Akebia’s COVID-19 Statement
(Updated August 10, 2020)
To date, we have not experienced any significant adverse impact from COVID-19 on our financial and operational performance and our fundamentals have remained strong. We believe our innovative therapies are critical to dialysis and non-dialysis CKD patients, who are among the most at risk during this pandemic. Continuing to provide and support our therapies is a priority. However, we are continuing to monitor and assess the potential impact of the COVID-19 pandemic on our business and operations, including our sales, supply chain, manufacturing, and clinical trials. We are also mindful of the potential macrolevel risks from the impact on the healthcare system to us, our patients, our customers, healthcare providers, our collaboration partners, and our vendors, as well as the potential impact on payer mix.
The majority of our office-based employees have been working from home since March 13, 2020 and are not expected to return to the office before the end of 2020. In addition, consistent with Centers for Disease Control and Prevention guidance and in accordance with evolving COVID-19 safety restrictions imposed by many of our customers, we suspended in-person interactions by our customer-facing personnel with healthcare providers, including dialysis centers and hospitals. Although we began permitting in-person interactions in the second quarter of 2020 where appropriate and permissible, healthcare facilities have continued, or begun again, to restrict access for non-patients, including the members of our sales force. For example, DaVita, Inc., or DaVita, and Fresenius Medical Care, or Fresenius, which account for a vast majority of the dialysis population in the United States, have restricted access to their clinics. As a result, we continue to primarily engage with healthcare providers and other customers virtually, where possible. Given this uncertain environment and the lack of clear visibility, we are actively monitoring the demand for our marketed therapy, including the potential for material declines or changes in prescription trends and in customer orders.
At this time, our third party contract manufacturing partners continue to operate at or near normal levels. While we currently do not anticipate any interruptions in our manufacturing process due to COVID-19, we believe that we have inventory to help mitigate the impact should they occur. However, it is possible that the COVID-19 pandemic and response efforts may have an impact in the future on our contract manufacturing partners’ ability to manufacture our marketed product or to have our marketed product reach our markets, which would also impact our inventory reserves.
In terms of our clinical trials, our PRO2TECT studies for vadadustat have advanced significantly and as previously disclosed, we expect to announce top-line data in early September. Our FO2RWARD-2 trial for vadadustat is fully enrolled, and we continue to expect top-line data by year end. COVID-19 precautions are, however, causing a delay in enrolling new clinical trials. We are using remote monitoring and performing remote patient visits, where possible.
This uncertain COVID-19 environment has presented new risks to our business. While we are working aggressively to mitigate impacts on our business, we are mindful that many of these risks and the impact to the larger healthcare market are outside our control.
Cautionary Note on Forward-Looking Statements
This statement includes forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended. These statements are not historical facts, but instead represent only Akebia’s beliefs regarding future events, many of which, by their nature, are inherently uncertain and outside of Akebia’s control. For a discussion of risks related to the forward-looking statements in this statement, including the risks related to COVID-19, commercialization, our clinical trials, manufacturing, and our financial position, including our cash runway, see the “Risk Factors” section of Akebia’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, filed with the SEC on August 10, 2020, and other filings that Akebia may make with the SEC in the future. These forward-looking statements (except as otherwise noted) speak only as of the date of this statement, and Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this statement.