Paratek Pharmaceuticals, Inc. - FORM 8-K - EX-99.1 - COMPANY SLIDE PRESENTATION DATED JULY 2012.

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8-K - CURRENT REPORT ON FORM 8-K - Paratek Pharmaceuticals, Inc.	d379540d8k.htm

July 2012

A specialty pharmaceutical company focused on the development

and commercialization of proprietary products to address important

therapeutic needs in the field of neuroscience

Exhibit 99.1

This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other

than statements of historical facts, included in this presentation are forward-looking statements. Examples of such statements

include

our

expectations

regarding

the

potential

market

for

Intermezzo®

and

the

potential

market

size

for

middle

the

night sleep aid; our expectations regarding an ideal therapeutic; Purdue plans to invest approximately $100 million to support

sales and marketing over the first 12 months of commercialization of Intermezzo in the U.S.; the success of the commercial

launch of Intermezzo by Purdue in the U.S., including continued growth in the number of Intermezzo prescriptions;

improvement in the Intermezzo adoption curve; our eligibility for and the receipt and size of royalty and milestone payments

from

Purdue

pursuant

our

Collaboration

Agreement;

anticipated

reimbursement

coverage;

intellectual

property

protection

being obtained and maintained; plans for the Phase 2 study of TO-2061, including the expected timing of completion of

enrollment and receipt of clinical trial results; our expectations regarding the potential market size for TO-2061 as

augmentation treatment for patients with OCD; and our strategy to build a specialty sales and marketing organization, in-

license or acquire additional product candidates, and determine the future development path for TO-2061. All of these

forward-looking

statements

are

based

estimates

and

assumptions

our

management

that,

although

believe

reasonable, are inherently uncertain. Forward-looking statements involve risks and uncertainties, including, but not limited to,

achieving acceptance of Intermezzo by physicians, patients and third-party payors; the impact of competitive products and

the market for Intermezzo generally; our dependence on Purdue’s commercialization efforts, including our reliance on Purdue

to set the future pricing of Intermezzo and our Collaboration Agreement with Purdue; obtaining, maintaining and protecting

marketing and other regulatory exclusivity and intellectual property protection for Intermezzo and TO-2061, as well as

protection from generic versions of our products; competitive product commercialization; manufacturing and supply risks for

Intermezzo and TO-2061; adverse patent decisions at the USPTO or in court; our intent and ability to carry out plans to

promote

Intermezzo

psychiatrists

the

United

States

through

our

co-promotion

option;

our

intent

and

ability

successfully in-license or acquire additional product candidates; and variability in the business of Transcept generally. These

and other risks are described in greater detail in the "Risk Factors" section of Transcept periodic reports filed with the

Securities and Exchange Commission. Forward-looking statements do not reflect the potential impact of any future in-

licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments Transcept may enter into or make.

Transcept does not assume any obligation to update any forward-looking statements, except as may be required by law.

Forward looking statements

Therapeutic focus

Large markets,

unmet needs

Commercial

platform

U.S.

primary

care

partnership:

Purdue

Pharma

Option

co-promote

Intermezzo

psychiatrists

3/31/12: ~$59M cash, equivalents & investments

5/1/12: ~$38M in net proceeds from public offering

Neuroscience / psychiatry

Strong balance

sheet

Transcept corporate overview

Intermezzo:

first

FDA

approval

for

middle

the

night awakening

TO-2061

treatment resistant

OCD,

Ph2

data

Q1-13

Work with Purdue to maximize Intermezzo adoption

In-license or acquire marketed and/or late-stage products that

complement psychiatry focus

Begin next phase of TO-2061 development assuming

successful completion of Phase 2 trial in Q1 2013

Build specialty sales/marketing capability

XDecision driven by:

–

Intermezzo Rx growth and expectation that co-promote royalty will

support sales/marketing expense

–

Success in acquiring additional products that complement psychiatry

focus

Key strategic goals

Intermezzo: national product launch April 2012

Indication statement as approved by FDA:

–

Intermezzo

is indicated for use as needed for the

treatment of insomnia when a middle-of-the-night

awakening is followed by difficulty returning to sleep.

–

Intermezzo

is not indicated for the treatment of middle-

of-the-night insomnia when the patient has fewer than 4

hours of bedtime remaining before the planned time of

waking.

Intermezzo: the first and only prescription sleep aid

approved for middle-of-the-night dosing

Intermezzo: the first and only prescription sleep aid

approved for middle-of-the-night dosing

Middle of the night (MOTN) awakening:

a major unmet medical need in the insomnia category

Large U.S. insomnia market

–

million

new

and

refill

prescriptions

(1)

Insomnia

under-treated

condition

(2)

–

million

patients

receive

(3)

–

are

not

diagnosed

treated

physician

(2,3)

MOTN

awakening:

the

most

common

insomnia

symptom

(4)

–

35%

Americans

suffer

from

MOTN

awakenings

least

week

(4)

–

>90% report awakenings persist more than six months;

50%

report

awakenings

persist

than

five

years

(5)

(1)

IMS

Oct

2010

Sep

2011;

(2)

Institute

Medicine

Sleep

disorders

and

sleep

deprivation

Apr.

2006;

(3)

BluePrint

Research

Group;

(4) Ohayon,

Nocturnal awakenings and comorbid disorders in the American general population. J of Psych Research (2009); (5) Ohayon, Difficulty in resuming or

inability

resume

sleep

and

the

links

daytime

impairment,

Psych

Research (2009).

MOTN awakenings typically do not occur every night

7-8

sleep

aids

(Ambien

Ambien

Lunesta

)

require

bedtime prophylactic dosing to prevent awakenings

An ideal therapeutic would:

–

Be used only at the time patients need help returning to sleep,

not every night in advance of a problem that may not occur

–

Return patients to sleep rapidly

–

Be effective despite the low dose necessary to avoid next day

residual effects when used in the middle of the night

Commonly prescribed sleep aids are indicated

only for bedtime use

Novel zolpidem formulation

–

Sublingual tablet

–

Bicarbonate-carbonate buffers

Approved dose

–

1.75 mg in women & patients > 65 years

–

3.5 mg in men < 65 years

Rapidly absorbed in both men and women

Effective vs. placebo in sleep laboratory & outpatient studies

Instructions to patients

–

Take Intermezzo “while in bed”

–

“When you wake up in the morning, be sure that at least 4 hours have passed

since you have taken Intermezzo

and you feel fully awake before driving. Do

not do dangerous activities until you know how Intermezzo

affects you.”

Intermezzo: the first and only sleep aid approved for

middle-of-the night dosing

Purdue plans to invest ~$100M during

first 12 months of Intermezzo launch

~275 field representatives in new national

sales force devoted exclusively to the promotion of

Intermezzo to highest insomnia prescribers

Presentations to drug wholesaler, retailer and managed

care decision makers began in early 2012

Presentations to physicians began April 2012

Purdue Pharma: Intermezzo launch underway

Purdue commercialization agreement:

key Transcept benefits

Remaining potential milestone payments

–

$10M

when

patent

app.

11/439,874

issued

published

Orange

Book

–

Up to $70M upon the achievement of certain net sales targets

Base royalty

–

Base royalty: mid-teens up to mid 20% level on net sales

Co-promote option: foundation for a commercial future

–

Option to exercise co-promote extends through August 2015

–

After option exercise, Transcept must wait 8 to 15 months to begin

promotion, depending on when in the calendar year the exercise is made

–

Co-promote royalty

•

22% to 40% on psychiatrist Rx net sales, based on timing of opt-in

•

Net revenue qualifying for this additional co-promote royalty is

capped at 15% of total Intermezzo annual net U.S. sales

Intermezzo weekly Rx

Source: Wolters Kluwer Pharmaceutical Audit Suite

Intermezzo launch update

Substantial managed care coverage achieved

Improvement in adoption curve expected over time

–

Newly hired sales force calling on new physician targets

–

Physician audience unaccustomed to differentiating

middle of the night insomnia

•

Requires a different interaction with the patient

•

Sales force focused on educating prescribers to

identify appropriate Intermezzo patient candidates

Intermezzo:

intellectual property

Intermezzo:

intellectual property

Two issued U.S. patents: 7,682,628 and 7,658,945

–

Buffered dosage forms

–

Claims require absorption of zolpidem across the oral mucosa

–

Patent coverage through at least 2025

Notice of allowance: July 2012

–

Methods of treating middle of the night insomnia No. 11/439,874

•

Claims cover a broad range of dosage forms

•

Once patent issues, coverage through at least 2026

–

After patent issues and is listed in the Orange Book, TSPT will be

eligible for a $10M milestone payment from Purdue

Intermezzo patent protection

TO-2061

(low dose ondansetron)

TO-2061

(low dose ondansetron)

Proposed indication: adjunctive therapy in adult patients

with obsessive compulsive disorder (OCD) not adequately

responsive to currently approved OCD medication

Obsessive Compulsive Disorder

–

Intrusive thoughts and repetitive actions to reduce distress

–

Affects 1% to 2% of U.S. adult population, 40% to 50% seek treatment

–

Significantly impacts everyday life activities of patients and their families

–

40% to 60% of OCD patients do not respond adequately to approved

medications,

which

include

the

SSRIs

Prozac

Luvox

Paxil

Zoloft

No FDA approved medication for treatment resistant OCD

–

Atypical antipsychotics are often used off-label to augment approved

medications

•

~68% of treatment resistant OCD patients do not respond

•

Frequently reported adverse events: weight gain, metabolic disorder

Significant unmet medical need: OCD patients not

responding adequately to approved medication

All Patients: n=21

26.4% improvement at 12 weeks

Responders: n=12 of 21 (57%)

44.0% improvement at 12 weeks

Pilot Study, n=21

Pilot Study: patients showed mean 26% improvement at 12

wks on the Yale Brown Obsessive Compulsive Disorder Scale

505b2 NDA pathway

Phase

double

blind,

placebo

controlled

study,

150,

complete enrollment est. Fall 2012, top line data est. Q1 2013

Intellectual property

–

Method of use patent application filed, priority date May 19, 2009

–

Ondansetron, up to ~1.5 mg/day

–

Pending claims for treating SSRI resistant OCD with ondansetron augmentation

* SDI Physician Drug and Diagnosis Audit

Managed care survey (~108M lives): unmet medical need

acknowledged, Tier 3 formulary placement expected

Strategic fit: psychiatry

~87% of patient visits for OCD were to psychiatrists in 2009

Complements Transcept psychiatry focus

TO-2061

development

overview

Financial overview

3/31/2012

Employees:

22 M

Total:

Options / warrants / other:

3 M

Shares outstanding

19 M

Net proceeds from public offering:

$38 M

5/1/2012 update

Cash, equivalents & investments:

$59 M

Financial position

Intermezzo launched April 2012

–

First approval for middle of the night awakening

–

Large potential market

–

Significant royalty and co-promote opportunities

–

Increasing patent protection

TO-2061 Phase 2 OCD data Q1 2013

Strong balance sheet

Key investment highlights

Intermezzo

is a registered trademark of Purdue Pharmaceuticals L.P.

Ambien

and

Ambien

are

registered

trademarks

sanofi-aventis

Lunesta

is a registered trademark of Sunovion Pharmaceuticals Inc.

Paxil

is a registered trademark of The GlaxoSmithKline Group of Companies

Prozac

is a registered trademark of Eli Lilly & Co.

Luvox

is a registered trademark of Solvay Pharmaceuticals, Inc.

Zoloft

is a registered trademark of Pfizer Inc.

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