[ad_1]
SIphotography/iStock by way of Getty Pictures AQST brand
Aquestive Therapeutics (NASDAQ:AQST) was based in 2004 and relies in Warren, NJ. The corporate is growing oral or sublingual modes of administration for current medication, thus offering handy various modes of administration for sufferers. The firm has developed PharmFilm expertise for high-performance drug supply via the sublingual, lingual, or buccal routes.
Current 5 commercialized merchandise utilizing PharmFilm expertise
The corporate has 5 commercialized merchandise, that are marketed via its companions in america and worldwide. These embrace Sympazan (clobazam) oral movie and Suboxone sublingual movie. The corporate has additionally acquired FDA tentative approval for Libervant, diazepam buccal movie for acute remedy of seizures in inpatients 12 years of age and extra. The corporate is planning to out-license Libervant in China within the close to time period. The US launch is deliberate for 2027.
Anaphylm, a greater resolution to a $1 billion drawback
The corporate is growing Anaphylm, a sublingual Epinephrine movie to deal with anaphylactic reactions. The sublingual route has the benefit of fast onset of motion with direct entry into the systemic circulation. That is the primary orally administered formulation of epinephrine to deal with this doubtlessly deadly situation. The product candidate is competing with epinephrine auto-injectors like Epipen and epinephrine intramuscular injections, that are generally used for the emergency remedy of anaphylaxis.
Roughly 32 million individuals within the US are at continual danger for acute anaphylaxis. The goal addressable market is roughly $1 billion per 12 months. Epinephrine auto-injectors are cumbersome and arduous to hold. In a survey, 52% of sufferers with a historical past of anaphylaxis had by no means acquired an Epinephrine auto-injector prescription. In the identical survey, 60% of sufferers didn’t have an Epinephrine auto-injector presently out there. 25 to 50% of sufferers refuse remedy with Epinephrine autoinjectors because of reluctance to needles. 25 to 30% of sufferers and their caregivers fail to correctly administer injectable Epinephrine when wanted. Just lately, FDA has additionally highlighted the boundaries to injectable Epinephrine use in a public doc.
The corporate’s resolution to this drawback is Anaphylm, Epinephrine sublingual movie which is developed utilizing Pharmfilm expertise. It’s the first and solely non-device-based Epinephrine formulation and might be conveniently carried in a pocket or pockets. It’s also extra handy to hold and administer than current or newer merchandise in growth like Epinephrine nasal spray. The corporate has patent purposes to increase its mental property till 2042.
Pharmacokinetic, PK research confirmed sooner onset of motion than current therapies. The median time to peak focus or Tmax of Anaphylm was 12 minutes in comparison with 23 minutes for EpiPen and 50 minutes for 0.3 mg intramuscular injection.
Quicker onset of motion for Anaphylm in comparison with Epipen and IM injections (Investor presentation)
The remedy confirmed comparable publicity to Epinephrine auto-injectors in the course of the first 10 minutes after dosing. That signifies that the Cmax ranges had been bracketed by presently authorized therapies as really useful by the FDA.
Cmax ranges for Anaphylm are bracketed by current injectable formulations as really useful by the FDA (Investor presentation)
The subsequent steps are to refine administration directions within the ongoing pilot research, AQ109103, and to finalize the pivotal research protocol, which is predicted to be submitted to the FDA this quarter. The corporate is focusing on NDA submission for FDA approval within the second half of subsequent 12 months and a possible business launch in 2024.
Skilled Administration for efficient commercialization:
CEO Dan Barber earlier served because the Chief Working Officer of the corporate and held numerous positions in Quest Diagnostics within the company planning and worldwide divisions. SVP of Operations Cassie Jung held numerous positions in areas like High quality Assurance, Alliance Administration, Scientific Operations, and Portfolio Administration on the firm since 2004. Chief Medical Officer Dr. Kraus was a Medical Officer for the Heart of Drug Analysis and Analysis, CDER, and was the founder and CEO of Arrevus, which was acquired by Aceragen. Chief Industrial Officer Ken Marshall served in numerous roles at GSK (GSK) for 17 years together with the Vice President of Advertising and marketing for the Neurology, Urology, Lifecycle, and HIV enterprise items. He additionally served because the US President and World Chief Advertising and marketing Officer for Aerocrine Inc.
The corporate is undervalued primarily based on simply the prevailing income, excluding Anaphylm
The corporate had $48 million in income in 2022. The web earnings was $8.1 million in Q1 2023. The administration’s forecast for 2023 income is $42M-$48M. Money reserves are $27 million on the finish of Q1 this 12 months. Lengthy-term debt was $25.2 million on the finish of Q1 and the corporate is engaged on lowering it. The long-term debt/fairness ratio is suitable at round 22% (often lower than 50% is suitable). Money reserves appear ample for the subsequent 12 months contemplating that the online working money stream was optimistic within the final 12 months.
Taking a look at relative valuation, the ahead EV/gross sales ratio is 2.6, which is decrease than the sector common of round 4. The present enterprise worth of the corporate is simply $115 million, which is low simply contemplating the prevailing income. The corporate has a shot at capturing market share within the $1 billion/12 months Epinephrine for anaphylaxis market, contemplating the comfort, sooner onset of motion, comparable most serum ranges of Anaphylm vs. current Epinephrine merchandise, and comfort for repeated dosing if wanted. One other alternative for the corporate is Libervant, which is focusing on acute rescue remedy of seizures, a market anticipated to achieve $4.3 billion/12 months by 2027.
The imply Wall Road analyst value goal on the inventory is $6 or 270% upside potential (supply: Searching for Alpha). The newest top-ranked Wall Road analyst value goal is $3 or 87% upside potential from Wedbush 18 days in the past.
The inventory has gone up 3x this 12 months since March and has pulled again round 35%, thus providing a very good entry level with a timeframe of no less than 1 to 1.5 hours until Anaphylm approval. Score Purchase.
Dangers within the funding
Potential dangers on this funding embrace a delay within the timeline for Anaphylm NDA submission because of extra requests from the FDA which might trigger the inventory value to fall. Anaphylm is competing with a number of merchandise together with a nasal spray in growth and will not be capable to acquire vital market share after commercialization. Gross sales of current merchandise could not present progress whereas a rise in working bills because of components like commercialization of newer merchandise could trigger the online earnings to be destructive. The corporate is predicted to want extra capital for the commercialization of Anaphylm after launch leading to dilution. Investing in developmental-stage biotech/pharma shares is dangerous and is probably not appropriate for all buyers. It’s attainable to lose all of the capital invested. This word represents my very own opinion and isn’t skilled funding recommendation. Please conduct your individual analysis earlier than making any investing choices.
Editor’s Observe: This text covers a number of microcap shares. Please concentrate on the dangers related to these shares.
[ad_2]
