- The proposed acquisition represents a significant step forward
in Lundbeck’s Focused Innovator strategy, adding a highly
innovative and complementary product in late-stage development for
Developmental and Epileptic Encephalopathies (DEEs) - an area of
high unmet medical need
- The acquisition will enhance and complement Lundbeck’s
capabilities and presence within neuro-rare conditions
- The lead asset, bexicaserin, holds blockbuster potential and is
in development for the treatment of DEEs in a program enrolling
patients diagnosed with Dravet syndrome, Lennox-Gastaut syndrome,
and other DEE syndromes
- Bexicaserin has shown encouraging anti-seizure effects to date
in preclinical and clinical studies, with its next-generation
superagonist mechanism specifically targeting 5-HT2C receptors,
supporting bexicaserin’s potential to offer a highly differentiated
and best-in-class profile
- A global phase III trial (DEEp SEA) evaluating bexicaserin for
the treatment of seizures associated with Dravet syndrome was
initiated in September 2024
- Total transaction value of approximately USD 2.6 billion equity
value and USD 2.5 billion net of cash (approximately DKK 17
billion). Funding will be through existing cash resources and bank
financing
H. Lundbeck A/S (Lundbeck) and Longboard Pharmaceuticals, Inc
(NASDAQ: LBPH) (Longboard) today announced an agreement for
Lundbeck to acquire Longboard. Under the terms of the agreement,
Lundbeck will commence a tender offer for all outstanding shares of
Longboard common stock, whereby Longboard shareholders will be
offered a payment of USD 60.00 per share in cash. The transaction
is valued at approximately USD 2.6 billion equity value and USD 2.5
billion (approximately DKK 17 billion) net of cash, on a fully
diluted basis.
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the full release here:
https://www.businesswire.com/news/home/20241013952344/en/
The board of directors of both companies have unanimously
approved the transaction. The transaction is expected to close in
the fourth quarter of 2024, subject to the tender of at least a
majority of the total number of Longboard outstanding voting
shares, receipt of required regulatory clearances, and other
customary conditions.
Longboard is a clinical-stage biopharmaceutical company focused
on developing novel, transformative medicines for neurological
diseases. Its lead asset, bexicaserin, has shown encouraging
anti-seizure reduction to date in preclinical and clinical studies,
with its next-generation superagonist mechanism specifically
targeting 5-HT2C receptors, which support bexicaserin’s potential
to offer a highly differentiated and best-in-class profile.
Bexicaserin is now being evaluated in a global phase III clinical
program (the DEEp Program).
“This transformative transaction will become a cornerstone in
Lundbeck’s neuro-rare franchise, with a potential to drive growth
into the next decade. Bexicaserin addresses a critical unmet need
for patients suffering from rare and severe epilepsies, for which
there are very few good treatment options available. With this
acquisition, we continue to execute on our Focused Innovator
strategy, transforming the lives of patients suffering from severe
brain disorders,” said Charl van Zyl, President and CEO of
Lundbeck.
“Longboard was founded to transform the lives of people living
with devastating neurological conditions. I am incredibly proud of
what our team has achieved; delivering groundbreaking data with a
differentiated and inclusive clinical approach to address the needs
of a wide range of DEEs and obtaining Breakthrough Therapy
designation,” stated Kevin R. Lind, President and Chief Executive
Officer of Longboard. “I would like to thank the entire DEE
community, in particular bexicaserin’s study participants and their
caregivers as well as the advocacy groups, investigators, sites and
coordinators for their support and partnership. Lundbeck’s
remarkable capabilities will accelerate our vision to provide
increased equity and access for underserved DEE patients with
significant unmet medical needs.”
Strategic benefits
The acquisition of Longboard marks a strategic milestone for
Lundbeck, enhancing and complementing our Focused Innovator
strategy and advancing our goal of building a neuro-rare disease
franchise.
Through the acquisition of Longboard, Lundbeck gains access to
bexicaserin, a novel 5-HT2C agonist in development for the
treatment of seizures associated with DEEs, including Dravet
syndrome, Lennox-Gastaut syndrome, and other rare epilepsies. This
aligns with Lundbeck’s expertise in delivering innovative
treatments and re-establishes our scientific and commercial
leadership in rare epilepsies. Bexicaserin has entered a global
phase III trial (DEEp SEA Study) evaluating bexicaserin for the
treatment of seizures associated with Dravet syndrome in
participants two years of age and older. The DEEp SEA Study is part
of a broader DEEp Program (DEEp SEA, DEEp OCEAN and DEEp OLE) which
is planned to take place across ~80 sites globally and include ~480
participants with a range of DEEs. Bexicaserin has received
Breakthrough Therapy Designation (BTD) from the U.S. FDA and is set
to become a cornerstone of Lundbeck’s new neuro-rare disease
franchise. Recent nine-month open-label data further supports the
de-risked nature of its 5-HT2C mode-of-action, highlighting its
superior target product profile.
The bexicaserin asset complements Lundbeck’s mid- to late-stage
pipeline and diversifies revenue growth following the expected
launch in the fourth quarter of 2028 and with a global peak sales
potential estimated by Lundbeck between USD 1.5 - 2 billion.
Terms, closing conditions and financing
Under the terms of the agreement, Lundbeck will commence a
tender offer for all outstanding shares of Longboard common stock,
whereby Longboard shareholders will be offered a payment for USD 60
per share in cash. The cash consideration represents a 77% premium
to the 30-day volume-weighted average price (“VWAP”) of shares of
Longboard common stock as of September 30, 2024.
If the tender offer is consummated, Lundbeck will acquire any
shares of Longboard common stock not tendered into the tender offer
through a merger for the same per share consideration as will be
payable in the tender offer. The merger will occur as soon as
practicable after the closing of the tender offer.
Lundbeck expects to fund the acquisition through existing cash
resources and its existing bank financing facility. Following
closing of the transaction, Lundbeck will focus on de-leveraging
and leverage is expected to be in Lundbeck’s target range of
<2.5x NIBD/EBITDA within 18-24 months.
The terms and conditions of the tender offer will be described
in the tender offer documents, which will be filed with the U.S.
Securities and Exchange Commission.
We expect to recognize integration costs in the amount of
approximately USD 80 million (approximately DKK 550 million), which
predominantly will impact 2024 and will be adjusted for in Adjusted
EBITDA. Lundbeck’s financial guidance for 2024 is confirmed.
Advisors
For Lundbeck, PJT Partners LP is acting as exclusive financial
advisor and Baker McKenzie is acting as legal advisor in this
transaction. For Longboard, Evercore and Centerview Partners LLC
are acting as financial advisors and Cooley LLP is acting as legal
advisor.
Conference Call
Today at 13:30 pm (CET), Lundbeck will be hosting a conference
call for the financial community. To participate in the conference
call please follow the instructions below
Webcast streaming link: Conference call
Teleconference registration link: Teleconference
registration
About the DEEp SEA Study
The DEEp SEA Study (LP352-302) is a global phase III
double-blind, placebo-controlled clinical trial to evaluate the
efficacy of bexicaserin in Dravet syndrome as assessed by countable
motor seizures in ~160 participants between the ages of two and 65
years old. An important secondary objective is to evaluate the
safety and tolerability of bexicaserin. Following a 5-week
screening period and baseline evaluations, study participants
initiate dose titration over a 3-week period and subsequently
continue on the highest tolerated dose throughout the maintenance
period of 12-weeks. Following the maintenance period, eligible
participants will be given the opportunity to enroll in the 52-week
DEEp Open-Label Extension (DEEp OLE Study LP352-303). The phase III
DEEp SEA Study is part of the broader DEEp Program which will take
place across ~80 sites globally and include ~480 participants with
a range of Developmental and Epileptic Encephalopathies (DEEs).
About Developmental and Epileptic Encephalopathies (DEEs)
Epilepsy is the third leading contributor to the global burden
of neurological disorders and affects 65 million people worldwide.
DEEs are a group of severe early-childhood onset epilepsies
characterized by refractory seizures and developmental delay and/or
regression. These diseases are often progressive and commonly show
resistance to treatment. DEEs encompass a diverse range of over 25
syndromes, of which only four currently have FDA-approved therapies
with partial treatment responses. Consequently, there is a
remaining significant unmet need to find therapies that efficiently
act across the DEE spectra. Some common epilepsy syndromes that are
DEEs include:
- Dravet syndrome
- Lennox-Gastaut syndrome
- Tuberous sclerosis complex
- CDKL5 deficiency disorder
- Early infantile epileptic encephalopathy, including Ohtahara
syndrome and early myoclonic encephalopathy
- Infantile epileptic spasms syndrome, including West
syndrome
- Febrile infection-related epilepsy syndrome
- Epilepsy of infancy with migrating focal seizures
- Epilepsy with myoclonic-atonic seizures, otherwise known as
myoclonic-atonic epilepsy (MAE) or Doose syndrome.
- Landau-Kleffner syndrome
- Developmental and epileptic encephalopathy with spike and wave
activation in sleep (DEE-SWAS)
While these syndromes are individually considered an orphan
disease, altogether we estimate approximately 220,000 patients are
affected by DEE syndromes in the U.S.
About Longboard Pharmaceuticals
Longboard is a clinical-stage biopharmaceutical company focused
on developing novel, transformative medicines for neurological
diseases. Longboard’s small molecule product candidates are based
on more than 20 years of GPCR research. Bexicaserin (LP352), an
oral, centrally acting 5-hydroxytryptamine 2C (5-HT2C) receptor
super-agonist, with no observed impact on 5-HT2B and 5-HT2A
receptor subtypes, is being evaluated in a global phase III
clinical program (the DEEp Program). Bexicaserin has Rare Pediatric
Disease and Orphan Drug designations, and the FDA has granted
Breakthrough Therapy designation for bexicaserin for the treatment
of seizures associated with Developmental and Epileptic
Encephalopathies (DEEs) for patients two years of age and
older.
Bexicaserin is an investigational compound that is not approved
for marketing by the FDA or any other regulatory authority.
About H. Lundbeck A/S
Lundbeck is a biopharmaceutical company focusing exclusively on
brain health. With more than 70 years of experience in
neuroscience, we are committed to improving the lives of people
with neurological and psychiatric diseases.
Brain disorders affect a large part of the world’s population,
and the effects are felt throughout society. With the rapidly
improving understanding of the biology of the brain, we hold
ourselves accountable for advancing brain health by curiously
exploring new opportunities for treatments.
As a focused innovator, we strive for our research and
development programs to tackle some of the most complex
neurological challenges. We develop transformative medicines
targeting people for whom there are few or no treatments available,
expanding into neuro-specialty and neuro-rare from our strong
legacy within psychiatry and neurology.
We are committed to fighting stigma and we act to improve health
equity. We strive to create long term value for our shareholders by
making a positive contribution to patients, their families and
society as a whole.
Lundbeck has approximately 5,500 employees in more than 50
countries and our products are available in more than 80 countries.
For additional information, we encourage you to visit our corporate
site www.lundbeck.com and connect with us via LinkedIn.
IMPORTANT INFORMATION FOR INVESTORS AND SECURITY
HOLDERS
The tender offer (the Offer) for the outstanding common stock of
Longboard referred to in this corporate release has not yet
commenced. The description contained in this corporate release is
neither an offer to purchase nor a solicitation of an offer to sell
any securities, nor is it a substitute for the tender offer
materials that Lundbeck and its acquisition subsidiary will file
with the U.S. Securities and Exchange Commission (the SEC). The
solicitation and offer to buy the common stock of Longboard will
only be made pursuant to an offer to purchase and related tender
offer materials. At the time the Offer is commenced, Lundbeck will
file a tender offer statement on Schedule TO and thereafter
Longboard will file a solicitation/recommendation statement on
Schedule 14D-9 with the SEC with respect to the Offer. THE TENDER
OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER
OF TRANSMITTAL AND CERTAIN OTHER OFFER DOCUMENTS) AND THE
SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 WILL
CONTAIN IMPORTANT INFORMATION. ANY HOLDERS OF SHARES ARE URGED TO
READ THESE DOCUMENTS CAREFULLY WHEN THEY BECOME AVAILABLE BECAUSE
THEY WILL CONTAIN IMPORTANT INFORMATION THAT HOLDERS SHOULD
CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR
SHARES.
The offer to purchase, the related letter of transmittal and the
solicitation/recommendation statement will be made available for
free at the SEC’s website at www.sec.gov. Free copies of the offer
to purchase, the related letter of transmittal and certain other
offering documents will be made available by Lundbeck and when
available may be obtained by directing a request to the Information
Agent for the tender offer which will be named in the Schedule TO.
Copies of the documents filed with the SEC by Longboard’s will be
available free of charge on Longboard’s internet website
https://ir.longboardpharma.com/financial-information/sec-filings or
by contacting Longboard’s investor relations contact at
IR@LongboardPharma.com.
In addition to the offer to purchase, the related letter of
transmittal and certain other tender offer documents filed by
Lundbeck, as well as the solicitation/recommendation statement
filed by Longboard, Longboard will also file annual, quarterly and
current reports with the SEC. You may read and copy any reports or
other information filed by Lundbeck or Longboard at the SEC public
reference room at 100 F Street, N.E., Washington, D.C. 20549.
Please call the SEC at 1-800-SEC-0330 for further information on
the public reference room. Longboard’s filings with the SEC are
also available to the public from commercial document-retrieval
services and at the website maintained by the SEC at
http://www.sec.gov.
Safe Harbor/Forward-Looking Statements
This corporate release contains forward-looking statements that
provide our expectations or forecasts of future events such as new
product introductions, product approvals and financial performance.
Forward looking statements include, without limitation, any
statement that may predict, forecast, indicate or imply future
results, performance or achievements, and may contain words like
"believe", "anticipate", "expect", "estimate", "intend", "plan",
"project", "will be", "will continue", "will result", "could",
"may", "might", or any variations of such words or other words with
similar meanings. All statements other than statements of
historical facts included in this corporate release, including,
without limitation, those regarding Lundbeck and Longboard’s
financial position, business strategy, plans and objectives of
management for future operations (including development plans and
objectives relating to Lundbeck and Longboard’s products), are
forward looking statements.
Such forward looking statements involve known and unknown risks,
uncertainties and other factors which may cause Lundbeck and
Longboard's actual results, performance or achievements to be
materially different from any future results, performance or
achievements expressed or implied by such forward looking
statements. Factors that may affect future results include, among
others, interest rate and currency exchange rate fluctuations;
delay or failure of development projects, production or
distribution problems; unexpected contract breaches or
terminations; government-mandated or market-driven price decreases
for Lundbeck's products; introduction of competing products;
Lundbeck's ability to successfully market both new and existing
products; exposure to product liability and other lawsuits; changes
in reimbursement rules and governmental laws and related
interpretation thereof; and unexpected growth in costs and
expenses. Additional risks and uncertainties include, but are not
limited to, risks related to Lundbeck’s ability to complete the
transaction on the proposed terms and schedule; whether the tender
offer conditions will be satisfied; whether sufficient stockholders
of Longboard tender their shares in the transaction; the outcome of
legal proceedings that may be instituted against Longboard and/or
others relating to the transaction; the failure to receive (or
delay in receiving) the required regulatory approvals relating to
the transaction; the possibility that competing offers will be
made; risks associated with acquisitions, such as the risk that the
businesses will not be integrated successfully, that such
integration may be more difficult, time-consuming or costly than
expected or that the expected benefits of the transaction will not
occur; risks related to future opportunities and plans for
Longboard and its products, including uncertainty of the expected
financial performance of Longboard and its products; disruption
from the proposed transaction, making it more difficult to conduct
business as usual or maintain relationships with customers,
employees or suppliers; the occurrence of any event, change or
other circumstance that could give rise to the termination of the
acquisition agreement; and other uncertainties pertaining to the
business of Longboard, including those detailed in Longboard’s
public filings with the SEC from time to time, including
Longboard’s most recent Annual Report on Form 10-K for the year
ended December 31, 2023 and its subsequent Quarterly Reports on
Form 10-Q. The reader is cautioned not to unduly rely on these
forward-looking statements. The forward-looking statements in this
corporate release and any oral presentations speak only as at the
date of this corporate release. Longboard and Lundbeck disclaim any
intent or obligation to update or revise these forward-looking
statements, or to confirm such statements to reflect subsequent
events or circumstances after the date of the corporate release or
in relation to actual results, other than as may be required under
applicable law or applicable stock exchange regulations.
Certain assumptions made by Lundbeck are required by Danish
Securities Law for full disclosure of material corporate
information. Some assumptions, including assumptions relating to
sales associated with products that are prescribed for unapproved
uses, are made considering past performances of other similar drugs
for similar disease states or past performance of the same drug in
other regions where the product is currently marketed. It is
important to note that although physicians may, as part of their
freedom to practice medicine in the US, prescribe approved drugs
for any use they deem appropriate, including unapproved uses, at
Lundbeck, promotion of unapproved uses is strictly prohibited.
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Lundbeck Contacts Palle Holm Olesen Vice President, Investor
Relations PALO@lundbeck.com +45 30 83 24 26
Thomas Mikkel Mortensen Media Relations Lead, Corp.
Communication THMR@lundbeck.com +45 30 83 30 24
Longboard Pharmaceuticals Contact Megan E. Knight Vice
President, Head of Investor Relations IR@longboardpharma.com +1
858.789.9283
Longboard Pharmaceuticals (NASDAQ:LBPH)
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