The proposed acquisition strengthens Pharming’s late-stage pipeline with a potential access to first-in-disease
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 $66.1 million
No external funding is required to fund acquisition and KL1333 development costs
Pharming will host a conference call on Monday, December 16, 2024 at 14:00 CET (08:00 EST)
Leiden, Netherlands, 15 December 2024: Pharming Group NV (“Pharming” or the “Company”) (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) announced today a recommended public cash offer to the shareholders of Abliva AB (“Abliva”) to acquire all issued and outstanding shares in Abliva Pharming offers, through its wholly owned subsidiary Pharming Technologies BV, the shareholders SEK 0.45 in cash per share in Abliva worth approximately USD 66.1 million.
Abliva is a biotechnology company, based in Lund, Sweden, focused on developing drugs for the treatment of mitochondrial disease. Abliva’s leading product, KL1333, a regulator of the essential coenzymes NAD? and NADH, is in a pivotal clinical trial (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 could potentially be addressed by KL1333 in the US, EU4 (France, Germany, Italy, Spain) and the UK. KL1333 has shown positive clinical effects in a proof-of-concept phase 1b study, and a preplanned interim analysis of the ongoing pivotal FALCON study showed promising differences compared to placebo in both alternative primary endpoints. KL1333 has received Fast Track designation in the US and Orphan Drug Designation for the treatment of PMD in the US and EU.
Sijmen de Vries, Chief Executive Officer of Pharming, said:
“Abliva has made exciting progress in 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 US, 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 that KL1333 has blockbuster potential in the U.S. alone and can significantly alter Pharming’s future growth trajectory.We will finance this acquisition using existing cash, and expect to cover the costs of completing the trial with positive cash flows from our existing operations of Abliva would further strengthen our clinical pipeline with the addition of a therapy, with US launch expected in 2028, in line with our vision to become a leading global company for rare diseases We are pleased that Abliva’s independent board and major shareholders recognize the expertise and value that 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 breakthrough and important medicine to patients and their caregivers.”
Transaction Highlights
Today 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 in 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 USD 66.1 million. Abliva’s board of directors unanimously recommends that the shareholders of Abliva accept the Offer. The board of Abliva has obtained a fairness opinion from PwC, according to which the Offer, based on the assumptions and reservations stated in the opinion, is reasonable for Abliva’s shareholders from a financial perspective. Pharming has received acceptance commitments from the three largest shareholders, who account for 49.82% of Abliva’s outstanding shares. The offering is subject to customary regulatory approvals and Pharming expects to obtain such approvals prior to the end of the acceptance period. Pharming Group NV has cash on hand to finance the Offer in its entirety.
The acceptance period in the offer is expected to begin around January 16, 2025 and expire around February 7, 2025. For information about the Offer, see www.raredisease-offer.com. An offer document will be published by Pharming shortly before the acceptance period begins.
Van Lanschot Kempen NV is the sole financial advisor and NautaDutilh NV and Mannheimer Swartling Advokatbyrå are legal advisors to Pharming in connection with the Offer.
Invitation to conference calls
Pharming will host a conference call on Monday, December 16, 2024, at 2:00 p.m. CET (8:00 a.m. EST). The conference call presentation is available on pharming.com’s website from 14:00 CET on 16 December 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 via the link below. Once registered, dialer details and a unique PIN code will be provided, allowing access to the call.
Dial-in information for conference calls:
Please note that the company only accepts questions from dial-in participants.
For further public information, contact:
Pharming Group, Leiden, The Netherlands
Michael Levitan, VP Investor Relations & Corporate Communications
T: +1 (908) 705 1696
E: investor@pharming.com
FTI Consulting, London, UK
Victoria Foster Mitchell/Alex Shaw/Amy Byrne
T: +44 203 727 1000
LifeSpring Life Sciences Communication, Amsterdam, The Netherlands
Leon Melens
T: +31 6 53 81 64 27
E: pharming@lifespring.nl
Alive investors
Leo Wei
T: +46?(0)709 910 081
E: pharming@fogelpartners.se
About KL1333
KL1333 has been designed to treat chronic fatigue and myopathy (muscle weakness) in genetically confirmed adult patients with primary mitochondrial disease. Diagnoses may 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 between NAD+ and NADH, thereby leading to the formation of new mitochondria and improved energy levels. In a cohort of patients with mitochondrial disease in a phase 1a/b trial, patients receiving KL1333 showed both improvements in fatigue symptoms and functional improvements. KL1333 is currently being evaluated in a global, potentially registrable, phase 2 study (the FALCON study) and has received orphan drug designation in both the US and Europe and Fast Track designation in the US.
About the FALCON study
FALCON is a phase 2, global, randomized, placebo-controlled, prospective registration 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 worsening symptoms. . A total of 180 patients with mitochondrial DNA mutations who meet eligibility criteria are randomized 3:2 to receive KL1333 (50mg-100mg) or placebo twice daily for 48 weeks. The two alternative primary endpoints consistently assess fatigue (using the PROMIS® Fatigue Mitochondrial Disease Short Form) and myopathy (using the 30-second Sit-to-Stand test), only one of which needs to be positive to apply 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 both have the potential to show benefit in the final analysis of the study.
About Abliva AB
Abliva discovers and develops drugs for the treatment of mitochondrial disease. This rare and often very serious disease occurs when the cell’s energy suppliers, the mitochondria, do not function properly. The company has prioritized two projects. KL1333, a powerful regulator of the essential coenzymes NAD? and NADH, have entered a late stage of 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, visit www.abliva.com.
About Pharming Group NV
Pharming Group NV (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 commercializes and develops an innovative portfolio of protein replacement therapies and precision medicine, including small molecules and biologics. Headquartered in Leiden, the Netherlands, Pharming has employees worldwide serving 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 at 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 by those statements. These forward-looking statements are identified by their use of terms and phrases such as “aim”, “aim”, “anticipate”, “believe”, “could”, “estimate”, “expect”, “goal”, ‘intend’, ‘may’, ‘milestones’, ‘goals’, ‘prospects’, ‘plan’, ‘probably’, ‘projects’, ‘risks’ ‘, “schedule”, ”search”, ”should”, ”paint”, ”will” and similar terms and phrases . Examples of forward-looking statements may include statements regarding the 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 needs 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 implications for the costs of these; and clinical, scientific, regulatory, commercial, competitive and technological developments. In light of these risks and uncertainties, and other risks and uncertainties described in Pharming’s 2023 Annual Report and Annual Report on Form 20-F for the year ended December 31, 2023, filed with the US Securities and Exchange Commission, the events and circumstances discussed occurred in such forward-looking statements may not occur, and Pharming’s actual results may differ materially and adversely from those anticipated or implied hence. 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. All 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 press release. Pharming undertakes no obligation to publicly update or revise any forward-looking statement as a result of new information, future events or other information.
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