|Bid||0.00 x 1000|
|Ask||0.00 x 900|
|Day's Range||9.18 - 9.99|
|52 Week Range||1.94 - 22.08|
|Beta (5Y Monthly)||3.26|
|PE Ratio (TTM)||N/A|
|Earnings Date||Oct 29, 2020|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||26.00|
Usually when a pharma company announces approval of one of its products, it usually merits an upwards rejig to an analyst’s model. But "usually" doesn't mean "always." On Wednesday, KemPharm (KMPH) announced that the FDA had given its nod of approval for Azstarys, the company's once a day treatment of attention deficit hyperactivity disorder (ADHD). But where the analyst’s model is concerned, H.C. Wainwright analyst Oren Livnat points out why his reaction to the approval is not as would be anticipated. As Livant highlights, the decision makes Azstarys the first approved prodrug version of any MPH-based ADHD product— putting it amongst a group that generates almost 20 million prescriptions annually. So, good news there. What’s more, the potential cash windfall from the approval is significant. KemPharm has a commercial partnership with Corium, a portfolio company of Gurnet Point Capital. KemPharm could be due a $48 million approval milestone payment, royalties of high-single digits up to mid-20%, and sales-based milestones that could reach up to $42 million. However, “potential cash windfall” is the key phrase here, says Livnat, because of a “disagreement on terms given the final Azstarys label.” Livnat has long maintained that Azstarys’ label notes regarding onset and duration of efficacy, will be key. “We believe the drug has best-in-class 0.5-13 hour efficacy, but its pivotal classroom study—with an unorthodox SAP—yielded 1-10 hours. Post hoc analysis using FDA’s typical method, as well as secondary endpoints and PK data, support 0.5-13 hours,” the 5-star analyst said. “The approved label seems to be an FDA compromise, with an efficacy curve reflecting as reported pivotal data rather than better post hoc curves, but without error bars specifying lack of statistical significance at the earliest and latest timepoints, thus still conveying drug superiority vs. placebo for 0.5-13 hours.” That issue aside, Livnat says the label looks good, and should help make Azstarys the “Vyvanse of methylphenidate.” But while Livnat still believes that Azstarys’ peak sales could reach over $300 million and the label should be enough for Corium to “differentiate the product,” there could be trouble ahead. “There now appears to be risk that GPC does not view the label as sufficiently reflecting the best-case 0.5-13 hour profile, which represents downside risk to deal terms, including the $48M approval milestone and perhaps royalty rates,” the analyst said. Therefore, while the approval amounts to a “major achievement,” given the “uncertainty around economics,” and the recent January dilution far beyond Livnat’s prior estimates, the analyst downgraded his rating from Buy to Neutral (i.e. Hold). Livnat also slashed his price target from $24 to $12, leaving room for 19% upside from current levels. (To watch Livnat’s track record, click here) Only one other analyst has recently posted a KMPH review, but his outlook is far rosier. The extra Buy provides the stock with a Moderate Buy consensus rating, and the $20 average price target suggests 99% upside in the year ahead. (See KMPH stock analysis on TipRanks) To find good ideas for health stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights. Disclaimer: The opinions expressed in this article are solely those of the featured analyst. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.
CELEBRATION, Fla., March 04, 2021 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced that Travis C. Mickle, Ph.D., President and CEO of KemPharm, will present at the 33rd Annual Roth Conference being held virtually from March 15-17, 2021. The presentation will be available on demand during the virtual event for all registered attendees. Details regarding KemPharm’s presentations are as follows: Event: 33rd Annual Roth ConferenceDate: Monday, March 15, 2021 to Wednesday, March 17, 2021Time: Available on DemandRegistration: https://roth.meetmax.com/sched/event_70981/conference_home.html During the pre-recorded virtual presentation, Dr. Mickle will provide an overview of KemPharm’s corporate achievements and potential milestones, including the U.S. Food and Drug Administration’s (FDA) recent approval of AZSTARYS™ (formerly known as KP415), a once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years and older. AZSTARYS consists of serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH. The complete label for AZSTARYS, including prescribing information and important safety information, may be found at https://kempharm.com/wp-content/uploads/2021/03/AZSTARYS-Master-Label-Final_20210302.pdf. 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 product portfolio is highlighted by AZSTARYS™, an FDA-approved, once-daily treatment for attention deficit hyperactivity disorder (ADHD) which is based on serdexmethylphenidate, (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH). KemPharm is also advancing several clinical development candidates, including KP484 for the treatment of ADHD and KP879 for the treatment of Stimulant Use Disorder (SUD). AZSTARYS, KP484, and KP879 are all based on SDX. 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 KemPharm’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 include statements about the commercial launch of AZSTARYS, including the timing of launch, the regulatory milestone payment, and the potential clinical benefits of AZSTARYS. These forward-looking statements 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 the “Risk Factors” sections of KemPharm’s Annual Report on Form 10-K for the year ended December 31, 2019, KemPharm’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, and KemPharm’s other filings 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: Tiberend Strategic Advisors, Inc.Jason Rando/Maureen McEnroe, CFA(212) 375-2665 / firstname.lastname@example.org@tiberend.com
The biotech sector was in focus last week with regulatory and pipeline updates from quite a few companies like Regeneron (REGN), Vir (VIR) and KemPharm, Inc. (KMPH).