d******8
发帖数: 1972 | 1 老牛从6块时就一直推荐的牛股。这几天从13多调整下跌12块左右，今天下午ER，不知
会怎么
样？在FDA 6月决定之前，我觉得上16块的可能性很大。
现在犹豫是现在买入还是等ER后再看？ | c**t
发帖数: 2889 | 2 我是一直hold的，打算过了FDA之后再看
【在 d******8 的大作中提到】
: 老牛从6块时就一直推荐的牛股。这几天从13多调整下跌12块左右，今天下午ER，不知
: 会怎么
: 样？在FDA 6月决定之前，我觉得上16块的可能性很大。
: 现在犹豫是现在买入还是等ER后再看？
| c**t
发帖数: 2889 | 3 我赌大，虽然输的次数比较多
【在 d******8 的大作中提到】
: 老牛从6块时就一直推荐的牛股。这几天从13多调整下跌12块左右，今天下午ER，不知
: 会怎么
: 样？在FDA 6月决定之前，我觉得上16块的可能性很大。
: 现在犹豫是现在买入还是等ER后再看？
| d******8
发帖数: 1972 | 4 好像没有什么影响。
http://finance.yahoo.com/news/amarin-reports-first-quarter-2012
BEDMINSTER, N.J., and DUBLIN, Ireland, May 8, 2012 (GLOBE NEWSWIRE) --
Amarin Corporation plc (Nasdaq:AMRN - News), a late-stage biopharmaceutical
company focused on cardiovascular disease, today announced financial results
for the quarter ended March 31, 2012 and provided an update on company
operations.
Amarin noted the following highlights since the quarter ended December 31,
2011:
Received Notice of Allowance for patent application 12/052,598 known as the
EPA with no DHA in a capsule application
Strengthened balance sheet with the issuance of $150M exchangeable senior
notes ending Q1 2012 with a cash balance of $245.8 million
Received notification from FDA that no Advisory Committee meeting will be
scheduled in connection with its review of the AMR101 NDA
Appointed industry veteran Steve Ketchum to head research and development
Continued progress with AMR101 NDA review (PDUFA date of July 26)
"The first quarter was very positive for Amarin as we made significant
progress on many fronts highlighted by the Notice of Allowance for the '598
patent application," stated Joseph Zakrzewski, Amarin's Chairman and Chief
Executive Officer. "With the MARINE indication PDUFA date in July 2012, we
are advancing our business plan to maximize the value of AMR101 which we
believe is differentiated in its class with the potential to redefine lipid
management therapy."
Operational update
AMR101 intellectual property update
A top priority for Amarin in the first quarter of 2012 was, and continues to
be the ongoing prosecution of the company's patent application portfolio
consisting of greater than 16 patent applications. On March 20, Amarin
announced that the United States Patent Trademark Office issued a Notice of
Allowance for Amarin's patent application 12/052,598 titled "Highly Purified
Ethyl EPA and Other EPA Derivatives." Amarin submitted the fee associated
with this application and expects the patent to issue within the customary
period. Amarin's strategy for enhancing the competitive position of AMR101
consists of pursuing robust patent protection, seeking regulatory
exclusivity, maintaining trade secrets and taking advantage of manufacturing
barriers to entry, with the goal of protecting the commercial potential of
AMR101 until 2030 and beyond.
AMR101 regulatory update
Amarin's New Drug Application (NDA) on file with the U.S. Food and Drug
Administration (FDA) requesting approval of AMR101 for use in the treatment
of patients with very high triglycerides (>=500 mg/dL), the patient
population studied in Amarin's MARINE Phase 3 trial, has been assigned a
Prescription Drug User Fee Act (PDUFA) date of July 26, 2012. Amarin is
currently supporting the FDA's review of the NDA. Amarin reiterates prior
guidance regarding expectations for both AMR101 approval in the second half
of 2012, and commercial launch in Q1 2013.
Amarin currently plans to file a supplemental NDA (sNDA) for the use of
AMR101 in the treatment of patients with high triglyceride levels (>=200 and
<500mg/dL) who are also on statin therapy for elevated low-density
lipoprotein cholesterol, or LDL-C levels (mixed dyslipidemia), or what the
company refers to as the ANCHOR indication. This population was studied in
Amarin's ANCHOR Phase 3 trial. The sNDA for this indication can be submitted
once the submitted NDA for the MARINE indication is approved and Amarin's
cardiovascular outcomes study, REDUCE-IT, is substantially underway as
determined by the FDA.
The MARINE, ANCHOR and REDUCE-IT studies are each conducted under a Special
Protocol Assessment (SPA) agreement with the FDA. An SPA represents
agreement between the FDA and a company on the design and analysis of a
clinical trial before it begins.
Outcomes study update
Amarin's REDUCE-IT cardiovascular outcomes study, designed to evaluate the
efficacy of AMR101 in reducing major cardiovascular events in a high-risk
patient population on statin therapy, is currently underway with the first
patient dosed in December 2011. The REDUCE-IT outcomes study is estimated to
be completed in about six years and is anticipated to include approximately
8,000 patients. Amarin expects to have the REDUCE-IT outcomes study
substantially underway by the end of 2012.
Anticipated presentations
As part of Amarin's program for communicating further details of its
clinical results, Amarin expects to present posters at May and June
conferences of the National Lipid Association, the American Diabetes
Association and the International Society for the Study of Fatty Acids and
Lipids.
In addition, Amarin is scheduled to present at various upcoming investor
conferences
In addition, Amarin is scheduled to present at various upcoming investor
conferences, including the 2012 Jefferies Global Healthcare conference (New
York, June 7), the 32nd Annual Canaccord Genuity Growth Conference (Boston,
August 14-16) and the Wedbush 2012 Life Sciences Management Access
Conference (New York, August 14-15).
Financial update
Amarin reported cash and cash equivalents of $245.8 million at March 31,
2012. This cash balance includes proceeds from the issuance in January 2012
of $150 million in 3.5% exchangeable senior notes due 2032, the net proceeds
of which were approximately $144.3 million.
During the three months ended March 31, 2012, net cash outflows were
approximately $15.9 million. Included in these cash outflows were $4.7
million paid to clinical research organizations in connection with Amarin's
AMR101 clinical trial activities as well as various costs associated with
commercial readiness and expanded patent prosecution.
Under U.S. Generally Accepted Accounting Principles (GAAP), Amarin reported
net loss of $88.3 million in the first quarter of 2012, or basic and diluted
loss per share of $0.65, primarily due to a $66.2 million non-cash loss on
the change in value of the warrant derivative liability. In the first
quarter of 2011, GAAP net income was $18.3 million (basic income per share
of $0.15 and diluted income per share of $0.12), primarily due to a $25.3
million non-cash gain on the change in value of derivative.
Excluding non-cash gains or losses for share-based and warrant-based
compensation and change in value of derivative, non-GAAP adjusted net loss
was $15.8 million for the first quarter of 2012 (basic and diluted loss per
share of $0.12), compared to a non-GAAP adjusted net loss of $6.2 million (
basic and diluted earnings per share of $0.05) for the same period in the
prior year.
As of March 31, 2012, Amarin had approximately 136.4 million ADSs
outstanding as well as approximately 21.1 million warrants, 12.8 million
stock options and 0.6 million restricted stock units outstanding at average
exercise prices of $1.48, $5.91 and $8.86, respectively. In addition, the $
150 million of 3.5% exchangeable senior notes due 2032 issued in January
2012 are exchangeable, subject to certain conditions, into up to
approximately 17.0 million ADSs. The notes accrue interest at an annual rate
of 3.5%, payable semiannually in arrears on January 15 and July 15 of each
year, beginning on July 15, 2012. The notes mature on January 15, 2032,
unless earlier repurchased or redeemed by the company or exchanged by the
holders.
Conference call and webcast information
Amarin will host a conference call at 4:30 p.m. EDT today, May 8, 2012. To
participate in the call, please dial (877) 407-0778 within the United States
or (201) 689-8565 from outside the United States. A replay of the call will
be made available for a period of two weeks following the conference call.
To hear a replay of the call, dial (877) 660-6853 (inside the U.S.) or (201)
612-7415 (outside the U.S.). A replay of the call will also be available
through Amarin's website shortly after the call. For both dial-in numbers
please use account number 286 and conference ID 393499. The conference call
can also be heard live through the investor relations section of Amarin's
website at www.amarincorp.com.
Use of non-GAAP adjusted financial information
Included in this press release and the conference call referenced above are
non-GAAP adjusted financial information as defined by SEC Regulation G. The
GAAP financial measure most directly comparable to each non-GAAP adjusted
financial measure used or discussed, and a reconciliation of the differences
between each non-GAAP adjusted financial measure and the comparable GAAP
financial measure, are included in this press release after the condensed
consolidated financial statements.
Non-GAAP adjusted net loss was derived by taking GAAP net loss and adjusting
it with non-cash gains or losses for share-based compensation, warrant
compensation, and change in value of derivative. The company's management
believes that these non-GAAP adjusted measures provide investors with a
better understanding of the company's historical results from its core
business operations.
While management believes that these non-GAAP adjusted financial measures
provide useful supplemental information to investors regarding the
underlying performance of the company's business operations, investors are
reminded to consider these non-GAAP measures in addition to, and not as a
substitute for, financial performance measures prepared in accordance with
GAAP. Non-GAAP measures have limitations in that they do not reflect all of
the amounts associated with the company's results of operations as
determined in accordance with GAAP. In addition, it should be noted that
these non-GAAP financial measures may be different from non-GAAP measures
used by other companies, and management may utilize other measures to
illustrate performance in the future.
About AMR101
AMR101 (icosapent ethyl) is an ultra pure omega-3 fatty acid, comprising not
less than 96% EPA (icosapent ethyl), that Amarin is developing as a
treatment for patients with very high triglyceride levels (>=500 mg/dL), and
for patients with high triglyceride levels (>=200 and < 500mg/dL) who are
also on statin therapy for elevated low-density lipoprotein cholesterol, or
LDL-C, levels (which we refer to as mixed dyslipidemia). The efficacy and
safety of AMR101 were studied in two Phase 3 clinical trials, the MARINE
trial, which studied patients with very high triglyceride levels, and the
ANCHOR trial, which studied patients with high triglyceride levels who were
also on statin therapy for elevated LDL-C levels. These two Phase 3 clinical
trials showed favorable results in triglyceride reduction compared to
placebo in the studied patient populations. Reduction in triglyceride levels
was achieved without a statistically significant increase in LDL-C levels,
and in the 4 gram AMR101 ANCHOR results, with a statistically significant
decrease in LDL-C levels. These trials also showed favorable results,
particularly with the 4 gram dose of AMR101, in other important lipid and
inflammation biomarkers, including Apo-B, non-HDL-C, Total-Cholesterol, VLDL
-C, Lp-PLA2, and hs-CRP. In these trials, AMR101 exhibited a safety profile
comparable to placebo. In December 2011, Amarin commenced patient dosing in
a cardiovascular outcomes study of AMR101, titled REDUCE-IT (Reduction of
Cardiovascular Events with EPA -- Intervention Trial), that is designed to
evaluate the efficacy of AMR101 in reducing major cardiovascular events in a
high risk patient population on statin therapy.
About Amarin
Amarin Corporation plc is a late-stage biopharmaceutical company with
expertise in lipid science focused on the treatment of cardiovascular
disease. Amarin has filed a New Drug Application (NDA) with the U.S. Food
and Drug Administration (FDA) for the use of its lead product candidate,
AMR101, in the treatment of patients with very high triglyceride levels (the
population studied in Amarin's MARINE trial), and the FDA has assigned a
Prescription Drug User Fee Act (PDUFA) date of July 26, 2012. Amarin plans
to separately seek approval for use of AMR101 in the treatment of patients
with high triglyceride levels who are also on statin therapy for elevated
LDL-C levels, the population studied in the ANCHOR trial, if the FDA
approves the MARINE indication and after the REDUCE-IT cardiovascular
outcomes trial is substantially underway. Each of the MARINE, ANCHOR and
REDUCE-IT studies is the subject of a Special Protocol Assessment (SPA)
agreement with the FDA. Amarin also has next-generation lipid candidates
under evaluation in preclinical development.
Forward looking statements
This press release contains forward-looking statements, including statements
about the timing of FDA decisions regarding AMR101 and the likelihood of
advisory committee review, the efficacy, safety and therapeutic benefits of
AMR101, Amarin plans to seek approval for its product candidates, prepare
for commercialization of its product candidates, obtain patent protection
and regulatory exclusivity for its product candidates, maintain trade
secrets, take advantage of manufacturing barriers to entry, enroll patients
in its cardiovascular outcomes study and expected costs related thereto and
publish data from its studies. These forward-looking statements are not
promises or guarantees and involve substantial risks and uncertainties.
Among the factors that could cause actual results to differ materially from
those described or projected herein include the following: uncertainties
associated generally with research and development, clinical trials and
related regulatory approvals; the risk that SPAs are not a guarantee that
FDA will approve a product candidate upon submission; the risk that FDA may
not complete its review of the NDA by the PDUFA goal date or grant new
chemical entity regulatory exclusivity to AMR101; the risk that historical
clinical trial enrollment and randomization rates may not be predictive of
future results and related cost may increase beyond expectations; the risk
that patent applications may not result in issued patents, issued patents
may not prevent competitors from competing with AMR101, trade secrets may
not be maintained and that circumstances that create manufacturing barriers
to entry may not last; and the risk that publications of scientific data may
not accept proposals to publish AMR101 data. A further list and description
of these risks, uncertainties and other risks associated with an investment
in Amarin can be found in Amarin's filings with the U.S. Securities and
Exchange Commission, including its most recent Annual Report on Form 10-K
and its most recent Quarterly Report on Form 10-Q. Existing and prospective
investors are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. Amarin undertakes no
obligation to update or revise the information contained in this press
release, whether as a result of new information, future events or
circumstances or otherwise.
Amarin's product candidates are in various stages of development and are not
available for sale or use outside of approved clinical trials. Nothing in
this press release should be construed as marketing the use of such product
candidates. |
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