Merck & Co (MRK) investor relations material

HIV landscape and unmet needs

• Nearly 40 million people live with HIV globally, with over 1.2 million new infections annually and only 73% achieving viral suppression.

• UNAIDS 2030 goals target 95% diagnosis, treatment, and viral suppression, but stigma and discrimination remain significant barriers.

• Treatment fatigue, stigma, and complex PrEP implementation hinder adherence and access, especially as the HIV-positive population ages.

HIV treatment and prevention strategy

• Focus on simplifying HIV regimens with once-weekly and monthly oral options to reduce pill burden and improve adherence.

• Positive phase III results for islatravir/lenacapavir (ISL/LEN) support its potential as the first once-weekly oral HIV treatment.

• Phase II data for islatravir/ulonivirine (ISL/ULO) show high efficacy and safety, with plans to advance to phase III trials.

• Monthly oral PrEP candidate alimatravir offers rapid onset and discreet dosing, with global access initiatives planned.

Pipeline and clinical data updates

• Multiple next-generation oral regimens are advancing, including once-weekly and monthly options for both treatment and PrEP.

• ISL/LEN demonstrated non-inferior efficacy to daily regimens, with viral suppression rates above 93% at 48 weeks and no emergent resistance.

• ISL/ULO maintained viral suppression over 94% at 24 weeks in Phase IIb, with no resistance and favorable safety profile.

• Safety and tolerability of once-weekly regimens were comparable to daily standards, with no new safety concerns identified.

• SYMPHORIA phase III studies for ISL/ULO will target both virologically suppressed and treatment-naive adults, with results expected in 2027.

• Alimatravir's phase III EXPrESSIVE trials are expected to read out in 2027.