Scenario Analysis Planning for Phase III Results

3 Scenarios, 2 Months, 1 Message



Phase III data lock in sight? Your internal scenario analysis starts now. That’s three scenarios, two months in advance, one unified message. The three scenarios may be overwhelming efficacy, modest efficacy and insufficient efficacy. Each scenario analysis should consider the primary endpoint data, preliminary views, interpretation of the possible results and an explanation of next steps. Considerations include statistical significance, patient results, regulatory implications and commercial relevance.

3 Scenario Analyses Your internal scenario analysis begins with the statistical boundaries that frame the three levels of efficacy – overwhelming, modest and insufficient. Outcomes include the goal of the study, number of patients, FDA protocol, primary endpoints and statistical methodology. Below this top-line overview are the bullet points specific to each outcome – the statistical results, the interpretation and implications for the study. Under message development, the points are the words that will be used to convey the results. Is this a “new treatment option” for which you now have “the confidence to proceed”?  Or maybe the trial “did not meet its primary end point” and there are “additional analyses” and “realignment of resources” needed.

2 Months in Advance With data lock in sight, evaluate the statistical boundaries that frame the three levels of efficacy – overwhelming, modest and insufficient. Each of these levels will need appropriate interpretation for all stakeholders. This is also the time to identify impacted audiences – patients, caregivers and advocacy groups; employees and partners; KOLs and investigators; scientific and medical media; investors and financial media. The message development must include key proof points that support the overarching message pillars and channels of communication for each. What parts of the website need updating and who will be responsible? Is there print collateral that should be developed, presentations to create and/or refine?

1 Unified Message It’s critical to begin an integrated communications plan with a well-developed methodology. This ensures message development across all possible outcomes and communicated to all stakeholders. The announcement of top-line data results is too important to leave to chance. Start early and plan thoroughly for high efficacy message impact.

LaVoieHealthScience is all-in for biotech and pharma with 15 years’ experience delivering strategic communications for life science companies. Contact us today to learn more about how we help our clients ensure appropriate communication of Phase III results.

Get the Most Out of Your Perception Survey: 5 Top Tips

BethKurth1Beth Kurth
Senior Counselor
Investor Relations

First you have to listen.  Investor relations professionals know the importance of listening to the investment community.  To tell a story well, it’s important to have audience feedback.  Therefore IR pros know the Perception Audit is an important piece of every investor relations program.  Is the management team well-regarded, does the company strategy make sense, are the financials in alignment?

At LaVoieHealthScience, we routinely conduct perception audits and are sharing our 5 top tips to conduct an audit and generate actionable insights.

Who to target?  Spread the net wide for the Perception Audit. Buy- and sell-side, holders and non-holders. This means reaching out not only to investors who have initiated a position, but also to those who have declined further interest. The best insight comes from understanding the viewpoint of those who like you and those who do not. For every responder, we estimate you’ll need 8 targets.

Questions to ask?  Questions should be targeted to gain insight into the company’s management team, products, pipeline, go-to-market strategy and financial metrics.  Importantly, life sciences companies have a distinct landscape that includes science, regulatory and clinical metrics. Be sure to ask when was the last time you heard the company story, what changed your view on the company, and how you prefer to get updates on the company.

Is it possible for an IRO to conduct a perception audit?  It is, but just not of your own company. It’s best when a third party conducts the perception audit. Not only will investors provide more candid feedback to a third party, but also an independent company will provide more forthright recommendations. Let’s face it, the point of the audit is to use the feedback in a meaningful way going forward. Which firm to use? The best firm to use is the one that understands your company’s ecosystem. This is critical because the most useful feedback is obtained when the person conducting the audit can ask insightful follow-on questions. “Why do you like that add-on therapy? How do you see it becoming the standard of care?” As a corollary, the most useful recommendations are also based on knowing your company’s industry, investors and opinion makers.

Timing an audit?  Some companies conduct an audit every year or two to see how investor perceptions change over time. A periodic study will capture changes in perception around your company, sector and overall market.

Management teams frequently make biased assumptions about how their company or product messages are perceived. A formal survey can serve as an essential reality check. With a candid view of investor feedback and deep insight into the life science market, we are able to make actionable recommendations to our clients.

Contact us today to start a dialog on how to ensure that your communication and IR program are on track to build recognition, maximize sales and optimize value for your health science innovations.


Conference Strategy Planning


As the fall/winter investor conference season winds down, it is time to strategize and plan for future conferences during the remainder of 2016. Companies should optimize their time and budget by aligning their conference strategy with their corporate goals.

First, let’s take a look at the decision-making process on attending conferences.

      • Who should attend from your company?
        • Investor:  CEO, CFO, IRO
        • Partnering:  CEO, Marketing, CSO
        • Medical:  CEO, CSO
      • What is your goal in attending?
        • Seeking Partner(s)
        • Raising capital
      • Where is the conference being held?
        • Does the location of this conference fall within your budget?
        • Could you combine this trip with a meeting in the same area with one of your stakeholders?
      • When does this conference coincide with a major announcement or corporate goal?
        • Announcing big news at a conference can gain additional publicity
      • How is your presenting officer prepared to tell your story?
        • Develop your story in 15 – 18 slides targeting two types of meetings:
          • One on Ones
          • Group

Next, research the conferences that meet your basic criteria. LaVoieHealthScience offers a comprehensive list of investor, partnering and medical conferences that you can find here.

Investor Conferences
If you are looking to increase your company’s visibility among potential investors for an upcoming IPO, additional capital raising or attracting new investors, attending investor conferences will maximize your outreach efforts. Online partnering offered by many conferences enables you to target potential investors who are attending the conference and conveniently set up one-on-one meetings helping to ensure a full schedule of meetings upon arrival at the conference.

Partnering Conferences
Perhaps your goal this year is to is to find a partner to help you develop or market your product. These conferences match those looking to develop or market their products with those companies looking to invest in future products.  Many times investor conferences also attract those looking for partnering opportunities.

Medical Conferences
If you plan to achieve a major milestone in your product development pipeline this year, unveiling the news during a medical conference can optimize your exposure to stakeholders on the cutting edge of the medical area where you are working.  These conferences may also be a good option if you are developing products in a particular therapeutic area, and you are looking to build relationships with key opinion leaders (KOLs) and advocacy organizations in that area.

For additional resources as you develop your 2016 conference plan, check out our resources on:

Lastly, if you are looking to consider all of your conference options for 2016, download our comprehensive conference calendar here and check back for updates throughout the year.

Thought Leadership Series on Public Speaking

LaVoieHealthScience, sponsored by the Biotechnology Industry Organization, produced these videos to help you prepare your conference presentations and improve your public speaking style.

Watch these videos as you put the finishing touches on your presentation for the upcoming life science conferences.

The LHS Fifteen-Slide Presentation™
Being a great scientist or a great business visionary is just not enough; you must also be a great communicator to a diverse group of stakeholders. Develop 15 well-crafted slides to tell your company story.
Video 1

Public Speaking Strategies for the CEO
Learn and practice the most effective public speaking techniques, and let your authenticity and passion for the company shine through your speeches.
Video 2

Creating Your Elevator Pitch
Create a compelling elevator pitch that summarizes the basic facts about your company and customizes to appeal to the listeners, make a memorable impression, and reach your business goals at the upcoming life science conferences!Video 3

For more information on maximizing the company presentation experience, download our LHS whitepapers here.

An Effective Health Science Company Presentation in 15 Slides

CEOs of health science companies are asked to do it all!15 Slide GraphicBeing a great scientist or a great business visionary is just not enough; you must also be a great communicator to a diverse group of stakeholders – investors, customers, partners, suppliers, regulators, attorneys, employees, doctors, patients, caregivers and advocacy groups.

Communication is an art acquired only from years of learning and practice. Donna LaVoie, President and CEO of LaVoieHealthScience, describes the best practices to develop 15 well-crafted slides to tell your company story.

For more information, download the LHS White Paper. Complete the form below and hit “Next”.

Please fill out the required fields below.

If you follow these recommendations, we are confident that you will effectively communicate your key messages to engage your key stockholders and achieve your goals. We at LaVoieHealthScience are ready to work with you to make you a better presenter if you want to engage experts to craft your message, train your spokespeople and set expectations.


Public Speaking Strategies for the CEO

Successful leaders and inspiring business executives must be expert public speakers, letting their authenticity and passion for their company shine through.

The art of public speaking is an acquired skill. Anyone can become a better public speaker by learning and practicing the most effective public speaking techniques.



Biotechnology Industry Organization has asked LaVoieHealthScience to develop a series of videos to help the thought leaders of healthcare companies communicate better with their stakeholders. In this video, Donna LaVoie, President and CEO of LaVoieHealthScience, describes best practices to refine CEOs’ public speaking skills for more effective communication.

If you follow these practices, we are confident that you will become a better public speaker and deliver your thoughts to your stakeholders more effectively. We at LaVoieHealthScience are ready to work with you to make you a better public speaker.

The JP Morgan Healthcare Conference Is Coming—Is Your Corporate Presentation Ready?

Where did the year go? We’re heading into the fourth quarter, and it’s already time to begin planning for 2016. That means the annual confluence of biotech/pharma/healthcare financial conferences in San Francisco.
Whether you are participating in the JP Morgan 34nd Annual Healthcare Conference, the Ninth Annual OneMedForum or the Eighth Annual Biotech ShowcaseTM 2016, it’s time to review, refresh and reinvigorate your corporate deck and your delivery. LaVoieHealthScience is pleased once again to provide some friendly advice and reminders to ensure a successful trip to the West Coast.

Over the next few weeks, we will be sending you three whitepapers and videos that the Biotechnology Industry Organization asked us to create. They will help you prepare your conference presentations and improve your public speaking style. The Fifteen-Slide Presentation will show how you can communicate the essence of your company’s message in just 15 slides. The Elevator Speech will help you create a 60-second pitch about your company to use at your many upcoming networking events. And The Basics of Public Speaking will show you how to capture your audience’s attention and interest most effectively.

We hope these tools will help you communicate your company’s unique message, regardless of the setting.
We’ll see you in San Francisco in January! Check back with us late in January for follow up after the San Francisco conferences. Contact us with any questions or if you need help!

Can Social Media Help You Meet Your Organization’s Communication Goals?

LaVoieHealthScience joined communications pros from around the world at the IPREX Global Leadership Conference and discussed – in person – how to help our clients with digital content and social media. The top 3 social media outlets are: Linked In, Twitter and Facebook.  If you’re not using them, you may want to reconsider. Here’s how:

Get started.  Start by thinking about your target audience:  What are management’s priorities and who are they trying to reach?  Investors, advocacy organizations, customers, media, potential and existing partners as well as the general public.  Today’s world is built by fostering relationships with these target audiences, and social media can help your organization communicate with these target audiences.  Also, don’t forget to check out what your competitors are doing.

Think about each audience and what they would like to hear from you.  Asking and listening are much more important than talking.  Investors want to hear about how your development projects are coming along, what your plans are to raise more capital and whether you will meet your financial projections.  Advocacy organizations want to hear about what you are doing to support their cause and lend your expertise to further develop visibility in that particular disease area.  Customers want updates and more information about the product or technology they are buying.  Existing partners want to hear about how the product they are involved with is progressing.  Potential partners want to know about complementary expertise in their specific disease areas.  The general public wants to know how your advancements are changing the world in your particular disease area.

How can you achieve your communication goals through social media?  Let’s consider your target audiences and what you can send their way that would address their needs.  Investors might like to hear about a milestone or quarterly financial results. Advocacy organizations might want to hear about the scientific paper you are presenting at an upcoming medical/scientific meeting.  Customers might like to hear about new enhancements to an existing product although you need to keep in mind the FDA Best Practices for Internet and Social Media Promotion.  Check out our FDA Best Practices for Internet and Social Media Promotion, Part 1 and Part 2.  Existing and potential partners might like any updates about the organization and/or its products.  The general public might like to know about any medical and scientific meetings where you are presenting and any advances you are making in a particular disease area.

How can you measure your success?  It is not about quantity.  It is about quality.  Are you addressing your target audiences’ needs?  Use Google Analytics (because it’s free) to figure out whether you reached your social media goals and try to link new trends back to your social media outreach.

Digital is an essential part of everything we do today.  Take advantage of this opportunity by building a relationship with your target audience through social media today!

social media-resized-600

Initial Public Offering: A Fleeting Thought or a Fast-Moving Plan

Last year was a record year for biotech with the NASDAQ Biotechnology Index up 65.61% and the S&P Biotech Index up 48.4%.  Performance in the biotech sector beat out the S&P 500 which was up 29.6% and NASDAQ which was up 38.3%, both of which were at record highs.

This year got off to a hot start, too, with 29 life science companies going public in Q1.

Still, many companies thinking about it remain on the sidelines due to past volatility of the markets, demands of “living in a fish bowl,” and the costs associated with being public.

If you’re thinking about it, here are some things to think about:

ipo infographic

Preparation Phase. Choosing your partners can take a few months. Investment bankers will help determine fair value for your company and its brand, choose the ideal time to go public and conduct due diligence to verify the financial information, your market and technology/product story to determine how it will resonate with investors. Legal counsel leads SEC filings and responses, corporate governance issues and contracts. Corporate and public relations counsel will provide a roadmap for building value for your health science innovations such as how to craft messaging around corporate milestones and dissemination and coverage. This phase is about storytelling and connecting your brand to the right stakeholders that matter to you most.  The right investor audiences are important in this phase but so are the influencers with whom investors rely on for their information such as Key Opinion Leaders in the medical community.

Registration Phase. Considerations in choosing the right exchange for you should include stock liquidity, process and timeline of going public, valuation, regulatory environment and the listing standards and fees.  You will also want to come up with the company story for your roadshow.  You should be prepared to tell a compelling equity story with a clear message about how IPO proceeds will be used to fund growth and how your strong management and advisory teams are positioned to bring success in the future.  Is your message clear, consistent, sustainable and supportable?  Speaking of management, identify your company spokesperson and consider training that individual to improve on their verbal and nonverbal communication skills.

Marketing Phase. Bankers will be training their salesforce to sell your stock and you and your CFO will hit the road.  The roadshow, where the bankers will take your senior management team on a whirlwind tour, will begin, and the bankers will start to build the order book where they will compile a list of interested buyers.   At this point you will also want to get investor relations professional’s input on investor allocations.

Check out our next blog about developing your communications process post-IPO.

That Damn Agency! Achieving ROI

With the IPO boom in biotech and healthcare, more small-cap companies from pre-IPO through commercialization stage are incorporating public relations and/or investor relations into their corporate strategy. But many companies are not 100% happy with their agency relationship; hence: “that damn agency”!

There are a few things to consider when engaging with an investor relations and/or public relations partner, or reevaluating a current relationship, in order to maximize your return on investment. By putting time and thought into the process, you will be more satisfied with the end results.

What do you want to achieve from IR/PR?
Many companies employ an IR/PR agency to check a box without identifying what they want and how to achieve it. It is important that you and your board have a clear understanding of the company’s goals and communicate them to your agency partner. Your agency partner can help create the strategy, define the deliverables and ways in which to use research and analytical tools to measure progress over time.

Does the firm understand your world?
Your firm should spend time in your field, understand and have relationships with media, investors, analysts, advocacy groups, and the key opinion leaders that matter most. Be sure this firm understands your company, its background, the product(s) and their unique selling position, the technology platform and market. This is fundamental to ensuring your IR/PR partner can build an effective communications program for you. Your firm should be digging deep and showing a genuine interest in what you do. After all, you and the firm are investing in the relationship for long-term success.

Know who you will you be working with day-to-day.
Be sure you talk to and meet with the actual team that you will be working with. This will give you a better understanding of the team you are buying. Generally speaking, small firms are staffed with industry experts and have deep experience despite being small. If you want strategy, a small firm may provide you with what you need versus a larger firm may provide more arms and legs.

Make your IR/PR partner part of your company and they will become your advocates. Keep your IR/PR partner in the know and make them part of the team. Make sure you like each other. It’s a long journey and you want to enjoy the ride and get value from the firm you select. The more informed members of the team are, the better they are able to provide creative ideas, strategic counsel and metrics that mean something.

How much is your budget and does it match your goals?
Understand what you are paying for and the billing structure. With industry normal budget allocations for your effort (based on stage of development and expected outcome), you are sure to achieve success. Achieving a major business milestone is sure demonstration of the value. Ask about other case studies of like firms.

Agencies Love Good Clients and Perform Better. Be prepared to invest in the agency relationship and be a good client. Good clients – a client that truly partners with their IR/PR teams – get more from their agencies. Trust the firm has the experience to take you through your upcoming milestones and reach your goals. Make them a true partner and stay engaged in the relationship so you can maximize the relationship to achieve your goals.roi-graphic