Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM)
today reported financial results and provided a business update for
the second quarter ended June 30, 2022.
“Rhythm is executing on our global mission to transform the
lives of patients and families living with hyperphagia and severe
obesity caused by rare MC4R pathway diseases,” said David Meeker,
M.D., Chair, President and Chief Executive Officer of Rhythm. “Our
commercial launch of IMCIVREE® (setmelanotide) in Bardet-Biedl
syndrome (BBS) is off to a strong start, and we continue to make
meaningful progress towards securing market access in Europe, for
both our initial indications and, more recently, BBS.”
Dr. Meeker added, “We are highly encouraged by the interim data
from our Phase 2 trial evaluating setmelanotide in hypothalamic
obesity and the potential role it may play in transforming how this
disease is treated. We look forward to reviewing these data with
the U.S. Food and Drug Administration (FDA) and seeking input on a
pivotal Phase 3 trial, which we plan to initiate in the first half
of 2023. We are excited to add a potential Phase 3 trial in
hypothalamic obesity to our broad setmelanotide clinical
development program, which also includes the ongoing Phase 3
EMANATE trial, Phase 2 DAYBREAK trial, Phase 3 switch study
evaluating a weekly formulation of setmelanotide and our Phase 3
pediatrics trial, which has completed enrollment.”
Second Quarter and Recent
Business Highlights:
Regulatory and Commercial Updates:
Bardet-Biedl Syndrome:
- Today, Rhythm announced that more than 35 physicians have
written more than 50 prescriptions for IMCIVREE for patients with
BBS in the first six weeks since IMCIVREE was approved by the FDA
on June 16, 2022 for chronic weight management in adult and
pediatric patients 6 years of age and older with obesity due to
BBS.
- In July 2022, Rhythm announced that the European Medicines
Agency’s Committee for Medicinal Products for Human Use (CHMP)
adopted a positive opinion recommending to expand the current
indication for IMCIVREE to include the treatment of obesity and
control of hunger in adult and pediatric patients 6 years of age
and older with genetically confirmed BBS.
- In July 2022, Rhythm announced that the French National Agency
for Medicines and Health Products Safety (ANSM) and Haute Autorité
de santé (HAS) granted post-marketing authorization AP1
(autorisation d’accès précoce -- early access authorization) for
setmelanotide for the treatment of obesity and control of hunger in
patients with genetically confirmed BBS. AP1 allows for early
access to innovative therapies in France prior to regulatory
approval when a positive benefit/risk ratio is recognized and when
no other therapeutic alternatives are available.
POMC and LEPR Deficiency Obesities:
- In July 2022, Rhythm announced that the National Institute for
Health and Care Excellence (NICE) issued guidance recommending
IMCIVREE as an option for treating obesity and controlling hunger
caused by POMC, PCSK1 or LEPR deficiency in people 6 years of age
or older. With this recommendation under the Highly Specialised
Technologies (HST) pathway, IMCIVREE will be funded and available
for use within 90 days in the National Health Service.
- In June 2022, Rhythm launched IMCIVREE in Germany for patients
with POMC, PCSK1 or LEPR deficiency obesity. IMCIVREE is the first
precision medicine designed to induce weight loss and control of
hunger that has received a lifestyle exemption from the German
Federal Joint Committee (G-BA).
- Also in June 2022, Rhythm announced that the European
Commission (EC) authorized a variation for IMCIVREE that allows for
dosing in patients aged 6 years or older with POMC or LEPR
deficiency who have mild, moderate or severe renal impairment.
Clinical Development Updates:
- Today, Rhythm announced it completed enrollment in the Phase 3,
open-label trial evaluating one year of setmelanotide therapy in
pediatric patients with MC4R pathway deficiencies between the ages
of 2 and 6 years old.
- In July 2022, Rhythm announced positive interim results from
the Phase 2 study in patients with hypothalamic obesity. All 11
evaluable patients achieved the primary endpoint of at least 5%
reduction in body mass index (BMI) (P<0.0001) at 16 weeks on
therapy, with a mean change in BMI of -17.2% and a mean change in
hunger score of -2.7. Consistent with prior clinical experience in
other rare MC4R pathway diseases, setmelanotide was observed to be
generally well tolerated.
- In June 2022 at the Endocrine Society Annual Meeting & Expo
(ENDO), Rhythm and its collaborators presented new data from the
Company’s long-term extension (LTE) trial, which show continued BMI
and weight reductions in patients with BBS or POMC or LEPR
deficiency obesity (biallelic) receiving between 18 months and
three years of setmelanotide therapy. Also at ENDO, Rhythm
presented initial data from the LTE trial demonstrating continued
BMI and weight reductions in patients with SH2B1 or SRC1 deficiency
obesity, or with POMC or LEPR insufficiency obesity
(heterozygous).
Corporate:
- In June 2022, Rhythm entered into a non-dilutive Revenue
Interest Financing Agreement (RIFA) with HealthCare Royalty
Partners for a total investment amount of up to $100 million. In
exchange for the total investment amount received by Rhythm,
HealthCare Royalty Partners will receive a tiered royalty based on
global net product sales generated by IMCIVREE.
Key Upcoming Milestones:In the second half of
2022, Rhythm expects to:
- Complete regulatory review by the European Commission and,
pending approval, make IMCIVREE commercially available in Europe
for the treatment of obesity and control of hunger in adult and
pediatric patients 6 years old and older with genetically confirmed
BBS.
- Launch IMCIVREE in the U.K. and Italy for patients with POMC,
PCSK1 or LEPR deficiencies.
- Present full data from the 18 patients enrolled in the Phase 2
clinical trial evaluating setmelanotide for the treatment of
hypothalamic obesity at a medical meeting.
Second Quarter 2022 Financial Results:
- Cash Position: As of June 30, 2022,
cash, cash equivalents and short-term investments were
approximately $235.6 million, as compared to $294.9
million as of December 31, 2021, primarily due to
operating activities in the first half of 2022. This amount was
partially offset by the initial investment of $37.5 million from
HealthCare Royalty, which Rhythm received following FDA approval of
IMCIVREE for use in patients with BBS.
- Revenue: Product net revenues relating to
sales of IMCIVREE were $2.3 million for the second quarter of 2022,
as compared to $0.3 million for the second quarter of 2021.
- License Revenue: License revenue relating to
the Company’s out-license arrangement with RareStone was $6.8
million for the second quarter of 2022. There were no comparable
transactions in the prior year.
- R&D Expenses: R&D expenses
were $31.5 million in the second quarter of 2022, as
compared to $25.1 million in the second quarter of 2021.
The year-over-year increase was due to an increase of $4.6 million
in clinical trial costs associated with new and planned clinical
trials, including the Phase 2 DAYBREAK and Phase 3 EMANATE trials,
Phase 3 pediatrics trial, QTc study and Phase 2 hypothalamic
obesity trial, and increased enrollment in the long-term extension
trial. These increases were partially offset by reduced activity
and winding down of the Phase 3 BBS and Phase 2 Basket trials, and
the GO-ID study. In addition, there was an increase of $0.7 million
for gene sequencing costs, an increase of $1.3 million in
compensation and benefits due to the hiring of additional full-time
employees in order to support the growth of Rhythm’s research and
development programs and regulatory affairs operations, and $1.0
million associated with support for regulatory filing and clinical
supply material. These increases were partially offset by a
decrease of $1.2 million in costs associated with medical
affairs.
- S,G&A Expenses: S,G&A expenses
were $22.3 million for the second quarter of 2022, as compared to
$15.5 million for the second quarter of 2021. The year-over-year
increase was primarily due to an increase of $5.0 million related
to increased costs associated with commercial operations, sales and
marketing activities for IMCIVREE in connection with preparing for
the U.S approval and commercial launch in BBS, an increase of $1.0
million due to increased compensation and benefits related costs
associated with additional headcount to support expanding business
operations and global commercial operations, and an increase of
$1.0 million due to increased costs associated with office support
and insurance costs for Rhythm’s expanding workforce.
- Net Loss: Net loss was ($45.0) million
for the second quarter of 2022, or a net loss per basic and diluted
share of ($0.89), as compared to a net loss of ($35.4) million for
the second quarter of 2021, or a net loss per basic and diluted
share of ($0.70).
Year to Date 2022 Financial
Results:
- Revenue: Product revenues relating to sales of
IMCIVREE were $3.8 million for the six months ended June 30, 2022,
as compared to $0.3 million for the six months ended June 30,
2021.
- License Revenue: License revenue relating to
the Company’s out-license arrangement with RareStone was $6.8
million for the six months ended June 30, 2022. There were no
comparable transactions in the prior year.
- R&D Expenses: R&D expenses were $64.0
million for the six months ended June 30, 2022, as compared to
$45.0 million for the six months ended June 30, 2021. This increase
was primarily due to an increase of $14.0 million in clinical trial
costs associated with new and planned clinical trials, including
Phase 2 DAYBREAK and Phase 3 EMANATE trials, Phase 3 pediatrics
trial, QTc study, Phase 2 hypothalamic obesity study, and increased
enrollment in the long-term extension study. These increases were
partially offset by reduced activity due to the completion and
winding down of BBS, Phase 2 basket, renal and GO-ID studies.
Additional increases during the period included; an increase of
$4.2 million due to increased purchases of clinical supply
material; an increase of $1.5 million in compensation and benefits
due to the hiring of additional full-time employees in order to
support the growth of R&D programs and expansion of regulatory
affairs operations; an increase of $1.2 million due to gene
sequencing costs; and an increase of $1.0 million in development
milestones earned by Camurus, related to development milestone
achieved related to the weekly formulation. These increases were
partially offset by a decrease of $3.2 million in costs associated
with medical affairs.
- S,G&A Expenses: S,G&A expenses were
$43.8 million for the six months ended June 30, 2022, as compared
to $30.0 million for the six months ended June 30, 2021. The
increase was primarily due to an increase an increase of $7.3
million related to increased costs associated with commercial
operations, sales and marketing activities for IMCIVREE in
connection with preparing for the U.S approval for BBS obtained in
June 2022; an increase of $4.4 million due to increased
compensation and benefits related costs associated with additional
headcount to support expansion of business operations and build out
of commercial operations in the United States and internationally;
and an increase of $2.0 million due to increased costs associated
with information technology, international office space,
sponsorships and travel related expenses for our expanding
workforce.
- Other income, net: Other income decreased by
$100.1 million in the six months ended June 30, 2022 as compared to
the six months ended June 30, 2021 primarily due to the sale of the
priority review voucher (PRV) in February 2021. The sale of the PRV
in the prior year was a non-recurring transaction.
- Provision for income taxes: There is no
provision for income taxes for the six months ended June 30, 2022,
as Rhythm projects to generate operating losses during the year.
The Company recorded a provision for income taxes of $17.0 million
as a result of the sale of its PRV during the six months ended June
30, 2021.
- Net (loss) income: Net loss was ($97.7)
million for the six months ended June 30, 2022, or a net loss per
basic and diluted share of ($1.94), as compared to a net income of
$8.4 million for the six months ended June 30, 2021, or a net
income per basic and diluted share of $0.17.
Financial Guidance: Based on its current
operating plans, Rhythm expects that its existing cash and cash
equivalents and short-term investments as of June 30, 2022
will be sufficient to fund operations into 2024, and that such
existing cash and cash equivalents and short term investments,
together with the second investment tranche under the RIFA with
HealthCare Royalty Partners expected in the second half of 2022,
will be sufficient to fund its operating expenses and capital
expenditure requirements into at least the second half of 2024.
Conference Call InformationRhythm
Pharmaceuticals will host a live conference call and webcast at
8:00 a.m. ET today to review its second quarter 2022 financial
results and recent business activities. Participants may register
for the conference call here. While not required, 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 http://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 PharmaceuticalsRhythm is a
commercial-stage biopharmaceutical company committed transforming
the lives of patients and their families living with hyperphagia
and severe obesity caused by rare melanocortin-4 receptor (MC4R)
pathway diseases. Rhythm’s precision medicine, IMCIVREE
(setmelanotide), 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 POMC, PCSK1 or LEPR deficiency confirmed
by genetic testing, or patients with a clinical diagnosis of
Bardet-Biedl syndrome (BBS). The European Commission (EC) and Great
Britain’s Medicines & Healthcare Products Regulatory Agency
(MHRA) have authorized IMCIVREE for the treatment of obesity and
the control of hunger associated with genetically confirmed
loss-of-function biallelic POMC, including PCSK1, deficiency or
biallelic LEPR deficiency in adults and children 6 years of age and
above. IMCIVREE is the first-ever FDA-approved and EC- and
MHRA-authorized therapy for patients with these rare genetic
diseases of obesity. Rhythm received a positive Committee for
Medicinal Products for Human Use (CHMP) opinion on its Type II
variation application to the European Medicines Agency seeking
regulatory approval and authorization for setmelanotide to treat
obesity and control of hunger in adult and pediatric patients 6
years of age and older with BBS in the European Union and a
decision from the EC is expected in the fourth quarter of 2022.
Additionally, Rhythm is advancing a broad clinical development
program for setmelanotide in other rare genetic diseases of obesity
and is leveraging the Rhythm Engine and the largest known obesity
DNA database -- now with approximately 45,000 sequencing samples --
to improve the understanding, diagnosis and care of people living
with severe obesity due to certain genetic deficiencies. Rhythm’s
headquarters is in Boston, MA.
About SetmelanotideSetmelanotide is a
melanocortin-4 receptor (MC4R) agonist. The MC4R is part of the key
biological pathway that regulates hunger, caloric intake and energy
expenditure. Variants in genes may impair the function of the MC4R
pathway, potentially leading to hyperphagia and early-onset, severe
obesity. Rhythm is developing setmelanotide as a targeted therapy
to potentially restore the function of an impaired MC4R pathway
and, in so doing, potentially reduce hunger and weight in patients
with rare genetic diseases of obesity.
In the EU and Great Britain, IMCIVREE is indicated for the
treatment of obesity and the control of hunger associated with
genetically confirmed loss-of-function biallelic POMC, including
PCSK1, deficiency or biallelic LEPR deficiency in adults and
children 6 years of age and above. IMCIVREE should be prescribed
and supervised by a physician with expertise in obesity with
underlying genetic etiology.
Rhythm’s Type II variation application to the European Medicines
Agency (EMA) for the treatment of obesity and control of
hyperphagia in adult and pediatric patients 6 years of age and
older with BBS is under review. The Company is also continuing to
advance the most comprehensive clinical research program ever
initiated in MC4R pathway diseases, including the pivotal Phase 3
EMANATE clinical trial evaluating setmelanotide in four independent
sub-studies in patients with obesity due to POMC insufficiency
caused by heterozygous variants in the POMC or PCSK1 genes, LEPR
insufficiency caused by heterozygous variants in the LEPR gene,
SRC1 deficiency caused by a variant in the NCOA1 gene, and SH2B1
deficiency caused by a variant in the SH2B1 gene or 16p11.2
deletion encompassing the SH2B1 gene. The Phase 2 DAYBREAK trial is
evaluating setmelanotide in patients with severe obesity and
hyperphagia caused by rare variants associated with 10 prioritized
MC4R-relevant genes. Rhythm has also initiated a Phase 3 pediatric
trial and a Phase 3 trial evaluating a weekly formulation of
setmelanotide.
IMCIVREE®
(setmelanotide) IndicationIn the United
States, IMCIVREE is indicated 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 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)
- Bardet-Biedl syndrome (BBS)
Limitations of UseIMCIVREE is not indicated for
the treatment of patients with the following conditions as IMCIVREE
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
Disturbance in Sexual Arousal: Spontaneous
penile erections in males and sexual adverse reactions in females
have occurred. Inform patients that these events may occur and
instruct patients who have an erection lasting longer than 4 hours
to seek emergency medical attention.
Depression and Suicidal Ideation: Depression
and suicidal ideation have occurred. Monitor patients for new onset
or worsening depression or suicidal thoughts or behaviors. Consider
discontinuing IMCIVREE if patients experience suicidal thoughts or
behaviors, or clinically significant or persistent depression
symptoms occur.
Skin Pigmentation and Darkening of Pre-existing
Nevi: Generalized increased skin pigmentation and
darkening of pre-existing nevi have occurred. Perform a full body
skin examination prior to initiation and periodically during
treatment to monitor pre-existing and new pigmentary lesions.
Risk of Serious Adverse Reactions Due to Benzyl Alcohol
Preservative in Neonates and Low Birth Weight Infants:
IMCIVREE is not approved for use in neonates or infants. Serious
and fatal adverse reactions including “gasping syndrome” can occur
in neonates and low birth weight infants treated with benzyl
alcohol-preserved drugs.
ADVERSE REACTIONS
- The most common adverse reactions (incidence ≥20%) included
skin hyperpigmentation, injection site reactions, nausea, headache,
diarrhea, abdominal pain, vomiting, depression, and spontaneous
penile erection.
USE IN SPECIFIC POPULATIONSTreatment with
IMCIVREE is not recommended when breastfeeding. Discontinue
IMCIVREE when pregnancy is recognized unless the benefits of
therapy outweigh the potential risks to the fetus.
To report SUSPECTED ADVERSE REACTIONS, contact Rhythm
Pharmaceuticals at 833-789-6337 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
Please see the full Prescribing Information for
additional Important Safety Information.
Forward-Looking
StatementsThis 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 potential, safety, efficacy, and
regulatory and clinical progress of setmelanotide, including the
anticipated timing for initiation of clinical trials and release of
clinical trial data and our expectations surrounding potential
regulatory submissions, approvals and timing thereof, including in
the United States and Europe, our business strategy and plans,
including regarding commercialization of setmelanotide, sales of
our lead product candidate IMCIVREE, our participation in upcoming
events and presentations, and the sufficiency of our cash, cash
equivalents and short-term investments to fund our operations.
Statements using word such as “expect”, “anticipate”, “believe”,
“may”, “will” 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 impact of competition, the ability to achieve or obtain
necessary regulatory approvals, risks associated with data analysis
and reporting, our liquidity and expenses, the impact of the
COVID-19 pandemic on our business and operations, including our
preclinical studies, clinical trials and commercialization
prospects, and general economic conditions, 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, 2022 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
release or to update them to reflect events or circumstances
occurring after the date of this release, whether as a result of
new information, future developments or otherwise.
Rhythm Pharmaceuticals,
Inc.Condensed Consolidated Statements of
Operations and Comprehensive (Loss) Income(in
thousands, except share and per share
data)(Unaudited)
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
Six months ended June 30, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Product revenue, net |
|
|
$ |
2,312 |
|
|
$ |
274 |
|
|
$ |
3,810 |
|
|
$ |
309 |
|
License revenue |
|
|
|
6,754 |
|
|
|
— |
|
|
|
6,754 |
|
|
|
— |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
|
|
378 |
|
|
|
137 |
|
|
|
608 |
|
|
|
141 |
|
Research and development |
|
|
|
31,456 |
|
|
|
25,104 |
|
|
|
63,966 |
|
|
|
45,015 |
|
Selling, general, and administrative |
|
|
|
22,328 |
|
|
|
15,465 |
|
|
|
43,777 |
|
|
|
29,983 |
|
Total costs and expenses |
|
|
|
54,162 |
|
|
|
40,706 |
|
|
|
108,351 |
|
|
|
75,139 |
|
Loss from operations |
|
|
|
(45,096 |
) |
|
|
(40,432 |
) |
|
|
(97,787 |
) |
|
|
(74,830 |
) |
Other income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
100,000 |
|
Interest income, net |
|
|
|
95 |
|
|
|
21 |
|
|
|
22 |
|
|
|
175 |
|
Total other income, net |
|
|
|
95 |
|
|
|
21 |
|
|
|
22 |
|
|
|
100,175 |
|
(Loss) income before
taxes |
|
|
|
(45,001 |
) |
|
|
(40,411 |
) |
|
|
(97,765 |
) |
|
|
25,345 |
|
(Benefit from) provision for
income taxes |
|
|
|
— |
|
|
|
(5,022 |
) |
|
|
— |
|
|
|
16,984 |
|
Net (loss) income |
|
|
$ |
(45,001 |
) |
|
$ |
(35,389 |
) |
|
$ |
(97,765 |
) |
|
$ |
8,361 |
|
Net (loss) income per
share |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
$ |
(0.89 |
) |
|
$ |
(0.70 |
) |
|
$ |
(1.94 |
) |
|
$ |
0.17 |
|
Diluted |
|
|
$ |
(0.89 |
) |
|
$ |
(0.70 |
) |
|
$ |
(1.94 |
) |
|
$ |
0.17 |
|
Weighted-average common shares
outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
|
50,398,003 |
|
|
|
50,209,484 |
|
|
|
50,362,512 |
|
|
|
48,931,127 |
|
Diluted |
|
|
|
50,398,003 |
|
|
|
50,209,484 |
|
|
|
50,362,512 |
|
|
|
49,644,704 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive (loss)
income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income |
|
|
$ |
(45,001 |
) |
|
$ |
(35,389 |
) |
|
$ |
(97,765 |
) |
|
$ |
8,361 |
|
Unrealized (loss) income on marketable securities and other
long-term assets |
|
|
|
(277 |
) |
|
|
79 |
|
|
|
(905 |
) |
|
|
(28 |
) |
Comprehensive (loss)
income |
|
|
$ |
(45,278 |
) |
|
$ |
(35,310 |
) |
|
$ |
(98,670 |
) |
|
$ |
8,333 |
|
Rhythm Pharmaceuticals,
Inc.Condensed Consolidated Balance
Sheets(in thousands, except share and per share
data)(Unaudited)
|
|
|
|
|
|
|
|
|
June 30, 2022 |
|
December 31, 2021 |
|
|
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Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
113,207 |
|
|
$ |
$ |
59,248 |
|
Short-term investments |
|
|
122,389 |
|
|
|
|
235,607 |
|
Accounts receivable, net |
|
|
1,707 |
|
|
|
|
1,025 |
|
Prepaid expenses and other current assets |
|
|
12,029 |
|
|
|
|
12,507 |
|
Total current assets |
|
|
249,332 |
|
|
|
|
308,387 |
|
Property and equipment,
net |
|
|
2,559 |
|
|
|
|
2,813 |
|
Right-of-use asset |
|
|
1,359 |
|
|
|
|
1,522 |
|
Intangible assets, net |
|
|
8,311 |
|
|
|
|
4,658 |
|
Restricted cash |
|
|
328 |
|
|
|
|
328 |
|
Other long-term assets |
|
|
15,786 |
|
|
|
|
11,815 |
|
Total assets |
|
$ |
277,675 |
|
|
$ |
$ |
329,523 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
6,012 |
|
|
$ |
$ |
5,737 |
|
Accrued expenses and other current liabilities |
|
|
35,605 |
|
|
|
|
30,084 |
|
Deferred revenue |
|
|
2,309 |
|
|
|
|
7,000 |
|
Lease liability |
|
|
644 |
|
|
|
|
606 |
|
Total current liabilities |
|
|
44,570 |
|
|
|
|
43,427 |
|
Long-term liabilities: |
|
|
|
|
|
|
Deferred royalty
obligation |
|
|
34,273 |
|
|
|
|
— |
|
Lease liability |
|
|
1,614 |
|
|
|
|
1,945 |
|
Derivative liability |
|
|
1,590 |
|
|
|
|
— |
|
Total liabilities |
|
|
82,047 |
|
|
|
|
45,372 |
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred Stock, $0.001 par value: 10,000,000 shares authorized; no
shares issued and outstanding at June 30, 2022 and
December 31, 2021 |
|
|
— |
|
|
|
|
— |
|
Common stock, $0.001 par value: 120,000,000 shares authorized;
50,454,170 and 50,283,574 shares issued and outstanding at
June 30, 2022 and December 31, 2021,
respectively |
|
|
50 |
|
|
|
|
50 |
|
Additional paid-in capital |
|
|
823,188 |
|
|
|
|
813,041 |
|
Accumulated other comprehensive loss |
|
|
(906 |
) |
|
|
|
(1 |
) |
Accumulated deficit |
|
|
(626,704 |
) |
|
|
|
(528,939 |
) |
Total stockholders’ equity |
|
|
195,628 |
|
|
|
|
284,151 |
|
Total liabilities and stockholders’ equity |
|
$ |
277,675 |
|
|
$ |
$ |
329,523 |
|
Corporate
Contact:David ConnollyHead of Investor Relations and
Corporate CommunicationsRhythm Pharmaceuticals,
Inc.857-264-4280dconnolly@rhythmtx.com
Investor
Contact:Hannah DeresiewiczStern Investor Relations,
Inc.212-362-1200hannah.deresiewicz@sternir.com
Media Contact:Adam
DaleyBerry & Company Public
Relations212-253-8881adaley@berrypr.com
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