KemPharm and Corium Expand Relationship with New Consultation Services Agreement

Rhea-AI Summary

KemPharm, Inc. (OTCQB: KMPH) has expanded its agreement with Corium, Inc. to provide product development consultation services, potentially bringing in up to $15.6 million in service fees through March 31, 2022. This agreement follows the 2019 License Agreement with Gurnet Point Capital for the exclusive rights to develop KemPharm’s SDX product candidates, including KP415. The new arrangement enhances revenue visibility and extends the revenue stream related to KP415 beyond its PDUFA date of March 2, 2021, indicating strong collaboration and confidence in the product's potential commercialization.

Positive

• Expanded agreement with Corium may generate up to $15.6 million in service fees.
• Increases revenue visibility and extends revenue stream past KP415's PDUFA date.

Negative

• None.

New agreement provides additional revenue potentially through Q1 2022

CELEBRATION, Fla., Oct. 05, 2020 (GLOBE NEWSWIRE) -- KemPharm, Inc. (OTCQB: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that it has expanded its relationship with Corium, Inc. (Corium) through a new consultation services agreement under which KemPharm will provide product development consultation services to Corium. These new activities are in addition to KemPharm’s ongoing commercial support activities for KP415.

In September 2019, KemPharm entered into the License Agreement with an affiliate of Gurnet Point Capital (GPC), for the exclusive worldwide rights to develop, manufacture and commercialize KemPharm’s product candidates containing serdexmethylphenidate (SDX), including KemPharm’s ADHD product candidates, KP415 and KP484 (the KP415/KP484 License Agreement). Corium, a GPC portfolio company, is leading all commercialization activities for KP415.

Through the new consultation services arrangements, Corium has engaged KemPharm to guide the product development and regulatory activities for certain current and potential future products in Corium’s portfolio, as well as to continue supporting preparation for the potential commercial launch of KP415, if approved. The initial work order under this expanded relationship provides for KemPharm to receive service fees of up to $15.6 million paid in quarterly installments through March 31, 2022. Additional details were not disclosed.

“We are very pleased to expand our working relationship with Corium to include initiatives beyond the ongoing regulatory review of KP415 and preparation for its potential commercialization,” said Travis Mickle, Ph.D., President and CEO of KemPharm. “This expansion of our work with Corium is a testament to the success of this relationship and an affirmation of KemPharm’s product development capabilities.”

“This new arrangement with Corium brings additional revenue and provides more visibility for KemPharm’s operating forecast through March 31, 2022,” said LaDuane Clifton, Chief Financial Officer of KemPharm. “In addition, the original consultation services component of the KP415/KP484 License Agreement for commercial support of KP415 has been converted into a flat-fee arrangement that will extend the related revenue stream more than a year past the KP415 PDUFA date of March 2, 2021.”

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. KemPharm’s prodrug product candidate pipeline is focused on the high need areas of attention deficit hyperactivity disorder, or ADHD, and stimulant use disorder. KemPharm’s 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 the Company’s 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 and probability of potential FDA approval of the KP415 NDA, and the potential commercial launch of KP415. The potential clinical benefits of KP415 or any of KemPharm’s product candidates, its operating forecast or its ability to continue as a going concern 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 KemPharm’s business are described in detail in KemPharm’s Annual Report on Form 10-K for the year ended December 31, 2019, and KemPharm’s 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 McEnroe
Tiberend Strategic Advisors, Inc.
(212) 375-2665 / 2664
jrando@tiberend.com
mmcenroe@tiberend.com

 

FAQ

What is KemPharm's agreement with Corium about?

KemPharm has expanded its relationship with Corium to provide product development consultation services, potentially earning up to $15.6 million.

How much revenue can KemPharm expect from the new agreement with Corium?

KemPharm may receive up to $15.6 million in service fees paid quarterly through March 31, 2022.

What is the significance of the KP415 product candidate for KemPharm?

KP415 is part of KemPharm's ADHD product candidates, with its commercialization activities spearheaded by Corium under a license agreement.

When is the PDUFA date for KemPharm's KP415?

The PDUFA date for KP415 is March 2, 2021.