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ALIGNED INTELLIGENCE. FOCUSED RESULTS. MOLEKULE CONSULTING Our Consulting & Services Offerings Prepared in 2016 by Molekule Consulting

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Page 1: MOLEKULE CONSULTINGmolekuleconsulting.com/wp-content/uploads/2016/01/Molekule_Firm... · to “block” human capital and hard resources in support of our client partners and client-

ALIGNED INTELLIGENCE.FOCUSED RESULTS.

M O L E K U L E C O N S U L T I N G Our Consulting & Services Offerings

Prepared in 2016 by Molekule Consulting

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MOLEKULE CONSULTING 2016 2

Molekule Consulting – Redefining GlobalCompetitive Intelligence Consulting

You, our client partners, return measurable ROIs on key biopharmaceutical business goals and objectives based on informed, rational and pragmatic primary competitive intelligence.

Granularity, accuracy and precision of key intelligence findings

Robust, meaningful and actionable insights and intelligence

Clear client centricity, through communication and engagements

Refined and highly synthesized work product and deliverables

“Advancingthe Intelligent

Choice”

– David Alderman, President Molekule Consulting, Inc

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MOLEKULE CONSULTING 2016 3

Molekule ConsultingGlobal Organizational Overview

• Molekule is a specialist management consul-tancy exclusive to the biopharmaceutical and life sciences verticals. We employ MDs, PhDs, PharmaDs and MBAs with real-world biophar-maceutical industry, medical/academic and/or intelligence experience, delivering to our client partners best-in-class competitive insight and intelligence.

• All Molekule consultants are dedicated to CI research and associated strategic management consulting, based upon a framework of primary CI research. Molekule is amenable and able to “block” human capital and hard resources in support of our client partners and client-Molekule project engagement.

• Our use of freelancers and/or subcontractors is infrequent and depends on two (2) factors – 1. MSA or service agreements enabling the use thereof and, 2. an enlightened and significant project-level contribution to be made due to robust and deep subject matter or therapy area expertise of the non-FTE contractor.

U.S.

MOLEKULE BIOPHARMACEUTICAL

CONSULTING, LLC

EX-U.S.

MOLEKULE CONSULTING

INTERNATIONAL, LTD

GLOBAL

MOLEKULE CONSULTING, INC

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MOLEKULE CONSULTING 2016 4

Molekule Consulting, Inc.By The Facts And Numbers

OUR INCORPORATION• Global Headquarters in Miami, Florida, USA

• Founded and Incorporated in 2012

• EU Headquarters in London, UK

• Incorporated in 2014

MOLEKULE & COMPETITIVE INTELLIGENCE• We leverage primary competitive

intelligence as the fundamental basis of our insights and actionable recommendations to drive improved business results

OUR GLOBAL OPERATIONS

• Principal ex-U.S. physical operations in the EU, CIS/ CEE, Asia-Pacific, LATAM and Israel

• Our global footprint has “feet-on-the-street” and language fluency in 27 core geographies

OUR STAFFING MODEL• Operates a diverse staffing model

• Employs FTE subject matter experts and seasoned pharmaceutical & management consulting industry professionals

MOLEKULE’S EMPLOYMENT QUALIFICATIONS• Employs intelligence industry experts, MDs,

Ph.D.s, Pharm.D.s and experienced business professionals (MBAs)

MOLEKULE & CLIENT PARTNERS• Continually devoted to client centricity and

ongoing client communication

MOLEKULE & ACTIONABILITY DELIVERED• Molekule drives excellence in

biopharmaceutical consulting and competitive intelligence. We deliver actionability returns that are key to biopharmaceutical business goals

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MOLEKULE CONSULTING 2016 5

Molekule’s broad industry expertise and diverse client base is evidenced through repeat client engagement, successful intelligence development and delivery and measurable ROIs on key biopharmaceutical business objectives.

Molekule Consulting, Inc.Overview Perspective

PRINCIPAL FOCUS

Biopharmaceutical consulting leveraging primary competitive intelligence as the cornerstone of Molekule Consulting’s portfolio of industry-specific consulting and service offerings.

CORE SERVICE OFFERINGS

Our portfolio of key consulting services spans a broad range of core offerings enabling Molekule’s client partners to intrinsically align consulting engagements for measurable success and to drive marked ROIs on biopharmaceutical business goals.

1

18

KEY THERAPY AREAS SERVED

Molekule’s Therapy Area Leadership (“TAL”)program mandates all FTE consulting staff maintain therapy area fluency and clinical, commercial, manufacturing and supply chain/logistics and regulatory excellence in therapeutic spaces where they are actively engaged.

CLIENTS

Our client base continues to grow based upon repeat client engagement, client satisfaction and active client referrals. We serve numerous clients globally in the U.S., EU, LATAM, CEE/CIS, Middle East and APAC regions on an international scope and scale.

GLOBAL CLINICAL, COMMERCIAL& REGULATORY SOURCES

Molekule’s robust and growing organic source network spans > 20,000 contacts, globally. We foster persistent source development via active project engagement and regular attendance of global medical congresses and biopharmaceutical trade shows.

21

30+

20K+

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MOLEKULE CONSULTING 2016 6

Molekule ConsultingOur Client Promise

WE GUARANTEEreal-time robust two-way communication and interaction with Molekule Consulting and the Molekule executive leadership team. We are here to support your efforts and our engagements reflect this with continuous communication and contact available.

WE DELIVER actionable and strategic insight and intelligence asserting implications and recommendation to support our clients’ business

WE LEVERAGEan organic and growing global source network across commercial & marketing, clinical & medical, regulatory & technical affairs, and manufacturing and supply chain/logistics stakeholders. Molekule yields deep, actionable and robust primary competitive insights degrees beyond the Key intelligence topics and questions (“KIT/Qs”) set forth by our client partners, resulting in markedly improved outcomes on overall client biopharmaceutical business objectives.

WE BELIEVE simply providing competitive insights and analytics is inadequate – Molekule transcends the norm and provides additional relevant intelligence data that are meaningful to you and your organization, further elucidating the answers to your KIT/Qs.

WE CUSTOMIZEall output and deliverables for you. We provide the option of either using the Molekule Consulting template, or your brand, franchise or corporate template of choice.

ENGAGING AND PARTNERINGwith Molekule provides stunning intelligence and insight into the competitive dynamics of the biopharmaceutical world. Whether a clinical, commercial, regulatory, or manufacturing and supply chain/logistics competitive exercise, the overall impact and implications is a positive ROI yielding significant and applicable business results.

MOLEKULE CONSULTING IS COMMITTED to providing the highest quality competitive intelligence materially impacting your seminal biopharmaceutical business objectives and benefiting your organization’s bottom line.

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MOLEKULE CONSULTING 2016 7

MolekuleCustomized Consulting & Services In Strategic Intelligence As a specialty consulting firm focused specifically

on the biopharmaceutical, medical device, and life sciences verticals, Molekule delivers high impact and actionable primary competitive intelligence solutions yielding significantly positive returns on your biopharmaceutical business objectives. Partnering with Molekule results in transformational changes to your overall bottom line.

Our client partners accurately invest and/or divest in in-line and developmental pipeline assets based upon Molekule’s accurate, timely, and informed primary competitive intelligence research.

Molekule is thoroughly committed to ongoing two-way client communication facilitating positive

engagement outcomes and robust ROIs on your key biopharmaceutical business goals.

Primary Competitive Intelligence Strategy Workshops Market Intelligence & Analytics Scientific and Commercial Biopharmaceutical Conference Coverage Generics and Biosimilars Threat Assessments & Technical Evaluations

AT MOLEKULE WE PROVIDE PREMIUM SERVICES

AND BRING ADDED VALUE TO YOU AND YOUR ORGANIZATION

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MOLEKULE CONSULTING 2016 8

Molekule’sTherapy Area Excellence

We offer a depth and breadth of functional, therapy area, and industry expertise that is rare among management consultancies.

Our cross-functional team approach ensures that subject matter experts provide the industry specific technical expertise and analysis needed for comprehensive, accurate, and efficient outcomes, implication & actionability.

Anti-infectives

Cardiovascular

CNS

Dermatology

Endocrinology

Gastroenterology

Generics and Biosimilars

Hematology

Immunology

Manufacturing and Supply Chain & Logistics

Metabolic Disease

Oncology

Ophthalmology

Orphan Disease

Pain

Respiratory

Sexual Medicine

Strategic Business Intelligence

Urology

Vaccines

Women’s Health

Molekule’s comprehensive and growing global network including KOLs and clinical trialists across extensive therapy areas, biopharmaceutical, medical device & diagnostics company sources and vendors, allows us to derive first-hand intellgence with reliability, depth, and timeliness.

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MOLEKULE CONSULTING 2016 9

Molekule’s Ethical Approach ToStrategic & Competitive Intelligence

Molekule Consulting (“Molekule”) is committed to the highest standard of ethics throughout its global offices and worldwide consulting staff. Molekule neither has active, pending, nor prior litigation or litigious activity against it as a legal entity.

As a firm, Molekule strictly complies with all global, regional and local laws and regulations. Molekule abides by all SCIP rules, regulations and guidelines, globally, across all office locations and human capital resources. Furthermore, no Molekule representative ever misrepresents, or discloses client names.

Molekule leverages iterative and intensive desk and field research efforts based upon informed primary competitive research to deliver actionable and meaningful engagement results in support of our client partners.

Molekule maintains thorough nondisclosure and confidentiality of all client-specific materials and all intelligence and intellectual properties developed are strictly protected under client confidential NDA/CDA.

PRIMARY RESEARCH CONDUCTED BY MOLEKULE GAINS TIMELY AND ACTIONABLE INSIGHTS INTO CRITICAL HEALTH, INDUSTRY AND PHARMACEUTICAL ISSUES.

Interviews are proactively performed with key KOLs, regulators (global), payers, and and other relevant industry stakeholders as a means of developing robust competitive insights into the overarching competitive biopharmaceutical landscape.

Leveraging a robust and actively growing organic global stakeholder network, including relationships with well-placed clinical, commercial, regulatory, manufacturing and supply chain logistics sources affords Molekule Consulting the ability to comprehensively address identified key intelligence topics and questions set forth by our client partners across all relevant proactive monitoring and responsive ad hoc research streams.

Molekule’s robust and growing organic source network spans > 20,000 contacts, globally. We foster persistent source development via active project engagement and the regular attendance of global medical congresses and biopharmaceutical trade shows.

Further responsive ad hoc interviews are performed at the request of our client partners addressing specific questions allowing defined and granular “drill-down” into specific issues and/or queries.

Molekule’s consultants engage in true “peer-to-peer” conversations with key targeted respondents as a means of gleaning insights into competitor strategies, tactics, pricing and methodologies.

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MOLEKULE CONSULTING 2016 10

SeeThe Molekule Difference

Understanding the complete engagement team from planning and kick-off to its completion is critical to a project’s success. At Molekule, we understand this holistically. At Molekule we understand the holistic nature of the project and how it fits into your business.

Molekule’s robust, organic, growing and global >20,000 person covntact network

Our experienced consultants are strategically matched for each engagement by Molekule senior management who oversees the engagement until it’s completion

We facilitate ongoing two-way communication with our client partners enabling better engagement and overall business outcomes for our client partners

Molekule always goes beyond expectations transcending beyond the norm for our client partners.

After all, our team is made up from former industry professionals who understand how to use CI to positively impact your business goals and objectives. Our focus on quality stems from a multi-factorial approach including, but not limited to:

From the moment we receive a request for proposal/quotation (“RFP” / “RFQ”) to the fulfillment of all engagement deliverables exceeding our client partner’s satisfaction, Molekule provides world class and differentiated primary CI research and consulting to biopharmaceutical, medical device and life sciences clients, globally.

We methodically respond to RFPs in a detailed and intricate fashion, corresponding to Molekule’s commitment to robust client centricity and best-in-class primary competitive intelligence research. Following this, we openly communicate with our prospective client partners as a means of establishing the rationale and reasoning as to why Molekule is the intelligent choice for primary CI partner.

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MOLEKULE CONSULTING 2016 11

ExperienceThe Molekule Difference

Once firmly engaged, Molekule and its client partners formally kick-off engagements with either in-person on-site or virtual kick-offs via WebEx. We seek to comprehensively understand the basis and reasoning of your hypotheses and base knowledge so we may springboard and either prove or disprove these data points as “valid” or “invalid.”

While engaged with Molekule, our client partners receive world class and robust two-way communication. Our commitment and ongoing communication to our client partners is evidenced by Molekule’s efforts to keep engagements moving seamlessly.

Our leadership team is committed to you because we understand the pressure you are under - we are industry veterans driven to facilitate actionable strategic intelligence outcomes in support of our client partners.

We guarantee a unique and differentiated value proposition at Molekule – one where you and your organization will robustly benefit and return marked ROIs on seminal business objectives and goals.

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MOLEKULE CONSULTING 2016 12

UnderstandThe Molekule Difference

Molekule differs from the norm, which typically disengages upon final deliverable presentation. That is simply not the case with Molekule. Our goal is to ensure your expectations are exceeded and your organization ultimately sees significant added value. Molekule has earned a reputation as a trusted and valued consulting and primary competitive intelligence partner – we have earned this due to exhaustive, meaningful and granular actionable primary competitive insights and intelligence into the overarching biopharmaceutical and life sciences landscape.

Molekule seeks to be your trusted and valued consulting primary competitive intelligence partner of today and tomorrow. We work with our clients in a client-partnership, rather than a “pure play” client-vendor relationship, so as to extend our mutual understanding of one another’s organizations. In so doing, Molekule and our client partners establish a sense of appreciation for each other, as well as a mutual confidence factor.

Our client partners continue to re-engage Molekule for continuations and renewals on engagements and via word-of-mouth have extended our relationships within their own broader organizations. Furthermore, via strong and reliable recommendations, and an established track record of success, Molekule continues to grow its client base whilst not assuming conflicts of interest within the same therapeutic area or disease space.

“TACTICS WITHOUT STRATEGY

IS THE NOISE BEFORE DEFEAT”

– Sun Tzu The Art of War

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MOLEKULE CONSULTING 2016 13

Our Expert Source NetworkGlobal, Growing & Organic

Molekule’s robust organic global source network continues to actively grow via the regular attendance of global medical congresses, industry trade shows and worldwide consultancy project engagement. We foster long-standing “peer-to-peer” relationships with key sources as a means of facilitating positive client outcomes and goals during project engagements — small and large.

International KOL

National KOL

Regional KOL

Local KOL

Academician

Physician

Scientist

Other Academic, Clinical, Scientific & Medical Sources

Global Regulators

National Regulators

Regional Regulators

Local Regulators

Payers

Wholesalers

Distributors

Pharmacies (Retail & Hospital)

Third-Party Enablers

Sales & Marketing

Commercialization

Executive Leadership

Manufacturing

Research & Development

Clinical/Medical Affairs

Scientific Affairs

Regulatory Affairs

Brand Management/ LeadershipStrategy & Operations

Management

Supply Chain/Logistics Business Development

Market Research & Analytics

Other Competitor

Functional Roles

KEY OPINION LEADER (“KOL”) / CLINICAL / ACADEMIC /

MEDICAL SOURCES

COMPETITOR EMPLOYEE SOURCES

(CURRENT & RECENTLY FORMER)

REGULATOR / REGULATORY SOURCES

OTHER SOURCES

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MOLEKULE CONSULTING 2016 14

2012

2013

2014

2015

2016

3 Year Longitudinal Competitive Intelligence OutcomesFrom Therapy Area X - Timeline Overview

Date Reported to Client

Date Intelligence Materialized

Competitor X to unveil and leverage new global marketing campaign at key global therapy area

conference

Competitor R to develop aggresive

follow-on molecules in “therapy area X portfolio

approach” via both in-house R&D and licensed

molecule approach.

Competitor R to develop novel, co-formulated dual moiety biologic

pipeline therapy leveraging high potential

proprietary academia and

biotechnology partnership

EMA and PMDA to favorably respond to competitor P’s MAA

and NDA, respectively, enabling competitor P to launch product M in 3Q’14 (EU) and 2Q’15

(Japan)

Competitor Y will initiate broad range of label

extension and lifecycle management (“LCM”)

clinical trials

Competitor C to re-organize field support of blockbuster brand

L, reducing sales rep headcount while

increasing MSL and KAM resourcing driving a

“softer sell” of brand L

EU

JAPA

N

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MOLEKULE CONSULTING 2016 15

MOLEKULE CONDUCTED COMPREHENSIVE LANDSCAPE MONITORING

Inclusive of:– Congress Coverage– KOL Interviews– Competitor interviews– Regulatory Stakeholder Interviews– Payer Interviews

Our client faced near-term direct competition from both generic and novel FDC HIV ARV assets

In support of a Top-10 ethical MNC biopharma player, Molekule conducted a comprehensive landscape monitoring of the HIV market for FDC ARV generics – either direct ANDA competitors to established brands of novel FDCs of generics components. We worked with a Director of Strategic Planning to assess the impact and implications of generic threats to established ARV agents, as well as novel FDC ARV agents.

Molekule Case Studies: In Support Of ATop - 10 Ethical MNC Biopharma

SITUATION

ACTION

RESULTS

Molekule accurately identified a short list of key generic competitors poised to enter the FDC ARV market. Accordingly, our client was able to correlate its manufacturing of product to scale with the forthcoming genericization, conterring significant cost savings to our client.

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MOLEKULE CONSULTING 2016 16

Molekule Case Studies: In Support Of ATop - 5 MNC Ethical Pharma

Our client sought high value antibiotic targets for in-licensing, acquisition and/or partnership.

Molekule was engaged by a Top-5 MNC U.S.-based ethical pharmaceutical player to conduct a targeted assessment of the market dynamics and associated implications of novel antibiotics and associated potential licensing partnerships/ agreements in select markets including the U.S., Big-5 EU and Japan. Our client was an Associate Director of Business Development and Licensing and the overall engagement enabled our client to elucidate BD&L opportunities in the U.S., Big-5 EU and Japan markets for key antibiotic assets.

Molekule assessed a wide-spanning universe of potential BD&L targets and opportunities. We winnowed this universe to high and moderate potential opportunities. Thereafter, we developed a short-list of warm, high potential BD&L targets, which our client’s BD team pertomed internal due diligence and negotiations.

MOLEKULE CONDUCTED A BUSINESS DEVELOPMENT & LICENSING DUE DILIGENCE TARGETED CI ASSESSMENT

Inclusive of:– KOL Interviews– BD&L Target Interviews– Congress Coverage

SITUATION

ACTION

RESULTS

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MOLEKULE CONSULTING 2016 17

Molekule Case Studies: In Support Of ASpecialty Biopharma

Our client is engaged in the highly competitive IBD space and needed a focused and robust universe of KIT/Qs answered to better address emerging competitive dynamics.

Molekule was engaged by a specialty gastroenterology player to conduct comprehensive congress coverage of the UEGW and ACG congresses in support of a blockbuster anti-TNF asset. Our client was a Senior Manager of Global Competitive Intelligence; engaging together, Molekule depicted clear answers to the client’s high, medium and low priority KIT/Qs, enabling the client company to position itself for robust success in the gastroenterology space, forward-looking in the U.S. and EU.

Molekule furnished our client high impact, accurate, timely and actionable strategic insight and intelligence leveraging congressess as venues flush with high value human source resulted in our client hardening competitive pinch points and elucidating blind spots.

MOLEKULE WAS ENGAGED TO CONDUCT COMPREHENSIVE CONGRESS COVERAGE

Inclusive of:– Congress Coverage– Competitor interviews– KOL Interviews

SITUATION

ACTION

RESULTS

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MOLEKULE CONSULTING 2016 18

Molekule Case Studies: In Support Of AMajor EU Biopharma

Our client wanted to understand competitive commercial strategies across global mid-sized biopharmaceutical players.

Molekule was engaged by a large cap EU-based biopharmaceutical player to conduct a targeted assessment of novel strategic implementation models across mid-sized (i.e.- $300MM – $750MM market capitalization) biopharmaceutical players approaches to global market access and go-to-market strategy. Our client was a Senior Director of Marketing Analytics and Business insights.

Partnered together, Molekule and client developed keen insights and market intelligence regarding middle market capitalization competitors’ global market access and go-to-market access strategies, worldwide.

MOLEKULE WAS ENGAGED TO CONDUCT A TARGETED CI ASSESSMENT MARKET ACCESS & GO-TO-MARKET STRATEGY ASSESSMENT

Inclusive of:– Competitor interviews– Internal Stakeholder Interviews– KOL Interviews

SITUATION

ACTION

RESULTS

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MOLEKULE CONSULTING 2016 19

Molekule Case Studies: In Support Of ATop - 3 MNC Biopharma

Our client sought market intelligence regarding competitive blunting strategies and tactics across key players and markets

Molekule was engaged by a global Top-3 ethical MNC biopharmaceutical player to conduct an elucidation of competitor strategies and tactics that are leveraged to driver and/or blunt market uptake and traction of novel biopharmaceutical products in North America, LATAM and the Big-5 EU markets. Our client was a Senior Manager of Global Commercial Insights.

Molekule developed clear, concise and actionable intelligence regarding the drivers and key factors leverageable to blunt market uptake and traction of competitor novel biopharmaceutical assets in North America, LATAM and Big-5 EU markets.

MOLEKULE CONDUCTED COMPETITIVE LANDSCAPE MONITORING & CONGRESS COVERAGE

Inclusive of:– Competitor interviews– Internal Stakeholder Interviews– KOL Interviews

SITUATION

ACTION

RESULTS

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MOLEKULE CONSULTING 2016 20

Molekule Case Studies: In Support Of ABoutique Biotech

Our client sought overall firm-wide diversification via a new business and commercial model.

Molekule was engaged by a niche/specialist U.S.-based biopharmaceutical company with a mid-sized market capitalization to develop a new business plan for strategic diversification from a “one-stop-shop” biopharmaceutical player into a diversified specialty pharmaceutical company. Our client was a VP of Global Strategy.

Partnered together, Molekule and client developed a concerted growth and development plan including decisive diversification for the client across three (3) key therapeutic areas of potential pipeline growth opportunity.

MOLEKULE CONDUCTED A COMPETITIVE CORPORATE STRATEGY ASSESSMENT

Inclusive of:– Internal Stakeholder Interviews– External Competitor Stakeholder Interviews– Subject Matter Expert Interviews– Therapy Area Expert Interviews

SITUATION

ACTION

RESULTS

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MOLEKULE CONSULTING 2016 21

Client Testimonials“It takes a lot of coordination and effort to drive home consistency and quality in terms of high impact deliverables and high quality, accurate and precise intelligence. The folks over at Molekule Consulting have an amazing ability to do that time in and time out.”

– Associate Director, Global Commercial Strategy, MNC Biopharmaceutical Company, U.S.

“There are few and far between [competitive intelligence] agencies that do the job ethically and right - collecting solid intelligence findings and reporting it properly, strategically and actionably. Molekule Consulting does just that - after 23 years in the industry on the client-side, inside the walls of Pharma, I can wholeheartedly endorse the Molekule [Consulting] team.”

– Sr. Director, Global Competitive Intelligence, Major Pharma, Europe

“I must compliment Molekule [Consulting] on their ability to develop sources and track down individuals, globally, who are difficult-to-reach. As a firm, Molekule [Consulting] can develop some of the best primary [competitive intelligence] out there and they synthesize it quite well. Their deliverables are well refined and to the point of a ‘MBB-style’ consultancy.”

– Director, Global Commercial Insights, Top-5 Pharmaceutical Company, U.S.

“The dedication and real, two-way communication between the Molekule team and us was stellar - and helped better fulfill the engagement objectives, significantly. Communication is key in any services industry - even down to the consultancy level - and they knocked it out of the park in terms of the intelligence and deliverables - when you get that synergized with the communication, it is great!”

– Associate Director, Competitive Strategic Insights, Top-10 Biotech, U.S.

“It takes a lot of coordination and effort to drive home consistency and quality in terms of high impact deliverables and high quality, accurate and precise intelligence. The folks over at Molekule Consulting have an amazing ability to do that time in and time out.”

– Director, Business Analysis and Insights, Top-15 Biopharmaceutical, U.S.

“Wargaming may no longer be politically correct – but let us be true – it is a war game. Strategy workshops conducted by Molekule Consulting are standout – they are well prepared and facilitated. The level of engagement with our internal key stakeholders was extreme and the key take-homes was solid. Overall, I was very impressed with the job the Molekule group did and would definitely re-engage with them”

– Sr. Manager, Top 5 Global Pharmaceutical Company, Switzerland

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MOLEKULE CONSULTING 2016 ALIGNED INTELLIGENCE. FOCUSED RESULTS. 22

MOLEKULE CONSULTING

OUR CONSULTING & SERVICES OFFERINGS

Blinded Illustrative Output FromMolekule Project Engagements

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MOLEKULE CONSULTING 2016 23

The Importance Of Therapy Area X ToCompetitor Strategic & Tactical Plans

Strategic Importance Tactical Importance

Competitor Product-a Franchise-b Corporate Product-a Franchise-b Corporate

Competitor 1

Competitor 2

Competitor 3

Significant

1 – Represents overall broad-based importance to product, franchise, and corporate levels

2 – Represents specific tactical importance (i.e.- what initiatives competitors take to promote products or combat/blunt competitors)

a – Represents the aggregate of all brands within the competitor’s therapy area x portfolio

b – Represents the entirety of the competitor’s Therapy Area X portfolio

Moderate

Insignificant

EXHIBIT S

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MOLEKULE CONSULTING 2016 24

The Psoriasis Disease StateThe Fundamental Opportunity Assessment

Sources indicate opportunity exists in both the broad-based dermatologic therapeutic area, as well as in the psoriasis disease state for new biologics entrants and marketed products.

LOW HIGH

HIGH

LOW

“I recognize there are many available good medicines for the treatment of psoriasis; however at the same time, we as psoriasis prescribers need newer and more robust treatment modalities to add to the overall armamentarium – there is huge potential to be realized here”

– KOL

Prescriber’s loyalty toinnovators/marketers ofpsoriasis assets – in-lineand pipeline

Psoriasis KOLs (composite of n=21 interviews conducted @ EADV 2014)

PA general disparity exists between KOL and non-KOL psoriasistreating dermatologists with respect to the psoriasis opportunity; KOLs are more bullish on psoriasis, whereas non-KOLs are more bullish on the dermato-logic therapeutic area as a whole

Non-KOL biologic prescribing psoriasis treating dermatologists (composite n=24 interviews conducted @ EADV 2014)

Strength of innovators/marketers of psoriasis assets – in-line and pipeline

X

1 – A composite hybrid matrix of qualitative and quantitative of psoriasis non-KOL high volume biologic prescribingdermatologists for the treatment of psoriasis interviews conducted at the 2014 EADV congress

EXHIBIT T

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MOLEKULE CONSULTING 2016 25

EXHIBIT Q

Rationalizing Therapy Area Competitive Landscapes Elucidates Strengths, Opportunities, Weaknesses and Threats

Note: Competitor 1 and 2 are considered standouts among rheumatologists due to overt initiatives performed to garner enthusiasm. Although their respective RA assets in the EU28 are considered “mature…” rheumatologists claim Competitor 1 and 2 continue to drive measurable excitement via new initiative development on a yearly basis

“Competitor 1 just seems to get what I want to have happen and every year they drive new and transformational programming for prescribers who treat RA. Humira is a great drug and when they [Competitor 1] come to the gate with new offerings and programs to boot, how can they be beat?” – KOL, The Netherlands

12

High Impact of Competitor New Commercial Offerings

Low Impact of Competitor New Commercial Offerings

Low Impact of Competitive Asset Label Expansion

High Impact of Competitive Asset Label Expansion

6

54

37

1. Competitor A2. Competitor B3. Competitor C4. Competitor D5. Competitor E6. Competitor F7. Competitor G

In-line RA Player Pipeline RA Player

(Note: approved for non-RA indications)

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MOLEKULE CONSULTING 2016 26

Key Intelligence Findings Competitor 1 Therapy Area X New Commercial Models

Competitor 1 New Strategic

Initiative NameProspective Rollout Date Description Key Representative Verbatim

Initiative 1 1Q/2Q’15

A benchmark metrics program, subsidized 50:50 between Competitor 1 and the physician office - enabling physicians to see where their office benchmarks relative to other practices in terms of overall efficacy and turnover

“Physicians will be able to clearly be able to see where their respective office and the [healthcare providers] who practice there benchmark versus other offices and physicians in terms of overall efficiency – how long they spend with each patient – how much money they are being reimbursed, lots of other variables and factors like those”

- Sr. Manager, Strategic Customer Solutions

Initiative 2 2Q’15

Patient Engagement System- enables patient to be engaged by physician offices via iOS (i.e.- iPhone/iPad) and/or Android-powered devices via their respective App Stores

“Initiative 2 is something really neat and novel – it enables the patient to be engaged by the physician office – imagine a patient who hasn’t been in contact with the office for quite some time, this solution bridges the gap between engagement, EHR and EMR and reaches out to them automatically either via push notifications on their iPhone, iPad or Android device, or via email or phone. It also enables a seamless two-way communication between the patient and the office staff regarding outstanding questions and issues, maybe about prescriptions or the like”

- Sr. Manager, Strategic Customer Solutions

Initiative 3 3Q/4Q’15Patient referral app for iOS and/or Android powered devices

“This is an iPhone, iPad and/or Android-specific app that is downloaded from the App Store on the user’s device free of charge. Patients can make referrals to a specific provider for their friends, family or colleagues with this program – it highlights physician loyalty”

- Sr. Manager, Strategic Customer Solutions

Initiative 4 2H’16

Behavioral Training solution for HCP offices – defines office staff and patient personality types

“We received from a wide number of respondents the need to communicate well – and to speak the same language among the office staff, [healthcare] providers and patients and their caregivers. So to do so, we are launching Initiative 4 in 2016 to validate and assess the personality types of office staff, as well as patients and their families and caregivers. Personality [types] will be rated from A-F [A,B,C,D,E and F] and specific matches will be made to ensure alignment and proper communication so that fewer things are lost in translation”

- Sr. Manager, Strategic Customer SolutionsEXHIBIT U

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MOLEKULE CONSULTING 2016 27

EXHIBIT X

Competitive Commercial Manufacturing andScalability Dashboard

MAXIMUM API 1 CAPACITY

Competitor 3 ~50 MT

Competitor 2 ~25 MT

Competitor 9 ~10 MT

Competitor 10 ~7.5 MT

Competitor 12 ~30 MT

Competitor 7 ~10 MT

Competitor 13 ~5 MT

Competitor 5 ~25 MT

The approximate tonnage of API 1 produced globally by competitors is ~175 metric tons

Competitor 5, Competitor 3 and Competitor 13 represent the 3 manufacturers with large capacities and abilities to scale up… smaller manufacturers are limited to smaller capacities and no scalability.

COMMENTS

• Competitor 7 produces API 1 at its Montreal, Canada based facility, but sources a bulk of its API 1 from Competitor 3

• Competitor 5 produces API 1 in Andhra Pradesh, India at a facility with approximately 300% up-scalability relative to current capacity

• Competitor 12’s API 1 is produced in Reykjavik, Iceland at a facility with approximately 125% up-scalability relative to current capacity

• Competitor 13’s API 1 is produced in Andhra Pradesh at a facility with ~65% up-scalability

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MOLEKULE CONSULTING 2016 28

A “Representative Community” of EU28 Psoriasis Prescribers – Needs, Wants & Aspirations

“Psoriasis pharmaceutical companies are not all bad, but they certainty are not all good. I personally and we as dermatologists have multiple unmet needs to care well for the psoriatic patient, but so too do we have dimensions we strive for. Pharma, please help us!” – KOL, Belgium

NEEDS• Reduce relative cost of psoriasis biologics to a more “reasonable,”

customer-friendly price

• Drive long-term investment into public/academic psoriasis clinical and translation research

• Foster the growth of overall psoriasis disease state awareness and understanding among non-medical professionals

WANTS• Understanding the interplay among pharmacos and striving for

industry-psoriasis HCP transparency

• Facilitating novelty in terms of initiatives and programs sponsored by leading psoriasis pharmacos will “bridge the gap” for prescribers

• Leverage an EU28 centralized model for psoriasis biologics than a geography- or country- variant model

ASPIRATIONS• Seek better overall relationship with industry – necessitates

“partnership for tomorrow”

• Wants to link data transparency via open-access psoriasis clinical data consortium

• Keen on understanding pharmacos’ lifecycle management and long-range planning to be aligned in terms of how to better manage patients in the long-term

NEEDS

WANTS

ASPIRATIONS

EXHIBIT Y

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MOLEKULE CONSULTING 2016 29

Country Current and Planned Manufacturing Capacity Device Activity-a

China

• Competitor 1’s Tianjin plant expansion project was officially completed in 2006; capital expenditure was approximately RMB 200 million and expansion of floor space was ~40,000 square meters

• Competitor 1moved its worldwide production line of Competitor 1Pen 3 from Denmark to Tianjin in 2006; bulk insulin imported from Denmark)

• The Tianjin facility possesses GMP certificate for small-sized packages

• Competitor 1will switch production from Competitor 1Pen 3 to Competitor 1Pen 4 in March 2013

• Competitor 1produces Competitor 1Pen 3 at the Tianjin facility for China and export to the regional A-P markets

• All other devices are sourced from Denmark and imported into China for local packaging at the Tianjin facility

India

• Competitor 1plans to launch a $100 million insulin fill/finish production plant in 3-4 years (planned staffing of 100-120 headcount)

• The future plant will support Competitor 1’s leading market share in Russia as well as exports in CIS countries

• API and devices to be imported

• Currently Competitor 1supplies only ready-for-use forms (in devices) of insulin in Russia which comes in from Denmark

• Pens/cartridges will be imported from Denmark (no local production of pen/cartridge is planned) for the new facility

Russia

• Currently operates a bulk insulin production facility in Montes Claros

• Product is shipped to Denmark for global market sourcing and re-importation.

• Plant for cartridge filling will have an annual capacity of 200 million units by 2012

• A new $50 million plant is under construction and will come on stream by YE2013; it is highly likely that this facility will produce pens to be sourced locally and to the worldwide market

• Devices are currently imported into Brazil from Danish manufacturing facilitates

Competitor 1: Manufacturing facility descriptionChina & Russia are the only EM countries with any current production...Russian facility on stream by 2013 or 2014

Note: In all other markets, products are imported into local markets from Danish manufacturing facilities in finished form

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MOLEKULE CONSULTING 2016 30

Competitor 1: Supply chain for emerging markets Competitor 1’s sources its insulins in a ready-made form from denmark across all EM-8 geographies

Brazil

Competitor 1 is constructing a new manufacturing facility north of Minas Gerais which will have cartridge filling capacity

Mexico

Turkey

Poland

China

Competitor 1’s Tianjin plant produces competitor 1 Pen 3 and fill/finish capacity for China and AP region years

Russia

Competitor 1 plans to build a fill/finish production facility for insulins, which will be completed within 3-4 years

API/bulk insulin

Source site for Insulin and/or API

Finished Product

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MOLEKULE CONSULTING 2016 31

Competitor 1: Planned headcount expansionsManufacturing capacity investments target China, Russia and Brazil with major long-term R&D investment in India

CountrySales Force Marketing R&D Mfg Comments

China

• Plans to expand overall headcount from 1700 (2008) to 3000 by 2012

• Beijing R&D staff to increase to 150 staff• Tianjin manufacturing headcount to increase

from 350 to 500 staff by 2012

India Competitor 1’s sales force in India is to increase headcount by 50 to support Victoza launch

Russia

Competitor 1 intends to increase its investment in Russia manufacturing; however, does not intend to increase headcount across sales, marketing and R&D

Poland There are no plans to increase headcount in the Polish market

S. Korea Competitor 1 plans to increase sales force headcount to increase share of voice for Levemir

Turkey There are no plans to increase headcount in the Turkish market

Mexico Presently, there are no plans to increase headcount in the Mexican market

Brazil Brazilian manufacturing facility is actively expanding headcount throughout 2012-2013

Country

2014 or beyond expansion plans

No expansion plans

2012/2013 Expansion Plans

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MOLEKULE CONSULTING 2016 32

Competitor 1: Local market portfolioCompetitor 1’s focus is on transitioning key markets to analogs and expects to roll out its GLP-1 in China and India this year

Country

InsulinAna-

loguesHuman Insulin

GLP-1Analog

OralAnti-

diabetics Comments

China

• Full range of analogue and human insulins with 2012 launch of Levemir

• A regulatory decision regarding Victoza is currently pending

IndiaCompetitor 1’s diabetes portfolio includes Human Mixtard (30/70 & 50/50). Actrapid®, Novomix®, NovoRapid® and Levemir®; Victoza

Russia Key diabetes brands include Levemir®, NovoRapid®, NovoMix® 30, Glucagen®, Hypokit® and NovoNorm®

Poland Key diabetes brands include Mixtard®, Insulatard®, Actrapid®, Novorapid®, NovoMix® and Levemir®

S. KoreaKey diabetes products in S. Korea include Novolet®, Novolin®, Insulatard®, Innolet®, Insulatard HM®, Mixtard®, NovoRapid®, NovoMix® and Levemir®

TurkeyMarkets human Mixtard®, Actrapid®, Insulatard®, Insulatard®, Novomix®, NovoRapid®, Levemir® and Repaglinide®

MexicoMarkets an insulin portfolio consisting of Levemir®, Novolin 30/70, Novolin N, Novolin R, Novomix 30 and Novorapid

BrazilCompetitor 1’s diabetes portfolio in Brazil includes Novomix®, Levemir®, Novorapid®, Novolin R, Novolin NPH®, Victoza® and Glucoformin®

Competitor 1 is clearly focusing on development of its newer analogue products and GLP-1 products. However, company recognizes that reimbursement differences will continue to drive human insulin “tail” products in most major markets in the near term

PORTFOLIO COMMENT

Significant

Moderate

Insignificant

Portfolio Focus

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MOLEKULE CONSULTING 2016 33

Competitor 1: Insulin activities in emerging marketsCompetitor 1’s near-term expansion plans in emerging markets clearly focus on China, Russia, India & Brazil

Significant active expansion of insulin business, including manufacturing and/or research

Incremental expansion of existing capabilities

No significant expansion

Brazil

New cartridge filling capacity on stream in 2012

Mexico

Turkey

Poland

China

• Doubling of headcount in 4 years

• New production and r&D

Russia

New production facility being built

India

Expanding commercial capabilities and major R&D investment

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MOLEKULE CONSULTING 2016 34

Emerging Market OverviewGlobal players have clearly focused investment priorities on markets with growth potential and/or access issues

Low

Incremental

MA

RK

ET U

PSID

E PO

TE

NT

IAL

NATURE OF INVESTMENT

Hig

h

New Capabilities

Poland

S. Korea

Mexico

Turkey

India

Brazil

Russia

China

Well penetrated, relatively static markets

Dynamic growth markets with high investment focus

• Market Access is a key driver for manufacturing investment in all markets

– Investments are being made specifically aimed at gaining - improving goverment support in Russia and China

• China appears to be also viewed as low cost manufacturing base and regional supply chain hub

– All three global players are making substantial investments

• Competitor 1 currently supplies API into its global supply chain through Brazilian facility and is adding fill/finish capacity

• India investment is more driven by access to low cost R&D and incremental commercial capabilities to drive market expansion

INVESTMENT DRIVERS

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MOLEKULE CONSULTING 2016 35

Executive Summary API 1

Although consistently of high quality, the impact of competitor-produced API1 differs based on geographical reach, potential scalability, and API1-specific strategic intent.

• Competitor 5 impacts the Client up and down the FDF 1 supply chain and has built a large capacity around production of API1

• Competitor 12’ large production capacity and scalability for API1 is of significance, as the company sells API1 worldwide

• Competitor 13 produces high quality API1 and currently sells to customers in India and Asia. Competitor 13 hopes to expand capacity and enter into ROW markets by 2014

• Competitor 3 represents a significant threat based on its capabilities and because it is currently the supplier to several ex-US markets

• Competitor 9 has a lower capacity of annual API1 and is a lesser threat as it doesn’t supply API to customers

Low

Low

QU

AN

TIT

Y O

F A

PI 1

PR

OD

UC

ED

QUALITY OF API

Hig

h

High

12

4

7

5

133

10

2

9

Note: Size of Circle is Indicative of Overall Competitor Impact

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MOLEKULE CONSULTING 2016 36

Source: Blinded Molekule Consulting Analysis, 2014

Asset AAsset BAsset CAsset D

Competitive Manufacturing and Supply Chain Map

API Mfg. Site

Global Wholesale Supply Distribution Hub

Fill/Finish Facility

Supply Chain Mapping is a Fundamental CI Exercise Enabling Clients to Accurately Predict Competitive Shortfalls and to Make Informed Decisions About Internal Manufacturing and Supply Chain Dynamics

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MOLEKULE CONSULTING 2016 37

Through Accurate Competitive Landscaping, Generics Players Envisage Clear and Concise Snapshots of the Current and Prospective Competitive Set with Respect to KIT/Qs

Generics Company

Origin of Gx Asset Manufacturing API FF Mktg cGMP

BE Status

Current Level of Gx Asset

Development

Player A Hungary/Israel • • • •

Player B CEE • • • •

Player C China • • • •

Player D South Korea • • • •

Player E India • • •

Player F India • • •

Player G LATAM • • • •

Player H India • • • •

Player I U.S. • • • •

Player J Canada • • • •

Planned Manufacturing Integration–a

Source: Blinded Molekule Consulting Analysis, 2014

a – For regulated markets

Complete

Currently Undergoing

Have Yet to Begin

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MOLEKULE CONSULTING 2016 38

Competitor 1: Insulin Headcount by countryCompetitor 1’s focus on the potential opportunity in China and India is reflected in its relative staffing size

$ 169

69%

China India Russia Poland S. Korea Turkey Brazil Mexico

Insulin Sales,$ Millions

Insulin Market Share

$ 31.1

12%

$ 66.1

64%

$ 138

48%

$ 113

59%

$ 19.9

32.4%

$ 97.4

54%

$ 31.1

38%

Mktng

Manufacturing

Sales

Clinical / R&D

0

500

1000

1500

2000

2500

HE

AD

CO

UN

T

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