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 second quarter ended June 30, 2023.
“The first half of 2023 was marked by strong execution across
global commercial and clinical development programs. Our strong
revenue performance was supported by robust patient demand for
IMCIVREE® (setmelanotide) in the U.S. with more than 125
Bardet-Biedl syndrome (BBS) prescriptions written in the second
quarter of 2023. Globally, we have expanded our footprint with
IMCIVREE to include Canada and in Gulf Cooperation Council
(GCC) countries,” said David Meeker, M.D., Chair, President and
Chief Executive Officer of Rhythm. “And in July, we achieved the
specified sales milestone under our Revenue Interest Financing
Agreement (RIFA) with Healthcare Royalty Partners, making us
eligible to receive an additional investment of $25 million in
non-dilutive capital.”
“Based on rapid progress and substantial patient and physician
interest in our ongoing pivotal Phase 3 clinical trial of
setmelanotide in hypothalamic obesity, we now expect to complete
enrollment by the end of 2023. Finally, we look forward to
providing additional details on our pre-clinical development
programs later this year, including RM-718, a new weekly,
MC4R-specific agonist designed not to cause hyperpigmentation. This
program is on track for an IND submission by the end of this
year.”
Second Quarter and Recent Business
Highlights
Commercial Updates
- Today, Rhythm announced that more than 125 new prescriptions
for IMCIVREE for BBS have been written in the second quarter of
2023 and more than 425 in the United States since U.S. Food and
Drug Administration (FDA) approval on June 16, 2022 through June
30, 2023. More than 250 physicians have written prescriptions since
launch, and the Company has received payor approval for
reimbursement for more than 250 of those prescriptions, as of June
30, 2023.
- Today, Rhythm announced that IMCIVREE is now commercially
available in Canada following the May 5, 2023 approval by Health
Canada of IMCIVREE for weight management in adult and pediatric
patients 6 years of age and older with obesity due to BBS or
genetically-confirmed biallelic pro-opiomelanocortin (POMC),
proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin
receptor (LEPR) deficiency due to variants interpreted as
pathogenic, likely pathogenic or of uncertain significance.
- In May 2023, Rhythm announced a collaboration with Genpharm
Services FZ LLC (Genpharm) to commercialize IMCIVREE in GCC
countries, including Saudi Arabia, United Arab Emirates, Kuwait,
Qatar, Oman, and Bahrain. Under the terms of this exclusive
agreement, Genpharm will distribute IMCIVREE to patients in GCC
countries for the treatment of hyperphagia and obesity due to BBS
or genetically-confirmed biallelic POMC, PCSK1 or LEPR deficiency.
Providers in the region now have the ability to prescribe IMCIVREE
to qualifying patients.
Clinical Development Updates
- Today, Rhythm provided an update on progress of its pivotal,
Phase 3 clinical trial evaluating setmelanotide in patients with
acquired hypothalamic obesity. Based on the initial pace of patient
screening and site activations, Rhythm now expects to complete
enrollment in the fourth quarter of 2023. This Phase 3 trial is
designed to enroll 120 patients aged 4 years or older randomized
2:1 to setmelanotide therapy or placebo for a total of 60 weeks,
including up to eight weeks for dose titration.
- Today, Rhythm announced that it anticipates submitting an
investigational new drug application for RM-718, a new, weekly,
MC4R-specific agonist, by the end of 2023. RM-718 is designed to be
more targeted and potent than setmelanotide, and designed to be
MC1R sparing, with the potential to not cause hyperpigmentation.
This new product candidate is being developed as an injection
administered through an autoinjector, for which Rhythm has patent
protection into 2041, including patent term adjustment and patent
term extension.
- On July 19, the Company announced two new publications
detailing the burden of hyperphagia and obesity for adult
caregivers, families and patients living with BBS based on results
of The CAREgiver Burden in BBS (CARE-BBS) study were published in
the peer-reviewed journal, The Orphanet Journal of Rare
Diseases.
- In June 2023 at the Endocrine Society Annual Meeting & Expo
(ENDO), Rhythm and its collaborators presented new data from the
long-term extension portion of Rhythm’s Phase 2 trial evaluating
setmelanotide in patients with hypothalamic obesity. The data
showed sustained and deepening reductions in weight and body mass
index (BMI) in patients receiving at least six months of
setmelanotide therapy. As of a data cutoff of November 30, 2022, 13
patients who had reached the 6-month point had achieved a 21.0 mean
percent reduction in BMI from baseline, which progressed from
a 16.8 mean percent reduction at week 16 across these 13
patients.
Corporate
- Today, Rhythm announced that in July 2023 it achieved a
commercial sales milestone under the RIFA with HealthCare Royalty
Partners entered into in June 2022. In connection with the
achievement of the milestone, Rhythm became eligible for a final
investment tranche of $25.0 million from HealthCare Royalty
Partners. Rhythm previously received two tranches totaling $75.0
million under the RIFA.
Anticipated Upcoming Milestones
Rhythm expects to achieve the following near-term
milestones:
- Present data analysis from the Phase 2 and long-term extension
trials in hypothalamic obesity at a medical conference in the fall
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;
- Provide pharmacokinetic and tolerability data from the ongoing
Phase 3 switch trial evaluating a weekly formulation of
setmelanotide in the second half of 2023;
- Complete patient enrollment in the pivotal Phase 3 clinical
trial in hypothalamic obesity in the fourth quarter of 2023;
- Provide an update on pre-clinical development programs,
including RM-718 and the Company’s congenital hyperinsulinism (CHI)
program, in the fourth quarter of 2023; and
- 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
2024.
Second Quarter 2023 Financial
Results:
- Cash Position: As of June 30, 2023, cash, cash
equivalents and short-term investments were approximately $253.6
million, as compared to $333.3 million as of December 31, 2022. The
June 30, 2023 cash position does not include the anticipated
commercial sales milestone payment from HealthCare Royalty Partners
of $24.4 million of proceeds, net of debt issuance costs.
- Revenue: Net product revenues relating to
global sales of IMCIVREE were $19.2 million for the second quarter
of 2023, as compared to $2.3 million for the second quarter of
2022. For the second quarter ended June 30, 2023, 86% of the
Company’s product revenue was generated in the United States.
- License Revenue: The Company did not record
license revenue relating to out-license arrangements in the second
quarter of 2023, following the termination of its agreement with
RareStone Group Ltd. (RareStone) in October 2022. License revenue
relating to the Company’s out-license arrangement with RareStone
was $6.8 million for the second quarter of 2022.
- R&D Expenses: R&D expenses were $33.5
million in the second quarter of 2023, as compared to $31.5 million
in the second quarter of 2022. The year-over-year increase was
primarily due to increased costs associated with certain clinical
trials and pre-clinical studies and increased headcount. This was
partially offset by decreased costs associated with certain trials
and manufacturing of clinical material.
- S,G&A Expenses: S,G&A expenses were
$30.0 million for the second quarter of 2023, as compared to $22.3
million for the second quarter of 2022. The year-over-year increase
was primarily due to increased headcount in the United States and
internationally, professional services and other expenses. This
increase was partially offset by decreased marketing activities
associated with the U.S. BBS launch.
- Other income (expense), net. Other income
(expense), net decreased by $0.2 million from the second quarter of
2022 to the second quarter of 2023, primarily due to $3.3 million
of interest expense related to the RIFA with HealthCare Royalty and
a $0.1 million fair market value adjustment related to the RIFA
embedded derivative, offset by interest income of $3.3 million
earned on our short-term investments.
- Net Loss: Net loss was ($46.7) million for the
second quarter of 2023, or a net loss per basic and diluted share
of ($0.82), as compared to a net loss of ($45.0) million for the
second quarter of 2022, or a net loss per basic and diluted share
of ($0.89).
Year to Date 2023 Financial
Results:
-
Revenue: Net product revenues relating to
sales of IMCIVREE were $30.7 million for the six months
ended June 30, 2023, as compared to $3.8 million for
the six months ended June 30, 2022.
- License
Revenue: The Company did not report license revenue
relating to out-license arrangements in the six months ended June
30, 2023, following the termination of its agreement with RareStone
in October 2022. License revenue relating to the Company’s
out-license arrangement with RareStone was $6.8 million for the six
months ended June 30, 2022.
- R&D
Expenses: R&D expenses were $71.5
million for the six months ended June 30, 2023, as
compared to $64.0 million for the six months ended June 30, 2022.
This increase was primarily due to the acquisition of Xinvento B.V.
and increased costs associated with headcount, certain clinical
trials, pre-clinical studies and gene sequencing and was partially
offset by decreased costs associated with manufacturing of clinical
material, certain clinical trials and a development milestone
payment associated with the weekly formulation paid to Camurus AB
in 2022.
- S,G&A Expenses: S,G&A expenses were
$54.7 million for the six months ended June 30, 2023, as compared
to $43.8 million for the six months ended June 30, 2022. The
increase was primarily due to increased headcount to support
business and commercial operations in the United Sates and
internationally, professional services and other expenses and was
partially offset by decreased marketing activities associated with
the BBS U.S. launch.
- Other income (expense), net: Other (income)/
expense, net increased by $0.2 million to $0.2 million for the six
months ended June 30, 2023. Total other (income)/ expense, net for
the six months ended June 30, 2023 consists of interest income of
$6.7 million primarily due to higher interest rates, partially
offset by $6.4 million of interest expense related to our RIFA with
HealthCare Royalty. The fair market value adjustment related to our
RIFA embedded derivative for the six months ended June 30, 2023 was
de minimis.
- Net
Loss: Net loss was ($98.9) million for the six
months ended June 30, 2023, or a net loss per basic and diluted
share of $(1.74), as compared to a net loss of ($97.8)
million for the six months ended June 30, 2022, or a net loss
per basic and diluted share of ($1.94).
Financial Guidance:
For the year ending December 31, 2023, Rhythm continues to
anticipate 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 June 30, 2023, together with the anticipated $25 million
milestone payment based on commercial sales from Healthcare Royalty
Partners, 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
second quarter 2023 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 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 proopiomelanocortin (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., expectations surrounding lead development
candidate selection for the treatment of CHI and related timing,
our anticipated financial performance and financial position,
including estimated Non-GAAP Operating Expenses for the year ending
December 31, 2023, the sufficiency of our cash, cash equivalents
and short-term investments to fund our operations and the
anticipated commercial sales milestone payment from Healthcare
Royalty Partners, 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 Quarterly Report on Form 10-Q for the quarter ended
June 30, 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 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
MeasuresThis 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 ConnollyExecutive Director, Investor
Relations and Corporate CommunicationsRhythm Pharmaceuticals,
Inc.857-264-4280dconnolly@rhythmtx.com
Media Contact:Adam
DaleyBerry & Company Public
Relations212-253-8881adaley@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, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net |
$ |
19,221 |
|
|
$ |
2,312 |
|
|
$ |
30,691 |
|
|
$ |
3,810 |
|
License revenue |
|
— |
|
|
|
6,754 |
|
|
|
— |
|
|
|
6,754 |
|
Total revenues |
|
19,221 |
|
|
|
9,066 |
|
|
|
30,691 |
|
|
|
10,564 |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
2,236 |
|
|
|
378 |
|
|
|
3,657 |
|
|
|
608 |
|
Research and development |
|
33,543 |
|
|
|
31,456 |
|
|
|
71,487 |
|
|
|
63,966 |
|
Selling, general, and administrative |
|
30,046 |
|
|
|
22,328 |
|
|
|
54,674 |
|
|
|
43,777 |
|
Total costs and expenses |
|
65,825 |
|
|
|
54,162 |
|
|
|
129,818 |
|
|
|
108,351 |
|
Loss from operations |
|
(46,604 |
) |
|
|
(45,096 |
) |
|
|
(99,127 |
) |
|
|
(97,787 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
Other income, net |
|
(17 |
) |
|
|
(133 |
) |
|
|
34 |
|
|
|
(366 |
) |
Interest expense |
|
(3,303 |
) |
|
|
(46 |
) |
|
|
(6,449 |
) |
|
|
(46 |
) |
Interest income |
|
3,221 |
|
|
|
274 |
|
|
|
6,660 |
|
|
|
434 |
|
Total other (expense) income, net |
|
(99 |
) |
|
|
95 |
|
|
|
245 |
|
|
|
22 |
|
Net loss |
$ |
(46,703 |
) |
|
$ |
(45,001 |
) |
|
$ |
(98,882 |
) |
|
$ |
(97,765 |
) |
Net loss per share, basic and diluted |
$ |
(0.82 |
) |
|
$ |
(0.89 |
) |
|
$ |
(1.74 |
) |
|
$ |
(1.94 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
56,867,662 |
|
|
|
50,398,003 |
|
|
|
56,788,757 |
|
|
|
50,362,512 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(46,703 |
) |
|
$ |
(45,001 |
) |
|
$ |
(98,882 |
) |
|
$ |
(97,765 |
) |
Foreign currency translation adjustment |
|
(48 |
) |
|
|
— |
|
|
|
(27 |
) |
|
|
— |
|
Unrealized gain (loss), net on short-term investments |
|
40 |
|
|
|
(277 |
) |
|
|
105 |
|
|
|
(905 |
) |
Comprehensive loss |
$ |
(46,711 |
) |
|
$ |
(45,278 |
) |
|
$ |
(98,804 |
) |
|
$ |
(98,670 |
) |
Condensed Consolidated Balance Sheets(in
thousands, except share and per share
data)(Unaudited) |
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
115,684 |
|
|
$ |
127,677 |
|
Short-term investments |
|
137,918 |
|
|
|
205,611 |
|
Accounts receivable, net |
|
13,831 |
|
|
|
6,224 |
|
Inventory |
|
6,178 |
|
|
|
2,917 |
|
Prepaid expenses and other current assets |
|
10,267 |
|
|
|
11,807 |
|
Total current assets |
|
283,878 |
|
|
|
354,236 |
|
Property and equipment,
net |
|
1,773 |
|
|
|
2,197 |
|
Right-of-use asset |
|
990 |
|
|
|
1,182 |
|
Intangible assets, net |
|
7,456 |
|
|
|
7,883 |
|
Restricted cash |
|
328 |
|
|
|
328 |
|
Other long-term assets |
|
15,518 |
|
|
|
16,655 |
|
Total assets |
$ |
309,943 |
|
|
$ |
382,481 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
8,383 |
|
|
$ |
4,797 |
|
Accrued expenses and other current liabilities |
|
35,708 |
|
|
|
32,894 |
|
Deferred revenue |
|
1,286 |
|
|
|
1,434 |
|
Lease liability |
|
726 |
|
|
|
684 |
|
Total current liabilities |
|
46,103 |
|
|
|
39,809 |
|
Long-term liabilities: |
|
|
|
|
|
Deferred royalty
obligation |
|
79,347 |
|
|
|
75,810 |
|
Lease liability |
|
888 |
|
|
|
1,260 |
|
Derivative liability |
|
1,320 |
|
|
|
1,340 |
|
Total liabilities |
|
127,658 |
|
|
|
118,219 |
|
Stockholders’ equity: |
|
|
|
|
|
Preferred stock, $0.001 par value: 10,000,000 shares authorized; no
shares issued and outstanding at June 30, 2023 and
December 31, 2022 |
|
— |
|
|
|
— |
|
Common stock, $0.001 par value: 120,000,000 shares authorized;
56,896,068 and 56,612,429 shares issued and outstanding at
June 30, 2023 and December 31, 2022,
respectively |
|
57 |
|
|
|
56 |
|
Additional paid-in capital |
|
991,182 |
|
|
|
974,356 |
|
Accumulated other comprehensive loss |
|
(14 |
) |
|
|
(92 |
) |
Accumulated deficit |
|
(808,940 |
) |
|
|
(710,058 |
) |
Total stockholders’ equity |
|
182,285 |
|
|
|
264,262 |
|
Total liabilities and stockholders’ equity |
$ |
309,943 |
|
|
$ |
382,481 |
|
Rhythm Pharmaceuticals (NASDAQ:RYTM)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Rhythm Pharmaceuticals (NASDAQ:RYTM)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024