U.S.
				authorization

	(CMA) of FILSPARI
3Q24	for IgAN in Europe

commercial

launch of

FILSPARI

• Multiple

regulatory and

clinical events

FY24		FY '24 | IgAN	FY '24 | IgAN	FY '24 | FSGS
Update on studies evaluating	KDIGO guidelines anticipated to be	Establish potential pathway to approval
	FILSPARI + SGLT2i and potential	updated for FILSPARI use	based on additional analyses of FSGS
	effect as first-line treatment			data and engagement with regulators
					2025

to advance

pipeline

HCU: Focal segmental glomerulosclerosis, CHMP: Committee for Medicinal Products for Human Use, EU: European Union, IgAN: Immunoglobulin A nephropathy, sNDA: supplemental new drug application,
EC: European Commission, SGLT2i: sodium-glucosecotransporter-2 inhibitor, FSGS: Focal segmental glomerulosclerosis
1In partnership with European collaborator CSL Vifor	6

© 2024 Travere Therapeutics, Inc.

FILSPARI® (sparsentan)

First and only endothelin and angiotensin II receptor antagonist in development for rare kidney disorders

IgA

Nephropathy

(IgAN)

1Le W, et al. Nephrol Dial Transplant 2012; 27:1479-1485;2McGrogan A, et al. Nephrol Dial Transplant. 2011;26:414-430;3Nasri H, et al. J Nephrol. 2015; 4:1-5;4currently addressable population numbers are estimates sourced from McGrogan et al. Nephrol Dial Transplant (2011); Sim et al., AJKD (2016); Simon et al., 2004; Zara et al. Nephrol Dial Transplant (2013); Braun et al., Int Urol Nephrol (2011), and data on file; 5estimated potential growth through 2033, 6Source: independent market research, data on file 7Barratt J, et al. "Natural History of IgA Nephropathy: Analysis of a UK National RaDaR IgA Nephropathy Cohort." ASN 2021; Poster presentation (Abstract P01577); , 8Nair R & Walker PD. Kidney Int 2006; 69:1455-1458;9Uffing A et al. Clin J Am Soc Nephrol. 2021 Aug;16(8):1247-1255.

is a Serious Unmet Rare Kidney Disease (RKD)

IgAN is the most prevalent primary glomerulonephritis worldwide1

Often uncontrolled, progressive IgAN is a major cause of kidney failure2,3

30k-50k	~11 years
Currently addressable IgAN	median time to
population for FILSPARI®4;	kidney failure in high-risk
potential to grow up to ~70k	adult patients7
patients5,6

25-39	30-40%
peak incidence age of	of transplants fail due to
IgAN8	disease recurrence9

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The Progression of IgA Nephropathy to Kidney Failure is Driven by Two Critical Pathways - Endothelin-1(ET-1) and Angiotensin II (ANG-II)1-3

Galactose-deficient,IgA-containing immune complexes are deposited in the mesangium4

ET-1 levels

ET-1and

ANG-IImutually upregulate

one another2ANG-II levels

ET-1 and ANG-II act	Causes	Rapid
together to damage	proteinuria	decline in	Progression
the glomerular	to rise to	kidney	to kidney
filtration barrier and	detrimental	function	failure8
tubulointerstitium1,2	levels1,2	(eGFR)5-8

FILSPARI®	Blocks actions of	Reduces
Dual Endothelin Angiotensin
ET-I and ANG-II	proteinuria
Receptor Antagonist
Ang II: angiotensin II; ET-1:endothelin-1; IgAN: Immunoglobulin A Nephropathy.
Figure adapted from Lai K, et al. Nat Rev Dis Primers. 2016;16001
1Komers R, et al. Am J Physiol Regul Integr Comp Physiol. 2016;310(10):R877-R884.2Kohan DE, et al. Kidney Int. 2014;86(5):896-904.3Raina R, et al. Kidney Dis. 2020;6(1):22-34.4Ebefors K, Bergwall L,
Nyström J. Front Med (Lausanne). 2022;8:740527. doi:10.3389/fmed.2021.740527. 5Zoja C, Morigi M, Figliuzzi M, et al. Am J Kidney Dis. 1995;26(6):934-941.6Morigi M, Buelli S, Angioletti S, et al. Am J
Pathol. 2005;166(5):1309-1320.7Tejera N, Gómez-Garre D, Lázaro A, et al. Am J Pathol. 2004;164(5):1817-1826.8Lai K, et al. Nat Rev Dis Primers. 2016;2:160001.	9
© 2024 Travere Therapeutics, Inc.

Phase 3 PROTECT Study* is the Only Head-to-Head, Active- Controlled Trial in IgAN to Date

Objective	Test the efficacy and safety of FILSPARI® vs.	Endpoints	•	Primary efficacy endpoint: change
	active control (irbesartan) in a global,			in UPCR from baseline to week 36
	multicenter, double-blind, randomized study of		•	Key secondary efficacy endpoint: eGFR
	404 patients with IgAN, ages 18+			slope: total (day 1 - week 110) and chronic
				(week 6 - 110)

Maximized

ACEi/ARBs

• ≥12 weeks prior to screening
• ≥50% maximum approved dose

Randomized (1:1) and received study drug

(N=404)

• Adults (≥18 years)
• Biopsy-provenIgAN
• UPCR ≥1 g/day
• eGFR ≥30 mL/min/1.73 m2

Double-blind treatment

110 weeks, randomized 1:1

FILSPARI®

200 mg / day →

400 mg / day at week 2

Irbesartan

150 mg / day →

300 mg / day at week 2

4 weeks post-cessation of randomized treatment

Study drug

withdrawal period;

resume SOC ACEi/ARBs

Week -12	Day -1	Day 1	Week 36
	Discontinue maximized	Baseline UP/C	Primary efficacy endpoint:
	ACEi/ARBs (no washout)	Initial dose	interim analysis

Week 110	Week 114
End of randomized	End of double-
treatment	blind period

UPCR: urine protein/creatinine ratio, g/day: grams per day, eGFR: estimated glomerular filtration rate, ACEi: angiotensin converting enzyme inhibitors, ARBs: angiotensin receptor blockers, SOC: standard of
care
*ClinicalTrials.gov ID: NCT03762850	10
© 2024 Travere Therapeutics, Inc.