Attached files
| file | filename |
|---|---|
| 8-K - AMAG PHARMACEUTICALS, INC. | amag8-kxq4earningsreleasea.htm |
| EX-99.3 - EXHIBIT 99.3 - AMAG PHARMACEUTICALS, INC. | ex993endoceuticslicense.htm |
| EX-99.1 - AMAG PHARMACEUTICALS, INC. | ex991q4fy2016earningsrelea.htm |
AMAG Pharmaceuticals
2016 Financial Results and
Intrarosa License Agreement
February 14, 2017
Forward-Looking Statements
2
This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA) and other federal securities
laws. Any statements contained herein which do not describe historical facts, including, among others, statements regarding expected 2016 financial results, including
revenues, adjusted EBITDA; AMAG’s anticipated expansion in women’s health through the licensing transaction with Endoceutics, Inc., including the expected timing for
the closing of Intrarosa transaction; Makena’s position in the market and future growth drivers for Makena, including its potential market opportunity, filing a
supplemental new drug application (sNDA) for the Makena subcutaneous (SC) auto-injector and customer engagement and outreach; beliefs that the current Makena
SC auto-injector formulation offers benefits to physicians and patients, including the potential for greater convenience and alternative administration; AMAG’s beliefs
that bioavailability is a key parameter and that the PK study demonstrated comparable bioavailability between the SC and intramuscular (IM) arms; expectations
regarding timing for the submission of the Makena auto-injector sNDA (including expected timing for an FDA decision on the sNDA and commercial launch, if
approved); growth drivers for Cord Blood Registry (CBR), including plans to differentiate CBR offerings and increase engagement and communications in the industry;
expected timing for topline data and submission of the sNDA for the expanded Feraheme label (including expected timing for an FDA decision on the sNDA and
commercial launch, if approved); growth drivers for Feraheme, including plans to optimize net revenue per gram, grow in key segments and expectations that the size
of the addressable market, if the broader indication is approved, would double; expectations regarding the potential benefits, safety profile and commercial
opportunity of Intrarosa and its’ strategic fit for AMAG’s women’s health business; the competitive landscape and breadth of the vulvovaginal atrophy (VVA) markets
and Intrarosa’s market potential; expectations on timing of Intrarosa launch, AMAG’s ability to leverage existing commercial and medical affairs teams and to expand its
current sales force and deploy its digital engagement platform, and Intrarosa label expansion opportunities (including timing of initiation of Phase 3 female sexual
dysfunction study); AMAG’s belief that its well-positioned to improve women’s health care and that Intrarosa will build long-term shareholder value; expectations on
timing of Rekynda NDA submission (including expected timing for an FDA decision on the sNDA and commercial launch, if approved); and the expected timing of
initiation of the Velo Phase 2b/3a study are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from
those discussed in such forward-looking statements.
Such risks and uncertainties include, among others, (1) the possibility that the closing conditions set forth in the Intrarosa License Agreement, including, those related
to antitrust clearance, will not be met and that the parties will be unable to consummate the proposed transactions; (2) the possibility that AMAG will not realize the
expected benefits of the transaction, including the anticipated market opportunity and the ability of its current or expanded sales force to successfully commercialize
Intrarosa; (3) the possibility that significant safety or drug interaction problems could arise with respect to Intrarosa; (4) the ability of AMAG to drive awareness of
dyspareunia and the potential benefits of Intrarosa; (5) uncertainties regarding the manufacture of Intrarosa; (6) uncertainties relating to patents and proprietary rights
associated with Intrarosa in the United States; (7) that the cost of the transaction to AMAG will be more than planned and/or will not provide the intended positive
financial results; (8) that AMAG or Endoceutics will fail to fully perform their respective obligations under the Intrarosa License Agreement or the Intrarosa Supply
Agreement; (9) uncertainty regarding AMAG’s ability to compete in the dyspareunia market in the United States; and (10) other risks identified in AMAG’s Securities
and Exchange Commission (“SEC”) filings, including its Annual Report on Form 10-K for the year ended December 31, 2015, its Quarterly Reports on Form 10-Q for the
quarters ended March 31, 2016, June 30, 2016 and September 30, 2016 and subsequent filings with the SEC, including its Current Reports on Form 8-K filed with the
SEC on January 9, 2017 and February 3, 2017, as well as in its upcoming Annual Report on Form 10-K for the year ended December 31, 2016. AMAG cautions you not to
place undue reliance on any forward-looking statements, which speak only as of the date they are made. AMAG disclaims any obligation to publicly update or revise
any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the
likelihood that actual results will differ from those set forth in the forward-looking statements.
AMAG Pharmaceuticals® and Feraheme® are registered trademark of AMAG Pharmaceuticals, Inc. MuGard® is a registered trademark of Abeona Therapeutics, Inc.
Makena® is a registered trademark of AMAG Pharmaceuticals IP, Ltd. Cord Blood Registry® and CBR® are registered trademarks of CBR Systems, Inc. Rekynda is a
trademark of Palatin Technologies, Inc. IntrarosaTM is a trademark of Endoceutics, Inc.
Today’s Agenda
3
2016 Highlights and Recent Events1
5 Value Drivers and Upcoming Potential Product Launches
4 IntrarosaTM: Further Expansion into Women’s Health
3 2016 Financial Overview
6 Q&A
2 2016 Product Performance and 2017 Growth Drivers
2016 Highlights and
Recent Events
2016 Highlights and Recent Events
Makena
Drove 44% quarterly sales growth over 4Q-2015 and 33% growth year over year through:
‒ Successful launch of single-dose, preservative free formulation
‒ Expansion of Makena @Home service, including enhanced agreement with Optum Home Health
Completed Makena pharmacokinetic study and preparing sNDA filing for subcutaneous auto-injector
- Feraheme
Achieved record sales
Completed enrollment in broad iron deficiency anemia (IDA) study to support 2017 sNDA filing
- Cord Blood Registry (CBR)
Added more than 40,000 stored units of cord blood and cord tissue
Increased revenue per consumer by 8.5% over 2015
Achieved Financial and Business Development Goals
Grew net revenue 27% to $532M
Generated significant cash flow; ended 2016 with $579M of cash and equivalents
Expanded product portfolio
5
Further Expanding AMAG’s Product Portfolio
6
Pregnancy & Birth Wellness
Post-Menopausal
Health
Feraheme Makena
Velo Option
Cord Blood
Registry
Used for the treatment of iron
deficiency anemia (IDA) in adult
patients with chronic kidney disease
(CKD)
The only FDA-approved
therapy to reduce
recurrent preterm birth in
certain at-risk women
World’s largest umbilical
cord stem cell collection
and storage company
At completion of a Phase
2b/3a clinical trial, AMAG
has the option to acquire
an orphan drug candidate
for the treatment of
severe preeclampsia
Intrarosa1
Recently FDA-approved
non-estrogen product to
treat moderate-to-severe
dyspareunia, and only FDA
approved VVA (vulvar and
vaginal atrophy) treatment
without a boxed warning
Recent successful
completion of two Phase 3
clinical trials for on-
demand treatment of
hypoactive sexual desire
disorder (HSDD)
Rekynda
MuGard
Prescriptive mucoadhesive for the
management of oral mucositis, a
common side effect of radiation or
chemotherapy
Maternal and Women’s Health
Hematology/Oncology
1 Announced exclusive U.S. license agreement for Intrarosa on February 14, 2017.
The transaction license expected to close in the first half of 2017.
7
$67.4
$97.2
4Q-2015 4Q-2016
Makena: Strong Commercial Execution
$251.6
$334.1
2015 2016
Fourth Quarter Revenue ($M)
Full Year Revenue ($M)
W O M E N ’ S H E A L T H : M A K E N A
2017 Growth Drivers
Continue to take share from compounders
Grow Makena @Home administration
Greater share of voice with target customers
Expand use in late preterm birth segment
Majority of prescriptions flow through Makena Care
Connection (~66%)
Launch subcutaneous auto-injector1
2016 Accomplishments
Successfully launched single-dose, preservative free
formulation
Increased market share to 42%
Enhanced patient access to Makena
Expanded Optum Home Health Services relationship
Initiated and fully enrolled PK study
+44%
+33%
1 If regulatory approved is received.
Makena intramuscular (IM)
‒ Only approved product to lower the risk of preterm birth
‒ Most frequent AE is injection site pain1
Makena exclusivity and patents
‒ IM orphan drug exclusivity through February 2018
‒ Auto-injector covered by multiple issued Antares patents to 2026
‒ Additional patent applications pending
Makena subcutaneous formulation offers the potential for:
‒ Greater convenience for healthcare providers
• No vials, needle switching or lengthy IM injection
‒ Alternative to IM injection for patients
• Smaller concealed needle, rapid auto-injection, can be injected discretely
Makena auto-injector sNDA submission on-track
‒ Company believes PK study results demonstrated comparable bioavailability between SC and IM
injections
• Bioequivalence met on AUC, a key PK parameter given Makena’s long-acting duration of action
‒ Moving forward with sNDA submission in 2Q-2017
‒ Anticipate FDA decision in 4Q-2017
Makena: Next Generation Program Update
W O M E N ’ S H E A L T H : M A K E N A
1 Meis et al, N Engl J Med 2003; 348:2379-2385, June 12, 2003.
8
9
CBR: Attractive Recurring Revenue Stream
W O M E N ’ S H E A L T H : C O R D B L O O D R E G I S T R Y
$24.1
$99.6
2015 2016
$118.6
2015 2016
GAAP Full Year Revenue ($M)
$116.6
Non-GAAP, Pro Forma Full Year Revenue2,3 ($M)
1 Represents revenues from August 17, 2015 to December 31, 2015. CBR was acquired by AMAG on August 17, 2015.
2 Non-GAAP CBR revenue includes purchase accounting adjustments related to CBR deferred revenue of $1.4M and $17M for the
fourth quarter and full year of 2016, respectively.
3 Represents pro forma revenue for 2015. AMAG acquired CBR on August 17, 2015.
1
2017 Growth Drivers
Differentiate CBR’s offerings
‒ Highlight cord tissue storage offering
‒ Enhance product offerings
Build value proposition on storing newborn stem cells
Increase engagement with the HCP community
2016 Accomplishments
Increased 4Q revenue to $29.1M (non-GAAP)2
Grew revenue per consumer 8.5% year-over-year
Increased stored units by ~40k
Began implementation of enhanced messaging to better
target millennial families
10
$23.2
$26.3
4Q-2015 4Q-2016
Feraheme: Differentiated Product, Expect Future Growth
$88.5
$97.1
2015 2016
Fourth Quarter Revenue1 ($M)
Full Year Revenue1 ($M)
2017 Growth Drivers
Continued growth in key segments
Optimize net revenue per gram
Prepare for expanded label to include IDA patients with all
causes
‒ Would double addressable market, if approved
Pull through recent GPO access wins
2016 Accomplishments
Achieved $97M in revenues1
6% growth in grams over 2015
Expanded presence in integrated delivery networks and
group purchasing organizations
Completed enrollment in head-to-head trial for broader
indication, accelerating sNDA filing by 6 months to mid-2017
+13%
+10%
H E M A T O L O G Y / O N C O L O G Y : F E R A H E M E
1 Represents revenues from Feraheme only. Excludes revenues from MuGard as reported on financial statements.
GAAP Total Revenue and Operating Income
11
$108.7
$151.6
+39%
1 Collaboration revenue related to the termination of AMAG’s ex-US ferumoxytol marketing partnership agreement.
3-months ended December 31 ($M)
$22.7
$14.6
12-months ended December 31 ($M)
4Q-2015 4Q-2016
$418.3
$532.1
$111.2
$78.9
2015 2016
+27%
Makena CBRFeraheme/MuGard Collaboration revenue1 Operating Income
GAAP Financial Summary
For the 3- and 12- Months Ended December 31
($M, except per share data)
Total revenues
Costs and expenses
Operating income
Interest expense and other
Net income (loss) before taxes
Income tax expense (benefit)
Net income (loss)
Net income (loss) per basic share
Net income (loss) per diluted share
Weighted average basic shares
Weighted average diluted shares2
1 Calculation requires the adjustment of interest expense to account for treatment of convertible debt.
2 See slide 32 for share reconciliation.
4Q-2016 4Q-2015
$151.6 $108.7
137.0 86.0
$14.6 $22.7
($17.3) ($17.9)
($2.7) $4.8
$7.8 ($2.4)
($10.6) $7.2
($0.31) $0.21
($0.31) $0.20
34.3 34.7
34.3 42.8
2016 2015
$532.1 $418.3
453.2 307.1
$78.9 $111.2
($69.8) ($71.4)
$9.0 $39.8
11.5 7.0
($2.5) $32.8
($0.07) $1.04
($0.07) $0.93
34.3 31.5
34.3 35.3
1
12
Non-GAAP Total Revenue and Adjusted EBITDA
13
$120.6
$153.0
+27%
3-months ended December 31 ($M)
$61.3
$77.4
12-months ended December 31 ($M)
4Q-2015 4Q-2016
$397.4
$549.1
$213.4
$265.7
2015 2016
+38%
Makena CBRFeraheme/MuGard Collaboration revenue4 Adjusted EBITDA
1 Represents CBR revenues from August 17, 2015 to December 31, 2015. CBR was acquired by AMAG on August 17, 2015.
2 Non-GAAP CBR revenue includes purchase accounting adjustments related to CBR deferred revenue of $11.8M and $19.1M for the fourth
quarter and full year of 2015, respectively.
3 Non-GAAP CBR revenue includes purchase accounting adjustments related to CBR deferred revenue of $1.4M and $17M for the fourth
quarter and full year of 2016, respectively.
4 Collaboration revenue related to the termination of AMAG’s ex-US ferumoxytol marketing partnership agreement.
33 1,22
Strong Cash Flow Generation
14
($M) 12/31/16 12/31/15
Cash, cash equivalents and investments $5791 $466
Principal debt outstanding
Convertible senior notes (2.5%) $200 $200
Term loan facility (4.75%) 328 346
2023 senior notes (7.875%) 500 500
Total debt outstanding $1,028 $1,046
($M) 12/31/16 12/31/15
Net debt $454 $580
Net leverage ratio2 1.7x 2.7x
Total leverage ratio2 3.9x 4.9x
Added $113M of cash to Balance Sheet, net of $100M milestone
payment, $20M stock repurchases and $17.5M debt payments
1 Amount represents 12/31/16 balance. On February 2, 2017, the company made a $60M payment to Palatin Technologies in
connection with the closing of its licensing transaction.
2 Leverage ratios based on LTM adjusted EBITDA for each period.
Strong Financial Profile, Management Team & Corporate Infrastructure
Market Access, Analytics, and Other Commercial Functions
Continuing to Expand AMAG’s Product Portfolio
15
Future
Product
Digital Consumer Marketing Expertise, Public Relations and Medical Affairs
Women’s Health (Including Maternal Health)
Hematology / Oncology, Nephrology &
Hospital
RekyndaTM
IntrarosaTM
Makena®
Leveraging expertise and acquiring innovative products/companies that provide
long-term, durable growth potential and revenue streams
IntrarosaTM (prasterone)
A first-of-its-kind, non-estrogen
women’s health therapy
Exclusive U.S. License for Intrarosa
Will address a significant unmet need for
post-menopausal women
Strong safety and efficacy profile
Large near-term commercial opportunity
‒ FDA approved in November 2016
‒ 3 Orange Book listed patents out to 2031
Leverages AMAG’s current commercial
platform in women’s health
Capital efficient transaction structure
Another key step forward in AMAG’s
portfolio expansion strategy
W O M E N ’ S H E A L T H : I N T R A R O S A
17
Intrarosa: Potential to Address Significant Unmet Need
18
Approximately 32M post-menopausal women in the U.S. suffer from symptoms of vulvar
and vaginal atrophy (VVA)1
- 44% to 78% of women with VVA report symptoms of moderate-to-severe dyspareunia1,2
- Growing population of post-menopausal women in the U.S.
VVA is undertreated
- ~10% are treated with prescription therapy
- ~60% do not receive any treatment at all
- Remainder using OTC products1
80% decline in use of estrogen therapy by post-menopausal women
- Landmark Women’s Health Initiative (WHI)3 led to warnings of increased risks of certain types of
cancers, cardio vascular disease and probable dementia associated with exogenous estrogen therapy
Safety concerns of systemic estrogen exposure are barriers to initiation and
persistency with Rx treatment of VVA symptoms1
As a local, non-estrogen therapy, Intrarosa is not subject to a boxed warning or labeling
restrictions associated with estrogen-containing therapies
1 Wysocki et al. Management of Vaginal Atrophy: Implications from the REVIVE Survey. Clinical Medicine Insights: Reproductive Health 2014:8 23–30.
2 F. Palma et al: Vaginal atrophy of women in postmenopause. Results from a multicentric observational study: The AGATA study.
3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3607288/
W O M E N ’ S H E A L T H : I N T R A R O S A
Overview: Vulvovaginal Atrophy (VVA)1
19
3
2
W O M E N ’ S H E A L T H : I N T R A R O S A
Intrarosa is indicated for moderate-to-severe dyspareunia (pain during intercourse),
a symptom of VVA, due to menopause
Post-menopausal VVA:
- Common and underreported condition associated with decreased sex steroid levels
- Results in tissue changes that decrease lubrication and erode superficial lining of the vagina
- Symptoms include dyspareunia, dryness, irritation, itching, soreness
- Most common in post-menopausal women – prevalence is ~50% of post-menopausal women
- Current treatments include OTC lubricants, prescription oral and vaginal creams, inserts and a ring
1 Mayo Clin Proc v. 85(1); 2010 Jan PMC2800285
2 Wysocki et al. Management of Vaginal Atrophy: Implications from the REVIVE Survey. Clinical Medicine Insights: Reproductive
Health 2014:8 23–30
3 The North American Menopause Society. Menopause. 2007;14:357-69
Non-Estrogen-
Based
Intrarosa contains prasterone (DHEA), a precursor of hormones
that is converted locally inside the vaginal cells into androgens
and estrogens
Does not carry the boxed warning that is currently required in
the labels of all estrogen-containing vaginal therapies
‒ Class labeling warns of the increased risks associated with exogenous
estrogen therapy, as described from the results of the Women’s Health
Initiative1, that has caused fear and apprehension among patients
Clinical Efficacy
In two 12-week placebo-controlled efficacy trials, women
taking Intrarosa experienced a significant reduction in
moderate-to-severe dyspareunia, significant improvements in
the percentage of vaginal superficial cells and parabasal cells
(deeper layer), as well as vaginal pH (all primary endpoints
were statistically significant)
Safety
Favorable safety profile
52 week long-term safety study (n=422) in post-menopausal
women showed no evidence of endometrial hyperplasia
Vaginal discharge and atypical pap smears were reported as a
treatment-emergent adverse reaction in ≥ 2% of Intrarosa
women
Contraindicated in women with undiagnosed abnormal uterine
bleeding; precaution for use in women with current or past
breast cancer
1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3607288/
Intrarosa: Strong Efficacy and Safety Profile
W O M E N ’ S H E A L T H : I N T R A R O S A
20
Affected, but not yet seeking treatment
Utilizing OTC treatments
Previous estrogen
therapy users
Intrarosa: Sizable Untapped Market for Treating Dyspareunia
21
Currently on
Rx estrogen
therapy
Safety concerns about estrogen-
containing treatment options
Efficacy and/or safety concerns about
estrogen-containing treatment options
Efficacy and/or not treating
underlying pathology of VVA
Unaware of condition/
treatment options
and/or safety concerns
Local (intra-vaginal) estrogen
therapies = sales of >$1B per year1
1 Based on IMS SMART Tool NSP and NPA data.
2 IMS Health Plan Claims (April 2008-11).
3 AMAG estimate based on a) Wysocki et al. Management of Vaginal Atrophy: Implications from the REVIVE Survey. Clinical Medicine Insights: Reproductive
Health 2014:8 23–30 and b) F. Palma et al: Vaginal atrophy of women in postmenopause. Results from a multicentric observational study: The AGATA study.
4 Trinity Partners, Quantitative Market Assessment, December 2016 (n=100 PCPs, 100 OBGYNS).
5 Based on multiple publications based on patient surveys.
1.7M women2
~6M women3,4
~12M women5
W O M E N ’ S H E A L T H : I N T R A R O S A
Intrarosa Serves Significant Unmet Medical Need
22
1.7 M on
estrogen therapy2
Local (intra-vaginal) estrogen
therapies = sales of >$1B per year1
Brand(s) Current Intra-vaginal Therapies Intrarosa
Administration Vaginal insert or cream by applicator Vaginal insert by applicator
Indication
Approved for various symptoms of VVA, including
dyspareunia, atrophic vaginitis, dryness, itching and
burning1
Approved for moderate-to-
severe dyspareunia, a
common symptom of VVA
Boxed Warning
Boxed warnings regarding increased risk of certain types
of cancers, such as endometrial cancer, CVD and probable
dementia
No boxed warning
Dosing
Most require an initial induction phase of daily dosing
with varying frequency thereafter
Warnings: use lowest effective dose and shortest duration
of treatment consistent with treatment goals
Daily
1 Based on IMS SMART Tool NSP and NPA data.
2 IMS Health Plan Claims (April 2008-11).
Safety concerns about estrogen-
containing treatment options
W O M E N ’ S H E A L T H : I N T R A R O S A
Leverages AMAG’s Current Commercial Platform
Leverage existing AMAG commercial and medical affairs teams
- Deep relationships and experience with the OB/GYN community and women’s health KOLs
- Successful patient access and commercial analytics platform
- Strong record of consistent growth (40% in 2016) across current product portfolio
- Significant experience building market awareness for new therapeutics and patient support programs
Expand current women’s health sales force
- Targeting ~25,000 OB/GYNs across the country
- Dedicated new ~150-person team focused on the launch of Intrarosa
- Maintain current 100-person team’s focus on Makena/CBR promotion and preparations for
subcutaneous auto-injector launch1
- Future sales force flexibility as portfolio evolves (e.g., launch of Rekynda)
Opportunities for label expansion and lifecycle management
- Female Sexual Dysfunction
Deploy digital engagement platform
- Consumer education/content about novel treatment alternative to estrogen-containing therapy
Preparing for mid-2017 launch of recently approved first-of-its-kind therapy
W O M E N ’ S H E A L T H : I N T R A R O S A
231 If regulatory approved is received.
AMAG: At the Nexis of Key Drivers in Women’s Health
Science
Patients Healthcare Providers
W O M E N ’ S H E A L T H : I N T R A R O S A
Awareness-building capabilities and novel product create transformational opportunity
New mechanism of action
New therapeutic class
Only non-estrogen therapy with no boxed warning
Proven experience
Expanded share of voice
Broad patient access
Congress engagement
Ease of application
Patient assistance and
affordability programs
Digital awareness &
engagement
24
• $50M upfront cash payment and 600K shares of AMAG stock
• Up to $10M on delivery of commercial supply for launch
• $10M on the first anniversary of the effective date of the agreement
• Sales milestones
• $15M payment when net sales exceed $150M annually
• $30M payment when net sales exceed $300M annually
• $850M of payments triggered at various net sales levels exceeding $500M annually
• Tiered royalties as a percent of net sales starting at mid-teens
Intrarosa: Designed to Build Long-Term Shareholder Value
25
Transaction
• Licensed U.S. rights from Endoceutics, a private pharmaceutical company based in
Quebec City, Canada
• Founded by Fernand Labrie, MD, PhD, a world-renowned endocrinologist
• Endoceutics research/development focused in the field of women’s health
• Endoceutics will supply product to AMAG
Licensor
• Hart-Scott-Rodino (HSR) review
• Expect to close transaction in first half of 2017Timing
• Will co-fund Phase 3 program of Intrarosa for the treatment of female sexual
dysfunctionDevelopment
Upcoming Value Drivers
and Potential Product
Launches
Frank Thomas
President and Chief Operating
Officer
AMAG Portfolio: Multiple Value Drivers
27
Milestone 2017 2018
MAKENA AUTO-INJECTOR PROGRAM Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Topline PK data
sNDA submission
Expected FDA action and commercial launch
FERAHEME IDA LABEL EXPANSION Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Enrollment completed
Topline data
sNDA submission
Expected FDA action and commercial launch
INTRAROSA Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Commercial launch in dyspareunia
Initiate Phase 3 female sexual dysfunction study
REKYNDA Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
NDA submission
Expected FDA action and commercial launch
VELO – SEVERE PREECLAMPSIA
Initiate Phase 2b/3a study
Key Product Launch Milestones
28
Makena
subcutaneous
auto-injector
Velo (severe
preeclampsia)
IDA (non-CKD)
R
ev
e
nu
e
Today 2017 2018 2019 2020
5 Potential Product Launches over Next 4 Years
AMAG Pharmaceuticals
Q&A
February 14, 2017
Appendix
Reconciliation of GAAP to Non-GAAP 2016 Results
31
($M)
GAAP operating income
Purchase accounting adjustments related to
CBR deferred revenue
Non-cash collaboration revenue
Depreciation & intangible asset amortization
Inventory reserve
Non-cash inventory step-up adjustments
Stock-based compensation
Adjustments to contingent consideration
Option rights to license orphan drug
Impairment charges of intangible assets
Transaction-related costs
Restructuring costs
Non-GAAP adjusted EBITDA
4Q-2016 4Q-2015
$14.6 22.7
1.4 11.8
-- --
29.1 16.9
-- 1.0
1.0 0.9
5.7 5.7
20.6 (0.3)
-- --
3.7 --
1.3 0.2
0.0 2.4
$77.4 $61.3
2016 2015
$78.9 $111.2
17.0 19.1
-- (40.0)
94.2 57.5
-- 1.0
5.7 12.8
22.5 17.2
25.7 4.3
-- 10.0
19.7 --
1.3 13.8
0.7 6.5
$265.7 $213.4
Share Count Reconciliation
32
(M)
Weighted average basic shares outstanding
Employee equity incentive awards
Convertible notes
Warrants
GAAP diluted shares outstanding
Employee equity incentive awards
Convertible notes
Effect of bond hedge and warrants
Non-GAAP diluted shares outstanding
4Q-2016 4Q-2015
34.3 34.7
--1 0.7
--1 7.4
--1 --1
34.3 42.8
0.8 --
-- --
-- (1.2)
35.1 41.6
2016 2015
34.3 31.5
--1 1.4
--1 --1
--1 2.4
34.3 35.3
0.5 --
-- 7.4
-- (3.5)
34.8 39.2
1 Employee equity incentive awards, convertible notes and warrants would be anti-dilutive in this period utilizing the “if-converted”
method, which adjusts net income for the after-tax interest expense applicable to the convertible notes.
2 Reflects the Non-GAAP dilutive impact of employee equity incentive awards and convertible notes.
3 Reflects the impact of the non-GAAP benefit of the bond hedge and warrants.
2
2
2
33
AMAG Pharmaceuticals
2016 Financial Results and
Intrarosa License Agreement
February 14, 2017