Sage Therapeutics Q2 2024 Financial Results and Business Update

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company dedicated to advancing brain health, has announced its business highlights and financial outcomes for the second quarter ending June 30, 2024.

Barry Greene, CEO of Sage Therapeutics, expressed satisfaction with the initial commercial performance of ZURZUVAE, a treatment for postpartum depression (PPD). Despite disappointing results from the KINETIC 2 study, the company remains focused on progressing its pipeline, anticipating more clinical data later in 2024.

Second Quarter 2024 Portfolio Highlights

Sage is advancing a range of novel chemical entities, aiming to improve brain health by targeting GABA-A and NMDA receptor systems, which are integral to numerous neuropsychiatric disorders.

Postpartum Depression Treatments

ZURZUVAE: Approved by the FDA in August 2023, ZURZUVAE is the first oral treatment specifically for PPD in adults and became commercially available in December 2023. The treatment is being developed and commercialized in collaboration with Biogen Inc.

Sage and Biogen aim to establish ZURZUVAE as the first-line therapy for PPD. Utilizing a specialty pharmacy distribution model, the treatment is shipped directly to patients. Key metrics for the second quarter of 2024 include:

- $7.4 million in collaboration revenue, a 19% increase from the first quarter.
- Approximately 2,000 prescriptions written, up by over 60% from the first quarter.
- Over 1,400 prescriptions shipped and delivered, representing a 95% increase.

OBGYNs accounted for more than 70% of prescriptions, followed by psychiatrists and PCPs. Discussions with payors continue to ensure broad access for women with PPD. By late July 2024, around 80% of commercial lives were covered by payor policies, with most having no step therapy or complex prior authorizations.

Sage and Biogen's support program, ZURZUVAE For You, offers educational resources, insurance navigation, and financial assistance. Most commercially insured patients using the savings card paid no copay.

ZULRESSO: Also marketed by Sage, ZULRESSO is another treatment for PPD available as an injection.

Pipeline Developments

Dalzanemdor (SAGE-718): This NMDA receptor positive allosteric modulator is being developed as an oral therapy for cognitive impairment in neurodegenerative disorders. It has received designations from the FDA and EMA for treating Huntington's Disease (HD). Ongoing phase 2 studies include the DIMENSION study for cognitive impairment in HD and the LIGHTWAVE study for mild cognitive impairment due to Alzheimer's Disease (AD).

In June, Sage reported that the SURVEYOR Study met its primary endpoint, highlighting the cognitive impact of HD. However, the DIMENSION Study will shift its primary endpoint to the Symbol Digit Modalities Test (SDMT). Sage anticipates reporting topline data from the DIMENSION and LIGHTWAVE studies by late 2024.

SAGE-324: Developed as a potential oral therapy for Essential Tremor (ET) in collaboration with Biogen, the KINETIC 2 study did not show a significant dose-response relationship. As a result, no further clinical development for ET is planned.

Financial Performance

Cash Position: Sage reported $647 million in cash, cash equivalents, and marketable securities as of June 30, 2024.

Revenue: Collaboration revenue from ZURZUVAE was $7.4 million, marking a 19% increase from the first quarter. Net revenue from ZULRESSO was $0.6 million, down from $2.5 million in the same period of 2023.

Expenses: Research and development expenses decreased to $62.6 million from $97.2 million, reflecting reduced headcount and lower spending on early-stage pipeline and manufacturing. Selling, general, and administrative expenses decreased to $56.0 million from $75.6 million.

Net Loss: Sage reported a net loss of $102.9 million for the second quarter of 2024, compared to $160.3 million in the same period in 2023.

Financial Outlook

Sage expects its existing cash reserves, ongoing collaborations, and anticipated revenues to support operations into 2026. With ZURZUVAE's entry into the market, ZULRESSO revenues are expected to decline over time. Operating expenses are projected to decrease in 2024 compared to 2023.

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