KTOV September 19th DD: Market Cap,Cash,sales prediction,Highlights: Many thanks to :Sugarplum, zj3001, RBNEWS, LearnToTrade, scottsmith, BEANPOLE, No-dough-go, Rymankoly, TrumpsVP, ylama3, salgovernale69, TradeFlow for bringing great highlights past recent months (my apologies if forget someone).
Cap $22m, Cash $18m, no debt.
Q4 2016 / Q1 2017 Submission of NDA to U.S. FDA
Highlights:
# Kitov’s drug passed Phase III with stunning results,showed extra efficacy.
# Both components already approved.
# "The FDA confirmed that an Advisory Committee Review should not be required for the NDA review, and that the FDA may accept 6 months data of long term stability at the time of submission". "The FDA requested that the statistical calculation for the primary efficacy endpoint be performed using an alternate mathematical technique. This calculation was subsequently performed by Kitov and also demonstrates that KIT-302 met its primary efficacy endpoint".
# FDA encouraging combination drugs."The 505(b)(2) process was established at the same time that Congress created the generic drug industry with passage of the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman) in 1984. This legislation included section 505(b)(2) to encourage further innovation for drugs that have already received FDA approval". Hillary gonna like it:).
# 40% of docs "will prescribe over Celebrex",25 percent of doc's that won't RX Celebrex would RX KIT.(check new fact sheet at the bottom).
# Pg 20 Presentation, Third Party Payors say:
"People are going to use this... At the price range similar to branded Celebrex, it would enter the formulatory without a problem."
# Was supposed to be bought out 4 years ago for more than double the current MC, before P3 success(Dec. 2015) and granted patent till 2030 (Aug, 2016).
# a former FDA officer + a former FDA chemist.
# Cash on hand almost equal to market cap,no debt.
# SABBY is the $2B hedge Fund recently invested about $6m in KTOV. other Institutional invested the rest almost $6m (for the first time ever,kitov has solid Insiders).
# Celebrex (Pfizer's Drug) has major risks while KIT-302 is actually an improved Celebrex. folks might drop Celebrex overnight and switch to Kitov drug and not worry about side effects. with the improved celebrex Pfizer could easily pass $2.4B(2014 sales) even $3B sales IMO.
# "Today, there is no drug on the market that handles both things together - in pain as a result of osteoarthritis and high blood pressure. Therefore, the KIT-302 will be the only drug with indication for the treatment of pain while reducing the risk of heart attack and stroke may even brought a dying patient". Many Thanks TrumpsVP : http://investorshub.advfn.com/boards/read_msg.aspx?message_id=125070573
Sales Prediction (based on September 19th presentation+fact sheet) : Even at $0.25 a pill a day would be sales prediction. those numbers based on US market only. add also also 7-10 yrs in EU and the rest of the World. Even w/$100m/year, present value based on US patent years is more than $1b in the US alone. Celebrex Prices This Celebrex price guide is based on using the Drugs.com discount card which is accepted at most U.S. pharmacies https://www.drugs.com/price-guide/
That's $7 per pill,not $.25 per pill and kitov's drug reduced Celebrex Side effects!
"Lead Drug Candidate Addresses Multi Billion $ Market With Better Alternative KIT-302 offers a superior alternative for patients, doctors, and payors for the treatment of pain caused by osteoarthritis and hypertension. Osteoarthritis is the most common form of arthritis, causing significant physical pain and decreased mobility. Pain medications for osteoarthritis account for billions of dollars in sales globally. Most of these drugs, including celecoxib, are NSAIDs which have the side effect of increasing hypertension. Of the 27 million Americans who live with osteoarthritis, 13.5 million also suffer from hypertension, which increases the risk of heart attack, stroke, and death. KIT-302 combines an effective, safe hypertension drug amlodipine (the active ingredient in Pfizer's Norvasc®) with celecoxib (the active ingredient in Pfizer’s Celebrex®), which had global sales of $2.7 billion in 2014. Based on a recent U.S. Market Assessment commissioned by Kitov, physicians stated they would prescribe KIT-302 to 40% of their osteoarthritis patients currently using celecoxib and to 25% of osteoarthritis patients not using celecoxib. Third party payors, including insurers, reacted very positively to KIT-302 based on estimated pricing and improved compliance, which is estimated by Kitov to potentially save the U.S. healthcare system $650 million annually.
Milestones, S.S : Fully diluted including all warrants supposedly equates to 15,220,000 O/S. Fully diluted it's still only a $44m and change company with $20m+ in cash. there is no chance of fully diluted the coming years, even not 50% imo, but even w/fully diluted(warrants) cap is still a joke relating "blockbuster peak annual sales potential in the United States alone": http://www.analystratings.com/2016/02/16/rodman-renshaw-initiates-a-buy-rating-on-kitov-pharmceuticals/431432/
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