Ironwood pharmaceuticals, inc. (irwd.o): linzess launch yields solid ims ramp, steady growth

M O R G A N S T A N L E Y R E S E A R C H
N O R T H A M E R I C A

Morgan Stanley & Co. LLC
David Friedman, M.D.
David.Friedman@morganstanley.com
+1 212 761 4217
Marshall Urist, M.D., Ph.D.
Sara Slifka
Sara.Slifka@morganstanley.com
+1 212 761 3920
Brienne Kugler
Brienne.Kugler@morganstanley.com
Ironwood
Overweight
Pharmaceuticals, Inc.
Key Ratios and Statistics
Reuters: IRWD.O Bloomberg: IRWD US
Biotechnology / United States of America
Price target
We are updating our IMS TRx analysis which we
first published (11/20/12) pre-Linzess launch. We
believe the launch has been strong to date.

Fiscal Year ending
We are updating our IMS TRx analysis which shows
ModelWare EPS ($)
our estimate of the TRx ramp necessary to meet our
Prior ModelWare EPS ($)
and (Forest) consensus US Linzess estimates from
2013-2016 (Ex. 1-3). Below, we highlight some key
Consensus EPS ($)§
points of our analysis and the launch to date. Unless otherwise noted, all metrics are based on Morgan Stanley ModelWare Launch is Strong: We believe that the Linzess launch,
framework (please see explanation later in this note).
§ = Consensus data is provided by Thomson Reuters Estimates.
based on a few key metrics, has been strong to date. e = Morgan Stanley Research estimates
A) There have been ~575 TRx’s added per wk on avg.
since leaving the holiday period (Ex. 2, starting with 1/11/13 wk which is the first one post holidays). This avg
1) has held over the most recent month as well, 2) has
been augmented with recent wk over wk TRx gains
topping 700 TRx, and 3) is slightly ahead of our
expected, above consensus 525-550 wkly 2013 TRx
adds (minimally changed from prior analysis).
B) Our modified slope analysis (Ex. 4), which evaluates
the magnitude of TRx’s and the growth trends, signals a
trajectory that still reflects an initial rapid growth phase,
despite being a few months into the launch.
C) Our analysis of Linzess and Amitiza TRx suggests
that the Linzess launch has led to IBS-C/CC mkt
expansion (Ex. 4). Given that Amitiza TRx are roughly
flat, we see all of this growth (and currently ~20% share
of the wkly TRx) are attributable to Linzess.
11/20/12 Analysis: We performed a similar analysis
pre-launch, which despite two important changes below
yielded similarly positive conclusions. The two changes
are a) a lower price per TRx, in line with management’s
comments implying a >15% gross to net rebate vs. our
previously assumed 10%, and b) a slower ramp around
Morgan Stanley does and seeks to do business with the 2012 holiday/new year time (we used the actual IMS companies covered in Morgan Stanley Research. As TRx’s from that period). To the second change, given a result, investors should be aware that the firm may have a conflict of interest that could affect the that a) all wks of this type of analysis build/compound off objectivity of Morgan Stanley Research. Investors of the initial ones and b) our original analysis did not should consider Morgan Stanley Research as only a include typical holiday slowness, we wanted to re-set single factor in making their investment decision. our initial ests., which we view as fair. For analyst certification and other important
disclosures, refer to the Disclosure Section,
located at the end of this report.
M O R G A N S T A N L E Y R E S E A R C H
March 19, 2013
Ironwood Pharmaceuticals, Inc.
IMS Methodology and Assumptions:
FRX Consensus vs. MS Estimates 2013-2016
1) We have chosen to use FRX analyst estimates for our consensus modeling as our source for consensus numbers Forest Consensus
(Thomson) appears to have a more reliable (only including US Revenue (000's)
$106,747
revenue) and robust (many more analysts included) consensus Morgan Stanley
Revenue (000's)
$138,546
2) We model Linzess actual TRx numbers through early January 2013 in the Morgan Stanley and consensus launch to Forest Consensus
1,472,032
Revenue (000's)
$270,874
3) We model a linear ramp in ’13 and beyond. Most primary Morgan Stanley
care drug launches have tended to be relatively linear in terms 2,187,069
Revenue (000's)
$402,450
of their initial IMS ramp. For simplicities sake, we have assumed a linear launch in our quarterly projections, adding an Forest Consensus
equal number of prescriptions per week on top of the prior 2,134,331
Revenue (000's)
$404,528
Morgan Stanley
4) We use a price per prescription of ~$179 ($7.10/day with a 3,489,583
Revenue (000's)
$661,394
17.5% gross to net discount) in 2012 and 2013 with 3% per year price increases thereafter. This is below Amitiza’s monthly 2016
Forest Consensus
3,588,004
Revenue (000's)
$700,449
Morgan Stanley
4,697,593
Revenue (000's)
$917,063
Source: Company Data, Morgan Stanley Research M O R G A N S T A N L E Y R E S E A R C H
March 19, 2013
Ironwood Pharmaceuticals, Inc.
Exhibit 2
Linzess Prescription Ramp:
TOP) Progress to Date vs. MS and Consensus (Zelnorm is a comparator)
BOTTOM) MS vs Consensus through 2013 (Zelnorm is a comparator)
ns
o
ti 5,000
Weekl 2,000
Week of Launch
criptions
Week of Launch
Source: Company Data, Morgan Stanley Research M O R G A N S T A N L E Y R E S E A R C H
March 19, 2013
Ironwood Pharmaceuticals, Inc.
Exhibit 3
2013-2016 IMS Forecast – MS vs. Consensus
Labeling on graphs highlight Zelnorm data points that help explain TRx trajectory over time
Year markers on top of graph are for Linzess related estimates (not Zelnorm)
tions
rip
Week of Launch
Source: Company Data, Morgan Stanley Research Exhibit 4
Linzess Modified Slope Ramp Appears Strong
This analysis was performed by calculating the slope of the line that connects baseline (launch-time) to each week’s TRx level. As the
TRx growth tapers down, the line connecting it to baseline is shallower (i.e. lower slope). This modified slope line is impacted by the
absolute TRx level as well as the trajectory of the IMS curve.
rescr
P
y 150
ekl
e
W 100
Source: Company Data, Morgan Stanley Research M O R G A N S T A N L E Y R E S E A R C H
March 19, 2013
Ironwood Pharmaceuticals, Inc.
Exhibit 5
Amitiza Prescriptions Have Been Stable, Market Seems to be Growing
cription
Source: Company Data, Morgan Stanley Research M O R G A N S T A N L E Y R E S E A R C H
March 19, 2013
Ironwood Pharmaceuticals, Inc.
Risk-Reward Snapshot: Ironwood Pharmaceuticals (IRWD, OW, PT $21)
Linzess Success Drives Risk Reward
Investment Thesis
potential. Linzess is a first-in-class GC-C (guanylate cyclase type-C) $21.00 (+14%)
We model peak WW sales of ~$2bn,
and believe the stock is pricing in
peak sales lower than that.
 Linzess’ advantages are its strong pain, with relatively limited side effects Current Stock PriceWARNINGDONOTEDIT_RRS4RL~IRWD.O~ Source: Thomson Reuters, Morgan Stanley Research Our $21 price target is derived from a discounted cash flow analysis using a WACC of 10% and a terminal growth rate of 0% post 2029. The revenue driver in Linzess becomes dominant player in IBS and CC markets.
Linzess becomes a preferred treatment in both IBS key difference from our base case is greater penetration into the chronic constipation market, which will likely be the more difficult market as CC patients tend to have milder disease than IBS (pain is defining characteristic of IBS-C). This scenario assumes rapid adoption by physicians, no reimbursement issues, and that hundreds of thousands of patients who deemed themselves  Linzess’ cost is a concern as the CC previously satisfied with current treatment decide to switch therapies due to a potentially even better benefit with Linzess. Linzess becomes a notable player in IBS market, but less so in
competitive cost/benefit profile and use CC. Linzess takes meaningful share of the IBS market, but gains
<20% of the Linzess eligible CC patients. We expect the CC market to be more difficult to penetrate as the disease is less urgent for many. Nevertheless, we expect Linzess’ profile will help it gain enough uptake to reach ~$2bn peak sales globally. This scenario Risks to our price target
also assumes that cost and reimbursement is not a significant issue for most patients, and a proportion of patients previously relatively  Linzess could fail to meet our sales satisfied on laxatives decide to switch to Linzess for a potentially Linzess falters commercially. This scenario assume Linzess
struggles to gain significant uptake due to physician hesitancy to adopt a novel agent or reimbursement issues. Patient awareness remains limited and there are few patients that switch from laxatives to Linzess. M O R G A N S T A N L E Y R E S E A R C H
March 19, 2013
Ironwood Pharmaceuticals, Inc.
Valuation and Catalysts
Exhibit 5
DCF Drives Valuation
Source: Company data, Morgan Stanley Research
Exhibit 6
of Ironwood’s pipeline is relatively early-stage, thus DCF Valuation Supports Upside to Stock Price
Linzess-independent longer-term growth is uncertain. Valuation Date
Discount Rate
Revenue The revenue driver in our model is the launch of
Linzess.
Economics: Ironwood has partnerships in place in the US
(Forest: 50/50 profit split), EU (Almirall; royalty where
Ironwood has stated the terms approach ~50% of the profits
assuming modest sales) and most of Asia (Astellas: we
estimate royalty of high-teens/low 20s).
COGS: We expect Linzess, a pill, will have
“pharmaceutical-like” margins of >90%.
Equity Value
Operating Expenses:
Equity Value/Sh
R&D: We expect R&D will decline modestly in the near-term as
Source: Company data, Morgan Stanley Research SG&A: We expect SG&A will remain relatively stable
near-term as Ironwood works to sell/market Linzess. Over $21 PT includes Linzess Launch
time, we expect SG&A to decline modestly as the company We derive our PT from a discounted cash flow (DCF) analysis using a WACC of 10% and a terminal growth rate of 0% post Collaboration Expense: Forest will staff ~1,400 primary care
2029. We incorporate the cash cost of stock options. sales reps and Ironwood will build its own ~150 patient GI physician focused sales force. Ironwood splits all salesforce Valuation Methodology: We use DCF to value Ironwood as
and marketing costs with Forest 50/50. Given the significant well as most other companies under coverage. We believe spending needed to build a strong primary care salesforce, we DCF best captures the longer term nature of drug development expect these companies will take a loss on Linzess in the first and commercialization. We do not feel that a multiples year of launch. This loss is accounted for in collaboration analysis accomplishes the same goal, as it only evaluates a Financings: We do not model any future financings for
Discount Rate: We typically apply a discount rate of 10% to
Risks to our price target include: Linzess could fail to gain
Terminal Growth Rate: We model a 0% terminal growth rate
post-2029 after a steep decline in cash flows in 2026 as Linzess’ composition of matter patent expires in 2025. The rest M O R G A N S T A N L E Y R E S E A R C H
March 19, 2013
Ironwood Pharmaceuticals, Inc.
Exhibit 7
Upcoming Catalysts
Expected Timing
Source: Company Data, Morgan Stanley Research Exhibit 8
Changes to Model
2014E 2015E 2016E 2017E 2018E 2019E 2020E
Comments
Linaclotide US Sales ($mn)
Linaclotide ex-US Sales ($mn)
Linaclotide US Profit Split ($mn)
Total Revenues ($mn)
COGS ($mn)
R&D ($mn) -ex-ESOs
SG&A ($mn) - ex-ESOs
Interest and Other Income, net
Net Income ($MM) - Non GAAP, excludes options
EPS Non-GAAP, Diluted, excludes options
EPS - GAAP (Diluted)
Basic Shares Outstanding
Dilluted Shares Outstanding
Source: Company data, Morgan Stanley Research M O R G A N S T A N L E Y R E S E A R C H
March 19, 2013
Ironwood Pharmaceuticals, Inc.
Exhibit 9
Quarterly Income Statement
Revenue to IRWD:
Linaclotide US Profit Split
Operating Expenses:
Cost of Sales
Operating Income (Loss)
Other Expense / Forward Purchase Contracts
Pretax Income (Loss)
Provision for Income Taxes / Benefit
Effective tax rate
Net Loss pre MI
Net Loss attributed to minority interest
Net Income (Loss)
Tax benefit from optionsNet Income (excl one-time items) Non-GAAP, diluted (inc. ESOs)
GAAP EPS, diluted (inc. options expense)
Source: Company data, Morgan Stanley Research estimates M O R G A N S T A N L E Y R E S E A R C H
March 19, 2013
Ironwood Pharmaceuticals, Inc.
Exhibit 10
Annual Income Statement
($ in millions except per share data) 913.69 1,161.83 1,402.39 1,616.11 1,778.28 780.08 1,123.87 1,473.20 1,802.15 2,026.78 2,197.65 Revenue to IRWD:
Collaboration Revenue (Linaclotide US Profit Split)
Collaboration Revenue (upfront & milestones) $132.51 $268.24 $380.73 $518.20 $649.77 $745.79 $817.79 Operating Expenses:
COGS
Total Operating Expenses
Operating Income (Loss)
Other Income / Forward Purchase Contracts Pretax Income (Loss)
($53.12) ($55.05) ($219.71) ($105.78) $29.41 Net Income (Loss)
Net Income (Loss) to Ironwood Pharma
Non-GAAP, diluted (inc. ESOs)
GAAP EPS, diluted (including ESOs)
Source: Company data, Morgan Stanley Research M O R G A N S T A N L E Y R E S E A R C H
March 19, 2013
Ironwood Pharmaceuticals, Inc.
Exhibit 11
Balance Sheet
Prepaid expenses & other current assets Current assets of discontinued operations
Total Current Assets
1,315.99
1,947.37
Long-term assets of discontinued operations
Total Assets
Current portion of capital lease obligations Current liabilities of discont operations Total Current Liabilities
Long-term liabilities of discont operations Total Liabilities
(432.39) (505.02) (742.80) (865.60) (856.62) (731.68) (464.77) (57.00) Noncontrol ing Interest
Total stockholders' equity
Total liabilities and stockholders' equity
Source: Company data, Morgan Stanley Research M O R G A N S T A N L E Y R E S E A R C H
March 19, 2013
Ironwood Pharmaceuticals, Inc.
Exhibit 12
Cash Flow Statement
Income (loss) from discontinued operations Income / (Loss) from continuing operations Loss (gain) on disposal of property and equipment Remeasurement of forward purchase contracts Accretion of discount / premium on investment securities Changes in operating assets liabilities:
Accounts receivable
Prepaid expenses and other current assets Deferred rent & Capital Lease Obligations Net cashed used in operating activities from disc ops Net cash used in operating activities
Investing Activities:
Purchases of available-for-sale securities
Sales and maturities of available-for-sale securities Proceeds from the sale of property and equipment / subsidi Net cashed used in investing activities from disc ops Financing activities:
Proceeds from issuance of preferred stock, net of issuance costs
Proceeds from share issuance
Proceeds from exercise of stock options, stock purchase pl Proceeds from sale of noncotrolling interest in subsidiary Disbursements from repurchase of common stock Payments on borrowings and capital lease obligations Net cash (used in) provided by fin activities from disc ops Net cash provided by financing activities Cash and equivalents at beginning of year Source: Company data, Morgan Stanley Research M O R G A N S T A N L E Y R E S E A R C H
March 19, 2013
Ironwood Pharmaceuticals, Inc.
Morgan Stanley ModelWare is a proprietary analytic framework that helps clients
uncover value, adjusting for distortions and ambiguities created by local accounting
regulations. For example, ModelWare EPS adjusts for one-time events, capitalizes operating
leases (where their use is significant), and converts inventory from LIFO costing to a FIFO
basis. ModelWare also emphasizes the separation of operating performance of a company
from its financing for a more complete view of how a company generates earnings. Disclosure Section
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March 19, 2013
Ironwood Pharmaceuticals, Inc.
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M O R G A N S T A N L E Y R E S E A R C H
March 19, 2013
Ironwood Pharmaceuticals, Inc.
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March 19, 2013
Ironwood Pharmaceuticals, Inc.
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M O R G A N S T A N L E Y R E S E A R C H
The Americas
Asia/Pacific
United States
United Kingdom
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Industry Coverage:Biotechnology
Company (Ticker)
Rating (as of) Price* (03/18/2013)
David Friedman, M.D.
AMAG Pharmaceuticals, Inc.
(AMAG.O) Alexion Pharmaceuticals (ALXN.O) Sara Slifka
Neurocrine Biosciences Inc
(OPTR.O)
Marshall Urist, M.D., Ph.D.
Amgen Inc. (AMGN.O)
Stock Ratings are subject to change. Please see latest research for each company. * Historical prices are not split adjusted.

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