What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-05-07 compared with 2024-11-06 · 150 added, 176 removed, 166 unchanged (66% of the section changed)

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the promise or potential of any of our products or product candidates;

the marketing, commercialization, and sales of IMCIVREE (setmelanotide), the design, success, cost and timing of our product development activities and clinical trials for setmelanotide, RM-718, bivamelagon (LB54640), and our other product candidates;

our ability to obtain regulatory approval for setmelanotide in further indications, as well as for RM-718, bivamelagon (LB54640), and our other product candidates;

our ability to obtain regulatory approval for setmelanotide in further indications, as well as for RM-718, bivamelagon, and our other product candidates;

our financial performance, including our expectations regarding our existing cash, operating losses, expenses and sources of future financing;

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expectations surrounding our manufacturing arrangements;

the potential financial impact and, the ongoing integration process of Xinvento B.V.;

the impact of the current or future economic conditions on our business and operations and our future financial results;

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We are a global, commercial-stage biopharmaceutical company dedicated to transforming the lives of patients living with rare neuroendocrine diseases.

We are focused on advancing our melanocortin-4 receptor (MC4R) agonists, including our lead asset, IMCIVREE® (setmelanotide), as a precision medicine designed to treat hyperphagia and severe obesity caused by rare MC4R pathway diseases.

While obesity affects hundreds of millions of people worldwide, we are advancing therapies for a subset of individuals who have hyperphagia, a pathological hunger that leads to abnormal food-seeking behaviors, and severe obesity due to impaired MC4R pathway signaling, which may be caused by genetic variants or injury to the hypothalamic region.

The MC4R pathway is an endocrine pathway in the brain that is responsible for regulating hunger, caloric intake and energy expenditure, which consequently affect body weight.

IMCIVREE, an MC4R agonist for which we hold worldwide rights, is the first-ever therapy developed for patients with certain rare diseases that is approved or authorized in the United States, European Union (EU), Great Britain, Canada and other countries and regions.

We are focused on advancing our melanocortin-4 receptor (MC4R) agonists, including our lead asset, IMCIVREE® (setmelanotide), as precision medicines designed to treat hyperphagia and severe obesity caused by MC4R pathway diseases.

While obesity affects hundreds of millions of people worldwide, we are advancing therapies for a subset of individuals who have hyperphagia, a pathological, insatiable hunger and impaired satiety accompanied by persistent and abnormal food-seeking behaviors, decreased energy expenditure and severe obesity due to diseases such as acquired or congenital hypothalamic obesity, Bardet-Biedel syndrome (BBS) or other diseases caused by impaired MC4R pathway signaling.

The MC4R pathway is a neuro-endocrine pathway in the brain that is responsible for regulating hunger, caloric intake and energy expenditure, which consequently affect body weight.

IMCIVREE, an MC4R agonist for which we hold worldwide rights, is the first-ever therapy developed for patients with certain rare diseases that is approved or authorized in the United States, European Union (EU), United Kingdom, Canada and other countries and regions.

IMCIVREE 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:

(i) proopiomelanocortin (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);

or (ii) Bardet-Biedl syndrome (BBS).

The European Commission (EC) has authorized IMCIVREE 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 2 years of age and above.

Great Britain’s Medicines & Healthcare Products Regulatory Agency (MHRA) has authorized IMCIVREE 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.

We have achieved market access or named patient sales of IMCIVREE for BBS or POMC and LEPR deficiencies, or both, in more than 15 countries outside the United States, and we continue to collaborate with authorities to achieve access in additional markets.

In addition to initial commercial efforts, we are advancing what we believe is the most comprehensive clinical research program ever initiated in MC4R pathway diseases, with multiple ongoing and planned clinical trials.

Our MC4R pathway program is designed to expand the total number of patients who would benefit from setmelanotide therapy or one of our new drug candidates, RM-718, which is designed to be a more selective MC4R agonist with weekly administration, or bivamelagon (LB54640), an investigational oral small molecule MC4R agonist in Phase 2 clinical trials.

With setmelanotide, we have completed enrollment in our Phase 3 trial in patients with acquired hypothalamic obesity.

Our Phase 3 EMANATE trial, comprised of four independent substudies evaluating setmelanotide in genetically caused MC4R pathway diseases is ongoing, and we recently completed our Phase 2 DAYBREAK trial evaluating setmelanotide in additional genetic indications.

With RM-718, in March 2024 we initiated Phase 1 in-human trials, including a multiple-ascending dose study in patients with acquired hypothalamic obesity and expect to begin dosing patients in Part C of this Phase 1 trial in the first quarter of 2025, following completion and final analysis of non-clinical toxicology studies to support long-term dosing and the submission to applicable regulatory authorities of our amendment to the protocol to enable longer term dosing of these patients.

In July 2024, we announced that we had dosed the first patients in our Phase 2 trial evaluating bivamelagon (LB54640) in patients with acquired hypothalamic obesity.

In our recently completed Phase 3 pediatrics trial in 12 patients between the ages of 2 and younger than 6 with BBS or POMC or LEPR deficiency obesities, setmelanotide achieved the primary endpoint with a 3.04 mean reduction in BMI-Z score (a measure of body mass index deviations from what is considered normal) and 18.4 percent mean reduction in BMI.

We are seeking regulatory approval in the United States to expand the label for IMCIVREE to treat patients as young as 2 years of age with these diseases based on these data.

We are leveraging what we believe is the largest known DNA database focused on obesity - with almost 80,000 sequencing samples as of December 31, 2023 - to improve the understanding, diagnosis and care of people living with severe obesity due to certain variants in genes associated with the MC4R pathway.

Food and Drug Administration (FDA) to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients aged 2 years and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or 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).

The European Commission (EC) and the United Kingdom’s Medicines & Healthcare Products Regulatory Agency (MHRA) have authorized IMCIVREE for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above.

In addition to the United States, we have achieved market access or named patient sales of IMCIVREE for BBS or POMC and LEPR deficiencies, or both, in more than 15 countries outside the United States, and we continue to collaborate with authorities to achieve access in additional markets.

We anticipate submitting applications to seek regulatory approval for setmelanotide as a treatment for acquired hypothalamic obesity in multiple geographies in the near term.

Acquired hypothalamic obesity is a rare form of obesity that occurs following damage to the hypothalamic region of the brain.

This disease most frequently follows the growth or surgical removal of craniopharyngioma, astrocytoma or other rare brain tumors.

Additional causes of injury may include traumatic brain injury, stroke, or inflammation due to infection.

Patients experience accelerated weight gain, a reduction in energy expenditure, and hyperphagia (a chronic pathological condition characterized by insatiable hunger, impaired satiety, and persistent abnormal food-seeking behaviors) leading to severe obesity within six to 12 months following tumor resection or other injury.

On April 7, 2025, we announced positive topline results from the pivotal Phase 3 TRANSCEND trial evaluating setmelanotide for the treatment of acquired hypothalamic obesity.

The global trial, which we believe is the largest and longest placebo-controlled trial to evaluate a therapy for patients with acquired hypothalamic obesity, met its primary endpoint with a statistically significant and highly clinically meaningful reduction in body mass index (BMI) with setmelanotide in both adult and pediatric patients versus placebo.

No new safety signals with setmelanotide were observed, in line with setmelanotide’s well-established and well-understood safety profile.

Given these compelling new efficacy data with setmelanotide, we are preparing to submit a supplemental New Drug Application to the FDA and a Type II variation request to the European Medicines Agency in the third quarter of 2025.

We anticipate reading out data from a 12-patient cohort in Japan in the first quarter of 2026 which we believe, if successful, could support registration of setmelanotide in Japan for this disease.

With these planned submissions, we believe setmelanotide has the potential to become the first-ever approved therapy for patients with acquired hypothalamic obesity.

We estimate there are 5,000 to 10,000 people living with hypothalamic obesity in the U.S., 5,000 to 8,000 people living with hypothalamic obesity in Japan, and 3,500 to 10,000 people living with hypothalamic obesity in the E.U.

In addition to our commercial efforts and inclusive of late-stage development efforts, we are advancing what we believe is the most comprehensive clinical research and development program ever initiated in MC4R pathway diseases, with multiple ongoing and planned clinical trials.

Our MC4R pathway program is designed to expand the total number of patients who we believe would benefit from setmelanotide therapy or from one of our new drug candidates, RM-718,

which is designed to be a more selective MC4R agonist with weekly administration, or bivamelagon, an investigational oral small molecule MC4R agonist in Phase 2 clinical trials.

As mentioned above, our Phase 3 trial of setmelanotide in patients with acquired hypothalamic obesity met the primary and key secondary endpoints, and we have initiated an additional, independent substudy in patients with congenital hypothalamic obesity as part of that trial.

We are advancing next-generation MC4R agonists in clinical trials.

We anticipate reading out topline data from our Phase 2 trial evaluating bivamelagon in patients with acquired hypothalamic obesity in the third quarter of 2025, and we anticipate completing enrollment in Part C of the Phase 1 trial evaluating the weekly RM-718 in patients with acquired hypothalamic obesity.

In addition, our Phase 3 EMANATE trial, comprised of four independent substudies evaluating setmelanotide in genetically caused MC4R pathway diseases is ongoing, and we recently completed our Phase 2 DAYBREAK trial evaluating setmelanotide in additional genetic indications.

We are leveraging what we believe is the largest known DNA database focused on obesity - with approximately 100,000 sequencing samples as of December 31, 2024 - to improve the understanding, diagnosis and care of people living with severe obesity due to certain variants in genes associated with the MC4R pathway.

Our sequencing-based epidemiology estimates show that each of these genetically-defined MC4R pathway deficiencies are considered rare diseases, according to established definitions based on patient populations.

Our epidemiology estimates are approximately 4,600 to 7,500 for U.S.

patients in initial FDA-approved indications, including obesity due to biallelic POMC, PCSK1 or LEPR deficiencies,

We estimate the epidemiology for patients with acquired hypothalamic obesity to be between 5,000 and 10,000 in the United States, based on our analysis of published literature.

Our epidemiology estimates for the indications being studied in our Phase 3 EMANATE trial suggest that approximately 53,000 U.S.

patients in initial FDA-approved indications, including obesity due to biallelic POMC, PCSK1 or LEPR deficiencies, and BBS.

Our epidemiology estimates for the two more prevalent indications being studied in our Phase 3 EMANATE trial (SH2B1 and POMC/PCSK1) suggest that approximately 29,000 U.S.

patients with one of these genetically driven obesities have the potential to respond well to setmelanotide.

Similarly, our epidemiology estimates for patients with genetic indications who demonstrated an initial response in our Phase 2 DAYBREAK trial is approximately 65,300.

Similarly, our epidemiology estimates for patients with genetic indications who demonstrated an initial response following stage 1 of our Phase 2 DAYBREAK trial is approximately 65,300.

We believe that all these patients face similar challenges as other patients with rare diseases, namely lack of awareness, resources, tests, tools and, especially, therapeutic options.

Additional recent clinical, regulatory, corporate and commercial updates include:

On November 5, 2024, we reported that revenue from global sales of IMCIVREE was $33.3 million for the third quarter of 2024, an increase of 14% percent on a sequential basis from the second quarter of 2024, primarily driven by sales for BBS.

In the third quarter of 2024, revenue of $23.3 million, or 70% of product revenue, was generated in the United States, an increase of 8% on a sequential basis;

revenue of $10.0 million, or 30% of product revenue, was generated outside the United States, an increase of 35% on a sequential basis.

On November 5, 2024, during the Obesity Society’s ObesityWeek® conference in San Antonio, we and our collaborators delivered several presentations, including:

● Real-world data from patients participating in an early-access program in France that showed eight adult patients with acquired hypothalamic obesity achieved a mean BMI reduction of 12.8% at three months on setmelanotide therapy;

three of these patients reached six months on therapy and achieved a mean

BMI reduction of 15.4%.

These results demonstrate the clinical benefit of setmelanotide in adult patients who had lived with hypothalamic obesity for an average of 12.1 years;

● Data from the extension phase of our Phase 2 trial of setmelanotide showed that patients with acquired hypothalamic obesity who were on therapy for more than one year (n=11) achieved a mean overall percent reduction in fat mass of 29.6%, versus a reduction in lean muscle mass of 7.7% (these same patients had achieved mean BMI reduction of 25.5%);

and four male patients between 11 and 14 years old at baseline exhibited an increase in muscle mass;

● Encouraging data from the our exploratory Phase 2 DAYBREAK study showing that 27 of 32 patients on setmelanotide, or 84% of patients, achieved or maintained >5% BMI reduction from baseline through stage 2 for a total of 40 weeks, compared to 5 of 17 patients, or 29.4% of patients, who transitioned to placebo for 24 weeks during stage 2;

also in DAYBREAK, a 12.4% mean percent BMI reduction was observed for all patients on continuous setmelanotide therapy over 40 weeks (n=32).

On October, 24, 2024, we announced a joint research collaboration with Axovia Pharmaceuticals, led by Professor Philip Beales, CEO and Co-founder, in order to better understand the global epidemiology of BBS, how various symptoms impact patients and their families’ lives, the underlying genetics of this disease, and the need for improved diagnosis and additional treatment options.

On August 26, 2024, we announced that the FDA accepted with Priority Review our supplemental New Drug Application (sNDA) for IMCIVREE to treat children as young as 2 years old in its approved indications.

The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 26, 2024.

On May 7, 2025, we announced:

● revenue from global sales of IMCIVREE was $37.7 million for the first quarter of 2025.

The number of patients on reimbursed therapy increased 14% in the first quarter of 2025 compared to the fourth quarter of 2024, as patient demand for IMCIVREE remained strong.

Revenue of $24.5 million, or 65% of product revenue, was generated in the United States.

The number of patients on reimbursed therapy in the United States continued to increase during the quarter.

revenue was affected by an $8.3 million decrease in inventory at the specialty pharmacy that dispenses IMCIVREE to patients and a $1.1 million increase in product dispensed to patients, resulting in a net decrease in product revenue of $7.2 million in the first quarter of 2025 compared to the fourth quarter of 2024.

Revenue of $13.2 million, or 35% of product revenue, was generated outside the United States, an increase of $3.2 million quarter over quarter.

On April 7, 2025, we announced the pivotal Phase 3 TRANSCEND trial met its primary endpoint with a -19.8% placebo-adjusted body mass index (BMI) reduction with setmelanotide in patients (N=120) with acquired HO.

Highlights included:

● Patients with acquired HO on setmelanotide therapy (n=81) achieved mean BMI change of -16.5% compared with +3.3% for placebo (n=39) at 52 weeks (p<0.0001);

● -19.2% placebo-adjusted BMI reduction achieved in adult patients 18 years old and older (n=49) at 52 weeks;

● -20.2% placebo-adjusted BMI reduction achieved in patients younger than 18 years old (n=71) at 52 weeks;

● 80% of patients on setmelanotide achieved BMI reduction of 5% or greater at 52 weeks;

● No new safety signals with setmelanotide were observed, in line with setmelanotide’s well-established and well-understood safety profile.

Today, we announced new data from the Phase 3 TRANSCEND trial that demonstrated a consistent and statistically significant mean BMI reduction across three stratified age groups:

● -19.5% placebo-adjusted BMI reduction achieved in pediatric patients ages 4 to younger than 12 years old (n=31:

20 setmelanotide, 11 placebo) at 52 weeks (p<0.0001);

● -21.0% placebo-adjusted BMI reduction achieved in adolescent patients ages 12 to younger than 18 years old (n=40:

28 setmelanotide, 12 placebo) at 52 weeks (p<0.0001);

● -19.2% placebo-adjusted BMI reduction achieved in adult patients ages 18 and older (n=49:

33 setmelanotide, 16 placebo) at 52 weeks (p<0.0001).

Additionally, on April 7, 2025, we announced that we dosed the first patients with Prader-Willi syndrome in a 26-week, open-label Phase 2 trial of setmelanotide.

The trial will assess the safety and efficacy of a daily dose of subcutaneous setmelanotide in approximately 20 patients for up to 26 weeks.

On March 20, 2025, we announced that we reacquired the rights to IMCIVREE® (setmelanotide) in China, including mainland China, Hong Kong and Macau, as we terminated our 2021 licensing agreement with RareStone Group Ltd.

On March 19, 2025, we announced that we received orphan drug designation from Japan’s Ministry of Health, Labour and Welfare (MHLW) for setmelanotide as a treatment for acquired hypothalamic obesity.

On March 18, 2025, we announced a new research collaboration with the Raymond A.

Wood Foundation, a patient advocacy organization for survivors of craniopharyngioma and hypothalamic-pituitary brain tumors, to study the impact of fatigue on persons with craniopharyngioma.

We currently expect to achieve the following, near-term milestones:

● Complete enrollment in the supplemental, 12-patient Japanese cohort of our global Phase 3 trial evaluating setmelanotide in acquired hypothalamic obesity by the end of 2024;

● Complete enrollment in two substudies in the Phase 3 EMANATE trial evaluating setmelanotide in genetically caused MC4R pathway diseases by the end of 2024;

● Complete enrollment in our Phase 2 trial evaluating oral MC4R agonist bivamelagon (LB54640) in acquired hypothalamic obesity in the first quarter of 2025;

● Begin dosing patients with acquired hypothalamic obesity in Part C of the Phase 1 trial evaluating the weekly, MC4R agonist RM-718 in the first quarter of 2025;

● Announce top-line data in the Phase 3 trial evaluating setmelanotide in acquired hypothalamic obesity in the first half of 2025.

Up until recently, our operations have been limited primarily to conducting research and development activities for setmelanotide.

To date, we have not generated sufficient cash flow from product sales and have financed our operations primarily through the proceeds received from our sales of common and preferred stock, royalty interest financing, asset sales, as well as capital contributions from the former parent company, Rhythm Holdings LLC.

From August 2015 through August 2017, we raised aggregate net proceeds of $80.8 million through our issuance of series A preferred stock.

Since our initial public offering, or IPO, on October 10, 2017 and our underwritten follow-on offerings through October 2022, we have raised aggregate net proceeds of approximately $791.5 million through the issuance of our common stock after deducting underwriting discounts, commissions and offering related transaction costs.

We also received $100.0 million from the sale of our Rare Pediatric Disease Priority Review Voucher, or PRV, to Alexion Pharmaceuticals, Inc.

in February 2021.

In June 2022, we entered into the Revenue Interest Financing Agreement (“RIFA”), with entities managed by HealthCare Royalty Partners, collectively referred to as the Investors, and through December 31, 2023 have received cumulative proceeds of $96.7 million, net of certain transaction costs.

On April 1, 2024, we entered into an Investment Agreement with certain investors resulting in the issuance of convertible preferred

stock to the investors and proceeds to the Company of $150.0 million, as disclosed in Note 10, “Series A Preferred Stock”.

IMCIVREE became commercially available to patients 6 years of age and older with obesity due to POMC, PCSK1 or LEPR deficiency in the U.S.

● Submit a supplemental New Drug Application to the FDA and a Type II variation request to the European Medicines Agency for setmelanotide for the treatment of acquired HO in the third quarter of 2025;

● Announce topline data from the bivamelagon Phase 2 trial in acquired HO in the third quarter of 2025;

● Complete enrollment in the setmelanotide Phase 2 trial in Prader-Willi syndrome (PWS) in the third quarter of 2025;

● Complete enrollment in the Phase 1, Part C trial evaluating the weekly, MC4R agonist RM-718 in patients with acquired hypothalamic obesity and provide an update from the trial on efficacy, safety and tolerability results in the second half of 2025;

● Complete enrollment in the setmelanotide Phase 3 trial substudy in congenital hypothalamic obesity in the second half of 2025;

● Announce topline data in the 12-patient Japanese cohort of the setmelanotide Phase 3 trial in acquired HO in the first quarter of 2026;

● Announce topline data in the Phase 3 EMANATE trial evaluating setmelanotide in genetically caused MC4R pathway diseases in the first quarter of 2026.

IMCIVREE first became commercially available to patients 6 years of age and older with obesity due to POMC, PCSK1 or LEPR deficiency in the U.S.

in the first quarter of 2021 and patients 6 years of age and older with obesity due to BBS during June 2022.

Following marketing authorizations in the EU, Great Britain and Canada, we are pursuing a country-by-country strategy to establish market access and reimbursement for IMCIVREE in several additional countries.

During March 2022, we treated the first patients with IMCIVREE in France under the paid early access program and we treated the first patients with IMCIVREE in Germany during June 2022.

Following marketing authorizations in the EU, Great Britain and Canada, as well as expanded labels in the U.S., the EU and Great Britain and 2024 to make IMCIVREE available to patients as young as 2 years of age, we are continuing to pursue a country-by-country strategy to establish market access and reimbursement for IMCIVREE in additional countries.

We expect to continue to fund our operations through the sale of equity, debt financings or other sources.

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If we fail to raise capital or enter into such other arrangements as, and when, needed, we may have to significantly delay, scale back or discontinue the development or commercialization of setmelanotide.

As of September 30, 2024 we had an accumulated deficit of $1.1 billion.

Our net loss was $43.6 million, $217.3 million, $44.2 million and $143 million for the three and nine months ended September 30, 2024 and 2023, respectively.

From August 2015 through August 2017, we raised aggregate net proceeds of $80.8 million through our issuance of Convertible Preferred Stock.

Since our initial public offering, or IPO, on October 10, 2017, through our underwritten follow-on offerings and through our ATM program through March 31, 2025, we have raised aggregate net proceeds of approximately $864.8 million through the issuance of our common stock after deducting underwriting discounts, commissions and offering related transaction costs.

We also received $100.0 million from the sale of our Rare Pediatric Disease Priority Review Voucher (“PRV”), to Alexion Pharmaceuticals, Inc.

in February 2021.

In June 2022, we entered into the Revenue Interest Financing Agreement (“RIFA”), with entities managed by HealthCare Royalty Partners, collectively referred to as the Investors, and through March 31, 2025 have received cumulative proceeds of $96.7 million, net of certain transaction costs.

On April 1, 2024, we entered into an Investment Agreement with certain affiliates of Perceptive Advisors LLC, or Perceptive, and certain other investors, relating to the issuance and sale of 150,000 shares of a new series of the Company’s Series A Convertible Preferred Stock, par value $0.001 per share, titled the “Series A Convertible Preferred Stock”, or the Convertible Preferred Stock, for an aggregate purchase price of $150.0 million, or $1,000 per share (as disclosed in Note 9, “Series A Preferred Stock”).

We received $147.8 million in net proceeds under the Investment Agreement.

We expect to continue to fund our operations through the sale of equity, debt financings or other sources.

We have built our own marketing and commercial sales infrastructure in the United States and are in the process of building a similar infrastructure in several European markets and the United Kingdom.

We may enter into collaborations with other parties for certain markets outside the United States.

However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms, or at all.

As of March 31, 2025 we had an accumulated deficit of $1.2 billion.

Our net loss was $49.5 million and $141.4 million for the three months ended March 31, 2025 and March 31, 2024, respectively.

We expect to continue to incur significant expenses and operating losses for the foreseeable future.

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● continue to operate as a public company.

As of September 30, 2024, our existing cash and cash equivalents and short-term investments were approximately $298.4 million.

We expect that our existing cash and cash equivalents and short-term investments as of September 30, 2024 will be sufficient to fund our operations into 2026.

Corporate Background

We are a Delaware corporation organized in February 2013 under the name Rhythm Metabolic, Inc., and as of October 2015, under the name Rhythm Pharmaceuticals, Inc.

As of March 31, 2025, our existing cash and cash equivalents and short-term investments were approximately $314.5 million.

We expect that our existing cash and cash equivalents and short-term investments will be sufficient to fund our operations into 2027.

Financial Operations Overview

Product revenue, net

Revenues from product sales are recorded at the net sales price, or the transaction price, which includes estimates of variable consideration for which reserves are established and which result from discounts, rebates, and co-pay assistance that are offered within contracts between us and our customers, health care providers and other indirect customers relating to the sale of IMCIVREE.

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We recorded our first sales of IMCIVREE in the United States in March 2021 and we made our first sales in France during March 2022 under the paid early access program.

IMCIVREE was approval by the FDA and the EC in adult and pediatric patients six years of age and older with obesity due to BBS in June and September 2022, respectively.

Following these approvals for BBS, we expect our sales of IMCIVREE will continue to grow as we identify and treat more patients with this disease and obtain reimbursement throughout the international markets in which we operate.

IMCIVREE was approved by the FDA and the EC in adult and pediatric patients six years of age and older with obesity due to BBS in June and September 2022, respectively.

In 2024, IMCIVREE was approved by the FDA to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients aged 2 years and older with syndromic or monogenic obesity due to BBS or 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).

Also in 2024, the EC and MHRA authorized IMCIVREE for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above.

Following these approvals, we expect our sales of IMCIVREE will continue to grow as we identify and treat more patients with this disease and obtain reimbursement throughout the international markets in which we operate.

License revenue

For the three months ended March 31, 2025, we recognized a reduction of previously-recognized license revenue of $5.0 million in connection with the termination of our exclusive license agreement with RareStone.

See Note 12, “Significant Agreements” to the unaudited condensed consolidated financial statements included under Part I, Item 1 of this Quarterly Report on Form 10-Q.

Cost of sales

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● facilities, depreciation, and other expenses, which include rent and maintenance of facilities, insurance and other operating costs;

● acquired in process research and development costs associated with the acquisition of Xinvento B.V., or Xinvento in the three months ended March 31, 2023;

● acquired in process research and development costs associated with the acquisition of LG Chem, Ltd.’s, or LGC’s proprietary compound bivamelagon (LB54640) in the three months ended March 31, 2024.

● acquired in process research and development costs associated with the acquisition of LG Chem, Ltd.’s, or LGC’s proprietary compound bivamelagon in the three months ended March 31, 2024.

We expense research and development costs to operations as incurred.

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Three Months Ended

Nine Months Ended

September 30,

Research and development summary

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We are unable to predict the duration and costs of the current or future clinical trials of our product candidates.

The duration, costs, and timing of clinical trials and development of setmelanotide, RM-718, bivamelagon (LB54640), and a potential therapeutic product candidate for congenital hyperinsulinism (CHI) will depend on a variety of factors, including:

The duration, costs, and timing of clinical trials and development of setmelanotide, RM-718, bivamelagon, and a potential therapeutic product candidate for congenital hyperinsulinism (CHI) will depend on a variety of factors, including:

● the scope, rate of progress, and expense of our ongoing, as well as any additional, clinical trials and other research and development activities;

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Three Months Ended

Nine Months Ended

September 30,

Selling, general and administrative summary

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Results of Operations

Comparison of the three months ended September 30, 2024 and 2023

The following table summarizes our results of operations for the three months ended September 30, 2024 and 2023, together with the changes in those items in dollars and as a percentage:

Comparison of the three months ended March 31, 2025 and 2024

The following table summarizes our results of operations for the three months ended March 31, 2025 and 2024, together with the changes in those items in dollars and as a percentage:

Three Months Ended

September 30,

(in thousands)

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Product revenue, net

License revenue

Costs and expenses:

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Product revenue, net .

Product revenue, net increased by $10.7 million to $33.3 million for the three months ended September 30, 2024 from $22.5 million for the three months ended September 30, 2023, an increase of 48%.

We expect our sales of IMCIVREE to continue to increase following the FDA approval for the treatment of patients with BBS in the United States in June 2022.

For the three months ended September 30, 2024 and 2023, a substantial amount of our product revenue, or 68% and 80%, respectively, was generated from sales of our product to patients in the United States.

Product revenue, net increased by $11.8 million to $37.7 million for the three months ended March 31, 2025 from $26.0 million for the three months ended March 31, 2024, an increase of 45%.

We expect our sales of IMCIVREE to continue to increase.

We have achieved market access for IMCIVREE for BBS or POMC and LEPR deficiencies, or both, in more than 15 countries outside the United States, and we continue to collaborate with authorities to achieve access in additional markets.

For the three months ended March 31, 2025 and 2024, a substantial amount of our product revenue, or 65% and 74%, respectively, was generated from sales of our product to patients in the United States.

License revenue .

See Note 12, “Significant Agreements” to the unaudited condensed consolidated financial statements included under Part I, Item 1 of this Quarterly Report on Form 10-Q.

Cost of sales.

Cost of sales increased by $1.4 million to $3.8 million for the three months ended September 30, 2024 from $2.4 million for the three months ended September 30, 2023, an increase of 59%, which was driven by a corresponding increase in revenue in the three months ended September 30, 2024 .

Cost of sales is composed of royalty expense due to Ipsen Pharma S.A.S., or Ipsen, on our net product revenue, amortization of our capitalized sales-based milestone payment made to Ipsen, upon our first commercial sale in the United States and European Union, the cost of product, as well as costs associated with our patient assistance programs.

Specifically, the $1.4 million increase in cost of sales in the three months ended September 30, 2024 from the same period in 2023 was due to $0.5 million of additional royalties due to our growth in sales and $0.9 million attributed to increased product cost associated with higher sales volume.

We expect cost of sales to continue to increase as a percentage of product revenue, net to continue to be in a range of 10% to 12% in the foreseeable future.

Cost of sales increased by $0.8 million to $3.6 million for the three months ended March 31, 2025 from $2.8 million for the three months ended March 31, 2024, an increase of 30%, which was driven by a corresponding increase in revenue in the three months ended March 31, 2025 .

Cost of sales is composed of royalty expense due to Ipsen Pharma S.A.S., or Ipsen, on our net product revenue;

amortization of our capitalized sales-based milestone payment made to Ipsen, upon our first commercial sale in the United States and European Union, the cost of product, as well as costs associated with our patient assistance programs.

Specifically, the $0.8 million increase in cost of sales in the three months ended March 31, 2025 from the same period in 2024 was due to $0.6 million of additional royalties due to our growth in sales and $0.2 million attributed to increased product cost associated with higher sales volume.

We expect cost of sales as a percentage of revenue to continue to be in a range of 10% to 12% in the foreseeable future.

Research and development expense.

Research and development expense increased by $4.4 million to $37.9 million for the three months ended September 30, 2024 from $33.6 million for the three months ended September 30, 2023, an increase of 13%.

The net increase was primarily due to the following:

● an increase of $2.1 million for ongoing manufacturing development costs for bivamelagon (LB54640).

● an increase of $1.5 million in our clinical trial costs associated with increased activity in our Phase 3 acquired hypothalamic obesity trial, our Phase 1 clinical trial of RM-718 and the Phase 2 trial of bivamelagon (LB54640);

● an increase of $1.4 million in salaries, benefits and stock-based compensation related to the hiring of additional full-time employees in order to support the growth of our research and development program.

The above increases were partially offset by:

● a decrease in our clinical trial costs associated with decreased activity in our Phase 2 DAYBREAK trial and pediatrics trial for setmelanotide therapy of approximately $1.3 million.

Research and development expense decreased by $91.7 million to $37.0 million for the three months ended March 31, 2025 from $128.7 million for the three months ended March 31, 2024, a decrease of 71%.

The net decrease was primarily due to the following:

● a decrease of $92.5 million related to acquired In-Process Research and Development (“IPR&D”) costs associated with the acquisition of LGC’s proprietary compound bivamelagon in the three months ended March 31, 2024, which did not recur in 2025;

● a net decrease of $4.7 million in our clinical trial costs due to the completion and wind down of our long-term extension trial, Phase 2 Basket trial, Phase 3 pediatrics trial, and switch trial, as well as decreased genetic sequencing costs.

The above decreases were partially offset by:

● an increase of $2.9 million in salaries, benefits and stock-based compensation related to the hiring of additional full-time employees in order to support the growth of our research and development programs;

● an increase of $2.1 million associated with chemistry, manufacturing, and controls (CMC) costs for drug formulation to support our ongoing Phase 1 clinical trial of RM-718 and the Phase 2 bivamelagon trial acquired from LGC.

Selling, general and administrative expense.

Selling, general and administrative expense increased by $4.9 million to $35.4 million for the three months ended September 30, 2024 from $30.5 million for the three months ended September 30, 2023, an increase of 16%.

Selling, general and administrative expense increased by $4.7 million to $39.1 million for the three months ended March 31, 2025 from $34.4 million for the three months ended March 31, 2024, an increase of 14%.

The increase was primarily due to the following:

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● an increase of $1.3 million related to increased marketing and promotion costs to support continued revenue growth.

● an increase of $0.7 million related to professional services costs, including legal, consulting and tax services.

Other income (expense), net.

Other income (expense), net decreased by $0.3 million to ($0.1) million for the three months ended September 30, 2024 from $0.2 million for the three months ended September 30, 2023.

The increase was primarily due to the following:

● recognition of $1.0 million of non-cash interest expense in the three months ended September 30, 2024 associated with accretion of our other current liability payable to LGC in July, 2025;

● an increase in non-cash interest expense of $1.0 million related to amortization of debt discount and deferred financing fees associated with our 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.

The above amounts were partially offset by:

● a net increase $1.2 million recognized for the net change in fair value of the embedded derivatives in our debt royalty obligation, as well as realized foreign currency gains;

● an increase in interest income of $0.6 million earned on our short-term investments, based on higher investment balances from the proceeds of $150.0 million from the convertible preferred stock issuance.

Comparison of the nine months ended September 30, 2024 and 2023

Nine Months Ended

September 30,

(in thousands)

Statement of Operations Data:

Product revenue, net

Total revenues

Costs and expenses:

Cost of sales

Research and development

Selling, general, and administrative

Total costs and expenses

Loss from operations

Other income (expense), net

Loss before income taxes

Provision for income taxes

Product revenue, net.

Product revenue, net increased by $35.1 million to $88.3 million for the nine months ended September 30, 2024 from $53.2 million for the nine months ended September 30, 2023, an increase of 66%.

We expect our sales of IMCIVREE to continue to increase following the FDA approval for the treatment of patients with BBS in the United States in June 2022.

During the nine months ended September 30, 2024 and 2023, a substantial amount of our product revenue, or 73% and 84%, respectively, has been generated in the United States.

Cost of sales.

Cost of sales increased by $3.5 million to $9.6 million for the nine months ended September 30, 2024, an increase of 58%.

Cost of sales primarily reflects a royalty due to Ipsen, on our net product sales and the amortization of our capitalized sales-based milestone payment made to Ipsen, upon our first commercial sale in the U.S.

and EU, the cost of product as well as costs associated with our patient assistance programs.

Specifically, the $3.5 million increase in cost of sales for the nine months ended September 30, 2024 was due to $1.8 million of additional royalties due to our growth in net product revenue and $1.7 million due to higher product costs from higher net product revenue.

We expect cost of sales as a percentage of product revenue, net to be in a range of 10% to 12% in the foreseeable future .

Research and development expense .

Research and development expense increased by $91.7 million to $196.8 million for the nine months ended September 30, 2024 from $105.1 million for the nine months ended September 30, 2023, an increase of 87%.

The net increase was primarily due to the following:

● acquired in process research and development costs associated with the acquisition of LGC’s proprietary compound bivamelagon (LB54640) of $92.4 million in the nine months ended September 30, 2024;

● an increase of $4.3 million in salaries, benefits and stock-based compensation related to the hiring of additional full-time employees in order to support the growth of our research and development programs;

● an increase of $0.9 million in our clinical trial costs associated with increased activity in our Phase 3 hypothalamic obesity trial, our RM-718 clinical trial and the Phase 2 bivamelagon (LB54640) trial acquired from LG Chem;

The above increases were partially offset by:

● the purchase of in-process research and development assets of $5.7 million from Xinvento in the nine months ended September 30, 2023, which did not recur in the nine months ended September 30, 2024.

Selling, general and administrative expense.

Selling, general and administrative expense increased by $21.0 million to $106.2 million for the nine months ended September 30, 2024 from $85.2 million for the nine months ended September 30, 2023, an increase of 25%.

The increase was primarily due to the following:

● an increase of $12.2 million due to increased salaries, benefits and stock-based compensation related costs associated with additional headcount to support our expanding business operations as well as to build out our commercial operations in the United States and internationally;

● an increase of $3.5 million related to professional services costs;

● an increase of $4.5 million due to increased costs associated with marketing, data analytics, website and sponsorships;

● an increase of $1.6 million due to increased costs associated with information technology, international office space, and general corporate travel related expenses for our expanding workforce.

● a decrease of $2.0 million related to professional services costs, including legal, consulting and tax services;

● a decrease of $0.8 million related to CMC costs.

Other income (expense), net.

Other income (expense), net was $7.4 million for the nine months ended September 30, 2024 as compared to $0.4 million for the nine months ended September 30, 2023.

Other (expense), net increased by $1.2 million to $2.4 million for the three months ended March 31, 2025 from $1.2 million for the three months ended March 31, 2024.

The increase was primarily due to the following:

● a gain of $8.9 million recognized for the change in fair value of a forward contract recorded with the issuance of convertible preferred stock;

● a change in fair value of the embedded derivative in our debt royalty obligation of $1.2 million and realized foreign currency gains of $1.3 million and other income of $0.4 million;

● an increase in interest income of $1.1 million earned on our short-term investments, based on higher investment balances from the proceeds of $150.0 million from the convertible preferred stock issuance;

The above amounts were partially offset by:

● recognition of $3.0 million of non-cash interest expense in the nine months ended September 30, 2024 associated with accretion of the non-current liability payable to LGC in July, 2025;

● an increase in non-cash interest expense of $2.7 million related to amortization of debt discount and deferred financing fees associated with our 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.

● recognition of $1.1 million of non-cash interest expense in the three months ended March 31, 2025 associated with accretion of the non-current liability payable to LGC in July 2025;

● a net increase of $0.6 million recognized for the net change in fair value of the embedded derivatives in our debt royalty obligation, as well as realized foreign currency losses.

The above amount was partially offset by:

Liquidity and Capital Resources

As of September 30, 2024, our cash and cash equivalents and short-term investments were approximately $298.4 million.

The following table provides information regarding our cash flows for the nine months ended September 30, 2024 and 2023:

Nine Months Ended September 30,

As of March 31, 2025, our cash and cash equivalents and short-term investments were approximately $314.5 million.

The following table provides information regarding our cash flows for the three months ended March 31, 2025 and 2024:

Three Months Ended March 31,

(in thousands)

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Effect of exchange rates on cash

Net (decrease) increase in cash, cash equivalents and restricted cash

Net increase (decrease) in cash, cash equivalents and restricted cash

Net cash used in operating activities

The use of cash in all periods resulted primarily from our net loss adjusted for non-cash charges and changes in components of operating assets and liabilities.

Net cash used in operating activities was $95.0 million for the nine months ended September 30, 2024 and consisted primarily of a net loss of $217.3 million adjusted for non-cash items of $121.9 million, which consisted of non-cash stock-based compensation, non-cash interest expense, non-cash accretion and amortization of short-term investments, non-cash accretion of other current liability, gain on settlement of forward contract, depreciation and amortization, rent expense and the change in the fair value of our embedded derivative liability, totaling $29.5 million.

Our net loss adjusted for non-cash items also includes $92.4 million of acquired In Process Research and Development (IPR&D) assets, which are classified as investing activities.

The change in operating assets and liabilities used net cash of approximately $0.3 million, primarily driven by net increases in accounts receivable and inventory of $9.7 million, offset by net decreases in accounts payable and accrued expenses of $6.7 million and net decreases in long-term assets of $3.2 million.

Net cash used in operating activities was $106.8 million for the nine months ended September 30, 2023 and consisted primarily of a net loss of $143.0 million adjusted for non-cash items of $34.7 million, which consisted of noncash stock-based compensation, depreciation and amortization, rent expense and the change in the fair value of our embedded derivative liability.

Our net loss also includes $5.7 million of acquired In-Process Research and Development (IPR&D) assets, which are classified as investing activities.

The change in operating assets and liabilities used net cash of approximately $4.1 million, primarily driven by net increases in accounts receivable and inventory of $13.2 million from our increasing revenues and a net increase in prepaid expenses and other assets of $0.8 million, offset by a net increase in accounts payable and accrued expenses of $9.9 million due to the timing of vendor and employee bonus payments.

Net cash used in investing activities

Net cash used in investing activities was $69.3 million for the nine months ended September 30, 2024 and relates to purchases of short term investments for $201.9 million and cash used for the purchase of LGC’s proprietary compound bivamelagon (LB54640) for $40.0 million in January 2024, offset by gross maturities of short-term investments of $173.1 million.

Net cash used in investing activities was $28.3 million for the nine months ended September 30, 2023 and relates to gross purchases of short-term investments of $314.2 million and cash used to purchase Xinvento’s IPR&D assets for $5.7 million in February 2023.

These cash uses were offset by maturities of short-term investments of $291.7 million.

Net cash used in operating activities was $40.4 million for the three months ended March 31, 2025 and consisted primarily of a net loss of $49.5 million adjusted for non-cash items of $17.1 million, which consisted of stock-based compensation, non-cash interest expense, non-cash accretion and amortization of short-term investments, depreciation and amortization, rent expense and the change in the fair value of our embedded derivative asset.

The change in operating assets and liabilities used net cash of approximately $7.9 million and was primarily driven by net decreases in accounts payable and accrued expenses of $3.6 million, the change in deferred revenue of $1.3 million, and net increases in prepaids and other current assets of $3.2 million.

These net uses of cash were offset by net increases in other long-term assets of $0.1 million and net increases in accounts receivable and inventory of $0.1 million.

Net cash used in operating activities was $40.7 million for the three months ended March 31, 2024 and consisted primarily of a net loss of $141.4 million adjusted for non-cash items of $102.8 million, which consisted of stock-based compensation, depreciation and amortization, and the change in the fair value of our embedded derivative liability, totaling $10.4 million.

Our net loss adjusted for non-cash items also includes $92.4 million of acquired IPR&D assets, which are classified as investing activities.

The change in operating assets and liabilities used net cash of approximately $2.2 million, primarily driven by net increases in prepaid expenses and other assets of $2.4 million and net decreases in accounts payable and accrued expenses of $1.3 million, offset by a net increase in long-term assets of $1.2 million and decreases in accounts receivable and inventory of $0.3 million.

Net cash provided by investing activities

Net cash provided by investing activities was $24.8 million for the three months ended March 31, 2025 and relates to gross maturities of short-term investments of $58.3 million, offset by purchases of short-term investments for $33.5 million.

Net cash provided by investing activities was $30.1 million for the three months ended March 31, 2024 and relates to gross maturities of short-term investments of $70.1 million, offset by cash used for the purchase of LGC’s proprietary compound bivamelagon for $40.0 million in January 2024.

Net cash provided by financing activities

Net cash provided by financing activities was $152.9 million for the nine months ended September 30, 2024, and consisted of net proceeds of $147.8 million from the issuance of Series A Preferred Stock as well as proceeds of $14.3 million from the exercise of stock options and the issuance of common stock from our Employee Stock Purchase Plan.

These proceeds were offset by $9.1 million of repayments of our deferred royalty obligation.

Net cash provided by financing activities was $71.9 million for the nine months ended September 30, 2023, and consisted of net proceeds of $48.9 million from the issuance of common stock, net proceeds of $24.4 million from the final investment tranche of our deferred royalty obligation and proceeds of $3.5 million from the exercise of stock options, and the issuance of common stock from Employee Stock Purchase Plan.

Net cash provided by financing activities was $32.5 million for the three months ended March 31, 2025, and consisted of net proceeds of $34.0 million from our ATM equity offering, as well as proceeds of $3.1 million from the exercise of stock options and the issuance of common stock from our Employee Stock Purchase Plan.

These proceeds were offset by $4.6 million of repayments of our deferred royalty obligation.

Net cash provided by financing activities was $4.2 million for the three months ended March 31, 2024, and consisted of proceeds of $7.0 million from the exercise of stock options and the issuance of common stock from our Employee Stock Purchase Plan.

These proceeds were offset by $2.8 million of repayments on our deferred royalty obligation.

Funding requirements

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We also expect to incur additional costs associated with operating as a public company.

We expect that our existing cash and cash equivalents and short-term investments as of September 30, 2024, will be sufficient to fund our operations into 2026.

We expect that our existing cash and cash equivalents and short-term investments as of March 31, 2025, will be sufficient to fund our operations into 2027.

Our cash and cash equivalents are maintained at financial institutions in amounts that exceed federally-insured limits.

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● the cost to continue to commercialize setmelanotide, by growing our internal sales force or entering into collaborations with third parties and providing support services for patients;

● the scope, progress, results and costs of clinical trials for our setmelanotide program as well as for RM-718 and bivamelagon (LB54640), and in connection with a therapeutic product candidate for CHI ;

● the costs, timing and outcome of regulatory review of our setmelanotide program as well as for RM-718 and bivamelagon (LB54640), and in connection with a therapeutic product candidate for CHI ;

● the obligations owed to Ipsen, Camurus and Takeda Pharmaceutical Company Limited, or Takeda, and LGC pursuant to our license agreements;

● the scope, progress, results and costs of clinical trials for our setmelanotide program as well as for RM-718 and bivamelagon, and in connection with a therapeutic product candidate for CHI ;

● the costs, timing and outcome of regulatory review of our setmelanotide program as well as for RM-718 and bivamelagon, and in connection with a therapeutic product candidate for CHI ;

● the obligations owed to Ipsen, Camurus AB, and LGC pursuant to our license agreements;

● the extent to which we acquire or in-license other product candidates and technologies;

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1 to Sales Agreement (the “Amendment”) to increase the aggregate offering price of the shares of common stock that may be issued and sold pursuant to the Sales Agreement to $200,000,000 (excluding the aggregate offering price of shares of common stock issued and sold pursuant to the Sales Agreement prior to February 29, 2024).

In connection with the Amendment, on February 29, 2024, the Company filed with the Securities Exchange Commission a prospectus supplement, dated February 29, 2024, which, combined with the Base Prospectus (together, the “New Prospectus”), amended the Prior Prospectus in its entirety.

In connection with the Amendment, on February 29, 2024, we filed with the SEC a prospectus supplement, dated February 29, 2024, which, combined with the Base Prospectus (together, the “New Prospectus”), amended the Prior Prospectus in its entirety.

The issuances and sales under the Sales Agreement, as amended by the Amendment, will be made pursuant to the Registration Statement and the New Prospectus.

From December 10, 2024 to December 31, 2024, the Company sold 744,595 shares of common stock in the ATM Program for net proceeds of $41.2 million as of December 31, 2024.

The Company sold an additional 587,510 shares of common stock in the ATM Program from January 1, 2025 through January 21, 2025 for net proceeds of approximately $32.1 million in the quarter ending March 31, 2025.

Contractual obligations

As of September 30, 2024, apart from additional contractual obligations under our acquisition of Xinvento and LGC’s bivamelagon ( LB54640) as disclosed in Note 3, “Asset Acquisitions” to the unaudited condensed consolidated financial statements included under Part I, Item 1 of this Quarterly Report on Form 10-Q, there were no other material

changes to our principal contractual obligations and commitments as reported in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023.

As of March 31, 2025, there were no other material changes to our principal contractual obligations and commitments as reported in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024.

Quantitative and Qualitative Disclosures About Market Risk

As of September 30, 2024, there were no material changes to our quantitative and qualitative disclosures about market risks as reported in Part II, Item 7A “Quantitative and Qualitative Disclosures About Market Risks” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023.

As of March 31, 2025, there were no material changes to our quantitative and qualitative disclosures about market risks as reported in Part II, Item 7A “Quantitative and Qualitative Disclosures About Market Risks” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis