NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

Speaking of Merck, some interesting (edited) comments on Merck’s Q1 conference call from Tuesday as it could relate to Northwest Bio, and the impact of COVID-19 on BioPharma sales and clinical development. They basically said that they are seeing declines in physician office visits, and elective and non-critical surgeries, but they are continuing to enroll and launch new clinical trials. And although they will temporarily discontinue their stock repurchase program, they still continue to search for “value-enhancing” companies with which to partner and acquire, which remains a top priority.

https://news.alphastreet.com/merck-co-nyse-mrk-q1-2020-earnings-call-transcript/

Ken Frazier - Chairman and CEO

In many markets around the world, including the U.S., while our offices and laboratories remain open, our colleagues are primarily working from home. And for patients currently enrolled in our clinical trials, we're making every effort to ensure that patients in affected areas are able to continue their treatment and receive appropriate care and monitoring. Conditions are fluid and evolving. But as conditions allow, we are enrolling patients in ongoing studies, and we're starting new studies. . .

Importantly, our financial strength and strong balance sheet allow us to continue with our capital allocation priorities, including investing in R&D and in our growth drivers, investing in manufacturing capacity expansion, paying our dividends, and continuing our search for value enhancing business development, which remains a top priority. . .

And in the United States physician office visits across various areas of medicine are currently running down in the neighborhoods of 70% versus pre-COVID-19 levels. . . Non-urgent elective procedures have also been postponed or cancelled in most major markets in order to slow the spread of disease and enable hospital prioritization of COVID-19 patients. . .

Many sources are reporting current declines in elective procedures of over 70% with urgent procedure volumes also being affected, though to a much lesser degree. . . And even oncologists are delaying appointments and procedures as they prioritize patients based on severity and the immediate needs of different tumor types, resulting in extended dosing schedules for existing patients, as well as delays in the start of therapy for newly diagnosed patients.

Rob Davis - EVP, Global Services, and CFO

. . . In addition, as Ken noted, business development remains a priority, and we will continue to look for the best external sources of science to augment our pipeline. We will assess the environment on an ongoing basis and consider reactivating the repurchase program as warranted.


Roger Perlmutter - EVP and President, Merck Research Laboratories

So let me begin with our operational status. As an early point, our global clinical operations team recognized the importance of the SARS-CoV-2 infections that were reported in Wuhan, China, and made advanced preparations to manage what became the COVID-19 pandemic. These preparations included prepositioning clinical supplies, strengthening our clinical supplies network, putting in place processes to enable virtual monitoring and over time developing processes for home deliveries, investigational agents, including in some cases, developing alternative infusion sites. Operating virtually the clinical operations team, including data management and our quality organization has been able to maintain our overall clinical trial schedule. We have in some cases reduced enrollment in certain jurisdictions. But we have not halted enrollment and are continuing to launch new clinical trials across most jurisdictions.

As examples, our team processed 36 database logs in the month of March, and enrolled more than 700 new patients across our Europe, Middle East, Africa sites. These numbers provide substantial reassurance that our clinical programs are moving forward. Indeed, although I cannot predict what the course of the pandemic will be in the future, for now, our 2020 MRL objectives are not in jeopardy. This progress is owed entirely to the extraordinary work of teams across our organizations spanning five continents, and a very broad set of government regulatory agencies with whom we interact.


Q & A

Terence Flynn with Goldman Sachs

So can you just give us any more detail, the main driver there, is that you see an increasing number of M&A or BD opportunities now in this environment?

Rob Davis

. . . And then on your question about share repurchase program, just to be clear, and I had it in the prepared remarks, but it's worth reinforcing. We really decided to temporarily stop the share repurchase program predominantly out of an abundance of caution. Our financial position continues to be strong. And as we said, it really was to make sure that we can continue to do all of the investments we want to do in R&D and CapEx to support our future growth, and in business development, as you asked. So it's really across all those areas that we want to make sure we can prioritize investment. And we will continue to look at it and very well could reinstate the share repurchase as we see the situation evolve in the marketplace.