- Akebia regains full rights to sell Vafseo® (vadadustat) Tablets
in the U.S. following the execution of a royalty-based termination
agreement with CSL Vifor to simplify operational execution and
improve economics
- Announced Vafseo WAC pricing of $1,278 for a 30-day supply
- Submitted TDAPA application for Vafseo in June 2024 and expects designation on January 1, 2025
Akebia to host investor conference call at
8:00 a.m. ET on July 11, 2024
CAMBRIDGE, Mass., July 11,
2024 /PRNewswire/ -- Akebia Therapeutics®,
Inc. (Nasdaq: AKBA), a biopharmaceutical company with the
purpose to better the lives of people impacted by kidney disease,
today announced key updates pertaining to the commercial launch of
Vafseo® (vadadustat) Tablets. Akebia will host an investor
conference call at 8:00 a.m. ET on
Thursday, July 11, 2024.
"Since Vafseo approval in late March, our team has worked
diligently on commercial launch activities to drive prescriber
demand with the goal to optimize Vafseo's revenue ramp during the
two-year Transitional Drug Add-on Payment Adjustment (TDAPA) period
expected to begin in January 2025 and
beyond," said John P. Butler, Chief
Executive Officer of Akebia. "This is a multi-faceted endeavor, and
today I am excited to share progress made on multiple fronts.
First, we have established a wholesale acquisition cost (WAC) that
reflects the value of Vafseo in both the dialysis and, if approved,
non-dialysis populations. Additionally, contracting effectively
with dialysis organizations is critical to a successful launch. To
help facilitate the contracting process, as well as simplify the
operational management of the product, we have agreed with CSL
Vifor to terminate the existing license, resulting in Akebia
regaining rights to sell Vafseo to Fresenius Kidney Care dialysis
centers and specific other third-party dialysis organizations in
the U.S. In addition, we have made significant progress in contract
discussions with dialysis organizations for both Auryxia and
Vafseo. Having now executed this agreement with CSL Vifor, we can
accelerate contracting discussions and expect to have contracts in
place with dialysis providers treating the vast majority of
eligible Vafseo patients before January
2025. I want to thank our colleagues at CSL Vifor for their
collaboration over the past years, and I look forward to continuing
to work with them under this new relationship."
Vafseo Commercial Launch Updates:
CSL Vifor Agreement: Akebia and CSL Vifor have entered
into a termination agreement of the license agreement providing for
the payment of royalties by Akebia to CSL Vifor on Vafseo U.S. net
product sales. As a result, Akebia regained full rights to sell
Vafseo in the U.S. and is able to contract directly with all
dialysis organizations effective immediately. Akebia believes its
existing and well-established renal sales and medical affairs teams
are equipped to drive prescriber demand and enable dialysis
organization contracting. Under the terms of the agreement, CSL
Vifor is entitled to quarterly tiered royalty payments ranging from
a high single-digit percentage on annual net sales up to
$450 million to a mid-single digit
percentage on annual net sales above $450
million. Akebia has the opportunity to buy down the royalty
agreement beginning on July 1, 2027
with a one-time payment to CSL Vifor, which would decrease the
royalty payments to a mid-single digit percentage of Akebia's
annual net sales of Vafseo up to $450
million and eliminate the royalty payment on annual net
sales above $450 million.
TDAPA Submission: In June, Akebia submitted its TDAPA
application. Akebia expects to have Healthcare Common Procedure
Coding System (HCPCS) codes assigned in October 2024 and full TDAPA designation by
January 1, 2025.
Vafseo Pricing: Vafseo WAC has been set at $1,278 for a 30-day supply at the minimum
starting dose, or approximately $15,500 per year. The entire dialysis business
will be a contracted business, offering an off-invoice discount as
well as volume tier discounts off this WAC price. The potential
label expansion into non-dialysis patients was an important factor
in determining the WAC pricing for Vafseo.
Conference Call Information
Akebia will host a
conference call on Thursday, July 11,
2024 at 8:00 a.m. Eastern Time
to discuss Vafseo commercial updates. To access the call, please
register by clicking on this Registration Link, and you will be
provided with dial in details. To avoid delays and ensure timely
connection, we encourage dialing into the conference call 15
minutes ahead of the scheduled start time.
A live webcast of the conference call will be available via the
"Investors" section of Akebia's website at:
https://ir.akebia.com/. An online archive of the webcast can be
accessed via the Investors section of Akebia's website at
https://ir.akebia.com approximately two hours after the event.
About Akebia Therapeutics
Akebia Therapeutics, Inc. is
a fully integrated biopharmaceutical company with the purpose to
better the lives of people impacted by kidney disease. Akebia was
founded in 2007 and is headquartered in Cambridge, Massachusetts. For more
information, please visit our website at www.akebia.com, which does
not form a part of this release.
Forward-Looking Statements
Statements in this press
release regarding Akebia Therapeutics, Inc.'s ("Akebia's")
strategy, plans, prospects, expectations, beliefs, intentions and
goals are forward-looking statements within the meaning of the U.S.
Private Securities Litigation Reform Act of 1995, as amended, and
include, but are not limited to, statements regarding: Akebia's
updates pertaining to the commercial launch of Vafseo (vadadustat)
Tablets, including that commercial launch activities will drive
prescriber demand or optimize Vafseo's revenue ramp during the
two-year TDAPA period beginning in January
2025 and beyond, and that the WAC price reflects the value
of Vafseo in both the dialysis and, if approved, non-dialysis
populations; Akebia's significant progress in contract discussions
with dialysis organizations for both Auryxia and Vafseo, including
Akebia's expectations for timing to have contracts in place with
dialysis providers treating the vast majority of eligible [Vafseo]
patients; the execution of a royalty-based termination agreement
with CSL Vifor to simplify operational execution, improve economics
and facilitate the contracting process, including beliefs that
Akebia's existing and well-established renal sales and medical
affairs teams are equipped to drive prescriber demand and enable
dialysis organization contracting; Akebia's expectations for timing
to have HCPCS codes and full TDAPA designation; and Akebia's
potential label expansion of Vafseo into non-dialysis patients. The
terms "intend," "believe," "plan," "goal," "potential,"
"anticipate, "estimate," "expect," "future," "will," "continue,"
derivatives of these words, and similar references are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Actual
results, performance or experience may differ materially from those
expressed or implied by any forward-looking statement as a result
of various risks, uncertainties and other factors, including, but
not limited to, risks associated with: the implementation of the
provisions of the termination agreement with CSL Vifor, including
the ability of Akebia to successfully contract with dialysis
organizations; whether Vafseo will be commercially available when
expected; the potential demand and market potential and acceptance
of, as well as coverage and reimbursement related to, Auryxia® and
Vafseo, including estimates regarding the potential market
opportunity; the competitive landscape for Auryxia and Vafseo,
including potential generic entrants; the ability of Akebia to
attract and retain qualified personnel; Akebia's ability to
implement cost avoidance measures and reduce operating expenses;
decisions made by health authorities, such as the FDA, with respect
to regulatory filings; the potential therapeutic benefits, safety
profile, and effectiveness of Vafseo; the results of preclinical
and clinical research; the direct or indirect impact of the
COVID-19 pandemic on the markets and communities in which Akebia
and its partners, collaborators, vendors and customers operate;
manufacturing, supply chain and quality matters and any recalls,
write-downs, impairments or other related consequences or potential
consequences; and early termination of any of Akebia's
collaborations. Other risks and uncertainties include those
identified under the heading "Risk Factors" in Akebia's Quarterly
Report on Form 10-Q for the quarter ended March 31, 2024, and other filings that Akebia may
make with the U.S. Securities and Exchange Commission in the
future. These forward-looking statements (except as otherwise
noted) speak only as of the date of this press release, and, except
as required by law, Akebia does not undertake, and specifically
disclaims, any obligation to update any forward-looking statements
contained in this press release.
Akebia Therapeutics®, Auryxia® and Vafseo® are registered
trademarks of Akebia Therapeutics, Inc. and its
affiliates.
Akebia Therapeutics Contact
Mercedes Carrasco
mcarrasco@akebia.com
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SOURCE Akebia Therapeutics, Inc.