Crinetics (CRNX) Q2 Revenue Jumps 150%

Key Points

• GAAP revenue of $1.0 million in Q2 2025 exceeded analyst expectations by 62.9%, driven by licensing income.

• GAAP net loss per share widened to $(1.23) in Q2 2025, reflecting increased R&D and commercial launch investment.

• Cash reserves remained strong at $1.2 billion as of Q2 2025 and are projected to support operations into 2029.

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Crinetics Pharmaceuticals (NASDAQ:CRNX), a biotechnology company focused on developing oral therapies for rare endocrine diseases, reported its latest quarterly results on August 7, 2025, for the second quarter of fiscal 2025. The most critical news was that GAAP revenue rose to $1.0 million, surpassing the consensus GAAP estimate of $0.61 million. However, the company's GAAP net loss per share widened to $(1.23), a larger loss than the anticipated $(1.08) per share, driven by higher research and development and administrative spending. The period saw rapid scaling ahead of the potential commercial debut for its lead drug, paltusotine, with a noticeably larger GAAP net loss of $115.6 million compared to $74.1 million in Q2 2024. Overall, the quarter reflected solid execution on clinical and commercial preparations but underscored the ongoing pre-commercial stage and heavy investment cycle.

Source: Analyst estimates for the quarter provided by FactSet.

What Crinetics Pharmaceuticals Does and Why the Pipeline Matters

The company specializes in discovering and developing oral, small-molecule drugs for endocrine diseases where existing treatments are often injectable and less convenient. Its lead programs target rare conditions such as acromegaly, carcinoid syndrome, congenital adrenal hyperplasia (CAH), and Cushing’s disease. The central products in development are paltusotine, an oral therapy for acromegaly and carcinoid syndrome, and atumelnant, aimed at CAH and Cushing’s disease. Both are in late-stage clinical or regulatory review, with additional drug candidates advancing in earlier stages.

Recently, Crinetics Pharmaceuticals has concentrated on preparing for its first commercial drug launch, scaling its organization, and strengthening clinical trial progress. Key success factors include securing regulatory approvals, demonstrating effectiveness of its therapies, building relationships with healthcare professionals and payers, and maintaining robust intellectual property protections for its proprietary drugs.

Quarter in Review: Financials, Pipeline Progress, and Strategic Milestones

The company generated $1.0 million in GAAP revenue, derived entirely from licensing and supply agreements related to paltusotine in Japan, reflecting its status as a pre-commercial stage company. The top-line figure beat consensus by 62.9%, although the absolute number remains small relative to anticipated commercial sales post-approval. Quarterly research and development spending (GAAP) jumped to $80.3 million, up 37.7% from the prior-year period. This increase primarily reflects higher headcount, clinical trial activity, and manufacturing costs as the company prepares for pivotal trials and scales for commercial operations.

Selling, general, and administrative costs doubled year over year to $49.8 million. The largest contributors were increased staff and outside services tied to launch readiness, including a new commercial organization and patient support platform. Net loss expanded to $(115.6) million, compared to $74.1 million for Q2 2024. Most of this widening loss stems from the deliberate acceleration of spending to support multiple late-stage trials and the forthcoming U.S. launch of paltusotine.

On the product side, the review process for paltusotine’s New Drug Application (NDA) for treating acromegaly in adults tracked to plan, with a U.S. Food and Drug Administration (FDA) decision target set for September 25, 2025. The European Medicines Agency validated its own review, putting a decision on possible EU approval in the first half of 2026. Paltusotine is designed as an oral alternative to current standard injectable therapies, and recent data presented at endocrinology meetings highlighted its benefit in controlling hormone levels (specifically insulin-like growth factor 1, or IGF-1) and reducing symptom burden.

Development continued for atumelnant, another oral small-molecule candidate, with enrollment completed for Cohort 4 of the adult Phase 2 trial for CAH and Phase 3 studies being planned for both adult and pediatric populations. The company also advanced its first drug-conjugate therapy for certain solid tumors, CRN09682, with a Phase 1/2 dose-escalation trial about to begin. Engagement with medical communities through abstract presentations and roundtables enhanced the program’s visibility in the U.S.

There were no significant one-time events this quarter. All cash utilized for operations tracked with company guidance, reflecting higher levels of investment in R&D and commercialization. No dividend was paid or announced, consistent with the company’s stage of development.

Pipelines, Market Strategy, and Industry Positioning

The company’s commercial organization, including sales and patient support infrastructure, neared completion in anticipation of paltusotine’s possible approval. Its CrinetiCare platform, established prior to launch, is designed to offer patient outreach and education as well as logistical support for those who may receive the forthcoming oral therapy. These preparations target key prescriber networks, primarily concentrated at pituitary treatment centers and academic hospitals in the U.S. and Europe. The company’s presentations at major medical meetings communicated both the persistence of symptoms with current injectable therapies and the possible benefits of once-daily oral dosing.

The pipeline remains diversified, with late-stage and preclinical assets spanning additional endocrine conditions. Atumelnant is positioned to address continued unmet needs in CAH and Cushing’s by potentially enabling better hormonal control with less dependence on glucocorticoids. For acromegaly and carcinoid syndrome, company leaders emphasized the opportunity to disrupt current standards of care, characterized by frequent painful injections, with oral alternatives that could improve both compliance and symptom management. Conference communications bolstered the argument for differentiated patient experience, drawing on real-world data around therapy discontinuation, adherence, and symptom recurrence with existing treatments.

Intellectual property remains a cornerstone of the company's defense strategy. In-house discovered compounds are protected by patents set to last into the 2030s and 2040s.

No new strategic partnerships were announced in the quarter. All current period revenue was tied to a licensing agreement with Sanwa Kagaku Kenkyusho in Japan. Other arrangements, such as those with Radionetics Oncology and optional milestone payments from Eli Lilly, remain as possible future sources of non-dilutive funding. The absence of new deals this period did not impact current results or operational runway.

Outlook and Key Milestones Ahead

Management did not offer formal guidance for either revenue or earnings for the next quarter or full fiscal year, in line with many biotechnology companies prior to first product launch. The central focus for the remainder of 2025 is the FDA’s action on paltusotine’s NDA, with September 25, 2025, noted as the Prescription Drug User Fee Act (PDUFA) date. European regulatory clarity is expected during the first half of 2026, which may offer further commercial expansion opportunities.

The company estimated full-year 2025 cash use in operations of $340 to $370 million, consistent with commercial launch readiness and multiple large-scale late-stage trials. Leadership projects that the $1.2 billion balance of cash, cash equivalents, and investment securities as of June 30, 2025, will fund the current operating plan into 2029. Investors are likely to monitor not only upcoming regulatory milestones and clinical readouts, but also the real-world rate of payer adoption, launch execution, and subsequent revenue ramp if approval is granted. CRNX does not currently pay a dividend.

Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.

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