www.pwc.com/ca/lifesciences The missing ingredient Canadian Life Sciences Industry Forecast 2013 Contents 1Preface 2 Key findings 3 Survey respondent profile 4 Outlook & challenges 10 Access to capital 14 Government partnership 16 3 Ps – Products, profits & places 20 Liquidity – Mergers, acquisitions & strategic alliances 23 What’s next for the sector? 26Contributors Preface Over the past two years, the Canadian life sciences industry has endured despite significant global economic uncertainty. The data gathered from this year’s respondents provides evidence of a sector that is showing positive signs of maturity. Yet it again highlights access to capital as the missing ingredient that will continue to constrain the sector’s success. The innovative industry leaders who form our respondents, the survivors of a protracted period of capital shortage, provide evidence of this maturity as they are: focusing more on their product development and current businesses; looking for more partnering transactions than before; asking for larger amounts of capital to align with their product development milestones; and the majority are starting to earn profits. The industry must remain at the leading edge of innovation, but it won’t happen in isolation. Canada has made progress in securing important building blocks for a growing bioeconomy. The need for coordinated actions from all parties remains. By working together, industry and governments can set in place a competitive market framework that will attract investment and allow the Canadian life sciences industry to play a significant role in the long-term health and prosperity of Canadians. PwC’s fifth Canadian Life Sciences Industry Forecast, presented in collaboration with BIOTECanada, is designed to understand the challenges and concerns of the Canadian life sciences industry, explore new trends and communicate recurring themes. The online survey, conducted in October 2012, was completed by 69 respondents from corporate, academic, government and other organizations in the industry. The information gathered and contained within this report builds on findings from previous reports and provides an overview of current industry issues and trends, augmenting the dialogue on pertinent industry issues. Prabh (Bob) Singh Andrew Casey National Leader, Pharmaceuticals and Life Sciences President and CEO PwCBIOTECanada Key findings There are a number of key findings from the forecast that can be used by industry and government to shape the future for the Canadian life sciences sector. 1. Outlook & challenges Short-term confidence has declined slightly due to the difficulty of raising capital. Respondents have progressed in the product development life cycle and need in excess of CA$1 billion of capital to achieve further growth. 2. Access to capital Access to capital remains challenging, with Canadian organizations increasingly looking for partnerships and licensing strategies to fund operations. 3. Government partnership A majority of respondents are asking the government to facilitate access to risk capital and ensure existing capital programs and incentives are broadly applicable to support the life sciences sector. 4. 3 Ps – Products, profits & places Respondents to our survey are more mature companies with more than half of the respondents indicating current profitability. About 79% of respondents will use new capital in their operations for growth displacing research and development (R&D) as the number one choice for the first time. Over three quarters of our respondents indicate that they do not plan to relocate any portion of their business activities outside of Canada. 5. Liquidity – Mergers, acquisitions & strategic alliances The Canadian life sciences sector continues to evolve with pharmaceutical companies facing continuing pressure from a number of blockbuster drugs coming off patent, low R&D productivity, changes in healthcare reform and the advent of personalized medicine. Companies have adapted by altering their business models and are seeking licensing or mergers and acquisitions (M&A) as a solution to their growth challenges. 2 Canadian Life Sciences Industry Forecast 2013 A total of 69 respondents primarily from corporations in the industry contributed to this year’s Canadian life sciences industry survey. The respondents represent a total of approximately 1800 employees across Canada and have revenues of approximately CA $0.6 billion. Survey respondent profile All regions of Canada were represented in this year’s survey, with 48% of companies’ head offices based in Ontario, 28% in Western Canada (Manitoba, Saskatchewan, Alberta and British Columbia), 17% in Quebec, 4% in Atlantic Canada and 3% in other international locations. Of the life sciences organizations surveyed, 84% have less than 100 full-time employees and 16% state that they have five or fewer full-time employees. Over half (55%) of survey respondents consisted of chief executive officers or presidents of the organization, 20% were chief financial officers, and the remainder included various positions such as chief operating officer, business development and regulatory affairs. Of the companies which disclosed whether they generated revenues, more than half reported that they currently generate revenues. About 47% of revenue generating companies reported revenues of less than CA$5 million annually. Companies that were privately held accounted for 66% of all respondents, while 32% were public companies (Figure 1). The respondents surveyed cover a breadth of products and services with the largest area of focus being therapeutics (28%), followed by branded pharmaceuticals (26%), medical devices (17%) and diagnostics (12%). Figure 1: Respondent business Life sciences/ biotechnology – public 32% Life sciences/ biotechnology – private 66% Research or academic institute 1% Provider of financial capital 1% Canadian Life Sciences Industry Forecast 2013 3 Outlook & challenges 41% of Canadian respondents are moderately to extremely confident about the industry’s long-term outlook. 4 Canadian Life Sciences Industry Forecast 2013 The Canadian life sciences sector continues to show determination and resiliency even though, like other sectors of the Canadian economy, it’s faced significant challenges as a result of the global economic slowdown. Nevertheless, the fundamentals remain strong. The business respondents to our survey, similar to the 2011 respondents, are seeking in excess of CA$1 billion of capital and there’s a strong view that governments need to help stimulate capital formation. Compared to global pharmaceutical and life sciences CEOs who participated in PwC’s 16th Annual Global CEO Survey, respondents to our survey were much less confident than their global counterparts. Forty nine percent of global pharmaceutical and life sciences CEOs are very confident that their organizations will be able to generate higher revenues over the short term, and 46% are very confident of being able to do so over the next three years1. 1 PwC. (2012). 16th Annual Global CEO Survey. http://www.pwc.com/gx/en/ceo-survey/index.jhtml. Retrieved February 22, 2013. In Canada, respondents’ short-term confidence has declined slightly from our 2011 report: 67% of respondents are somewhat to not at all confident in the short-term outlook for the Canadian industry versus 63% in 2011. When asked about the industry’s long-term outlook, 59% of respondents continue to indicate they are somewhat to not at all confident versus 41% who are moderately to extremely confident. The decrease in short-term confidence from our respondents is consistent with the expectation of low economic growth in Canada and United States in the near term. The long-term outlook is similar to 2011 results. It is interesting to note that more of our respondents are focused on their current business (as seen in Figure 14). As they achieve successes, we anticipate that the longer term confidence in the industry should strengthen. Canadian Life Sciences Industry Forecast 2013 5 Not surprisingly, 58% of respondents have indicated that the most challenging factor for their organizations over the next two years will be the raising of capital (Figure 2). Attracting a licensing or strategic partner has become an even more important issue – 54% of respondents indicated it as a challenging factor compared to 43% in 2011. It’s also interesting to note that an increasing number of respondents believe product development will be the third most challenging issue that they’ll face in the next two years – 42% compared to 31% in 2011. This change is positive and suggests that respondents’ companies have moved to a later stage in the product development life cycle. This factor seems to be even more prevalent in Quebec, where 61% respondents have indicated that product development will be the most challenging factor for their organization. The focus on attracting and retaining key employees noted in 2011 has dropped from 39% in 2011 to 28%, suggesting that respondents believe they currently have the talent needed to move forward on achieving their key business objectives. Figure 2: Which of the following issues do you feel will be the most challenging over the next two years for your organization? (respondents were asked to select top 3 choices) 58% 60% 54% Raising capital 54% Attracting a licensing or strategic partner 43% Consistent with all of the previous PwC Canadian life science forecast reports, the biggest challenge for the Canadian life sciences industry to become a stronger global competitor continues to be the ability to access capital (87% of respondents as per Figure 3). The industry faces additional challenges including access to strategic partners (54%), and the development of experienced entrepreneurs (33%). Respondents continue to express the need for the synchronization of various government initiatives within Canada to further support their ability to compete in a changing global market. As seen in Figure 4, the top-rated critical success factor for the industry continues to be access to capital. In the current year, respondents now identify tax incentives that encourage investment by providers of capital as the second highest critical success factor. Access to experienced talent pool has jumped back into the top three, slightly ahead of access to strategic partners. More success stories from Canadian life sciences businesses dipped slightly in the respondents’ rankings, but clearly this is important in order to gain interest from investors and from the government as the industry moves through this difficult global economic cycle. Quebec respondents ranked success stories as the second most critical success factor for the industry, as it’s essential in attracting competing dollars within a global organization and in the open market. Figure 3: What do you believe are the key challenges for the Canadian life sciences and biotech industry to become a stronger global competitor? (respondents were asked to select top 3 choices) 87% 84% 78% Ability to access capital 54% 46% 47% Ability to access strategic partners 22% 42% Product development Managing the regulatory process 21% Attracting and retaining key employees Development of experienced entrepreneurs 31% 31% 32% 31% 28% 39% 25% 6 Canadian Life Sciences Industry Forecast 2013 2013 2011 2009 33% 32% 41% Synchronization of various government initiatives 33% 26% 17% Availability of expertise within Canada 22% 33% 26% 2013 2011 2009 Accessing capital is a critical success factor, but also an increasing challenge. The decrease in the importance of Canadian venture capital to 23% is alarming when combined with respondents’ desire to access capital from any source. Respondents are frustrated with the lack of Canadian venture capital since the beginning of this difficult economic cycle (i.e. late 2007). If future capital is only available from non-domestic sources, over time Canadian technologies, and the companies that have developed them, will migrate to markets that better support and value the innovation and jobs created in this sector. This will further limit the opportunity for successes in Canada. Policy makers must collaborate with Canadian venture capitalists to identify the most appropriate types of incentives required to reinvigorate interest in this industry in the short term among institutional investors and pension funds. Of equal importance is the need for Canadian venture capitalists to better support Canadian life sciences innovation. “The Canadian life sciences sector desperately needs new success stories to increase the venture or strategic capital available to fuel new product development initiatives.” Survey respondent If Canada is to capture a larger piece of the global bioeconomy pie, it must maintain its competitive position globally. Other leading nations are moving aggressively to position their life sciences industries at the forefront of the next generation of economic growth. The allocation of the CA$400 million recently announced by the federal government as part of the Venture Capital Action Plan, to help increase private sector investments in early-stage risk capital and support the creation of large-scale venture capital funds led by the private sector, will play an important role in how Canada keeps pace. For a sample of recent Canadian successes, refer to the data on pages eight and nine and recent commercial events on page 25. Figure 4: Which of the following are critical success factors for the Canadian life sciences and biotech industry now? (respondents were asked to select top 3 choices) Access to capital from any source Tax incentives that encourage investment by providers of capital 41% 24% More success stories from existing Canadian life sciences businesses Increased Canadian venture capital Positive financial markets 36% 38% 33% 30% 40% Access to experienced talent pool Access to strategic partners 75% 73% 30% 30% 28% 29% 33% 26% 23% 35% 33% 17% 18% 33% 2013 2011 2009 Canadian Life Sciences Industry Forecast 2013 7 Recent notable deals involving Canadian companies CANADA CANADA Financing Bellus Health CA$17 million Share offering CANADA CANADA Financing Trimel CA$13 million Share offering CANADA Financing Novadaq CA$40 million Share offering M&A Pharmascience and Rivex Pharma CA$8 million CANADA Financing Financing Oncolytics CA$21 million Share offering CANADA Financing YM Biosciences CA$80 million Share offering CANADA M&A Valeant & Afexa CA$85 million Medicago and Pharma Partner CA$15 million Loan CANADA Financing CANADA Resverlogix CA$25 million Debt offering USA M&A USA M&A Cephalon & GeminX US$525 million 8 Canadian Life Sciences Industry Forecast 2013 CANADA Financing OncoGenex Pharmaceuticals US$50 million Share offering CANADA Financing Aeterna Zentaris US$16 million Share offering M&A USA Methylgene CA$26 million Share offering Financing Bioniche CA$20 million Royalty financing Alexion & Enobia US$1080 million Financing CANADA Gilead & YM Biosciences US$510 million SWITZERLAND Strategic alliance Genentech and Xenon CHINA Strategic alliance Medicago and Philip Morris Canadian Life Sciences Industry Forecast 2013 9 Access to capital Life sciences companies of all sizes are interconnected. Through this unique ecosystem companies rely on one another. 10 Canadian Life Sciences Industry Forecast 2013 While gaining access to capital remains at the forefront, Canadian organizations are increasingly looking to partnerships and licensing strategies for funding (Figure 2 and Figure 3). The survey results reveal that while 58% of respondents view access to capital as the greatest near term challenge, 54% believe attracting a licensing or strategic partner will also be difficult (up significantly from 43% in 2011). Since 2009, biotechnology companies faced increasing competition for strategic partners, with partnering deals in 2012 trending 10-15% below that of 20112 with very few late stage partnering deals involving companies in Canada. Redistribution of partnering dollars to academia and nonprofit organizations, coupled with financial pressures on pharmaceutical companies, has materially changed the landscape in the types of deals pharmaceutical companies are willing to complete. As a result, respondents consistently report that the most critical factor to success in the Canadian life sciences industry is the ability to access capital from any source that will allow companies to further develop products and provide proof of efficacy data- a key milestone for investors and partnering companies (Figure 4). The survey results reveal that 64% of respondents cited unfavourable industry and market conditions as the top challenge to successfully raising capital for Canadian life sciences businesses (Figure 5). This is down significantly from 80% in 2011, indicating that capital market challenges have eased as companies recover and investors begin to invest in growth again. The greater challenge now appears to be investors’ understanding of the value proposition (Figure 5), as they now place greater emphasis on proof of efficacy in products in humans. The threshold for value creation has markedly increased, posing a greater challenge for emerging companies seeking funding. In addition, the cost to reach these milestones has also increased significantly due to greater regulatory requirements. Figure 5: What do you perceive to be the top three challenges to successfully raising capital for a Canadian life sciences and biotech business? (respondents were asked to select top 3 choices) Figure 6: Approximately how much funding will you be seeking in your next round of financing? 35% 64% Unfavourable industry/market conditions for raising capital 80% CA$0 - 5 Million 34% 44% 64% 15% 62% Investors' inability to understand the value proposition CA$5 - 10 Million 49% 18% 17% 31% 33% 52% Too many business risks for the investors CA$10 - 25 Million 56% 34% 23% 38% Investors have other more attractive options, e.g. flow-through shares 51% 63% NA 2013 2011 2009 CA$25 - 100 Million 15% 9% 12% CA$100 Million + 2% 4% 4% 2 The Burrill Report, Vol. 2 Issue 9. September 2102. Partnering Dollars Decline for Biotechs. 2013 2011 2009 Canadian Life Sciences Industry Forecast 2013 11 Access to capital continues to be one of the most significant priorities for respondents. With the contraction of traditional capital sources, the Canadian life sciences industry is challenging itself by looking for new ways to access the CA$1 billion of new capital it will need. Respondents seeking up to CA$5 million and those seeking CA$10 million to CA$25 million continue to be the most sought out financing ranges (Figure 6). These amounts should allow companies to achieve either proof of concept with less than CA$5 million or proof of efficacy with CA$10 million to CA$25 million; both key milestones for raising additional capital. It’s also interesting to note the increase in the respondents seeking funding in the CA$25 million to CA$100 million category, suggesting a further maturation of Canadian life sciences companies with products in late stage clinical trials in the near future. Figure 7: From what sources do you expect to get this funding? (respondents were asked to select top 3 choices) 79% 84% Strategic partners 35% 30% 44% Using an average for each funding category (e.g. CA$7.5 million for the CA$5 million to CA$10 million category), we estimate that respondents are seeking in excess of CA$1 billion of new capital. In Figure 7, respondents report the top three sources of funding are from strategic partners (79%), private equity (44%) and venture capital (42%), which indicates that public markets remain soft for companies in the life sciences sector. In Quebec, 46% of respondents are seeking funding through a combination of private equity and debt financing to bridge the gap. Figure 7 also reveals that the number of respondents expecting funding from private equity has increased to 44% from 29% in 2011, reflecting the recovery in Canadian private equity deal activity since 2008. Over the last 24 months, the Canadian market has seen 32 private equity transactions for a total consideration of CA$197 million, compared to 23 transactions worth CA$126 million in the two years from 2008 to 20103. 29% 20% 20% Private equity funds 42% 42% Venture capitalists 19% 27% 29% 37% Government - federal and provincial 16% 24% 29% 25% 18% 17% Angel investors 25% 24% Debt financing 14% 14% 23% 22% 12% 20% Secondary public offering 12% 18% 11% Mergers and acquisitions NA 12 Canadian Life Sciences Industry Forecast 2013 2013 2011 2009 2007 3 Captial IQ The recent emergence of molecule development funds such as TVM Life Science Ventures VII4 has resulted in an inflow of capital to fund molecules or technologies instead of companies with diversified portfolios, which we anticipate may facilitate strategic partnering at later stages in technological development. In addition to conventional methods of funding, there’s been growing support from government and the investment community5 for new alternatives to access capital that are less cost prohibitive for emerging companies, such as equity-based crowdfunding6. As recently as November 2012, reports of provincial support for crowdfunding initiatives from the province of Ontario provide an encouraging outlook for companies seeking funding outside of public markets. The province of Quebec is also exploring how crowdfunding can be used to propel the Quebec economy. Driven by public investors looking to get a head start on the newest emerging technology, Canadian governments are asking securities regulators to approve crowdfunding to prevent early stage Canadian innovators from heading south of the border to the US, where this investment structure is more proactively supported. “We need to find ways to support our biotechs through subsequent funding rounds sufficient to ensure that they remain competitive internationally and can keep our innovation in Canada until it becomes profitable.” Survey respondent 4 Investment Quebec, July 2012, Trelays Capital and Eli Lilly Invest in a New $150M Fund. 5 The Financial Post. November 29, 2012. Ontario minister Duguid indicating support for equity-based crowdfunding. 6 Crowdfunding is the practice of funding a project or venture by raising many small amounts of money from a large number of people, typically via the Internet. http://oxforddictionaries.com/definition/english/crowdfunding. Retrieved January 23, 2013. Canadian Life Sciences Industry Forecast 2013 13 Government partnership Government support is critical to encourage much needed investments in the sector. Industry and government need to work collaboratively to create the policy framework that will support an innovative life sciences sector. 14 Canadian Life Sciences Industry Forecast 2013 The challenge of access to capital is in many ways linked with the way government policies and incentives are designed and implemented to spur investment, innovation and long-term growth in our economy. Ranked highly among other challenges facing the sector for which government is directly responsible, is also the lack of synchronisation of various government programs (Figure 3). Common tools used by legislators to create incentives for deployment of capital in new and emerging technologies include favourable tax incentives and research grants and funding. When asked what they would like government to focus on as the key actions to support the competitiveness of the sector, the message was clear and consistent with prior years. Respondents have ranked programs to encourage availability of risk capital, increasing favourable tax incentives, and more research grants as the top three government actions (Figure 8). This is not surprising given the rising need for capital as the sector matures and products progress through various trial phases. There also appears to be a clear call to have all levels of government synchronize their incentive programs and in so doing promote access to capital, particularly in light of increased global competition for investment in this sector. Tax measures that encourage and reward investment in the Canadian life sciences industry are identified as one of the most important initiatives governments can undertake. Globally, there’s been a clear trend among emerging and established economies that have announced significant programs, which in whole or in part were designed to increase economic support of the life sciences sector. Specifically, countries such as Australia, France, Norway, United Kingdom, China, India and Singapore have adapted their policies to promote investment in the life sciences sector, which they acknowledge will have a direct positive influence on innovation and job creation. In Canada, the need for such policies becomes even more important when attempting to foster growth in an industry that is at its roots Canadian owned and operated (84% of private company respondents indicated that they are Canadian Controlled Private Companies (CCPC), up from 82% in 2011) and driven by scientists and researchers from Canadian academic institutions. The level of Canadian federal and provincial tax incentives and credits awarded for investments in R&D by life science companies have remained stagnant over the last few years. In fact, though the 2012 federal budget proposed changes to reduce the Scientific Research and Experimental Development (SR&ED) tax credit for large corporations from 20% to 15%, the 35% refundable tax credit for CCPCs meeting the required size tests on their first CA$3 million of SR&ED expenditures remained untouched as a key source of capital for smaller Canadian life sciences companies. The introduction of new incentives similar to the British Columbia Small Business Venture Capital Program tax credit, and more direct funding by government as proposed by the Jenkins report, may address part of the industry’s capital needs. The most recent Quebec budget in which the R&D wage credit was increased from 17.5% to 27.5% for companies with more than CA$75 million in assets, is an example of measures aimed to increase research spending by larger companies in Quebec. As mentioned earlier, the recent announcement that the federal government has made available CA$400 million to reinvigorate the venture capital industry in Canada will also hopefully have a positive impact for life science companies seeking capital. The key to effectiveness of such programs will be through focused initiatives in this sector. In contrast to the importance of government involvement in promoting access to capital and funding, improvement to the regulatory process has continued on a downward trend over the last few years (Figure 8). However, it’s also interesting to note that when respondents were asked whether they would support initiatives to change the traditional drug development model to a live licensing7 concept over 50% supported change. In past reports the majority were undecided. This suggests a growing sentiment among respondents that there needs to be a shift in the regulatory and approval process to bring products to market faster, within the confines of patient safety. Figure 8: What do you believe are the most important actions that government can take to improve Canada’s ability to compete globally in the life sciences and biotech industry? (respondents were asked to select top 3 choices) 87% 78% 75% Create incentives for risk capital NA 54% 63% 62% 67% Create more favourable tax incentives Research grants to companies Improve speed of the regulatory process 51% 49% 38% 51% 28% 37% 37% 40% 2013 2011 2009 2007 7 Live licensing refers to the issuance of a license to market a product on a limited basis once it has demonstrated sufficient efficacy, value and safety in an initial trial population, as opposed to the traditional license granted after a lengthy regulatory approval process. Canadian Life Sciences Industry Forecast 2013 15 3 Ps – Products, profits & places Committed to Canada. 78% of survey respondents have no plans to relocate outside of Canada in the next two years. 16 Canadian Life Sciences Industry Forecast 2013 More than half of the respondents’ companies are currently profitable with 50% of these companies generating profits of up to CA$5 million. About 75% of companies not currently earning profits believe it will take over three years to generate a profit. These results have remained relatively consistent over the past few years. Further evidence of the long timeline to generate revenues and profits comes from the Canadian Life Sciences Database which indicates that 93% of current products are in the preclinical to phase II stage of development (Figure 9). The length of time needed to become revenue producing and ultimately profitable is a key reason why survey respondents have identified access to capital as one of the top challenges for the Canadian life sciences industry. Figure 9: Number of biotechnology therapeutic products in Canada’s pipeline (Source: Biotech Gate Life Sciences Statistics 2011 & 2012) 22 Phase III Phase II Phase I Discovery and preclinical 30 26 72 76 79 72 72 73 149 154 141 2012 2011 2010 Canadian Life Sciences Industry Forecast 2013 17 Of our survey respondents, 78% have no plans to relocate some or all of their business outside of Canada in the next two years; this represents an increase from 70% in our 2011 survey. Of the 22% of respondents planning to relocate, two-thirds plan to head south to the US which is comparable to the findings in 2011. Primarily, they plan to relocate their sales department (13%), R&D (13%), manufacturing (13%) and head office (13%). The number of survey respondents indicating that they planned to relocate their entire operations decreased to 7% from 14% in our 2011 survey. Reasons for planning to move include access to capital, a larger customer market, proximity to strategic partners and access to an experienced talent pool (Figure 10). Better government incentives decreased significantly as a reason quoted for relocation (from 38% in 2011 to 7% in 2013). 18 Canadian Life Sciences Industry Forecast 2013 As noted in Figure 11, working capital and operations was selected by 79% of respondents as the most likely use of capital, up from 62% in the prior survey. This is an interesting development, since it’s the first time in our survey’s history that a category has ranked higher than R&D. When this observation is combined with the increase in the likelihood of using funds for manufacturing and marketing, it would suggest a continued maturation of the Canadian sector. R&D has continued to rank in the top three uses of capital at 75% currently, compared to 74% in the prior survey (Figure 11). About 55% of respondents say that they plan on increasing their R&D spending in Canada in the next year, down from 67% in 2011. A majority of respondents (68%) state that more than half their R&D is performed in Canada; however this represents a significant decline from the 87% reported in 2011. Build it here. The life sciences industry is continuing to grow and mature in Canada. Working capital and operations becomes the number one use of capital displacing R&D for the first time. Figure 10: What are your main reasons for relocating your business? (respondents were asked to select top 3 choices) 79% 53% 48% 44% Access to larger customer markets 53% 29% 75% 74% R&D Manufacturing 24% Proximity to strategic partners 62% Working capital/operations 53% 52% 64% Access to capital Figure 11: What is the most likely use of funds from your round of funding? (respondents were asked to select top 3 choices) 42% 39% 32% 14% 4% 35% 47% 45% 44% Access to experienced talent pool 7% Better government initiatives 38% 2% Marketing/sales 32% 20% 25% 2013 2011 2009 Hiring key management expertise 33% 11% 2013 2011 2009 Canadian Life Sciences Industry Forecast 2013 19 Liquidity – Mergers, acquisitions & strategic alliances 20 Canadian Life Sciences Industry Forecast 2013 Figure 12 shows that 87% of respondents believe being acquired or participating in a merger is the most likely scenario for success. In addition to M&A, 80% of respondents believe that co-development or partnerships are also a likely option, up from 70% in 2011 (Figure 12). In Quebec, 92% of respondents have actually ranked co-development or partnerships as the most likely scenario for success. These findings are reflective of the current economic conditions, as access to both public and private capital is limited and the public markets have not rewarded companies with increased valuations based on positive clinical news. In the US, the top ten deals of 2012 accounted for more than half of the total value in transactions as pharmaceuticals companies competed to build their pipeline by investing in emerging technologies. From a long-term perspective, building or maintaining a sustainable business continues to retract as a scenario for success, down to 29% of respondents compared to 33% in 2011, as does going public; a reflection of the current financing environment and public company valuations. The survey results continue to suggest that the Canadian industry must address the need for large levels of investment from both public and private sectors in order to achieve the critical mass and scale required to effectively compete on the global stage. This requires the government and industry to work collaboratively to create an environment suitable to retain operations in Canada and to create a sustainable thriving industry. 8 Capital IQ Figure 13 shows 76% of respondents believe valuation issues are the main barrier to M&A in the industry. Valuation issues were also the most highly rated choice in previous years, largely owing to the perceived valuation difference among shareholders and management versus partnering companies. In addition, higher investor scrutiny and sensitivity to negative or neutral events have resulted in sustained market volatility, making valuation challenging for emerging companies seeking investment dollars. In mergers between emerging companies, funding remains the key issue, as it’s now necessary to fund two clinical pipelines instead of one. The total number of announced M&A deals in North America in Q4 2012 was 31, compared to 24 in Q3 2012 and 26 in Q2 2012, bringing the number of announced deals year to date (YTD) to 141, similar to 2011 levels. Disclosed deal value YTD was CA$57 billion. Canada continues to represent approximately 10% of the total deals by volume8. Canadian Life Sciences Industry Forecast 2013 21 Trends in 2012 include deals in emerging markets; deals in biosimilars with both branded and generic companies coming together; and pharmaceutical companies starting to license platform technologies again with some blockbuster early stage deals. According to PwC’s Corporate Finance group, the North American life sciences sector continues to evolve in response to the changes in the pharmaceutical industry. The industry today is seeing a number of key blockbuster drugs coming off patent, low R&D productivity, changes in healthcare reform and the advent of personalized medicine. This has resulted in companies altering their business models or seeking licensing or M&A as a solution to their growth issues. Figure 12: What do you consider to be the most likely scenario for the typical successful Canadian life sciences or biotech business? (respondents were asked to select top 3 choices) Being acquired/merger 66% Co-development/partnerships 48% 87% 90% Figure 13: What do you see as the most significant barriers to mergers and acquisitions in the life sciences industry? (respondents were asked to select top 3 choices) Valuation issues 80% 80% 70% Funding NA Licensing or selling IP 46% 71% 71% Lack of interest on the part of large firms 64% Build or maintain a sustainable business Going public 29% 33% 22% 38% 12% 25% 28% 22 Canadian Life Sciences Industry Forecast 2013 44% 47% 29% 30% 2013 2011 2009 2007 62% 54% 52% 51% 41% 27% 32% 36% Conflicting management personalities 76% 71% 34% 47% 49% 2013 2011 2009 2007 What’s next for the sector? Part of the answer to this question may be evident from the data in Figure 14. Respondents indicate that the first and most important action industry can take to improve Canada’s ability to compete globally is to first focus on success in their current businesses. Next, respondents suggest that a relatively equal level of focus is required on increasing the volume of inlicensing and out-licensing of intellectual property (IP), the effective lobbying government and the recruitment of experienced senior management. In contrast, 70% of Quebec respondents view effective lobbying as the most important action the industry should undertake. The 2013 survey data in Figures 7 and 12 demonstrates the respondents’ strong focus on establishing strategic partnerships as a means of accessing much needed capital, which is consistent with their message that capital continues to be the missing ingredient in their recipe for success. This view is shared with global pharmaceutical and life sciences CEOs, of whom 34% have indicated that they’ve entered into new strategic alliances or joint ventures in the past year and 17% of whom believe this will present one of the main opportunities to grow their businesses in the coming year9. Accordingly, the Canadian life science industry needs to position itself for successful partnering by thinking more like potential investors and understanding the needs and wants of its partners. Similar to large multinational pharmaceutical companies, the industry must be able to provide leading real-world data on the outcomes that its medicines or therapies will deliver10. Canadian companies could also position themselves for successful partnering by hiring management teams that possess a strong understanding of customer and consumer needs, and have experience partnering products with large pharmaceutical or medical device companies. Close to half (46%) of the respondents recognize the importance of the consumer or patient in their decision making process. Furthermore, employees that have had global experience in creating a data package with strong IP and clinical results that demonstrate a clear regulatory pathway to commercialisation and reimbursement, should increase the likelihood of partnering and M&A successes. A number of recent deals involving Canadian life sciences companies with late stage assets (e.g. YM Biosciences, Enobia, and Gemin X) serve as an example of the value that can be generated for investors by management teams that are able to identify and develop mutually beneficial partnering or M&A arrangements. 9 PwC. 2012. 16th Annual Global CEO Survey. http://www.pwc.com/gx/en/ceo-survey/index.jhtml. Retrieved February 22, 2013. 10 PwC. 2011. From Vision to Decision: Pharma 2020. www.pwc.com/pharma2020. Retrieved January 23, 2013. Canadian Life Sciences Industry Forecast 2013 23 Now is the time to position Canada’s life sciences industry as central to the emerging global bioeconomy and enable the industry to take advantage of global population growth and economic development. A healthy and innovative life sciences sector will play a central role in enabling Canada to maintain a competitive and relevant position in this new global bioeconomy. However, we acknowledge that this will also require a reengineering of traditional industries, such as the manufacturing sector more broadly, so they can support the needs of this emerging bioeconomy. We are confident that Canadian life sciences technology and ingenuity can propel the sector beyond simply remaining competitive. Rather, with the right partnerships and strategic investments we anticipate that Canadian life sciences companies can become world leaders, within a sustainable and thriving life sciences industry. Figure 14: What do you believe are the most important actions that the industry can take to improve Canada´s ability to compete globally in the life sciences industry? (respondents were asked to select top 3 choices) Continued focus on success in current business 48% 36% 65% 65% 41% 37% 38% Increase volume of in-licensing and out-licensing of IP NA 39% 42% 47% 49% Recruit experienced senior management 39% Effective lobbying to government 40% 41% 53% 28% 29% 35% 27% Implement mergers or acquisitions 23% Concentrate business in regional clusters Support local, regional or national industry associations Active involvement in mentoring programs 24 Canadian Life Sciences Industry Forecast 2013 36% 21% 27% 15% 27% 19% 25% 12% 11% 17% 24% 2013 2011 2009 2007 Recent commercial events Organization Activity DiagnoCure US FDA approval for PROGENS PCA3 test Miraculins PreVu Non-Invasive Skin Cholesterol Point of Care Test CE marked with distribution agreements in Canada Paladin Labs Announced Health Canada approval of Oralair™, a sublingual grass pollen immunotherapy tablet Cipher Pharmaceuticals US FDA approval for Absorica Covalon Technologies US FDA approval for IV Clear Covalon Technologies US FDA approval for SurgiClear Tekmira Pharmaceuticals US FDA approval for Marqibo11 Medicago Inc Commercial agreement with Philip Morris Products for influenza vaccines 11 Equicom Canadian Healthcare Review, Q1-Q3 2012. Canadian Life Sciences Industry Forecast 2013 25 Contributors PwC Bob Singh Ernesto Basso Keshia Claxton Shivalika Handa Ahmed Jadoon Gord Jans Nitin Kaushal Miriam Pozza Lisa Simeoni Naveli Gupta Sharlene Sansone PwC Alumni Jacqueline Rullo BIOTECanada Andrew Casey Cate McCready Nadine Lunt Interviewees We would like to thank all of the survey respondents for completing the survey and sharing their point of view. PwC Pharmaceuticals and Life Sciences practice We measure success by our ability to create the value that our clients, people and the wider investing public are looking for. We have extensive experience working with organizations across the industry, including: proprietary and generic drug manufacturers, specialty drug makers, medical device and diagnostics suppliers, biotechnology companies, wholesalers, pharmacy benefit managers, contract research organizations, and industry associations. We also author numerous thought leadership publications on emerging industry issues. For additional information, please visit www.pwc.com/ca/life sciences. BIOTECanada BIOTECanada is dedicated to the sustainable commercial development of biotechnology innovations in Canada. It is the national industry-funded association with over 250 member companies representing the broad spectrum of biotech constituents including emerging and established firms in the health, industrial, and agricultural sectors, as well as academic and research institutions and other related organizations. BIOTECanada is the national non-profit association dedicated to building the bio-based economy in Canada. From cleaner energy to sustainable agriculture; from greener manufacturing to life-saving health therapies, Canadian biotech firms are discovering ways to revolutionalize the economy and improve our lives, everyday. We are the voice of Canadian biotechnology to governments, investors, stakeholders, and the public. For additional information regarding this report, please contact: Prabh (Bob) Singh National Leader, Pharmaceuticals and Life Sciences PwC 905 897 4519 26 Canadian Life Sciences Industry Forecast 2013 Andrew Casey President and CEO BIOTECanada 613 230 5585 ext 229 © 2013 PricewaterhouseCoopers LLP. All rights reserved. “PwC” refers to PricewaterhouseCoopers LLP, an Ontario limited liability partnership, wich is a member firm of PricewaterhouseCoopers International Limited, each member firm of wich is a separate legal entity. 3191-02-02.12.13