0001658551false00016585512023-05-112023-05-11

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 11, 2023

AMYLYX PHARMACEUTICALS, INC.

(Exact name of Registrant as Specified in Its Charter)

Delaware	001-41199	46-4600503
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)
43 Thorndike, St., Cambridge, MA		02141
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s Telephone Number, Including Area Code: (617) 682-0917

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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 Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

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. ☐

 

 

---

Item 2.02 Results of Operations and Financial Condition.

 

On May 11, 2023, Amylyx Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended March 31, 2023. A copy of the press release is furnished as Exhibit 99.1 hereto.

The information provided in this Form 8-K, including Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 9.01 Financial Statements and Exhibits

(d) Exhibits.

 

Exhibit Number		Description
99.1		Press Release of the Company, dated May 11, 2023
104		Cover Page Interactive Data File (embedded with the Inline XBRL document).

 

---

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

		AMYLYX PHARMACEUTICALS, INC.
Date: May 11, 2023		By:	/s/ James M. Frates
			James M. Frates
			Chief Financial Officer

 

 

---

 

 

Exhibit 99.1

 

Amylyx Pharmaceuticals Reports First Quarter 2023 Financial Results

 

 

 

 

 

CAMBRIDGE, Mass. May 11, 2023 – Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the first quarter ended March 31, 2023.

 

“During the first quarter, we made significant progress on our commercial launches of RELYVRIO in the U.S. and ALBRIOZA in Canada as we advanced our goal of ensuring efficient access for every eligible person living with ALS. We continue to see strong engagement and interest from physicians and the ALS community and are encouraged that the vast majority of payors who have published formal policy decisions are providing broad access to RELYVRIO. We remain focused on our key commercial priorities to drive awareness, educate payors, and help people gain access to therapy as quickly as possible,” said Joshua Cohen, co-CEO of Amylyx. “We also continue to engage with the European Medicines Agency as it reviews our Marketing Authorisation Application for AMX0035 and continue to expect a decision later this year.”
 

 

Justin Klee, co-CEO of Amylyx, added, “We are pleased with our recent progress but understand there is much more work to be done to achieve our mission of one day ending the suffering caused by ALS and other neurodegenerative diseases. With this in mind, we are excited to announce our plans to initiate a new Phase 3 study of AMX0035 in progressive supranuclear palsy later this year, supported by findings from our PEGASUS Phase 2 study in Alzheimer’s disease as well as a number of preclinical studies which indicate the potential for AMX0035 to lower levels of tau, a biomarker often seen in people with neurodegenerative diseases, including PSP.”
 

 

First Quarter 2023 and Recent Business Highlights:

 

 

 

 

1

---

 

 

 

 

 

 

Financial Results for the First Quarter Ended March 31, 2023

 

For the three months ended March 31, 2023, net product revenue was $71.4 million and cost of sales were $5.3 million. Both net product revenue and cost of sales during the period were attributable to sales of RELYVRIO in the U.S. and ALBRIOZA in Canada. There were no product revenues or cost of sales for the comparable period in 2022.

Research and development expenses were $24.2 million for the three months ended March 31, 2023, compared to $21.5 million for the same period in 2022. The increase was mainly driven by an increase in personnel-related expenses due to added headcount to support research and development efforts.

Selling, general and administrative expenses were $44.0 million for the three months ended March 31, 2023, compared to $26.3 million for the same period in 2022. The increase was mainly driven by higher personnel-related expenses due to added headcount to support our growth, as well as commercialization initiatives.

Net income for the three months ended March 31, 2023, was $1.6 million, or $0.02 per share, compared to a net loss of $47.8 million, or $0.93 per share for the same period in 2022.

Cash, cash equivalents, and short-term investments were $345.7 million at March 31, 2023, compared to $346.9 million at December 31, 2022.

Investor Conference Call Information

Amylyx’ management team will host a conference call and webcast today, May 11, 2023, at 4:30 p.m. ET to discuss financial results and provide an update on the business. To access the conference call, please dial (833) 816-1395 (U.S.) or +1 (412) 317-0488 (international) at least 10 minutes prior to the start time and ask to be joined into the Amylyx Pharmaceuticals call. A live audio webcast of the call will be available under “Events and Presentations” in the Investor section of the Company’s website, https://investors.amylyx.com/news-events/events. The webcast will be archived and available for replay for 90 days following the event.

2

---

 

 

Available Information

We periodically provide other information for investors on our corporate website, https://amylyx.com, and our investor relations website, https://investors.amylyx.com. This includes press releases and other information about financial performance, information on corporate governance, and details related to our annual meeting of stockholders. We intend to use our website as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD. Accordingly, investors should monitor our website, in addition to following the Company's press releases, SEC filings, and public conference calls and webcasts.

 

About RELYVRIO®/ALBRIOZA™ /AMX0035
 

RELYVRIO®, an oral, fixed-dose medication of sodium phenylbutyrate and taurursodiol (known as ursodoxicoltaurine outside of the U.S.), is approved to treat amyotrophic lateral sclerosis (ALS) in adults in the U.S. and approved with conditions as ALBRIOZA™ for the treatment of ALS in Canada. Additionally, the European Medicines Agency (EMA) is reviewing the Company’s Marketing Authorisation Application for AMX0035 for the treatment of ALS in Europe. AMX0035 is being explored for the potential treatment of other neurodegenerative diseases. The formulation of RELYVRIO, ALBRIOZA and AMX0035 are identical.

 

RELYVRIO® (sodium phenylbutyrate and taurursodiol) Safety Information for United States

 

WARNINGS AND PRECAUTIONS

 

Risk in Patients with Enterohepatic Circulation Disorders, Pancreatic Disorders, or Intestinal Disorders

 

RELYVRIO contains taurursodiol, which is a bile acid. In patients with disorders that interfere with bile acid circulation, there may be an increased risk for worsening diarrhea, and patients should be monitored appropriately for this adverse reaction. Pancreatic insufficiency, intestinal malabsorption, or intestinal diseases that may alter the concentration of bile acids may also lead to decreased absorption of either of the components of RELYVRIO. Because different enterohepatic circulation, pancreatic, and intestinal disorders have varying degrees of severity, consider consulting with a specialist. Patients with disorders of enterohepatic circulation (e.g., biliary infection, active cholecystitis), severe pancreatic disorders (e.g., pancreatitis), and intestinal disorders that may alter concentrations of bile acids (e.g., ileal resection, regional ileitis) were excluded from the study; therefore, there is no clinical experience in these conditions.

Use in Patients Sensitive to High Sodium Intake

 

RELYVRIO has a high salt content. Each initial daily dosage of 1 packet contains 464 mg of sodium; each maintenance dosage of 2 packets daily contains 928 mg of sodium. In patients sensitive to salt intake (e.g., those with heart failure, hypertension, or renal impairment), consider the amount of daily sodium intake in each dose of RELYVRIO and monitor appropriately.

 

ADVERSE REACTIONS

 

The most common adverse reactions (at least 15% and at least 5% greater than placebo) with RELYVRIO were diarrhea, abdominal pain, nausea, and upper respiratory tract infection. Gastrointestinal-related adverse reactions occurred throughout the study but were more frequent during the first 3 weeks of treatment.

 

Please click here for RELYVRIO Full U.S. Prescribing Information.

 

About Amylyx Pharmaceuticals

 

Amylyx Pharmaceuticals, Inc. is committed to supporting and creating more moments for the neurodegenerative community through the discovery and development of innovative new treatments. Amylyx is headquartered in Cambridge, Massachusetts and has operations in Canada and EMEA. For more information, visit amylyx.com and follow us on LinkedIn and Twitter. For investors, please visit investors.amylyx.com.

 

Forward-Looking Statements

3

---

 

 

Statements contained in this press release and related comments in our earnings conference call regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the potential approval of AMX0035 for the treatment of ALS in the European Union; the timing of an anticipated decision in Europe regarding whether to approve AMX0035 for the treatment of ALS; the potential of AMX0035 (sodium phenylbutyrate and taurursodiol) as a treatment for ALS and other neurodegenerative diseases including Wolfram syndrome and progressive supranuclear palsy; the ongoing commercialization of RELYVRIO and ALBRIOZA; the potential continued market acceptance and market opportunity for RELYVRIO and ALBRIOZA; statements regarding coverage and policy decisions by insurance plans related to RELYVRIO and ALBRIOZA and whether those decisions will be favorable; expectations regarding access to and coverage for RELYVRIO and ALBRIOZA; our ability to execute a successful launch in Europe, if approval is obtained; the Company’s expectations with respect to completion of and the timing of results from its ongoing PHOENIX trial; the potential for new pipeline programs and clinical indications for AMX0035; statements regarding regulatory developments, including those relating to the Company’s ongoing clinical trial of AMX0035 in Wolfram syndrome; the Company’s expectations with respect to its planned clinical trial of AMX0035 in patients with PSP; the anticipated commercialization of AMX0035 for the treatment of ALS,ra subject to regulatory review and approval, in Israel, Gaza, West Bank, and the Palestinian Authority; the anticipated benefits of strategic new hires; the Company’s expectations regarding its financial performance, the anticipated ramp in its R&D and SG&A expenses, gross-to-net revenue and its ability to achieve break even cash flow; and expectations regarding the Company’s longer-term strategy. Any forward-looking statements in this press release and related comments in the Company's earnings conference call are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of Amylyx’ program development activities, Amylyx’ ability to successfully commercialize RELYVRIO in the United States and ALBRIOZA in Canada, Amylyx’ ability to execute on its commercial and regulatory strategy, regulatory developments, expectations regarding the timing of EMA review of AMX0035 for the treatment of ALS, Amylyx’ ability to fund operations, and the impact that the ongoing COVID-19 pandemic, global macroeconomic uncertainty and geopolitical instability will have on Amylyx’ operations, as well as the risks and uncertainties set forth in Amylyx’ United States Securities and Exchange Commission (SEC) filings, including Amylyx’ Annual Report on Form 10-K for the year ended December 31, 2022, and subsequent filings with the SEC. All forward-looking statements contained in this press release and related comments in our earnings conference call speak only as of the date on which they were made. Amylyx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

 

4

---

 

 

 

 

AMYLYX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
UNAUDITED
(in thousands)
		March 31, 2023				December 31, 2022
Assets
Cash, cash equivalents and short-term investments		$	345,674			$	346,945
Prepaid expenses and other current assets			12,749				10,113
Accounts receivable, net			17,555				15,306
Inventories			23,148				9,769
Other assets			8,832				9,320
Total assets		$	407,958			$	391,453
Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)
Accounts payable and accrued expenses		$	49,523			$	44,569
Other liabilities			5,787				6,277
Total liabilities			55,310				50,846
Stockholders’ equity (deficit)			352,648				340,607
Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit)		$	407,958			$	391,453

 

AMYLYX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
UNAUDITED
(in thousands, except share and per share data)
		Three Months Ended March 31,
		2023				2022
Product revenue, net		$	71,428			$	—
Operating expenses:
Cost of sales			5,283				—
Research and development			24,192				21,464
Selling, general and administrative			44,006				26,350
Total operating expenses			73,481				47,814
Loss from operations			(2,053	)			(47,814	)
Other income, net			3,456				112
Income (loss) before income taxes			1,403				(47,702	)
(Benefit) provision for income taxes			(170	)			146
Net income (loss)		$	1,573			$	(47,848	)
Net income (loss) per share attributable to common stockholders
Basic		$	0.02			$	(0.93	)
Diluted		$	0.02			$	(0.93	)
Weighted-average shares used in computing net income (loss) per share attributable to common stockholders
Basic			66,717,271				51,604,310
Diluted			70,863,665				51,604,310

 

 

 

 

5

---

 

 

Contacts

 

Media

Amylyx Media Team

+1 (857) 799-7274
 

amylyxmediateam@amylyx.com

 

Investors
Lindsey Allen
Amylyx Pharmaceuticals, Inc.
+1 (857) 320-6244
Investors@amylyx.com

 

6

---