iHub News
2月前
Achieve Life Sciences reports fourth-quarter results in line with expectationsMarch 24, 2026 8:37 AM
IH Market News
Achieve Life Sciences Inc. (NASDAQ:ACHV) reported fourth-quarter results that matched analyst forecasts, posting a loss of -$0.28 per share, in line with the consensus estimate of -$0.28.The company’s shares were unchanged in pre-market trading following the announcement.The late-stage pharmaceutical company, which is developing cytisinicline as a treatment for nicotine dependence, reported a net loss of $14.7 million for the three months ended December 31, 2025, compared with a net loss of $12.4 million in the same quarter a year earlier. For the full year 2025, Achieve recorded a net loss of $54.6 million. Total operating expenses for the fourth quarter rose to $14.7 million from $12.2 million in the prior-year period.Achieve also announced a new manufacturing partnership with U.S.-based Adare Pharma Solutions to produce cytisinicline drug product. The collaboration is intended to lower manufacturing costs and reduce risks tied to international pharmaceutical imports, including potential tariffs.The company said it has begun transferring manufacturing technology to Adare and expects to launch the treatment commercially in the United States during the first half of 2027.“Achieve is fully committed to bringing cytisinicline to the millions of people who continue to struggle with nicotine dependence and need a new solution to help them quit,” said Rick Stewart, President and Chief Executive Officer.Achieve also reported progress toward regulatory approval. The U.S. Food and Drug Administration has accepted the company’s New Drug Application for cytisinicline and set a PDUFA target action date of June 20, 2026.The company completed its ORCA-OL long-term exposure study, with 334 participants finishing the one-year trial. Cytisinicline was also selected as one of nine therapies included in the FDA Commissioner’s National Priority Voucher program for treatments targeting e-cigarette or vaping cessation.As of December 31, 2025, Achieve reported cash, cash equivalents and marketable securities totaling $36.4 million.Achieve Life Sciences stock price
Original: Achieve Life Sciences reports fourth-quarter results in line with expectations
BakedLangostino
2年前
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
6年前
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
6年前
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
6年前
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
6年前
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
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