Ad hoc announcement pursuant to Art. 53 LR
A conference call will be held on
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 andUK , 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 byU.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 andAustria ; revenue of CHF 4.7 million, cash onMarch 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,
“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
In 2023 and into 2024, Santhera achieved critical milestones, securing regulatory approvals for AGAMREE in DMD across the
REVIEW OF PIPELINE AND BUSINESS PROGRESS
2023 key events and post-period updates
- AGAMREE approved in the
U.S. , EU and theUK 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 toUSD 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
AGAMREE was approved by the
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
In
After closing of the transaction in
In
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
On
Santhera plans to make AGAMREE available to patients in additional key geographies in
Activities surrounding market access, stakeholder and key opinion leader engagement in the target countries progressed throughout the period under review. After
Full divestment of RAXONE/idebenone business to
In a transaction closed on
Santhera retains contingent value for LHON in the
Lonodelestat development terminated and compound to be returned to Spexis
Santhera’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
Within the next five years, the Company estimates it will achieve annual sales in excess of EUR 150 million in
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 income
In 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
Cost of goods sold
Cost 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 result
Operating 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
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
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
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 result
The 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
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 liabilities
Intangible 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
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’ equity
Total consolidated equity as of
Settlement reached on pricing/reimbursement for RAXONE in
In
On
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
The agreement simplified the RAXONE business significantly for both companies with Chiesi becoming the marketing authorization holder for RAXONE/idebenone in
Equity-linked financings and share capital
In 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 (
Share capital and treasury shares. In
At the Annual General Meeting (AGM) held on
As of
Amendments of
In
The Company had outstanding exchangeable instruments at nominal value as of
Funding prospects
As previously noted, the grant of the
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
The first market launch of AGAMREE occurred on
Cash and cash equivalents as of
DECISION OF SIX EXCHANGE REGULATION
SIX Exchange Regulation has permitted Santhera to publish its 2023 Annual Report by
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
a. SIX
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
- 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
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 | (preliminary unaudited) | (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 |
(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 | (preliminary unaudited) | (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 | 1,353 | 21,208 |
Cash and cash equivalents at | 30,370 | 1,353 |
Share Capital
(number of shares with a par value of CHF 0.10 | (preliminary unaudited) | |
Ordinary shares issued | 12,620,376 | 7,532,051 |
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
Conference Call
Santhera will host a conference call on
United Kingdom: +44 207 107 06 13
USA: +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:
Dang 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).
Heier 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 Santhera
AGAMREE® is a trademark of
For further information please contact:
public-relations@santhera.com or
Phone: +41 79 875 27 80
eva.kalias@santhera.com
Disclaimer / Forward-looking statements
This communication does not constitute an offer or invitation to subscribe for or purchase any securities of
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Attachment
- 2024 04 25_FY2023prelim_e_final
Source:
2024 GlobeNewswire, Inc., source