Executive Summary

Q3 2024 featured continued execution on the DEE strategy: Longboard initiated the Phase 3 DEEp SEA Study in Dravet syndrome, received a positive EMA PDCO opinion on its Paediatric Investigation Plan down to age 2, and secured FDA Orphan Drug and Rare Pediatric Disease designations for bexicaserin in Dravet .
Financially, cash, cash equivalents and short-term investments were $288.4M; operating expenses rose on program scaling (R&D $21.45M, G&A $6.67M, including ~$0.7M merger-related costs), producing a net loss of $24.54M and EPS of -$0.63 .
EPS missed third-party consensus by $0.05 (actual -$0.63 vs. -$0.58) as tracked by Nasdaq; S&P Global consensus was unavailable, limiting formal estimate comparisons. Bold miss: EPS miss of $0.05 vs. third-party consensus .
A key external catalyst: Lundbeck agreed on Oct 14, 2024 to acquire Longboard for $60/share (~$2.6B equity value), framing investor expectations around bexicaserin’s late-stage potential and integration prospects .

What Went Well and What Went Wrong

What Went Well

Initiated late-stage development: Global Phase 3 DEEp SEA (Dravet) began, advancing the DEE franchise to pivotal trials as planned .
Regulatory momentum: EMA PDCO positive opinion for the PIP (down to age 2), plus FDA Orphan Drug and Rare Pediatric Disease designations for bexicaserin in Dravet, strengthening probability of expedited pathways and potential priority review voucher economics .
Clinical durability: The PACIFIC OLE interim continued to demonstrate sustained seizure reduction and favorable tolerability over ~9 months across DEEs, supporting the Phase 3 risk profile .
Management tone: “The PACIFIC Data and Breakthrough Therapy designation have been the most rewarding achievement since the founding of Longboard…We are expeditiously preparing to start our Phase III program” – Kevin R. Lind, CEO (Q2 call) .

What Went Wrong

Earnings miss and heavier OpEx: EPS of -$0.63 missed third-party consensus by $0.05; R&D rose 105% YoY to $21.45M and G&A rose 116% YoY to $6.67M (including ~$0.7M merger-related costs), reflecting scaling and corporate actions .
Pre-revenue profile persists: No revenue line item; losses widened with the transition toward Phase 3 and expanded team/infrastructure .
LP659 regulatory overhang: On Q2 call, management noted a partial clinical hold remained pending a complete response and MAD proposal, a lingering risk as development advances .

Financial Results

P&L and Cash Position (oldest → newest)

Metric	Q1 2024	Q2 2024	Q3 2024
Total Cash, Cash Equivalents & Short-term Investments ($USD Millions)	$321.0	$304.9	$288.4
Research & Development Expense ($USD Millions)	$13.17	$20.45	$21.45
General & Administrative Expense ($USD Millions)	$4.94	$5.20	$6.67
Total Operating Expenses ($USD Millions)	$18.11	$25.64	$28.12
Interest Income, net ($USD Millions)	$3.13	$3.91	$3.66
Net Loss ($USD Millions)	$(14.99)	$(21.79)	$(24.54)
Diluted EPS ($USD)	$(0.42)	$(0.56)	$(0.63)

Year-over-Year Comparison (Q3 2024 vs. Q3 2023)

Metric	Q3 2023	Q3 2024
Research & Development Expense ($USD Millions)	$10.49	$21.45
General & Administrative Expense ($USD Millions)	$3.09	$6.67
Net Loss ($USD Millions)	$(12.93)	$(24.54)
Diluted EPS ($USD)	$(0.55)	$(0.63)

EPS vs. Estimates (S&P Global unavailable)

Metric	Q3 2024
EPS Actual ($USD)	$(0.63)
EPS Consensus ($USD)	$(0.58)
Surprise ($USD)	$(0.05)

Note: S&P Global consensus estimates were unavailable for LBPH during Q3 2024; third-party consensus is provided for context .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Bexicaserin Phase 3 Initiation (Dravet/DEE program)	H2 2024	“Phase 3 initiation expected in H2 2024”	“Recently initiated Phase 3 global DEEp SEA Study (Dravet; ages 2–65)”	Executed (raised from plan to action)
Cash Runway	Through 2027	“Runway…into 2027” (as of 6/30/24)	No update provided in Q3 PR	Maintained (no change communicated)
EMA PDCO Paediatric Investigation Plan	2024	Not previously disclosed	Positive PDCO opinion for PIP down to age 2	New
FDA Orphan & Rare Pediatric Disease (Dravet)	2024	Not previously disclosed	Designations granted for bexicaserin in Dravet	New

Earnings Call Themes & Trends

Topic	Previous Mentions (Q1 & Q2)	Current Period (Q3 2024)	Trend
R&D Execution (Bexicaserin)	Q1: Phase 3 expected YE 2024 ; Q2: Phase 3 expected H2 2024; EoP2 completed; BTD granted	Initiated Phase 3 DEEp SEA (Dravet)	Accelerating on plan
Regulatory/Legal	Q2: FDA BTD for DEEs ≥ age 2; global regulator alignment ongoing	EMA PDCO positive PIP; Orphan & Rare Pediatric Disease designations (Dravet)	Regulatory momentum improving
PACIFIC OLE data	Q1: OLE data expected H2 2024 ; Q2: OLE interim sustained efficacy/safety	OLE interim continues to show durable reduction over ~9 months	Consistent supportive signal
Financial Runway	Q1: ~$321.0M cash/investments ; Q2: ~$304.9M and runway to 2027	~$288.4M as of 9/30/24	Cash trending lower with program scale, runway intact (per Q2)
LP659 Program	Q2: SAD showed safety and dose/formulation-dependent ALC reductions; partial clinical hold pending resolution ahead of MAD in Q1 2025	No new formal update in Q3 PR	Await MAD resolution; ongoing risk

Note: No Q3 2024 earnings call transcript was available in our document set; this table leverages Q2 call insights plus Q3 press release updates .

Management Commentary

“We are expeditiously preparing to start our Phase III program…include 2 pivotal studies, one for Dravet syndrome and 1 DEE study that will include Lennox-Gastaut and all the other DEEs.” – Kevin R. Lind (Q2 call) .
“The PACIFIC Data and Breakthrough Therapy designation have been the most rewarding achievement since the founding of Longboard…both support our thesis…to treat DEEs broadly and provide more equitable access…” – Kevin R. Lind (Q2 call) .
“LP659 was generally safe and well tolerated…[with] a dose- and formulation-dependent lymphocyte reduction in healthy volunteers.” – Dr. Randall Kaye (Q2 call and Q2 8-K) .

Q&A Highlights

Phase 3 design and global regulator alignment: Management deferred detailed sizing/DEE mix to a dedicated R&D event; indicated constructive dialogue globally and FDA BTD setting precedent for other agencies .
DEE market sizing: Team emphasized a large opportunity while working to avoid double-counting and account for evolving diagnoses; more specifics promised later .
LP659 formulation and safety: MAD will use a formulation with better plasma exposure and lower variability; SAD showed significant ALC reduction without cardiac/ECG issues or infections; ocular/pulmonary profiles were clean in SAD, with caveats given single-dose setting .
Partial clinical hold: Still in place at Q2; company plans a complete response tied to MAD proposal to resolve .

Estimates Context

S&P Global consensus estimates were unavailable for LBPH for Q3 2024, limiting formal comparisons.
Third-party trackers indicated EPS -$0.63 vs. consensus -$0.58 (miss $0.05) for Q3 2024; revenue estimates not meaningful for a pre-revenue profile .
Given increased OpEx from Phase 3 initiation and corporate actions, near-term street models may need to reflect higher R&D/G&A trajectories and incorporate merger-related costs .

Key Takeaways for Investors

Bexicaserin’s DEE strategy is de-risking: initiation of Phase 3 (Dravet) and positive pediatric/regulatory steps support trial viability and potential acceleration paths .
Near-term financials will reflect scaling: R&D and G&A will likely remain elevated as Phase 3 enrolls and organizational build-out continues; interest income partially offsets but losses should widen near term .
Earnings optics: EPS missed third-party consensus by $0.05; with S&P estimates unavailable, watch for models to rebase OpEx, especially given merger-related spend .
Corporate catalyst: Lundbeck’s $60/share acquisition proposal (Oct 14) reframes valuation around late-stage bexicaserin; integration and regulatory execution will drive subsequent milestones and potential 2028 launch timelines per acquirer commentary .
Risk watch: LP659’s partial clinical hold resolution and MAD initiation remain gating events; any delays could modestly affect the secondary asset’s timeline .
Fundamental narrative: Continued OLE durability and broad DEE inclusion strengthen the strategic case; regulatory tailwinds (BTD, Orphan/RPD, PDCO) are supportive, though final outcomes depend on Phase 3 data and regulatory interpretations .
Trading lens: Expect stock reactions to be driven by regulatory/milestone headlines (Phase 3 enrollment pace, EMA decisions, acquisition steps) and any new clinical data disclosures; near-term EPS/OpEx prints are secondary to pipeline progress .

Source Documents Read in Full

Q3 2024 8-K 2.02 and attached press release and financial tables .
Q2 2024 earnings call transcript .
Q2 2024 8-K press release and corporate presentation excerpts .
Q1 2024 8-K press release .
Related external confirmations (acquisition terms; third-party EPS consensus/miss; EMA PDCO decision references) .

Longboard Pharmaceuticals, Inc. (LBPH)·Q3 2024 Earnings Summary