Akebia’s COVID-19 Statement
(updated May 5, 2020)
The current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), or COVID-19, pandemic has presented a substantial public health and economic challenge around the world and is affecting our employees, patients, customers, collaboration partners, vendors, communities and business operations. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted, including new information that may emerge concerning COVID-19, the actions taken to contain it or treat its impact and the economic impact on local, regional, national and international markets where the healthcare providers with whom we interact, our partners, our clinical research organizations, our contract manufacturing organizations, and our other vendors operate.
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 chronic kidney disease 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 macro-level 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.
We have asked all of our office-based employees to work from home since March 13, 2020. In addition, consistent with Centers for Disease Control and Prevention guidance and in accordance with new COVID-19 safety restrictions imposed by many of our customers, we have suspended in-person interactions by our customer-facing personnel with all patients and healthcare providers, including dialysis centers and hospitals. Where possible, we are engaging with healthcare providers and our customers virtually as we seek to continue to support patient care. 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. While it is possible that we may benefit in the near term if the prior authorization requirement for our marketed product is waived or relaxed consistent with Centers for Medicare & Medicaid Services’ guidance for the COVID-19 pandemic, or from any precautionary measures that could be taken by our customers due to the COVID-19 pandemic, such as increasing their levels of stock of our marketed product in anticipation of any supply interruptions from the pandemic, over the longer term, any such advance sales may negatively impact future revenue.
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, 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 we continue to expect top-line data in mid-2020, as previously disclosed. 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.
Our team has continued to support local and national response efforts to the COVID-19 pandemic by donating supplies and meals to frontline healthcare workers in the Boston area, volunteering to provide medical care at clinics treating COVID-19 patients, and donating to the American Kidney Fund COVID-19 emergency fund to support the needs of kidney patients.
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 March 30, 2020, filed with the SEC on May 5, 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.