Rhythm Pharmaceuticals, Inc. RYTM
New risk paragraphs, branching off last year
Each branch is a paragraph in Risk Factors with nothing like it in the 10-K filed Feb 28, 2025. A box jumps to the paragraph as filed, below.
Paragraphs with nothing like them in last year's 10-K
22 paragraphs in Risk Factors of the 10-K filed Feb 26, 2026 with nothing like them in the 10-K filed Feb 28, 2025. Quoted exactly. Paragraphs that were only edited are under 10-K change.
Since our inception, we have raised funds through the issuance of common and preferred equity, the sale of assets and a Revenue Interest Agreement, or RIFA. As of December 31, 2025, our cash and cash equivalents and short-term investments were approximately $388.9 million.
Given the etiology of the disease, our estimates on HO are based on our internal review and interpretation of the literature and available prevalence data.
Our clinical trials will compete with other clinical trials that are in the same therapeutic areas as our product candidates, including general obesity, and this competition reduces the number and types of patients available to us, as
Furthermore, on April 28, 2025, the UK adopted an amendment to the UK clinical trials regulations intended to support a more streamlined and flexible regulation of clinical trials, removing unnecessary administrative burdens on trial sponsors, whilst protecting the interests of trial participants. It also intends to bring the UK regulatory framework for clinical trials, which is still based on the EU Clinical Trials Directive, into closer alignment with the (EU) CTR. The amendment will become applicable on April 28, 2026 following a one-year transition period.
•conduct scientific discovery in areas that are uncertain, unproven and complex;
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We have also been granted orphan designation for setmelanotide for the treatment of: (i) Alström syndrome in both the United States and the EU; (ii) Prader-Willi syndrome in the United States and the EU; and (iii) acquired hypothalamic obesity in the EU and Japan.
Based on data from our Phase 2 trial, in 2023 setmelanotide was granted pre-marketing early-access authorization (AP1) in France for use in patients with hypothalamic obesity. This authorization was granted within France's early-access framework by the French National Agency for Medicines and Health Products Safety (ANSM), with the involvement of the French High Health Authority (HAS), and permits temporary access to a (presumed) innovative product candidate prior to European marketing authorization provided that certain conditions are met and especially when no suitable alternatives exist and when the benefit‑risk profile is considered favorable. Through the AP1 program we have collected real‑world evidence that we believe may support the potential of setmelanotide in this patient population; however, such data may not be predictive of outcomes in controlled trials or of any future regulatory decisions. Early‑access authorization is time‑limited, subject to ongoing review and renewal, may be modified, suspended, or terminated at any time by the competent authorities, and does not constitute, nor imply, marketing authorization in France, the EU, or elsewhere. AP1 status may not be maintained or extended, additional patients may not receive treatment under this program, and European or other regulatory authorities may not approve setmelanotide for hypothalamic obesity.
In the United States, which accounts for the largest portion of our total revenues, the Company sells its product through a specialty pharmacy and through a 3PL company. Internationally, we make sales primarily to specialty distributors and retail pharmacy chains, as well as hospitals, many of which are government-owned or supported. We believe our pharmacy and distribution partners are appropriate and optimized for our commercialization efforts at present, however, these arrangements may not continue to operate as intended or be sufficient as we expand our commercialization efforts to include additional indications, such as acquired hypothalamic obesity. In particular, we partner with our U.S. specialty pharmacy for a significant portion of our revenue. Switching to an alternative, or adding another, specialty pharmacy or distributor would involve substantial cost and require extensive management time and focus. In addition, there is a natural transition period when a new specialty pharmacy or distributor commences work. If we choose to or are required to transition to a new specialty pharmacy or distributor, such transition could result in a material decline in our revenue, results of operations and cash flows.
Additionally, we have evaluated, and will continue to evaluate, potential relationships with additional suppliers to increase overall capacity as well as further reduce risks associated with reliance on a limited number of suppliers for manufacturing.
Certain of our pharmaceutical products are manufactured outside of the United States. Recently, the U.S. government has initiated substantial changes in U.S. trade policy and U.S. trade agreements, including the initiation of tariffs on certain foreign goods, and has indicated an intention to impose tariffs on imported pharmaceutical products. In response to these tariffs, foreign governments have instituted or are considering imposing tariffs on certain U.S. goods, in addition to other retaliatory measures. If the U.S. imposes additional tariffs or other trade measures on pharmaceutical products, and in response other countries take further retaliatory trade measures, these actions could impose additional costs on our business.
The One Big Beautiful Bill Act, which was enacted in July 2025, imposes significant reductions in the funding of the Medicaid program. Such reductions are expected to decrease the number of persons enrolled in Medicaid and reduce the services covered by Medicaid, which could adversely affect our sales of IMCIVREE or any other product candidate that we commercialize.
The Trump administration is pursuing a two-fold strategy to reduce drug costs in the U.S. While it is unclear whether and how the Trump proposals will be implemented, the Trump policies are likely to have a negative impact on the pharmaceutical industry and on our ability to receive adequate revenues for IMCIVREE. On the one hand, President Trump has threatened to impose significant tariffs on pharmaceutical manufacturers that do not adopt pricing policies such as most favored nation pricing, which would tie the price for drugs in the U.S. to the lowest price in a group of other countries. In response, multiple manufacturers have reportedly entered into confidential pricing agreements with the federal government. On the other hand, the Trump administration is pursuing traditional regulatory pathways to impose drug pricing policies, and published two proposed regulations in December 2025, referred to as Globe and Guard. If finalized, these regulations would implement mandatory payment models under which manufacturers of eligible drugs would be required to pay rebates to the federal government on a portion of the units of their drugs that are reimbursed by Medicare, with the rebate amount based on most favored nation pricing. Imposing a rebate in the U.S. that is based on drug prices outside the U.S. would mark a drastic and unprecedented shift in the U.S. pharmaceutical market, and while the impact of the Globe and Guard proposed regulations, if finalized, cannot yet be determined, it is likely to be significant. Even regulatory proposals or executive actions that are ultimately deemed unlawful could negatively impact the U.S. pharmaceutical sector and our business. In addition, pharmaceutical pricing and marketing has long been the subject of considerable discussion in
Congress and among policymakers, and it is possible that Congress could enact additional laws that negatively affect the pharmaceutical industry.
In the event that CMS terminates our rebate agreement pursuant to which we participate in the MDRP, no federal payments would be available under Medicaid or Medicare Part B for our covered outpatient drugs. Our failure to comply with our MDRP price reporting and rebate payment obligations could negatively impact our financial results.
imprisonment. These laws may further limit or restrict the advertising and promotion of our products to the general public and may also impose limitations on our promotional activities with health care professionals.
In the United States, numerous federal and state laws and regulations, including HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and regulations implemented thereunder, collectively HIPAA, state data breach notification laws, state health information privacy laws and federal and state consumer protection laws, including Section 5 of the Federal Trade Commission Act, which govern the collection, use, disclosure and protection of health-related and other personal information, may apply to our operations and the operations
In 2024, the National Security Division of the U.S. Department of Justice (DOJ) issued a new rule—referred to as the “Data Security Program” (DSP)—to implement Executive Order 14117 aimed at preventing access to “bulk U.S. sensitive personal data” and “government-related data” by “countries of concern” (including China, Russia, Iran, North Korea, Cuba, and Venezuela) and “covered persons” (as all such terms are defined in the DSP). Effective as of April 8, 2025, and fully enforceable as of July 9, 2025, the DSP imposes stringent obligations on companies within its scope and prohibits or restricts “covered data transactions” that grant countries of concern or covered persons access to bulk U.S. sensitive personal data or any amount of government-related data. The DSP is new, complex and has yet to be enforced, and as such, there is a risk that our interpretation of its applicability, scope, and requirements is incorrect, incomplete, or misapplied. Compliance with the DSP may require us to invest in data security and compliance measures, such as implementing and complying with the Cybersecurity and Infrastructure Security Agency’s guidelines and other burdensome recordkeeping, reporting, and auditing requirements. It may also require us to implement new processes, stop or restrict certain data transfers, alter the geographic scope of our operations, cease doing business with certain third parties or using certain tools or vendors, or change how data flows throughout our business, any of which could materially impact our business operations or hinder our ability to grow our business. Finally, non-compliance with the DSP could result in significant civil or criminal penalties, which could materially adversely affect our business, results of operations, and financial condition.
to collaborate effectively with our employees outside the U.S. and to retain the qualified personnel needed for our operations. If we and our impacted candidates or employees are unable to obtain work visas in sufficient quantities or at a sufficient rate for a significant period of time, our business could be adversely affected.
systems for an extended period of time. Our cybersecurity risk management program and processes, including our policies, controls or procedures, may not be fully implemented, complied with or effective in protecting our systems and information. We maintain cyber liability insurance; however, it may not be sufficient to cover the financial, legal, business or reputational losses that may result from a service interruption or breach of our systems.
•general market conditions and overall fluctuations in U.S. and global equity markets;
•our ability to raise additional capital and the terms on which we can raise it;
concluded that these control deficiencies constitute a material weakness and that our internal control over financial reporting was not effective as of December 31, 2023.
Paragraphs in the 10-Q filed Nov 3, 2026 that were not in the one before
New in the latest 10-Q
61 paragraphs in the 10-Q filed Nov 3, 2026 with nothing like them in the 10-Q filed Aug 4, 2026 (at least half the words must differ; new numbers alone do not count). Quoted exactly, grouped by the item heading above them. This is text that changed, not a judgement of how serious it is.
Financial statements and notes
Government rebates: The Company is subject to discount obligations under government programs, including Medicaid programs, Medicare and Tricare in the United States as well as certain government rebates and pricing
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In September 2025, the FASB issued ASU 2025-07, "Derivatives and Hedging (Topic 815) and Revenue from Contracts with Customers (Topic 606): Derivatives Scope Refinements and Scope Clarification for Share-Based Noncash Consideration from a Customer in a Revenue Contract." The amendments provide a derivative scope exception for certain contracts with underlyings based on operations or activities specific to one of the parties to the contract and clarify the accounting for share-based noncash consideration received from customers. The amendments are effective for the Company beginning January 1, 2027, with early adoption permitted. The Company is currently evaluating the amendments but does not expect adoption to have a material effect on its consolidated financial statements.
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On November 2 2026, the Company entered into an amendment to the license agreement with LGC (the “LGC Amendment”), refer to Note 16. Subsequent Events.
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issuance to satisfy the shares of common stock issuable upon conversion of the remaining 115,000 shares of Convertible Preferred Stock.
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On November 2, 2026, the Company entered into a new term loan facility with entities affiliated with KKR & Co. Inc.’s HealthCare Royalty and entities affiliated with Blackstone (collectively, the “Lenders”), and in connection therewith, the Company entered into an amended and restated Revenue Interest Financing Agreement with Health Care Royalty Management, LLC (the “A&R RIFA”). Refer to Note 16. Subsequent Events.
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On November 2 2026, the Company entered into an amendment to the license agreement with LGC (the “LGC Amendment”). Under the LGC Amendment, the Company agreed to pay LGC additional non-refundable, non-creditable consideration of $ 350.0 million, consisting of $ 70.0 million payable within 15 business days of the effective date of the Amendment, $ 100.0 million payable in September 2027, $ 100.0 million payable in September 2028 and $ 80.0 million payable in September 2029. Subject to LGC’s prior written consent, the Company may elect to satisfy each of the payments due in 2027, 2028 and 2029 through low single digit increases to the royalty rate payable to LGC in lieu of the applicable upfront cash payment.
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The LGC Amendment also modified the commercial milestone and royalty provisions of the license agreement. Under the LGC Amendment, the Company may be required to make commercial and developmental milestone payments of up to $ 405 million, inclusive of the $ 205 million from the original agreement, upon achievement of specified annual net sales thresholds, certain of which also require regulatory approval of bivamelagon in the United States. The LGC Amendment also provides for a base royalty rate of 1 % on net sales of products within the Company's MC4R portfolio, commencing on the earlier of January 1, 2029, or first commercial sale of bivamelagon, subject to adjustment pursuant to its terms, including increases resulting from the Company’s exercise of the option to satisfy certain of the additional payments through increased royalties.
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On November 2, 2026, the Company entered into a Loan Agreement and Guaranty (the “Loan Agreement”) with entities affiliated with KKR & Co. Inc.’s HealthCare Royalty and entities affiliated with Blackstone (collectively, the “Lenders”), and Wilmington Trust, National Association, as administrative agent and collateral agent, which provides for term loan financing of up to $ 750.0 million, consisting of:
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• $ 250.0 million of delayed draw A term loan commitments, available following the closing date through June 30, 2028, subject to specified borrowing conditions, in no more than three draws, each in a principal amount of $ 50.0 million or $ 100.0 million; provided that no more than one draw may be in an amount of $ 50.0 million and no more than two draws may be in an amount of $ 100.0 million, in such order as the Company may elect; and
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• up to an additional $ 250.0 million of uncommitted delayed draw B term loans, available through June 30, 2029, subject to the applicable lenders agreeing to provide such financing in their sole discretion.
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Borrowings under the Loan Agreement bear interest, at the Company's election, at either Adjusted Term Secured Overnight Financing Rate ("SOFR") plus 4.60 % or an alternative base rate plus 3.60 %, with Adjusted Term SOFR subject to a 1.00 % floor. Interest is payable quarterly in arrears. Each funding of term loans under the Loan Agreement, including the initial term loans and any delayed draw A or delayed draw B term loans, is subject to an original issue discount equal to 1.00 % of the principal amount funded. The term loans mature and are payable in full on November 2, 2031. The Company may prepay the term loans in whole, but not in part, and any prepayment (whether optional, mandatory or upon acceleration) is subject to customary prepayment premiums that decline over the term of the loan.
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The Loan Agreement requires the Company to maintain qualified cash of no less than $ 50.0 million plus the amount of any accounts payable that remain unpaid more than 150 days after their due date, and contains customary affirmative and negative covenants restricting, among other matters, the incurrence of indebtedness and liens, investments, restricted payments, asset transfers, and mergers and acquisitions. The obligations under the Loan Agreement are secured by the term loan collateral.
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Amended and restated Revenue Interest Financing Agreement with Health Care Royalty, LLC
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On November 2, 2026, in connection with the Company’s entry into a new term loan facility as described above, the Company entered into an amended and restated Revenue Interest Financing Agreement with Health Care Royalty, LLC (the “A&R RIFA”). The A&R RIFA amended and restated the Company’s existing RIFA to, among other things, limit the collateral securing the Company’s obligations under the RIFA and remove or modify certain covenants and events of default.
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Under the A&R RIFA, the tiered Revenue Interest payable to the Investors remains 11.5 % on the portion of annual net revenues up to $ 125.0 million, 7.5 % on the portion of annual net revenues exceeding $ 125.0 million and up to $ 300.0 million, and 2.5 % on the portion of annual net revenues exceeding $ 300.0 million. The minimum cumulative payment requirements also remain unchanged. If the Investors have not received cumulative payments equal to 60 % of the
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Investment Amount by March 31, 2027 or 120 % of the Investment Amount by March 31, 2029, the Company is required to make an underperformance payment sufficient to increase cumulative payments to the applicable minimum amount.
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The A&R RIFA also maintains the existing Hard Cap structure. The Company’s aggregate Revenue Interest payments are subject to a Hard Cap equal to 185 % of the Investment Amount if the applicable payments are received by June 30, 2028, 200 % if received by June 30, 2031, 225 % if received by December 31, 2032, and 250 % thereafter. The Company may make voluntary prepayments at any time, which are credited against both the Hard Cap and the applicable minimum payment requirements.
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The A&R RIFA narrows the collateral securing the Company’s obligations to primarily the Company’s and its subsidiaries’ gross receivables relating to IMCIVREE product sales, cash held in specified accounts used to collect the IMCIVREE related receivables. The collateral expressly excludes intellectual property and rights associated with IMCIVREE itself and other products that may be developed or marketed by the Company or its subsidiaries.
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The Company is evaluating the accounting for the amendment to the RIFA, including whether the amendment will be accounted for as a modification or extinguishment of the existing deferred royalty obligation.
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◦ Definition and Diagnostic Criteria for Acquired Hypothalamic Obesity: Global Expert Consensus;
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◦ Patient-Reported Outcomes From the TRANSCEND Trial in Acquired Hypothalamic Obesity;
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◦ Weight Category Improvement Following Setmelanotide in Patients With Acquired Hypothalamic Obesity.
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• On November 2, 2026, we announced an amendment to our exclusive license agreement with LG Chem for bivamelagon. Under the terms of the amendment, Rhythm has agreed to pay LG Chem $350 million in fixed payments over four years in order to reduce the low-to-mid single digit royalty in the original agreement to 1% royalty on net product revenue generated by Rhythm’s MC4R portfolio;
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• On November 2, 2026, we announced the Company entered into a five-year term loan facility led by KKR's HealthCare Royalty in partnership with Blackstone, providing access to up to $750 million of capital. In connection with entry into this loan facility the Company entered into an amended and restated Revenue Interest Financing Agreement with Health Care Royalty.
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• On October 13, 2026, we announced the commercial launch of IMCIVREE® (setmelanotide) in Japan for patients with acquired HO;
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• On September 22, 2026, we announced Health Canada approval of IMCIVREE (setmelanotide) for weight management in adult and pediatric patients 4 years of age and older with acquired HO;
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◦ A Phase 3 post-hoc analysis demonstrating improvements across multiple cardiometabolic risk indices with setmelanotide in paediatric patients with acquired HO;
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◦ Additional analyses evaluating metabolic syndrome severity and risk in acquired HO and clinical characteristics associated with BBS.
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• On August 17, 2026, we announced the appointment of Manher (“AJ”) Joshi, M.D., as Chief Medical Officer;
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• On August 11, 2026, we announced that IMCIVREE® (setmelanotide) received expanded Marketing Authorization in the United Kingdom for the treatment of obesity and control of hunger in patients with acquired HO due to hypothalamic injury or impairment;
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The LGC Amendment and term-loan facility mentioned above are intended to support the continued advancement of our MC4R portfolio, including the planned Phase 3 development of bivamelagon. The LGC Amendment modifies certain payment, commercial milestone and royalty provisions applicable to bivamelagon and other products in our MC4R portfolio, while the term-loan facility provides additional financial flexibility to support our commercial, clinical-development and general corporate activities. These transactions also increase our fixed and contingent payment obligations, future interest expense and debt-service requirements. See Note 16, Subsequent Events, to our unaudited condensed consolidated financial statements and “Liquidity and Capital Resources” below for additional information.
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• Initiate 6-month hyperphagia study to evaluate bivamelagon in Prader-Willi syndrome in 2027, pending alignment with the FDA.
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• a decrease of $1.2 million in interest income based on decreasing average cash and short-term investments.
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• an increase of $2.0 million due to our achievement of a development milestone for our program focused on developing therapies for CHI,
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In November 2026, we amended our license agreement with LGC relating to bivamelagon and other products in our MC4R portfolio. The amendment modifies certain commercial milestone, upfront payments, and royalty provisions. The Amended agreement includes additional non-refundable, non-creditable upfront consideration totaling $350.0 million, including $70.0 million payable in November 2026 and $280.0 million payable in installments through September 2029. Subject to LGC’s prior written consent, we may elect to satisfy certain installment obligations through increases in the applicable royalty rate rather than cash payments. The ultimate economic effect of the amendment will depend on future bivamelagon approvals and net sales, as well as the timing and form of the installment payments.
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Also in November 2026, we entered into a five-year term-loan facility providing access to up to $750.0 million of capital, comprised of $250.0 million funded at closing, $250.0 million committed delay draw, and an additional $250.0 million at mutual agreement. The term-loan facility provides financing to support the upfront payments to LG Chem from the amended license agreement, as well as additional financial flexibility to support our commercial, clinical-development and general corporate activities, Amounts available under the delayed-draw tranches are subject to the conditions specified in the loan agreement and should not be considered cash currently available to fund our operations. The amended revenue-interest financing arrangement narrows the collateral securing our obligations, while the revenue-interest rates, minimum cumulative payment requirements and hard-cap structure remain unchanged.
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After giving effect to the initial loan proceeds, the initial payment to LGC, transaction expenses and other closing uses of cash, we expect these transactions to enhance our financial flexibility to support our planned operations. However, the transactions also increase our fixed and contingent payment obligations, future interest expense and debt-service requirements and impose covenants that may restrict certain business activities. Our future liquidity will depend on, among other factors, the timing and amount of our operating expenditures, future product revenues, compliance with applicable covenants and satisfaction of the conditions to funding under the delayed-draw tranches.
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and other current assets of $1.1 million, and a net decrease in deferred revenue of $0.2 million. These net uses of cash were offset by a net source of cash from increases in accounts payable, accrued expenses and other liabilities of $23.7 million.
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We expect that our cash and cash equivalents and short-term investments as of September 30, 2026, together with the net proceeds from the initial term loan funded in November 2026, will be sufficient to fund our planned operations for at least 24 months. Our funding requirements also include the additional consideration payable under the LGC amendment, interest and principal payments under the term-loan facility and payments under the A&R RIFA. Although the term-loan facility provides for additional delayed-draw financing, our ability to access those amounts is subject to the satisfaction of specified conditions, and certain amounts are subject to the applicable lenders agreeing to provide such financing. Accordingly, we may need to obtain substantial additional funding to support our research and development, commercialization and other operating activities and to satisfy our contractual obligations.
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In November 2026, we entered into an amendment to our license agreement with LGC, a term-loan facility and an amended and restated revenue-interest financing arrangement, each of which creates, modifies or continues material payment obligations. See Note 16, Subsequent Events, to our unaudited condensed consolidated financial statements for additional information.
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Risk Factors
On November 2, 2026, the Company entered into an amended and restated Revenue Interest Financing Agreement with Health Care Royalty Management, LLC (the “A&R RIFA”). Refer to Note 16. Subsequent Events.
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Our Term-Loan agreement contains restrictions that limit our flexibility in operating our business.
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On November 2 2026, the Company entered into a Loan Agreement and Guaranty (the “Loan Agreement”) with entities affiliated with KKR & Co. Inc.’s HealthCare Royalty and entities affiliated with Blackstone (collectively, the “Lenders”), and Wilmington Trust, National Association, as administrative agent and collateral agent, which provides for term loan financing of up to $750.0 million, Our Loan Agreement contains restrictions that limit our flexibility in operating our business and imposes significant operating and financial restrictions. These covenants may limit our ability, under certain circumstances, to, among other things,
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Our Loan Agreement also contains certain customary affirmative and negative covenants and events of default. As a result of these covenants and restrictions, we may be limited in how we conduct our business, and we may be unable to raise additional debt or equity financing to compete effectively or to take advantage of new business opportunities. The terms of any future indebtedness we may incur could include more restrictive covenants. We cannot guarantee that we will be able to maintain compliance with these covenants in the future and, if we fail to do so, that we will be able to obtain waivers from the lenders and/or amend the covenants. Non-compliance with one or more of these covenants could result in our debt becoming immediately due and payable, and the termination of the lenders’ commitments under our Loan Agreement.
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them, we could incur substantial liabilities. In addition, regardless of merit or eventual outcome, product liability claims may result in, among other things:
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intellectual property rights, particularly in countries where the laws may not protect those rights as fully as in the United States.
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materially and adversely impact our future revenue, profitability and cash flows and substantially limit our ability to obtain a return on the investments we have made in setmelanotide.
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regulation by numerous government authorities in the United States and in other countries where we intend to test and, if approved, market such product candidates.
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If we or the manufacturing facilities for setmelanotide fail to comply with applicable regulatory requirements, a regulatory agency may, among other things:
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• The federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, or HIPAA, imposes criminal and civil
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incorporation or bylaws to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving the dispute in other jurisdictions, which could seriously harm our business.
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Our results of operations could be adversely affected by general conditions in the global political system, economy and in the global financial markets. The global economy, including credit and financial markets, has recently experienced extreme volatility and disruptions, including severely diminished liquidity and credit availability, rising
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Other information
The Information set forth below is included for the purpose of providing disclosure under Item 1.01 - “Entry into a Material Definitive Agreement” and Item 2.03 - Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant” of Form 8-K.
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On November 2, 2026, we entered into the LGC Amendment, the Loan Agreement and the A&R RIFA. For more information on the LGC Amendment, Loan Agreement and A&R RIFA for purposes of Item 1.01 of Form 8-K and the Loan Agreement and the A&R RIFA for purposes of Item 2.03 of Form 8-K, see Note 16. Subsequent Events, to our unaudited condensed consolidated financial statements..
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Item 6
3.1 Amended and Restated Certificate of Incorporation of Rhythm Pharmaceuticals, Inc. dated October 10, 2017, and the Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Rhythm Pharmaceuticals, Inc. dated June 25, 2025. 8-K 06/26/2025 3.1
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31.1* Certification of the Principal Executive Officer, as required by Section 302 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. 1350).
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31.2* Certification of the Principal Financial Officer, as required by Section 302 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. 1350).
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32.1** Certification of the Principal Executive Officer, as required by Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. 1350).
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32.2** Certification of the Principal Financial Officer, as required by Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. 1350).
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101. INS* Inline XBRL Instance Document - the Instance Document does not appear in the interactive data file because its XBRL tags are embedded within the Inline XBRL document.
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104* Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
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The 10-Q's risk factors against the 10-K
Item 1A of the 10-Q filed Nov 3, 2026 against Item 1A of the 10-K filed Feb 26, 2026.
A 10-Q repeats only the risks that changed, so a 10-K paragraph that is missing from it is not counted as removed.
Added is a paragraph with nothing like it in the 10-K, Reworded a sentence that is in both with several words changed,
Quiet changes a sentence in both where one to four words changed and one is a hedge or a modal
(cut words struck through, new words highlighted).
Text on the page, not a score; each links to the filing at sec.gov.
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The first 28 of 68 are shown (at most 12 of each type).
Phrases used for the first time
Two-word phrases in Risk Factors of the 10-K filed Feb 26, 2026 that are in none of the 1 earlier 10-Ks stored, back to Feb 28, 2025
Where each one is used
- specialty pharmacy: In the United States, which accounts for the largest portion of our total revenues, the Company sells its product through a specialty pharmacy and through a 3PL company. Internationally, we make sales primarily to specialty distributors and retail pharmacy chains, as well as hospitals, many of which are...
- trials regulations: Furthermore, on April 28, 2025, the UK adopted an amendment to the UK clinical trials regulations intended to support a more streamlined and flexible regulation of clinical trials, removing unnecessary administrative burdens on trial sponsors, whilst protecting the interests of trial participants. It also intends...
- people living: •Hypothalamic obesity. Our addressable patient population estimate for hypothalamic obesity (HO) is approximately 10,000 patients in the United States. We estimate there are 5,000 to 8,000 people living with hypothalamic obesity in Japan, and approximately 10,000 people living with hypothalamic obesity in the E.U....
- flexible regulation: Furthermore, on April 28, 2025, the UK adopted an amendment to the UK clinical trials regulations intended to support a more streamlined and flexible regulation of clinical trials, removing unnecessary administrative burdens on trial sponsors, whilst protecting the interests of trial participants. It also intends...
- trials removing: Furthermore, on April 28, 2025, the UK adopted an amendment to the UK clinical trials regulations intended to support a more streamlined and flexible regulation of clinical trials, removing unnecessary administrative burdens on trial sponsors, whilst protecting the interests of trial participants. It also intends...
- removing unnecessary: Furthermore, on April 28, 2025, the UK adopted an amendment to the UK clinical trials regulations intended to support a more streamlined and flexible regulation of clinical trials, removing unnecessary administrative burdens on trial sponsors, whilst protecting the interests of trial participants. It also intends...
- unnecessary administrative: Furthermore, on April 28, 2025, the UK adopted an amendment to the UK clinical trials regulations intended to support a more streamlined and flexible regulation of clinical trials, removing unnecessary administrative burdens on trial sponsors, whilst protecting the interests of trial participants. It also intends...
- administrative burdens: Furthermore, on April 28, 2025, the UK adopted an amendment to the UK clinical trials regulations intended to support a more streamlined and flexible regulation of clinical trials, removing unnecessary administrative burdens on trial sponsors, whilst protecting the interests of trial participants. It also intends...
Used at least twice, small words left out. Counted, not picked: a phrase can be new because the company renamed something.
What was taken out
25 paragraphs of last year's Risk Factors with nothing like them now. The longest are quoted.
Sources
Item 1A of each 10-K and 10-Q on EDGAR, quoted exactly. Each paragraph links to the filing at sec.gov.
Also
10-K change: what was reworded or cut, section by section.
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