Vanda Pharmaceuticals(VNDA) - 2024 Q1 - Quarterly Results

Financial Highlights Q1 2024 saw total revenues of $47.5 million, a 24% YoY decrease, resulting in a $4.1 million net loss, while cash and marketable securities increased to $394.1 million Q1 2024 Revenue Performance (in millions) | Product | Q1 2024 | Q1 2023 | YoY Change | Q4 2023 | QoQ Change | | :--- | :--- | :--- | :--- | :--- | :--- | | Total Net Product Sales | $47.5 | $62.5 | -24% | $45.3 | +5% | | Fanapt® | $20.6 | $22.9 | -10% | $22.6 | -9% | | HETLIOZ® | $20.1 | $39.6 | -49% | $21.1 | -5% | | PONVORY® | $6.8 | N/A | N/A | N/A | N/A | Q1 2024 Profitability and Cash Position (in millions) | Metric | Q1 2024 | Q1 2023 | Q4 2023 | | :--- | :--- | :--- | :--- | | Net Income (Loss) | $(4.1) | $3.3 | $(2.4) | | Cash, cash equivalents and marketable securities | $394.1 | N/A | $388.2 | - The decrease in HETLIOZ® net product sales compared to Q1 2023 was a direct result of continued generic competition in the U.S.[6] Key Operational Highlights & Pipeline Update Vanda is advancing its pipeline with key milestones including the Q3 2024 launch of Fanapt® and PONVORY®, an NDA review for tradipitant, and new Phase III programs - The company highlighted several expected milestones, including product launches, potential approvals, Phase III results, and new NDA filings, positioning it for potential growth[3] Psychiatry Portfolio The psychiatry portfolio expands with Fanapt® FDA approval and Q3 2024 launch, an NDA planned for milsaperidone, and development of Fanapt® LAI and HETLIOZ® LQ, despite HETLIOZ® challenges - Fanapt® was approved by the FDA for acute bipolar I disorder in adults, with a commercial launch and sales force expansion planned for Q3 2024[10] - Vanda plans to submit an NDA for milsaperidone (active metabolite of Fanapt®) for schizophrenia and bipolar I disorder in early 2025, with potential patent exclusivity into the 2040s[10] - A Phase III program for a long-acting injectable (LAI) formulation of Fanapt® is expected to begin by the end of 2024[10] - The company plans to initiate a HETLIOZ® LQ program for pediatric insomnia, targeting a significant unmet need as there are no currently approved treatments[10] PONVORY® (ponesimod) Vanda plans a Q3 2024 commercial launch of PONVORY® for multiple sclerosis and will initiate Phase III studies for psoriasis and ulcerative colitis by year-end 2024, targeting significant patient populations - The commercial launch of PONVORY® for multiple sclerosis is expected in Q3 2024, supported by a new specialty sales force and marketing programs[9] - Vanda plans to initiate a Phase III study of PONVORY® for psoriasis by the end of 2024, based on positive prior Phase II results[9] - A Phase III study of PONVORY® for ulcerative colitis is also planned to start by the end of 2024, aiming to expand its addressable patient population[9][11] Tradipitant Tradipitant's NDA for gastroparesis is under FDA review with a September 2024 PDUFA date, while a motion sickness NDA is planned for Q4 2024 following Q2 2024 Phase III results - The NDA for tradipitant in gastroparesis is under FDA review, with a PDUFA target action date set for September 18, 2024[16] - Results from the second Phase III study of tradipitant for motion sickness are expected in Q2 2024, with an NDA submission to the FDA planned for Q4 2024[16] Early-Stage Programs Vanda's early-stage pipeline is progressing with a Phase II study for VSJ-110 (dry eye) over 50% enrolled and Phase I studies initiated or underway for VCA-894A, VTR-297, and VQW-765 - The pipeline includes several ongoing clinical programs: - VSJ-110 (dry eye): Phase II study is more than 50% enrolled - VCA-894A (CMT2S): Phase I study expects to enroll its first patient in mid-2024 - VTR-297 (onychomycosis): Phase I study was initiated in April 2024 - VQW-765 (performance anxiety): Currently in clinical development[16] 2024 Financial Guidance Vanda Pharmaceuticals has withheld 2024 financial guidance due to uncertainties from HETLIOZ® generic competition and upcoming Fanapt® and PONVORY® commercial launches - The company is currently unable to provide 2024 financial guidance[14] - Key uncertainties cited for withholding guidance include continued generic competition for HETLIOZ® and the upcoming commercial launches for Fanapt® and PONVORY®[14] Consolidated Financial Statements Unaudited Q1 2024 financial statements show a $4.1 million net loss on $47.5 million revenue, with $394.1 million in cash and marketable securities and $652.7 million in total assets Condensed Consolidated Statements of Operations Q1 2024 saw total revenues of $47.5 million, operating expenses of $56.7 million, and a net loss of $4.1 million or ($0.07) per share, a decline from Q1 2023 net income Q1 2024 Statement of Operations (in thousands, except per share data) | Line Item | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Total revenues | $47,462 | $62,498 | | Total operating expenses | $56,697 | $60,494 | | Income (loss) from operations | $(9,235) | $2,004 | | Net income (loss) | $(4,146) | $3,252 | | Net income (loss) per share, diluted | $(0.07) | $0.06 | Condensed Consolidated Balance Sheets As of March 31, 2024, total assets reached $652.7 million, with $394.1 million in cash and marketable securities, total liabilities at $108.7 million, and stockholders' equity at $544.0 million Balance Sheet Highlights (in thousands) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $125,158 | $135,821 | | Marketable securities | $268,984 | $252,443 | | Total Assets | $652,682 | $648,440 | | Total current liabilities | $93,342 | $87,697 | | Total Liabilities | $108,687 | $103,530 | | Total Stockholders' Equity | $543,995 | $544,910 |