Rhythm Pharmaceuticals Files 8-K

Ticker: RYTM · Form: 8-K · Filed: Jan 10, 2025 · CIK: 1649904

Rhythm Pharmaceuticals, Inc. 8-K Filing Summary
FieldDetail
CompanyRhythm Pharmaceuticals, Inc. (RYTM)
Form Type8-K
Filed DateJan 10, 2025
Risk Levellow
Pages6
Reading Time7 min
Key Dollar Amounts$0.001, $42 million, $130 million
Sentimentneutral

Sentiment: neutral

Topics: financial-condition, operations, filing

Related Tickers: RYTM

TL;DR

RHYTHM PHARMACEUTICALS FILED AN 8-K ON JAN 10, 2025, COVERING FINANCIALS AND OTHER EVENTS.

AI Summary

Rhythm Pharmaceuticals, Inc. filed an 8-K on January 10, 2025, reporting on results of operations and financial condition, Regulation FD disclosures, and other events. The filing also includes financial statements and exhibits. The company is incorporated in Delaware and its principal executive offices are located in Boston, MA.

Why It Matters

This 8-K filing provides an update on Rhythm Pharmaceuticals' financial condition and operational results, which is crucial for investors to assess the company's performance and future prospects.

Risk Assessment

Risk Level: low — This filing is a routine 8-K reporting on financial condition and other events, without any specific material adverse or positive news disclosed.

Key Players & Entities

  • RHYTHM PHARMACEUTICALS, INC. (company) — Registrant
  • Delaware (jurisdiction) — State of incorporation
  • Boston, MA (location) — Principal executive offices
  • January 10, 2025 (date) — Date of earliest event reported

FAQ

What is the primary purpose of this 8-K filing by Rhythm Pharmaceuticals?

The primary purpose of this 8-K filing is to report on the Results of Operations and Financial Condition, Regulation FD Disclosure, Other Events, and to include Financial Statements and Exhibits.

When was the earliest event reported in this filing?

The earliest event reported in this filing was on January 10, 2025.

Where are Rhythm Pharmaceuticals' principal executive offices located?

Rhythm Pharmaceuticals' principal executive offices are located at 222 Berkeley Street, 12th Floor, Boston, MA 02116.

What is the state of incorporation for Rhythm Pharmaceuticals?

Rhythm Pharmaceuticals is incorporated in Delaware.

What is the SEC file number for Rhythm Pharmaceuticals?

The SEC file number for Rhythm Pharmaceuticals is 001-38223.

Filing Stats: 1,791 words · 7 min read · ~6 pages · Grade level 13 · Accepted 2025-01-10 07:17:23

Key Financial Figures

  • $0.001 — ange on which registered Common Stock, $0.001 par value per share RYTM The Nasdaq
  • $42 million — CIVREE (setmelanotide) of approximately $42 million for the fourth quarter of 2024, an incr
  • $130 million — hird quarter of 2024, and approximately $130 million for the full year of 2024. The sequenti

Filing Documents

02. Results of Operations and Financial Condition

Item 2.02. Results of Operations and Financial Condition. On January 10, 2025, Rhythm Pharmaceuticals, Inc. (the "Company") issued a press release announcing, among other things, the Company's preliminary unaudited net product revenues for the fourth quarter of 2024 and the fiscal year ended December 31, 2024. The full text of the press release issued by the Company is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information contained in Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1 ) shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the "Securities Act"), or the Exchange Act, except as expressly provided by specific reference in such a filing.

01. Regulation FD Disclosure

Item 7.01. Regulation FD Disclosure. On January 10, 2025, in connection with its participation in the J.P. Morgan Healthcare Conference, the Company posted a corporate slide presentation in the "Investors" portion of its website at www.rhythmtx.com. A copy of the presentation is furnished as Exhibit 99.2 to this Current Report on Form 8-K. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.2. The information contained in Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.2) shall not be deemed "filed" for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act, or the Exchange Act, except as expressly provided by specific reference in such a filing.

01. Other Events

Item 8.01. Other Events. On January 10, 2025, the Company announced preliminary unaudited net revenues from global sales of IMCIVREE (setmelanotide) of approximately $42 million for the fourth quarter of 2024, an increase of 26% on a sequential basis from the third quarter of 2024, and approximately $130 million for the full year of 2024. The sequential quarter-over-quarter increase was due to growth in reimbursed patients on therapy and inventory growth in the United States. U.S. sales of IMCIVREE contributed approximately 74% of the fourth quarter preliminary unaudited net product revenues and approximately 73% of the full year 2024 preliminary unaudited net product revenues. The Company also provided the following clinical development updates: The Company is on track to report topline data from its Phase 3 trial evaluating setmelanotide in acquired hypothalamic obesity (the "Phase 3 acquired HO trial") in the first half of 2025. The Company completed enrollment in the supplemental, 12-patient Japanese cohort of the Phase 3 acquired HO trial. Data from this supplemental cohort will serve as the basis for a regulatory submission in Japan. The Company anticipates enrolling the first patients with congenital HO in a 34-week substudy of the Phase 3 acquired HO trial in the first quarter of 2025. This substudy is independent from the Phase 3 acquired HO trial. The Company completed enrollment in the Phase 3 EMANATE trial, which is comprised of four substudies: SH2B1 (n=121); POMC and/or PCSK1 (n=79); SRC1 (n=73); and LEPR (n=23). The four-substudy design of this trial allows for independent data readouts and potential registration for each genetic cohort. The primary endpoint for each substudy is the difference in mean percent change in BMI from baseline to 52 weeks in the setmelanotide arm compared to the placebo arm. The Company anticipates reporting topline data from the Phase 3 EMANATE trial in the first half of 2026. The Company plans to initiate a new

Forward-Looking Statements

Forward-Looking Statements This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the Company's anticipated financial performance for any period of time, including preliminary unaudited revenues, for the fourth quarter and full year ending December 31, 2024; the potential, safety, efficacy, and regulatory and clinical progress, potential regulatory submissions, approvals and timing thereof of setmelanotide and other product candidates, including bivamelagon (LB54640) and RM-718; the announcement of data from our clinical trials, including our global Phase 3 trial evaluating setmelanotide in patients with acquired hypothalamic obesity; the ongoing enrollment of patients in our clinical trials; our participation in upcoming events and presentations; and the timing of any of the foregoing. Statements using words such as "expect", "anticipate", "believe", "may", "will", "aim" and similar terms are also forward-looking statements. Such statements are subject to numerous risks and uncertainties, including, but not limited to, our actual financial results for the fourth quarter and full year 2024 may differ from our preliminary estimates; our ability to enroll patients in clinical trials, the design and outcome of clinical trials, the ability to achieve necessary regulatory approvals, risks associated with data analysis and reporting, failure to identify and develop additional product candidates, unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, risks associated with the laws and regulations governing our international operations and the costs of any related compliance programs, the impact of competition, risks relating to product liability

01. Financial Statements and Exhibits

Item 9.01. Financial Statements and Exhibits. (d) Exhibits The following Exhibits 99.1 and 99.2 relate to Items 2.02 and 7.01, respectively, and shall each be deemed to be furnished, and not filed: Exhibit No. Description 99.1 Press release dated January 10, 2025 99.2 Corporate Presentation dated January 10, 2025 104 Cover Page Interactive Data File (embedded within the inline XBRL document)

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. RHYTHM PHARMACEUTICALS, INC. Date: January 10, 2025 By: /s/ Hunter Smith Hunter Smith Chief Financial Officer

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