2021 BDO LIFE SCIENCES CFO OUTLOOK SURVEY - BDO USA
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Table of Contents THE ROAD TO RECOVERY 3 PANDEMIC PIVOTS 4 OPPORTUNITIES ABOUND 8 SUPPLYING THE FUTURE 13 RESPONDENT PROFILE 18
2021 BDO LIFE SCIENCES CFO OUTLOOK SURVEY / 3 The Road to Recovery As COVID-19 continues to disrupt the entire life It’s been a demanding year for life sciences. sciences ecosystem, the The pandemic caused sweeping disruption across every industry, leading many pressure to innovate businesses to take a defensive position. Life sciences companies, on the other hand, is higher than ever took the field on offense. before. To compete, life Whether rapidly pivoting the pipeline to aid in the crucial development of tests, sciences leaders must treatments and vaccines for COVID-19, increasing the production of ventilators reimagine and reinvent and personal protective equipment (PPE), or ensuring that pandemic-related the ways in which they restrictions do not hinder access to important drugs and medical devices, life sciences work. Those who further organizations have been called to act, at speed, during this critical time. collaboration, build As the coronavirus-induced recession is expected to continue well into 2021, one greater resilience into thing is clear: Nothing returns to normal without life sciences. their supply chains and Tasked with charting a sustainable road to recovery for both the industry and the invest in outcomes-based global economy at large, life sciences organizations must advance COVID-19 R&D to R&D will be best set up to the point of commercialization and widespread adoption of a novel vaccine. However, thrive in what’s next. according to the 2021 BDO Life Sciences CFO Outlook Survey, to truly thrive beyond the pandemic, companies must also persist in demonstrating value, capitalizing on new opportunities, and effectively preparing their organizations to succeed in an TODD BERRY environment rife with emerging risk and accelerated disruption. Assurance Partner and National Co‑Leader of BDO’s Life Sciences practice LIFE SCIENCES CFO OPTIMISM Life sciences CFOs are the most optimistic headed into 2021. Explore our 2021 BDO Middle Market CFO Outlook Survey to see how other industries are faring. NOW ONE YEAR FROM NOW 10% 29% 61% CFOs Identify as 80% 17% 3% Struggling Surviving Thriving Thriving Surviving Struggling forecast a forecast a expect an economic 69% revenue increase 81% profitability increase 61% recovery in 2021
4 / 2021 BDO LIFE SCIENCES CFO OUTLOOK SURVEY Pandemic Pivots DOUBLING DOWN ON R&D COVID-19 largely altered life sciences leaders’ R&D priorities. As states and organizations implemented severe restrictions on many operations, access to clinical trial sites and patients were hindered, and lab capacities were 30% have rerouted reduced to essential employees only. The industry faced immediate pressure to pivot resources to develop and produce therapeutics and vaccines for COVID-19. In this resources to environment, life sciences leaders had to be decisive about which research projects COVID‑related made the most sense to advance. research While investments in non-COVID-19 areas of R&D slowed over the past year, life sciences organizations have shown immense agility in reallocating resources effectively, efficiently and at scale to meet greater pandemic-driven need. WHERE ARE CFOS INVESTING? Cell therapy 32% 16% 57% Gene therapy 36% 17% 47% Immunotherapies 40% 24% 56% Diagnostics 49% 39% 51% Consumables 40% 36% 53% Wearables 32% 29% 57% COVID-19 vaccine 36% 45% COVID-19 therapeutics 31% 43% In 2019 Currently In 2021
2021 BDO LIFE SCIENCES CFO OUTLOOK SURVEY / 5 Headed into 2021, life sciences CFOs are once again doubling down on R&D, with 69% planning to increase investment and 68% citing three to four promising products in their current portfolio for commercialization. While the prioritization of COVID-19 R&D is expected to continue until effective treatments and/or vaccines are commercialized, a significant bounce back of R&D investments in areas outside of COVID-19 vaccine and therapeutics research is expected in the new year. From immunotherapies to diagnostics to wearables, the influx of pandemic-related cash, energy and resources is likely to spill over into R&D areas like antivirals and remote monitoring. FEDERAL R&D TAX CREDIT ELIGIBILITY The cost of R&D in life sciences continues to increase—as does the risk—given public pressure to rein in drug prices and demonstrate value. As expenses rise, life sciences organizations can claim R&D tax credits to reduce their tax liability and allow for further investment in innovation. Each year, however, billions of dollars go unclaimed at the federal and state levels because companies either aren’t aware of or don’t fully understand eligibility for R&D tax credits. At the federal level, life sciences organizations working to develop new or improved products, processes, software or formulas are eligible for R&D tax credits—especially if the research is related to treating COVID-19. Under current IRS guidance, life sciences companies who received COVID-19 relief funding can claim R&D tax credits but only for qualified research expenditures that: 1. Were not paid for with proceeds from a PPP loan; or 2. Were paid for with proceeds from a PPP loan but only if: u The PPP loan ultimately wasn’t forgiven; u The taxpayer doesn’t request forgiveness for the PPP loan; or u The taxpayer doesn’t reasonably expect that the PPP loan will be forgiven. If a life sciences company reasonably expects the PPP loans will be forgiven, it should consider recent IRS guidance and speak to a tax professional in regards to its R&D tax credit eligibility. Try our R&D Tax Credit Calculator to see if your organization is missing out or undercapitalizing on valuable credits.
6 / 2021 BDO LIFE SCIENCES CFO OUTLOOK SURVEY ENABLING TRANSFORMATION AND EXPANSION To thrive in 2021 and beyond, life sciences CFOs are placing greater emphasis on driving digital transformation initiatives and downturn-proofing their organizations. TOP BUSINESS STRATEGY FOR 2021 ECONOMIC OUTLOOK A prolonged economic downturn is life sciences’ top threat in 2021 63% Digital Only 17% Transformation of CFOs predict a fast economic recovery in 2021 TOP 3 BUSINESS PRIORITIES IN 2021 33% 15% 15% Investing in Technology M&A Integration Managing Through or Infrastructure Economic Downturn Expansion is also high on the list for life sciences CFOs, with 41% citing plans to pursue product or service expansion in 2021. However, as life sciences organizations look to expand their offerings, they must do so with a focus on building a digitally-enabled workforce and infrastructure to support their growth.
2021 BDO LIFE SCIENCES CFO OUTLOOK SURVEY / 7 On a practical level, as life sciences leaders lay the groundwork for expansion, they need to consider how they can best evolve their operations and workforce strategies to fit current and DRIVING SUCCESSFUL DIGITAL future needs. For example: TRANSFORMATION u How can they maintain continuity of operations given sustained disruption to their workforces, R&D, supply To achieve desired ROI, life sciences chains and manufacturing capacities due to COVID-19? organizations looking to embark on digital transformation initiatives must do so with a u Can they shift to conducting clinical trials remotely? full understanding of: u Can manufacturing workflows and development schedules be redesigned to keep essential employees safe and remote How digital employees connected? transformation u Can they leverage digital platforms to engage with can best optimize healthcare professionals? their people, processes, platforms u Are there safeguards in place that will allow them to and protections protect intellectual property and proprietary information while operating in a remote setting? Life sciences CFOs must answer these questions and think through how to engage their workforces when executing on How to properly these shifts. execute their digital Life sciences organizations will also need to rethink how transformation they manage and incentivize talent in a remote, or partially strategy remote, setting—especially given 10% of CFOs say recruiting and retaining top talent is their #1 priority in 2021. As the life sciences industry continues to grow at a rapid pace and the pool for skilled employees shrinks, ensuring workforce Life sciences organizations who know how to best retention, specifically the retention of high performers, will leverage digital enablers—like cloud computing, be critical. advanced analytics and blockchain—and embrace digital transformation from a holistic perspective will be able to move beyond digital transformation as a disruptor and towards digital transformation as an enabler of better business outcomes.
8 / 2021 BDO LIFE SCIENCES CFO OUTLOOK SURVEY Opportunities Abound While the pandemic’s toll on health and the economy has been massive, disruption can drive positive change. In the last six months, life sciences CFOs say they have experienced: 42% 41% 40% New opportunities for product or Faster decision-making Accelerated digital service innovation transformation 38% 32% 31% Improved workforce New investment or Enhanced community / culture and unity expansion opportunities government partnerships As pandemic pivots continue to spark meaningful change, life sciences CFOs are seeking collaboration and capital.
2021 BDO LIFE SCIENCES CFO OUTLOOK SURVEY / 9 STRATEGIC PARTNERSHIPS & COLLABORATION In the life sciences space, R&D is always high-cost, high-risk and—if successful—high‑reward. To lighten the load and hasten outcomes, life sciences leaders are increasingly seeking opportunities to partner and collaborate with other organizations in the development and commercialization of new drugs, medical devices and technologies. PLANNED PARTNERSHIPS 44% 41% 36% 30% Data and/or technology Research Commercialization Clinical studies 23% 23% 22% 20% Licensing agreement Academic institution Artificial intelligence Joint venture 18% 17% 14% M&A Government contract Private equity or partnership
10 / 2021 BDO LIFE SCIENCES CFO OUTLOOK SURVEY SPOTLIGHT: COVID-19 COLLABORATION & INNOVATION IN ACTION AMGEN AND ADAPTIVE ASTRAZENECA, CEPI ROCHE AND GILEAD BIOTECHNOLOGIES AND GAVI On May 28, Roche and Gilead On April 2, Amgen and Adaptive On June 4, AstraZeneca announced announced the initiation of a global Biotechnologies announced a a $750 million agreement with the Phase III, randomized, double- collaboration, bringing together Coalition for Epidemic Preparedness blind, multicenter study to evaluate Adaptive's proprietary immune Innovations (CEPI) and Gavi, the the safety and efficacy of Roche’s medicine platform for the Vaccine Alliance, to manufacture, Actemra® in combination with identification of virus-neutralizing procure and distribute 300 million Gilead’s investigational antiviral antibodies with Amgen's expertise doses of AstraZeneca-Oxford’s Remdesivir, versus placebo plus in immunology and novel antibody potential COVID-19 vaccine, Remdesivir, in hospitalized patients therapy development to develop a AZD1222, by the end of 2020. with severe COVID-19 pneumonia. therapeutic for COVID-19. Collaborative partnerships are quickly becoming table stakes for accelerated innovation, and life sciences organizations will need to be strategic about attracting and engaging with the right partner for the right goal. Whether looking for traditional partnerships or cross-industry partnerships with sectors like healthcare or technology, life sciences leaders should evaluate and consider a variety of deal structures, as well as tax considerations, with a clear focus on which partnership opportunities will have the greatest impact on the company’s ability to scale, fund future innovation and further diversify their product and service mix. Once the right partnership is secured, proper alignment on strategy, objectives and execution will be key to success—especially when partnering with new entrants who may not have a clear understanding of how the industry operates in a highly regulated environment. The industry’s efforts in the battle against COVID-19 have fast-tracked opportunities for collaboration, innovation and expansion. As we look to the future, a focus on efficient, sustainable and value-based transformation—and financing—will be key. As organizations seek the scale, scope and speed to level up in today’s environment, they must do so with a focus on driving digital agility, improving patient outcomes and fostering transparency to prove efficacy to investors and the public. LANCE MINOR Principal and National Co-Leader of BDO’s Life Sciences practice
2021 BDO LIFE SCIENCES CFO OUTLOOK SURVEY / 11 FINANCING FOR SPACS AS AN EXPRESS GROWTH TRACK TO IPO Life sciences funding has spiked in Although the COVID-19 pandemic has 2020 as the industry’s push to produce caused significant economic hardship COVID-19 treatments continues to for most, Special Purpose Acquisition attract and intensify both investor Companies, or SPACs, have gained interest and federal funding. In fact traction in the life sciences space as as of September 2020, 59% of life an opportunity for organizations to sciences organizations secured funding quickly access capital and increase or assistance from government public visibility. programs in response to COVID-19. To finance plans for growth, as well For investors, SPAC IPOs are low‑risk as relieve high R&D and clinical trial as they can recoup finances, and expenses, life sciences CFOs will look the potential for returns are higher for opportunities to capitalize on this than ever given the access to capital, heightened attention in 2021. low interest rates and the ability to move quickly to close an acquisition. Yet, to maintain interest from both For target life sciences companies, investors and the public, life sciences SPAC IPOs provide the potential organizations will need to prove to access additional capital and their value. grow exponentially despite the economic downturn. 2021 FINANCIAL PLANS FOR GROWTH 25% plan to pursue PE investment 25% plan to pursue M&A 24% of private companies plan to pursue an IPO, of which 25% are biotechs
12 / 2021 BDO LIFE SCIENCES CFO OUTLOOK SURVEY To demonstrate their effectiveness at reducing costs and improving outcomes, the majority of life sciences organizations (78%) are partaking in some form of outcomes-based contracting. However, while outcomes-based contracts with providers seem to be increasing in popularity—specifically with biopharmaceuticals, pharmaceuticals and biotechs—outcomes-based contracts with payers are down slightly from last year. OUTCOMES-BASED CONTRACTS IN LIFE SCIENCES Have an outcomes-based Have an outcomes-based contract Do not have contract with a payer with a provider outcomes-based contracts 33% 30% 53% 57% 14% 22% 2019 2020 2019 2020 2019 2020 A Closer Look at Outcomes-Based Contracts with Healthcare Providers 70% 68% 68% 64% 52% 44% Biopharmaceutical Pharmaceutical Biotech 2019 2020 2019 2020 2019 2020 Outcomes-based contracts with providers are increasing in the life sciences space as pressure mounts to demonstrate value to investors, patients and the general public. As life sciences organizations partner with providers to prove out value in the current environment, they must do so with a heightened focus on constructing the right value-based payment model to support lower costs, improve patient outcomes and mitigate disruption. Life sciences leaders who work to identify changes in their operational landscape and restructure their provider contracts accordingly will be better prepared to operate in the reimbursement landscape post-pandemic. JIM WATSON Principal in The BDO Center for Healthcare Excellence & Innovation
2021 BDO LIFE SCIENCES CFO OUTLOOK SURVEY / 13 Supplying the Future In the last year, the life sciences industry has hustled to address pandemic pain points as efficiently as possible. Today, supply chains have been rerouted, resources have been reallocated and manufacturing has been ramped up to better meet global need and aim to mitigate against further disruption. As COVID-19 continues to impact the supply and manufacturing of essential products, While connecting with life sciences CFOs are using lessons learned in the early days of the pandemic to vendors, suppliers and optimize and build more agility into the supply chain of the future—which will be distributors to gauge crucial to the successful deployment of eventual vaccines and therapeutics. manufacturing capacity is a good first step, life sciences CAPACITY CONCERNS organizations should seek to develop a clear line of sight To successfully bring products to market, life sciences organizations must have access into the current product to sufficient manufacturing capacity. market and capacity landscape as a whole. For example, However, as directives to produce COVID-19 products at scale compete with the BDO’s bioTRAK® database existing manufacturing need for non-COVID products, life sciences manufacturers are provides life sciences leaders grappling with how to free up capacity to meet demand. with detailed information and As manufacturing plans are disrupted, life sciences CFOs must understand what analysis on biomanufacturing non-COVID products are also vying for demand and ensure that essential medicines, capacity supply and demand. devices and technologies have sufficient capacity. Organizations that leverage data to inform their understanding of the types of WHICH LIFE SCIENCES SUBSECTORS ARE STRUGGLING capacity available throughout MOST WITH PRODUCTION CAPACITY? the biomanufacturing space will be better able to forecast what products are competing for capacity and adjust their manufacturing strategy 16% as needed. 25% Medical equipment and Biopharmaceuticals medical supplies manufacturing 22% Biotech 19% 18% Physical, engineering and life sciences Pharmaceuticals (except biotech)
14 / 2021 BDO LIFE SCIENCES CFO OUTLOOK SURVEY SUPPLY CHAIN SHIFTS More than one in 10 life sciences CFOs say supply chain disruption is the greatest threat to their business in 2021, and for good reason. Global supply chains, international economic shutdowns and the reallocation of resources towards 26% COVID‑19-related products and projects have led to supply shortages and struggles across the industry. As the pandemic continues to highlight vulnerabilities on an international scale, many of CFOs say trade & organizations are looking to reduce their risk by identifying alternative suppliers, contemplating a reallocation or reshoring of resources and building more resiliency tariffs is their biggest and agility into their supply chain in 2021. policy concern in 2021 WHICH OF THE FOLLOWING SUPPLY CHAIN ACTIONS ARE LIFE SCIENCES CFOS UNDERTAKING? 61% 57% 54% 50% 29% 28% Identifying Conducting a Investing in Bolstering or Relocating to Reshoring to alternative / supply chain risk supply chain adding redundant another country the U.S. backup suppliers assessment technology inventory of select (non-U.S.) drugs or devices Looking ahead, as life science leaders use lessons learned from the pandemic to reassess their supply chain plans—especially from a business continuity and resiliency perspective—they must also carefully consider trade and tariff implications. Trade and tariffs are important tools in managing geopolitical relations, which can directly impact supply chain stability and access to critical resources and raw materials for life sciences companies— including active pharmaceutical ingredients (APIs). As international supply chains may be further disrupted by ongoing or emerging trade and tariff moves at the federal level, life sciences organizations should consider geographical diversification of their supply chains to minimize regional and country- specific impacts to their sourcing and production processes. These considerations also impact global transfer pricing and customs valuation ramifications—which are top enforcement priorities for governments worldwide. In short, considering the “Global Value Chain” should be a top priority in the coming year for all life sciences companies. DAMON V. PIKE Principal and Customs & International Trade Leader at BDO
2021 BDO LIFE SCIENCES CFO OUTLOOK SURVEY / 15 COVID-19 VACCINE CHALLENGES Once a vaccine has been developed and approved for should strive to get ahead of consumer apprehension about distribution, the road to economic recovery will still be taking a newly approved vaccine by being ultra-transparent long. If getting a vaccine to commercialization is like scaling and communicative about their research. Vaccines that can a mountain, supplying the treatment to large, diverse build consumer confidence early through clear, science- populations will be akin to summiting Mount Everest. backed communication will have a better chance of garnering acceptance from the general public. In addition, continued While the efficacy of a vaccine is essential, once proven optimization of supply chain manufacturing process effective, life sciences CFOs know that consumer confidence engineering will be necessary in order to overcome any will be crucial to widespread adoption. Life sciences manufacturing and sourcing constraints. organizations currently working on COVID-19 vaccines WHAT DO LIFE SCIENCES CFOS EXPECT TO BE THE BIGGEST CHALLENGE FOR AN APPROVED COVID-19 VACCINE? 8% Reimbursement 32% Efficacy 18% Efficient deployment 18% Sourcing and manufacturing enough quantity 24% Consumer adoption
16 / 2021 BDO LIFE SCIENCES CFO OUTLOOK SURVEY Pioneers on the road to global recovery, life sciences CFOs are optimistic about the year ahead. But, as increased investment, accelerated transformation and collaborative innovation continue, life sciences organizations must adapt with intention and prepare to thrive beyond the pandemic. As we enter a new year, life sciences organizations must continue to advance COVID-19 vaccines and therapeutics, as well as other areas of R&D, build greater resilience into their supply chains and remain agile in an increasingly digital world. Organizations that can do this and lead with value and transparency will build a strong foundation for future growth. Our research goes beyond life sciences. View the survey results from 600 CFOs across industries in our 2021 BDO Middle Market CFO Outlook Survey.
2021 BDO LIFE SCIENCES CFO OUTLOOK SURVEY / 17
18 / 2021 BDO LIFE SCIENCES CFO OUTLOOK SURVEY Respondent Profile The 2021 BDO Life Sciences CFO Outlook Survey polled 100 CFOs at biopharmaceutical, pharmaceutical, biotech, medical equipment and supplies manufacturing, and physical, engineering and life sciences subsectors with revenues ranging from $250 million to $3 billion in September 2020. The survey was conducted by Rabin Research Company, an independent marketing research firm, using Op4G’s panel of executives. Average tenure in current CFO role: 5 years TYPE OF LIFE SCIENCES ORGANIZATION How the life sciences CFO respondents self-identified their organization: BIOPHARMACEUTICALS 23% PHARMACEUTICAL 22% BIOTECH 22% MEDICAL EQUIPMENT AND SUPPLIES MANUFACTURING 21% PHYSICAL, ENGINEERING AND LIFE SCIENCES (EXCEPT BIOTECH) 12% ANNUAL REVENUE COMPANY TYPE $250M-$500M 10% 50% Public $501M-$750M 35% $751M-$999M 22% $1B-$2B 26% 50% $2B-$3B 7% Private
2021 BDO LIFE SCIENCES CFO OUTLOOK SURVEY / 19 ABOUT BDO’S LIFE SCIENCES PRACTICE BDO’s Life Sciences Practice provides the guidance that pharmaceutical, biotech, and medical device manufacturers need, when they need it. From understanding the complexities of research and development tax credits and FDA regulations, to licensing agreements and due diligence, we help our clients grow. ABOUT BDO USA BDO is the brand name for BDO USA, LLP, a U.S. professional services firm providing assurance, tax, and advisory services to a wide range of publicly traded and privately held companies. For more than 100 years, BDO has provided quality service through the active involvement of experienced and committed professionals. The firm serves clients through more than 65 offices and over 740 independent alliance firm locations nationwide. As an independent Member Firm of BDO International Limited, BDO serves multi-national clients through a global network of more than 88,000 people working out of more than 1,600 offices across 167 countries and territories. BDO USA, LLP, a Delaware limited liability partnership, is the U.S. member of BDO International Limited, a UK company limited by guarantee, and forms part of the international BDO network of independent member firms. BDO is the brand name for the BDO network and for each of the BDO Member Firms. For more information please visit: www.bdo.com. Material discussed is meant to provide general information and should not be acted on without professional advice tailored to your needs.
Contact Us For more information on BDO USA’s service offerings in this industry vertical, please contact one of the regional service leaders below: TODD BERRY National Life Sciences Co-Leader 617-239-4125 / tberry@bdo.com LANCE MINOR National Life Sciences Co-Leader 301-354-0711 / lminor@bdo.com ELENI LAGOS Life Sciences National Tax Leader 212-817-1739 / elagos@bdo.com People who know Life Sciences, know BDO. © 2021 BDO USA, LLP. All rights reserved.
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