Proposed acquisition strengthens
Pharming’s late-stage pipeline with a potential first-in-disease
asset
Abliva’s lead product KL1333 is currently
in a pivotal clinical trial, with a positive interim analysis
achieved, in mitochondrial DNA-driven primary mitochondrial
diseases
Total transaction value of approximately
US$66.1 million
No external funding required to fund
acquisition and KL1333 development costs
Pharming to host a conference call on
Monday, December 16, 2024 at 14:00 CET (8:00 am EST)
Leiden, the Netherlands, December 15,
2024: Pharming Group N.V. (“Pharming” or “the Company”)
(EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) today announced a
recommended public cash offer to the shareholders of Abliva AB
(“Abliva”) to acquire all issued and outstanding shares of Abliva.
Pharming, through its wholly-owned subsidiary Pharming Technologies
B.V., offers the shareholders SEK 0.45 in cash per share in Abliva.
The transaction is valued at approximately US$66.1 million.
Abliva is a biotechnology company, based in
Lund, Sweden, focused on developing medicines for the treatment of
mitochondrial disease. Abliva’s lead product, KL1333, a regulator
of the essential co-enzymes NAD⁺ and NADH, is in a pivotal clinical
study (FALCON) in adult patients with genetically confirmed primary
mitochondrial disease (PMD) with mitochondrial DNA (mtDNA)
mutations who experience consistent, debilitating fatigue and
muscle weakness (myopathy), and reduced life expectancy. Over
30,000 patients diagnosed with mtDNA mitochondrial disease would be
potentially addressable by KL1333 in the U.S., EU4 (France,
Germany, Italy, Spain) and the UK. KL1333 has shown positive
clinical effects in a proof-of-concept Phase 1b study, and a
pre-planned interim analysis of the ongoing pivotal FALCON trial
demonstrated promising differences over placebo in both alternate
primary efficacy endpoints. KL1333 has received Fast Track
designation in the U.S. and Orphan Drug Designation for the
treatment of PMD in the U.S. and EU.
Sijmen de Vries, Chief Executive Officer
of Pharming, said:“Abliva has made exciting progress
developing KL1333, a potential first-in-disease treatment
undergoing a pivotal clinical trial that offers new hope to
patients with rare mtDNA mitochondrial disease who experience
debilitating fatigue and muscle weakness. With over 30,000
addressable patients in the U.S., EU4 and UK, we are excited about
the potential of this asset, which achieved a positive interim
analysis in the registration trial in July 2024. We believe KL1333
has blockbuster potential in the U.S. alone and can significantly
change Pharming’s future growth trajectory. We will fund this
acquisition using existing cash, and anticipate covering costs to
complete the pivotal trial with positive cash flows from our
existing business. The acquisition of Abliva would further
strengthen our clinical pipeline with the addition of a therapy,
with U.S. launch expected in 2028, aligning with our vision to
become a leading global rare disease company. We are pleased that
Abliva’s independent Board of Directors and major shareholders
recognize the expertise and value Pharming brings to the
development and eventual commercialization of KL1333, and
unanimously support this transaction. We look forward to welcoming
the Abliva team with their strong expertise in mitochondrial
research and drug development and to combining with our resources,
capabilities and commercial infrastructure to bring this
groundbreaking and important medicine to patients and their
healthcare providers.”
Transaction highlightsToday at
19:45 CET, Pharming announced a recommended cash offer to the
shareholders of Abliva AB. Hereby Pharming, through a wholly owned
subsidiary, has offered SEK 0.45 in cash for each outstanding share
of Abliva (the ''Offer''). The total value of the Offer based on
all outstanding 1,611,884,536 shares in Abliva amounts to
approximately SEK 725,348,041, or approximately US$66.1 million.
The Board of Directors of Abliva unanimously recommends the
shareholders of Abliva to accept the Offer. The Board of Directors
of Abliva has obtained a fairness opinion from PwC, according to
which, based on the assumptions and reservations stated in the
opinion, the Offer is fair to Abliva’s shareholders from a
financial perspective. Pharming has obtained acceptance
undertakings from the three largest shareholders, accounting for
49.82% of Abliva's outstanding shares. The Offer is subject to
customary regulatory approvals, and Pharming expects to obtain such
approvals prior to the end of the acceptance period. Pharming Group
N.V. has cash on hand to finance the Offer in full.
The acceptance period in the offer is expected
to commence on or around January 16, 2025 and to expire on or
around February 7, 2025. For information in relation to the Offer,
please refer to www.raredisease-offer.com. An offer document will
be made public by Pharming shortly before the commencement of the
acceptance period.
Van Lanschot Kempen N.V. is sole financial
advisor and NautaDutilh N.V. and Mannheimer Swartling Advokatbyrå
are legal advisors to Pharming in connection with the Offer.
Invitation to conference
callPharming to host a conference call on Monday, December
16, 2024, at 14:00 CET (8:00 am EST). The conference call
presentation is available on the pharming.com website from 14:00
CET on December 16, 2024
A transcript will be made available on the
pharming.com website in the days following the call.
To participate in the conference call, please
register in advance using the link below. Once registered, dial-in
information and a unique PIN will be provided, allowing access to
the call.
Conference call dial-in
details:Please note, the Company will only take questions
from dial-in attendees.
https://register.vevent.com/register/BIfcd1fd2bdf0e443cbf6192dc063763ad
Webcast Link:
https://edge.media-server.com/mmc/p/2hfpccyi
For further public information,
contact:Pharming Group, Leiden, the NetherlandsMichael
Levitan, VP Investor Relations & Corporate CommunicationsT: +1
(908) 705 1696E: investor@pharming.com
FTI Consulting, London, UKVictoria Foster
Mitchell/Alex Shaw/Amy ByrneT: +44 203 727 1000
LifeSpring Life Sciences Communication, Amsterdam,
the NetherlandsLeon MelensT: +31 6 53 81 64 27E:
pharming@lifespring.nl
Abliva investorsLeo Wei T:
+46 (0)709 910 081E: pharming@fogelpartners.se
About KL1333KL1333 has been
designed to treat chronic fatigue and myopathy (muscle weakness) in
genetically confirmed adult patients with primary mitochondrial
disease. Diagnoses can include MELAS-MIDD and KSS-CPEO spectrum
disorders as well as MERRF syndrome. The drug candidate is intended
for long-term oral treatment. KL1333 has the ability to restore the
ratio of NAD+ and NADH, and thus leads to the formation of new
mitochondria and improved energy levels. In a cohort of
mitochondrial disease patients in a Phase 1a/b study, the patients
who received KL1333 showed both improvements in symptoms of fatigue
as well as functional improvements. KL1333 is currently being
evaluated in a global, potentially registrational, Phase 2 study
(the FALCON study) and has received orphan drug designation in both
the USA and Europe as well as Fast Track designation in the
USA.
About the FALCON StudyFALCON is
a Phase 2, global, randomized, placebo-controlled, potentially
registrational study evaluating the safety and efficacy of KL1333
in adult patients with primary mitochondrial disease who experience
consistent, debilitating fatigue and myopathy (muscle weakness),
the most common and impairing symptoms. A total of 180 patients
with mitochondrial DNA mutations who meet the eligibility criteria
are randomized 3:2 to receive KL1333 (50mg-100mg) or placebo twice
daily for 48 weeks. The two alternative primary endpoints assess
consistent fatigue (using the PROMIS® Fatigue Mitochondrial Disease
Short Form) and myopathy (using the 30 second Sit-to-Stand test),
only one of which must be positive to file for marketing approval.
An interim analysis evaluating 24-week data from the first wave of
patients confirmed the strong safety profile of KL1333, and both
primary endpoints passed futility, meaning that both have the
potential to demonstrate benefit in the final analysis of the
study.
About Abliva ABAbliva discovers
and develops medicines for the treatment of mitochondrial disease.
This rare and often very severe disease occurs when the cell’s
energy provider, the mitochondria, do not function properly. The
company has prioritized two projects. KL1333, a powerful regulator
of the essential co-enzymes NAD⁺ and NADH, has entered late-stage
development. NV354, an energy replacement therapy, has completed
preclinical development. Abliva, based in Lund, Sweden, is listed
on Nasdaq Stockholm, Sweden (ticker: ABLI). For more information,
please visit www.abliva.com.
About Pharming Group
N.V. Pharming Group N.V. (EURONEXT Amsterdam:
PHARM/Nasdaq: PHAR) is a global biopharmaceutical company dedicated
to transforming the lives of patients with rare, debilitating, and
life-threatening diseases. Pharming is commercializing and
developing an innovative portfolio of protein replacement therapies
and precision medicines, including small molecules and biologics.
Pharming is headquartered in Leiden, the Netherlands, and has
employees around the globe who serve patients in over 30 markets in
North America, Europe, the Middle East, Africa, and
Asia-Pacific.
For more information, visit www.pharming.com and
find us on LinkedIn.
Forward-Looking
Statements This press release may contain
forward-looking statements. Forward-looking statements are
statements of future expectations that are based on management’s
current expectations and assumptions and involve known and unknown
risks and uncertainties that could cause actual results,
performance, or events to differ materially from those expressed or
implied in these statements. These forward-looking statements are
identified by their use of terms and phrases such as “aim”,
“ambition”, ‘‘anticipate’’, ‘‘believe’’, ‘‘could’’, ‘‘estimate’’,
‘‘expect’’, ‘‘goals’’, ‘‘intend’’, ‘‘may’’, “milestones”,
‘‘objectives’’, ‘‘outlook’’, ‘‘plan’’, ‘‘probably’’, ‘‘project’’,
‘‘risks’’, “schedule”, ‘‘seek’’, ‘‘should’’, ‘‘target’’, ‘‘will’’
and similar terms and phrases. Examples of forward-looking
statements may include statements with respect to timing and
progress of Pharming's preclinical studies and clinical trials of
its product candidates, Pharming's clinical and commercial
prospects, and Pharming's expectations regarding its projected
working capital requirements and cash resources, which statements
are subject to a number of risks, uncertainties and assumptions,
including, but not limited to the scope, progress and expansion of
Pharming's clinical trials and ramifications for the cost thereof;
and clinical, scientific, regulatory, commercial, competitive and
technical developments. In light of these risks and uncertainties,
and other risks and uncertainties that are described in Pharming's
2023 Annual Report and the Annual Report on Form 20-F for the year
ended December 31, 2023, filed with the U.S. Securities and
Exchange Commission, the events and circumstances discussed in such
forward-looking statements may not occur, and Pharming's actual
results could differ materially and adversely from those
anticipated or implied thereby. All forward-looking statements
contained in this press release are expressly qualified in their
entirety by the cautionary statements contained or referred to in
this section. Readers should not place undue reliance on
forward-looking statements. Any forward-looking statements speak
only as of the date of this press release and are based on
information available to Pharming as of the date of this release.
Pharming does not undertake any obligation to publicly update or
revise any forward-looking statement as a result of new
information, future events or other information.
Inside Information This
press release relates to the disclosure of information that
qualifies, or may have qualified, as inside information within the
meaning of Article 7(1) of the EU Market Abuse
Regulation.
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