Ad hoc announcement pursuant to Art. 53 LR
A conference call will be held on April 25,
2024, at 14:30 CEST / 13:30 BST / 08:30 EDT. Details are at the end
of this news release.
Santhera Announces Preliminary Unaudited
2023 Annual Results and Provides Corporate Update Ahead of Full
Report Publication in May
- 2023
financial key
figures: Revenue
from contracts with customers of CHF 103.4 million (2022:
CHF 7.5
million) Net result
of CHF 54.8 million (2022: CHF -71.1 million)
Cash flow from
operating activities of CHF 47.6 million (2022: CHF -29.8
million)
-
Regulatory approvals in key territories – AGAMREE®
(vamorolone) approved for Duchenne muscular dystrophy (DMD)
treatment in the U.S., EU and UK, showcasing safety benefits over
traditional corticosteroids
-
Strategic partnership – licensing agreement signed
with Catalyst Pharmaceuticals Inc. (NASDAQ: CPRX) for North
America, focusing on commercialization of AGAMREE in DMD and
exploring joint development of indications beyond DMD
- First
launches – first launch in Germany, followed by U.S.
launch by Catalyst, plans for gradual roll-out in larger European
countries by Santhera and partnering for other territories
- Cash
reach into 2025 – significant financial gains from
Catalyst deal, divestment of RAXONE business, and product sales,
overall strengthening the balance sheet and securing financing of
operations (excluding maturing convertible bonds)
- First
quarter 2024 — positive uptake with approx. 150 patients
treated with AGAMREE in Germany and Austria; revenue of
CHF 4.7 million, cash on March 31, 2024 of CHF 26.8
million
-
Outlook – expected peak annual sales over
EUR 150 million in Europe for AGAMREE in DMD alone, with
additional revenue from partnerships, aiming for financial
breakeven by mid-2026
Pratteln, Switzerland, April 25,
2024 – Santhera Pharmaceuticals (SIX: SANN) announces the Company’s
preliminary unaudited financial results for the year ended
December 31, 2023, reports on business progress achieved in
2023 and extending into 2024, and provides updates on its strategic
and financing initiatives. As permitted by SIX Exchange Regulation,
the Company will publish the full 2023 Annual Report in
May.
“The last 15 months were a pivotal phase for
Santhera, characterized by remarkable successes and important
milestones. We have successfully navigated the regulatory
landscapes and secured approvals for AGAMREE in key territories and
across continents within just three months. Our collaboration with
Catalyst Pharmaceuticals has strategically positioned us to enable
product availability to patients in North America as well as to
explore strategy of joint development of AGAMREE in indications
beyond DMD. In addition, by divesting non-core assets and focusing
on AGAMREE, we have streamlined our operations and strengthened our
financial base,” said Dario Eklund, CEO of
Santhera. “Looking ahead, we are poised to continue this
momentum, driving forward our mission to improve care for the DMD
community and enhance the quality of life for patients. I am
incredibly proud of our team's dedication and innovative spirit and
am optimistic about the future as we move toward profitability and
expand AGAMREE's therapeutic reach.”
In 2023 and into 2024, Santhera achieved
critical milestones, securing regulatory approvals for AGAMREE in
DMD across the U.S., EU and UK, and submitting the product for
approval in China. Strategic moves included licensing AGAMREE to
Catalyst Pharmaceuticals in North America and focusing operations
on Europe, culminating in AGAMREE's first global market launch in
Germany in January 2024. Financially, Santhera reported a 2023
revenue of CHF 103.4 million and net income of CHF 54.8
million, driven by the Catalyst licensing deal. With CHF 30.4
million in cash reserves at year-end, and anticipated revenue from
product sales, this is expected to support operations into 2025.
Additional funding will be necessary to meet debt obligations
(maturing convertible bonds) and support further market launches,
aiming for cash breakeven by the first half of 2026.
REVIEW OF PIPELINE AND BUSINESS
PROGRESS
2023 key events and post-period
updates
- AGAMREE approved in the U.S., EU
and the UK for the treatment of DMD
- European regulators acknowledged safety benefits of AGAMREE
with regards to preserving bone health and maintaining growth
compared to standard of care corticosteroids
- China’s regulatory authority
accepted and granted priority review for vamorolone NDA in DMD
- Exclusive North America license for
AGAMREE granted to Catalyst in deal valued at up to USD 231 Million
plus royalties
- AGAMREE launched in Germany as
first market for the treatment of DMD, with encouraging early
uptake
- Santhera’s partner Catalyst
launched AGAMREE in the U.S. in Q1-2024
- Divestment of RAXONE/idebenone
business to Chiesi Group completed
- Focusing on AGAMREE and following
portfolio review, lonodelestat license terminated by Santhera and
asset to be returned to Spexis
AGAMREE (vamorolone) approved across the
U.S., EU and UKAGAMREE was approved by the U.S. FDA (on
October 26, 2023), the European Medicines Agency (EMA) in the EU
(on December 18, 2023) and the Medicines and Healthcare products
regulatory agency (MHRA) in the UK (on January 11, 2024). Thereby,
it became the first DMD treatment approved across these three
territories. In the EU, AGAMREE is the first and only approved
medication for treating all patients from age 4 years with DMD.
The EMA and the MHRA acknowledged clinically
important safety benefits of AGAMREE with regards to maintaining
normal bone metabolism, density and growth compared to standard of
care corticosteroids, while demonstrating similar efficacy. In
March 2024, the Center for Drug Evaluation (CDE) of China’s
National Medical Products Administration (NMPA) accepted the NDA
for vamorolone, granting priority review. Subject to a positive
outcome, this could lead to approval by Q1-2025.
North America license for AGAMREE
granted to Catalyst PharmaceuticalsIn June 2023, Santhera
announced the signing of an exclusive license and collaboration
agreement for AGAMREE in North America (NA) with Catalyst, a
commercial-stage biopharmaceutical company focused on novel
medicines for patients living with rare diseases. The agreement
covers the development and commercialization of AGAMREE in DMD and
rights to all potential future indications in NA. Total
consideration to Santhera is up to USD 231 million (including
equity investment) plus royalty payments from product sales.
After closing of the transaction in July 2023,
Santhera received an upfront payment of USD 90 million
(USD 75 million in cash and USD 15 million equity
investment). Upon U.S. FDA approval of AGAMREE in DMD on
October 26, 2023, Santhera received an additional USD 36
million from Catalyst, of which Santhera paid contractually agreed
third-party regulatory milestone obligations (USD 26 million).
Furthermore, Catalyst may pay Santhera sales-based milestones of up
to USD 105 million as well as up to low-teen percentage
royalties and will assume corresponding third-party royalty
obligations of Santhera on AGAMREE sales in all indications in
NA.
In March 2024, following the U.S. FDA approval
on October 26, 2023, Catalyst announced that AGAMREE is now
available by prescription and dispensed throughout the United
States through a specialty pharmacy network.
Santhera and Catalyst have made considerable
progress to define the strategic framework of a joint clinical
development program and shared funding of AGAMREE for global
indications, in addition to DMD.
First launch in Germany in early
2024—pre-commercialization measures advancing across
EuropeOn January 15, 2024, Santhera launched AGAMREE
as a 40 mg/ml oral suspension for the treatment of DMD in
Germany as the first market worldwide. Since February 2024, AGAMREE
is also available in Austria. This significant milestone
represented Santhera’s commitment to fill a high unmet medical need
by providing a safe and effective treatment for DMD patients. For
Santhera, this launch signified a leap forward as the Company
entered the commercial stage in the DMD space.
Santhera plans to make AGAMREE available to
patients in additional key geographies in Europe (France, UK,
Italy, Spain, Benelux and Switzerland), and is in the late stages
of negotiations with distribution partners for commercialization in
other European countries.
Activities surrounding market access,
stakeholder and key opinion leader engagement in the target
countries progressed throughout the period under review. After
Germany, the build-up of a core commercial organization is well
underway in the UK, France, Italy and the Benelux countries.
Full divestment of RAXONE/idebenone
business to Chiesi Group In a transaction closed on
July 28, 2023, Chiesi Group acquired all assets and certain
liabilities related to idebenone in all indications worldwide. This
included RAXONE in Leber hereditary optic neuropathy (LHON), for
which Chiesi already held exclusive license rights globally since
2019, except for North America and France. Under the terms of the
agreement, Chiesi Group assumed the responsibility for the
settlement agreed between Santhera and the French reimbursement
authorities relating to RAXONE in LHON amounting to EUR 25.3
million. The transaction significantly reduced debt and
strengthened Santhera’s balance sheet. Furthermore, the cessation
of RAXONE-related activities allowed Santhera to streamline
business processes, reducing operating costs and freeing up
resources for AGAMREE and its European launch.
Santhera retains contingent value for LHON in
the U.S. and other indications worldwide. Santhera is eligible to
participate in a potential marketing approval of RAXONE in LHON in
the U.S. through variable payments in the single-digit percentage
range on net sales or milestone payments of up to USD 10
million. In the event that Chiesi chooses to pursue idebenone in
non-ophthalmological indications, Santhera would be eligible for an
additional milestone payment of USD 10 million related to the
approval in the US for the first non-ophthalmological indication
and variable payments in the high single-digit percentage range on
net sales.
Lonodelestat development terminated and
compound to be returned to SpexisSanthera’s priority over
the recent past was on advancing AGAMREE through the regulatory
process towards approval and on preparations for market entry. As
previously communicated, Santhera had paused the development of
lonodelestat, stating that continuation of the program was
dependent on additional funding and partnering. As part of the
Company’s portfolio review and the focus on AGAMREE, Santhera has
terminated the development activities and license agreement
relating to lonodelestat and will return the asset to Spexis. This
has no further financial impact on the 2023 accounts, as an
impairment was already recognized under development costs in the
2022 consolidated income statement.
Santhera’s next steps—outlook
With the successful launch of AGAMREE in Germany, the company is
set to introduce the product in the UK later in 2024, followed by
France, Italy and Spain in early 2025, alongside launches in the
Benelux region. Concurrently, Santhera has applied for the France
early access program and is actively engaged in price negotiations,
anticipating the commencement of launches in the UK post the
completion of pricing reviews by the National Institute for Health
and Care Excellence (NICE) in summer 2024.
Within the next five years, the Company
estimates it will achieve annual sales in excess of EUR 150
million in Europe in DMD alone (the first indication for AGAMREE)
with additional revenue expected to be generated through sales
milestones and royalties from its partners in the U.S and China.
Beyond that, Santhera is seeking to widen geographic access to
AGAMREE through additional distribution partnerships in yet
uncovered regions. Together, Santhera and Catalyst aim at expanding
AGAMREE into additional indications with a focus on rare pediatric
diseases.
Santhera has successfully reduced near-term
liabilities and extended its cash reach into 2025, excluding
maturing convertible bonds. Santhera continues to evaluate options
for additional financing, to meet bond requirements and support
market growth and pipeline development with AGAMREE, and will
prioritize debt financing and monetization of royalties over equity
options. The Company expects to start breaking even on a cash basis
by the first half of 2026.
PRELIMINARY UNAUDITED 2023 FINANCIAL
RESULTS & FINANCING
- Revenue from contracts with
customers of CHF 103.4 million (2022: CHF 7.5
million)
- Operating result of CHF 68.8
million (2022: CHF -52.0 million)
- Net result of CHF 54.8 million
(2022: CHF -71.1 million)
- Cash flow from operating activities
of CHF 47.6 million (2022: CHF -29.8 million)
- Cash and cash equivalents of
CHF 30.4 million (Dec 31, 2023)
- Cash runway into 2025, excluding
convertible bond maturity in August 2024
- 2024 update: revenue CHF 4.7
million (Q1 2024); liquid funds of CHF 26.8 million (Mar 31,
2024)
2023 full-year revenue boosted by
licensing incomeIn 2023, Santhera reported total revenue
from contracts with customers of CHF 103.4 million (2022:
CHF 7.5 million). Net sales amounted to CHF 0.8 million
and constituted resumed RAXONE direct product sales in France
(2022: CHF -5.6 million, net of CHF 0.4 million product
sales and CHF 6.0 million non-recurring adjustment associated
with the now settled reimbursement dispute for RAXONE in France).
Revenue from out-licensing transactions in 2023 increased to
CHF 99.9 million (2022: 11.2 million) mainly due to income
from the exclusive licensing agreements with Catalyst
(CHF 98.0 million) and Sperogenix Therapeutics (CHF 1.9
million) for the granted license rights to AGAMREE in North America
and China, respectively. Net sales to licensing partners in 2023
amounted to CHF 2.7 million (2022: CHF 1.9 million) and
were related to RAXONE sales in Europe.
Cost of goods soldCost of goods
sold amounted to CHF 3.2 million and was slightly below the
prior year level (2022: CHF 3.6 million), attributable to a
lower supply of RAXONE and lower amortization of intangible
assets.
Operating expenses and
resultOperating expenses of CHF 32.0 million (2022:
CHF 56.1 million) were 43% lower year-on-year, primarily due
to lower development expenses and the net gain on the sale of the
RAXONE disposal group, partially offset by higher general and
administrative expenses.
Development expenses amounted to CHF 18.7
million (2022: CHF 30.5 million). The decrease of 39% stems
from lower third-party clinical and regulatory services which were
largely related to the support of marketing authorization dossiers
for AGAMREE in DMD with the authorities in the U.S., EU and UK up
to approval.
Marketing and sales expenses were CHF 9.8
million (2022: CHF 10.9 million). On a comparable basis, i.e.
excluding the nonrecurring accrual of CHF 2.1 million in
relation to the reimbursement dispute for RAXONE in France in the
prior year, this represents a slight increase due to higher
pre-commercialization activities for AGAMREE in the U.S. during the
first half of the year prior to licensing and in Europe.
General and administrative expenses amounted to
CHF 21.2 million (2022: CHF 14.6 million), for which the
increase year-on-year reflects the costs related to licensing
activities and addition of personnel in key functions in view of
market readiness preparations for AGAMREE in the U.S (prior to the
Catalyst outlicensing) and Europe.
The operating result amounted to an income of
CHF 68.8 million (2022: loss of CHF -52.0 million).
Financial income and expenses
The financial income in 2023 amounted to CHF 19.4 million
(2022: CHF 6.0 million). The increase was predominantly
related to net positive changes in fair value of financial
instruments and in (un)realized foreign exchange gains.
2023 financial expenses rose by 36% to
CHF 33.4 million (2022: CHF 24.6 million), primarily
driven by higher net negative changes in fair value of financial
instruments and in (un)realized foreign exchange losses. The
largest expense item, interest and make-whole expenses remained
steady year-on-year (2023: CHF -21.3 million vs 2022:
CHF -20.1 million).
In summary, this resulted in a net financial
expense of CHF 14.0 million, a reduction of 25% on the
previous year (2022: CHF 18.6 million).
Net resultThe net result in 2023 was an income of
CHF 54.8 million, compared to a net loss of CHF 71.1
million in the year 2022.
Cash balance and cash flows As
of December 31, 2023, the Company had cash and cash
equivalents of CHF 30.4 million compared to CHF 1.4
million as of December 31, 2022.
Net cash flow from operating activities amounted
to CHF 47.6 million (2022: net cash outflow of CHF 29.8
million). Main contributors to the positive cash flow from
operating activities were the out-licensing income reflected in net
income before taxes and the total financial result, partially
offset by a negative change in noncurrent provisions.
Net cash flow used in investing activities was
higher year-on-year and amounted to CHF 18.0 million (2022:
CHF 3.9 million). This mainly consisted of regulatory-based
milestone payments for AGAMREE from Santhera to its licensing
partners (classified as intangible assets) of CHF -23.7
million (2022: CHF 3.9 million) which were partially offset by
cash proceeds from the sale of financial assets.
Net cash flow used in/from financing activities
in 2023 was CHF -0.1 million (2022: CHF 14.0 million).
This was the net result of proceeds from financing transactions
(involving shares, warrants and exchangeable notes) totaling
CHF 26.3 million which was offset by cash used for financing,
above all the repayment of exchangeable notes in the amount of
CHF 25.5 million.
In summary, the net increase in cash and cash
equivalents in 2023 amounted to CHF 29.0 million (2022: net
decrease of CHF 19.9 million).
Assets and
liabilitiesIntangible assets increased by CHF 14.7
million to CHF 74.0 million reflecting the milestones paid of
CHF 23.4 million for approval of AGAMREE in the U.S offset by
the sale of idebenone and amortization.
Total liabilities decreased by CHF 58.3
million to CHF 49.2 million mainly due to debt repayments and
liabilities transferred on the sale of idebenone.
Shareholders’ equityTotal
consolidated equity as of December 31, 2023, amounted to
CHF 60.5 million compared to a total equity deficit of
CHF -43.7 million as of December 31, 2022, as a result of
the net gain for the period as well as the issue of equity during
the year.
Settlement reached on
pricing/reimbursement for RAXONE in France – business sold to
Chiesi Group In February 2023, Santhera concluded the
negotiations with the Comité économique des produits de santé
(CEPS), securing a final pricing reimbursement, and resumed sales
of RAXONE in France from April 2023. Since the new reference price
was lower than the price applied under the temporary pricing scheme
since launch in 2015, this entailed a staggered reimbursement
obligation due 2024/25. For this purpose, Santhera had gradually
accrued a total amount of CHF 24.8 million (as of
December 31, 2022) in noncurrent provisions, recognized
partially against net sales and as marketing and sales
expenses.
On July 28, 2023, Santhera completed the full
divestment of its RAXONE/idebenone business worldwide and for all
indications to Chiesi Farmaceutici S.p.A., an international
research focused healthcare group (Chiesi Group). The transaction
replaced the license agreement between the two companies entered
into in 2019. Under the terms of the agreement, Chiesi Group
acquired the idebenone intangible asset, its associated inventory,
and assumed the responsibility for the settlement agreed between
Santhera and the French reimbursement authorities.
The net gain on the sale of the disposal group
in the amount of CHF 17.7 million has been recognized in the
consolidated income statement for the year ended December 31,
2023. The net gain is mainly due to the derecognition of the
noncurrent provision (CHF 24.8 million), which was partially
offset by the loss on the derecognition of the idebenone intangible
asset (CHF 6.6 million).
The agreement simplified the RAXONE business
significantly for both companies with Chiesi becoming the marketing
authorization holder for RAXONE/idebenone in Europe and the global
brand owner while enabling Santhera to focus on the launch of
AGAMREE in Europe.
Equity-linked financings and share
capitalIn a difficult market environment, Santhera managed
to reduce the balance sheet debt through repayment of a convertible
bond and engaged in equity-linked financings to provide sufficient
funding for operations and advancing its lead product towards
approval. Presently, the Company still has treasury shares
available for placement, subject to adequate market conditions.
Bond instruments. During 2023,
Santhera reduced debt (convertible bonds and exchangeable notes)
from a total amount of CHF 43.2 million (December 31,
2022) by CHF 22.3 million, and has currently convertible bonds
outstanding in the carrying amount of CHF 20.9 million,
maturing in August 2024. Of the senior unsecured convertible bonds
(2021/24 Bonds), CHF 1.5 million were converted during the
year 2023 and an aggregate amount of CHF 11.0 million was
outstanding on December 31, 2023. For the 2021/24 Private Bonds, in
February 2023, Santhera and Highbridge agreed on a new conversion
price of CHF 5.00 for a CHF 5 million tranche and to
CHF 10.00 for the remaining outstanding tranche. The nominal
value of convertible bonds maturing August 2024 outstanding at
December 31, 2023 total CHF 24.5 million, comprising
CHF 13.6 million (Public 2021/24), CHF 7.0 million
(Private 2021/24 conversion price CHF 10.00) and CHF 4.0
million (Private 2021/24 conversion price CHF 5.00)
Share capital and treasury shares. In February
2023, Santhera completed the ordinary capital increase resolved by
its shareholders on November 29, 2022, by issuing 40 million
shares. Thereof, 3 million shares were delivered in the context of
the Highbridge financing, and the remainder held in treasury.
Additionally, during the period a further 0.5 million new shares
were issued for financing transactions and share-based
compensation.
At the Annual General Meeting (AGM) held on
June 27, 2023, the shareholders approved a reverse share split
in the ratio of 10:1. The reverse share split was completed on
July 3, 2023. Additionally, shareholders also gave their
consent to the creation of a capital range which authorizes the
Board to increase or reduce the share capital within a certain
range and over a period of up to five years. Furthermore,
shareholders endorsed the replacement of the existing conditional
capital for financing purposes and for employee participation by a
corresponding new, increased conditional capital.
As of December 31, 2023, issued share
capital consisted of 12,620,376 shares with a total nominal value
of CHF 1,262,037 (nominal value CHF 0.10 per share), and
the Company held 1,305,167 treasury shares with total nominal value
of CHF 130,517 for future equity-based financings.
Amendments of Highbridge facility to
satisfy near-term cash requirements In February 2023,
Santhera and Highbridge further amended the existing financing
arrangement. Under the amended agreement, Highbridge agreed to
provide up to CHF 22.2 million, thereof around CHF 2.2
million through the purchase of 3 million shares at CHF 7.50
per share and up to CHF 20 million through the existing
financing arrangement, subject to conditions, to fund Santhera up
to the PDUFA date in October 2023. An initial amount of CHF 5
million was drawn immediately and CHF 15 million were to
become available in subsequent tranches, conditional on certain
milestones and other conditions.
The Company had outstanding exchangeable
instruments at nominal value as of June 30, 2023, of
CHF 25.5 million, all amounts outstanding under exchangeable
notes were settled during July 2023 post the closing of U.S.
license transaction.
Funding prospectsAs previously
noted, the grant of the U.S. license for AGAMREE, completion of the
RAXONE transfer and repayment of exchangeable debt are expected to
provide, together with anticipated revenue from AGAMREE in
self-market countries, for a cash runway into 2025, excluding
convertible bond maturity. Cash net outflow from operations for
2024 is anticipated to average approx. CHF 2.5 million per month
for 2024 compared to approx. CHF 4.0 million per month in 2023
excluding one-off licensing income.
Santhera keeps under review the need for further
financing to support market growth, line extension development for
AGAMREE and securing operations. The Company is evaluating
potential royalty and debt financings and in addition has treasury
shares, conditional and authorized capitals available for future
placement, subject to market conditions.
Q1-2024 TRADING UPDATE
Revenue in the quarter to March 31, 2024,
amounted to CHF 4.7 million and primarily includes initial
product sales of AGAMREE in Germany and Austria (CHF 2.1
million) as well as milestone payments related to the regulatory
progress in China and supply of product to partners (CHF 2.6
million).
The first market launch of AGAMREE occurred on
January 15 in Germany, where around 3,000 patients are affected by
DMD. Furthermore, since February 15, AGAMREE has also become
available in Austria. The reception has been very positive,
evidenced by strong demand and proactive inquiries from patients
and caretakers. Within only a few months of availability, AGAMREE
has been prescribed to around 150 patients in Germany and
Austria.
Cash and cash equivalents as of March 31, 2024,
totaled CHF 26.8 million.
DECISION OF SIX EXCHANGE
REGULATION
SIX Exchange Regulation has permitted Santhera
to publish its 2023 Annual Report by May 31, 2024, at the
latest. Santhera is in the process of completing the 2023 Annual
Report and the postponement enables Santhera and its auditors to
complete the preparation and audit of the financial statements in
the light of the material events outside the ordinary course of
business during and after the end of the reporting period. As
required by SIX Exchange Regulation, Santhera hereby reprints the
following extract of the decision of SIX Exchange Regulation
(translation from the German original):
The exemption from the obligations for
maintaining listing and thus the deferral of the publication of the
annual report for the year 2023 as well as the filing of this
report with SIX Exchange Regulation Ltd by Friday, May 31,
2024, at the latest is hereby approved subject to the following
provision (lit. a) and conditions (lit. b):
a. SIX Exchange
Regulation Ltd reserves the right to potentially suspend trading in
the securities of Santhera Pharmaceuticals Holding Ltd for a
certain period of time if it does not publish its annual report for
the year 2023 in accordance with the provisions on ad hoc publicity
(art. 53 Listing Rules in conjunction with the Directive on Ad hoc
Publicity) and submit it to SIX Exchange Regulation Ltd by 11:59
p.m. on Friday, May 31, 2024, at the latest.
b. Santhera has to
publish a media release regarding the present decision in
accordance with the provisions on ad hoc publicity (art. 53 Listing
Rules in conjunction with the Directive on Ad hoc Publicity) by
7:30 a.m. on Tuesday, April 30, 2024 at the latest. Such media
release
- has to include
the full text of clause I of the present decision in a prominent
place;
- must mention the
reasons for postponing the publication and filing of the annual
report for the year 2023;
- must mention the
unaudited key figures such as net sales, EBITDA, EBIT, net
profit/loss, total assets, equity etc. with regard to the business
results 2023.
Full-year Financial
Information
The preliminary unaudited figures presented in
this press release are subject to change. The Company plans to
publish its audited 2023 Annual Report in May 2024.
Consolidated Income Statement
IFRS, in CHF
thousands |
2023(preliminary unaudited) |
2022(audited) |
|
|
|
Net sales |
754 |
(5,578) |
Revenue from
out-licensing transactions |
99,923 |
11,190 |
Net sales to
licensing partner |
2,699 |
1,861 |
Revenue from contracts with customers |
103,376 |
7,473 |
|
|
|
Cost of goods
sold |
(3,235) |
(3,592) |
Of which
amortization intangible assets |
(2,405) |
(3,040) |
Other operating
income |
664 |
259 |
|
|
|
Development |
(18,674) |
(30,536) |
Marketing and
sales |
(9,782) |
(10,857) |
General and
administrative |
(21,184) |
(14,565) |
Other operating
expenses |
(42) |
(158) |
Net gain on sale of disposal group |
17,683 |
0 |
Operating expenses |
(31,999) |
(56,116) |
Operating result |
68,806 |
(51,976) |
|
|
|
Financial
income |
19,391 |
5,984 |
Financial
expenses |
(33,376) |
(24,624) |
Result before taxes |
54,821 |
(70,616) |
Income taxes |
(39) |
(460) |
Net result |
54,782 |
(71,076) |
|
|
|
Consolidated Balance Sheet
IFRS, in CHF
thousands |
Dec 31,
2023(preliminaryunaudited) |
Dec 31, 2022(audited) |
|
|
|
Assets |
|
|
Tangible
assets |
582 |
1,008 |
Intangible
assets |
73,966 |
59,206 |
Financial assets
long-term |
424 |
444 |
Deferred tax
assets |
0 |
3 |
Noncurrent assets |
74,972 |
60,661 |
Prepaid
expenses |
321 |
513 |
Inventories |
1,811 |
108 |
Trade and other
receivables |
2,155 |
1,091 |
Cash and cash
equivalents |
30,370 |
1,353 |
Current assets |
34,657 |
3,065 |
Total assets |
109,629 |
63,726 |
|
|
|
Equity
and liabilities |
|
|
Share
capital |
1,261 |
753 |
Capital reserves
and share premium |
629,236 |
581,116 |
Retained
deficit |
(572,719) |
(627,501) |
Employee benefit
reserve |
2,819 |
2,722 |
Treasury
shares |
(131) |
(94) |
Translation
differences |
(2) |
(682) |
Total equity |
60,464 |
(43,686) |
Noncurrent
convertible bonds |
0 |
21,080 |
Noncurrent
derivative financial instruments |
0 |
4,335 |
Noncurrent
warrant financial instruments |
1,478 |
5,171 |
Noncurrent lease
liabilities |
35 |
607 |
Noncurrent
provisions |
0 |
24,961 |
Pension
liabilities |
3,858 |
1,844 |
Noncurrent liabilities |
5,371 |
57,998 |
Trade and other
payables |
5,616 |
7,583 |
Accrued
expenses |
9,051 |
10,852 |
Income tax
payable |
182 |
553 |
Current lease
liabilities |
571 |
623 |
Current
exchangeable notes |
0 |
22,127 |
Current
convertible bonds |
20,943 |
0 |
Current
derivative financial instruments |
5,255 |
5,440 |
Current warrant
financial instruments |
2,035 |
2,225 |
Current
provisions |
141 |
11 |
Current liabilities |
43,794 |
49,414 |
Total liabilities |
49,165 |
107,412 |
Total equity and liabilities |
109,629 |
63,726 |
Consolidated Statement of Cash
Flows
IFRS, in CHF
thousands |
Dec 31,
2023(preliminaryunaudited) |
Dec 31, 2022(audited) |
|
|
|
Result
before taxes |
54,821 |
(70,616) |
Depreciation and
impairment of tangible assets |
635 |
608 |
Amortization and
impairment of intangible assets |
2,405 |
9,250 |
Share-based
compensation |
5,990 |
5,452 |
Change in fair
value of financial instruments, net |
(7,609) |
198 |
Realized gain on
repurchase of convertible bonds |
0 |
(1,504) |
Loss on
modification of convertible bonds |
254 |
0 |
Change in pension
liabilities |
310 |
104 |
Reversal of
current provisions |
(243) |
(67) |
Change in
noncurrent provisions |
(24,961) |
8,153 |
Income taxes
paid |
(405) |
(78) |
Change in net
working capital |
(1,352) |
1,394 |
Total financial
result |
24,722 |
19,793 |
Interest
received |
506 |
0 |
Interest
paid |
(7,450) |
(2,530) |
Net cash flow from/(used in) operating
activities |
47,623 |
(29,843) |
|
|
|
Investments in
tangible assets |
(90) |
(53) |
Investments in
intangible assets |
(23,653) |
(3,903) |
Change in
financial assets long-term |
20 |
24 |
Proceeds from
sale of financial assets |
5,679 |
0 |
Net cash flow from/(used in) investing
activities |
(18,044) |
(3,932) |
|
|
|
Proceeds from
shares sold through a private placement |
15,657 |
0 |
Proceeds from
sale of treasury shares |
474 |
474 |
Proceeds from
exercise of equity rights |
29 |
37 |
Proceeds from
exercise of warrants financial instruments |
2,660 |
0 |
Proceeds
from/(repayment) of exchangeable notes |
(17,975) |
33,000 |
Repayment of
convertible bonds |
0 |
(13,935) |
Repurchase of
convertible bonds |
0 |
(4,511) |
Financing
transaction costs |
(102) |
(153) |
Cost of issuance
of capital |
(155) |
(273) |
Payment of lease
liabilities |
(712) |
(646) |
Net cash
flow from/(used in) financing activities |
(124) |
13,993 |
|
|
|
Effects of
exchange rate changes on cash and cash equivalents |
(438) |
(73) |
Net increase/(decrease) in cash and cash
equivalents |
29,017 |
(19,855) |
|
|
|
Cash and cash
equivalents at January 1 |
1,353 |
21,208 |
Cash and cash equivalents at December 31 |
30,370 |
1,353 |
Share Capital
(number of shares with a par value of CHF 0.10 |
Dec 31,
2023(preliminaryunaudited) |
Dec 31, 2022 1 (audited) |
Ordinary
shares issued |
12,620,376 |
7,532,051 |
Treasury
shares |
1,305,167 |
943,802 |
Conditional
capital for employee participations (Art 3b) |
542,450 |
503,458 |
Conditional
capital for financing purposes (Art 3c) |
5,500,000 |
3,015,662 |
Authorized capital |
4,686,069 |
3,686,068 |
1 2022 numbers are adjusted for the reverse
share split in the ratio of 10:1, completed on July 3,
2023
Conference Call Santhera will
host a conference call on April 25, 2024, at 14:30 CEST /
13:30 BST / 08:30 EDT. CEO Dario Eklund, CFO Andrew Smith and CMO
Shabir Hasham, MD, will discuss the 2023 annual financial results
and comment on ongoing corporate developments. Participants are
invited to call one of the following numbers (no dial-in code is
required):
Switzerland/Europe: +41
58 310 50 00United
Kingdom: +44 207 107
06 13USA: +1 631 570
56 13
A replay will be accessible at
https://www.santhera.com/ad-hoc-news from about two hours after the
call has ended.
References
Publications and applicable drug labeling to
which this press release makes reference to:Labeling: United States
Prescribing Information; European Union Summary of Product
CharacteristicsDang UJ et al. (2024) Neurology 2024;102:e208112.
doi.org/10.1212/WNL.0000000000208112. Link.Guglieri M et al (2022).
JAMA Neurol. 2022;79(10):1005-1014.
doi:10.1001/jamaneurol.2022.2480. Link.Liu X et al (2020). Proc
Natl Acad Sci USA 117:24285-24293Heier CR et al (2019). Life
Science Alliance DOI: 10.26508 Ward et al., WMS 2022, FP.27 -
Poster 71. Link. Hasham et al., MDA 2022 Poster presentation.
Link.
About SantheraSanthera
Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical
company focused on the development and commercialization of
innovative medicines for rare neuromuscular and pulmonary diseases
with high unmet medical need. The Company has an exclusive license
from ReveraGen for all indications worldwide to AGAMREE®
(vamorolone), a dissociative steroid with novel mode of action,
which was investigated in a pivotal study in patients with Duchenne
muscular dystrophy (DMD) as an alternative to standard
corticosteroids. AGAMREE for the treatment of DMD is approved in
the U.S. by the Food and Drug Administration (FDA), in the EU by
the European Medicines Agency (EMA), and in the UK by the Medicines
and Healthcare products Regulatory Agency (MHRA). Santhera has
out-licensed rights to AGAMREE for North America to Catalyst
Pharmaceuticals, Inc. and for China to Sperogenix Therapeutics. For
further information, please visit www.santhera.com.
AGAMREE® is a trademark of Santhera
Pharmaceuticals.
For further information please
contact: public-relations@santhera.com orEva Kalias, Head
Investor Relations & CommunicationsPhone: +41 79 875 27
80eva.kalias@santhera.com
Disclaimer / Forward-looking
statements This communication does not constitute an offer
or invitation to subscribe for or purchase any securities of
Santhera Pharmaceuticals Holding AG. This publication may contain
certain forward-looking statements concerning the Company and its
business. Such statements involve certain risks, uncertainties and
other factors which could cause the actual results, financial
condition, performance or achievements of the Company to be
materially different from those expressed or implied by such
statements. Readers should therefore not place undue reliance on
these statements, particularly not in connection with any contract
or investment decision. The Company disclaims any obligation to
update these forward-looking statements.
# # #
- 2024 04 25_FY2023prelim_e_final