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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):
August 6, 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 August 6, 2024, Rhythm Pharmaceuticals, Inc.
(the “Company”) announced its financial results for the quarter ended June 30, 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: August 6, 2024 |
By: |
/s/ Hunter Smith |
|
|
Hunter Smith |
|
|
Chief Financial Officer |
Exhibit 99.1
Rhythm Pharmaceuticals Reports Second Quarter
2024 Financial Results and Business Update
-- Second quarter 2024 net revenue from global
sales of IMCIVREE® (setmelanotide) of $29.1 million --
-- Dosed first patients in supplemental,
12-patient Japanese cohort in global Phase 3 trial evaluating setmelanotide in hypothalamic obesity; On track for topline data
from 120-patient, pivotal cohort in 1H 2025 --
-- Completed sNDA submission seeking to expand
U.S. label of IMCIVREE to treat pediatric patients as young as 2 years old in approved indications --
-- Cash on-hand expected to support planned
operations into 2026 --
-- Management to host conference call today
at 8:00 a.m. ET --
BOSTON, August 6, 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 second quarter ended
June 30, 2024.
“We delivered a strong quarter executing on our global strategy
to bring IMCIVREE® (setmelanotide) to patients with rare melanocortin-4 receptor (MC4R) diseases to treat their hyperphagia
and severe obesity,” said David Meeker, M.D., Chair, President and Chief Executive Officer of Rhythm. “This included steady
growth in global sales of IMCIVREE, and the achievement of regulatory milestones in Europe and the United States that brings us closer
to expanding its availability to patients as young as 2 years old. We believe this pediatric expansion will improve long-term clinical
outcomes by treating these genetically-caused diseases when hyperphagia and obesity begin.”
Dr. Meeker continued, “We are making rapid progress in
developing our MC4R portfolio assets to bring much needed therapeutic options to patients with rare MC4R diseases, starting with acquired
hypothalamic obesity. We remain on track to report topline data from the pivotal cohort of our ongoing, global Phase 3 trial of setmelanotide
for this indication in the first half of 2025, and we recently began dosing patients in a supplemental cohort in Japan, where the prevalence
rate is higher than in the United States and Europe. In addition, we dosed the first patients with hypothalamic obesity in the Phase
2 trial evaluating an oral MC4R agonist, LB54640, and we are advancing our dose-finding, Phase 1 trial of the weekly RM-718.”
Second 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 the Company has received payor approval for reimbursement
for approximately 70 prescriptions during the second quarter of 2024; |
| · | Today,
Rhythm announced it dosed the first patients in the supplemental, 12-patient Japanese cohort
of its global Phase 3 trial evaluating setmelanotide in hypothalamic obesity; |
| · | Today,
Rhythm announced it has completed submission of its supplemental New Drug Application (sNDA)
to the U.S. Food and Drug Administration to expand the label of IMCIVREE to treat pediatric
patients between the ages of 2 and younger than 6 years old in approved indications; |
| · | On
July 31, 2024, Rhythm announced that the European Commission (EC) expanded the marketing
authorization for IMCIVREE to include children as young as 2 years old with obesity due to
BBS or pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1),
or leptin receptor (LEPR) deficiency; |
| · | On
July 23, 2024, Rhythm announced that it dosed the first patients in the Company’s
Phase 2 clinical trial evaluating LB54640, an investigational oral MC4R agonist, in hypothalamic
obesity; |
| · | Effective
July 1, 2024, Alastair “Al” Garfield, Ph.D. was appointed Chief Scientific
Officer; |
| · | On
June 3, 2024, Rhythm announced that it presented the first patient and caregiver reported
experiences from qualitative interviews following the completion of a Phase 2 trial that
evaluated treatment with setmelanotide in hypothalamic obesity during the Endocrine Society
Annual Meeting & Expo (ENDO 2024); |
| · | On
May 22, 2024, Rhythm announced that the National Institute for Health and Care Excellence
(NICE) in Great Britain issued guidance that recommends IMCIVREE as an option for treating
obesity and the control of hunger (hyperphagia) in patients between 6 years old and younger
than 18 with BBS; and |
| · | On
April 1, 2024, Rhythm announced that the Company entered into 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 for
gross proceeds of $150 million to the Company. This transaction closed on April 15,
2024. |
Anticipated Upcoming Milestones
Rhythm expects to achieve the following near-term milestones:
| · | Announce
Stage 2 data from the Phase 2 DAYBREAK clinical trial during a medical meeting in the second
half of 2024; |
| · | Complete
enrollment in two or more substudies in the Phase 3 EMANATE trial evaluating setmelanotide
in genetically caused MC4R pathway diseases in the second half of 2024; |
| · | Announce
top-line data in the Phase 3 trial evaluating setmelanotide in hypothalamic obesity in the
first half of 2025; |
Second Quarter 2024 Financial Results:
| · | Cash
Position: As of June 30, 2024, cash, cash equivalents and short-term investments
were approximately $319.1 million, as compared to $275.8 million as of December 31,
2023. |
| · | Revenue: Net
product revenues relating to global sales of IMCIVREE were $29.1 million for the second quarter
of 2024, as compared to $19.2 million for the second quarter of 2023. For the second
quarter ended June 30, 2024, 74% of the Company’s product revenue was generated
in the United States. |
| · | R&D
Expenses: R&D expenses were $30.2 million in the second quarter of 2024, as
compared to $33.5 million in the second quarter of 2023. The year-over-year decrease
was primarily due to a decrease in clinical trial costs. This decrease was partially offset
by increased headcount. |
| · | S,G&A
Expenses: S,G&A expenses were $36.4 million for the second quarter of 2024,
as compared to $30.0 million for the second quarter of 2023. The year-over-year increase
was primarily due to increased headcount and expenses for professional services. |
| · | Other
income (expense), net. Other income (expense), net increased by $8.8 million from
the second quarter of 2023 to the second quarter of 2024, primarily due to a gain of $8.9
million on settlement of the forward contract associated with the issuance of our convertible
preferred stock. |
| · | Net
Loss: Net loss attributable to common stockholders was ($33.6) million for the second
quarter of 2024, or a net loss per basic and diluted share of ($0.55), as compared to a net
loss attributable to common stockholders of ($46.7) million for the second quarter of 2023,
or a net loss per basic and diluted share of ($0.82). |
Year to Date 2024 Financial Results:
| · | Revenue: Net
product revenues relating to sales of IMCIVREE were $55.0 million for the six months
ended June 30, 2024, as compared to $30.7 million for the six months
ended June 30, 2023. |
| · | R&D
Expenses: R&D expenses were $158.9 million for the six months ended June 30,
2024, as compared to $71.5 million for the six months ended June 30, 2023. This
increase was primarily due to the acquisition of LG Chem’s proprietary compound LB54640
for $92.4 million in the six months ended June 30, 2024, and increased costs associated
with headcount and certain clinical trials. |
| · | S,G&A
Expenses: S,G&A expenses were $70.8 million for the six months ended June 30,
2024, as compared to $54.7 million for the six months ended June 30, 2023. The
increase was primarily due to increased headcount to support business and commercial operations
in the United States and internationally, expenses for professional services and other expenses. |
| · | Other
income (expense), net: Other (income)/ expense, net was $7.5 million for the six
months ended June 30, 2024, as compared to $0.2 million for the six months ended June 30,
2023. This increase was primarily due to a gain of $8.9 million on settlement of the
forward contract associated with the issuance of our convertible preferred stock. This was
partially offset by recognition of $1.9 million of non-cash interest expense in the six months
ended June 30, 2024 associated with accretion of the non-current liability payable to
LG Chem in July, 2025 and an increase in non-cash interest expense of $1.5 million related
to amortization of debt discount and deferred financing fees associated with a higher deferred
royalty obligation balance, based on the receipt of our final $25.0 million sales milestone
in the three months ended September 30, 2023. |
| · | Net
Loss: Net loss attributable to common stockholders was ($174.9) million for
the six months ended June 30, 2024, or a net loss attributable to common stockholders
per basic and diluted share of $(2.89), as compared to a net loss attributable to common
stockholders of ($98.9) million for the six months ended June 30, 2023, or a net
loss per basic and diluted share of ($1.74). |
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 | S,G&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 June 30, 2024, 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 second 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 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, potential benefits of, and clinical design or progress of any of our products or product candidates at
any dosage or in any indication, including, LB54640 and RM-718 the potential expansion of IMCIVREE for use by patients as young as 2
years old; our expectations surrounding potential regulatory submissions, progress, or approvals and timing thereof for any of our product
candidates; the announcement of data from our clinical trials, including our Phase 2 DAYBREAK trial, Phase 3 trial evaluating setmelanotide
for patients with hypothalamic obesity, Phase 1 clinical trial of RM-718, and Phase 2 trial evaluating LB54640; the enrollment of patients
in the Phase 3 EMANATE trial; the Company’s business strategy and plans, including regarding commercialization of setmelanotide;
our anticipated financial performance and financial position for any period of time, 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; 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 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 Quarterly Report on Form 10-Q for the quarter ended June 30,
2024 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 depend 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 June 30, | | |
Six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Revenues: | |
| | | |
| | | |
| | | |
| | |
Product revenue, net | |
$ | 29,078 | | |
$ | 19,221 | | |
$ | 55,045 | | |
$ | 30,691 | |
Total revenues | |
| 29,078 | | |
| 19,221 | | |
| 55,045 | | |
| 30,691 | |
Costs and expenses: | |
| | | |
| | | |
| | | |
| | |
Cost of sales | |
| 2,947 | | |
| 2,236 | | |
| 5,753 | | |
| 3,657 | |
Research and development | |
| 30,194 | | |
| 33,543 | | |
| 158,858 | | |
| 71,487 | |
Selling, general, and administrative | |
| 36,415 | | |
| 30,046 | | |
| 70,797 | | |
| 54,674 | |
Total costs and expenses | |
| 69,556 | | |
| 65,825 | | |
| 235,408 | | |
| 129,818 | |
Loss from operations | |
| (40,478 | ) | |
| (46,604 | ) | |
| (180,363 | ) | |
| (99,127 | ) |
Other (expense) income: | |
| | | |
| | | |
| | | |
| | |
Other income (expense), net | |
| 300 | | |
| (17 | ) | |
| 824 | | |
| 34 | |
Gain on forward contract | |
| 8,900 | | |
| — | | |
| 8,900 | | |
| — | |
Interest expense | |
| (4,603 | ) | |
| (3,303 | ) | |
| (9,358 | ) | |
| (6,449 | ) |
Interest income | |
| 4,097 | | |
| 3,221 | | |
| 7,143 | | |
| 6,660 | |
Total other income (expense), net | |
| 8,694 | | |
| (99 | ) | |
| 7,509 | | |
| 245 | |
Loss before income taxes | |
| (31,784 | ) | |
| (46,703 | ) | |
| (172,854 | ) | |
| (98,882 | ) |
Provision for income taxes | |
| 479 | | |
| — | | |
| 779 | | |
| — | |
Net loss | |
$ | (32,263 | ) | |
$ | (46,703 | ) | |
$ | (173,633 | ) | |
$ | (98,882 | ) |
Accrued dividends on convertible preferred stock | |
| (1,302 | ) | |
| — | | |
| (1,302 | ) | |
| — | |
Net loss attributable to common stockholders | |
$ | (33,565 | ) | |
$ | (46,703 | ) | |
$ | (174,935 | ) | |
$ | (98,882 | ) |
Net loss per share attributable to common stockholders, basic and diluted | |
$ | (0.55 | ) | |
$ | (0.82 | ) | |
$ | (2.89 | ) | |
$ | (1.74 | ) |
Weighted-average common shares outstanding, basic and diluted | |
| 61,011,824 | | |
| 56,867,662 | | |
| 60,577,691 | | |
| 56,788,757 | |
Other comprehensive loss: | |
| | | |
| | | |
| | | |
| | |
Net loss attributable to common stockholders | |
$ | (33,565 | ) | |
$ | (46,703 | ) | |
$ | (174,935 | ) | |
$ | (98,882 | ) |
Foreign currency translation adjustment | |
| (302 | ) | |
| (48 | ) | |
| (373 | ) | |
| (27 | ) |
Unrealized gain (loss), net on marketable securities | |
| (134 | ) | |
| 40 | | |
| (378 | ) | |
| 105 | |
Comprehensive loss | |
$ | (34,001 | ) | |
$ | (46,711 | ) | |
$ | (175,686 | ) | |
$ | (98,804 | ) |
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
(Unaudited)
| |
June 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
Assets | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 161,669 | | |
$ | 60,081 | |
Short-term investments | |
| 157,461 | | |
| 215,765 | |
Accounts receivable, net | |
| 17,598 | | |
| 14,867 | |
Inventory | |
| 11,994 | | |
| 8,624 | |
Prepaid expenses and other current assets | |
| 8,644 | | |
| 8,931 | |
Total current assets | |
| 357,366 | | |
| 308,268 | |
Property and equipment, net | |
| 973 | | |
| 1,341 | |
Right-of-use asset | |
| 3,696 | | |
| 781 | |
Intangible assets, net | |
| 6,601 | | |
| 7,028 | |
Restricted cash | |
| 460 | | |
| 328 | |
Other long-term assets | |
| 12,750 | | |
| 14,999 | |
Total assets | |
$ | 381,846 | | |
$ | 332,745 | |
Liabilities, convertible preferred stock and stockholders’ equity | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 4,543 | | |
$ | 4,885 | |
Accrued expenses and other current liabilities | |
| 48,077 | | |
| 48,262 | |
Deferred revenue | |
| 1,286 | | |
| 1,286 | |
Lease liability | |
| 816 | | |
| 770 | |
Total current liabilities | |
| 54,722 | | |
| 55,203 | |
Long-term liabilities: | |
| | | |
| | |
Deferred royalty obligation | |
| 108,372 | | |
| 106,143 | |
Lease liability, non-current | |
| 3,301 | | |
| 490 | |
Derivative liability | |
| 660 | | |
| 1,150 | |
Other long-term liabilities | |
| 35,596 | | |
| — | |
Total liabilities | |
| 202,351 | | |
| 162,986 | |
Commitments and contingencies (Note 15) | |
| | | |
| | |
Series A convertible preferred stock, $0.001 par value: 150,000 shares authorized; 150,000 and 0 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively | |
| 140,152 | | |
| — | |
Stockholders’ equity: | |
| | | |
| | |
Preferred Stock, $0.001 par value: 10,000,000 shares authorized; no shares issued and outstanding at June 30, 2024 and December 31, 2023 | |
| — | | |
| — | |
Common stock, $0.001 par value: 120,000,000 shares authorized; 61,095,949 and 59,426,559 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively | |
| 60 | | |
| 59 | |
Additional paid-in capital | |
| 1,108,269 | | |
| 1,064,302 | |
Accumulated other comprehensive income (loss) | |
| (617 | ) | |
| 134 | |
Accumulated deficit | |
| (1,068,369 | ) | |
| (894,736 | ) |
Total stockholders’ equity | |
| 39,343 | | |
| 169,759 | |
Total liabilities, convertible preferred stock and stockholders’ equity | |
$ | 381,846 | | |
$ | 332,745 | |
v3.24.2.u1
Cover
|
Aug. 06, 2024 |
Cover [Abstract] |
|
Document Type |
8-K
|
Amendment Flag |
false
|
Document Period End Date |
Aug. 06, 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
|
Soliciting Material |
false
|
Pre-commencement Tender Offer |
false
|
Pre-commencement Issuer Tender Offer |
false
|
Title of 12(b) Security |
Common Stock, $0.001 par value per share
|
Trading Symbol |
RYTM
|
Security Exchange Name |
NASDAQ
|
Entity Emerging Growth Company |
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Rhythm Pharmaceuticals (NASDAQ:RYTM)
過去 株価チャート
から 8 2024 まで 9 2024
Rhythm Pharmaceuticals (NASDAQ:RYTM)
過去 株価チャート
から 9 2023 まで 9 2024