Executive Summary

Q2 2025 revenue beat consensus while EPS missed: $1.03M vs $0.49M consensus (+$0.54M), EPS $(1.23) vs $(1.10) consensus; EBITDA was below consensus (actual $(128.2)M vs $(115.9)M). Management highlighted continued FDA engagement with a 9/25/2025 PDUFA for PALSONIFY (paltusotine) and reiterated commercial readiness *.
Cash, cash equivalents and investments were $1.20B, supporting runway into 2029; CFO narrowed FY25 net cash used in operations guidance to $340–$370M (from $340–$380M) and flagged a higher H2 burn as trials and commercialization ramp .
Operating expenses rose sharply YoY as R&D and SG&A scaled for multiple late-stage programs and launch build-out, driving a wider net loss of $(115.6)M vs $(74.1)M YoY .
Near-term stock catalysts: PDUFA decision (9/25), Phase 3 initiations (carcinoid syndrome, adult/pediatric CAH), and continued payer/formulary progress; management emphasized launch cadence will be gradual given visit frequency and payer timelines .

What Went Well and What Went Wrong

What Went Well

Paltusotine NDA review “on track” with continued, productive FDA engagement; EMA MAA validated with potential EMA decision in H1 2026 .
Commercial build-out nearly complete; ~30 sales reps targeted; pre-approval payer discussions receptive to value proposition (faster disease control, lower burden, improved adherence) .
Strong cash balance of $1.20B and extended runway “into 2029,” enabling parallel execution across late-stage programs and launch prep .
- Quote: “Overall, Crinetics is in the strongest position in its history, with unprecedented momentum… and a clear path toward delivering transformative therapies to patients.” — CEO Scott Struthers .
- Quote: “We are more confident than ever in the long term potential for PALSONIFY to become the preferred treatment for the acromegaly community.” — CCO Isabel Kalofonos .

What Went Wrong

EPS missed consensus (actual $(1.23) vs $(1.10)), and EBITDA underperformed estimates (actual $(128.2)M vs $(115.9)M), reflecting heavier spend into R&D and SG&A *.
Operating expenses surged YoY (R&D $80.3M vs $58.3M; SG&A $49.8M vs $24.8M) as clinical programs and commercial readiness scaled, widening net loss to $(115.6)M (vs $(74.1)M YoY) .
Launch pace expected to be gradual (patients see endos 2–4x/yr; formulary placement 6–9 months), tempering near-term revenue ramp clarity; distribution will be closed and data blocked from services like IQVIA, limiting external tracking at launch .

Financial Results

Quarterly Results (oldest → newest)

Metric	Q2 2024	Q1 2025	Q2 2025
Revenue ($USD Millions)	$0.40	$0.36	$1.03
Net Loss ($USD Millions)	$(74.06)	$(96.77)	$(115.64)
Net Loss per Share (EPS) ($USD)	$(0.94)	$(1.04)	$(1.23)
Loss from Operations (EBIT) ($USD Millions)	$(82.78)	$(111.41)	$(129.11)
EBIT Margin %	-20,751%	-30,861%	-12,529%

Notes: EBIT margin % computed from Loss from Operations ÷ Revenue; citations reference source values.

Operating Expenses and Balance Sheet

Metric	Q2 2024	Q1 2025	Q2 2025
R&D Expense ($USD Millions)	$58.34	$76.24	$80.30
SG&A Expense ($USD Millions)	$24.84	$35.53	$49.84
Cash, Cash Equivalents & Investments ($USD Millions)	—	$1,274.12	$1,196.36
Working Capital ($USD Millions)	—	$1,233.74	$1,148.87

Q2 2025 Actual vs Wall Street Consensus (S&P Global)

Metric	Actual	Consensus	Surprise
Revenue ($USD)	$1,031,000	$485,790*	+$545,210 (Beat)
EPS ($USD)	$(1.23)	$(1.0988)*	$(0.1312) (Miss)
EBITDA ($USD)	$(128,152,999.99)*	$(115,930,800)*	$(12,222,200) (Miss)

Values marked with * retrieved from S&P Global consensus estimates.

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Net Cash Used in Operations ($USD)	FY 2025	$340M–$380M	$340M–$370M	Lowered high end
Cash Runway	Multi-year	Into 2029	Into 2029	Maintained
H2 Cash Burn Cadence	2H 2025 vs 1H	Not specified	Higher H2 vs H1	New qualitative color

No revenue/EPS guidance provided; management declined to comment on consensus and has not guided launch metrics .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q4 2024)	Previous Mentions (Q1 2025)	Current Period (Q2 2025)	Trend
Regulatory/legal (FDA/EMA)	NDA accepted; PDUFA 9/25; EMA filing imminent	FDA review on track; EMA MAA validated + ODD	FDA review “on track”; EMA MAA validated; EMA decision H1 2026	Consistent progress
Commercial readiness	Hiring CCO; building U.S./EU org	~30 reps planned; HCP/payer engagement; CrinetiCARE hub	Sales force onboarding; closed distribution; gradual ramp expectations	Execution maturing
Payer access/prior auth	Positive value proposition early	PA expected to reflect label; no step therapy anticipated	Continued payer receptivity; pricing unannounced	Steady progress
R&D execution (CAH)	Phase 2 positive; adult/ped Phase 3 planning	Adult Phase 3 composite endpoint; pediatric seamless II/III plan	Cohort 4 fully enrolled; adult Phase 3 “locked”; pediatric II/III design detailed	Advancing
Cushing’s syndrome	Early normalization of UFC data at NIH	Seamless II/III design proposed	Rapid UFC normalization in ~10-day NIH treatment; Phase II/III timing clarified	Positive early signals
Product performance (Acromegaly)	Strong PATHFNDR results	OLE data durability to 96 weeks; symptom control	ENDO 2025 OLE durability + symptom burden reductions presented	Reinforced evidence
International strategy	EU hub in Switzerland; Germany focus	EMA validated; Brazil considered	EMA timeline; EU launch prep continues	Building footprint

Management Commentary

“We continue to make significant progress towards our goal of becoming a fully-integrated, commercial-stage company… As we approach our PDUFA date, our interactions with the FDA remain on track.” — CEO Scott Struthers .
“Healthcare professionals were impressed with new data… showing PALSONIFY maintained control of IGF‑1 and symptoms through 96 weeks; and post hoc analysis demonstrated improved symptom stability vs injectable SRLs.” — CCO Isabel Kalofonos .
“Cohort four is now fully enrolled with 10 patients… we intend to share full data in early 2026.” — CMO Dana Pizzuti .
“We are lowering the high end of our guidance for net cash used in operations… now expect $340M to $370M… H2 burn will be higher than H1.” — CFO Tobin Schilke .

Q&A Highlights

Consensus and launch metrics: Management declined to comment on consensus; reiterated comfort with launch preparation and FDA progress .
Distribution and data visibility: Launch to use a closed distribution system with data blocked from broad reporting services like IQVIA .
Pricing and payer flexibility: Pricing to be discussed post-approval; payers receptive to value proposition and burden reduction vs SRLs .
CAH program details: Adult Phase 3 protocol “locked”; low expected placebo response; composite endpoint targets normal A4 with physiologic GC; pediatric seamless II/III design includes dose-finding Part A and GC tapering in Part B .
Safety scrutiny (atumelnant LFTs): Management expressed comfort with emerging experience; will update if meaningful signals arise .

Estimates Context

Q2 2025: Revenue beat and EPS/EBITDA missed. Revenue $1.03M vs $0.49M consensus (Beat); EPS $(1.23) vs $(1.10) consensus (Miss); EBITDA $(128.2)M vs $(115.9)M consensus (Miss) *.
Near-term trajectory: Consensus implies continued pre-commercial losses with improving revenues into Q4/Q1 2026 as launch progresses; target price consensus ~$80.21 with Buy-leaning recommendations unchanged*.