• | 3,258,192 shares of common stock issuable upon exercise of outstanding options pursuant to our stock incentive plans at a weighted average option exercise price of $8.14 per share as of December 31, 2020; |
• | 13,491 shares of common stock issuable upon vesting of restricted stock units outstanding under our stock incentive plans as of December 31, 2020; |
• | 1,714,429 shares of common stock issuable upon exercise of outstanding warrants: 1,571,429 of which are exercisable at a weighted average exercise price of $4.25 per share and 143,000 of which are exercisable at a weighted average exercise price of $5.55 per share; |
• | 1,644,715 shares of common stock sold in an “at-the-market offering” pursuant to the Amended Equity Distribution Agreement under the Prior Prospectus after December 31, 2020; and |
• | $8,384,532 of our shares of common stock remain available for future issuance pursuant to the Equity Distribution Agreement under the Prior Prospectus. |
• | 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 regulatory advancement through the FDA of Libervant and our other drug candidates or failure to receive approval, including the failure to receive orphan drug exclusivity; |
• | risk that a competitor obtains other FDA marketing exclusivity that blocks U.S. market access for Libervant or any of our other product candidates; |
• | 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 revenue stream from the monetization of the Company’s royalty rights for the product KYNMOBI®, as well as the achievement of royalty targets worldwide or in any jurisdiction and certain other commercial targets required for contingent payments under the KYNMOBI monetization transaction; |
• | risk of development of our sales and marketing capabilities; |
• | 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; |
• | 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; |
• | risk 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 of legislation and regulatory actions and changes in laws or regulations affecting our business; |
• | risk of loss of significant customers; |
• | risks related to legal proceedings including patent infringement, securities, investigative, product safety or efficacy and antitrust litigation matters; |
• | risk of product recalls and withdrawals; |
• | the COVID-19 pandemic and its impact on our business; and |
• | uncertainties related to general economic, political, business, industry, regulatory and market conditions and other unusual items. |
Assumed offering price per share | | | | | $4.36 | |
Net tangible book value (deficit) per share as of December 31, 2020 | | | $(1.41) | | | |
Increase in net tangible book value per share attributable to new investors | | | $1.40 | | | |
As adjusted net tangible book value per share after this offering | | | | | $(0.01) | |
Net dilution per share to new investors participating in this offering | | | | | $4.37 |
• | 3,258,192 shares of common stock issuable upon exercise of outstanding options pursuant to our stock incentive plans at a weighted average option exercise price of $8.14 per share as of December 31, 2020; |
• | 13,491 shares of common stock issuable upon vesting of restricted stock units outstanding under our stock incentive plans as of December 31, 2020; |
• | 1,714,429 shares of common stock issuable upon exercise of outstanding warrants: 1,571,429 of which are exercisable at a weighted average exercise price of $4.25 per share and 143,000 of which are exercisable at a weighted average exercise price of $5.55 per share; |
• | 1,644,715 shares of common stock sold in an “at-the-market offering” pursuant to the Amended Equity Distribution Agreement under the Prior Prospectus after December 31, 2020; and |
• | $8,384,532 of our shares of common stock remain available for future issuance pursuant to the Equity Distribution Agreement under the Prior Prospectus. |
• | our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 9, 2021; |
• | our Current Reports on Form 8-K filed with the SEC on January 7, 2021, January 21, 2021, February 9, 2021, February 25, 2021, March 25, 2021 and March 26, 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. |
• | Libervant™, a buccal soluble film formulation of diazepam used as a rescue therapy for breakthrough epileptic seizures and an adjunctive therapy for use in recurrent convulsive seizures, for which a pre-new drug application (NDA) meeting was held in December 2018 with the FDA. The meeting resulted in a plan to complete a small single-dose crossover study comparing Libervant to the reference listed drug, Diastat®. This study was initiated in the first quarter of 2019, and enrollment into the study was completed in May 2019. The Company also began a rolling NDA submission process during the second quarter of 2019. The Company has completed the crossover study and is evaluating the data generated and plans to complete the NDA filing by the end of the year; and |
• | Exservan™, an oral soluble film formulation of riluzole for the treatment of Amyotrophic Lateral Sclerosis, or ALS, for which we submitted an NDA in the first quarter of 2019; the Prescription Drug User Fee Act (PDUFA) goal date for FDA action is November 30, 2019. |
• | AQST-108, a sublingual soluble film formulation for the treatment of anaphylaxis and severe allergic reactions, which is intended to provide an adjunct and or alternative to injection treatments such as EpiPen. After the Company’s first human proof of concept trials, a re-formulated and more advanced prototype has been developed, for which we completed additional phase 1 proof of concept trials. The Company is evaluating the data generated from these trials and plans on seeking a pre-IND meeting with the FDA before the end of the year; and |
• | AQST-305, a sublingual soluble film formulation of octreotide for the treatment of acromegaly and neuroendocrine tumors. As a result of early stage clinical proof of concept studies, re-formulation work is currently underway. |
• | designation or classification; |
• | aggregate principal amount or aggregate offering price; |
• | maturity; |
• | original issue discount, if any; |
• | rates and times of payment of interest or dividends, if any; |
• | redemption, conversion, exchange or sinking fund terms, if any; |
• | conversion or exchange prices or rates, if any, and, if applicable, any provisions for changes to or adjustments in the conversion or exchange prices or rates and in the securities or other property receivable upon conversion or exchange; |
• | ranking; |
• | restrictive covenants, if any; |
• | voting or other rights, if any; and |
• | important U.S. federal income tax considerations. |
• | the names of those underwriters or agents; |
• | applicable fees, discounts and commissions to be paid to them; |
• | details regarding over-allotment options, if any; and |
• | the estimated net proceeds to us. |
• | 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; |
• | the risks of delays in FDA approval of our drug candidates or failure to receive approval; |
• | the risks inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); |
• | the risk that a competitor obtains orphan drug exclusivity and blocks our product for the same indication for seven years; |
• | 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; |
• | 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 availability of refinancing of existing debt facilities; |
• | risk of failure to satisfy all debt covenants and of any default under our senior secured notes; |
• | 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; |
• | risks related to the outsourcing of certain sales, marketing and other operational and staff functions to third parties; |
• | risk of the rate and degree of market acceptance of our products and product candidates; |
• | the success of any competing products, including generics; |
• | risk of the size and growth of our product markets; |
• | risk of the effectiveness and safety of our products and product candidates; |
• | risk 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 action affecting pharmaceutical product pricing, reimbursement or access; |
• | claims and concerns 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 governmental 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. |
• | the title of the series of debt securities; |
• | any limit upon the aggregate principal amount that may be issued; |
• | the maturity date or dates; |
• | the form of the debt securities of the series; |
• | the applicability of any guarantees; |
• | whether or not the debt securities will be secured or unsecured, and the terms of any secured debt; |
• | whether the debt securities rank as senior debt, senior subordinated debt, subordinated debt or any combination thereof, and the terms of any subordination; |
• | if the price (expressed as a percentage of the aggregate principal amount thereof) at which such debt securities will be issued is a price other than the principal amount thereof, the portion of the principal amount thereof payable upon declaration of acceleration of the maturity thereof, or if applicable, the portion of the principal amount of such debt securities that is convertible into another security or the method by which any such portion shall be determined; |
• | the interest rate or rates, which may be fixed or variable, or the method for determining the rate and the date interest will begin to accrue, the dates interest will be payable and the regular record dates for interest payment dates or the method for determining such dates; |
• | our right, if any, to defer payment of interest and the maximum length of any such deferral period; |
• | if applicable, the date or dates after which, or the period or periods during which, and the price or prices at which, we may, at our option, redeem the series of debt securities pursuant to any optional or provisional redemption provisions and the terms of those redemption provisions; |
• | the date or dates, if any, on which, and the price or prices at which we are obligated, pursuant to any mandatory sinking fund or analogous fund provisions or otherwise, to redeem, or at the holder’s option to purchase, the series of debt securities and the currency or currency unit in which the debt securities are payable; |
• | the denominations in which we will issue the series of debt securities, if other than denominations of $1,000 and any integral multiple thereof; |
• | any and all terms, if applicable, relating to any auction or remarketing of the debt securities of that series and any security for our obligations with respect to such debt securities and any other terms which may be advisable in connection with the marketing of debt securities of that series; |
• | whether the debt securities of the series shall be issued in whole or in part in the form of a global security or securities; the terms and conditions, if any, upon which such global security or securities may be exchanged in whole or in part for other individual securities; and the depositary for such global security or securities; |
• | if applicable, the provisions relating to conversion or exchange of any debt securities of the series and the terms and conditions upon which such debt securities will be so convertible or exchangeable, including the conversion or exchange price, as applicable, or how it will be calculated and may be adjusted, any mandatory or optional (at our option or the holders’ option) conversion or exchange features, the applicable conversion or exchange period and the manner of settlement for any conversion or exchange; |
• | if other than the full principal amount thereof, the portion of the principal amount of debt securities of the series which shall be payable upon declaration of acceleration of the maturity thereof; |
• | additions to or changes in the covenants applicable to the particular debt securities being issued, including, among others, the consolidation, merger or sale covenant; |
• | additions to or changes in the events of default with respect to the securities and any change in the right of the trustee or the holders to declare the principal, premium, if any, and interest, if any, with respect to such securities to be due and payable; |
• | additions to or changes in or deletions of the provisions relating to covenant defeasance and legal defeasance; |
• | additions to or changes in the provisions relating to satisfaction and discharge of the indenture; |
• | additions to or changes in the provisions relating to the modification of the indenture both with and without the consent of holders of debt securities issued under the indenture; |
• | the currency of payment of debt securities if other than U.S. dollars and the manner of determining the equivalent amount in U.S. dollars; |
• | whether interest will be payable in cash or additional debt securities at our or the holders’ option and the terms and conditions upon which the election may be made; |
• | the terms and conditions, if any, upon which we will pay amounts in addition to the stated interest, premium, if any and principal amounts of the debt securities of the series to any holder that is not a “United States person” for federal tax purposes; |
• | any restrictions on transfer, sale or assignment of the debt securities of the series; and |
• | any other specific terms, preferences, rights or limitations of, or restrictions on, the debt securities, any other additions or changes in the provisions of the indenture, and any terms that may be required by us or advisable under applicable laws or regulations. |
• | if we fail to pay interest when due and payable and our failure continues for 90 days and the time for payment has not been extended; |
• | if we fail to pay the principal, premium or sinking fund payment, if any, when due and payable at maturity, upon redemption or repurchase or otherwise, and the time for payment has not been extended; |
• | if we fail to observe or perform any other covenant contained in the debt securities or the indenture, other than a covenant specifically relating to another series of debt securities, and our failure continues for 90 days after we receive notice from the trustee or we and the trustee receive notice from the holders of at least 25% in aggregate principal amount of the outstanding debt securities of the applicable series; and |
• | if specified events of bankruptcy, insolvency or reorganization occur. |
• | the direction so given by the holder is not in conflict with any law or the applicable indenture; and |
• | subject to its duties under the Trust Indenture Act, the trustee need not take any action that might involve it in personal liability or might be unduly prejudicial to the holders not involved in the proceeding. |
• | the holder has given written notice to the trustee of a continuing event of default with respect to that series; |
• | the holders of at least 25% in aggregate principal amount of the outstanding debt securities of that series have made a written request and such holders have offered reasonable indemnity to the trustee or security satisfactory to it against any loss, liability or expense or to be incurred in compliance with instituting the proceeding as trustee; and |
• | the trustee does not institute the proceeding and does not receive from the holders of a majority in aggregate principal amount of the outstanding debt securities of that series other conflicting directions within 90 days after the notice, request and offer. |
• | to cure any ambiguity, defect or inconsistency in the indenture; |
• | to comply with the provisions described above under “Description of Debt Securities—Consolidation, Merger or Sale;” |
• | to comply with any requirements of the SEC in connection with the qualification of any indenture under the Trust Indenture Act; |
• | to add to, delete from or revise the conditions, limitations, and restrictions on the authorized amount, terms, or purposes of issue, authentication and delivery of debt securities, as set forth in the indenture; |
• | to provide for the issuance of and establish the form and terms and conditions of the debt securities of any series as provided above under “Description of Debt Securities—General” to establish the form of any certifications required to be furnished pursuant to the terms of the indenture or any series of debt securities, or to add to the rights of the holders of any series of debt securities; |
• | to evidence and provide for the acceptance of appointment under any indenture by a successor trustee; |
• | to provide for uncertificated debt securities and to make all appropriate changes for such purpose; |
• | to add such new covenants, restrictions, conditions or provisions for the benefit of the holders, to make the occurrence, or the occurrence and the continuance, of a default in any such additional covenants, restrictions, conditions or provisions an event of default or to surrender any right or power conferred to us in the indenture; or |
• | to make any change that does not adversely affect the interests of any holder of debt securities of any series in any material respect. |
• | extending the fixed maturity of any debt securities of any series; |
• | reducing the principal amount, reducing the rate of or extending the time of payment of interest, or reducing any premium payable upon the redemption of any series of any debt securities; or |
• | reducing the percentage of debt securities, the holders of which are required to consent to any amendment, supplement, modification or waiver. |
• | register the transfer or exchange of debt securities of the series; |
• | replace stolen, lost or mutilated debt securities of the series; |
• | maintain paying agencies; |
• | hold monies for payment in trust; |
• | recover excess money held by the trustee; |
• | compensate and indemnify the trustee; and |
• | appoint any successor trustee. |
• | issue, register the transfer of, or exchange any debt securities of that series during a period beginning at the opening of business 15 days before the day of mailing of a notice of redemption of any debt securities that may be selected for redemption and ending at the close of business on the day of the mailing; or |
• | register the transfer of or exchange any debt securities so selected for redemption, in whole or in part, except the unredeemed portion of any debt securities we are redeeming in part. |
• | the title of such securities; |
• | the offering and exercise price or prices and aggregate number of warrants offered; |
• | the currency or currencies for which the warrants may be purchased; |
• | if applicable, the designation and terms of the securities with which the warrants are issued, and the number of warrants issued with each such security or each principal amount of such security; |
• | if applicable, the date on and after which the warrants and the related securities will be separately transferable; |
• | if applicable, the minimum or maximum amount of such warrants which may be exercised at any one time; |
• | in the case of warrants to purchase debt securities, the principal amount of debt securities purchasable upon exercise of one warrant and the price at which, and currency in which, this principal amount of debt securities may be purchased upon such exercise; |
• | in the case of warrants to purchase common stock or preferred stock, the number of shares of common stock or preferred stock, as the case may be, purchasable upon the exercise of one warrant and the price at which, and the currency in which, these shares may be purchased upon such exercise; |
• | the effect of any merger, consolidation, sale or other disposition of our business on the warrant agreements and the warrants; |
• | the terms of any rights to redeem or call the warrants; |
• | the terms of any rights to force the exercise of the warrants; |
• | any provisions for changes to or adjustments in the exercise price or number of securities issuable upon exercise of the warrants; |
• | the dates on which the right to exercise the warrants will commence and expire; |
• | the manner in which the warrant agreements and warrants may be modified; |
• | a discussion of any material or special U.S. federal income tax consequences of holding or exercising the warrants; |
• | the terms of the securities issuable upon exercise of the warrants; and |
• | any other specific terms, preferences, rights or limitations of or restrictions on the warrants. |
• | in the case of warrants to purchase debt securities, the right to receive payments of principal of, or premium, if any, or interest on, the debt securities purchasable upon exercise or to enforce covenants in the applicable indenture; or |
• | in the case of warrants to purchase common stock or preferred stock, the right to receive dividends, if any, or, payments upon our liquidation, dissolution or winding up or to exercise voting rights, if any. |
• | the title and aggregate number of the rights; |
• | the subscription price or a formula for the determination of the subscription price for the rights and the currency or currencies in which the subscription price may be payable; |
• | if applicable, the designation and terms of the securities with which the rights are issued and the number of rights issued with each such security or each principal amount of such security; |
• | the number or a formula for the determination of the number of the rights issued to each stockholder; |
• | the extent to which the rights are transferable; |
• | in the case of rights to purchase debt securities, the principal amount of debt securities purchasable upon exercise of one right; |
• | in the case of rights to purchase common stock or preferred stock, the type of stock and number of shares of stock purchasable upon exercise of one right; |
• | the date on which the right to exercise the rights will commence, and the date on which the rights will expire (subject to any extension); |
• | if applicable, the minimum or maximum amount of the rights that may be exercised at any one time; |
• | the extent to which such rights include an over-subscription privilege with respect to unsubscribed securities; |
• | if applicable, the procedures for adjusting the subscription price and number of shares of common stock or preferred stock purchasable upon the exercise of each right upon the occurrence of certain events, including stock splits, reverse stock splits, combinations, subdivisions or reclassifications of common stock or preferred stock; |
• | the effect on the rights of any merger, consolidation, sale or other disposition of our business; |
• | the terms of any rights to redeem or call the rights; |
• | information with respect to book-entry procedures, if any; |
• | the terms of the securities issuable upon exercise of the rights; |
• | if applicable, the material terms of any standby underwriting, backstop or other purchase arrangement that we may enter into in connection with the rights offering; |
• | if applicable, a discussion of certain U.S. Federal income tax considerations; and |
• | any other terms of the rights, including terms, procedures and limitations relating to the exchange and exercise of the rights. |
• | the designation and terms of the units and of the securities comprising the units, including whether and under what circumstances those securities may be held or transferred separately; |
• | any provisions of the governing unit agreement that differ from those described below; and |
• | any provisions for the issuance, payment, settlement, transfer or exchange of the units or of the securities comprising the units. |
• | underwritten public offerings; |
• | negotiated transactions; |
• | block trades; |
• | “At the Market Offerings,” within the meaning of Rule 415(a)(4) of the Securities Act, into an existing trading market, at prevailing market prices; or |
• | through a combination of these methods. |
• | at a fixed price or prices, which may be changed; |
• | at market prices prevailing at the time of sale; |
• | at prices related to such prevailing market prices; or |
• | at negotiated prices. |
• | the name or names of the underwriters, dealers or agents, if any; |
• | if the securities are to be offered through the selling efforts of brokers or dealers, the plan of distribution and the terms of any agreement, arrangement, or understanding entered into with broker(s) or dealer(s) prior to the effective date of the registration statement, and, if known, the identity of any broker(s) or dealer(s) who will participate in the offering and the amount to be offered through each; |
• | the purchase price of the securities or other consideration therefor, and the proceeds, if any, we will receive from the sale; |
• | if any of the securities being registered are to be offered otherwise than for cash, the general purposes of the distribution, the basis upon which the securities are to be offered, the amount of compensation and other expenses of distribution, and by whom they are to be borne; |
• | any delayed delivery arrangements; |
• | any over-allotment or other options under which underwriters may purchase additional securities from us; |
• | any agency fees or underwriting discounts and other items constituting agents’ or underwriters’ compensation; |
• | any public offering price; |
• | any discounts, commissions or concessions allowed or reallowed or paid to dealers; |
• | the identity and relationships of any finders, if applicable; and |
• | any securities exchange or market on which the securities may be listed. |
• | our Annual Report on Form 10-K for the year ended December 31, 2018, filed with the SEC on March 14, 2019; |
• | our Definitive Proxy Statement on Schedule 14A, filed with the SEC on April 29, 2019; |
• | our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2019 and June 30, 2019, as filed with the SEC on May 8, 2019 and August 6, 2019; |
• | our Current Reports on Form 8-K filed with the SEC on May 8, 2019, June 18, 2019 and July 16, 2019, 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. |