ALK (ALKB:DC / OMX: ALK B) today announced that it has entered
into a strategic license agreement with US-based ARS
Pharmaceuticals, Inc. (“ARS Pharma”, NASDAQ: SPRY). The agreement
grants ALK exclusive global rights to the neffy® adrenaline
(epinephrine) nasal spray, with exception of the USA, Australia,
New Zealand, Japan and China. The deal delivers on key elements in
ALK’s new strategy Allergy+ and supports ALK’s long-term financial
ambitions.
- Needle-free, nasal delivery of
adrenaline has the potential to become an important treatment
option in anaphylaxis
- ALK also gains rights to future
indications, including acute urticaria flares (in development)
- ALK to pay USD 145 million in
upfront and additional future milestones and sales royalties
neffy® is the first and only approved needle-free emergency
treatment for patients experiencing acute and potentially
life-threatening allergic reactions. The European Commission
granted EURneffy® (the trade name for neffy® in the EU) market
authorisation in the EU in August 2024. Furthermore, neffy® was
approved by the US Food and Drug Administration also in August
2024. Submission for regulatory approval in Canada is planned for
by the end of 2024.
ALK’s CEO, Peter Halling, said: “We are excited about the deal
with ARS Pharma. It is an important step in ALK’s strategic efforts
to establish leading positions in anaphylaxis, food allergy, and
new disease areas such as urticaria, supplementing our core allergy
offerings. Emergency treatment of life-threatening allergic
reactions has strong scientific and commercial ties to our existing
portfolio and prescriber base. We are convinced that neffy® will
transform anaphylaxis, benefitting patients at risk and leading to
a significant expansion of the market.”
Exclusive rights to new indicationsARS Pharma
is also developing its intranasal adrenaline (epinephrine)
technology for the treatment of acute flares in patients with
chronic urticaria, with plans to begin a Phase IIb clinical trial
in 2025. The license agreement gives ALK exclusive rights for any
new indications in the licensed territories. This aligns well with
ALK's strategy, as it enables the ALK to take the first steps in
addressing new adjacent disease areas.
Expanding market opportunitiesALK will
initially focus on bringing neffy® to the markets in Europe and
Canada, the world’s second and third largest adrenaline
autoinjector (“AAI”) markets. In both markets, the product can be
added to ALK’s existing infrastructure and sales channels. The
agreement also holds potential in other markets e.g. in Asia and
Middle East.
Anaphylaxis requires immediate treatment with adrenaline
(epinephrine), which today is predominantly administered
intra-muscularly, including using AAIs, such as ALK’s Jext® pen.
While adrenaline autoinjectors have been shown to be highly
effective, there are well published limitations that result in many
patients and caregivers delaying or not administering treatment in
an emergency situation.
In Europe, ALK’s main market, more than 20 million people are
estimated to be at risk of experiencing anaphylaxis, however only
approximately 2 million people are picking up their recommended
rescue medication and many also fail to renew their prescription
when needed. The combined value of the European and Canadian AAI
markets is estimated at approximately DKK 1.6 billion (2023) and
has been growing steadily in recent years.
Portfolio approachIn line with its Allergy+
strategy, ALK is committed to helping patients at risk of
anaphylaxis with a portfolio of innovative solutions with multiple
administration forms. ALK will continue to market the adrenaline
autoinjector Jext® in Europe and several international markets. ALK
will also continue the in-house Genesis project to develop a
next-generation adrenaline autoinjector.
CEO Peter Halling said: “While we believe that nasal delivery of
adrenaline could become an important new standard of care in
anaphylaxis management over the next decade, we also acknowledge
that changing long-standing clinical practices may take time.
Therefore, we will maintain a portfolio approach to meet the
diverse needs of patients and prescribers.”
Financials considerationsThe agreement
supplements ALK’s financial ambitions and is expected to diversify
the long-term revenue growth. ALK estimates that neffy® holds a
long-term annual peak sales potential in anaphylaxis of up to DKK 3
billion in the licensed territories. There may be substantial
upsides to this potential from new indications in e.g.
urticaria.
Under the agreement, ARS Pharma is entitled to receive an
upfront payment of USD 145 million (DKK 1 billion) from ALK.
Furthermore, ARS Pharma may receive up to USD 320 million (DKK 2.2
billion) related to regulatory and commercial milestones,
potentially over the next 15+ years as well as tiered royalties in
the teens on future sales. ARS Pharma will supply finished goods to
ALK, while ALK will be responsible for local market access,
marketing and sales.
ALK will finance the upfront payment out of its available cash
and existing credit facilities, and equally plans to finance future
milestone payments and royalties out of ALK's available cash.
Following settlement of the upfront payment, ALK's net debt to
EBITDA ratio for 2024 will expectedly still be below 1.
The first launches are expected to take place in Europe in 2025
once local market access negotiations are completed. The license
agreement is expected to contribute to revenue growth from 2025
onwards, with an initially limited impact, and is projected to be
earnings accreditive within a few years. The deal is therefore
expected to support ALK's long-term financial ambitions, which
remain unchanged.
This announcement does not change ALK’s revenue and earnings
outlook for 2024. ALK’s ambition of achieving a 25% EBIT margin in
2025 remains unchanged.
ALK-Abelló A/S
For further information please contact:
Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile
+45 2261 2525Media: Maiken Riise Andersen, tel. +45 5054 1434
ALK is hosting a conference call for analysts and investors
at 8.00-8.30 a.m. (CET) on Monday 11 November 2024
regarding the licence agreement with ARS Pharma. The conference
call will be audio cast on https://ir.alk.net where the
relevant presentation will be available shortly before the call
begins.
To register for the conference call, please use this link:
https://dpregister.com/sreg/10194511/fdfa1c19d7 and follow the
registration instructions. You will receive an email
from diamondpass@choruscall.com with dial-in details,
including a passcode and a pin code. Please make sure to whitelist
diamondpass@choruscall.com and/or check your spam filter. We
advise you to register well in advance and to call in
before 7.55 a.m. (CET).
About ALKALK is a global specialty
pharmaceutical company focused on allergy and allergic asthma. ALK
markets allergy immunotherapy treatments and other products and
services for people with allergy and allergy doctors. Headquartered
in Hørsholm, Denmark, ALK employs around 2,900 people worldwide and
is listed on Nasdaq Copenhagen. Find more information at
www.alk.net.
About neffy®neffy® is a
compact nasal spray, designed to provide rapid absorption of
adrenaline (epinephrine). The solution is simple to use,
non-invasive and more convenient for patients to carry and use, and
it offers longer shelf-life and superior temperature stability
compared to existing adrenaline pens (AAIs). In Europe, it is
currently indicated for emergency treatment of allergic reactions
(anaphylaxis) due to insect stings or bites, foods, medicinal
products, and other allergens as well as idiopathic or exercise
induced anaphylaxis in adults and children who weigh 30 kg or
greater. Subject to approval in Europe, a dose for children
weighing 15-30 kg is expected to be available from late 2025.
About ARS PharmaARS Pharmaceuticals is a
biopharmaceutical company dedicated to empowering at-risk patients
and their caregivers to better protect patients from allergic
reactions that could lead to anaphylaxis. The Company is
commercializing neffy® 2 mg (trade
name EURneffy® in the EU) (previously referred to as
ARS-1), an epinephrine nasal spray indicated in the U.S. for
emergency treatment of Type I allergic reactions, including
anaphylaxis, in adult and pediatric patients who weigh 30 kg or
greater, and in the EU for emergency treatment of allergic
reactions (anaphylaxis) due to insect stings or bites, foods,
medicinal products, and other allergens as well as idiopathic or
exercise induced anaphylaxis in adults and children who weigh 30 kg
or greater. For more information,
visit www.ars-pharma.com. Forward-looking
StatementsThis announcement contains forward-looking
statements, including forecasts of future revenue and operating
profit as well as expected business-related events. Such statements
are naturally subject to risks and uncertainties as various
factors, some of which are beyond the control of ALK, may cause
actual results and performance to differ materially from the
forecasts made in this announcement. Such factors include but are
not limited to general economic and business-related conditions,
including legal issues, uncertainty relating to demand, pricing,
reimbursement rules, regulatory approvals, partners' plans and
forecasts, fluctuations in exchange rates, competitive factors and
reliance on suppliers. Additional factors include the risks
associated with the sourcing and manufacturing of ALK's products.
ALK undertakes no obligation to publicly update or revise
forward-looking statements to reflect subsequent events or
circumstances after the date made, except as required by law.
- FM_18_24UK_09112024-final