MoonLake Immunotherapeutics
For the period ended Dec 31, 2023. Filed Feb 29, 2024.
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FY2023 · Filed Feb 29, 2024
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Notes to Consolidated Financial Statements
Note 1 —Overview of the Company
Corporate Information
MoonLake Immunotherapeutics is a clinical stage biotechnology company advancing therapies to address significant unmet needs in inflammatory skin and joint diseases. MoonLake Immunotherapeutics is currently a single asset company focused on the development of Sonelokimab (“SLK”), a novel tri-specific IL-17A and IL-17F inhibiting Nanobody that has the potential, based on response levels seen in clinical trials, to drive disease modification in dermatology and rheumatology patients.
Unless the context otherwise requires, “MoonLake”, and the “Company” refer to the combined company following the Business Combination (as defined in Note 2— Business Combination Agreement with Helix and Recapitalization), together with its subsidiaries.
Note 2 —Business Combination Agreement with Helix and Recapitalization
On April 5, 2022 (the “Closing Date”), MoonLake Immunotherapeutics, a Cayman Islands exempted company (formerly known as Helix Acquisition Corp.) (prior to the Closing Date, “Helix” and after the Closing Date, “MoonLake” or the “Company”) consummated the previously announced business combination (the “Closing”) pursuant to that certain Business Combination Agreement dated October 4, 2021 (the “Business Combination Agreement”), by and among Helix, MoonLake Immunotherapeutics AG, a Swiss stock corporation (Aktiengesellschaft) registered with the commercial register of the Canton of Zug, Switzerland under the number CHE-433.093.536 (“MoonLake AG”), the existing equityholders of MoonLake AG set forth on the signature pages to the Business Combination Agreement and the equityholders of MoonLake AG that executed joinders to the Business Combination Agreement (collectively, the “ML Parties”), Helix Holdings LLC, a Cayman Islands limited liability company and the sponsor of Helix (the “Sponsor”), and the representative of the ML Parties (such transactions contemplated by the Business Combination Agreement collectively, the “Business Combination”). Net proceeds from the Business Combination totaled $134.7 million, which included funds held in Helix’s trust account and the completion of a concurrent PIPE investment.
Pursuant to the Business Combination Agreement, approved by the boards of directors of each of MoonLake AG and Helix, (i) the Company changed its name from Helix Acquisition Corp. to MoonLake Immunotherapeutics, and (ii) MoonLake AG merged with and into MoonLake, with MoonLake AG as the surviving company in the Business Combination and, after giving effect to such Business Combination, MoonLake AG as a subsidiary of MoonLake.
The Business Combination Agreement provided for, among other things, the following transactions:
i. Two business days prior to the Closing Date, the ML Parties and MoonLake AG effectuated a restructuring of MoonLake AG’s share capital to, among other things, (x) convert the Series A preferred shares of MoonLake AG, par value of CHF 0.10 per share, into an equal number of MoonLake AG Common Shares such that the ML Parties held a single class of capital share of MoonLake AG immediately prior to the Closing and (y) approve a capital increase for the issuance of 4,006,736 Class V Voting Shares of MoonLake AG, par value CHF 0.01 per share, to Helix, each Class V Voting Share due to its lower par value havingten times the voting power of a MoonLake AG Common Share (the “Restructuring”).
ii. At the Closing,2,875,000 Class B ordinary shares of Helix, par value $0.0001 per share (the “Class B Ordinary Shares”), constituting all of the then-outstanding Class B Ordinary Shares, were automatically converted into Class A Ordinary Shares on aone-for-one basis.
iii. At the Closing, Helix amended and restated its existing memorandum and articles of association to, among other things, establish a share structure consisting of the Class A Ordinary Shares, which carry economic and voting rights, and Class C Ordinary Shares, which carry voting rights but no economic rights.
iv. On the Closing Date, Helix paid all unpaid transaction expenses and contributed $134.7 million to MoonLake AG, including $15.0 million loan repayment pursuant to a convertible loan agreement dated March 20, 2022, by and between MoonLake AG and Cormorant Asset Management LP (“Cormorant”), and assigned by Cormorant to Helix on March 31, 2022.
v. On the Closing Date, following the Restructuring, Biotechnology Value Fund, L.P., Biotechnology Value Fund II, L.P., and Biotechnology Value Trading Fund OS, L.P. (collectively, the “BVF Shareholders”) assigned all of their MoonLake AG Common Shares to Helix and Helix issued to the BVF Shareholders 18,501,284 Class A Ordinary Shares.
vi. On the Closing Date, following the Restructuring, Helix issued 15,775,472 Class C Ordinary Shares to the ML Parties (other than the BVF Shareholders). Please refer to Note 12 — Shareholders’ Equity (Deficit) for additional details on the exchange mechanism adopted.
Additionally, on the Closing Date, Helix issued to the PIPE Investors (as defined below in the section entitled “PIPE Financing”) an aggregate of 11,700,000 Class A Ordinary Shares.
As of the open of trading on April 6, 2022, the Class A Ordinary Shares, formerly those of Helix, began trading on The Nasdaq Capital Market (“Nasdaq”) under the trading symbol “MLTX”.
PIPE Financing
On October 4, 2021, concurrently with the execution of the Business Combination Agreement, and subsequently on March 31, 2022 and April 4, 2022, Helix entered into subscription agreements with certain investors (collectively, the “PIPE Investors”, which includes affiliates of the Sponsor and certain existing equityholders of MoonLake AG) pursuant to which, and on the terms and subject to the conditions of which, the PIPE Investors have collectively subscribed for 11,700,000 Class A Ordinary Shares,11,600,000 shares of which were issued at a price of $10.00 per share for gross proceeds of $116.0 million and 100,000 shares of which were issued to placement agents of the PIPE in satisfaction of an aggregate of $1.0 million of fees owed by Helix to such placement agents.
Summary of Net Proceeds
The following table summarizes the elements of the net proceeds from the Business Combination:
| in thousands | |
|---|---|
| Investments held in Trust Account | $115,051 |
| Less cash to cover redemptions of the Class A Ordinary Shares issued by Helix prior to the Closing Date | (80,842) |
| Plus PIPE investment | 116,000 |
| Less Helix transaction expense | (15,520) |
| of which accrued expenses | (5,798) |
| of which deferred IPO underwriting fee | (4,025) |
| of which other transaction expenses | (5,697) |
| Available Closing Date Cash | $134,689 |
Summary of Ordinary Shares Issued
The following table summarizes the number of Ordinary Shares outstanding immediately following the consummation of the Business Combination:
| Helix Acquisition Corp. Ordinary Shares prior to the Business Combination | 14,805,000 |
|---|---|
| Of which Class A Ordinary Shares (Helix management - IPO private placement shares) | 430,000 |
| Of which Class A Ordinary Shares redeemable | 11,500,000 |
| Of which Class B Ordinary Shares (Helix management - sponsor promote) | 2,875,000 |
|---|---|
| Less redemptions of the Class A Ordinary Shares issued by Helix prior to the Closing Date | (8,080,645) |
| Plus issuance of Helix Class A Ordinary Shares to PIPE Investors | 11,700,000 |
| Plus issuance of Helix Class A Ordinary Shares to BVF Shareholders | 18,501,284 |
| Total MoonLake Class A Ordinary Shares Outstanding at Closing | 36,925,639 |
| Plus issuance of Helix Class C Ordinary Shares to ML Parties (other than the BVF Shareholders) | 15,775,472 |
| Total MoonLake Class A and Class C Ordinary Shares Outstanding at Closing | 52,701,111 |
Further information about the Business Combination can be found on Form S-1/A filed with the SEC on July 26, 2022, declared effective on August 2, 2022 and to the exhibits included therein, available at www.sec.gov.
Note 3 —Basis of Presentation and Significant Accounting Policies
Basis of Presentation
The accompanying consolidated financial statements include those of the Company and its subsidiaries, MoonLake Immunotherapeutics AG, a Swiss stock corporation (Aktiengesellschaft) registered with the commercial register of the Canton of Zug, Switzerland under the number CHE-433.093.536 (“MoonLake AG”), MoonLake Immunotherapeutics Ltd., a private limited company incorporated in the United Kingdom, and MNLK Immunotherapeutics, Unipessoal Lda ("MNLK PT"), a private limited company incorporated in Portugal, after elimination of all intercompany accounts and transactions. The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board ("FASB").
Pursuant to ASC 805, for financial accounting and reporting purposes, MoonLake AG was deemed the accounting acquirer and Helix was treated as the accounting acquiree, and the Business Combination was accounted for as a reverse recapitalization. Accordingly, the Business Combination was treated as the equivalent of MoonLake AG issuing shares for the net assets of Helix, accompanied by a recapitalization. The net assets of Helix were stated at historical costs, with no goodwill or other intangible assets recorded, and are consolidated with MoonLake AG’s financial statements on the Closing Date.
In accordance with the Business Combination Agreement, the ML Parties received 33.638698 Ordinary Shares in the Company for every MoonLake AG Common Share or Series A Preferred Share (the “Exchange Ratio”). The BVF Shareholders received 18,501,284 Class A Ordinary Shares whereas the rest of the ML Parties (excluding the BVF Shareholders) received 15,775,472 Class C Ordinary Shares which can be converted into Class A Ordinary Shares at the discretion of the shareholder (refer to Note 12 — Shareholders’ Equity (Deficit) for further details on the classes of ordinary shares). The number of shares, and the number of shares within the net income (loss) per share held by the ML Parties in MoonLake AG prior to the Business Combination have been adjusted by the Exchange Ratio to reflect the equivalent number of ordinary shares in the Company (identified as “the equivalent of” throughout these consolidated financial statements).
Certain MoonLake AG shareholders (ML Parties other than the BVF Shareholders), did not exchange their shares in MoonLake AG for Class A Ordinary Shares in the Company and therefore continued to hold an economic interest in MoonLake AG and Class C Ordinary Shares in the Company. The Company recognized a noncontrolling interest equal to the ML Parties’ (other than the BVF Shareholders) proportionate interest in the net assets of MoonLake AG.
All amounts are presented in U.S. Dollar (“$”), unless otherwise indicated. The term “Swiss franc” and “CHF” refer to the legal currency of Switzerland, "GBP" refers to the legal currency of the United Kingdom, and “€” refers to euros.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires the Company to make judgments, estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses. The significant judgments, estimates and assumptions relevant to the Company relate to:
determining whether the in-process research and development expenditure (“IPR&D”) has an alternative future use;
determining assumptions used in estimating the fair value of share-based compensation;
estimating the recoverability of the deferred tax asset; and
estimating the amount of accruals in connection with the completion of clinical trial milestones.
The Company bases its judgments and estimates on various factors and information, which may include, but are not limited to, the Company’s forecasts and future plans, current economic conditions and observable market-based transactions of its own shares, the results of which form the basis for making judgments about the carrying value of assets and liabilities and recorded amounts of expenses that are not readily apparent from other sources. To the extent there are material differences between the Company’s estimates and the actual results, the Company’s future results of operation may be affected.
Cash and Cash Equivalents
The Company considers all highly liquid investments with an original maturity of three months or less at the date of purchase to be cash equivalents. Cash and cash equivalents are recorded at cost, which approximates fair value. As of December 31, 2023, the Company considers $129.4 million of short-term marketable debt securities in the form of eurocommercial papers and certificates of deposit to be cash equivalents. As of December 31, 2022, the Company considered $19.9 million of short-term marketable debt securities in the form of eurocommercial papers and certificates of deposit to be cash equivalents.
Marketable securities and short-term investments
The Company invests in short-term marketable securities in the form of debt securities. At the time of purchase, the Company assesses whether such debt security should be classified as held-to-maturity or available-for-sale debt securities.
Debt securities are classified as held-to-maturity when the Company has the positive intent and ability to hold the securities to maturity. Held-to-maturity debt securities are carried at amortized cost, adjusted for accretion of discounts or amortization of premiums to maturity computed under the effective interest method. Such accretion or amortization is included in “Interest and dividend income”. Marketable debt securities not classified as held-to-maturity are classified as available-for-sale and reported at fair value.
Net unrealized gains and losses on available-for-sale debt securities are excluded from the determination of earnings and are instead recognized in the “Accumulated other comprehensive income (loss)” component of shareholders’ equity (deficit) until realized. Realized gains and losses on available-for-sale debt securities are computed based upon the historical cost of these securities, using the specific identification method.
A decline in the fair value of any security below cost that is deemed other than temporary results in a charge to earnings and the corresponding establishment of a new cost basis for the security. Dividend and interest income are recognized when earned. Realized gains and losses are included in "Other income" and the cost of securities sold is determined using the specific-identification method.
Marketable debt securities are classified as either “Cash and cash equivalents” or “Short‑term marketable debt securities” according to their original maturity at the time of acquisition. Changes in unrealized gains and losses pertaining to cash equivalent securities are added back into the consolidated statement of cash flows as those are excluded from the determination of earnings but impact the cash and cash equivalents position.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to concentration of credit risk consist of cash accounts in large financial institutions which, at times, may exceed the CHF 100,000 deposit protection limit in Switzerland, the $250,000 Federal Deposit Insurance Corporation deposit insurance coverage limit in the United States, the GBP 85,000 Financial Services Compensation Scheme deposit protection limit in the United Kingdom, or the €100,000 Fundo de Garantia de Depósitos deposit protection limit in Portugal. The Company believes it is not exposed to significant credit risk due to the financial strength of the depository institutions in which the cash and cash equivalents are held. Additionally, the Company ensures further protection against credit risk by diversifying its cash holdings across a variety of credit institutions, thereby minimizing the potential impact of any adverse events on a single institution. Further, the Company's investment strategy for cash (in excess of current business requirements) is set to invest in short-term marketable debt securities. Management actively monitors credit risk in the investment portfolio. Credit risk exposures are controlled in accordance with policies approved by the board of directors to identify, measure, monitor and control credit risks.
Fair Value Measurements
The Company follows the guidance included in ASC 820, Fair Value Measurement. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.
There are three levels of inputs to fair value measurements:
Level 1, meaning the use of quoted prices for identical instruments in active markets;
Level 2, meaning the use of quoted prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active or are directly or indirectly observable; and
Level 3, meaning the use of unobservable inputs. Observable market data is used when available.
Transfers between Levels 1, 2 or 3 within the fair value hierarchy are recognized at the end of the reporting period when the respective transaction occurred.
Segment Information
The Company operates as a single operating segment. The Company’s chief operating decision maker, its Chief Executive Officer, manages the Company’s operations on a stand-alone basis for the purposes of allocating resources, and assessing financial performance.
Property and Equipment
Property and equipment, net is stated at cost, net of accumulated depreciation. Depreciation is computed using the straight-line method based on the estimated useful lives ofthree tofive years. As of December 31, 2023, property and equipment, net relates to information technology, office equipment, and leasehold improvements.
Research and Development Contract Costs and Accruals
Research and development expenses include employee payroll, consulting, contract research and contract manufacturing costs attributable to research and development activities and are expensed as incurred.
Upfront payments and milestone payments made for the licensing of technology are expensed as research and development expenses in the period in which it is probable that a liability has been incurred. Advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed.
The Company has entered into various research and development contracts with companies both inside and outside of the United States. These agreements are generally cancellable, and related payments are recorded as research and development expenses as incurred. The Company records accruals for estimated ongoing research costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies or trials, including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates. The Company’s historical accrual estimates have not been materially different from the actual costs.
Share-Based Transaction
Goods or services received in a share-based payment transaction are measured using a fair value-based measure.
Stock-Based Compensation
The Company recognizes compensation expense based on estimated fair values for all stock-based payment awards made to eligible employees, members of the board of directors and independent contractors that are expected to vest.
The valuation of stock option awards is determined at the date of grant using the Black-Scholes option pricing model. The Black-Scholes option pricing model requires the Company to make assumptions and judgements about the inputs used in the calculations, such as the fair value of the common stock, expected term, expected volatility of the Company’s common stock, risk-free interest rate and expected dividend yield. The valuation of restricted stock awards is measured by the fair value of the Company’s common stock on the date of the grant.
For all stock options granted, the Company calculated the expected term as the period that share-based awards are expected to be outstanding. The estimate of expected volatility is based on comparative companies’ volatility within the Company's industry. The risk-free rate is based on the yield available on United States Treasury zero-coupon issues corresponding to the expected term of the award.
The fair value of the common stock granted under the ESPP (as defined below) has historically been estimated by management with reference to the market-based transaction with the other Series A Preferred Shares Investors, as there was no public market for the common stock.
Share-based payment arrangements are accounted for under the fair value method. Total compensation is measured at grant date, based on the fair value of the award at that date, and recorded in earnings over the period the employees are required to render service. The Company recognizes compensation cost only for those awards expected to meet the service conditions on a straight-line basis over the requisite service period of the award.
Foreign Currency
The functional currency of the Company and its subsidiaries is the U.S. dollar. Balances and transactions denominated in foreign currencies are converted as follows: monetary assets and liabilities are translated using exchange rates in effect at the balance sheet dates and non-monetary assets and liabilities are translated at historical exchange rates. Revenue and expenses are translated at the daily exchange rate on the respective accounting date.
Gains or losses from foreign currency translation are included in the consolidated statement of operations in "other income, net". The Company recognized foreign currency transaction gain of $151,493 for the year ended December 31, 2023 and a foreign currency transaction gain of $325,317 for the year ended December 31, 2022.
Income Taxes
The Company accounts for income taxes by using the asset and liability method of accounting for income taxes. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. A valuation allowance is recorded to the extent it is more likely than not that all or a portion of the Company's deferred tax assets will not be realized. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date.
Net Loss per Class A Ordinary Shares
Basic net loss per Class A Ordinary Share is calculated using the two-class method under which earnings are allocated to both Class A Ordinary Shares and participating securities. Basic net loss per share is calculated by dividing the net loss attributable to Class A Ordinary Shares by the weighted-average number of Class A Ordinary Shares outstanding for the period. The diluted net loss per Class A Ordinary Share is computed by dividing the net loss using the weighted-average number of Class A Ordinary Shares and, if dilutive, potential Class A Ordinary Shares outstanding during the period.
In periods in which the Company reports a net loss attributable to shareholders of Class A Ordinary Shares, diluted net loss per share attributable to shareholders of Class A Ordinary Shares is the same as basic net loss per share attributable to shareholders of Class A Ordinary Shares, since dilutive Class A Ordinary Shares are not assumed to be outstanding if their effect is anti-dilutive.
Acquisitions
The Company evaluates acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first assessing whether substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. On April 29, 2021, MoonLake AG entered into an in-licensing agreement (the “In-License Agreement”) with Merck Healthcare KGaA, Darmstadt, Germany (“MHKDG”) to acquire the Sonelokimab program (the “SLK Program”) and determined that substantially all of the fair value of the gross assets acquired related to IPR&D of SLK. Therefore, this transaction was accounted for as an asset acquisition.
IPR&D represents incomplete technologies that the Company acquires, which at the time of acquisition, are still under development and have no alternative future use. The fair value of such technologies is expensed upon acquisition. A technology is considered to have an alternative future use if it is probable that the Company will use the asset in its current, incomplete state as it existed at the acquisition date, in another research and development project that has not yet commenced, and economic benefit is anticipated from that use. If a technology is determined to have an alternative future use, then the fair value of the program would be recorded as an asset on the balance sheet rather than expensed.
Contingent consideration payments (for example milestone payments due upon the occurrence of a specific event) in asset acquisitions are recognized in the period in which it is probable that a liability has been incurred (unless the contingent consideration meets the definition of a derivative, in which case the amount becomes part of the cost in the asset acquired). Upon recognition of the contingent consideration payment, the amount is expensed if it relates to IPR&D or capitalized if it relates to a developed product which is generally considered to be when clinical trials have been completed and regulatory approval obtained.
Future royalty payments due on net sales will be recognized in cost of goods sold when net sales are recognized.
Pension Accounting
The Company accounts for pension assets and liabilities in accordance with ASC 715, Compensation – Retirement Benefits, which requires the recognition of the funded status of pension plans in the Company’s consolidated balance sheet. The liability in respect to defined benefit pension plans is the projected benefit obligation calculated annually by independent actuaries using the projected unit credit method. The projected benefit obligation as of December 31, 2023 represents the actuarial present value of the estimated future payments required to settle the obligation that is attributable to employee services rendered before that date. Service costs for such pension plans, represented in the net periodic pension benefit cost, are included in the personnel expenses of the various functions where the employees are engaged. The other components of net benefit cost are included in the consolidated statement of operations separately from the service cost component, in “other income (expenses), net.” Plan assets are recorded at their fair value.
Gains or losses arising from plan curtailments or settlements are accounted for at the time they occur. Any net pension asset is limited to the present value of the future economic benefits available to the Company in the form of refunds from the plan or expected reductions in future contributions to the plan. Actuarial gains and losses arising from differences between the actual and the expected return on plan assets are recognized in accumulated other comprehensive income (loss).
Leases
The Company determines if an arrangement is or contains a lease at contract inception. For these arrangements, it is evaluated if the arrangement involves an identified asset that is physically distinct or whether the Company has the right to substantially all of the capacity of an identified asset that is not physically distinct. In arrangements that involve an identified asset, there is also judgment in evaluating if the Company has the right to direct the use of that asset.
MoonLake does not have any finance leases. As of December 31, 2023, the Company hasthree operating leases related to the office spaces which are located in (i) Dorfstrasse 29, 6300, Zug, Switzerland, (ii) 95 Regent Street, CB2 1AW, Cambridge, England, United Kingdom, and (iii) Rua Manuel Pinto de Azedevo 860, 4150-335, Porto, Portugal. The operating leases are recognized over a straight-line basis over the lease term commencing on the date the Company has the right to use the leased property. Right-of-Use (“RoU”) assets and lease liabilities are measured at the lease commencement date based on the present value of the remaining lease payments over the lease term, determined using the discount rate for the lease at the commencement date. Because the rate implicit in the leases is not readily determinable, the Company uses the incremental borrowing rate as the discount rate, which approximates the interest rate at which the Company could borrow on a collateralized basis with similar terms and payments and in similar economic environments.
Leases with an initial term of 12 months or less and that do not have the option to purchase the underlying asset are not recorded on the balance sheet, with lease expense for these leases recognized on a straight-line basis over the lease term commencing on the date the Company has the right to use the leased property.
Recently Adopted Accounting Pronouncements
In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-13, Financial Instruments — Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which amends guidance on reporting credit losses for assets held at amortized cost basis and available-for-sale debt securities. The FASB also issued subsequent amendments to the initial guidance, ASU 2019-04, ASU 2019-05, ASU 2019-11, and ASU 2020-03 (collectively, “Topic 326”). The Current Expected Credit Losses model requires a company to estimate credit losses expected over the life of the financial assets based on historical experience, current conditions and reasonable and supportable forecasts. The Company adopted this new guidance as of December 31, 2023 upon the loss of its “emerging growth company” status. The adoption did not have a material impact on the balances reported in the Company’s consolidated financial statements.
In November 2023, the FASB issued ASU 2023-07, Segment reporting — Improvements to Reportable Segment Disclosures, which amends guidance on reportable segment disclosure requirements. It is effective for fiscal years beginning after December 15, 2023. The Company is currently evaluating the impact. The early adoption option will not be exercised.
In December 2023, the FASB issued ASU 2023-09, Income taxes -Improvements to Income Taxes Disclosure, which amends guidance on to enhance the transparency and decision usefulness of income tax disclosures. It is effective for fiscal years beginning after December 15, 2024. The Company is currently evaluating the impact. The early adoption option will not be exercised.
Large Accelerated Filer Status
As of December 31, 2023, the Company is considered a “large accelerated filer” and no longer qualifies as an emerging growth company or smaller reporting company. The Company is required, pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002, to include in its Annual Report on Form 10-K for the year ended December 31, 2023 an attestation report as to the effectiveness of the Company's internal control over financial reporting that is issued by its independent registered public accounting firm. In addition, beginning with the Company's Quarterly Report on Form 10-Q for the quarter ending March 31, 2024, it will no longer be permitted to take advantage of the reduced reporting requirements applicable to smaller reporting companies.
Note 4— Risks and Liquidity
Going Concern, Liquidity and Capital Resources
The Company incurred a loss of $44.1 million for the year ended December 31, 2023. As of December 31, 2023, the Company’s current assets exceeded its current liabilities by $504.2 million.
As of December 31, 2023, the Company had $451.2 million of cash and cash equivalents. Based on the Company's current operating plan, management believes that the Company has sufficient capital to fund its operations and capital expenditures until the end of 2026.
Note 5—Fair Value Measurements
The following table presents information about the Company's short-term marketable debt securities measured at fair value on a recurring basis and indicate the level in the fair value hierarchy in which the Company classifies the fair value measurement:
| December 31, 2023 | December 31, 2022 | |||
|---|---|---|---|---|
| Level 2 | Total | Level 2 | Total | |
| Eurocommercial Papers | $109,608,915 | $109,608,915 | $42,552,608 | $42,552,608 |
| Certificates of deposit | 79,626,727 | 79,626,727 | 9,937,899 | 9,937,899 |
| Total | $189,235,642 | $189,235,642 | $52,490,507 | $52,490,507 |
Cash, accounts payable and accrued liabilities approximate their fair values as of December 31, 2023 and December 31, 2022, due to their short-term nature. Pension plan assets fair value is determined based on Level 2 inputs.
Note 6— Investments
The fair value and amortized cost of investments in short-term marketable debt securities by major security type as of December 31, 2023 and December 31, 2022 are as follows:
| Amortized cost | Gross unrealized gains | Gross unrealized losses | Fair value | |
|---|---|---|---|---|
| Eurocommercial Papers | $107,624,341 | $1,984,574 | $— | $109,608,915 |
| Certificates of Deposit | 78,890,447 | 736,280 | — | 79,626,727 |
| Total | $186,514,788 | $2,720,854 | $— | $189,235,642 |
| Of which classified within cash and cash equivalents | 128,197,581 | 1,199,161 | — | 129,396,742 |
| Of which classified within short-term marketable debt securities | 58,317,207 | 1,521,693 | — | 59,838,900 |
| Amortized cost | Gross unrealized gains | Gross unrealized losses | Fair value | |
|---|---|---|---|---|
| Eurocommercial Papers | $42,265,129 | $287,479 | $— | $42,552,608 |
| Certificates of Deposit | 9,834,625 | 103,274 | — | 9,937,899 |
| Total | $52,099,754 | $390,753 | $— | $52,490,507 |
| Of which classified within cash and cash equivalents | 19,775,171 | 106,228 | — | 19,881,399 |
| Of which classified within short-term marketable debt securities | 32,324,583 | 284,525 | — | 32,609,108 |
The following table presents the changes in fair values of the Company’s short-term marketable debt securities, classified as Level 2 financial assets, and recognized in accumulated other comprehensive income:
| Beginning balance, January 1, 2023 | $390,753 |
|---|---|
| Other comprehensive income before reclassifications | 8,751,307 |
| Amounts reclassified from accumulated other comprehensive income | (6,421,206) |
| Ending balance, December 31, 2023 | $2,720,854 |
As of December 31, 2023, the Company’s marketable debt securities maturities are all due within one year.
Note 7 —Prepaid Expenses
| Prepaid expenses - current | December 31, 2023 | December 31, 2022 |
|---|---|---|
| Insurances | $1,077,478 | $1,416,597 |
| Non-clinical research and clinical development services | 842,729 | 2,443,863 |
| Other consulting and advisory services | 70,018 | 105,651 |
| Other prepayments | 111,978 | 213,357 |
| Total | $2,102,203 | $4,179,468 |
| Prepaid expenses - non-current | December 31, 2023 | December 31, 2022 |
|---|---|---|
| Supply and manufacturing services | $8,423,468 | $— |
| Total | $8,423,468 | $— |
Prepaid expenses - non-current relate to advance payments made to a contract manufacturing organization pursuant to a manufacturing run reservation agreement for the commercial-scale manufacturing of Sonelokimab in 2025.
Note 8 —Trade and Other Payables
| December 31, 2023 | December 31, 2022 | |
|---|---|---|
| Research and development services | $911,454 | $31,687 |
| Supply and manufacturing fees payable | 553,459 | 65,979 |
| Rent / leases | 108,249 | — |
| Other payables | 264,522 | 157,306 |
| Total | $1,837,684 | $254,972 |
Note 9 —Accrued Expenses and Other Current Liabilities
| December 31, 2023 | December 31, 2022 | |
|---|---|---|
| Bonuses and related employees compensation expenses | $2,780,219 | $1,109,734 |
| Supply and manufacturing services | 1,603,739 | — |
| Research and development services and license fees | 1,226,281 | 5,803,432 |
| Consultant and other fees | 853,905 | 218,021 |
| Tax liabilities | 367,976 | 109,826 |
| Legal fees | 98,000 | 15,832 |
| Total | $6,930,120 | $7,256,845 |
Note 10 —Leases
In August 2021, the Company entered into an open-ended office lease agreement, effective November 1, 2021, to lease approximately 2,300 square feet of space on the last two floors of the building located at Dorfstrasse 29, 6300 Zug, Switzerland (the “Office Lease"). The Company estimated the effective duration of the Office Lease at inception and determined a period of 3 years, with expected expiration in November 2024. In December, 2023, the contract was extended, leading to a new estimated effective duration of the lease period of 3 years, with expected expiration in January 2027.
On October 9, 2023, the Company entered into an office lease agreement, effective as of October 9, 2023, to lease approximately 3,900 square feet of office space on the fifth floor of the building located at Rua Manuel Pinto de Azedevo 860, 4150-335, Porto, Portugal. This lease has a 3-year initial term, withtwo extendable periods of 3 years each. It is expected to be extended once until October 2029.
On October 13, 2023, the Company entered into an office lease agreement, effective as of October 16, 2023, to lease approximately 6,000 square feet of office space on the first floor of the building located at 95 Regent Street, CB2 1AW, Cambridge, England, United Kingdom. This lease has a 3-year term agreement and is set to expire in October 2026.
The weighted average remaining lease term and weighted average discount rate for the operating leases as of December 31, 2023 and December 31, 2022 were as follows:
| December 31, 2023 | December 31, 2022 | |
|---|---|---|
| Weighted average remaining lease term (in months) | 39 | 22 |
| Weighted average discount rate | 4.9% | 0.8% |
The future minimum annual lease payments under these operating leases as of December 31, 2023 are as follows:
| Year ending December 31, | Amount |
|---|---|
| 2024 | $1,343,255 |
| 2025 | 1,343,255 |
| 2026 | 1,029,249 |
| 2027 | 95,794 |
| 2028 | 95,794 |
| Thereafter | 65,923 |
| Total lease payments | 3,973,270 |
| Less imputed interest | (275,404) |
| Total lease liability | 3,697,866 |
| Less current portion of lease liability | (1,197,876) |
| Long-term portion operating lease liability | $2,499,990 |
The Company recorded lease expense related to its operating leases of $399,882 and $155,552 for the years ended December 31, 2023 and December 31, 2022, respectively.
Note 11 —Employee Benefit Plans
The Company operates a defined benefit pension plan in Switzerland (“the Plan”) and a defined contribution pension plan in the United Kingdom and Portugal, in accordance with local regulations and practices. As of December 31, 2023 the Plan covers the Company’s employees in Switzerland with benefits in the event of death, disability, retirement, or termination of employment.
A summary of the changes in projected benefit obligations (“PBO”) and plan assets is presented below:
| December 31, 2023 | December 31, 2022 | |
|---|---|---|
| Beginning PBO | $1,321,969 | $1,322,874 |
| Service cost | 122,698 | 451,075 |
| Interest cost | 30,639 | 5,056 |
| Contributions by plan participants | 200,424 | 138,243 |
| Actuarial (gain) / losses | 487,991 | (374,317) |
| Benefits paid | 229,902 | (204,695) |
| Foreign currency exchange rates changes | 208,608 | (16,267) |
| Plan amendment | (107,750) | — |
| Ending PBO | $2,494,481 | $1,321,969 |
| December 31, 2023 | December 31, 2022 | |
|---|---|---|
| Beginning fair value of plan assets | $1,039,763 | $1,083,014 |
| Expected return on plan assets | 36,523 | 15,522 |
| Return on plan assets above expected return | 48,938 | (115,877) |
| Contributions by the employer | 200,424 | 138,243 |
| Contributions by plan participants | 200,424 | 138,243 |
| Benefits paid | 229,902 | (204,695) |
| Foreign currency exchange rates changes | 155,082 | (14,687) |
| Ending fair value of plan assets | $1,911,056 | $1,039,763 |
Amounts recorded on the consolidated balance sheets:
| December 31, 2023 | December 31, 2022 | |
|---|---|---|
| Fair value of plan assets | $1,911,056 | $1,039,763 |
| Present value of projected benefit obligation | (2,494,481) | (1,321,969) |
| Funded status | $(583,425) | $(282,206) |
Amounts recorded in accumulated other comprehensive (income) / loss:
| December 31, 2023 | December 31, 2022 | |
|---|---|---|
| Actuarial (gain) / loss - beginning of year | $(101,716) | $168,177 |
| Actuarial (gain) / loss of current year | 444,329 | (268,076) |
| Amortization | — | (1,817) |
| Prior service (cost) / credit recognized in current year | (107,750) | — |
| Total | $234,863 | $(101,716) |
The assumptions used to calculate the ASC 715 liabilities are summarized in the table below:
| December 31, 2023 · December 31, 2022 | ||||
|---|---|---|---|---|
| Discount rate | 1.35% | p.a. | 2.20% | p.a. |
| Expected return on plan assets | 3.00% | p.a. | 3.80% | p.a. |
| Inflation | 1.80% | p.a. | 1.80% | p.a. |
| Long-term expected rate of salary increase | 2.30% | p.a. | 2.30% | p.a. |
Service cost of $122,698 was recognized in the net periodic benefit cost for the year ended December 31, 2023.
The allocation of plan assets is presented below:
| December 31, 2023 | December 31, 2022 | |
|---|---|---|
| Equities | 34.00% | 34.11% |
| Bonds | 32.00% | 28.89% |
| Mortgages | 4.00% | 3.86% |
| Liquidity | 1.00% | 2.41% |
| Real estate | 26.00% | 27.17% |
| Alternative investments | 3.00% | 3.40% |
| Infrastructure | —% | 0.16% |
The fair value of plan assets is determined based on Level 2 inputs.
As all members of the Plan are active, no future expected benefit payments are currently in payment and foreseen to occur within the next ten years.
Note 12 —Shareholders’ Equity (Deficit)
| Class A Ordinary Shares(1) · Class C Ordinary Shares(1) · Total Number of Shares | ||||||
|---|---|---|---|---|---|---|
| Authorized | Issued | Authorized | Issued | Authorized | Issued and Outstanding | |
| Balance - January 1, 2023 | 500,000,000 | 38,977,600 | 100,000,000 | 13,723,511 | 600,000,000 | 52,701,111 |
| Issuance of Class A Ordinary Shares | — | 10,270,818 | — | — | — | 10,270,818 |
| Conversion of Class C Ordinary Shares into Class A Ordinary Shares | — | 11,218,035 | — | (11,218,035) | — | — |
| Balance - December 31, 2023 | 500,000,000 | 60,466,453 | 100,000,000 | 2,505,476 | 600,000,000 | 62,971,929 |
(1)Fully paid-in registered shares with a par value of $0.0001
As of December 31, 2023, the Company had the following classes of shares:
Class A Ordinary Shares
On April 6, 2022, the Company's Class A Ordinary Shares began trading on The Nasdaq Capital Market ("Nasdaq") under the symbol “MLTX”. As of December 31, 2023, there were 60,466,453 Class A Ordinary Shares issued and outstanding. The Company is authorized to issue up to 500,000,000 Class A Ordinary Shares, par value $0.0001 per share. Holders of Class A Ordinary Shares are entitled toone vote for each share.
Class C Ordinary Shares
As of December 31, 2023, there were 2,505,476 Class C Ordinary Shares issued and outstanding. The Company is authorized to issue up to 100,000,000 Class C Ordinary Shares, with a par value $0.0001 per share. Each Class C Ordinary Share entitles the holders thereof toone vote per share, but carries no economic rights.
At the closing of the Business Combination (the "Closing"), MoonLake, MoonLake AG and each ML Party entered into a Restated and Amended Shareholders' Agreement (the “A&R Shareholders' Agreement”). With the intent to approximate the rights, obligations and restrictions that an ML Party would enjoy if it were a holder of Class A Ordinary Shares, the A&R Shareholders’ Agreement (i) imposes certain transfer and other restrictions on the ML Parties, (ii) provides for the waiver of certain statutory rights and (iii) establishes certain mechanics whereby MoonLake and each of the ML Parties are able to effect the conversion of MoonLake AG Common Shares and Class C Ordinary Shares into a number of Class A Ordinary Shares equal to the Exchange Ratio. In 2022, pursuant to the A&R Shareholders’ Agreement, a ML Party submitted an exchange notice to the Company, pursuant to which the ML Party effected the conversion of 61,000 MoonLake AG Common Shares and 2,051,961 Class C Ordinary Shares into 2,051,961 Class A Ordinary Shares using the Exchange Ratio. In 2023, pursuant to the A&R Shareholders’ Agreement, certain ML Parties submitted exchange notices to the Company, pursuant to which such ML Parties effected, in the aggregate, the conversion of 333,486 MoonLake AG Common Shares and 11,218,035 Class C Ordinary Shares into 11,218,035 Class A Ordinary Shares using the Exchange Ratio. The foregoing description of the A&R Shareholders’ Agreement is not complete and is qualified in its entirety by reference to, and should be read in connection with, the full text of the A&R Shareholders’ Agreement filed as an exhibit on the Company's Current Report on Form 8-K filed with the SEC on April 11, 2022.
Equity Offerings
For the year ended December 31, 2023, the Company issued 10,270,818 Class A Ordinary Shares under the following:
At-the-Market Offering
On May 11, 2023, the Company entered into a Sales Agreement (the “May 2023 Sales Agreement”) with Leerink Partners LLC (formerly known as SVB Securities LLC) (“Leerink Partners”), through which the Company could issue and sell up to $200,000,000 of its Class A Ordinary Shares (the “May 2023 ATM Shares”), through Leerink Partners as its sales agent. The May 2023 ATM Shares to be sold under the May 2023 Sales Agreement, if any, would be issued and sold pursuant to the Company's shelf registration statement on Form S-3 (File No. 333-271546), which was declared effective by the SEC on May 9, 2023, and a prospectus supplement thereto filed with the SEC on May 11, 2023.
On June 27, 2023, the Company reduced the maximum aggregate offering amount of its Class A Ordinary Shares that could be issued and sold under the May 2023 Sales Agreement to $0 and no longer intends to sell Class A Ordinary Shares under the May 2023 Sales Agreement unless the Company files a further prospectus supplement indicating an amount of shares proposed to be sold.
On August 31, 2023, the Company entered into a Sales Agreement with Leerink Partners (the “August 2023 Sales Agreement” and together with the May 2023 Sales Agreement, the “Sales Agreements”), through which the Company could issue and sell up to $350,000,000 of its Class A Ordinary Shares (the “August 2023 ATM Shares”), through Leerink Partners as its sales agent. The August 2023 ATM Shares to be sold under the August 2023 Sales Agreement, if any, would be issued and sold pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-274286), which was declared effective by the SEC on September 11, 2023, and a prospectus supplement thereto filed with the SEC on August 31, 2023.
In May 2023, the Company sold 544,894 Class A Ordinary Shares for gross proceeds of $15.2 million. In December 2023, the Company sold a further 525,924 Class A Ordinary Shares for gross proceeds of $31.7 million.
Public Offering of Class A Ordinary Shares
On June 27, 2023, the Company entered into an underwriting agreement with SVB Securities LLC and Guggenheim Securities LLC as the representatives of the underwriters named therein, to issue and sell 8,000,000 Class A Ordinary Shares at a public offering price of $50.00 per share (the “Offering”). In addition, the Company granted the underwriters an option for a period of 30 days to purchase up to an additional 1,200,000 Class A Ordinary Shares at the public offering price less the underwriting discounts and commissions (the “Option”), and such Option was exercised in full by the underwriters.
The Offering closed on June 30, 2023, and net proceeds from the Offering, including proceeds from the exercise in full by the underwriters of the Option, were $436.7 million, after deducting the underwriting discounts and commissions and the offering expenses in the amount of $23.3 million.
Following the completion of the Offering, the Company opted to direct a substantial portion of the net proceeds to MoonLake AG. This was executed as a two-step process: (1) the Company acquired the remaining 22,756 shares of MoonLake AG common stock held in treasury through a share purchase and assignment agreement formally executed on July 09, 2023 ($38.9 million) and (2) the Company contributed additional funds to MoonLake AG’s capital reserves through a cash contribution agreement formally executed on July 10, 2023 ($275 million). A stamp duty tax of $2.8 million was levied on the aforementioned capital contribution which the Company has classified as cash flows from financing activities in order to correctly mirror the underlying nature of the transaction.
Note 13 —Net Loss per Share
As a result of the Business Combination, the Company has retroactively restated the weighted average number of outstanding prior to April 5, 2022 to give effect to the Exchange Ratio.
The following table sets forth the loss per share calculations for the year ended December 31, 2023 compared to the year ended December 31, 2022:
| Year Ended December 31, 2023 | Year Ended December 31, 2022 | |
|---|---|---|
| Numerator | ||
| Net loss attributable to controlling interests shareholders | $(36,007,260) | $(49,973,249) |
| Denominator | ||
| Total weighted average number of outstanding shares | 49,122,534 | 29,361,353 |
| Net loss per share – basic and diluted | $(0.73) | $(1.70) |
The weighted average number of shares used to calculate the net loss per share – basic for the year ended December 31, 2023 excludes 2,505,476 Class C Ordinary Shares as they do not carry economic rights.
In the event that ML Parties (other than Biotechnology Value Fund, L.P., Biotechnology Value Fund II, L.P., and Biotechnology Value Trading Fund OS, L.P.) elected to convert their 74,482 MoonLake AG Common Shares into 2,505,476 Class A Ordinary Shares, the weighted average number of shares outstanding would have been 57,679,106 for the year ended December 31, 2023, resulting in a net loss per share of $0.76. Upon conversion,2,505,476 Class C Ordinary Shares would be forfeited and there would no longer be any non-controlling interests.
Upon conversion, the Company's number of Class A Ordinary Shares outstanding would be 63,886,757 as of February 29, 2024, the date the consolidated financial statements were issued.
Note 14 —Share-based Compensation
As of December 31, 2023 the Company had the following share-based compensation arrangements:
a. Restricted Founder Shares (as defined below) – created in April 2021 by MoonLake AG (no longer active and fully vested as of April 2023);
b. The Employee Share Participation Plan (“ESPP”) – created in July 2021 by MoonLake AG;
c. The Employee Stock Option Plan (“ESOP”) – created in July 2021 by MoonLake AG;
d. MoonLake Immunotherapeutics 2022 Equity Incentive Plan – created in April 2022 by MoonLake Immunotherapeutics.
The purpose of the arrangements is to attract and retain the best available personnel and to provide participants with additional incentive to increase their efforts on behalf and in the best interest of the Company and its subsidiaries.
MoonLake AG's compensation plans are settled with Common Shares, and with a number of Class C Ordinary Shares determined by multiplying the number of Common Shares by the Exchange Ratio. The reference to “Common Shares” in this Note 14 refers to common shares in MoonLake AG. As a result of the Business Combination, the Company has adjusted the share numbers related to the Restricted Founder Shares and Common Shares (under the ESPP and ESOP) prior to the Business Combination by the Exchange Ratio. The owners of Common Shares have the right to exchange their Common Shares for a number of Class A Ordinary Shares derived using the Exchange Ratio. In the event MoonLake AG shareholders elect to exchange their Common Shares, such MoonLake AG shareholder forfeits a number of Class C Ordinary Shares equal to the number of Class A Ordinary Shares issued (refer to Note 12 — Shareholders’ Equity (Deficit) -Class C Ordinary Shares).
For the year ended December 31, 2023, the Company has recognized an increase in equity in the consolidated balance sheet, and share-based compensation expense in the consolidated statement of operations of $7.1 million. The share-based compensation expense was driven by the following share-based compensation plans and programs:
| Compensation Plan | Year Ended December 31, 2023 | Year Ended December 31, 2022 |
|---|---|---|
| MoonLake AG Restricted Founder Shares | $1,574,300 | $4,840,608 |
| ESPP | 3,352,885 | 3,910,076 |
| ESOP | 973,868 | 539,713 |
| MoonLake Immunotherapeutics 2022 Equity Incentive Plan | 1,204,952 | 364,381 |
| Total share-based compensation expense | $7,106,005 | $9,654,778 |
| Of which: included in research and development expense | 1,524,715 | 954,379 |
| Of which: included in general and administrative expense | 5,581,290 | 8,700,399 |
As of December 31, 2023,11,079 Common Shares (the equivalent of 372,683 Class C Ordinary Shares) issuable from the authorized conditional capital shares remain available for future grants under the ESPP and the ESOP by MoonLake AG.
MoonLake AG - Restricted Founder Shares
On April 28, 2021, the shareholders’ agreement between the co-founders, the Series A investors and MoonLake AG imposed a reverse vesting condition on 90% of the total 110,000 Common Shares (the equivalent of 3,700,257 Class C Ordinary Shares) held by each of thethree co-founders. Therefore,99,000 Common Shares (the equivalent of 3,330,231 Class C Ordinary Shares) held by each of the co-founders were subject to these restrictions and considered unvested (the “Restricted Founder Shares”). The Restricted Founder Shares vested on the 28th of each month at a rate of 4.166% over a period oftwo years until April 28, 2023. In the event of a termination of the contractual relationship of the relevant co-founder before the end of the vesting period, MoonLake AG in first priority, or any third party designated by it, and the other shareholders in second priority pro rata to their shareholdings, had an option to purchase all or a pro rata portion of the leaver shares that remained unvested on the effective day of the termination at nominal value of CHF 0.10 (equivalent of $0.0001) per share.
The assumptions used in the valuation of the Restricted Founder Shares awarded are summarized below:
| Grant date | 4/28/2021 |
|---|---|
| Estimated fair value of Restricted Founder Shares on the grant date (USD) (1) | 49 |
| Estimated fair value of Restricted Founder Shares on the resignation date of one of the co-founders (USD) (2) | 336.39 |
| Purchase price (CHF) | 0.10 |
| (1) MoonLake AG estimated the fair value of the Restricted Founder Shares with reference to the market-based transaction with the other Series A Preferred Shares Investors (refer to Note 9 of MoonLake AG's audited consolidated financial statements for the year ended December 31, 2021, as filed by Helix Acquisition Corp. together with its revised definitive proxy soliciting materials with the SEC on March 4, 2022). | |
| (2) MoonLake AG estimated the fair value of the Restricted Founder Shares at co-founder’s resignation date by dividing the Company Enterprise Value ($360,000,000) as defined by the Business Combination Agreement by the Company’s fully diluted shares (1,070,196). | |
| Grants awarded | |
|---|---|
| Program | Restricted Founder Shares |
| Awards unvested as of January 1, 2022 | 4,440,309 |
| Awards vested for the year ended December 31, 2022 | (3,330,231) |
| Awards unvested as of January 1, 2023 | 1,110,078 |
| Awards vested for the year ended December 31, 2023 | (1,110,078) |
| Awards unvested as of December 31, 2023 | 0 |
Employee Share Participation Plan (ESPP) 2021-2025 - MoonLake AG
The ESPP grants will vest 25% on each anniversary of the grant date. In the event of a termination of contractual relationship between the Company and the entitled employee, the awards can be deemed forfeited by MoonLake AG if certain conditions are met. Awards feature an accelerated vesting condition linked to a “Change of Control”, defined as any transfer of shares that results in the proposed acquirer holding more than 50% of the then issued share capital of MoonLake AG or the Company, as the case may be, where all the outstanding awards (whether currently outstanding or granted in the future) will be deemed fully vested.
| ESPP 2021 | |
|---|---|
| Assumptions for the awards issued during the year ended December 31, 2022 | |
| Grant date | 01/18/2022 |
| Estimated fair value per share of Common Shares on the grant date ($) (1) | 336.39 |
| Purchase price (CHF) | 0.10 |
| (1) MoonLake AG estimated the fair value of the Common Shares by dividing the Company Enterprise Value (USD 360,000,000) as defined by the Business Combination Agreement by the Company’s fully diluted shares (1,070,196). | |
| Grants awarded | |
| Program | ESPP |
| Awards outstanding as of January 1, 2022 | 1,060,561 |
| Additional awards granted for the year ended December 31, 2022 | 1,177,354 |
| Awards outstanding as of January 1. 2023 | 2,237,915 |
| Of which vested as of January 1, 2023 | 307,794 |
| Awards granted for the year ended December 31, 2023 | — |
| Awards outstanding as of December 31, 2023 | 2,237,915 |
| Of which vested as of December 31, 2023 | 1,607,425 |
As of December 31, 2023, MoonLake AG had $6.2 million of total unrecognized compensation expense related to the ESPP that will be recognized over the weighted average period of 2.05 years.
Employee Stock Option Plan (ESOP) 2021-2025 - MoonLake AG
The ESOP grants will vest 25% on each anniversary of the grant date. In the event of a termination of the contractual relationship between the Company and the entitled employee, options can be deemed forfeited by MoonLake AG if certain conditions are met. Awards feature an accelerated vesting condition linked to a “Change of Control”, defined as any transfer of shares that results in the proposed acquirer holding more than 50% of the then issued share capital of MoonLake AG or the Company, as the case may be, where all the outstanding awards (whether currently outstanding or granted in the future) will be deemed fully vested.
| ESOP 2021 | |
|---|---|
| Weighted average assumptions for the awards issued during the year ended December 31, 2022 | |
| Grant dates | 5/1/2022, 6/22/2022 |
| Estimated fair value of the option on the grant date using Black-Scholes model ($) | 4.21 |
| Exercise price (USD) | 3.64 |
| Expected term of the award on the grant date (years) (1) | 6 |
| Expected volatility of the share price (2) | 75% |
| Risk-free interest rate (3) | 3% |
| Expected dividend rate | —% |
| (1) The expected term represents the period that share-based awards are expected to be outstanding.(2) The expected volatility was derived from the historical stock volatilities of comparable peer public companies within the Company’s industry.(3) The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the measurement date with maturities approximately equal to the expected term. | |
| Weighted average assumptions for the awards issued during the year ended December 31, 2023 | |
|---|---|
| Grant dates | 01/01/2023, 04/24/2023, 07/03/2023, 07/17/2023, 08/01/2023, 08/07/2023, 08/21/2023, 08/29/2023, 09/01/2023, 09/11/2023 |
| Estimated fair value of the option on the grant date using Black-Scholes model ($) | 25.5 |
| Exercise price (USD) | 37.1 |
| Expected term of the award on the grant date (years) (1) | 6 |
| Expected volatility of the share price (2) | 75% |
| Risk-free interest rate (3) | 4% |
| Expected dividend rate | —% |
| (1) The expected term represents the period that share-based awards are expected to be outstanding.(2) The expected volatility was derived from the historical stock volatilities of comparable peer public companies within the Company’s industry.(3) The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the measurement date with maturities approximately equal to the expected term. | |
| Grants awarded | |
|---|---|
| Program | ESOP |
| Awards issued as of January 1, 2022 | 224,033 |
| Additional awards granted for the year ended December 31, 2022 | 242,736 |
| Awards issued as of January 1, 2023 | 466,769 |
| Awards granted for the year ended December 31, 2023 | 133,446 |
| Awards forfeited for the year ended December 31, 2023 | (15,137) |
| Awards outstanding at December 31, 2023 | 585,078 |
| Of which exercisable as of December 31, 2023 | 219,223 |
As of December 31, 2023, MoonLake AG had $4.2 million of total unrecognized compensation expense related to the ESOP that will be recognized over the weighted average period of 2.45 years.
MoonLake Immunotherapeutics 2022 Equity Incentive Plan
On April 5, 2022 (the “Effective Date”) the Company created the “MoonLake Immunotherapeutics 2022 Equity Incentive Plan” (the “Equity Incentive Plan”) to promote and closely align the interests of employees, officers, non-employee directors and other service providers of MoonLake Immunotherapeutics and its shareholders by providing share-based compensation and other performance-based compensation.
The Equity Incentive Plan provides for the grant of options, stock appreciation rights, restricted stock units, restricted stock and other share-based awards and for incentive bonuses, which may be paid in cash, Common Shares or a combination thereof, as determined by the compensation committee of the board of directors or such other committee as designated by the board of directors to administer the Equity Incentive Plan. The Equity Incentive Plan shall remain available for the grant of awards until the 10 th anniversary of the Effective Date.
Awards made under the Equity Incentive Plan to a person who is initially elected or appointed to the Board, and who is a non-employee director at the time of such initial election or appointment, vests and becomes exercisable in 3 equal yearly installments occurring over thethree year period following the date of grant, subject to the non-employee director continuing in service on the Board through each such vesting date. Each subsequent award vests and becomes exercisable on the earlier of (i) the 12-month anniversary of the date of grant, and (ii) the next annual meeting of the Company’s stockholders following the date of grant, subject to the non-employee director continuing in service on the Board through such vesting date. Awards made to employees, officers and other service providers of the Company under the Equity Incentive Plan vest 25% on each anniversary date. In the event of a termination of the contractual relationship between the Company and the beneficiary, options can be deemed forfeited by the Company if certain conditions are met. Awards feature an accelerated vesting condition linked to a “Change of Control”, defined as any transfer of shares that results in the proposed acquirer holding more than 50% of the then issued share capital of MoonLake AG or the Company, as the case may be, where all the outstanding awards (whether currently outstanding or granted in the future) will be deemed fully vested.
| Weighted average assumptions for the awards issued during the year ended December 31, 2022 | |
|---|---|
| Grant date | 4/6/2022 |
| Estimated fair value of the option on the grant date using Black-Scholes model ($) | 8.25 |
| Exercise price ($) | 12.25 |
| Expected term of the award on the grant date (years) (1) | 6 |
| Expected volatility of the share price (2) | 75% |
| Risk-free interest rate (3) | 3% |
| Expected dividend rate | - |
| (1)The expected term represents the period that share-based awards are expected to be outstanding.(2) The expected volatility was derived from the historical stock volatilities of comparable peer public companies within the Company's industry. (3) The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the measurement date with maturities approximately equal to the expected term. | |
| Weighted average assumptions for the awards issued during the year ended December 31, 2023 | |
|---|---|
| Grant dates | 06/08/2023, 10/11/2023, 10/25/2023, 11/01/2023, 11/06/2023, 11/15/2023, 11/16/2023, 11/20/2023, 11/27/2023, 12/01/2023, 12/04/2023 |
| Estimated fair value of the option on the grant date using Black-Scholes model ($) | 25.58 |
| Exercise price ($) | 37.22 |
| Expected term of the award on the grant date (years) (1) | 6 |
| Expected volatility of the share price (2) | 0.75 |
| Risk-free interest rate (3) | 4% |
| Expected dividend rate | 0 |
| (1)The expected term represents the period that share-based awards are expected to be outstanding.(2) The expected volatility was derived from the historical stock volatilities of comparable peer public companies within the Company's industry. (3) The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the measurement date with maturities approximately equal to the expected term. | |
| Grants awarded | |
|---|---|
| Program | MoonLake Immunotherapeutics 2022 Equity Incentive Plan |
| Awards issued as of January 1, 2022 | — |
| Awards granted for the year ended December 31, 2022 | 180,000 |
| Awards issued as of December 31, 2022 | 180,000 |
| Awards exercisable as of December 31, 2022 | — |
| Awards granted for the year ended December 31, 2023 | 132,400 |
| Awards issued as of December 31, 2023 | 312,400 |
| Awards exercisable as of December 30, 2023 | 60,000 |
As of December 31, 2023, the Company had $3.3 million of total unrecognized compensation expense related to the Equity Incentive Plan that will be recognized over the weighted average period of 1.75 years.
Note 15 —Income Taxes
The Company's effective tax rate (“ETR”) was -0.3% and 0.1% for the year ended December 31, 2023, and for the year ended December 31, 2022, respectively. The Company is not aware of any items that would cause the quarterly or period-to-date ETR to be significantly different from the Company's annual ETR. The difference between the income tax provision that would be derived by applying the statutory rate to the Company's loss before income taxes and the income tax provision recorded was primarily attributable to non-deductible expense which includes the Swiss entity's recognition of taxable income associated with the sale of treasury shares from MoonLake AG to MoonLake Immunotherapeutics.. The Company continues to incur losses for the Cayman Island and Swiss entity and its ability to utilize the deferred tax asset related to the tax losses is not considered more likely than not.
The Company's main operating affiliate, MoonLake AG, is subject to taxation in the Canton of Zug, Switzerland. For the years ended December 31, 2023 and 2022, the Company did not incur any significant income tax expense or benefit, as the Company incurred tax losses and provided a full valuation allowance.
The components of income or loss before income tax were as follows:
| Year Ended December 31, 2023 | Year Ended December 31, 2022 | |
|---|---|---|
| Switzerland | $(43,469,946) | $(62,115,251) |
| Foreign | (514,783) | (2,354,434) |
| Total | $(43,984,729) | $(64,469,685) |
The provision for income taxes differs from the amount computed by applying the statutory income tax rate to loss before income taxes as follows:
| Year Ended December 31, 2023 | Year Ended December 31, 2022 | |
|---|---|---|
| Statutory income tax rate | 11.8% | 11.9% |
| Effect of income taxed at different rates | (0.4)% | —% |
| Change in prior year estimates | (0.5)% | 0.1% |
| Utilization of unrecognized losses | 0.6% | —% |
| Change in valuation allowance | 0.5% | (10.0)% |
| Non-deductible expense | (12.3)% | (1.4)% |
| Other | —% | (0.5)% |
| Effective income tax rate | (0.3)% | 0.1% |
Significant components of the Company’s deferred tax assets (liabilities) were:
| December 31, 2023 | December 31, 2022 | |
|---|---|---|
| Intangible assets | $4,493,559 | $4,492,435 |
| Defined benefit plan | 69,173 | 33,451 |
| Lease liabilities | 56,527 | — |
| Net operating loss carry forward | 6,715,534 | 7,210,383 |
| Total deferred tax assets | 11,334,793 | 11,736,269 |
| Operating lease right-of-use assets | (55,862) | — |
| Total deferred tax liabilities | (55,862) | — |
| Total deferred tax assets (net) | 11,278,931 | 11,736,269 |
| Valuation allowance | (11,278,931) | (11,736,269) |
| Total deferred tax (net) | $— | $— |
As of December 31, 2023, the Company’s net deferred tax assets before valuation allowance were $11.3 million. In assessing the realizability of its deferred tax assets, the Company considers whether it is more likely than not that some portion or all of its deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. The Company considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies in making this assessment. Based on the weight of all evidence, the Company has determined that it is not more likely than not that the net deferred tax assets will be realized. A valuation allowance of $11.3 million has been recorded against the deferred tax assets.
As of December 31, 2023, MoonLake AG had net operating losses of approximately $56.6 million of which $12.6 million will expire in 2028 and $44.0 million will expire in 2029.
The Company’s net operating losses will not be subject to any limitation due to change in ownership according to Swiss Income Tax Law.
The Company has no unrecognized tax benefits and does not expect that uncertain tax benefits will change significantly in the next twelve months.
Note 16 —Commitments and Contingencies
Commitments
The Company has entered into agreements as of December 31, 2023 primarily in regards to the clinical and non-clinical development services with contract research organizations ("CROs"), as well as supply and logistics services with contract manufacturing organizations ("CMOs"), for the advancement of SLK. As of December 31, 2023, the total committed expense under these agreements amounted to $44.2 million, of which $8.4 million are recognized under Prepaid expenses - non-current and the rest remain unrecognized.
The Company's In-License Agreement with MHKDG includes contractual milestone payments related to the achievement of pre-specified research, development, regulatory and commercialization events and indemnification provisions, which are common in such agreements. Pursuant to the agreements, the Company is obligated to make research and development and regulatory milestone payments upon the occurrence of certain events. Subject to the terms of the license, additional milestone payments of up to €299.6 million ($331.3 million using a December 31, 2023 exchange rate) are potentially payable upon satisfying specific milestones related to regulatory filing acceptance, first commercial sales, and aggregate annual net sales. The milestone payments are payable in cash. Milestone payments due prior to obtaining regulatory approval will be recorded as research and development expense upon determination that a milestone payment is probable to occur. Milestone payments due after obtaining regulatory approval will be capitalized when and if incurred. The Company will use commercially reasonable efforts to cause the milestones to occur. However, if the Company reasonably determines that a technical failure or commercial failure has occurred with respect to all or a part of the SLK Program, the Company, at its sole discretion, can terminate all or part of the SLK Program. As of December 31, 2023, the Company made a total of €7.5 million ($8.1 million using the then applicable exchange rate) in additional milestone payments.
In addition, on May 12, 2023, MoonLake AG entered into an agreement with Research Cooperation Technologies, Inc. (“RCT”) and MHKDG, effective as of June 1, 2023, pursuant to which the Company was granted a royalty-bearing, nonexclusive, sublicensable right and license under RCT’s patents and know-how related to a manufacturing process using an underlying yeast strain, Pichia pastoris, to develop, manufacture, use, sell, offer for sale, and import and otherwise commercialize SLK on a world-wide basis, subject to certain restrictions. This agreement replaces the Company’s sublicense for similar rights under the In-License Agreement. In the aggregate, the Company is required to pay royalties within the range of low to mid-teen percent of net sales under the aforementioned agreements with MHKDG and RCT. Royalties will be recognized in the consolidated statement of operations when net sales are recognized.
Office Lease
On December 12, 2023, the Company committed to an open-ended lease agreement with an effective start date of January 15, 2024, for additional office space at its corporate headquarters at Dorfstrasse 29, 6300 Zug, Switzerland. The Company estimated the effective duration of the Office Lease at inception and determined a 3-year term, commencing at the effective start date of January 15, 2024.
Note 17 —Segment Information and Geographic Data
Long-lived assets, net of consisting of property and equipment, and operating lease right-of-use assets by geographical area as of December 31, 2023 are as follows:
| Country | December 31, 2023 | December 31, 2022 |
|---|---|---|
| Switzerland | $507,392 | $331,969 |
| United Kingdom | 2,704,555 | — |
| Portugal | 737,398 | — |
| Total | $3,949,345 | $331,969 |
Note 18 —Subsequent Events
Partial Share Conversion
On January 2, 2024, pursuant to the A&R Shareholders’ Agreement, a ML Party submitted an exchange notice to the Company, pursuant to which such ML Party effected the conversion of 44,394 MoonLake AG Common Shares and 1,493,356 Class C Ordinary Shares into 1,493,356 Class A Ordinary Shares using the Exchange Ratio. Please refer to Note 12— Shareholders’ Equity (Deficit) — Class C Ordinary Shares for more information regarding the conversion mechanics.
At-the-Market offering
In January and February 2024, the Company sold an aggregate of 914,828 Class A Ordinary shares through the August 2023 Sales Agreement for gross proceeds of $53.3 million, bringing total gross proceeds under the August 2023 Sales Agreement to $85.0 million.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.