1. Biotechnology
Oncothyreon
Outperform (1)
ONTY reports earnings on the heels of a tough
March 7, 2012
trading day
Analysts Conclusion: ONTY held its 4Q11/FY2011 earnings call yesterday after market
Simos Simeonidis, Ph.D. close. The call focused on the news of the continuation of the START trial
(646) 562-1386
simos.simeonidis
following the second interim look and provided financial and pipeline updates.
@cowen.com
We view "the trial must go on" news as neutral for the stock. For
Yatin Suneja more on our view on the impact of the continuation of the START trial, see
(646) 562-1388
yatin.suneja@cowen.com
our report published yesterday morning. Briefly, we view the news that the
DMC recommended that the trial must go on to completion as a net neutral
for the stock; we don't believe that the fact that the trial was not stopped for
efficacy at the 75% mark, precludes a successful outcome at the final
analysis. In addition, we remind investors that there were futility and safety
analyses in this second interim look, and the fact that the DMC did not
recommend that the trial be stopped for either reason looks positive.
Finally, we see yesterday's sell-off as a buying opportunity, regardless of
any conviction about the final outcome of the trial, even for investors with a
short-term, 6-9 month horizon, since we would expect the stock to recover
at least some, if not all, of yesterday's losses as we get closer to release of
the final data.
Non-Stimuvax pipeline update. ONT-10 will go in the clinic this quarter
and the company expects to present data from the monotherapy Phase II
trial of PX-866 in GBM at ASCO, while data from the two randomized Phase II
trials will be presented in late 2012. The company also guided that they
expect to complete enrollment in all 4 Phase II trials of PX-866 in 2012.
4Q11 and FY2011 numbers reported. ONTY spent $6.6M ($4.2M in
R&D, $2.4M in SG&A) in 4Q and $25M ($18M in R&D, $7M in SG&A) in 2011.
ONTY ended 2011 with $66.4M or ~$1.18/share in cash and guided that cash
used in operations in 2012 will be $30M-$33M.
ONTY (03/06) $5.07 Revenue $MM
Mkt cap $263.6MM FY 2011 2012E 2013E
Dil shares out 52.0MM Dec Actual Prior Current Prior Current
Avg daily vol 15,252.0K Q1 0.1 — 0.0 — —
52-wk range $3.1-11.6 Q2 0.0 — 0.0 — —
Dividend Nil Q3 0.0 — 0.0 — —
Dividend yield Nil Q4 0.0 20.0 0.0 — —
BV/sh $0.64 Year 0.1 20.0 0.0 — 20.0
Net cash/sh $1.18 EV/S — — — — 10.3x
Debt/cap 0.0%
ROA (LTM) NA
5-yr fwd EPS NA EPS $
growth (Norm) FY 2011 2012E 2013E
Dec Actual Prior Current Prior Current
Q1 (0.24) (0.14) (0.17) — —
Q2 (0.09) (0.16) (0.17) — —
Q3 0.22 (0.16) (0.17) — —
S&P 500 1343.4 Q4 (0.27) 0.20 (0.19) — —
Year (1.12) (0.23) (0.71) — (0.35)
CY — (0.22) (0.71) — —
P/E — — — — —
Please see addendum of this report for important disclosures. www.cowen.com
2. Oncothyreon
Company Description
Oncothyreon is an oncology-focused biotech company. The company’s lead
program, Stimuvax, is a therapeutic cancer vaccine that targets the MUC-1 antigen,
and is currently in two Phase III trials in patients with Stage III NSCLC:
(1) the 1476-patient START trial (with final data expected in early 2013), and
(2) the 420-patient INSPIRE trial conducted in five Asian countries, which is expected
to read out around 2014. Oncothyreon is developing Stimuvax via a worldwide
partnership with Merck KGaA, and is entitled to milestones and royalties on net
sales. Oncothyreon's second compound, PX-866, is an oral, irreversible, pan-isoform,
small molecule inhibitor of PI3K, developed as mono- and combination therapy in
four Phase II trials in a variety of solid tumors. Oncothyreon’s is also developing
ONT-10, a next-generation version of Stimuvax, which is currently in preclinical
development, with a Phase I planned for 1Q12. Oncothyreon was founded in 1985, is
headquartered in Bellevue, WA and has approximately 25 employees.
Oncothyreon R&D pipeline
Candidate nam e Indication P- C I II III FILING MKT Com m ents
Stimuvax NSCLC • Final d ata early 2 0 1 3
ONT- 1 0 Oncology • Phase I trial exp ected to start in 1 Q1 2
PX- 8 6 6 Head & Neck, NSCLC • Comb ination with Taxotere (d ocetaxel)
PX- 8 6 6 Head & Neck, CRC • Comb ination with Erb itux (cetuximab )
PX- 8 6 6 Gliob lastoma • Monotherap y trial was initiated b y NCI of Canad a
PX- 8 6 6 Chemotherap y naïve Prostate • Monotherap y trial was initiated b y NCI of Canad a
PX- 8 6 6 IPF •
ONT- 7 0 1 Oncology •
Total D rugs in D evelopm ent 3 0 4 1 0 0
Bellevue, WA Investor Relations Contact: Julie Rathbun - 2 0 6 .7 6 9 .9 2 1 9
Source: Oncothyreon, Cowen and Company
Oncothyreon upcoming milestones
Milestones Timing
Init iat e a Phase I clinical t rial of ONT-10 in solid t umors 1Q12
Dat a from t he Phase II t rials of PX-866 in GBM ASCO 2012
Dat a from t he t wo randomized Phase II t rials of PX-866 EORTC-NIC-AACR 2012
START t rial: Full dat a early 2013
Source: Oncothyreon, Cowen and Company
2 March 7, 2012
3. Oncothyreon
Investment Thesis
Oncothyreon is an oncology-focused biotech with two compounds in the clinic:
(1) Stimuvax, an off-the-shelf, therapeutic cancer vaccine that targets MUC-1-
expressing cells, in a WW partnership with Merck KGaA, currently in two Phase III
trials in Stage III NSCLC, with final data expected in early 2013, and
(2) PX-866, an oral, irreversible, pan-isoform inhibitor of PI3K, which is being tested
as both a monotherapy and in combination with Erbitux and Taxotere in four Phase
II trials in a number of solid tumors, with data expected in mid-2012. The company
plans to initiate clinical development of its third asset, ONT-10, an improved, next-
generation version of Stimuvax, in 1Q12.
(1) Stimuvax: A therapeutic cancer vaccine for lung cancer with Phase III data
expected early 2013. Oncothyreon’s lead program, Stimuvax, a therapeutic cancer
vaccine that targets MUC-1-expressing cells, is being developed via a WW
partnership with Merck KGaA, and has shown a 17.3-month survival benefit in a
randomized, controlled Phase IIb trial in Stage IIIb NSCLC patients. Oncothyreon and
Merck KGaA are testing Stimuvax in two Phase III trials in patients with Stage III
NSCLC: the 1476-patient START trial (with final data expected in early 2013), and the
420-patient INSPIRE trial in an Asian patient population, which we expect to read out
around 2014. If the START trial results in a clinically meaningful overall survival
benefit, Stimuvax has the potential to become a blockbuster in the NSCLC setting
alone; furthermore, given MUC-1's aberrant expression in a number of other cancers,
success in NSCLC could translate in a role for Stimuvax in other solid tumor settings.
Oncothyreon is entitled to receive up to $90M more in regulatory (filings and
approvals) and sales milestones from Merck KGaA, in addition to royalties on sales
ranging from the mid-teens (North America) to the high single digits (ROW).
(2) PX-866: an oral, irreversible, pan-isoform inhibitor of PI3K, in a broad
Phase II development program. With investors’ attention understandably focused
on the Stimuvax, and with the development of Stimuvax being handled by and paid
for by Merck KGaA, Oncothyreon is focusing its efforts on PX-866, an oral,
irreversible, pan-isoform inhibitor of PI3K. PX-866 has a promising preclinical
profile and has shown activity in Phase I data presented at the 2010 ASCO. In late
2010, the company started a broad Phase II development program, with four trials of
PX-866 as monotherapy and in combination with Erbitux and Taxotere in a variety of
solid tumors, with data expected in mid-2012, probably at the 2012 ASCO meeting.
Stimuvax and PX-866: we should know the answers about both of these
programs in the next 9-12 months. In December 2010, the company announced
that the START trial Data Monitoring Committee (DMC) completed the first interim
look (futility and safety analysis) in the trial, triggered by the occurrence of 50% of
the events (353), and recommended that the trial continues. In March 2012, the DMC
completed the second interim look, which was triggered by the occurrence of 75% of
the events (529), and the DMC recommended that the trial continues until
completion, with final results now expected in early 2013. Data from the second
compound in ONTY’s pipeline, oral PI3K inhibitor, PX-866, are expected at ASCO
2012 and in 2H2012. Thus, in the next 9-12 months, we expect to have a steady
stream of data read-outs from ONTY, which should provide investors with answers
as to whether either compound is a drug or not.
Therapeutic cancer vaccines and Phase II oncology: high-risk/high-reward
arenas, even within the volatile small-cap biotech. Therapeutic cancer vaccine
March 7, 2012 3
4. Oncothyreon
development and small molecule oncology are high-risk/high-reward investment
arenas, even within the already volatile small-cap biotech space, with significantly
more failures than successes in both. In addition, our positive view on Stimuvax’s
efficacy and safety is based on a small, albeit promising and prospectively-defined,
subset of a Phase IIb trial of 65 patients (35 and 30 in the Stimuvax and control arms,
respectively), and a confirmatory Phase I/II trial in 22 patients. Finally, on the PI3K
inhibitor program, we believe it is still early days in the development of PX-866,
given that we only have Phase I data from this compound and we will not have a
better understanding of its potential until we have seen data from the Phase II trials,
which will start reading out in mid-2012.
Oncothyreon P&L ($MM)
($MM) 2009A 2010A Q1:11A Q2:11A Q3:11A Q4:11A 2011A Q1:12E Q2:12E Q3:12E Q4:12E 2012E 2013E
Revenues
Royalties on US Net Sales 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Royalties on EU Net Sales 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Royalties on Japan Net Sales 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Royalties on ROW Net Sales 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Total WW Royalties 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Less: Royalties Paid to Univesities on US sales 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Total WW Royalties (Net of royalties on US sales) 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Licensing Revenue from Collaborative Agreements 2.1 0.0 0.1 0.0 0.0 0.0 0.1 0.0 0.0 0.0 0.0 0.0 20.0
Total Revenues 2.1 0.0 0.1 0.0 0.0 0.0 0.1 0.0 0.0 0.0 0.0 0.0 20.0
COGS 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Gross margin
R&D 6.1 11.2 4.2 4.2 5.4 4.2 17.9 6.1 6.3 6.6 7.6 26.6 32.0
SG&A 6.6 7.8 1.8 1.6 1.1 2.4 6.9 1.6 1.8 2.0 2.2 7.6 9.5
Total Operating expenses 12.9 19.5 6.0 5.8 6.4 6.6 24.8 7.7 8.1 8.6 9.8 34.2 41.5
Operating Income/Loss (10.9) (19.5) (5.9) (5.8) (6.4) (6.6) (24.7) (7.7) (8.1) (8.6) (9.8) (34.2) (21.5)
Interest Expense 0.0 0.0 0.1 0.2 0.2 0.2 0.6 0.1 0.1 0.1 0.1 0.5 0.3
Change in Fair Value of Warrant Liability 6.2 (3.0) 1.5 28.0 (16.6) 4.8 17.6 0.0 0.0 0.0 0.0 0.0 0.0
Investment and Other Income/Expense 0.0 0.6 0.3 0.1 (0.1) 0.0 0.3 0.2 0.2 0.2 0.2 0.7 0.7
Pretax income (17.0) (15.8) (7.1) (34.0) 9.9 (11.5) (42.7) (7.7) (8.1) (8.6) (9.8) (34.0) (21.1)
Income tax expense 0.2 (0.2) 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Tax rate 0% 0% 0% 0% 0% 0% 0%
Net Income (Loss) (17.2) (15.6) (7.1) (34.0) 9.9 (11.5) (42.7) (7.7) (8.1) (8.6) (9.8) (34.0) (21.1)
GAAP EPS
Basic $ (0.76) $ (0.58) $ (0.24) $ (0.91) $ 0.24 $ (0.27) $ (1.12) $ (0.17) $ (0.17) $ (0.17) $ (0.19) $ (0.71) $ (0.35)
Diluted $ (0.76) $ (0.58) $ (0.24) $ (0.91) $ 0.22 $ (0.27) $ (1.12) $ (0.17) $ (0.17) $ (0.17) $ (0.19) $ (0.71) $ (0.35)
Basic shares 22.7 26.9 30.1 37.4 41.9 43.2 38.2 45.1 47.0 48.9 50.9 48.0 60.4
Diluted shares 26.4 35.0 39.2 50.8 50.3 52.0 48.1 52.5 53.0 53.6 54.1 53.3 63.8
Source: Oncothyreon, Cowen and Company estimates
4 March 7, 2012
5. Oncothyreon
Stimuvax WW NSCLC revenue model
US Stimuvax NSCLC Revenue Model 2010E 2011E 2012E 2013E 2014E 2015E 2016E 2017E 2018E 2019E 2020E 2021E 2022E
# of newly-diagnosed lung cancer patients 222,520 224,478 226,454 228,446 230,457 232,485 234,531 236,594 238,676 240,777 242,896 245,033 247,189
Population growth 0.88% 0.88% 0.88% 0.88% 0.88% 0.88% 0.88% 0.88% 0.88% 0.88% 0.88% 0.88% 0.88%
% of pts with NSCLC 80% 80% 80% 80% 80% 80% 80% 80% 80% 80% 80% 80% 80%
# of NSCLC patients 178,016 179,583 181,163 182,757 184,365 185,988 187,624 189,276 190,941 192,621 194,317 196,027 197,752
% of pts with Stage III NSCLC 25% 25% 25% 25% 25% 25% 25% 25% 25% 25% 25% 25% 25%
# of pts with Stage III NSCLC 44,504 44,896 45,291 45,689 46,091 46,497 46,906 47,319 47,735 48,155 48,579 49,007 49,438
% of pts eligible for chemotherapy 75% 75% 75% 75% 75% 75% 75% 75% 75% 75% 75% 75% 75%
# of pts eligible for chemotherapy 33,378 33,672 33,968 34,267 34,569 34,873 35,180 35,489 35,801 36,117 36,434 36,755 37,078
% of pts with Stable disease or better 50% 50% 50% 50% 50% 50% 50% 50% 50% 50% 50% 50% 50%
# of pts with Stable disease or better 16,689 16,836 16,984 17,133 17,284 17,436 17,590 17,745 17,901 18,058 18,217 18,377 18,539
Stimuvax Penetration 6% 11% 17% 24% 31% 38% 42% 45% 45%
# of NSCLC patients treated 1,037 1,918 2,990 4,259 5,549 6,862 7,651 8,270 8,343
Cost of treatment/year $75,000 $76,500 $78,030 $79,591 $81,182 $82,806 $84,462 $86,151 $87,874
% price increase 2% 2% 2% 2% 2% 2% 2% 2% 2%
Total US Sales ($MM) $0.0 $0.0 $0.0 $0.0 $77.8 $146.7 $233.3 $339.0 $450.5 $568.2 $646.2 $712.5 $733.1
EU Stimuvax NSCLC Revenue Model 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
# of newly-diagnosed lung cancer patients 387,848 388,235 388,624 389,012 389,401 389,791 390,180 390,571 390,961 391,352 391,743 392,135 392,527
Population growth 0.10% 0.10% 0.10% 0.10% 0.10% 0.10% 0.10% 0.10% 0.10% 0.10% 0.10% 0.10% 0.10%
% of pts with NSCLC 80% 80% 80% 80% 80% 80% 80% 80% 80% 80% 80% 80% 80%
# of NSCLC patients 310,278 310,588 310,899 311,210 311,521 311,833 312,144 312,456 312,769 313,082 313,395 313,708 314,022
% of pts with Stage III NSCLC 25% 25% 25% 25% 25% 25% 25% 25% 25% 25% 25% 25% 25%
# of pts with Stage III NSCLC 77,570 77,647 77,725 77,802 77,880 77,958 78,036 78,114 78,192 78,270 78,349 78,427 78,505
% of pts eligible for chemotherapy 75% 75% 75% 75% 75% 75% 75% 75% 75% 75% 75% 75% 75%
# of pts eligible for chemotherapy 58,177 58,235 58,294 58,352 58,410 58,469 58,527 58,586 58,644 58,703 58,762 58,820 58,879
% of pts with Stable disease or better 50% 50% 50% 50% 50% 50% 50% 50% 50% 50% 50% 50% 50%
# of pts with Stable disease or better 29,089 29,118 29,147 29,176 29,205 29,234 29,264 29,293 29,322 29,351 29,381 29,410 29,440
Stimuvax Penetration 5% 9% 14% 19% 25% 30% 34% 36% 36%
# of NSCLC patients treated 1,402 2,573 3,980 5,624 7,272 8,923 9,872 10,588 10,598
Cost of treatment/year $56,250 $57,375 $58,523 $59,693 $60,887 $62,105 $63,347 $64,614 $65,906
% price increase 2% 2% 2% 2% 2% 2% 2% 2% 2%
Total EU Sales ($MM) $0.0 $0.0 $0.0 $0.0 $78.9 $147.6 $232.9 $335.7 $442.8 $554.1 $625.4 $684.1 $698.5
Japan Stimuvax NSCLC Revenue Model 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
# of newly-diagnosed lung cancer patients 86,161 85,972 85,783 85,594 85,406 85,218 85,030 84,843 84,657 84,470 84,284 84,099 83,914
Population growth -0.22% -0.22% -0.22% -0.22% -0.22% -0.22% -0.22% -0.22% -0.22% -0.22% -0.22% -0.22% -0.22%
% of pts with NSCLC 80% 80% 80% 80% 80% 80% 80% 80% 80% 80% 80% 80% 80%
# of NSCLC patients 68,929 68,777 68,626 68,475 68,325 68,174 68,024 67,875 67,725 67,576 67,428 67,279 67,131
% of pts with Stage III NSCLC 25% 25% 25% 25% 25% 25% 25% 25% 25% 25% 25% 25% 25%
# of pts with Stage III NSCLC 17,232 17,194 17,157 17,119 17,081 17,044 17,006 16,969 16,931 16,894 16,857 16,820 16,783
% of pts eligible for chemotherapy 75% 75% 75% 75% 75% 75% 75% 75% 75% 75% 75% 75% 75%
# of pts eligible for chemotherapy 12,924 12,896 12,867 12,839 12,811 12,783 12,755 12,726 12,698 12,671 12,643 12,615 12,587
% of pts with Stable disease or better 50% 50% 50% 50% 50% 50% 50% 50% 50% 50% 50% 50% 50%
# of pts with Stable disease or better 6,462 6,448 6,434 6,420 6,405 6,391 6,377 6,363 6,349 6,335 6,321 6,307 6,294
Stimuvax Penetration 5% 9% 14% 19% 25% 30% 34% 36%
# of NSCLC patients treated 307 561 865 1,219 1,571 1,922 2,119 2,266
Cost of treatment/year $57,375 $58,523 $59,693 $60,887 $62,105 $63,347 $64,614 $65,906
% price increase 2% 2% 2% 2% 2% 2% 2% 2%
Total Japan Sales ($MM) $0.0 $0.0 $0.0 $0.0 $0.0 $17.6 $32.8 $51.7 $74.2 $97.6 $121.7 $136.9 $149.3
ROW Stimuvax NSCLC Revenue Model 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
# of newly-diagnosed lung cancer patients 857,244 858,101 858,959 859,818 860,678 861,539 862,400 863,263 864,126 864,990 865,855 866,721 867,588
Population growth 0.10% 0.10% 0.10% 0.10% 0.10% 0.10% 0.10% 0.10% 0.10% 0.10% 0.10% 0.10% 0.10%
% of pts with NSCLC 80% 80% 80% 80% 80% 80% 80% 80% 80% 80% 80% 80% 80%
# of NSCLC patients 685,795 686,481 687,168 687,855 688,543 689,231 689,920 690,610 691,301 691,992 692,684 693,377 694,070
Population growth 0.10% 0.10% 0.10% 0.10% 0.10% 0.10% 0.10% 0.10% 0.10% 0.10% 0.10% 0.10% 0.10%
% of pts with Stage III NSCLC 25% 25% 25% 25% 25% 25% 25% 25% 25% 25% 25% 25% 25%
# of pts with Stage III NSCLC 171,449 171,620 171,792 171,964 172,136 172,308 172,480 172,653 172,825 172,998 173,171 173,344 173,518
% of pts eligible for chemotherapy 75% 75% 75% 75% 75% 75% 75% 75% 75% 75% 75% 75% 75%
# of pts eligible for chemotherapy 128,587 128,715 128,844 128,973 129,102 129,231 129,360 129,489 129,619 129,749 129,878 130,008 130,138
% of pts with Stable disease or better 50% 50% 50% 50% 50% 50% 50% 50% 50% 50% 50% 50% 50%
# of pts with Stable disease or better 64,293 64,358 64,422 64,486 64,551 64,615 64,680 64,745 64,809 64,874 64,939 65,004 65,069
Stimuvax Penetration 2% 4% 6% 8% 11% 13% 15% 16%
# of NSCLC patients treated 1,357 2,490 3,852 5,444 7,039 8,637 9,556 10,248
Cost of treatment/year $38,250 $39,015 $39,795 $40,591 $41,403 $42,231 $43,076 $43,937
% price increase 2% 2% 2% 2% 2% 2% 2%
Total ROW Sales ($MM) $0.0 $0.0 $0.0 $0.0 $0.0 $51.9 $97.2 $153.3 $221.0 $291.4 $364.7 $411.6 $450.3
Total WW Sales ($MM) $0.0 $0.0 $0.0 $0.0 $156.6 $363.8 $596.2 $879.6 $1,188.5 $1,511.4 $1,758.1 $1,945.1 $2,031.2
Source: Cowen and Company estimates
March 7, 2012 5
6. Oncothyreon
Addendum
STOCKS MENTIONED IN IMPORTANT DISCLOSURES
Ticker Company Name
ONTY Oncothyreon
ANALYST CERTIFICATION
Each author of this research report hereby certifies that (i) the views expressed in the research report accurately reflect
his or her personal views about any and all of the subject securities or issuers, and (ii) no part of his or her compensation
was, is, or will be related, directly or indirectly, to the specific recommendations or views expressed in this report.
IMPORTANT DISCLOSURES
Cowen and Company, LLC and or its affiliates make a market in the stock of ONTY securities.
Cowen and Company, LLC and/or its affiliates managed or co-managed a public offering of ONTY within the past twelve
months.
Cowen and Company, LLC and/or its affiliates received in the past 12 months compensation for investment banking
services from ONTY.
ONTY is or was in the past 12 months a client of Cowen and Company, LLC; during the past 12 months, Cowen and
Company, LLC provided IB services.
ONTY has been client(s) of Cowen and Company, LLC in the past 12 months.
Cowen and Company, LLC and/or its affiliates expect to receive, or intend to seek, compensation for investment banking
services in the next 3 months from ONTY.
Cowen and Company, LLC compensates research analysts for activities and services intended to benefit the firm's
investor clients. Individual compensation determinations for research analysts, including the author(s) of this report, are
based on a variety of factors, including the overall profitability of the firm and the total revenue derived from all sources,
including revenues from investment banking. Cowen and Company, LLC does not compensate research analysts based on
specific investment banking transactions.
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6 March 7, 2012