Item 1.01 Entry into a Material Definitive Agreement.
On July 30, 2022, Tricida, Inc. ("Tricida") and Patheon Austria GmbH & Co KG
("Patheon") entered into an amendment ("Amendment No. 3"), effective as of July
1, 2022, which amends certain terms of the Manufacturing and Commercial Supply
Agreement, effective October 4, 2019 (as amended by amendment no. 1 dated March
30, 2021 and amendment no. 2 dated August 26, 2021, collectively the
"Agreement"), between Tricida and Patheon.
Pursuant to Amendment No. 3 the parties have agreed, among other things, to (i)
manufacture veverimer for commercial use using a payment structure that, in
addition to payment for delivery of commercial product on a per kilogram basis
as established by the Agreement, provides an additional incremental payment to
Patheon to cover certain manufacturing costs, (ii) maintain the existing cap on
maximum compensation to Patheon for commercial manufacturing during the upcoming
campaign, (iii) work on development of a second generation manufacturing
process, and (iv) defer payment of certain costs to the fourth quarter of 2023.
The foregoing description of terms of the Amendment No. 3 does not purport to be
complete and is qualified in its entirety by reference to the full text of the
Amendment No. 3. A copy of the Amendment No. 3 will be filed with the Securities
and Exchange Commission as an exhibit to Tricida's Quarterly Report on Form 10-Q
for the third quarter ended September 30, 2022, or via an amendment to this
Current Report on Form 8-K.
Item 7.01 Regulation FD Disclosure.
Tricida expects the financial impact of this Amendment No. 3 to be a deferral
until the fourth quarter of 2023 of approximately $8 million in costs from the
prior manufacturing campaign that were budgeted to be spent under the Agreement.
Amendment No. 3 does not impact Tricida's previous financial guidance. Tricida
currently has the financial resources to fund its planned operations into early
in the second quarter of 2023, which is approximately six months from the
anticipated announcement of its top-line results for the VALOR-CKD trial.
The information included under Item 7.01 of this Current Report on Form 8-K
shall not be deemed "filed" for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the "Exchange Act") or otherwise subject to
the liabilities of that section, nor shall it be deemed incorporated by
reference in any filing under the Securities Act of 1933, as amended, or the
Exchange Act, except as expressly set forth by specific reference in such
Forward Looking Statements
This Current Report on Form 8-K contains "forward-looking statements" within the
meaning of Section 27A of the Securities Act and Section 21E of the Exchange
Act. Forward-looking statements relate to expectations concerning matters that
are not historical facts. Words such as "projects," "believes," "anticipates,"
"plans," "expects," "intends," "may," "will," "could," "should," "would," and
similar words and expressions are intended to identify forward-looking
statements. These forward-looking statements include, but are not limited to,
statements related to deferral of certain costs until the fourth quarter of
2023, our financial resources being sufficient to fund our planned operations
into early in the second quarter of 2023, risks associated with our
manufacturer's commercial production capacity, risks associated with our
business prospects, financial results and business operations. These and other
factors that may affect our future business prospects, results and operations
are identified and described in more detail in our filings with the Securities
and Exchange Commission, including Tricida's most recent Annual Report filed on
Form 10-K, or Quarterly Reports filed on Form 10-Q. You should not place undue
reliance on these forward-looking statements, which speak only as of the date of
this filing. Except as required by applicable law, the company does not intend
to update any of the forward-looking statements to conform these statements to
actual results, later events or circumstances or to reflect the occurrence of
Item 9.01 Financial Statements and Exhibits.
Exhibit Number Description
Cover Page Interactive Data File (embedded within the Inline XBRL
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