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Acerus Pharmaceutical Corp. LD Micro main event conference Ed Gudaitis President and CEO December 10, 2019

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Page 1: Acerus Pharmaceutical Corp.s2.q4cdn.com/417379002/files/doc_presentations/2019/12/...This presentation and certain statements in regards thereto contain forward looking information

Acerus Pharmaceutical Corp. LD Micro main event conference

Ed Gudaitis

President and CEO

December 10, 2019

Page 2: Acerus Pharmaceutical Corp.s2.q4cdn.com/417379002/files/doc_presentations/2019/12/...This presentation and certain statements in regards thereto contain forward looking information

Forward Looking Statements

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 f uture 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 ass umptions 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 results or 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 compe titive 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 t o 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 mater ially from those contained in any forward-looking information contained in this presentation.

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Acerus Market Facts

3

Exchange : Ticker TSX:ASP

OTCQB: ASPCF

Recent Share Price (Dec 3, 2019) C$0.075

Shares Outstanding (Dec 3, 2019) 261.2 million basic

298.2 million diluted

Market Capitalization C$19.6 million

52-Week Range ($0.07 - $0.20)

Insider Ownership ~56%

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Who Is Acerus?

Global commercial product,

NATESTO®, generating

increasing revenue

Business Strategy focused on

profitable growth, select

geographic diversification and

advancing near term pipeline

opportunities

Proprietary nasal delivery

technology with applications

across a range of API’s and indications

EMERGING COMMERCIAL STAGE SPECIALTY PHARMACEUTICAL COMPANY FOCUSED

ON NATESTO® AND A PIPELINE OF COMPLIMENTARY ASSETS

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Experienced Management Team In Place

ED GUDAITIS PRESIDENT & CHIEF EXECUTIVE OFFICER

• 25+ years of pharmaceutical experience as C-Level executive

• Joined Acerus May 2018

Prior Experience: • General Manager Gilead Sciences Canada Inc. – established and built a top 6 pharma co. in Canada

• Sr. Director, U.S. HIV Marketing, Gilead Sciences – launched two large HIV products in the US, COMPLERA® and STRIBILD®

• Vice President Specialty Care, Roche Canada – Oncology, HIV, HCV and Transplant experience

BOB MOTZ CHIEF FINANCIAL OFFICER

• 30+ years of finance and operations experience

• Joined Acerus October 2018

Prior Experience: • Chief Financial Officer, Hydrogenics – TSX and NASDAQ cross-listed

• Vice President & CFO, Aeroquest International Limited – M&A and International operations

GAVIN DAMSTRA SENIOR VP, INTERNATIONAL COMMERCIAL

• 16+ years of international pharmaceutical and operational experience

• Joined Acerus 2019

Prior Experience: • Executive Director, WH and GI, Allergan Canada – in-line and new product growth accelerated

• General Manager, Takeda Columbia – top performing affiliate in emerging markets

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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

6

As Men Age Less Testosterone Is Produced

And Bio-available1-4

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

is 38.7% in men ≥45 years presenting to primary care offices5

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. Mul l igan T, et al. Int J Cl in Pract 2006;60(7):762-769.

As the population ages, the incidence of low testosterone is expected to increase

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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

• 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

7

There is a market need for better ways to delivery therapy

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Convenient & Differentiated Testosterone Therapy

• 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

• Preserved spermatogenesis

NATESTO® is a self-administered,

fixed-dose gel delivered 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 transference risk and

secondary exposure

PK profile based on BID dosing. TID dosing approved in the U.S.

8

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NATESTO Patient Share

Majority of share captured

from gels with marginal

utilization from injections

~70% HCPs are open to prescribing

NATESTO

1% 8% 17% 20% 25% 55%

Min 1s t Q Max Median 3rd Q Mean

Gels

Injections

NATESTO

NATESTO Share Source

U.S. Specialists Anticipate Using NATESTO® For 5%-20%

Of Patients

NATESTO viewed as important alternative to topical gels for new and switch patients NATESTO viewed as important alternative to topical gels for new and switch patients

Source: HCP interviews (n20) Aug 2019. U.S.-based specialists. Syneos Health

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Patients Are Willing To Switch To NATESTO®

Acceptance of

nasal route of admin

72%

Acceptable

Confident in how to

apply after < 2 days

84%

Confident

Would switch

to Natesto®

70% Yes

No

Source: NATESTO® Phase 3 Patient Use/Preference Questionnaire

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Estimated Hypogonadism (HG) Prevalence by Age (000’s)

HG prevalence increases with age and

co-morbidity

14M total patients

Approx. 700k newly diagnosed patients/yr5

Over 2M treated3,4

Of the treated population, it is estimated

that close to 70% will switch treatment at

least once5

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.

Entry point for NATESTO® therapy is new and switch patients

Large Market Opportunity in the U.S.

1 124

428

1 766

2 486

3 315

2 897

2 340

-

500

1 000

1 500

2 000

2 500

3 000

3 500

20-29 30-39 40-49 50-59 60-69 70-79 80+

11

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Acerus has amended 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.

Acerus assumes 5 Aytu sales FTE focused on specialty market.

• Acerus to lead sales efforts directed to specialists (Uro/Endo); Aytu to lead

sales effort to primary care (PCP)

• Acerus to take control of U.S. market authorization for NATESTO® (NDA)

• Acerus to lead overall U.S. Marketing, Medical & Reimbursement strategy and execution

New Commercial Model For the U.S.

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• Acerus has engaged Syneos Health to be our contract commercial partner in the U.S.

• Syneos Health is built to drive clinical and commercial excellence

Advantages: • Rapid launch 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

• Flexible resource deployment – time and location

• Cost conservation - avoids back office, IT and logistics support expenses

• Leverages Syneos’ experience in men’s health and with NATESTO®

SYNEOS HEALTH - Commercial Partnership

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

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

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Source: Salesforce.com

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• Optimize brand positioning and messaging

• Improve market access for NATESTO®

• Enhance effectiveness of personal

promotion (specialist focus)

PHASE ONE Optimize existing efforts

PHASE TWO Broader sales deployment

PHASE THREE Pull through and push

• Expand specialist-focused sales footprint

aligned with improved market access

• Enhance PCP pull through with Aytu

• Deploy targeted consumer promotion

Our U.S. Growth Strategy

Acerus/Syneos Health will utilize a phased and targeted approach to improve commercial

execution in the U.S.

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Acerus-owned commercial team with

national sales force of up to 8 sales reps

calling on primary care physicians and

specialists in the fields of urology and

men’s health

Acerus: Specialty sales force of up to 44

sales reps focusing on high-prescribing

specialists in urology and endocrinology

Aytu: Primary care sales force of up to

36 sales reps focusing on high

prescribing PCPs

16

North American Commercial Platform Buildout

8

44

Field Sales Reps:

36

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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 to leverage

operational structure in place for NATESTO ®

• Proactively engage with the investor and analyst community on

an ongoing basis to increase the capital markets profile of Acerus

Aytu Amended and Restated Agreement 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. partnership for NATESTO® represents a transformative transaction which will

turn around Acerus creating a leading Specialty Pharma company with significant growth potential

Plan to Transform Acerus by 2021

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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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Select Near Term Pipeline Candidates

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20

Accretive asset leveraging the NATESTO® call point and infrastructure

49% of Men Over 40 suffer from ED1

Acquired Canadian Marketing Rights from

Metuchen Pharma LLC

Indication

Treatment of erectile dysfunction (ED)

Advantage

Potential faster onset of action

Fewer off target effects

Fewer food and alcohol restrictions

Regulatory Status

Filed NDS with Health Canada March 1, 2019

Approval & launch expected H2 2020

$231 million (CAD)2

Canadian ED market value.

Growing at 5.6% vs. prior year 2

Source:

1. 2015 CUA Practice Guidelines for Erectile Dysfunction as published in CAN UROL ASSOC J 2015; 9(1-2): 23-9

2. IQVIA Canadian Drugstore and Hospital Audit, December 2017

Avanafil – Pipeline Candidate Canada 2nd Generation PDE5 inhibitor for treatment of erectile dysfunction (ED)

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21

Monetizing Nasal Technology In Other Fields

Cannabinoid Initiative Leveraging Nasal Technology In Other Applications

“We have engaged Paradigm Capital to run a

process to secure a partner

interested in developing

medical cannabis product(s).”

Phase I PK study completed December 2018 • N = 12 subjects with prior cannabis experience

• 5 mg cannabis oil orally vs. equivalent dose

delivered by nasal gel

Results • Nasal formulation was absorbed

• Extended PK profile with Tmax @ 7h after

administration

• Approx. 2.2 times better bioavailability of THC

from nasal formulation vs. oral dronabinol

capsules1

• Subjects reported appreciation of nasal product

for quick/easy use, consistent dosing, portability

and absence of smoke.

1. Oh et al., Clinical Pharmacology: Advances and Applications 2017, 9, 9

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22

Will Consider Partnership or Acerus-led Commercial Effort

Other Applications Of Nasal Technology Future R&D Options

We are investigating other

API’s and formulations that could lead to new products

for Acerus

Potential Differentiating Features

• Rapid absorption and onset of action

• Mucosa highly vascularized

• Lower dose; fewer side effects

• Potentially avoid first pass metabolism

• High bioavailability-requires less API

• Potentially improved compliance &

persistence

• Non-invasive and user-friendly

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• Focus on NATESTO® in core markets (US, EU, CND)

• Launch avanafil in Canada

• Restructure and strengthen the balance sheet

PHASE ONE Grow core franchises

PHASE TWO Leverage internal R&D

PHASE THREE Expand and pivot

• Out-licence nasal tech in cannabis opportunity

• Identify and advance new API opportunities

with nasal technology

• Act on opportunities to expand urology and

andrology franchise

• Add complimentary therapeutic areas via

development or BD

Our 5 Year Strategic Road Map

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Thank You

Ed Gudaitis President & CEO

[email protected]