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

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8-K - FORM 8-K - Paratek Pharmaceuticals, Inc.	d313745d8k.htm

March 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

Forward

looking

statements

Forward

looking

statements

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

such

statements

include

our

expectation

regarding

the

potential

market

for

Intermezzo

and

the

potential market size for a middle of the night sleep aid; our expectations regarding an ideal therapeutic; the

average value of a branded insomnia prescription and the resulting revenue for each 1% of market share; Purdue

plans to hire 275 sales representatives to exclusively promote Intermezzo; 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 expected timing for and the success of the commercial launch of Intermezzo by Purdue in the U.S.; the

receipt of royalty and milestone payments from Purdue pursuant to 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 clinical trial results; and our expectations regarding the

potential market size for TO-2061 as augmentation treatment for patients with OCD. All of these forward-looking

statements are based on estimates and assumptions by our management that, although we believe to be

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; supplying

sufficient quantities of Intermezzo from third-party manufacturers and suppliers to meet anticipated market

demand; the impact of competitive products and the market for Intermezzo generally; our dependence on

Purdue’s

commercialization

efforts

and

our

Collaboration

Agreement

with

Purdue;

obtaining,

maintaining

and

protecting regulatory exclusivity and intellectual property protection for Intermezzo; competitive product

commercialization; manufacturing and supply risks for TO-2061; adverse patent decisions at the USPTO or in

court; 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.

Therapeutic focus

Large markets,

unmet needs

Commercial

platform

U.S. primary care partnership: Purdue Pharma

Option

co-promote

Intermezzo

post

launch

9/30/11: ~$54 M cash, equivalents & investments

$10M

milestone

payment

from

Purdue:

2011

No debt

Neuroscience / psychiatry

Intermezzo: middle of the night awakenings

: treatment resistant OCD

Transcept: preparing for Intermezzo

commercialization

Transcept: preparing for Intermezzo

commercialization

Strong balance

sheet

Intermezzo product launch: early April 2012

Phase

results:

estimated

2013

Near term

catalysts

TO-2061

Intermezzo

(zolpidem tartrate) sublingual tablet C-IV

Intermezzo

(zolpidem tartrate) sublingual tablet C-IV

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

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

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 is an under-treated condition

(2)

–

million

patients

receive

(3)

–

are

not

diagnosed

treated

physician

(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)

Institutes

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

resuming

inability

resume

sleep

and

the

links

daytime

impairment,

Psych

Research

(2009).

Commonly prescribed sleep aids are indicated

only for bedtime use

Commonly prescribed sleep aids are indicated

only for bedtime use

MOTN awakenings typically do not occur every night

7-8 hr sleep aids (Ambien

, Ambien CR

, 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

Intermezzo: the first and only sleep aid approved for

middle-of-the night dosing

Intermezzo: the first and only sleep aid approved for

middle-of-the night dosing

Novel zolpidem formulation

–

Sublingual tablet

–

Bicarbonate-carbonate buffers

Approved dose

–

1.75 mg in women & patients > 65 years

–

3.5 mg in non-elderly men

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.”

Significant Rx insomnia market opportunity:

each

$130M

branded

prices

Significant Rx insomnia market opportunity:

each

$130M

branded

prices

U.S. insomnia market

Hypothetical market

(1) IMS Health, National Prescription Audit, Sept 2011; (2) Wolters Kluwer WAC pricing (branded) Jan 2011, $5.05

$5.67

(products

evaluated:

Ambien

Lunesta

Silenor

;

Ambien

and

Ambien

are

currently

available

generic

form;

Lunesta

WAC

pricing

was

$6.13);

(3)

Transcept

estimate

based

IMS

Health,

National Prescription Audit, Sept 2011.

Branded pricing

penetration

Average

value:

$165

tablets

per

~$5

per

tablet

million

TRx

per

year

1% Intermezzo share

790,000 TRx, approx $130M sales

Initial shipments and physician

promotion planned for early April 2012

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

Purdue began contacting drug wholesaler, retailer and

managed care decision makers in early 2012

Intermezzo launch plans

Purdue commercialization agreement:

key Transcept benefits

Purdue commercialization agreement:

key Transcept benefits

Co-promote option: foundation for a commercial future

–

Transcept option: co-promote to psychiatrists can begin as early as

1 year and as late as 4.5 years after Purdue launch

Royalty structure

–

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

–

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

Milestone payments

–

$10M

for

first

formulation

patent

listed

Orange

Book,

paid

2011

–

Up to $80M additional upon the achievement of certain patent

milestones and net sales targets

Intermezzo managed markets advisory board with

decision makers covering >170M lives

Intermezzo managed markets advisory board with

decision makers covering >170M lives

Broad formulary access expected

Unmet medical need generally recognized by payers

–

Unique insomnia indication

–

Low dose used less often

–

Rapidly absorbed

Tier 3 formulary placement anticipated by most plans

Utilization management criteria consistent with other brands

Intermezzo

brand parity pricing not viewed as a major barrier

with managed markets

Intermezzo:

intellectual property

Intermezzo:

intellectual property

Two U.S. patents issued, additional patent

applications pending

Two U.S. patents issued, additional patent

applications pending

Two issued U.S. patents -

7,682,628 and 7,658,945

–

Claims are not limited to use of buffers

–

Compositions and methods of treating middle of the night

awakenings

–

Any patents issuing from these applications would expire no sooner

than February 2025

Patent applications pending

–

Buffered formulations

–

Compositions and methods of treating insomnia

–

Claims require absorption of zolpidem across the oral mucosa

–

Patents expire no sooner than February 2025

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

Significant unmet medical need: OCD patients not

responding adequately to approved medication

Significant unmet medical need: OCD patients not

responding adequately to approved 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

–

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

No FDA approved medication for treatment resistant

OCD

Pilot Study B:

Improvement measured as % decrease below baseline

Pilot Study B:

Improvement measured as % decrease below baseline

All Patients: n=21

26.3% improvement at 12 weeks

Responders: n=12 of 21 (57%)

44.3% improvement at 12 weeks

Pilot Study B, n=21

Week

50%

40%

30%

20%

10%

All patients

Week

50%

40%

30%

20%

10%

Responders

Non-responders

development

overview

development

overview

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

Strategic fit: psychiatry

–

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

–

Complementary to Intermezzo

psychiatry co-promote option with Purdue

* SDI Physician Drug and Diagnosis Audit

TO-2061

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

acknowledged, Tier 3 formulary placement expected

Financial overview

Financial position –

Q4 2011 release and

teleconference on 3/14/12 at 1:30 PM PT

Financial position –

Q4 2011 release and

teleconference on 3/14/12 at 1:30 PM PT

9/30/11

*During Q3 2011, Transcept paid severance of approximately $1.0 million to former

employees whose positions were eliminated in the July 15, 2011 reduction in force.

Excluding this severance payout, cash use during the quarter averaged approximately

$1.5 million per month.

Milestone payment recvd (12/21/11):

$10.0 M

Shares outstanding:

13.9 M

Options / warrants / other:

3.6

Total:

17.5 M

Employees:

2/1/12 update

Cash & investments:

$54.1 M

Q3 2011 cash burn rate*:

$ 1.9 M / month

Intermezzo

is a registered trademark of Transcept Pharmaceuticals, Inc.

Ambien

and Ambien CR

are registered trademarks of sanofi-aventis

Lunesta

is a registered trademark of Sunovion Pharmaceuticals Inc.

Zofran

and Paxil

are registered trademarks 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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Paratek Pharmaceuticals, Inc. Reports

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