a5882v-1
Exhibit 99.1
Indivior Provides Business Update; Conference Call at 8:00 AM U.S.
EDT
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF
ARTICLE 7 OF THE MARKET ABUSE REGULATION (EU) 596/2014 (AS IT FORMS
PART OF DOMESTIC LAW IN THE UK BY VIRTUE OF THE EUROPEAN UNION
(WITHDRAWAL) ACT 2018).
Richmond, VA, July 9, 2024 - Indivior PLC (Nasdaq/LSE: INDV) today
announces a business update encompassing the Group's outlook for Q2
and FY 2024 financial performance, its product portfolio and
litigation. Indivior is:
●
Updating
Q2 net revenue (NR) expectations and FY 2024 guidance to reflect
continued adverse market dynamics impacting near-term SUBLOCADE NR
growth as well as the initial commercial adoption of OPVEE; At the
mid-point, the Group continues to expect strong YOY NR growth for
SUBLOCADE of 25% and YOY adjusted operating income growth of 12% in
FY 2024;
●
Reiterating
its medium-term financial outlook for double-digit NR growth and
operating margin expansion, based on its confidence in achieving
its intermediate and peak NR goals for SUBLOCADE as well as peak NR
expectations for OPVEE;
●
Discontinuing
sales and marketing for PERSERIS due to expected adverse impacts
from increased payor management of the category that crystalized in
Q2 and that are expected to make the product no longer financially
viable; and,
●
Reaching
a settlement agreement with end payor plaintiffs in the Health Care
Services Corp (HCSC) consolidated cases to resolve the litigation
for $85m.
Comment by Mark Crossley, CEO of Indivior PLC
"Despite positive early performance trends at the start of the
second quarter, SUBLOCADE net revenue (NR) has continued to be
impacted more than we expected by a combination of transitory
factors, primarily the elimination of COVID emergency measures
related to automatic Medicaid coverage renewals. Furthermore, as we
look to the second half of the year, the U.S. government has
extended renewal allowances for certain States which will further
delay the annualization of this significant headwind. We are
therefore reducing our FY 2024 guidance to reflect these impacts.
Importantly, despite the disproportionate disruption to our patient
base, we expect SUBLOCADE NR to grow by 25% at the mid-point of our
new guidance range, reflecting strong underlying
demand.
Looking beyond these transitory impacts, we remain firm in our
conviction that SUBLOCADE's unique profile to address high-powered
synthetic opioids, such as fentanyl, provides us with a tremendous
opportunity to meet the growing and changing needs of patients. As
a result, we continue to be confident that SUBLOCADE will achieve a
net revenue run rate of $1 billion as we exit 2025 and ultimately
meet our target of greater than $1.5 billion in peak annual net
revenue, underpinning the successful delivery of our medium-term
profitable growth ambitions.
Separately, we are taking decisive
action that we believe is in the best interest of shareholders in
two areas. First, we are creating greater certainty for all
stakeholders by settling with Plaintiffs ahead of our antitrust
trial on July 15th.
Second, due to anticipated increased payor management of the
category that makes PERSERIS' future no longer financially viable,
we have determined to take the required actions to discontinue the
product. While we believe discontinuing PERSERIS is the right
business decision, unfortunately it will impact our people and
patients, and we will support them through this
transition."
Discontinuation of PERSERIS Sales & Marketing:
The Group will immediately cease all sales and marketing activities
related to PERSERIS. The Group believes this action is in the best
interests of shareholders due to the highly competitive market and
impending changes that are expected to intensify payor management
in the treatment category in which PERSERIS participates. Analysis
of forthcoming changes suggests that there is no longer a path
forward for PERSERIS that is financially viable. Indivior will
continue to supply PERSERIS for the foreseeable future to avoid
disruption to patient care but will no longer deploy a dedicated
sales force. As a result, we expect to reduce headcount by
approximately 130 employees. Indivior does not anticipate material
impacts on its other marketed products because of this
decision.
Total expected charges related to this action are expected to be
approximately $65m, of which approximately $20m are expected to be
cash related to severance and termination of certain agreements.
These charges will be recognized in the second and third quarters
and excluded from adjusted earnings. Ongoing annual operating
expense savings are expected to be approximately $50m, with $20m
expected to be realized in H2 2024. The impact of this decision on
FY 2024 guidance is included in the updated guidance set out
below.
Preliminary Q2 Net Revenue Expectations:
The Group is providing the below preliminary expectations for key
NR drivers for Q2 2024.
|
|
July 9, 2024
|
|
Net
Revenue (NR)
|
$295m to $303m (+8% vs. Q2 2023 at the
mid-point)
|
|
SUBLOCADE NR
|
$188m to $196m (+24% vs. Q2 2023 at the
mid-point)
|
|
PERSERIS NR
|
$10m to $13m
|
Continued transitory patient treatment disruptions from ongoing
Medicaid disenrollments that accelerated at the end of the quarter
have disproportionately impacted SUBLOCADE. Combined with
lower-than-expected stocking levels in key channels and
longer-than-expected activation times with new criminal justice
system accounts, SUBLOCADE NR was lower than expected in the second
quarter.
●
Ongoing Medicaid disenrollments in the second
quarter continued to impact new patient starts and refills. At the
end of the second quarter, Medicaid disenrollments stood at
approximately 23 million1 versus
approximately 19 million1 at
the end of the first quarter. The continued decline in Medicaid
patient levels in the second quarter combined with fewer patients
returning to treatment from first quarter Medicaid disenrollments
and the Change Healthcare cyber-attack disruption had a greater
than expected impact on NR performance in the second quarter. As a
result, despite early positive performance trends in the quarter,
overall new SUBLOCADE patient growth and refills were below
expectations. In addition, Medicaid renewal actions in some
instances are being permitted by Centers for Medicare &
Medicaid Services (CMS) to extend into the third quarter, likely
prolonging the period of SUBLOCADE patient
disruption.
1
www.kff.org
●
Stocking
in the second quarter was also lower than expected, as days of
SUBLOCADE inventory on-hand remained relatively unchanged at first
quarter levels of under two weeks, which is historically low. The
Group now believes its specialty pharmacy and specialty
distributors have made permanent one-off inventory adjustments to
take advantage of shortened lead times associated with supply
efficiencies to organized health and criminal justice system
customers.
●
While
SUBLOCADE NR from the criminal justice system continued to grow
strongly in the second quarter, increasing approximately 85%
compared to the year-ago quarter, longer lead times to open new
criminal justice system accounts also impacted expectations for NR
in the second quarter. The Group remains confident this timing
issue does not undermine the potential for SUBLOCADE to address the
large unmet need in this important and growing new
channel.
●
Impact
of competitor activity was in line with expectations.
OPVEE NR in the second quarter was immaterial (<$1m). The OPVEE
experience program continues to increase trial among target
customers and user feedback remains overwhelmingly positive.
Expected adoption is, however, lagging expectations. The Group
continues to update standing orders and grant funding for all
opioid reversal medications. As a result, the Group expects that
OPVEE NR in FY 2024 will be driven predominantly by fulfilling the
first delivery of product under the 10-year contract with BARDA
(~$8m).
Updated FY 2024
Guidance1:
Considering the above factors and the cessation of PERSERIS sales
and marketing, the Group is updating FY 2024 guidance as set out
below. The Group continues to expect solid adjusted operating
income growth and adjusted operating margin expansion at the
midpoint of approximately 100 basis points versus FY 2023. Beyond
2024, the Group will no longer separately report PERSERIS
NR.
|
|
Updated (July 9, 2024)
|
May 23, 2024
|
|
Net Revenue (NR)
|
$1,150m to $1,215m
(+8% at mid-point vs. FY 2023)
|
$1,240m to $1,330m (+18% at mid-point vs. FY
2023)
|
|
SUBLOCADE NR
|
$765m to $805m
(+25% at mid-point vs. FY 2023)
|
$820m to $880m (+35% at mid-point vs. FY
2023)
|
|
OPVEE NR
|
$9m to $14m
Predominantly expected to come from fulfilling first delivery as
part of 10-year BARDA2 contract
(~$8m)
|
$15m to $25m
|
|
PERSERIS NR
|
$27m to $33m
|
$55m to $65m (+43% vs. at mid-point vs. FY 2023)
|
|
SUBOXONE Film Market Share3
|
No change
|
Assumes historic rate of share decline of 1 to 2 percentage points
and the potential impact from a fourth buprenorphine/naloxone
sublingual film generic in the U.S. market
|
|
Adjusted Gross Margin
|
No change
|
Low to mid 80% range
|
|
Adjusted SG&A
|
($550m) to ($560m)
Reflecting discontinuation of the sales and marketing of
PERSERIS
|
($575m) to ($590m)
|
|
R&D
|
No change
|
($120m) to ($130m)
|
|
Adjusted Operating Profit
|
$285m to $320m
(approx. 100 bps of margin expansion vs. FY 2023)
|
$330m to $380m
|
1
Guidance assumes no material change in exchange rates for key
currencies compared with FY 2023 average rates, notably USD/GBP and
USD/EUR
2
Biomedical Advanced Research and Development Authority
3
Reflecting underlying share erosion at a similar rate to the last
two years (approximately 2 share points p.a.)
Long-term Net Revenue Targets Remain Unchanged:
The Group remains confident that given the scale of the U.S. opioid
epidemic, which is now being driven by misuse of fentanyl and other
synthetic opioids, its opportunity to help patients and deliver
value for shareholders remains intact. The unique profile of
SUBLOCADE's paradigm-shifting treatment gives the Group confidence
in delivering on its stated NR targets for SUBLOCADE: exiting 2025
at a $1 billion NR run-rate and achieving greater than $1.5 billion
in peak annual NR.
Settlement with Certain End Payors:
On July 8, 2024, Indivior Inc. and Indivior Solutions Inc. reached
an agreement via mediation with Blue Cross Blue Shield of
Massachusetts, Inc., Health Care Service Corp., Blue Cross and Blue
Shield of Florida, Inc., Molina Healthcare, Inc., Aetna, Inc., and
certain of their affiliates (collectively, the "Plaintiffs") to
resolve consolidated antitrust litigation proceedings in Roanoke
County Circuit Court. These actions had been pending since 2020.
The agreement will terminate the trial that was scheduled to begin
on July 15, 2024.
As part of the agreement with the plaintiffs, Indivior will pay $85
million and will take a charge of $85 million in the second
quarter, which will be excluded from adjusted earnings. Payment
will be funded from Indivior's existing cash balance.
Conference Call Information:
Indivior will host a presentation via live webcast at 1:00 p.m.
London time (8:00 a.m. U.S. Eastern) today. The webcast event can
be accessed on the "Investors" section of the Group's website
at www.indivior.com
before the event begins.
Participants may access the event telephonically to ask a question
by registering with the following link:
https://register.vevent.com/register/BI07a0798620a745bca417b4b9d15d9fe2
(Registrants will have an
option to be called back directly immediately prior to the call or
be provided a call-in # with a unique pin code following their
registration)
The webcast link is: https://edge.media-server.com/mmc/p/nga7b6n
Important Cautionary Note Regarding Forward-looking
Statements
This press release contains certain statements that are
forward-looking. Forward-looking statements include, among other
things, statements regarding financial guidance for 2024, including
sales expectations for SUBLOCADE, PERSERIS, and OPVEE, expected
growth in adjusted operating income and expected margin expansion;
expected medium term margin expansion and cash flow generation;
peak net revenue goals for SUBLOCADE and OPVEE, and a $1 billion
net revenue run rate for SUBLOCADE by the end of 2025; our
expectation that we will continue to grow and increase shareholder
value; our expectation that cessation of PERSERIS marketing efforts
will not impact sales of our other products; expected costs and
timing of costs, and related expense savings, from no longer
marketing PERSERIS; our expectation that the Court will approve the
settlement with the end payors; and other statements containing the
words "believe," "anticipate," "plan," "expect," "intend,"
"estimate," "forecast," "strategy," "target," "guidance,"
"outlook," "potential," "project," "priority," "may," "will,"
"should," "would," "could," "can," "outlook," "guidance," the
negatives thereof, and variations thereon and similar expressions.
By their nature, such forward-looking statements involve risks and
uncertainties as they relate to events or circumstances that may or
may not occur in the future.
Actual results may differ materially from those expressed or
implied in these forward-looking statements due to a number of
factors, including: lower than expected future sales of our other
products; increased impacts from competition; failure to achieve
market acceptance of OPVEE; the possibility that the Court will not
approve the settlement, the possibility that the Court will require
changes to the settlement prior to approving it, potential delays
in obtaining Court approval of the settlement; and those factors
described in Indivior's Annual Report on Form 20-F for the fiscal
year 2023 and its other filings with the U.S. Securities and
Exchange Commission.
We have based the forward-looking statements in this press release
on our current expectations and beliefs concerning future events.
Forward-looking statements contained in this press release apply
only at the date of this press release, and we undertake no
obligation publicly to update or revise any forward-looking
statement, whether due to new information, future developments or
otherwise.
About Indivior
Indivior is a global pharmaceutical company working to help change
patients' lives by developing medicines to treat substance use
disorders (SUD) and serious mental illnesses. Our vision is that
all patients around the world will have access to evidence-based
treatment for the chronic conditions and co-occurring disorders of
SUD. Indivior is dedicated to transforming SUD from a global human
crisis to a recognized and treated chronic disease. Building on its
global portfolio of OUD treatments, Indivior has a pipeline of
product candidates designed to both expand on its heritage in this
category and potentially address other chronic conditions and
co-occurring disorders of SUD, including alcohol use disorder and
cannabis use disorder. Headquartered in the United States in
Richmond, VA, Indivior employs more than 1,100 individuals globally
and its portfolio of products is available in 37 countries
worldwide. Visit www.indivior.com to learn more. Connect with
Indivior on LinkedIn by visiting www.linkedin.com/
company/indivior.
This release is being made by Kathryn Hudson, Company Secretary
Indivior PLC.
Contact:
Jason Thompson
Vice President, Investor Relations
Tel: 804-402-7123 or jason.thompson@indivior.com
Tim Owens
Director, Investor Relations
Tel: 804-263-3978 or timothy.owens@indivior.com
###