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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 7, 2024
RHYTHM PHARMACEUTICALS, INC.
(Exact name of registrant as specified in
its charter)
Delaware |
|
001-38223 |
|
46-2159271 |
(State or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(IRS Employer
Identification Number) |
222 Berkeley Street
12th Floor
Boston, MA 02116
(Address of principal executive offices)
(Zip Code)
Registrant’s telephone number, including
area code: (857) 264-4280
N/A
(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, $0.001 par value per share |
RYTM |
The Nasdaq Stock Market LLC (Nasdaq Global 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 7, 2024, Rhythm Pharmaceuticals, Inc.
(the “Company”) announced its financial results for the quarter ended March 31, 2024. The full text of the press release
issued by the Company in connection with the announcement 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 attached hereto) 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, or the Exchange
Act, except as expressly provided by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
The following Exhibit 99.1 relates to Item 2.02, and shall be
deemed to be furnished, and not filed:
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: May 7, 2024 |
By: |
/s/ Hunter Smith |
|
|
Hunter Smith |
|
|
Chief Financial Officer |
Exhibit 99.1
Rhythm Pharmaceuticals Rhythm Pharmaceuticals
Reports First Quarter 2024 Financial Results and Business Update
-- First quarter 2024 net revenue from global
sales of IMCIVREE® (setmelanotide) of $26.0 million --
-- On track to submit sNDA to the FDA to treat
pediatric patients between 2 and younger than 6 years old in approved indications in second quarter of 2024 --
-- Phase 3 trial evaluating setmelanotide in
hypothalamic obesity remains on track for topline data readout in 1H 2025; dosing of first patients in Japan anticipated in 2Q 2024 --
-- Secured $150 million in convertible preferred
stock financing, funding planned operations into 2026 --
-- Management to host conference call today
at 8:00 a.m. ET --
BOSTON, May 7, 2024 – Rhythm
Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients
and their families living with rare neuroendocrine diseases, today reported financial results and provided a business update for the first
quarter ended March 31, 2024.
“We continue to execute our global strategy of delivering IMCIVREE®
(setmelanotide) to patients with hyperphagia and severe obesity caused by rare melanocortin-4 receptor (MC4R) pathway diseases,”
said David Meeker, M.D., Chair, President and Chief Executive Officer of Rhythm. “We had another solid quarter marked by steady
growth in global sales of IMCIVREE, which is now available in 14 markets.”
Dr. Meeker continued, “We remain focused on expanding the
global opportunity for setmelanotide in additional indications, most notably in hypothalamic obesity with our ongoing, global Phase 3
trial. This pivotal trial is progressing as planned, and we anticipate dosing the first patients with hypothalamic obesity in Japan in
the second quarter of 2024. In addition, we expect to submit a supplementary New Drug Application (sNDA) to the FDA seeking a label expansion
for IMCIVREE to treat pediatric patients between 2 and younger than 6 years old in approved indications in the second quarter of 2024.
While we work to maximize the setmelanotide opportunity, we are also advancing our broader MC4R portfolio with continued progress with
our RM-718 and LB54640 programs.”
First Quarter and Recent Business
Highlights
| · | Today, Rhythm announced that approximately 100 new prescriptions for IMCIVREE
for Bardet-Biedl syndrome (BBS) were written by U.S. prescribers and that the Company has received payor approval for reimbursement for
approximately 70 prescriptions during the first quarter of 2024. |
| · | On May 2, Rhythm and its collaborators delivered
one oral presentation and two posters at The Pediatric Endocrine Society’s (PES) Annual Meeting May 2-5, 2024 in Chicago, IL,
which highlighted previously disclosed data that showed setmelanotide achieved clinically meaningful weight reduction in pediatric patients
with hypothalamic obesity, BBS or POMC and LEPR deficiency obesities. |
| · | On April 29, the Company announced the publication
of results from its Phase 2 study of setmelanotide for the treatment of hypothalamic obesity in the peer-reviewed journal The Lancet
Diabetes & Endocrinology. The publication highlights that setmelanotide achieved a mean
percent reduction in BMI of 15% from baseline at 16 weeks of therapy (N=18), and preliminary data from Rhythm’s long-term extension
study showing setmelanotide achieved mean BMI reduction of approximately 26% at one year (n=12). |
| · | On April 1, 2024, Rhythm announced an investment agreement with current
shareholders, led by Perceptive Advisors LLC and its Discovery Fund and a life-sciences focused institutional investor, for the sale of
its series A convertible preferred stock (“Preferred Stock”) for gross proceeds of $150 million to the Company. This transaction
closed on April 15, 2024. |
| · | On March 25, Rhythm announced that the first
patients had been dosed in the Company’s Phase 1 clinical trial of RM-718, an investigational, weekly MC4R agonist designed to be
MC1R-sparing and to potentially avoid hyperpigmentation. |
Anticipated Upcoming Milestones
Rhythm expects to achieve the following near-term milestones:
| · | Complete submission of a supplementary New Drug Application (sNDA) to the
FDA seeking a label expansion to treat pediatric patients between 2 and younger than 6 years old in approved indications in the second
quarter of 2024, with EMA approval for this pediatric expansion potentially in the fourth quarter of 2024; |
| · | Begin dosing patients in the Japanese, 12-patient supplemental cohort of
the Phase 3 trial evaluating setmelanotide in hypothalamic obesity in the second quarter of 2024; |
| · | Begin dosing the first patients in the Phase 2 SIGNAL trial evaluating LB54640,
an investigational oral small molecule MC4R agonist, in patients with hypothalamic obesity, in the third quarter of 2024. The 28-patient
SIGNAL trial is a randomized, placebo-controlled, double-blind study designed to evaluate three dose levels of LB54640. The primary endpoint
of the study is the change from baseline in body mass index after 14 weeks of treatment, and patients may continue on therapy for up to
52 weeks; |
| · | Announce data from stage 2 of the exploratory Phase 2 DAYBREAK study evaluating
setmelanotide in certain genetically-caused MC4R pathway diseases in the third quarter of 2024; |
| · | Complete enrollment in two or more substudies in the Phase 3 EMANATE trial
evaluating setmelanotide in a total of four genetically caused MC4R pathway diseases in the second half of 2024; |
| · | Complete the Company’s Phase 1 clinical trial of RM-718, an investigational,
weekly MC4R-specific agonist, and announce data from this trial – including data from a planned cohort of patients with hypothalamic
obesity - in the first half of 2025; and |
| · | Announce top-line data in the Phase 3 trial evaluating setmelanotide in hypothalamic
obesity in the first half of 2025. |
First Quarter Financial
Results:
| · | Cash Position: As of March 31, 2024, cash, cash equivalents
and short-term investments were approximately $201 million, as compared to $275.8 million as of December 31, 2023. This decrease
in cash during the quarter included $40 million for an up-front payment to LG Chem for global rights to LB-54640 paid in January 2024.
This cash on-hand amount does not include gross proceeds of $150 million from the sale of preferred stock during the second quarter. |
| · | Revenue: Net product revenues relating to sales of IMCIVREE were $26.0
million for the three months ended March 31, 2024, as compared to $11.5 million for the three months ended March 31, 2023. For
the three months ended March 31, 2024 and 2023, a substantial amount of our product revenue, or 74% and 83%, respectively, was generated
from sales of our product in the United States. |
| · | R&D Expenses: R&D expenses were $128.7 million for the
three months ended March 31, 2024, as compared to $37.9 million for the three months ended March 31, 2023. The year-over-year
increase was primarily due to in-process research and development costs totaling $92.4 million associated with the acquisition of LG Chem’s
proprietary compound LB54640. Additional increased costs were associated with salaries, benefits and stock-based compensation related
to the hiring of additional full-time employees, and clinical trial activities. These increases were partially offset by the one-time
costs recorded in the three months ended March 31, 2023, for the purchase of research and development assets from Xinvento, BV. |
| · | S,G&A Expenses: S,G&A expenses were $34.4 million
for the three months ended March 31, 2024, as compared to $24.6 million for the three months ended March 31, 2023. The year-over-year
increase was primarily due to increased compensation and benefits related costs associated with additional headcount to support our expanding
business operations and commercial operations, increases in professional services and consulting costs and increases in costs associated
with ongoing sales and marketing activities. |
| · | Other income (expense), net: Other income (expense), net decreased
by $1.6 million to ($1.2) million for the three months ended March 31, 2024, from $0.4 million for the three months ended March 31,
2023, primarily due to an increase in non-cash interest expense from amortization of debt discount and deferred financing fees associated
with a higher deferred royalty obligation balance, and recognition of non-cash interest expense associated with accretion of the non-current
liability payable to LG Chem in July 2025; this decrease was partially offset by an increase in other income from the change in fair
value of the embedded derivative of $0.5 million associated with the Revenue Interest Financing Agreement, or RIFA, entered into with
HealthCare Royalty Partners in June 2022. |
| · | Net Loss: Net loss was $(141.4) million for the three
months ended March 31, 2024, or a net loss per basic and diluted share of ($2.35), as compared to a net loss of ($52.2) million for
the three months ended March 31, 2023, or a net loss per basic and diluted share of ($0.92). |
Financial Guidance: For
the year ending December 31, 2024, Rhythm anticipates approximately $250 million to $270 million in Non-GAAP Operating Expenses.
Non-GAAP Operating Expenses are derived from:
| · | GAAP total operating expenses, inclusive of: |
| o | SG&A expenses of $105 million to $110 million; and |
| o | R&D expenses of $145 million to $160 million, |
| § | inclusive of $10 million to $15 million of LB54640 development costs; |
| o | Stock-based compensation, and |
| o | $92.4 million in fixed consideration related to in-licensing of global rights to LB54640, which was recognized in the first quarter
of 2024. |
Non-GAAP Operating Expenses is defined as
GAAP operating expenses excluding stock-based compensation and fixed consideration related to in-licensing (see below under "Non-GAAP
Financial Measures" for more details).
Based on its current operating plans, Rhythm
expects that its existing cash, cash equivalents and short-term investments as of March 31, 2024 along with the proceeds from the
sale of $150 million in preferred stock, will be sufficient to fund its operating expenses and capital expenditure requirements into 2026.
Conference
Call Information
Rhythm Pharmaceuticals will host a live conference
call and webcast at 8:00 a.m. ET today to review its first quarter 2024 financial results and recent business activities. Participants
may register for the conference call here. It is recommended that participants join the call ten minutes prior to the scheduled
start.
A live webcast of the call will also
be available under "Events and Presentations" in the Investor Relations section of the Rhythm Pharmaceuticals website at https://ir.rhythmtx.com/.
The archived webcast will be available on Rhythm Pharmaceuticals’ website approximately two hours after the conference call and
will be available for 30 days following the call.
About Rhythm Pharmaceuticals
Rhythm is a commercial-stage biopharmaceutical company committed to
transforming the lives of patients and their families living with rare neuroendocrine diseases. Rhythm’s lead asset, IMCIVREE®
(setmelanotide), an MC4R agonist designed to treat hyperphagia and severe obesity, is approved by the U.S. Food and Drug Administration
(FDA) for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due
to pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency confirmed
by genetic testing, or patients with a clinical diagnosis of Bardet-Biedl syndrome (BBS). Both the European Commission (EC) and the UK’s
Medicines & Healthcare Products Regulatory Agency (MHRA) have authorized setmelanotide for the treatment of obesity and the
control of hunger associated with genetically confirmed BBS or genetically confirmed loss-of-function biallelic POMC, including PCSK1,
deficiency or biallelic LEPR deficiency in adults and children 6 years of age and above. Additionally, Rhythm is advancing a broad clinical
development program for setmelanotide in other rare diseases, as well as RM-718 and a preclinical suite of small molecules for the treatment
of congenital hyperinsulinism. Rhythm’s headquarters is in Boston, MA.
Setmelanotide Indication
In the United States, setmelanotide is indicated for chronic
weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to POMC, PCSK1 or
LEPR deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1 or LEPR genes that are interpreted as pathogenic,
likely pathogenic, or of uncertain significance (VUS) or BBS.
In the European Union, setmelanotide is indicated for the treatment
of obesity and the control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS) or genetically confirmed loss-of-function
biallelic proopiomelanocortin (POMC), including PCSK1, deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children
6 years of age and above.
Limitations of Use
In the United States and Europe, Setmelanotide should
be prescribed and supervised by a physician with expertise in obesity with underlying genetic etiology.
Setmelanotide is not indicated for the treatment of patients with the
following conditions as setmelanotide would not be expected to be effective:
| · | Obesity due to suspected POMC, PCSK1 or LEPR deficiency with POMC, PCSK1 or LEPR variants
classified as benign or likely benign |
| · | Other types of obesity not related to POMC, PCSK1 or LEPR deficiency, or
BBS, including obesity associated with other genetic syndromes and general (polygenic) obesity. |
WARNINGS AND PRECAUTIONS
Skin Monitoring: Setmelanotide
may lead to generalized increased skin pigmentation and darkening of pre-existing naevi because of its pharmacologic effect. Full body
skin examinations should be conducted annually to monitor pre-existing and new skin pigmentary lesions before and during treatment with
setmelanotide.
Heart rate and blood pressure monitoring: Heart
rate and blood pressure should be monitored as part of standard clinical practice at each medical visit (at least every 6 months) for
patients treated with setmelanotide.
Prolonged penile erection: Spontaneous
penile erections have been reported in clinical trials with setmelanotide. Patients who have a penile erection lasting longer than 4 hours
should be instructed to seek emergency medical attention for potential treatment of priapism.
Depression: In clinical
trials, depression has been reported in patients treated with setmelanotide. Patients with depression should be monitored at each medical
visit during treatment with setmelanotide. Consideration should be given to discontinuing setmelanotide if patients experience suicidal
thoughts or behaviors.
Pediatric Population: The
prescribing physician should periodically assess response to setmelanotide therapy. In growing children, the impact of weight loss on
growth and maturation should be evaluated. The prescribing physician should monitor growth (height and weight) using age- and sex-appropriate
growth curves.
Excipients: This medicinal
product contains 10 mg benzyl alcohol in each ml. Benzyl alcohol may cause allergic reactions. Patients who are pregnant or breastfeeding
should be advised of the potential risk from the excipient benzyl alcohol, which might accumulate over time and cause metabolic acidosis.
This medicinal product should be used with caution in patients with hepatic or renal impairment, because of the potential risk from the
excipient benzyl alcohol which might accumulate over time and cause metabolic acidosis.
Sodium: This medicinal
product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free.”
ADVERSE REACTIONS
The most frequent adverse reactions are hyperpigmentation (51%), injection
site reaction (39%), nausea (33%), and headache (26%).
USE IN SPECIFIC POPULATIONS
Pregnancy
There are no data from the use of setmelanotide in pregnant women.
Animal studies do not indicate direct harmful effects with respect to reproductive toxicity. However, administration of setmelanotide
to pregnant rabbits resulted in decreased maternal food consumption leading to embryo-fetal effects. As a precautionary measure, setmelanotide
should not be started during pregnancy or while attempting to get pregnant as weight loss during pregnancy may result in fetal harm. If
a patient who is taking setmelanotide has reached a stable weight and becomes pregnant, consideration should be given to maintaining setmelanotide
treatment as there was no proof of teratogenicity in the nonclinical data. If a patient who is taking setmelanotide and still losing weight
gets pregnant, setmelanotide should either be discontinued, or the dose reduced while monitoring for the recommended weight gain during
pregnancy. The treating physician should carefully monitor weight during pregnancy in a patient taking setmelanotide.
Breast-feeding
It is unknown whether setmelanotide is excreted in human milk. A nonclinical
study showed that setmelanotide is excreted in the milk of nursing rats. No quantifiable setmelanotide concentrations were detected in
plasma from nursing pups. A risk to the newborn/infant cannot be excluded. A decision must be made whether to discontinue breastfeeding
or to discontinue/abstain from setmelanotide therapy taking into account the benefit of breastfeeding for the child and the benefit of
therapy for the mother.
Fertility
No human data on the effect of setmelanotide on fertility are available.
Animal studies did not indicate harmful effects with respect to fertility.
To report SUSPECTED ADVERSE REACTIONS,
contact Rhythm Pharmaceuticals at +1 (833) 789-6337. See Summary of Product Characteristics’ APPENDIX
V for a list of European national reporting systems to communicate adverse reactions.
Please see the full Prescribing Information for additional Important
Safety Information.
Forward-Looking Statements
This press
release 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 safety, efficacy, and regulatory and clinical design or progress, potential regulatory submissions,
approvals and timing thereof of setmelanotide and LB54640, including our Phase 3 trial of setmelanotide for patients with hypothalamic
obesity and Phase 2 SIGNAL trial, the potential benefits of setmelanotide for patients with hypothalamic obesity, our expectations surrounding
potential regulatory submissions, approvals and timing thereof, including the sNDA for the label expansion of IMCIVREE, the Company’s
business strategy and plans, including regarding commercialization of setmelanotide, our anticipated financial performance and financial
position, including estimated Non-GAAP Operating Expenses for the year ending December 31, 2024, and the sufficiency of our cash,
cash equivalents and short-term investments to fund our operations. 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 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 lawsuits, inability to maintain
collaborations, or the failure of these collaborations, our reliance on third parties, risks relating to intellectual property, our ability
to hire and retain necessary personnel, general economic conditions, risks related to internal control over financial reporting, and the
other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended
December 31, 2023 and our other filings with the Securities and Exchange Commission. Except as required by law, we undertake no obligations
to make any revisions to the forward-looking statements contained in this press release or to update them to reflect events or circumstances
occurring after the date of this press release, whether as a result of new information, future developments or otherwise.
Non-GAAP Financial Measures
This press release includes Non-GAAP Operating
Expenses, a supplemental measure of our performance that is not required by, or presented in accordance with, U.S. GAAP and should not
be considered as an alternative to operating expenses or any other performance measure derived in accordance with GAAP.
We define Non-GAAP Operating Expenses as GAAP
operating expenses excluding stock-based compensation and fixed consideration related to in-licensing.
We caution investors that amounts presented
in accordance with our definition of Non-GAAP Operating Expenses may not be comparable to similar measures disclosed by our competitors
because not all companies and analysts calculate this non-GAAP financial measure in the same manner. We present this non-GAAP financial
measure because we consider it to be an important supplemental measure of our performance and believe it is frequently used by securities
analysts, investors, and other interested parties in the evaluation of companies in our industry. Management believes that investors’
understanding of our performance is enhanced by including this non-GAAP financial measure as a reasonable basis for comparing our ongoing
results of operations.
Management uses this non-GAAP financial measure
for planning purposes, including the preparation of our internal annual operating budget and financial projections; to evaluate the performance
and effectiveness of our operational strategies; and to evaluate our capacity to expand our business. This non-GAAP financial measure
has limitations as an analytical tool, and should not be considered in isolation, or as an alternative to, or a substitute for operating
expenses or other financial statement data presented in accordance with GAAP in our consolidated financial statements.
Rhythm has not provided a quantitative reconciliation
of forecasted Non-GAAP Operating Expenses to forecasted GAAP operating expenses because the Company is unable, without making unreasonable
efforts, to calculate stock-based compensation expenses. These items, which could materially affect the computation of forward-looking
GAAP operating expenses, are inherently uncertain and depends on various factors, some of which are outside of Rhythm's control.
Corporate Contact:
David Connolly
Executive Director, Investor Relations
and Corporate Communications
Rhythm Pharmaceuticals, Inc.
857-264-4280
dconnolly@rhythmtx.com
Media Contact:
Adam Daley
Berry & Company Public Relations
212-253-8881
adaley@berrypr.com
Rhythm Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
and Comprehensive Loss
(in thousands, except share and per share data)
(Unaudited)
| |
Three months ended March 31, | |
| |
2024 | | |
2023 | |
Revenues: | |
| | | |
| | |
Product revenue, net | |
$ | 25,967 | | |
$ | 11,469 | |
License revenue | |
| — | | |
| — | |
Total revenues | |
| 25,967 | | |
| 11,469 | |
Costs and expenses: | |
| | | |
| | |
Cost of sales | |
| 2,807 | | |
| 1,421 | |
Research and development | |
| 128,665 | | |
| 37,945 | |
Selling, general, and administrative | |
| 34,382 | | |
| 24,634 | |
Total costs and expenses | |
| 165,854 | | |
| 64,000 | |
Loss from operations | |
| (139,887 | ) | |
| (52,531 | ) |
Other income (expense): | |
| | | |
| | |
Other income (expense), net | |
| 524 | | |
| (27 | ) |
Interest expense | |
| (4,755 | ) | |
| (3,061 | ) |
Interest income | |
| 3,046 | | |
| 3,440 | |
Total other income (expense), net | |
| (1,185 | ) | |
| 352 | |
Loss before income taxes | |
| (141,072 | ) | |
| (52,179 | ) |
Provision for income taxes | |
| 300 | | |
| — | |
Net loss | |
$ | (141,372 | ) | |
$ | (52,179 | ) |
Net loss per share, basic and diluted | |
$ | (2.35 | ) | |
$ | (0.92 | ) |
Weighted-average common shares outstanding, basic and diluted | |
| 60,143,558 | | |
| 56,708,975 | |
| |
| | | |
| | |
Other comprehensive loss: | |
| | | |
| | |
Net loss | |
$ | (141,372 | ) | |
$ | (52,179 | ) |
Foreign currency translation adjustment | |
| (71 | ) | |
| 21 | |
Unrealized gain (loss), net on marketable securities | |
| (244 | ) | |
| 65 | |
Comprehensive loss | |
$ | (141,687 | ) | |
$ | (52,093 | ) |
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
(Unaudited)
| |
March 31, | | |
December 31, | |
| |
2024 | | |
2023 | |
Assets | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 53,428 | | |
$ | 60,081 | |
Short-term investments | |
| 147,771 | | |
| 215,765 | |
Accounts receivable, net | |
| 14,695 | | |
| 14,867 | |
Inventory | |
| 8,507 | | |
| 8,624 | |
Prepaid expenses and other current assets | |
| 11,352 | | |
| 8,931 | |
Total current assets | |
| 235,753 | | |
| 308,268 | |
Property and equipment, net | |
| 1,149 | | |
| 1,341 | |
Right-of-use asset | |
| 670 | | |
| 781 | |
Intangible assets, net | |
| 6,815 | | |
| 7,028 | |
Restricted cash | |
| 460 | | |
| 328 | |
Other long-term assets | |
| 13,804 | | |
| 14,999 | |
Total assets | |
$ | 258,651 | | |
$ | 332,745 | |
Liabilities and stockholders’ equity | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 7,550 | | |
$ | 4,885 | |
Accrued expenses and other current liabilities | |
| 44,531 | | |
| 48,262 | |
Deferred revenue | |
| 1,286 | | |
| 1,286 | |
Lease liability | |
| 793 | | |
| 770 | |
Total current liabilities | |
| 54,160 | | |
| 55,203 | |
Long-term liabilities: | |
| | | |
| | |
Deferred royalty obligation | |
| 107,368 | | |
| 106,143 | |
Lease liability, non-current | |
| 284 | | |
| 490 | |
Derivative liability | |
| 660 | | |
| 1,150 | |
Other long-term liabilities | |
| 34,598 | | |
| — | |
Total liabilities | |
| 197,070 | | |
| 162,986 | |
Commitments and contingencies (Note 14) | |
| | | |
| | |
Stockholders’ equity: | |
| | | |
| | |
Preferred Stock, $0.001 par value: 10,000,000 shares authorized; no shares issued and outstanding at March 31, 2024 and December 31, 2023 | |
| — | | |
| — | |
Common stock, $0.001 par value: 120,000,000 shares authorized; 60,964,468 and 59,426,559 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively | |
| 60 | | |
| 59 | |
Additional paid-in capital | |
| 1,097,810 | | |
| 1,064,302 | |
Accumulated other comprehensive income (loss) | |
| (181 | ) | |
| 134 | |
Accumulated deficit | |
| (1,036,108 | ) | |
| (894,736 | ) |
Total stockholders’ equity | |
| 61,581 | | |
| 169,759 | |
Total liabilities and stockholders’ equity | |
$ | 258,651 | | |
$ | 332,745 | |
v3.24.1.u1
Cover
|
May 07, 2024 |
Cover [Abstract] |
|
Document Type |
8-K
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Amendment Flag |
false
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Document Period End Date |
May 07, 2024
|
Entity File Number |
001-38223
|
Entity Registrant Name |
RHYTHM PHARMACEUTICALS, INC.
|
Entity Central Index Key |
0001649904
|
Entity Tax Identification Number |
46-2159271
|
Entity Incorporation, State or Country Code |
DE
|
Entity Address, Address Line One |
222 Berkeley Street
|
Entity Address, Address Line Two |
12th Floor
|
Entity Address, City or Town |
Boston
|
Entity Address, State or Province |
MA
|
Entity Address, Postal Zip Code |
02116
|
City Area Code |
857
|
Local Phone Number |
264-4280
|
Written Communications |
false
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Soliciting Material |
false
|
Pre-commencement Tender Offer |
false
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Pre-commencement Issuer Tender Offer |
false
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Title of 12(b) Security |
Common Stock, $0.001 par value per share
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Trading Symbol |
RYTM
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Security Exchange Name |
NASDAQ
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Entity Emerging Growth Company |
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Rhythm Pharmaceuticals (NASDAQ:RYTM)
過去 株価チャート
から 5 2024 まで 6 2024
Rhythm Pharmaceuticals (NASDAQ:RYTM)
過去 株価チャート
から 6 2023 まで 6 2024