Milestone Pharmaceuticals Q3 Earnings Call Highlights

Key Points

• Milestone plans to cut operating expenses by about 30% and bring its sales team in-house, extending its cash runway into late 2028—through the expected ReVeRA-301 Phase 3 readout. The restructuring is expected to be completed by Q1 2027 and incur about $2 million in one-time costs.
• CARDAMYST prescriptions rose 50% quarter over quarter to approximately 1,800 in Q3, while net product revenue increased to $1 million from $600,000. Commercial coverage also expanded to roughly two-thirds of commercially insured lives, though broad CVS Caremark and national Medicare coverage remain challenges.
• Milestone reported a Q3 net loss of $25.8 million and ended September with $145.4 million in cash and short-term investments. ReVeRA-301 is enrolling patients, with a 500–700-patient target and an anticipated readout in the second half of 2028.

Milestone Pharmaceuticals NASDAQ: MIST plans to cut operating expenses by approximately 30% as it seeks to extend its cash runway while building sales of CARDAMYST and advancing a late-stage clinical trial.

The company reported approximately 1,800 CARDAMYST prescriptions in the third quarter of 2026, up 50% from the prior quarter, and $1 million in net product revenue, compared with $600,000 in the second quarter. CARDAMYST is being marketed for paroxysmal supraventricular tachycardia, or PSVT.

President and CEO Joseph Oliveto said the cost measures, alongside an amendment to a financing agreement, are expected to extend Milestone’s operating cash runway into late 2028, more than a year beyond its prior guidance. That would carry the company through the anticipated second-half 2028 readout of its Phase 3 ReVeRA-301 study in atrial fibrillation with rapid ventricular rate, or AFib-RVR.

Sales Force and Leadership Changes

Milestone plans to bring its contracted field team of approximately 45 representatives in-house and internalize data systems and analytical capabilities. The sales team had already been reduced from approximately 60 representatives in August, with the company focusing on electrophysiology and high-prescribing cardiology accounts, Oliveto said.

The company also plans to discontinue marketing and support programs it considers less effective and streamline headquarters operations. Chief Financial Officer Amit Hasija and Chief Medical Officer Dr. David Bharucha have departed the leadership team; Bharucha will continue as a consultant. Vice President of Finance Anthony Krick has been named principal financial and principal accounting officer.

Milestone expects to complete the changes by the first quarter of 2027 and incur approximately $2 million in one-time charges, primarily for severance, conversion fees and other workforce-reduction costs. The company also amended its note purchase agreement with RTW Investments LP to extend the payment-in-kind interest period from March 31, 2027, to March 2029.

Prescription Growth and Insurance Coverage

Approximately 750 unique health care providers prescribed CARDAMYST in the third quarter, bringing the total since launch through September to about 1,600, the company said. Prescriptions were written for roughly 1,400 patients during the quarter and 2,700 since launch.

Chief Commercial Officer Lorenz Muller said approximately 40% of prescribers had written the drug for more than one patient. Milestone has identified more than 5,000 high-value health care providers who treat disproportionately large numbers of patients with PSVT and is seeking to increase both the number of prescribers and the number of patients treated by each.

Oliveto said the company expects prescriptions to continue increasing in the fourth quarter, but noted that growth could flatten somewhat in the first quarter as patients’ out-of-pocket costs and insurance plans reset. Milestone did not provide numerical sales guidance.

Formulary coverage has expanded to approximately two-thirds of commercially insured lives, up from about 50% at the time of the company’s second-quarter call, Muller said. Milestone has not secured broad national formulary placement with CVS Caremark and continues to engage with the pharmacy benefit manager.

Muller said Medicare is unlikely to be a major driver of prescription growth in the near term. A small number of regional Medicare plans have added CARDAMYST for the start of 2027, but national Part D coverage has been challenging. The company plans to invest in medical necessity exception pathways while remaining selective about Medicare contracting.

Financial Results and Trial Outlook

Milestone reported a third-quarter net loss of $25.8 million, or $0.18 per share, compared with a loss of $11.9 million, or $0.12 per share, a year earlier. Selling, general and administrative expenses rose to $24.2 million from $7.9 million, primarily because of costs associated with the CARDAMYST launch. Research and development expenses, net of tax credits, fell to $3.5 million from $3.9 million.

The company ended September with $145.4 million in cash, cash equivalents and short-term investments, compared with $106 million at the end of 2025.

ReVeRA-301 is enrolling patients in the United States, Canada and Europe. Oliveto said the event-driven study is expected to enroll approximately 500 to 700 patients to reach a target of about 150 treatment events. The study’s primary endpoint is reduction in ventricular rate; it is powered around a second endpoint measuring symptom improvement, which Oliveto said is also needed for regulatory approval.

About Milestone Pharmaceuticals (NASDAQ:MIST)

Milestone Pharmaceuticals is a biopharmaceutical company focused on developing treatments for cardiovascular conditions. Its work centers on therapies intended to give patients and caregivers options for managing acute heart rhythm episodes outside of a clinical setting. The company's lead product is etripamil, a short-acting calcium channel blocker formulated as a nasal spray. It is designed for self-administration to treat episodes of paroxysmal supraventricular tachycardia, a condition involving sudden episodes of abnormally fast heart rate.

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