INVESTOR DAY 2015 - Biotech Due Diligence2015/02/19 · ACTAVIS INVESTOR DAY 2015 OVERVIEW/Q4 and FY 2014 HIGHLIGHTS Brent Saunders Q4: EXCEPTIONAL FINISH TO 2014 $4.0 Billion Revenue

2015

INVESTOR

DAY

Title

Lisa

DeFrancesco

ACTAVIS INVESTOR DAY 2015

INTRODUCTION

ACTAVIS CAUTIONARY STATEMENT REGARDING

FORWARD-LOOKING STATEMENTS

Statements contained in this communication that refer to Actavis’ estimated or anticipated future results, including estimated synergies, or other non-historical facts are forward-looking statements that reflect Actavis’ current

perspective of existing trends and information as of the date of this communication. Forward looking statements generally wil l be accompanied by words such as “anticipate,” “believe,” “plan,” “could,” “should,” “estimate,” “expect,”

“forecast,” “outlook,” “targets,” “guidance,” “intend,” “may,” “might,” “will,” “possible,” “potential,” “predict,” “project,” or other similar words, phrases or expressions. Such forward-looking statements include, but are not limited to,

statements about the benefits of the Allergan acquisition, including future financial and operating results, Actavis’ and Allergan’s plans, objectives, expectations and intentions and the expected timing of completion of the

transaction. It is important to note that Actavis’ goals and expectations are not predictions of actual performance. Actual results may differ materially from Actavis’ current expectations depending upon a number of factors affecting

Actavis’ business, Allergan’s business and risks associated with acquisition transactions. These factors include, among others, the inherent uncertainty associated with financial projections; restructuring in connection with, and

successful closing of, the Allergan acquisition; subsequent integration of the Allergan acquisition and the ability to recognize the anticipated synergies and benefits of the Allergan acquisition; the ability to obtain required regulatory

approvals for the transaction (including the approval of antitrust authorities necessary to complete the acquisition), the timing of obtaining such approvals and the risk that such approvals may result in the imposition of conditions

that could adversely affect the combined company or the expected benefits of the transaction; the ability to obtain the requisite Allergan and Actavis shareholder approvals; the risk that a condition to closing of the Allergan

acquisition may not be satisfied on a timely basis or at all; the failure of the proposed transaction to close for any other reason; risks relating to the value of the Actavis shares to be issued in the transaction; the anticipated size of

the markets and continued demand for Actavis’ and Allergan’s products; Actavis’ and Allergan’s ability to successfully develop and commercialize new products; Actavis’ and Allergan’s ability to conform to regulatory standards

and receive requisite regulatory approvals; availability of raw materials and other key ingredients; uncertainty and costs of legal actions and government investigations; the inherent uncertainty associated with financial projections;

fluctuations in Actavis’ operating results and financial condition, particularly given our manufacturing and sales of branded and generic products; risks associated with acquisitions, mergers and joint ventures, such as difficulties

integrating businesses, uncertainty associated with financial projections, projected synergies, restructuring, increased costs, and adverse tax consequences; the adverse impact of substantial debt and other financial obligations on

the ability to fulfill and/or refinance debt obligations; risks associated with relationships with employees, vendors or key customers as a result of acquisitions of businesses, technologies or products; our compliance with federal

and state healthcare laws, including laws related to fraud, abuse, privacy security and others; risks of the generic industry generally; generic product competition with our branded products; uncertainty associated with the

development of commercially successful branded pharmaceutical products; uncertainty associated with development and approval of commercially successful biosimilar products; costs and efforts to defend or enforce technology

rights, patents or other intellectual property; expiration of Actavis’ and Allergan’s patents on our branded products and the potential for increased competition from generic manufacturers; risks associated with owning the branded

and generic version of a product; competition between branded and generic products; the ability of branded product manufacturers to limit the production, marketing and use of generic products; Actavis’ and Allergan’s ability to

obtain and afford third-party licenses and proprietary technology we need; Actavis’ and Allergan’s potential infringement of others’ proprietary rights; our dependency on third-party service providers and third-party manufacturers

and suppliers that in some cases may be the only source of finished products or raw materials that we need; Actavis’ competit ion with certain of our significant customers; the impact of our returns, allowance and chargeback

policies on our future revenue; successful compliance with governmental regulations applicable to Actavis’ and Actavis’ respective third party providers’ facilities, products and/or businesses; the difficulty of predicting the timing or

outcome of product development efforts and regulatory agency approvals or actions, if any; Actavis’ and Allergan’s vulnerabil ity to and ability to defend against product liability claims and obtain sufficient or any product liability

insurance; Actavis’ and Allergan’s ability to retain qualified employees and key personnel; the effect of intangible assets and resulting impairment testing and impairment charges on our financial condition; Actavis’ ability to obtain

additional debt or raise additional equity on terms that are favorable to Actavis; difficulties or delays in manufacturing; our ability to manage environmental liabilities; global economic conditions; Actavis’ ability to continue foreign

operations in countries that have deteriorating political or diplomatic relationships with the United States; Actavis’ and Al lergan’s ability to continue to maintain global operations; risks associated with tax liabilities, or changes in

U.S. federal or international tax laws to which we are subject, including the risk that the Internal Revenue Service disagrees that Actavis is a foreign corporation for U.S. federal tax purposes; risks of fluctuations in foreign currency

exchange rates; risks associated with cyber-security and vulnerability of our information and employee, customer and business information that Actavis stores digitally; Actavis’ ability to maintain internal control over financial

reporting; changes in the laws and regulations, affecting among other things, availability, pricing and reimbursement of pharmaceutical products; the highly competitive nature of the pharmaceutical industry; Actavis’ ability to

successfully navigate consolidation of our distribution network and concentration of our customer base; the difficulty of predicting the timing or outcome of pending or future litigation or government investigations; developments

regarding products once they have reached the market and such other risks and uncertainties detailed in Actavis’ periodic pub lic filings with the SEC, including but not limited to Actavis’ Annual Report on Form 10-K for the year

ended December 31, 2014, as amended from time to time in Actavis’ other investor communications. Except as expressly required by law, Actavis disclaims any intent or obligation to update or revise these forward-looking

statements.

Important Information for Investors and Shareholders

This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer,

solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdict ion. In connection with the proposed merger between Actavis and Allergan, Actavis has filed with the SEC a

registration statement on Form S-4, including Amendment No. 1 thereto, that contains a joint proxy statement of Actavis and Allergan that also constitutes a prospectus of Actavis. The registration statement was declared effective

by the SEC on January 26, 2015. Each of Actavis and Allergan commenced mailing the joint proxy statement/prospectus to its shareholders or its stockholders on January 28, 2015. INVESTORS AND SECURITY HOLDERS OF

ACTAVIS AND ALLERGAN ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS AND OTHER DOCUMENTS THAT HAVE BEEN FILED OR WILL BE FILED WITH THE SEC CAREFULLY AND IN THEIR

ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION. Investors and security holders are able to obtain free copies of the registration statement and the

joint proxy statement/prospectus and other documents filed with the SEC by Actavis and Allergan through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by Actavis are

available free of charge on Actavis’ internet website at www.Actavis.com or by contacting Actavis’ Investor Relations Department at (862) 261-7488. Copies of the documents filed with the SEC by Allergan are available free of

charge on Allergan’s internet website at www.Allergan.com or by contacting Allergan’s Investor Relations Department at (714) 246-4766.

Participants in the Merger Solicitation

Actavis, Allergan, their respective directors and certain of their executive officers and employees may be considered participants in the solicitation of proxies in connection with the proposed transaction. Information regarding the

persons who may, under the rules of the SEC, be deemed participants in the solicitation of the Actavis and Allergan shareholders in connection with the proposed merger is set forth in the joint proxy statement/prospectus.

Information about the directors and executive officers of Allergan is set forth in its proxy statement for its 2014 annual meeting of stockholders, which was filed with the SEC on March 26, 2014 and certain of its Current Reports

on Form 8-K. Information about the directors and executive officers of Actavis is set forth in Actavis’ proxy statement for its 2014 annual meeting of stockholders, which was filed with the SEC on March 28, 2014 and certain of

Actavis’ Current Reports on Form 8-K. Additional information regarding the participants in the proxy solicitations and a description of their direct and indirect interests, by security holdings or otherwise, is contained in the joint

proxy statement/prospectus filed with the above-referenced registration statement on Form S-4 and other relevant materials to be filed with the SEC when they become available.

http://www.sec.gov/http://www.actavis.com/http://www.allergan.com/

NA Brands

2014 Review & Outlook

Bill Meury, EVP

Brands R&D

David Nicholson, EVP

Growth Pharma –

2015 Forecast & Beyond

Brent Saunders

Q&A

.

AGENDA

1 Q4/FY 2014 Review

Highlights

Brent Saunders, CEO & PRES.

Financials

Tessa Hilado, CFO

NA Generics,

International &

Global Operations


Bob Stewart, COO

Generics R&D Update

Hafrun Fridriksdottir, SVP

2

3

4


OVERVIEW/Q4 and

FY 2014 HIGHLIGHTS

Brent

Saunders

Q4: EXCEPTIONAL FINISH TO 2014

$4.0 Billion Revenue

46% increase

$1.5 Billion Adjusted EBITDA

80% increase

*Please refer to the Adjusted EBITDA and GAAP to non-GAAP reconciliation tables in the appendix for a

reconciliation of our non-GAAP results.

Non-GAAP EPS($)

$3.91 Non-GAAP EPS

23% increase

$812 Million Cash Flow

from Operations

Adjusted EBITDA ($mm)

Net Revenue($mm)

$2,779

$4,057

$3.17

$3.91

$817

$1,473

Q4 2014 COMMERCIAL HIGHLIGHTS

Sales for Top 10 products (~70% of sales) up in Q4 over Q3

Sales for 6 of Top 10 products increased double digit

Linzess®, Teflaro®, Estrace®, Bystolic®, Carafate®

largest % gains

Namenda XR® conversion on track

US GENERICS

Strong US product sales: Gx Lidoderm® Patch &

Gx Concerta®

US launches of Gx Intuniv™ and Gx Celebrex®

INTERNATIONAL GENERICS

Launched 500+ products in global markets

Strong sales performance in key markets, including UK and

Russia

.

NA

GENERICS

& INT’L

NA

BRANDS

.

.

.

.

.

.

.

2014 DOUBLE-DIGIT FULL-YEAR GROWTH

$13 Billion Revenues

50%+ increase

$4.5 Billion Adjusted EBITDA

99% increase



Revenue ($mm)

Adjusted EBITDA ($mm)

Non-GAAP EPS($)

$8,678

$13,062

$2,244

$4,457

$9.50

$13.98

$13.98 Non-GAAP EPS

47% increase

$2.2 Billion Cash Flow

from Operations

~$1 BILLION INVESTMENT IN R&D

DELIVERING RESULTS

Namzaric™ Approved

AVYCAZ™ Positive Ad Comm

Cariprazine NDA filed

Saphris® sNDA filed

Xydalba™ CHMP Positive Opinion

Teflaro® sNDA Filed

18 ANDAs filed in Q4; 44 in 2014

65+ First to Files, 220+ pending ANDAs

1,200+ Pending MAAs Internationally

.

BRANDS

NA

GENERICS

& INT’L

Non-GAAP R&D

($mm)

$580

$987

.

.

.

.

.

.

.

.

FIRING ON ALL CYLINDERS

WHILE EXECUTING STRATEGIC ACQUISITIONS

Eluxadoline for IBS-D

PDUFA Q2 2015

Expands IBS franchise

Adds Dalvance™

–

Novel treatment for skin

infections caused by

MRSA to Actavis

anti-infectives portfolio

Complements Teflaro®

and AVYCAZ

Pipeline: One Dose

formulation and

Osteomyelitis indication

Exclusive option to

acquire relamorelin

Potent, best-in-class

Phase 2 ghrelin

agonist for treatment

of diabetic

gastroparesis

Phase 2b clinical trial

initiation expected

early 2015

Creates #1 Generics

Company in the UK; #3

position in the supply of

UK pharmaceuticals

post-Allergan close

Portfolio of exclusive

and semi-exclusive

generic products

PREPARING FOR 2015:

INTEGRATION MILESTONES

Synergy Capture

Defined;

Planning for

Accelerated

Capture

Shareholder

Approval Vote:

March 10th

Debt and Equity

Offering

Upcoming

Leadership

Defined

and

Communicated

Preparing

to Operate

as 1 Company

– Day 1

Top Priority:

Maintaining Business Momentum


Tessa Hilado

Q4/FY 2014

FINANCIAL REVIEW

ACTAVIS Q4 2014 FINANCIAL SUMMARY

*Please refer to the Adjusted EBITDA and GAAP to non-GAAP reconciliation tables in the

appendix for a reconciliation of our non-GAAP results.

$ millions, except per share amounts Q4 2014 Q4 2013 y/y Growth

Non-GAAP Net Revenue

Non-GAAP R&D Investment

Non-GAAP SG&A as a %

of Revenue

Adjusted EBITDA*

Non-GAAP Earnings Per Share*

Non-GAAP Tax Rate

Cash Flow From Operations

$4,014.9

$321.1

21.0%

$1,473.0

$3.91

14.8%

$811.6

$2,779.7

$182.2

20.3%

$817.1

$3.17

18.7%

$651.7

+44%

+76%

0.7ppts

+80%

+23%

(3.9ppts)

+25%

ACTAVIS FY 2014 FINANCIAL SUMMARY



$ millions, except per share amounts 2014 2013 y/y Growth

Non-GAAP Net Revenue

Non-GAAP R&D Investment


of Revenue

Adjusted EBITDA*

Non-GAAP Earnings Per Share*

Non-GAAP Tax Rate

Cash Flow From Operations

$12,846.8

$987.1

20.8%

$4,456.7

$13.98

16.0%

$2,243

$8,689.3

$579.5

20.1%

$2,244.4

$9.50

23.5%

$1,213.5

+48%

+70%

0.7ppts

+99%

+47%

(7.5ppts)

+85%

NORTH AMERICAN &

INTERNATIONAL GENERICS PERFORMANCE

• Revenues driven by strong sales of key products and new product

launches globally

• Adjusted gross margin higher due to product mix globally

• Lower Non-GAAP SG&A due to lower spending in NA

$ millions Q4 2014 Q4 2013 y/y Change

$1,782.7

17.3%

57.2%

$1,761.2

20.1%

50.7%

+1%

(2.8ppts)

+6.5ppts

North American Generics &

International Revenue


of Revenue

Adjusted Gross Margin

Please refer to the Adjusted EBITDA and GAAP to non-GAAP reconciliation tables in the


Anda DISTRIBUTION PERFORMANCE

$ millions Q4 2014 Q4 2013 y/y Growth

$443.3

9.1%

13.0%

$17.3

$383.0

9.0%

15.4%

$24.4

+16%

0.1ppts

(2.4ppts)

(29%)

Anda Distribution Revenue

SG&A as a % of revenue

Gross Margin

Segment Contribution

• Record revenues driven by volume increases and product launches

with key customers

• Gross margin lower due to product mix versus prior year

• Segment contribution lower due to product mix and higher freight

costs

NORTH AMERICAN BRANDS PERFORMANCE

Q4 14/Q4 13

Please refer to the Adjusted EBITDA and GAAP to non-GAAP reconciliation tables in the


$ millions Q4 2014 Q4 2013 y/y Growth

$1,830.9

$604.3

$388.5

$267.4

$215.9

$75.9

$36.0

$242.9

80.4%

27.4%

$635.1

--

$150.2

$224.6

--

$86.0

--

$174.3

86.5%

27.4%

+188%

--

+159%

+19%

--

(12%)

--

+39%

(6.1)ppts

NC

North American Brands

CNS

Gastroenterology

Women’s Health

Cardiovascular/Respiratory

Urology

Anti-Infectives

Dermatology/Established Brands

Adjusted Gross Margin

Non-GAAP SG&A as a % of Revenue*

STRONG CASH FLOW FROM OPERATIONS

Debt to pro forma adjusted EBITDA ratio at 12/31/14 was 2.77x

Net Cash Flow from Operations

Q1 Q2 Q3 Q4

In $Millions


INCREASING 2015

STANDALONE FORECAST –

POSITIONED FOR GROWTH

Brent

Saunders

Updated Guidance

Total Net Revenue ~$15 billion ~$15 billion

FY 2015 Non-GAAP

EPS*$16.30 - $17.30 $15.60-16.80

Effective Tax Rate ~16% ~16%

Fully Diluted Shares

Outstanding~270 million ~270 million

R&D spending $1.1 billion $1.2 billion

SG&A as a percent of

Revenues19% 20%

Prior Guidance

FULL YEAR 2015 FORECAST

(as of Feb 16th

, 2015)

KEY ASSUMPTIONS - 2015 FORECAST

• Net Revenues at $15 billion including the following

adjustments:

- Durata Acquisition

- Auden McKenzie Acquisition

- Respiratory Divestiture

- Doryx® Divestiture

- Pharmatech Divestiture

• Guidance range $16.30 - $17.30

• R&D spending of ~$1.1 billion

• SG&A as a percent of revenue to ~19% by year-end

• Fx rates assumes Jan 31st closing rates

Please refer to GAAP to Non-GAAP reconciliation tables in the appendix for a reconciliation of our

expected adjusted EPS

STANDALONE ACTAVIS

MANY LEVERS FOR GROWTH

Industry-leading

management team

focused on execution

Highly diversified with focus

on key therapeutic areas

and key markets

Strong organic

growth across our

business

Opportunistic in strategic

business development to

enhance growth

Commitment to R&D

– generic, brand,

biosimilars

Best-in-class global

supply chain with high

standards of quality

R&D PHILOSOPHY

• R&D is Lifeblood of our company – and Growth Pharma

– Commitment to invest growing in organic portfolio

– Commitment to complement organic portfolio with business development

– Innovation is a key driver Commitment to “fast kill” process

• Maximize ROI on R&D by focusing on commercialization of acquired

development candidates (post-proof of concept)

- Robust business development function pursues opportunities for externally-sourced

innovation

- Supports efficient management of fixed and variable R&D costs

• Commitment to exceed investment for significant opportunities

– Won’t peg our investment to % of sales—not a useful metric

NA Brands


Bill Meury, EVP

Brands R&D

David Nicholson, EVP

AGENDA

NA Generics,

International &

Global Operations


Bob Stewart, COO

Generics R&D Update

Hafrun Fridriksdottir, SVP


NA & INTERNATIONAL

GENERICS and ANDA OVERVIEW

Bob Stewart

OVERVIEW

• Review of 2014 Global Generic Business Performance

• Review of Global Operations

• Global Generics R&D

• Strategies and Opportunities for 2015

OUR BUSINESS TODAY:

A WORLD CLASS LEADER

Generics, OTC,

Hospital, Branded

generics, and

Legacy Brands

Actavis Commercial

Medis

Anda

Out-licensing of

Actavis products

Distribution of

medications in the

US

Delivering pharmaceutical

products to patients around

the world:

• Diversified portfolio of

products

• Best-in-class R&D

• Optimized commercial

footprint

• World-class supply chain

STRUCTURED FOR GLOBAL SUCCESS

Close alignment between functional areas is critical to success

Commercial Operations R&D/ Portfolio

Global Operations

Procurement

Anda Distribution

US Generics

International

Gx, OTC, BGx

Medis

Out-licensing

Generic R&D

Portfolio

Business

Development

Robert Stewart

Chief Operating Officer

2014: STRONG PERFORMANCE

ACROSS ALL SEGMENTS

• Further strengthened position in US Generic markets - $4.0 billion sales

- Strong new product launch performance, despite FDA slowdown- Top player well positioned as customers further consolidate and globalize

• International business showing margin improvement despite FX headwind

- Divested unprofitable Western European business- Shifted focus and resources to profitable markets and growth opportunities

• Outstanding performance by R&D

- Record number of US First-to-files- Complex projects (inhalation, injectables) progressing well

• Anda Distribution showed stellar growth as the #4 in a highly competitive market

• Operations delivered… top customer service and quality

• Utilizing M&A to complement organic growth

- Integration of Warner/Forest/Aptalis International – OTC Products, Cystic Fibrosis- Tuck-in acquisitions for Thailand (Silom) and UK (Auden McKenzie)

• Offer customers value

in exclusive product

offerings

• Ability to achieve

desired market share

• Positioned to

optimize product

pricing

Customer

Relationships

& Access

Breadth of

Portfolio &

Pipeline

High Quality &

Consistent

Product Supply

• #2 position by Net sales

• Ability to work with an

increasingly global customer

base

• Best-in-class pipeline,

leading in exclusive

offerings (FTFs, complex

products)

• Broad in-market portfolio

• Entering Injectable/Hx

segment

• Long history of successful

FDA quality inspections

• Available capacity to meet

customer needs

US GENERICS – STRONG 2014 AND

WELL-POSITIONED FOR THE FUTURE

Actavis is the

Best positioned

company in the US

Generic market

US GENERICS – NEW LAUNCHES CONTINUE TO

DRIVE SIGNIFICANT VALUE

2014 Launches

2013 Launches

Net Sales of New Gx Launches in US

• $1.6 billion sales from new

products launched 2013-2014

• Significant launches in Dec. 2014

(Gx Intuniv®, Gx Celebrex®) carry

forward into 2015

• Impressive value given slowdown

of approvals at the FDA

• Strong ROI on R&D – we will

continue to invest!

200

300

0

100

400

500

600

700

800

900

1,000

1,100

20142013

2014 Launches

2013 Launches

• +12% sales growth, with strong growth across all core

business segments. Entering OTC with Sudocrem

• Achieving #1 Gx position post Auden acquisition

• Continued success driven by leading market position,

portfolio and local manufacturing capabilities

INTERNATIONAL

HIGHLIGHTS FROM KEY REGIONS

• +44% sales growth (constant currency), +21% USD

• Actavis became fastest growing company in Russia’ s retail

market by IMS

• Troxevasin entered top 10 OTC brands in Russia

• +14% sales growth plus margin improvement

• One of the fastest growing companies with 4-yr CAGR of 27%

• 9th largest generic company, up from 14th in 2010

• Established strong position in key CV and CNS products

Actavis 2014 International

United

Kingdom

Russia

Poland

DEMONSTRATED COMMITMENT TO

BUILDING MARKET LEADERSHIP

• Brings Actavis to #1 UK Gx position

• Portfolio of niche and semi-exclusive

generic products

• Quick, low risk integration managed

by UK team

• Robust profit margin

• Top 5 Gx company in Thailand

• Expands Actavis geographic

footprint into growth market

• Leverages Actavis portfolio and

capabilities in this region

• Delivered +20% growth in 2014

Geographic Expansion Building on Strength

UKThailand

INTERNATIONAL:

STRONG DIVERSIFICATION ACROSS SEGMENTS

Durable business with many opportunities for growth

International 2014 Sales*

Hx

9%

Rx18%

BGx

21%

OTC

22%

Gx

30%

• Chart Excludes US Generics & Medis Out-license business

• Pro forma 2014

• Niche and mature brands

• Select therapeutic categories - GI,

Cystic fibrosis, Women’s Health

• Traditional INN Generic market

• Generics sold under unique brand

names

• Sales force promotion

• Cash-pay markets, pharmacy

driven

• S&M investment required

• Used in hospital/clinic setting

• Focus on oncology, improved

injectables, 505(b)2s

Description

Generics

GX

Branded

Generics

BGx

Hospital

(Hx)

Niche &

Mature Rx

OTC

OUR COMMERCIAL MODEL IS TAILORED TO EACH

MARKET, LEVERAGING OUR BROAD PORTFOLIO

• Focus on profitable

and sustainable

segments

• Prioritize growth

opportunities

• Leverage Medis out-

licensing in non-

core countries and

segments

US UK Russia Thailand

NEW

NEW

New = New growth driver

NEW

Generics

GX

Branded

Generics

BGx

Hospital

(Hx)

Niche &

Mature Rx

OTC

TRADITIONAL GENERIC MARKETS

REMAIN APPEALING FOR ACTAVIS

• Actavis top two markets

are INN Generics

- US & UK

- No shortage of new

product targets

- High ROI on R&D

investments

• Expansion opportunities

for generics in emerging

markets

• Still low Gx penetration

in many countries

(e.g. Japan)

IMS predicts ~50% of pharma growth will come from generics

Generics Continue to Drive Sales Growth Globally

Source: IMS Market Prognosis, September 2014; IMS Institute for Healthcare Informatics, October 2014 (reprinted with permission)

Chart notes: Growth in US$ using constant exchange rates. Other. OTC products and Rx products that never had patent protection and

launched prior to expiration of the originator product. Asia: China, India, Russia, CIS state, SE Asia, Oceania and Japan.

AFME: Africa and Middle East

GROWING OTC BUSINESS WILL

EXCEED $500 MILLION IN 2015

OTC Sales International

2015 Est.20142013

550

500

450

400

350

300

250

200

150

100

50

0

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRw&url=http://pinex.se.temp-url.se/&ei=4iDaVMNvl7HIBL2HgsgF&bvm=bv.85464276,d.aWw&psig=AFQjCNHKiFUVKiN9EoD4iPzZzdfNNdv1ug&ust=1423667774971056http://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRw&url=http://pinex.se.temp-url.se/&ei=4iDaVMNvl7HIBL2HgsgF&bvm=bv.85464276,d.aWw&psig=AFQjCNHKiFUVKiN9EoD4iPzZzdfNNdv1ug&ust=1423667774971056

BRANDED GENERICS ARE LONG-TERM ASSETS

Similar to Brands, no Loss of Exclusivity (LOE) or Patent Cliff

Russia Valsartan Market Share

(% of Sales)

Novartis

Other

KRKA

G. Richter

Actavis

• Branded market and largely

out-of-pocket cash pay

• Actavis has 200 Sales

Representative promoting

cardiovascular products

• Valz™ (BGx Diovan®) &

Valz H™ (BGx Diovan

HCT®) were launched in

2009 and 2010

• Valsartan market has

grown substantially

– 45% Sales CAGR 2010-

2014

Russian Branded Gx Market

90

80

70

60

50

40

30

20

10

0

2010 2011 2012 2013 2014

COMPLEX PRODUCTS TO DRIVE GROWTH

Strong Record of Delivering on Challenging Products

2013 2014 2015 2016 2017 2018 2019 2020

Product Opportunities

Incremental Revenue / Growth

Small Molecule Oral Solids

Transdermals

Ophthalmic Suspensions

Topicals (Creams, Ointments, Gels)

Inhalation

Complex Injectables

Biosimilars

Illustrative

Potential Targets

• Bx Herceptin®

• Bx Avastin®

• Bx Rituxan®

• Gx Advair®

• Gx Invega Sustenna®

• Gx Abraxane®

• Gx Epiduo®

• Gx Suboxone®

• Gx Ciprodex®

• Gx Oxycontin®

• Gx Intuniv®

• Gx Crestor®

Leading global generics third-party

outsourcing business

• +9% Sales growth in 2014

• 200+ active customers

• 130 countries

• 190 new deals signed in 2014

• 200+ product portfolio

• Growth opportunities in emerging

markets

THIRD-PARTY OUT-LICENSE BUSINESS PROVIDES

STRATEGIC VALUE FOR BOTH R&D & OPERATIONS

• Maximizes ROI from R&D

activities

• Economies of scale for

Supply Chain &

Manufacturing

• Geographical reach - Ability

to participate in markets

where Actavis does not have

a commercial presence

• A profitable, growing

business

Strategic Asset

• Where we don’t have commercial presence

• Serve our customers the way our competitors can’t

• 4th largest US distributor of

pharmaceuticals

• State-of-the-art distribution centers with

10,000+ products

• Ship to more than 85% of the US

pharmacies

• Provides customized supply chain solutions

• Distributed segment revenue

growth +41% over prior year

• Expansion of Chain virtual

warehousing business

• Sales to Retail Independents

delivered double digit

increase

• Strong Gx Launches (e.g. Gx

Cymbalta)

• Expanded Distribution

capacity in Florida

2014 Anda Highlights

• 40 Manufacturing Sites

• 12,000 Employees

• Supply 100+ Markets

• All dosage forms and

therapies

• API

• SOD (IR, ER,

Hormones)

• Liquid,Gel, Cream,

Ointment, Gum

• Transdermals

• IUD’s

• Injectables

• Ophthalmics

• Biologics

• Medical Devices

GLOBAL MANUFACTURING NETWORK

SOD SPECIALITY API

ALLERGAN FACILITIES COMPLEMENT WORLD-CLASS

ORGANIZATION WITH TREMENDOUS CAPABILITIES

Allergan biologic

expertise +

Actavis Biologics

(formerly Eden

Biodesign)

Fills the few

remaining gaps in

Actavis capabilities

Complemented by

Allergan Assets

IR Oral Solids

ER Oral Solids

Semi Solids & Liquids

Rings/Suppositories

Transdermals

Injectables

Biologics/Biosimilars

Inhalation

Ophthalmics/Otics

R&D Mfg.Capabilities

AGN

AGN

AGN

EXCEPTIONAL COMPLIANCE RECORD

* Other - AIFA, BDA (Bulgaria), BFSA, DHMA (+MHRA), Egyptian MOH, SFDA, HSA (Singapore), MMA, MOH Serbia, NDAMD

(Romania), NOM (Greece), Health Care Inspectorate , PMDA (Japan), EU, ANSM, IMA, Korean FDA, ANSM (France), GCC,

Nigeria & Germany

Commitment to

Leadership in

Quality Driving

Growth and

Opportunity

Capture

20142013

Regulatory

Inspections

Other*

HEALTH

CANADA

TGA

(Australia)

ANVISA

(Brazil)

MHRA/

EMA/EDQM

FDA

Hafrun

Fridriksdottir


GENERIC R&D UPDATE

SUCCESS IN GENERICS TAKES MORE THAN JUST

GOOD DEVELOPMENT

All functions

must do their

part in close

alignment

There is no

room for

mistakes or

delays

Function What is needed

Portfolio Right product, right timing,

creative ideas

Legal/IP Patent assessments,

aggressive strategies

API Sourcing Global network, negotiating

power with suppliers

Development/

Formulation

Speed and expertise

Clinical Speed and flexibility

Quality No compromises

Manufacturing Capacity to support

development

Regulatory Speed and FDA experience

ESTABLISHED GLOBAL GX R&D NETWORK

• India

• Iceland

• Ireland

• Florida, USA

• New Jersey, USA

• Bulgaria

• Utah, USA

• Bulgaria

• Italy

• Romania

• UK• India

• Utah, USA

• Ireland

Hafnarfjordur • Iceland

Salt Lake City, UT • USA

Weston, FL • USA

Miramar, FL • USA

Nerviano • Italy

Liverpool • UK

Bucharest • Romania

Ambernath • India

Bangalore • India

Chennai • India

Troyan • Bulgaria

Navi, Mumbai • India

Elizabeth, NJ • USA

London • UK

Larne • Northern Ireland

Parsippany, NJ • USA

Oral SolidsSemi Solids

& LiquidsInjectables Inhalation API

Transdermal

& Specialty

Clinical Study Sites

• 6 sites in Florida and India

• Majority of studies done

internally

• 600 beds averaging 25-30

studies per month

Ora

• IR tablets & capsules

• Bilayer/ triple-layer tablets

• ER matrix tablets

• DR tablets (potency/oncology)

• OROS

• Variety of other products

Semi Solids & Liquids• Topicals (e.g., gels)

• Solutions

• Foams

Injectables• IV Dosage forms

• Pre-filled Syringes

• High-potency products

• Oncology/cyto-toxics

Inhalation

• Metered Dose Inhalers

• Dry Powder Inhalers

• Nasal Sprays

• Nebulizer Solutions

Transdermal

& Specialty

• Patches

• Films (e.g., Mucosal)

• Intravaginal Rings

• Vaginal Gels & Applicators

• Suppositories

API• Small molecule

development

BROAD INTERNAL CAPABILITIES

• Ability to develop

almost all small

molecule products

in a variety of

dosage forms

• Supplement few

gaps with external

partnerships

• Internal Clinical

sites add

flexibility and cost

savings

Dosage Form Technologies

Clinical Capabilities

Oral Solids

Semi Solids

& Liquids

Injectables

Inhalation

Transdermal

& Specialty

API

Clinical

Study Sites

GENERIC DEVELOPMENT TIMES

Opportunity to Drive Near-term Growth

2014 2015 2016 2017 2018 2019 2020

Relatively short Generic and

OTC development and

review timelines

Gx R&D activities today will

impact company

performance in 2018+

Product

Development

9 to 36 months

US Regulatory

Review/ Legal Stay

EU Regulatory

Review

Potential launch of

2014 / 2015 filings

Potential launch of 2014 / 2015 filings

Injectable

Topical/Patch

MR Oral Solid

IR Oral Solid

HormonesOral Solution

InhalationOphthalmic & Optic

In Market Filed at FDA In Development

US Products & Development Projects*

DEVELOPMENT PORTFOLIO WELL DIVERSIFIED

ACROSS DOSAGE FORMS

*Based on # of products in each dosage form

Other

INDUSTRY-LEADING GENERIC R&D

2014 PERFORMANCE

New Development Projects

New and existing

dossiers resulted in

965 filings in 2014 in

European countries

and other markets that

accept EU Dossiers

Country/Region

United States

EU (dossier completion)

Brazil/Mexico

Canada

Japan

Australia

Russia

New Project Totals

Count

44

29

8

10

5

9

9

114

FIRST-TO-FILE PERFORMANCE

BUILDING THE GX PIPELINE

Confirmed # of Actavis FTFs by Year Brand IMS Value of FTFs by Year ($Bn)

2014 Actavis share of Industry FTFs*

% of products: 33%

% of Brand $: 46%

*Includes some shared FTFs

Beyaz®

Cymbalta®

Epiduo®

Exjade®

Pristiq®

Xopenex®

Absorica®

Acanya®

Axiron®

Exelon®

Fortesta®

Nucynta®

Nuvaring®

Rayos®

Suboxone®

Vimpat®

Ampyra®

Butrans®

Diclegis®

Gilenya®

Multaq®

Neupro®

Nexium OTC®

Pradaxa®

Qsymia®

Quillivant XR®

Vascepa®

Zohydro ER®

Zubsolv®

ACTAVIS REMAINS THE LEADER

IN U.S. FIRST-TO-FILES

Apotex Dr.

Reddy’s

SandozPar Auro-

bindo

AccordSun *Others

(24)

LupinGlen-

mark

AmnealTevaMylanActavis

Note: Total is greater than 76 FTFs posted in 2014 due to shared FTFs

FTF company not identified for 18 products

*24 other companies had ≤3 FTFsSource: FDA Paragraph IV Certifications Website, IPD Analytics and internal analysis

Confirmed First-to-File # Products in 2014 by Company (As of January 8, 2015)

5 5 55544

≤344

67

8

25

17

8

US GENERICS

Select 2014 FTF Additions to Disclosed Pipeline

Opportunities

for exclusive or

semi-exclusive

launches

Status

Actavis FTF

Actavis FTF

Actavis FTF

Actavis FTF

Actavis FTF

Actavis FTF

Actavis shared FTF

Actavis shared FTF

Actavis FTF

Actavis FTF

Actavis FTF

Actavis FTF

Actavis FTF

Actavis FTF

Actavis FTF

Actavis FTF

Actavis shared FTF

Actavis shared FTF

Actavis shared FTF

Actavis FTF

Actavis shared FTF

30-Month Stay

2015

2015

2016

2016

2016

2016

2016

2016

2016

2016

2016

2016

2017

2017

2017

2017

2017

2017

2017

2017

2018

Product

Gx Beyaz

Gx Fortesta

Gx Suboxone Film

Gx Nuvaring

Gx Absorica

Gx Axiron

Gx Nucynta IR

Gx Nucynta ER

Gx Zubsolv

Gx Diclegis

Gx Vascepa

Gx Qsymia

Gx Quillivant XR

Gx Nexium OTC

Gx Zohydro ER

Gx Neupro

Gx Ampyra

Gx Livalo

Gx Onglyza

Gx Butrans

Gx Gilenya

Dosage Form

Oral Contraceptive

Topical Gel

Sublingual Thin Film

Vaginal Ring

Capsules

Topical Solution

Immediate Release Tablets

Modified Release Tablets

Orally Disintegrating Tablets


Soft Gel Capsules

Modified Release Capsules

Powder for Suspension

Modified Release Capsules


Transdermal


Tablets

Tablets

Transdermal

Capsules

Green = 2014 additions to disclosed pipeline, does not include all filings

GENERIC R&D – PRIORITIES

Keep the Momentum going

• Continue to retain top talent from legacy R&D organizations

• Deliver on new product filings – fast, high quality development

• The machine is running well – no disruptions or distractions

Maximize Return on R&D investments

• Continue focus on challenging, high barrier products

• There is no shortage of product opportunities

• Be creative – product ideas, patent challenges, speed to market

Make the most of New Actavis

• Leverage Gx expertise to protect and extend Brand franchises

• Utilize Brand R&D expertise on the complex products


2015 Global Generics

OBJECTIVES

Bob Stewart

GLOBAL GENERIC STRATEGY

PRIORITIZE OPPORTUNITIES

Focus on the right markets

• Where Actavis is strong and positioned to compete

• Markets with significant growth potential

• Businesses that offer positive synergies with Allergan assets

Focus on the right segments

• INN generics, where it is profitable

• Building durable OTC and Branded Gx franchises

• Select Rx Brands – niche or mature where it complements

Optimize flat or declining businesses

• Maximize profit

• Exit if limited long-term potential

• Shift resources to the best opportunities

2015 KEY BUSINESS DRIVERS

Key Products

• Gx Lidoderm®, Gx Concerta®: Assumes one competitor each in 2015

• Product launches: Gx Intuniv®, Gx Oxycontin®, Gx Celebrex®, Gx Pulmicort®

• Risk adjusted opportunities: Gx Epiduo®, Gx Fortesta®

Business Initiatives

• Launch of US Injectable Hospital Business in January

• Closing on Auden McKenzie late Q1/early Q2

• International OTC expansion and branded generics strategy

Upside Opportunities

• Revenue synergies with Allergan business

• Lower Gx price erosion than forecasted

• Other PIV patent challenges and undisclosed launches

SUMMARY

• We have a proven team that will continue to deliver

• Our pipeline provides long duration and durable assets

• Organic R&D will drive continued results

• Business Development opportunities still exist in a

consolidating industry

• We are always adapting to a changing landscape

Bill Meury


NA BRANDS OVERVIEW

EXECUTIVE SUMMARY

• Broad and deep product lines in 7 core therapeutic areas

• Balanced between primary care and specialty as well as

commercial and Part D

• Fundamentals and growth prospects are strong

• Top performing sales and marketing team & organizational

momentum

• Promising late stage pipeline

PRODUCT LINE DEPTH DRIVES

COMMERCIAL ADVANTAGES

~2.3 B ~1.3 B ~0.9 B ~0.6 B ~0.1 B ~0.1 B ~0.9 B

AlCNS UroWomen’s

HealthGI CardioDerm &

Established

Pro forma 2014

http://www.namendaxr.com/Default.aspxhttp://www.namendaxr.com/Default.aspx

ALL TOP 10 PRODUCTS INCREASE SALES

QTR OVER QTR

Source: Actavis Finance

2014 Top 10 Products (~70% of sales) Key 2015 Growth Drivers

Product 3Q 4Q +/-%

increase

Namenda +

XR428 472 + 10% DTC and Namzaric Launch

Bystolic 139 154 + 11% Maintaining user base and formulary coverage

Asacol/Delz 141 146 + 4% Improving formulary coverage

Linzess 80 94 + 18%Converting OTC with continued professional and

DTC

Lo Loestrin 72 75 + 4%Emphasize unique “low dose” and strong

formulary coverage

Estrace 67 80 + 19% Regained market leadership by doubling field effort

Viibryd 53 55 + 4% Launch of 20 mg Viibryd dose

Carafate 42 49 + 17% Strong demand since the re-launch

Teflaro 20 36 + 80% Price reset and volume above expectations

NAMENDA XR & NAMZARIC: CONVERT & GROW

• Conversion rate is climbing at a high rate

• DTC has been highly impactful

• Managed care coverage is at 85% in 2015

• Namzaric potential sales accelerator by expanding use of combination

therapy

Conversion Rate is Climbing

DTC

Jan 6

Supply Restored

Source: IMS NPA as of 1/30/15 , IMS Xponent of 1/2/15 and IMS Source of Business Report, Nov 2014

MD Interest in the FDC is High

Nam XR

22%

Nam IR

18%

MDs surveyed reported the fixed dose would

account for 60% of total use in 6 months

N=50

FDC

60%

43.4%

25.00%

30.00%

35.00%

40.00%

45.00%

LINZESS: SUSTAINED DOUBLE-DIGIT GROWTH

• High double digit growth

• High MD satisfaction

• Linzess DTC has exceeded industry

norms

• Future product enhancements in

development

Passed Zelnorm on Rx Volume

Linzess DTC has Exceeded

Industry Norms1

89% of MDs Report High Satisfaction

1. Actavis: Based on an NTB analysis of 58 DTC campaigns

New to Brand Growth due to DTC

44%

27%

Linzess Industry Avg*

500

450

400

350

300

250

200

150

100

50

0

Q1

2013

Q2

2013

Q3

2013

Q4

2013

Q1

2014

Q2

2014

Q3

2014

Q4

2014

52

120

172

216

240

326

399

450

th

ou

sa

nd

s


64%49%

22%

25%

33%

22%

4%11%

36%

0% 1% 5%

7% 4% 2%

Linzess Amitiza OTC Stimulant

Laxatives

Satisfaction with Medications (1-7 scale)

N/A

1-2

3

4

5

6-7

Top

Score

6-7

13%


BYSTOLIC: RELIABLE AND DURABLE SALES

• Sales totaled over $500MM in 2014

• Over ~85% unrestricted formulary

coverage

• Excellent MD perceptions

• Broad user base with over 300,000 MDs

High Volume and Demand

Bystolic Rates High on

Efficacy & Tolerability1

Strong Formulary Coverage

Tablet Volume

1. Hypertension Study, GfK


TEFLARO: STRONG FUNDAMENTALS

AND GROWTH PROSPECTS

• Sales annualizing at ~$150MM in 4th

quarter 2014

• Volume up 15% in 2014 vs. 2013

• Over 5,000 hospitals have used Teflaro

• Rates high on key efficacy and side effect

attributes

• 60% of ID expect to increase use

High Volume and Demand

Ranked #1 on Key Attributes

60% of IDs Expect to Increase Use

Days of Therapy

Volume up 15% vs. PY

52 weeks ending 1/15/201552 weeks ending 1/14/2015

Certificate 23% 60%

% of ID specialists

Speed

Safety

Side effect profile

Value for Money

Broad Spectrum

44 64 65 49 62

32 59 77 56 60

37 57 73 47 47

73 23 44 26 21

19 35 62 58 32

Key

AttributesVanco Cubicin Teflaro Tygacil Zyvox IV

LO LOESTRIN AND ESTRACE: MARKET LEADERS

Lo Loestrin Double Digit Growth

Estrace Regained Market Leadership

Formulary Coverage is High

• Lo Loestrin and Estrace have a strong

following in the OB/GYN community

• Sales for both products estimated to

increase at a double digit rate

• Formulary coverage is high—copay for

Lo Loestrin is $0 for many patients as a

result of ACA

• Supported by low-dose guidelines

Unrestricted Coverage

Source: IMS NPA as of 1/30/15 , IMS Xponent of 1/2/15 and IMS Source of Business Report, Nov 2014`

TRx

TRx Linear(TRx)

TRx Linear(TRx)

1,365 1,519 1,613 1,675

TRx

747 1,958 2,915 3,285

THE COMMERCIAL MODEL

Industry Trends

Customize sales force deployment

Created new account manager

capabilities to cover IHSs

Greater emphasis on HEOR

Rely more on DTC, internet, and

social media

Provider

Consolidation

Standardization

of treatment

practices

Rising burden

of proof for

new product

data

Declining

physician

access &

time

Staying Competitive

Declining

physician

access & time

Standardization

of treatment

practices

Provider

Consolidation

Rising burden of

proof for new

product data

SCALED FOR PRIMARY CARE, FOCUS FOR SPECIALTY

Primary Care Teams – 1,610 Representatives

PCR 1 PCR 2 PCR 3 PCR 4

Linzess, Fetzima, Viibryd, Namenda XR, Bystolic, Saphris

Lo

Lo/Minastrin

Estrace

Nuvessa

Liletta

Atelvia

Crinone

Trelstar

Specialty Teams – 1,075 Representatives Institutional Teams - 330 Representatives

Bystolic

Rapaflo

Androgel

Linzess

Delzicol

Asacol HD

Canasa

Zenpep

Fetzima

Viibryd

NamXR

Saphris

Doryx

Cordran

Tape

Dalvance

Teflaro

AvyCaz

Nam XR

Nam

FDC

Zenpep

Ultresa

Women’s

HealthCardiology GI CNS Derm Anti-

Infective

Long Term

CareCF

Actavis #3 in Sales Force Size

Actavis is #1 in Calls Per Day

Actavis Ranks #1 in Total Sales Calls

Source: IMS Promotional Audit, 2014 & Sales Force Structure & Strategies. Audited data may differ from internally reported. company data.

• Actavis sales force leads

industry in calls per day

• Ranked #3 in sales force size

• Leads industry in total calls

FIELD FORCE A COMPETITIVE ADVANTAGE

3,368

Actavis Avg. Top 10 Companies

3,542 3,495

Actavis Avg. Top 10 CompaniesActavis Avg. Top 10 Companies

2,003

10.0

7.3


BRANDS R&D OVERVIEW

David

Nicholson

CONTINUED STRONG COMMITMENT TO R&D

Our R&D Strategy:

We build our Pipeline through partnerships, collaborations and in-licensing,

with a focus on enhancing strong organic growth in the following key

therapeutic areas:

CardioDermUrology

CNS

Infectious

Diseases

Women’s

HealthGI

ACTAVIS BRANDED R&D PIPELINE

STRONGEST IN COMPANY HISTORY

Delzicol Next GenEluxadoline

IBS-DCariprazine

Bipolar Depression

Armour ThyroidHypothyroidism

1mg NA/20ug EE Tab s

Oral Contraception

Aztreonam-AvibactumBacterial Infection

CariprazineAdj. MDD

TRV-027 (Option)Acute Heart Failure

Etonogestral Ring Contraception

UndisclosedHyperhidrosis

Linaclotide Low DoseCIC

CariprazineSchiz./Bipolar Mania

Amg/Act Biosimilar Rituxan (also for rheumatology)

Estradiol Vaginal CapsDyspareunia

ESMYA (Ulipristal)Fibroids

Amgen/Actavis (Amg/Act) Biosimilar

Erbitux

DiafertIVF Diagnostic

AvyCazcUTI, cIAI

SarecyclineAcne

Estradiol Vaginal Cream

Dyspareunia

Amg/Act Biosimilar Herceptin

Liletta IUDContraception

Amg/Act Biosimilar Avastin

Nebivilol/ValsartanHypertension

Preclinical Phase 1 Phase 2 Phase 3 Registration Building the Brand

Teflaro

Bacteremia

Enablex

OAB

BiosimilarUndisclosed

RelamorelinDiabetic Gasteroparesis

Cariprazine

Schiz. Relapse Preven

Dalvance – EUABSSSI

Viibryd Peds/PWR

MDD

Saphris Low Dose

Schiz. Main/ BP Mania

Dalvance Single Dose

Osteomyelitis

Enzepi EUEPI

ACTAVIS INDUSTRY-LEADING R&D PRODUCTIVITY

1. CDER. New Molecular Entity (NME and New Biologic Approvals for calendar years 2009 through 2013 (2014 not yet online).

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/NDAandBLAApprovalReports/ucm

373420.htm.

2. FDA. Vaccines, Blood and Biologics. Biological Approvals by Year.

http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicalApprovalsbyYear/ucm385842.htm.

3. FDA Drug Approval reports – Original New Drug Approvals (NDAs and BLAs) by month: searchable at

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.ReportsMenu by month.

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/NDAandBLAApprovalReports/ucm373420.htmhttp://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicalApprovalsbyYear/ucm385842.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.ReportsMenu

ACTAVIS BRANDED PIPELINE HIGHLIGHTS

Women’s Health

ESMYA

LILETTA / LEVOSERT

Gastro-Intestinal

LINZESS

Eluxadoline

CNS

Cariprazine

Anti-Infectives

AVYCAZ

DALVANCE

Dermatology

Sarecycline

Biosimilars

Early Stage

PipelineRelamorelin

GASTROINTESTINAL (GI)

LINZESS (linaclotide)

• Current Indication: IBS-C, CIC

• Future Indications:

– Low Dose, Chronic Idiopathic Constipation (CIC)

– Opioid Induced Constipation (OIC)

ELUXADOLINE

• Indication: IBS-D

LINZESS (LINACLOTIDE)

AT-A-GLANCE

Submucosa

Intellectual Property Synopsis:

Composition of Matter:

Jan 2024, pending PTE to Aug 2026

Method of Use formulation: Jan 2031

Pending Patent Term Extension:

Aug 2026

• Linzess is a 1st-in-class

once-daily orally

administered drug

• Guanylate Cyclase-C

agonist (GC-C) agonist

• Two Pharmacological

Properties

- Increases fluid secretion

- Attenuates nociceptor

Present & Future Therapies

MEETING UNMET NEED

• ~13 million adults in the US with IBS, and ~35 million adults suffer from CIC

• Few agents are approved

• Uniform, sustained responses to the full spectrum of IBS symptoms including

bowel movement and abdominal pain

Amitiza (Lubiprostone) • IBS-C in women only; BID dosing; CIC in men and women

• Dose adjustment for hepatic impairment

MiraLAX (PEG 3350,

OTC)

• Indication only for occasional constipation

• Indication only for up to 7 days’ usage

• Not indicated for treatment of IBS-C (including abdominal pain)

Resolor/Resotran

(Prucalopride, Ex-US)

• Indicated for women only, for chronic (idiopathic) constipation where

laxatives fail to provide adequate relief

• If not effective during first 4 weeks, discontinue therapy

• Dose adjustments for renal impairment

Plecanatide • Phase 3 for CIC and IBS-C

LINZESS (LINACLOTIDE)

SAFE, EFFECTIVE TREATMENT FOR IBS-CC

hange in

CS

BM

s

% C

hange in

Abdom

inal P

ain

Least Squares Means 95% Confidence Interval

Trial 31 Trial 302

CSBM: Complete Spontaneous Bowel Movement

Trial Week Trial Week

0

-10

-20

-30

-40

-50

-60

0

-10

-20

-30

-40

-50

-60

3

2

1

0

3

2

1

0

BL 1 2 3 4 5 6 7 8 9 10 11 12 BL 2 4 6 8 10 12 14 16 18 20 22 24

BL 1 2 3 4 5 6 7 8 9 10 11 12 BL 2 4 6 8 10 12 14 16 18 20 22 24 26

Linaclotide 290 mcg

Placebo

LINACLOTIDE

BUILDING THE BRAND

Low Dosage Form for Chronic Idiopathic Constipation

(Next Target: sNDA submission)

New Indication: Opioid-Induced Constipation

(Top-line results for ongoing Phase 2 study 2015)

Delayed Release Formulation

ELUXADOLINE

Inflammatory Bowel Syndrome-

Diarrhea (IBS-D)

ELUXADOLINE

AT-A-GLANCE

• First-in-Class mixed mu-opioid receptor agonist and delta-opioid receptor

antagonist

– Acts locally in the GI tract and has low systemic absorption and

bioavailability

• If approved, Eluxadoline will be indicated for the treatment of IBS-D in

adults

• NDA was accepted for filing by FDA on September 9, 2014 (PDUFA date:

Expected Q215)

N

O OMe

O

O

NH3+O

NH2

NH

N

Ph

Eluxadoline

-

Intellectual Property Synopsis

Composition of Matter patent coverage until March 2028 (U.S.)

and March 2025 (Europe) subject to PTE / SPC

ELUXADOLINE

MEETING UNMET NEED

• ~13 million adults in the US with IBS

• Currently No Approved Drug for the Treatment of IBS-D [in males]

• Effective over the Duration of Treatment

• Need for sustained efficacy

Xifaxan

Salix• 2/3 patients have symptom recurrence within

6 months after treatment

Asimadoline

Tioga Pharma• Phase 3 completed June 2013 (per ClinTrials);

no results reported

Ibodutant (MEN 15596)

Menarini• Restricted to women

Present & Future Potential Therapies

ELUXADOLINE: RAPID & SUSTAINED IMPROVEMENT

IN DAILY SYMPTOMS 12-Weeks

(FDA Primary Endpoint)

∆ = 8.0

∆ = 6.8

∆ = 13.4

∆ = 12.7

∆ = 10.3

∆ = 9.5

n=427 n=426

n=427

n=381 n=382

n=382

n=808 n=806

n=809

PooledStudy 3002Study 3001

Composite of Bowel Movements and Pain

CURRENTLY NO APPROVED DRUG FOR

TREATMENT OF IBS-D IN MALES

Eluxadoline is Effective in Males and Females

(Pooled Phase 3 Data)

ELX, ELUXADOLINE; PBO, placebo

Data herein is from separate subset analyses of males and females and reports the

proportion of patients who were composite responders over weeks 1-12 and weeks 1-26

ELX, eluxadoline; PBO, placeboMales Females

PBO75 mg

ELX

100 mg

ELXPBO

75 mg

ELX

100 mg

ELX

N=282 N=271 P value N=268 P value N=527 N=537 P value N=538 P value

Weeks

1-1215.2% 27.3%

ELUXADOLINE PANCREATITIS AND SCHEDULING

Pancreatitis

• 9 cases of reversible mild

pancreatitis were seen in the

clinical development program of

2,400 patients, no clinical

sequela

• 8 of the 9 cases involving

patients with known alcohol

abuse or increased alcohol

intake, prior cholecystectomy or

biliary sludge

• 9th case occurred after the

patient’s withdrawal from the

study

• All cases were resolved

• Expect class labeling for opioids

Scheduling

• Scheduling likely following FDA

approval

• FDA and the DEA have a number

of options for scheduling

(schedules I-V)

ELUXADOLINE

BUILDING THE BRAND

FDA PDUFA date: Q215

EMA Submission Target: Q215

LCM project: 6 Possible Additional Programs

ANTI-INFECTIVE FRANCHISE

AVYCAZ (ceftazidime-avibactam)

• Complicated Urinary Tract Infections (cUTI), Complicated Intra-

abdominal Infections (cIAI)

DALVANCE (dalbavancin)

• Future Indication:

- Single Dose Acute Bacterial Skin and Skin Structure Infections

(ABSSSI)

AVYCAZ (CEFTAZIDIME-AVIBACTUM)

AT-A-GLANCE

Ceftazidime Avibactam

• Novel, non-β-lactam β-lactamase inhibitor

• Restores ceftazidime activity

AVYCAZ

• Developed to treat serious bacterial infections caused by susceptible Gram-negative

pathogens

– Ceftazidime-resistant, specifically, β-lactamase producing Gram-negative bacilli

• Based on urgent unmet need, FDA allowed NDA filing prior to completion of Phase III studies

• Established injectable third

generation cephalosporin


Composition of Matter – February 24, 2022, eligible for patent term extension

-lactamase inhibitor and antibiotic (e.g., cephems, ceftazidime) compositions – November 12, 2026

Crystal forms – August 12, 2031


MEETING UNMET NEED

• cIAIs affect ~1.1 million US patients per year

• cUTIs affect ~2.9 million US patients per year

• Urgent need for new antibiotics that treat serious gram-negative infections

with limited treatment options or suspected to be caused by multiple drug-

resistant pathogens that produce β-lactamases

ESBL = Extended spectrum β-lactamase

KPC = Klebsiella pneumoniae carbapenemase

AmpC = Class C Cephalosporinases

Ceftolozane/Tazobactam

Launched 2014• Most isolates are resistant to the KPC and exhibit variable

susceptibility to the ESBL and AmpC β-lactamase mediated

resistance mechanisms

Tigecycline

Launched 2005

• Most isolates are resistant to P. aeruginosa

• Safety & tolerability – variable susceptibility

Present and Future Therapies

BROAD SPECTRUM BACTERICIDAL ACTIVITY

Unique Profile of Avibactam

100

1 Drawz SA, Papp-Wallace KM, and Bonomo RA. New ß-lactamase inhibitors: a therapeutic renaissance in a MDR world. Antimicrob

Agents Chemother 2014;58(4):1835-1846.

Class A

TEM, SHV and ESBLs

CTX-M and ESBLs

PER, VEB, GES

KPC

Class B IMP, VIM, NDM

Class C

Chromosomal Enterobacteriaceae AmpC

Chromosomal Pseudomonas AmpC

Plasmidic ACC, DHA, FOX, LAT, MIX, MIR, ACT

Class D

Penicillinase-type OXA-1, -31, -10, -13Variable

OXA-1, -10

Variable Variable

OXA-1, 31

Carbapenemase-type OXA-23, -40, -48, -58Variable Variable

OXA-23, -48

Variable

OXA-48

Clavulanate(currently available)

Tazobactam(currently available)

Avibactam(novel agent)

β-Lactamase

AVYCAZ (CEFTAZIDIME-AVIBACTUM) CLINICAL

EFFICACY

Demonstrated Efficacy Against CAZ-Not Susceptible Pathogens

in Patients with cIAI1

Overall N Percent 90% CI

AVYCAZ* + MTZ 85 82.4 (74.1-88.8)

Meropenem 89 88.8 (81.7-93.8)

CAZ-Susceptible

AVYCAZ + MTZ 42 76.2 (63.0-86.5)

Meropenem 53 88.7 (78.9-95.0)

CAZ-Not Suscp.

AVYCAZ + MTZ 30 90.0 (76.1-97.2)

Meropenem 23 82.6 (64.5-93.8)

CAZ-Resistant

AVYCAZ + MTZ 30 90.0 (76.1-97.2)

Meropenem 23 82.6 (64.5-93.8)

Meropenem-Suscp.

AVYCAZ + MTZ 76 81.6 (72.7-88.5)

Meropenem 76 88.2 (80.2-93.7)

The response rates in the subgroup of AVYCAZ-treated patients with infections due to CAZ-NS pathogens was similar to those for the overall population, suggesting that the in vitro

evidence for the impact of avibactam on the antimicrobial activity of ceftazidime translates to clinical efficacy versus CAZ-NS pathogens

* Ceftazidime-Avibactam, MTZ = Metronidazole, 1 Data on file, Actavis.

Percentage

50 60 70 80 90 100

AVYCAZ Meropenem


BUILDING THE BRAND

sNDA filing with Phase III data 2015

AVYCAZ in Carbapenem sparing regimens and against

CAZ not susceptible organisms

NDA Approval

DALVANCE™ (Dalbavancin)

Single Dose - Acute Bacterial Skin

& Skin Structure Infections

(ABSSSI) Osteomyelitis


AT-A-GLANCE

3,3-dimethylaminopropyl amide

Fatty

acid

chain

• Long fatty acid chain correlates with extended

half life (t1/2) in vivo

• The opportunity to provide a week’s worth

of treatment in one dose changes the

paradigm for treatment of skin infections

• This novel dosing regimen and potent activity

against the key target pathogens will decrease

hospitalization

New Chemical Entity exclusivity – May 23, 2019

GAIN Act exclusivity – May 23, 2024

Method of use (two dose) – December 25, 2023, pending patent term extension to May 23, 2028

Organism (No. tested)

IC50,

µg/mL% at MIC, µg/mL

≤0.25 ≤0.5 ≤1

S. Aureus Methicillin resistant (MRSA) 0.06 >99.9 100.0 100.0

S. Aureus Methicillin susceptible (MSSA) 0.06 100.0 100.0 100.0



MEETING UNMET NEEDS

• Simplify patient care

• Make it safer and easier to treat the sickest patients

• Provide an option to get patients back to health at home

• Reduce exposure within hospital setting

Oritavancin

The Medicines

Company

• ABSSSI

• One intravenous infusion over three hours

• Interference with in-vitro coagulation assay; osteomyelitis warning in FDA label

Daptomycin

Cubist

• Complicated skin and skin structure infections (cSSSI); Staphylococcus aureus

bloodstream infections (bacteremia), including those with right-sided infective

endocarditis

• Once daily infusion for 7 to 14 days

• Muscle inflammation (Creatine Phosphokinase elevation)

Telavancin

Theravance

• cSSSI; Hospital-acquired and ventilator-associated bacterial pneumonia

(HABP/VABP) caused by susceptible isolates of Staphylococcus aureus.

• Once daily infusion for 7 to 14 days

• Nephrotoxicity, reproductive toxicity

*LEK 2011

Key Present and Future Therapy


ADDITIONAL STUDIES PROGRESSING

SINGLE DOSE AND OSTEOMYELITIS

• Single Dose Study – Last Patient Last Visit (LPLV)

February 2015

A Phase 3b, Double-Blind, Multicenter, Randomized, Non-Inferiority

Study to Compare the Efficacy and Safety of Single Dose Dalbavancin

(1500 mg) to a Two Dose Regimen of Dalbavancin (1000 mg followed

one week later by 500 mg) for the Treatment of Acute Bacterial Skin and

Skin Structure Infections– Sample Size: 698 patients; Length of Study: 28 days; Primary Endpoint: Clinical

Response at day 3-4

• Pediatric Osteomyelitis Study – First Patient First Visit

(FPFV) 2015

• Adult Osteomyelitis Study – First Patient First Visit 2015

(FPFV)


BUILDING THE BRAND

EU approval March 2015

Single-Dosing sNDA 2015

Additional Indications:

Bone & Joint (Pediatric & Adults

Osteomyelitis, Joint Infection), Endocarditis

Phase 4 Programs: Early discharge; prevent

admission; patient satisfaction

ACTAVIS WILL BE A LEADER

IN THE BIOSIMILARS MARKET

• Biosimilars present a compelling

opportunity

- Regulatory pathways are established

- The market potential is significant

- US at an inflection point – biosimilars are on

the horizon

• Actavis is well positioned to succeed in

this market

- Both Rx & Gx capabilities – have expertise

needed to play in the Branded Gx Biosimilar

space

- Flexibility to adjust to an evolving

marketplace

• Competitive landscape has narrowed

- Small players dropping out

- Some big players have stumbled, and many

projects facing delays

Source: IMS Health Whitepaper - Searching for Terra Firma in the Biosimilars and Non-Original Biologics

Market, MIDAS, MAT Dec 2012. IMS analysis & estimates. NOBs are recombinant and synthesised only.

Global Biologic and Biosimilars

Market ($Bn) Estimates

171

261 - 275

Biosimilars/NOBs:

Potentially $11-25Bn

market

Biologics:

Potential targets for

future development

20202012

Branded Biologics Specialty & Gx Pharma

• Deep expertise in biologics

development

- Formulation, CMC, clinical,

regulatory

• 1st in class manufacturing

capabilities

• Strong Oncology sales teams

- US and International

• Expertise in Rx, BGx and Gx

business

- Contracting, tendering,

formulary access in a

competitive environment

• Speed & agility

- Rapid response to market

shifts

• Direct relationships with

Hospital buyers

• Excellent company

reputations

• Financial strength

• Long-term, global

strategy

• High-quality products

• Deep / sustainable market share

• Global reach

• Consistent, reliable product supply

COMPLEMENTARY STRENGTHS WITH

ACTAVIS + AMGEN PARTNERSHIP

Product Status Indication

Herceptin®

ABP 980 /

trastuzumab

Phase 3 Breast Cancer

Avastin® ABP 215 /

bevacizumabPhase 3

Non Small Cell Lung

Cancer (NSCLC)

RITUXAN®

ABP 798 / rituximabClinical Ready

ERBITUX®

ABP 494 / cetuximabProcess Development

rFSHTerminated as part of

portfolio rationalization

Product # 5 -

UndisclosedCell Line Development

Aligned with Actavis therapeutic category

Additional

opportunities

are under active

assessment

Expansion of Amgen

partnership

Products for in-house

development

Partner with other 3rd

party developers

ACTAVIS BIOSIMILARS PIPELINE PROGRESSING

Ongoing

commitment to

investing in

Biosimilars

Establishing a

diverse

portfolio of

opportunities

WOMEN’S HEALTH FRANCHISE

LILETTATM

/LEVOSERT®

(levonorgestrel-releasing intrauterine system)

• Contraception

ESMYA® (ulipristal acetate)

• Reduction of bleeding associated with uterine fibroids

MIRENA / Bayer • Hormonal IUD; 20% amenorrhea rate; 5 yr contraception

SKYLA / Bayer • Hormonal IUD; 6% amenorrhea rate; 3 yr contraception

PARAGARD / Teva • Non-hormonal IUD; 10 yr contraception

LILETTATM

/LEVOSERT®

AT-A-GLANCE

• Hormone-releasing Intra-uterine Device (IUD) placed within the uterine cavity,

which works as a contraceptive through several mechanisms including thickening

of cervical mucous which prevents sperm from entering through the cervix

• Medicines360 and Actavis filed an NDA on April 29, 2014 for levonorgestrel-

releasing intrauterine system

– US FDA accepted NDA on July 14, 2014

– NDA is under active FDA review

• LILETTA trial (n=1,751) largest hormonal IUD study in US; reflects broad range of

age, weight, races and ethnicities

• 3 years duration of contraception under review and longer durations under

evaluation

Competition

LEVOSERT®

has been approved in the EU

since 2012 for menorrhagia

Ongoing efforts to expand indication to

include contraception in Europe

US FDA accepted NDA on July 14, 2014

LILETTATM

/LEVOSERT®

BUILDING THE BRAND

ESMYA (Ulipristal Acetate)

Uterine Fibroids

Elagolix (AbbVie) GnRH antagonist; Phase II development

Vilaprisan (Bayer) SPRM; Phase II development

Proellex (Repros) SPRM; Phase II development

ESMYA (ULIPRISTAL ACETATE)

AT-A-GLANCE

• Ulipristal acetate is an oral, selective progesterone receptor modulator (SPRM)

• Mechanism of Action:

– Acts on progesterone receptors in the uterus to control bleeding

– Inhibits ovulation without causing negative effects on estradiol levels

– Acts directly on fibroids to induce apoptosis and inhibit proliferation

– Advantages in efficacy/safety/convenience of use vs. GnRH agonists (leuprolide

acetate); medical alternative to surgical options


Method of Use patent expiration January 2028

Present and Future Therapies


MEETING UNMET NEED

• Uterine fibroids are the most common tumor of the female

reproductive tract in pre‐menopausal women

• Asymptomatic affecting approx. 40% of women between 35 and 55

years

• When symptomatic, the cardinal symptoms are heavy uterine

bleeding, anemia, abdominal pressure, abdominal pain, increased

urinary frequency and infertility

• Current mainstay of symptomatic uterine fibroids treatment is

surgery

• The only Rx treatment approved is Lupron

• Superior to placebo and non-inferior to Gonadotropin Releasing Hormone (GnRH)

agonist in: Reducing excessive bleeding, and fibroid volume

Correcting anemia and inducing amenorrhea

Reducing fibroid-related pain and improving quality of life

• More rapid onset of activity

• More sustained efficacy

1Donnez et al, N Engl J Med 2012; 366: 409-202Donnez et al, N Engl J Med 2012; 366: 421-32

**PBAC=pictorial blood-loss assessment chart

*** significantly different from placebo (p


BUILDING THE BRAND

NDA submission expected 2017: Treatment

of abnormal uterine bleeding in women with

leiomyomas

Currently Evaluating Other Indications

CENTRAL NERVOUS SYSTEM (CNS)

CARIPRAZINE

• Indications:

– Schizophrenia

– Acute Bipolar Mania

– Bipolar Depression

– Adjunctive Major Depressive Disorder (MDD)

CARIPRAZINE AT-A-GLANCE

• Atypical antipsychotic

• Novel Mechanism of Action and Pharmacokinetic profile

• Robust efficacy across multiple indications

– Schizophrenia – NDA Under Review

– Bipolar Mania (Type I Disorder) – NDA Under Review

– Schizophrenia Relapse Prevention - Phase III

– Adjunctive Treatment of MDD - Phase III

– Bipolar Depression – Phase II

• Negative Symptoms: Gedeon Richter Phase IIIb Study

• Safe and well-tolerated, within the recommended dosing range of 6mg/day


Composition of Matter patent coverage until March 27, 2027

(plus eligible for further patent term extension)

Polymorph Patent – December 20, 2028

http://www.guidetopharmacology.org/GRAC/RefineChemicalStructureSearchForward?ligandId=7671http://www.guidetopharmacology.org/GRAC/RefineChemicalStructureSearchForward?ligandId=7671

CARIPRAZINE: MEETING UNMET NEED

• Improved efficacy of: negative symptoms, cognitive deficits and depressive

symptoms

• Lower impact on prolactin levels, metabolic disorders and EPS

• Improving anxiety, depression and mood disorders

Present Therapies

Schizophrenia, Bipolar I disorder (manic or mixed episodes), Bipolar depression,

Maintenance of bipolar I disorder as adjunctive therapy, Adjunctive treatment of MDD

Schizophrenia, Bipolar I disorder mania or mixed episodes, Irritability associated with

autistic disorder

Schizophrenia, Bipolar I disorder mania or mixed episodes, Irritability associated with

autistic disorder

Schizophrenia, Bipolar I disorder (manic or mixed episodes) Maintenance treatment

of bipolar I disorder, Adjunctive treatment Of MDD, Irritability associated with autistic

disorder

Seroquel XR

Olanzapine

Risperidone

Abilify

RGH-MD-16 Cariprazine 1.5 mg/day

Cariprazine 3.0 mg/day


RGH-MD-04 Cariprazine 3.0 mg/day


RGH-MD-05 Cariprazine 3.0-6.0 mg/day


LS Mean for Between-treatment Difference (95% CI)

CONSISTENT EFFECT ON

SYMPTOMS OF SCHIZOPHRENIA

Baseline to Week 6 in Positive And Negative Syndrome Scale (PANSS) Total

Score (Three Studies ITT Population)

LS Mean for Between-treatment Difference (95% CI)LS Mean for Between-treatment Difference (95% CI)

SCHIZOPHRENIA RELAPSE PREVENTION

Kaplan-Meier Curves of Cumulative Rate of Relapse

HR cariprazine 3-9 mg/d vs. pbo= 0.45 (0.28, 0.73)

P-value= 0.0010

CARIPRAZINE:

POSITIVE STUDY ON NEGATIVE SYMPTOMS

Gedeon Richter Plc. Announces Positive

Phase IIIb Top-line Results of Cariprazine

for the Treatment of Patients with

Predominant Negative Symptoms of

Schizophrenia 1/22/2015

Budapest, 22 January 2015 – Gedeon Richter Plc. today announced

positive top-line results from a Phase IIIb trial evaluating the efficacy,

safety and tolerability of cariprazine, a new atypical antipsychotic, in adult

schizophrenia patients with persistent and predominant negative

symptoms.

The cariprazine treatment group showed statistically significant improvement in the primary outcome measure, the Positive and Negative

Syndromes Scale Factor Score for Negative Symptoms (PANSS-NFS) compared to risperidone. The cariprazine treatment group also

showed statistically significant improvement with regard to the secondary outcome measure, the Personal and Social Performance Scale

(PSP) compared to risperidone. The patients tolerated the treatment well. Data will be further analyzed in the coming weeks.

"We are very pleased about these positive phase III results. The preliminary data clearly demonstrates that in addition to the already shown

efficacy in patients with schizophrenia and acute mania associated with bipolar I disorder, cariprazine has also the potential to become a

novel promising therapeutic option for the unmet medical need of patients suffering from predominant negative symptoms of schizophrenia,"

said Dr István Greiner, Research Director of Gedeon Richter Plc.

"This is the first study to demonstrate clinically relevant efficacy in a group of patients who had been without a reliable treatment option.

Based on the preliminary data of the study, cariprazine may offer a unique treatment to improve the patients' and their relatives' quality of

life," added Dr György Németh, Chief Medical Officer of Gedeon Richter Plc.

Source: Gedeon Richter Plc Press Release

Schizophrenia / Bipolar Acute Mania NDA

Action Date – June 2015

Phase 3 initiation Bipolar (Type I)

Depression – 2015

sNDA submission Schizophrenia Relapse Prevention

Adjunctive MDD Phase 3 ongoing

CARIPRAZINE

BUILDING THE BRAND

DERMATOLOGY

SARECYCLINE

Indication:

– Acne Treatment

SARECYCLINE

AT-A-GLANCE

• Novel tetracycline derived antibiotic being

developed for treatment of acne vulgaris

• Solid oral dosage form for once daily

administration

• In vitro demonstrated potent activity

against P. acnes and anti-inflammatory

activity


Composition of Matter: Jan 2024

Composition of Matter/Method of Use: March 2031

(eligible for patent term extension)

Pending Patent Term Extension: Aug 2026

Competition

SARECYCLINE

MEETING UNMET NEED

• Acne Vulgaris: Most common chronic skin disorder affecting adolescents and

young adults.

– Moderate-to-severe acne affects around 20% of young people*

• Selective Activity: Limited antibacterial activity against aerobic gram-negative

gastro-intestinal organisms when compared with minocycline and doxycycline

• Lipophilicity of sarecycline is higher than that of minocycline and doxycycline at

physiologically-relevant pH and believed to penetrate better into the lipid-rich

sebaceous follicular tissues, where P. acnes resides

Doxycycline • High incidence of nausea, vomiting

Minocycline • Acute vestibular events (e.g. dizziness, tinnitus)

SARECYCLINE PHASE 2 STUDY: SUCCESSFUL OUTCOME

BASED ON INVESTIGATORS GLOBAL ASSESSMENT

* Significant difference to placebo p

SARECYCLINE

US CLINCAL DEVELOPMENT PROGRAM: PHASE 3

Two randomized, multicenter, double-blind, placebo-controlled

studies to evaluate the safety and efficacy of sarecycline in the

treatment of moderate to severe acne

• 1.5 mg/kg of sarecycline vs. placebo

• 12 week duration

• 1000 patients for each study

• Co-Primary endpoints:

– Absolute change from Baseline in the inflammatory lesion count at

Week 12

– Proportion of subjects with clear or almost clear score and ≥2 grade

decrease from Baseline in IGA score at Week 12

Subjects will be rolled-over into a long-term (9 months) open label

safety study

SARECYCLINE

BUILDING THE BRAND

Topline results for safety/efficacy studies – 2016

NDA Submission – 2017

NDA Approval – 2018

EARLY STAGE PIPELINE

Relamorelin

Diabetic Gasteroparesis

RELAMORELIN AT-A-GLANCE

• Ghrelin is naturally occurring hormone that plays a

critical role in GI motility

• First-generation ghrelin agonists = predominantly small

molecules with limited potency and efficacy

• Relamorelin peptide retains specificity, functionality of

naturally occurring ghrelin hormone with > potency

• Phase 1 and Phase 2 clinical trials: significant efficacy

for accelerating stomach emptying and improving

diabetic gastroparesis symptoms


US Composition of Matter: Oct. 2024 (eligible for patent term extension)

Method of Use: Dec. 2027

EU pending

RELAMORELIN

MEETING UNMET NEED

• Diabetic Gastroparesis is characterized by delayed gastric emptying

- With symptoms including vomiting, nausea, pain, bloating, and

early satiety

- A complication of diabetes (Types 1 and 2) due to damage to the

vagus nerve, which controls GI musculature/motility

• Prevalence of moderate/severe DG is estimated at ~2.3 million

patients in the U.S.

- Impact: Hospitalization, loss of diabetic control

• Limited treatment options

- No new gastroparesis therapy approved in US >30 yrs

- Standard of care (metoclopramide) is poorly tolerated

• Fast track grant

Documents

INVESTOR DAY 2015 - Biotech Due Diligence2015/02/19 · ACTAVIS INVESTOR DAY 2015 OVERVIEW/Q4 and FY 2014 HIGHLIGHTS Brent Saunders Q4: EXCEPTIONAL FINISH TO 2014 $4.0 Billion Revenue