GlobeNewswire Inc | Aug 12, 2020 04:05PM EDT

August 12, 2020

Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Today at 4:30 p.m. ET

Corporate and Regulatory Highlights:

-- Received Day-74 Letter for KP415 NDA; FDA has set PDUFA date of March 2, 2021 -- Announced that Corium, Inc., a portfolio company of GPC, will lead all commercialization activities for KP415 -- Announced issuance of two additional U.S. patents governing KP415 and KP484

Financial Highlights

-- Reported Q2 2020 revenue of $6.9 million, including $5 million milestone payment for NDA acceptance on May 1, 2020, and $1.9 million from research and development consulting services -- Q2 2020 net income of $0.01 per basic share and diluted share compared to a net loss of $0.33 per basic and diluted share for Q2 2019 -- Total cash, cash equivalents and restricted cash was $6.6 million at June 30, 2020

CELEBRATION, Fla., Aug. 12, 2020 (GLOBE NEWSWIRE) -- KemPharm, Inc. (OTCQB: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today reported its financial results for the second quarter ended June 30, 2020.

The second quarter was a period of continued advancement at KemPharm, highlighted by the FDAs acceptance of the New Drug Application (NDA) for KP415 and, following that, receipt of the Day-74 Letter from the FDA, said Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. Contained within the Day-74 Letter were two important updates from the FDA. The FDA informed us that the action date (PDUFA) for KP415 is March 2, 2021, and that an advisory committee is not required at this time.

Dr. Mickle continued, Dovetailing with these important regulatory advancements, KemPharm also reported two key events in our collaboration with Gurnet Point Capital (GPC). Upon the FDAs acceptance of the KP415 NDA, KemPharm received the $5 million milestone payment as provided by the definitive collaboration and license agreement. Additionally, Corium, Inc., a GPC portfolio company, will lead all commercialization activities for KP415, providing what we believe is the most well-suited and experienced commercial organization to launch and maximize the potential market for KP415. In addition, that opportunity has since been strengthened by the recent issuance of two U.S. patents governing KP415 and KP484. Both patents have an expiration date of December 9, 2037, which is an extension of approximately five years beyond prior serdexmethylphenidate (SDX) patents.

Dr. Mickle concluded, Based on these recent events and accomplishments, we are very optimistic about KemPharms short- and long-term prospects. While certain headwinds remain, momentum continues to build behind the value potential of KP415, and we are excited to be working with the Corium team to develop the marketing and commercialization strategy for KP415, which we look forward to unveiling as soon as we are in a position to do so.

Q2 2020 Financial Results:

For Q2 2020, KemPharm reported revenue of $6.9 million which is comprised of a $5.0 million milestone payment received upon the FDAs acceptance of the NDA for KP415 and $1.9 million from research and development services under the definitive collaboration and license agreement (KP415 License Agreement) and other consulting arrangements, as compared to Q1 2020 revenue of $2.1 million. KemPharm had no revenue in Q2 2019. This is KemPharms fourth sequential quarter reporting revenue, and the Company expects to continue earning revenue as the Company provides services under the KP415 License Agreement and other consulting arrangements.

KemPharms net income for Q2 2020 was $0.9 million, or $0.01 per basic share and diluted share, compared to a net loss of $9.3 million, or $0.33 per basic and diluted share for the same period in 2019. Net income for Q2 2020 was driven primarily by operating income of $2.6 million, partially offset by net interest expense and other items of $1.7 million. The net operating income of $2.6 million for Q2 2020 was an increase of $10.4 million compared to a net operating loss of $7.8 million in the same period in 2019, which was primarily due to revenue of $6.9 million, a decrease in research and development expenses of $2.8 million and a decrease in general and administrative expenses of $1.3 million, partially offset by royalty and direct contract acquisition costs of $0.6 million.

As of June 30, 2020, total cash, cash equivalents and restricted cash was $6.6 million, which was an increase of $4.0 million compared to March 31, 2020. Based on the Companys current operating forecast, the Company believes that its expected revenues and existing resources are sufficient to continue operations past the potential March 2, 2021 PDUFA date for the KP415 NDA and up to the debt maturity date of March 31, 2021.

Conference Call Information:

KemPharm will host a conference call and live audio webcast with slide presentation onWednesday, August 12, 2020, at 4:30 p.m. ET, to discuss its corporate and financial results for the second quarter 2020. Interested participants and investors may access the conference call by dialing either:

-- (866) 395-2480 (U.S.) -- (678) 509-7538 (international) -- Conference ID: 5176398

An audio webcast with slide presentation will be accessible via the Investor Relations section of the Companys website, http://investors.kempharm.com/. An archive of the webcast and presentation will be available for 90 days beginning at approximately5:30 p.m. ET, onAugust 12, 2020.

About KemPharm:

KemPharm is a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its proprietary LAT (Ligand Activated Therapy) technology.KemPharm utilizes its proprietary LAT technology to generate improved prodrug versions of FDA-approved drugs as well as to generate prodrug versions of existing compounds that may have applications for new disease indications. KemPharms prodrug product candidate pipeline is focused on the high need areas of attention deficit hyperactivity disorder, or ADHD, and stimulant use disorder. KemPharms co-lead clinical development candidates for the treatment of ADHD, KP415 and KP484, are both based on a prodrug of d-methylphenidate, but have differing duration/effect profiles. In addition, KemPharm has received FDA approval for APADAZ, an immediate-release combination product containing benzhydrocodone, a prodrug of hydrocodone, and acetaminophen. For more information on KemPharm and its pipeline of prodrug product candidates visit www.kempharm.com or connect with us on Twitter, LinkedIn, Facebook and YouTube.

Caution Concerning Forward Looking Statements:

This press release 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 our proposed development and commercial timelines, and can be identified by the use of words such as may, will, expect, project, estimate, anticipate, plan, believe, potential, should, continue or the negative versions of those words or other comparable words. Forward-looking statements are not guarantees of future actions or performance. These forward-looking statements, including the timing of the PDUFA date and potential FDA approval of the KP415 NDA, the potential commercial launch of KP415, the expectations regarding continued research and development services revenue, the potential clinical benefits of KP415 or any of the Companys product candidates, the potential initiation or timeline for the development of any of our product candidates, cash runway, and the potential timeline to complete a debt restructuring, if at all, are based on information currently available to KemPharm and its current plans or expectations and are subject to a number of uncertainties and risks that could significantly affect current plans. Risks concerning KemPharms business are described in detail in KemPharms Annual Report on Form 10-K for the year ended December 31, 2019, KemPharms Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, and KemPharms other Periodic and Current Reports filed with the Securities and Exchange Commission. KemPharm is under no obligation to, and expressly disclaims any such obligation to, update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.

KemPharm Contacts:

Jason Rando / Maureen McEnroeTiberend Strategic Advisors, Inc.(212) 375-2665 / 2664jrando@tiberend.commmcenroe@tiberend.com

KEMPHARM, INC.UNAUDITED CONDENSED STATEMENTS OF OPERATIONS(in thousands, except share and per share amounts)

Three months ended Six months ended June 30, June 30, 2020 2019 2020 2019Revenue $ 6,908 $ ? $ 8,997 $ ? Operating expenses:Royalty anddirectcontract 642 ? 1,305 ? acquisitioncostsResearch and 1,954 4,803 4,080 13,334 developmentGeneral and 1,719 2,989 3,964 5,827 administrativeSeverance ? ? 830 ? expenseTotaloperating 4,315 7,792 10,179 19,161 expensesIncome (loss)from 2,593 (7,792 ) (1,182 ) (19,161 )operationsOther(expense) income:Interestexpenserelated toamortization (574 ) (305 ) (1,145 ) (610 )of debtissuance costsand discountInterestexpense on (1,197 ) (1,232 ) (2,457 ) (2,461 )principalFair valueadjustmentrelated to (3 ) (21 ) 72 432 derivative andwarrantliabilityInterest andother income 40 84 (183 ) 235 (expense), netTotal other (1,734 ) (1,474 ) (3,713 ) (2,404 )expensesIncome (loss)before income 859 (9,266 ) (4,895 ) (21,565 )taxesIncome tax ? 9 ? 17 benefitNet income $ 859 $ (9,257 ) $ (4,895 ) $ (21,548 )(loss) Net income(loss) per share ofcommon stock:Basic $ 0.01 $ (0.33 ) $ (0.09 ) $ (0.78 )Diluted $ 0.01 $ (0.33 ) $ (0.09 ) $ (0.78 ) Weightedaverage numberof shares of common stockoutstanding:Basic 63,163,251 28,386,119 55,618,446 27,548,657 Diluted 63,164,403 28,386,119 55,618,446 27,548,657

KEMPHARM, INC.CONDENSED BALANCE SHEETS(in thousands, except share and par value amounts)

June 30, December 31, 2020 2019 (unaudited) Assets Current assets: Cash and cash equivalents $ 6,369 $ 3,217 Accounts and other receivables 2,093 1,865 Prepaid expenses and other current assets 603 1,552 Total current assets 9,065 6,634 Property and equipment, net 1,146 1,471 Operating lease right-of-use assets 1,404 1,537 Restricted cash 186 338 Other long-term assets 527 527 Total assets $ 12,328 $ 10,507 Liabilities and stockholders' deficit Current liabilities: Accounts payable and accrued expenses $ 4,729 $ 4,911 Current portion of convertible notes 67,271 ? Current portion of operating lease liabilities 309 284 Other current liabilities 240 236 Total current liabilities 72,549 5,431 Convertible notes, less current portion, net ? 77,343 Derivative and warrant liability 47 120 Operating lease liabilities, less current portion 1,755 1,901 Loans payable 781 ? Other long-term liabilities 59 168 Total liabilities 75,191 84,963 Stockholders? deficit: Preferred stock: Series A convertible preferred stock, $0.0001 parvalue, 9,578 shares authorized, 9,577 shares ? ? issued and no shares outstanding as of June 30,2020 (unaudited) and December 31, 2019Series B-1 convertible preferred stock, $0.0001par value, 1,576 shares authorized, 1,576 shares ? ? issued and no shares outstanding as of June 30,2020 (unaudited) and December 31, 2019Series B-2 convertible preferred stock, $0.0001par value, 27,000 shares authorized, no shares ? ? issued or outstanding as of June 30, 2020(unaudited) and December 31, 2019Undesignated preferred stock, $0.0001 par value,9,961,846 shares authorized, no shares issued or ? ? outstanding as of June 30, 2020 (unaudited) andDecember 31, 2019Common stock, $0.0001 par value, 250,000,000shares authorized, 67,223,913 shares issued andoutstanding as of June 30, 2020 (unaudited); 7 4 36,350,785 shares issued and outstanding as ofDecember 31, 2019Additional paid-in capital 187,739 171,254 Accumulated deficit (250,609 ) (245,714 )Total stockholders' deficit (62,863 ) (74,456 )Total liabilities and stockholders' deficit $ 12,328 $ 10,507