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

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

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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: Information

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

 

 

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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: Webinars

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: News

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 published in October of 2016, 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

 

 

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.

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: Information

4 Best Practices For Raising Capital

Posted by ShareVault on Dec 2, 2016 2:20:46 PM

Companies often investigate and pursue funding sources during a transition of ownership, as a way to accelerate product development, to improve their sales process, and for many other reasons that may fuel corporate growth. While it’s a necessary process, finding the right source of funding is also stressful and fraught with uncertainty.

The main reason for the challenge in finding funding is the low probability of receiving it. The chances of getting venture funding are between 0.2 and 0.5%. Only one in three companies make it through to due diligence and one in ten actually receive funding.

1) Understand Your Stage in the Investment Cycle

It is crucial to select an investor that is best suited to your organization’s transition stage, as noted in the chart below. 

growth stage new.png

  Amount Risk Potential Return Investment Stage
Government Small to Medium Low to Mid Medium to High Any
Crowd Funding Small to Medium Mid to High Any Early
Angel Funding  Medium to Large  High High Early to Mid
Friends & Family  Small  Any  Any Early 
Venture Capital Large High High Any

If you only need a small amount of seed money, possible sources include government funding, crowdfunding or from family and friends. Government funding is often provided in the early stages, for seed or startup funding, and tends to cap at $2 million. Government funds are often given to low-risk organizations likely to have a high return on investment. For early to mid-stage funding, crowdfunding has become increasingly popular and successful, especially after a company has been unsuccessful in gaining funding from other sources.

If your company seeks mid-stage growth funding or later stage bridge funding, angel investors and venture capital are more appropriate, as these investors are more willing to take a risk if the potential return is high.

Learn About Financial Valuation Models

2) Match Your Needs with the Right Venture Capital Organization

If your organization strategically selects which venture capital (VC) organizations you send proposals to, you will have a higher likelihood of success. It is important to look for VC organizations with the skills that add value and/or fill a gap in your organization. For example, if you seek to expand into the Asian-Pacific market, you will need a venture capital firm with experience in that market. 

You also want to make sure your company and the VC firm have similar investment timelines. If you have a business plan that says you will achieve the highest level of growth in ten years, you wouldn’t select an organization that wants to exit in five years.

It is advisable to reach out to potential investors in your geographic area and industry sector. Not all venture capital organizations invest in companies that market in a different country. You will also appear unprepared if you pitch a solution to a VC for an industry in which they don’t typically invest. Having a strategy for pitching the right venture capital firm will increase your odds of gaining funding.

3) Timing

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A fundraising process can take six to twelve months. It is best to plan for more time than you may actually need and to not assume that it will go smoothly from the beginning.

Companies generally receive the highest valuation when they reach out to investors when they are growing and have funds left to execute plans for the future. If you exhaust your resources before looking for additional funding, you will have little negotiation leverage when discussing your organization’s valuation. With spare resources, it will be easier to negotiate an agreement and avoid terms that don’t meet your needs.

Investments are often linked to your ability to grow and meet a potential target. It is therefore important to correctly map your growth targets to the stages that funds will be released. If you don’t get a required investment at the right time, you may not be able to meet the growth target that is needed to release future venture capital funds. Missing growth targets can damage broader investments and affect your ability to raise additional funds in the future. 


4) Reduce the Perceived Risk

Most investors adjust future cash flows based on perceived risk. If risk is high, the amount of money you will get is much lower. Thus, you want to reduce the perceived risk to minimize the rate of your discounted cash flow.

Risk.jpgIt may be possible to reduce perceived risk by showing:

  • You have a previous track record of growing companies from the ground up.
  • You are in financial control and have met your cost projections.
  • Other companies in your sector have made money for investors from their products and solutions.
  • You have learned from the challenges/pitfalls that other organizations in your sector have had.
  • You are trustworthy, perhaps because you have used your network to gain a referral or introduction to the VC you are pitching.
  • You understand your industry sector, competitors and market-share capabilities.

In order to become one of the “lucky 3” that make it to the due diligence stage, make sure you have a well-developed business plan that shows your vision for the type of transformation you are pursuing. Tell a compelling story to help investors see why your organization has the potential for a high return. And don't get discouraged by one "no" – successful companies may receive dozens of rejections before finding a willing investor.

Learn About Financial Valuation Models

Topics: Information, White Papers, M&A

Five Steps to a High M&A Valuation

Posted by ShareVault on Nov 23, 2016 5:14:39 PM

5 Steps to a High M&A Valuation

In a Price Waterhouse study of CEOs and CFOs who recently completed a deal, 38% claimed that if they had provided more detailed information to the buyer during due diligence, they would have had a higher valuation.

What would have improved you M&A Valuation?.png            goeswithcirclediagram.png

When selling a company, preparation is key. Being prepared for an exit well in advance of the M&A process shows interested parties that you’re in control of your business, that you’re goal-focused, and that from the beginning you’ve had a plan for an organized and smooth integration.

It also greatly increases the speed of due diligence. In due-diligence, time is not your friend; the longer the diligence process, the higher the probability that challenges, along with price adjustments, will occur.

STEP 1: START EARLY

Most companies market themselves for acquisition too late. Often the growth curve has flattened out or competitors have entered the market before company executives perceive the need to sell. By then, the value has diminished.

The ideal time to be acquired is at the front end of the growth pattern or when a beta product has hit the market. This necessitates that CEOs, CFOs, and Corporate Development team members begin seller due diligence early on, so they have an honest, transaction readiness assessment for the organization from the get-go. Sometimes the perception is that the company is too young at this point to be ready for acquisition, but often the opposite is true.

STEP 2: GET ON THE RADAR OF SERIAL ACQUIRERS 

Companies are often bought and not sold. Acquirers generally make acquisitions when they’re ready to buy, not necessarily when the company is ready to sell.

Get on the Radar of Serial Acquirers.pngCompanies that engage in serial acquisitions do so for long-term, strategic objectives. They may be hoping to fill a gap in their portfolio, expand into new markets, gain increased synergies or consolidate in a divided market. 

It’s effective for companies looking to be acquired to focus on building relationship with serial acquirers. Organizations can create relationships through joint development agreements, joint marketing agreements, private label agreements or reseller agreements. Sometimes the best partnerships are based on purchase orders. Keep in mind that these agreements must be mutually beneficial; be a good partner and show that your company is fair, easy to work with, and the partnerships will have potential to grow into acquisitions.

STEP 3: KNOW WHAT THE BUYER WANTS 

Most sell-side companies get a due diligence checklist from the buyer and only then think about how to provide documentation to prove the companies worth. They immediately have to decide how they are going to organize the information and what tool they will use to share sensitive company documentation. Very few organizations know how to strategically share the right information at the right time and instead withhold important information from the get go, which lengthens the due diligence time period and causes devaluation.

Make sure your organization has a due diligence checklist on hand in order to pre-stage important documentation ahead of time, so you have time to tie up any loose ends that are exposed. A few tips based on common mistakes companies have made during M&A include:

  • Know what the buyer wants.jpgKnow what IP you own, what you have the right to transfer and what third-party technology you are using.
  • Address all outstanding litigation.
  • Resolve all discrepancies in financial, accounting or operational planning.
  • Store all company agreements (vendor, customer, employee) in one place because you will need to provide each and every one to the buyer.
  • Ensure that your key employees don’t leave during the deal.

The objective, of course, is to avoid surprises late in the M&A process.

STEP 4: VALIDATE BENEFIT TO THE BUYER 

It’s essential that you understand the value you will bring to your acquirer. You must be able to develop a business case that shows the buying company your worth.

The buyer will be looking for the following qualities, and therefore it’s crucial to focus on these aspects of your company in order to attract a buyer willing to pay maximum value:

  • Strength: market share, sales, team 
  • Ideas: IP, patents, trademarks, branding
  • People: investors, employees, customer base, ecosystem, press
  • Competition: market advantage, execution advantage, sector growth

If you’d like an overview of what a buyer will be looking for you to show, download our white paper on “The Art & Science of High M&A Valuation.”

View White Paper

STEP 5: LEVERAGE AN ECOSYSTEM OF FACILITATORS & CATALYSTS 

Ecosystem.pngDepending on your internal staff, you will likely hire an investment banker (ibanker), legal advisor or an accountant.

While not every M&A transaction involves a sell-side ibanker, in many circumstances, the right ibanker can add significant value. When selecting an ibanker, it’s imperative to find one with expertise in your industry and one who has significant experience with similar transactions. Think of investment bankers as individuals. In other words, hire a banker first and a firm second. Also, think about your deal size and the size of the ibanker’s firm. You will most likely get assigned a junior level ibanker if the deal is small given the firm’s clients.

Whomever you select, it is essential that your M&A team have a positive synergy and that every individual bring a complementary asset to the table, so your M&A due diligence process ensures a high valuation.

Today’s buyers are ruthless when it comes to due diligence. It’s therefore necessary that, before a potential buyer even approaches, you have thoroughly organized your due diligence documentation to be sure that everything a buyer wishes to see is present and accurate.

 

Topics: Information, White Papers, M&A

Four Essential Steps For Effectively Presenting Your Company Or Assett To Potential In-Licensors

Posted by ShareVault on Nov 15, 2016 9:01:37 AM

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 VAULT STAR

GAUTAM AGGARWAL, Partner

Triangle Insights Group, LLC

KNOWS HOW TO OPTIMIZE THE COMMERCIALIZATION OF BIOPHARMA ASSETS

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Given the rapid pace of innovation in today’s Life Sciences industry,  it has become more important than ever for biotech companies to align themselves with strategic partners in order to advance their most promising drug candidates toward market readiness.

Successful BioPharma partnerships don’t happen by chance, and negotiating an out-licensing deal can be complex— especially when the company is also focusing on progressing the clinical portfolio.

While the partnering or licensing process is often daunting, it can be simplified by focusing on four key steps that we, at Triangle Insights Group, believe are critical to preparing for partnering and a successful transaction.

Gautam’s Four Essential Steps for Successful BioPharma Partnering and Licensing

#1 PREPARE EARLY

Preparing early means identifying potential partners well in advance of the partnering process. This can be done by attending major industry conferences, utilizing partnering booths, initiating discussions with potential partners and maintaining a relationship with them as advances are made or situations change over time.

#2 DETERMINE VALUE

Determining the value of your asset and understanding how a potential partner might perceive value is critical to the partnering process. This means having an appropriate level of understanding about the commercial value and market dynamics and being able to clearly relate that narrative to potential partners. It also means having the flexibility to adapt that narrative to the specific needs of different potential partners. A good place to start is by looking at current market size and how that market size is anticipated to evolve over the next ten or twenty years.

#3 ALIGN EXPECTATIONS

Aligning expectations is an internal process that balances board and other stakeholder expectations versus potential partner expectations. Ask your team what they would consider a good deal and what they would consider a bad one. For instance...

  • What are the key components or “must haves” for the deal?
  • What are those components that would be nice to have, but are not essential to getting the deal done?
When deal expectations are aligned internally, there’s a greater chance of achieving what you want.

#4 ORGANIZE AND SHARE INFORMATION SECURELY AT THE RIGHT STAGE

A virtual data room is essential for successful biopharma partnering. It’s what buyers or licensors expect, and it’s the best way to ensure your IP remains secure throughout the deal process. Virtual data rooms are also ideal when staging information prior to a deal. During the early stages of due diligence, you may only want the potential partner to have access to a limited number of files. As diligence progresses, and the seriousness of the partner is demonstrated, more access can be granted. It’s also possible that different groups within the same company might be granted different levels of access to the data room.

A typical data room structure might include folders such as:

  • Corporate Overview
  • Investment Overview
  • Commercial Strategy
  • Pre-Clinical Program
  • Clinical Program
  • Regulatory
  • Intellectual Property
  • Manufacturing Processes

BioPharma partnering and out-licensing can be daunting, but it doesn’t have to be prohibitively so. The key to successful biopharma partnering is being prepared well in advance of negotiations, determining the appropriate value of the asset, being internally aligned on both deal value and deal structure, and then presenting due diligence materials in a well-organized data room for partner review.

If you would like a deeper dive into optimizing the value of your biopharma asset, download Guatam's white paper:

Download the White Paper >>

ABOUT GAUTAM AGGARWAL, Partner, Triangle Insights Group, LLC

With thirteen years of pharmaceutical and consulting experience, Gautam focuses on providing strategic guidance to clients within life sciences organizations. He has provided strategic advice to a wide range of clients, spanning Top-5 pharmaceutical manufacturers, emerging biotechnology manufacturers, bio-pharmaceutical investors, and service providers to biopharmaceutical companies. Gautam’s previous employers have included GlaxoSmithKline, Boston Consulting Group and Campbell Alliance.

Gautam received his MBA from the Fuqua School of Business at Duke and holds an MS and a BS in Bio-Statistics from UNC-Chapel Hill. 

Stay tuned for our next Vault Series featuring another great BioPharma star with insights to make you a better deal maker.

Topics: Information

6 Best Practices for Sharing Regulatory Submission Documents with Third Parties (If You Don't Do #2 and #4, You'll Drive Your Users Crazy)

Posted by John Badger on Oct 24, 2016 7:22:39 PM

electronic-submission.jpgWhether it's an IND (Investigational New Drug Application), NDA (New Drug Application), ANDA (Abbreviated New Drug Application), BLA (Biologics License Application), or any other type of electronic regulatory documents submitted to the FDA, EMA or other government regulatory agency, the information in the submission documents is extremely sensitive.
 
Regulatory submissions are rich in sensitive information that must be strictly controlled. Here are six recommended best practices:

#1 Share Only What Each Party Needs to See

Be sure to share your regulatory documents using a virtual data room that can provide granular access controls. In other words, make sure that you have the ability to set permissions at the folder level and also the document level.

It's also important to select the right time to share your documents. Staged access is a best practice that can be used to increase the amount of information disclosed in stages, as the degree of trust with the third party increases. Make sure your virtual data room provides granular access controls and also has powerful tools to rapidly permission large and complex document hierarchies with minimal clicking.

If you are deadline driven, your document sharing solution should allow you to set an automatic expiration date that removes access at a specific date and time to help you control your process according to the deadlines that you’ve established.

#2 Allow Your Documents to be Saved

There are a number of document sharing solutions that allow view-only access to your documents. However, if you force your users to view large documents without allowing them to save, you’ll be slowing down the document review process. It will drive your users nuts if you give them read-only access because most secure document viewers that prevent document download are slow and take a long time to load large documents. When choosing a data room provider, make sure to ask if the solution allows users to download documents for rapid viewing in a fast and secure viewer.

#3 Keep Tight Control of the Documents Being Shared

We’ve just recommended that you allow your end users to download documents in order to speed the document review process. You may be wondering how you will now maintain control of the shared regulatory documents?

Make sure your virtual data room allows you to retroactively revoke a user’s right to view a file, even if it’s already been downloaded. This capability, combined with the automatic expiration feature, allows you to automatically “shred” the documents at a specific date/time.

In addition, make sure you choose a virtual data room that provides several other document security features ideally suited for sharing regulatory documents:

  • Prevent copy/paste
  • Prevent print, or allow print only to physical printers (not PDF)
  • Automatic watermarking that identifies the user
  • Screenshot prevention

You'll need the ability to pick-and-choose the document security features in a document security policy that can be applied as desired to the appropriate documents based on your specific business case.

#4 Preserve the Document-to-Document Hyperlinks

Because of the very confidential nature of eCTD document sets, they are often uploaded to a secure virtual data room for two secure external processes – 1) communicating with outside regulatory advisors in preparation for a regulatory filing, or 2) the sharing of previous filings with prospective partners, investors, potential acquirers, or other third parties.

When eCTD documents are prepared within an eCTD publishing tool, they may refer to other documents in the set using hyperlinks. Since these documents are stored in separate folders, the links between them have a relationship that allows them to be moved without breaking. Unfortunately, these relationships do not persist when uploaded to all cloud-based document repositories. Make sure you choose one that has links that are automatically fixed, so that the appropriate document opens when a hyperlink is clicked - assuming that the user has permission to view the target document.

#5 Maintain a Detailed Audit Trail for Access to The Documents

You will want page-level tracking and time-based monitoring of who's seen what and when, down to the page level, providing detailed audit trails for compliance as well as insightful business intelligence into your users' document review progress.

Because there are often hundreds of questions when completing an NDA and dozens for INDs, it's important to have a good Q&A tool built into your virtual data room, so regulatory committees can ask questions in context with your document within your virtual data room/eCTD viewer solution. 

#6 Ensure The Submission Documents are Easily Searchable

Regulatory submissions are massive, and it can be a daunting task to review the full submission. One of the best ways to facilitate quick review of regulatory documents is to be sure that they can be rapidly searched for keywords. This requires a virtual data room with a powerful and fast full-text search engine, which provides relevance ranking, synopsis display with hit-highlighting, stemming and support for international character sets, provides the tools needed by your end users to quickly identify contents for focused review based on keywords.

ShareVault is used by 44 of the top 45 global biopharmas and is the preferred virtual data room for BIO. We're also the only virtual data room provider to offer a secure eCTD viewer that preserves document-to-document hyperlinking. 

As a leader in the life sciences space, we give you the confidence to simply and securely share regulatory documentation with the FDA, EMA and other government regulatory agencies. 

Topics: Products, News

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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.

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