UNITED THERAPEUTICS CORPORATION
January 2021
SAFE HARBOR STATEMENT
Remarks today concerning
United Therapeutics may include forward- looking statements which represent United Therapeutics' expectations or beliefs regarding future events. We caution that such statements involve risks and uncertainties that may cause actual results to differ materially from those in the forward-looking statements. Consequently, all such forward-looking statements are qualified by the cautionary language and risk factors set forth in United Therapeutics' periodic and other reports filed with the SEC.
There can be no assurance that the actual results, events or developments referenced in such forward- looking statements will occur or be realized. United Therapeutics assumes no obligation to update these forward-looking statements to reflect actual results, changes in assumptions or changes in factors affecting such forward- looking statements.
The discussions
during this presentation could include certain financial measures that were not prepared in accordance with U.S. Generally Accepted Accounting Principles (GAAP). Reconciliations of those non-GAAP financial measures to the most directly comparable U.S. GAAP financial measures can be found in our earnings releases filed with the SEC in Current Reports on Form 8-K for the relevant time period. These reports are available on our website at
www.unither.com
in the "Investor RelationsFinancial Information SEC Filings" section.
This presentation
and any related discussions or statements are intended to educate investors about our company. Sometimes that process includes reporting on the progress and results
of clinical trials or other developments with respect to our products. This presentation and any related discussions or statements are not intended to promote our products, to suggest that our products are safe and effective for any use other than what is consistent with their FDA-approved labeling, or to provide all available information regarding the products, their risks, or related clinical trial results. Anyone seeking information regarding the use of one of our products should consult the full prescribing information for the product available on our website at www.unither.com.
ORENITRAM®, REMODULIN®, TREVYENT®, TYVASO®, and UNITUXIN® are registered trademarks of United Therapeutics Corporation and its subsidiaries.
Implantable System for Remodulin® (ISR), REMUNITY™, REMOPRO™, TYVASO DPI™, AURORA-GT™, ORENIPRO™, and UNEXISOME™ are trademarks of United Therapeutics Corporation and its subsidiaries. BLUHALE® and DREAMBOAT® are registered trademarks of MannKind Corporation.
JANUARY 2021 | |
2 |
OUR FOCUS
DEVELOPING NOVEL, LIFE-EXTENDING TECHNOLOGIES
FOR PATIENTS IN TWO CORE AREAS:
1 | 2 | |
PAH(1)ILD(2)
(1) PAH = Pulmonary Arterial Hypertension. (2) ILD = Interstitial Lung Disease.
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3 |
EXCELLING IN OPERATIONAL EFFICIENCY
FINANCIALS, PER EMPLOYEE TTM, NOVEMBER 2020
COMPANY | MARKET | REVENUE(1) | NET | FREE | ||||||||||||||||||||||||||||||||||||
CAPITALIZATION(1) | PROFIT/LOSS(1) | CASH FLOW(1) | ||||||||||||||||||||||||||||||||||||||
$m | $'000 | $'000 | $'000 | |||||||||||||||||||||||||||||||||||||
Netflix | ||||||||||||||||||||||||||||||||||||||||
25.1 | 2,769.7 | 326.3 | 75.1 | |||||||||||||||||||||||||||||||||||||
Apple | ||||||||||||||||||||||||||||||||||||||||
13.6 | 1,867.4 | 390.6 | 499.1 | |||||||||||||||||||||||||||||||||||||
Microsoft | ||||||||||||||||||||||||||||||||||||||||
9.8 | 902.5 | 291.4 | 302.0 | |||||||||||||||||||||||||||||||||||||
Alphabet | ||||||||||||||||||||||||||||||||||||||||
9.9 | 1,444.1 | 300.4 | 286.1 | |||||||||||||||||||||||||||||||||||||
UTHR | ||||||||||||||||||||||||||||||||||||||||
6.6 | 1,532.1 | 509.3 | 717.7 | |||||||||||||||||||||||||||||||||||||
Amazon | 1.9 | 436.0 | 21.8 | 30.9 | ||||||||||||||||||||||||||||||||||||
Disney | 1.1 | 293.1 | (12.8) | 16.1 | ||||||||||||||||||||||||||||||||||||
Comcast | 54.3 | 86.8 | ||||||||||||||||||||||||||||||||||||||
1.2 | 548.7 | |||||||||||||||||||||||||||||||||||||||
AT&T | 0.8 | |||||||||||||||||||||||||||||||||||||||
697.7 | 44.2 | 112.7 | ||||||||||||||||||||||||||||||||||||||
(1) Metric is on a per employee basis. Financial data pulled from respective public filings via Bloomberg.
CHANGE IN SHARE PRICE
IN 18 YEARS AFTER IPO
Times, log scale, 1=IPO
1x | 10x | 100x | 1000x |
Netflix
Apple
Microsoft
Alphabet*
UTHR
Amazon
Disney
Comcast n/a
AT&T
*16 years
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TYVASO® THERAPEUTIC PLATFORM
TYVASO® - 8 MIXES OF PRODUCTS AND INDICATIONS(1)
PAH(2) | PH-ILD(4) | |
(PH(3) WHO Group 1) | (PH WHO Group 3) | |
FDA | INCREASE | |
APPROVED | STUDY | |
2009 | UNDER FDA REVIEW | |
(7) | 2021 NDA | 2021 NDA | |||||||||
Potential indications & future events.
PH-COPD(5)
(PH WHO Group 3)
PERFECT
STUDY
PHASE 3
DREAMBOAT®
BLUHALE®
IPF(6)
TETON
STUDY
PHASE 3
DREAMBOAT®
BLUHALE®
- Tyvaso® is not approved for PH WHO Group 3 or IPF patients. (2) PAH = Pulmonary Arterial Hypertension. (3) PH = Pulmonary Hypertension. (4) PH-ILD = Pulmonary Hypertension associated with Interstitial Lung Disease. (5) PH-COPD = Pulmonary Hypertension associated with Chronic Obstructive Pulmonary Disease. (6) IPF = Idiopathic Pulmonary Fibrosis. (7) Tyvaso DPITM is not approved for any indication in any jurisdiction
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5 |
TYVASO® THERAPEUTIC PLATFORMTYVASO®(1) PORTFOLIO POSITIONED
TO ADVANCE OUR GROWTH
45K PAH
Pulmonary Arterial
Hypertension
NO DISEASE-MODIFYING RX
100K IPF
Idiopathic
Pulmonary Fibrosis
TETON STUDY
ESTIMATED US PATIENT POPULATION(1)
NO APPROVED RX
30K PH-ILD
Pulmonary Hypertension associated with Interstitial Lung Disease
INCREASE STUDY
NO APPROVED RX
100K PH-COPD
Pulmonary Hypertension associated with Chronic Obstructive Pulmonary Disease
PERFECT STUDY
(1) Tyvaso® is not approved for PH WHO Group 3 or IPF patients. (2) Estimated patient populations based on United Therapeutics internal market research.
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6 |
TYVASO® THERAPEUTIC PLATFORM
TYVASO® FOR IPF(1,2)
100K IPF
~US PATIENT POPULATION
A potentially disease modifying therapy in IPF
Exploratory endpoints from
INCREASE suggest FVC(3)
IMPROVEMENT
on top of existing standards of care
Mean change in FVC (mL) by week from baseline | STUDIES(4): |
120 | INCREASE IPF SUBGROUP(5) | ||||||
Tyvaso® | |||||||
100 | |||||||
Placebo | |||||||
(mL) | 75 | ||||||
PHASE 3 STUDIES(6) | |||||||
BASELINE | 25 | ||||||
50 | POOLED PIRFENIDONE | ||||||
FROM | 0 | Pirfenidone | |||||
-25 | Placebo | ||||||
CHANGE | |||||||
-50 | POOLED NINTEDANIB | ||||||
MEAN | -75 | ||||||
INPULSIS PHASE 3 | |||||||
-100 | |||||||
STUDIES(7) | |||||||
-120 | Nintedanib | ||||||
0 | 1 | 8 | 16 | 24 | 26 | ||
Placebo | |||||||
TREATMENT WEEKS | |||||||
- Tyvaso® is not approved for PH WHO Group 3 or IPF patients. (2) IPF = Idiopathic Pulmonary Fibrosis. (3) FVC = Forced Vital Capacity. (4) For visualization purposes only as it is not scientifically accurate to compare among different studies. (5) INCREASE clinical data to be published by United Therapeutics. (6) Eur Respir J. 2016 Jan; 47(1): 243-253. (7) N Engl J Med 2014; 370:2071-2082.
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7 |
REMODULIN® THERAPEUTIC PLATFORM | 45K PAH | ||||||
NEXT GENERATION | DEVICES FOR PAH | ||||||
~US PATIENT | |||||||
POPULATION | |||||||
IMPLANTABLESYSTEM FOR 1
REMODULIN® (ISR)(1)
FDA APPROVED
REMUNITY™ 2
30-40%(3) | 3TREVYENT®(4,5) |
OF PAH PATIENTS REFUSE
PARENTERAL THERAPY
BECAUSE OF CONCERNS
AROUND DEVICES
4REMOLIFE(4)
PAH
PATIENTS
FDA CLEARED(2) LAUNCH PREP UNDERWAY
- FDA requires that certain conditions of Medtronic's PMA approval of the Implantable System for Remodulin must be satisfied prior to launch or sale of the Implantable System for Remodulin; accordingly, Implantable System for Remodulin labeling may be revised in the process of satisfying such conditions of approval. (2) FDA clearance of pharmacy-filled version. U.S. launch preparations underway. (3) Based on United Therapeutics internal market research. (4) Trevyent® and RemoLife are development-stage product not approved for sale in any jurisdiction. (5) CRL response in 2021.
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8 |
ORENITRAM® THERAPEUTIC PLATFORM | 45K PAH | ||||
KEY BENEFITS | OF | AN EXPANDED | |||
POPULATION | |||||
ORENITRAM® LABEL | ~US PATIENT | ||||
FREEDOM-EV and other studies showed that Orenitram can
DELAY | INDICATE A | REDUCE | ||||||||||||
DISEASE | POSITIVE IMPACT ON | PAH-ASSOCIATED | ||||||||||||
PROGRESSION | SURVIVAL(1) | HEALTHCARE | ||||||||||||
COSTS RELATIVE | ||||||||||||||
With a 61% | With a 37% reduction | TO SELEXIPAG(2,3) | ||||||||||||
reduction in risk | in risk of death vs placebo | |||||||||||||
at study closure | PAH-relatedhealthcare-costs were | |||||||||||||
67% higher for selexipag patients than | ||||||||||||||
for Orenitram patients | ||||||||||||||
61% | 37% | |||||||||||||
- Based on vital status substudy of Freedom EV, Orenitram was associated with a 37% decreased risk of mortality compared with placebo at study closure (which includes additional data accrued in the open-label extension study) in participants for which data was available (89%). Difference in risk of death was not statistically significant at the end of the randomized treatment period or OLE. (2) Results were primarily driven by significantly lower pharmacy costs with Orenitram. Please see full reference for study limitations. Comparison of products does not imply clinical comparisons of safety or efficacy. 3) Dean BB, Saundankar V, Stafkey-Mailey D, et al. Medication Adherence and Healthcare Costs Among Patients with Pulmonary Arterial Hypertension Treated with Oral Prostacyclins: A Retrospective Cohort Study. Drugs - Real World Outcomes. 2020 Mar 6. Dean BB. Healthcare costs lower with treprostinil versus selexipag for PAH. PharmacoEcon Outcomes News. 2020;849:12.
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NCE & NOVEL BIOLOGICS THERAPEUTIC PLATFORM | 45K PAH | ||||
RALINEPAG IP | RECEPTOR AGONIST | ||||
POPULATION | |||||
(1) | ~US PATIENT | ||||
THERAPY FOR PAH |
In phase 2 studies, Ralinepag demonstrated a potential QD dosing profile and
potentially enhanced affinity v. selexipag
Single-Dose PK Profile Comparison | Ralinepag activation effect is closer | |||||||||||||||||||||||
of Ralinepag (XR Tablet) vs. Selexipag | RALINEPAG XR 180 mcg (N=9) | to parenteral prostacyclins than selexipag | ||||||||||||||||||||||
in Healthy Subjects, separate studies | SELEXIPAG 600 mcg (N=12) | |||||||||||||||||||||||
Selexipag | ||||||||||||||||||||||||
Metric | Ralinepag | Iloprost | ||||||||||||||||||||||
Prolonged plasma | 10 | (Oral) | active | (IV) | ||||||||||||||||||||
metabolite | ||||||||||||||||||||||||
9 | ||||||||||||||||||||||||
PK profile of | Functional | |||||||||||||||||||||||
(ng/mL) | 8 | Potency | ||||||||||||||||||||||
ralinepag XR tablet | 24 nM | 151 nM | 3.3 nM | |||||||||||||||||||||
7 | G-protein | (EC50) | ||||||||||||||||||||||
supports QD dosing; | 6 | |||||||||||||||||||||||
CONC | ||||||||||||||||||||||||
selexipag plasma PK | 5 | activation | Efficacy | 67% | 48% | 100% | ||||||||||||||||||
profile consistent | 3 | (cAMP)(2) | ||||||||||||||||||||||
PLASMA | 4 | |||||||||||||||||||||||
with need for more | 2 | Extent of | Strong | Weak | ||||||||||||||||||||
frequent dosing | 1 | |||||||||||||||||||||||
Receptor | Full | |||||||||||||||||||||||
0 | 0 | 4 | 8 | 12 | 16 | 20 | 24 | Partial | Partial | |||||||||||||||
Agonism | ||||||||||||||||||||||||
TIME (hr) | ||||||||||||||||||||||||
(1) Ralinepag is a development-stage product not approved for sale in any jurisdiction. (2) cAMP= Cyclic Adenosine Monophosphate. Arena Pharmaceuticals data on file.
JANUARY 2021 | |
10 |
OMG THERAPEUTIC PLATFORM ORGAN MANUFACTURING AT UTHR
EVLP | 3DAP | LUNG LOBES | |||||
XENO-
TRANSPLANTATION
JANUARY 2021 | |
11 |
KEY 2021 CATALYSTS
Implantable
Remunity™INCREASESystemTyvaso DPITMfor Remodulin® (1)
Commercial | sNDA PDUFA Date | Commercial | Anticipated | |||||
Launch | April 2021 | Launch | NDA PDUFA | |||||
- FDA requires that certain conditions of Medtronic's PMA approval of the Implantable System for Remodulin must be satisfied prior to launch or sale of the Implantable System for Remodulin; accordingly, Implantable System for Remodulin labeling may be revised in the process of satisfying such conditions of approval.
JANUARY 2021 | |
12 |
RETURNING TO REVENUE GROWTH
REVENUE (in Millions)
Total Treprostinil | Unituxin® | Adcirca® |
$2,400 | Adcirca LOE May 2018 | (2) | ||||||||||
$2,200 | ||||||||||||
GROWTH | ||||||||||||
$2,000 | ||||||||||||
YOY | performance | |||||||||||
$1,800 | 10% | |||||||||||
recent | ||||||||||||
on | ||||||||||||
$1,600 | Based | |||||||||||
$1,400 | ||||||||||||
$1,200 | ||||||||||||
$1,000 | ||||||||||||
$800 | ||||||||||||
$600 | ||||||||||||
$400 | ||||||||||||
$200 | ||||||||||||
$0 | ||||||||||||
2014 | 2015 | 2016 | 2017 | 2018 | 2019 | 2020 | 2021(2) | 2022(2) | 2023(2) | 2024(2) | 2025(2) | |
Consensus(1) |
(1) Bloomberg consensus, shown for illustrative purposes only, and does not reflect company guidance. (2) 2021-2025 illustrated revenues are extrapolations based on recent quarterly results and do not represent financial guidance.
13 | JANUARY 2021 |
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United Therapeutics Corporation published this content on 11 January 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 18 January 2021 22:18:59 UTC