DEF 14A of Aquestive Therapeutics, Inc., Apr 26, 2024

DEF 14A of Aquestive Therapeutics, Inc.

Filed Apr 26, 2024 · FY20230001140361-24-022493

Open on EDGAR
  1. PROPOSAL NO. 1: ELECTION OF DIRECTORS

    PROPOSAL NO. 1: ELECTION OF DIRECTORS In accordance with Aquestive's Amended and Restated Certificate of Incorporation (“Certificate of Incorporation”) and Amended and Restated Bylaws (“Bylaws”), the Board is divided into three classes of directors of approximately equal size. The members of each class of directors are elected to serve for a three-year term with the term of office of each class ending in successive years. Our Certificate of Incorporation requires that each of our three classes of directors consist, as nearly as may be possible, of one-third of the total number of directors constituting the entire Board. Abigail L. Jenkins was appointed to the Board as a Class II director in April 2024. In connection with the appointment of Ms. Jenkins, the size of the Board was increased from seven to eight members. Santo J. Costa, Julie Krop, M.D., and Marco Taglietti, M.D. are the Class III directors whose terms expire at the 2024 Annual Meeting. Mr. Costa, Dr. Krop and Dr. Taglietti have each consented to being named in this Proxy Statement as a director nominee, and each has agreed to stand for election to the Board to serve as a Class III director of Aquestive until the 2027 Annual Meeting of Stockholders and until his or her successor is duly elected and qualified or until his or her earlier death, resignation or removal, and to serve if elected. It is intended that, unless a stockholder gives contrary instructions, shares represented by proxies will be voted for the election of each of Mr. Costa, Dr. Krop and Dr. Taglietti. Although not anticipated, if for any reason any nominee becomes unable to serve or for good reason will not serve, the discretionary authority provided in the proxies solicited by the Board may be used to vote for a substitute or substitutes whom the Board may propose to replace such nominee(s) for election at the Annual Meeting. It is not expected that any of the Board’s nominees will be unable or unwilling to serve as a director. Information relating to each of Mr. Costa, Dr. Krop and Dr. Taglietti as the Board’s nominees for election as a director, including his or her period of service as a director of Aquestive, principal occupation and other biographical material, is included below.

  2. THE BOARD OF DIRECTORS UNANIMOUSLY RECOMMENDS THAT YOU VOTE “FOR”

    THE BOARD OF DIRECTORS UNANIMOUSLY RECOMMENDS THAT YOU VOTE “FOR” THE NOMINEES FOR ELECTION AS CLASS III DIRECTORS.

  3. BOARD OF DIRECTORS

    BOARD OF DIRECTORS

  4. Board Composition and Structure

    Board Composition and Structure Our business and affairs are organized under the direction of our Board of Directors, which currently consists of eight members, seven of whom are independent directors. The primary responsibilities of our Board of Directors are to provide oversight, strategic guidance and direction to our management. Our Board meets on a regular basis and additionally as required. Our Certificate of Incorporation provides that our Board is divided into three classes of directors. Each of our directors identified below serves in the class indicated. Subject to any earlier resignation or removal in accordance with the terms of our Certificate of Incorporation and Bylaws, our Class III director nominees being nominated for election will, if elected at this Annual Meeting, serve until the 2027 Annual Meeting of Stockholders, our current Class I directors will serve until the 2025 Annual Meeting of Stockholders, and our current Class II directors will serve until the 2026 Annual Meeting of Stockholders; and, in each case, until their successors are duly elected and qualified. Below is a list of the names, ages and class of the individuals who currently serve as our directors.

  5. Board Composition and Structure

    | Name | Age | Position | Class | | Daniel Barber | 48 | President, Chief Executive Officer, and Director | I | | Gregory B. Brown, M.D. | 70 | Chairman of the Board | II | | John S. Cochran | 58 | Vice Chairman of the Board | II | | Santo J. Costa | 78 | Director | III | | Abigail L. Jenkins | 48 | Director | II | | Julie Krop, M.D. | 57 | Director | III | | Timothy E. Morris | 62 | Director | I | | Marco Taglietti, M.D. | 64 | Director | III |

  6. Board Composition and Structure

    The Board has determined that the classified Board structure is appropriate for the Company at this time. A classified board provides for stability, continuity and experience among our Board. The Board believes that building a cohesive board is an important goal. In our industry in particular, the time horizon required for successful development of pharmaceutical products and product candidates makes it important that we have a Board that understands the implications of this process and has the ability to develop long-term strategies while benefiting from an in-depth knowledge of Aquestive’s business, development processes and timetables, and operations. A classified board structure helps to provide continuity and stability of leadership while resisting pressure to focus on short-term results at the expense of long-term value.

  7. Director Biographies

    Director Biographies Information concerning our directors standing for re-election and for those directors continuing on the Board is set forth below. The biographical description of each director includes the specific experience, qualifications, attributes and skills that led the Board to conclude that each nominee should serve as a director.

  8. Nominees for Director (Class III Directors)

    Nominees for Director (Class III Directors)

  9. Santo J. Costa

    Santo J. Costa Santo J. Costa served as our Board Chairman from August 2018 to April 2024 and has served as a member of our Board of Directors since December 2015. Since 2007, Mr. Costa has served as Of Counsel to the law firm of Smith, Anderson, Blount, Dorsett, Mitchell and Jernigan, L.L.P. of Raleigh, North Carolina, specializing in corporate law for healthcare companies. Mr. Costa has served on the board of directors of Cytokinetics Inc. (Nasdaq:CYTK) since October 2010. From 1994 to 2001, he held various positions at Quintiles Transnational Corporation, including as Vice Chairman, President and Chief Operating Officer. Prior to joining Quintiles, Mr. Costa spent 23 years in the pharmaceutical industry, most recently as General Counsel and Senior Vice President, Administration with Glaxo Inc. Prior to joining Glaxo, he served as U.S. Area Counsel with Merrell Dow Pharmaceuticals and as Food & Drug Counsel with Norwich Eaton Pharmaceuticals, Inc. Mr. Costa served as chairman of the board of directors of Alchemia Limited, a biopharmaceutical company, from March 2014 to June 2015 and on the board of directors of Metabolon, Inc., a private company, from April 2013 to May 2019. He also served on the board of directors of Magor Corporation, formerly Biovest Corp., from March 2010 until March 2013. He also served as chairman of the board of directors of LaboPharm, Inc. from March 2006 to November 2011 and a director of OSI Pharmaceuticals from June 2006 to June 2010, as well as serving as a director at other private companies. Mr. Costa earned both a B.S. in Pharmacy and a J.D. from St. John’s University. Our Board believes that Mr. Costa’s experience in the biotechnology industry, his broad experience advising global corporations and boards of directors of publicly held companies, and his experience serving as a director of public and private companies, qualifies him to serve on our Board of Directors. Julie Krop, M.D. Julie Krop, M.D. has served as a member of our Board since February 2021. Dr. Krop currently serves as Chief Medical Officer of PureTech Health plc (Nasdaq:PRTC), a clinical stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for people living with psychiatric and neurological conditions. Prior to assuming her position with PureTech Health, Dr. Krop served as Chief Medical Officer of Freeline Therapeutics (Nasdaq:FRLN), a clinical stage gene therapy company, from April 2020 to August 2021. Dr. Krop was also the Chief Medical Officer and Executive Vice President, Development of AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG), where she oversaw clinical development, medical affairs, program management, and pharmacovigilance and regulatory affairs, from 2015 to 2020. From 2012 to 2015, Dr. Krop served as the Vice President, Clinical Development for Vertex Pharmaceuticals (Nasdaq:VRTX). In addition, Dr. Krop was Vice President, Clinical Development and Regulatory Affairs for Stryker Biotech (NYSE:SYK) from 2006 to 2012. Dr. Krop received both a B.A. and an M.D. from Brown University School of Medicine. Our Board believes that Dr. Krop’s extensive experience successfully designing and executing clinical development programs from early-stage development through FDA approval, and senior leadership roles across clinical development, regulatory affairs, clinical operations, pharmacovigilance, medical affairs and program management during her career in the pharmaceutical and biotechnology industry, as well as her medical background, qualifies her to serve on our Board of Directors. Marco Taglietti, M.D. Marco Taglietti, M.D. has served as a member of our Board since February 2021. Dr. Taglietti served as President and Chief Executive Officer and a director of Scynexis, Inc. (Nasdaq:SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug resistant infections, from 2015 until his retirement at the end of 2022. Prior to joining Scynexis, Dr. Taglietti held various executive positions with Forest Laboratories (now Abbvie (NYSE:ABBV)) from 2007 until 2014, including President, Forest Research Institute, Chief Medical Officer and Executive Corporate Vice President, Research & Development. Dr. Taglietti was also the Senior Vice President, Head of Global Research and Development for Stiefel Laboratories, Inc. (now a GlaxoSmithKline company) from 2004 until 2007 and served in a number of executive positions from 1992 to 2004 with Schering-Plough Research Institute, including Vice President, Clinical Research, Anti-Infectives, CNS, Dermatology and Endocrinology. From 1987 until 1992, Dr. Taglietti served in a number of executive positions with Marion Merrel Dow Research Institute, including as the European Product Team Leader – Anti-Infectives. Dr. Taglietti has served, since 2023, as a director of Aurobac Therapeutics SAS, a biopharmaceutical company developing products to fight antimicrobial resistance. Dr. Taglietti previously served on the boards of directors of Delcath (Nasdaq:DCTH) from 2014 to 2021 and NephroGenex (Nasdaq:NRX) from 2014 to 2017. Dr. Taglietti also served as a director of Stiefel International, Ltd., a private company, from 2004 to 2007 and a director of TransCelerate BioPharma, a non-profit pharma coalition dedicated to streamlining and accelerating the research and development of innovative new therapies, from 2013 to 2014. Dr. Taglietti served on the board of directors of BioNJ, a life sciences trade association in New Jersey, from 2011 through 2022. In addition, Dr. Taglietti served on the board of directors of HINJ, Health Institute of New Jersey, a trade association for the leading research-based biopharmaceutical and medical technology companies in New Jersey, from 2011 to 2014, and is currently on the boards of directors of Orchestra of St. Luke, a New York City based orchestra, and American Foundation for Suicide Prevention, the largest non-profit organization dedicated to saving lives and bringing hope to those affected by suicide. Dr. Taglietti received his Degree in Medicine from the University of Pavia, Italy. Our Board believes Dr. Taglietti’s extensive senior experience in the pharmaceutical and biotechnology industry, his experience on the boards of both public and private companies, as well as his medical background, qualifies him to serve on our Board of Directors.

  10. Class I Directors (with terms expiring at the 2025 Annual Meeting of Stockholders)

    Class I Directors (with terms expiring at the 2025 Annual Meeting of Stockholders)

  11. Daniel Barber

    Daniel Barber Daniel Barber was appointed by the Board as President and Chief Executive Officer and as a director in May 2022. Mr. Barber joined the Company in July 2007 and had served as our Senior Vice President – Chief Operating Officer since May 2019. Mr. Barber has led our strategy and development functions since April 2014. In 2010, Mr. Barber had executive oversight of our launch activities for our first two FDA approved products. Beginning in 2013, Mr. Barber helped lead our effort to develop an internal pipeline of proprietary assets. Since that time, he has had executive responsibility for our pipeline and partnership activities. Prior to joining the Company, Mr. Barber held various positions with Quest Diagnostics in its corporate planning and international divisions. Mr. Barber received his B.A. from State University of New York at Geneseo and an M.B.A. from Seton Hall University. Our Board believes that Mr. Barber’s experience as the Company’s Chief Executive Officer and his past experience as the Company’s Chief Operating Officer, as well as his extensive experience in being a leader of our pipeline development activities, qualifies him to serve on our Board of Directors.

  12. Timothy E. Morris

    Timothy E. Morris Timothy E. Morris has served as a member of our Board of Directors since August 2022. Mr. Morris recently served as the Chief Financial Officer of Opthea Limited (Nasdaq:OPT), a clinical stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, until October 2023. Previously, he served as Chief Operating Officer and Chief Financial Officer of Humanigen, Inc. (Nasdaq:HGEN) from 2020 to 2022. He was on the Board of Directors at Humanigen from 2016 to 2020, where he was chairman of the audit committee and a member of the compensation committee. He was the Chief Financial Officer of Iovance Biotherapeutics, Inc. from 2017 to 2020. Prior to Iovance, Mr. Morris was Chief Financial Officer of AcelRx Pharmaceuticals (Nasdaq:ACRX) from 2014 to 2017. Mr. Morris has extensive Board experience, currently serving as chairman of the board of DBV Technologies (Euronext:DBV, Nasdaq:DBVT), where he also serves as the chair of the audit committee and a member of the pricing committee, Univercells S.A., where he is the chair of the audit committee, and Humanetics Corporation, where he serves as the chair of the audit committee and a member of the compensation committee. Mr. Morris previously served on the boards of directors of Humanigen, Inc. from 2016 to 2020, and PAION, Inc., a U.S. subsidiary of PAION AG. Mr. Morris earned a B.S. in Business, with an emphasis in Accounting, from California State University and is a Certified Public Accountant (inactive). Our Board believes that Mr. Morris’ extensive operations experience and Board and finance experience qualify him to serve on our Board of Directors.

  13. Class II Directors (with terms expiring at the 2026 Annual Meeting of Stockholders)

    Class II Directors (with terms expiring at the 2026 Annual Meeting of Stockholders) Gregory B. Brown, M.D. Gregory B. Brown, M.D. has served as our Board Chairman since April 2024 and has served as a member of our Board of Directors since March 2007. Dr. Brown is currently Chief Executive Officer and a director of Memgen, Inc., a private development-stage biotechnology company. Dr. Brown is also a co-founder at HealthCare Royalty Partners, or HCR Partners, and is a member of that firm’s Senior Advisor Board. Educated as a transplantation immunologist and trained as a thoracic and vascular surgeon, Dr. Brown practiced thoracic and vascular surgery in a community setting where he also founded and led a health maintenance organization. Before co-founding HCR Partners, Dr. Brown was a partner at Paul Capital Partners, where he co-managed that firm’s royalty investments as a member of the royalty management committee. Prior to beginning his principal investment career in 2003, Dr. Brown was co-head of investment banking and head of healthcare at Adams, Harkness & Hill (now Canaccord Genuity) and a ranked biotechnology research analyst at Vector Securities International. Dr. Brown holds a B.A. from Yale University, an M.D. from SUNY Upstate Medical Center and an M.B.A from Harvard Business School. Dr. Brown currently serves on the board of Lisata Therapeutics, Inc. (Nasdaq:LSTA) and Adimab, LLC, a privately-held company which is a leader of therapeutic antibody discovery and engineering technologies, and previously served on the board of Faron Pharmaceuticals, Oy (LON: FARN) and Cambrex Corporation (formerly, NYSE: CBM) and FAST BioMedical, a privately-held company developing late clinical-stage medical technology. Our Board believes that Dr. Brown’s extensive experience in the pharmaceutical industry and investing in life sciences companies, as well as his medical and scientific background, qualifies him to serve on our Board of Directors.

  14. John S. Cochran

    John S. Cochran John S. Cochran has served as a member of our Board of Directors since January 2004. Mr. Cochran has been a partner at Bratton Capital Management L.P. since October 1998 and is responsible for its private equity investments. Mr. Cochran is also a partner and Chief Operating Officer of Crestline Investors, an institutional alternative investment management firm. Prior to joining Bratton Capital Management L.P., Mr. Cochran spent 10 years with KPMG focused primarily on audit and merger and acquisition due diligence. Mr. Cochran received his B.A. in Accounting from Texas Christian University and is also a licensed certified public accountant. Our Board believes that Mr. Cochran’s private equity investment and company oversight experience, along with his strong finance and management background, qualifies him to serve on our Board of Directors.

  15. Abigail L. Jenkins

    Abigail L. Jenkins Abigail L. Jenkins was appointed as a member of our Board of Directors in April 2024. Ms. Jenkins is currently President and Chief Executive Officer of Gamida Cell Ltd. (Nasdaq: GMDA), a pioneer in cell therapies, and a member of the company's board of directors. Prior to joining Gamida Cell, from March 2021 through August 2022, Ms. Jenkins served as Chief Commercial and Business Officer of Lyndra Therapeutics, Inc., a clinical-stage biopharmaceutical company, where she established and led global commercial, business development, corporate strategy and portfolio management across multiple therapeutic areas. From May 2018 to March 2021, Ms. Jenkins served as Senior Vice President and head of the Vaccines Business Unit of Emergent BioSolutions Inc. From June 2016 to May 2018, Ms. Jenkins served as Chief Commercial Officer and U.S. business head of Aquinox Pharmaceuticals, Inc. (now Neoleukin Therapeutics, Inc.). Ms. Jenkins has also previously held senior commercial and business development positions at Relypsa, Inc., Actavis plc (now Teva Pharmaceuticals Ltd.), Pfizer Inc. and Medimmune, LLC (now AstraZeneca PLC). Ms. Jenkins has served as a director of XORTX Therapeutics Inc. (Nasdaq: XRTX) since April 2024. Ms. Jenkins holds a B.A. from Indiana University Bloomington and a M.S. from The Johns Hopkins University, and completed the Executive Scholar Program in General Management, Business & Leadership from Northwestern University’s Kellogg School of Management. Our Board believes that Ms. Jenkins' extensive experience in commercialization of pharmaceutical products, her business development and corporate strategy expertise and her experience in senior leadership roles across several biopharmaceutical companies qualifies her to serve on our Board of Directors.

  16. NON-EMPLOYEE DIRECTOR COMPENSATION

    NON-EMPLOYEE DIRECTOR COMPENSATION We provide cash and equity-based compensation to our non-employee directors for the time and effort necessary to serve as a member of our Board of Directors. Under our non-employee director compensation program, we pay each of our non-employee directors a cash retainer for service on the Board and for service on each committee on which the director serves. The chair of each committee receives an additional retainer for such service. These retainers are payable in arrears in equal quarterly installments on the last day of each quarter, provided that the amount of such payment will be prorated for any portion of such quarter that the director is not serving on our Board of Directors. The retainers to non-employee directors for service on the Board and our Board committees are as follows:

  17. NON-EMPLOYEE DIRECTOR COMPENSATION

    | Name | Annual Service Retainer | Chairperson Additional Retainer | | Board of Directors | $50,000 | $50,000 | | Audit Committee | 10,000 | 20,000 | | Compensation Committee | 8,750 | 17,500 | | Nominating and Corporate Governance Committee | 5,000 | 10,000 | | Science and Technology Committee | 8,750 | 17,500 |

  18. NON-EMPLOYEE DIRECTOR COMPENSATION

    Pursuant to our non-employee director compensation program, in connection with her appointment to the Board in April 2024, Ms. Jenkins will be granted an award of 57,000 stock options. The stock options will vest in annual equal one-third increments commencing on the first anniversary of the date of grant. Additionally, each non-employee director receives an annual equity grant in the form of stock options. In 2023, each non-employee director was granted an award of 25,000 stock options (increased in 2022 from stock options for 20,000 shares in 2021). An annual equity grant is awarded each year on the date of the Annual Meeting of Stockholders in accordance with the Company’s equity grant policy. The stock options vest one year from the date of grant. This program is intended to provide a total compensation package that enables us to attract and retain qualified and experienced individuals to serve as directors and to align our directors’ interests with those of our stockholders.

  19. 2023 Director Compensation Table

    2023 Director Compensation Table The following table sets forth information concerning the compensation that we paid or awarded to our non-employee directors during the fiscal year ended December 31, 2023. For more information on the compensation of Daniel Barber, our director who is also our CEO, see below under “Executive Compensation.” Ms. Jenkins did not join our Board until April 2024 and accordingly did not receive any compensation for 2023.

  20. 2023 Director Compensation Table

    | Name | Fees Earned or Paid in Cash ($) | Options Awards(1) ($) | All Other Compensation ($)(2) | Total ($) | | Gregory B. Brown, M.D. | $105,095 | $39,610 | 6,063 | $150,768 | | John S. Cochran | 92,188 | 39,610 | 5,430 | 137,228 | | Santo J. Costa | 157,813 | 39,610 | 4,734 | 202,157 | | Julie Krop, M.D. | 98,077 | 39,610 | — | 137,687 | | Timothy E. Morris | 93,222 | 39,610 | 12,397 | 145,229 | | Marco Taglietti, M.D. | 81,130 | 39,610 | 1,035 | 121,775 |

  21. 2023 Director Compensation Table

    | (1) Represents the aggregate grant date fair value of stock option awards computed in accordance with Financial Accounting Standards Board Accounting Standards Codification Topic 718 (“FASB ASC 718”). A discussion of the assumptions used in calculating the fair value of such awards may be found in Note 17 to our 2023 audited financial statements included in our Annual Report on Form 10-K filed with the SEC on March 6, 2024. Amounts reflect a stock option grant awarded on June 21, 2023 with a grant date fair value of $2.02 per share. The grant date fair value of option awards is determined using the Black-Scholes option pricing model. |

  22. 2023 Director Compensation Table

    | (2) Represents reimbursable travel expense. |

  23. 2023 Director Compensation Table

    As of December 31, 2023, each person in the above table held outstanding stock options as follows: Dr. Brown, 124,050; Mr. Cochran, 124,050; Mr. Costa, 124,050; Dr. Krop, 98,500; Mr. Morris, 53,500; and Dr. Taglietti, 98,500.

  24. Compensation Philosophy and Process

    | • | Provide incentives that award the achievement of performance goals that directly correlate to the enhancement of stockholder value, as well as to facilitate executive retention |

  25. Compensation Philosophy and Process

    | • | Align executive interests with those of stockholders through short-term and long-term incentives linked to performance |

  26. Annual Incentive Compensation

    Annual Incentive Compensation We have an annual goal-setting and review process for our executive officers that is the basis for determining potential annual bonuses for our NEOs. Our Compensation Committee sets our annual financial objectives for the year as well as strategic and operational goals which are aligned with our strategic plan and operating budget approved by the Board. Our employment agreements with our executive officers provide that they will be eligible for annual performance-based bonuses based on achievement of the financial, strategic and/or operational objectives established by the Compensation Committee. Pursuant to the terms of their employment agreements, the target bonus opportunities for our NEOs expressed as a percentage of annual base salary are: Mr. Barber, 60%, Ms. Braender, 50%, and Mr. Toth, 50%. Each NEO’s annual bonus is capped at a maximum of 200% of his or her target bonus opportunity. The Compensation Committee assessed Company performance for 2023 with respect to each of the performance metrics and determined achievement against those metrics. The Compensation Committee determined to award the bonus amounts to our NEOs for 2023 set forth in the Summary Compensation Table below under “Non-Equity Incentive Plan Compensation.”

  27. Equity-Based Incentive Awards

    Equity-Based Incentive Awards Our equity-based awards are designed to provide our NEOs with a strong link to our long-term performance, create an ownership culture and help align the interests of our executive officers and our stockholders. Prior to the closing of our initial public offering, we adopted our 2018 Equity Incentive Plan. 2023 Annual Long-Term Incentive Awards. The Compensation Committee, as part of its regular cycle of annual equity incentive grants under its long-term executive compensation program, determined to award equity incentive grants to eligible participants in the form of time-based RSUs. In prior years, the annual long-term incentive awards had been granted in the form of stock options, but commencing in 2023, the Committee determined to change the program to grant time-based RSUs to our NEOs and all other participants. RSUs are understood to have a higher retention value needed to maintain a stable leadership team and retain other employees required to achieve corporate goals. The RSUs vest in annual installments of 25%, 25% and 50% on the first three anniversaries of the March 9, 2023 grant date. 2023 PSU Retention Awards. Due to the fact that a substantial portion of our outstanding, previously-granted stock options to the executives of the Company were significantly underwater at the time and to address the retention issues the Company believed it was facing, on March 16, 2023, the Committee approved a supplementary performance-based long-term equity incentive program for the executives of the Company (the “Executive PSU Program”) for the purpose of awarding additional retentive grants to the Company’s executive officers, including our NEOs, in the form of performance stock units (“PSU Retention Awards”) in two 50% tranches as follows:

  28. Equity-Based Incentive Awards

    | Name | Tranche #1 | Tranche #2 | Total PSU Retention Awards at Target | | Barber, Daniel | 223,500 | 223,500 | 447,000 | | Braender, Lori | 75,000 | 75,000 | 150,000 | | Toth, A. Ernest Jr. | 70,000 | 70,000 | 140,000 |

  29. Equity-Based Incentive Awards

    Tranche #1 of these PSU Retention Awards was granted by the Compensation Committee with an effective date of May 5, 2023, following the Company’s release of first quarter earnings, in accordance with the Company’s equity grant policy. Tranche #2 of these PSU Retention Awards was granted by the Compensation Committee following stockholder approval of the amendment of our 2018 Equity Incentive Plan, as amended, at the 2023 Annual Meeting of Stockholders. The vesting of these PSU Retention Awards is subject to achievement of stock price goals as follows:

  30. Equity-Based Incentive Awards

    | Performance Price* | Vesting Percentage | Vesting Level | | $1.75 | 50% | Threshold | | $2.50 | 100% | Target | | $3.25 | 150% | Maximum |

  31. Equity-Based Incentive Awards

    The Performance Price is measured as the 30-day average of the closing prices of the Company’s common stock as reported on the Nasdaq Stock Market immediately prior to and including the last calendar day of the three-year performance period (which ends on the third anniversary of the grant date, or May 5, 2026). To the extent the Performance Price is less than $1.75, the Vesting Percentage will be zero. To the extent the Performance Price is $1.75, the Vesting Percentage will be 50%. To the extent the Performance Price is $1.76 or greater, but less than $2.50, the Vesting Percentage will be an amount between 50.01% and 99.99%, based on straight-line interpolation. To the extent the Performance Price is $2.50, the Vesting Percentage will be 100%. To the extent the Performance Price is $2.51 or greater, but less than $3.25, the Vesting Percentage will be an amount between 100.01% and 149.99%, based on straight-line interpolation. To the extent the Performance Price is $3.25 or greater, the Vesting Percentage will be 150%. In no event will the Vesting Percentage exceed 150%. To vest in a PSU Retention Award, an executive officer must generally be employed on the last day of the performance period. Under the terms of the award agreement, in the event of an executive officer’s qualifying termination of employment due to death or disability of the executive officer, by the executive officer for good reason or by the Company not for cause, as defined in the award agreement, or in connection with a change in control during the three-year performance period, the performance period will be deemed to end on the date of such qualifying termination, and performance achievement will be measured as of such date. Equity Grant Policy. The Compensation Committee has adopted an equity grant policy with respect to the issuance of equity awards under our 2018 Equity Incentive Plan. Among other provisions, the equity grant policy establishes parameters for the grant date of equity awards made to executive officers and non-employee directors. Under the policy, the grant date for annual long-term incentive awards to officers and other employees is generally the date of the Compensation Committee’s regularly scheduled meeting in the first quarter of each year, but if the date of such meeting is not in an open trading window, the awards will be granted effective on the second full trading date following the next public release of earnings. Pursuant to the policy, annual equity awards to our non-employee directors are granted on the date of the Company’s annual meeting of stockholders. Additionally, “off-cycle” equity awards may be granted at other times during the year for circumstances such as new hires, promotions, director appointments and other special bases for grants, during open trading windows, or if the date the Compensation Committee takes action to approve such an award is not in an open trading window, then the awards will be granted effective on the second full trading date following the next public release of earnings.

  32. Summary Compensation Table

    Summary Compensation Table The following table provides information regarding the compensation provided to our NEOs during the fiscal year ended December 31, 2023 and 2022:

  33. Summary Compensation Table

    | Name & Principal Position | Year | Salary ($) | Stock Awards ($)(1) | Option Awards ($)(1) | Non-Equity Incentive Plan Compensation ($)(2) | All Other Compensation ($)(3) | Total ($) | | Daniel Barber Chief Executive Officer | 2023 | $600,000 | $1,432,635 | $— | $435,600 | $27,906 | $2,496,141 | | | 2022 | 541,591 | — | 401,253 | 355,547 | 28,207 | 1,326,598 | | Lori J. Braender Senior Vice President, General Counsel, Chief Compliance Officer and Corporate Secretary | 2023 | 417,300 | 480,750 | — | 263,942 | 31,973 | 1,193,965 | | | 2022 | 412,575 | — | 268,636 | 216,805 | 37,894 | 935,910 | | A. Ernest Toth, Jr.* Chief Financial Officer | 2023 | $407,880 | $448,700 | $— | $234,531 | $24,776 | $1,115,887 |

  34. Summary Compensation Table

    | * Mr. Toth was not an NEO in 2022. |

  35. Summary Compensation Table

    | (1) Represents the aggregate grant date fair value of equity awards computed in accordance with FASB ASC 718. A discussion of the assumptions used in calculating the fair value of such awards may be found in Note 19 to our 2023 audited financial statements included in our Annual Report on Form 10-K filed with the SEC on March 6, 2024. |

  36. Summary Compensation Table

    | (2) Represents annual incentive compensation for 2023 and, as applicable, 2022, paid in the first quarter of the following year. |

  37. Summary Compensation Table

    | (3) For 2023, this column includes the following: |

  38. Summary Compensation Table

    | | Mr. Barber ($) | Ms. Braender ($) | Mr. Toth ($) | | 401(k) Company Match | $19,800 | $19,800 | $19,800 | | Disability insurance premiums | 4,534 | 7,197 | — | | Life insurance premiums | 3,572 | 4,976 | 4,976 | | Severance | — | — | — | | Total | $27,906 | $31,973 | $24,776 |

  39. Outstanding Equity Awards at Fiscal Year End Table

    Outstanding Equity Awards at Fiscal Year End Table The following table sets forth certain information regarding equity awards granted to our NEOs that remain outstanding as of December 31, 2023:

  40. Outstanding Equity Awards at Fiscal Year End Table

    | | Stock Awards | | | | Stock Awards | | | | | | Number of Securities Underlying Unexercised Options (#) | | Option Exercise Price ($) | Option Expiration Date | Number of Shares or Units of Stock That Have Not Vested (#) | Market Value of Shares or Units of Stock That Have Not Vested ($) | Equity Incentive Plan Awards: Number of Unearned Shares or Units That Have Not Vested (#) | Equity Incentive Plan Awards: Number of Unearned Shares or Units That Have Not Vested ($) | | | Exercisable | Un-exercisable | | | | | | | | Mr. Barber | 25,997 | —(1) | $6.54 | 4/18/2028 | — | — | — | — | | | 96,507 | —(2) | $15.00 | 7/24/2028 | — | — | — | — | | | 70,000 | —(3) | $8.05 | 2/28/2029 | — | — | — | — | | | 50,000 | —(4) | $4.83 | 5/9/2029 | — | — | — | — | | | 110,000 | —(5) | $1.54 | 3/16/2030 | — | — | — | — | | | 50,000 | 50,000(6) | $5.30 | 3/11/2031 | — | — | — | — | | | 56,250 | 168,750(7) | $2.55 | 3/10/2032 | — | — | — | — | | | 25,000 | 75,000(8) | $0.88 | 8/5/2032 | — | — | — | — | | | — | — | $— | — | 447,000(11) | $362,070 | | | | | — | — | $— | — | — | $— | 223,500(12) | $525,225 | | | — | — | $— | — | — | $— | 223,500(13) | $545,340 | | Ms. Braender | 85,000 | —(9) | $18.67 | 9/10/2028 | — | — | — | — | | | 100,000 | —(3) | $8.05 | 2/28/2029 | — | — | — | — | | | 60,000 | —(5) | $1.54 | 3/16/2030 | — | — | — | — | | | 37,500 | 37,500(6) | $5.30 | 3/11/2031 | — | — | — | — | | | 40,000 | 120,000(7) | $2.55 | 3/10/2032 | — | — | — | — | | | 10,000 | 30,000(8) | $0.88 | 11/4/2032 | — | — | — | — | | | — | — | $— | — | 150,000(11) | $121,500 | — | $— | | | — | — | $— | — | — | $— | 75,000(12) | $176,250 | | | — | — | $— | — | — | $— | 75,000(13) | $183,000 | | Mr. Toth | 1,250 | 1,250(6) | $5.30 | 3/11/2031 | — | — | — | — | | | 60,000 | 60,000(10) | $4.04 | 6/15/2031 | — | — | — | — | | | 17,500 | 52,500(7) | $2.55 | 3/10/2032 | — | — | — | — | | | 10,000 | 30,000(8) | $0.88 | 11/4/2032 | — | — | — | — | | | — | — | $— | — | 140,000(11) | $113,400 | — | $— | | | — | — | $— | — | — | $— | 70,000(12) | $164,500 | | | — | — | $— | — | — | $— | 70,000(13) | $170,800 |

  41. Outstanding Equity Awards at Fiscal Year End Table

    | (1) Options granted on April 18, 2018. These options vested as follows: 25% on each of the first and second anniversaries of the grant date and 50% on the third anniversary of the grant date. |

  42. Outstanding Equity Awards at Fiscal Year End Table

    | (2) Options granted on July 24, 2018. These options vested as follows: 25% on each of the first and second anniversaries of the grant date and 50% on the third anniversary of the grant date. |

  43. Outstanding Equity Awards at Fiscal Year End Table

    | (3) Options granted on February 28, 2019. These options vested as follows: 25% on each of the first and second anniversaries of the grant date and 50% on the third anniversary of the grant date. |

  44. Outstanding Equity Awards at Fiscal Year End Table

    | (4) Options granted on May 9, 2019. These options vested as follows: 25% on each of the first and second anniversaries of the grant date and 50% on the third anniversary of the grant date. |

  45. Outstanding Equity Awards at Fiscal Year End Table

    | (5) Options granted on March 16, 2020. These options vested as follows: 25% on each of the first and second anniversaries of the grant date and 50% on the third anniversary of the grant date. |

  46. Outstanding Equity Awards at Fiscal Year End Table

    | (6) Options granted on March 11, 2021. These options vested as follows: 25% on each of the first and second anniversaries of the grant date and 50% on the third anniversary of the grant date. |

  47. Outstanding Equity Awards at Fiscal Year End Table

    | (7) Options granted on March 10, 2022. These options vest as follows: 25% on each of the first and second anniversaries of the grant date and 50% on the third anniversary of the grant date. |

  48. Outstanding Equity Awards at Fiscal Year End Table

    | (8) Options granted on August 5, 2022. These options vest as follows: 25% on each of the first and second anniversaries of the grant date and 50% on the third anniversary of the grant date. |

  49. Outstanding Equity Awards at Fiscal Year End Table

    | (9) Options granted on September 10, 2018. These options vested as follows: 25% on each of the first and second anniversaries of the grant date and 50% on the third anniversary of the grant date. |

  50. Outstanding Equity Awards at Fiscal Year End Table

    | (10) Options granted on June 15, 2021. These options vest as follows: 25% on each of the first and second anniversaries of the grant date and 50% on the third anniversary of the grant date. |

  51. Outstanding Equity Awards at Fiscal Year End Table

    | (11) Service-based restricted stock units (RSUs) granted on March 9, 2023. These RSUs vest as follows: 25% on each of the first and second anniversaries of the grant date and 50% on the third anniversary of the grant date. |

  52. Outstanding Equity Awards at Fiscal Year End Table

    | (12) Market condition vesting-based restricted stock units (RSUs) granted on May 5, 2023 (“First Tranche”). These RSUs vest based on a Performance Price measured as the 30-day average of the closing prices of the Company’s common stock as reported on the Nasdaq Stock Market immediately prior to and including the last calendar day of the three-year performance period (which ends on the third anniversary of the grant date or May 5, 2026). |

  53. Outstanding Equity Awards at Fiscal Year End Table

    | (13) Market condition vesting-based restricted stock units (RSUs) granted on August 9, 2023. These RSUs vest based on a Performance Price measured as the 30-day average of the closing prices of the Company’s common stock as reported on the Nasdaq Stock Market immediately prior to and including the last calendar day of the three-year performance period of the First Tranche or May 5, 2026. |

  54. Severance Arrangements

    | • | accelerated vesting of outstanding equity awards subject to time-based vesting as if the NEO had continued being employed through the end of the year in which employment terminates, or, in the case of awards subject to “cliff vesting,” pro-rata accelerated vesting based on the percentage of the vesting period that had elapsed as of the termination date (and stock options and stock appreciation rights will remain exercisable for one year following termination, subject to any earlier expiration date); and |

  55. Severance Arrangements

    | • | pro-rata accelerated vesting of outstanding equity awards which are subject to “performance-based” vesting conditions or a performance period which ends at or after the time of termination, with performance goals assumed to have been achieved at “target” and with pro-ration based on the percentage of the performance period that had elapsed as of the termination date. |

  56. Pay Versus Performance Disclosure

    Pay Versus Performance Disclosure In accordance with rules adopted by the Securities and Exchange Commission pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, we provide the following disclosure regarding executive compensation for our principal executive officer (“PEO”) and Non-PEO NEOs and Company performance for the fiscal years listed below. The Compensation Committee did not consider the pay versus performance disclosure below in making its pay decisions for any of the years shown.

  57. Pay Versus Performance Disclosure

    | Year | Summary Compensation Table Total for PEO 1(1) ($) | Summary Compensation Table Total for PEO 2(1) ($) | Compensation Actually Paid to PEO 1(1)(2)(3) ($) | Compensation Actually Paid to PEO 2(1)(2)(3) ($) | Average Summary Compensation Table Total for Non-PEO NEOs(1) ($) | Average Compensation Actually Paid to Non-PEO NEOs(1)(2)(3) ($) | Value of Initial Fixed $100 Investment based on:(4) | Net Income ($ Thousands) | | | | | | | | | TSR ($) | | | 2023 | 2,496,141 | 3,275,779 | — | — | 1,154,926 | 1,476,717 | 51.93 | (7,870) | | 2022 | 1,326,598 | 704,731 | 3,075,923 | 1,859,220 | 872,965 | 489,737 | 23.19 | (54,410) |

  58. Pay Versus Performance Disclosure

    | 1. | Keith J. Kendall was our PEO until his resignation on May 17, 2022. Daniel Barber became our PEO commencing on May 17, 2022. The individuals comprising the Non-PEO named executive officers for each year presented are listed below. |

  59. Pay Versus Performance Disclosure

    | 2022 | 2023 | | Lori J. Braender | Lori. J Braender | | A. Mark Schobel | A. Ernest Toth |

  60. Pay Versus Performance Disclosure

    | 2. | The amounts shown for Compensation Actually Paid have been calculated in accordance with Item 402(v) of Regulation S-K and do not reflect compensation actually earned, realized, or received by the Company’s NEOs. These amounts reflect the Summary Compensation Table Total with certain adjustments as described in footnote 3 below. |

  61. Pay Versus Performance Disclosure

    | 3. | Compensation Actually Paid reflects the exclusions and inclusions of certain amounts for the PEO and the Non-PEO NEOs as set forth below. Equity values are calculated in accordance with FASB ASC Topic 718. Amounts in the Exclusion of Stock Awards and Option Awards column are the totals from the Stock Awards and Option Awards columns set forth in the Summary Compensation Table. |

  62. Pay Versus Performance Disclosure

    | Year | Summary Compensation Table Total for PEO 1 ($) | Exclusion of Stock Awards and Option Awards for PEO 1 ($) | Inclusion of Equity Values for PEO 1 ($) | Compensation Actually Paid to PEO 1 ($) | | 2023 | 2,496,141 | (1,432,635) | 2,212,273 | 3,275,779 | | 2022 | 1,326,598 | (401,253) | (220,614) | 704,731 |

  63. Pay Versus Performance Disclosure

    | Year | Summary Compensation Table Total for PEO 2 ($) | Exclusion of Stock Awards and Option Awards for PEO 2 ($) | Inclusion of Equity Values for PEO 2 ($) | Compensation Actually Paid to PEO 2 ($) | | 2023 | — | — | — | — | | 2022 | 3,075,923 | (579,291) | (637,412) | 1,859,220 |

  64. Pay Versus Performance Disclosure

    | Year | Average Summary Compensation Table Total for Non-PEO NEOs ($) | Average Exclusion of Stock Awards and Option Awards for Non-PEO NEOs ($) | Average Inclusion of Equity Values for Non-PEO NEOs ($) | Average Compensation Actually Paid to Non-PEO NEOs ($) | | 2023 | 1,154,926 | (464,725) | 786,516 | 1,476,717 | | 2022 | 872,965 | (202,983) | (171,245) | 498,737 |

  65. Pay Versus Performance Disclosure

    The amounts in the Inclusion of Equity Values in the tables above are derived from the amounts set forth in the following tables:

  66. Pay Versus Performance Disclosure

    | Year | Year-End Fair Value of Equity Awards Granted During Year That Remained Unvested as of Last Day of Year for PEO 1 ($) | Change in Fair Value from Last Day of Prior Year to Last Day of Year of Unvested Equity Awards for PEO 1 ($) | Vesting- Date Fair Value of Equity Awards Granted During Year that Vested During Year for PEO 1 ($) | Change in Fair Value from Last Day of Prior Year to Vesting Date of Unvested Equity Awards that Vested During Year for PEO 1 ($) | Fair Value at Last Day of Prior Year of Equity Awards Forfeited During Year for PEO 1 ($) | Value of Dividends or Other Earnings Paid on Equity Awards Not Otherwise Included for PEO 1 ($) | Total - Inclusion of Equity Values for PEO 1 ($) | | 2023 | 1,946,676 | 253,278 | — | 12,319 | — | — | 2,212,273 | | 2022 | 230,106 | (320,419) | — | (130,301) | — | — | (220,614) |

  67. Pay Versus Performance Disclosure

    | Year | Year-End Fair Value of Equity Awards Granted During Year That Remained Unvested as of Last Day of Year for PEO 2 ($) | Change in Fair Value from Last Day of Prior Year to Last Day of Year of Unvested Equity Awards for PEO 2 ($) | Vesting- Date Fair Value of Equity Awards Granted During Year that Vested During Year for PEO 2 ($) | Change in Fair Value from Last Day of Prior Year to Vesting Date of Unvested Equity Awards that Vested During Year for PEO 2 ($) | Fair Value at Last Day of Prior Year of Equity Awards Forfeited During Year for PEO 2 ($) | Value of Dividends or Other Earnings Paid on Equity Awards Not Otherwise Included for PEO 2 ($) | Total - Inclusion of Equity Values for PEO 2 ($) | | 2023 | — | — | — | — | — | — | — | | 2022 | — | — | 311,140 | (948,552) | — | — | (637,412) |

  68. Pay Versus Performance Disclosure

    | Year | Average Year-End Fair Value of Equity Awards Granted During Year That Remained Unvested as of Last Day of Year for Non-PEO NEOs ($) | Average Change in Fair Value from Last Day of Prior Year to Last Day of Year of Unvested Equity Awards for Non-PEO NEOs ($) | Average Vesting- Date Fair Value of Equity Awards Granted During Year that Vested During Year for Non-PEO NEOs ($) | Average Change in Fair Value from Last Day of Prior Year to Vesting Date of Unvested Equity Awards that Vested During Year for Non- PEO NEOs ($) | Average Fair Value at Last Day of Prior Year of Equity Awards Forfeited During Year for Non- PEO NEOs ($) | Average Value of Dividends or Other Earnings Paid on Equity Awards Not Otherwise Included for Non-PEO NEOs ($) | Total - Average Inclusion of Equity Values for Non-PEO NEOs ($) | | 2023 | 631,471 | 140,526 | — | 14,519 | — | — | 786,516 | | 2022 | 111,769 | (213,299) | — | (69,715) | — | — | (171,245) |

  69. Pay Versus Performance Disclosure

    Description of Relationship Between PEOs and Non-PEO NEO Compensation Actually Paid and Company Total Shareholder Return (“TSR”) The following chart sets forth the relationship between Compensation Actually Paid to our PEOs, the average of Compensation Actually Paid to our Non-PEO NEOs, and the Company’s cumulative TSR over the two most recently completed fiscal years. Description of Relationship Between PEOs and Non-PEO NEO Compensation Actually Paid and Net Income The following chart sets forth the relationship between Compensation Actually Paid to our PEOs, the average of Compensation Actually Paid to our Non-PEO NEOs, and our Net Income during the two most recently completed fiscal years.

  70. Registration Rights to Directors and Officers

    Registration Rights to Directors and Officers We have granted certain registration rights to Mr. Barber, pursuant to his employment agreement, and to MRX Partners LLC, Monoline RX L.P., Monoline Rx II, L.P., Monoline Rx III, L.P., Monoline Rx Genpar, MonoSol Investors L.P. and Douglas K. Bratton, as well as Gregory B. Brown, M.D., John S. Cochran, Santo J. Costa and A. Mark Schobel. Pursuant to the terms of a registration rights agreement, if, following the completion of our initial public offering, we were to register any of our securities for public sale in another offering, these related parties (and such other persons as may be determined by the Company) would have the right to include their shares in the registration statement, subject to reduction provisions whereby the Company and the underwriters of any underwritten offering would have the right to limit the number of shares registered by these holders if they were to determine that marketing factors require limitation. In such a case the number of shares to be registered would be apportioned pro rata among these holders, according to the total amount of registrable securities entitled to be included by each holder. Pursuant to the Company’s Registration Statements on Form S-3 filed with the SEC on September 11, 2019 and on January 8, 2021, shares of our common stock were registered for resale, pursuant to such registration rights, for each of Daniel Barber, Lori J. Braender, Peter Boyd, A. Mark Schobel, Gregory B. Brown, M.D. and Santo J. Costa.