Albireo Pharma, Inc. (Nasdaq: ALBO), a rare disease company
developing novel bile acid modulators to treat pediatric and adult
liver diseases, entered into a royalty monetization agreement with
Sagard Healthcare Partners (“Sagard”) for a total of $115 million
upfront in return for a mid-single digit average royalty rate on
Bylvay global annual net revenues.
“With this agreement, we are significantly
strengthening our balance sheet, providing us flexibility, and
extending our cash runway beyond at least the topline data readout
of our BOLD study in biliary atresia in 2024,” said Ron Cooper,
President and Chief Executive Officer of Albireo. “These additional
resources allow us to build Bylvay into a billion-dollar product
and advance the development of our early asset pipeline.”
“We are thrilled to support Albireo in its
mission to develop novel medicines to treat rare pediatric and
adult liver diseases,” said David MacNaughtan, Partner & Head
of Sagard Healthcare Partners. “Sagard’s investment reflects our
confidence in Bylvay’s commercial prospects in PFIC and will
provide Albireo with the resources to further develop this
important therapy for the treatment of other rare liver
diseases.”
Sagard will provide the $115 million of funding.
The agreement provides Albireo with a buy-out option at 1.3x
invested capital in the first three years, rising to 1.45x in the
fourth year, 1.65x in the fifth year, and 2.0x thereafter, net of
royalties paid. The agreement grants a first lien security interest
on Albireo’s worldwide annual consolidated net revenues relating to
Bylvay and associated additional collateral, and does not provide
for liens on Albireo’s intellectual property.
For the commitment to provide this cash payment,
Sagard will receive a 12.5% royalty rate on Albireo’s worldwide
Bylvay annual net revenues for revenues up to $250 million; the
royalty rate reduces to 5% for annual net revenues above $250
million, and further reduces to 1% on annual net revenues exceeding
$350 million if the FDA approves Bylvay in biliary atresia,
providing a mid-single digit average royalty rate based on current
sales forecasts. The total royalties are capped at 1.6x invested
capital if repaid by December 31, 2028, and 2.0x thereafter. Upon
achievement of the cap amount, the royalty agreement will
terminate.
Morgan Stanley & Co. LLC acted as sole
structuring agent on the transaction. Paul, Weiss, Rifkind, Wharton
& Garrison LLP served as legal counsel for Albireo. Covington
& Burling LLP served as legal counsel to Sagard.
About Bylvay (odevixibat)
Bylvay is the first drug approved in the U.S.
for the treatment of pruritus in patients 3 months of age and older
in all types of progressive familial intrahepatic cholestasis
(PFIC). Limitation of Use: Bylvay may not be effective in PFIC type
2 patients with ABCB11 variants resulting in non-functional or
complete absence of bile salt export pump protein (BSEP-3). The
European Commission (EC) and UK Medicines and Healthcare Products
Regulatory Agency (MHRA) have also granted marketing authorization
of Bylvay for the treatment of PFIC in patients aged 6 months or
older. Bylvay is available in Italy, Germany and the UK and will be
available for sale in other European countries following pricing
and reimbursement approval. A potent, once-daily, non-systemic
ileal bile acid transport inhibitor, Bylvay acts locally in the
small intestine. Bylvay can be taken as a capsule for patients that
are able to swallow capsules, or opened and sprinkled onto food,
which is a factor of key importance for adherence in a pediatric
patient population. The most common adverse reactions for Bylvay
are diarrhea, liver test abnormalities, vomiting, abdominal pain,
and fat-soluble vitamin deficiency. The medicine can only be
obtained with a prescription. For more information about using
Bylvay, see the package leaflet or contact your doctor or
pharmacist. For full prescribing information, visit
www.bylvay.com.
In the U.S. and Europe, Bylvay has orphan
exclusivity for its approved PFIC indications, and orphan
designations for the treatment of ALGS, biliary atresia and primary
biliary cholangitis. Bylvay is being evaluated in the ongoing
PEDFIC 2 open-label trial in patients with PFIC, in the BOLD Phase
3 study for patients with biliary atresia and the ASSERT Phase 3
study for ALGS.
Important Safety Information
- The most common adverse reactions
for Bylvay are diarrhea, liver test abnormalities, vomiting,
abdominal pain, and fat-soluble vitamin deficiency.
- Liver Test Abnormalities: Patients
should obtain baseline liver tests and monitor during treatment.
Dose reduction or treatment interruption may be required if
abnormalities occur. For persistent or recurrent liver test
abnormalities, consider treatment discontinuation.
- Diarrhea: Treat dehydration.
Treatment interruption or discontinuation may be required for
persistent diarrhea.
- Fat-Soluble Vitamin (FSV)
Deficiency: Patient should obtain baseline vitamin levels and
monitor during treatment. Supplement if deficiency is observed. If
FSV deficiency persists or worsens despite FSV supplementation,
discontinue treatment.
About Albireo
Albireo Pharma is a rare disease company focused
on the development of novel bile acid modulators to treat pediatric
and adult liver diseases. Albireo’s lead product, Bylvay, was
approved by the U.S. FDA as the first drug for the treatment of
pruritus in all types of progressive familial intrahepatic
cholestasis (PFIC), and it is also being developed to treat other
rare pediatric cholestatic liver diseases with Phase 3 trials in
Alagille syndrome (ALGS) and biliary atresia, as well as Open-label
Extension (OLE) studies for PFIC and ALGS. In Europe, Bylvay is
reimbursed for the treatment of PFIC in Germany, England, Wales
& Northern Ireland, Scotland, Italy, and Belgium. The Company
has also completed a Phase 1 clinical trial for A3907 to advance
development in adult cholestatic liver disease, with IND-enabling
studies progressing with A2342 for viral and cholestatic liver
disease. Albireo was spun out from AstraZeneca in 2008 and is
headquartered in Boston, Massachusetts, with its key operating
subsidiary in Gothenburg, Sweden. For more information on Albireo,
please visit www.albireopharma.com.
About Sagard
Sagard is a multi-strategy alternative asset
manager with more than US$13 billion under management and
professionals located in Canada, the US, and Europe. Sagard seeks
attractive investment returns by combining its entrepreneurial and
disciplined culture with flexible capital and a unique global
network of portfolio companies, limited partners, advisors and
other valued relationships. As a firm, Sagard operates platforms
that invest across five asset classes: private equity, private
credit, healthcare royalties, real estate and venture capital.
Through its ecosystem partners, Sagard also engages in private
wealth management and new venture creation.
Forward-Looking Statements
This press release includes “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements include statements,
other than statements of historical fact, regarding, among other
things: the royalty monetization transaction with Sagard, including
the potential benefits of the transaction and the expected average
royalty rate; Albireo’s expected cash runway; Albireo’s
commercialization plans; the plans for, or progress, scope, cost,
initiation, duration, enrollment, results or timing for
availability of results of, development of Bylvay, A3907, A2342 or
any other Albireo product candidate or program; the target
indication(s) for development or approval; potential regulatory
approval and plans for potential commercialization of Bylvay in
biliary atresia or ALGS or Albireo’s other product candidates; the
potential benefits or competitive position of Bylvay or any other
Albireo product candidate or program or the commercial opportunity
in any target indication; or Albireo’s plans, expectations or
future operations, financial position, revenues, costs or expenses.
Albireo often uses words such as “anticipates,” “believes,”
“plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,”
“should,” “could,” “estimates,” “predicts,” “potential,” “planned,”
“continue,” “guidance,” or the negative of these terms or other
similar expressions to identify forward-looking statements. 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: the amounts we are obligated to pay under the
royalty monetization agreement will depend on a number of factors,
including the commercial success and revenues from sales of Bylvay;
the average royalty rate may be higher than we expect and our
estimates depend on regulatory approval of Bylvay in biliary
atresia; we may choose to buy out Sagard’s interest or, in certain
circumstances, Sagard may require us to repurchase Sagard’s
interest in the royalty interest payments; there are no guarantees
that Bylvay will be commercially successful; we may encounter
issues, delays or other challenges in commercializing Bylvay;
whether Bylvay receives adequate reimbursement from third-party
payors; the degree to which Bylvay receives acceptance from
patients and physicians for its approved indication; challenges
associated with execution of our sales activities, which in each
case could limit the potential of our product; challenges
associated with supply and distribution activities, which in each
case could limit our sales and the availability of our product;
results achieved in Bylvay in the treatment of patients with PFIC
may be different than observed in clinical trials, and may vary
among patients; potential negative impacts of the COVID-19
pandemic, including on manufacturing, supply, conduct or initiation
of clinical trials, or other aspects of our business; whether
favorable findings from clinical trials of Bylvay to date,
including findings in indications other than PFIC, will be
predictive of results from other clinical trials of Bylvay; there
is no guarantee that Bylvay will be approved in jurisdictions or
for indications (such as biliary atresia or ALGS) beyond the
jurisdictions in which or indications for which Bylvay is currently
approved; there is no guarantee that our other product candidates
will be approved; estimates of the addressable patient population
for target indications may prove to be incorrect; the outcome and
interpretation by regulatory authorities of the ongoing third-party
study pooling and analyzing of long-term PFIC patient data; the
timing for initiation or completion of, or for availability of data
from, clinical trials of Bylvay, including BOLD and ASSERT and the
Phase 2 clinical trial of A3907, and the outcomes of such trials;
Albireo’s ability to obtain coverage, pricing or reimbursement for
approved products in the United States or Europe; delays or other
challenges in the recruitment of patients for, or the conduct of,
the Company’s clinical trials; and the Company’s critical
accounting policies. These and other risks and uncertainties that
Albireo faces are described in greater detail under the heading
“Risk Factors” in Albireo’s most recent Annual Report on Form 10-K
or in subsequent filings that it makes with the Securities and
Exchange Commission. As a result of risks and uncertainties that
Albireo faces, the results or events indicated by any
forward-looking statement may not occur. Albireo cautions you not
to place undue reliance on any forward-looking statement. In
addition, any forward-looking statement in this press release
represents Albireo’s views only as of the date of this press
release and should not be relied upon as representing its views as
of any subsequent date. Albireo disclaims any obligation to update
any forward-looking statement except as required by applicable
law.
Media Contacts: Colleen Alabiso,
857-356-3905, colleen.alabiso@albireopharma.com Lance
Buckley, 917-439-2241, lbuckley@lippetaylor.com
Investor Contact: Hans Vitzthum, LifeSci Advisors, LLC.,
617-430-7578
Albireo Pharma (NASDAQ:ALBO)
Historical Stock Chart
Von Mär 2024 bis Apr 2024
Albireo Pharma (NASDAQ:ALBO)
Historical Stock Chart
Von Apr 2023 bis Apr 2024