Achieved record net product sales of $44.6 million in 2025, a 50% year-over-year increase driven by expanding active patient counts and new account acquisition.

Strategic pivot toward the Adolescent and Young Adult (AYA) market, which management identifies as ten times larger than the core pediatric segment.

Enhanced commercial execution through a 70% conversion rate in the Fennec HEARS program, up from 50% in Q1, by reducing administrative and reimbursement friction.

Strengthened financial health by eliminating all debt and raising $42 million in net proceeds, resulting in the strongest balance sheet in corporate history.

Transitioned from a pediatric-only focus to a broader oncology supportive care model by initiating studies in testicular and head and neck cancers.

Optimized the cost structure by exiting European operations following the Norgine partnership, allowing for redeployment of capital into U.S. commercial expansion.

Anticipate generating positive cash flow in Q1 2026, supported by early collection of receivables that were delayed in the fourth quarter.

Projecting cash operating expenses to increase to approximately $50 million in 2026 to fund expanded field force reach and frequency.

Expect material revenue contributions from the Norgine partnership in the second half of 2026 as launches expand to 8-10 additional European countries.

Guidance methodology focuses on a high-leverage model where every 100 additional patients can contribute approximately $30 million in net revenue.

Prioritizing a partnership for the Japanese market following positive Phase II/III results to initiate the local regulatory registration process.

Settled patent litigation with Cipla, securing market exclusivity for PEDMARK until September 1, 2033, and eliminating millions in annual legal expenses.

Addressed historical physician concerns regarding cisplatin interference by citing long-term data showing no difference in overall survival over 5-8 years.

Identified the AYA testicular cancer segment as the largest immediate opportunity, with an addressable market exceeding 20,000 patients annually.

Reported 95% to 100% reimbursement rates across the top three national insurance plans, mitigating previous concerns regarding AYA market access.

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Management highlighted new retrospective data in head and neck cancer showing safe administration 6 hours post-cisplatin without disrupting curative intent.

Current strategy focuses on 'evidence first' to naturally lead to NCCN guideline expansion and potential regulatory label updates for AYA and adult patients.

The Q1 expansion was targeted at Tier 1 accounts where existing managers had high productivity but limited reach and frequency.

New hires are expected to reach full productivity and make material contributions to net product sales by the second half of 2026.

The program is described as an 'enabler' that converts prescribed vials into infused vials by removing financial and administrative barriers.

Management clarified that demand originates from clinical adoption, while the support program ensures continuity of care and captures otherwise lost utilization.

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