Slide 1: ADHD Prodrug Pipeline Update
K Pharm ADHD Prodrug Pipeline Update
Slide 2: Cautionary Note Regarding Presentation Information
Cautionary Note Regarding Presentation Information This presentation contains forward-looking statements, including statements about our plans to develop and commercialize our product candidates, our planned clinical trials for our prodrug product candidates, the timing of and our ability to obtain
Slide 3: Extending ADHD Prodrug Pipeline & Value Potential
Extending ADHD Prodrug Pipeline & Value Potential ¥ Completed End-of-Phase 1 Meeting with FDA for KP415 ADHD treatment focused on addressing unmet need with a faster onset of efficacy with a longer total duration than current methylphenidate treatment options KP415 clinical program affirmed by FDA S
Slide 4: ADHD Prodrug Product Pipeline - Addressing Unmet Needs
ADHD Prodrug Product Pipeline —- Addressing Unmet Needs KP415 — ADHD Product Candidate for Fast Onset and Longer Total Duration + Extended release prodrug of d-threo- methylphenidate (d-MPH) + Phase 1 PoC data complete + Additional PK studies underway; final PK study data anticipated in 2H 2017 thro
Slide 5: Predicted Oral PK Data - KP415
Predicted Oral PK Data - KP415 Commercial KP415- Predicted PK, Single Dose Commercial KP415~ Predicted Oral PK, Steady State 2 4 - kP415,9/42 me e 2x05, 9/42 mg 8 “a Concerta, 36 mg “#- Concerta, 36 mg d-MPH Concentration (ng/mL) «MPH Concentration (ng/mL) 4 4 2 2 o ° o 4 8 2 6 2» 2 ; q 8 2 6 0 Time
Slide 6: Oral Pharmacokinetic Data - KP484
Oral Pharmacokinetic Data — KP484 KP484 — Oral PK, Single Dose KP484 - Predicted Oral PK, Steady State KP484, 60 mg KP484, 60 mg 7 9 —2-Kna84,60 mg —o-KPA84, 60 mg ug . Bs > = <8 i. 25 ag me ge a4 8 83 z2 = = 32 a a ° ot o 4 8 2 6 2» m o 4 8 2 6 2» 2m Time (hours) Time (hours) Note: Steady-state pla
Slide 7: Completed Clinical Studies of KP484
Completed Clinical Studies of KP484 + KP484 Clinical Data to Date o Single dose oral bioavailability and dose proportionality of 20, 40, and 60 mg in capsules o Urinary excretion study following single oral dose of 6 and 60 mg administered as oral liquids o Effect of food on the oral bioavailability
Slide 8: ADHD and ER Methylphenidate Market
ADHD and ER Methylphenidate Market + ~$13 billion ADHD market with prescriptions growing at >5% year-over-year + Methylphenidate accounted for approximately 19.8 million TRx’s and $3.8 billion in sales in 2016 + KemPharm believes ADHD key opinion leaders have significant interest in an ER methylphen
Slide 9: KP415: ADHD Market Dynamics
KP415: ADHD Market Dynamics + Although the ADHD market has become more genericized, many generics are priced closely to their branded comparator's. In 2016, the branded ADHD market was ~$6.4B«) o >95% of these branded products are Extended Release «:), + In the prior 4 years, there have been seven (
Slide 10: KP484: Adult ADHD Market Dynamics
KP484: Adult ADHD Market Dynamics + Itis estimated that 4.4% of adults in the U.S. have ADHD» + When applied to the full U.S. adult population aged 18 and over, there are potentially 10.5 million adults in the U.S. with ADHDe) + If approved, KP484 would launch into the high growth adultADHD market.
Slide 11: KP484: Adult ADHD Market Dynamics, cont.
KP484: Adult ADHD Market Dynamics, cont. There is an estimated 38MM patients on ADHD medications, of which ~9% are taking an ER+ER and 10% are ER+IRq oe Aonce daily dose could eliminate the need for multiple drugs, potentially improving adherence & reducing patient OOP costs (single copay) It is est
Slide 12: KP484: Other Potential Indications
KP484: Other Potential Indications KP484 could provide the potential for other indications that have either been demonstrated by other stimulants or are unmet medical needs including: 1. Binge Eating Disorder (Vyvanse™) 2. Excessive Daytime Sleepiness (various modafinil products) 3. Stimulant depend
Slide 13: KemPharm Clinical Product Pipeline
KemPharm Clinical Product Pipeline Potential Product Development Next Categor 5 Parent Dru: + NDA ‘S°rY | candidate 9] Status Milestone a Submission ADHD Methylphenidate PK + Efficacy a KP415 Clinical 2018 (Pediatric) (ER) Data ADHD Methylphenidate PK + Efficacy (adult) KP484 eR Clinical Daa 2019 KP
Slide 14: Expected ADHD Pipeline Milestones
Expected ADHD Pipeline Milestones 2017 2018 2019 Product KP415 KP415 KP484 KP415/ KP484 KP415 KP484 KP415 / KP484 KP415 KP484 KP484 Evel Report Additional PK Data (2H) Initiate Pivotal Efficacy Trial (2H) IND Filing (3) IV Human Abuse Liability Data (2H) Pivotal Efficacy Trial Results (1H) Initiate
Slide 15: ADHD Prodrug Pipeline Update
K Pharm ADHD Prodrug Pipeline Update
Slide 16: KP484 Market Dynamics: Sources
KP484 Market Dynamics: Sources o @ 2 @ @ ® @ @ Symonony Heath, PHAST 2011-2016 Ronald. Keesler eta. (4pri2006). Te Prevalence and Correates of Aut ADMD nthe Untad States: Renu From th National Corerbity Survey Replat, ‘Amasican Jouraal of Psychiatry 1635).71 Symoneny Heath, PHAST 2011-2016 Symonony