Day One Biopharmaceuticals, Inc. (DAWN): Marketing Mix Analysis [Dec-2025 Updated]

You're looking to get a sharp read on how Day One Biopharmaceuticals, Inc. is translating its science into sales with OJEMDA, especially now that they've got solid data in hand. Honestly, after two decades analyzing pharma scale-ups, I can tell you the next few quarters are critical for setting the long-term value; they are already guiding for $145 million to $150 million in net product revenue for 2025, fueled by a 19% jump in new patient starts last quarter. This commercial engine is running hot. Let's break down the Product, Place, Promotion, and Price strategy that's driving this early momentum in the tough pediatric oncology market, so you can see exactly where the value is being built.

Day One Biopharmaceuticals, Inc. (DAWN) - Marketing Mix: Product

The product element for Day One Biopharmaceuticals, Inc. centers on its oncology portfolio, anchored by its first commercial product, OJEMDA (tovorafenib).

OJEMDA (tovorafenib) is the lead product, an oral, once-weekly Type II RAF inhibitor designed to penetrate the blood-brain barrier. Day One Biopharmaceuticals, Inc. received FDA accelerated approval for OJEMDA in April 2024. The drug is indicated for the treatment of patients $\text{6}$ months of age and older with relapsed or refractory pediatric low-grade glioma (pLGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is contingent upon verification of clinical benefit in a confirmatory study. Day One Biopharmaceuticals, Inc. is also developing OJEMDA for front-line pLGG in the pivotal Phase 3 FIREFLY-2/LOGGIC trial, which compares OJEMDA versus chemotherapy in patients aged $\text{6}$ months through $\text{25}$ years. Enrollment completion for the FIREFLY-2 trial is anticipated in the first half of $\text{2026}$.

The pivotal Phase 2 FIREFLY-1 trial, which supported the accelerated approval, evaluated $\text{137}$ relapsed or refractory BRAF-altered pLGG patients across two study arms. The efficacy analysis arm ($\text{77}$ patients) demonstrated a best overall response rate of $\text{51\%}$. As of the June 6, 2025 data cut-off, the updated median study duration for this arm was $\text{40.6}$ months. The drug has received Breakthrough Therapy and Rare Pediatric Disease designations from the FDA for pLGG harboring an activating RAF alteration. Furthermore, tovorafenib was added as a category $\text{2a}$ recommended therapy in the National Comprehensive Cancer Network (NCCN) treatment guidelines for adult patients with recurrent or progressive BRAF-altered glioma.

Day One Biopharmaceuticals, Inc.'s commercial performance for OJEMDA shows significant uptake. Net product revenue for the third quarter of $\text{2025}$ was $\text{\$38.5}$ million. Year-to-date net product revenue through the third quarter of $\text{2025}$ reached $\text{\$102.6}$ million. Based on this strength, the Company raised its full-year $\text{2025}$ net product revenue guidance to $\text{\$145}$ to $\text{\$150}$ million. Quarterly prescriptions (TRx) grew to $\text{1,256}$ in the third quarter of $\text{2025}$.

The product is available in formats designed for pediatric dosing flexibility. It is available as a tablet or as an oral suspension, allowing for dosing with or without food once weekly. The recommended dosage is $\text{380 mg/m}2$ orally once weekly, with a maximum recommended dosage of $\text{600 mg}$ orally once weekly, based on body surface area. The tablet strength is $\text{100 mg}$, and the oral suspension concentration is $\text{25 mg/mL}$ (with each bottle delivering $\text{300 mg/12 mL}$).

Beyond the lead asset, Day One Biopharmaceuticals, Inc.'s pipeline includes DAY301, a novel antibody-drug conjugate (ADC) targeting protein-tyrosine kinase 7 (PTK7) for solid tumors in both adult and pediatric populations. The Investigational New Drug (IND) application for DAY301 was cleared by the FDA in April 2024. The Company expects to present data from the Phase 1a/b trial, which is actively enrolling patients as of August $\text{2025}$. The licensing agreement for DAY301 included an upfront payment of $\text{\$55}$ million to MabCare Therapeutics, with potential milestone payments up to $\text{\$1.152}$ billion plus low-to-mid single-digit royalties on net sales outside Greater China.

• DAY301 is a PTK7-targeted ADC.
• DAY301 is in Phase $\text{1a/b}$ clinical trial for solid tumors.
• Phase $\text{1a}$ dose escalation was advancing as of August $\text{2025}$.
• Licensing upfront payment for DAY301 was $\text{\$55}$ million.
• Potential milestone payments for DAY301 development total up to $\text{\$1.152}$ billion.

Day One Biopharmaceuticals, Inc. (DAWN) - Marketing Mix: Place

You're looking at how Day One Biopharmaceuticals, Inc. gets its key product, OJEMDA (tovorafenib), into the hands of specialized pediatric oncologists. The 'Place' strategy here isn't about mass retail; it's about precision access in highly specialized healthcare settings. It's a bifurcated model, which is smart for a company with a newly approved, targeted therapy.

The core of the distribution model is direct commercialization within the United States. Day One Biopharmaceuticals retains exclusive global development and U.S. commercial rights for tovorafenib. This means their internal teams, leveraging leadership experience from places like Gilead Sciences, are responsible for the logistics, inventory management, and direct sales force deployment to pediatric oncology centers where pLGG patients are treated. For context on scale, analysts projected OJEMDA's U.S. peak sales could reach $750 million.

For everything outside the U.S., Day One Biopharmaceuticals has strategically partnered. Global distribution rights outside the U.S. were licensed to Ipsen. This partnership immediately expands the reach without Day One having to build out its own international infrastructure. Ipsen is responsible for the regulatory and commercial activities in those territories. This deal structure is cemented by significant financial terms: Day One received an upfront payment of approximately $111 million, which included $71 million in cash and a $40 million equity investment at a premium. Plus, Day One is set to receive tiered double-digit royalties starting at the mid-teens percentage on ex-U.S. sales, along with up to approximately $350 million in additional milestone payments.

The focus on specialized settings dictates the entire supply chain. The distribution model centers on these specialized healthcare settings and key research centers. This is not a product you'll find in a general pharmacy; it requires specialized handling and administration knowledge. For instance, the Wholesale Acquisition Cost (WAC) in the U.S. was set at $33,916 for a 28-day supply of tablets or powder for oral suspension. The initial U.S. launch performance showed traction, with Day One reporting $8.2 million in OJEMDA net product revenues in the initial two months of launch in 2024. By the third quarter of 2025, the company was raising its full-year 2025 net product revenue guidance to $145 million as a floor.

The global regulatory push is underway. While the European Commission granted Orphan Drug Designation for tovorafenib for glioma back in 2021, Ipsen is driving the current commercialization efforts. We know that Ipsen filed a Marketing Authorization Application for tovorafenib in the European Union in March 2025. This filing is crucial for activating the ex-U.S. commercial rights in a major market. The Phase III FIREFLY-2 trial, which informs first-line treatment, is enrolling patients across more than 100 sites activated in the United States, Canada, Europe, Australia, and Asia, which sets the stage for a broad, multi-national supply chain execution.

Day One Biopharmaceuticals emphasizes that its high-performing supply chain relies on CMO partnerships for integrity. The company positions itself as a flexible partner known for its scientific and integration acumen, focusing on developing and scaling treatments for market. This suggests a reliance on established Contract Manufacturing Organizations (CMOs) to ensure product quality and integrity, which is non-negotiable for a pediatric oncology product.

Here's a quick look at the geographic division of commercial responsibility:

The operational focus for Place is clearly defined by the product's nature:

• Direct sales force targeting U.S. pediatric oncology centers.
• Reliance on Ipsen for ex-U.S. regulatory submissions and commercial launch.
• Distribution channels limited to specialized hospital systems.
• Supply chain built on CMO partnerships for manufacturing integrity.
• Clinical trial footprint (FIREFLY-2) spanning over 100 sites globally.

Honestly, the distribution plan is a classic biotech out-licensing model for international scale, keeping the high-value U.S. market control in-house. Finance: review the Q4 2025 inventory projections against the Ipsen territory forecast by next Wednesday.

Day One Biopharmaceuticals, Inc. (DAWN) - Marketing Mix: Promotion

You're looking at how Day One Biopharmaceuticals, Inc. is pushing OJEMDA into the market, which is all about getting the right message to the right specialists. Honestly, in this space, promotion isn't about flashy billboards; it's about data, credibility, and establishing a new norm for treatment.

The central promotional strategy focuses on establishing OJEMDA as the second-line standard-of-care for relapsed or refractory pediatric low-grade glioma (pLGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This goal was explicitly stated as a top priority for 2025 by the CEO. The entire promotional narrative is built around this positioning to drive adoption beyond the initial indication.

A major push to solidify this involved the presentation of long-term clinical evidence. Day One Biopharmaceuticals presented three-year FIREFLY-1 data in November 2025 to boost prescriber confidence. Specifically, the three-year results from the pivotal Phase 2 FIREFLY-1 trial were shared in an oral presentation at the Society for Neuro-Oncology (SNO) Annual Meeting on November 23, 2025. This data showed, for instance, that the median time to next treatment (TTNT) following initiation of OJEMDA exceeded 3.5 years. Also, 77% of patients who entered the treatment-free observation period following OJEMDA treatment remained off therapy for at least 12 months.

This data delivery immediately translated to commercial traction. The impact of this data dissemination is visible in the third quarter results: Q3 2025 new patient starts grew 19% quarter-over-quarter due to new data. This acceleration in new patient starts, alongside an 18% quarter-over-quarter growth in total prescriptions (TRx) to 1,256 in Q3 2025, shows prescribers are responding to the clinical updates.

The promotional cadence relies heavily on scientific forums. Investor and medical conference presentations (SNO, AACR) drive clinical awareness. Beyond the SNO presentation in November 2025, Day One Biopharmaceuticals presented two posters at the 2025 American Association for Cancer Research (AACR) annual meeting in April 2025. The AACR meeting itself saw over 22,100 registrants from 85 countries, providing a massive platform for scientific exchange.

The core message centers on addressing the critical unmet need in pediatric cancer. Day One Biopharmaceuticals was founded specifically to address the 'dire lack of therapeutic development in pediatric cancer.' This patient-centric framing underpins all communications, linking the clinical data directly to a profound medical necessity.

Here's a quick look at the commercial metrics reflecting the promotional success through Q3 2025:

The promotional activities are also supported by regulatory milestones that enhance the product profile:

• Tovorafenib (OJEMDA) received Breakthrough Therapy and Rare Pediatric Disease designations from the FDA.
• Tovorafenib was added as a category 2a recommended therapy in the National Comprehensive Cancer Network (NCCN) treatment guidelines for adult patients with recurrent or progressive BRAF-altered glioma.
• The company ended Q3 2025 with $451.6 million in cash, cash equivalents and short-term investments, providing runway for continued promotional investment.

Finance: draft the Q4 2025 promotional spend vs. new patient start correlation analysis by next Wednesday.

Day One Biopharmaceuticals, Inc. (DAWN) - Marketing Mix: Price

Price for Day One Biopharmaceuticals, Inc.'s product, OJEMDA (tovorafenib), is strategically set reflecting its status as a first-in-class, targeted oncology therapy for pediatric low-grade glioma (pLGG), positioning it within a high-value orphan drug pricing model. This approach is necessary given the specialized nature of the treatment and the small patient population.

The company's commercial performance directly informs its pricing strategy's success. Day One Biopharmaceuticals raised its full-year 2025 net product revenue guidance to a range of $145 million to $150 million, demonstrating confidence in market uptake at the established price points. This guidance followed a strong third quarter, with Q3 2025 U.S. net product revenue reaching $38.5 million.

The list below summarizes key financial and access metrics related to the pricing and reimbursement strategy for OJEMDA:

• Full-year 2025 net product revenue guidance is $145 million to $150 million.
• Q3 2025 U.S. net product revenue was $38.5 million.
• Over 95% of patients on OJEMDA are paid patients, indicating strong payer coverage.
• 90% of initial submissions receive approval, minimizing access defintely hurdles.

The list price structure is indicative of a high-cost specialty medication. For instance, the Wholesale Acquisition Cost (WAC) for the OJEMDA 100 MG TABLET (16 tablets) was listed as $35,272.64 as of January 1, 2025. You should note that WAC does not account for the various discounts and rebates negotiated with payers.

To ensure accessibility despite the high WAC, Day One Biopharmaceuticals employs patient support programs that directly impact the final out-of-pocket cost for patients. These programs are critical for making the therapy accessible to the target market, which is a population of children with life-threatening diseases. The company's EveryDay Support From Day One program is designed to help manage the process.

The pricing strategy is clearly supported by robust payer engagement, as evidenced by the high rate of on-label patient coverage. Furthermore, Day One Biopharmaceuticals offers financial assistance programs, including a Copay Program that can reduce out-of-pocket costs to as little as $0 per month for eligible patients not covered by government insurance. This directly addresses the affordability element of the marketing mix for the patient population.

Finance: draft 13-week cash view by Friday.