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Kodiak Sciences Inc. (KOD)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 net loss improved year over year: $(45.1)M vs. $(80.2)M in Q2 2023; diluted EPS $(0.86) vs. $(1.53) driven primarily by lower R&D tied to reduced tarcocimab manufacturing and clinical activities .
  • Cash and equivalents were $219.2M with runway reiterated “into 2026” .
  • Clinical execution advanced: GLOW2 (DR) completed site activations and continues accelerated screening/randomizations; DAYBREAK (wet AMD) is now actively enrolling with parallel tarcocimab and KSI-501 arms vs aflibercept; KSI-101 APEX Phase 1b was activated and is enrolling .
  • Near-term catalysts: continued enrollment updates for GLOW2/DAYBREAK and APEX; management scheduled an Investor Day on September 23, 2024 to provide program updates .

What Went Well and What Went Wrong

What Went Well

  • Clinical momentum: “The DAYBREAK Phase 3 study is now actively enrolling patients,” with GLOW2 also accelerating screenings and randomizations; APEX (KSI-101) was activated and is enrolling .
  • Expense discipline: R&D fell to $32.5M from $67.0M YoY; management attributed the decline “primarily [to] reduced manufacturing and clinical activities for tarcocimab” .
  • Liquidity visibility: Cash of $219.2M; management reiterated “current cash will support…operations into 2026” .

What Went Wrong

  • Pre-revenue losses continue: Q2 2024 net loss $(45.1)M; sequentially wider vs Q1 2024 $(43.0)M, reflecting ongoing clinical investment despite lower YoY R&D .
  • Interest income down YoY (Q2 2024 $3.0M vs $4.7M) as average cash balances decline, modestly offsetting operating losses less than in the prior year .
  • Regulatory and execution dependency persists: approvals hinge on successful pivotal outcomes (e.g., GLOW2, DAYBREAK) as emphasized in forward-looking statements and program descriptions .

Financial Results

Income statement highlights (oldest → newest):

MetricQ2 2023Q4 2023Q1 2024Q2 2024
Research & Development ($M)$67.0 $46.6 $29.9 $32.5
General & Administrative ($M)$17.9 $16.7 $16.1 $15.5
Total Operating Expenses ($M)$84.8 $63.4 $46.1 $48.0
Loss from Operations ($M)$(84.8) $(63.4) $(46.1) $(48.0)
Interest Income ($M)$4.7 $3.9 $3.4 $3.0
Other Income (Expense), net ($M)$(0.04) $(0.04) $(0.34) $(0.09)
Net Loss ($M)$(80.2) $(59.5) $(43.0) $(45.1)
Diluted EPS ($)$(1.53) $(1.13) $(0.82) $(0.86)

Balance sheet and cash runway:

MetricQ4 2023Q1 2024Q2 2024
Cash & Cash Equivalents ($M)$285.5 $245.9 $219.2
Working Capital ($M)$247.6 $226.7 $203.4
Total Stockholders’ Equity ($M)$265.8 $241.2 $214.5
Cash Runway GuidanceInto 2026 Into 2026 Into 2026

Estimates vs. actuals (S&P Global consensus):

MetricQ2 2024 ActualQ2 2024 ConsensusBeat/Miss
Revenue ($M)Not reported (pre-revenue) Unavailable via S&P Global (data not retrievable)N/A
Diluted EPS ($)$(0.86) Unavailable via S&P Global (data not retrievable)N/A

Notes: Kodiak presents only operating expenses and losses; no product or collaboration revenue was reported for the quarter, as indicated by statements of operations listing operating expenses and loss from operations equal to total operating expenses .

Segment breakdown: Not applicable (no commercial revenue) .

KPIs (operational and P&L):

KPIQ4 2023Q1 2024Q2 2024
R&D Stock-based Comp ($M)$11.9 $8.7 $8.9
G&A Stock-based Comp ($M)$10.9 $9.7 $9.4
Studies Actively Enrolling—GLOW2 (DR) GLOW2 (DR); DAYBREAK (wet AMD); APEX (KSI-101)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayMulti-year“Into 2026” (Q4’23, Q1’24) “Into 2026” (Q2’24) Maintained
DAYBREAK (Phase 3) Status2024“On track to activate mid-2024” (Q1’24) “Now actively enrolling patients” (Q2’24) Progressed
GLOW2 (Phase 3) Status2024Recruiting/actively enrolling (Q4’23/Q1’24) Site activations completed; accelerated screenings/randomizations (Q2’24) Progressed
KSI-101 APEX (Phase 1b)2024“Initiate enrollment in June 2024” (Q1’24) “Activated and enrolling patients” (Q2’24) Progressed

No revenue, margin, OpEx, OI&E, tax rate, or dividend guidance ranges were provided beyond operating updates and cash runway .

Earnings Call Themes & Trends

Note: We found no Q2 2024 earnings call transcript in our database after searching for “earnings-call-transcript” for the July–September 2024 window (0 documents returned) [ListDocuments result]. We instead track themes from Q4 2023, Q1 2024, and Q2 2024 press materials.

TopicPrevious Mentions (Q4’23, Q1’24)Current Period (Q2’24)Trend
R&D execution/pipelinePlan to run GLOW2 and DAYBREAK; KSI-101 pivotal path discussed; KSI-501 Phase 3 plan; manufacturing readiness DAYBREAK actively enrolling; GLOW2 screenings/randomizations accelerating; APEX activated/enrolling Improving execution cadence
Regulatory interactionsFDA feedback on bridging to go‑to‑market formulation; alignment on GLOW2; DAYBREAK design discussions DAYBREAK operationalized; both pivotal studies using enhanced 50 mg/mL formulations From planning to enrollment
Manufacturing (URSUS)Go-to-market formulation released; Ursus commissioned and batches released New leadership appointments support commercial-facing manufacturing activities Organizational build-out
Cash runway/financingCash into 2026 reiterated Cash into 2026 reiterated with $219.2M cash Stable
Competitive/macroPositioning for durability and multi-biology targeting (IL‑6/VEGF) CEO noted disappointments in competing long-acting DR therapies; emphasizes KOD differentiation and prevention/treatment in DR Opportunity amid mixed competitor data
Safety/platformFavorable platform safety reiterated; ARVO data across programs Continued safety narrative; enhanced formulations balancing durability/immediacy Consistent

Management Commentary

  • “Our three clinical programs of tarcocimab, KSI-501 and KSI-101 are making strong operational progress…DAYBREAK…is now actively enrolling patients…APEX…is now enrolling patients.” — Victor Perlroth, CEO .
  • On staffing and readiness: “We…strengthened our executive team…[CSO, CQO, CTO, CMO]…support Kodiak’s commercial-facing manufacturing activities…[and] BLA-facing clinical activities…” .
  • On GLOW2/DAYBREAK design and vision: Both studies use enhanced 50 mg/mL formulations “intended to balance durability and immediacy” to strengthen competitive position and regulatory package in wet AMD and DR .
  • On cash: “We believe that our current cash will support our current and planned operations into 2026.” .
  • On competitive context in DR: “Competing long-acting retinal therapies in development have posted disappointing…results…GLOW1…achieved…treating existing disease and preventing disease progression.” — CEO .

Q&A Highlights

We did not find a Q2 2024 earnings call transcript for Kodiak Sciences in our database (0 results for “earnings-call-transcript” in the July–September 2024 window). As a result, Q&A themes and guidance clarifications are unavailable for this period based on our sources [ListDocuments result].

Estimates Context

  • We attempted to retrieve S&P Global consensus estimates for Q2 2024 EPS and revenue but could not due to provider rate limits; thus consensus was unavailable at the time of analysis. Consequently, we cannot quantify beats/misses vs. S&P Global consensus for Q2 2024. KOD remains pre-revenue; GAAP diluted EPS was $(0.86) .

Key Takeaways for Investors

  • Execution inflection: With DAYBREAK and GLOW2 enrolling and APEX activated, the story shifts from planning to execution across three programs—these are the central stock catalysts into 2025 .
  • DR strategy: GLOW2 mirrors successful GLOW1 with an added third loading dose; if successful, GLOW2 could be one of two pivotal studies underpinning tarcocimab’s DR marketing application, a potential path to first approval .
  • Wet AMD positioning: DAYBREAK’s parallel arms (tarcocimab and KSI‑501 vs aflibercept) are designed to address durability (tarcocimab) and potential efficacy differentiation via IL‑6/VEGF dual inhibition (KSI‑501) .
  • Balance sheet runway: $219.2M cash with runway into 2026 provides capacity to reach key readouts without near-term financing, though outcomes remain pivotal-dependent .
  • Expense profile: R&D down materially YoY with continued sequential discipline; sustained investment will track trial enrollment velocity and pivotal study requirements .
  • Competitive backdrop: Management highlights disappointing DR data from competing long-acting agents, potentially improving tarcocimab’s relative positioning if GLOW2 succeeds .
  • Watch list: Enrollment updates, protocol/regulatory disclosures, safety/efficacy signals at medical meetings, and the September 23 Investor Day for deeper visibility into timelines and differentiation .

Citations

  • Q2 2024 8-K and press release with financials and operations: ; .
  • Q1 2024 8-K and press release: ; .
  • Q4 2023 8-K: .
  • ARVO and GLOW2 press releases: .
  • Earnings call transcript availability (none found in period): ListDocuments query returned 0 for “earnings-call-transcript” (July–September 2024).