Extension of Delivery Schedule for Bio-Manguinhos Purchase Order
On July 20, 2021, we received a $28.3 million purchase order
from Bio-Manguinhos, or the Bio-Manguinhos Purchase Order, for the purchase of DPP SARS-CoV-2 Antigen tests for delivery during 2021 to support the needs of Brazil’s Ministry of Health in addressing the COVID-19 pandemic. Bio-Manguinhos, a
subsidiary of the Oswaldo Cruz Foundation (known as Fiocruz), is responsible for the development and production of vaccines, diagnostics, and biopharmaceuticals, primarily to meet demands of Brazil’s national public health system. For additional
information, please see the information contained in our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2021 filed with the Securities and Exchange Commission, which we refer to as the Third Quarter 10-Q,
including without limitation the information set forth in the Third Quarter 10-Q under the headings “Part 1. Financial Information—Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Recent Events—July Purchase Orders” and “Part II. Other Information—Item 1A. Risk Factors—Because of our liquidity and operational limitations, including the availability of
staffing and supply chain resources that are necessary but outside of our control, we will not be able to timely fulfill all of the requirements of the July Purchase Order from Bio‑Manguinhos and it is difficult to reliably estimate the extent to
which we will be able to timely meet those requirements.”
As described in the Third Quarter 10-Q, our delivery of the full number of tests covered by the Bio-Manguinhos Purchase Order has been, and is expected to continue to be, negatively affected by limitations of our supply chain, staffing and liquidity, including matters that are outside
our control. Because of those limitations, at the time of the filing of the Third Quarter 10-Q we expected that, as set forth in the Third Quarter 10-Q, we would be unable to deliver at least $11.5 million of the Bio-Manguinhos Purchase Order by
December 31, 2021, the end of the shipment schedule under the order.
On November 12, 2021 Bio-Manguinhos notified us that it was extending the delivery schedule for shipments under the Bio‑Manguinhos
Purchase Order to allow for a portion of the shipments into March 2022. We believe this extension provides us with an opportunity to timely deliver all of the shipments contemplated by the Bio‑Manguinhos Purchase Order, including the $11.5 million
of shipments that, prior to the extension, we anticipated we would be unable to deliver by December 31, 2021. We expect, however, that our ability to manufacture tests covered by the July Purchase Order from Bio-Manguinhos will continue to be
limited in the first quarter of 2021, and the number of uncertainties related to third parties—including the availability of required personnel, raw materials and other resources—continue to preclude us from reliably estimating the extent to which
we will be able to fulfill the Bio‑Manguinhos Purchase Order on time and at an acceptable cost, or at all.
Submission of EUA Application for New DPP SARS-CoV-2 Antigen Test System
On November 15, 2021 we submitted an application for an emergency use authorization, or EUA, to the U.S. Food and Drug Administration for
the new DPP SARS-CoV-2 Antigen test system.