A Specialty Pharmaceutical Leader Focused in Pain and ... · Migraine Attacks Breakthrough Cancer...

26
A Specialty Pharmaceutical Leader Focused in Pain and Neurology Jefferies Healthcare Conference June 2, 2015

Transcript of A Specialty Pharmaceutical Leader Focused in Pain and ... · Migraine Attacks Breakthrough Cancer...

Page 1: A Specialty Pharmaceutical Leader Focused in Pain and ... · Migraine Attacks Breakthrough Cancer Pain Mild to Moderate Acute Pain Differentiation Dual MOA; only opioid FDA-approved

A Specialty Pharmaceutical Leader Focused in Pain and Neurology

Jefferies Healthcare Conference

June 2, 2015

Page 2: A Specialty Pharmaceutical Leader Focused in Pain and ... · Migraine Attacks Breakthrough Cancer Pain Mild to Moderate Acute Pain Differentiation Dual MOA; only opioid FDA-approved

Forward-Looking Statements

The statements that are not historical facts contained in this presentation are forward-looking statements that involve risks

and uncertainties including, but not limited to, those related to Depomed’s acquisition of the NUCYNTA® franchise in the

United States, Depomed’s post-acquisition strategy, plans, objectives, expectations (financial or otherwise) and intentions,

future financial results and growth potential, our plans, prospects and strategy related to Gralise®, CAMBIA®, Lazanda® and

Zipsor ®, and other statements that are not historical facts. These forward-looking statements are based on Depomed’s

current expectations and inherently involve significant risks and uncertainties.

Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a

result of these risks and uncertainties, which include, without limitation, risks associated with product acquisition

transactions, such as the risk that the acquired products will not be integrated successfully, that such integration may be

more difficult, time-consuming or costly than expected or that the expected benefits of the transaction will not occur; risks

related to Depomed’s future opportunities and plans, including uncertainty of Depomed’s expected financial performance

following completion of the transaction; disruption from the transaction, making it more difficult to conduct business as usual

or maintain relationships with customers, employees or suppliers; and the possibility that if Depomed does not achieve the

perceived benefits of the transaction as rapidly or to the extent anticipated by financial analysts or investors, the market price

of Depomed’s shares could decline, as well as other risks related to Depomed's business detailed from time-to-time under

the caption "Risk Factors" and elsewhere in Depomed's SEC filings and reports, including in its Annual Report on Form 10-K

for the year ended December 31, 2014, and in its Quarterly Report on our 10-Q for the quarter ended March 31, 2015.

Depomed undertakes no duty or obligation to update any forward-looking statements contained in this presentation as a

result of new information, future events or changes in its expectations.

June 2015 2

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Depomed Acquires NUCYNTA® April 2, 2015

NUCYNTA - Becomes Flagship Product

June 2015 3

Transformational acquisition enhances Depomed’s position as a leading

pain and neurology focused specialty pharmaceutical company

Expect to be Top 5 U.S. Pain Company by 2016

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Reworked

Santarus deal

and tripled

net revenue

>67% y/y

revenue growth

and 25% volume

growth

in 2014

Acquired Dec

2013;relaunched

Q1 2014; Q1 2015

demand up 34%

over Q1 2014

TYPE 2

DIABETES DEAL

Non-strategic

milestones

& royalties sold

for $240 millionRelaunch Q4

2013 following

acquisition;

369% increase in

net sales Q1 2015

over Q1 2014

$60 million

net sales since

acquisition;

>95% gross

margins

Depomed Track Record of Successful Deals -Acquire and Integrate Products, then Generate Growth

Exceptional fit

with core

portfolio

June 2015 4

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NUCYNTA® ER and NUCYNTA ® Have Broad Pain Indications

With Untapped Potential

for the management of moderate-

to-severe acute pain in adults

US Approval in November 2008

for the management of pain severe enough to

require daily, around-the-clock, long-term opioid

treatment and for which alternative treatment

options are inadequate

for the management of neuropathic pain

associated with diabetic peripheral neuropathy

(DPN) in adults severe enough to require daily,

around-the-clock, long-term opioid treatment and

for which alternative treatment options are

inadequate

US Approval in August 2011

June 2015 5

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NUCYNTA is an Ideal Strategic Fit for Depomed

Highly differentiated, long-tailed asset in multi-billion

dollar pain market

Transformative acquisition in scale, market coverage

and financial impact

• $310-335 million net product sales per 2015 guidance

• Leverages Depomed’s expanded sales force and

expertise (pain specialists, neurologists and primary care)

• >65% of NUCYNTA ER prescriptions written by pain

specialists and mid-levels as Depomed core targets

Provides scale to drive further growth, cash flow and

additional acquisitions

6June 2015

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Tapentadol (NUCYNTA/NUCYNTA ER) – A Unique, Highly

Differentiated Molecule With Unrealized Potential

Proprietary new chemical entity (NCE) with dual

mechanism of action (MOA)

Only NCE approved in U.S. CII opioid space in the last

30 years

Strong IP with composition of matter to 2022/2023,

with potential exclusivity beyond that timeframe

Addresses both nociceptive and neuropathic pain

Only opioid approved for pain associated with diabetic

peripheral neuropathy (DPN) and chronic pain

Low abuse profile and side effect rate

7June 2015

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Large Market and Strong Baseline to Potentially Grow

NUCYNTA

8June 2015

Short Acting Opioid Market Long Acting Opioid Market

$7.1B in 2014 $5.5B in 2014

~230MM TRx in 2014 ~20M TRx in 2014

NUCYNTA 0.3% market share NUCYNTA ER 1.5% market share

Over 800,000 prescriptions written for NUCYNTA and NUCYNTA ER in 2014

with modest promotion

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NUCYNTA Integration

Transaction closed April 2, 2015

• NDA immediately transferred to Depomed

• Product shipments to wholesalers began April 6th

• Pricing adjustment upon closing; monthly price of

NUCYNTA ER is now approximately equal to Oxycontin

Provides full quarter of NUCYNTA revenue in Q2

9June 2015

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Flexible Loan Agreement Supports Potential Future

Acquisitions and Avoids Dilution

All debt transaction for $575 million

• 7 year secured loan; no principal payment required for 3years

• Coupon at three month LIBOR plus 9.75% (1% floor), subject to quarterly adjustment with rate cap

Loan flexibility supports continued growth

• Allows EBITDA positive acquisitions

• Allows pre-payments; $100 million after year one at par plus 5%; full pre-payment allowed after two years

Zero dilution to shareholders

‘Covenant-lite’ structure – only financial covenant is net sales based

10June 2015

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NUCYNTA Re-launch

Re-launch targeted for June 2015

• New product positioning and ad campaign

• Resumption of full medical education support with Medical

Science Liaisons (MSLs) and speaker programs

• Quintile’s contract sales organization (CSO) reps currently

promoting NUCYNTA until re-launch

• Expanded sales force of >270 reps expected at launch

–Early deal closing helps recruiting: over 3,000 applicants for

130 field positions

11June 2015

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NUCYNTA is Transformative:

Adds Significant Revenue and Earnings

Financial Guidance for 2015

• Total Product Sales (9 months NUCYNTA) $310-$335mm

• Total SG&A and R&D (Includes ~ $21mm of 1x costs) $195-$210mm

• Adjusted EBITDA $85-$100mm

• Non-GAAP Adjusted Earnings $16-$28mm

$0

$50

$100

$150

$200

$250

$300

$350

2011 2012 2013 2014 2015guidance

DIRECT MARKETED PRODUCT REVENUE (MILLIONS)

June 2015 12

2016

Full year with NUCYNTA

*Reconciliation of GAAP to non-GAAP can be found at end of presentation

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Depomed’s Products are Differentiated in Large Markets

Product

IndicationModerate to Severe

Chronic/Acute Pain

Management of

Postherpetic

Neuralgia

Acute Treatment of

Migraine Attacks

Breakthrough

Cancer Pain

Mild to Moderate

Acute Pain

Differentiation

Dual MOA; only

opioid FDA-approved

for both chronic pain

and DPN

1x daily with less

dizziness and

somnolence

Only single agent in

its therapeutic class

for acute migraine

attacks

Only fentanyl

product

delivered nasally

Rapidly dispersed,

low dose version of

diclofenac

Q1 Annualized

Sales$176MM (1) $70MM $21MM $13MM $27MM

Year over Year

Sales Growth(Acquired 4/2/15) 59% 16% 369% 9%

IPPatent protection out

to 2025+

August 2014 D.Ct.

ANDA victory

upholds patents;

appeal now settled;

exclusivity expected

to 2024

ANDA settlement with

exclusivity expected

to January 2023

Patents out to

October 2024

Patents out to

February 2029

Sales Reps 188 Sales Representatives and expanding to approximately 300 by June 2015 (2)

(1) Does not include April price increase of 44%

(2) Over 270 representatives will promote NUCYNTA, Gralise, CAMBIA, and Zipsor; 24 representatives promote Lazanda.

13June 2015

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PATENT PROTECTION 2015 2020 2025 2030

DEPOMED PRODUCTS

NUCYNTA

(Mod/severe pain) Acquired April 2015; composition of matter to 2022/23; patents to 2025/2028

Gralise

(PHN)

Exclusivity expected to 2024; D.Ct. ANDA litigation victory and

settlements resolve all ANDAs

CAMBIA

(Acute migraine) ANDA settlement with expected protection to Jan 2023

Lazanda

(BTCP) 2 orange book patents; patents pending; last OB patent to expire Oct 2024

Zipsor

(Mild/Mod pain) 5 orange book patents; last to expire Feb 2029

PARTNERED PRODUCTS: Xartemis XR (Mallinkrodt); MNK-155 (Mallinkrodt) and IW-3718 (Ironwood)

Provide milestones and royalty income out to 2032

Lengthy Exclusivity Periods Mean Products

Contributing to Revenue Growth for a Long Time

14June 2015

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Gralise Showing Strong Revenue Growth

Indicated for the management of

postherpetic neuralgia (PHN)

~$75 million run rate as of April 2015,

tablet demand up 19% year over year

for quarter ended March 2015

Will be promoted by >270 sales

professionals who also sell NUCYNTA,

CAMBIA and Zipsor

Tier 2 coverage at the three largest

pharmacy benefit managers:

CVS/Caremark, ESI, Catamaran

Market exclusivity expected until 2024;

won District Court decision vs. first filer,

Actavis; appeal with Actavis now settled

15

Q1 2015 Gralise prescriptions up 18% over Q1 2014

June 2015

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Gralise Prescriptions Continue to Build – up +18%

since Q1 2014

16June 2015

$8

$10

$12

$14

$16

$18

$20

Q1 14 Q2 14 Q3 14 Q4 14 Q1 15

Gralise Quarterly Product Sales (Net $MM)

Source: Symphony Healthcare Analytics PHAST

Annual run rate ~$75 million as of April 2015.

50

60

70

80

90

Q1 14 Q2 14 Q3 14 Q4 14 Q1 15

Gralise Quarterly Prescriptions (000s)

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CAMBIA is Differentiated in Acute Migraine

Only single agent in its therapeutic class

approved in the U.S. for treatment of

acute migraine attacks in adults

Powdered formulation of diclofenac

dissolves in liquid; provides rapid relief of

pain and is easy to take

Cambia can be a complementary

treatment for patients taking triptans

American Headache Society updated

guidelines in Jan 2015, upgrading

diclofenac powder (CAMBIA) to first line

therapy for acute migraine treatment

17June 2015

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CAMBIA Total Rx up 34% and New Rx up 46% Since

Depomed’s Re-launch in Q1 2014

18June 2015

$3

$4

$5

$6

$7

Q1 14 Q2 14 Q3 14 Q4 14 Q1 15

CAMBIA Quarterly Product Sales (Net $MM)

Source: Symphony Healthcare Analytics PHAST

CAMBIA prescriptions reached an all-time high in April 2015

>$30 million annual run rate at April 2015

15

20

25

30

35

Q1 14 Q2 14 Q3 14 Q4 14 Q1 15

CAMBIA Quarterly Prescriptions (000s)

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Lazanda is Contributing to Core Growth

Rapid-acting fentanyl nasal spray for the

management of breakthrough cancer pain in

cancer patients 18 years of age and older who

are already receiving and who are tolerant to

opioid therapy for their underlying persistent

cancer pain

Focus on expanded prescriber base of pain

specialists as well as oncologists; salesforce

expanded to 24 in January 2015

Concentrated marketing opportunity as ~ 2,000

providers write 90% of prescriptions; may only be

dispensed by providers enrolled in TIRF REMS

Access program

Only branded TIRF product currently covered on

the Express Scripts National Formulary

19June 2015

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Lazanda Net Sales More Than Tripled in Q1 2015

compared to Q1 2014 – Total Sprays up +44% over Q4

20June 2015

$0

$1

$2

$3

$4

Q1 14 Q2 14 Q3 14 Q4 14 Q1 15

Lazanda Quarterly Net Product Sales ($MM)

Source: Symphony Healthcare Analytics PHAST, Sprays calculation based on 8 sprays per bottle

In April, TRx market share exceeded 4% for the first time

0

20

40

60

80

100

120

Q1 14 Q2 14 Q3 14 Q4 14 Q1 15

Lazanda Total Sprays by Quarter (000s)

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Zipsor Strong Financial Contribution with 95% Gross Margins

Rapidly dispersed, liquid-filled

capsule provides acute pain relief in

<1 hour

Acquired in 2012; cumulative net

sales of > $60 million since

acquisition

Depomed halted sales decline and

resumed growth of product in 2013

Current annual run rate > $27 million

21June 2015

$-

$1.0

$2.0

$3.0

$4.0

$5.0

$6.0

$7.0

$8.0

1Q14 2Q14 3Q14 4Q14 1Q15

Zipsor Quarterly Net Revenue

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Collaborations and Intellectual Property Provide Revenue Upside

Over the Next Decade

22

Licenses

Acetaminophen /opiate combination products with abuse resistance potential

• Xartemis XR launched March 2014; high single digit royalty

• MNK-155 $10 million approval milestone; timing unknown

• High single-digit royalties for 15+ years from first sale of each product

IW-3718

• Program for refractory GERD

• Positive Phase 2a reported February 2015

• Future milestones and royalties

IP Litigation

Potential future cash flow from IP litigation against Purdue Pharma and Endo

June 2015

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NUCYNTA Transforms Depomed Achieving Scale, Growth

and Significant Cash Flow

June 2015 23

NUCYNTA is a perfect fit, combining a differentiated long-tailed NCE with Depomed’s already strong business

Deal financing flexibility allows further growth from acquisitions

2015 net product sales guidance of $310-335 million, up from $114 million in 2014

Growth opportunities abound, with long periods of exclusivity

• NUCYNTA ER dual MOA, unique profile and DPN

• Gralise Q1 2015 net sales up 59% over Q1 2014

• CAMBIA Rx up 34% in twelve months since re-launch

• Lazanda Q1 2015 net sales up >300% over Q1 2014

Page 24: A Specialty Pharmaceutical Leader Focused in Pain and ... · Migraine Attacks Breakthrough Cancer Pain Mild to Moderate Acute Pain Differentiation Dual MOA; only opioid FDA-approved

Thank You

www.depomed.com

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GAAP to Non-GAAP Reconciliation – Q1 2015

25June 2015

Non-GAAP adjusted earnings and non-GAAP adjusted earnings per share are not based on any

standardized methodology prescribed by GAAP and represent GAAP net income and GAAP earnings

per share adjusted to exclude (1) non-cash PDL royalty revenue, net of related costs, (2) non-cash

interest expense on the liability related to the sale of future royalties and milestones to PDL, (3)

amortization related to product acquisitions, (4) stock-based compensation expense, (5) non-cash

interest expense related to convertible debt, and to adjust (6) the income tax provision to reflect the

estimated amounts payable in cash. Non-GAAP financial measures used by the Company may be

calculated differently from, and therefore may not be comparable to, non-GAAP measures used by

other companies.

(in millions of $) FY 2014 Q1 2015

GAAP net income 131.8$ (11.6)$

Non-cash PDL royalties, net of related costs (241.7) -

Non-cash interest expense on PDL liability 14.6 -

Non-cash interest expense on convertible debt 4.2 3.4

Amortization related to product acquisitions 16.9 1.6

Stock based compensation 8.9 2.8

Non-cash income tax adjustment 81.3 (4.2)

Non-GAAP adjusted earnings 16.0$ (8.0)$

Non-GAAP adjusted earnings per share 0.21$ (0.13)$

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GAAP to Adjusted EBITDA Reconciliation – FY 2014 And Q1 2015

26June 2015

Adjusted EBITDA are not based on any standardized methodology prescribed by GAAP and represent

GAAP net income adjusted to exclude (1) amortization related to product acquisitions, (2) stock-based

compensation expense, (3) interest Income (4) interest expense (5) depreciation (6) taxes, and (7) one

time transaction costs for NUCYNTA. Adjusted EBITDA measures used by the Company may be

calculated differently from, and therefore may not be comparable to, adjusted EBITDA measures used

by other companies.

(in millions of $) Q1 2015

GAAP net income (11.6)$

Amortization related to product acquisitions 1.6

Stock based compensation 2.8

Interest income (0.1)

Interest expense 5.6

Depreciation 0.3

Taxes (4.2)

Transaction costs 2.4

Adjusted EBITDA (3.2)$