Jazz Pharmaceuticals Provides COVID-19 Business Update

PR Newswire

DUBLIN, March 31, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today provided an update regarding the impact of COVID-19 on its business and the actions it is taking to mitigate the spread of this virus.

"Jazz provides essential medicines to patients around the world and we are committed to delivering on this important mission. We have implemented a robust continuity plan to address the impact of COVID-19 on our business. We are highly focused on ensuring patients have access to our medicines and protecting the health and safety of our employees and the communities in which we operate," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. "The company is in a strong financial position, having entered the year with over $1 billion in cash and investments and access to significant additional liquidity. Our financial strength prepares us to navigate through this pandemic while continuing to execute on our key strategic objectives to support our long-term growth."

Jazz sees a limited financial impact today, given its portfolio of differentiated products addressing chronic and life-threatening diseases. However, given the global economic slowdown, reduced field-based interactions with healthcare professionals and the uncertainty surrounding the scale and duration of the pandemic, the company, at this time, cannot rule out future impact on its business and associated guidance. Jazz expects to provide an update on all key business areas during its first quarter 2020 financial results in early May.

The company will continue to closely monitor COVID-19 in order to make timely, informed decisions, in an effort to minimize the impact to key business areas.

Employees and Communities

Jazz supports broad public health strategies designed to prevent the spread of COVID-19 and is focused on the health and welfare of its employees.
In accordance with guidance issued by the Centers for Disease Control and Prevention, the World Health Organization and local authorities, beginning on March 16 the company's global workforce began working remotely, including the suspension of work-related travel and in-person customer interactions.
Field sales force, market access and reimbursement, and medical support employees are utilizing telephone and web-based means to continue to engage healthcare professionals to support their patients and practices. The medical science liaison team continues their support of all brands and studies.
Jazz is committed to support the company's local communities and patient focused organizations, and continues to explore additional ways to support local response efforts to COVID-19.

Supply of Jazz Medicines

The company remains confident in its ability to supply its medicines to patients around the world and currently has ample supply to meet commercial needs well into the future, with the exception of Erwinaze® (asparaginase Erwinia chrysanthemi). The manufacturer of Erwinaze continues to have supply disruptions unrelated to COVID-19.
Currently, the company expects adequate supply of lurbinectedin and JZP-258 to support the U.S. launches following potential U.S. Food and Drug Administration (FDA) approvals.
Jazz's manufacturing facility in Athlone, Ireland which produces Xyrem® (sodium oxybate) oral solution and JZP-258, continues to be operational. Jazz's Villa Guardia, Italy manufacturing facility, which produces defibrotide, temporarily ceased operations as of March 20 given the sufficient inventory and, importantly, the need to ensure the safety of the company's employees and communities in northern Italy.
Jazz is working closely with the company's third-party manufacturers, distributors and other trusted partners to manage the supply chain activities and mitigate any potential disruptions to the company's product supply as a result of COVID-19. To date, all third-party manufacturers are continuing operations.

Clinical Studies and Regulatory Update

Jazz is committed to the safety and well-being of patients enrolled in clinical studies with the goal of minimizing patient treatment disruptions due to COVID-19.
For ongoing clinical studies, the company has taken proactive measures to implement remote and virtual approaches, including remote patient monitoring, where possible. With the current stress on the healthcare system, the company anticipates an impact to patient enrollment in certain studies and delays in the initiation of new clinical studies.
Jazz remains engaged with regulatory authorities and is working closely with FDA on its two product candidates under review. JZP-258 and lurbinectedin are under priority review at FDA with Prescription Drug User Fee Act (PDUFA) action dates of July 21, 2020 and August 16, 2020, respectively. At this time, FDA has not notified Jazz of any planned delays in the New Drug Application reviews of these candidates.

About Jazz Pharmaceuticals plc
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases — often with limited or no options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas. Our focus is in neuroscience, including sleep medicine and movement disorders, and in oncology, including hematologic and solid tumors. We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including, but not limited to, statements related to Jazz Pharmaceuticals' expectations regarding business and financial impacts of COVID-19, including with respect to product supply chain, regulatory activities, clinical studies (including patient enrollment) and all other business operations; Jazz Pharmaceuticals' belief that its financial strength prepares it to navigate through the pandemic while executing on key strategic objectives to support long-term growth; and other statements that are not historical facts. These forward-looking statements are based on Jazz Pharmaceuticals' current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting global economic and financial disruptions; potential impacts on Jazz Pharmaceuticals' supply chain (including availability of packaging and logistics facilities and transportation), commercial, regulatory and clinical development plans, and all other business operations; and other risks and uncertainties including those described from time to time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including Jazz Pharmaceuticals' Annual Report on Form 10-K for the year ended December 31, 2019 and future filings and reports by Jazz Pharmaceuticals. Other risks and uncertainties of which Jazz Pharmaceuticals is not currently aware may also affect Jazz Pharmaceuticals' forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by Jazz Pharmaceuticals on its website or otherwise. Jazz Pharmaceuticals undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.

Investor Contact:
Kathee Littrell, Vice President, Investor Relations
Ireland +353 1 634 7887 U.S. +1 650 496 2717

Media Contact:
Jacqueline Kirby, Vice President, Corporate Affairs & Government Relations
Ireland +353 1 697 2141 U.S. +1 215 867 4910