6-K
Relief Therapeutics Holding SA (RLFTY)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report ofForeign Private Issuer
Pursuant to Rule 13a-16 or15d-6
under the Securities Exchange Act of 1934
For the Month of August, 2024
Commission File Number: 001-41174
RELIEF THERAPEUTICS Holding SA
(Exact name of Registrant as specified in its charter)
NotApplicable
(Translation of registrant’s name into English)
Switzerland
(Jurisdiction of incorporation or organization)
Avenue de Sécheron 15
1202 Geneva
Switzerland
Tel: +41 22 545 11 16
(Address of principal executive offices)
Indicate by check mark if the registrant files or will file annual reports under cover of Form 20-F or Form 40-F
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1) ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7) ☐
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
On August 30, 2024, RELIEF THERAPEUTICS Holding SA (the “Company”) presented to its shareholders (i) a corporate update and presentation, and (ii) its Condensed Consolidated Financial Statements (unaudited) as of June 30, 2024, which are attached hereto as Exhibits 99.1 and 99.2, respectively.
On August 30, 2024, the Company issued a press release reporting on its results for the six months ended June 30, 2024 and providing a corporate update, which press release is attached hereto as Exhibit 99.3.
INDEX TO EXHIBITS
1
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| RELIEF THERAPEUTICS Holding SA | |
|---|---|
| By: | /s/ Jeremy Meinen |
| Jeremy Meinen | |
| Chief Financial Officer |
Dated: August 30, 2024
2
EX-99.2
Exhibit 99.2
- 1 -
CONSOLIDATED INTERIM BALANCE SHEET
(unaudited)
| in CHF thousands | Notes | June 30,<br>2024 | December 31,<br>2023 | |||||
|---|---|---|---|---|---|---|---|---|
| ASSETS | ||||||||
| Intangible assets | 6 | 53,393 | 54,414 | |||||
| Right-of-use<br>assets | 7 | 2,363 | 2,570 | |||||
| Property and equipment | 338 | 397 | ||||||
| Other non-current assets | 116 | 116 | ||||||
| Deferred tax assets | 22 | — | 589 | |||||
| Non-current assets | **** | 56,210 | **** | **** | 58,086 | **** | ||
| Inventories | 8 | 374 | 557 | |||||
| Trade receivables | 964 | 1,171 | ||||||
| Other current assets | 9 | 2,645 | 2,020 | |||||
| Cash and cash equivalents | 10,728 | 14,556 | ||||||
| Current assets | **** | 14,711 | **** | **** | 18,304 | **** | ||
| Total assets | **** | 70,921 | **** | **** | 76,390 | **** | ||
| EQUITY AND LIABILITIES | ||||||||
| Share capital | 10 | 1,404 | 56,163 | |||||
| Reserves | 270,799 | 220,330 | ||||||
| Treasury shares | (150 | ) | (6,001 | ) | ||||
| Accumulated losses | (222,786 | ) | (218,264 | ) | ||||
| Equity | **** | 49,267 | **** | **** | 52,228 | **** | ||
| Non-current lease liabilities | 7 | 2,019 | 2,086 | |||||
| Non-current borrowings | — | 9 | ||||||
| Defined benefit obligations | 11 | 1,072 | 1,589 | |||||
| Provisions | 12 | 6,465 | 6,203 | |||||
| Deferred tax liabilities | 7,335 | 7,366 | ||||||
| Non-current liabilities | **** | 16,891 | **** | **** | 17,253 | **** | ||
| Current lease liabilities | 7 | 386 | 524 | |||||
| Current borrowings | 12 | 337 | ||||||
| Trade payables | 1,291 | 1,025 | ||||||
| Financial liabilities due to related parties | 13 | — | 1,355 | |||||
| Provisions | 12 | — | 235 | |||||
| Other current payables and liabilities | 14 | 3,074 | 3,433 | |||||
| Current liabilities | **** | 4,763 | **** | **** | 6,909 | **** | ||
| Total equity and liabilities | **** | 70,921 | **** | **** | 76,390 | **** |
The accompanying notes form an integral part of these consolidated interim financial statements.
- 2 -
CONSOLIDATED INTERIM STATEMENT OF COMPREHENSIVE LOSS
(unaudited)
| Six-month period ended June 30, | |||||||
|---|---|---|---|---|---|---|---|
| in CHF thousands | Notes | 2024 | 2023 | ||||
| Revenue | 5 | 5,581 | 3,023 | ||||
| Other gains | 15 | 73 | 66 | ||||
| Total income | **** | 5,654 | **** | **** | 3,089 | **** | |
| Raw materials and consumables expenses | 16 | (1,562 | ) | (779 | ) | ||
| External selling and distribution expenses | 16 | (398 | ) | (1,442 | ) | ||
| External research and development expenses | 17 | (733 | ) | (933 | ) | ||
| Personnel expenses | 18 | (3,484 | ) | (6,259 | ) | ||
| Other administrative expenses | 19 | (2,017 | ) | (3,462 | ) | ||
| EBITDA | **** | (2,540 | ) | **** | (9,786 | ) | |
| Change in fair value of contingent consideration | 12 | — | 3,962 | ||||
| Impairment expense | 6 | — | (55,824 | ) | |||
| Amortization and depreciation expense | 20 | (1,438 | ) | (1,704 | ) | ||
| Operating result | **** | (3,978 | ) | **** | (63,352 | ) | |
| Financial income | 21 | 200 | — | ||||
| Financial expense | 21 | (219 | ) | (790 | ) | ||
| Net loss before taxes | **** | (3,997 | ) | **** | (64,142 | ) | |
| Income taxes | 22 | (560 | ) | 7,643 | |||
| Net loss for the period | **** | (4,557 | ) | **** | (56,499 | ) | |
| OTHER COMPREHENSIVE INCOME | |||||||
| Remeasurement of defined benefit obligations | 35 | — | |||||
| Items that will not be reclassified to profit or loss | **** | 35 | **** | **** | — | **** | |
| Currency translation differences | (32 | ) | 415 | ||||
| Items that may be reclassified to profit or loss | **** | (32 | ) | **** | 415 | **** | |
| Other comprehensive income for the period, net of tax | **** | 3 | **** | **** | 415 | **** | |
| Total comprehensive loss for the period | **** | (4,554 | ) | **** | (56,084 | ) | |
| EARNINGS PER SHARE | |||||||
| Basic and diluted loss per share (in CHF) | 23 | (0.363 | ) | (5.098 | ) |
The accompanying notes form an integral part of these consolidated interim financial statements.
- 3 -
CONSOLIDATED INTERIM STATEMENT OF CASH FLOW
(unaudited)
| Six-month period ended June 30, | ||||||||
|---|---|---|---|---|---|---|---|---|
| in CHF thousands | Notes | 2024 | 2023 | |||||
| Net loss for the period | (4,557 | ) | (56,499 | ) | ||||
| Adjustments: | ||||||||
| Income tax | 22 | 560 | (7,643 | ) | ||||
| Amortization and depreciation expense | 20 | 1,438 | 1,704 | |||||
| Impairment of intangible assets | — | 55,734 | ||||||
| Impairment of receivables and inventories | — | 98 | ||||||
| Reversal of impairment | (7 | ) | — | |||||
| Gain from fair value adjustments on contingent liabilities | — | (3,962 | ) | |||||
| Finance expenses, net | 21 | 56 | 535 | |||||
| Change in defined benefit obligations | 11 | (483 | ) | — | ||||
| Share-based payment expense | 225 | 511 | ||||||
| Changes in working capital: | ||||||||
| Decrease/(Increase) in inventories | 183 | (223 | ) | |||||
| Decrease/(Increase) in trade receivables | 214 | 301 | ||||||
| Decrease/(Increase) in other assets | (626 | ) | (312 | ) | ||||
| (Decrease)/Increase in trade payables | 266 | 577 | ||||||
| (Decrease)/Increase in provisions | (79 | ) | (136 | ) | ||||
| (Decrease)/Increase in other payables and liabilities | (356 | ) | (1,151 | ) | ||||
| Cash flow used in operating activities | **** | (3,166 | ) | **** | (10,466 | ) | ||
| Payments for property, plant and equipment | — | (369 | ) | |||||
| Payments for intangible assets | 6 | (86 | ) | — | ||||
| Proceeds from acquisition price adjustment of intangible assets | — | 149 | ||||||
| Interest received | 21 | 79 | — | |||||
| Cash flow from (used in) investing activities | **** | (7 | ) | **** | (220 | ) | ||
| Proceeds from capital increases | — | 4,992 | ||||||
| Sale of treasury shares | — | 17 | ||||||
| Equity transaction costs | — | (487 | ) | |||||
| Repayment of lease liabilities | (271 | ) | (344 | ) | ||||
| Repayment of borrowings | (345 | ) | (4 | ) | ||||
| Cash flow from (used in) financing activities | **** | (616 | ) | **** | 4,174 | **** | ||
| Net decrease in cash and cash equivalents | **** | (3,789 | ) | **** | (6,512 | ) | ||
| Cash and cash equivalents at beginning of period | 14,556 | 19,237 | ||||||
| Exchange difference on cash and cash equivalents | (39 | ) | 67 | |||||
| Cash and cash equivalents at end of period | **** | 10,728 | **** | **** | 12,792 | **** |
The accompanying notes form an integral part of these consolidated interim financial statements.
- 4 -
CONSOLIDATED INTERIM STATEMENT OF CHANGES IN EQUITY
(unaudited)
| in CHF thousands | Sharecapital | Treasury<br>shares | Reserves | Accumulated<br>loss | Total<br>equity | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Balance at January 1, 2023 | **** | 56,163 | **** | **** | (12,108 | ) | **** | 220,961 | **** | **** | (119,599 | ) | **** | 145,417 | **** |
| Result for the period | — | — | — | (56,499 | ) | (56,499 | ) | ||||||||
| Other comprehensive income for the period | — | — | 415 | — | 415 | ||||||||||
| Total comprehensive result for the period | **** | — | **** | **** | — | **** | **** | 415 | **** | **** | (56,499 | ) | **** | (56,084 | ) |
| Direct Share Placement program | — | 12 | 5 | — | 17 | ||||||||||
| Private placement | — | 4,800 | 195 | — | 4,995 | ||||||||||
| Withdrawal of fractional shares | — | (12 | ) | (10 | ) | — | (22 | ) | |||||||
| Capital increase transaction costs | — | — | (487 | ) | — | (487 | ) | ||||||||
| Exercise of options | — | 19 | — | — | 19 | ||||||||||
| Share-based compensation cost | — | — | 511 | — | 511 | ||||||||||
| Balance at June 30, 2023 | **** | 56,163 | **** | **** | (7,289 | ) | **** | 221,590 | **** | **** | (176,098 | ) | **** | 94,366 | **** |
| Balance at January 1, 2024 | **** | 56,163 | **** | **** | (6,001 | ) | **** | 220,330 | **** | **** | (218,264 | ) | **** | 52,228 | **** |
| Result for the period | — | — | — | (4,557 | ) | (4,557 | ) | ||||||||
| Other comprehensive income for the period | — | — | (32 | ) | 35 | 3 | |||||||||
| Total comprehensive result for the period | **** | — | **** | **** | — | **** | **** | (32 | ) | **** | (4,522 | ) | **** | (4,554 | ) |
| Nominal value reduction (note 10) | (54,759 | ) | 5,851 | 48,908 | — | — | |||||||||
| Share-based compensation cost | — | — | 225 | — | 225 | ||||||||||
| Issuance of warrants (note 13) | — | — | 1,368 | — | 1,368 | ||||||||||
| Balance at June 30, 2024 | **** | 1,404 | **** | **** | (150 | ) | **** | 270,799 | **** | **** | (222,786 | ) | **** | 49,267 | **** |
The accompanying notes form an integral part of these consolidated interim financial statements.
- 5 -
NOTES TO THE CONSOLIDATED INTERIM FINANCIAL STATEMENTS
1. General information
RELIEF THERAPEUTICS Holding SA (“Relief”, the “Company” or the “Group”) is a Swiss stock corporation domiciled at 15 Avenue de Sécheron, 1202 Geneva, Switzerland. The Company’s shares are listed on the SIX Swiss Exchange (ticker: RLF) and quoted in the U.S. on OTCQB (tickers: RLFTF, RLFTY).
The Group focuses on the identification, development and commercialization of novel, patent protected products intended for the treatment of dermatological, metabolic, and pulmonary rare diseases with a portfolio of clinical and marketed products that serve unmet patient needs.
In March 2021, Relief signed a collaboration and license agreement with Acer Therapeutics, Inc. (“Acer”) for the worldwide development and commercialization of ACER-001 (OLPRUVA^®^) for the treatment of urea cycle disorders (“UCDs”) and maple syrup urine disease (“MSUD”). In December 2022, the FDA approved OLPRUVA for the treatment of UCDs in the U.S. In August 2023, Relief and Acer terminated the March 2021 collaboration and license agreement and entered into a new exclusive license agreement for the development and commercialization of OLPRUVA for the treatment of UCDs, MSUD, and other potential indications. Under the terms of the new agreement, Acer retains development and commercialization rights worldwide, excluding Europe where Relief retains these rights. Relief was entitled to receive from Acer a 10% continuing royalty on net sales of OLPRUVA in the Acer territory (worldwide, excluding Europe), and 20% of any value received by Acer from licensing or divestment transactions relating to OLPRUVA, up to a cumulative amount of USD 45 million (CHF 40.4 million). In August 2024 (post-reporting period), Relief sold its royalty entitlement to SWK, subject to certain terms and conditions (note 26).
In June 2021, Relief acquired APR Applied Pharma Research SA (“APR”), a privately held Swiss pharmaceutical company specialized in formulating, developing, and commercializing known molecules designed with proprietary drug delivery systems for niche and specialty diseases. The acquisition transformed the Company into a fully integrated commercial-stage biopharmaceutical group. The acquisition further diversified Relief’s pipeline and portfolio with both commercial products and clinical-stage programs, provided a commercial infrastructure in Europe, and strengthened internal research and development capabilities. The same year, Relief acquired AdVita Lifescience GmbH (“AdVita”). The acquisition strengthened the Group’s expertise and intellectual property rights around the inhaled formulation and delivery of Aviptadil.
The Group maintained an internal marketing and sales infrastructure in Switzerland, the U.S., Italy, and Germany, dedicated to the direct commercialization of PKU GOLIKE^®^. For the commercialization of its other commercially available products, as well as PKU GOLIKE outside of these key markets, the Group entered into licensing or distribution agreements with third parties. In December 2023, the Group initiated a progressive transition from its direct marketing and sales infrastructure to a partnership-based model for PKU GOLIKE.
These unaudited condensed consolidated interim financial statements were approved for publication by the Company’s Board of Directors on August 29, 2024.
2. New and revised International Financial Reporting Standards (IFRS)
There were no new standards or amendments to existing standards that have a significant impact on the Group’s accounting policies and these interim financial statements.
3. Summary of significant accounting policies
3.1 Basis of preparation
These condensed consolidated interim financial statements were prepared in accordance with IAS 34 ‘Interim Financial Reporting’ as issued by the International Accounting Standards Board (IASB). They do not include all disclosures that would otherwise be required in a complete set of financial statements and should therefore be read in conjunction with the Group’s annual consolidated financial statements for the year ended December 31, 2023. They have been prepared under the historical cost convention, as modified by the revaluation of financial instruments at fair value and are presented in Swiss francs (CHF). All values are rounded to the nearest thousand (TCHF), except when otherwise indicated.
3.2 Significant accounting policies
The accounting policies used in the preparation and presentation of the condensed interim consolidated financial statements are consistent with those applied for the Group’s annual consolidated financial statements for the year ended December 31, 2023.
Certain comparative figures have been reclassified to conform with the current period’s presentation.
- 6 -
3.3 Interim measurement note
The business is not subject to any seasonality. Expenses largely depend on the phase of the respective projects, particularly with regard to external research and development expenditures.
Costs that incur unevenly during the financial year are anticipated or deferred in the interim report only if it would also be appropriate to anticipate or defer such costs at the end of the financial year.
4. Summary of critical accounting judgments and key sources ofestimation uncertainty
The preparation of the consolidated financial statements in conformity with IFRS requires management to make estimates and assumptions that affect the application of policies and reported amounts of assets, liabilities, income, expenses and related disclosures. The estimates and underlying assumptions are based on historical experience and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates.
The critical judgments in applying accounting policies and the key sources of estimation uncertainty are consistent with those used in the consolidated financial statements for the year ended December 31, 2023, with the following amendments:
License and Supply Agreement with EtonPharmaceuticals, Inc.
On March 21, 2024, the Company entered into a License and Supply Agreement (“LSA”) granting Eton Pharmaceuticals, Inc. (“Eton”) the exclusive rights to commercialize the GOLIKE family of products in the United States. Under the terms of the agreement, the Company received an upfront payment of USD 2.2 million (CHF 2.0 million) and is eligible to receive up to USD 2.0 million (CHF 1.8 million) in additional sales milestones, as well as variable mid-teens royalties on net sales.
Revenue from this transaction is recognized in accordance with IFRS 15, based on the substance of the agreement. Management has applied its judgment to determine performance obligations, transaction prices, and the completion of performance obligations over time. The following distinct performance obligations were identified in the Eton LSA: (i) delivery of an exclusive license for the commercialization of existing GOLIKE products, (ii) delivery of an exclusive license for the commercialization of certain GOLIKE product line extensions under development, and (iii) commitment to manufacture and supply the GOLIKE products for a specified duration.
The transaction price was allocated based on the estimated stand-alone selling price of each performance obligation. Of the CHF 2.0 million non-refundable upfront payment received from Eton, CHF 1.6 million was allocated to the first performance obligation and recognized as revenue upon execution of the LSA, as the license constitutes functional intellectual property transferred on that date. The remaining CHF 0.4 million was allocated to the second performance obligation and will be recognized as revenue upon completion of development. The allocation of the transaction proceeds was estimated based on a discounted cash flow approach, considering several factors, including estimated sales, manufacturing costs, development timelines, and probabilities of success.
In accordance with the sales-based royalties exception, royalties and milestone payments are recognized when the corresponding sales occur, to the extent the Company is entitled to such revenue. Revenue derived from manufacturing and supply is recognized upon delivery of products, as control of the products transfers at that point.
For the six-month period ended June 30, 2024, the Company recognized CHF 1.6 million as license revenue under the Eton LSA, in addition to accrued royalties and product sales for supply to Eton. As of June 30, 2024, CHF 0.4 million was recorded as deferred income on the consolidated balance sheet for the performance obligations that were not yet completed.
Issuance of warrants to GEM
As described in note 13, the Company extinguished an outstanding liability of TCHF 1,368 by issuing warrants to purchase the Company’s ordinary shares at a predetermined price. The issuance of the warrants has been accounted for as consideration paid for the extinguishment of the liability. The fair value of the warrants, determined using the Black-Scholes valuation model, closely approximated the carrying amount of the liability. Consequently, no gain or loss was recognized on the extinguishment of the liability. The fair value of the warrants issued was credited to equity.
Going concern
These consolidated financial statements have been prepared assuming the Group will continue as a going concern which contemplates the continuity of operations, realization of assets and the satisfaction of liabilities in the ordinary course of business.
As of August 30, 2024, the Group had cash and cash equivalents of CHF 15.1 million. Based on financial projections and available cash, the Group is expected to have sufficient resources to fund operations for at least the next twelve months.
- 7 -
Since its inception, the Group has primarily relied on external financing to fund its cash needs and has experienced recurring losses. The Group may continue to generate operating losses in the foreseeable future. The Group’s long-term viability depends on its ability to raise additional capital or to generate positive cash flows to support its operations. The Group may never achieve sustainable profitability and is exposed to all the risks inherent in establishing a business. Management intends to continue to explore options to obtain additional funding. However, there can be no assurance that capital will be available in sufficient amounts or on acceptable terms. If Relief is unable to obtain the required funding, it will be forced to delay, reduce or eliminate some or all of its research and development programs, which could adversely affect its business prospects or result in the Group’s inability to continue operations.
5. Segment information
5.1 Information on revenue
The disaggregation of the Group’s revenue is presented in the following table:
| TCHF | 01.01.-30.06.2024 | 01.01.-30.06.2023 | ||
|---|---|---|---|---|
| Revenue streams | ||||
| Royalties | 832 | 812 | ||
| Product sales | 2,668 | 2,042 | ||
| Licensing fees | 1,675 | — | ||
| Revenue from research and development services | 406 | 169 | ||
| Total revenue | **** | 5,581 | **** | 3,023 |
| Geographical area | ||||
| Switzerland | 730 | 237 | ||
| Europe (excluding Switzerland) | 1,544 | 1,319 | ||
| North America | 2,541 | 735 | ||
| Rest of the world | 766 | 732 | ||
| Total revenue | **** | 5,581 | **** | 3,023 |
| Timing of revenue recognition | ||||
| Point in time | 5,581 | 3,023 | ||
| Over time | — | — | ||
| Total revenue | **** | 5,581 | **** | 3,023 |
Effective March 21, 2024, Relief ceased direct commercialization of PKU GOLIKE in the United States and began generating revenue from supplying PKU GOLIKE to Eton and receiving sales royalties. As detailed in note 4, the Company recognized licensing income of TCHF 1,553 in the current reporting period.
5.2 Geographical location of non-current assets
| TCHF | June 30, 2024 | December 31, 2023 | ||
|---|---|---|---|---|
| Switzerland | 55,998 | 57,189 | ||
| Rest of the world | 96 | 193 | ||
| Total non-current assets * | **** | 56,094 | **** | 57,382 |
| * | Without financial assets and deferred tax assets | |||
| --- | --- |
- 8 -
6. Intangible assets
| TCHF | Technologies,patents and<br>trademarks | Licenses | In-processresearch and<br>development | Goodwill | Total | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Historical cost | |||||||||||||||
| January 1, 2023 | **** | 39,531 | **** | **** | 13,729 | **** | **** | 132,709 | **** | **** | 8,658 | **** | **** | 194,627 | **** |
| Acquisition price adjustment | — | — | (188 | ) | — | **** | (188 | ) | |||||||
| Divestment | — | (9,747 | ) | — | (455 | ) | **** | (10,202 | ) | ||||||
| December 31, 2023 | **** | 39,531 | **** | **** | 3,982 | **** | **** | 132,521 | **** | **** | 8,203 | **** | **** | 184,237 | **** |
| Addition | 86 | — | — | — | **** | 86 | **** | ||||||||
| June 30, 2024 | **** | 39,617 | **** | **** | 3,982 | **** | **** | 132,521 | **** | **** | 8,203 | **** | **** | 184,323 | **** |
| Accumulated amortization and impairment | |||||||||||||||
| January 1, 2023 | **** | (29,543 | ) | **** | — | **** | **** | (529 | ) | **** | (1,640 | ) | **** | (31,712 | ) |
| Amortization | (1,930 | ) | (752 | ) | — | — | **** | (2,682 | ) | ||||||
| Impairment | — | — | (89,878 | ) | (6,017 | ) | **** | (95,895 | ) | ||||||
| Divestment | — | 466 | — | — | **** | 466 | **** | ||||||||
| December 31, 2023 | **** | (31,473 | ) | **** | (286 | ) | **** | (90,407 | ) | **** | (7,657 | ) | **** | (129,823 | ) |
| Amortization | (965 | ) | (142 | ) | — | — | **** | (1,107 | ) | ||||||
| June 30, 2024 | **** | (32,438 | ) | **** | (428 | ) | **** | (90,407 | ) | **** | (7,657 | ) | **** | (130,930 | ) |
| Carrying amount per class | |||||||||||||||
| December 31, 2023 | 8,058 | 3,696 | 42,114 | 546 | 54,414 | ||||||||||
| June 30, 2024 | **** | 7,179 | **** | **** | 3,554 | **** | **** | 42,114 | **** | **** | 546 | **** | **** | 53,393 | **** |
| Carrying amount per asset | |||||||||||||||
| PKU Golike | 4,263 | — | — | — | **** | 4,263 | **** | ||||||||
| Diclofenac | 2,916 | — | — | 360 | **** | 3,276 | **** | ||||||||
| ACER-001 | — | 3,554 | — | 186 | **** | 3,740 | **** | ||||||||
| RLF-100 | — | — | 17,130 | — | **** | 17,130 | **** | ||||||||
| RLF-TD011 | — | — | 24,858 | — | **** | 24,858 | **** | ||||||||
| RLF-OD032 | — | — | 126 | — | **** | 126 | **** | ||||||||
| June 30, 2024 | **** | 7,179 | **** | **** | 3,554 | **** | **** | 42,114 | **** | **** | 546 | **** | **** | 53,393 | **** |
| PKU Golike | 4,344 | — | — | — | **** | 4,344 | **** | ||||||||
| Diclofenac | 3,714 | — | — | 360 | **** | 4,074 | **** | ||||||||
| ACER-001 | — | 3,696 | — | 186 | **** | 3,882 | **** | ||||||||
| RLF-100 | — | — | 17,130 | — | **** | 17,130 | **** | ||||||||
| RLF-TD011 | — | — | 24,858 | — | **** | 24,858 | **** | ||||||||
| RLF-OD032 | — | — | 126 | — | **** | 126 | **** | ||||||||
| December 31, 2023 | **** | 8,058 | **** | **** | 3,696 | **** | **** | 42,114 | **** | **** | 546 | **** | **** | 54,414 | **** |
Impairment test
Intangible assets with finite lives are amortized over their useful economic life and assessed for impairment whenever there is an indication that the intangible asset may be impaired. Intangible assets with indefinite useful lives are not amortized but are tested for impairment either individually or at the cash-generating unit level. The Group generally tests its intangible assets for impairment at the end of the year, or more frequently if events or changes in circumstances indicate that intangible assets may be impaired. As of June 30, 2024, the Group did not identify significant changes that would indicate the carrying value of its intangible assets and goodwill might exceed their respective carrying amounts. Consequently, no impairment test was conducted.
The completion of the development of in-process research and development assets is subject to the availability of capital, which is uncertain as discussed in note 4. If the Group is unable to secure sufficient capital, it will be forced to delay or abandon certain development activities, which could lead to a material impairment of the affected assets.
- 9 -
7. Leases
7.1 Right-of-use assets
| TCHF | Building | Equipment | Total | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Historical cost | |||||||||
| January 1, 2023 | **** | 2,529 | **** | **** | 686 | **** | **** | 3,215 | **** |
| Addition | 86 | 468 | **** | 554 | **** | ||||
| Disposal | (89 | ) | (46 | ) | **** | (135 | ) | ||
| Foreign exchange difference | (6 | ) | (2 | ) | **** | (8 | ) | ||
| December 31, 2023 | **** | 2,520 | **** | **** | 1,106 | **** | **** | 3,626 | **** |
| Addition | — | 136 | **** | 136 | **** | ||||
| Disposal | (98 | ) | (81 | ) | **** | (179 | ) | ||
| Foreign exchange difference | 13 | 1 | **** | 14 | **** | ||||
| June 30, 2024 | **** | 2,435 | **** | **** | 1,162 | **** | **** | 3,597 | **** |
| Accumulated depreciation | |||||||||
| January 1, 2023 | **** | (436 | ) | **** | (137 | ) | **** | (573 | ) |
| Depreciation | (285 | ) | (252 | ) | **** | (537 | ) | ||
| Disposal | 41 | 11 | **** | 52 | **** | ||||
| Foreign exchange difference | 1 | 1 | **** | 2 | **** | ||||
| December 31, 2023 | **** | (679 | ) | **** | (377 | ) | **** | (1,056 | ) |
| Depreciation | (131 | ) | (142 | ) | **** | (273 | ) | ||
| Disposal | 54 | 45 | **** | 99 | **** | ||||
| Foreign exchange difference | (4 | ) | — | **** | (4 | ) | |||
| June 30, 2024 | **** | (760 | ) | **** | (474 | ) | **** | (1,234 | ) |
| Carrying amount | |||||||||
| December 31, 2023 | 1,841 | 729 | 2,570 | ||||||
| June 30, 2024 | **** | 1,675 | **** | **** | 688 | **** | **** | 2,363 | **** |
7.2 Maturity of lease liabilities
| TCHF | June 30, 2024 | December 31, 2023 | ||
|---|---|---|---|---|
| < 1 year | 386 | 524 | ||
| 1-5 years | 1,891 | 1,824 | ||
| > 5 years | 128 | 262 | ||
| Total | **** | 2,405 | **** | 2,610 |
7.3 Amounts recognized in profit or loss
| TCHF | 01.01.-30.06.2024 | 01.01.-30.06.2023 | ||
|---|---|---|---|---|
| Lease expense for short-term and low value leases | 28 | 25 | ||
| Depreciation expense on<br>right-of-use assets (note 20) | 273 | 220 | ||
| Interest expense on lease liabilities (note 21) | 22 | 13 |
8. Inventories
| TCHF | June 30, 2024 | December 31, 2023 | ||||
|---|---|---|---|---|---|---|
| Raw material | 2,942 | 2,728 | ||||
| Finished goods | 140 | 656 | ||||
| Gross inventories | 3,082 | 3,384 | ||||
| Valuation allowance | (2,708 | ) | (2,827 | ) | ||
| Total | **** | 374 | **** | **** | 557 | **** |
- 10 -
9. Other current assets
| TCHF | June 30, 2024 | December 31, 2023 | ||
|---|---|---|---|---|
| Other receivables | 1,081 | 972 | ||
| Accrued revenue | 724 | 501 | ||
| Prepaid expenses | 668 | 345 | ||
| VAT receivable | 133 | 168 | ||
| Deposits | 4 | 9 | ||
| Other | 35 | 25 | ||
| Total | **** | 2,645 | **** | 2,020 |
10. Share capital
10.1 Issued share capital
As of June 30, 2024, and December 31, 2023, the share capital consisted of 14,040,837 issued, fully paid shares, including 1,500,398 shares in treasury. In the six-month period ended June 30, 2024, the Company reduced the nominal value of its share capital from CHF 4.00 to CHF 0.10 per share. The reduction proceeds, amounting to TCHF 54,759, were allocated to the share premium reserve.
10.2 Capital band
As of June 30, 2024, the Board of Directors was authorized, at any time until 25 April 2029, to increase the share capital by the issuance of up to 7,000,000 ordinary shares with a nominal value of CHF 0.10, under the terms and conditions set forth in Article 3a^ter^ of Relief’s Articles of Association.
10.3 Conditional share capital
The conditional share capital of the Company as of June 30, 2024, was TCHF 700, consisting of 7,000,000 shares with a par value of CHF 0.10 each, of which 1,000,000 shares to be used for stock options and 6,000,000 shares for grant of option rights in connection with bonds, notes or similar financial instruments issued by the Company.
10.4 Outstanding options and warrants
As of June 30, 2024, the Company had 403,242 outstanding stock options under its stock option plans and 4,850,000 outstanding warrants. Of these warrants, 1,500,000 represent the unexercised portion of warrants issued in a private placement in June 2023, with an exercise price of CHF 3.40 per share and exercisable until June 21, 2028. The remaining 3,350,000 warrants were issued in February 2024, as described in note 13. Each option and warrant entitle the holder to acquire one share at a predetermined price, subject to certain vesting conditions where applicable.
11. Defined benefit obligations
| TCHF | June 30, 2024 | December 31, 2023 | ||||
|---|---|---|---|---|---|---|
| Present value of pension benefit obligation | 3,953 | 4,517 | ||||
| Fair value of pension plan assets | (3,171 | ) | (3,532 | ) | ||
| Net pension defined benefit obligation | 782 | 985 | ||||
| Present value of other benefit obligations | 290 | 604 | ||||
| Total defined benefit obligations | **** | 1,072 | **** | **** | 1,589 | **** |
11.1 Defined benefit plan
The actuarial valuation of plan assets and the present value of the defined benefit obligation was conducted as of December 31, 2023. During the six-month period ended June 30, 2024, the Group significantly reduced the number of employees covered by the defined benefit plans. Consequently, a curtailment was recognized, resulting in a reduction of the net defined benefit obligation to TCHF 782 from TCHF 985 as of December 31, 2023.
The gain from the reduction in the present value of the net defined benefit obligation due to the curtailment, amounting to TCHF 169, has been recognized in the consolidated statement of loss under ‘Personnel expenses’ as past service cost (note 18).
11.2 Other employee benefits
The obligations for other employee benefits mainly consist of end of service indemnities, which do not have the character of pensions, and are classified as a defined benefit plan in accordance with IAS 19.
- 11 -
12. Provisions
| TCHF | Contingentconsideration (i) | Legal andregulatory (ii) | Other (iii) | Total | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Balance at December 31, 2023 | **** | 6,203 | **** | — | **** | 235 | **** | **** | 6,438 | **** |
| Unwinding of discount on provisions | 155 | — | — | 155 | ||||||
| Variation due to assumption adjustment | — | — | — | — | ||||||
| Foreign exchange difference | 107 | — | — | 107 | ||||||
| Utilization | — | — | (216 | ) | (216 | ) | ||||
| Unused amounts reversed | — | — | (19 | ) | (19 | ) | ||||
| Balance at June 30, 2024 | **** | 6,465 | **** | — | **** | — | **** | **** | 6,465 | **** |
(i) Contingent consideration for business acquisitions
As of June 30, 2024, the Group recognized provisions of TCHF 6,465 for contingent payments that may become due to the former shareholders of APR and AdVita upon completion of pre-agreed milestones.
(ii) Legal and regulatory proceedings
In the ordinary course of business, the Group is subject to potential liabilities arising from litigations and other disputes. As of June 30, 2024, there was no litigation considered to have a reasonably possible or probable impact that could result in a material loss to the Group.
(iii) Other
As of December 31, 2023, the Group had constituted provisions totaling TCHF 235 for remaining termination costs anticipated in connection with the transition from a direct marketing and sales infrastructure to a partnership-based model. As of June 30, 2024, the Group did not expect any additional material costs related to this transition.
13. Financial liabilities due to related parties
In January 2021, the Company signed a financing agreement with its largest shareholder, GEM Global Yield LLC SCS and GEM Yield Bahamas Limited (“GEM”), for the implementation of a share subscription facility (the “SSF”) in the amount of up to CHF 50 million until January 20, 2024. The Company agreed to pay GEM a commitment fee (the “Fee”) of TCHF 1,250 plus accrued interest. The Fee was payable on demand and bore interest at 1% above the base rate of Barclays Bank plc. As the obligation to pay the Fee arose with the execution of the agreement, the Company recorded it in full as a liability on the signature date. The corresponding expense was recognized as financial expense (note 21) over the SSF commitment period of three years ended January 20, 2024.
In February 2024, the Company renewed the SSF agreement with GEM for an additional three-year period ending January 20, 2027. As part of the renewal agreement, GEM agreed to forgive an outstanding liability of TCHF 1,368, constituted by the Fee and accrued interests as of the renewal date. In consideration of GEM’s capital commitment and this debt waiver, Relief issued GEM warrants to purchase up to 3,350,000 ordinary shares at a price of CHF 1.70 per share, exercisable from the issuance date, and expiring on January 20, 2027.
As of June 30, 2024, the Company had not drawn on the SSF.
14. Other current payables and liabilities
| TCHF | June 30, 2024 | December 31, 2023 | ||
|---|---|---|---|---|
| Accrued expenses | 1,587 | 1,736 | ||
| Personnel-related accruals and payables | 857 | 1,049 | ||
| Deferred revenue | 426 | 114 | ||
| Other current liabilities | 204 | 534 | ||
| Total | **** | 3,074 | **** | 3,433 |
- 12 -
15. Other gains
| TCHF | 01.01.-30.06.2024 | 01.01.-30.06.2023 | ||
|---|---|---|---|---|
| Income from sublease agreements | 51 | 50 | ||
| Other | 22 | 16 | ||
| Total other gains | **** | 73 | **** | 66 |
16. Cost of sales
Expenses incurred with third parties in relation to the purchase and manufacturing of drug products for sale, as well as laboratory supplies in connection with research and development services provided to customers, are classified in ‘raw materials and consumables expenses’. Expenses incurred with third parties in relation to advertising, marketing, sales promotion, shipping, distribution and commission on sales, are classified as ‘external selling and distribution expenses’.
The increase in ‘raw materials and consumables expenses’ correlates with the increase in revenue from product sales and contract services. A change in the product mix, with a lower proportion of sales stemming from higher-margin products, increased the ratio of raw materials and consumables expenses over product sales and contract services revenue.
External selling and distribution expenses decreased mainly due to scaled-back marketing activities for PKU GOLIKE following the Company’s decision to transition its commercial business model.
17. External research and developmentexpenses
External research and development expenses include costs associated with outsourced clinical research organization activities, sponsored research studies, clinical trial costs, process development, and product manufacturing expenses in relation to research and development programs.
During the six-month period ended June 30, 2024, external research and development expenses primarily consisted of costs associated with the clinical and drug product development of RLF-OD032 and RLF-TD011.
18. Personnel expenses
| TCHF | 01.01.-30.06.2024 | 01.01.-30.06.2023 | |||
|---|---|---|---|---|---|
| Salaries and social security expense | 3,579 | 5,735 | |||
| Share-based payment expense | 225 | 511 | |||
| Past service cost for pension obligations | (169 | ) | — | ||
| Service cost for other benefit obligations | (151 | ) | 13 | ||
| Total personnel expenses | **** | 3,484 | **** | **** | 6,259 |
During the six-month period ended June 30, 2024, the Company scaled back its commercial operations, which included a phased reduction in its sales and marketing workforce. Additionally, the Company undertook further reductions in its management and administrative personnel. As of June 30, 2024, Relief employed 36 full-time equivalents, a decrease from 49 full-time equivalents as of December 31, 2023.
These measures have resulted in a significant decrease in personnel expenses and a reduction in post-employment benefit obligations (note 11). The full financial impact of these reductions is expected to be realized in the second half of 2024.
19. Other administrative expenses
| TCHF | 01.01.-30.06.2024 | 01.01.-30.06.2023 | ||
|---|---|---|---|---|
| Professional services | 1,059 | 1,947 | ||
| Other administrative expenses | 958 | 1,515 | ||
| Total other administrative expenses | **** | 2,017 | **** | 3,462 |
The decrease in administrative expenses is primarily attributable to the Company’s efforts to streamline its expense base and the completion of certain non-recurring corporate projects from the comparative period.
- 13 -
20. Amortization and depreciation expense
| TCHF | 01.01.-30.06.2024 | 01.01.-30.06.2023 | ||
|---|---|---|---|---|
| Amortization of intangible assets (note 6) | 1,107 | 1,456 | ||
| Depreciation of<br>rights-of-use assets (note 7) | 273 | 220 | ||
| Depreciation of property and equipment | 58 | 28 | ||
| Total amortization and depreciation expense | **** | 1,438 | **** | 1,704 |
21. Financial income and expense
| TCHF | 01.01.-30.06.2024 | 01.01.-30.06.2023 | ||
|---|---|---|---|---|
| Interest income on cash deposits | 79 | — | ||
| Interest income on deferred payments | 43 | — | ||
| Foreign exchange gain, net | 78 | — | ||
| Total financial income | **** | 200 | **** | — |
| Unwinding of discount on provisions (note 12) | 155 | 171 | ||
| SSF commitment fee (note 13) | 23 | 207 | ||
| Interest expense related to leases | 22 | 13 | ||
| Bank charges | 6 | 17 | ||
| Foreign exchange loss, net | — | 323 | ||
| Other financial expenses | 13 | 59 | ||
| Total financial expense | **** | 219 | **** | 790 |
22. Income taxes
| TCHF | 01.01.-30.06.2024 | 01.01.-30.06.2023 | |||
|---|---|---|---|---|---|
| Current tax expense for the year | — | — | |||
| Deferred tax income recognized in the year | 29 | 7,643 | |||
| Write-down of deferred tax assets | (589 | ) | — | ||
| Net income tax (expense)/gain | **** | (560 | ) | **** | 7,643 |
In the current reporting period, income tax expenses primarily resulted from the write-down of deferred tax assets related to a foreign subsidiary. The winding down of this subsidiary’s operations was part of the Group’s strategic shift in its commercial activities.
In the six-month period ended June 30, 2023, the Company recognized an income tax gain primarily related to the amortization and impairment of intangible assets, which resulted in a corresponding reduction in the temporary difference between the carrying amount of these assets and their tax base.
23. Earnings per share
| 01.01.-30.06.2024 | 01.01.-30.06.2023 | |||||
|---|---|---|---|---|---|---|
| Loss attributable to shareholders (in TCHF) | (4,557 | ) | (56,499 | ) | ||
| Weighted average number of shares | 12,540,439 | 11,082,004 | ||||
| Total basic and diluted loss per share (in CHF) | **** | (0.363 | ) | **** | (5.098 | ) |
Basic and diluted results per share are calculated by dividing the net result attributable to the shareholders of the Group’s parent company by the weighted average of shares outstanding during the period.
Neither outstanding options and warrants nor effects from the contingent liabilities payable in shares have been considered in the diluted loss calculation as their effect is anti-dilutive.
- 14 -
24. Related party transactions
24.1 Related party transactions
During the six-month period ended June 30, 2024, the Company did not engage in any related party transactions, except for compensation provided to its management and the renewal of its SSF agreement with GEM (note 13).
24.2 Related party balances
As of June 30, 2024, the Company had no outstanding balances payable to or receivable from related parties.
25. Contingent liabilities
25.1 Business combinations with APR and AdVita
The acquisition agreements for APR and AdVita provide for remaining contingent payment obligations in the aggregate maximum amounts of CHF 28 million and EUR 10 million (CHF 9.6 million), respectively, payable upon achievement of pre-agreed objectives. As of June 30, 2024, a provision totaling CHF 6.5 million (December 31, 2023: CHF 6.2 million) was recognized to account for the probability-weighted present value at the balance sheet date of these possible future payments (note 12).
25.2 Acquisition of RLF-OD032
Pursuant to the agreement concluded with Meta Healthcare Ltd. for the acquisition of RLF-OD032 in July 2022, Relief may issue additional payments of approximately TCHF 250 contingent on pre-specified development milestones. Relief committed to paying Meta Healthcare Ltd. royalties on possible future net commercialization profit from RLF-OD032 of a low double-digit percentage.
25.3 License agreement with Acer
Pursuant to the license agreement concluded with Acer in August 2023, Relief shall pay Acer a variable, continuing royalty up to a maximum of 10% of potential future net sales of OLPRUVA^®^ in Europe and 20% of any value received by Relief from sublicensing transactions relating to OLPRUVA^®^.
25.4 Settlement agreement with NRx Pharmaceuticals
Pursuant to the settlement and asset purchase agreements concluded with NRx Pharmaceuticals, Inc. (“NRx”) in November 2022, Relief committed to paying NRx up to USD 13 million (CHF 11.7 million) in aggregate as milestone payments upon marketing approval of an Aviptadil product. Additionally, Relief has agreed to pay single-digit percentage royalties on potential future sales of an Aviptadil product, up to a maximum of USD 30 million (CHF 27.0 million) in aggregate.
26. Events after the reporting period
Sale of royalty interests to SWK
On August 2, 2024, the Company entered into a definitive agreement with SWK Funding LLC (“SWK”) for the sale of royalty interests in OLPRUVA^®^, GOLIKE^®^ and CAMBIA^®^. Relief received USD 5.75 million (CHF 5 million) from SWK and may receive an additional USD 5.25 million (CHF 4.6 million) contingent on the achievement of near-term milestones.
Under the terms of the agreement, SWK acquired all future OLPRUVA royalties from Relief’s August 2023 agreement with Acer and all future royalties and milestone payments from the March 2024 license agreement with Eton. SWK will return to Relief 80% of OLPRUVA royalties exceeding USD 2.25 million annually and all royalties exceeding USD 4.5 million. For GOLIKE, SWK will return 80% of GOLIKE royalties exceeding USD 1.32 million annually and all royalties exceeding USD 1.98 million. Additionally, SWK acquired all future royalties from CAMBIA, which represented CHF 0.17 million in net royalty income in the six-month period ended June 30, 2024.
The agreement will terminate, and all royalties will revert to Relief once SWK has received 2.75 times its invested capital.
There were no other material events after the balance sheet date that would require adjustment to these consolidated financial statements or disclosure under this heading.
- 15 -
EX-99.3
Exhibit 99.3
Ad hoc announcement pursuant to Art. 53 LR
Relief Therapeutics Reports Half-Year 2024 Financial Results and Provides Corporate Update
| • | RLF-TD011 investigator-initiated trial results for EB wound treatment<br>anticipated in the coming weeks |
|---|---|
| • | RLF-OD032 pilot PK study progresses with potential NDA filing by mid- to late 2025 |
| --- | --- |
| • | Streamlined operations and CHF 15.1 million cash reserves expected to provide funding into at least 2026<br> |
| --- | --- |
GENEVA (AUG. 30, 2024) – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today reported its financial results for the half-year ended June 30, 2024, and provided a corporate update.
Relief provided updates on its key development programs and strategic initiatives, including RLF-TD011, a hypochlorous acid topical spray designed for the treatment of epidermolysis bullosa (EB), and RLF-OD032, a novel liquid formulation of sapropterin dihydrochloride for the management of phenylketonuria (PKU).
The Company reported significant financial improvements in the first half of 2024, with revenue up 85% and operating expenses down 45%, driven by strategic realignment and cost-reduction initiatives. Investments in R&D, however, were stable. Remaining debt-free, the Company expects its cash reserves of CHF 15.1 million as of August 30, 2024, and projected revenue to fund operations into at least 2026.
The Relief 2024 half-year report is available on the Company’s website.
ABOUT RELIEF
Relief is a commercial-stage biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety, and convenience to benefit the lives of patients living with select specialty and rare diseases. Relief’s portfolio offers a balanced mix of marketed, revenue-generating products, proprietary, globally patented TEHCLO^™^ and Physiomimic^™^ platform technologies and a targeted clinical development pipeline consisting of risk-mitigated assets focused in three core therapeutic areas: rare skin diseases, rare metabolic disorders, and rare respiratory diseases. In addition, Relief is commercializing several legacy products via licensing and distribution partners. Headquartered in Geneva, Relief is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com.
1 / 2
CONTACT:
RELIEF THERAPEUTICS Holding SA
Jeremy Meinen
Chief Financial Officer
contact@relieftherapeutics.com
DISCLAIMER
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, including its ability to achieve its corporate, development and commercial goals, and other factors which could cause the actual results, financial condition, performance or achievements of Relief to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. A number of factors, including those described in Relief’s filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission (SEC), could adversely affect Relief. Copies of Relief’s filings with the SEC are available on the SEC EDGAR database at www.sec.gov. Relief does not undertake any obligation to update the information contained herein, which speaks only as of this date.
2 / 2