Sarepta Therapeutics, Inc. (SRPT): Marketing Mix Analysis [Dec-2025 Updated]

You're looking at Sarepta Therapeutics, Inc. right now, and honestly, what you see is a company at a genuine inflection point in genetic medicine. As a former head analyst, I can tell you the four P's here aren't about widgets; they're about a $3.2 million one-time gene therapy, ELEVIDYS, navigating a tricky label and a pipeline facing headwinds after a late 2025 trial miss. The strategy is high-risk, high-reward, aiming for a revised 2025 revenue between $2.3 billion and $2.6 billion despite these pressures. Let's break down exactly how the Product, Price, Place, and Promotion structure is set up to manage this intense regulatory and commercial tightrope walk below.

Sarepta Therapeutics, Inc. (SRPT) - Marketing Mix: Product

You're looking at the core offerings from Sarepta Therapeutics, Inc. as of late 2025, and honestly, the product landscape is defined by a high-stakes gene therapy and the ongoing evolution of its foundational exon-skipping franchise. The company's product strategy centers on addressing Duchenne muscular dystrophy (DMD) through two distinct modalities.

ELEVIDYS (delandistrogene moxeparvovec) represents the one-time gene therapy component. This product is designed to deliver a functional copy of the dystrophin gene via an AAV vector. However, its commercial trajectory has been significantly altered by safety events in 2025. As of November 14, 2025, the U.S. Food and Drug Administration (FDA) approved substantial updates to the prescribing information, which includes the addition of a Boxed Warning. This warning highlights the risk of serious liver injury, acute liver failure, and fatal outcomes associated with the therapy. Consequently, the indication has been significantly restricted; ELEVIDYS is now approved exclusively for ambulatory DMD patients aged four years and older with a confirmed mutation in the dystrophin gene. Furthermore, the label explicitly states it is contraindicated in patients with deletions involving DMD exons 8 and/or 9. Physicians are now advised that patients should remain near an appropriate medical facility for at least two months post-infusion.

The established foundation of Sarepta Therapeutics, Inc.'s revenue stream is its portfolio of three Phosphorodiamidate Morpholino Oligomer (PMO) exon-skipping therapies. These therapies use proprietary PMO chemistry to treat DMD patients with specific, amenable exon mutations. For over a decade, these PMO therapies have been used to treat over 1,800 amenable patients worldwide.

The PMO franchise faces a period of uncertainty following the readout of the ESSENCE trial. This global, Phase 3 study, which was a confirmatory trial commitment for VYONDYS 53 and AMONDYS 45, missed its primary endpoint. The study showed an observed difference of only 0.05 steps/second in least square means (LSM) on the 4-step ascend velocity test at 96 weeks, which resulted in a high p-value of 0.309, failing to achieve statistical significance. Sarepta Therapeutics, Inc. is still planning to discuss a path to traditional approval with the FDA, citing encouraging numerical trends and a wealth of published real-world evidence.

The company's forward-looking product development is clearly shifting focus. Sarepta Therapeutics, Inc. is prioritizing its potentially best-in-class siRNA platform for other neuromuscular and pulmonary diseases. Specifically, the Phase 1/2 clinical study of SRP-1003 for Myotonic Dystrophy Type 1 (DM1) has completed enrollment for the single-ascending dose (SAD) cohort, and cohort 4 of the multiple-ascending dose (MAD) is ongoing as of November 2025. Progress in this siRNA expansion, following label updates for ELEVIDYS, triggered a milestone payment of US$200 million to Arrowhead Pharmaceuticals.

To give you a sense of the current revenue contribution from these products, here's the quick math from the latest reported quarterly figures leading up to late 2025:

The overall expectation for the full fiscal year 2025 remains a total net product revenue guidance of $2.9 to $3.1 billion. The recent label restriction on ELEVIDYS, while significant, is being managed alongside the ongoing evidence generation for the PMO franchise. The company is defintely leaning on the siRNA platform to secure future growth.

Finance: draft 13-week cash view by Friday.

Sarepta Therapeutics, Inc. (SRPT) - Marketing Mix: Place

You're looking at how Sarepta Therapeutics, Inc. gets its specialized, single-dose, intravenous (IV) infusion products, like ELEVIDYS, to the patient. For these types of therapies, Place isn't about stocking shelves; it's about managing a highly controlled, clinical delivery system. The entire distribution model hinges on a limited network of specialized, certified infusion centers capable of handling complex gene therapy administration and immediate post-treatment monitoring.

The post-treatment logistics create a significant distribution hurdle. The updated labeling for ELEVIDYS directs that Duchenne muscular dystrophy patients must maintain proximity to an appropriate healthcare facility for at least two months following infusion. This requirement is on the high end compared to other cell and gene therapies, where most centers previously recommended a stay near the dosing site for only two to three weeks. This extended proximity necessity directly impacts patient and caregiver planning and the capacity management of the certified centers.

The primary commercial market for all approved products from Sarepta Therapeutics remains the United States (U.S.). The recent challenges in the U.S. market highlight the sensitivity of this distribution channel. For instance, Sarepta generated $131.5 million from ELEVIDYS sales in the third quarter of 2025, a 27% year-over-year decline, largely because of the voluntary shipment pause to non-ambulatory patients that began in June 2025. Still, the company maintained an expectation of at least $500 million in annual revenue from ELEVIDYS infusions in the ambulatory population for the full year 2025. Shipments for the ambulatory population resumed in late July 2025, and the company anticipated Q4 infusion volumes to be flat to slightly down sequentially versus Q3 2025 due to the restart and seasonal factors.

Globally, the commercialization of ELEVIDYS outside the U.S. is managed through a partnership with Roche. Roche secured the non-U.S. commercial rights back in December 2019, which included an upfront payment of $1.15 billion in cash and stock. As of mid-2025, Roche had secured approval for ELEVIDYS in eight countries outside the U.S., including Japan, Brazil, Israel, Qatar, Kuwait, Oman, Bahrain, and the United Arab Emirates. However, following the safety events in the U.S., Roche temporarily paused new shipments in July 2025 to countries whose local approvals reference the FDA's decision, while continuing supply in nations like Japan and Brazil that do not rely on the FDA for their authorization.

While specific numbers on the secondary infusion center strategy aren't public, the overall structure relies on established specialized facilities. To give you a sense of the environment these centers operate in, the segment comprising hospitals and specialized infusion centers accounted for the largest revenue share, approximately 60%, in the broader Cell and Gene Therapy Pharmaceuticals Market in 2024. Intensifying support for secondary centers is a necessary action to manage patient flow and reduce backlogs caused by the highly restrictive post-infusion monitoring requirements.

Here are some key figures related to the distribution and market context for Sarepta Therapeutics' gene therapy:

Sarepta Therapeutics, Inc. (SRPT) - Marketing Mix: Promotion

Promotion activities for Sarepta Therapeutics, Inc. are heavily focused on targeted communication within the rare disease community, especially concerning safety, access, and patient support, given the nature of their specialized therapies.

SareptAssist Patient Support Program

SareptAssist functions as the core patient support mechanism, designed to help eligible individuals residing in the United States navigate the process of starting and staying on therapy. This support is explicitly detailed to include personalized case management and financial assistance options. The program's last update noted was on 10/15/2025.

The process for initiating support is structured for direct action:

• Download and complete the Enrollment Form.
• Fax the form to 1-800-621-5203.
• A dedicated Case Manager will contact the patient.

For direct contact, the number is 1-888-SAREPTA (1-888-727-3782), available Monday through Friday, 8:30am - 6:30pm ET.

Direct-to-Consumer (DTC) and Digital Educational Outreach

Communication regarding significant product updates, such as label changes, is managed through direct outreach to the community. For instance, following the FDA review of a supplement, Sarepta Therapeutics, Inc. issued a Community Letter on November 16, 2025, to detail updates to the ELEVIDYS prescribing information. This outreach was necessary to address patient safety concerns stemming from the required addition of a boxed warning for the risk of acute serious liver injury (ALI) and acute liver failure (ALF).

The company also engaged in proactive communication following safety events, such as the July 19, 2025, Community Letter clarifying the status of ELEVIDYS shipments for non-ambulatory patients and distinguishing a tragic event in the SRP-9004 clinical trial.

Frequent Community Letters

Sarepta Therapeutics, Inc. maintains a cadence of direct communication with patient families regarding regulatory and clinical milestones. The November 3, 2025, Community Letter specifically addressed the completion of the ESSENCE confirmatory study, which involved 225 patients aged 6 to 13 years old.

The regulatory action that necessitated the November 2025 letter was the FDA approval of the label supplement on November 14, 2025.

Professional Promotion Targeting Specialists

Promotion efforts are concentrated on specialists and centers capable of administering specialized therapies. The company holds leadership positions in Duchenne Muscular Dystrophy (DMD) and is building a portfolio across muscle, central nervous system, and cardiac diseases. The Patient Affairs team serves as a bridge to the community, supporting the ethos of urgency in developing precision genetic medicines.

The scale of the business supporting these promotional efforts is reflected in the financial reporting:

• Q3 2025 Net Product Revenue totaled $370.0 million.
• ELEVIDYS contributed $131.5 million to the Q3 2025 Net Product Revenue.
• Full-year guidance for combined non-GAAP Research & Development and Selling, General & Administrative expenses is approximately $1.86 billion.

Route 79 Duchenne Scholarship Program

The Route 79, The Duchenne Scholarship Program, is a key community-facing initiative supporting post-secondary education. The program's name references the 79 exons in the dystrophin gene.

Sarepta Therapeutics, Inc. (SRPT) - Marketing Mix: Price

You're looking at the pricing strategy for Sarepta Therapeutics, Inc.'s key assets, which is heavily centered on its gene therapy offering. The Wholesale Acquisition Cost (WAC) for ELEVIDYS, the one-time treatment for Duchenne muscular dystrophy, is set at $3.2 million per treatment. This gross price is subject to various statutory and commercial discounts, which analysts estimate brings the effective net price down to approximately $2.4 million. That discount range is generally described as being in the mid-20% range off the WAC.

The company's overall revenue expectations for the year reflect the commercial performance of its portfolio, including ELEVIDYS and its RNA-based PMOs (antisense oligonucleotide therapies). Sarepta Therapeutics, Inc. has provided a revised 2025 full-year net product revenue guidance in the range of $2.3 billion to $2.6 billion. This pricing strategy for a one-time gene therapy is designed to reflect the perceived long-term value while navigating the realities of payer negotiations for rare disease treatments.

Here's a quick look at how the revenue performance stacked up through the third quarter of 2025:

The third quarter of 2025 saw total net product revenue reach $370.0 million. Of that total, ELEVIDYS contributed $131.5 million in net product revenue. To give you a sense of the prior quarter's performance, Q2 2025 net product revenue for ELEVIDYS was $282 million, on total net product revenue of $513.1 million for that period.

In terms of managing the cost side of the equation, Sarepta Therapeutics, Inc. initiated a strategic restructuring. This effort is on track to realize over $100 million in cost savings by the end of 2025. The broader restructuring, announced in July 2025, aims for approximately $400 million in annual cost reductions starting in 2026, achieved through workforce reductions and pipeline reprioritization.

You should also note these specific financial details related to pricing and revenue realization:

• ELEVIDYS WAC is $3.2 million per one-time treatment.
• The estimated net price for ELEVIDYS is around $2.4 million.
• The company reiterated 2025 full-year guidance of $2.9 to $3.1 billion in January 2025, though later reports indicated suspension due to safety labeling discussions.
• The restructuring aims to reduce non-GAAP R&D and SG&A expenses to between $800 million and $900 million starting in 2026.
• The workforce reduction component of the restructuring is projected to save approximately $120 million annually in 2026.