MoonLake Immunotherapeutics 10-Q for FY2024 Q3

MoonLake Immunotherapeutics (MLTX)

10-Q 2024-11-07 For: 2024-09-30

Added on April 08, 2026

About this 10-Q

MoonLake Immunotherapeutics filed this 10-Q on November 7, 2024, covering the quarter ended September 30, 2024 (FY2024 Q3).

Headline figures

Quarter ended September 30, 2024, as reported in this filing, compared with the same period a year earlier where the filing states it.

Net loss: $35.39M; compared with a net loss of $9.43M a year earlier
Diluted EPS: -$0.56; compared with -$0.18 a year earlier

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Cayman Islands						98-1711963
(State or other jurisdiction of incorporation or organization)						(I.R.S. Employer Identification No.)

Dorfstrasse 29
6300 Zug
Switzerland						N/A
(Address of principal executive offices)						(ZIP Code)


PART I. FINANCIAL INFORMATION			2
Item 1. Financial Statements (Unaudited)			2
Condensed Consolidated Balance Sheets			2
Condensed Consolidated Statements of Operations and Comprehensive Loss			3
Condensed Consolidated Statements of Changes In Equity			4
Condensed Consolidated Statements of Cash Flows			6
Notes to Condensed Consolidated Financial Statements			7
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations			26
Item 3. Quantitative and Qualitative Disclosures About Market Risk			39
Item 4. Controls and Procedures			39
PART II. OTHER INFORMATION			41
Item 1. Legal Proceedings			41
Item 1A. Risk Factors			41
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds			41
Item 3. Defaults Upon Senior Securities			41
Item 4. Mine Safety Disclosures			41
Item 5. Other Information			41
Item 6. Exhibits			42
SIGNATURES			43


	September 30, 2024 (Unaudited)		December 31, 2023
Current assets
Cash and cash equivalents	$	375,656,291	$	451,169,337
Short-term marketable debt securities	118,268,400		59,838,900


Other receivables	2,407,062		1,056,862
Prepaid expenses - current	15,984,425		2,102,203

Total current assets	512,316,178		514,167,302

Non-current assets
Operating lease right-of-use assets	3,251,197		3,628,480
Property and equipment, net	581,378		320,865
Prepaid expenses - non-current	2,064,575		8,423,468




Total non-current assets	5,897,150		12,372,813
Total assets	$	518,213,328	$	526,540,115

Current liabilities
Trade and other payables	$	10,710,603	$	1,837,684
Short-term portion of operating lease liabilities	1,444,893		1,197,876

Accrued expenses and other current liabilities	7,925,524		6,930,120


Total current liabilities	20,081,020		9,965,680

Non-current liabilities
Long-term portion of operating lease liabilities	1,935,709		2,499,990
Pension liability	694,959		583,426

Total non-current liabilities	2,630,668		3,083,416
Total liabilities	22,711,688		13,049,096
Commitments and contingencies (Note 15)

Equity



Class A Ordinary Shares: $0.0001 par value; 500,000,000 shares authorized; 63,046,025 shares issued and outstanding as of September 30, 2024; 60,466,453 shares issued and outstanding as of December 31, 2023	6,305		6,047
Class C Ordinary Shares: $0.0001 par value; 100,000,000 shares authorized; 841,269 shares issued and outstanding as of September 30, 2024; 2,505,476 shares issued and outstanding as of December 31, 2023	84		251
Additional paid-in capital	675,343,443		609,969,236
Accumulated deficit	(189,988,477)		(116,657,472)
Accumulated other comprehensive income	2,833,970		2,357,621
Total shareholders’ equity	488,195,325		495,675,683
Noncontrolling interests	7,306,315		17,815,336
Total equity	495,501,640		513,491,019
Total liabilities and equity	$	518,213,328	$	526,540,115


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023


Operating expenses
Research and development	$	(35,735,514)	$	(7,585,136)	$	(72,411,709)	$	(23,704,087)
General and administrative	(7,376,495)		(5,391,607)		(21,099,001)		(15,390,117)
Total operating expenses	(43,112,009)		(12,976,743)		(93,510,710)		(39,094,204)
Operating loss	(43,112,009)		(12,976,743)		(93,510,710)		(39,094,204)

Other income, net	7,089,691		1,386,313		18,903,070		2,952,557



Loss before income tax	(36,022,318)		(11,590,430)		(74,607,640)		(36,141,647)

Income tax expense	(92,106)		(28,923)		(241,059)		(50,080)
Net loss	$	(36,114,424)	$	(11,619,353)	$	(74,848,699)	$	(36,191,727)
Of which: net loss attributable to controlling interests shareholders	(35,390,337)		(9,426,049)		(73,331,005)		(28,570,184)
Of which: net loss attributable to noncontrolling interests shareholders	(724,087)		(2,193,304)		(1,517,694)		(7,621,543)

Net unrealized gain (loss) on marketable securities and short term investments	(325,510)		3,437,291		508,860		3,046,538

Actuarial gain (loss) on employee benefit plans	(115,629)		39,157		(110,878)		(19,323)
Other comprehensive income (loss)	(441,139)		3,476,448		397,982		3,027,215
Comprehensive loss	$	(36,555,563)	$	(8,142,905)	$	(74,450,717)	$	(33,164,512)
Comprehensive loss attributable to controlling interests shareholders	(35,822,526)		(6,590,259)		(72,941,435)		(26,095,926)
Comprehensive loss attributable to noncontrolling interests	(733,037)		(1,552,646)		(1,509,282)		(7,068,586)

Weighted-average number of Class A Ordinary Shares, basic and diluted	62,896,782		53,517,655		62,803,220		45,485,650
Basic and diluted net loss per share attributable to controlling interests shareholders	$	(0.56)	$	(0.18)	$	(1.17)	$	(0.63)


	Class A Ordinary Shares	Class C Ordinary Shares			Additional Paid-In Capital	Accumulated Deficit	Accumulated Other Comprehensive Income	Total Shareholders' Equity		Noncontrolling Interests		Total Equity
		Shares	Amount															Shares		Amount
Balance at December 31, 2022		38,977,600	$	3,898			13,723,511	$	1,373	$	129,192,291	$	(80,650,212)	$	350,946	$	48,898,296	$	19,868,402	$	68,766,698
Share-based compensation under the ESPP, ESOP, Equity Incentive Plan and reverse vesting of Restricted Founder Shares		—	—				—	—		1,875,992		—		—		1,875,992		701,195		2,577,187
Refund of stamp duty fees		—	—				—	—		3,517		—		—		3,517		1,406		4,923
Net loss for the three months ended March 31, 2023		—	—				—	—		—		(9,004,856)		—		(9,004,856)		(3,214,131)		(12,218,987)
Other comprehensive loss		—	—				—	—		—		—		(12,625)		(12,625)		(5,047)		(17,672)
Conversion of MoonLake Class C Ordinary Shares into Class A Ordinary Shares		176,603	18				(176,603)	(18)		237,049		—		1,787		238,836		(238,836)		—
Balance at March 31, 2023		39,154,203	$	3,916			13,546,908	$	1,355	$	131,308,849	$	(89,655,068)	$	340,108	$	41,999,160	$	17,112,989	$	59,112,149
Share-based compensation under the ESPP, ESOP, Equity Incentive Plan and reverse vesting of Restricted Founder Shares		—	—				—	—		1,247,416		—		—		1,247,416		250,245		1,497,661
Issuance of Class A Ordinary Shares, net of transaction costs (Note 11)		9,744,894	974				—	—		451,284,119		—		—		451,285,093		—		451,285,093
Net loss for the three months ended June 30, 2023		—	—				—	—		—		(10,139,279)		—		(10,139,279)		(2,214,108)		(12,353,387)
Other comprehensive loss		—	—				—	—		—		—		(348,906)		(348,906)		(82,655)		(431,561)
Conversion of MoonLake Class C Ordinary Shares into Class A Ordinary Shares		4,587,713	459				(4,587,713)	(459)		5,709,595		—		43,922		5,753,517		(5,753,517)		—
Balance at June 30, 2023		53,486,810	$	5,349			8,959,195	$	896	$	589,549,979	$	(99,794,347)	$	35,124	$	489,797,001	$	9,312,954	$	499,109,955
Share-based compensation under the equity incentive plan ESPP, ESOP, and 2022 MoonLake Immunotherapeutics Equity Incentive Plan		—	—				—	—		1,238,144		—		—		1,238,144		187,507		1,425,651
Net loss for the three months ended September 30, 2023		—	—				—	—		—		(9,426,049)		—		(9,426,049)		(2,193,304)		(11,619,353)
Other comprehensive income		—	—				—	—		—		—		2,835,790		2,835,790		640,658		3,476,448
Conversion of MoonLake Class C Ordinary Shares into Class A Ordinary Shares		74,678	7				(74,678)	(7)		545,591		—		3,149		548,740		(548,740)		—
Capital injection from MoonLake to MoonLake AG (Note 11)		—	—				—	—		(60,061,761)		—		1,135		(60,060,626)		57,310,111		(2,750,515)
Balance at September 30, 2023		53,561,488	$	5,356			8,884,517	$	889	$	531,271,953	$	(109,220,396)	$	2,875,198	$	424,933,000	$	64,709,186	$	489,642,186


	Nine Months Ended September 30, 2024		Nine Months Ended September 30, 2023
Cash flow from operating activities
Net loss	$	(74,848,699)	$	(36,191,727)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	83,440		9,869
Share-based compensation expense	5,348,062		5,500,499

Net periodic pension benefit (gain) cost for the qualified pension plan	(2,678)		(50,740)
Other non-cash items	1,189,056		96,364
Changes in operating assets and liabilities:
Other receivables	(1,350,200)		(503,626)


Operating lease right-of-use assets	(5,443)		—
Prepaid expenses	(7,523,329)		869,187
Trade and other payables	8,872,919		3,149,756
Operating lease liabilities	(872,121)		(117,832)
Accrued expenses and other current liabilities	995,404		(3,195,591)


Net cash flow used in operating activities	(68,113,589)		(30,433,841)

Cash flow from investing activities
Purchase of short-term marketable debt securities	(203,334,691)		(175,732,711)
Proceeds from maturities of short-term marketable debt securities	145,414,050		33,681,688
Purchase of property and equipment	(343,953)		—
Net cash flow used in investing activities	(58,264,594)		(142,051,023)

Cash flow from financing activities

Issuance of Class A Ordinary Shares, net of transaction costs	52,540,190		451,285,093
Stamp duty on capital injection from MoonLake to MoonLake AG	(1,470,436)		—
Proceeds from options exercised under the Equity Incentive Plan	91,298		—





Buyback of unvested MoonLake AG Common Shares by MoonLake AG following an employee contract termination	(50)		—


Net cash flow provided by financing activities	51,161,002		451,285,093

Effect of movements in exchange rates on cash held	(295,865)		(140,047)
Net change in cash and cash equivalents	(75,513,046)		278,660,182

Cash and cash equivalents, beginning of period	451,169,337		39,505,627
Cash and cash equivalents, end of period	$	375,656,291	$	318,165,809

Supplementary disclosure of cash flow information:

Non-cash operating lease right-of-use assets obtained in exchange for lease obligations	$	554,857	$	—


	September 30, 2024				December 31, 2023
	Level 2		Total			Level 2		Total
Eurocommercial Papers	$	89,072,100	$	89,072,100		$	109,608,915	$	109,608,915
Certificates of Deposit	88,991,100		88,991,100			79,626,727		79,626,727
Total	$	178,063,200	$	178,063,200		$	189,235,642	$	189,235,642


	Amortized cost		Gross unrealized gains		Gross unrealized losses		Fair value
Eurocommercial Papers	$	87,231,307	$	1,840,793	$	—	$	89,072,100
Certificates of Deposit	87,602,179		1,388,921		—		88,991,100
Total	$	174,833,486	$	3,229,714	$	—	$	178,063,200


Of which classified within cash and cash equivalents	59,212,123	582,677	—	59,794,800
Of which classified within short-term marketable debt securities	115,621,363	2,647,037	—	118,268,400


Beginning balance, January 1, 2024	$	2,720,854
Other comprehensive income before reclassifications	13,000,645
Amounts reclassified from accumulated other comprehensive income	(12,491,785)

Ending balance, September 30, 2024	$	3,229,714


	September 30, 2024		December 31, 2023
Research and development services and license fees	$	7,113,098	$	911,454
Supply and manufacturing fees payable	3,044,237		553,459
Consulting and advisory services	307,581		80,695
Legal advisory fees payable	104,317		47,095


Other payables	141,370		244,981
Total	$	10,710,603	$	1,837,684


	September 30, 2024		December 31, 2023
Weighted average remaining lease term (in months)	32		39
Weighted average discount rate	4.7	%	4.9	%


Year ending December 31,	Amount
Remainder of fiscal 2024	$	386,519
2025	1,571,589
2026	1,242,550
2027	140,313
2028	140,313
Thereafter	95,627
Total lease payments	3,576,911
Less imputed interest	(196,309)
Total lease liability	3,380,602
Less current portion of lease liability	(1,444,893)
Long-term portion operating lease liability	$	1,935,709


	Three Months Ended September 30, 2024		Three Months Ended September 30, 2023		Nine Months Ended September 30, 2024		Nine Months Ended September 30, 2023
Operating lease expense	$	358,583	$	39,562	$	1,061,029	$	117,832
Variable lease expense1	5,398		—		5,398		—
Total lease expense	$	363,981	$	39,562	$	1,066,427	$	117,832


	Class A Ordinary Shares(1)		Class C Ordinary Shares(1)		Total Number of Ordinary Shares
		Authorized	Issued	Authorized	Issued	Authorized	Issued and Outstanding

Balance at January 1, 2024		500,000,000	60,466,453	100,000,000	2,505,476	600,000,000	62,971,929
Conversion of Class C Ordinary Shares into Class A Ordinary Shares		—	1,493,356	—	(1,493,356)	—	—
Issuance of Class A Ordinary Shares under the ATM facility		—	914,828	—	—	—	914,828
Cancellation of Class C shares following an employee contract termination in MoonLake AG		—	—	—	(16,853)	—	(16,853)
Balance at March 31, 2024		500,000,000	62,874,637	100,000,000	995,267	600,000,000	63,869,904
Balance at June 30, 2024		500,000,000	62,874,637	100,000,000	995,267	600,000,000	63,869,904
Conversion of Class C Ordinary Shares into Class A Ordinary Shares		—	153,998	—	(153,998)	—	—
Options exercised under the Equity Incentive Plan		—	17,390	—	—	—	17,390
Balance at September 30, 2024		500,000,000	63,046,025	100,000,000	841,269	600,000,000	63,887,294


Weighted average assumptions for the awards issued during the nine months ended September 30, 2024
Estimated fair value of the option on the grant date using Black-Scholes model ($)			31.31
Exercise price ($)			45.63
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)			4.3%
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.


Country	September 30, 2024		December 31, 2023
Switzerland	$	680,946	$	507,392
United Kingdom	2,012,806		2,704,555
Portugal	1,138,823		737,398
Total	$	3,832,575	$	3,949,345


	Total		Less than 1 year		1 to 5 Years		More than 5 years

Purchase obligations(1)	$	145,087,507	$	107,076,429	$	38,011,078	$	—
Lease commitments(2)	3,576,911		1,565,211		2,011,700		—
Total contractual obligations	$	148,664,418	$	108,641,640	$	40,022,778	$	—


Compensation Plan	Three Months Ended September 30, 2024		Three Months Ended September 30, 2023		Nine Months Ended September 30, 2024		Nine Months Ended September 30, 2023
MoonLake AG Restricted Founder Shares	$	—	$	—	$	—	$	1,574,299
ESPP	741,154		762,309		2,191,557		2,590,576


ESOP	—		255,171		—		614,469


Equity Incentive Plan	1,101,455		408,171		3,156,505		721,155
Total share-based compensation expense	$	1,842,609	$	1,425,651	$	5,348,062	$	5,500,499
Of which: included in research and development expense	508,697		262,717		1,446,049		1,150,815
Of which: included in general and administrative expense	1,333,912		1,162,934		3,902,013		4,349,684


Grants awarded
Restricted Founder Shares			Number of Shares
Awards unvested as of January 1, 2023			1,110,078
Awards vested for the nine months ended September 30, 2023			(1,110,078)
Awards unvested as of September 30, 2023			—


Grants awarded
ESOP			Number of Options
Awards outstanding as of January 1, 2023			466,770
Awards granted for the nine months ended September 30, 2023			133,444
Awards outstanding as of September 30, 2023			600,214
Awards exercisable as of September 30, 2023			186,593

Awards outstanding as of January 1, 2024			585,078

Awards converted from ESOP to Equity Incentive Plan for the nine months ended September 30, 2024			(486,685)
Awards outstanding as of September 30, 2024			98,393
Awards exercisable as of September 30, 2024			98,393


	Three Months Ended September 30, 2024		Three Months Ended September 30, 2023		Change		Change %

Operating expenses
Research and development	$	(35,735,514)	$	(7,585,136)	$	(28,150,378)	371.1	%
General and administrative	(7,376,495)		(5,391,607)		(1,984,888)		36.8	%
Total operating expenses	(43,112,009)		(12,976,743)		(30,135,266)		232.2	%
Operating loss	(43,112,009)		(12,976,743)		(30,135,266)		232.2	%



Other income, net	7,089,691		1,386,313		5,703,378		411.4	%
Loss before income tax	(36,022,318)		(11,590,430)		(24,431,888)		210.8	%

Income tax expense	(92,106)		(28,923)		(63,183)		218.5	%
Net loss	(36,114,424)		(11,619,353)		(24,495,071)		210.8	%

Net unrealized gain (loss) on marketable securities and short term investments	(325,510)		3,437,291		(3,762,801)		(109.5)	%
Actuarial gain (loss) on employee benefit plans	(115,629)		39,157		(154,786)		(395.3)	%
Other comprehensive income (loss)	(441,139)		3,476,448		(3,917,587)		(112.7)	%
Comprehensive loss	$	(36,555,563)	$	(8,142,905)	$	(28,412,658)	348.9	%


	Nine Months Ended
	September 30, 2024		September 30, 2023
Net cash used in operating activities	$	(68,113,589)	$	(30,433,841)
Net cash used in investing activities	(58,264,594)		(142,051,023)
Net cash provided by financing activities	51,161,002		451,285,093
Effect of movements in exchange rates on cash held	(295,865)		(140,047)
Net (decrease) increase in cash and cash equivalents	$	(75,513,046)	$	278,660,182


No.						Description of Exhibit
3.1						Memorandum and Articles of Association of MoonLake Immunotherapeutics (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the SEC on April 11, 2022)
31.1*						Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rules 13a-14(a) and 15(d)-14(a), as adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2*						Certification of Principal Financial and Accounting Officer Pursuant to Securities Exchange Act Rules 13a-14(a) and 15(d)-14(a), as adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1**						Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2**						Certification of Principal Financial and Accounting Officer Pursuant to 18 U.S.C. Section 1350, as adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS*						Inline XBRL Instance Document.
101.SCH*						Inline XBRL Taxonomy Extension Schema Document.
101.CAL*						Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF*						Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB*						Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE*						Inline XBRL Taxonomy Extension Presentation Linkbase Document.
104*						Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).