HOUSE_OVERSIGHT_024016.jpg

2.78 MB

Extraction Summary

1
People
5
Organizations
3
Locations
1
Events
0
Relationships
3
Quotes

Document Information

Type: Investment memorandum / private placement memorandum (page 5)
File Size: 2.78 MB
Summary

This document appears to be page 5 of a confidential investment memorandum for a fund named 'NLV-III' (likely New Leaf Ventures III). It outlines the investment thesis, citing a favorable regulatory environment due to increased FDA approvals and the FDASIA act of 2012, as well as favorable capital market dynamics caused by a contraction in venture capital fundraising which reduces competition for deals. The document bears a House Oversight Committee stamp, indicating it was part of a congressional investigation.

People (1)

Name Role Context
The Fund Managers Investment Managers
Group managing the NLV-III fund, expressing beliefs about market conditions.

Organizations (5)

Name Type Context
NLV-III
The investment fund being discussed (likely New Leaf Ventures III).
FDA
U.S. Food and Drug Administration, discussed regarding regulatory approvals.
Dow Jones
Cited in footnote regarding market analysis.
Fenwick & West
Law firm cited in footnote regarding market analysis.
House Oversight Committee
Implied by the document stamp 'HOUSE_OVERSIGHT_024016'.

Timeline (1 events)

July 9, 2012
Food and Drug Administration Safety and Innovation Act (FDASIA) signed into law.
U.S.
U.S. Government

Locations (3)

Location Context
United States, mentioned regarding regulatory legislation.
European Union, mentioned regarding regulatory environments.
Mentioned regarding regulatory environments.

Key Quotes (3)

"The Fund Managers believe the massive expansion and integration of capabilities occurring in biology and information technology is enabling a period of innovation in healthcare that sets a uniquely positive environment for the investment of NLV-III."
Source
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Quote #1
"Capital Markets And Industry Dynamics Are Favorable For New Investments & Exits"
Source
HOUSE_OVERSIGHT_024016.jpg
Quote #2
"Since the most recent peak in fundraising in 2008, it has been estimated that the life sciences venture capital fundraising has contracted by 68%, from $7.8 billion in 2008 to $2.5 billion in 2012"
Source
HOUSE_OVERSIGHT_024016.jpg
Quote #3

Full Extracted Text

Complete text extracted from the document (3,798 characters)

reducing clinic visits and hospital admissions and by controlling or curing disease so that the patient can return to a fully productive life. At the same time as this revolution in the biological sciences is unfolding, exponential increases in the ability to manage, process, and store information at low cost are coming out of the information technology (IT) industry. This rapid technological progress in IT is allowing the creation of entirely new systems and applications that will fundamentally improve how healthcare systems monitor and manage patients across the full range of care settings. The Fund Managers believe the massive expansion and integration of capabilities occurring in biology and information technology is enabling a period of innovation in healthcare that sets a uniquely positive environment for the investment of NLV-III.
• More Favorable Regulatory Environment For New Drug Approvals: Increasing numbers of FDA drug approvals and recently passed U.S. regulatory legislation are reflective of a more favorable regulatory environment. The number of new drug approvals by FDA in both 2012 (39 NDAs) and 2013 (27 NDAs) trended meaningfully higher compared to the previous 6 years and versus historic averages¹⁰. In addition, the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law on July 9, 2012, providing for additional tools to enable the FDA to promote innovation by streamlining parts of the approval process and improving communication and administrative processes between the agency and pharmaceutical and biotech companies. Chief among these new tools is the "Breakthrough Therapy" designation. This new designation helps the FDA assist drug developers to expedite the development and review of new drugs with preliminary clinical evidence that indicates the drug may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases. Overall, these initiatives and others, both in the U.S. and abroad (e.g., E.U. and Japan), have made the regulatory environment more favorable for investors in the biopharmaceutical sector, and have reduced some of the uncertainty and risk in a critical aspect of drug development.
• Capital Markets And Industry Dynamics Are Favorable For New Investments & Exits: Since the most recent peak in fundraising in 2008, it has been estimated that the life sciences venture capital fundraising has contracted by 68%, from $7.8 billion in 2008 to $2.5 billion in 2012¹¹. The Fund Managers believe that there has been a corresponding decline in the number of active venture capital firms investing into life sciences companies (especially earlier stage), resulting in fewer investors competing for new deals. At the same time, large and mid-sized biopharmaceutical companies have become increasingly dependent on development stage companies as the source of innovation and new products to supplement R&D pipelines and stimulate future growth. Most of these big companies are committing a large and growing portion of their R&D budgets to external facing search and evaluation efforts that have the goal of obtaining assets through high value mergers, acquisitions, and partnerships, which disproportionally benefit smaller, venture-backed, development stage companies. In the years ahead, we believe that this trend is likely to continue, and possibly accelerate, driven by expected patent expirations on commercial products and continued low productivity of pharma R&D. The Fund Managers believe these dynamics offer venture
10 Food and Drug Administration. Center For Drug Evaluation and Research
11 Dow Jones; Fenwick & West Analysis in 2012 Trends in Terms of Life Science Venture Financings
5
CONTROL NUMBER 257 - CONFIDENTIAL
HOUSE_OVERSIGHT_024016

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