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• | AQST-108, using Aquestive’s proprietary PharmFilm technologies, is a “first of its kind” oral sublingual film formulation delivering systemic epinephrine in development for the treatment of anaphylaxis. We recently completed a second pharmacokinetic (PK) trial for AQST-108. The Phase 1 study featured a 4-treatment crossover design that compared the pharmacokinetics, safety and pharmacodynamics of epinephrine administered in a sublingual film to that of epinephrine administered via both subcutaneous and intramuscular injections in 24 healthy adult subjects. Based on top-line results, AQST-108 was generally well-tolerated, with adverse events observed that are consistent with the known adverse events profile for epinephrine. AQST-108 also achieved a similar time to maximal concentrations, or median Tmax, when compared to both the subcutaneous and intramuscular injections of epinephrine. The data from both this Phase 1 PK trial and the previous trials collectively demonstrate that AQST-108 can consistently deliver epinephrine sublingually and, after receiving AQST-108, all subjects had measurable plasma concentrations of epinephrine. The Company plans on conducting another PK trial beginning in the first calendar quarter of 2021 as it continues to progress towards a final product formulation and dose. |
• | AQST-305 is a sublingual film formulation of octreotide, a small peptide that has a similar pharmacological profile to natural somatostatin, for the treatment of acromegaly, as well as severe diarrhea and flushing associated with carcinoid syndrome. Acromegaly is a hormone disorder that results from the overproduction of growth hormone in middle-aged adults. While we focus our efforts on Libervant and AQST-108 in the short-term, we have taken the necessary steps to prepare AQST-305 for additional research trials. |
• | 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; |
• | risk of delays in FDA approval of Libervant, AQST-108 and our other drug candidates or failure to receive approval; |
• | risk of our ability to demonstrate to the FDA “clinical superiority” within the meaning of the FDA regulations of our drug candidate Libervant relative to FDA-approved diazepam rectal gel and nasal spray products, including by establishing a major contribution to patient care within the meaning of FDA regulations relative to the approved products 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 exclusivity granted by the FDA for the approved nasal spray product of a competitor in the U.S. and there can be no assurance that we will be successful; |
• | risk that a competitor obtains FDA orphan drug exclusivity for a product with the same active moiety as any of our other drug products for which we are seeking FDA approval and that such earlier approved competitor orphan drug blocks such other product candidates in the U.S. for seven years for the same indication; |
• | risk that a competitor will obtain other FDA marketing exclusivity that blocks U.S. market access for Libervant; |
• | risk inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); |
• | risks and uncertainties concerning the royalty and other revenue stream of KYNMOBI™ (apomorphine), achievement of royalty targets worldwide or in any jurisdiction and certain other commercial targets required for contingent payments under the monetization transaction, and of sufficiency of net proceeds of the monetization transaction after satisfaction of and compliance with the 12.5% Senior Notes obligations, as applicable, and for funding the Company’s operations; |
• | risk of development of our sales and marketing capabilities; |
• | risk of legal costs associated with and the outcome of our patent litigation challenging third-party at risk generic sale of our proprietary products and other litigation matters in which the Company is a party; |
• | risk of sufficient capital and cash resources, including access to available debt and equity financing and revenues from operations, to satisfy all of our short-term and longer-term 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; |
• | risk related to government claims against Indivior for which we license, manufacture and sell Suboxone® and which accounts for the substantial part of our current operating revenues; |
• | risk associated with Indivior’s cessation of production of its authorized generic buprenorphine naloxone film product, including the impact from loss of orders for the authorized generic product and risk of eroding market share for Suboxone and risk of sunsetting product; |
• | risks related to the outsourcing of certain marketing and other operational and staff functions to third parties; |
• | risk of the rate and degree of market acceptance of our product and product candidates; the success of any competing products, including generics; |
• | risk of the size and growth of our product markets; |
• | 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; |
• | risk associated with 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; |
• | changes in government laws and regulations; |
• | risk of product recalls and withdrawals; and |
• | uncertainties related to general economic, political, business, industry, regulatory and market conditions and other unusual items. |
| | Beneficial Ownership Before This Offering(1) | | | | | Beneficial Ownership After This Offering(3) | ||||||||
Selling Stockholder | | | Number of Shares Owned | | | Percentage of Outstanding Shares(2) | | | Shares Offered Hereby | | | Number of Shares Owned | | | Percentage of Outstanding Shares(2) |
Entities affiliated with Bracebridge Capital, LLC | | | 459,216 | | | 1.3% | | | 30,645(4) | | | 428,571 | | | 1.3% |
Entities affiliated with Madryn Asset Management | | | 1,530,717 | | | 4.4% | | | 102,145(5) | | | 1,428,572 | | | 4.1% |
Morgan Stanley & Co. LLC 1585 Broadway New York, NY 10036 | | | 153,067 | | | * | | | 10,210 | | | 142,857 | | | * |
Lori Braender | | | 81,667(6) | | | * | | | 14,000 | | | 67,667 | | | * |
Peter Boyd | | | 92,848(7) | | | * | | | 2,000 | | | 90,848 | | | * |
* | Represents beneficial ownership of less than one percent (1%) of our outstanding Common Stock. |
(1) | Includes (a) shares of our Common Stock held by the applicable Selling Stockholder and (b) shares of Common Stock issuable upon exercise |
(2) | Based on a denominator equal to the sum of (a) 33,619,796 shares of our Common Stock outstanding on November 2, 2020, and (b) the number of shares of Common Stock issuable upon exercise or conversion of convertible securities that are currently exercisable or convertible or are exercisable or convertible within 60 days of November 2, 2020 beneficially owned by the applicable Selling Stockholder. |
(3) | For purposes of this table, the Company assumes that all of the shares covered by this prospectus will be sold by the Selling Stockholders. |
(4) | Consists of (i) 22,065 shares of Common Stock issuable upon the exercise of warrants held by FFI Fund Ltd. (“FFI”), (ii) 4,905 shares of Common Stock issuable upon the exercise of warrants held by FYI Ltd. (“FYI”), and (iii) 3,675 shares of Common Stock issuable upon the exercise of warrants held by Olifant Fund, Ltd. (“Olifant Fund” and, collectively with FFI and FYI, the “Bracebridge Capital Affiliated Entities”). Bracebridge Capital, LLC (“Bracebridge Capital”) is the investment manager of each of the Bracebridge Capital Affiliated Entities. Bracebridge Capital may be deemed to beneficially own the shares of Common Stock issuable upon the exercise of warrants held by the Bracebridge Capital Affiliated Entities. Bracebridge Capital disclaims beneficial ownership of such shares except to the extent of its respective pecuniary interest therein. The address of each of the Bracebridge Capital Affiliated Entities and Bracebridge Capital is 888 Boylston Street, Suite 1500, Boston, Massachusetts 02199-8193. |
(5) | Consists of (i) 37,794 shares of Common Stock issuable upon the exercise of warrants held by Madryn Health Partners, LP (“Madryn Health Partners”), and (ii) 64,351 shares of Common Stock issuable upon the exercise of warrants held by Madryn Health Partners (Cayman Master), LP (“Madryn Health Partners (Cayman)” and, together with Madryn Health Partners, the “Madryn Funds”). Madryn Asset Management, LP (“Madryn Asset Management”) is the investment advisor to each of the Madryn Funds. Madryn Health Advisors, LP (“Madryn Health Advisors”) is the general partner of each of the Madryn Funds. Each of Madryn Asset Management and Madryn Health Advisors may be deemed to beneficially own the shares of Common Stock issuable upon the exercise of warrants held by the Madryn Funds. Each of Madryn Asset Management and Madryn Health Advisors disclaims beneficial ownership of such shares except to the extent of its respective pecuniary interest therein. The address of each of Madryn Asset Management, Madryn Health Advisors and the Madryn Funds is 140 East 45th Street, 15th Floor, New York, New York 10017. |
(6) | Consists of (a) 25,000 shares held by Lori Braender directly and (b) 56,667 shares of common stock issuable upon the exercise of options exercisable within 60 days of the Record Date. |
(7) | Consists of (a) 52,239 shares held by Peter Boyd directly and (b) 40,609 shares of common stock issuable upon the exercise of options exercisable within 60 days of the Record Date. |
• | in the over-the-counter market; |
• | in transactions otherwise than on these exchanges or systems or in the over-the-counter market; |
• | through the writing of options, whether such options are listed on an options exchange or otherwise; |
• | ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
• | block trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block as principal to facilitate the transaction; |
• | purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
• | an exchange distribution in accordance with the rules of the applicable exchange; |
• | privately negotiated transactions; |
• | short sales; |
• | sales pursuant to Rule 144 of the Securities Act of 1933, as amended, or the Securities Act; |
• | broker-dealers may agree with the Selling Stockholders to sell a specified number of such security at a stipulated price per security; |
• | a combination of any such methods of sale; or |
• | any other method permitted pursuant to applicable law. |
• |
• | our Definitive Proxy Statement on Schedule 14A, filed with the SEC on April 29, 2020; |
• | our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2020, June 30, 2020 and September 30, 2020, as filed with the SEC on May 5, 2020, August 4, 2020 and November 4, 2020; |
• | our Current Reports on Form 8-K filed with the SEC on January 12, 2020, March 20, 2020, April 20, 2020, April 24, 2020, June 18, 2020, November 3, 2020, November 18, 2020, November 23, 2020, December 17, 2020 and January 7, 2021, to the extent the information in such reports is filed and not furnished; and |
• | the description of our common stock contained in our Registration Statement on Form 8-A, filed with the SEC on July 20, 2018, including any amendments or reports filed for the purposes of updating this description. |
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