NATESTO® U.S. Partnerships2.q4cdn.com/417379002/files/doc_presentations/2019/... · 2019-07-30 ·...
Transcript of NATESTO® U.S. Partnerships2.q4cdn.com/417379002/files/doc_presentations/2019/... · 2019-07-30 ·...
NATESTO® U.S. PartnershipAmended and Restated Agreement with Aytu BioScience
Ed GudaitisPresident and CEO
July 30, 2019
Forward Looking Statements
2
This presentation and certain statements in regards thereto contain forward looking information. This forward-looking information is not based on historical facts but rather on the expectations of Acerus Pharmaceuticals Corporation's (“APC") management regarding the future growth of APC, its respective results of operations, performance and business prospects and opportunities. Forward-looking information may include financial and other projections, as well as statements regarding future plans, objectives or economic performance, or the assumptions underlying any of the foregoing. This presentation uses words such as "will", "expects", "anticipates", "intends", "estimates", or similar expressions to identify forward-looking information. Such forward-looking information reflect the current beliefs of APC's management based on information currently available to them.
Forward-looking information included in this presentation is based in part, on assumptions that may change, thus causing actual future resultsor anticipated events to differ materially from those expressed or implied in any forward-looking information. Such assumptions include general industry and economic conditions; changes in the APC’s relationship with its suppliers; and pricing pressures and other competitive factors. APC has also made certain macroeconomic and general industry assumptions in the preparation of such forward-looking statements. While APC considers these factors and assumptions to be reasonable based on information currently available, there can be no assurance that actual results will be consistent with these forward-looking statements.
Forward-looking information involves known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of APC to differ materially from any future results, performance or achievements expressed or implied by the forward-looking information. For more information on these risks and uncertainties, please see the annual information form of APC dated March 4, 2019, available on SEDAR at www.SEDAR.com. Actual results, performance or achievement could differ materially from that expressed in, or implied by, any forward-looking information in this presentation, and, accordingly, investors should not place undue reliance on any such forward-looking information. Further, any forward-looking information speaks only as of the date on which such statement is made and APC undertakes no obligation to update any forward-looking information to reflect the occurrence of unanticipated events, except as required by law including applicable securities laws. New factors emerge from time to time and the importance of current factors may change from time to time and it is not possible for management of APC to predict all of such factors, changes in such factors and to assess in advance the impact of each such factor on the business of APC or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking information contained in this presentation.
• Founded in 2008 as Trimel Pharmaceuticals Corporation
• Iterated through multiple strategic directions and management teams to date
• Under new leadership as of May 2018
• Now operating with a focused strategy and emphasis on execution
About The New Acerus
3
What’s the objective?
Where will we play?
How will we win?
• Top line revenue growth• Positive EBIDTA• Free cash flow
• Prescription products business• Urology and andrology (Men’s Health)• North America and Europe
• Optimize uptake of NATESTO®• Leverage outsourced expertise• Monetize our nasal gel technology
ACERUS’ FOUNDATIONAL ASSET
NATESTO® is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone including primary hypogonadism and hypogonadotropic hypogonadism
44
1. Rhoden EL, Morgantaler A. N Engl J Med. 2004;350:482-492. 2. Harman SM, et al.. J Clin Endocrinol Metab. 2001;86(2):724-731.; 3. Feldman HA, et al. J Clin Endocrinol Metab. 2002;87(2):589-598.; 4. Stanworth RD, et al. Clin Interv Aging. 2008;3(1):25-44. 5. Mulligan T, et al. Int J Clin Pract 2006;60(7):762-769.
As the population ages, the incidence of low testosterone is expected to increase
▪ Testosterone levels decline with age in men. After 40, testosterone decreases ~1.6% per year
▪ Reduction in serum testosterone is associated with increases in SHBG (~1% per year)
▪ HIM Study – Prevalence of hypogonadism 38.7% in men ≥45 years presenting to primary care offices5
5
As Men Age Less Testosterone Is Produced And Bio-available1-4
• Black Box Warning
• Secondary exposure to testosterone
• Pulmonary oil micro embolism (POME) and anaphylaxis shock
• MACE and Hypertension
Challenges With Non-nasal Testosterone Therapy
6
• Poor persistence
• 50% of patients discontinue Androgel at 5 months
• Infertility
• Chronic, elevated levels of exogenous testosterone shut down HPG axis leading to infertility
• Inconvenient application or painful injection
6
There is a market need for better ways to delivery therapy
Innovative, Pulsatile Testosterone Therapy:Unique Features Of NATESTO®
7
• Max conc. achieved within 45 minutes of administration
• Half-life ranging from 10 - 100 mins
• PK profile returns to near baseline after each dose -maintaining residual natural testosterone production
• Improved hematocrit profile
• Potential for preserved spermatogenesis
NATESTO® is self-administered via a fixed-dose gel delivery from a nasal applicator
• Simple and easy to administer – less than 10 seconds per application
• Highly concentrated, low volume of gel
• Low incidence of irritation to nose
• Small, discrete dispenser
• Minimizes the transference risk and secondary exposure
PK profile based on BID dosing. TID dosing approved in the U.S.
7
Acerus Knows How To Commercialize NATESTO®: CND Experience
Source: IQVIA CompuScript Audit, May 2019Restatement of TRX and NRx for NATESTO® was applied in January 2019 for all of 2017 and 2018. IQVIA has changed the projection methodology and now is including the TSA sales as part of the restatement to provide a better estimate of TRx and NRx.1. Defined as four key provinces where sales representatives are detailing NATESTO® - BC, AB, ON and QC
Increased commercial investment and focus
444481 482 498 498
622
719
906 929
1,135 1,136 1,118
1,274 1,259
1,364 1,373
1,235
1,382 1,461
0
200
400
600
800
1000
1200
1400
1600
Oct-17 Nov-17 Dec-17 Jan-18 Feb-18 Mar-18 Apr-18 May-18 Jun-18 Jul-18 Aug-18 Sep-18 Oct-18 Nov-18 Dec-18 Jan-19 Feb-19 Mar-19 Apr-19
NATESTO® TRx NATESTO® NRx
Pre
scri
pti
on
Vo
lum
e
Generating ~4,000 TRx per quarter in Canada
8
ACERUS HAS 6.5% SHARE OF THE CANADIAN TOPICAL TRT MARKET1
9
Hypogonadism Affects Up To 20M American Men1,2
Up to
20M Men
in America70% Undiagnosed/Asymptomatic
30% Diagnosed (6M3)
19%In care /
Untreated
11%In care / Treated
(2.2M4)
68%
32%
Previously treated, switch patients
Approx. 700K new patients per year 5
1. US Census data. http://www.infoplease.com/us/census/data/demographic.html. 2. Mulligan T, et al. Int J Clin Pract. 2006 Jul;60(7):762-9. 3. Araujo, et al. J Clin Endo Metabol 2007
92(11):4241-7. 4. Symphony Healthcare 2014. 5. IMS Health Sept 2015.
1) TRT Market Exists, 2) U.S. Market Is Large, 3) Entry Point is Therapy Switch
LARGE MARKET OPPORTUNITY IN THE U.S.
Source: HCP interviews (n=10) Jul 2018. HCPs interviewed wrote an average of 35 gel Rxs/month, placing them within the intended target audience of D10-7 gel prescribers
Assessment: Market
10
Traditional gel therapies not only have a transference risk, but they also are inconvenient and often not absorbed properly in many patients
9 out of 10 HCPs said they would switch some of their patients to Product X, a blinded representation of NATESTO®
vs.
“I am satisfied with the options available to me and my patients.”- Urologist
“I could see myself switching all my patients to [Natesto].” – Same Urologist
Also what they saidWhat they said
10 out of 10 physicians claimed they were satisfied with the therapy options currently available
HCPs Are Open To Adopting New Treatment Options
Acerus has amended and restated the partnership agreement with Aytu with respect to the commercialization of NATESTO® in the U.S.
• Moves to a co-promotion arrangement from the prior out-licence model
• 2 commercial stage speciality pharmaceutical companies will work together to optimize NATESTO® sales in the U.S.
• Expected to gain scale and optimize execution immediately
• Revenue growth expected to increase relatively quickly upon closing
The Transformative Transaction
11
Transaction Highlights
12
Acerus to take back the NDA for NATESTO® from Aytu
Acerus to lead overall U.S. Marketing, Medical & Reimbursement strategy and execution*
Acerus to lead sales efforts to specialists (Uro/Endo); Aytu to lead sales effort to primary care (PCP)
Geographic Expansion: Acerus establishes U.S. commercial infrastructure
Business Development Enhancement: Establish platform to in-license other products for U.S. and Canada
Compelling Financial Profile: Expected significant revenue growth post-transaction
1
2
3
4
5
6
* Aytu will retain its primary care sales force (Aytu Sales Channel) and will continue to book all product net revenue while serving as the exclusive U.S. supplier of NATESTO® to wholesalers, pharmacies and other customers that receive a direct shipment.
Prior Agreement
Aytu
• Records net revenue
• Retains net profit
Acerus
• Receives 25% royalty on sales (includes COGS)
• Inventory purchases by Aytu
Restated Agreement
Aytu
• Records net revenue
Acerus & Aytu
• Tiered split of net revenue (post-COGS) based on annual sales performance
Split Of U.S. NATESTO® Economics Significantly Amended
13
• Tier 1 ($0 – 5.5mm), status quo split (Acerus receives a commission of 25% of net revenue generated)
• Tier 2 ($5.5 - $10mm), Equal split (Acerus receives a commission of 50% of net revenue generated)
• Tier 3 (over $10mm), Channel specific (Acerus receives a commission of 90% of Specialist channel plus 10% of PCP channel net revenue)
14
• Tier 1 protects both parties with status quo if revenue does not grow above current trend
• Expected share of return moves towards 50/50 as net revenue from NATESTO® grows in the U.S.
• Assumes 55/45 contribution from Spec. vs. PCP to TRx
14
NATESTO® U.S. Tiered Revenue Split: Acerus commission schedule
63.7%
57.8%54.9%
53.1%49.9%
36.3%
41.4%45.1%
46.9%50.1%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
$10.0 $15.0 $20.0 $25.0 $45.0
AB share of net contribution ASP share of net contribution
Ne
t R
eve
nu
e S
har
e b
y P
artn
er
Net US NATESTO® Revenue
Aytu share of net contribution Acerus share of net contribution
• Acerus has engaged Syneos Health as our contract commercial partner in the U.S.
• Syneos is purpose built to drive clinical and commercial performance
Advantages:
• Rapid stand up of commercial team in the U.S. (e.g. approx. 3 months to stand up of field sale force)
• Ability to scale across all aspects of commercialization – medical affairs, managed markets, marketing and sales
• Flexibility in resource deployment – time and location
• Avoids Acerus having to build back office, IT and logistics support
• Leverage of Syneos experience in men’s health and with NATESTO®
Fast Stand-Up Using Syneos Health
15
Syneos Health Has Extensive Experience In Men’s Health(U.S., Europe, and Asia Pacific)
16
Consulting Advertising PR & Medical Comms Selling Solutions Patient Outcomes
• Pricing Studies
• Market Assessments
• MPA Client Target Projection, Quarterly MPA reports
• AOR Men’s Health Brands
• Brand Name Development and Testing
• Market Research
• Consumer Positioning, Patient Insights Research
• Brand Stories
• Physician Message and Position Testing
• Campaign Development and Activation
• Patient Campaigns
• Ad Boards
• Speaker Programs, Speaker Bureau Implementation
• Post-program Communications
• Account Management
• Message Map
• Rollout Support
• Global Disease State Communications
• Contract Sales Reps
• MSLs
• TeleDetailing
• Advanced Analytics
• Direct-to-Patient Adherence Programs:
• inPharmacy
• inHome
• inOffice
• inStore
• PatientLink
Bra
nd
/ T
A E
xp
eri
en
ce E
xam
ple
sP
roje
cts
2010–2019
Pro
ject
Exam
ple
s
Source: Salesforce.com
Proposed Structure: During Execution PhaseSyneos Health can flex as needed by Acerus to execute against the U.S. strategy
17
Medical Lead
(50%)
Medical Strategy
Medical Communications
Regulatory Affairs
Medical Information
PV Team
1 MSL Manager (Player Coach)
3 MSLs
* Note: Syneos Health does not provide managed markets operations, distribution or 3PL services, but can support planning and management
Commercial Lead (100%)
Ops Support Lead
(50%)
Finance Team
Compliance Team
Resourcing Team
Legal and Contracting Team
Quality Team
Sales Lead/NBD
(100%)
Field Recruitment
Sales Operations
Sales Analytics
CRM Team
Sales Training
Market Access Lead
(50%)
Pricing and Market Access Strategy
Payer Marketing
Trade and Distribution*
Managed Markets Ops*
Marketing Lead
(50%)
Brand Strategy
HCP Marketing
Patient Marketing
Public Relations
Social Medial / Digital
Launch and Project Management
Medical Organization Commercial Organization
Chief Executive Officer
Chief Medical Officer
Medical Information Call Center
Engagement Center
40-70 Full Time Representatives
1 KAM
1 GAM
2 RAM
Medical Affairs SVP Int’l Commercial Marketing
Chief Compliance Officer
Full or Partially Dedicated SYNH
Core Team Resources
Variable SYNH Project Resources
(Delivered via Advisory, Agency,
and Operations)
Dedicated SYNH Field and
Engagement Center Teams that
can be flexed up or down
In-House Leadership Team
Compliance
Syneos Health
18
Acerus owned commercial team with
national sales force of 8 sales reps calling
on primary care physicians and specialists
in the fields of urology and men’s health
Acerus: Specialty sales force of at least 25
sales reps focusing on high prescribing
specialists in urology and endocrinology
Aytu: Primary care sales force of up to 37
sales reps focusing on high prescribing
PCPs (certified as of June 2019)
18
North American Commercial Platform
8
25
Field Sales Reps:
37
• Acerus has rights to four Orange Book listed patents in the United States that include claims regarding the nasal gel delivery technology for NATESTO®
• Additional patents have been issued or are pending in over 60 more countries worldwide
• Patents covering NATESTO® only start to expire in 2024, with pending patent applications that could extend coverage to 2032 globally and 2034 in the U.S.
NATESTO® IP Position
19
20
• Effectively launch NATESTO® in the U.S. with Syneos Health
• Medical affairs focus to generate key opinion leader support
• Managed markets focus to secure formulary access
• HCP and consumer awareness campaigns to generate new
prescriptions
• Generate meaningful EBITDA from NATESTO®
• Scout and sign additional complementary product agreements
for both urology and andrology in North America
• Proactively engage with the investor and analyst community on
an ongoing basis to increase the capital markets profile of Acerus
Post Agreement Restatement Plan Transaction Benefits
1) Scale-up and obtain critical
mass
2) Acerus to lead strategy and
execution for U.S. NATESTO®
3) Expansion into the U.S.
Market
4) BD pipeline enhancement
5) Compelling financial profile
6) Catalyst for further turn-
around of Acerus
The restructuring of the U.S. commercial licence for NATESTO® and subsequent financing together
represent a transformative transaction which is expected to turnaround Acerus creating a leading
Specialty Pharma company with significant growth potential
SUMMARY: Transformation Of Acerus
21
Thank You
Ed GudaitisPresident & [email protected](905) 817-8194
Bob MotzChief Financial [email protected](905) 817-8288