Upload
vankhuong
View
213
Download
1
Embed Size (px)
Citation preview
Jefferies Healthcare ConferenceJune 6, 2017
Disclaimer
This presentation contains forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 andother federal securities laws, including, but not limited to, statements concerning: the Prescription Drug User Fee Act (PDUFA) dates forCotempla XR-ODT™; Neos Therapeutics, Inc.’s ability to successfully commercialize Adzenys XR-ODT™ and, if approved, Cotempla XR-ODT™ and its other product candidates in the United States and the timing thereof; its ability to successfully advance its pipeline ofproduct candidates; its ability to maintain and protect its intellectual property; the outcome or success of its clinical trials; the rate anddegree of market acceptance of its products; and its ability to develop sales and marketing capabilities. In some cases, you can identifyforward looking statements by terms such as “may,” ”will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,”“project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similarexpressions. The forward looking statements of this presentation are only predictions and are subject to a number of risks, uncertaintiesand assumptions, including, without limitation, our commercialization strategy for Adzenys XR-ODT™ and other products that may beapproved, our ability to successfully address the deficiencies identified by the FDA or which may be identified by the FDA which precludeapproval of the NDA for our Cotempla XR-ODT™ product candidate, including that we demonstrate bioequivalence between the clinicaltrial material and to-be-marketed drug product and that we assess the food effect on the to-be-marketed drug product; the receipt ofregulatory approval for Cotempla XR-ODT™ and NT-0201; the timing of such approval; Neos Therapeutics’ ability to market and sellAdzenys XR-ODT™ and any other products that may be approved; Neos Therapeutics’ ability to successfully compete in the market formedications indicated for ADHD; the manufacture of Adzenys XR-ODT™ and, if approved, Cotempla XR-ODT™ or Neos Therapeutics’other product candidates; and other risks set forth under the caption “Risk Factors” in Neos Therapeutics’ most recent Annual Report onForm 10-K and its other SEC filings. Moreover, Neos Therapeutics operates in a very competitive and rapidly changing environment. Newrisks emerge from time to time. It is not possible for Neos Therapeutics’ management to predict all risks, nor can Neos Therapeuticsassess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results todiffer materially from those contained in any forward looking statements it may make. In light of these risks, uncertainties andassumptions, the forward looking events and circumstances discussed in this presentation may not occur and actual results could differmaterially and adversely from those anticipated or implied in the forward looking statements. You should not rely upon forward lookingstatements as predictions of future events. Although Neos Therapeutics believes that the expectations reflected in the forward lookingstatements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstancesreflected in the forward looking statements will be achieved or occur. Moreover, except as required by law, neither Neos Therapeuticsnor any other person assumes responsibility for the accuracy and completeness of the forward looking statements. Forward lookingstatements in this presentation represent Neos Therapeutics’ views only as of the date of this presentation. Neos Therapeuticsundertakes no obligation to update or review any forward looking statement, whether as a result of new information, futuredevelopments or otherwise, except as required by law.
This presentation may contain trade names, trademarks or service marks of other companies. Neos Therapeutics does not intend theuse or display of other parties’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of,these other parties. Solely for convenience, the trade names, trademarks or service marks in this presentation are referred to withoutthe symbols ® and ™, but such references should not be construed as any indicator that their respective owners will not assert, to thefullest extent under applicable law, their rights thereto.
2
Investment Highlights
First and only FDA-approved extended
release orally disintegrating tablet for
the treatment of ADHD in patients 6
years and older
Robust prescription growth since
launch in May 2016
Number of prescribers and new to
brand (NBRx) market share growing
rapidly
Composition of matter patent through
2032
3
• Two additional ADHD product
candidates under FDA review with
PDUFA dates Jun 19, 2017 and Sept
15, 2017
• Launches anticipated in the fall of
2017 and Jan 2018
• Experienced commercial team with
50+ years of track record in ADHD
• Expanded ADHD product portfolio
would offer both amphetamine and
methylphenidate options
• Proprietary platform technology for
additional product candidates
Extended-Release
Orally Disintegrating Tablets
ADHD is a $10.4B Market
4
• Estimated to affect 11.0% of children between the ages
of 4 and 171 and 4.4% of adults in the U.S.2
• ADHD prescriptions grew by 5.6% during 20163
• Prescriptions for stimulant medications account for ~92% of the market4
Drug Type12 Months4 of
Prescriptions (Million)
12 Months5 of $
(Billion)
Amphetamine 44.1 $5.7
Methylphenidate 20.6 $3.4
Non-Stimulants 5.7 $1.3
1. 2011-2012 National Survey of Children’s Health (US-DHHS) http://www.cdc.gov/nchs/slaits/nsch.htm. Accessed March 19, 2015.
2. Brus ML, et al. J. Psychiatr Pract. 2014; (6):428-37.
3. QuintilesIMS: National Prescription Audit – trailing 12 month data as of December 2016
4. QuintilesIMS; National Prescription Audit – trailing 12 month data as of December 2016
5. QuintilesIMS; National Sales Perspective – trailing 12 month data as of November 2016
Patient-Friendly Features of Adzenys XR-ODTAttractive to Both Pediatric & Adult Patient Populations
Portable,
child-resistant
blister pack
• Available in
6 dosage strengths
• Therapeutically
Equivalent to
Adderall XR
• Disintegrates in the mouth
• Orange Flavor
Can be taken without water
Once-daily
Administration
5
• Team of 125 sales
professionals calling on
12,500 physicians
• Focused on high volume
prescribers
• Programs and strategies
to provide accessibility
and affordability
Adzenys XR-ODT: Commercial Overview
6
196870
1520
3088
4335
5535
71197676
8870
10201
1322512942
0
2000
4000
6000
8000
10000
12000
14000
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
Jan
Feb
Mar
Apr
Adzenys XR-ODT TRx
• Average 14% monthly
prescription growth in 2017
• 88,704 total TRx through May
26th
• Utilization across both
pediatric and adult patient
populations
Adzenys XR-ODT: Robust Prescription Growth Since Launch
7
Source: QuintilesIMS Health National Prescription Audit
68253
550912
13421617
18942167
23862780
2965
106362
486
684
782
660
640
548
476
577
665538
0
500
1000
1500
2000
2500
3000
3500
4000
May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr
Pre
scri
bers
6,524 Adzenys XR-ODT PrescribersThrough April 2017
Repeat New
Source: QuintilesIMS Xponent Weekly
Adzenys XR-ODT: New and Repeat Prescribers Continue to Grow
8
Patient Switching Accounts for Majority of New to Brand Business (NBRx)
9
61%Pediatric NBRx
39%Adult NBRx
Switches, 72%
New Therapy Starts, 28%
Switches, 77%
New Therapy Starts, 23%
Source: QuintilesIMS Health New To Brand NPA; Launch to date through May 19 2017
Patients are Switching to Adzenys XR-ODT from Multiple Products
Source: QuintilesIMS Health New To Brand NPA Data; Launch through Mar 2017
10
Switches to Adzenys XR-ODT
Vyvanse26%
Adderall XR 17%
Adderall IR19%
Dyanavel XR1%
Quillivant XR6%
Concerta9%
Daytrana1%
Other Methylphenidates
16%
Non-Stimulants6%
0
2000
4000
6000
8000
10000
12000
14000
Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr
TRx V
olu
me
TRx Uptake Curves – Through Apr 2017
ADZENYS XR-ODT 05-2016 DYANAVEL XR 04-2016 QUILLICHEW ER 04-2016
2016 2017
Source: QuintilesIMS Health National Prescription Audit
Adzenys XR-ODT: Tracking Well Against Recent ADHD Launches
11
New to Brand Market Share of Adzenys XR-ODT is Growing Rapidly
12
3.4%
10.5% 11.7% 11.9%
62.5%
8.3%
12.6%10.4%
23.3%
45.4%
12.4% 11.7%
7.8%
28.0%
40.2%
0%
10%
20%
30%
40%
50%
60%
70%
DYANAVEL XR QUILLICHEW ER DAYTRANA ADZENYS XR-ODT QUILLIVANT XR
NB
Rx
Sh
are
Alternative Dosage Form - New to Brand (NBRx) Market Share
Jun 16 Jan 17 Apr 17
Source: Quintiles IMS Health National Prescription Audit
• New-to-market blocks have been lifted by all of the major
commercial accounts
Managed Care Coverage With Over 80% of Lives Covered by Commercial Payers
Ensure Adzenys
XR-ODT is
Accessible &
Affordable to
Patients
Minimize the Impact of Prior Authorizations (PA)
Obtain Open Access with Government & Commercial Payers
Ensure Out-of-Pocket Expenses are not a Barrier to Use
1
2
3
13
14
• Cotempla XR-ODT™ (Methylphenidate) – PDUFA Date
June 19, 2017
• Amphetamine XR-Liquid Suspension – PDUFA Date
September 15, 2017
Two Additional ADHD Product Candidates Under FDA Review
• If approved, Cotempla XR-ODT™ is positioned
to be the first methylphenidate XR-ODT for
once-a-day treatment of ADHD
• Composition-of-matter patent scheduled to
expire in 2032
• Compelling Phase 3 efficacy data in children
with ADHD
• NDA resubmitted Dec 19, 2016 (responded to
CRL)
• PDUFA date: June 19, 2017
• Expected to launch in the fall of 2017
Cotempla XR-ODT
15
• NDA resubmitted Dec 19, 2016 (Responded to CRL)
• Conducted a bridging study demonstrating bioequivalence between the clinical
trial (Pilot Scale) and to-be-marketed (Commercial Scale) material
• Completed three-month stability and process validation studies
• Compelling Phase 3 efficacy data in children with ADHD
Cotempla XR-ODT Regulatory and Clinical Update
16
• Statistically significant
effects of Cotempla vs.
placebo across all endpoints
• Time to onset: within 1 hour
• Duration of effect: 12 hours
SKAMP: Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale
• Amphetamine XR-liquid suspension for
once-a-day treatment of ADHD
• Composition-of-matter patents
scheduled to expire in 2032
• Completed human bioequivalence trial
vs. Adderall XR capsules
• Completed bridging study with
commercial scale material
• PDUFA date: September 15, 2017
• Expected to launch in Jan 2018
Amphetamine XR-Liquid Suspension (NT-0201)
17
Adzenys XR-ODT®(Amphetamine)
ADHD
Cotempla XR-ODT®(Methylphenidate)
ADHD
AMPH XR-Liquid (NT-0201)
ADHD
Tussionex®1 Generic(Liquid Suspension)
Cough/Cold
NT-0400 CNS/GI
NT-0500 CNS/GI
Growing Product Portfolio
18
Launched May 2016
PDUFA Date June 19, 2017
PDUFA Date Sept 15, 2017
Launched Sept 2014
1 Tussionex® is a registered trademark of the UCB Group of Companies
Financial Overview
Three Months Ended March 31, 2017 (in 000s)
Net Product Sales $5,627
Gross Profit $1,012
Operating Loss $(14,957)
Net Loss $(17,090)
Weighted Average Shares 19,625
Cash, Cash Equivalents & ST Investments $54,232
19
• Adzenys XR-ODT three month net revenues of $3.1 million • Tussionex three month net revenues of $2.5 million
• Adzenys XR-ODT launched May 2016
• Robust prescription growth since launch
• Number of prescribers and NBRx market share growing
rapidly
• 88,704 total TRx through May 26th, 2017
• Two additional ADHD product candidates under FDA review,
with launches anticipated in the fall of 2017 and Jan 2018
• Protection against generic competition through long-term
composition-of-matter patents
• Platform technology for additional branded product
candidates in multiple therapeutic areas
Summary
20