Exhibit 99.1

 

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KemPharm Reports Fourth Quarter and Full-Year 2020 Financial Results

 

 

Corporate and Regulatory Highlights:

 

 

AZSTARYS™ NDA approved by the FDA on March 2, 2021

 

Co-hosted “KP415 Market Opportunity and Commercialization Strategy” Investor Event with Corium, Inc.

 

Received FDA clearance to initiate KP879 clinical program for the treatment of Stimulant Use Disorder

 

Financial Highlights

 

 

Completed financial restructuring and re-listed on The Nasdaq Capital Market, resulting in no debt and receiving gross proceeds of approximately $94 million

 

Reported Q4 2020 revenue of $2.4 million and FY 2020 revenue of $13.3 million

 

Q4 2020 net loss of ($1.07) per basic share and diluted share compared to a net loss of ($2.90) per basic share and diluted share for Q4 2019

 

FY 2020 net loss of ($3.21) per basic and diluted share compared to a net loss of ($13.23) per basic and diluted share for the year ended December 31, 2019

 

Total cash, cash equivalents and restricted cash was $77.6 million at March 10, 2021

 

Celebration, FL March 11, 2020 – KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today reported its financial results for the fourth quarter and year ended December 31, 2020.

 

“The fourth quarter of 2020 and early 2021 was a period of significant activity and accomplishment for KemPharm as the company has restructured its balance sheet, extinguished its debt, re-listed on The Nasdaq Capital Market and perhaps most importantly, received approval for the AZSTARYS NDA,” said Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “Completing the multi-phased financial restructuring process was critically important during this timeframe, and bringing this together required a series of transactions that had to be orchestrated in a specific sequence.  Now, combined with the approval of AZSTARYS, KemPharm is in a position of strength as we look forward to realizing the value from our development investments and the growth that is possible for the Company as a result.”

 

Dr. Mickle continued, “Now with the AZSTARYS approval behind us, we are working alongside the Corium team on the product’s commercial launch which is expected as early as the second half of 2021. As discussed during the December investor event, Corium is enthusiastic about AZSTARYS’ potential as a treatment for ADHD with what we believe is a clear strategy for bringing the product to market.” 

 

Dr. Mickle concluded, “We are also pleased to have received FDA clearance for the Investigational New Drug (IND) application for KP879, our extended-duration, agonist replacement therapy for the treatment of Stimulant Use Disorder (SUD). KP879 is an important addition to our product candidate portfolio as it provides an opportunity to address a disease indication – SUD – for which there are no FDA-approved medications, as well as to demonstrate the versatility and value potential of serdexmethylphenidate (SDX), our prodrug of d-methylphenidate.  SDX is the primary API for KP879, as well as AZSTARYS and KP484, showcasing the potential for our prodrugs a platform technology.  We now look forward to initiating the clinical program for KP879 in 2021.”

 

 

The following information was filed by Kempharm, Inc (KMPH) on Thursday, March 11, 2021 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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