SEC Filing | Amylyx Pharmaceuticals, Inc.

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10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

(Mark One)


☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2023


☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ___________________ to ___________________

Commission File Number: 001-41199

Amylyx Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)


Delaware	46-4600503
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)
43 Thorndike St. Cambridge, Massachusetts	02141
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: (617) 682-0917

N/A

(Former name, former address and former fiscal year, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading
Symbol(s)

Name of each exchange on which registered

Common Stock, $0.0001 par value per share

AMLX

Nasdaq Global Select Stock Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☐
		Emerging growth company	☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of August 7, 2023, the registrant had 67,377,743 shares of common stock, $0.0001 par value per share, outstanding.

AMYLYX PHARMACEUTICALS, INC.

QUARTERLY REPORT ON FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2023

Table of Contents


		Page

PART I.	FINANCIAL INFORMATION	3

Item 1.	Financial Statements (Unaudited)	3
	Condensed Consolidated Balance Sheets	3
	Condensed Consolidated Statements of Operations	4
	Condensed Consolidated Statements of Comprehensive Income (Loss)	5
	Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity	6
	Condensed Consolidated Statements of Cash Flows	8
	Notes to Condensed Consolidated Financial Statements	9
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	19
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	33
Item 4.	Controls and Procedures	33

PART II.	OTHER INFORMATION	34

Item 1.	Legal Proceedings	34
Item 1A.	Risk Factors	34
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	93
Item 3.	Defaults Upon Senior Securities	93
Item 4.	Mine Safety Disclosures	93
Item 5.	Other Information	93
Item 6.	Exhibits	94
Signatures		95

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q, or Quarterly Report, contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. All statements other than statements of historical facts contained in this Quarterly Report are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” or the negative of these terms or other comparable terminology. These statements are not guarantees of future results or performance and involve substantial risks and uncertainties. Forward-looking statements in this Quarterly Report include, but are not limited to, express or implied statements about:

•

our ability to maintain existing and obtain additional regulatory approvals of AMX0035 and any future product candidates;

•

our ability to successfully commercialize and market AMX0035 and any future product candidates, if approved, and the timing of any commercialization and marketing efforts;

•

our ability to contract with third-party suppliers, manufacturers and other service providers and their ability to perform adequately and to produce sufficient quantities of clinical and commercial supplies;

•

the potential market size, opportunity, demand and growth potential for AMX0035 and any future product candidates, if approved;

•

our ability to build and maintain our own sales and marketing capabilities, or seek collaborative partners, to commercialize AMX0035 and any future product candidates, if approved;

•

our ability to obtain funding for our operations;

•

the initiation, timing, progress and results of our preclinical studies and clinical trials, including our Phase 3 clinical trial of AMX0035 for the treatment of amyotrophic lateral sclerosis, or ALS, known as the PHOENIX trial, our Phase 3 clinical trial of AMX0035 for the treatment of progressive supranuclear palsy, or PSP, known as the ORION trial, and our Phase 2 clinical trial of AMX0035 for the treatment of Wolfram syndrome, known as the HELIOS trial, and our research and development activities;

•

our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals;

•

our ability to continue to advance AMX0035 and advance any future product candidates into, and successfully complete, clinical trials;

•

our ability to successfully recruit and enroll suitable patients in our clinical trials;

•

the timing or likelihood of the accomplishment of various scientific, clinical, regulatory filings and approvals and other product development objectives, including the timing and outcome of a decision by the European Medicines Agency, or the EMA, regarding whether to approve AMX0035 for the treatment of adults with ALS following a re-examination procedure;

•

the pricing and reimbursement of AMX0035 in the U.S., Canada and in any other jurisdictions in which AMX0035 is approved, if any, and of any other product candidates, if approved;

•

the rate and degree of market acceptance of AMX0035 and any future product candidates by physicians, patients, third-party payors and others in the medical community;

•

the implementation of our business model, strategic plans for our business, product candidates and technology;

•

the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;

•

developments relating to our competitors and our industry, including any regulatory developments;

•

our estimates regarding expenses, revenue, capital requirements, cash runway and future and needs for additional financing;

•

our financial performance;

•

the effect of global economic uncertainty and financial market volatility caused by economic effects of rising inflation and interest rates, the COVID-19 pandemic or any future outbreak of any highly infectious or contagious diseases, geopolitical instability, changes in international trade relationships and military conflicts, such as the ongoing conflict between Russia and Ukraine, on any of the foregoing or other aspects of our business or operations; and

•

other statements about future events, including those listed under the section entitled “Risk factors”.

Any forward-looking statements in this Quarterly Report reflect our current views with respect to future events and with respect to our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those described under the section titled “Risk Factors” and elsewhere in this Quarterly Report. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.

All of our forward-looking statements are as of the date of this Quarterly Report only. In each case, actual results may differ materially from such forward-looking information. We can give no assurance that such expectations or forward-looking statements will prove to be correct. An occurrence of or any material adverse change in one or more of the risk factors or risks and uncertainties referred to in this Quarterly Report or included in our other public disclosures or our other periodic reports or other documents or filings filed with or furnished to the Securities and Exchange Commission, or the SEC, could materially and adversely affect our business, prospects, financial condition and results of operations. Except as required by law, we do not undertake or plan to update or revise any such forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or projections or other circumstances affecting such forward-looking statements occurring after the date of this Quarterly Report, even if such results, changes or circumstances make it clear that any forward-looking information will not be realized. Any public statements or disclosures by us following this Quarterly Report that modify or impact any of the forward-looking statements contained in this Quarterly Report will be deemed to modify or supersede such statements in this Quarterly Report.

We may from time to time provide estimates, projections and other information concerning our industry, the general business environment, and the markets for certain diseases, including estimates regarding the potential size of those markets and the estimated incidence and prevalence of certain medical conditions. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties, and actual events, circumstances or numbers, including actual disease prevalence rates and market size, may differ materially from the information reflected in this Quarterly Report. Unless otherwise expressly stated, we obtained this industry, business information, market data, prevalence information and other data from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data, and similar sources, in some cases applying our own assumptions and analysis that may, in the future, prove not to have been accurate.

TRADEMARKS

Solely for convenience, our trademarks and trade names in this report are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that we will not assert, to the fullest extent under applicable law, our rights thereto.

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

AMYLYX PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share data)

(Unaudited)


	June 30, 2023			December 31, 2022
Assets
Current assets:
Cash and cash equivalents	$	247,760		$	62,526
Short-term investments		109,516			284,419
Accounts receivable, net		33,473			15,306
Inventories		24,858			9,769
Prepaid expenses and other current assets		11,787			10,113
Total current assets		427,394			382,133
Property and equipment, net		2,637			2,611
Restricted cash equivalents		719			719
Operating lease right-of-use assets		4,643			5,524
Long-term inventories		17,729			—
Other assets		466			466
Total assets	$	453,588		$	391,453
Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity
Current liabilities:
Accounts payable	$	24,695		$	6,257
Accrued expenses		37,241			38,312
Operating lease liabilities, current portion		2,146			2,040
Total current liabilities		64,082			46,609
Operating lease liabilities, net of current portion		3,141			4,237
Total liabilities		67,223			50,846
Commitments and contingencies (Note 13)
Stockholders’ equity:
Preferred stock, $0.0001 par value; 10,000,000 shares authorized no shares issued or outstanding		—			—
Common stock, $0.0001 par value; 300,000,000 shares authorized; 67,354,417 and 66,512,011 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively		7			7
Additional paid-in capital		717,003			694,906
Accumulated deficit		(330,573	)		(354,220	)
Accumulated other comprehensive loss		(72	)		(86	)
Total stockholders’ equity		386,365			340,607
Total liabilities, redeemable convertible preferred stock and stockholders’ equity	$	453,588		$	391,453

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

AMYLYX PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share data)

(Unaudited)


	Three Months Ended June 30,						Six Months Ended June 30,
	2023			2022			2023			2022
Product revenue, net	$	98,216		$	—		$	169,644		$	—
Operating expenses:
Cost of sales		5,580			—			10,863			—
Research and development		29,044			24,259			53,236			45,723
Selling, general and administrative		43,391			29,994			87,397			56,344
Total operating expenses		78,015			54,253			151,496			102,067
Income (loss) from operations		20,201			(54,253	)		18,148			(102,067	)
Other income, net:
Interest income		3,887			402			7,605			533
Other expense, net		(81	)		(42	)		(343	)		(61	)
Total other income, net		3,806			360			7,262			472
Income (loss) before income taxes		24,007			(53,893	)		25,410			(101,595	)
Provision for income taxes		1,933			174			1,763			320
Net income (loss)	$	22,074		$	(54,067	)	$	23,647		$	(101,915	)

Net income (loss) per share attributable to common stockholders
Basic	$	0.33		$	(0.93	)	$	0.35		$	(1.85	)
Diluted	$	0.31		$	(0.93	)	$	0.34		$	(1.85	)
Weighted-average shares used in computing net income (loss) per share attributable to common stockholders
Basic		67,233,617			58,275,903			66,976,871			54,958,537
Diluted		70,132,040			58,275,903			70,471,821			54,958,537

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

AMYLYX PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(in thousands)

(Unaudited)


	Three Months Ended June 30,						Six Months Ended June 30,
	2023			2022			2023			2022
Net income (loss)	$	22,074		$	(54,067	)	$	23,647		$	(101,915	)
Other comprehensive income (loss):
Foreign currency translation gain (loss)		(18	)		58			60			(10	)
Net unrealized loss on investments held		(79	)		(103	)		(46	)		(195	)
Other comprehensive income (loss)		(97	)		(45	)		14			(205	)
Comprehensive income (loss)	$	21,977		$	(54,112	)	$	23,661		$	(102,120	)

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

AMYLYX PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY

(in thousands, except share data)

(Unaudited)


	Series A Redeemable Convertible Preferred Stock				Series B Redeemable Convertible Preferred Stock				Series C-1 Redeemable Convertible Preferred Stock				Series C-2 Redeemable Convertible Preferred Stock				Common Stock				Additional Paid-In		Accumulated Other Comprehensive			Accumulated			Total Stockholders’
	Shares		Amount		Shares		Amount		Shares		Amount		Shares		Amount		Shares		Amount		Capital		Income (Loss)			Deficit			Equity
Balance as of December 31, 2022		—	$	—		—	$	—		—	$	—		—	$	—		66,512,011	$	7	$	694,906	$	(86	)	$	(354,220	)	$	340,607
Issuance of common stock upon exercise of stock options		—		—		—		—		—		—		—		—		451,298		—		2,777		—			—			2,777
Issuance of common stock upon vesting of RSUs		—		—		—		—		—		—		—		—		132,294		—		—		—			—			—
Stock-based compensation expense		—		—		—		—		—		—		—		—		—		—		7,580		—			—			7,580
Other comprehensive income		—		—		—		—		—		—		—		—		—		—		—		111			—			111
Net income		—		—		—		—		—		—		—		—		—		—		—		—			1,573			1,573
Balance as of March 31, 2023		—	$	—		—	$	—		—	$	—		—	$	—		67,095,603	$	7	$	705,263	$	25		$	(352,647	)	$	352,648
Issuance of common stock upon exercise of stock options		—		—		—		—		—		—		—		—		226,138		—		1,687		—			—			1,687
Issuance of common stock upon vesting of RSUs		—		—		—		—		—		—		—		—		32,676		—		—		—			—			—
Stock-based compensation expense		—		—		—		—		—		—		—		—		—		—		10,053		—			—			10,053
Other comprehensive loss		—		—		—		—		—		—		—		—		—		—		—		(97	)		—			(97	)
Net income		—		—		—		—		—		—		—		—		—		—		—		—			22,074			22,074
Balance as of June 30, 2023		—	$	—		—	$	—		—	$	—		—	$	—		67,354,417	$	7	$	717,003	$	(72	)	$	(330,573	)	$	386,365


	Series A Redeemable Convertible Preferred Stock				Series B Redeemable Convertible Preferred Stock				Series C-1 Redeemable Convertible Preferred Stock				Series C-2 Redeemable Convertible Preferred Stock				Common Stock				Additional Paid-In		Accumulated Other Comprehensive			Accumulated			Total Stockholders’
	Shares		Amount		Shares		Amount		Shares		Amount		Shares		Amount		Shares		Amount		Capital		Income (Loss)			Deficit			(Deficit) Equity
Balance as of December 31, 2021		6,289,609