- AIS reported 3q11 results and held a conference call 11/8/2011
- Click here to access earnings PRs from all companies I cover
- Click here for complete Upcoming Events calendar with links to my notes
- Visit the complete Antares Pharma stock research page for additional details
- My notes from the conference call are below:
- Achieved record quarterly revenues of $3.9 million for the third quarter and $11.0 million for the year-to-date period.
- Increased quarter and year-to-date product revenue 33% and 41%, respectively, compared to the same periods in 2010.
- Granted U.S. Patent number 8,021,335 by the United States Patent and Trademark Office (USPTO), covering technology used in the Company’s VIBEX platform of needle-assisted jet injection devices. The patent provides protection for the VIBEX technology until 2027 [protects entire VIBEX platform. Two MTX-specific patents have also been filed].
- Ended the quarter with $32.2 million in cash and investments.
Conference call notes:
- 3q2011 completed VIBEX MTX (methotrexate for rheumatoid arthritis) trial vs conventional needle and syringe. Continue to have productive discussions with regulatory agencies - believe we have clear development path forward that we are more than capable of executing on
- MTX program can capture much larger share of economics by commercializing alone in US and partnering in Europe - where a number of interested parties have approached us
- Anturol gel for OAB: confident that unique metered dosing will provide differentiation and drive adoption. PDUFA date in 12/8/2011 - encouraged by interactions to date and look forward to the decision. Eligible for regulatory and commercial milestone payments and escalating royalties
- Libigel top-line data this quarter from BPAX. Also this quarter received notice of allowance of new patent that will cover LibiGel and enhance its IP protection.
- Teva alliance - continues to drive growth.
- 3q11 development revenue includes funding fro Watson re Anturol manufacturing prep for commercialization
- Lower R&D costs from finishing Anturol trial partially offset by increased spend on MTX
- Sales, marketing, business development expenses $0.4m in 3q11 vs $0.2m 3q10, mostly due to professional services related to potential partnerships, plus market research for MTX
- "We continue to see expanding market opportunities coming from the differentiating value of our proprietary injectable delivery system as well as new geographic licensing opportunities for our gel based products"
HgH - trends in new patient starts? Teva or Ferring price increases?
New patient starts from Teva continue to be really strong with a number of "third party wins" - get all lives of a particular plan/HMO (for a discount). Don't believe there was significant price increases. Ferring - sales continue to grow every year - increasing patient numbers in face of pricing decreases. Nice split between 5 and 10 mg dose, expanding into new Asian territories
Teva PK study using 10 mg dose, was supposed to start in 3q2011, any update?
The study is ongoing now by Teva as we speak. Expect to finish by end of year, don't know how long for data after that and file with FDA. Hopeful that 10 mg works and is approved over next year or so.
MTX - have you met with FDA this quarter - is proposal for 1-2 mont usability study is sufficient?
We did meet this quarter, quite pleased with outcome. Very clear path forward - now an execution story. Do have to do some usability studies (plural) in patients with RA using VIBEX MTX device.
MTX - timing of path to approval?
Timing of development - FDA did require adding usability study into program - still projecting filing in next 15-18 months (this is a slip from prior guidance of NDA filing in 2012), approval and launch within 9-12 months thereafter. Already tarted with marketing research. Session this week at ACR, very excited by reaction from rheumatoligists who liked the device.
MTX - costs to finish development and launch?
Still working out those details, only met with FDA few weeks ago, now getting usability studies priced out. Next quarter call will be able to better indicate cost, no where near total for Anturol program. Need about 30-35 reps for rheumatology market, don't have marketing budget in mind, but imagine somewhere in $5-6m range between now and launch. Since August data publication, have had a lot of pharma interest both in US and EU - good validation of market research. Keeping options open on marketing vs partnering, comes down to economics. Would only look at profit share deal not royalties - need to drive top-line growth and not just royalty growth, don't want to just be royalty company. May be able to use ex-US partnering to fund internal spend. Don't see big increase in burn in 2012.
R&D at $1.4m run rate going forward?
Generally around this range. Down a bit in 4q11. Start rest of MTX program at end of 2011 or early 2012. Will see increase in capital for MTX - buying molds, tooling in 2012 - before this always paid for by Teva.
High COGS this period?
Still in 50% range. Last year benefited from license payments. Some of revenue from Watson $WPI have been pass-throughs - cost is 100% of revenue. Still expect about 50% margin on products. Watson payments for manufacturing readiness will continue in fourth quarter - getting validation lots ready and commercial product assuming approval.
MTX - any modifications needed to device vs that used in PK study?
Clinical study completed in August results in us making two changes to device to make it easier for patients to use/handle. New device will be incorporated in usability study. Really happy with OP around device and product. 15-18 month timeline is conservative.
Teva programs update and "state of the union"?
EpiPen claims construction hearing held in September between Teva and King. Went well in our opinion. Next key date is hearing in February 2012 with final resolution potentially in March 2012.
Development revenue ($2.7m for year) speaks to progress we're having with second autoinjector and pen products.
Second autoinjector, still pushing hard to launch product next year, depends on how long it takes FDA to review info when we will file the amendment (hope to file early next year -later said "first half of 2012"). Will conduct user study, hopefully finish that up this year.
Pen programs - they're a little bit farther along, dealing with patent expirations and so forth. Teva is looking to file ANDA for one and potentially 505(b)(2) for the other. They are working on drug side of it - getting cartridge line going for the two products. We haven't missed any milestones on device side of it. Teva controls development side.
Anturol NDA, comment on discussions?
Let me just say we are looking forward to PDUFA date only 4 weeks away. We believe PDUFA date will be met based on type of questions.