Evofem Biosciences (EVFM) 8-K Regulation FD Disclosure

August 2018

SAUNDRA PELLETIER, CEO

NASDAQ: EVFM

Exhibit 99.1

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,”

“designed,”

“suggest,”

“currently,”

“could,”

“intend,”

“target,”

“project,”

“contemplate,”

“believe,”

“estimate,”

“predict,”

“potential”

or

“continue”

or

the

negative

of

these

terms

or

other

similar

expressions.

The

forward

looking

statements

of

this

presentation

are

only

predictions

and

are

subject

to

a

number

of

risks,

uncertainties

and

assumptions,

including,

without

limitation

risks

and

uncertainties

relating

to:

the

outcome

or

success

of

Evofem’s

clinical

trials;

Evofem’s

ability

to

obtain

the

necessary

regulatory

approvals

for

its

product

candidates,

including

approval

from

the

U.S.

Food

and

Drug

Administration

for

the

use

of

Amphora

®

as

a

contraceptive,

and

the

timing

of

such

approvals;

the

rate

and

degree

of

market

acceptance

of

Amphora

®

;

Evofem’s

ability

to

successfully

commercialize

Amphora

®

and

its

ability

to

develop

sales

and

marketing

capabilities;

Evofem’s

ability

to

maintain

and

protect

its

intellectual

property;

Evofem’s

ability

to

raise

additional

capital

when

needed

and

to

rely

on

existing

cash

reserves

to

fund

its

current

development

plans

and

operations;

Evofem’s

reliance

on

third

party

providers,

such

as

third

party

manufacturers

and

clinical

research

organizations;

the

absence

of

any

adverse

events

or

side

effects

relating

to

the

use

of

Amphora

®

;

Evofem’s

ability

to

retain

members

of

its

management

and

other

key

personnel;

and

other

risk

factors

detailed

in

Evofem’s

filings

from

time

to

time

with

the

U.S.

Securities

and

Exchange

Commission.

The

forward

looking

statements

in

this

presentation

represent

Evofem’s

views

only

as

of

the

date

of

this

presentation,

August

8,

2018,

and

Evofem

undertakes

no

obligation

to

update

or

review

any

forward

looking

statement,

whether

as

a

result

of

new

information,

future

developments

or

otherwise,

except

as

required

by

law.

Disclaimer

2

•

Clinical-stage biopharmaceutical company

•

Committed to discovery, development and commercialization of innovative

women’s health pharmaceuticals

•

Lead product candidate Amphora

®

is a non-hormonal, on-demand, woman-

controlled vaginal gel

•

Phase 3 confirmatory study in contraception

•

Phase 2b study for the prevention of chlamydia

•

Accomplished executive leadership team with more than 80 years of combined

experience in women’s healthcare

•

Located in San Diego, CA

Company Overview

3

Leadership Headlines

“

Globally experienced pharmaceutical executive with 25+ years of management

experience in women’s health, raising capital,

and launching brands”

“25 years of experience in accounting and finance with over

$600M in equity and debt offerings in the biotech

and biopharma industries”

“Board-certified OB/GYN with ~20 years of medical oversight in

women’s health who served as the Medical Officer

with W.H.O. and the IPPF”

“26 years of global marketing & sales experience with experiencing launching over

6 prescription and OTC brands worldwide that today bring in as much $1.2B

annually”

4

Saundra Pelletier

Chief Executive Officer

Jay File

Chief Financial Officer

Kelly Culwell, M.D.

Chief Medical Officer

Russell Barrans

Chief Commercial Officer

Amphora -

Normal Vaginal

pH Level

3.5 –

4.5

Water

pH Level 7

Semen/Blood

pH Level 7.1 –

8

pH Levels

Soap

pH Level 7 –

14

Acidic

Basic

Body

pH Level 5

Lead Asset: Amphora Vaginal Contraceptive Gel

5

4

1

2

3

5

6

7

8

9

10

11

12

13

0

•

L-lactic acid, citric acid, and potassium

bitartrate

•

Buffering properties keep the vaginal

environment in the pH acidic range

•

Maintains acidic vaginal environment,

preventing the survival of spermatozoa

•

The introduction of semen into the

vagina raises the pH above 6.0

•

Amphora maintains the natural

vaginal pH, inhibiting spermatozoa

•

Highly bioadhesive, forming a layer

over vaginal and cervical surfaces

Amphora: Attributes and Mechanism of Action

6

•

Single-arm, open label trial in 1,400 women age 18-35 at 112 U.S. sites

•

Enrollment completed in February 2018

•

5 gram dose of Amphora administered up to one hour before intercourse

•

Primary endpoint: contraceptive efficacy over seven cycles

•

Exploratory endpoint: sexual satisfaction

•

Top-line results expected late 2018

AMP-002: Confirmatory Phase 3 Trial

7

Enrollment

Confirmatory Phase 3 Trial

Anticipated

Top Line Results

Anticipated Approval & Launch

Anticipated

NDA Resubmission

2017

2018

2019

2020

Hormone-free

On-demand & woman-controlled

Easy to self-administer

Bioadhesive

No weight restrictions / BMI agnostic

Personal lubricant properties

Patent protection through 2033*

Amphora is Poised to Expand the Women’s Healthcare

(WHC) Market

8

*Patent pending

•

Greater than 80% of women, and their partners, rated their Amphora experiences as

satisfying or extremely satisfying

•

Note –

more than half of respondents rated their experience as “extremely

satisfied”

•

More than 4 out of 5 those who completed the study would recommend Amphora to

a friend

•

80% of respondents indicated that they felt confident the contraceptive gel, if

approved, would be effective in preventing pregnancy

User

Experience

Satisfaction

Survey

1

9

Source:

1. Survey commissioned with Integrated Insights Consulting: Data on file

–

Healthcare Provider, AMP002

“Study participants just like how easy it is to use. They don't have to do a lot of pre-

planning. It's as easy to use as a tampon. It's portable. Their boyfriends, husbands,

whoever –

they like the lubricant aspect.”

16.5M Women in the U.S. Currently are Sexually Active but

do Nothing to Prevent Pregnancy

10

Source:

1. Derived from NCHS Data Brief No. 173_December 2014 and the 2016 US Census Bureau data.  

Sexually active,

not using

contraception

16.5M

Rhythm Method

0.7M

Withdrawal

Method

1.9M

Condoms

6M

Amphora Targets in U.S. Women 15-44

(in Millions)

1

Amphora Consumer Segmentation: Market research supports a

shift in women’s attitudes towards a non-hormonal option

Life Stage

“Focused on School”

“Family Focused”

“Relationship

Focused”

“Focused on Career”

Age

26

35

28

45

Occupation

Law Student

Homemaker

Financial Analyst

Director of Global

Marketing

Relationship

Status

Single,

casual dater

Married,

1 toddler

Committed

relationship,

no children

Single, casual dater,

2 teens

Hormone

Attitude

Experienced

hormonal side effects

and inconsistent

pill user

Breast feeding and

is concerned about

hormones

Concerned about

hormones and

prefers to add

Amphora

Currently using

barrier method and

likes lubricating

properties

Nicole*

Jessica*

Amanda*

Laura*

Alternatives

Supplementers

11

Source:

Commissioned

Market

Research

–

Data

on

File.

*Not an actual study participant

Amphora Healthcare Providers Segmentation:

A more effective

way to predict future prescribing patterns

12

We believe the healthcare provider community applicable to Amphora breaks down as follows:

Segment A (31%)

Segment B (27%)

Segment C (13%)

Segment D (11%)

Segment E (9%)

Segment F (9%)

Name

Attentive Adrian

Traditional Terry

Surly Stanley

Joan of LARC

Mindful Marcia

Rooted Rose

Demographics

Gender 50/50,

physicians, more

likely single-

specialty

Older, more likely

male, lowest # mid-

levels in practice

Older, more likely

male

Younger,

more likely female,

more likely rural

Mid-Levels, more

likely female

Older, more likely

female

Attitude

Driver –

Patient

Satisfaction

Least likely to

believe patient

knows the best

option for herself

Least patient

oriented

Influenced by

colleagues

Most reliant on

KOLs and

guidelines for

treatment

High concern about

hormones and their

safety

Behavior

Average speed of

adoption

More conservative

about adoption

Late adopters

Highest

contraception

procedures (surgical

& non surgical)

Highest

contraceptive

usage

Slow adopter and

will like the idea of

Amphora

85

Sales

Representatives

cover

~96%

of

Deciles

6-10

oral

contraceptive

prescriptions

1

•

Optimize deciles 6-10 OB/GYN coverage

at the prescribed reach and frequency

•

98% of total prescriptions of the top

10K writers in the oral contraceptive

marketplace

come

from

OB/GYNs

2

•

Expected salesforce cost $15-20M

annually

•

Affordable Care Act (ACA)

•

Under the federal mandate,

Amphora

is expected to be classified

as a new class of prescription

contraception allowing for it to be

covered at $0 copay and $0

deductible for a majority of women

Sources:

1. Quintiles –

March 18, 2016: Evofem_Target_Universe_PCP+OBGYN_10USC_4Feb2016.xlsx

2. IMS Nov’15 Prescription Data

Direct Sales Opportunity

13

Precise Targeting thru Direct-to-Consumer Digital Marketing

14

Strategy

•

Initiate direct-to-consumer (DTC) 6-9 months post launch 

•

Shape the Amphora market by creating awareness and excitement among women

who need and desire non-hormonal contraception

•

Annual DTC Budget ~$25-30M

Paid

Search

Paid

Ads

Paid

Digital

Related

Blogs

Contextually 

Relevant

Articles

Search

Engine 

Marketing

amphora.com Consumer

Website

SEARCH

Digital

Booklet

“I am unhappy,

currently sexually

active, and not

using any forms

of birth control.

I

have tried many

different options.

What else is left?

“

Sponsored

Events

Facebook

Page

DOCTOR

VISIT

“My patient

came 

in unhappy

with

the hormonal side

effects she has

been experiencing

and cannot

remember to take

her pill daily. She

is inquiring about

non-hormonal

options.”

Pipeline: Targeting Unmet Needs in Women’s Healthcare

15

Sources:

1.

Guttmacher Institute. Contraceptive Use in the United States. Available at: https://www.guttmacher.org/article/2017/10/contraceptive-method-use-united-

states-trends-and-characteristics-between-2008-2012. Accessed 01 April 2018.

2.

CDC 2016 Sexually Transmitted Disease Surveillance Report.

3.

Multipurpose prevention technologies (MPTs) have a combination of contraceptive, microbicidal and/or anti-sexually transmitted infection (STI) properties to

prevent pregnancy, HIV and/or STIs.

4.

The Prevalence of Bacterial Vaginosis in the United States, 2001–2004; Associations With Symptoms, Sexual Behaviors, and Reproductive Health.

5.

While we have received a QIDP designation, we may be required to reapply should we alter the formulation of this product candidate.

Source:

1. CDC 2016 Sexually Transmitted Disease Surveillance Report

•

1.6M

new

cases

of

chlamydia

in

2016

in

U.S.

1

•

Phase 2b trial –

enrollment ongoing

•

Double-blinded,

placebo-controlled

efficacy

trial

at

up

to

50

U.S.

sites

•

844 women, 18-45 years old, with chlamydia infection in past four months

•

Four-month interventional period + one-month follow-up

•

Primary endpoint: prevention of chlamydia trachomatis in women

•

Exploratory endpoint: sexual satisfaction

•

Fast Track designation for prevention of urogenital chlamydia in women

•

The additional protection from chlamydia will make Amphora an even more

appealing addition to a woman’s current contraceptive method

Amphora Label Expansion Opportunity:

Prevention of Chlamydia

16

•

BV is caused by an imbalance of a woman’s vaginal bacteria

•

Symptoms include unpleasant odor and abnormal vaginal discharge

•

BV

has

up

to

58%

recurrence

rate

1

•

Phase 1 dose-finding study completed

•

pH levels maintained to seven days

•

FDA

designated

QIDP

for

BV

2

•

Eligible for FDA’s Fast Track

•

Adds five years market exclusivity for BV indication

Pipeline Development:

Prevention of Recurrent Bacterial Vaginosis (BV)

17

Sources:

1.

Bradshaw CS et al., High Recurrence Rates of Bacterial Vaginosis over the Course of 12 Months after Oral Metronidazole Therapy and Factors

Associated with Recurrence. The Journal of Infectious Diseases 193:1478-86 (2006).

2.

While we have received a QIDP designation, we may be required to reapply should we alter the formulation of this product candidate.

Ticker

NASDAQ: EVFM

Shares outstanding

(as of 07/30/2018)

25.8M

Common stock warrants

outstanding:

Merger-related

May 2018 offering

2.0M @ $8.35

1.7M @ $7.50

Unrestricted Cash

(as of 6/30/2018)

$22.8M

Key Stock Data

18

Initiate Phase 2b Amphora STI trial (first patient in)    

Dec 2017

FDA grants Fast Track designation to Amphora for the

prevention of urogenital chlamydia in women

Feb 2018

Complete enrollment in Phase 3 Amphora contraceptive trial

Feb 2018

Last patient last visit in Phase 3 Amphora contraceptive trial

Fall 2018

Expected top-line results from Phase 3 Amphora

contraceptive trial

Late 2018

Resubmit Amphora NDA for contraception

1H 2019

Anticipated FDA action on Amphora NDA for contraception

Q4 2019

Launch Amphora for contraception

Q1 2020

Multiple Near-Term Catalysts

19

Evofem Biosciences Highlights

20

*Patent pending

Innovation

Expertise

Unmet Need

Measurement

Analytics

Pipeline

Exclusivity

Amphora is first in class, non-hormonal, on-demand

•

Commercial launch anticipated January 2020

World class executive leadership team

16.5M women feel the trade-off avoiding hormones is worth the increased risk of

pregnancy

Segmentation allows for precision in marketing messaging and sales force target

customers

Near term catalysts:

•

Phase 3 confirmatory study, last patient out expected in the Fall 2018

•

Topline results expected late 2018

•

Expected NDA submission 1H 2019

Lifecycle management: prevention of chlamydia

Additional product candidate: prevention of recurrent bacterial vaginosis

IP through 2033*