BakedLangostino
12 meses hace
In case anyone stumbles upon this company, first, congratulations on discovering perhaps the most undervalued stock that I've ever seen. Now I've been wrong a million times before so this could potentially backfire on me if there's something I am missing, which is partially why I am posting here -- the off chance someone can find the hole in this investment thesis. Because from my vantage point it's a perfect storm that is brewing around Achieve Life Sciences. Here's why:
1. There are an estimated 26 million smokers in the United States and even more in Western Europe, where Achieve holds exclusive rights for its lead drug candidate, Cytisinicline (Cytisine). This is an alkaloid that is found naturally in the Laburnum tree, which is grown in only a handful of regions across the world. Cytisine has been used for decades in Eastern Europe, and was recently approved for use in Canada, due to its strong safety, tolerability and efficacy for smoking cessation.
2. Chantix is no longer available now that Pfizer shelved the drug. There is a generic version that is available and made nearly $300 million revenue without any serious marketing effort. At its peak, Chantix was a billion dollar drug, but it underperformed expectations because of its poor tolerability and safety profile. First, it was believed to contribute to increased likelihood of suicidal thoughts. Recently, it's been shown to potentially contribute to higher odds of developing cancer. So while it may be effective for some, a lot of people didn't stick with the program because Chantix wasn't the right drug for them.
3. Achieve Life Sciences has the exclusive rights from Sopharma, a Bulgarian big pharma with decades of experience manufacturing cytisine. There is currently a five-year stockpile and the trees take approximately 5 years to mature, providing an ample moat.
4. The main weakness is that because cytisine is plant based, there are certain patent protections that aren't available. Achieve has done what it can to make it very difficult and expensive for a competitor, and even if one could source the Laburnum tree and figure out the extraction process, it would still need to run FDA trials with a new dosage because Achieve patented its proprietary dosage amount and schedule.
5. Two Phase 3 trials both showed significantly statistic superior efficacy to the placebo with the trials overseen by Dr. Nancy Rigotti of Harvard Medical School and Mass General Hospital -- a rockstar in her field of research. The data was also published in the esteemed JAMA and Achieve is on the cusp of submitting an NDA to the FDA. The CEO expects this to happen sometime before July 2024.
6. The CEO has stated repeatedly that he always sees this in the hands of a big pharma. He has a goal to partner or sell, and is as transparent as anyone about his exit strategy.
7. The perfect storm. There's a massive need for a safe nicotine-free smoking cessation drug. There are decades of top-notch safety and efficacy data, but the FDA required clean new trials because it couldn't trust old data from 1960s Eastern Europe. These new trials passed with flying colors. Most Americans will not have to pay out of pocket because most insurance plans are mandated to cover smoking cessation, so even if a generic competitor does hit market, it'll be the equivalent of Viagra vs. those sketchy pills they sell on gas station counters. People serious about quitting smoking will get an Rx from their MD, and they won't pay a dime for it. For what it's worth, the CEO expects a three-month treatment to run around $1500, the same as Chantix cost.
The only other lingering concern I can think of is that somehow Sopharma can't get its manufacturing facility up to FDA standards. I do not see this as a major issue, Achieve is running mock trials and Sopharma is a big company in its own right with thousands of employees. It's not a mom-and-pop operation. Now that Cytisine is available in Canada, it makes it more likely the FDA will approve its use in the USA where the CEO said he expects 75% of sales to come from.
Speaking of sales, let's run some numbers:
We know Chantix made $1 billion at its peak. At $1500/Rx, that means 666k prescriptions were filled. Let's assume this is the same for Achieve. Yes, there's now a generic version but it's still the same drug Pfizer discontinued. Most doctors won't prescribe it. Also, Cytisine is more tolerable with fewer side effects, which means fewer people stop using it.
So, $1 billion revenue * 15% estimated profit margin = $150 million net income.
$150 million net income / 30 million shares outstanding (fully diluted) = $5 EPS
$5 EPS * 20x P/E multiple (you can use whatever price-to-earnings multiple you'd like, but 15-20% is around the norm) = $100/share. It's currently trading around $5.50/share.
Oh yeah, management. participated in the most recent offering, as did entities affiliated with the Hunt Family.
This was a $300 stock if you look at pre-split numbers. Past management pretty much ruined it for early investors, but the new CEO seems to be a straight shooter and wants to get this approved and sold ASAP. I wouldn't be surprised to see a sale before cash runs out around mid-2024, although there is a chance for another offering should insiders want more cheap shares. Either way, the risk/reward here is silly whether there are 30 million or 50 million outstanding shares.
Do your research, just my thoughts here, we'll check back to see how this post aged in 12-18 months.
Eat your vegetables. Say no to drugs. Go with God.
whalecatcher
4 años hace
sounds promising.."With the initiation of the Phase 3 ORCA-2 trial and the breakthrough evidence, both mechanistically and clinically, in support of cytisinicline in comparison to Chantix, the third quarter of 2020 has undeniably been the most pivotal in the history of our company," commented John Bencich, Chief Executive Officer of Achieve.
Q3 results
whytestocks
4 años hace
News; $ACHV Achieve Life Sciences Announces Presentation of Cytisinicline Data at the 20th Annual Society for Research on Nicotine & Tobacco Europe (SRNT-E) Virtual Conference
SEATTLE and VANCOUVER, BC , Sept. 10, 2020 /PRNewswire/ -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, today announced that cytisinicline data w...
In case you are interested ACHV - Achieve Life Sciences Announces Presentation of Cytisinicline Data at the 20th Annual Society for Research on Nicotine & Tobacco Europe (SRNT-E) Virtual Conference
xgin
4 años hace
SEATTLE, Wash. and VANCOUVER, British Columbia, August 3. 2020 — Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced a proposed underwritten public offering in which it intends to offer and sell shares of its common stock and, to certain investors whose purchase of common stock would result in the investor, together with its affiliates, beneficially owning more than 9.99% of Achieve’s common stock following the completion of the offering, pre-funded warrants to purchase shares of common stock. In addition, Achieve intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. All of the securities are being offered by Achieve. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
Lake Street Capital Markets LLC is acting as the sole book-running manager in the offering.
Achieve intends to use the proceeds from the offering to fund clinical research and development, and for general working capital.
The securities are being offered by Achieve pursuant to a registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to this offering will be filed with the SEC. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: Lake Street Capital Markets LLC, Prospectus Department, 920 Second Avenue South, Suite 700, Minneapolis, Minnesota 55402 or by email at info@lakestreetcm.com. Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the website of the SEC at http://www.sec.gov.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Achieve, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
http://achievelifesciences.com/2020/08/03/achieve-announces-proposed-public-offering/
whytestocks
4 años hace
News: $ACHV Achieve Announces Patent Granted in the U.S. for Novel Analogs of Cytisinicline for Use in CNS and Addiction Indications
SEATTLE and VANCOUVER, British Columbia , July 31, 2020 /PRNewswire/ -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, today announced that the Uni...
Find out more ACHV - Achieve Announces Patent Granted in the U.S. for Novel Analogs of Cytisinicline for Use in CNS and Addiction Indications
JoeWo
4 años hace
I guess it is going to speak to you a lot today since the patent news just came out:
-------------------------
Achieve Announces Patent Granted in the U.S. for Novel Analogs of Cytisinicline for Use in CNS and Addiction Indications
Source: PR Newswire (US)
SEATTLE and VANCOUVER, British Columbia, July 31, 2020 /PRNewswire/ -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, today announced that the United States Patent and Trademark Office has granted Achieve a patent (US 2020/0172544 A1) on novel analogs of cytisinicline, a process for their preparation, and their use in the prevention or treatment of CNS and addictive disorders.
?
Cytisinicline is a selective partial agonist of nicotinic acetylcholine receptors (nAChRs), which underlies its activity in nicotine addiction. nACHRs are more broadly involved in a range of physiological functions, such as cognitive function, learning and memory, emotion and control of movement. The newly patented analogs provide the opportunity for selective targeting of nAChRs in the brain in order to treat a number of conditions, such as Alzheimer's disease, depression, anxiety, schizophrenia, epilepsy, Parkinson's disease and addiction.
"While smoking cessation and nicotine addiction continue to be our primary focus, it is critically important that we continue to expand our intellectual property portfolio through patent extensions and future potential indications of cytisinicline," stated Rick Stewart, Chairman and Chief Executive Officer of Achieve.
About Achieve and Cytisinicline
Tobacco use is currently the leading cause of preventable death and is responsible for more than eight million deaths annually worldwide1. It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking2. Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.
Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.
As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the timing and nature of cytisinicline clinical development activities, the potential market size for cytisinicline and the effectiveness and potential uses and benefits of cytisinicline. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including, among others, the risk that cytisinicline may not demonstrate the hypothesized or expected benefits; the risk that cytisinicline may not be effective in treating a larger breadth of diseases and addictions; the risk that Achieve may not be able to obtain additional financing to fund the development of cytisinicline; the risk that cytisinicline will not receive regulatory approval or be successfully commercialized; the risk that new developments in the smoking cessation landscape require changes in business strategy or clinical development plans; the risk that Achieve's intellectual property may not be adequately protected; general business and economic conditions; impacts from the COVID-19 pandemic; and the other factors described in the risk factors set forth in Achieve's filings with the Securities and Exchange Commission from time to time, including Achieve's Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable.
Media Contact
Glenn Silver
Email: Glenn.Silver@Finnpartners.com
Telephone: 1 646 871 8485
1 World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017
2 Annals of Epidemiology, Volume 25, Issue 3, 179 - 182.e1
? View original content to download multimedia:http://www.prnewswire.com/news-releases/achieve-announces-patent-granted-in-the-us-for-novel-analogs-of-cytisinicline-for-use-in-cns-and-addiction-indications-301103740.html
SOURCE Achieve Life Sciences, Inc.
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