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Item 7. Management’s Discussion and Analysis

2026-03-20 compared with 2025-03-13 · 136 added, 164 removed, 231 unchanged (56% of the section changed)

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We are a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines.

Our objective is to commercialize and develop CARDAMYST (also known as etripamil) in the United States as a fast-acting, portable nasal spray treatment for use by patients anywhere, anytime an attack of supraventricular tachycardia, or “SVT” occurs.

Our approved product CARDAMYST TM (etripamil) nasal spray is available in the United States and is the first and only U.S.

Food and Drug Administration, or the “FDA,” approved self-administered treatment for use by patients anywhere, anytime an attack of paroxysmal supraventricular tachycardia, or “PSVT,” occurs.

We continue to seek, either directly or through collaboration with our partners, marketing approval from regulatory agencies responsible for regions outside the United States.

We are also developing etripamil for the indication of atrial fibrillation with rapid ventricular rate, or “AFib-RVR”.

CARDAMYST TM (etripamil) nasal spray

We are currently focused on obtaining marketing approval of CARDAMYST for the treatment of paroxysmal supraventricular tachycardia, or “PSVT” from the U.S.

Food and Drug Administration, or “FDA.” We expect that the FDA will make their final decision regarding the marketing approval of CARDAMYST for PSVT by March 27, 2025, which is also known as the Prescription Drug User Fee Act, or “PDUFA,” review goal date.

We are also developing etripamil nasal spray for a subsequent indication to treat patients with AFib-RVR.

Similar to our approach for PSVT, we believe that etripamil has the potential to help the person experiencing a symptomatic episode of AFib-RVR to self-treat themselves and to conveniently, reliably, and quickly, reduce their elevated heart rate, with the goal of reducing the need for emergency department utilization.

We completed a successful Phase 2 study in patients presenting urgently with AFib-RVR, i.e., to an emergency department.

We publicly presented these positive Phase 2 data in November 2023, which demonstrated that patients receiving etripamil nasal spray experienced rapid and statistically superior ventricular rate reduction and improved symptom-relief compared to placebo, with safety and tolerability findings generally consistent with those observed in our PSVT program.

This data supports the development of etripamil, self-administered in the medically unmonitored setting, for the treatment of AFib-RVR and, following dialogue with FDA, have finalized a Phase 3, potentially registrational study.

We are currently focusing our efforts and financial resources on (i) the commercialization of CARDAMYST TM (etripamil) nasal spray for the treatment of PSVT, (ii) the development of etripamil for the treatment of AFib-RVR and (iii) corporate development activities that have the potential to increase company value through strategic collaborations.

PSVT Market Overview

On December 12, 2025, we announced the FDA approved our first commercial product, CARDAMYST™ (etripamil) nasal spray, a prescription medication for the conversion of acute symptomatic episodes of PSVT to sinus rhythm in adults.

We have currently begun focusing on the commercialization of CARDAMYST, which became available in retail pharmacies in the first quarter of 2026.

PSVT is a condition that causes a patient’s heart to suddenly start beating faster than normal.

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Other oral drugs are sometimes used to treat attacks in a concept called “pill in the pocket.” However, those drugs have never been proven effective or safe and are not approved for this use.

Doctors are often frustrated by the lack of effective treatment options besides a prolonged, unpleasant, and costly trip to the emergency department or, for some patients, an invasive ablation procedure.

Doctors are often frustrated by the limited effective treatment options with the only approved options involving prolonged, unpleasant, and costly trips to the emergency department or, for some patients, an invasive ablation procedure.

PSVT can be traumatic for patients, frustrating for healthcare providers, and costly for payors.

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We believe that PSVT is a large and under-recognized market which we estimate affects more than two million Americans.

From this diagnosed population, we define the immediate target addressable market for CARDAMYST as approximately 60% of patients who are actively managed by clinical cardiologists, interventional cardiologists and electrophysiologists.

The remaining patients with PSVT can become addressable over time, as they are inconsistently managed (cycling in and out of the healthcare system) and/or being managed less frequently by primary care healthcare providers.

Furthermore, PSVT is expected to increase in prevalence in coming years as wearable electrocardiogram, or “ECG,” technology (e.g., smartphone, watches) becomes both more adept at diagnosing PSVT and more widely used by patients and clinical practitioners, in turn shortening the current two to three year average time to diagnosis.

From this diagnosed population, we define the immediate target addressable market for CARDAMYST as approximately 50% of patients with PSVT who have sufficient disease burden that they are compelled to seek care for their condition and are primarily managed by approximately 40,000 healthcare providers composed primarily of clinical cardiologists, interventional cardiologists and electrophysiologists.

The remaining patients with PSVT can become addressable over time, as they are inconsistently managed (cycling in and out of the healthcare system).

Furthermore, PSVT is expected to

increase in diagnosed prevalence in coming years as wearable electrocardiogram, or “ECG,” technology (e.g., smartphone, watches) becomes both more adept at diagnosing PSVT and more widely used by patients and clinical practitioners, in turn shortening the time to diagnosis.

Following the release of data from the RAPID clinical study, in market research, cardiologists reported a willingness to prescribe CARDAMYST to approximately 50% of the patients with PSVT in their care, which suggests approximately 500,000 to 800,000 patients can potentially be treated with CARDAMYST in peak years.

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Of note, catheter ablations following diagnosis represented only 23% of this increased spend, meaning most costs were unrelated to ablations.

Recent data from the Healthcare Cost and Utilization Project (HCUP) database indicate that in 2019 there were approximately 140,000 emergency department, or “ED,” visits for PSVT when coded in the primary diagnostic position, and a total of approximately 525,000 ED visits when PSVT was coded in any diagnostic position.

Recent data from the Healthcare Cost and Utilization Project, or “HCUP,” database indicate that in 2019 there were approximately 140,000 emergency department, or “ED,” visits for PSVT when coded (for billing) in the primary diagnostic position, and a total of approximately 525,000 ED visits when PSVT was coded in any diagnostic position.

Of these, approximately 25% of ED admissions for PSVT resulted in a hospital admission.

HCUP estimates a total of approximately 40,000 to approximately 120,000 inpatient admissions for PSVT in 2019 (based again if PSVT were found in the primary v.

any diagnostic position).

HCUP estimates a total of approximately 40,000 to approximately 120,000 inpatient admissions for PSVT in 2019 (based again if a PSVT billing code was found in the primary versus any diagnostic position).

Despite the effectiveness of catheter ablation, claims data suggests that only approximately 15% of patients with PSVT are ablated over a three-year period, leading to a total of approximately 100,000 catheter ablations annually.

In total, at least $5 billion is spent annually in the United States on the management of PSVT.

In total, up to $15.0 billion is spent annually in the United States on the management of PSVT.

PSVT Continued Development Highlights

In November 2025, we submitted our marketing authorization application, or “MAA,” to the European Medicines Agency, or “EMA,” for review for approval to market etripamil nasal spray, under the trade name TACHYMIST TM , in the European Union.

The MAA utilizes much of the clinical, manufacturing and quality data package that was submitted in the NDA which lead to the US FDA approval.

In January 2025, our licensing partner, Corxel Pharmaceuticals, or “Corxel,” formerly Ji Xing Pharmaceuticals Limited, JIXING, announced that the Center for Drug Evaluation, or “CDE,” of the National Medical Products Administration, or “NMPA,” of the People’s Republic of China has accepted the New Drug Application, or “NDA,” for etripamil nasal spray for the treatment of PSVT.

The NDA to the NMPA included data from the successful Phase 3 JX02002 clinical trial of etripamil nasal spray in patients with PSVT in China in addition to data included in the NDA that Milestone submitted to the FDA.

The 500-patient Phase 3 trial (JX02002) met its primary endpoint, with a Kaplan Meier analysis shows a statistically significantly greater proportion of patients who self-administered etripamil converted from PSVT to sinus rhythm within 30 minutes compared to placebo (40.5% vs.

15.9%, respectively;

hazard ratio [HR] = 3.00;

95% CI 1.58-5.71;

Statistically significant (p<0.05) results were also shown for the secondary efficacy endpoints for percent of patients’ PSVT converted to sinus rhythm by 10, 15, 45 and 60 minutes after self-administration of study drug.

Corxel further reported that, overall, treatment emergent adverse events were comparable between treatment groups, and there were no reported serious adverse events related to etripamil.

The safety and tolerability data from the JX02002 trial were consistent with previous clinical studies.

This important study further expands the etripamil global development program to more than 2,000 unique patients treated with etripamil.

Etripamil Nasal Spray for the Treatment of AFib-RVR

Similar to our approach for PSVT, we believe that etripamil has the potential to help people experiencing a symptomatic episode of AFib-RVR to self-treat and to conveniently, reliably, and quickly reduce their elevated heart rate, with the goal of reducing the need for emergency department utilization.

We completed a successful Phase 2 study, named “ReVeRA” or the “ReVeRA study”, in patients presenting urgently with episodes of AFib-RVR to the emergency department.

We have published the ReVeRA study and results, which demonstrated that patients receiving etripamil nasal spray experienced rapid and statistically superior ventricular rate reduction and improved symptom-relief compared to placebo, with safety and tolerability findings generally consistent with those observed in our PSVT program.

We believe these data support the continued development of etripamil, self-administered in the medically unmonitored setting, for the treatment of AFib-RVR.

Incorporating FDA’s guidance, we have developed a Phase 3 registrational program to evaluate self-administered etripamil as a potential treatment for patients with AFib-RVR.

We intend to pursue a supplemental new drug application, or “sNDA,” regulatory approval pathway for a potential second indication for etripamil in Afib-RVR.

As such, we will leverage the PSVT indication and PSVT program data, along with a single pivotal Phase 3 study in patients with AFib-RVR.

AFib-RVR Market Overview

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however, this requires a burdensome trip to an emergency department which may lead to a hospital admission.

Acute treatment can be attempted by administration of an oral rate control drug;

however, such drugs do not adequately provide immediate or adequate ventricular rate control due to a 30- to 90-minute delayed onset of action, and, as a result, many patients need faster and more certain rate-reduction and symptom-resolution and so seek acute-medical care by going to the emergency department for treatment utilizing intravenous rate control and/or electrical cardioversion of their atrial fibrillation.

Acute treatment can be attempted with an oral rate-control drug;

however, such agents often fail to provide immediate or dependable ventricular rate control because they have a 30- to 90-minute delayed onset of action.

As a result, many patients require faster and more reliable rate reduction and symptom resolution, leading them to seek acute medical care in the emergency department for intravenous rate control and/or electrical cardioversion of their atrial fibrillation.

Furthermore, the chronic administration of oral rate-control drugs does not broadly prevent episodes of AFib-RVR.

Similar to PSVT, patients may feel a loss of control by needing to visit the emergency department for overcoming their AFib-RVR episode and the unpredictable nature of these episodes, which can occur anytime and anywhere.

Doctors have expressed frustration

at the lack of options for patients to self-manage these acute rate attacks;

Doctors have expressed frustration at the lack of options for patients to self-manage these acute rate attacks;

and payor organizations would prefer to treat the AFib-RVR attacks in a more cost effective and time-efficient manner.

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While these episodes, known as AFib-RVR, may be treated by oral calcium channel blockers and/or beta blockers, patients frequently seek acute care in the ED to address symptoms.

In 2019, nearly 1.1 million patients were admitted to the ED due to AFib symptoms.

Initial data suggests that approximately 60% of all AFib ED visits were attributable to AFib-RVR, as symptoms driving patients to seek care generally become more pronounced at higher heart rates.

In 2019, nearly 1.1 million patients were admitted to the emergency department due to AFib symptoms.

Initial data suggests that approximately 60% of all AFib emergency department visits were attributable to AFib-RVR, as symptoms driving patients to seek care generally become more pronounced at higher heart rates.

Treatment for such symptoms typically includes medically supervised intravenous administration of calcium channel blockers or beta blockers, or electrical cardioversion.

With little available data for AFib-RVR, we believe, based on our initial market research, that 30% to 40% of patients with AFib experience one or more symptomatic episodes of RVR per year that require treatment, suggesting a target addressable market of up to approximately four to five million patients by 2030 for etripamil in patients with AFib-RVR.

We believe that etripamil has the potential to be developed such that it can be used by patients to rapidly reduce their heart rate at home, self-administered, to provide a supplemental option to either the acute oral rate or rhythm control strategy their physician would use.

When presented with a target product profile reflecting this potential use case, cardiologists and electrophysiologists in a 2021 market research study perceived utility in the product profile and indicated that they would prescribe to approximately 67% of their patients that experience episodes of AFib-RVR.

With little available data for AFib-RVR, we believe, based on our initial market research, that 30% to 40% of patients with AFib experience one or more symptomatic episodes of RVR per year that require treatment, suggesting a current target addressable market of approximately three to four million patients for etripamil in patients with AFib-RVR.

We believe that etripamil has the potential to be developed such that it can be used by patients to rapidly reduce their heart rate to provide a supplemental option to either the acute oral rate or rhythm control strategy their physician would use.

When presented with a target product profile reflecting this potential use case, cardiologists and electrophysiologists, in a 2021 market research study perceived utility in the product profile and indicated that they would prescribe to approximately two-thirds of their patients that experience episodes of AFib-RVR.

They further indicated that a rapidly-acting intranasal calcium channel blocker could serve as a “bridge” to the longer onset times of acute oral agents.

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Additionally, the forecasted growth in atrial fibrillation prevalence is anticipated to result in healthcare expenditures of $46 billion in direct costs and $10 billion in indirect costs in the United States by 2030.

New Drug Application Status

In May 2024, we announced that the FDA accepted our New Drug Application, or “NDA,” for CARDAMYST (etripamil) for the treatment of PSVT.

The Company continues to engage the FDA throughout the NDA review process in the form of responses to FDA requests for information, as well as audits of manufacturing facilities and testing labs, clinical sites, clinical study support services and of our headquarters.

The PDUFA goal date for action on the NDA is March 27, 2025.

If approved, we believe that CARDAMYST will be the first and only self-administered therapy for the rapid termination of episodes of SVT wherever and whenever they occur.

PSVT Clinical Development Highlights

In April 2024, we announced new clinical data demonstrating real-world application of etripamil, an investigational new drug, for conversion of recurrent PSVT.

Conducted in North and South America, an open label, Phase 3 study of etripamil in PSVT (the NODE-303 study) was presented at The American College of Cardiology Scientific Sessions.

NODE-303 evaluated self-administered etripamil (70 mg, nasal spray) in an outpatient setting for up to four episodes of PSVT per patient.

Other key characteristics of the NODE-303 study that distinguish the study from earlier Phase 3 studies, include the removal of the in-office test dose as well as the use of a broader inclusion exclusion study entry criteria.

For example, NODE-303 did not exclude patients with a history of co-morbid AFib or atrial flutter.

demonstrated that symptom-prompted treatment with etripamil restored sinus rhythm with a median time-to-conversion of 17 minutes and was generally well tolerated.

The conversion of PSVT to sinus rhythm was similar among multiple episodes of PSVT and the frequency of treatment-emergent adverse events within 24 hours decreased with successively treated episodes.

Adverse events, or “AEs,” were predominantly localized to the drug’s nasal administration site, consistent with prior trial findings.

The protocol was amended during the trial to allow for a repeat dose of drug if symptoms persisted 10 minutes following the first dose, however most of the clinical trial was conducted prior to the amendment and used the 70 mg single dose.

Efficacy of etripamil for PSVT conversion (restoration of sinus rhythm) in NODE-303 was 60.0% by 30 minutes after drug self-administration, and 69.9% by 60 minutes after drug self-administration;

these rates of conversion are similar to those demonstrated in double-blinded and other open-label etripamil studies.

This data supports a potentially significant shift in the management approach for recurrent PSVT.

In October 2022, we announced positive and statistically significant topline efficacy and safety data from the Phase 3 RAPID clinical trial of etripamil in patients with PSVT.

These results were further presented shortly thereafter, in November 2022, as a Late-Breaking Clinical Trial Session at the American Heart Association Scientific Sessions 2022 (Chicago, IL) and subsequently published in The Lancet (June 2023) .

RAPID, our multi-center, randomized, double-blind, placebo-controlled, event-driven Phase 3 trial, enrolled 706 patients across clinical sites in North America and Europe.

Patients were randomized 1:1 to a regimen of self-administering a first dose etripamil nasal spray, with a repeat dose 10 minutes later if symptoms persisted, or a matching placebo regimen.

Self-administration was prompted by a patient’s customary symptoms and was performed in the at-home setting without medical supervision.

The RAPID trial achieved its primary endpoint, with patients taking the regimen with etripamil demonstrating a highly statistically significant and clinically meaningful difference in time to SVT conversion as compared to placebo.

A Kaplan Meier analysis demonstrated a significantly greater proportion of patients who took etripamil converted within thirty minutes compared to placebo (64.3% vs.

hazard ratio, or “HR,” 2.62;

95% CI 1.66, 4.15;

By 90 minutes post-study drug administration, 80.6% of etripamil patients converted versus 60.7% of placebo patients (HR = 1.93;

95% CI 1.349, 2.752;

p<0.001) and statistical significance was maintained throughout the 5-hour observation window.

Statistically significant reductions in time to conversion in patients who took etripamil were evident early and persisted throughout the observation window of the study compared to placebo.

The median time to conversion for patients in RAPID who self-administered etripamil was 17.2 minutes compared to 53.3 minutes for patients on placebo.

The safety and tolerability data from the RAPID trial continues to support the potential self-administration use of etripamil, with findings consistent with those observed in prior trials.

The most common randomized-treatment emergent adverse events, or “RTEAEs,” and AEs which occurred within 24 hours of administration of etripamil, were related to the nasal local administration site.

Overall, the majority of RTEAEs were reported as mild (68%) or moderate (31%).

There were no serious AEs related to etripamil.

The use of additional medical interventions and visits to an emergency department were important secondary measures of efficacy for both the RAPID and NODE-301 studies, although with the understanding that neither study was individually powered to expect statistical differences.

In a pre-planned analysis across both studies, patients who self-administered etripamil sought additional medical interventions 43% less frequently (15% vs.

p=0.013) and had 39% fewer emergency department visits (14% vs.

p=0.035) than patients in the placebo arm.

In March 2023 we completed NODE-303, a Phase 3, multi-center, open-label safety trial, evaluating the safety of etripamil when self-administered without medical supervision over multiple, separate episodes of SVT.

Data from the completed NODE-303 open-label safety and RAPID extension studies are included in the PSVT NDA submission for etripamil to the FDA.

In September 2024, our licensing partner, Corxel (formerly Ji Xing Pharmaceuticals Limited, JIXING), a clinical-stage biopharmaceutical company announced positive topline data from the Phase 3 JX02002 clinical trial of etripamil nasal spray in patients with PSVT in China.

15.9%, respectively;

hazard ratio [HR] = 3.00;

95% CI 1.58-5.71;

Corxel further reported that, overall, treatment emergent adverse events were comparable between treatment groups, and there were no reported serious adverse events related to etripamil.

The safety and tolerability data from the JX02002 trial were consistent with previous clinical studies.

This important study further expands the etripamil global development program to more than 2,000 unique patients treated with etripamil.

AFib-RVR Clinical Development Highlights

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Further trial details are below in this document.

During 2024, we met with the FDA on the ReVeRA study, during which the FDA confirmed its guidance from our Pre-IND meeting (2023) regarding the availability of a supplemental new drug application, or “sNDA,” pathway for the marketing approval for etripamil for the indication of AFib-RVR.

During 2024, we met with the FDA on the ReVeRA study, during which the FDA confirmed its guidance from our Pre-IND meeting (2023) regarding the availability of a sNDA pathway for the marketing approval for etripamil for the indication of AFib-RVR.

The sNDA pathway potentially permits a single pivotal efficacy study to be sufficient for filing for marketing approval if etripamil is already approved for PSVT.

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In addition, the study would have to show statistical significance (p<0.05) on the key secondary endpoint of symptom relief as a patient benefit, also in the ITT population.

The secondary endpoint could use a PRO measure, and the application of a seven-point anchored scale was discussed with the FDA.

We have finalized the Phase 3 study protocol following FDA’s review, obtained concurrence with the FDA to proceed, are operationally starting the study, and anticipating enrolling patients in 2025.

The secondary endpoint could use a PRO measure, and various PROs were discussed with the FDA.

We have finalized the Phase 3 study protocol following FDA’s review and obtained concurrence with the FDA to proceed.

The Phase 3 study will be conducted in a medically unmonitored setting (e.g., at-home) in a manner very similar to the conduct of our Phase 3 development program for PSVT.

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Since the commencement of our operations in 2003, we have devoted substantially all of our resources to performing research and development activities in support of our product development efforts, hiring personnel, raising capital to support and expand such activities, providing general and administrative support for these operations and, more recently, preparing for commercialization.

We operate our business using a significant outsourcing model.

As such, our team is composed of a relatively smaller core of employees who direct a significantly larger number of team members who are outsourced in the forms of vendors and consultants to enable execution of our operational plans.

We do not currently have any products approved for sale, and we continue to incur significant research and development and general administrative expenses related to our operations.

We have historically operated our business using a significant outsourcing model.

As such, our team is currently composed of a relatively smaller core of employees who direct a significantly larger number of team members who are outsourced in the forms of vendors and consultants to enable execution of our operational plans.

On December 12, 2025, we announced that the FDA approved our first commercial product, CARDAMYST™ (etripamil) nasal spray, a prescription medication for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia, or “PSVT,” to sinus rhythm in adults.

As a result, we expect our future commercial expenses will increase as we invest in the infrastructure, personnel, and operational expenses required to commercialize CARDAMYST in the United States.

We also expect inventory balances to increase as we capitalize costs related to the production of CARDAMYST for commercial sale in the United States .

In addition, we expect to continue to incur significant research and development and general administrative expenses related to our operations as we advance etripamil nasal spray for the treatment AFib-RVR and continue to invest in the resources needed to support a developing commercialized public company.

Since inception, we have incurred significant operating losses.

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

We anticipate that a substantial portion of our capital resources and efforts in the foreseeable future will be focused on completing the necessary development activities required for obtaining regulatory approval and preparing for potential commercialization of our product candidates.

We anticipate that a substantial portion of our capital resources and efforts in the foreseeable future will be focused on commercialization of CARDAMYST and the development of an additional etripamil indication.

We had $73.0 million of cash and cash equivalents and $32.9 million of short-term investments at December 31, 2025.

We expect to continue to incur significant expenses and increasing operating losses for at least the next several years.

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

Our net losses may fluctuate significantly from period to period, depending on the timing of our planned clinical trials and expenditures on other research and development activities.

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• continue our ongoing and planned development of etripamil, including future Phase 3 clinical trials for the treatment of AFib-RVR and potential Phase 4 clinical trials for treatment of PSVT;

• seek marketing approvals for etripamil for the treatment of PSVT, AFib-RVR and other cardiovascular indications;

• establish a sales, marketing, manufacturing and distribution capability, either directly or indirectly through third parties, to commercialize etripamil or any future product candidate for which we may obtain marketing approval;

• build a portfolio of product candidates through development, or the acquisition or in-license of drugs, product candidates or technologies;

• seek, either directly or through collaboration with our partners, marketing approval for etripamil nasal spray for the treatment of PSVT from regulatory agencies responsible for regions outside the United States;

• seek marketing approvals for etripamil for the treatment of AFib-RVR and other cardiovascular indications;

• increase our sales, marketing, manufacturing, and distribution capability, either directly or indirectly through third parties;

• build a portfolio of product candidates through development, or the acquisition of in-license of drugs, product candidates or technologies;

• initiate preclinical studies and clinical trials for etripamil for any additional indications we may pursue, including the clinical trials for the treatment of atrial fibrillation and rapid ventricular rate as well as other areas of unmet medical need, and for any additional product candidates that we may pursue in the future;

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• hire additional clinical, regulatory, and scientific personnel;

• add operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts;

• add operational, financial, and management information systems and personnel, or other general & administrative personnel, including personnel to support our product development and potential expansion of our future commercialization efforts;

• incur additional legal, accounting, insurance and other expenses associated with operating as a public company.

Recent Developments

In February 2025, we announced that we received Notice of Allowance from the United States Patent and Trademark Office, or “USPTO” on a new Method of Use patent for etripamil nasal spray (proposed trade name CARDAMYST™).

The patent (U.S.

Patent Application No.:

17/865,697) covers the repeat dose regimen used in the RAPID Phase 3 study that evaluated CARDAMYST in PSVT and proposed for the package insert as part of the CARDAMYST New Drug Application, or “NDA,” currently under review by the U.S.

Food and Drug Administration, or “FDA.” The issuance of the Notice of Allowance for this new patent for CARDAMYST potentially extends our intellectual property protection in the United States until July 2042, which is an additional 6 years of potential protection for our intellectual property portfolio.

As previously disclosed, on March 27, 2023, we entered into a Purchase and Sale Agreement, or the “Royalty Purchase Agreement,” with RTW Royalty I DAC, an affiliate of RTW Investments, LP, or “RTW,” pursuant to which RTW agreed to purchase, following U.S.

Food and Drug Administration approval of etripamil for the treatment of PSVT (subject to certain conditions), at a purchase price of $75.0 million, the right to receive tiered quarterly royalty payments, or the “royalty interest,” on net product sales of CARDAMYST (etripamil) in the United States.

On January 12, 2026, we closed the sale of the royalty interest under the Royalty Purchase Agreement and received cash of $75.0 million from RTW.

The Macroeconomic Climate

Inflation rates may also materially adversely affect our business and corresponding financial position and cash flows.

Inflation rates may materially adversely affect our business and corresponding financial position and cash flows.

Inflationary factors, changes to interest rates, and overhead costs may adversely affect our operating results.

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economy and could make it more difficult for us to obtain traditional financing on acceptable terms, if at all, in the future.

Additionally, geopolitical events such as the Russia-Ukraine war and unrest and/or further escalation in Israel and Gaza, recent banking instabilities, new or changing international tariffs, and other U.S.

Additionally, geopolitical events, including war and terrorism, banking instabilities, ongoing changes to U.S.

and international tariffs and other trade restrictions and trade barriers, renegotiation of international trade agreements, or further escalations of trade tensions, and other U.S.

geopolitical issues affecting other territories and employee availability and wage increases, and economic markets all of which may result in additional stress on our working capital resources.

The ongoing trade tensions between the U.S.

and other jurisdictions have resulted in multiple rounds of tariffs and anticipated tariffs affecting pharmaceuticals and pharmaceutical ingredients, including finished drug products, manufacturing equipment, and related supplies.

In any event, the dynamic and unpredictable tariff and trade landscape may create substantial uncertainty and planning challenges for our operations.

Components of Results of Operations

We have not generated any revenues from product sales to date.

We would only expect to generate revenues from product sales in the near future if the FDA approves the NDA.

We generated no revenue for the year ended December 31, 2024, compared to $1.0 million for the year ended December 31, 2023.

The prior year revenue is due to a milestone reached as a result of the successful initiation of a Phase 1 Clinical Trial of the product by or on behalf of Corxel for the treatment of PSVT in the People’s Republic of China, or “the Territory,” including mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan.

License revenue

We generated $1.5 million of license revenue for the year ended December 31, 2025, compared to no revenue generated for the year ended December 31, 2024.

The current year license revenue was the result of having reached a milestone pursuant to our License and Collaboration Agreement, dated May 15, 2021, with Corxel Pharmaceuticals, or “Corxel,” formerly known as Ji Xing Pharmaceuticals Limited, such party being referred to as “Ji Xing” and, such agreement, as the “Ji Xing License Agreement,” due upon the successful NDA approval by the FDA in the U.S.

of etripamil for the treatment of PSVT.

For additional information about our Revenue, see Note 2, “Summary of Significant Accounting Policies”, and Note 3, “Revenue” in the accompanying notes to our consolidated financial statements.

Research and Development Expenses

Research and development expenses consist primarily of salaries and fees paid to external service providers and also include personnel costs, including share-based compensation expense and other related compensation expenses.

Research and development expenses consist primarily of salaries and fees paid to external service providers, as well as personnel costs, including share-based compensation expense, and other related compensation expenses.

We expense research and development costs in the periods in which they are incurred.

Costs for certain development activities are recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors, collaborators and third-party service providers.

To date, substantially all of our research and development expenses have been related to the preclinical and clinical development of etripamil.

To date, the majority of our research and development expenses have been related to the preclinical and clinical development of etripamil inclusive of manufacturing costs pre-FDA approval.

As we advance etripamil or other product candidates for other indications, we expect to allocate our direct external research and development costs across each of the indications or product candidates.

Further, we expect our research and development costs to increase for the development of etripamil in atrial fibrillation with rapid ventricular rate, and we expect our research and development expenses related to the development of etripamil for PSVT decrease as a percentage of our total research and development expenses.

Further, we expect our research and development costs to increase for the development of etripamil in AFib-RVR, and we expect our research and development expenses related to the development of etripamil for PSVT to decrease as a percentage of our total research and development expenses.

The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming and is subject to uncertainties and delays.

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General and Administrative Expenses

General and administrative expenses include personnel and related compensation costs, expenses for outside professional services, lease expense, insurance expense and other general administrative expenses.

General and administrative expenses include personnel and related compensation costs, expenses for outside professional services, lease expenses, insurance expenses and other general administrative expenses.

Personnel costs consist of salaries, bonuses, benefits, related payroll taxes, and share-based compensation.

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first, we want to leverage rigorous primary and secondary research to fully understand our target disease states from the perspective of the patient, healthcare provider, and payer;

second, we want to understand and document the burden of disease posed by PSVT and AFib-RVR from an epidemiology, healthcare resource use, and cost perspective;

second, we want to understand and document the burden of

disease posed by PSVT and AFib-RVR from an epidemiology, healthcare resource use, and cost perspective;

and third, we want to engage our target patient, physician, and payer stakeholders with evidence-based and compliant educational materials that serve to increase the awareness and understanding of the impact of PSVT and AFib-RVR on patients and the overall healthcare system.

If the FDA approves the NDA, we anticipate our commercial expenses will increase as we invest in the infrastructure, personnel, and operational expenses required to launch our first product in the United States.

We anticipate our commercial expenses will increase as we invest in the infrastructure, personnel, and operational expenses required to commercialize CARDAMYST in the United States.

Interest Income

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Interest expense

We recorded no revenue for the year ended December 31, 2024, compared to revenue of $1.0 million for the year ended December 31, 2023.

This prior year revenue was the result of having reached a milestone pursuant to our License and Collaboration Agreement, dated May 15, 2021, with Corxel Pharmaceuticals, or “Corxel,” formerly known as Ji Xing Pharmaceuticals Limited, such party being referred to as “Ji Xing” and, such agreement, as the “Ji Xing License Agreement”, due upon the successful initiation of a Phase 1 Clinical Trial of a pharmaceutical product that uses a device to deliver etripamil by nasal spray by or on behalf of Corxel for the treatment of PSVT in the People’s Republic of China, or “the Territory,” including mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan.

License revenue

We recorded $1.5 million of license revenue for the year ended December 31, 2025, compared to no revenue recorded for the year ended December 31, 2024.

The license revenue for the year ended December 31, 2025 was the result of having reached a milestone pursuant to our License and Collaboration Agreement, dated May 15, 2021, with Corxel Pharmaceuticals, or “Corxel,” formerly known as Ji Xing Pharmaceuticals Limited, such party being referred to as “Ji Xing” and, such agreement, as the “Ji Xing License Agreement,” due upon the successful NDA approval by the FDA for CARDAMYST for the treatment of PSVT in the United States.

Research and Development Expenses

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Total R&D expenses

Research and development expenses decreased by $16.7 million, or 53.8% for the year ended December 31, 2024, compared to the year ended December 31, 2023.

The decrease was primarily due to lower clinical expenses.

This decrease in clinical expenses was driven by lower clinical development costs and clinical personnel-related costs as a result of the completion of phase 3 studies.

This decrease was also driven by a decrease in drug manufacturing and regulatory costs.

Research and development expenses increased by $3.8 million, or 26.1%, for the year ended December 31, 2025, compared to the year ended December 31, 2024.

The increase was primarily due to higher consulting and outside service costs.

These higher costs were partially offset by lower personnel-related costs.

General and Administrative

General and administrative expenses increased $0.8 million, or 5.1%, for the for the year ended December 31, 2024, compared to the year ended December 31, 2023.

This increase was driven primarily by an increase in outside service costs, partially offset by a decrease in personnel costs.

Commercial expenses decreased by $4.1 million, or 27.2%, for the year ended December 31, 2024, compared to the same period in 2023.

While successfully resolving the Refusal to File letter issued by the FDA in December 2023, we implemented a reduction in personnel costs, professional costs and other operational expenses related to commercialization.

General and administrative expenses increased $0.5 million, or 3.2%, for the year ended December 31, 2025, compared to the year ended December 31, 2024.

This increase was driven primarily by an increase in outside service costs and higher personnel costs.

Commercial expenses increased by $17.3 million, or 157.2%, for the year ended December 31, 2025, compared to the year ended December 31, 2024.

This increase is primarily a result of additional personnel costs, professional costs, and other operational expenses related to preparation for the launch of CARDAMYST.

Interest Income

Interest income was $2.9 million and $4.2 million for the year ended December 31, 2025 and 2024, respectively.

The increase in interest income was due to higher average interest rates earned on investments in 2024 when compared to 2023.

The decrease in interest income in 2025 was driven decreasing interest rates and a smaller average investment balance in 2025 when compared to 2024.

Interest Expense

Interest expense was $3.6 million for the year ended December 31, 2024, compared to $2.6 million for the year ended December 31, 2023.

The increase in interest expense was due to the issuance of the 2029 Convertible Notes on March 29, 2023.

Interest expense remained materially consistent for the year ended December 31, 2025 compared to the year ended December 31, 2024.

Liquidity and Capital Resources

Sources of Liquidity

We have incurred operating losses and experienced negative operating cash flows since our inception, and we anticipate continuing to incur losses for at least the next several years.

We have incurred operating losses and experienced negative operating cash flows since our inception, and we anticipate continuing to incur losses for the foreseeable future.

As of December 31, 2025, we had cash, cash equivalents, and short-term investments of $106.0 million and an accumulated deficit of $430.6 million.

On February 28, 2024, we entered into an underwriting agreement, or the “Underwriting Agreement,” related to an underwritten public offering, or the “Offering,” of 16,666,667 of our common shares, without par value, at a public offering price of $1.50 per share and, in lieu of common shares to certain investors, pre-funded warrants to purchase 3,333,333 Shares at a public offering price of $1.499 per pre-funded warrant.

Under the terms of the Underwriting Agreement, we granted the Underwriters an option to purchase up to an additional 3,000,000 common shares at the same price per share as the other common shares sold in the Offering, which was exercised by the Underwriters in full on February 29, 2024.

Each pre-funded warrant has an exercise price of $0.001 per share.

O n July 11, 2025, we entered into an underwriting agreement, or the “Underwriting Agreement,” related to an underwritten public offering, or the “2025 Offering,” of (i) 31,500,000 of our common shares, accompanying Series A common warrants, or the “Series A Common Warrants,” to purchase an aggregate of 31,500,000 common shares and accompanying Series B common warrants, or the “Series B Common Warrants,” to purchase an aggregate of 31,500,000 common shares, at a combined public offering price of $1.50 per share and accompanying Series A Common Warrant and Series B Common Warrant and (ii) in lieu of common shares to certain investors that so choose, pre-funded warrants or the “2025

Pre-Funded Warrants” and, together with the Series A Common Warrants and the Series B Common Warrants, the “Warrants,” to purchase 3,502,335 common shares, accompanying Series A Common Warrants to purchase an aggregate of 3,502,335 common shares and accompanying Series B Common Warrants to purchase an aggregate of 3,502,335 common shares, at a combined public offering price of $1.499 per Pre-Funded Warrant and accompanying Series A Common Warrant and Series B Common Warrant, which represented the combined public offering price for the Common Shares and accompanying Common Warrants less the $0.001 per share exercise price for each such Pre-Funded Warrant.

The net proceeds to the Company from the 2025 Offering were $48.6 million after deducting underwriting commissions and other offering expenses payable by us, in the amount of $3.9 million.

On February 28, 2024, we entered into an underwriting agreement related to an underwritten public offering, or the “February 2024 Offering,” of 16,666,667 of our common shares, without par value, at a public offering price of $1.50 per share and, in lieu of common shares to certain investors, pre-funded warrants to purchase 3,333,333 common shares, or the “2024 Pre-Funded Warrants,” at a public offering price of $1.499 per 2024 Pre-Funded Warrants.

Each of the 2024 Pre-Funded Warrants has an exercise price of $0.001 per share.

The 2024 Pre-Funded Warrants were exercisable immediately upon issuance, subject to certain beneficial ownership limitations.

The net proceeds to the Company from the Offering, including the proceeds from the exercise by the Underwriters of their option to purchase the additional 3,000,000 common shares in full, was $31.9 million after deducting underwriting commissions and offering expenses payable by the Company.

On March 27, 2023, we entered into a purchase and sale agreement, as amended, or the “Royalty Purchase Agreement,” and a note purchase agreement, or, as amended, the “Note Purchase Agreement,” with RTW Investments, LP and certain of its affiliates, or collectively, “RTW.”

On March 29, 2023, the Company closed the transaction contemplated by the Note Purchase Agreement and issued and sold the $50 million principal amount of 6.0% Convertible Senior Notes due 2029, or the “2029 Convertible Notes,” to the holders in a private placement transaction.

The 2029 Convertible Notes are senior secured obligations and are guaranteed on a senior secured basis by our wholly owned subsidiary, Milestone Pharmaceuticals USA, Inc.

Interest, at the annual rate of 6.0%, is payable quarterly in cash or, at our option, payable in kind for the first three years.

The maturity date for the 2029 Convertible Notes will be March 31, 2029.

The obligations under the 2029 Convertible Notes are secured by substantially all of our and our subsidiary guarantor’s assets.

Each $1,000 of principal of the 2029 Convertible Notes (including any interest added thereto as payment in kind) is convertible into 191.0548 common shares, equivalent to an initial conversion price of approximately $5.23 per share, subject to customary anti-dilution and other adjustments.

Subject to specified conditions, on or after March 27, 2027, the 2029 Convertible Notes are redeemable by us subject to certain conditions, at a redemption price equal to 100% of the principal amount of the 2029 Convertible Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

On July 29, 2020, we entered into an Open Market Sale Agreement SM , or the “Sales Agreement,” with respect to an at-the-market offering program, or the “ATM Program,” under which the Company may issue and sell its common shares having an aggregate offering price of up to $50 million through Jefferies as its sales agent or principal.

On May 31, 2023, we filed a prospectus supplement (File No.

333-261049) that amended and restated the information in our prospectus supplement dated July 29, 2020, and, accordingly, the information in this prospectus supplement superseded the information contained in that prospectus supplement, or the prior prospectus supplement.

Pursuant to that prior prospectus supplement and accompanying base prospectus contained in our Registration Statement on Form S-3 (File No.

333-239318), we issued 361,236 common shares under the Sales Agreement, resulting in net proceeds of $2.6 million (net of issuance costs of $0.1 million).

No common shares were sold under the Sales Agreement during the year ended December 31, 2024.

Under the terms of the agreement, we granted the underwriters party thereto an option to purchase up to an additional 3,000,000 common shares at the same price per share as the other common shares sold in this offering, which was exercised by such underwriters in full on February 29, 2024.

The net proceeds to us from the February 2024 Offering, including the proceeds from the exercise by the underwriters of their option to purchase the additional 3,000,000 common shares in full, was $31.9 million after deducting underwriting commissions and offering expenses payable by us.

On July 29, 2020, we entered into an Open Market Sale Agreement SM , or the “Original Sale Agreement,” with respect to an at-the-market offering program, or the “ATM Program,” under which we could issue and sell our common shares having an aggregate offering price of up to $50.0 million through Jefferies LLC, or “Jefferies,” as sales agent or principal.

On March 18, 2025, we entered into an Amended and Restated Open Market Sale Agreement SM , or the “Amended Agreement,” with Jefferies.

The Amended Agreement amends and restates, in its entirety, the Original Sale Agreement.

Under the Amended Agreement, we may issue and sell its common shares, no par value per share, for an aggregate offering price of up to $77.8 million (which includes the $2.8 million of sales previously made pursuant to the Original Sale Agreement through the date the Amended Agreement was entered into), or the “ATM Shares.” The ATM Shares will be sold pursuant to our shelf registration statement on Form S-3 (File No.

We previously issued 361,236 common shares under the Original Sale Agreement, resulting in net proceeds of approximately $2.6 million (net of issuance costs of approximately $0.1 million).

We issued 5,690,920 shares under the amended agreement resulting in net proceeds of $14.5 million, after deducting sales agent commissions payable by us of $0.4 million, during the year ended December 31, 2025.

We expect that our operating plan, existing cash and cash equivalents and short-term investments to be sufficient to fund our operations for at least the next 12 months from the date of issuance of this Annual Report on Form 10-K for the year ending December 31, 2025 and that there are no known events or conditions that may cast substantial doubt on our ability to continue as a going concern for at least the next 12 months from the date of this filing.

Contingent future source of funding

Royalty Purchase Agreement

Pursuant to the Royalty Purchase Agreement, RTW agreed to purchase, following FDA approval of etripamil (subject to certain conditions), in exchange for a purchase price of $75.0 million, the right to receive a tiered quarterly royalty payments, or “royalty interest,” on the annual net product sales of etripamil in the United States.

This represents a contingent future source of funding, in order for the Company to receive the $75 million, the closing conditions specified in the Royalty Purchase Agreement, which includes the Company receiving marketing approval from the FDA on or prior to September 30, 2025, must be met.

On January 12, 2026, we closed the sale of the royalty interest under the Royalty Purchase Agreement and received the $75.0 million purchase price from certain funds managed by RTW in exchange for the future royalty interest.

Funding Requirements

We use our cash primarily to fund research and development expenditures.

We expect our expenses to increase as we continue the development of etripamil and prepare for regulatory approval.

We expect to incur increasing operating losses for the foreseeable future as we continue the clinical development of our product candidate.

At this time, due to the inherently unpredictable nature of clinical development, we cannot reasonably estimate the costs we will incur and the timelines that will be required to complete development, obtain marketing approval, and commercialize etripamil or any future product candidates, if at all.

For the same reasons, we are also unable to predict when, if ever, we will generate revenue from product sales or whether, or when, if ever, we may achieve profitability.

We anticipate that we will use our cash and cash equivalents primarily to fund commercialization and research and development expenditures.

We expect our expenses to increase as we continue the development of etripamil and invest in the infrastructure, personnel, and operational expenses required to commercialize CARDAMYST in the United States.

We expect to incur increasing operating losses for the foreseeable future as we continue the clinical development of subsequent etripamil indications or any future product candidates.

At this time, due to the inherently unpredictable nature of clinical development, we cannot reasonably estimate the costs we will incur and the timelines that will be required to complete development, obtain marketing approval, and commercialize subsequent etripamil indications or any future product candidates, if at all.

For the same reasons, we are also unable to predict when, if ever, we may achieve profitability generated from product sales.

Clinical and preclinical development timelines, the probability of success, and development costs can differ materially from expectations.

In addition, we have exclusive development and commercialization rights for etripamil for all indications that we may pursue, and as such, have the potential to license development and or commercialization rights for etripamil to a potential partner in regions outside of Greater China.

We plan to establish commercialization and marketing capabilities using a direct sales force to commercialize etripamil in the United States.

We have established commercialization and marketing capabilities using a direct sales force to commercialize CARDAMYST in the United States.

Outside of the United States, we are considering commercialization strategies that may include collaborations with other companies.

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The timing and amount of our operating expenditures will depend largely on:

• the timing, progress and results of our ongoing and planned clinical trials and other development activities of etripamil in PSVT, AFib-RVR and in other cardiovascular indications;

• the timing, progress and results of our ongoing and planned clinical trials and other development activities of etripamil in AFib-RVR and in other cardiovascular indications;

• the scope, progress, results, and costs of preclinical development, laboratory testing, and clinical trials of etripamil for additional indications or any future product candidates that we may pursue;

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• the ability of vendors and third-party service providers to accurately forecast expenses and deliver on expectations;

• the costs, timing and outcome of regulatory review of etripamil and any future product candidates;

• the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for etripamil and any future product candidates for which we receive marketing approval;

• the costs, timing, and outcome of regulatory review of subsequent etripamil indications and any future product candidates;

• the costs and timing of CARDAMYST commercialization activities, including product manufacturing, marketing, sales, and distribution for CARDAMYST and any future product candidates for which we receive marketing approval;

• the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims;

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The sale of additional equity would result in additional dilution to our shareholders.

The incurrence of debt financing would result in debt service obligations and the instruments governing such debt could provide for operating and financing covenants that restrict our operations or our ability to incur additional indebtedness or pay dividends, among other items.

The incurrence of debt financing would result in debt service obligations and the

instruments governing such debt could provide for operating and financing covenants that restrict our operations or our ability to incur additional indebtedness or pay dividends, among other items.

If we are not able to secure adequate additional funding, we may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, and/or suspend or curtail planned programs.

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Net cash used in operating activities during the year ended December 31, 2025, was $49.0 million, which consisted primarily of a net loss of $63.1 million.

The net loss was partially offset by a net cash increase of $3.7 million related to the change in assets and liabilities, non-cash charges of $5.8 million related to share-based compensation and non-cash interest charges of $3.2 million related to the 2029 Convertible Notes.

The net loss was partially offset by a net cash increase of $2.7 million related to the change in assets and liabilities, non-cash charges of $7.5 million related to share-based compensation and non-cash interest and debt charges of $3.8 million related to the 2029 Convertible Notes.

Net cash used in operating activities during the year ended December 31, 2024, was $28.8 million, which consisted primarily of a net loss of $41.5 million.

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During the year ended December 31, 2025, our financing activities provided cash proceeds of $85.5 million.

These proceeds were primarily a result of the $31.9 million received from the issuance of common shares and pre-funded warrants, net of $2.6 million in issuance costs paid under the Underwriting Agreement.

These proceeds were primarily a result of $48.6 million received, net of issuance costs, from the issuance of common shares, pre-funded warrants, and common warrants under the 2025 Offering, proceeds of $21.7 million, net of issuance costs, for the exercise of common warrants, and proceeds of $14.5 million, net of issuance costs, for shares sold under the ATM Program.

We also had proceeds of $0.4 million and $0.3 million for the exercise of employee options and shares issued as part of the employee stock purchase plan, respectively.

During the year ended December 31, 2024, our financing activities provided cash proceeds of $32.1 million.

These proceeds were primarily a result of the $50 million received from the issuance of the 2029 Convertible Notes under the Note Purchase Agreement, which was partially offset by $2.8 million in debt costs, and $0.6 million in cash proceeds from the exercise of share options and issuance of common shares under the employee stock purchase plan.

Contractual Obligations

We enter into contracts in the normal course of business with clinical research organizations, or “CROs,” contract manufacturing organizations, or “CMOs,” and other third parties for clinical trials, preclinical research studies and testing and manufacturing services.

We enter into contracts in the normal course of business with clinical research organizations, or “CROs,” contract

manufacturing organizations, or “CMOs,” and other third parties for clinical trials, preclinical research studies, and testing and manufacturing services.

These contracts are generally cancelable at our option with various notice requirements as defined in the contract.

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Research and development costs are charged against income in the period of expenditure.

Our research and development costs consist primarily of salaries and fees paid to CROs and to CMO.

Our research and development costs consist primarily of salaries and fees paid to CROs and to CMO for clinical trial expenses and manufacturing costs prior to FDA approval.

Clinical trial expenses include direct costs associated with CROs, direct CMO costs for the formulation and packaging of clinical trial material, as well as investigator and patient-related costs at sites at which our trials are being conducted.

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The actual costs and timing of clinical trials are highly uncertain, subject to risks and may change depending upon a number of factors, including our clinical development plan.

If the actual timing of the performance of services of the level of effort varies from the estimate, we will adjust the accrual accordingly.

If the actual timing of the performance of services and of the level of effort varies from the estimate, we will adjust the accrual accordingly.

Adjustments to prior period estimates have not been material.

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Options Granted

January 16, 2023

February 16, 2023

February 27, 2023

March 19, 2024

March 21, 2023

June 19, 2023

July 15, 2024

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August 28, 2024

September 3, 2024

October 1, 2024

October 4, 2024

November 1, 2024

January 2, 2025

January 26, 2025

January 31, 2025

March 3, 2025

July 15, 2024

July 17, 2024

March 17, 2025

June 10, 2025

August 29, 2025

September 3, 2024

October 1, 2025

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November 24, 2025

December 1, 2025

December 15, 2025

Recent Accounting Pronouncements

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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-K

Item 7. Management’s Discussion and Analysis