CORPORATE OVERVIEW
March 2024
Safe harbor statement
This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, anticipated milestones, anticipated cash runway, expectations of generating stability data necessary to support the proposed shelf life of vonoprazan, business strategy, prospective products, product approvals, research and development costs, timing and likelihood of success, plans and objectives of management for future operations, and future results of current and anticipated products, are forward-looking statements.
In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks, uncertainties and other factors include, without limitation: our ability to launch and successfully commercialize approved products containing vonoprazan; our new drug application for non-erosive GERD may not be approved by the FDA; our Phase 3 trial for as need dosing of vonoprazan for non- erosive GERD may not successfully be completed; the inherent risks of clinical development of vonoprazan; our dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of vonoprazan that may limit its development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; our ability to obtain and maintain intellectual property protection for vonoprazan; our ability to comply with our license agreement with Takeda; our ability to achieve and maintain adequate levels of coverage and reimbursement for vonoprazan; the availability of additional funds under our revenue interest financing agreement and term loan agreement; the sufficiency of our capital to fund our operations; and other risks described in our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to revise or update this presentation to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
This presentation also contains estimates and other statistical data made by independent parties and by us relating to market size and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions, and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk.
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VOQUEZNA®:
First innovative acid-suppressant from a new drug class in the US in over 30 years
Going beyond
to advance treatments for patients with acid related disorders
Belongs to a novel class of therapies called PCABs (Potassium Competitive Acid Blockers)
- First and only approved PCAB in the US
- US FDA approval for the treatment of Erosive GERD and H. pylori in adults
- VOQUEZNA launch underway
- Commercial product available as of 4Q 2023
- Potential to displace PPIs
- Large market opportunity
Approved in numerous countries | |||
US / Europe / | in Asia & Latin America, including: | ||
Japan, China, | |||
Locations | Formed In 2019 | Canada rights | |
HQ: Florham Park, NJ | Listed on NASDAQ: | licensed from | Brazil, & Russia |
Buffalo Grove, IL | PHAT | Takeda | |
FDA APPROVED PRODUCTS | |||
~$850M
Annual net sales in Japan. Achieving market leadership of 60% revenue-based market share1
1 US dollars based on conversion rate of 0.0090 dollars to one yen. Annual net sales figure reflects the twelve-months ended Dec. 31, 2021. | |
3 | Revenue-based market share reflects the three-months ended June 30, 2023. |
Commercial success of acid suppression treatments
ANTACIDS | H2 ANTAGONISTS | PPIs |
PCAB
Introduced in Japan
2015
Marketed
OTC
Japan
Revenue-
Based Market
Share1
25 YEARS
No Innovation
~$3.5b | ~$12.5B |
peak US sales | peak US sales |
70%
60%
50% Generics
40%
30%
20%
10%
0%
2015 | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 |
(vonoprazan)
>$850M annual
net sales in Japan1
Vonoprazan has been highly successful in Japan
Driven predominantly by volumetric gains from generic competitors
Branded premium price
Majority of vonoprazan sales are in
GERD
1 | US dollars based on conversion rate of 0.0090 dollars to one yen. Annual net sales figure reflects the twelve-months ended Dec. 31, 2021. Revenue-based market share reflects the three-months ended June 30, 2023. | |
4 | ||
Vonoprazan demonstrated improved acid control versus PREVACID (lansoprazole) in a Phase 1 study
RAPID, POTENT, DURABLE ACID SUPPRESSION*
Day 1 | TIME ABOVE | ||
7.0 | pH 4.0 (%) | ||
6.0 | Vonoprazan | ||
20 mg | |||
5.0 | 62% | 88% | |
4.0 | PREVACID | ||
pH | (lansoprazole) 30 mg | ||
3.0 | 23% | 42% | |
2.0 | Baseline | ||
1.0 | 4% | 4% | |
0.0 |
0 | 6 | 12 | 18 | 24 | 0 |
Interval end time from dosing (hr) |
Day 7
6 | 12 | 18 | 24 | |||
Mean gastric pH profiles for vonoprazan were higher than PREVACID (lansoprazole) on both Days 1 and 7
5 | * VONO-103: Mean 0-24 hour gastric pH profiles; study evaluating the PK, PD, safety and tolerability of vonoprazan in comparison to PREVACID (lansoprazole) in 41 healthy adult subjects (out of 44 total subjects enrolled) |
Mechanistic differences between PPIs and PCABs
PPI:VOQUEZNA:
COVALENTLY BINDING PRODRUG | COMPETITIVE ENZYME INHIBITOR |
Secretory
canaliculus
Secretory
canaliculus
Quiescent phase | Active phase after meal | |
Tubulovesicle | Proton pump (H+, K+ -ATPase) | |
Quiescent phase | Active phase after meal | |
Tubulovesicle | Proton pump (H+, K+ -ATPase) | |
- Short plasma half-life
- Acid needed for activation but unstable in presence of acid
- Meal required to stimulate pumps
Slow onset of action
Limited potency
Limited duration of activity
- Long plasma half-life
- Stable in acid
- High accumulation in canaliculus
- Very slow dissociation rate
Rapid onset of action
Potent acid control
Durable 24-hr activity
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Three approved products across two indications, with more anticipated
NOW APPROVED & COMMERCIALLY AVAILABLE
Non-Erosive GERD
EoE
Target indications | Phase 11 | Phase 21 | Phase 3 | Milestones | ||
PDUFA target action date: | ||||||
Daily dosing treatment of heartburn | July 19, 2024 | |||||
associated with Non-Erosive GERD | Targeting US | |||||
Launch in 3Q 2024 | ||||||
As Needed treatment of heartburn | Positive Phase 2 results | |||||
Phase 3 trial initiation | ||||||
associated with Non-Erosive GERD | ||||||
anticipated in 2024 |
Treatment of eosinophilic esophagitis | Phase 2 trial initiation | ||
(EoE) for adult & pediatric use | anticipated in 2024 | ||
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1 Phase 1 and 2 studies supporting applications for Erosive GERD and H. pylori were conducted by Takeda; Phathom has development & commercialization rights to vonoprazan in the US, Europe, & Canada
VOQUEZNA vision builds on each targeted indication with the potential to transform the landscape of acid-related disorders
Targeting US Daily | Phase 3 As Needed |
dosing launch | trial initiation |
in 3Q 20241 | anticipated in 2024 |
Goal:
Displace PPIs
GERD | Non-Erosive GERD | Non-Erosive GERD |
(or non-erosive reflux | (or non-erosive reflux | |
disease / NERD) | disease / NERD) | |
Daily dosing | As Needed (or on-demand)dosing | |
Symptom control | Symptom relief |
Erosive GERD
(or erosive esophagitis / EE)
Improved healing and maintenance
-
pylori
(or HP)
Increased eradication
Launch Sequence: | Combined First Launch | Second Launch | Third Launch |
~45M
people
~20M
people
~2M
people
Growth opportunity
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1 Pending FDA approval.
VOQUEZNA is now the FIRST AND ONLY FDA APPROVED PCAB in the US
Commercial product NOW AVAILABLE
VOQUEZNA is indicated for the
healing and maintenance of healing of all grades of erosive esophagitis and relief of heartburn in adults.
VOQUEZNA is a novel, first-in-class,potassium-competitive acid blocker (PCAB) and the first innovative
acid suppressant from a new drug class approved in the US in over 30 years.
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Erosive GERD label includes multiple superiority claims
Healing
Maintenance of Healing
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Phathom Pharmaceuticals Inc. published this content on 12 April 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 12 April 2024 20:41:34 UTC.