For those that just don't have the time to read the 10+ page transcript, just for you....can you feel the love??
Earnings Call Aug 7, 2013 my Abstract of the Transcript provided by Seeking Alpha.
This abstract will solely focus on the programs discussed during the call and as such, not the financials which are readily available and clear.
Recap / Intro from CEO Wotton:
• Extremely active 2nd Q
• Update for Otrexup launch – primary focus
o Successfully recruited highly qualified 8 person marketing and sales team resulting in over 100yrs of experience in marketing, launching and selling.
o Engaged 6 national account managers (agreement with Quintiles, largest provider of commercial outsourcing services in the development / commercializing the top 50 selling drugs on the market.
o Already met with 3rd party payers.
o In process of engaging 6 medical science liaison professionals to implement sales force activity w/ approx 25 personnel in 4th Q.
o Grew Board of Directors with recruitment of Marvin Samson (Former Group VP Worldwide Injectables at TEVA, founded Sicor) and Bob Roche Jr., (former Exec VP,Worldwide Pharma Operations Cephalon).
o Recently participated in prestigious European League Against Rheumatism (EULAR)
o Successfully manufactured the validation batches of OTREXUP.
o Conducted positive mid-cycle review with FDA – continue to have positive interactions.
o April saw 1st shipment to TEVA of the Vibex EpiPen and pleased with progress made w/ respect to broad partnership with TEVA
• Intellectual Property
o Over the past 18 months, filed 43 patent application and received 9 new patents.
o In June, USPO issued patent number 8,480,631 (Hazardous Agent Injection System for OTREXUP = 17 years of intellectual property protection for OTREXUP.
o QS device received a new patent no. 8,496,619 (QuickShot device QS T)
? Accelerated development of QS T program
? Expect initial dosing of 1st patients during the 3rd Q
? Continue to plan for a 2016 launch.
? 100% dosage efficiency
“EXPECT TO SEE MUCH MORE SUCH OPPORTUNITIES EMERGING FROM OUR PIPELINE”
Antares Business Model Recap:
o Implemented October 13, 2008, implemented a 5 year strategic plan.
o Refocus the business
o Invest in the pipeline
o Establish position as a specialty pharma co. built on world class injection technology.
o Market cap of $.5billion
o Only US company with comprehensive range of injector platforms.
o ANDA for the 1st multi-dose pens on track.
o FDA (this yr) all 3 device platforms (needle free, VIBEX Medi Jet and multi dose pens) will either been filed and under review or potentially approved for marketing.
o Disciplined approach to screening potential drug device combinations to create novel products.
o Screened approx 200 compounds resulting in 60 interesting candidates.
o 30 compounds deemed feasible.
o 3 to date have been selected (OTREXUP, QS T and QS M)
o Our product process targets already approved molecules.
o Pursuing (always) meaningful clinical benefit with the route switch to SubQ delivery.
o Produce enhanced products with significant revenue potential.
o Antares is an efficient 505(b)(2) machine.
o Entering a new planning cycle.
TEVA:
o EpiPen program, launch date of June 2015, believe that target will be met.
o Approval of the auto-injector well before that date is our belief.
o ANDA program – filing shortly – expect a 30 month stay once filed.
o There is another multi dose pen program as well.
o Spearheaded in Europe
o A branded generic 505(b)(2) type of approach (moving real well)
o TEVA relationship “have gone extremely well the past few months. And I would say the relationship with Teva goes all the way to the top of the company and across the company……it’s better than it’s ever been before.”
