INSMED Inc - FORM 8-K - EX-99.2 - FREE WRITING PROSPECTUS

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Developing Innovative Inhaled Treatments for Serious

Lung Infections

August 2012

Free Writing Prospectus

Registration Statement No. 333-182124

Exhibit 99.2

This presentation contains forward-looking statements which are made pursuant to provisions of Section 21E

of the Securities Exchange Act of 1934. Investors are cautioned that such statements in this presentation,

including statements relating to our financial position, projected year end cash and cash runway, the status

and the results of preclinical studies and clinical trials and preclinical and clinical data described herein, the

timing of responses to information and data requests from FDA, the development of our products, our

estimates of the size of the potential markets for our product candidates, and the business strategies,

evaluations, plans and objectives of management, constitute forward-looking statements which involve risks

and uncertainties that could cause actual results to differ materially from those anticipated by the forward-

looking

statements.

Our

results

may

affected

such

factors

the

receipt

and

timing

FDA

and

other

regulatory reviews and approvals, if at all, competitive developments affecting our product development,

delays in product development or clinical trials, and patent disputes involving currently developing products.

The risks and uncertainties include, without limitation, we may experience unexpected regulatory actions,

delays or requests, our future clinical trials may not be successful, we may be unsuccessful in developing our

product candidates or receiving necessary regulatory approvals, we may experience delays in our product

development or clinical trials, our product candidates may not prove to be commercially successful, our

expenses may be higher than anticipated and other risks and challenges detailed in our filings with the U.S.

Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended

December

31,

2011

and

our

Quarterly

Report

Form

10-Q

for

the

quarter

ended

June

30,

2012.

Investors

are cautioned not to place undue reliance on any forward-looking statements which speak only as of the date

of this presentation. We undertake no obligation to publicly release the results of any revisions to these

forward-looking statements that may be made to reflect events or circumstances that occur after the date of

this release or to reflect the occurrence of unanticipated events.

Safe Harbor Statement

Insmed: Value Proposition

Attractive

Late-Stage

Opportunity

ARIKACE has strong Phase 2 efficacy and safety data in CF

Amikacin is an FDA-approved antibiotic, long recognized as one of the most

effective treatments for gram-negative infections

Compelling

Business Model

Two orphan indications with high unmet need and combined global market

potential of over $1 billion

Limited commercial infrastructure required

Strong IP and potential for extended exclusivity

Strong Balance

Sheet &

Experienced

Management

As of 6/30/12, company reported ~$75 million in cash, investments & CD

We believe cash is sufficient to take Company through the availability of

top-line data for both CF CLEAR-108 trial and TARGET-NTM trial

Management has extensive anti-infective development, regulatory, and

commercial experience

ARIKACE

* is a highly differentiated product that offers a compelling

business opportunity in two orphan diseases

* ARIKACE

is a registered trademark of Insmed Incorporated

ARIKACE (liposomal amikacin for inhalation), is in Phase 3 (CLEAR-108)

for cystic fibrosis (CF) Pseudomonas (Pa) lung infections and Phase 2

(TARGET-NTM) for non-TB mycobacteria (NTM) lung infections

ARIKACE: Amikacin Summary

Amikacin is an FDA-approved antibiotic with proven efficacy in the

treatment of gram-negative infections, including Pseudomonas and NTM

Aminoglycoside antibiotic

Value of the IV use has been limited

by nephro-toxicity and ototoxicity

ARIKACE (liposomal amikacin for inhalation) delivers high, sustained levels of drug to

the lung while reducing systemic exposure to well below established toxicity levels

ARIKACE: Proprietary Liposomal Formulation Provides Basis

for Important Potential Benefits

Potential Benefit

Lipid Polar Head Groups

(at Both Surfaces)

Lipid Hydrophobic Chains

(Bi-Layer Interior)

Water Core (where Amikacin resides)

ARIKACE delivers the potency of Amikacin at the site of the lung

infection;

engineered specifically for improved PK-PD* profile in the lung providing for

potential enhanced efficacy, safety and convenience benefits

Greater efficacy by reaching infection site

Greater efficacy and once-a-day dosing

Reduces potential for systemic toxicity

Engineered Specifically for Lung Delivery

Prolonged lung residence time

Biofilm penetration

Preferential uptake into macrophages

Minimal systemic exposure

* Pharmacokinetic-Pharmacodynamic (PK-PD)

ARIKACE: Delivery Using Proprietary eFlow

Technology

ARIKACE is delivered once daily via the state-of-the-art PARI Optimized,

Investigational eFlow Nebulizer System with Advanced Mesh Technology

Fast

drug delivery with efficient

lung deposition

Small, portable, silent and

cordless

device weighs less than

10 ounces.

eFlow Technology Device

exclusivity

from PARI Pharma for

15 years after first commercial

sale of ARIKACE

* eFlow

is a registered trademark of PARI Pharma GmbH

ARIKACE: Development Plan

Target-NTM

Study in U.S.

ARIKACE vs. placebo in recalcitrant patients who are on a stable ATS/IDSA

guidelines-based

multi-drug

treatment

regimen;

100

inhaled

antibiotics

approved

for

treating

NTM

lung

infections

and

little

known competitive activity in clinic

Study

initiated

May-2012

top-line

results

from

randomized

portion

trial projected in 4Q13

CLEAR-109

CF Pseudomonas

Study for U.S.

FDA

removed

the

clinical

hold

for

Phase

study

May

Insmed

will

defer

plans

initiate

Phase

study

ARIKACE

the

U.S.

for

CF patients until the Company reviews top-line results from CLEAR-108

Insmed is focusing on CLEAR-108 (CF Pa Phase 3 Study) and TARGET-NTM

(NTM Phase 2 Study)

CLEAR-108

CF Pseudomonas

Study for

EU/Canada

ARIKACE

vs.

Tobi

(inhaled

tobramycin

solution);

300

Builds off of strong Phase 2 efficacy and safety data

Broad population with preferred trial design

Trial

initiated

April

2012

top-line

results

projected

mid-2013

Eligible

patients

roll-over

into

open-label

ARIKACE®

long

term

safety

and

tolerability study, CLEAR-110

* Tobi

is a Registered Trademark of Novartis Pharmaceuticals Corporation

Arikace—Cystic Fibrosis

Epidemiology and Disease Description

Cystic fibrosis is a life-threatening disease with significant unmet needs

Affects about 70,000 children

and adults worldwide (30,000 in

U.S. and Europe, each)

Inherited disease that causes

thick, sticky mucus to build up

in the lungs

Despite expanded use of current

products, lung function often

continues to decline

High treatment burden

major compliance issue

Source: Adapted from Cystic Fibrosis Foundation, Patient Registry

Annual Data Reports 2010

Mean = 51.2%

Pseudomonas Lung Infections Increase with Patient Age

Age (Years)

0.0

10.0

20.0

30.0

40.0

50.0

60.0

70.0

80.0

2 to 5

6 to 10

11 to 17

18 to 24

25 to 34

35 to 44

45+

ARIKACE: Cystic Fibrosis

Need for New Inhaled Antibiotics

Current inhaled antibiotics produce modest efficacy in a limited

patient

population providing an opportunity for ARIKACE to become first-line

treatment

Current inhaled antibiotics are not indicated for a significant segment of the

CF population --

patients with FEV-1 % predicted of greater than 75%

Improvement in lung function with current inhaled antibiotics is

not sustained

in the off-treatment period, and appears to decline over multiple cycles

Lung function continues to decline at an average rate of 1% to 3% per year

with some patients experiencing much greater declines

Cayston

vs. Tobi

CF Phase 3 Trial Results: Pulmonary Function

Lung Function

Adjusted

Mean

Relative

Change

FEV

Predicted

Source: 2010 North American CF Conference Poster 305 and Slide Presentation, 10/10.

* Cayston

(aztreonam

for

inhalation

solution)

registered

trademark

Gilead

Sciences.

** Tobi

(Tobramycin Inhalation Solution) is a registered trademark of Novartis.

*** AZLI = Cayston; TIS = Tobi

Lung function returned to baseline or lower during each off treatment

period and at the end of 24 weeks, both treatment groups showed a

decline in lung function from baseline

Week:

AZLI

TIS

+ 7.8

= 0.0001

95% CI (3.86, 11.73)

-6

-4

-2

AZLI/

TIS

28 Days

AZLI/

TIS

28 Days

AZLI/

TIS

28 Days

Off-Treatment

Period

P = 0.033

P = 0.003

(36/36)

(36/35)

(33/36)

(32/35)

(34/35)

(34/34)

(N=ARIKACE/Placebo)

ARIKACE: Cystic Fibrosis

Phase 2 Pooled Results (560mg QD): Pulmonary Function

(N)

Mean (SE)

ARIKACE demonstrated statistically significant and clinically meaningful

improvement in pulmonary function throughout the 28-day treatment

period that was sustained through the off-treatment period

-6%

-3%

12%

15%

18%

Visit Day

% Change in FEV

(ml) vs. Baseline

Arikace

560mg

Placebo

Visit Days

ARIKACE: Cystic Fibrosis

Open Label Extension (TR02-105): Durability of Response

Treatment

Period

* Significance at end of treatment over 6 cycles

** Significance 56 days off-treatment over 6 cycles

An open label extension study demonstrated the sustained efficacy

of ARIKACE during and between multiple cycles of therapy

Patients Receiving 560 mg ARIKACE Once Daily for 28 Days and Off-Treatment for 56 Days

p=0.0001**

p<0.0001*

Cycle

112

140

154

169

182

196

224

238

253

266

280

308

322

337

350

364

392

406

421

434

448

476

490

504

ARIKACE: Cystic Fibrosis

Phase 3 Program Has Been Initiated in Europe and Canada

Insmed has reached agreement with EMA and Health Canada on pivotal study

requirements for CF patients with Pseudomonas lung infections

* Patients who complete CLEAR-108 are eligible to participate in CLEAR-110, which is a long term

open-label extension study in which patients receive ARIKACE every other month for up to 2 years

CLEAR-108: Phase 3 Primary Efficacy Study (vs. Tobi

, N

300)*

Primary End-Point: Relative Change in FEV-1 at week 24

Key Secondary End-Point: Time to First Pulmonary Exacerbation

Patient

Population:

Patients

ages

and

above

with

FEV-1

Predicted

25%

Approximately 260 patients required to demonstrate non-inferiority at agreed upon

Top-Line results projected in mid-2013

margin with 80% power

ARIKACE: Non-TB Mycobacteria

Disease Description and High Unmet Need

NTM

are

intracellular

organisms

that

invade

and

multiply

chiefly

within

macrophages

the lung and are characteristically resistant to most antibiotics

NTM lung infections occurs commonly in patients with structural lung disease (e.g.

COPD, bronchiectasis and CF), patients taking immunosuppressive medications, and in

postmenopausal women without clear risk factors

NTM lung infections are often debilitating and progressive

Virtually all patients experience chronic or recurring cough

Other frequent symptoms including sputum production, fatigue, malaise, dyspnea,

fever, hemoptysis, chest pain and weight loss

Non-TB mycobacteria (NTM) are intracellular pathogens that can cause

severe, chronic pulmonary disease with limited effective treatment options

ATS -

American Thoracic Society;

IDSA -

Infectious Disease Society of America

Current

treatment

for

NTM

lung

disease

requires

lengthy

multi-drug

regimens

that

can

poorly

tolerated

and

have

limited

efficacy,

especially

patients

with

severe

disease

those

who

have

failed

prior

treatment

attempts”

David

Griffith,

M.D.,

Lead

author

the

ATS/IDSA's

diagnosis

and

treatment

guidelines

for

NTM,

and

Professor

Medicine

the

University

Texas

Health

Science

Center

Tyler;(Insmed

Press

Release,

6/27/12)

“

ARIKACE: Non-TB Mycobacteria

Market Opportunity

“The prevalence of this debilitating chronic disease continues to

grow, and

the current NTM treatment paradigm lacks acceptable treatment options”*

Sources: 1. Clarity Pharma Research, Patient Chart Study, 2012.

Adjemian et al. Prevalence of Pulmonary Nontuberculous Mycobacterial Disease among Medicare

Beneficiaries, USA, 1997-2007, American Journal of Respiratory and Critical Care Medicine. Apr 2012.

3. SDI Healthcare Database, July 2009.

Mycobacterium avium Complex; M. abscessus –

Mycobacterium abscessus

U.S. Patients Diagnosed with NTM Lung Infections in 2011

50K

40K

21K

Diagnosis

growing

at~

annually

MAC and M. abscessus* account for

75%-85% of NTM lung disease in U.S.

Mean age is ~ 57 years with 53%

treated

with

antibiotics

Treated patients use an average of 7.6

antibiotic

courses

per

year

Average length of inpatient hospital

stay

10.2

days

Patients over the age of 65 years were

40% more likely to die than those

without

NTM

from

1997

2007

* Mark Rolfe, M.D. FCCP, President of New Lung Associates P.A., Medical Director of the Lung Transplant and Adult Cystic F

Fibrosis Programs at Tampa General Hospital; Insmed press release, June 27, 2012

10,000

20,000

30,000

40,000

50,000

60,000

NTM Patients

Diagnosed

NTM Patients

Diagnosed with

MAC or M.

Abscessus

MAC & M.

abscessus

Patients Treated

with Anitbiotics

ARIKACE: Non-TB Mycobacteria

Rationale for ARIKACE

NTM lung infections are difficult to treat since NTM are taken

up and multiply inside lung macrophages and most antibiotics

have poor macrophage penetration

Amikacin IV is a recommended treatment for MAC and

M. abscessus in the ATS/IDSA's NTM diagnosis and treatment

guidelines

but

use

limited

due

nephro-

and

oto-toxicity

The proprietary liposomal formulation enables ARIKACE to be

preferentially

taken

and

concentrated

the

lung

macrophages

while

potentially

decreasing systemic exposure and related toxicities

ARIKACE

was

shown

have

superior

vitro

activity

against

MAC

and

abscessus

vs.

“free”

amikacin

ARIKACE

well

positioned

become

the

first

drug

approved

for

NTM

lung

infections

ARIKACE opportunity: achieve superior efficacy in NTM treatment by

better penetrating lung macrophages where NTM bacteria reside while

limiting systemic drug exposure

Sources: 1. Griffith et al. ATS/IDSA Statement: Diagnosis, Treatment, and Prevention of NTM

Diseases, American Journal of Respiratory and Critical Care Medicine, 2007.

Study conducted by L. E. Bermudez at Oregon State University. (Data on File)

ARIKACE: Non-TB Mycobacteria

TARGET-NTM Clinical Study Initiated in Mid-2012

Trial Design and Patient Population (N

100):

–

Randomized, double-blind, placebo controlled Phase 2 study in patients with

recalcitrant/persistent NTM lung infections who are on a stable ATS/IDSA

guidelines-based multi-drug treatment regimen

–

Patients receive ARIKACE or placebo daily for 84 days; then all patients can

receive ARIKACE 560 mg in an open-label manner for an additional 84 days

–

Study population: patients ages 18 to 75

Key Inclusion Criteria: History of chronic infection with either Mycobacterium avium

complex

(MAC)

Mycobacterium

abscessus

mixed

infection

with

both

species

Primary endpoint: Change in mycobacterial culture results from baseline to end of

treatment [Time

Frame:

84 days]

Insmed appears to be the only company with an NTM clinical program;

top-line Phase 2 data projected in 4Q 2013

There have been very few clinical trials to support current NTM treatment

recommendations, and no new drugs have been assessed in randomized trials

for NTM lung disease in many years. (Insmed Press Release, June 27, 2012)

according to Kenneth N. Olivier, M.D., M.P.H., Principal Investigator of the study

and staff pulmonologist at the NIAID, part of NIH

Projected

Cash at year

end 2012

(including cash,

investments & CD

)

Approximately $60 to $64 million currently forecast

We believe cash is sufficient to take Company through the

availability of top-line data for both CLEAR-108 and TARGET-NTM

top-line results

Current Overview: Capital Structure and Key Financials

Balance Sheet

Cash of ~$75 million as of June 30, 2012 consisting of cash,

investments & CD

Present Capital

Structure

(INSM)

26.5 million fully diluted shares:

24.9 million Common Shares

1.6 million options, restricted stock units, and warrants

Insmed has a strong cash position

Appendix

Addressing the Potential for Cross-Resistance of ARIKACE

Summary: Addressing Potential for Cross-Resistance in

ARIKACE

While resistance to TOBI (tobramycin) has been documented, we believe there is no cross-resistance in ARIKACE (amikacin)

for the following reasons.

Well-characterized clinical isolates of Pseudomonas aeruginosa (Pa) from Dr. Burns’

collection have been tested against amikacin

and

ARIKACE.

ARIKACE

has

shown

activity

against

aminoglycoside-resistant

and

multi-drug

resistant

isolates.

Dr.

Burns

felt

ARIKACE performed a bit better than free amikacin. (Report on file.)

Overall, amikacin has lower potential for inducing resistance as

compared to tobramycin (literature).

Additionally,

aminoglycoside-inactivating enzymes elaborated by Pa are different for these two aminoglycosides. Thus, we there is no

complete cross resistance. The issue of emerging tobramycin resistance secondary to TOBI (inhaled antibiotic) use is not

completely

quantified.

However,

primarily

due

poor

compliance

with

the

prescribed

regimen

TOBI.

Patients

not take

the drug twice a day consistently. This leads to drug levels much below the MICs of most phenotypes of Pa for prolonged periods,

and thus increased potential for emergence of resistance.

Additionally, there is non-specific binding of cationic tobramycin to

sputum and further low levels available to microbes. Typically, levels >10x of the MICs are needed for entire dosing interval.

Thus, compliance with dosing regimen is critical as is penetration of antibiotics into biofilms.

Features of ARIKACE that overcome some of the issues responsible

for resistance include: charge neutral liposomes shield

amikacin, providing penetration into biofilm, and high Cmax and AUC, enabling once a day dosing and improved compliance. The

unique features of ARIKACE will reduce potential for emergence of amikacin resistance vs. free aminoglycoside for inhalation.

Most importantly, the sustained clinical benefit of Arikace in the “off month”

and convenience of once a day will shape the use of

inhalation antibiotics in CF patients.

Use of ciprofloxacin is known to contribute to emergence of Pa isolates with antimicrobial resistance. Tobramycin is also used as

for

treatment

exacerbations

and

for

tune-ups.

This

may

also

contributing

emergence

resistance

low

levels

drug reach the lung after IV use.

Our phase 2 data have shown that 65% of isolates were resistant to aminoglycosides and ~90% were mucoid variant. However, we

were able to demonstrate reduction in bacterial density and improvement in lung function and pros. Thus, we expect to have

significant treatment effect in phase 3 studies even if isolates

are resistant. We have also done in vitro work against mdr isolates

and shown ARIKACE to be effective.

Percent Change in FEV

—ITT

Visit Day

Arikace 560 *

15.4% (16.5)

18.4% (21.3)

13.2% (15.3)

13.2% (16.2)

11.5% (16.4)

13.2% (24.3)

Arikace 280 *

10.9% (10.6)

9.4% (12.6)

9.6% (12.5)

10.1% (12.8)

1.7% (9.0)

2.0% (8.6)

Placebo *

0.6% (11.7)

-3.2% (12.2)

1.8% (10.9)

2.2% (11.9)

-0.3% (12.0)

-4.4% (13.0)

* Mean (SD)

Arikace 280

Placebo

Arikace 560

p=0.016

p=0.005

p=0.07

p=0.04

Change in FEV

(% predicted)—ITT

Visit Day

Arikace 560 *

12.9% (17.2)

15.8% (22.5)

10.5% (15.6)

11.0% (16.4)

8.6% (17.7)

13.8% (26.2)

Arikace 280 *

10.8% (10.8)

9.2% (13.1)

9.4% (12.9)

9.6% (13.7)

1.6% (9.6)

1.8% (8.8)

Placebo *

-0.9% (10.7)

-4.4% (11.3)

0.3% (9.9)

0.5% (10.5)

0.7% (9.6)

-3.8% (13.5)

Arikace 280

Placebo

Arikace 560

P=0.009

P=0.019

P=0.124

P=0.021

* Mean (SD)

ARIKACE—TR02-05

PFT: Prior Use of Inhalation Antibiotic

Arikace ™

( N = 8 )

Placebo

( N = 4 )

Day 28

10 %

-5 %

Day 56

5 %

-1 %

Relative Change FEV

(ml)

Tobramycin

FEV

(L) Absolute

ARIKACE—TR02-05

By Prior Tobramycin Use

Patients With Prior

Tobramycin Use

Patients Without Prior

Tobramycin Use

Arikace ™

N=5

Placebo

N=3

Arikace ™

N=16

Placebo

N=8

Day 28

0.326 (0.290)

-0.083 (0.123)

0.126 (0.203)

-0.016 (0.144)

Day 56

0.152 (0.186)

-0.040 (0.284)

0.001 (0.161)

-0.120 (0.168)

Absolute

Change

from

Baseline

FEV

(L)

Cohort I –

280 mg

ARIKACE—TR02-05

By Prior Tobramycin Use

* Mean (SD)

280mg Cohort

Patients without Tobramycin

280mg Cohort

Patients with Tobramycin

Arikace

Placebo

Arikace

Placebo

Visit Day

Arikace *

326 (290)

152 (186)

Placebo *

-83 (123)

-40 (284)

Arikace *

126 (203)

1 (161)

Placebo *

-16 (144)

-120 (168)

RUN12AUG2008

Tobramycin

FEV

(L) Relative

ARIKACE—TR02-05

By Prior Tobramycin Use

Patients With Prior

Tobramycin Use

Patients Without Prior

Tobramycin Use

Arikace ™

N=5

Placebo

N=3

Arikace ™

N=16

Placebo

N=8

Day 28

0.136 (0.088)

-0.052 (0.075)

0.091 (0.138)

-0.002 (0.067)

Day 56

0.051 (0.093)

-0.010 (0.148)

0.009 (0.084)

-0.053 (0.083)

* Mean (SD)

Relative

Change

from

Baseline

FEV

(L)

RUN12AUG2008

Cohort I –

280 mg

ARIKACE—TR02-05

By Prior Tobramycin Use

* Mean (SD)

RUN12AUG2008

280mg Cohort

Patients without Tobramycin

280mg Cohort

Patients with Tobramycin

Arikace

Placebo

Arikace

Placebo

Visit Day

Arikace *

13.6% (8.8)

5.1% (9.3)

Placebo *

-5.2% (7.5)

-1.0% (14.8)

Arikace *

9.1% (13.8)

0.9% (8.4)

Placebo *

-0.2% (6.7)

-5.3% (8.3)

Arikace™

Efficacy in Patients with Prior Tobramycin Use:

TR02-106

Mean

Change in Log

CFU

Subjects with 5-6 Cycles of TOBI in

prior 12 months

Change in FEV1

(ml)

Subjects with 5-6 Cycles of TOBI in

prior 12 months

Placebo

Visit Day

Arikace 560

90 (220)

90 (30)

230 (60)

90 (90)

Placebo

-140 (210)

-110 (350)

-200 (20)

-290 (10)

Arikace 560

-1.99

(0.70)

-1.26

(0.86)

-0.93

(1.19)

-1.43

(0.89)

-0.27

(0.44)

Placebo

0.15

0.03

-0.55

-0.29

0.08

Placebo

Arikace 560

Mean

-3

-2

-1

-300

-250

-200

-150

-100

-50

100

150

200

250

Insmed has filed a registration statement (including a prospectus) with the Securities and

Exchange Commission (the “SEC”) for the offering to which this communication relates.

Before you invest, you should read the prospectus in that registration statement and other

documents Insmed has filed with the SEC for more complete information about Insmed and

this offering. You may get these documents for free by visiting EDGAR on the SEC web site

www.sec.gov.

Alternatively,

Insmed

will

arrange

send

you

copy

the

prospectus

you request it by calling Insmed’s corporate secretary at: (732) 997-4600.

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