While the pharmaceutical industry is less susceptible to market dynamics during a downturn as compared to other industries, this unpredictable environment amid the COVID-19 pandemic has pharma rethinking their portfolios and pipeline assets, supply chains, API sourcing, and manufacturing.

Arda Ural, Ph.D., a Principal and the Americas Industry Markets Leader, Health Sciences and Wellness at Ernst & Young LLP, provides insights on market dynamics, enduring therapeutic areas, near term M&A for pharma/biopharma, and how industry can use this time for transformation in commercial, supply chain and product development. –KB

Contract Pharma: How are pharma/biopharma companies adjusting their portfolios as a result of the pandemic?

Arda Ural: COVID-19 has meant biopharma companies’ must reconsider their portfolios, prioritizing how to secure the performance of in-market products and re-thinking assets currently in the development pipeline.

As it relates to in-market products, companies have been exploring supply chain initiatives to pre-empt any disruption by securing their APIs and excipients. They are also forecasting demand for specific products based on the elasticity for each therapeutic area. We recommend a dynamic and scenario-driven forecasting methodology and increasing the number of sales and operational planning sync-ups between manufacturing and commercial functions to adjust to this highly unpredictable environment. Of note, commercial teams are pivoting to digital channels, given sales’ inability to meet in-person with target providers.

Companies are also closely assessing their pipeline. COVID-19 has already impacted the pace of patient enrollment in clinical trials. As a result, the net present value of these pipeline assets may have changed, leading to a reshuffling of portfolio priorities. We are aware of several companies who are re-optimizing their pipeline as a result of COVID-19. Our recommendation to clients is to analyze the full portfolio immediately in a scenario-based approach and keep refreshing it on a monthly and quarterly basis.

Finally, companies with a viable candidate for a diagnostic tool, treatment or vaccine for COVID-19 have prioritized all their developmental activities to bring it to the market. While it’s a pressing imperative for the public good, this also asserts the company as a leader in fighting COVID-19. 

CP: How are sponsors responding to new challenges conducting research and clinical trials? 

AU: The COVID-19 outbreak has made it difficult for pharmaceutical companies to recruit patients for new trials and to keep already-enrolled patients compliant with protocols to avoid invalidation of the study outcomes.

Studies suggest that approximately 56% of U.S. clinical research study sites and 81% of European sites are less likely to continue current enrolled clinical trials and comply with study protocols and schedules.¹ At this point, more than 30 pharma/biopharma companies have reported a clinical trial disruption due to COVID-19. Some companies have paused clinical trial enrollment, uncertain about the ability to access testing sites. In parallel, trials for therapeutics and vaccines for COVID-19 have been expedited. A silver lining of this pandemic may be the much-needed acceleration of the digitalization and simplification of clinical trials. Addressing these cumbersome processes is long-overdue. 

Biopharma companies spend approximately 17% of its revenue on R&D activities. This number has been consistently increasing over the last decade and is mostly driven by large and expensive later-stage clinical trials.  

 Additionally, we anticipate three potential benefits for sponsors as a result of COVID-19:

•          First, they may increase adoption of telehealth technologies, thereby enabling virtual visits, reducing patient travel and lowering dropouts.
•          Second, we foresee an increase in remote patient monitoring to bolster patient safety. By some estimates, 70% of patients enrolled currently live at least two hours away from their trial site.² 
•         Lastly, remote trial operations may significantly lower expenses. Digital capabilities could accelerate enrollment and enable improved retention and quality audits through electronic or video  consent platforms and would offer remote site monitoring solutions.

CP: Which therapeutic areas are likely to endure the coming downturn?

AU: Several therapeutic areas have shown an increase in demand due to managing COVID-19 infections. These include antibiotics, antivirals, respiratory nebulizers and inhalers, analgesics and anaesthetics used in acute care and intensive care settings. In fact, the sharp spike in their demand coupled with the disruption of the supply chain led to worldwide shortages. It should be noted that most of the medications in these therapeutic areas are commoditized.

Specialty therapeutics, including those for oncology, hematology and auto-immune diseases (e.g., multiple sclerosis, rheumatoid arthritis, psoriasis and diabetes) have mostly maintained their utilization. This may shift in the near future, since most companies have seen an uptick due to pre-emptive buy-in by wholesalers to accommodate anticipated demand.

The location of care of services is also a critical variable. Therapies that can be administered at home or at ambulatory surgical centers are less affected.

On the other hand, companies that rely on newly diagnosed patients to grow their products in these therapeutic areas are expecting a slow-down due to lack of access to primary care physicians who prioritized COVID-19 patients over non-emergency visits.

Finally, therapies for less acute needs, including ophthalmology, dermatology, gastroenterology, infertility treatments, life-style treatments, products for asymptomatic cardiovascular conditions and vaccines that are not related to COVID-19 may experience an adverse impact. The patients in these therapeutic areas may not actively seek care or renew prescriptions, and demand may drop. 

CP: What do you anticipate in the near term for pharma/biopharma M&A?

AU: M&A activity in 2019 demonstrated an all-time high transactions value at $370 billion, in which the lack of at-scale assets pushed up valuations.  In contrast to $147 billion worth of transactions in the first three months of 2019, the comparable period in 2020 only resulted $22 billion in capital deployment.

By studying three prior recessionary periods, we concluded that the life sciences industry is less susceptible to market dynamics during a downturn when compared to other industries, as measured by M&A volume. Specifically, in 1991, life sciences deal volume grew 54% while deal volume for all other sectors combined declined by 2.4%. In 2001, life sciences deal volume grew 18%. Deal volume for all other sectors declined by 32%. Finally, in 2008, life sciences deal volume declined by 25%, but that was still better than the 30% decline in deal activity for all other sectors.

The uncertainty COVID-19 ushered in will impact M&A across the industry. First, companies may use their balance sheets to preserve cash. These reserves would be used to finance their operations at a priority over other capital deployments including M&A, stock buybacks or dividends. Additionally, the ability to forecast and value the acquisition or divestiture of assets in this environment may be challenging.

However, when we polled life sciences executives, nearly half said they would consider M&A activity in the next 12 months. We believe this is driven by a few tailwinds, starting with the systemic need to replenish the pipeline with late stage assets. Biopharma has been challenged by an intrinsic R&D productivity and needs to maintain its growth by acquiring biotech assets.

Additionally, the industry is experiencing $160 billion worth of exclusivity loss through 2023, and the lost revenue needs to be supplemented by acquiring highly de-risked or in-market assets. A precipitous drop in targets’ values may encourage some opportunistic acquisitions.

It is also worth mentioning that the collective dry powder of the biopharma industry remains at $1 trillion as of March 2020—slightly down from $1.2 trillion at the end of last year, but still at a formidable level. As a comparison, private equity maintains $1.4 trillion capital ready to deploy.

In summary, while 2020 looks to be a relatively slow year, we believe the biopharma M&A activity may be resilient when compared to other industries. Our prediction is supported by past observations in prior recessions, underlying industry trends and liquidity on the side-lines.

CP: What lasting impact do you anticipate COVID-19 will have on life sciences in the months and years ahead? 

AU: This pandemic facilitated an unprecedented market environment which will compel the industry to reimagine and reinvent itself.

Starting with commercial, the industry may rely more heavily on digital and telemedicine platforms. Companies could be more willing to try new business models and rely less on traditional distribution and payment schemes.

We expect governments may provide strong guidelines to re-patriate manufacturing of some essential medications in the next 12 months, thus positively impacting supply chains. These regulations will likely require pharma companies to nimbly reshape their supply chain footprint, think differently about their API and excipient sourcing and develop compliance mechanisms. These adjustments may partially reverse the trend of globalization and outsourcing of the supply chain to lower cost geographies.

Finally, as we discussed earlier, the industry could fundamentally reimagine its traditional approach to the end-to-end clinical trial process. This would require significant digitalization and simplification in areas ranging from adoption of telehealth technologies to remote patient consent, patient monitoring and site monitoring.

Although this pandemic has been a global disruptor, the industry should leverage this moment as an accelerator to trigger transformation in commercial, supply chain and product development.
 

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[1] Continuum Clinical report

[2] Andy Coravos of Elekra Labs
 

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Arda is a Principal and the Americas Industry Markets Leader, Health Sciences and Wellness at Ernst & Young LLP in New York with a focus on the Life Sciences sector. Prior to joining EY, he was a Managing Director at a strategy consulting firm for six years, where he led the Life Sciences M&A Practice. Earlier, he worked as a VP of Strategic Marketing and a BU Lead at an American medical technology company. He also served as the SVP Marketing & Sales for a startup biotechnology company which went public.