Assertio Holdings, Inc. Q3 FY2024 earnings call

Management Statement and Operational Highlights

• Response to Alex Parker's Allegations: Addressed false claims, stating ROLVEDON is safe and effective, impairment charges followed accounting principles, and no payments to whistleblowers. Vigorously defends reputation.
• Board Changes: Peter Staple retired from the Board after 21 years; Dr. Jeff Vacirca stepped back to focus on other business interests. Heather Mason appointed Chairwoman, and David Stark joined the Board effective November 7.
• Business Progress: Focus on stabilizing the organization transitioning from INDOCIN to ROLVEDON. ROLVEDON sales steady with growth potential in hospital and other segments. INDOCIN managed for life cycle and cash flow. Sympazan piloting marketing tactics for growth. Assets categorized into growth (ROLVEDON), core (Sympazan, SPRIX), and legacy (INDOCIN, CAMBIA) buckets.

Segment Performance

• ROLVEDON: Q3 sales were approximately $15 million, steady quarter-over-quarter. Retains a stable ~33% share in the community oncology clinic space. Saw a dip in demand due to seasonality and Part B shifts, but offset by new customers expanding into hospital and community oncology clinics. Same day dosing trial data to be presented at San Antonio Breast Cancer Symposium in December.
• INDOCIN: Q3 sales were $5.7 million, down from $6.9 million in Q2 due to lower net pricing from generic competition. Market share holds steady at ~50% of the ex-compounding market.
• Sympazan: Smaller asset with underpenetrated market. Piloting sales and marketing tactics led to record prescription demand in July and August. Serves unmet medical need and has growing support among patients, caregivers, and providers.
• SPRIX: Indicated in moderate to moderately severe pain requiring opioid-level analgesia. NOPAIN Act could present an opportunity for expansion.
• Legacy assets: Include INDOCIN and CAMBIA, focusing on asset optimization and cash generation.

Guidance

• Currently maintain the remaining guidance range. Focus areas include stabilizing the business transitioning from INDOCIN to ROLVEDON, monitoring the generic competitive landscape of INDOCIN, and dynamic pricing and volume activity in the GCSF market.

Risks

• No detailed discussion of specific risks in the transcript, but notes that forward-looking statements involve risks and uncertainties, including those in the press release and SEC filings.

Question and Answer

• Q: Thomas Flaten asked about guidance and acquisition plans.

A: Ajay said they'll keep the remaining guidance range as there are flux areas; Brendan stated they continue to look for suitable deals, emphasizing the need for the right fit.

• Q: Naz Rahman inquired about ROLVEDON pricing stability and timeline for same day dosing data in NCCN guidelines.

A: Ajay said GCSF market is competitive with ongoing pricing declines; Brendan said data will be public in December and earliest NCCN consideration could be mid-next year.

• Q: Scott Henry asked about ROLVEDON growth outlook, SG&A trend, and Board changes.

A: Brendan said 2025 growth planned beyond clinic space; Ajay noted SG&A lower in second half; Brendan explained Board changes reasons including Peter Staple's long service and Dr. Vacirca's other business interests.

• Q: Raghuram Selvaraju asked about ROLVEDON new customer drivers and gross margin trend.

A: Brendan and Ajay explained new customer choice due to product appeal and contracting; Ajay said aiming to maintain 70%-75% gross margin in 2024.