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efta-01450727DOJ Data Set 10OtherEFTA01450727
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Equity Research
Healthcare I Biotechnology
ARIAD Pharmaceuticals, Inc.
Iclusig Comes Back With a New Label and REMS; Upgrade to
Outperform and Increase Price Target to $12
On Friday, December 20, Ariad announced that it has reached agreement with the
FDA for immediate reauthorization of Iclusig marketing in the United States, with a
narrower label and accompanying Risk Mitigation Strategy (REMS) and post-
marketing requirements (PMRs). Ariad plans to resume shipping of Iclusig by mid-
January 2014. The new label stipulates that Iclusig is indicated in adult patients with
T3151-positive chronic myeloid leukemia (CML) or T3151-positive Philadelphia
chromosome positive acute lymphoblastic leukemia (Ph+ ALL), or in adult patients with
CML and Ph+ ALL where no other tyrosine kinase Inhibitor (TKI) therapy is indicated. We
note that on October 31, the Food and Drug Administration (FDA) suspended marketing
of Iclusig based on the risk of life-threatening blood clots and severe narrowing of blood
vessels associated with Iclusig treatment We had been expecting the re-
commercialization of Iclusig with a narrower label, and we consider the REMS
accompanied by four PMRs without an Elements to Assure Safe Use (ETASU) to be a
favorable. We discuss the new label, REMS, and PMRs in detail herein.
We are upgrading Ariad shares to Outperform and increasing our price target from
$3 to $12 (exhibit 1, on page 5), based on the following: 1) limited downside with
REMS and PMRs in place, in our opinion; 2) positive physician feedback during ASH
and high number of single-agent INDs filed during marketing suspension; 3)
potential for safer administration of Iclusig with lower doses in the future; 4)
potential attempt at the frontline setting at lower doses as long-term upside; 5)
other potential indications of Iclusig that are not included in our model: GIST, and
NSCLC with FGFR and RET mutations; and 6) valuation: although the addressable
patient population in 2014 is cut in half because of the narrower label (from 2,500
to 1,300), the incidence is still substantial and the Iclusig patient population will
build over time. We have increased our peak worldwide Iclusig revenue forecast to $747
million in 2026 from our previous estimate of $275 million. Our revised probability-
adjusted NPV now assumes $10 per share for Iclusig and $2 for AP26113, compared with
our previous estimate of $1 and $2 per share, respectively.
•
Iclusig is now accompanied by a REMS and PMRs without a dedicated
restricted distribution plan, thus enabling relatively easy growth with
limited downside risk, in our opinion. We had expected an ETASU in the REMS
that could impose greater restrictions in the distribution of Iclusig. We believe
with the new label, REMS, PMRs, and no ETASU, associated risks can be identified
and managed without severely impeding Iclusig uptake and sales growth. From a
regulatory perspective, we believe that Iclusig has been de-risked in the near
term until perhaps 2016-2018 when we expect the readout of the required
randomized control study (part of the PMRs) assessing the long-term safety of
Iclusig treatment
Ariad Pharmaceuticals is a biopharmaceutical company based in Cambric*, Massachusetts The
company focuses Its research, development. and commercial efforts on the oncology space, in
particular leukemia and lung cancer.
V.
Fill ° Pet
(Wiliam Stair
December 23, 2013
Stock Rating:
Outperform
Company Profile: Aggressive Growth
Price Target
512.00
Symbol:
ARIA (NASDAQ)
Price:
56.43 (52-Wk. $2-$23)
Market Value (mil.):
Fiscal Year Mid:
Lang-Term EPS Growth Rate:
Dividend/Yield:
2012A
2013E
$1,025
December
None
2014E
Estimates
EPS FY
5.134
5.154
5.0.78
a
S-1.54
S-0.78
Sales (mil.)
1
44
109
Valuation
FY P/E
NM
NM
NM
CY P/E
NM
NM
Trading Data (FactSet)
Shares Outstanding (mil.)
Moat (mil.)
Avenge Daily Volume
185
179
15,567,546
Financial Data (FactSet)
Long-Term Deht/Total Capital (MRQ)
0.2
Book Value Per Share (MRQ)
1.4
Enterprise. Value (mu.)
973.0
EBITDA (TIM)
-256.8
Enterprise Value/EBrIDA (TTM)
-3.8x
Return on Equity (TIM)
-132.7
Tivo-Year Price Performance Chart
Tz
ti
`mounts: radtict. William Blair & Company
cstimatcs
Please consult pages 7-8 of this report for all disclosures. Analyst certification is on page 7.
William Blair 8 Company, L.L.C. does and seeks to do business with companies covered in its research reports.
As a result, investors should be aware that the firm may have a conflict of interest that could affect the objectivity
of this report. Investors should consider this report as a single factor in making an investment decision.
CONFIDENTIAL — PURSUANT TO FED. R. CRIM. P. 6(e)
DB-SDNY-0 106550
CONFIDENTIAL
SDNY_GM_00252734
EFTA01450727
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