From: Mike Sheikh [mailto:sheikh@the-lift.com]
Sent: Sunday, July 15, 2018 10:02 PM
To: Nader Pourhassan <npourhassan@cytodyn.com>
Subject: Final Article submission
Gilead’s HIV Franchise Under Assault As It Stares Down Paradigm Changing Drug
Jul. 16, 2018 ...
×
Title:
· Title should be compelling, succinct, and accurately reflect your main investment idea.
· Do not include ticker symbols in titles; write out company names.
· Use statements, avoid questions.
· Sensational and/or bombastic titles will be rejected. Avoid name-dropping as well.
· Mention the main company(s)/product covered in the article.
Michael Sheikh
Michael Sheikh
Long only, research analyst, biotech, small-cap
Falcon Strategic Research
Summary
Patent fight with Glaxo dampens Biktarvy sales.
HIV franchise losing dominance to new entrants.
Empty HIV pipeline could lead to acquisitions.
PRO 140 represents paradigm changing drug.
CytoDyn acquisition/license is only viable chance of corporate survival.
Gilead (GILD) has annual revenues in the HIV class of drugs of over $14.2 billion and only has only one phase 3 drug in clinical trials to protect its dominance in this category. GILD’s $14 billion annual income stream could be in jeopardy because they are literally one drug approval away from an armageddon they admit in their 10-K is coming. A small competitor, Cytodyn Inc. (CYDY) has been struggling for over a decade to get PRO 140 approved as a salvage therapy to drug resistant HIV patients. After two successful phase 3 studies (pivotal combination therapy & investigational monotherapy), they are in a position to file a BLA for combination therapy, but the real threat is that the data is so robust that it reduces the viral load to undetectable levels and keeps it there without the help of HAART, the current standard of care. A monotherapy filing might come right after CytoDyn’s BLA submission and could eventually rewrite the current standard of care. PRO-140 is much more than a salvage drug and the monotherapy has the potential to wipe out over half of GILD’s total income. This is a potent threat to GILD’s HIV dominance. There have been no real innovations in the HIV field since the disease has become more manageable using a cocktail of drugs known as the HAART treatment so how they deal with this impending threat is of real interest to GILD shareholders.
GILD would be silly not to buy or in-license CytoDyn’s PRO 140, should the drug get Breakthrough Therapy Designation for monotherapy. With over $32 billion in cash and marketable securities this $100 million market cap, CYDY seems like a bargain. Other drug makers like GlaxoSmithKlein (GSK), Johnson & Johnson (JNJ), Merck (MRK) and Bristol Myers (BMY) round out the top 11 drugs for HIV and are looking for cracks in GILD’s HIV franchise to exploit. They are likely meeting with CYDY in anticipation of the approval and if they get wind of a monotherapy filing, this could spark a fight for control of the next generation of HIV treatment. PRO 140 is a once a week injectable that could reshape the treatment of HIV and has a realistic shot at becoming the new standard of care that replaces over 20+ drugs currently being manufactured. Besides its potential dominant use in HIV, PRO 140 is a platform drug that could be used in Multiple Sclerosis and metastatic cancer.
