ro INC KemPharm Management Presentation September 2021 Cautionary Note Regarding Presentation Information This presentation may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation and can be identified by the use of w ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period From to Commission File No. 001-36913 KemPharm, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 20-5894398 (State or Other Jurisdiction of Inco ...

KemPharm, Inc. (KMPH) Q2 2021 Earnings Conference Call August 12, 2021 4:30 PM ET Company Participants Jason Rando - Tiberend Strategic Advisors Travis Mickle - President and CEO LaDuane Clifton - CFO Conference Call Participants Jonathan Aschoff - ROTH Operator Good day, and thank you for standing by. Welcome to the KemPharm Second Quarter 2021 Results Conference Call [Operator Instructions]. I'd now like to hand the conference over to your speaker today, Jason Rando, with Tiberend Strategic Advisors. Ple ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period From to Commission File No. 001-36913 KemPharm, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 20-5894398 (State or Other Jurisdiction of Inc ...

KemPharm, Inc. (KMPH) Q1 2021 Results Conference Call May 13, 2021 4:30 PM ET Company Participants Jason Rando - Tiberend Strategic Advisors Travis Mickle - President, CEO LaDuane Clifton - CFO Conference Call Participants Operator Ladies and gentlemen, thank you for standing by, and welcome to KemPharm's First Quarter 2021 Results Conference Call. At this time all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. Please be advised that to ...

Financial Data and Key Metrics Changes - For Q4 2020, the company reported revenue of $2.4 million, an increase of $0.5 million compared to Q3 2020 [22] - The net loss for Q4 2020 was $4.9 million, or $1.07 per share, compared to a net loss of $6 million, or $2.90 per share, in Q4 2019 [24] - Full-year 2020 revenue was $13.3 million, up from $12.8 million in 2019, with a net loss of $12.8 million compared to $24.5 million in 2019 [26] Business Line Data and Key Metrics Changes - The revenue for Q4 2020 was primarily composed of services revenue under the Corium consulting arrangement [22] - R&D expenses for Q4 2020 were $3.1 million, while G&A expenses were $2.5 million, maintaining the same expense posture as previous years [25] Market Data and Key Metrics Changes - The ADHD market is valued at $17.5 billion, with the company believing its product can meet key advantages over existing methylphenidate-based products [18] Company Strategy and Development Direction - The company has completed a multi-phase financial restructuring, resulting in approximately $94 million in growth proceeds and the elimination of all debt [20][21] - The company aims to optimize the value of its product AZSTARYS and is exploring new assets for potential acquisition to create shareholder value [68][69] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the approval of AZSTARYS and its potential impact on the company's future [8][12] - The company believes there is a disconnect between its current market valuation and the potential value from the AZSTARYS approval [48][52] Other Important Information - The company regained its listing on the NASDAQ Capital Market in January 2021 and reported total cash of $77.6 million as of March 10, 2021 [30][31] Q&A Session Summary Question: Clarification on fully diluted shares outstanding after restructuring - The number of fully diluted shares outstanding is 38.6 million, including 9.6 million of preferred stock [36] Question: Current market cap and cash position - The current cash position is $77.6 million, with a market cap of approximately $283 million based on shares outstanding [39] Question: Commercialization plans for AZSTARYS - The company believes it has an excellent label for AZSTARYS and is confident in Corium's commercialization strategy [46] Question: Disconnect between current evaluation and potential value from AZSTARYS approval - Management encouraged investors to compare the labels of AZSTARYS with existing products to understand its potential market share [50][52] Question: Capital deployment and potential new assets - The company is looking at new assets that add value and will continue to support the development of its existing products [68][69]

Part I [Item 1. Business](index=6&type=section&id=Item%201.%20Business) KemPharm is a specialty pharmaceutical company developing prodrugs using its LAT® technology for ADHD, SUD, and IH, with key FDA-approved products AZSTARYS™ and APADAZ® commercialized through partnerships - KemPharm is a specialty pharmaceutical company using its proprietary Ligand Activated Therapy (LAT®) technology to develop prodrugs for ADHD, Stimulant Use Disorder (SUD), and Idiopathic Hypersomnia (IH)[20](index=20&type=chunk) - On March 2, 2021, the FDA approved AZSTARYS™, a once-daily product for treating ADHD in patients aged six and older. Commercialization will be led by Corium, with availability expected as early as the second half of 2021[21](index=21&type=chunk) - The company has a collaboration and license agreement with Commave Therapeutics SA for the development and commercialization of AZSTARYS and other product candidates containing serdexmethylphenidate (SDX)[20](index=20&type=chunk)[23](index=23&type=chunk) - KemPharm has a commercial partnership with KVK-Tech, Inc. for APADAZ®, an FDA-approved immediate-release product for the short-term management of acute pain[20](index=20&type=chunk)[24](index=24&type=chunk) [Our Product Candidates and Approved Products](index=8&type=section&id=Our%20Product%20Candidates%20and%20Approved%20Products) This section outlines KemPharm's pipeline, including FDA-approved AZSTARYS™ and APADAZ®, and candidates like KP879 for SUD and KP1077 for IH KemPharm Product Pipeline Summary | Product Candidate / Product | Parent Drug (Effect Profile) | Indication | Status | Next Milestone | | :--- | :--- | :--- | :--- | :--- | | **AZSTARYS** (Partnered) | Methylphenidate (ER) | ADHD | FDA Approved | Commercial Launch - as early as H2 2021 | | **KP484** (Partnered) | Methylphenidate (ER) | ADHD | Clinical | Initiation of Pivotal Efficacy Trial - TBD by Partner | | **KP879*** | Methylphenidate (ER) | SUD | Clinical | Initiation of Clinical Program - 2021 | | **KP1077** | Prodrug | IH | Preclinical | Pre-IND Meeting - H1 2021 | - AZSTARYS and KP484 are extended-duration methylphenidate products for ADHD, utilizing the prodrug serdexmethylphenidate (SDX). AZSTARYS received FDA approval on March 2, 2021[37](index=37&type=chunk)[38](index=38&type=chunk) - KP879 is a d-methylphenidate prodrug candidate for Stimulant Use Disorder (SUD). An IND was filed in December 2020, and the clinical program is expected to begin in 2021[50](index=50&type=chunk) - APADAZ, an immediate-release combination of benzhydrocodone and acetaminophen, was approved by the FDA in February 2018 for short-term acute pain management[54](index=54&type=chunk) [Intellectual Property](index=13&type=section&id=Intellectual%20Property) KemPharm maintains a robust intellectual property portfolio with numerous active U.S. and foreign patents, protecting its LAT technology and product candidates - As of December 31, 2020, KemPharm holds **48 active U.S. patents** and **78 active foreign patents**, with terms extending to dates between 2030 and 2037[62](index=62&type=chunk) - The company has **13 pending patent applications in the U.S.** and **28 pending foreign applications**. Its patent portfolio provides protection in key jurisdictions including the U.S., Europe, China, and Japan[62](index=62&type=chunk) - The company also relies on trade secret protection and confidentiality agreements to protect its proprietary LAT technology and other know-how[65](index=65&type=chunk) [Commercialization](index=14&type=section&id=Commercialization) Commercialization efforts for AZSTARYS and APADAZ are led by partners Corium and KVK-Tech respectively, with potential for future in-house or collaborative sales for other candidates - Corium, Inc. will lead the commercialization of AZSTARYS in the U.S., with an expected launch as early as the second half of 2021[67](index=67&type=chunk) - KVK-Tech, Inc. is responsible for the commercialization of APADAZ in the U.S. A regional pilot launch began in Alabama in December 2020[24](index=24&type=chunk)[68](index=68&type=chunk) - For other product candidates, KemPharm may form collaborations or build its own sales and marketing organization, depending on the product and market opportunity[69](index=69&type=chunk) [Research and Development](index=14&type=section&id=Research%20and%20Development) Research and development expenses significantly decreased in 2020, with Commave responsible for reimbursing development costs for licensed product candidates Research and Development Expenses | Year | R&D Expense (in millions) | | :--- | :--- | | 2020 | $8.8 | | 2019 | $19.4 | - Under the KP415 License Agreement, Commave is responsible for reimbursing KemPharm for all development, commercialization, and regulatory expenses for licensed product candidates, subject to certain limitations[70](index=70&type=chunk) [Government Regulation](index=17&type=section&id=Government%20Regulation) The company's products are subject to extensive FDA and DEA regulations, often utilizing the 505(b)(2) pathway, and are primarily classified as Schedule II controlled substances - The company's products are subject to substantial regulation by the FDA, DEA, and other federal and state authorities, covering development, manufacturing, marketing, and distribution[86](index=86&type=chunk)[87](index=87&type=chunk) - KemPharm often utilizes the 505(b)(2) NDA pathway, which allows reliance on the FDA's previous findings of safety and effectiveness for approved drugs, potentially reducing development time and cost[97](index=97&type=chunk)[98](index=98&type=chunk) - Most of the company's products, including APADAZ and AZSTARYS, are regulated as Schedule II controlled substances by the DEA, subjecting them to strict registration, security, recordkeeping, and quota requirements[125](index=125&type=chunk)[126](index=126&type=chunk) [Item 1A. Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including uncertain commercial success of products, a history of net losses, reliance on third parties for operations, DEA controlled substance regulations, and intellectual property challenges - The commercial success of AZSTARYS and APADAZ is not guaranteed and depends on the efforts of collaboration partners Commave and KVK, respectively. Failure to successfully commercialize these products would harm the business[157](index=157&type=chunk)[158](index=158&type=chunk)[159](index=159&type=chunk) - The company has a history of significant recurring negative net operating cash flows, with an accumulated deficit of **$258.5 million** as of December 31, 2020, and may need additional funding to continue operations[210](index=210&type=chunk)[218](index=218&type=chunk) - KemPharm relies on third parties for manufacturing and clinical trials, which introduces risks related to regulatory compliance (cGMP, GCP), supply chain disruptions, and performance failures by these contractors[233](index=233&type=chunk)[240](index=240&type=chunk) - The company's products contain controlled substances (Schedule II), making them subject to strict regulation by the DEA, including production quotas, which could limit commercial supply[194](index=194&type=chunk)[195](index=195&type=chunk) - Intellectual property risks include the inability to obtain or maintain patent protection, potential infringement lawsuits, and challenges to the validity of existing patents, which could impair the company's ability to commercialize its products[263](index=263&type=chunk)[277](index=277&type=chunk) [Item 2. Properties](index=83&type=section&id=Item%202.%20Properties) KemPharm leases its headquarters in Celebration, Florida, along with additional laboratory and office spaces in Iowa, Virginia, and North Carolina - The company's headquarters is approximately **17,000 square feet** of leased office space in Celebration, Florida, with leases expiring in August 2025 and February 2026[418](index=418&type=chunk) - Additional leased facilities include laboratory space in Coralville, Iowa and Blacksburg, Virginia, and office space in Chapel Hill, North Carolina[418](index=418&type=chunk) [Item 3. Legal Proceedings](index=83&type=section&id=Item%203.%20Legal%20Proceedings) The company reports no pending litigation expected to have a material adverse effect on its financial condition or operations - The company states there is no pending litigation that is reasonably expected to have a material adverse effect on its results of operations or financial condition[419](index=419&type=chunk) Part II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities](index=84&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%2C%20and%20Issuer%20Purchases%20of%20Equity%20Securities) KemPharm's common stock is listed on Nasdaq under 'KMPH', with approximately 134 record holders as of December 31, 2020, and no history or future plans for cash dividends - The company's common stock is listed on The Nasdaq Capital Market with the ticker symbol **"KMPH"**[423](index=423&type=chunk) - As of December 31, 2020, there were approximately **134 holders of record** of the common stock[424](index=424&type=chunk) - The company has never declared or paid cash dividends and intends to retain future earnings to fund business growth[425](index=425&type=chunk) [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=85&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) KemPharm significantly reduced its net loss in 2020 due to decreased R&D expenses, and post-period financing activities in early 2021 substantially strengthened its financial position, extending cash runway through Q1 2024 Results of Operations Comparison (2020 vs. 2019) | Metric (in thousands) | 2020 | 2019 | Change | | :--- | :--- | :--- | :--- | | **Revenue** | $13,288 | $12,839 | $449 | | **Research and development** | $8,843 | $19,415 | ($10,572) | | **General and administrative** | $7,921 | $10,816 | ($2,895) | | **Loss from operations** | ($5,609) | ($20,337) | $14,728 | | **Net loss** | ($12,760) | ($24,522) | $11,762 | - The decrease in net loss for 2020 was primarily driven by a **$10.6 million reduction** in research and development expenses[489](index=489&type=chunk)[492](index=492&type=chunk) - In January and February 2021, the company executed several key financial transactions: a reverse stock split, relisting on Nasdaq, a public offering raising **$52.4 million**, a warrant exercise inducement raising **$44.0 million**, and a full payoff of its approximately **$7.6 million** remaining debt[438](index=438&type=chunk)[449](index=449&type=chunk)[452](index=452&type=chunk)[454](index=454&type=chunk) - Management believes that cash on hand following the early 2021 financing activities is sufficient to fund operations through at least the first quarter of 2024[563](index=563&type=chunk) [Item 9A. Controls and Procedures](index=111&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal controls over financial reporting were effective as of December 31, 2020, with a notable change being the engagement of a third-party financial accounting advisory firm - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2020[592](index=592&type=chunk) - Management concluded that the company's internal controls over financial reporting were effective as of December 31, 2020, based on the COSO framework[594](index=594&type=chunk) - A material change in internal controls during the most recent fiscal quarter was the engagement of a third-party financial accounting advisory firm for as-needed professional services[597](index=597&type=chunk) Part IV [Item 15. Exhibits and Financial Statement Schedules](index=113&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section presents KemPharm's audited financial statements for 2020 and 2019, including balance sheets, statements of operations, and cash flows, along with the independent auditor's report Balance Sheet Summary (as of Dec 31, 2020) | Metric (in thousands) | Amount | | :--- | :--- | | **Total Current Assets** | $8,382 | | **Total Assets** | $11,209 | | **Total Current Liabilities** | $7,536 | | **Total Liabilities** | $77,621 | | **Total Stockholders' Deficit** | ($66,412) | Statement of Operations Summary (Year ended Dec 31, 2020) | Metric (in thousands) | Amount | | :--- | :--- | | **Revenue** | $13,288 | | **Total Operating Expenses** | $18,897 | | **Loss from Operations** | ($5,609) | | **Net Loss** | ($12,760) | Cash Flow Summary (Year ended Dec 31, 2020) | Metric (in thousands) | Amount | | :--- | :--- | | **Net cash used in operating activities** | ($1,939) | | **Net cash (used in) provided by investing activities** | ($33) | | **Net cash provided by financing activities** | $2,739 | | **Net increase in cash** | $767 |

KemPharm, Inc. (KMPH) Q3 2020 Earnings Conference Call October 29, 2020 4:30 PM ET Company Participants Jason Rando - Tiberend Strategic Advisors, Inc. Travis Mickle - President and Chief Executive Officer LaDuane Clifton - Chief Financial Officer Conference Call Participants Oren Livnat - H.C. Wainwright & Co., LLC Operator Good afternoon, ladies and gentlemen, and welcome to KemPharm Q3 2020 Corporate Update Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period From to Commission File No. 001-36913 KemPharm, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 20-5894398 (State or Other Jurisdiction of ...

KemPharm, Inc. (KMPH) Q2 2020 Results Conference Call August 12, 2020 4:30 PM ET Company Participants Jason Rando - Tiberend Strategic Advisors, Inc. Travis Mickle - President & CEO LaDuane Clifton - CFO Conference Call Participants Oren Livnat - H.C. Wainwright Operator Ladies and gentlemen, thank you for standing by and welcome to the KemPharm Q2 2020 Corporate Update Conference Call. At this time, all participants’ lines are in a listen-only mode. After the speakers’ presentation, there will be a quest ...