Executive Summary

Strong first full quarter of EKTERLY commercialization: net product revenue of $13.7M, up from $1.4M in the prior quarter, with 937 patient start forms through Oct 31 and 423 unique prescribers, indicating rapid initial uptake in U.S. HAE patients .
Expense mix shifting to commercialization: SG&A rose to $46.5M (vs. $44.7M prior quarter; $24.8M YoY), while R&D declined to $12.0M (vs. $15.2M prior quarter; $18.7M YoY), reflecting launch investments and lower clinical trial spend .
Balance sheet strengthened: cash, cash equivalents and marketable securities of $309.2M; management expects this, plus EKTERLY revenues, to fund operations through profitability; a $144M convertible note offering closed ahead of the quarter’s report .
Ex-U.S. momentum: Germany launch initiated with initial orders; approvals in EU, Switzerland, Australia; U.K. pricing/reimbursement underway targeting 1H26; Japan launch targeted for Q1 2026 via partner Kaken .
Estimates: S&P Global consensus not available; CFO highlighted a wide dispersion with “over a threefold gap,” suggesting models may require recalibration given early mix of high-burden patients and evolving gross-to-net/access dynamics .

What Went Well and What Went Wrong

What Went Well

Commercial traction: “The US launch of EKTERLY is progressing with significant momentum,” supported by 937 start forms and 423 unique prescribers; repeat prescribers comprise 75% of start forms, with refills every 3–4 weeks among high-burden patients .
Clinical/medical momentum: New data at ACAAI showed 84% attack-level satisfaction in switchers to sebetralstat and interim pediatric results with median 30-minute time-to-dosing and 1.5-hour symptom relief, bolstering the usage case and future pediatric opportunity .
Liquidity runway: $309.2M in cash/investments and management commentary that funding extends through profitability, enabled by the recent $144M convertible notes, supports ongoing commercial build and ex-U.S. launches .

What Went Wrong

Bottom line still deeply negative during launch build: Net loss of $(49.5)M (EPS $(0.92)) despite strong initial revenue, with SG&A at $46.5M as commercial infrastructure scales .
Gross-to-net at low end of expectations (seasonal): CFO cited gross-to-net at the lower end of the expected range due to lower copay utilization typical for this time of year, highlighting near-term variability in realized revenue conversion .
Short-term cadence risks: Management flagged potential seasonal slowdown in patient visits during the holiday period, which could temporarily moderate PSF growth and demand in 4Q25, adding near-term volatility to quarterly revenue trajectories .

Financial Results

Income Statement – Key Metrics (oldest → newest)

Metric	Q3 2024 (3 mo ended Sep 30, 2024)	Q1 2026 (3 mo ended Jul 31, 2025)	Q3 2025 (3 mo ended Sep 30, 2025)
Net Product Revenue ($M)	$0.0	$1.4	$13.7
Cost of Revenue ($M)	n/a	$0.6	$1.2
Gross Profit ($M)	n/m	$0.8 (calc; 1.4–0.6)	$12.5 (calc; 13.7–1.2)
Gross Margin %	n/m	~58.6% (calc)	~91.0% (calc)
R&D ($M)	$18.7	$15.2	$12.0
SG&A ($M)	$24.8	$44.7	$46.5
Total OpEx ($M)	$43.5	$60.4	$59.7
Operating Loss ($M)	$(43.5)	$(59.0)	$(46.1)
Net Loss ($M)	$(39.1)	$(60.1)	$(49.5)
EPS (Basic & Diluted)	$(0.84)	$(1.12)	$(0.92)
Consensus Revenue ($M)	N/A (S&P Global consensus unavailable)	N/A (S&P Global consensus unavailable)	N/A (S&P Global consensus unavailable)
Consensus EPS	N/A (S&P Global consensus unavailable)	N/A (S&P Global consensus unavailable)	N/A (S&P Global consensus unavailable)

Notes: n/m = not meaningful given zero revenue in the YoY period; “calc” indicates derived from cited line items.

Balance Sheet and Liquidity (point-in-time)

Metric	Dec 31, 2024	Jul 31, 2025	Sep 30, 2025
Cash, Cash Equivalents & Marketable Securities ($M)	$268.3	$191.5	$309.2
Long-term Liabilities ($M)	$104.3	$136.3	$277.9
Stockholders’ Equity ($M)	$164.4	$40.8	$17.0

Commercial KPIs

KPI	Prior Period	Current Quarter / Latest
Patient Start Forms (PSFs)	460 through Aug 29, 2025	937 through Oct 31, 2025
Unique Prescribers	253 through Aug 29, 2025	423 through Oct 31, 2025
Refill Cadence (early)	Not disclosed	Every 3–4 weeks among high-burden patients (early data)
Payer Access	Medical exceptions beginning; early paid shipments	Formal coverage policies progressing; broader policies targeted early 2026
Ex-U.S.	CHMP positive; UK approved; EU/pending	Germany launched; approvals in EU/Switzerland/Australia; UK H1’26; Japan 1Q’26

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
SG&A trajectory	Remainder of 2025	Not explicitly guided	“Expect SG&A to remain relatively consistent” as EKTERLY global launch investment continues	New qualitative view
Liquidity runway	Multi-year	“Runway into 2027” as of July quarter	“Funded through profitability” given $309M cash plus EKTERLY revenues (post convert)	Upgraded framing (runway → through profitability)
U.S. market access	Early 2026	NA	Formal coverage with PBMs/major payers targeted early 2026	Operational milestone timing
Ex-U.S. launch timing	2025–2026	EU approval decision expected Oct 2025	Germany launched (Oct), U.K. launch targeted 1H26; Japan 1Q26 (Kaken)	Progressed to execution

No quantitative revenue/EPS guidance was provided. Management also noted potential seasonal moderation in PSF growth in Nov–Dec .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q-2 and Q-1)	Current Period (Q3 2025)	Trend
Early demand/PSFs	460 PSFs through Aug 29; breadth across prophylaxis users; initial paid shipments via medical exception	937 PSFs through Oct 31; 423 unique prescribers; 75% PSFs from repeat prescribers; refills every 3–4 weeks in high-burden cohort	Accelerating adoption; deepening utilization
Payer access	Medical exceptions; parity expected vs branded on-demand; occasional step-through for icatibant manageable	Policies forming across regional/national payers; target broad formal access early 2026	Moving from exceptions → formal coverage
Gross-to-net	Not disclosed	At low end of range this quarter due to seasonal copay dynamics	Near-term headwind; expected to evolve
Inventory/stocking	SPs stocking as network expands; 2–4 weeks inventory typical over time	SPs added locations; disciplined build; not at steady-state yet	Normalizing over time
Ex-U.S.	EU decision expected; UK approved; staged EU launch planned	Germany launch; UK HTA underway for 1H26; Japan 1Q26 with Kaken	Transitioning from regulatory to commercial
Clinical momentum	KONFIDENT-S data; laryngeal, adolescents, LTP patients	High satisfaction (84%); pediatric interim: median 30-min to dose, 1.5h to relief	Expanding real-world/age-segment evidence
Seasonality/macro	NA	Potential Q4 holiday slowdown in visits/PSFs	Transient demand cadence risk

Management Commentary

“Demand for EKTERLY is strong… We continue to believe that EKTERLY will evolve to become the foundational treatment for HAE.” – CEO Ben Palleiko .
“In less than four months since launch, we have received 937 start forms… We have 423 unique prescribers and continue to add three to four new prescribers each day.” – CCO Nicole Sweeny .
“Gross to net… came in toward the low end of our expected range this quarter, driven largely by lower copay utilization typical for this time of year.” – CFO Brian Piekos .
“With our recent convertible note offering, we are fully financed through profitability.” – CEO Ben Palleiko .

Q&A Highlights

Early adopter mix: Roughly half of switches self-report ≥2 attacks/month; higher refills and multi-carton shipments tied to this high-burden cohort, expected to normalize as adoption broadens .
Access/quantity limits: Quantity limits consistent with branded peers; not impeding access; medical exceptions broadly approved across PBMs/large payers; formal payer policies targeted early 2026 .
Seasonality: Management expects potential slowing in Nov–Dec due to holiday season effects on physician visits, with fundamentals for 2026 demand viewed as strong .
International: German price not disclosed; UK targeted for 1H26 launch; broader EU rollouts toward late 2026; Japan approval/launch planned for early 2026 with Kaken .
Gross-to-net/inventory: GtN at low end of range this quarter on seasonal factors; SP inventory building in a disciplined manner as network expands .

Estimates Context

S&P Global consensus estimates for revenue/EPS were not available for this analysis window; as such, we cannot determine beat/miss versus Wall Street at this time. Management noted that published estimates currently span “over a threefold gap,” reflecting modeling uncertainty early in the launch and a fiscal-to-calendar reporting transition .
Implication: Expect sell-side models to recalibrate for (i) high-burden patient mix driving higher initial refills/cartons, (ii) evolving gross-to-net, (iii) policy-driven access ramp in early 2026, and (iv) ex-U.S. contribution as Germany and subsequent geographies come online .

Key Takeaways for Investors

Demand narrative confirmed: Early U.S. uptake metrics (PSFs, prescribers, refills) and repeat prescribing indicate strong product-market fit for the first oral on-demand HAE therapy; this is the principal stock driver near term .
Operating leverage ahead: Gross margin implied ~91% this quarter, while SG&A is near peak as the company invests for the launch; operating losses should narrow as access normalizes and utilization expands beyond high-burden patients .
Access catalysts: Transition from medical exceptions to formal payer policies in early 2026 should improve predictability of gross-to-net and revenue conversion; track coverage bullets from major PBMs and nationals .
Ex-U.S. optionality: Germany launch is a proof point; U.K. 1H26 and Japan 1Q26 are next; EU scale-up later in 2026 adds to the multi-year growth runway .
Liquidity and risk: $309M cash and recent convert support a self-funded path “through profitability,” reducing financing overhangs during the commercialization ramp .
Modeling watchpoints: Near-term holiday seasonality, refills/carton size normalization as mix broadens, evolving GtN, and SP stocking dynamics can add quarterly volatility; focus on PSF growth, paid conversion rate, and policy milestones .
Clinical expansion: High satisfaction and pediatric interim data reinforce broader use cases and future label/market expansion potential, supporting a durable franchise thesis .

Sources

Q3 2025 8-K/Press Release and financials:
Q3 2025 Earnings Call Transcript (prepared remarks and Q&A): and parallel transcripts
Prior quarters for trend: Sep 11, 2025 8-K/Press Release (Q1 2026): and associated call
Other relevant Q3 2025 period press releases: ACAAI data and presentations ; conference participation ; October data updates .

Note on estimates: S&P Global consensus data were unavailable at the time of retrieval; management cited a wide dispersion in published models .

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