Market Potential for MDX Alcobra Investor Breakfast July 15, 2014

Transcription

1 Market Potential for MDX Alcobra Investor Breakfast July 15, 2014

2 Forward Looking Statement This presentation includes statements that are, or may be deemed, forward-looking statements. In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, including the terms believes, estimates, anticipates, expects, plans, intends, may, could, might, will, should, approximately, potential or, in each case, their negative or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. They appear in a number of places throughout this presentation and include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the translation of interest in using MDX into actual sales, MDX drawing patients from existing therapies, any forecast information provided herein, including market size, pricing, penetration rates and others and the future unmet need in the ADHD space. In addition, historic results of scientific research do not guarantee that the conclusions of future research would not suggest different conclusions or that historic results referred to in this press release would be interpreted differently in light of additional research. By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics, and healthcare, regulatory and scientific developments and depend on the economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. Although we believe that we have a reasonable basis for each forward-looking statement contained in this presentation, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this presentation as a result of, among other factors, the factors referenced in the Risk Factors section of the annual report on Forma 20-F for the year ended December 31, 2013 filed with the Securities and Exchange Commission on March 28, Any forward-looking statement that we make in this presentation speaks only as of the date of such statement, and we undertake no obligation to update such statements to reflect events or circumstances after the date of this presentation. 2

3 Agenda The ADHD Market Unmet Needs Physician Reaction to MDX Managed Care Reaction to MDX Data-driven Forecast of MDX Sales 3

4 Agenda The ADHD Market Unmet Needs Physician Reaction to MDX Managed Care Reaction to MDX Data-driven Forecast of MDX Sales 4

5 TRxs (millions) ADHD Market Growth 70 US ADHD Market TRxs (millions) % Annual Growth 9.3% 12.4% 10.4% 4.5% 6.2% 2013 Total ADHD Sales = $8.3 billion Source: IMS, NPA, TRxs 6 5

6 Adult ADHD is Now Half the Market and Growing Faster than Pediatric Adult vs. Pediatric Total Market TRxs (millions) % 46% 47% 56% 54% 53% TRx % Growth vs. Prior Year Pediatric 1.2% 3.4% Adult 9.0% 9.7% Total Market 4.5% 6.2% Pediatric Adult Source: IMS, NPA, TRxs, by Age 7 6

7 High Rxing MDs estimate that about Half of Adult ADHD Patients they see are Predominately Inattentive Subtype Estimate of Adult ADHD Patient Subtypes (Percent of Patients) 35% Predominately Inattentive 52% Predominately Hyperactive-impulsive 13% Combined Hyperactive-impulsive and Inattentive n=127 S7. Of the adult ADHD patients you see in a typical month, what percent have each of the following subtypes? 7

8 Time to Peak Share in the ADHD Market has been Fairly Rapid Product US Approval Date Year of Peak TRx Share Years to Peak Share Peak Share Peak Sales Concerta Aug % $1.3 BB Adderall XR Oct % $1.1 BB Strattera Nov % $667 MM Focalin XR May % ~$400 MM Vyvanse Jun % $1.2 BB* Intuniv Nov % $335 MM * Sales are still growing 8

9 US Pricing for Major ADHD Brands shows a Price per Month range of $200-$300 Product WAC Avg Price/Rx 5 Year Price CAGR Concerta $ % Vyvanse $ % Intuniv $ % * Strattera $ % *4 year CAGR Source: IMS NPA, Wolters Kluwer Prices represent weighted average of all doses 9

10 Agenda The ADHD Market Unmet Needs Physician Reaction to MDX Managed Care Reaction to MDX Data-driven Forecast of MDX Sales 10

11 Quantitative Research of Unmet Needs in ADHD Methodology Structured quantitative questionnaire Data collection via the Internet Fieldwork timing: April 2014 Sample size: 127 respondents recruited from target list High Prescribers recruited from list of top 5,000 ADHD prescribers in the US KOLs recruited from list of KOLs provided by Alcobra Specialty Number of Respondents PSYCHs 64 PCPs 31 Neuros 5 Total High Prescribers 100 KOLs 27 Total Respondents

12 Respondents indicate non-stimulants/medications w/low abuse potential are the greatest unmet need, followed by longer acting medications Unmet Needs Associated with Currently Available ADHD Treatments (Unaided) (Percent of Respondents) Non-stimulant / low abuse potential 42% Long-acting 36% Cost / coverage 20% Minimal side effects 17% Once-a-day dosing 13% Efficacy 6% Increased education 4% n = 127 A0. Doctor, in your opinion, what are the greatest unmet needs surrounding currently available ADHD treatments? 12

13 90% of respondents agree that there is an unmet need for a safe and effective non-addictive ADHD drug for adults; 80% agree that there is an unmet need for fast acting non-stimulant medications Agreement with Statements Regarding the Treatment with ADHD - Total Respondents Percent of Respondents Agreeing (High Rating: 5-7) Mean Rating It is very important to develop a safe and effective non-addictive ADHD drug for adults 90% 6.1 There is an unmet need for a fast acting non-stimulant ADHD medication 83% 5.7 The utility of stimulants for ADHD is hindered by the potential risk of abuse 70% 5.0 I have some adult ADHD patients that don't take medication because they don't want to take a stimulant 66% 4.9 n = 127 B1. Below is a list of statements regarding the treatment of ADHD. Please indicate the extent to which you agree with each of the following statements. 13

14 Agenda The ADHD Market Unmet Needs Physician Reaction to MDX Managed Care Reaction to MDX Data-driven Forecast of MDX Sales 14

15 MDX Product Profile Market Research Methodology Implementation of the project was via web-assisted telephone interviews (WTIDIs) A total of n=16 interviews were conducted among the target audience Psychs n=7 PCPs n=9 Interviews lasted approximately 60 minutes each All respondents were recruited from the client supplied list and Were board-certified or board-eligible In full-time practice, spent at least 75% of time in clinical practice and had been practicing for at least 2 years, but no more than 35 years Were treating at least 100 patients with ADHD per month and at least 70 of these patients were Adults (18 years of age or older) Currently treating at least 30% of their Adult ADHD patients with pharmacotherapy 15

16 MDs are interested in MDX and rated themselves very likely to consider MDX for their Adult ADHD patients, particularly ADHD-PI patients A sub-set of MDs were then asked to rate their likelihood to consider use of MDX for various patient types. Most indicate that MDX would be used primarily as a 1 st line agent, replacing stimulants. Interest in Using MDX Patient Types Average Score* Overall Adult ADHD Patients 8.1 Predominantly inattentive type 9.0 Patients with history (not active) of substance abuse 8.0 Patients with two or more cardiovascular risk factors, e.g., smoking and overweight, overweight and hypertension, etc. 8.1 Patients who don t want to take a scheduled drug 9.4 Patients who have taken ADHD medications in the past (NOT currently taking ADHD medications) 8.3 *1=not at all to 10=extremely 16

17 MDs report interest in using MDX for 35%+ of their Adult ADHD patients Candidates for MDX Patient Types % of Adult ADHD Patients % Candidates for MDX Overall Adult ADHD Patients 100% 36% Predominantly inattentive type 52% 44% Patients with history (not active) of substance abuse 25% 53% Patients with two or more cardiovascular risk factors, e.g., smoking and overweight, overweight and hypertension, etc. 19% 70% Patients who don t want to take a scheduled drug 12% 90% Physicians also reported that almost 40% of their patients who have taken ADHD medications in the past, but are NOT currently taking ADHD medications would be candidates for MDX 17

18 MDX would draw patients from all existing therapies particularly Adderall XR and Strattera When asked how they might use MDX, about half of the physicians queried suggest they might consider using MDX in combination with a stimulant, to achieve greater efficacy Impact of MDX on Use of Agents Currently Prescribed Prescribed for Newly Diagnosed ADHD Patients % Respondents mentioning LESS USE of current agent with MDX available Strattera (atomoxetine) 69% Adderall XR/long acting (Branded or Generic amphetamine) 81% Vyvanse (lisdexamfetamine dimesylate) 50% Methylphenidate, short acting (Branded or Generic) 56% Concerta (methylphenidate) 38% Other long acting methylphenidate (Branded or Generic) 38% Intuniv (guanfacine) 19% 18

19 Agenda The ADHD Market Unmet Needs Physician Reaction to MDX Managed Care Reaction to MDX Data-driven Forecast of MDX Sales 19

20 ADHD Pricing & Reimbursement Research Decision Resources conducted a series of 26 payer and KOL interviews to address key value proposition, pricing & market access, and product optimization dynamics. Respondents were recruited from national, regional, and local payer organizations. Stakeholder Groups Respondent Types Sample # of Lives Clinical KOLs P&T Advising Psychiatrists and Psychologists 4 N/A Commercial MCOs Medical Directors 7 Pharmacy Directors million Managed Medicaid MCOs Medical Directors 1 Pharmacy Directors million PBMs Pharmacy Directors million Total: 26 20

21 MCOs report limited attention to the ADHD category given the low to moderate budget impact Limited attention due to recent availability of generic versions of major brands (Adderall XR, Concerta) which offsets branded product costs MCOs are much more concerned about costs of specialty pharma products, e.g., Hepatitis C, and more populous conditions w/greater overall medical costs, e.g., Diabetes, Asthma Majority of respondents identify a reasonable price point for MDX between a premium to Vyvanse and a premium to Strattera price and report the likelihood of minimal management 21

22 Current ADHD Market Environment: Unmet Needs Respondents rate therapies with reduced potential for abuse, risk of addiction, and non scheduled agents as the three highest unmet medical needs Quality of Life data Dosing schedule Efficacy Onset of effect length of time for drug effect Effect on cognitive/executive function Risk of addiction Potential for abuse Non-scheduled Sexual side effects GI effects Effect on personality, creativity, mood lability Somnolence/sedation Effect on sleep (insomnia) Appetite suppression Effect on cardiovascular parameters Average Unmet Needs Total Payers and PBMs Average Rating Question: On a scale of 1 to 7 (1=low level of unmet need, 7= high level), how would you assess the level of unmet need for the following factors associated with existing drug therapies for ADHD? 22

23 Unmet Needs Evaluation of Product Z (MDX) for ADHD Level of Performance in Meeting Unmet Needs Respondents rate MDX the highest for its potential ability to reduce abuse, lower risk of addiction, and filling the unmet need for an unscheduled product option Level of Performance in Meeting Unmet Needs MDX Improved Quality of Life data 4.17 Convenient dosing schedule 4.77 Improved efficacy 3.66 Improved onset of effect 3.95 Effect on cognitive/executive function Reduced risk of addiction Reduced potential for abuse Non-scheduled Fewer sexual side effects Less GI upset Fewer negative effects on personality, etc. Improved somnolence/sedation Improved effect on sleep (insomnia) Less appetite suppression Improvement of cardiovascular parameters Rated Level of Performance Question: How would you assess the level of performance of Product Z, in meeting unmet needs, on a scale of 1 to 7 (1=lowest performance, 7= high level of performance)? 23

24 Agenda The ADHD Market Unmet Needs Physician Reaction to MDX Managed Care Reaction to MDX Data-driven Forecast of MDX Sales 24

25 Data Driven Forecast: Current Situation & Assumptions Parameter Current Environment Forecast Assumption Baseline TRxs TRx Growth Rate Intended Share Years to Peak Share Baseline Price Annual Price Increase Gross-Net Ratio 60 million (IMS NPA) 8.5% (5 year CAGR) 36% (from Mkt Res) 2-6 years (IMS NPA) $210/mo (Vyvanse) - $295/mo (Strattera) 11-15% (5 year CAGR) N/A 60 million 5% 9% 6 years $243/mo 5% 70% 25

26 Data Driven Forecast: Derivation of MDX Forecast* ADHD Market TRx 60 million 93 million x MDX TRx Share 9% x Price/Month $243 $377 Gross Sales $3.2 billion x Gross-Net Ratio 70% Net Sales Sensitivity Analysis +/- 1% Market Growth +/- $200 MM +/- 1% TRx Share +/- $250 MM +/- 1% Annual Price Increase +/- $200 MM +/- 1% Gross-Net Ratio +/- $30 MM *Assumes 2017 launch $2.2 billion

27 Summary and Conclusions ADHD Market is large and growing, especially Adults Despite the success of ADHD brands, substantial unmet need remains according to MDs MDs react very favorably to the product profile for MDX MCOs are not aggressively managing ADHD category and react favorably to MDX, as well >$8 billion in annual sales in the US Adult ADHD is now about half of all Rxs and growing at annual rate of ~10% Unscheduled, non-abusable drugs identified as greatest need Fast-acting, non-stimulant medications are highly desirable MDs indicate interest in MDX for 36% of Adult ADHD patients Even more favorable in key patient segments, e.g., PI-ADHD, History of substance abuse, Tolerability problems with simulants High receptivity to using MDX in diagnosed Adults with ADHD who are not currently taking Rx medications ADHD is not a high concern category for most MCOs MDX addresses unmet needs that MCOs identify Plans expect to manage MDX loosely through co-pays Projected Sales > $2 billion by

28 THANK YOU