Milestone Pharmaceuticals Inc. (NASDAQ: MIST) Reports Earnings Beat Amid Launch Progress and Regulatory Timeline AdjustmentMIST reported an EPS of -$0.16 for Q4 2025, beating the consensus estimate of -$0.18 (by $0.02). This was a positive surprise relative to expectations.Revenue was approximately $1.5 million, which beat the prior consensus estimate of around $1.20 million for that period. The company announced a minor delay in the European approval timeline for etripamil (conditionally branded TACHYMIST™ ...

• Milestone Pharmaceuticals stock is taking a hit today. Why is MIST stock falling?European Decision Timeline PushedIn January, the European Medicines Agency accepted the marketing application for etripamil in paroxysmal supraventricular tachycardia (PSVT), supported by the same global data package used for FDA approval in December 2025.PSVT is a type of arrhythmia (irregular heartbeat) characterized by sudden, sporadic bursts of a rapid, regular heart rate (120–230 bpm) that start and stop abruptly.The co ...

Financial Data and Key Metrics Changes - Milestone Pharmaceuticals reported $1.5 million in revenue for Q4 2025, with no revenue comparables in 2024, reflecting earnings under a licensing collaboration agreement following FDA approval of CARDAMYST [21] - R&D expenses for Q4 2025 were $5.5 million, up from $3.9 million in Q4 2024, with full-year R&D expenses at $18.1 million compared to $14.4 million in 2024 [21][22] - G&A expenses increased to $5.1 million in Q4 2025 from $4.0 million in the prior quarter, with full-year G&A expenses at $17.3 million compared to $16.7 million in 2024 [22][23] - Commercial expenses surged to $8.2 million in Q4 2025 from $4.4 million in Q4 2024, with full-year commercial expenses at $28.3 million compared to $11 million in 2024 [23] - The net loss for Q4 2025 was $17.4 million or $0.16 per share, compared to a net loss of $12.4 million or $0.19 per share in Q4 2024 [24] - As of December 31, 2025, the company had $106 million in cash equivalents and short-term investments, with a pro forma cash figure of approximately $200 million after subsequent financing activities [24][25] Business Line Data and Key Metrics Changes - The launch of CARDAMYST, an etripamil nasal spray for PSVT, marks a significant new therapeutic option for over 2 million patients, with the commercial strategy focused on driving new patient starts and achieving commercial coverage [5][7] - The commercial team has begun executing the launch strategy, with CARDAMYST available in retail pharmacies within six weeks of FDA approval [12][13] Market Data and Key Metrics Changes - The company is targeting around 10,000 healthcare providers who manage half of the 1 million patients with PSVT expected to receive treatment in 2026 [12] - Initial feedback from prescribers has been positive, with over 150 prescriptions filled in the first month, primarily from new patient starts [16][20] Company Strategy and Development Direction - The FDA approval of CARDAMYST is seen as a foundation for value creation, with plans to leverage clinical data for marketing approvals in other regions, including Europe [9] - The company aims to establish a strong commercial franchise in acute cardiovascular therapy, focusing on making CARDAMYST accessible and affordable for patients [20][26] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early launch phase, noting that while it is too early to identify durable patterns, they expect prescription volume to increase and commercial coverage to expand over time [20][26] - The company is actively engaging with payers to demonstrate the value of CARDAMYST, aiming for broad coverage while managing the natural dampening effect of reimbursement processes [53][54] Other Important Information - The company has enhanced its leadership team with the addition of David Sandoval as General Counsel and Chief Compliance Officer, expected to support long-term growth [10] Q&A Session Summary Question: Feedback on CARDAMYST launch and coverage denial reasons - Management noted broad adoption across cardiology and electrophysiology, with APPs being key prescribers; coverage denials are primarily due to paperwork requirements for patient eligibility [28][31] Question: Reimbursement timelines and patient access - Management indicated that scripts are being filled within days to weeks once the system is engaged, with ongoing efforts to support patients during the reimbursement process [35][38] Question: Current prescribing trends and patient demographics - Management reported a diverse patient mix, with some using CARDAMYST before ablation or as a routine course; they are optimistic about the drug's broad applicability [46][48] Question: Contracting strategy and formulary positioning - The company aims for open access with reasonable prior authorization requirements, expecting a 50/50 split between commercial and Medicare coverage [58][61]

Financial Data and Key Metrics Changes - Milestone Pharmaceuticals reported $1.5 million in revenue for Q4 2025, with no revenue comparables in 2024, reflecting earnings under a licensing collaboration agreement following FDA approval of CARDAMYST [21] - R&D expenses for Q4 2025 were $5.5 million, up from $3.9 million in Q4 2024, with full-year R&D expenses at $18.1 million compared to $14.4 million in 2024 [21][22] - G&A expenses increased to $5.1 million in Q4 2025 from $4.0 million in the prior quarter, with full-year G&A expenses at $17.3 million compared to $16.7 million in 2024 [22][23] - Commercial expenses surged to $8.2 million in Q4 2025 from $4.4 million in Q4 2024, with full-year commercial expenses at $28.3 million compared to $11 million in 2024 [23] - The net loss for Q4 2025 was $17.4 million or $0.16 per share, compared to a net loss of $12.4 million or $0.19 per share in Q4 2024, with a full-year net loss of $63.1 million or $0.75 per share compared to $41.5 million or $0.67 per share in 2024 [24] Business Line Data and Key Metrics Changes - The launch of CARDAMYST, an etripamil nasal spray for PSVT, marks a significant new therapeutic option for over 2 million patients, with the commercial strategy focused on driving new patient starts and achieving commercial coverage [5][7] - The commercial team has engaged with approximately 10,000 providers who manage half of the 1 million patients expected to receive treatment for PSVT in 2026 [12] Market Data and Key Metrics Changes - The PSVT market is identified as a clearly defined opportunity within cardiovascular specialty pharma, with efforts to demonstrate the value proposition of CARDAMYST to payers [13] - Initial feedback from prescribers has been positive, with over 150 prescriptions filled in the first month of launch, primarily from new patient starts [16] Company Strategy and Development Direction - The FDA approval of CARDAMYST is seen as a foundation for value creation, with plans to leverage clinical data for marketing approvals in other regions, including Europe [8][9] - The company aims to establish a strong commercial franchise and reduce reliance on emergency department care through the self-administered CARDAMYST [26] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early launch phase, noting that while it is too early to identify durable patterns, they expect prescription volume to increase and commercial coverage to expand over time [20] - The company is focused on ensuring that physicians can prescribe CARDAMYST, patients can access it, and payers recognize the demand in the marketplace [20] Other Important Information - The company reported a pro forma cash figure of approximately $200 million, supporting the successful launch of CARDAMYST and providing an operating runway into late 2027 [10][24] - The leadership team has been enhanced with the addition of David Sandoval as General Counsel and Chief Compliance Officer [10] Q&A Session Summary Question: Feedback on CARDAMYST launch and coverage denial reasons - Management noted broad adoption among cardiologists and advanced practice providers, with coverage denials primarily due to paperwork requirements for patient eligibility [28][31] Question: Reimbursement timelines and patient access - Management indicated that scripts are being filled within days to weeks after engaging the system, with ongoing efforts to support patients during the reimbursement process [35][38] Question: Replacement therapies for CARDAMYST and patient feedback - Management reported a broad range of patients using CARDAMYST, including those awaiting ablation, with positive early feedback from social media indicating excitement about having the treatment available [46][49] Question: Contracting strategy and formulary positioning - Management aims for open access with reasonable coverage terms, expecting a 50/50 split between commercial and Medicare patients, and is actively engaging payers for coverage [58][61]

Financial Data and Key Metrics Changes - Milestone Pharmaceuticals reported $1.5 million in revenue for Q4 2025, with no revenue comparables in 2024, reflecting earnings under a licensing collaboration agreement following FDA approval of CARDAMYST [19] - R&D expenses for Q4 2025 were $5.5 million, up from $3.9 million in Q4 2024, with full-year R&D expenses at $18.1 million compared to $14.4 million in 2024 [19] - G&A expenses increased to $5.1 million in Q4 2025 from $4.0 million in the prior quarter, with full-year G&A expenses at $17.3 million compared to $16.7 million in 2024 [20] - Commercial expenses rose significantly to $8.2 million in Q4 2025 from $4.4 million in Q4 2024, with full-year commercial expenses at $28.3 million compared to $11 million in 2024 [20] - The net loss for Q4 2025 was $17.4 million or $0.16 per share, compared to a net loss of $12.4 million or $0.19 per share in Q4 2024 [20] - Full-year net loss was $63.1 million or $0.75 per share, compared to $41.5 million or $0.67 per share in 2024 [21] Business Line Data and Key Metrics Changes - The launch of CARDAMYST is seen as a pivotal moment for the company, targeting over 2 million patients with PSVT, marking the first new therapeutic option in 30 years [4][5] - The commercial strategy focuses on driving new patient starts and achieving commercial coverage, with a sales force of approximately 60 representatives targeting around 10,000 providers [10] Market Data and Key Metrics Changes - The company has filed a marketing authorization application for CARDAMYST in Europe, with expectations for a decision in the first half of 2027 [7] - The company is actively engaging with payers to demonstrate the value proposition of CARDAMYST, aiming to reduce emergency department visits and hospital utilization [11] Company Strategy and Development Direction - The FDA approval of CARDAMYST is viewed as a foundation for value creation, with a focus on building a strong commercial franchise [5] - The company aims to leverage comprehensive clinical data to seek marketing approvals in other regions, enhancing the credibility of CARDAMYST [6] - The strategy includes ensuring a positive initial experience for patients and prescribers, with a focus on accessibility and affordability [12][17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early feedback from prescribers and the initial launch of CARDAMYST, indicating strong demand generation [12][18] - The company anticipates prescription volume to increase and commercial coverage to expand over time, with more meaningful progress expected in the latter half of the year [18] Other Important Information - The company reported a pro forma estimated cash figure of $200 million, supporting the successful launch of CARDAMYST and providing an operating runway into late 2027 [7][22] - The leadership team has been enhanced with the addition of David Sandoval as General Counsel and Chief Compliance Officer [8] Q&A Session Summary Question: Feedback on CARDAMYST launch and coverage denial reasons - Management noted a broad mix of prescribers adopting CARDAMYST, including cardiologists and advanced practice providers, with coverage denials primarily due to paperwork requirements for patient eligibility [26][28] Question: Reimbursement timelines and patient access - Management indicated that scripts are being filled within days to weeks once the system is engaged, with ongoing efforts to support patients in accessing the drug during the delay period [32][35] Question: Current prescribing trends and patient mix - Management reported that CARDAMYST is being prescribed to a diverse patient group, including those awaiting ablation and those with existing medications, but emphasized that it is too early to identify specific trends [43][44] Question: Contracting strategy and formulary positioning - The company aims for broad access with reasonable coverage terms, targeting commercial plans first, with Medicare coverage expected to follow in 2027 [50][57]

"We are excited to see that our commercial launch of CARDAMYST and the initial engagement with providers, patients and payers is tracking or exceeding our pre-launch expectations," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "Our national sales force was fully deployed within eight weeks of our mid-December approval. Feedback from prescribers supports our belief that there is meaningful demand for a convenient, self-administered option to treat episodes of PSVT, ...

Core Insights - Milestone Pharmaceuticals reported financial results for Q4 and full year 2025, highlighting the FDA approval and launch of CARDAMYST™ (etripamil) nasal spray for treating paroxysmal supraventricular tachycardia (PSVT) [1][5][6] Financial Performance - The company received a $75 million payment under a Royalty Purchase Agreement related to the FDA approval of CARDAMYST [12] - As of December 31, 2025, Milestone had cash and short-term investments of $106 million, up from $69.7 million in 2024 [13] - The company recorded $1.5 million in revenue for 2025, primarily from a milestone payment related to CARDAMYST's approval [13] - Research and development expenses for 2025 were $18.1 million, an increase from $14.4 million in 2024, driven by higher consulting costs [13][14] - The net loss for Q4 2025 was $17.4 million, or $0.16 per share, compared to a net loss of $12.4 million, or $0.19 per share, in Q4 2024 [14] Product Launch and Market Engagement - The commercial launch of CARDAMYST is tracking or exceeding pre-launch expectations, with a national sales force fully deployed within eight weeks of FDA approval [2][5] - Initial engagement with healthcare providers and payers has been positive, indicating strong demand for CARDAMYST [2][5] - CARDAMYST is the first new treatment option for PSVT in 30 years, with clinical studies showing participants were twice as likely to convert symptomatic PSVT to sinus rhythm compared to placebo [5][6] Regulatory and Development Updates - The marketing authorization application for etripamil nasal spray in Europe has been accepted, with a decision expected by the first half of 2027 [6] - A Phase 3 program for etripamil in patients with atrial fibrillation with rapid ventricular rate (AFib-RVR) is planned, following FDA guidance [8] Corporate Updates - David Sandoval was appointed as General Counsel and Chief Compliance Officer, bringing over 15 years of experience in the life sciences sector [10]

Financial Performance - The company incurred a net loss of $63.1 million and $41.5 million for the years ended December 31, 2025 and 2024, respectively, with an accumulated deficit of $430.6 million as of December 31, 2025[155]. - The company expects to continue incurring significant operating losses until revenue from CARDAMYST is sufficient to fund operations[155]. - The company requires substantial additional funding to finance operations and may face challenges in raising capital on acceptable terms[167]. Product Development and Clinical Trials - Future expenses are anticipated to increase due to ongoing development of etripamil, including planned Phase 3 and potential Phase 4 clinical trials[156]. - The NODE-301 trial of etripamil for PSVT did not meet its primary endpoint, highlighting the uncertainty in achieving regulatory approval for additional product candidates[168]. - The company currently has one approved product, CARDAMYST™ (etripamil) nasal spray, and is pursuing clinical development for additional indications of etripamil[178]. - The approval process for new indications of etripamil or any future product candidates is unpredictable and may take many years, affecting revenue generation[179]. - The company has invested significant resources in the development of etripamil and aims to obtain regulatory approval for subsequent indications[182]. - On November 11, 2023, the company announced positive Phase 2 clinical trial data for etripamil in treating AFib-RVR and plans to conduct Phase 3 development[186]. - The company may face substantial delays or difficulties in clinical trials, which could impact the commercialization of etripamil and future product candidates[194]. - Clinical trial results may be inconclusive or raise safety concerns, potentially delaying marketing approvals[198]. - Patient enrollment and retention in clinical trials are critical, and difficulties in identifying patients may delay development and approval of etripamil[204]. - Negative results from clinical trials can hinder patient recruitment for future studies, as seen with the failed primary endpoint in the NODE-301 trial[205]. - The potential for undesirable side effects could delay or prevent regulatory approval and limit commercial potential[206]. - The company may experience increased product development costs due to delays in testing or obtaining marketing approvals[201]. - Clinical trials for product candidates are expensive and time-consuming, with successful completion expected to take several years[203]. Market and Commercialization Risks - The company is in the preliminary stages of commercializing CARDAMYST for the treatment of PSVT, which is critical for achieving profitability[158]. - The revenue will depend on market size, product pricing, and the ability to obtain coverage and reimbursement[159]. - Unfavorable global economic conditions could adversely affect the company's business and financial condition, impacting demand for CARDAMYST and other product candidates[170]. - Market acceptance of CARDAMYST and future product candidates is uncertain and may affect revenue generation[215]. - The estimated addressable patient population for product candidates may be smaller than anticipated, impacting business operations[221]. - Competition from established companies may hinder the company's ability to develop and commercialize its products successfully[222]. - Coverage and adequate reimbursement for CARDAMYST or future product candidates may not be available, impacting market acceptance and sales[233]. Regulatory and Compliance Challenges - Regulatory authorities may impose additional requirements or change policies that could delay approvals or increase compliance costs[185]. - The pharmaceutical industry in China is highly regulated, and changes in regulations may negatively affect the commercialization of the Company's medicines and drug candidates[229]. - The Company anticipates that obtaining approval for etripamil or future product candidates outside the United States will involve complex regulatory requirements and may delay or prevent successful commercialization[240]. - The FDA and other regulatory authorities impose ongoing oversight and requirements for approved products, which may include costly post-marketing testing[245]. - The company must comply with various healthcare laws and regulations, and failure to do so could result in substantial penalties[253]. - Changes in third-party payor policies may pressure pharmaceutical pricing and coverage, affecting the commercial success of drug products[235]. - The company is subject to various healthcare regulations, including the False Claims Act and HIPAA, which impose significant compliance costs and risks of penalties for non-compliance[263]. Intellectual Property Risks - The company may face challenges in obtaining and maintaining patent protection for etripamil, which could allow competitors to develop similar products[287]. - Patent terms may be inadequate to protect the competitive position of etripamil, as patents could expire shortly after commercialization[296]. - Changes in patent laws may affect the scope and enforceability of the company's patent rights, impacting its competitive position[289]. - The company may not be aware of all third-party intellectual property rights related to etripamil, which could pose risks to its patent strategy[290]. - There is a risk that third parties may initiate legal proceedings alleging infringement of their intellectual property rights, which could negatively impact the company's business success[302]. Operational and Management Challenges - The company is highly dependent on key executives, including the President and CEO, Chief Medical Officer, Chief Commercial Officer, and Chief Financial Officer, which poses a risk if any of them were to leave[325]. - The company may experience significant growth in employee numbers and operational scope as it commercializes CARDAMYST and develops subsequent etripamil indications, requiring effective management of this growth[327]. - The company faces challenges in recruiting and retaining qualified personnel, particularly in scientific and clinical roles, which could impede its growth strategy[326]. Cybersecurity and Data Privacy Risks - Cybersecurity risks are a significant concern, with potential disruptions to product development programs and adverse consequences from security breaches, including regulatory investigations and reputational harm[329]. - The company processes sensitive information, making it vulnerable to various cyber threats, including ransomware attacks, which could lead to significant operational interruptions and financial losses[330]. - Compliance with stringent data privacy and security regulations is essential, as failures could result in regulatory actions, litigation, and reputational harm[342]. - The company has implemented security measures to protect against incidents, but there is no assurance these measures will be effective, and vulnerabilities may still be exploited[332]. - The company is subject to various data privacy and security laws globally, including the EU GDPR, UK GDPR, and China's PIPL, which impose strict requirements for processing personal data[344].

Core Viewpoint - Milestone Pharmaceuticals Inc. is set to report its fourth-quarter earnings on March 20, with analysts predicting a loss of 16 cents per share and revenue of $1.20 million [1]. Group 1: Earnings Report - The company will release its earnings before the market opens on March 20 [1]. - Analysts expect a quarterly loss of 16 cents per share [1]. - Projected revenue for the quarter is $1.20 million [1]. Group 2: Management Changes - On February 10, Milestone Pharmaceuticals appointed David Sandoval as general counsel and chief compliance officer [1]. Group 3: Stock Performance - Shares of Milestone Pharmaceuticals closed at $1.70 on the preceding Thursday [1].

MONTREAL and CHARLOTTE, N.C., March 16, 2026 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that a moderated poster presentation titled “Minimal Blood Pressure Effects of Intranasal Etripamil in Trials for Paroxysmal Supraventricular Tachycardia (PSVT)” will be featured at the 2026 American College of Cardiology Annual Scientific Session (ACC.26), March 28 ...