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Revolutionizing Women's Sexual and Reproductive Health: Saundra Pelletier, CEO

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47 views33 pages

Revolutionizing Women's Sexual and Reproductive Health: Saundra Pelletier, CEO

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Lulio Reategui
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Revolutionizing Women’s

Sexual and Reproductive Health


Saundra Pelletier, CEO
November 2020

NAS DAQ: E VFM


For investor discussions only. © 2020 Evofem
©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
1
Forward-Looking Statements
This presentation contains forward looking statements within the meaning of The Private Securities Litigation Reform Act
of 1995 and other federal securities laws. In some cases, you can identify forward looking statements by terms such as
“may,” ”will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “strategy,” “objective,” “designed,” “suggest,” “currently,” “could,”
“intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these
terms or other similar expressions. Each of these forward-looking statements involves risks and uncertainties. Actual
results may differ materially from those, express or implied, in these forward-looking statements. Factors that may cause
differences between current expectations and actual results include, but are not limited to, the following:
o the rate and degree of market acceptance of Phexxi™ (lactic acid, citric acid and potassium bitartrate) vaginal gel
o Evofem’s ability to successfully commercialize Phexxi™ and its ability to develop sales and marketing capabilities
o Evofem’s ability to maintain and protect its intellectual property
o Evofem’s ability to rely on existing cash reserves to fund its current development plans and operations and to
raise additional capital when needed
o Evofem’s reliance on third-party providers, such as third-party manufacturers and clinical research organizations
o the presence or absence of any adverse events or side effects relating to the use of Phexxi™ and EVO100
o the outcome or success of Evofem’s clinical trials including EVOGUARD
o Evofem’s ability to retain members of its management and other key personnel
o general risks to the economy represented by spread of the COVID-19 virus
o Evofem’s ability to obtain the necessary regulatory approvals for its product candidates and the timing of such
approvals, and,
o any other risk factors detailed in Evofem’s filings from time to time with the US Securities and Exchange
Commission including, without limitation, the 10-K filed on March 12, 2020, 8-K filed on June 2, 2020 and
subsequent filings.
The forward looking statements in this presentation represent Evofem’s views only as of the date of this presentation,
October 30, 2020, and Evofem expressly disclaims any obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to reflect any change in Evofem’s expectations with regard
thereto or any change in events, conditions or circumstances on which any such statements are based for any reason,
except as required by law, even as new information becomes available or other events occur in the future. All forward-
looking statements in this presentation are qualified in their entirety by this cautionary statement.

For investor discussions only. © 2020 Evofem


©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
2
Evofem Biosciences 101

• Commercial-stage biopharmaceutical company

• Mission: to improve women’s lives by developing and commercializing


innovative prescription products to address critical unmet needs in
women’s sexual and reproductive health
• Launched Phexxi™ in September 2020 as the first-and-only hormone-free,
on-demand, woman-controlled contraceptive vaginal gel
o 21 million US women at risk for pregnancy but NOT using hormonal
contraception1
• 10.3M women using non-Rx contraception (barrier methods, withdrawal,
periodic abstinence, other)
• 10.6M women using no contraception

o “Best in Class” commercial team with more than 60 product launches

• Phexxi peak gross revenue $1.4B - $2.3B2 (est.)

1. Daniels K, Abma JC. Current contraceptive status among women aged 15-49: United States, 2015-2017. NCHS Data Brief. 2018; 327: 1-14.
2. Gross value of Phexxi user = $267.50 WAC x 7 annual refills = $1,872.50

For investor discussions only. © 2020 Evofem


©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
3
Products and Pipeline Address Critical Needs in
Women’s Healthcare (WHC)

Approved
Product / - and - Peak Revenue
Candidate Indication Phase 1 Phase 2 Phase 3 Launched (gross, est.)

First-in-class1
Prevention of
pregnancy
FDA-approved $1.4B - $2.3B2
contraceptive

Prevention of
EVO100 chlamydia and $350M - $550M*
gonorrhea in women
* As label expansion.

Market research is
ongoing to assess
opportunity for a
second brand for
prevention of C/G in
women.
1. Phexxi™ (lactic acid/citric acid/potassium bitartrate). Medi-Span®; June 8, 2020, and First DataBank; June 15, 2020.
2. Gross value of Phexxi user = $267.50 WAC x 7 annual refills = $1,872.50

For investor discussions only. © 2020 Evofem


©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
4
Over $1 Bn US Market Opportunity

There are 21 million women at risk for pregnancy


who are NOT using hormonal contraception1
3% Acquisition 5% Acquisition 7% Acquisition

630,000 1,050,000 1,470,000


Phexxi users2 Phexxi users2 Phexxi users2

~7 refills per year


$267.50 WAC
per box of 12 pre-filled Phexxi applicators

$1.18 Billion $1.97 Billion $2.75 Billion


Sources:
1. Daniels K, Abma JC. Current contraceptive status among women aged 15-49: United States, 2015-2017. NCHS Data Brief. 2018; 327: 1-14
2. Phexxi Forecast Model Assumption.
For investor discussions only. © 2020 Evofem
©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
5
Strong and Experienced Leadership

Saundra Pelletier Jay File Kelly Culwell, MD Russ Barrans


Chief Executive Officer Chief Financial Officer Chief Medical Officer Chief Commercial Officer

7 years at Evofem 5 years at Evofem 5 years at Evofem 5 years at Evofem


30+ years of experience in 26+ years experience 20+ years specializing in 28+ years in the women's
executive management in finance and accounting in women’s health and healthcare, pharmaceutical
women’s health public & private biotechs contraceptive research and biotech space
Board-certified OB/GYN

For investor discussions only. © 2020 Evofem


©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
6
First-in-class
Vaginal pH Modulator1

• FDA-approved prescription contraceptive vaginal gel


• Non-hormonal
• Female-controlled & used on-demand
• Bio-adhesive properties
• Highly viscous

• Maintains vaginal pH level of 3.5 – 4.5 even in the


presence of semen 2,3,4,5
• Inhibits sperm motility

1. Phexxi™ (lactic acid/citric acid/potassium bitartrate). Medi-Span®; June 8, 2020, and First DataBank; June 15, 2020.
2. Garg et al. Contraception. 2001;64(1):67-75.
3. Nayak et al. Clin Exp Obstet Gynecol. 2019;46(5):736-742
4. Amaral et al. Contraception. 2004;70(6):492-497.
5. Keller et al. PLOS One.2012;7(10):e46901.

For investor discussions only. © 2020 Evofem


©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
7
Now Available

Indication: For the prevention of pregnancy in females of


reproductive potential for use as an on-demand method of
contraception.1
Innovative MOA: pH modulating effect2
Favorable Safety Profile: Only 1.6% discontinuation rate due to AEs
Unmet Need
– 21 million women at risk for pregnancy but not using hormonal
contraception – they are Beyond Hormones
– First non-hormonal, woman controlled, non-invasive, used in the
moment prescription drug with three naturally-occurring organic
compounds to address women that are Beyond Hormones
1. Phexxi [Prescribing Information] Evofem Biosciences, Inc. San Diego CA, May 2020
2. Demonstrated in in vitro studies

For investor discussions only. © 2020 Evofem


©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
8
WOMEN ARE DEMANDING MORE…

HAD ENOUGH WITH HORMONES

PREFERS NATURAL / ORGANIC

HIGHLY INFORMED

RESEARCH + REGULAR HCP VISITS

AVOIDS LONG-TERM BC OPTIONS

“…they are tired of figuring out the only


difference between new hormonal
contraception options and ones of past is
changing the way we deliver the same
old hormones.”
Dr. Charis Chambers
Phexxi MD Ambassador

For investor discussions only. © 2020 Evofem


©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
9
The Time is Right for Phexxi

In the US today, there are


21 million women
at risk for pregnancy
who are NOT using
hormonal contraception1

1. Daniels K, Abma JC. Current contraceptive status among women aged 15-49: United States, 2015-
2017. NCHS Data Brief. 2018; 327: 1-14.

10
10 © 2020 Evofem
©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
$2.3 BILLION Peak Revenue Potential

US Contraceptive Market:
72.2M Women1
Primary Targets 360k – 460k
3.5% - 4.5%2 users $670M - $860M
Non-Rx
Contraceptive
Users
+
Primary Targets 200k – 370k
10.3M
2.0% - 3.5%2 users
$375M - $690M
Sterilization, other No
non-targets -
32.5M
Contraceptive -
10.6M
+
Secondary 190k – 380k $350M - $710M
Rx Contraceptive Targets users
Users - 18.8M 1.0% - 2.0%2
Phexxi
Peak Revenue
* Non-Rx Contraceptives: 6.3M barrier methods; 2.8M withdrawal; 1.0M periodic abstinence; 0.1M other (gross, est.)
1. Daniels K, Abma JC. Current contraceptive status among women aged 15-49: United States, 2015-2017. NCHS Data Brief. 2018; 327: 1-14.
$1.4B - $2.3B3
2. Estimated market acquisition percentage in segment
3. Gross value of Phexxi user = $267.50 WAC x 7 annual refills = $1,872.50

For investor discussions only. © 2020 Evofem


©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
11
HCPs Recognize the Unmet Need for
Prescription Non-Hormonal Options
Baseline Post-allocation
% %
Oral Contraceptives (Regular, 28-day) 30% 26% Market Research
PHEXXI™ n/a 15% Survey Highlights
Hormonal IUD 12% 11%
Condom 10% 8% HCPs lowered allocation
Injectable 8% 7% for hormonal options
Oral Contraceptives (Extended) 8% 7% from 74% to 64%
No contraception used, not trying to
6% 5%
become pregnant
Implant 6% 5%
HCPs suggest >10% of
Non-hormonal IUD 4% 4% women currently using
Vaginal ring 5% 4% oral contraceptives are
Fertility awareness/ NFP/ Withdrawal 4% 3% potential candidates for
Patch 4% 3%
switching to Phexxi
Emergency contraception 1% 1%
Diaphragm/ Spermicide/ Cervical cap/
1% 1%
Sponge
Other 0% 0%
TOTAL 100% 100%
Source: KJT Group Phexxi HCP Segmentation Market Research – Q4 2018. n=1,024.
Q340 Imagine Product X is now available. How many of your patients would use each method as their primary form of contraception, including Product X?

TPP: Target Product Profile


For investor discussions only. © 2020 Evofem
©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
12
Reaching HCPs with “Best in Class” Sales Team
Resourced to be scalable, adaptable, flexible; efficiently designed to support our strategy

70 Women’s Health sales reps and regional managers


• Average experience: 15 years in Pharma, 8 of which are women’s health
o Existing relationships, credibility and access to healthcare providers
• Targeting ~3500 accounts and the top12K are the highest prescribing
HCPs
• Leverage HCP segmentation tool to quickly refine target accounts based
on customer response and business opportunities

Internal Sales Team (tele-reps)


• Engaging ~4,400 accounts, or ~8K HCPs, to sell Phexxi via telesales
model to drive additional Phexxi Rxs
• Partner = Archer Healthcare

For investor discussions only. © 2020 Evofem


©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
13
HCP Omnichannel Strategy
A Comprehensive Digital Promotional Programs Model to Drive Brand Awareness

Educational Videos

Patient Resources
HCP Website

MOA Video
Rep Leave Behind

For investor discussions only. © 2020 Evofem


©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
14
Journal Ads and Banners Building Awareness

For investor discussions only. © 2020 Evofem


©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
15
Consumer Omnichannel Strategy
A Comprehensive Digital Promotional Programs Model to Drive Brand Awareness

For investor discussions only. © 2020 Evofem


©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
16
Bold Visual Approach Breaks Category Conventions
to Ensure Phexxi Stands Out

For investor discussions only. © 2020 Evofem


©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
17
Strategic and Diverse Media Activation Plan

SEARCH

ADVOCACY

PROGRAMMATIC
DISPLAY

ENDEMIC DISPLAY

LIFESTYLE DISPLAY

AUDIO ADS

SPONSORED
CONTENT

POINT OF CARE

For investor discussions only. © 2020 Evofem


©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
18
Priming the Consumer Market and Amplifying the
Brand through Notable Outlets and Influential Voices

Ongoing Social Content & Sponsored Content


Executive Visibility Placements
Social Media
Communications Support
Influencer
Engagement
Sexual Satisfaction
Poll

Pre-Launch Launch Post-Launch


(August 20’) (September 20’) (October 20’ – February 21’)

Dr. Chambers Celebrity Instagram TV Bustle


Launch branded
HCP Engagement Series: Phexxi Sponsored
Phexxi Facebook
Fridays Virtual Event
and Instagram

ONGOING OPPORTUNISTIC AND PROACTIVE CORPORATE AND EXECUTIVE VISIBILITY COMMUNICATIONS SUPPORT

For investor discussions only. © 2020 Evofem


©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
19
Priming the Consumer Market and Amplifying the
Brand through Notable Outlets and Influential Voices

For investor discussions only. © 2020 Evofem


©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
20
Phexxi Concierge Experience:
An Innovative Digital Marketing Solution

An innovative
support
program

Caters to women at
any point in their birth
control journey

Provides options and


easy access to Phexxi

Provides information and data about


Provides information on our
Phexxi needed to make an informed
telehealth services and co-pay
decision about hormone-free birth control
program

For investor discussions only. © 2020 Evofem


©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
21
Talk to a Doctor About Phexxi Now…

For investor discussions only. © 2020 Evofem


©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
22
The Copay Assistance Program Helps Eligible
Patients Access Phexxi Prescriptions
• Designed to mitigate coverage gaps that occur while payers are making
final coverage decisions

• Must have commercial insurance

• Pay $0 OOP for first fill

• Pay as little as $30 OOP for subsequent fills

• Prior authorization support provided

Powered by
For investor discussions only. © 2020 Evofem
©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
23
Mail-order Pharmacy Increases Patient Options

Ensures coverage
Delivers drugs Provides
with prior
directly to patients’ prescription support
authorization
homes services
support

Partnering with a mail-order pharmacy will give patients


more options in the COVID environment

For investor discussions only. © 2020 Evofem


©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
24
Market Access

• 55% of commercial lives covered

• Unique classification in the payor-utilized pricing compendiums First Data


Bank and Medispan as “Vaginal pH Modulator” allowing for favorable
reimbursement1
• Phexxi on preventative drug list at $0 cost-share with many prominent
plans, encompassing 4.5M lives
ü Kaiser Washington ü United Healthcare (CA, CT, DC, IL, MD, OR, WA)
ü Harvard Pilgrim ü Geisinger Health Plan
ü Premera Blue Cross

• Robust copay assistance program and direct mail-order program for


patients to offset out-of-pocket costs

1. Phexxi™ (lactic acid/citric acid/potassium bitartrate). Medi-Span®; June 8, 2020, and First DataBank; June 15, 2020.

For investor discussions only. © 2020 Evofem


©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
25
Pipeline: EVO100 for
Prevention of Chlamydia and
Gonorrhea in Women

EVO100 is investigational and safety and efficacy have not been established.

26 © 2020 Evofem
©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
STI Prevention: A Large Market Opportunity
78 Million Sexually Active Women Chlamydia and Gonorrhea
in US Potentially at Risk for STIs Infections on the Rise in US & ROW

Estimated 2020 Market (US) 1


90 • Global incidence likely to reach ~95M
80
77.8 by 20254
70 • US chlamydia and gonorrhea infection
57.3 rates increased for 5th consecutive
Women (in Millions)

60
year despite availability of condoms
50 for STI prevention 2,3
40 33.3 • The CDC estimates 2.86M chlamydia
30 infections and 1.14M new
20 gonococcal infections occur
annually in US2,3
10
o Capturing just half of women that
0 experience chlamydia infections in a
Women at Risk for All Sexually Active All Sexually Active year represents almost 1.5M users
Pregnancy (18-49) Women (18-49) Women (18-65)

Sources:
1. Based on US Census Projections, CDC Data Brief 327, primary market research data collected Q2 2020
2. US. 2018. Centers for Disease Control and Prevention (2019): CDC detailed fact sheet on chlamydia
3. US. 2018. Centers for Disease Control and Prevention (2019): CDC detailed fact sheet on gonorrhea
4. Chlamydia, gonorrhea, trichomonas and syphilis: global prevalence and incidence estimates. June 6, 2019. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6653813/

EVO100 is investigational and safety and efficacy have not been established.
For investor discussions only. © 2020 Evofem
©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
27
AMPREVENCE: Statistically Significant Results
Efficacy: EVO100 Generally Safe & Well Tolerated
Met Primary & Secondary Endpoints Most side effects were mild to moderate

• 20.8% of women experienced an AE


10 9.7% 50% • Few women discontinued due to AEs in
Relative Risk either arm (EVO100, 1.1%; placebo, 1.5%)
8 (n=28) Reduction
(P=0.03) • Similar rates across both arms:
6 o All-cause AEs (EVO100: 21.3%; placebo:
20.4%)
4
4.8% 78%
Relative Risk o Treatment-related AEs (EVO100: 7.2%;
(n=14) 3.2% Reduction placebo: 7.5%)
2
0.7%
• Most common AEs:
0 Placebo EVO100 Placebo EVO100 o EVO100: vulvovaginal candidiasis (5.1%),
(n=9) (n=2) vaginal discharge (3.2%), UTI (3.2%)
C H L A M Y D I A G O N O R R H E A o Placebo: bacterial vaginosis (4.6%),
UTI (2.6%), vaginal discharge (2.6%)
Primary endpoint Secondary endpoint • No treatment-related serious AEs reported

Chappell et al. Efficacy and safety of a novel vaginal pH modulator for prevention of chlamydia and gonorrhea. Presented at 2020 STD Prevention Virtual Conference.

EVO100 is investigational and safety and efficacy have not been established.

28 © 2020 Evofem
©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
EVOGUARD Phase 3 Trial Underway
TRIAL DESIGN STUDY OBJECTIVES

• Phase 3, double-blind, placebo- Primary Objective


controlled study • Evaluate the efficacy of the EVO100 in the
prevention of urogenital Chlamydia trachomatis
• Enrolling 1,730 healthy women
(CT) and Neisseria gonorrhea (GC) infection
age ≥18 years
o Urogenital CT and/or GC infection Secondary Objective
within 16 weeks prior to enrollment
• Evaluate the safety of EVO100
o 1 risk factor if infection
documented; ≥2 risk factors if not
Exploratory Objectives
documented
• Assess the impact of EVO100 on overall
• 90 sites in the US sexual satisfaction and overall product
satisfaction
• 16-week treatment phase, 4-week • Determine the impact of EVO100 use rate
follow up (subject adherence to instructed use) on the
efficacy for combined infections
• Assess other subject satisfaction with EVO100

29 © 2020 Evofem
©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
EVO100: Timeline to Approval 1,2

2021 2022 2023

Potential
Initiate Pivotal Complete NDA US Approval
Phase 3 Trial enrollment1 submission2
& Commercial
Top-Line Launch
Results1

• FDA Fast Track designation for prevention of chlamydia in women


• FDA QIDP designation for prevention of gonorrhea in women
o Potential 5-year regulatory exclusivity extension
1. Assumes timely enrollment
2. Assumes favorable outcomes of the Phase 3 clinical trial

For investor discussions only. © 2020 Evofem


©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
30
Financial Overview

Shares outstanding: 81.3M1

Warrants outstanding: 10.4M2 (weighted average exercise price $4.54)

Unrestricted cash of $123.6M at June 30, 2020

• Includes $136M in aggregate gross proceeds from two


financing transactions closed in Q2 2020

$25M strategic investment from Adjuvant Capital in Oct. 2020

Runway into 2H 2021


• Based solely on projected expenses
• Phexxi revenues provide upside, extend runway
1. As of July 31, 2020.
2. As of June 30, 2020.

For investor discussions only. © 2020 Evofem


©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
31
Our Time is Now

• Marketing Phexxi™ as the first-and-only hormone-free, on-demand,


woman-controlled contraceptive vaginal gel
o Over $1 billion US market opportunity

o 21 million US women at risk for pregnancy but NOT using hormonal


contraception

o “Best in Class” commercial team with more than 60 product launches

• Phase 3 investigational candidate for two potential indications, both with


tremendous unmet need
• Deeply-committed, highly experienced leadership team
• Well capitalized with strong investor base

For investor discussions only. © 2020 Evofem


©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.
32
33 © 2020 Evofem
©2019 Evofem Biosciences,
Biosciences, Inc.
Inc.

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