UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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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 November 10, 2022, Amylyx Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended September 30, 2022. 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 |
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Description |
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded with the Inline XBRL document). |
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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.
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AMYLYX PHARMACEUTICALS, INC. |
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Date: November 10, 2022 |
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By: |
/s/ James M. Frates |
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James M. Frates |
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Chief Financial Officer |
Exhibit 99.1
Amylyx Pharmaceuticals Reports Third Quarter 2022 Financial Results
CAMBRIDGE, Mass. Nov. 10, 2022 -- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the quarter ended September 30, 2022.
“The third quarter has proven to be a transformative time for Amylyx and the ALS community, marked by the regulatory approval of our new oral therapy for the treatment of ALS in the United States and commercial availability of our first product in Canada,” said Joshua Cohen and Justin Klee, Co-CEOs of Amylyx. “We are thrilled that RELYVRIO and ALBRIOZA are now available to people living with ALS in the U.S. and Canada, and we are encouraged by the early trajectory of enrollment in our Amylyx Care Team (ACT) Support Program as well as the rate of new prescriptions for this important new therapeutic option. We continue to work expeditiously during the early stages of our commercial launch to ensure every elibible person living with ALS will gain access as quickly and efficiently as possible.”
Third Quarter 2022 and Recent Business Highlights:
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Financial Results for the Third Quarter Ended September 30, 2022
For the quarter ended September 30, 2022, net product revenue was $0.3 million and cost of sales were $0.2 million. Both net product revenue and cost of sales during the period were attributable to sales of ALBRIOZA in Canada. There were no product revenues or cost of sales for the comparable period in 2021.
Research and development expenses were $24.9 million for the quarter ended September 30, 2022, compared to $12.9 million for the quarter ended September 30, 2021. The increase was mainly driven by higher product manufacturing and development expenses in support of the global Phase 3 PHOENIX clinical trial and launch preparation activities for commercialization, as well as additional personnel-related expenses due to new headcount to support research and development efforts.
Selling, general and administrative expenses were $29.9 million for the quarter ended September 30, 2022, compared to $10.4 million for the quarter ended September 30, 2021. The increase was mainly driven by higher personnel-related expenses to support launch preparation initiatives as well as increased expenses for commercial readiness activities and operations as a public company.
Net loss for the quarter ended September 30, 2022, was $53.8 million, or $0.92 per share, compared to a net loss of $23.1 million, or $3.42 per share, for the same period in 2021.
Cash, cash equivalents and short-term investments were $162.6 million at September 30, 2022, compared to $206.7 million at June 30, 2022. The September 30, 2022 balance excludes aggregate net proceeds from Amylyx’ upsized public offering of common stock of $230.8 million after deducting underwriting discounts and commissions and offering expenses, which closed on October 11, 2022.
Investor Conference Call Information
Amylyx’ management team will host a conference call and webcast today, November 10, 2022, at 4:30 p.m. Eastern Time to discuss financial results and provide an update on the business. To access the conference call, please dial (877) 870-4263 (local) or (412) 317-0790 (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.
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™
RELYVRIO™ (sodium phenylbutyrate and taurursodiol) is an oral, fixed-dose medication approved to treat amyotrophic lateral sclerosis (ALS) in adults in the U.S. and approved with conditions as ALBRIOZA™ (sodium phenylbutyrate and ursodoxicoltaurine) for the treatment of ALS in Canada. Additionally, the European Medicines
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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.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR RELYVRIO (sodium phenylbutyrate and taurursodiol), for oral suspension
INDICATION
RELYVRIO is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults.
IMPORTANT SAFETY INFORMATION
Before you receive RELYVRIO, tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements and any taurursodiol products, such as tauroursodeoxycholic acid (TUDCA).
RELYVRIO may affect the way other medicines work, and other medicines may affect how RELYVRIO works.
What are the possible side effects of RELYVRIO?
RELYVRIO may cause serious side effects, including:
The most common side effects of RELYVRIO include diarrhea, abdominal pain, nausea, and upper respiratory tract infection.
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of RELYVRIO. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For more information about RELYVRIO, please see the full Prescribing Information and Medication Guide.
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.
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Forward-Looking Statements
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 sodium phenylbutyrate and taurursodiol for the treatment of ALS in countries other than the United States and Canada; the timing of an anticipated decision from the EMA regarding whether to approve AMX0035 for the treatment of ALS and our ability to resolve remaining major objections as part of the MAA process; the potential of sodium phenylbutyrate and taurursodiol as a treatment for ALS and the Company’s plans to explore the use of sodium phenylbutyrate and taurursodiol for other neurodegenerative diseases; the potential market acceptance and market opportunity for RELYVRIO and ALBRIOZA; the initial demand for RELYVRIO and our expectations around the timing of receipt of revenue from RELYVRIO; the anticipated timing of coverage and policy decisions by insurance plans related to RELYVRIO and whether those decisions will be favorable; the Company’s ability to maintain commercial availability of RELYVRIO in the United States and ALBRIOZA in Canada, as well as access to and coverage for RELYVRIO; our expectations with respect to recruitment and completion of our ongoing PHOENIX trial; the anticipated ramp in our selling, general and administrative expenses; and expectations regarding the Company’s longer-term strategy. Any forward-looking statements in this press release 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 launch RELYVRIO in the United States, 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’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, and subsequent filings with the SEC. All forward-looking statements contained in this press release 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.
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AMYLYX PHARMACEUTICALS, INC. |
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CONDENSED CONSOLIDATED BALANCE SHEETS |
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UNAUDITED |
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(in thousands) |
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September 30, 2022 |
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December 31, 2021 |
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Assets |
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Cash, cash equivalents and short-term investments |
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$ |
162,593 |
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$ |
96,118 |
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Prepaid expenses and other current assets |
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8,336 |
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5,392 |
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Accounts receivable, net |
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137 |
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— |
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Inventories |
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563 |
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— |
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Deferred offering costs |
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570 |
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3,441 |
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Other assets |
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9,244 |
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663 |
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Total assets |
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$ |
181,443 |
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$ |
105,614 |
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Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) |
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Accounts payable and accrued expenses |
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$ |
30,657 |
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$ |
17,396 |
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Other liabilities |
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6,758 |
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35 |
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Total liabilities |
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37,415 |
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17,431 |
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Redeemable convertible preferred stock |
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— |
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239,351 |
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Stockholders’ equity (deficit) |
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144,028 |
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(151,168 |
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Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) |
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$ |
181,443 |
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$ |
105,614 |
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AMYLYX PHARMACEUTICALS, INC. |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
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UNAUDITED |
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(in thousands, except share and per share data) |
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2022 |
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2021 |
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2022 |
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2021 |
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Revenues: |
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Product revenue, net |
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$ |
345 |
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$ |
— |
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$ |
345 |
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$ |
— |
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Grant revenue |
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— |
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285 |
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— |
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285 |
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Total revenues |
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345 |
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285 |
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345 |
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285 |
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Operating expenses: |
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Cost of sales |
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172 |
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— |
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172 |
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— |
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Research and development |
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24,914 |
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12,853 |
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70,637 |
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30,646 |
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Selling, general and administrative |
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29,940 |
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10,350 |
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86,284 |
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24,012 |
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Total operating expenses |
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55,026 |
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23,203 |
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157,093 |
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54,658 |
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Loss from operations |
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(54,681 |
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(22,918 |
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(156,748 |
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(54,373 |
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Other income (expense), net |
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800 |
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(224 |
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1,272 |
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(5,214 |
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Loss before income taxes |
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(53,881 |
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(23,142 |
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(155,476 |
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(59,587 |
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(Benefit) provision for income taxes |
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(125 |
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— |
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195 |
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— |
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Net loss |
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$ |
(53,756 |
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$ |
(23,142 |
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$ |
(155,671 |
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$ |
(59,587 |
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Net loss per share attributable to common stockholders —basic and diluted |
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$ |
(0.92 |
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$ |
(3.42 |
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$ |
(2.77 |
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$ |
(9.20 |
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Weighted-average shares used in computing net loss |
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58,533,226 |
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6,757,152 |
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56,163,194 |
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6,477,140 |
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Contacts
Media
Becky Gohsler
Finn Partners
(646) 307-6307
amylyxmediateam@amylyx.com
Investors
Lindsey Allen
Amylyx Pharmaceuticals, Inc.
(857) 320-6244
Investors@amylyx.com
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