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8-K - FORM 8-K - CONCEPTUS INC | d8k.htm |
EX-99.1 - PRESS RELEASE - CONCEPTUS INC | dex991.htm |
Second Quarter of 2011
August 4, 2011
Conceptus, Inc.
Conceptus, Inc.
Quarterly Results
Quarterly Results
Exhibit 99.2
©
2011 Conceptus, Inc. All rights reserved. |
Except for the historical information contained herein, the matters discussed in this
presentation include forward-looking statements, the accuracy of which is
subject to risks and uncertainties. These forward- looking statements
include discussions regarding: projected net sales and adjusted earnings
before interest, taxes, depreciation, amortization and stock- based
compensation (adjusted EBITDA) for the full year 2011, and the
expected impact of ongoing macroeconomic and insurance pressures on our growth in 2011,
trends in and market share related to competitive trialing, our continued success in
defending our physician accounts against competitive trialing, our ability to
expand physician market penetration, our ability to improve sales force
productivity, our ability to increase utilization of Essure through the
promotion of a compatible endometrial ablation product, our ability to market
effectively to physicians and prospective patients, our ability to
secure government reimbursement in foreign countries, our ability to make
strategic investments in our business, the impact to our business of permanent birth
control being covered under the Patient Protection and Affordable Care Act of 2010
(PPACA), and the expected attainment of strategic initiatives intended to grow
the business and make the Essure procedure the Standard of
Care in the permanent birth control market.
These discussions and other forward-looking statements included herein may differ
significantly from actual results. Such differences may be based upon factors
such as changes in strategic planning decisions by management,
re-allocation of internal resources, changes in the impact of domestic and
global macroeconomic pressures, reimbursement decisions by insurance companies and
domestic and foreign governments, scientific advances by third parties,
litigation risks, attempts to repeal all or part of the
PPACA,
and
the
introduction
of
competitive
products,
as
well
as
those
factors
set
forth
in
the
Company's most recent Annual Report on Form 10-K and most recent Quarterly Report
on Form 10-Q, and other filings with the Securities and Exchange
Commission. These forward-looking statements speak
only
as
to
the
date
on
which
the
statements
were
made.
We
undertake
no
obligation
to
update
or
revise publicly any forward-looking statements, whether as a result of new
information, future events, or otherwise.
Safe Harbor
Safe Harbor
2
©
2011 Conceptus, Inc. All rights reserved. |
Q211
Q211
Highlights
Highlights
Mark Sieczkarek,
President and
Chief Executive Officer
©
2011 Conceptus, Inc. All rights reserved. |
1.
Defend against
competitive
trialing
2.
Create
foundation to
increase
Essure
utilization
3.
Resume
expanding the
market for
Essure
POSITION FOR LONG-TERM GROWTH
Macro-economy: continuing unemployment and higher
insurance premiums, deductible and co-pays
Progress on Execution
Progress on Execution
Key areas of focus in 2011:
4
©
2011 Conceptus, Inc. All rights reserved. |
OB/GYN office visits improved Q/Q
OB/GYN
Patient
office
visits
in
millions
% change in select periods:
OB/GYN Office Visit Trends
OB/GYN Office Visit Trends
Source: IMS data provided by Credit Suisse Healthcare Team
5
Period:
2010
vs 2009
2 Years:
Q211
vs Q209
1 Year:
Q211
vs Q210
Sequential:
Q211
vs Q111
-15%
-20%
-2%
9%
OB/GYN |
Market Growth Trends
Market Growth Trends
Worldwide hysteroscopic sterilization market declined slightly Y/Y
in Q211 but improved Q/Q
(1)
Competitors national sales launch in April 2010
(2)
Competitors estimated net sales
6
©
2011 Conceptus, Inc. All rights reserved.
In $ millions
Q3 09
Q4 09
Q1 10
Q2 10
(1)
Q3 10
Q4 10
Q1 11
Q2 11
Total CPTS
Sales
$34.2
$37.0
$33.4
$36.8
$33.9
$36.5
$26.6
$33.8
Competitors
Estimated
Sales
(2)
$0.6
$1.5
$2.1
$3.8
$5.2
$5.3
$5.3
$5.6 -
$5.8
Hysteroscopic
Sterilization
Market
$34.8
$38.5
$35.5
$40.6
$39.1
$41.8
$31.9
$39.4 -
$39.6
Y/Y
31%
35%
31%
23%
12%
9%
(10%)
(2%) -
(3%) |
In
total
~500
accounts
were
covered
by
1-3
year Essure preferred vendor agreements
by the end of Q211
~1,300 accounts have trialed to date out of
up to ~1,800 accounts anticipated to trial
Trialing expected to last ~1 year at a rate of
~100 accounts entering trialing per quarter
+ one year to trial
FDA approved nickel contraindication on
Essure IFU reduced to warning; further
improves our competitive positioning
We continue to successfully defend our accounts
Sales Force
Redeployment
Number of Essure accounts that entered
competitive trialing by quarter
Competitive Trialing Declines
Competitive Trialing Declines
7
©
2011 Conceptus, Inc. All rights reserved. |
Market Share Stable
Market Share Stable
(1)
Competitors national sales launch in April 2010
(2)
Competitors estimated net sales
8
©
2011 Conceptus, Inc. All rights reserved.
Worldwide hysteroscopic sterilization market:
Conceptus remains market leader
In $ millions
Q3 09
Q4 09
Q1 10
Q2 10
(1)
Q3 10
Q4 10
Q1 11
Q2 11
Total CPTS
Sales
$34.2
$37.0
$33.4
$36.8
$33.9
$36.5
$26.6
$33.8
Competitors
Estimated
Sales
(2)
$0.6
$1.5
$2.1
$3.8
$5.2
$5.3
$5.3
$5.6 -
$5.8
Competitors
Market
Share
1.8%
3.8%
5.8%
9.4%
13.2%
12.6%
16.6%
14.2% -
14.6% |
Increase Essure Utilization
Increase Essure Utilization
(1)
Permanent birth control
(2)
Global
endometrial
ablation
(GEA)
product
manufactured
for
and
marketed
by
ETHICON
Womens
Health
&
Urology,
a
division of Ethicon, Inc.
9
>2,000 physicians
committed to trial
~680 physicians
trialed through
Q211
©
2011 Conceptus, Inc. All rights reserved.
Essure = medically necessary link between PBC
(1)
and GEA
Capture
share
of
in-office
GYNECARE
THERMACHOICE
®
III
(2)
patients
requiring PBC to potentially double annual market for Essure
GYNECARE
THERMACHOICE
®
III
Physician trials
GEA opportunity to
increase ~1 Essure
procedure per
account per month
interval tubal ligation
opportunity
Incremental
Essure Procedures |
10
Marketing To Drive Growth
Marketing To Drive Growth
(1)
9.3
million
women
in
the
U.S.
whose
families
are
complete
and
are
still
using
temporary
birth
control per
the 2006-08 CDC report, data from the National Survey of Family Growth,
published May 2010 Further develop key marketing strategies to increase
adoption of Essure and drive long-term growth
Direct-to-Consumer (DTC)
Publication Planning
Own unique in-office sales franchise
Physician Segmentation
Consumer Segmentation
©
2011 Conceptus, Inc. All rights reserved.
Target
underpenetrated
U.S. market for
Essure of 9.3M
women
(1) |
Integrate Value Proposition
Integrate Value Proposition
Consumer
Point of
Care
Physician
Resident, new-user and in-
office training
Clinician education
Reimbursement support
Essure candidate identification
tools for physicians
Patient support and
counseling through
all points of Essure
procedure
New Essurance Promise
Program
New Essure FlexPay
Plan
New Essure branding and
website
Launch new DTC marketing
campaign
Integrate patient and physician value proposition to increase
Essure utilization at point of care
11
©
2011 Conceptus, Inc. All rights reserved. |
Direct-to-Consumer Planned
Direct-to-Consumer Planned
Launch new DTC marketing campaign in Q311
Build upon our previous DTC experience
Leverage experience in temporary birth control advertising
National focus
Invest resources across the most cost-effective mediums
Segment potential patient base and target message accordingly
Maintain campaign into 2012 to drive a consistent message
12
©
2011 Conceptus, Inc. All rights reserved. |
Greg Lichtwardt
Executive Vice President, Operations
and Chief Financial Officer
Q211
Q211
Financials
Financials
©
2011 Conceptus, Inc. All rights reserved. |
Net
Sales ($M)
Gross Margin
(%)
Diluted GAAP
EPS
Operating
Exp. ($M)
Q210
Q211
$36.8
80.2%
81.9%
$33.8
$28.1
$25.8
($0.01)
$0.01
$5.2
(1)
Adjusted earnings before interest, taxes, depreciation, amortization
and stock-based compensation. See reconciliation in Appendix
$5.8
Q210
Q211
Q210
Q211
Q210
Q211
Q210
Q211
Q211 Snapshot
Q211 Snapshot
14
©
2011 Conceptus, Inc. All rights reserved.
Adj. EBITDA
(1)
($M) |
Q211 Net Sales (in $ millions)
Q211 Units (in
thousands): $36.8
Q210
Q211
$28.0
(76%)
$33.8
$24.8
(73%)
33.3
Q210
Q211
20.1
(60%)
13.2
(40%)
29.4
Domestic
International
$9.0
(27%)
$8.9
(24%)
Worldwide Sales
Worldwide Sales
17.8
(61%)
11.6
(39%)
15
©
2011 Conceptus, Inc. All rights reserved.
Columns may not add due to rounding |
Q211
Q111
(1)
Q410
(1)
Q310
(1)
Q210
(1)
Current Period Activity:
Physicians entering preceptorship
538
388
380
380
425
Physicians becoming certified
290
200
427
334
368
Physicians transitioning to in-office
110
89
202
185
163
Physician Base:
13,553
13,015
12,627
12,247
11,867
Physician Metrics Pipeline Grew
Physician Metrics Pipeline Grew
We returned to expanding the market for Essure in Q211
16
©
2011 Conceptus, Inc. All rights reserved.
Office-based procedures were ~69% of total volume in Q211
(1)
Includes adjustments made to the categories of physicians entering preceptorship,
physicians becoming certified and physician base due to an adjustment in our
data gathering process on these items. |
In
$ millions except for EPS (1)
Adjusted earnings before interest, taxes, depreciation, amortization and
stock-based compensation. See appendix. (2)
Net loss after taxes includes a net income tax benefit of $2.3 million.
Q211 Highlights
Q211 Highlights
17
©
2011 Conceptus, Inc. All rights reserved. |
Q211 Adjusted EBITDA
Q211 Adjusted EBITDA
Adjusted
EBITDA
$5.85
Amortization
of
intangibles
Stock-
based
compensation
$0.45
Net income
See reconciliation in appendix
Interest
and other
income
(expense)
net
$ millions
Depreciation
expense
Benefit
from
income
taxes
$1.63
($0.17)
$0.82
$1.73
$1.39
18
©
2011 Conceptus, Inc. All rights reserved. |
Balance Sheet
Balance Sheet
Cash & cash equivalents
Investments
Accounts receivable
Inventories & other assets
PP&E
Intangibles
Goodwill
Deferred tax asset
Total assets
ASSETS
25.8
69.8
19.6
9.8
10.4
22.8
17.4
81.7
257.3
6/30/11
A/P & other accrued ST
liabilities
Notes payable
(1)
Other accrued LT liabilities
Total Equity
Total liabilities & equity
LIABILITIES &
EQUITY
12/31/10
17.0
83.3
2.5
154.5
257.3
18.4
72.5
20.4
10.4
10.1
24.1
16.0
78.8
250.7
6/30/11
12/31/10
15.8
81.0
2.4
151.5
250.7
$ millions
19
©
2011 Conceptus, Inc. All rights reserved.
(1) Notes payable is a current liability
Columns may not add due to rounding |
Guidance
Guidance
Net Sales
$135M to
$140M
$141M
Gross Profit Margin
81.9% to
82.2%
80.9%
Operating
Expenses
$103M to
$105M
$104M
Adjusted EBITDA
(1)
$23M to
$26M
$25M
FY11E
as of 8/4/11
FY10
Actual
(1) See appendix
20
©
2011 Conceptus, Inc. All rights reserved. |
2011:
2011:
Strategic Plan
Strategic Plan
Update
Update
Mark Sieczkarek,
President and
Chief Executive Officer
©
2011 Conceptus, Inc. All rights reserved. |
Strategic Plan Goals
Strategic Plan Goals
Goals
Environment
Response
Navigate current
economy and
make Essure
Standard of
Care
in PBC
market
Drive long-term
growth
Challenging macroeconomic and
insurance trends continue
Patient utilization rates remain
low for non-urgent procedures
like Essure
HHS
(1)
decision to include
permanent birth control under
PPACA
(2)
at no cost to patients
beginning in 2013 represents a
key inflection point in our future
business
Continue to execute our
strategic plan and control
what we can
New DTC to build
consumer awareness
Launched innovative
offerings like the Essure
FlexPay Plan to make
patient deductible
payments for Essure
more affordable
We remain committed to our strategic plan to drive long-
term revenue growth across the world
22
©
2011 Conceptus, Inc. All rights reserved.
(1)
U.S. Department of Health and Human Services
(2)
Patient Protection and Affordable Care Act of 2010
TM |
Strategic Plan Update
Strategic Plan Update
Strategy
Details
Status
1. Minimize
impact of
competition
and gain back
market share
Defend our existing accounts
against competitive trialing
Filed with FDA to remove
contraindication of nickel
hypersensitivity in Essure IFU
Expanded sales force
Continue to educate
physicians on Essures
superior efficacy
Succeeded in reducing nickel
contraindication to a warning in
Essure IFU, which enhances
competitive positioning
Pace of competitive trialing in
Essure accounts continues to
slow
23
©
2011 Conceptus, Inc. All rights reserved. |
Strategic Plan Update
Strategic Plan Update
Strategy
Details
Status
2. Increase
Essure
utilization
Leverage in-office channel
strength to promote
GYNECARE
THERMACHOICE
®
III
to
U.S.
physician
offices
PBC is medically necessary for
GEA patients, doubles Essure
market opportunity
Secure trials and convert
physicians to using
GYNECARE
THERMACHOICE
®
III
in
the
office
setting
Capture PBC opportunity with
converted physicians
GEA
patients
Launched GYNECARE
THERMACHOICE
®
III
promotion
efforts in Q111
>2,000 physicians have
committed to trialing
~670 physicians have trialed;
work to get conversions
Will focus on increasing
Essure utilization in these
accounts
24
©
2011 Conceptus, Inc. All rights reserved. |
Strategic Plan Update
Strategic Plan Update
Strategy
Details
Status
3. Drive
adoption of
Essure through
strategic,
integrated
marketing
Growth strategies include
physician and consumer
segmentation, owning the
in-office sales process,
publication planning and DTC
Integrate patient and physician
value proposition to increase
Essure utilization at point of
care
Re-initiate DTC campaign and
run continuously nationwide
Expanded marketing
organization now in place
Launched Essure FlexPay
Plan to make patient
deductible payments for
Essure more affordable
Launched new
www.essure.com website
Launched Essurance
Promise
Program
Piloting patient education
system to help physicians
identify Essure candidates
25
©
2011 Conceptus, Inc. All rights reserved.
TM
TM |
Strategic Plan
Update Strategic Plan Update
Strategy
Details
Status
4. Expand
international
presence
Europe
France
U.K.
Brazil
Emerging markets
Europe: have launched
targeted PR campaigns in
various countries
France: working to reinstate
reimbursement for <40 market;
increased targeting of
40
market
U.K.: in discussions to
increase fee schedule of
hysteroscopic sterilization
Brazil: reimbursement focus
China and India: moving
forward on approval process
26
©
2011 Conceptus, Inc. All rights reserved. |
Strategic Plan Update
Strategic Plan Update
Strategy
Details
Status
5. Washington
DC focus and
reimbursement
issues
Include contraception under
the PPACA guidelines
Medicaid reimbursement and
cost saving issues
Seek ACOG recommendation
of hysteroscopic sterilization
as Standard of Care
HHS mandated inclusion of
permanent birth control under
PPACA at no cost to patients
represents a key inflection
point in our future business
35 states provide adequate
Essure Medicaid fee-for-
service office reimbursement
as of 6/30/11
Continuing discussions with
ACOG; AAGL to write a
position statement
27
©
2011 Conceptus, Inc. All rights reserved. |
Strategic Plan Update
Strategic Plan Update
Strategy
Details
Status
6. Create a
pipeline of
womens
health products
and services
Designed to accelerate
adoption of Essure
Provide more diversified
offerings
Ongoing review of potential
high-growth synergistic
opportunities
Prefer in-office setting
7. Product
enhancements
Develop next generation
Essure procedure
Seek FDA approval of
transvaginal ultrasound (TVU)
for U.S. Essure confirmation
instead of HSG
Hired new EVP of research
and development
Received conditional approval
from the FDA to conduct an
IDE clinical study to replace
the HSG confirmation test
currently required in the U.S.
with TVU
28
©
2011 Conceptus, Inc. All rights reserved. |
Key
Take-Aways Key Take-Aways
We are dedicated to making Essure the Standard of
Care
in the PBC market, even as macroeconomic and
insurance challenges remain
The competitive threat appears to be stabilized and we
will sharpen our focus on increasing utilization and
growing the market for Essure
Strategic marketing initiatives, including a new DTC
campaign, are expected to increase consumer adoption
of Essure and return the market to double-digit growth
29
©
2011 Conceptus, Inc. All rights reserved. |
Appendix
Appendix
©
2011 Conceptus, Inc. All rights reserved. |
Use
of Non-GAAP Financial Measures Use of Non-GAAP Financial
Measures The
Company
has
supplemented
its
GAAP
net
income
/
(loss)
with
a
non-GAAP
measure of adjusted earnings before interest, taxes, depreciation, amortization
and stock-based compensation (adjusted EBITDA).
Management believes that this non-GAAP financial measure provides useful
supplemental information to management and investors regarding the performance
of the Companys business operations, facilitates a better comparison of
results for current periods with the Companys previous operating
results, and assists management in analyzing future trends, making strategic
and business decisions and establishing internal budgets and forecasts.
A reconciliation of non-GAAP adjusted EBITDA to GAAP net income / (loss)
in the most directly comparable GAAP measure, is provided in the below
schedule. There are limitations in using this non-GAAP financial measure
because it is not prepared in accordance with GAAP and may be different from
non-GAAP financial measures used by other companies. This
non-GAAP financial measure
should
not
be
considered
in
isolation
or
as
a
substitute
for
GAAP
financial measures. Investors and potential investors should consider
non- GAAP financial measures only in conjunction with the Companys
consolidated financial statements prepared in accordance with GAAP and the
reconciliations of the non-GAAP financial measure provided in the below
schedules. 31
©
2011 Conceptus, Inc. All rights reserved. |
GAAP to Non-GAAP Reconciliation
32
©
2011 Conceptus, Inc. All rights reserved.
2011
2010
2011
2010
Net Income (Loss), as reported
454
$
(291)
$
(2,474)
$
(2,642)
$
Adjustments to net income (loss):
Interest and other income (expense), net (a)
1,626
1,585
3,173
3,044
Provision (benefit) for income taxes
(165)
123
(2,468)
257
Amortization of intangibles (b)
819
808
1,632
1,627
Stock-based compensation (c)
1,727
1,802
3,422
3,531
Depreciation expense (d)
1,388
1,144
2,631
2,241
Adjustments to net income (loss)
5,395
5,462
8,390
10,700
Adjusted EBITDA
5,849
$
5,171
$
5,916
$
8,058
$
(a) Consists of interest from available-for-sale securities, interest expense associated with
our convertible debt and foreign exchange currency transactions
(b) Consists of amortization of intangible assets, primarily licenses and customer relationships
(c) Consists of stock-based compensation in accordance with ASC 718
(d) Consists of depreciation, primarily on property, plant and equipment
Conceptus, Inc.
(Unaudited)
Reconciliation of Net Income (loss) to Adjusted Earnings Before Interest, Taxes, Depreciation,
Amortization and Stock-Based Compensation (Adjusted EBITDA)
(In thousands)
June 30,
Three Months Ended
Six Months Ended
June 30, |
GAAP to Non-GAAP Reconciliation
33
©
2011 Conceptus, Inc. All rights reserved.
From
To
Net Income Guidance
560
$
2,297
$
Estimated Non-GAAP Guidance
Interest and other income (expense), net (a)
6,300
6,300
Provision for income taxes
333
1,596
Amortization of intangibles (b)
3,261
3,261
Stock-based compensation (c)
7,116
7,116
Depreciation expense (d)
5,430
5,430
Adjustments to net income
22,440
$
23,703
$
Adjusted EBITDA
23,000
$
26,000
$
(a) Consists of interest from available-for-sale securities, interest expense associated with
our convertible debt and foreign exchange currency transactions
(b) Consists of amortization of intangible assets, primarily licenses and customer
relationships (c) Consists of stock-based compensation in accordance with ASC 718
(d) Consists of depreciation, primarily on property, plant and equipment
December 31, 2011
Conceptus, Inc.
Financial Measures To Projected GAAP Net Income
(Unaudited)
Twelve Months Ending
Reconciliation of Forward-Looking Guidance For Non-GAAP |
Revolutionizing womens healthcare
with innovative solutions
Conceptus, Inc.
Conceptus, Inc.
NASDAQ: CPTS
NASDAQ: CPTS
©
2011 Conceptus, Inc. All rights reserved.
CC-2847 4AUG11
F |