NATESTO® U.S. Partnerships2.q4cdn.com/417379002/files/doc_presentations/2019/... · 2019-07-30 ·...

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NATESTO® U.S. Partnership Amended and Restated Agreement with Aytu BioScience Ed Gudaitis President and CEO July 30, 2019

Transcript of NATESTO® U.S. Partnerships2.q4cdn.com/417379002/files/doc_presentations/2019/... · 2019-07-30 ·...

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NATESTO® U.S. PartnershipAmended and Restated Agreement with Aytu BioScience

Ed GudaitisPresident and CEO

July 30, 2019

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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.

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• 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

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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

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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

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As Men Age Less Testosterone Is Produced And Bio-available1-4

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• Black Box Warning

• Secondary exposure to testosterone

• Pulmonary oil micro embolism (POME) and anaphylaxis shock

• MACE and Hypertension

Challenges With Non-nasal Testosterone Therapy

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• 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

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There is a market need for better ways to delivery therapy

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Innovative, Pulsatile Testosterone Therapy:Unique Features Of NATESTO®

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• 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.

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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

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ACERUS HAS 6.5% SHARE OF THE CANADIAN TOPICAL TRT MARKET1

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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.

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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

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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

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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

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Transaction Highlights

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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.

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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

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• 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)

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• 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

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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

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• 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

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Syneos Health Has Extensive Experience In Men’s Health(U.S., Europe, and Asia Pacific)

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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

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Proposed Structure: During Execution PhaseSyneos Health can flex as needed by Acerus to execute against the U.S. strategy

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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

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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)

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North American Commercial Platform

8

25

Field Sales Reps:

37

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• 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

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• 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

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Thank You

Ed GudaitisPresident & [email protected](905) 817-8194

Bob MotzChief Financial [email protected](905) 817-8288