AMRN Looks for a deal…
Steve Schultz Sr. Director of IR
- 0:40 Safe harbor statement
- Schultz gives $AMRN’s website URL as “triple w amarin corp dot com” <- IR guy is a hipster?
CEO Joseph S. Zakrzewski
- 7 patents “in play” w/ USPTO [we’re gonna get ‘em even if we have to grease a few palms]
- 25 patents currently on file w/ USPTO [throw enough shit against the wall, some of it’s gonna stick]
- Also received “intention to grant” letter for MARINE method of use patent in Europe
- <blah blah blah…>
- Ended June 30,2012 w/ $250MM on hand
- Getting ready to file sNDA for high triglyceride w/ ANCHOR results
- Can file ANCHOR based sNDA when REDUCE-IT (cardiovascular outcomes trial - CVOT) is substantially underway expected in 2012 [why are they linked?]
- 3 paths to commercialization …(partner, buyout, solo)
- Launch anticipated in early Q1’13. Various preparatory steps to take for launch.
- Lead suppliers have passed inspections.
- Accumulate material for launch.
- 6:45 yada yada yada <Vascepa is not Lovaza…it’s Lovaza-Plus!>
- Vascepa exclusivity will be gained through patents, regulatory exclusivity [NCE], maintaining trade secrets [weak] & taking advantage of manufacturing barriers to entry [riiiiiiight…].
- Progress on patent front…
- Issuance of 1 patent, notice of allowance for one application & 5 “reasons for allowance” for others.
- *** NCE reg exclusivity…still in active dialog w/ FDA. Since approval, AMRN has had continued dialog w/ FDA about NCE. “Hopeful” [is not a strategy] for NCE decision in time for inclusion in August Orange Book supplement…but it’s “also possible that decision may go longer.” At this time, FDA has not advised AMRN of a delay [they also have not told AMRN that they will not be allowed to sell blow on street corners] OR a decision [bullshit].
- Since we’re still talking w/ FDA, we’re not going to make any more comments OR field questions about it…so everybody shut your pie holes about this.
Near-term potential newsflow
- partnering info
- NCE decision
- addition of 4th supplier
- REDUCE-IT CV outcomes study substantially underway
- sNDA filing using ANCHOR data
- sNDA submission for expanded supply chain
- additional news on patents
- scientific publications & presentation of MARINE data in Germany
- combination product vascepa + “leading” statin
- commercial launch
Financial results update
- $250.3 million on June 30.
- 9:52 <yawn>
- increased costs are due to launch and clinical trials
- Expect to spend ~ $25 - 35 million to stockpile Vascepa for launch inventory [any ideas on what this translates to in potential sales?]…how long can you keep stockpiled fish oil?
- Dewey Decimal (JPMorgan) Can you opine [Dewey must be a lawyer] on the recent stock sales? Were they previously planned? Could you have backed out of the sales? How much exposure does Sr. Mgmt still have? Why the F*#(* did you sell??
All sales previously planned. Represent 5% of CEO’s holdings. Fiscal fiduciary management [CEO sounds embarrassed].
- You said you were building launch supplies. How much of a supply do you anticipate $25 - 35 million worth of Vascepa will be?
We aren’t prepared to give guidance on that.
- Canaccord Genuity (??) Where are you on the hiring of sales people? Managers in place? Interviewing reps?
Large supply of sales people because the job market is in the crapper. Sales piece cranks up in october (if & when we get there) [wink wink].
- Will you have “activity” in American Heart Association meeting in the fall?
Yes. Continue CME efforts in many cardiovascular forums.
- Status on manufacturing sNDAs?
Hope to have 1 or 2 filed by EOY. Maybe a 3rd sNDA filed in Q1’13. Announce 4th supplier very shortly.
- You talked about a statin-combination product? Have you picked a final formulation? Are you only moving forward w/ 1 statin? Or multiple statins?
We *have* a final formulation, but that’s all we’re going to say. We have a statin or statins picked out [depends on partner/buyer?]. Expect to start statin combo study by EOY.
- Is the formulation a spray-coated capsule?
Not gonna say.
- Tommy Nguyen (Jefferies). Give some color on biz dev. Is there a value creation event (IP/NCE?) that potential partners are still looking for? Or are you beyond that in negotiations? What the F*#*#( is taking so long??
dodge…weave…”discussions continue to increase in activity”…dodge
- On timing of filing of sNDA for ANCHOR. Why are they tied to each other? Can you clarify how clear an understanding you have of the requirement to enroll in the outcomes study before filing? Is there some risk to delay from perhaps an incomplete understanding of the requirement?
Believe we’ll have [sNDA ANCHOR] approval in 2H’13…we’re comfortable with that guidance…and that’s all we’re gonna say about that.
- Vascepa is listed as 1 of 40 or so cardiovascular medicines on FDA website, but Lovaza isn’t. Does this mean anything significant?
Probably not. FDA is probably just lax on their website [tell me about it].
- Ram S (Avis capital?)? Supply situation. Have you had discussions w/ BASF following their acquisition of Equitech? What’s the status of your relationship w/ BASF and their commitment to large scale manufacturing of omega-3 fatty acids? [What the F@#@$ is Ram asking? Just spit it out. Don’t pussy foot around asking touchy-feely questions about your relationship].
CEO’s lips move, but say nothing
- REDUCE-IT. What are the other CV outcomes studies being performed with other drugs that are ongoing related to triglyceride lowering and how does REDUCE-IT compare?
Not the best person to ask about other people’s trials.
- Can you provide color on higher doses of Vascepa?…you didn’t reach a maximum effective dose. Will you run higher-dose trials?
[Seems lukewarm about higher dose trials.] MDs can dose at whatever dose they want.
- What about pricing of Vascepa, esp relative to PCSK9 (e.g., AMG-145) inhibitors?
We’re looking to shift [market] share (eat Lovaza’s lunch) and expand the market…our goal is to get to Tier 2 as quickly as possible.
A lot of exciting times over the next 60 to 90 days [probably shouldn’t read too much into this]