Full Press Release Details
Advancing medicines. Solving problems. Improving lives. Corporate
Presentation June 2023 1
Disclaimer This presentation and the accompanying oral commentary has been
prepared by Aquestive Therapeutics, Inc. (the "Company", "our" or "us") and contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believe," "anticipate," "plan," "expect,"
"estimate," "intend," "may," "will," or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the
advancement of Libervant , Anaphylm ("AQST-109"), and other product candidates through the regulatory and development pipeline and ability to bring those products to market and achieve market acceptance of those products; the potential
benefits our products could bring to patients; the outlicensing of our products in the U.S. and abroad; our growth and future financial and operating results and financial position, including regarding the profitability of the Company's
manufacturing operations and the current and future financial outlook of the Company; ability to refinance the Company's current debt; and business strategies, market opportunities (including total addressable market size), and other statements
that are not historical facts. These forward-looking statements are subject to the uncertain impact of global business or macroeconomic conditions, including as a result of inflation, rising interest rates, instability in the global banking
system, and geopolitical conflicts, including the war in Ukraine, our business including with respect to our clinical trials including site initiation, patient enrollment and timing and adequacy of clinical trials; on regulatory submissions and
regulatory reviews and approvals of our product candidates; pharmaceutical ingredient and other raw materials supply chain, manufacture, and distribution; sale of and demand for our products; our liquidity and availability of capital resources;
customer demand for our products and services; customers' ability to pay for goods and services; and ongoing availability of an appropriate labor force and skilled professionals. Given these uncertainties, the Company is unable to provide
assurance that operations can be maintained as planned prior to the global business or macroeconomic conditions discussed above. These forward-looking statements are based on our current expectations and beliefs and are subject to a number of
risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks associated with the Company's development
work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials and plans for Anaphylm and our other drug candidates; risk of failure to address the concerns identified in the FDA
End-of-Phase 2 meeting for Anaphylm; risk of delays in FDA approval of Anaphylm and our other drug candidates or failure to receive approval at all; risk of the failure to receive FDA approval for U.S. market access for Libervant, including by
establishing a major contribution to patient care within the meaning of FDA regulations, as well as risks related to other potential pathways or positions which are or may in the future be advanced to the FDA, to overcome the seven year orphan
drug market exclusivity granted by the FDA for a nasal spray product of another company, and there can be no assurance that the Company will be successful in such endeavors; risk of our ability to out-license our proprietary products in the
U.S. or abroad and risks that such product candidates will receive regulatory approval in those licensed territories and risk of the rate and degree of market acceptance of our product and product candidates in those territories; risk to
growing our manufacturing revenues and generate cash and capabilities to support demand for current and future licensed products; risk of eroding market share for Suboxone and risk of a sunsetting product, which accounts for the substantial
part of our current operating revenue; risk inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); the success of any competing products,
including generics; risks of compliance with all FDA and other governmental and customer requirements for our manufacturing facilities; risks associated with intellectual property rights and infringement claims relating to the Company's
products; risk of unexpected patent developments; the impact of existing and future legislation and regulatory provisions on product exclusivity; legislation or regulatory actions affecting pharmaceutical product pricing, reimbursement or
access; claims and risks that may arise regarding the safety or efficacy of the Company's products and product candidates; risk of loss of significant customers; risks related to legal proceedings, including patent infringement, investigative
and antitrust litigation matters and associated costs; changes in government laws and regulations; risk of product recalls and withdrawals; risk regarding the Company's future financial and operating results and financial position; risk of
insufficient capital and cash resources, including insufficient access to available debt and equity financing and revenues from operations, to satisfy all of the Company's short-term and longer term liquidity and cash requirements and other
cash needs, at the times and in the amounts needed; risk of failure to satisfy all financial and other debt covenants and of any default under debt financings; uncertainties related to general economic, political, business, industry,
regulatory, financial and market conditions and other unusual items; uncertainties related to general economic, financial, political, business, industry, regulatory and market conditions and other unusual items; and other uncertainties
affecting the Company described in the "Risk Factors" section and in other sections included in our Annual Report on Form 10-K, in our Quarterly Reports on Form 10-Q, and in our Current Reports on Form 8-K filed with the Securities Exchange
Commission ("SEC"). Given those uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. All subsequent forward-looking statements attributable to us or any person acting on
our behalf are expressly qualified in their entirety by this cautionary statement. The Company assumes no obligation to update forward-looking statements or outlook or guidance after the date of this press release whether as a result of new
information, future events or otherwise, except as may be required by applicable law. This presentation also contains estimates, projections and other information concerning the Company's business and the markets for the Company's products and
product candidates, including data regarding the estimated size of those markets, and the incidence and prevalence of certain medical conditions. Information that is based on estimates, forecasts, projections, market research, or similar
methodologies is inherently subject to uncertainties and actual events, or circumstances may differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, the Company obtained this industry,
business, market and other data from reports, research surveys, clinical trials studies and similar data prepared by market research firms and other third parties, from industry, medical and general publications, from other publicly available
information, and from government data and similar sources. This presentation shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer,
solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. PharmFilm , Sympazan and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. The
trade name for AQST-109 "Anaphylm" has been conditionally approved by the FDA. Final approval of the Anaphylm proprietary name is conditioned on FDA approval of the product candidate, AQST-109. All other registered trademarks referenced herein
are the property of their respective owners. 2023 Property of Aquestive Therapeutics, Inc. 2
Corporate Overview 3
Our Quest Advancing medicines, solving therapeutic problems, and improving
lives Our pipeline of product candidates aims to overcome barriers that patients face with existing treatment options and provide new paradigms for treating critical and complex conditions 4
Aquestive Is a Growth Story With Multiple Assets 5 Revenue-Generating Base of
Existing Collaborations 5 FDA-approved products 10+ years of product sales on 6 continents Multiple product launches since 2022 150+ patents worldwide Potential for 2 Commercialization Events Prior to 2027 Lead pipeline product
candidate is Anaphylm (epinephrine) sublingual film First and only non-device based, oral product candidate for the emergency treatment of severe allergic reactions, including anaphylaxis Anticipate filing for FDA approval in
2024 Received FDA tentative approval of Libervant (diazepam) buccal film for the treatment of seizure clusters in patients aged 12 and older with epilepsy Anticipate launch in 2027 (based on scheduled expiration of orphan drug block), or
sooner if approved by FDA Pipeline Renewal Will Come From In-house Technology Epinephrine prodrug platform has the potential for multiple future pipeline iterations and indications
We Have a Strong Vision for Building the Company In the next five years, we aim
to: Grow the existing and ex-U.S. collaboration revenue Secure FDA approval for Anaphylm in the U.S. Launch Libervant in the U.S. in 2027 Utilize our epinephrine prodrug platform for future product launches after Anaphylm and Libervant,
if approved by the FDA 6 1. Estimate is based on an orphan drug market exclusivity block until January of 2027 by a competing nasal spray product.
Where You Need It, When You Need It 7 Our Core Technology is Branded as
8 And Our Future Technology Is Already In-house AQST-108 Anaphylm (AQST-109)
Product Portfolio - Significant Licensing Opportunities in 2023 AQST-108
formulation (epinephrine) (Alternative Indications) Indivior license Zambon EU license / Mitsubishi Tanabe US license Sunovion license Hypera Brazil license Proprietary growth drivers Preclinical Clinical Filed Marketed
9 Hypera - Brazil Haisco - China Libervant (diazepam) Buccal Film (Seizure Clusters) Libervant (diazepam) buccal film United States Asia South America Anaphylm (epinephrine) sublingual film Ex-U.S. Rights Assertio
Therapeutics Indivior Kempharm Kempharm Mitsubishi Tanabe - U.S. Hypera - Brazil Zambon - EU Haisco - China Pharmanovia Licensing Opportunities Regional Licensing Agreements IP Licenses (Royalty-Only) Global Licensing
Agreements (riluzole) oral film (development stage) Anaphylm (epinephrine) Sublingual Film (Anaphylaxis)
Potential for Two Transformative Launches 10 Anaphylm (epinephrine)
Sublingual Film Potential indication of treatment of severe allergic reactions, including anaphylaxis Anticipate submitting New Drug Application (NDA) by the end of 2024 Estimated Total Addressable Market of ~ $1B 1. Estimated total
addressable market is an Aquestive Therapeutic's calculations based on (i) WAC Price for generic EipPen as of March 2020 and (ii) epinephrine market TRx volume as of December 2022. 2. Estimate is based on an orphan drug market exclusivity
block until January of 2027 by a competing nasal spray product. Libervant (diazepam) Buccal Film Indicated for the treatment of seizure clusters in patients aged 12 and older with epilepsy Tentatively approved by FDA Expected Launch
Strong Leadership Team Daniel Barber President, CEO and Director Lori J.
Braender SVP, General Counsel Ken Marshall Chief Commercial Officer Mark Schobel Chief Innovation & Technology Officer Ernie Toth Chief Financial Officer 11 Cassie Jung SVP, Operations Steve Wargacki SVP, R&D Gary
Slatko Chief Medical Officer Strong Operations & Partnering Team Experienced Science/IP/Development Team Peter Boyd SVP, IT, HR, & Communications
Executed on Key Deliverables in the Last 12 Months Since management change in
May 2022, the team has: Raised $47M in non-dilutive financing Signed 3 new licensing agreements on 3 continents Supported two new product launches of licensees Received FDA tentative approval for Libervant Successfully closed 4
litigation cases Continued to advance Anaphylm towards an NDA submission Reduced existing debt by 17.6% 12 1 1. As of December 31, 2022, the outstanding debt was $51,500,000. As of March 31, 2023, the outstanding debt was $42,414,025,
resulting in a difference of $9,085,975, or 17.6%.
We Are Now Focused on the Next Chapter Over the next 90 days, the Company aims
to: Continue to strengthen the balance sheet Refinance the existing debt (anticipate standard 5 yr, 3 yr i/o deal) Out-license Libervant in China Submit pivotal protocol for Anaphylm to the FDA for review 13
14 Potential Near-term Milestones Targeted Complete debt refinancing Start
Anaphylm pivotal study License Libervant in China H1 2024 Receive Anaphylm topline pivotal data AQST-108 first-in-human data License ex-U.S. rights to Anaphylm H2 2023 Anaphylm pre-NDA meeting Anaphylm NDA submission Ex-U.S.
Libervant launches begin Epinephrine prodrug pipeline additions H2 2024
Anaphylm (epinephrine) Sublingual Film 15
Anaphylaxis Market Overview 16
Anaphylaxis: A Serious Systemic Hypersensitivity Reaction That is Usually Rapid
in Onset And May Be Fatal 17 1. Turner PJ, et al. World Allergy Org J. 2019;12100066. 2. FARE, 2022; https://www.foodallergy.org/resources/facts-and-statistics. 3. Fromer L. The American Journal of Medicine (2016);129, 1244-1250. As many
as 32 million people in the United States are at chronic risk for acute anaphylactic episodes 52% of patients in a nationwide patient survey who had previously experienced anaphylaxis had never received an epinephrine auto-injector
prescription Direct costs of anaphylaxis have been estimated at $1.2 billion per year 60% of respondents in same patient survey did not have an epinephrine auto-injector currently available 1 2 3 3 3
Advancing medicines. Solving problems. Improving lives. 18 Treatment of
Anaphylaxis - Epinephrine 0.10 mg (for children 16.5 to 33 pounds) - AUVI-Q brand only 0.15 mg (for children under 66 pounds) 0.3 mg (for children and adults over 66 pounds) 1 Epinephrine is the first line of treatment for
anaphylaxis Epinephrine is the only medication proven to stop a life-threatening allergic reaction 1. Epinephrine in the Management of Anaphylaxis. Brown JC, Simons E, Rudders SA. J Allergy Clin Immunol Pract. 2020 Apr;8(4):1186-1195.
doi: 10.1016/j.jaip.2019.12.015 PMID: 32276687. 2. EpiPen Package Insert. 2 Epinephrine dosage (current medication delivery systems): 0.3-0.5 mg intramuscularly (IM) or subcutaneously Children's dosage is weight based: 2 A second
dose of epinephrine can be given as needed
Epinephrine Market 4M TRx in 2022 1. Symphony Health Data April 2023. The
2022 Epinephrine market surpassed 4 million TRx and has rebounded to historical highs following a downturn due to generics and the Covid-19 pandemic. TRx counts have exceeded prior year for 9 consecutive months. 1
Generic Market With High Levels of Dissatisfaction and Unmet Need 1. KOL
feedback; Aquestive Market Research. 2. Fromer L. The American Journal of Medicine (2016);129, 1244-1250. 3. Warren et al. Ann Allergy Asthma Immunol (2018). 4. Brooks et al. Ann Allergy Asthma Immunol (2017). 5. Asthma and Allergy Foundation
of America Patient Survey Report (2019). 6. El Turki et al. EmergMed J (2017). Current Standard of Care = Large, Needle Based Injectors Numerous Studies and Patient Surveys Articulate Significant Dissatisfaction with Current Offerings
Right place, right time <50% of patients carry their EpiPen - often due to hassle factor Refusal of treatment 25-50% of patients refuse treatment with EpiPen - often due to needle reluctance Time to treat post exposure 60% of
patients/caregivers delay treatment - often due to needle reluctance Failed administration in the field 23-35% of patients and caregivers fail to dose correctly Oversized devices Hard to carry Medical guidelines recommend always having 2
doses on hand Needle based High prevalence of needle phobia (especially in children) Not always intuitive to use Even trained health care providers have been shown to incorrectly inject 3,4,5 1 1 6 2
Recent FDA Public Document Highlighted the Barriers to Epinephrine Use 1 1.
Anaphylm (epinephrine) Sublingual Film First and only non-device based,
orally delivered epinephrine product candidate Fast absorption into the bloodstream Non-device administration Portability + +
PharmFilm Platform Projecting Robust Stability Chemical Stability > 2
years room temperature > 6 months accelerated conditions Successful Scale Up Executed Environmental Stability Light resistant Water resistant Withstands extreme cold conditions High temperature excursions while maintaining
Patents/Patent Applications Extending into 2042 Title Patent Status ENHANCED
DELIVERY EPINEPHRINE COMPOSITIONS Granted U.S. Patent 11,191,737 (5/4/2037) 8 Foreign applications Priority date: May 5, 2016 Possible patent term to 2037 ENHANCED DELIVERY EPINEPHRINE AND PRODRUG COMPOSITIONS 2 U.S. applications 8