Archive | June, 2013

Alternative Exit Models: Strategic Acquisitions by Earnout

27 Jun

By Max Klietmann, VP of Research, LSN

We are all aware that the IPO market has been less than stellar in recent history. This lack of exit opportunities has been particularly troubling for companies in the life sciences space due to the long time to market and considerable regulatory risk associated with drug development. Logically, M&A exits via strategic buyers has become the predominant exit route for many emerging biotech and medtech companies. M&A is of course not a new phenomeneon, however there is a significant trend in how these deals are being structured. Increasingly, M&A activity in the industry has been characterized by “acquisition via earn-out.”

Earn-outs are essentially pre-defined payments based on specific milestones. As an example, a strategic buyer would buy out an early-stage company (or asset) at phase IIa for a relatively small amount. Then, as the asset hits specific milestones (typically regulatory milestones), payments are triggered. One can think of it almost as a risk-adjusted buyout over time.

The advantage to this deal structure of course is that strategic buyers can afford to engage in more buyouts without putting too much capital at risk in the event of a failed trial. This is good for entrepreneurs and corporate buyers alike, who can diversify their bets on a myriad of assets.

This has overwhelmingly become the model for buyouts in recent time, and will likely become the standard. Moreover, the proportion of money in the upfront payment-versus-milestone payments is shifting as well. This means that entrepreneurs in the space seeking to exit via a strategic partner are likely to see an uptick in exit opportunities via this type of deal model. In turn, patients will see more drugs make it to market, and investors will see a significantly less volatile industry. All-in-all, this is a trend that is bound to solidify its position as an industry standard.

Hot Life Science Investor Mandate 1: European VC Interested in Wide Range of Biotech & Medtech Opportunities – June 27, 2013

26 Jun
A venture capital fund based in Europe has over €700 million in total assets under management, and has raised three funds. The firm is currently deploying assets from its third fund. The third fund’s portfolio currently consists of four companies. They are unsure of how many transactions they will execute in 2013, but aim to have ten to twelve companies in their portfolio for their third fund, and thus would invest in a firm over the next few quarters if a compelling opportunity is identified. Their typical equity check ranges from €6-10 million.

The firm is looking for companies in the biotech therapeutics & diagnostics space, and the medtech space. The fund invests in both therapeutics & diagnostics, and will consider the full gamut of subsectors and indications within the biotech therapeutics and diagnostics, as well as in the medtech space.

The VC invests in pre-revenue, early stage companies. With that being said, they are solely looking for companies that do not currently have a product on the market. In the biotech therapeutics and diagnostics space, the firm typically prefers to invest in companies one year prior to the firm starting their phase I clinical trials. In the medtech space, the firm looks for companies that have a prototype of their device.

Hot Life Science Investor Mandate 2: VC Creates Relationships with Universities for Spinoff Concepts – June 27, 2013

26 Jun
A venture capital fund that has relationships with nearly 50 university partnerships has around $100M in assets, and acts very opportunistically within the life science space. The firm also acquires participation rights for university spinout companies.

About 70% of the VC’s life sciences investments are in therapeutics, 30% of which are distributed between devices, diagnostics, and discovery platforms. Currently, the firm is most interested in therapeutics, and is avoiding med-tech opportunities due to an internal perspective of unpredictability of the FDA’s activities in the med-tech space.

Though they do not have a strict mandate in terms of subsector or indication, therapeutics for oncology, cardiovascular, anti-inflammatories, and ophthalmology drugs have historically done well, and are favored by, the investment team.

The VC does not have a specific timeline for allocation, and will make investments as opportunities arise. Typically, they will invest $500K – $1.5MM initially and reserve 1-3x initial invested capital for follow-on rounds, however the firm is comfortable investing broadly across stage, from seed to late stage, and will selectively invest $100K – $250K in angel rounds on an opportunistic basis. The firm prefers to be a co-investor alongside other firms or syndicates, and lays significant value on investing alongside notable “top-tier” firms.

Hot Life Science Investor Mandate 3: Pre- and Seed Stage Fund Interested in Medtech & Diagnostics – June 27, 2013

26 Jun
A pre-seed and seed stage fund that was established when its state government allocated $7 million in order to promote life science within its borders has managed to grow their initial investment to $20 million. The firm is now seeking new investments in the life sciences space, and typically initially invests around $500,000, but has the ability to invest upwards of $1 million. The firm has an evergreen structure, and thus is always looking for new investment opportunities. With that being said, the firm has no strict timeframe to make an allocation, but would invest in a firm within the next 6-9 months if a compelling opportunity is identified.

This particular firm is interested in the biotech therapeutics and diagnostics space, as well as in medical technologies. Although the firm does invest in therapeutic companies, they are most interested in the diagnostics and medical device space currently. Additionally, they are interested in companies that are developing research tools.

The firm makes seed and seed stage investments, and therefore does not consider firms that have raised a significant amount of venture capital, or more research-oriented projects that are better suited for an NIH grant. Consequently, the firm will consider companies that have a prototype of their medical device, or diagnostics companies that are in the pre-clinical phase of development.

Rescue and Repurposing of Drugs: Strategies for Faster and Cheaper Drug Development

26 Jun

By Jack Fuller, Business Development, LSN

The dramatic increase in cost-to-market for drugs over the last decade has put increasing pressure on drug discovery efforts to do more with less; accordingly, several different models have cropped up in the last few years. One strategy that has been gaining popularity with drug developers is the rescue and repurposing of drugs, often times by virtual pharma companies. A virtual pharmaceutical company typically in-licenses an asset, then out-sources all phases of research and manufacturing, while maintaining core executive and project management individuals.

Virtual pharma teams are generally made up of individuals with several decades of drug development experience, who recognize that it is not always necessary to take a candidate from square one. Many drugs are developed through IND enabling studies, only to fail in clinical trials due to poor bioavailability, off-target effects, or a lack of efficacy for a particular indication. At this point, several things can happen.

In a small- to medium-sized biotech company, often times the only option is to close up shop and sell off the company’s assets – including the failed drug candidate – in order to exit the investors without more loss. A savvy virtual pharma executive sees this as an opportunity to then rescue this failed drug for an indication not necessarily thought of previously. Similarly, just because a drug candidate is developed for a particular biological target, does not mean that it is the best or sole possible use of the drug. Repurposing is where a drug that is currently being sold for one indication is redeveloped and tested for use in an alternate indication – often times for a rare or orphan indication.

The US government is also getting involved in discovering new uses for existing molecules, as the National Center for Advancing Translational Sciences (NCATS) launched a program in 2012, in which several large pharmaceutical companies contributed 58 existing compounds to academic researchers in order to help re-engineer the research pipeline. These strategies are an attractive alternative to reduce the enormous average cost – $900 Million – and time – around 13 years – that it takes to develop a drug from start to finish.

Small biotech companies will always have a place in the market, as they are the ones translating the next generation of scientific discoveries into the next generation of revolutionary therapies. Rescuing and repurposing has become another example of the adaptability of the life science sector. In this case it is the formation of a niche market that experienced drug development teams are filling with alternative vehicles – such as Virtual Pharma companies – to provide the marketplace with a steady stream of therapeutics.

Winds of Change in the CRO Space

26 Jun

By Michael Quigley, Research Analyst, LSN

mike-2The CRO space is currently going through a restructuring that is driving CROs in one of two directions if they wish to remain competitive. The shift involves a group of global “giant” CROs holding exclusive, high profile partnerships, which have been eating away at the market share for mid-tier CROs, who rely on smaller deal structures to generate profits (since they cannot compete with the resources of their larger counterparts).

These mid-tier firms are also being pressured by smaller, more specialized boutique CROs who focus their efforts on particular diseases / technologies, and are capable of tailoring more client-specific arrangements. The growth of these niche organizations is being driven by the increase in companies developing specialized medicines that are capable of proving efficacy in clinical trials more clearly. As a result of the growth in these two extremes of the space, what is emerging is a group of CROs that are effectively stuck in the middle, and losing market share. (1)

Enter Private Equity

CROs are becoming increasingly attractive to PE firms as everyone from emerging biotechs to big pharma continue to push for strong pipelines of drug candidates, creating a steady demand for clinical testing. One opportunity that several PE firms are taking advantage of is making acquisitions of multiple medium-sized CROs in order to merge their resources, thus making them competitive with the “giants” in the space. Several of these deals have already taken place this past year, and some PE firms are positioning themselves for more. Other PEs are preforming massive buyouts of the “giant” CROs in order to provide them with the resources required to further expand. (2)

Implications for Emerging Life Science Companies

The increasingly competitive nature in the CRO space is an optimal situation for emerging companies interested in their services; both the large and the niche CROs of the world compete for the business of emerging companies. However, they offer different benefits. The larger group offers competitive pricing, as well as the proper expertise and resources required to perform clinical testing of a product in multiple markets around the globe. Alternatively, the niche group competes by offering a higher level of customer service and interaction, as well as a vast knowledge of the technology, and the specific regulatory hurdles that come with it.

One attribute shared by both groups, however, which will be paramount to their success, is their ability to find and contact emerging companies to set up contracts before their competition. These two groups competing for the business of emerging biotech and medtech companies will ultimately benefit the emerging companies as well as their investors, as the CROs will have to offer cheaper prices or better service to remain competitive.

1. Ha, Kimberly. “Mid-tier CROs Face Pressures Staying Independent as Consolidation Wave Intensifies, Bankers Say.Financial Times. Financial Times, 28 May 2013. Web. 26 June 2013.

(2) Garde, Damian. “Top-heavy Market Makes times Tough for Mid-size CROs.FierceCRO. FierceCRO, 3 June 2013. Web. 26 June 2013.

NIH Resurrecting Big Pharma Castoffs: What it means for the Industry

19 Jun

By Max Klietmann, VP of Research, LSN

The NIH has been faced with considerable difficulties as of late in terms of finding the required means to continue moving science forward at the early stage. However, the group recently announced a commitment of $12.7 million to a novel project – funding further research on assets that have been cast-off by big pharma in key indication areas that represent a significant unmet medical need (e.g. Alzheimers, Duchenne, etc.). The initiative has been fittingly named Discovering New Therapeutic Uses for Existing Molecules, and it may be a groundbreaking solution to several problems facing drug development today. These include reducing time to market, alleviating early stage investment risk, and creating even more incentive for research scientists to orient themselves towards commercialization of research.

Shortening time to market

The Discovering New Therapeutic Uses for Existing Molecules program’s single greatest benefit to the market is that it drastically reduces time to market. Rather than starting from scratch when developing compounds, researchers affiliated with the program are granted access to abandoned drug candidates owned by big pharmaceutical companies. These drugs may have been abandoned for a variety of reasons, and are now stagnant IP, sitting in a filing cabinet. This program puts them back to good use – One can think of it as subsidized out-licensing back to academia. The key is that these drug candidates have already undergone human safety trials. With this piece of the puzzle already taken care of, researchers have a much better shot of bringing them to market rapidly.

Investment risk reduction

Another big advantage to the program is that these assets have a reduced risk profile for investors seeking to capitalize on the opportunity. The NIH program will support the research for up to three years, allowing reasonable time to complete Phase IIa trials, at which point the projects will need to find other sources of financing. This gives investors an opportunity to invest in assets with a strong pedigree and minimal equity dilution risk, quite far down the pipeline.

So what does it all mean? At the most basic level, this pilot project represents a willingness on the part of the NIH to get creative. This program is very different from traditional research grants, and it shows that the agency is thinking within the context of the industry as a whole. This translates to a more attractive environment for investors, better deal terms for entrepreneurs, and more products making it to market. Keep your eyes on this program, as it will be a good indicator of how the NIH may be orienting itself on a larger scale moving forward.

1. “Discovering New Therapeutic Uses for Existing Molecules.Discovering New Therapeutic Uses for Existing Molecules. NIH, n.d. Web. 20 June 2013.