Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global
commercial-stage biopharmaceutical company focused on transforming
the lives of patients and their families living with hyperphagia
and severe obesity caused by rare melanocortin-4 receptor (MC4R)
pathway diseases, today reported financial results and provided a
business update for the fourth quarter and full year ended December
31, 2022.
“Rhythm had a very strong 2022. Following U.S. Food and Drug
Administration (FDA) approval in June, we successfully launched
IMCIVREE® (setmelanotide) for Bardet-Biedl syndrome (BBS) in the
United States, and we’ve continued to extend our reach globally,
with IMCIVREE now available in eight international markets,” said
David Meeker, M.D., Chair, President and Chief Executive Officer of
Rhythm. “With compelling Phase 2 data in hypothalamic obesity and
FDA alignment on our pivotal trial design, we recently began
screening patients for our Phase 3 study. We look forward to
working toward the achievement of several additional clinical
milestones in 2023 as we aim to expand the reach of setmelanotide
as the first and only precision medicine to address the needs of
patients and families living with hyperphagia and severe obesity
caused by rare MC4R pathway diseases.”
Dr. Meeker continued, “With the acquisition of Xinvento, we are
excited to expand our pipeline into congenital hyperinsulinism
(CHI), a rare disease that is well aligned with our corporate
strategy and broadens our focus into an adjacent endocrine
indication with a high unmet need.”
Fourth Quarter and Recent Business
Highlights
Bardet-Biedl Syndrome
- Today, Rhythm announced that it received more than 200 new
prescriptions for IMCIVREE for BBS from more than 125 physicians in
the United States with reimbursement approvals for more than 100 of
those prescriptions from FDA approval on June 16, 2022 to December
31, 2022.
- In November 2022, Rhythm announced that Great Britain’s
Medicines & Healthcare products Regulatory Agency (MHRA)
expanded the marketing authorization for IMCIVREE to include the
treatment of obesity and control of hunger associated with
genetically confirmed BBS in adult and pediatric patients 6 years
of age and older. The Company is working closely with the National
Health Service (NHS) to finalize guidance for coverage of IMCIVREE
for BBS.
- Also in November 2022, Rhythm announced that Health Canada
accepted for review its New Drug Submission (NDS) with Priority
Review for setmelanotide, indicated in adults and pediatric
patients 6 years of age and older with impairments in the MC4R
pathway due to genetic diseases, for the treatment of obesity and
control of hunger in BBS and POMC, PCSK1, or LEPR
deficiencies.
POMC, PCSK1 and LEPR Deficiency Obesities
- In December 2022, Rhythm launched IMCIVREE in The Netherlands
and Italy for patients with POMC, PCSK1 or LEPR deficiency obesity.
In addition, Rhythm secured access for patients with POMC, PCSK1 or
LEPR deficiency obesity through named patient sales programs in
Austria and Turkey, and early access in Argentina.
Clinical Development Updates
- Today Rhythm announced that its pivotal Phase 3 trial
evaluating setmelanotide in patients with acquired hypothalamic
obesity has been initiated, with patient screening underway.
- In January 2023, Rhythm announced that certain patients with
BBS and obesity who participated in the Company’s global Phase 3
clinical trial of setmelanotide reported clinically meaningful
improvements across multiple health-related quality of life (HRQOL)
measures, based on an analysis which was published in the
peer-reviewed Orphanet Journal of Rare Diseases.
- In November 2022, Rhythm announced the publication of
previously disclosed results from its Phase 3 clinical trial in
patients with BBS in the peer-reviewed journal The Lancet Diabetes
and Endocrinology.
Corporate Update
- In February 2023, Rhythm’s Netherlands subsidiary, Rhythm
Pharmaceuticals Netherlands B.V. (“Rhythm B.V.”), acquired Xinvento
B.V., a Netherlands-based biotech company focused on developing
therapies for CHI. CHI is a rare genetic disease in which cells
secrete excess insulin, causing hypoglycemia, which can result in
serious health outcomes including seizures, coma, permanent brain
damage and death. Xinvento is developing novel investigational
therapeutic candidates designed to improve the care of patients
with CHI. Following the closing of the transaction, Xinvento’s
founder Claudine van der Sande will join Rhythm B.V. as Vice
President, Head of CHI Program.
Key Upcoming 2023 Milestones
Rhythm expects to achieve the following near-term
milestones:
- Secure market access and launch IMCIVREE in Germany for BBS in
the second quarter of 2023, pending reimbursement negotiations with
German authorities; Rhythm also anticipates launching IMCIVREE for
BBS in The Netherlands in the second half of 2023, pending local
negotiations;
- Complete regulatory review by Health Canada and,
pending approval, make IMCIVREE commercially available
in Canada for the treatment of BBS, or POMC, PCSK1 or
LEPR deficiencies in the second half of 2023;
- Initiate a Phase 3, randomized, double-blind trial in patients
naïve to setmelanotide therapy (“de novo study”) to evaluate the
weekly formulation of setmelanotide in patients with BBS in the
second half of 2023;
- Announce preliminary data from the open-label part of the Phase
2 DAYBREAK trial from one or more genetically defined cohorts in
the second half of 2023;
- Announce topline data from the ongoing Phase 3, open-label
pediatrics trial evaluating one year of setmelanotide therapy in
patients with MC4R pathway deficiencies between the ages of 2 and 6
years old in the second half of 2023; and
- Announce topline data from the ongoing Phase 3 switch trial
evaluating a weekly formulation of setmelanotide in the second half
of 2023.
Fourth Quarter and Full Year
2022 Financial Results:
- Cash Position: As of December 31, 2022, cash,
cash equivalents and short-term investments were approximately
$333.3 million, as compared to $294.9 million as of December 31,
2021.
- Revenue: Product revenue, net relating to
global sales of IMCIVREE was $8.8 million for the fourth quarter of
2022 and $16.9 million for the year ended December 31, 2022, as
compared to $1.8 million for the fourth quarter of 2021 and $3.2
million for the year ended December 31, 2021. For the years ended
December 31, 2022, and 2021, 85% and 100%, respectively, of the
Company’s product revenue was generated in the United States.
- License Revenue: License revenue was $6.8
million in 2022 and was entirely related to the RareStone license
agreement. Rhythm, entered into a license agreement with RareStone
in December 2021 and completed activities required to transfer the
license to RareStone during the second quarter of 2022, which
resulted in the recognition of the license revenue.
- R&D Expenses: R&D expenses were $23.5
million in the fourth quarter of 2022 and $108.6 million for the
year ended December 31, 2022, as compared to $31.6 million in the
fourth quarter of 2021 and $104.1 million for the year ended
December 31, 2021. The year-over-year increase was due to:
- an increase of $2.9 million for purchases of clinical supply
material; an increase of $2.8 million in gene sequencing costs to
support expanded clinical programs; an increase of $2.4 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, Phase 2 hypothalamic obesity trial, Phase
3 hypothalamic obesity trial and increased enrollment in the
long-term extension and weekly switch trials. These increases were
partially offset by reduced activity due to the completion and
winding down of the Phase 3 POMC and LEPR trials, QTc trial, BBS
trial, Phase 2 Basket trial and renal study. These increases were
further offset by a $2.3 million refund due upon the close out and
reconciliation of the GO-ID study, all of which resulted in an
insignificant change in clinical trial expense; an increase of $2.1
million in salaries, benefits and stock-based compensation related
to the hiring of additional full-time employees in order to support
the growth of research and development programs; an increase of
$1.0 million in development milestones earned by Camurus AB,
related to development milestone achieved related to our weekly
formulation; and an increase of $0.9 million related to IP and
patent related filing activities.
- The above increases were partially offset by a decrease of $4.0
million in costs associated with medical affairs; and a decrease of
$0.9 million in costs associated with next generation research and
development activities.
- S,G&A Expenses: S,G&A expenses were
$26.3 million in the fourth quarter of 2022 and $92.0 million for
the year ended December 31, 2022, as compared to $21.0 million for
the fourth quarter of 2021 and $68.5 million for the year ended
December 31, 2021. The year-over-year increase was due to:
- an increase of $9.6 million due to increased compensation and
benefits related costs associated with additional headcount to
support expanding business operations as well as to establish
commercial operations in the United States and
internationally;
- an increase of $8.6 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 and EC approval in September
2022;
- an increase of $5.0 million due to increased costs associated
with information technology, international office space,
sponsorships and general corporate travel related expenses for an
expanding workforce.
- Other (expense) income, net: Other (expense)
income, net decreased by $102.4 million to ($2.0) million in 2022,
a decrease of 102%. The decrease was primarily due to the sale of
Rhythm’s Priority Review Voucher (PRV) in February 2021. The sale
of the PRV in the prior year was a non-recurring transaction. Other
(expense) income, net consists of $5.2 million of interest expense
related to Royalty Interest Financing Agreement (RIFA) with
HealthCare Royalty Partners (including amortization of debt
discount and deferred financing fees) and a $1.0 million other than
temporary impairment of RareStone equity, partially offset by $4.0
million of interest income and $0.3 million of other income
resulting from the remeasurement of the embedded derivative related
to the RIFA.
- Provision/(Benefit) for income taxes: There
was no provision (benefit) for income taxes during for the three
months and year ended December 31, 2022, respectively. During the
three months ended December 31, 2021, we recorded a benefit for
income taxes of $8.0 million related to the unwinding of the tax
provision recorded earlier in the year as a result of the sale of
the PRV upon generating sufficient losses from operations to offset
the tax provision.
- Net Loss: Net loss was $42.5 million for the
fourth quarter of 2022 and $181.1 million for the year ended
December 31, 2022, or a net loss per basic and diluted share of
($0.75) and ($3.47), respectively, as compared to a net loss of
$42.9 million for the fourth quarter of 2021 and $69.6 million for
the year ended December 31, 2021, or a net loss per basic and
diluted share of $0.85 and $1.40, respectively.
Financial
Guidance: Rhythm today announced that, for the year
ending December 31, 2023, it currently anticipates approximately
$200 million to $220 million in Non-GAAP Operating Expenses (see
below under "Non-GAAP Financial Measures" for more details),
comprised of $120 million to $130 million from R&D expenses and
$80 million to $90 million from S,G&A expenses.
Based on its current operating plans,
Rhythm expects that its existing cash, cash equivalents and
short-term investments as of December 31, 2022 will be
sufficient to fund its operating expenses and capital expenditure
requirements into 2025.
Conference Call
InformationRhythm Pharmaceuticals will host a live
conference call and webcast at 8:00 a.m. ET today to review its
fourth quarter and full year 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 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 PharmaceuticalsRhythm is a
commercial-stage biopharmaceutical company committed to
transforming the lives of patients and their families living with
hyperphagia and severe obesity caused by rare melanocortin-4
receptor (MC4R) diseases. Rhythm’s lead asset, IMCIVREE
(setmelanotide), an MC4R agonist designed to treat hyperphagia and
severe obesity caused by rare MC4R pathway diseases, 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 MC4R
pathway diseases, as well as a preclinical suite of small molecules
for the treatment of congenital hyperinsulinism. Rhythm’s
headquarters is in Boston, MA.
Setmelanotide IndicationIn 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 pro-opiomelanocortin (POMC),
including PCSK1, deficiency or biallelic leptin receptor (LEPR)
deficiency in adults and children 6 years of age and above.
Limitations of UseIn 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 REACTIONSThe most frequent adverse
reactions are hyperpigmentation (51%), injection site reaction
(39%), nausea (33%), and headache (26%).
USE IN SPECIFIC POPULATIONS
PregnancyThere 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-feedingIt 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.
FertilityNo 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
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, our expectations surrounding potential
regulatory submissions, approvals and timing thereof, our business
strategy and plans, including regarding commercialization of
setmelanotide in certain international regions, expectations
surrounding sales and reimbursement of IMCIVREE, the potential
financial impact, growth prospects and benefits of our acquisition
of Xinvento B.V., management changes, our anticipated financial
performance and financial position, including estimated Non-GAAP
Operating Expenses for the year ending December 31, 2023, and the
sufficiency of our cash, cash equivalents and short-term
investments to fund our operations, and our participation in
upcoming events and presentations. Statements using word 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, risks relating to our liquidity and expenses, 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 our 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, the impact of the COVID-19 pandemic and
general economic conditions on our business and operations,
including our preclinical studies, clinical trials and
commercialization prospects, failure to realize the anticipated
benefits of our acquisition of Xinvento B.V. or significant
integration difficulties related to the acquisition, 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, 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.
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.
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 the reconciling
item, stock-based compensation expenses, with confidence. This
item, which could materially affect the computation of
forward-looking GAAP operating expenses, is inherently uncertain
and depends on various factors, some of which are outside of
Rhythm's control.
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
Rhythm Pharmaceuticals, Inc.Condensed
Consolidated Statements of Operations(in
thousands, except share and per share
data)(Unaudited) |
|
|
Three months ended December 31, |
Twelve months ended December 31, |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Product revenue, net |
$8,790 |
|
$1,817 |
|
$16,884 |
|
$3,154 |
|
Collaboration revenue |
|
- |
|
|
- |
|
$6,754 |
|
|
- |
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
Cost of sales |
$1,028 |
|
$236 |
|
$2,133 |
|
$599 |
|
Research and development |
$23,548 |
|
$31,574 |
|
$108,630 |
|
$104,128 |
|
Selling, general, and
administrative |
$26,318 |
|
$20,997 |
|
$92,032 |
|
$68,486 |
|
Total operating expenses |
$50,894 |
|
$52,807 |
|
$202,795 |
|
$173,213 |
|
Loss from operations |
($42,104 |
) |
($50,990 |
) |
($179,157 |
) |
($170,059 |
) |
Other income (expense): |
|
|
|
|
Other income |
($420 |
) |
|
($790 |
) |
$100,000 |
|
Interest expense |
($3,010 |
) |
|
($5,201 |
) |
|
Interest income |
$3,040 |
|
$134 |
|
$4,029 |
|
$447 |
|
Total other income
(expense): |
($390 |
) |
$134 |
|
($1,962 |
) |
$100,447 |
|
Net income (loss) before
taxes |
($42,494 |
) |
($50,856 |
) |
($181,119 |
) |
($69,612 |
) |
Provision for taxes |
|
($7,989 |
) |
|
|
Net loss and comprehensive
loss |
($42,494 |
) |
($42,867 |
) |
($181,119 |
) |
($69,612 |
) |
|
|
|
|
|
net income |
($42,494 |
) |
($42,867 |
) |
($181,119 |
) |
($69,612 |
) |
Net loss per share, basic and
diluted |
$(0.75 |
) |
$(0.85 |
) |
$(3.47 |
) |
$(1.40 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
56,299,525 |
|
|
50,270,801 |
|
|
52,120,701 |
|
|
49,600,294 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rhythm Pharmaceuticals, Inc.Condensed
Consolidated Balance Sheets(in thousands, except
share and per share data)(Unaudited) |
|
|
|
December 31, |
|
December 31, |
|
|
2022 |
|
2021 |
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
127,677 |
|
|
$ |
59,248 |
|
Short-term investments |
|
|
205,611 |
|
|
|
235,607 |
|
Accounts receivable, net |
|
|
6,224 |
|
|
|
1,025 |
|
Inventory |
|
|
2,917 |
|
|
|
111 |
|
Prepaid expenses and other current assets |
|
|
11,807 |
|
|
|
12,396 |
|
Total current assets |
|
|
354,236 |
|
|
|
308,387 |
|
Property and equipment,
net |
|
|
2,197 |
|
|
|
2,813 |
|
Right-of-use asset |
|
|
1,182 |
|
|
|
1,522 |
|
Intangible assets, net |
|
|
7,883 |
|
|
|
4,658 |
|
Restricted cash |
|
|
328 |
|
|
|
328 |
|
Other long-term assets |
|
|
16,655 |
|
|
|
11,815 |
|
Total assets |
|
$ |
382,481 |
|
|
$ |
329,523 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
4,797 |
|
|
$ |
5,737 |
|
Accrued expenses and other current liabilities |
|
|
32,894 |
|
|
|
30,084 |
|
Deferred revenue |
|
|
1,434 |
|
|
|
7,000 |
|
Lease liability |
|
|
684 |
|
|
|
606 |
|
Total current liabilities |
|
|
39,809 |
|
|
|
43,427 |
|
Long-term liabilities: |
|
|
|
|
|
|
Deferred royalty
obligation |
|
|
75,810 |
|
|
|
— |
|
Lease liability |
|
|
1,260 |
|
|
|
1,945 |
|
Derivative liability |
|
|
1,340 |
|
|
|
— |
|
Total liabilities |
|
|
118,219 |
|
|
|
45,372 |
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred Stock, $0.001 par value: 10,000,000 shares authorized; no
shares issued and outstanding at December 31, 2022 and
December 31, 2021 |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value: 120,000,000 shares authorized;
56,612,429 and 50,283,574 shares issued and outstanding at
December 31, 2022 and December 31, 2021,
respectively |
|
|
56 |
|
|
|
50 |
|
Additional paid-in capital |
|
|
974,356 |
|
|
|
813,041 |
|
Accumulated other comprehensive loss |
|
|
(92 |
) |
|
|
(1 |
) |
Accumulated deficit |
|
|
(710,058 |
) |
|
|
(528,939 |
) |
Total stockholders’ equity |
|
|
264,262 |
|
|
|
284,151 |
|
Total liabilities and stockholders’ equity |
|
$ |
382,481 |
|
|
$ |
329,523 |
|
|
|
|
|
|
|
|
|
|
Rhythm Pharmaceuticals (NASDAQ:RYTM)
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