EPS of $-0.56 increased by 38.5% from previous year
Gross margin of 51.5%
Net income of -8.25M
"'we are ready to complete the PL9643 Phase III program with all remaining clinical studies to be conducted and completed in calendar year 2025 and an anticipated NDA filing in the first half of calendar year 2026.'" - Carl Spana
Palatin Technologies Inc (PTN) QQ4 2024 Results Analysis with Near-Term Catalysts in Dry Eye and Obesity Programs
Executive Summary
- Palatin reported a Q4 fiscal 2024 quarter with meaningful top-line sparsity following the December 2023 sale of Vyleesi rights to Cosette Pharmaceuticals, resulting in no recorded product sales for the quarter. The quarter posted revenue of 0.35 million and a net loss of 8.25 million, translating to an EPS of -0.56. Operating expenses remained elevated at 8.69 million, contributing to an EBITDA of -8.13 million and an operating loss of -8.34 million. For the full fiscal year 2024, the company benefited from a $7.8 million gain on Vyleesi’s sale, which helped reduce overall annual operating expenses versus the prior year, but Palatin still ended FY2024 with a net loss of 29.7 million as cash burn persisted.
Key Performance Indicators
Revenue
350.00K
QoQ: N/A | YoY:-80.14%
Gross Profit
180.09K
51.45% margin
QoQ: 204.83% | YoY:-89.14%
Operating Income
-8.34M
QoQ: 9.26% | YoY:22.89%
Net Income
-8.25M
QoQ: 2.20% | YoY:23.00%
EPS
-0.56
QoQ: -5.66% | YoY:38.46%
Revenue Trend
Margin Analysis
Key Insights
Revenue (Q4 2024): 0.35 million; Gross profit: 0.18 million; Gross margin: 51.45% for the quarter; Operating expenses: 8.69 million; EBITDA: -8.13 million; Operating income: -8.34 million; Net income: -8.25 million; EPS: -0.56; Cash and cash equivalents (as of 2024-06-30): 9.53 million; Net cash used in operating activities (Q4 2024): -6.47 million; Fiscal year 2024 total operating expenses: 27.0 million; Fiscal year 2024 net cash used in operating activities: -31.5 million; Fiscal year 2024 net loss: -29.7 million; 2024 Vyleesi annual gross product sales: 8.9 million; 2024 Vyleesi net product revenue: 4.5 million; NDA timeline: PL9643 Phase III MELODY-1 data supportive; Planned NDA filing for PL9643 in the first half of calendar year 2026; Interim data for PL8177 in UC, and ongoing ocular programs PL9588 and PL9654 progressing toward IND-enabling studies in 2025.
Financial Highlights
- Revenue (Q4 2024): 0.35 million; Gross profit: 0.18 million; Gross margin: 51.45% for the quarter; Operating expenses: 8.69 million; EBITDA: -8.13 million; Operating income: -8.34 million; Net income: -8.25 million; EPS: -0.56; Cash and cash equivalents (as of 2024-06-30): 9.53 million; Net cash used in operating activities (Q4 2024): -6.47 million; Fiscal year 2024 total operating expenses: 27.0 million; Fiscal year 2024 net cash used in operating activities: -31.5 million; Fiscal year 2024 net loss: -29.7 million; 2024 Vyleesi annual gross product sales: 8.9 million; 2024 Vyleesi net product revenue: 4.5 million; NDA timeline: PL9643 Phase III MELODY-1 data supportive; Planned NDA filing for PL9643 in the first half of calendar year 2026; Interim data for PL8177 in UC, and ongoing ocular programs PL9588 and PL9654 progressing toward IND-enabling studies in 2025.
Income Statement
Metric
Value
YoY Change
QoQ Change
Revenue
350.00K
-80.14%
N/A
Gross Profit
180.09K
-89.14%
204.83%
Operating Income
-8.34M
22.89%
9.26%
Net Income
-8.25M
23.00%
2.20%
EPS
-0.56
38.46%
-5.66%
Key Financial Ratios
currentRatio
1.01
grossProfitMargin
51.5%
operatingProfitMargin
-2383%
netProfitMargin
-2357%
returnOnAssets
-76.8%
returnOnEquity
7400%
debtEquityRatio
-5.29
operatingCashFlowPerShare
$-0.44
freeCashFlowPerShare
$-0.44
priceToBookRatio
-245.18
priceEarningsRatio
-0.83
Net Income vs. Revenue
Expense Breakdown
Management Commentary
- Strategy and near-term catalysts: Management highlighted PL9643’s Phase III MELODY-1 results, FDA Type C meeting approvals, and an NDA filing plan for PL9643 in 1H2026. Quote: 'we are ready to complete the PL9643 Phase III program with all remaining clinical studies to be conducted and completed in calendar year 2025 and an anticipated NDA filing in the first half of calendar year 2026.' (Carl Spana, Palatin CEO)
- Obesity program and combo potential: The company is pursuing a Phase II study combining the MCR4 agonist with tirzepatide, aiming to demonstrate additive or synergistic weight-loss effects in about 60 subjects; expectations are a 2-5% weight reduction window over four weeks with a clear signal of additivity. Quote: 'The primary analysis will be a comparison of the co-administered versus tirzepatide alone... you’re going to be in that 2% to 5% range.' (Carl Spana)
- Pigmentation risk and next-gen selectivity: Palatin discussed development of next-generation MCR4 agonists with minimal or no MCR1 activity to mitigate skin darkening, a concern with earlier MCR4/MCR1 activity. Quote: 'compounds that we are in final evaluation have substantial separation between the two receptors... we don’t expect any skin darkening with those compounds.' (Carl Spana)
- Dry eye collaboration and BD efforts: Management indicated active discussions with potential corporate collaborators and funding partners to support Phase III and BD efforts for PL9643 and related ocular programs post-Type C meeting clearance.
'we are ready to complete the PL9643 Phase III program with all remaining clinical studies to be conducted and completed in calendar year 2025 and an anticipated NDA filing in the first half of calendar year 2026.'
— Carl Spana
'The primary analysis will be a comparison of the co-administered versus tirzepatide alone... you’re going to be in that 2% to 5% range.'
— Carl Spana
Forward Guidance
- Near-term catalysts include MELODY-2 and MELODY-3 Phase III dry eye trials with NDA filing targeted for H1 2026, contingent on securing financing; manufacturing activities are planned to support regulatory submission by 1H2026. - The Phase II obesity program exploring MCR4 agonist co-administration with tirzepatide is expected to enroll and complete data in Q1 2025, with IND-enabling activities for long-acting MCR4 agonists projected for 2025 and first-in-human studies in H2 2025. - Additional programs (PL9588 for glaucoma and PL9654 for retinopathies) are advancing toward IND-enabling studies in 2025, expanding Palatin’s ocular and inflammatory disease portfolio. - Palatin remains heavily reliant on external funding pipelines; the company is actively pursuing licensing and collaboration deals to fund ongoing operations and late-stage development. Key factors for investors to monitor include: financing runway and timing of partnerships, NDA progress for PL9643, trial enrollment for dry eye programs, and the advancement of obesity and ocular assets through IND-enabling studies and preclinical development.
Competitive Position
Company
Gross Margin
Operating Margin
Return on Equity
P/E Ratio
PTN Focus
51.45%
-23.83%
74.00%
-82.80%
FBIO
68.00%
-98.60%
-41.20%
-87.20%
CKPT
-1,382.17%
-1,694.83%
1.47%
-81.70%
ATXI
0.00%
0.00%
40.50%
120.79%
PIRS
-2.43%
-4.22%
-17.10%
-98.20%
Gross Profit Margin
Operating Profit Margin
Return on Equity
P/E Ratio Comparison
Investment Outlook
Given Palatin’s current cash runway, negative equity, and reliance on external partnerships, the near-term investment thesis hinges on successful monetization of late-stage assets through licensing or collaboration, and validation of the PL9643 program leading to an NDA in 1H2026. The MELODY-1 readout supports a favorable regulatory path; however, execution risk remains high due to funding needs and competitive therapeutic landscapes. Investors should monitor: (1) progress and financing milestones for PL9643’s NDA submission; (2) enrollment status and interim data for the Phase II obesity co-administration study with tirzepatide; (3) advancing IND-enabling studies for PL9588 and PL9654; and (4) ongoing BD discussions that could crystallize partnerships or financing to extend Palatin’s cash runway. A base-case scenario envisions licensing deals critical to extending development timelines and turning potential clinical success into shareholder value, but a high-risk, high-variance profile persists until capital raises or strategic collaborations are secured.
Key Investment Factors
Growth Potential
Planned NDA for PL9643 in 1H2026 based on MELODY-1 data suggests a meaningful upside if MELODY-2/3 corroborate efficacy. The ocular franchise (PL9643, PL9588, PL9654) targets large, underserved dry eye and retinopathy markets with multipronged advantages (tolerability, rapid onset, broad symptom improvement) that could drive licensing deals and collaboration opportunities.
Profitability Risk
Liquidity and funding risk given net cash burn and negative stockholders’ equity; dependence on successful partnerships to fund late-stage development; regulatory risk for NDA filings and potential safety constraints; market risk from competition with established GLP-1 obesity therapies and existing dry eye treatments.
Financial Position
As of 2024-06-30, cash and cash equivalents were 9.53 million against total liabilities of 10.85 million and total assets of 10.74 million, yielding negative stockholders’ equity of -$111.5 thousand with accumulated deficit (retained earnings) of -$441.8 million. FY2024 net cash used in operations was -$31.5 million, and FY2024 net loss was -$29.7 million, highlighting ongoing cash burn despite a one-time gain on Vyleesi sale that reduced operating expenses for the year.
SWOT Analysis
Strengths
Diversified melanocortin portfolio spanning ocular (PL9643/PL9588/PL9654), obesity (MCR4), and sexual dysfunction (bremelanotide) with multiple near-term catalysts.
MELODY-1 dry eye Phase III results indicating broad symptom improvement and rapid onset (2 weeks) with tolerability advantages, supporting NDA readiness for 1H2026.
Active BD discussions and potential licensing partnerships for dry eye and obesity programs, increasing optionality for value realization.
Past Vyleesi asset sale demonstrates Palatin’s ability to monetize non-core assets while preserving rights in obesity indications, potentially funding pipelines.
Weaknesses
Net liquidity constrained: Q4 2024 saw no product sales; FY2024 cash burn persists with -$31.5 million operating cash flow.
Negative stockholders’ equity and a large accumulated deficit (retained earnings -$441.8 million) indicating a fragile balance sheet and need for external funding.
Heavy reliance on external financing and collaborations to advance late-stage programs; no guaranteed access to capital markets on favorable terms at present.
Opportunities
NDA filing for PL9643 could unlock licensing upside and royalty streams in the $30B dry eye market trajectory by 2030 supported by MELODY-1 results.
Obesity program with tirzepatide may create a differentiated combination approach that could appeal to partners seeking safer, additive weight-loss regimens.
IND-enabling progress for PL9588 (glaucoma) and PL9654 (retinopathies) could broaden the addressable ophthalmology market and attract BD interest.
Interim data from PL8177 ulcerative colitis and ongoing collaborations may generate near-term partnerships and co-development deals.
Threats
Regulatory risk surrounding NDA timelines and potential safety outcomes; reliance on securing financing could slow or derail late-stage development.
Competitive pressure from established obesity therapies (GLP-1 class) and a crowded ocular market with existing treatments; success depends on differentiating product profiles and obtaining favorable trial outcomes.
Macro uncertainty in biotech funding cycles, especially for small-cap names with high burn and no current product revenue beyond legacy Vyleesi arrangements.