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GILD Grants Right for HIV PrEP Candidate to Six Generic Companies
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Gilead Sciences (GILD - Free Report) has entered into licensing deals with six pharmaceutical companies to manufacture and supply a cheaper version of its investigational drug, lenacapavir, for HIV prevention, also called pre-exposure prophylaxis (PrEP). These companies will market the low-cost versions of lenacapavir, if approved, in 120 primarily low-and-lower-middle-income countries.
The companies chosen to manufacture and supply lenacapavir to 120 countries are Dr. Reddy’s Laboratories, Emcure, Eva Pharma, Ferozsons Laboratories, Hetero, and Mylan (a Viatris subsidiary).
While lenacapavir is not yet approved for use anywhere and its safety and efficacy are still unproven, Gilead believes the drug has the potential to be transformative for HIV prevention, where there is a significant unmet need. Currently, no cure exists for HIV or AIDS.
Earlier this year, Gilead reported that two pivotal late-stage studies, PURPOSE 1 and PURPOSE 2, evaluating the safety and efficacy of lenacapavir to reduce the chance of getting HIV, achieved their primary efficacy goals. Per the data readout, it was observed that the candidate, administered twice a year, demonstrated superior efficacy over the once-daily oral dose of Truvada and background HIV incidence.
Using data from these studies, Gilead plans to submit global regulatory filings by the end of 2024. Year to date, shares of GILD have gained 4.6% against the industry’s 1.5% decline.
Image Source: Zacks Investment Research
GILD’s Voluntary Licensing Agreement for Lenacapavir
Gilead plans to support low-cost access in high-incidence, resource-limited countries through a two-pronged approach – establishing a strong, royalty-free, voluntary licensing program and providing lenacapavir at no profit until generic manufacturers can meet demand. The agreements cover lenacapavir for both HIV prevention (pending approval) and for treatment in heavily treatment-experienced adults with multi-drug-resistant HIV.
Gilead selected these partners based on strict criteria due to the complexities of producing lenacapavir. All six companies have previously worked with Gilead to produce high-quality generics for HIV and other infectious diseases, and they are experienced in making sterile injectable medicines. Gilead also considered advice from global health advocates, opting for manufacturers from various countries and continents.
On the other hand, the licensees will work to build manufacturing capacity for lenacapavir rapidly. However, this will take time.
Therefore, until generic versions are available, Gilead will supply lenacapavir directly and is focusing on registering the candidate in 18 countries that account for about 70% of the HIV burden in the licensed regions. These countries, chosen in consultation with external partners, include Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, the Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia, and Zimbabwe.
In the past, Gilead’s partnerships with generic manufacturers have enabled millions to access affordable treatments for HIV, viral hepatitis and COVID-19. Over 30 million treatments have been distributed in low-and-middle-income countries through these collaborations.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.38 to $5.86. Year to date, shares of ANIP have gained 4.3%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for Krystal Biotech’s 2024 EPS have increased from $1.91 to $2.38. The consensus estimate for 2025 earnings has improved from $4.33 to $7.31. Year to date, shares of KRYS have soared 43%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from 46 cents to 28 cents. The consensus estimate for 2025 loss per share has narrowed from $1.67 to $1.14. Year to date, shares of FULC have plunged 42.7%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
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GILD Grants Right for HIV PrEP Candidate to Six Generic Companies
Gilead Sciences (GILD - Free Report) has entered into licensing deals with six pharmaceutical companies to manufacture and supply a cheaper version of its investigational drug, lenacapavir, for HIV prevention, also called pre-exposure prophylaxis (PrEP). These companies will market the low-cost versions of lenacapavir, if approved, in 120 primarily low-and-lower-middle-income countries.
The companies chosen to manufacture and supply lenacapavir to 120 countries are Dr. Reddy’s Laboratories, Emcure, Eva Pharma, Ferozsons Laboratories, Hetero, and Mylan (a Viatris subsidiary).
While lenacapavir is not yet approved for use anywhere and its safety and efficacy are still unproven, Gilead believes the drug has the potential to be transformative for HIV prevention, where there is a significant unmet need. Currently, no cure exists for HIV or AIDS.
Earlier this year, Gilead reported that two pivotal late-stage studies, PURPOSE 1 and PURPOSE 2, evaluating the safety and efficacy of lenacapavir to reduce the chance of getting HIV, achieved their primary efficacy goals. Per the data readout, it was observed that the candidate, administered twice a year, demonstrated superior efficacy over the once-daily oral dose of Truvada and background HIV incidence.
Using data from these studies, Gilead plans to submit global regulatory filings by the end of 2024. Year to date, shares of GILD have gained 4.6% against the industry’s 1.5% decline.
Image Source: Zacks Investment Research
GILD’s Voluntary Licensing Agreement for Lenacapavir
Gilead plans to support low-cost access in high-incidence, resource-limited countries through a two-pronged approach – establishing a strong, royalty-free, voluntary licensing program and providing lenacapavir at no profit until generic manufacturers can meet demand. The agreements cover lenacapavir for both HIV prevention (pending approval) and for treatment in heavily treatment-experienced adults with multi-drug-resistant HIV.
Gilead selected these partners based on strict criteria due to the complexities of producing lenacapavir. All six companies have previously worked with Gilead to produce high-quality generics for HIV and other infectious diseases, and they are experienced in making sterile injectable medicines. Gilead also considered advice from global health advocates, opting for manufacturers from various countries and continents.
On the other hand, the licensees will work to build manufacturing capacity for lenacapavir rapidly. However, this will take time.
Therefore, until generic versions are available, Gilead will supply lenacapavir directly and is focusing on registering the candidate in 18 countries that account for about 70% of the HIV burden in the licensed regions. These countries, chosen in consultation with external partners, include Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, the Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia, and Zimbabwe.
In the past, Gilead’s partnerships with generic manufacturers have enabled millions to access affordable treatments for HIV, viral hepatitis and COVID-19. Over 30 million treatments have been distributed in low-and-middle-income countries through these collaborations.
Gilead Sciences, Inc. Price and Consensus
Gilead Sciences, Inc. price-consensus-chart | Gilead Sciences, Inc. Quote
GILD’s Zacks Rank & Stocks to Consider
Gilead currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals (ANIP - Free Report) , Krystal Biotech, Inc. (KRYS - Free Report) and Fulcrum Therapeutics (FULC - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.38 to $5.86. Year to date, shares of ANIP have gained 4.3%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for Krystal Biotech’s 2024 EPS have increased from $1.91 to $2.38. The consensus estimate for 2025 earnings has improved from $4.33 to $7.31. Year to date, shares of KRYS have soared 43%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from 46 cents to 28 cents. The consensus estimate for 2025 loss per share has narrowed from $1.67 to $1.14. Year to date, shares of FULC have plunged 42.7%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.