5 Reasons Organizations Connect Their File Sync and Share Platforms to a Data Room

Posted by ShareVault on Feb 10, 2017 7:09:16 AM

FSS_image_1.jpgFile sync and share services have become an essential business tool. These cloud-based storage services began as a simple way to access personal files from any computer, tablet or smartphone but have quickly evolved into very important tools to access, share and collaborate on business documents. For sharing sensitive documents, they also connect into secure virtual data rooms, giving organizations control and confidence that content shared cannot be forwarded and can easily be digitally shredded. 

As an example, launched just ten years ago, Dropbox now reports having more than 500 million users in 200 countries who upload over 1.2 billion files every day.

Why have these cloud-based file sharing storage services become so popular? One of the reasons, no doubt, is due to the extent that today’s organizations collaborate with third party businesses such as partners, vendors, investors, board members, regulatory agencies and auditors. There is more connectivity in the modern workforce, meaning that the ability to collaborate is even more essential. 
FSS_image_3.jpg

In today’s increasingly borderless enterprise, file sync and share platforms (FSS) have become a preferred method for synchronizing files across devices and for sharing and collaborating on files with colleagues across the organization. They’ve made many business processes more efficient and employees more productive.


However, because file sharing platforms lack the ability to maintain control of content after it's been shared, they become inadequate when sharing confidential or sensitive information with parties outside of the organization. Once documents are shared, the recipients have permanent access to those documents, and you’ve lost control. So, when it becomes necessary to share confidential information with third parties, such as during due diligence, a more robust platform, such as a virtual data room, is required.


Virtual data rooms secure documents at all times, even after they’ve been shared. They offer the ability to set up granular document permissioning, giving users different levels of access and allowing you to revoke access, even after documents have been downloaded.

5 Reasons Organizations Connect

Their File Sync and Share Platforms to a Data Room:

#1 SEAMLESS INTEGRATION

Blend the convenience of your file sync and share platform’s simplicity with a virtual data room’s enterprise-grade document security and document organization tools. Simply choose the folders that need to be synced to the data room for external sharing, and the powerful sync engine will start its work, assuring that the contents are always kept current with the source folders. The hierarchical structure within the data room mirrors the structure of the synced FSS folders.

#2 ORGANIZATION

It's common for different departments within an organization to use several document sharing tools to store content. This often creates extra work when you need to consolidate documents for due diligence activities, an audit or to share information with board members. You are left trying to find documents across document sharing platforms. Virtual data rooms solve this because you can sync content directly from multiple file sync and share tools - Dropbox, Box, SharePoint - into the VDR, making it easy to keep track of essential information.

Virtual data rooms also organize documents in a logical hierarchy with auto-numbering and provide powerful search features so documents are easy to find and review. And, if users have permission to print documents, they can “batch print” in the order of the data room index complete with a table of contents and section separators.

#3 SINGLE PANE OF GLASS FOR ALL OF YOUR SENSITIVE CONTENT 

Organizations often connect secure virtual data rooms to their file sync and share tools, so they can give 3rd parties access to content in a simple and secure way. You can add several connectors to aggregate content from various organizations on a single “pane of glass,” so your outside users can access one web application to securely view documents from multiple platforms.

#4 DOCUMENT CONTROL

When files are shared via a virtual data room, you maintain complete control over those documents. You get to decide what the end user has permission to do - your document has an electronic leash on it.  A virtual data room's security policies include the ability to add customizable watermarks to documents, prevent saving and printing, block screenshots and “remotely shred” documents even after they’ve been downloaded.

 

#5 REAL TIME USER ACTIVITY REPORTING

Virtual data rooms allow you to monitor user activity in the data room, including specific pages viewed, time spent reading and IP address tracking. This enables you to see the full user journey and gauge which content end users are most interested in.


In a world where the media reports security breaches on a daily basis, it has become increasingly critical to ensure that sensitive business documents are completely secure when shared with third parties. With ShareVault, you can share sensitive corporate information in Box, DropBox, SharePoint or Office 365 while still maintaining control over the documents.

ShareVault-Connector-Diagram-5.jpgWith seamless integration, ShareVault's connectors enable users to aggregate content from different organizations, so their external users can log into one online repository and securely access content from multiple cloud-based platforms.

The ShareVault connectors require no additional software to be installed and enable users to automatically synchronize file structures from their existing FSS platforms to ShareVault, where they then enjoy all the security features that ShareVault provides, including the ability to prevent saving and printing, the application of customizable watermarks, blocking screenshots and the ability to “remotely shred” documents, even after they've been downloaded.

 

Learn More About ShareVault Connectors  

 

Topics: Secure File Sharing

The Seven Deadly Sins of M&A

Posted by ShareVault on Feb 8, 2017 11:01:39 AM

headers_vaultseries.jpg 

 VAULT STARdavid_stastny.jpg

DAVID STASTNY,

Managing Director of Centaur Partners

KNOWS HOW TO AVOID THE PITFALLS OF THE M&A PROCESS

  

Vault Series: Why do you think that companies are often undervalued during the M&A process, or that deals fall through completely?

David Stastny: Too often, technology companies seeking a profitable exit make the flawed assumption that the due diligence process resides solely in the hands of the buyer. This assumption can lead to fatal mistakes that can undermine value, slow the process, or even kill the deal. The truth is, as a selling company, you have an enormous opportunity to shorten due diligence timelines and maximize the value that the buyer assigns to your company. The trick is to avoid what I call the Seven Deadly Sins of M&A.

 SEVEN DEADLY SINS of M&A

#1 Failure to Validate Value to the Buyer

Of all the deadly sins, this is the most important. Can you provide the evidence to support the buyer’s business case to purchase your company? 

In all M&A deals there will be a sponsor at the buying company whose job is to create a business case for buying your company. If you don’t understand that business case, and if you can’t assist that internal sponsor in developing that case and presenting it to their support team, then the deal will likely never get off the ground.

It is crucial that you understand your company’s value in the hands of a potential buyer and be able to articulate the synergies your company will bring to theirs. 

#2 Failure to Prove Ownership of Intellectual Property

Often company executives are unaware of what’s in their code base—what they own, what they don’t own, what they have rights to transfer or not transfer, or what third-party technologies they are utilizing. Not having a firm grasp of your intellectual property can have serious ramifications on deal timing and deal success. Most top technology acquirers will demand an audit of your code base to determine that you own everything in it and that you have the right to transfer it. 

#3 Unresovled Litigation

Are there potential lawsuits or litigations that could surface during due diligence or after the deal is announced? It’s not uncommon for the due diligence process to reveal litigation exposure that the owners of the selling company were not even aware existed.

These exposures could relate to IP, customers, former or current employees or even company practices that are no longer in use. Don’t fool yourself: If your company is facing any real or potential lawsuits they will be exposed during the due diligence process likely resulting in reduced value.

#4 Discrepancies in Financial, Accounting or Operational Planning

Can your company face the scrutiny of a public company audit? Many small companies can’t. If your company is acquired by a public company, your company will be subjected to a public company audit. Any unidentified exposure in revenue recognition, booking, or deferred revenue practices will directly reduce your deal value at least dollar for dollar. Are your forecasts credible and consistent? Do you have any taxation issues? If you can’t credibly present your financial picture to a potential buyer, you throw your credibility into question - at best delaying a deal, at worst killing it.

#5 Failure to Validate Company Agreements

One of the frightening realizations you may experience when attempting to sell a company is that buyers will require you to produce all of your company agreements entered into from the very first day you started doing business.

These could be vendor agreements, customer agreements, employee agreements, or any other type of agreement you’ve entered into. The buyer will be interested to see if these agreements are all signed and that you’re not in default or out of compliance with any of them.

It’s important to take a complete inventory of these agreements and ensure that nothing is missing, incomplete or inaccurate.

#6 Unresolved HR or Employee Liabilities

Ensure that all your employee records and contracts are in order, current, signed and organized in a virtual data room for review. It’s of particular importance to ensure that proprietary rights agreements are current and in order. If there are proprietary rights agreements that apply to ex-employees and they are not current or in order, tracking down those ex-employees in the midst of the due diligence process can be a nightmare.

Ensure that you've kept up best practices for employee reviews, performance improvement, bonuses and termination. If you haven't, there’s a potential for litigation. It’s amazing how many employee disputes will arise during the deal process.

#7 Sloppy Corporate Governance

When scrutinizing your company a buyer will want to know how your company’s processes, customs, policies, laws and institutions impact how it is controlled. They’ll want to know the nature and extent of the accountability of the participants in the business as well as the relationships among the stakeholders and the goals by which the company is governed. When corporate governance policies are incomplete or sloppy, it causes delays in the due diligence process and is costly to tidy up. Do it ahead of time. Make sure everything is complete, organized and available for review in a virtual data room.

Remember today’s buyers are ruthless when it comes to due diligence, so it’s imperative when entering into a potential transaction to be organized, thorough, and to ensure that nothing the buyer might be interested in seeing is inaccurate or missing.

Read M&A Best Practices White Paper

ABOUT DAVID STASTNY

David is the Managing Director and Founder of Centaur Partners, LLC, a rapidly growing, premier M&A investment banking boutique. The Centaur senior team has completed $5 billion of M&A and $1 billion in private placements during their financial advisory careers. Their partner, Dresner Partners, maintains offices in Chicago and New York. They provide financial advisory services to middle market companies throughout the world, including institutional private placements of debt and equity, merger and acquisitions advisory, financial restructuring and valuations. Centaur and Dresner have combined their focus on mergers and acquisitions and private fund raising transactions to expand distribution to their clients.

Topics: M&A

The 10 Most Common Fallacies of BioPharma Partnering

Posted by ShareVault on Jan 31, 2017 11:59:59 AM

Today's biotech companies are increasingly recognizing the importance of aligning with strategic partners to advance their drug candidates to market. But how does the small biotech partner effectively? According to Linda Pullan, PhD, of Pullan Consulting, partnering successfully requires knowing how to play the partnering game, starting with deciding when you should partner, then understanding the partnering process both from your perspective and the partner’s, clearly defining what it is you want from a deal and having an understanding of alternatives, and then reaching out to a variety of partners in order to find one that best fits your needs.

Partnering_Process.jpg

Sounds easy, right? Well, with more than twenty years of drug industry experience, Linda has seen her fair share of mistakes made along the biopharma partnering path. As a result, she's compiled what she believes are the ten most common fallacies, or false assumptions, that are made during the partnering process. Here they are:

FALLACY #1: Later is Always Better

It would be logical to assume that the farther your drug is along the development path the more value you will get in a deal. But typically, the biggest deals with disclosed deal terms are those with Phase II data, not those deals signed with Phase III data. Data shows that both upfront payments and total deal values are bigger for Phase II deals than for Phase III deals.


biotechnology.jpgFALLACY #2: You Can't Partner at Pre-Clinical

Although deals done during Phase II typically see the biggest numbers, that doesn’t mean partnering earlier isn’t feasible. Many deals are done early. In fact, roughly 50-60 percent of deals done in recent years were done at pre-clinical or discovery stages. 

FALLACY #3: Novelty is Key

Novelty is great, but if your drug is truly novel, communicating your story becomes more challenging. Partners need to understand a lot of the biology before they invest in the development of your drug. If your drug is novel, that means creating that narrative from scratch rather than referring to existing literature or competitor’s data. Novelty can be an advantage, but realize it comes with greater challenges in providing all the needed information in a clear narrative.

FALLACY #4: Good Science Speaks For Itself

Yes, strong science can speak for itself, but often being able to appreciate the implications of that science is difficult. As a young company, you need to clearly tell your story in a way that is compelling and resonates with potential partners. This story must be powerfully conveyed from the very first point of contact.

FALLACY #5: No is Always Bad

It hurts to be rejected. You’ve worked hard on your asset and it’s disappointing to be told that someone isn’t interested in it. But the truth is, you need to evaluate the fit of a partner just as a partner needs to evaluate the fit of your opportunity. A small company should not spend its time pursuing partners who won’t do a deal, just as a big company shouldn’t spend time pursuing things that don’t fit their strategy.

dollar_sign.jpgFALLACY #6: Get to Talking Dollars Fast

Negotiations begin the moment you start talking, and moving quickly is almost always advantageous. However, you don’t want to start talking dollars before you know the scope of what is included and how the partnership will be structured. Typically, financials come after diligence is completed. Diligence is a big resource commitment and is the process that leads to a partner’s understanding of the value proposition. If terms are exchanged before diligence, the due diligence process will inevitably reveal issues, which can result in a reduction of terms. Generally, it is best to let the due diligence process play out before talking financials.

FALLACY #7: Ask For Everything

Sometimes small companies, knowing there will be compromises, will start by asking for the moon. This can be a good way to lose credibility and may make the other side walk away before they’ve even had the opportunity to understand your asset. Be sensible. Yes, ask for more than you expect to get, but don’t go crazy.

FALLACY #8: If We Lower The Price, We Can Get a Deal

Big companies are very willing to pay top dollar for what they perceive as a top opportunity. In contrast, a low price generally does not increase the probability of a deal. There is some point where no matter how cheap an opportunity becomes, it’s still not perceived as attractive due to too much uncertainty or risk. The industry is remarkably price insensitive for opportunities it wants and doesn’t see a lower price as driving deals.

FALLACY #9: We Already Know The Best Partner

Having a pre-conceived notion of the perfect partner for your opportunity can be a mistake. The public persona a company projects does not always reflect the current thinking inside the company. Often a single employee can influence a decision. Maybe the company has a new VP with a new vision or a past bad experience in your area. Sometimes a company’s past failure can look like an opportunity for your asset as their solution, when in actuality that experience has made them reluctant to pursue that area at all.

FALLACY #10: If We Could Just Talk to the CEO

Talking to the CEO might be effective if you have a relationship with that person. Otherwise, you risk being perceived as a nuisance and getting funneled off to the Business Development person who would have handled it in the first place. If you have a real connection, by all means take advantage of it. But don’t pester people you don’t know and remember that there is a process.

To learn more about successful biopharma partnering download ShareVault's free white paper by Linda Pullan, PhD, "How to Win at the Partnering Game."

Download the White Paper  

Topics: BioPharma

Share Outside the Box

Posted by ShareVault on Jan 24, 2017 9:26:19 AM

 
The Difference Between File Sync & Share Platforms & Virtual Data Rooms

Share_Outside_the_Boc.jpgBusiness file sync and share platforms (FSS) are great for sharing files with your business colleagues for collaboration. They’re also great for storing and syncing files across devices, and they offer best-of-breed features for collaborative authoring and editing. But these generic file sharing platforms, like Box and Dropbox, evolved from consumer-grade file sharing and consequently lack the features needed to maintain control of content after it's been shared.

Once a document has been shared, file sync and share services give recipients permanent access to the documents, and you have lost control. Because they lack the ability to "remotely shred" a file through Information Rights Management (IRM), solutions like Box and Dropbox offer significantly less control over shared content compared to some virtual data room providers. They can only protect your document while it remains within their storage cloud. Once the document has been shared with another user, the security ends. Contrast that with full-featured virtual data rooms that secure your documents at all times, even after they have been shared, by verifying, tracking, enforcing permissions and even being able to revoke access to documents after they've been downloaded.

In addition, full-featured virtual data rooms allow fine-grained control over the organization of your documents. You can use drag-and-drop to set the order of folders and files, as well as auto-numbering to quickly assign a decimal index to your hierarchical structure. Such features are expected for structured document review processes like due diligence.

If you’re sharing documents for collaboration with trusted internal users, then a file sync and share product like Box or Dropbox might be an excellent choice—that's what they were designed to do, and they're really good at it. Box offers comments, tasks, version history, controlled collaboration, deep integration with Microsoft Office for direct editing of content, and the Box API that enables so many third party solutions to integrate with Box.  This rich feature set allows Box customers to develop best practices for document-centric collaboration.

The matrices below show the many differences in features between file sync and share platforms (FSS) and a full-featured virtual data room.

Note that not all virtual data rooms are full-featured. Make sure you ask the right questions when making your technology selection as the features with astrisks by the check mark may not be supported.

Document Control

Virtual data rooms were designed to protect and control documents throughout the due diligence process, even after they've been shared or downloaded to a third-party computer. You can designate who gets to see what, apply dynamic watermarks to every page of a document, prevent printing, and disallow screen shots. 

With file sync and share platforms, documents can be deleted from folders by third parties, shared with others and, once accessed, kept on someone else's computer indefinitely. To ensure security, you need to trust the third party to properly dispose of the sensitive information, and to keep the document untouched in the file sync and share solution. In other words, once you share a document, it's out of your control. 

FEATURES VDRs  FSS
Information Rights Management for Remote Shredding green_check.png*  red_x.png
 Secure Print (prints to physical printers but not to PDF or TIFF) green_check.png  red_x.png
 Fully Configurable Document Security Policies by User, Group, Amount of Time and Viewing Permissions green_check.png*  red_x.png
Block Screen Capture, Even for 3rd Party Screen Capture Products green_check.png* red_x.png
Dynamic Watermarking green_check.png red_x.png

 

Content Organization / Presentation

File Sync and share solutions were created for individual users to house content, share it and engage with it. Folders are often organized differently depending on the user. While that's fine for internal file sharing, external sharing for due diligence, fundraising, partnering and compliance requires more structure.  

A virtual data room allows you to present your documents in a structured, attractive and professional way for efficient and rapid review on multiple computers and devices, thus streamlining the due diligence process. A good virtual data room allows for users to search for documents quickly, preview documents via zoomable thumbnails and provide features such as infinite scrolling to speed the document review process. 

FEATURES  VDRs FSS
Hierarchical Tags with Permissions green_check.png  red_x.png
 Place a Single Document in Multiple Places in the Organizational Hierarchy green_check.png*  red_x.png
 Zoomable Thumbnails to Facilitate Searching and Quick Overviews green_check.png*  red_x.png
Infinite Scrolling to Minimize Clicking green_check.png* red_x.png
Instant Full-Text Search with Relevance Ranking green_check.png* Limited
Smart Filters for Advanced Searches green_check.png* red_x.png
Auto-Numbering of the Hierarchical Index green_check.png  red_x.png

Monitor User Activity

A good virtual data room can provide both page-level tracking and time-based monitoring of who's seen which documents, when and for how long, providing detailed audit trails for compliance and insightful business intelligence into a users' document review progress. Virtual data rooms are also equipped with powerful and flexible reporting tools, allowing administrators to quickly generate insightful reports about user activity in the data room. File sync and share solutions have no such capability.

FEATURES VDRs   FSS
Page-Level Activity Monitoring green_check.png*  red_x.png
Monitoring of Viewing Time green_check.png*  red_x.png

 Expedited Document Review

Virtual data rooms provide many other features designed to facilitate document review, such as the ability to batch download documents and batch print documents (complete with a table of contents, page numbers and separator pages for a professional presentation). Most virtual data rooms also have a Q&A module to further facilitate the document review process and to ensure that questions are posted in a secure environment and routed to the appropriate expert.

File sync and share tools also offer the ablity to comment on a document, and the ability to co-edit documents in the cloud. This is a huge value add as organizations have a larger ecosystem of co-collaborators and require tools to communicate with remote team members. However, file sync and share tools have little in the way of privacy policies for Q&A that enable you to communicate with select individuals within the document, without outside parties seeing.

FEATURES VDRs   FSS
Secure Batch Download green_check.png*  red_x.png
 Secure Batch Print with Table of Contents & Separator Pages green_check.png*  red_x.png
Inter-Document Hyperlinking green_check.png* red_x.png
Q&A with Privacy Settings & Threaded Discussions green_check.png  red_x.png

 

Fast and Easy Setup

File sync and share solutions are easy to set up, but they lack advanced features that are designed specifically for the document review process required during due diligence, such as the ability to automatically unzip large uploads and to automatically covert documents into PDFs. 

FEATURES  VDRs  FSS
Auto Unzip for Large Uploads green_check.png*  red_x.png
 Easily Audit Permissions with Simple Permissions Report green_check.png*  red_x.png
Automatic PDF Conversion from Hundreds of File Types green_check.png* red_x.png

 

Industry Specific Features

File sync and share solutions are "one size fits all." This may work just fine if you are sharing a video with someone to edit or are co-editing a manuscript. However, if you have a more complex process - like regulatory submissions - you may require a more advanced document sharing tool. File sync and share tools do not provide additional features that specifically cater to specific industry needs such as Life Sciences. 

FEATURES VDRs   FSS
Inter-Document Hyperlinking for eCTD Regulatory Documents green_check.png*  red_x.png
 Auto Conversion of SAS Analytics Files to Protected PDF  green_check.png*  red_x.png

Service & Support

A good virtual data room is easy to set up and intuitive to use; however, if questions arise, virtual data room providers offer 24/7 support complete with screensharing capabilities to quickly resolve problems. File sync and share solutions offer limited support. 

FEATURES  VDRs  FSS
Free 24/7 Support green_check.png  green_check.png 
 Free One-on-One Training  green_check.png green_check.png

*Not all virtual data rooms offer this functionality

Discover the differences of virtual data rooms. 

Topics: Secure File Sharing

What's the Role of Non-Immuno-Oncology in an Immuno-Oncology World?

Posted by ShareVault on Jan 18, 2017 12:01:16 PM

Jeff_Bockman_pic.jpg

An Interview with Jeff Bockman, PhD of Defined Health

Dr. Jeff Bockman, Vice President of Defined Health, has scientific expertise that encompasses a broad range of therapeutic disciplines. He also has a wide commercial and strategic perspective on the pharmaceutical and biotech industries and has directed hundreds of in-depth assessments of licensing opportunities and valuations. In an oncology world that is increasingly dominated by immuno-oncology therapies, we were curious to find out from Jeff if non immuno-oncology therapies will maintain a role in oncology's future.

Jeff will be a panelist in our January 26th web discussion on non-IO and IO partnering and development. Register to attend or receive a video of the web panel. 

What excites you most about the immuno-therapy landscape?

Well, it’s exciting because it's both a qualitative and quantitative change in how we think about and treat cancer, and it’s led to a major shift in resources in biopharma. The oncology drug development space has been shaken by the results that immunotherapy drugs have had to date.

This is the first wave, and immunotherapy drugs will continue to improve; their efficacy will increase, and there will be further learnings on dose and how to combine them with other Immuno-Oncology (IO) and non-Immuno-oncology (non-IO) agents for tolerability.

Of course, the range of different IO agents will not address all cancers in all patients. That’s why we are having our web panel discussion on non-IO agents because they can be very successful with recalcitrant forms of cancer. While the checkpoint inhibitors have proven very successful for subsets of patients across various solid tumors, and less so in heme malignancies, the adoptive, personalized therapies like CAR-T cells are having the most success in heme cancers and have been pretty unsuccessful to date addressing solid tumors. The limitations of current IO is changing to combinations, such as when checkpoint inhibitors are coupled with other IO and non-IO agents, but there is still a need to couple them with other treatment methods.

biotechmoney600400xx304-304-0-19.jpgIs there controversy in partnering non-IO with IO therapy methods?

On the one hand, there is the very logical tried and true oncology development aspect: layering on any new agent on top of a standard of care. There are a number of clinical development discussions where checkpoint inhibitors are being added on top of chemotherapy, radiation, small molecules or tyrosine kinase inhibitor (TKI) model combinations.

At the end of the day, one could argue that every agent that has been used successfully in oncology patients and has had good responses (although for limited duration) has been enabled, abetted, and improved by the fact that the immune system is being engaged. Therefore, the idea of using non-IO agents to work alongside the IO agents makes sense. Using these elements together will likely benefit more patients.

Do you think non-IO organizations in the oncology space have pressure to partner with an Immuno-Oncology therapy organization given the landscape?

The need for IO and non-IO partnerships are both practical and scientifically driven because of the obvious clinical results benefit of combining both IO and non-IO agents together.

It is true that funding organizations are spending less time lately looking at companies outside of the IO space, unless they have stellar preclinical data or frankly really meaningful clinical results. While there are still non-IO deals being done, the amount of money being put into the IO deals is so much more significant. The non-IO companies are repositioning and engaging in clinical studies to show that they have an effect on the immune system or are compatible with an IO agent.

Could anyone have predicted that Immuno-Oncology (IO) therapies would supplant the standard of care for oncology?

I speculate that people did not envision that IO agents would supplant standard of care frontline. Instead, they most likely thought that they would be used in later lines of therapy.

If you look at lung cancer, no one guessed that IO agents would work so successfully, yet low and behold it’s one of the largest markets and where most IO agents are approved. These checkpoint inhibitors are performing well as a frontline regimen, without the need for chemo.

In the past, everyone was very careful to avoid the word “cure” when discussing oncology treatments. Do you think that in the future, the word “cure” could be used in an oncology setting?

We should still be cautious. However, by combining IO agents with each other and with non-IO agents, we are far exceeding what the previous median survival rates were for a number of cancers, so people can now begin to talk about ensuring that these long, durable remissions be maintained and that more patients in more cancers can benefit from them. So the idea of developing a “cure” is now not so much about “in the distant future” but may in fact be in the foreseeable future.

Has the FDA kept up with this seat change?

If you look at IO development, there has been breakthrough designations and accelerated approvals: some agents have jumped from phase I to phase III. This has not been such a common occurrence, and I don’t know how much of this is driven by the nature of checkpoint inhibitors or is driven by incentives to bring these agents to market. Certainly both have greatly enhanced the speed of development. And the regulatory agencies have been very helpful in facilitating these quicker timelines.

To learn more about partnering non-immuno oncology in an immuno-oncology world, register for our January 26th 11am PST web panel: 

Register for the Web Panel

About Jeff Bockman, Ph.D.
Vice President, Defined Health
 
Jeff leads the Oncology and Virology Practices at Defined Health. Jeff has extensive commercial and strategic perspective on the pharmaceutical and biotech industries. He has directed hundreds of in-depth licensing opportunity and valuation assessments during his tenure at DH. He often speaks at conferences on scientific and commercial issues in cancer, biologics and personalized medicine.

Before joining Defined Health, Jeff was a Senior Research Scientist and Research Project Leader in the commercial development of oligonucleotide therapeutics for viral diseases and cancer at Innovir Laboratories; and an Assistant Research Professor at The George Washington University School of Medicine. He has worked closely with two Nobel Prize recipients: Dr. Sidney Altman on ribozymes, and Dr. Stanley Prusiner on prions, and holds four patents in the use of ribozymes.

He received a BA from University of California at San Diego, a PhD in Medical Microbiology from the University of California at Berkeley, and an MA in English/Creative Writing from New York University.

Jeff is a member of the Licensing Executives Society (LES), the American Association for Cancer Research (AACR), the American Society of Clinical Oncology (ASCO), the American Society of Hematology (ASH), and the American Society of Gene and Cell Therapy (ASGCT).

Topics: BioPharma

New Web Panel Discussion: Non-Immuno-Oncology and Immuno-Oncology Partnering and Development: What's the Role of Non-I-O in an I-O World?

Posted by Steve Joseph on Jan 16, 2017 9:37:27 AM

Thursday, January 26, 2017
11:00am - 12:15pm PST / 2:00 - 3:15pm EST


Sponsored by:

 Pullan-Consulting.jpg        bio-logo-2.png       DefinedHealthLogo.jpg

 

 

Non-IO-in-an-IO-World-4.png


In a web panel discussion offered by ShareVault in October of 2015 entitled, "What's Hot & What's Not in Immuno-Oncology Licensing" the panelists expressed robust optimism in this nascent, but very promising, field of cancer treatment. Although the I-O field of research was only four years old at the time, when asked how promising I-O was, one of the panelists stated, "I-O therapies are not just qualitatively different, but quantitatively different from anything we’ve seen before." And when the moderator observed that the majority of biotech companies seemed to be focusing on I-O research and posed the question, "What doesn't fit with I-O?" the response was, "If you're a small biotech company, the answer is, very little."

In our up and coming live web panel discussion, some of the same panelists will explore the role of non-Immuno-Oncology treatments for cancer in a world where Immuno-Oncology is eating up the lion's share of biotech resources. 

In this discussion, biotech licensing and pharmaceutical business development consultant Linda Pullan will be joined by four panelists who are business development experts from global pharmaceutical companies, a leading academic cancer center, and a top business development consulting firm. 

Synopsis of the Discussion:

The clinical success of checkpoint inhibitors has made Immuno-Oncology an amazingly "hot" area for pharmaceutical and biotech deal making. With checkpoint antibodies seen as backbones for combination therapy in cancer, many in Oncology are asking:

  • What is the role of non-I-O in an I-O world and can you partner a non-I-O opportunity?
  • Is there still room for new anticancer agents that are not working in I-O models?
  • Are drug candidates evaluated with the assumption that everything will eventually be used in combination with I-O agents? Or are there indications or mechanisms for which I-O will never be important? Should I pursue combinations with I-O?
  • What kinds of mechanisms are attractive in non-I-O? What data and models will big pharma want to see? Do I need to run experiments with their molecule? Are there certain tumor types that are particularly attractive?
  • Is it too late to try to compete in the crowded space of combination with PD1 antibodies? What other I-O agents are likely to be backbones of oncology franchises?
  • What will make my non-I-O drug candidate compelling for partners and investors?

We will ask the experts from industry and academia these questions and answer your questions as well. Come join us for this lively discussion on January 26th, 2017.

Register for the Web Panel

Moderator and Panelists:

Moderator: Linda Pullan, PhD | Pullan Consulting
Jeff Bockman, PhD | Defined Health
Peter Sandor, MD, MBA | Astellas Pharma
Axel Hoos, MD, PhD | GlaxoSmithKline
Eric Haura, MD | H. Lee Moffitt Cancer Center

To better prepare for this discussion, find out why immuno-oncology therapies are dominating the oncology world by reading our white paper, "What's Hot & What's Not in Immuno-Oncology Licensing."

Download the White Paper

 

Topics: BioPharma

The Top 5 BioPharma IPOs of 2016

Posted by ShareVault on Jan 10, 2017 4:39:11 PM

IPO_graphic.jpg2016 was not exactly the year of the IPO. There were fewer overall offerings in 2016 and the total value of the IPO market was far less than the previous year. However, the biopharmaceutical industry seemed to be immune to the rather stagnant IPO waters.

In fact, biopharmaceutical financings remained robust in 2016, ranking third for the most money raised in a single year for the last 20 years.

In 2016, the biopharmaceutical industry raised $37.3B compared with $37B in 2014. 2016 falls only slightly behind what many consider the industry’s blockbuster year of 2000, which raised $38B.

Note: The year 2015 brought in $68.6B, but that figure reflects huge senior notes offerings from Celgene Corp. ($8B), Gilead Sciences Inc. ($10B) and Biogen Inc. ($6B).

The two biggest IPOs occurred overseas on foreign markets and the largest IPOs conducted on US markets included two headquartered in foreign countries and one US-based company, all three debuting on the Nasdaq Exchange.

Here are the five biopharmaceutical IPOs that raised the most money in 2016:

Biologics_pics.jpgSamsung Biologics - $2B

Samsung Biologics is the biopharmaceutical arm of tech giant SAMSUNG Group. Just as Samsung Electronics makes chips for Apple’s iPhones, BioLogics seeks to capitalize on Samsung’s manufacturing prowess to make drugs for big biotech companies. In their initial public offering last November the company raised almost $2B (US) giving the company a total value of $7.9B.

The Korean company intends to spend about half of its IPO proceeds on a third plant, making it the world’s largest biologics drug-making operation. Biologics already counts Bristol-Myers Squibb and Roche as customers for biologics, which are made from living cells, blood components, and tissue, rather than chemicals.

China Resources Pharmaceutical Group - $1.8B

The next big IPO money winner last year was another foreign company, China Resources Pharmaceutical Group Ltd. The company raised $1.8 billion in one of the biggest Hong Kong initial public offerings of the year.

The company, which is controlled by a Chinese state-owned conglomerate, priced its IPO at 9.10 Hong Kong dollars (US $1.17) per share. The pricing was toward the lower end of an indicative range of HK$8.45 to HK$10.15 per share.

A group of ten cornerstone investors—who buy big chunks of shares and hold them for at least six months after the listing—took nearly half of the offering even before the pricing was fixed.

China Resources Pharma plans to use around 45% of proceeds from the offering to make acquisitions in China and to expand its pharmaceutical manufacturing and distribution businesses. The remainder will be used to set up more logistics centers and warehouses, invest in research, upgrade its technology systems, and repay debt.

wall_street_pic.jpgMyovant Sciences - $218M

The biggest biotech IPO of the year in the US, and perhaps the most famous due to the age of its founder, was done for Myovant Sciences when Vivek Ramaswamy, a 31-year-old pharmaceutical deal maker and drug developer, raised $218M for a company that he had formed only months earlier. The IPO values Myovant at around $878M.

Earlier in the year, Myovant obtained its only assets, a prostate cancer drug and a female infertility drug, both under development, from Takeda Pharmaceuticals. Ramaswamy did not pay any cash for the drugs, but instead Myovant issued Takeda 5.1 million shares, 12% of Myovant, and promised to pay a high single-digit royalty on Myovant’s net sales of both drugs.

The Myovant IPO caught the attention of Pfizer, which was reported to purchase as much as $30 million of Myovant shares in the IPO. Ramaswamy’s holding company, Roivant Sciences, owned about 64% of Myovant after the IPO.

CRISPR_pic.pngIntellia Therapeutics - $108M

Demonstrating that Wall Street believes in the promise of gene modification to treat diseases, Intellia Therapeutics of Cambridge, Massachusetts went public last year raising a reported $108M.

Intellia owns the rights to an important piece of the CRISPR-Cas9 gene editing technology, a unique technology that enables geneticists and medical researchers to edit parts of the genome by removing, adding or altering sections of the DNA sequence. It is currently the simplest, most versatile and precise method of genetic manipulation, and is therefore causing a buzz in the life sciences world.

Intellia joins Editas Medicine, also of Cambridge, Cellectis of Paris, France, and Sangamo Biosciences of Richmond, CA, as publicly traded biotechs using gene editing to develop their primary products.

BeiGene - $158M

The prize for the first IPO of 2016 on a US market goes to BeiGene, a Chinese drug company developing immuno-oncology drugs for cancer treatments. Early in the year, BeiGene sold 6.6 million shares at an issue price of $24, to raise about $158M.

Immuno-oncology is a unique approach that uses the body’s own immune system to fight cancer, and although still in its nascent stages, has already garnered extreme optimism in the biopharma world.

BeiGene has offices and facilities around the world, including global clinical headquarters in Fort Lee, New Jersey with additional clinical facilities in Australia, New Zealand, and Beijing, China, an R&D center in Beijing, a manufacturing plant in Suzhou, and operations in Beijing, Shanghai, and Boston, Massachusetts.

While election-year rhetoric has certainly added to the volatility of biotech stocks, most experts agree that biotech's 5- to 10-year investment story remains promising providing investors can weather the ups and downs. 

To learn more about how ShareVault facilitates the biopharma business development, fundrasising and M&A processes <click here>

Topics: BioPharma

What to Know Before IPO

Posted by ShareVault on Dec 27, 2016 8:00:00 AM

8 Things to Consider Before Filing an IPO

IPO_newbanner2016.jpgAccording to a Wall Street Journal article, signs are mounting that the moribund IPO market is gaining some momentum. The article cites that investors have shown “intense interest” in new shares that have come to market recently, especially in the tech sector. Bankers who market IPOs for a living, and investors who buy them, say such performance from a key sector sets up the overall IPO market for a rebound in 2017.

At a time when the economy remains sluggish, that’s good news. It may also be good news for companies considering an IPO, because in a torpid economy investors are more likely to pay higher multiples for a strong growth prospect.

But how do you know if your company is ready to go public?

The process for filing an IPO is time-consuming and expensive and should not be entered into lightly. And sometimes, companies that are doing wonders before being launched on the stock exchange suddenly enter a death spiral—think Facebook, Vonage and Pets.com.

Here are 8 things to evaluate before considering taking your company public:

#1 Is an IPO even feasible?

Image 2 - Is an IPO Feasible_ .jpgAccording to Sigma Prime Ventures[1], an investment firm based in Boston, the first thing any company should consider when thinking about an IPO is whether an IPO is even feasible. To determine the answer to that question, they recommend that four criteria be examined:

  • First, how big is the market and how fast can you grow? The bigger the market, the more money you can make and the more money you can make the faster you can grow. If your company has a huge market and room to grow, you’re a fourth of the way there.
  • Second, how disruptive is your product? Is your product a new way of doing something? The more disruptive your product is, the better. You want to stand out, you want to be new, and you want to change the way things are done.
  • Third, how predictable is the business model? If you can accurately predict how you will do in the future, whether quarterly or yearly, you have a huge advantage. Public market investors love quality, predictable earnings. If you can prove to investors your company will succeed, investors will buy your story, but more importantly, your stock.
  • And fourth, how much leverage do you have? What gives your company a competitive advantage? What asset does your company control that lets it gain more leverage over rivals as you grow? If you’ve got a real advantage, then you have the final solution to the IPO equation.

#2 What’s your value narrative?

Wall Street investors will want to know your company’s story, so you need to be ready to tell it. They’ll want to know your growth prospects and the kind of numbers you're going to produce. They're also going to want to know what you offer that your competitors don't, and what your long-term strategy is. Familiarize yourself with how your competitor’s shares, once they’ve gone public, have performed and learn from those experiences. According to Arlene Weintraub, in an article in Entrepreneur,[2] the most important factor when considering going public is to determine up front whether Wall Street investors will be open to hearing your company's story.

BrdDirectors.jpg#3 Is your board of directors in good shape?

There are a number of regulations that require that public companies have a majority of board members who are independent of the company. An “independent director” is one who the board affirmatively determines has no “material relationship” with the company either directly or as a partner, shareholder or officer of an organization that has a relationship with the company.[3] Keep in mind that after going public, a board is reflecting the interests of shareholders, as well as of the business, so it’s critical that they are unbiased and independent enough from the company in order to ask the hard questions.

Other factors to consider are whether the board of directors is the appropriate size for the company and if board committees have been established and charged with particular tasks, such as auditing and compensation.

Many experts suggest that the process of identifying and recruiting new board members should commence at least a year before filing for an IPO.

#4 Is your financial staff up to snuff?

Once public, the Security & Exchange Commission (SEC) requires that the company file quarterly and annual reports, as well as other periodic reports. In addition to annual financial reports, company executives must provide a narrative account, called the Management Discussion and Analysis (MD&A) that outlines the previous year of operations and explains how the company fared in that time period. MD&A will usually also touch on the upcoming year, outlining future goals and approaches to new projects. This public reporting is crucial for investors to make sound decisions when investing in the capital markets.

Because of the complexity of the SEC’s reporting requirements, IPO experts will usually recommend hiring a general counsel and an investor-relations specialist with experience in SEC reporting. And, if you plan to offer stock options to employees, you may need to hire human resources professionals with experience putting together benefits packages that include stock.

#5 Have you weighed the risks and benefits?

risk_reward.jpgThere are both risks and benefits associated with taking a company public. Before filing an IPO, the risks and benefits should be assessed.

Benefits

The benefits of going public include an infusion of cash derived from the sale of stock. This enables a company to grow the business without having to borrow from traditional sources and avoid paying interest to service debt. This “free” cash can be spent on marketing and advertising, hiring more experienced personnel who require lucrative compensation packages, research and development of new products and services, new construction and dozens of other programs that expand the business and improve profitability.

Stock can also be used as an effective incentive program for recruiting talented senior management personnel. For employees, a performance-based program of stock and or option bonuses is an effective means of increasing productivity and managerial successes.

Also, a publicly traded company conveys a positive image and may have more leverage when negotiating with vendors, thus reducing costs. Customers also usually have a better perception of companies with a presence on a major stock exchange.

Risks

The downside to filing an IPO is that, once public, all of the company’s finances and business operations are open to government and public scrutiny, which can sometimes be perceived as less than ideal. Once public, the company is subject to SEC oversight and regulations and all the reports that entails.

Additionally, board pressure for profitability each quarter can be a difficult challenge for the senior management team. Failure to meet target numbers or forecasts often results in a decline in the stock price.

Lastly, remember that preparation for the IPO is expensive, complex and time consuming. Lawyers, investment bankers and accountants are required, and often, outside consultants must be hired. As much as a year or more may be required to prepare for an IPO, and during this period, business and market conditions can change radically enough to change the decision about going public, thus rendering all the preparation work and expense wasted.

#6 Is it wise to “test the waters”?

toe-in-water.jpgIn April of 2012, President Obama signed into law the Jumpstart Our Business Startups (JOBS) Act. Title IV of the JOBS Act not only raised the threshold for dollar amounts that smaller companies could raise, but also provided a provision for companies to “test the waters.” This provision essentially allows companies to file their IPOs in stealth mode, get feedback from the SEC, and then conduct meetings with potential investors before the official “road show” all companies have before going public. It's an opportunity to determine whether an IPO is a good idea, without tipping your hat to competitors and without the pressure of making all your corporate information public.

#7 Are you prepared for the “road show”?

A road show is a presentation of securities an issuer makes to potential buyers. A company assembles a team of executives to travel around the country and present to large groups of institutional or big money investors. The goal is to portray the company as profitable and progressive and to generate excitement and interest in its offering. But the presentations must be factual and they can only be held after a company registers its intentions to sell securities with the SEC. Road shows contain details about a company’s financial outlook, its reasons for an IPO, the probable sale price and its potential for growth. Today, many companies hold road shows online and some may hold private meetings with investors before the offering.

The road show is a vital step in the IPO process because it may be the first and only time investors meet your company’s senior management face to face. And since institutional investors rarely visit the companies they invest in, they rely heavily on the information you present at your road show meetings. In fact, an EY study found that the strong majority (82%) of institutional investors worldwide cite the quality of the road show as a key non-financial measure in their buying decisions.

#8 Have you considered the alternatives?

Sometimes the cost of going public and the burdens of SEC reporting make the IPO process too daunting. According to the Wall Street Journal,[4] many companies today are losing the urge to go public, despite a buoyant stock market, choosing instead to be acquired by corporate or private-equity suitors. In some cases, they fear that having to answer to a diverse crowd of public shareholders each quarter—as opposed to a few private-equity executives—would prevent them from deploying capital quickly or from focusing on long-term goals.

cash.jpgIndeed, there is plenty of nonpublic money available. According to data provider Preqin, private-equity funds currently have over $1.46 trillion in uninvested capital. That’s up from $1.39 trillion at the end of 2015. And with large public companies looking to grow through acquisitions, many companies have decided that the best exit plan might be a sale.

For many companies, going public is a perceived natural path to success and a beautiful means of making money. But with so many IPO disappointments, it’s important for CEOs to enter into the process vigilantly and to learn from industry experts, such as iBankers, legal advisors and competitors. Providing all the pros and cons have been understood and evaluated, and all the inherent risks assessed, if circumstances are right, an IPO may open profitable new opportunities for a company ready to be publicly traded.

 

[1] http://www.sigmaprime.com

[2] https://www.entrepreneur.com/article/227487

[3] https://en.wikipedia.org/wiki/Independent_director

[4] http://www.wsj.com/articles/companies-embrace-ipo-alternatives-1479169231

 

 

Topics: M&A

Maximizing Value, Minimizing Risk: Business Process Integration, Part II [webinar]

Posted by ShareVault on Dec 20, 2016 8:00:00 AM

MAintegration.pngThursday, January 12th, 2017

11-12 PDT | 2-3 EDT | 7-8 GMT

ShareVault is pleased to invite you to a new webinar in our "M&A Best Practices" series of resources. This webinar will provide 2017 market predictions and dive deeper into M&A integration strategies to ensure you maximize the value of your M&A. This is a continuation of a discussion that took place in February of 2016.

Register For Webinar

Webinar Overview:

Successful integrations often depend on establishing a common set of core business processes early in the integration phase as part of the target operating model. 

In this webinar, Manish Dabas and Elias Eliadis of Ernst & Young will discuss ways to plan and implement process integration to maximize value. From decades of experience consulting at Big Four firms, they will bring to life successful process integration methodologies and share lessons learned from recent large transactions.

This webinar will cover the following topics:

  • Industry Trends & 2017 M&A Market Predictions 
  • Challenges & Best Practices in Acquisition Integration
  • Process Integration Methodologies that Lead to Successful Integration for business processes including:
    • Procure-to Pay
    • Order-to-Cash

Register For Webinar

About the Presenters:

Manish Dabas - Profile.jpgManish Dabas
M&A Senior Manager, EY LLP 

With 13+ years of experience in strategy, large scale transformations, lean programs, digital technology and innovation across financial services, retail, healthcare and high tech industries, Manish has lead many successful post M&A integrations.  

Prior to his work at EY (formerly Ernst & Young Manish worked for the Boston Consulting Group (BCG) for seven years for various Fortune 500 companies and other privately-held and private equity backed companies as a turn-around expert with focus on IT & Operations topics. He holds an MBA with high distinction from University of Michigan's Stephen M. Ross School of Business and a B.Tech in Electrical Engineering from IIT Delhi. 

 

Elias-Eliadis.jpgElias Eliadis
Manager, EY LLP 

Elias Eliadis is a Manager in the Operational Transaction Services practice at EY LLP in San Francisco. He has 15 years of Business and Operations experience that includes M&A and Strategy consulting at Big Four firms and Product Development and Operations roles at Intel Corporation in Silicon Valley.

Elias’s client work focuses on merger integration and separation, operational and commercial due diligence, portfolio management, growth strategy and enterprise profitability improvements.  He has experience in a wide range of industries including semiconductors, software, SaaS, electronics, networking and medical devices.

Elias holds an MBA (with honors) from Columbia Business School and a PhD in Chemical Engineering from the University of Illinois at Urbana-Champaign.

Topics: M&A

How to Choose a Virtual Data Room: A Guide

Posted by ShareVault on Dec 16, 2016 8:00:00 AM

vdr_globe.jpgA virtual data room is a cloud-based repository of information employed for sharing sensitive documents during due diligence in a variety of applications including M&A transactions, fundraising, loan syndication, and licensing and partnering deals. Companies can control each user or group of users’ level of access to the information based on their need to see that information, and can revoke access at any time as situations evolve. Modern virtual data rooms employ a variety of features designed to facilitate and streamline the due diligence process, as well as keep sensitive information secure. When choosing a virtual data room, look for these features:

DOCUMENT CONTROL

At the heart of any modern virtual data room is the ability to secure and control sensitive documents while sharing them with third parties. A good virtual data room utilizes enterprise-grade security, even on computers and devices that are outside the control of a firm’s IT department. This security technology should be applied uniformly, regardless of whether documents are viewed on Windows, Macs, iOS or Android devices. Look for a data room that employs multi-level encryption, information rights management (IRM) and advanced document permissioning and security policies.

watermark_icon.pngDYNAMIC WATERMARKING

Based on the security policy you’ve defined, a VDR should have the ability to automatically apply dynamic watermarks to each page of protected documents. Watermarks should be clearly visible, yet not interfere with the readability of the underlying text. Look for watermarking text that is customizable, so you can embed dynamic information such as a user’s email address and IP address, as well as the current date and time, providing a clear reminder to the reader that the content is confidential.

SECURE PRINTING

In some cases you may wish to grant the right to a user to print a document, yet not allow the user to be able to print to PDF. This is a subtle, but important, additional security feature — without it, you risk inadvertently granting users the ability to easily save a permanent, irrevocable digital copy of the document on their computer.

THE ABILITY TO MONITOR USER ACTIVITY

The ability to monitor user activity in the data room can be very useful in gathering deal intelligence. Look for a data room that employs page-level tracking of who’s seen what and for how long. This information not only provides insightful information about your users’ review process, but also generates detailed audit trails necessary for compliance.


data_center.jpgA SECURE AND RELIABLE CLOUD INFRASTRUCTURE

When choosing a virtual data room, it is important to determine if their servers are located at world-class data centers and hosted by a high-end service provider. Ensure the provider is supplying comprehensive security and reliability through multiple levels of redundancy. Determine that servers are high availability with hot-swappable components and that the data center infrastructure is designed for high reliability, including redundant network connectivity, power systems, cooling systems, routers and cabling.

ACCELERATE DOCUMENT PREPARATION AND REVIEW

A virtual data room should accelerate the due diligence process rather than impede or frustrate it. Look for a virtual data room that employs features that are designed to expedite the deal process, such as infinite scrolling, drag-and-drop publishing, automated PDF conversion, no restriction on file sizes and the ability to batch download.

Remember, a virtual data room can be an essential tool for facilitating deal transactions and other applications where it’s imperative to share confidential documents securely. However, choosing the right virtual data room with the advanced functionality you require can be the difference between an efficiently streamlined process and one that is aggravating and compromises deal success. 

For more detailed information on choosing a virtual data room, download our white paper, “The Seven Habits of Highly Effective Data Rooms”.

Cover-Seven-Habits-of-Highly-Effective-Data-Rooms-5.jpg

Topics: Secure File Sharing

New Module

Add content here.

About ShareVault

Simple & Secure Document Sharing

ShareVault offers virtual data rooms for securely sharing documents with third parties. Typically used to share due diligence documents during M&A, partnering, fundraising and other dealmaking scenarios, ShareVault is increasingly being used for a wide variety of other applications, primarily in highly regulated industries, for securely sharing documents with third parties. ShareVault can be set up and deployed in an hour, yet offers enterprise-grade security and scaleability.

Learn More

Subscribe to Email Updates