Gilead Prepares for Long-Acting PrEP Launch Amid Policy Uncertainty

Gilead Sciences is gearing up for the highly anticipated launch of its long-acting HIV pre-exposure prophylaxis (PrEP) medication, lenacapavir, as the company navigates potential policy shifts and market dynamics. The twice-yearly PrEP candidate has been a focal point for Gilead, with the FDA decision expected on June 19, paving the way for what the company believes could "revolutionize HIV prevention."

Lenacapavir Launch Readiness and Market Expectations

Gilead's chief commercial officer, Johanna Mercier, emphasized the company's preparedness for the lenacapavir launch during the first-quarter earnings call. "We are absolutely ready for launch," Mercier stated, highlighting a targeted approach that includes detailed plans for the first 30 and 90 days post-launch.

The company anticipates rapid market growth, with indications that many PrEP-naïve individuals are waiting for lenacapavir's approval before starting treatment. This pent-up demand is expected to facilitate a speedy launch and expand the current PrEP market.

Gilead's existing daily PrEP medication, Descovy, has already shown strong performance, with sales increasing by 38% year-over-year to $586 million in the first quarter. The drug currently holds over 40% of the PrEP market share, a position that has grown due to increased access and focused commercial execution.

Navigating Policy Uncertainties and HIV Program Funding

As Gilead prepares for the lenacapavir launch, the company is closely monitoring potential policy changes and funding uncertainties in federal HIV programs. Recent developments, including layoffs in HIV-related offices and budget cuts to key agencies such as the HHS Office of Infectious Disease & HIV/AIDS Policy and the CDC's Division of HIV Prevention, have raised concerns about the broader impact on HIV drug access in the United States.

CEO Daniel O'Day emphasized that Gilead is "very closely attuned to" these policy shifts and is actively engaging with policymakers to stress the importance of lenacapavir for PrEP. The company is also addressing potential gaps in federal HIV initiatives by independently conducting HIV surveillance, education, and awareness programs.

Despite these challenges, Gilead has not identified any factors that would prompt changes to its launch plans or expectations for lenacapavir. The company remains committed to supporting HIV drug awareness and access, recognizing the critical nature of HIV treatment and prevention.

Financial Performance and Market Position

Gilead reported first-quarter sales of $6.7 billion, with HIV medications contributing $4.6 billion, representing 6% growth. The company's U.S.-focused footprint has positioned it favorably in the face of potential tariffs on pharmaceutical imports, with the majority of its intellectual property and profits based in the United States.

While Gilead's HIV portfolio continues to drive growth, the company faced challenges in its oncology segment, with declining sales for cell therapy Tecartus and antibody-drug conjugate Trodelvy. However, Gilead maintains that Trodelvy remains the market leader in second-line metastatic triple-negative breast cancer, attributing the sales dip to inventory dynamics.

As Gilead prepares for the lenacapavir launch, the company remains optimistic about its potential to transform HIV prevention and further solidify its position as a leader in the HIV treatment and prevention market.