EX-99.1 2 a16-16410_1ex99d1.htm EX-99.1

Exhibit 99.1

 

 

FOR IMMEDIATE RELEASE

 

AMAG Pharmaceuticals Reports Second Quarter 2016 Financial Results and Provides Corporate Update

 

Total GAAP quarterly product and service revenues increased approximately 50% to $127 million

Makena® (hydroxyprogesterone caproate injection) and Feraheme® (ferumoxytol) achieve record sales

Significant progress on next generation Makena and Feraheme development programs

 

Conference call scheduled for 8:00 a.m. ET today

 

WALTHAM, MA (August 9, 2016) — AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today reported unaudited consolidated financial results for the second quarter ended June 30, 2016. Total product and service revenues for the second quarter of 2016 increased approximately 50% to $127.4 million. This increase was driven by record sales of Makena and Feraheme and the addition of Cord Blood Registry® (CBR) to the company’s product portfolio in August of 2015. The company reported second quarter 2016 operating income of $18.1 million and a net loss of $0.6 million. Non-GAAP adjusted EBITDA for the second quarter of 2016 increased 24% to $64.6 million(1) versus the same period in 2015. After deducting cash interest expense from adjusted EBITDA, the company generated second quarter 2016 non-GAAP net income of $50.3 million.(1)

 

“Strong execution, including the recent successful launch of the single-dose, preservative-free formulation of Makena and expanded use of our Makena @Home service, drove 21% sales growth in the second quarter over the first quarter of 2016,” stated William Heiden, AMAG’s chief executive officer. “In addition to solid commercial performance during the quarter, we made further progress on both our Feraheme and Makena next-generation development programs.”

 

Makena Next Generation Development Update

 

AMAG has completed pilot pharmacokinetic (PK) studies and is preparing for the initiation of a definitive PK study later this year for the Makena subcutaneous auto-injector device. The company recently met with the U.S. Food and Drug Administration (FDA) to review its planned supplemental new drug application (sNDA) filing for this new Makena product. Based on those discussions, the company has accelerated its plan to conduct a comparative pain study concurrently with the definitive PK study so that it can include the pain data in the sNDA submission. Successfully demonstrating a reduction in pain will allow the company to apply for seven years of orphan drug exclusivity on the drug-device combination. Orphan drug exclusivity is based on the FDA’s assessment of clinical superiority as measured by a significant improvement in safety or efficacy over the existing standard of care. This exclusivity, along with the already issued patents on the auto-injector device and a filed patent application on the route of administration, would provide multiple layers of protection. The inclusion of clinical pain data in the sNDA will likely result in a 10 month regulatory review timeline. The company’s timeline to file the sNDA in the second quarter of 2017 remains unchanged, with an anticipated FDA approval in the first quarter of 2018.

 


(1)  See summaries of GAAP to non-GAAP adjustments at the conclusion of this press release.

 

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“We believe that submitting the pain data with the sNDA filing is the best strategy to extend and protect the Makena franchise and secure our leadership position in this market for many years to come,” said Mr. Heiden.

 

Second Quarter 2016 and Recent Business Highlights

 

·                  Delivered record net product and service revenues of $127.4 million in the second quarter of 2016, compared with $84.7 million in the same period last year. This increase of approximately 50% was driven by record sales of both Makena and Feraheme and the addition of CBR.

 

·                  Achieved record Makena sales of $78.4 million in the second quarter of 2016, compared with $63.6 million in the same period last year. This 23% growth in sales was driven exclusively by an increase in volume. This growth resulted in Makena market share of 37%, four percentage points over the first quarter of 2016.

 

·                  Generated a record $24.3 million of Feraheme sales in the second quarter of 2016, or 18% growth over the same period last year, the majority of which was driven by volume.

 

·                  Increased non-GAAP CBR revenue by 5%(1) over the first quarter of 2016 due to improved net revenue per new customer. In addition, new customer volume has stabilized on a sequential quarter basis.

 

·                  Received approval from the FDA in July 2016 of an additional source of supply for the single-dose, preservative-free formulation of Makena.

 

·                  Completed pilot PK studies for the Makena subcutaneous auto-injector and plans to conduct a pain study designed to establish clinical superiority over the current intramuscular injection concurrently with the definitive PK study.

 

·                  Exceeded forecasted patient enrollment to date in the company’s head-to-head, Phase 3 clinical trial evaluating Feraheme in adults with iron deficiency anemia (IDA). This study, which is now approximately 25% enrolled, is intended to support an sNDA filing to broaden the use of Feraheme beyond the current chronic kidney disease (CKD) indication to include all adult IDA patients who have failed or cannot tolerate oral iron treatment. The company anticipates filing an sNDA to broaden the Feraheme label in 2017.

 

·                  Generated an increase in cash, cash equivalents and investments of $80.1 million in the first half of 2016 to $546.5 million, net of $20.0 million utilized to repurchase the company’s common stock and $8.8 million to repay debt.

 

Second Quarter Ended June 30, 2016 (unaudited)

 

Financial Results (GAAP Basis)

 

Total revenues for the second quarter of 2016 were $127.4 million, compared with $123.9 million in the second quarter of 2015. Included in last year’s second quarter results was $39.2 million of collaboration revenue primarily related to the one-time acceleration of previously deferred revenue from the termination of the company’s ex-US ferumoxytol marketing partnership agreement. Net product and service revenues totaled $127.4 million in the second quarter of 2016, compared with $84.7 million in the same period last year. This increase is related to record sales of both Makena and Feraheme and the addition of CBR, which AMAG purchased in August 2015. Net product sales of Makena increased to $78.4 million in the second

 

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quarter of 2016, compared with $63.6 million in the same period last year. This growth in Makena sales was driven by a 24% increase in volume, primarily as a result of the successful launch of the single-dose, preservative-free formulation and increased enrollments in the company’s Makena @Home program. Sales of Feraheme and MuGard® totaled $24.6 million in the second quarter of 2016, compared with $21.1 million in the second quarter of 2015. Service revenue from CBR, on a GAAP basis, totaled $24.4 million in the second quarter of 2016.

 

Total costs and expenses, including costs of product sales and services, totaled $109.3 million for the second quarter of 2016, compared with $62.8 million for the same period in 2015. The increase in operating expenses in 2016 was related to: 1) the cost of services and operating expenses associated with CBR, which the company acquired in the third quarter of 2015, 2) a $15.7 million impairment charge of the MuGard intangible asset partially offset by a $5.6 million reduction in the contingent consideration liability, both due to the lack of broad reimbursement and insurance coverage for the product, 3) higher non-cash amortization of intangible assets from the company’s acquisitions, and 4) higher research and development (R&D) costs that included initiation of the company’s Phase 3 clinical trial to broaden the use of Feraheme to include all adult IDA patients and costs to support the company’s Makena subcutaneous auto-injector development program.

 

Second quarter 2016 operating income totaled $18.1 million, compared with $61.1 million in the second quarter of  last year. The company reported a net loss of $0.6 million, or ($0.02) per basic share and diluted share, for the second quarter of 2016, compared with net income of $33.3 million, or $1.09 per basic share and $0.82 per diluted share, for the same period in 2015. Both operating income and net income in the second quarter of 2015 benefitted from $39.2 million of collaboration revenue from a former ex-US licensing partner, which includes $5.6 million of cash received.

 

Balance Sheet Highlights

 

The company’s cash, cash equivalents and investments increased by $80.1 million in the first half of 2016 to approximately $546.5 million, net of $20.0 million utilized to repurchase the company’s common stock and $8.8 million to repay debt. Total debt (principal amount outstanding), including $200 million of convertible debt, was approximately $1.04 billion as of June 30, 2016.

 

“We are pleased with our financial performance during the first half of 2016,”stated Ted Myles, chief financial officer of AMAG. “With increasing revenue and a disciplined approach to expense management, our business successfully generated significant EBITDA and cash flows. This further strengthens our balance sheet giving us additional capacity to pursue our portfolio expansion strategy.”

 

Financial Results (Non-GAAP Basis)(1),(2)

 

Non-GAAP revenues totaled $132.5 million in the second quarter of 2016, up from $90.3 million in the second quarter of 2015. Non-GAAP CBR revenue totaled $29.4 million in the second quarter of 2016. The difference between GAAP and non-GAAP revenue for CBR represents purchase accounting adjustments related to deferred revenue. Non-GAAP revenue in 2015 excluded certain non-cash revenue related to the termination of the company’s ex-US ferumoxytol marketing agreement with its former partner.

 


(2)  See share count reconciliation at the conclusion of this press release.

 

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Total costs and expenses, including costs of product sales and services, on a non-GAAP basis totaled $67.8 million in the second quarter of 2016, compared with total costs and expenses of $38.3 million in the same period in 2015. Non-GAAP adjusted EBITDA for the second quarter of 2016 was $64.6 million, compared with $52.1 million for the same period in 2015. Included in second quarter 2015 adjusted EBITDA was the $5.6 million cash portion of collaboration revenue recognized in connection with the termination of the company’s ex-US ferumoxytol marketing partnership agreement.

 

After deducting cash interest expense from adjusted EBITDA, the company generated second quarter 2016 non-GAAP net income of $50.3 million, or $1.47 per non-GAAP basic share and $1.45 per non-GAAP diluted share. In the second quarter of 2015, non-GAAP net income totaled $44.8 million, or $1.46 per non-GAAP basic share and $1.12 per non-GAAP diluted share.

 

2016 Financial Guidance(3)

 

$ in millions

 

2016 GAAP
Guidance

 

2016 Non-GAAP
Guidance

 

Makena sales

 

$310 - $340

 

$310 - $340

 

Feraheme and MuGard sales

 

$95 - $105

 

$95 - $105

 

CBR revenue

 

$98 - $108

 

$115 - $125

 

Total revenue

 

$503 - $553

 

$520 - $570

 

 

 

 

 

 

 

Net income

 

$0 - $30

 

$195 - $225

 

Operating income

 

$93 - $123

 

N/A

 

Adjusted EBITDA

 

N/A

 

$255 - $285

 

 

Conference Call and Webcast Access

 

AMAG Pharmaceuticals, Inc. will host a conference call and webcast with slides today at 8:00 a.m. ET, during which management will discuss the company’s financial and operating results and recent developments. To access the conference call via telephone, please dial (877) 412-6083 from the United States or (702) 495-1202 for international access. A telephone replay will be available from approximately 11:00 a.m. ET on August 9, 2016 through midnight on August 18, 2016. To access a replay of the conference call, dial (855) 859-2056 from the United States or (404) 537-3406 for international access. The pass code for the live call and the replay is 45782895.

 

The call will be webcast with slides and accessible through the Investors section of the company’s website at www.amagpharma.com. The webcast replay will be available from approximately 11:00 a.m. ET on August 9, 2016 through midnight on September 9, 2016.

 

Use of Non-GAAP Financial Measures

 

AMAG has presented certain non-GAAP financial measures, including non-GAAP revenue, non-GAAP costs and expenses, non-GAAP adjusted EBITDA (earnings before income taxes, depreciation and amortization), non-GAAP net income, non-GAAP basic and diluted net income per share, and non-GAAP weighted average basic and diluted shares outstanding. These non-GAAP financial measures exclude certain amounts, revenue, expenses, income or dilutive shares from the corresponding financial measures determined in accordance with accounting principles generally accepted in the U.S. (GAAP). Due to the adjustments made to GAAP net

 


(3)  See reconciliation of 2016 financial guidance of non-GAAP adjusted EBITDA and non-GAAP net income at the conclusion of this press release. Non-GAAP CBR revenue and non-GAAP total revenue reflect the addition of $17 million related to purchase accounting adjustments for deferred revenue in connection with the CBR acquisition.

 

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income (loss) and GAAP net income (loss) per share to calculate non-GAAP adjusted net income and non-GAAP net income per share, the non-GAAP measures are higher than GAAP net income (loss) and GAAP net income (loss) per share.

 

Management believes this non-GAAP information is useful for investors, taken in conjunction with AMAG’s GAAP financial statements, because it provides greater transparency regarding AMAG’s operating performance and prospects for future performance and allows investors to better compare performance over different periods. Management uses these measures, among other factors, to assess and analyze operational results and trends and to make financial and operational decisions, including in compensation decisions. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of AMAG’s operating results as reported under GAAP, not as a substitute for GAAP, and AMAG encourages investors to review its consolidated financial statements and publicly filed reports in their entirety. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. Further, non-GAAP net income and non-GAAP net income per share should not be considered measures of our liquidity. The determination of the amounts that are excluded from non-GAAP financial measures is a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts. Reconciliations between these non-GAAP financial measures and the most comparable GAAP financial measures are included in the tables accompanying this press release after the unaudited condensed consolidated financial statements.

 

About AMAG

 

AMAG is a biopharmaceutical company focused on developing and delivering important therapeutics, conducting clinical research in areas of unmet need and creating education and support programs for the patients and families we serve. Our products support the health of patients in the areas of maternal health, anemia management and cancer supportive care. Through CBR®, we also help families to preserve newborn stem cells, which are used today in transplant medicine for certain cancers and blood, immune and metabolic disorders, and have the potential to play a valuable role in the ongoing development of regenerative medicine. For additional company information, please visit www.amagpharma.com.

 

About Makena® (hydroxyprogesterone caproate injection)

 

Makena® is a progestin indicated to reduce the risk of preterm birth in women pregnant with a single baby who have a history of singleton spontaneous preterm birth.

 

The effectiveness of Makena is based on improvement in the proportion of women who delivered <37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.

 

Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of Makena has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth.

 

Makena should not be used in women with any of the following conditions: blood clots or other blood clotting problems, breast cancer or other hormone-sensitive cancers, or history of these conditions; unusual

 

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vaginal bleeding not related to the current pregnancy, yellowing of the skin due to liver problems during pregnancy, liver problems, including liver tumors, or uncontrolled high blood pressure. Before patients receive Makena, they should tell their healthcare provider if they have an allergy to hydroxyprogesterone caproate, castor oil, or any of the other ingredients in Makena; diabetes or prediabetes, epilepsy, migraine headaches, asthma, heart problems, kidney problems, depression, or high blood pressure.

 

In one clinical study, certain complications or events associated with pregnancy occurred more often in women who received Makena. These included miscarriage (pregnancy loss before 20 weeks of pregnancy), stillbirth (fetal death occurring during or after the 20th week of pregnancy), hospital admission for preterm labor, preeclampsia (high blood pressure and too much protein in the urine), gestational hypertension (high blood pressure caused by pregnancy), gestational diabetes, and oligohydramnios (low amniotic fluid levels).

 

Makena may cause serious side effects including blood clots, allergic reactions, depression, and yellowing of the skin and the whites of the eyes. The most common side effects of Makena include injection site reactions (pain, swelling, itching, bruising, or a hard bump), hives, itching, nausea, and diarrhea.

 

For additional product information, including full prescribing information, please visit www.makena.com.

 

About Feraheme® (ferumoxytol)

 

Feraheme received marketing approval from the FDA on June 30, 2009 for the treatment of IDA in adult CKD patients and was commercially launched by AMAG in the U.S. shortly thereafter. Ferumoxytol is protected in the U.S. by six issued patents covering the composition and dosage form of the product. Each issued patent is listed in the FDA’s Orange Book, the last of which expires in June 2023.

 

Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest. Feraheme is contraindicated in patients with a known hypersensitivity to Feraheme or any of its components, or a history of allergic reaction to any intravenous iron product.

 

For additional product information, please see full Prescribing Information, including Boxed Warning, available at www.feraheme.com.

 

About Cord Blood Registry® (CBR)

 

CBR is the world’s largest private newborn stem cell company. Founded in 1992, CBR is entrusted by parents with storing more than 600,000 umbilical cord blood and cord tissue units. CBR is dedicated to advancing the clinical application of newborn stem cells by partnering with reputable research institutions on FDA-regulated clinical trials for conditions that have no cure today. For more information, visit www.cordblood.com.

 

Forward-Looking Statements

 

This press release 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, expectations for AMAG’s next generation development programs for Makena, including the FDA review period for the auto-injector, the anticipated timing to file a sNDA, the likelihood and timing of an anticipated approval for the subcutaneous auto-injector, AMAG’s intention to conduct a comparative pain study, AMAG’s ability to successfully demonstrate clinical superiority

 

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over the intramuscular injection by demonstrating a reduction in pain and to obtain orphan drug exclusivity for the drug-device combination and AMAG’s belief that submission of the pain data in the sNDA is the best strategy to protect the Makena franchise; expectations for AMAG’s Phase 3 clinical trial for the broader indication for Feraheme, including the expected timing of an sNDA submission; AMAG’s 2016 financial guidance, including GAAP and non-GAAP revenues, GAAP operating income, non-GAAP adjusted EBITDA and GAAP and non-GAAP net income; AMAG’s belief that the generation of significant EBITDA and cash flows in the first half of 2016 provides it with additional capacity to pursue its portfolio expansion strategy; and beliefs that newborn stem cells have the potential to play a valuable role in the development of regenerative medicine 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, those risks identified in AMAG’s filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2015, its Quarterly Report on Form 10-Q for the quarter ended March 31, 2016 and subsequent filings with the SEC. Any such risks and uncertainties could materially and adversely affect AMAG’s results of operations, its profitability and its cash flows, which would, in turn, have a significant and adverse impact on AMAG’s stock price. 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.

 

— Tables Follow —

 

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AMAG Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations

(unaudited, amounts in thousands, except for per share data)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2016

 

2015

 

2016

 

2015

 

Revenues:

 

 

 

 

 

 

 

 

 

Makena

 

$

78,406

 

$

63,574

 

$

143,438

 

$

119,103

 

Feraheme/MuGard

 

24,577

 

21,078

 

49,109

 

42,964

 

Cord Blood Registry

 

24,379

 

 

43,898

 

 

License fee, collaboration and other revenues

 

57

 

39,232

 

273

 

51,322

 

Total revenues

 

127,419

 

123,884

 

236,718

 

213,389

 

Operating costs and expenses:

 

 

 

 

 

 

 

 

 

Cost of product sales

 

21,937

 

19,679

 

40,236

 

40,705

 

Cost of services

 

5,195

 

 

10,721

 

 

Research and development expenses

 

14,234

 

8,184

 

28,463

 

15,172

 

Selling, general and administrative expenses

 

51,924

 

31,801

 

115,098

 

63,913

 

Impairment charges of intangible assets

 

15,963

 

 

15,963

 

 

Acquisition-related costs

 

 

2,653

 

 

2,653

 

Restructuring expenses

 

89

 

443

 

712

 

1,014

 

Total costs and expenses

 

109,342

 

62,760

 

211,193

 

123,457

 

Operating income

 

18,077

 

61,124

 

25,525

 

89,932

 

 

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

Interest expense

 

(18,250

)

(10,205

)

(36,693

)

(20,572

)

Interest and dividend income

 

773

 

372

 

1,481

 

443

 

Other income (expense)

 

 

2

 

220

 

2

 

Total other income (expense)

 

(17,477

)

(9,831

)

(34,992

)

(20,127

)

Income (loss) before income taxes

 

600

 

51,293

 

(9,467

)

69,805

 

Income tax expense (benefit)

 

1,196

 

18,035

 

(1,344

)

23,643

 

Net income (loss)

 

$

(596

)

$

33,258

 

$

(8,123

)

$

46,162

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.02

)

$

1.09

 

$

(0.24

)

$

1.60

 

Diluted

 

$

(0.02

)

$

0.82

 

$

(0.24

)

$

1.23

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding used to compute net income (loss) per share:

 

 

 

 

 

 

 

 

 

Basic

 

34,223

 

30,636

 

34,481

 

28,934

 

Diluted

 

34,223

 

43,181

 

34,481

 

40,791

 

 

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AMAG Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(unaudited, amounts in thousands)

 

 

 

June 30, 2016

 

December 31, 2015

 

Assets:

 

 

 

 

 

Cash and cash equivalents

 

$

251,110

 

$

228,705

 

Investments

 

295,359

 

237,626

 

Accounts receivable, net

 

66,086

 

85,678

 

Inventories

 

39,564

 

40,645

 

Receivable from collaboration

 

 

428

 

Prepaid and other current assets

 

13,437

 

13,592

 

Total current assets

 

665,556

 

606,674

 

Property, plant and equipment, net

 

27,173

 

28,725

 

Goodwill

 

639,484

 

639,188

 

Intangible assets, net

 

1,144,858

 

1,196,771

 

Restricted cash

 

2,593

 

2,593

 

Other long-term assets

 

1,146

 

2,259

 

Total assets

 

$

2,480,810

 

$

2,476,210

 

 

 

 

 

 

 

Liabilities and stockholders’ equity:

 

 

 

 

 

Accounts payable

 

$

8,653

 

$

4,906

 

Accrued expenses

 

107,599

 

106,363

 

Current portion of long-term debt

 

49,610

 

17,500

 

Current portion of acquisition-related contingent consideration

 

98,703

 

96,967

 

Deferred revenues

 

32,499

 

20,185

 

Total current liabilities

 

297,064

 

245,921

 

Long-term liabilities:

 

 

 

 

 

Long-term debt, net

 

764,543

 

803,669

 

Convertible 2.5% notes, net

 

174,953

 

170,749

 

Acquisition-related contingent consideration

 

125,106

 

125,592

 

Deferred tax liabilities

 

188,852

 

189,145

 

Deferred revenues

 

9,983

 

5,093

 

Other long-term liabilities

 

4,142

 

3,777

 

Total liabilities

 

1,564,643

 

1,543,946

 

Total stockholders’ equity

 

916,167

 

932,264

 

Total liabilities and stockholders’ equity

 

$

2,480,810

 

$

2,476,210

 

 

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AMAG Pharmaceuticals, Inc.

Reconciliation of Non-GAAP Adjustments to Net Income

(unaudited, amounts in thousands)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30, 2016

 

June 30, 2015

 

June 30, 2016

 

June 30, 2015

 

GAAP revenues

 

$

127,419

 

$

123,884

 

$

236,718

 

$

213,389

 

Service revenues

 

5,053

(4)

 

13,614

(4)

 

License fee, collaboration and other revenues

 

 

(33,563

)(5)

 

(39,965

)(5)

Non-GAAP revenues

 

132,472

 

90,321

 

250,332

 

173,424

 

 

 

 

 

 

 

 

 

 

 

GAAP CBR revenues

 

24,379

 

 

43,898

 

 

Service revenues

 

5,053

(4)

 

13,614

(4)

 

Non-GAAP CBR revenues

 

29,432

 

 

57,512

 

 

 

 

 

 

 

 

 

 

 

 

GAAP costs of product sales and services

 

27,132

 

19,679

 

50,957

 

40,705

 

Cost of product sales

 

(17,627

)(6)

(16,521

)(6)

(32,236

)(6)

(34,261

)(6)

Cost of services

 

(353

)(7)

 

(713

)(7)

 

Non-GAAP costs of product sales and services

 

9,152

 

3,158

 

18,008

 

6,444

 

 

 

 

 

 

 

 

 

 

 

GAAP costs and expenses

 

109,342

 

62,760

 

211,193

 

123,457

 

Cost of product sales

 

(17,627

)(6)

(16,521

)(6)

(32,236

)(6)

(34,261

)(6)

Cost of services

 

(353

)(7)

 

(713

)(7)

 

Research and development

 

(1,867

)(8)

(1,197

)(8)

(2,641

)(8)

(1,691

)(8)

Selling, general and administrative

 

(5,605

)(9)

(3,679

)(9)

(20,725

)(9)

(9,865

)(9)

Impairment charges of intangible assets

 

(15,963

)(10)

 

(15,963

)(10)

 

Acquisition-related

 

 

(2,653

)(11)

 

(2,653

)(11)

Restructuring

 

(89

)(12)

(443

)(12)

(712

)(12)

(1,014

)(12)

Non-GAAP costs and expenses

 

67,838

 

38,267

 

138,203

 

73,973

 

 

 

 

 

 

 

 

 

 

 

GAAP other income (expense)

 

(17,477

)

(9,831

)

(34,992

)

(20,127

)

Non-cash interest expense

 

3,104

(13)

2,944

(13)

6,162

(13)

5,830

(13)

Income tax expense (benefit)

 

1,196

(14)

17,655

(14)

(1,344

)(14)

23,025

(14)

Non-GAAP other income (expense)

 

(13,177

)

10,768

 

(30,174

)

8,728

 

 

 

 

 

 

 

 

 

 

 

GAAP net income (loss)

 

(596

)

33,258

 

(8,123

)

46,162

 

Total adjustments

 

50,857

 

11,529

 

91,422

 

38,374

 

Non-GAAP net income (loss)

 

50,261

 

44,787

 

83,299

 

84,536

 

 


(4) Represents purchase accounting adjustments related to deferred revenue in connection with the CBR acquisition.

(5) Represents adjustments to exclude certain non-cash revenue associated with the 2014 termination of the company’s ex-US ferumoxytol marketing agreement.

(6) Adjustments to eliminate the following: (i) non-cash step-up of inventory from purchase accounting; (ii) amortization expense related to intangible assets; (iii) depreciation expense; and (iv) stock-based compensation expense.

(7) Adjustments to eliminate depreciation expense.

(8) Adjustments to eliminate the following: (i) non-cash step-up of inventory used in research and development from purchase accounting; (ii) depreciation expense; and (iii) stock-based compensation expense.

(9) Adjustments to eliminate the following: (i) non-cash adjustments related to contingent consideration; (ii) amortization expense related to intangible assets; (iii) depreciation expense; and (iv) stock-based compensation expense.

(10) Impairment expense of $15.7 million related to the MuGard Intangible Asset and $0.2 million related to the favorable lease intangible asset

(11) Adjustments to eliminate one-time costs related to Cord Blood Registry acquisition.

(12) Adjustments to eliminate non-recurring restructuring costs.

(13) Adjustments to eliminate non-cash interest expense.

(14) Adjustments to eliminate non-cash income tax expense (benefit).

 

10



 

AMAG Pharmaceuticals, Inc.

Reconciliation of GAAP Net Income (Loss) to Non-GAAP Net Income to Non-GAAP Adjusted EPS

(unaudited, amounts in thousands, except per share data)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30, 2016

 

June 30, 2015

 

June 30, 2016

 

June 30, 2015

 

GAAP Net Income (Loss)

 

$

(596

)

$

33,258

 

$

(8,123

)

$

46,162

 

Adjustments:

 

 

 

 

 

 

 

 

 

Interest expense

 

17,477

 

9,831

 

34,993

 

20,127

 

Provision for income tax

 

1,196

 

18,035

 

(1,344

)

23,643

 

Operating income

 

18,077

 

61,124

 

25,526

 

89,932

 

Purchase accounting adjustments related to CBR deferred revenue

 

5,053

 

 

13,614

 

 

Non-cash collaboration revenue

 

 

(33,563

)

 

(39,965

)

Depreciation and intangible asset amortization

 

21,587

 

13,549

 

40,431

 

25,164

 

Non-cash inventory step-up adjustments

 

2,344

 

3,643

 

3,144

 

9,826

 

Stock-based compensation

 

5,178

 

4,015

 

11,341

 

6,684

 

Adjustments to contingent consideration

 

(3,657

)

(960

)

1,399

 

1,639

 

Impairment charges of intangible assets

 

15,963

 

 

15,963

 

 

Acquisition-related costs

 

 

2,834

 

 

2,834

 

Restructuring costs

 

89

 

1,412

 

712

 

3,337

 

Non-GAAP adjusted EBITDA

 

64,634

 

52,054

 

112,130

 

99,451

 

Cash interest

 

(14,373

)

(6,887

)

(28,831

)

(14,297

)

Cash taxes

 

 

(380

)

 

(618

)

Non-GAAP Net Income

 

$

50,261

 

$

44,787

 

$

83,299

 

$

84,536

 

 

 

 

 

 

 

 

 

 

 

Basic:

 

 

 

 

 

 

 

 

 

GAAP net income (loss) per share - Basic

 

$

(0.02

)

$

1.09

 

$

(0.24

)

$

1.60

 

Shares used in GAAP per share computation

 

34,223

 

30,636

 

34,481

 

28,934

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP net income per share - Basic

 

$

1.47

 

$

1.46

 

$

2.42

 

$

2.92

 

Shares used in non-GAAP per share computation

 

34,223

 

30,636

 

34,481

 

28,934

 

 

 

 

 

 

 

 

 

 

 

Diluted:

 

 

 

 

 

 

 

 

 

GAAP net income (loss) per share - Diluted

 

$

(0.02

)

$

0.82

 

$

(0.24

)

$

1.23

 

Shares used in GAAP per share computation

 

34,223

 

43,181

 

34,481

 

40,791

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP net income per share - Diluted

 

$

1.45

 

$

1.12

 

$

2.39

 

$

2.27

 

Shares used in non-GAAP per share computation

 

34,607

 

40,002

 

34,839

 

37,182

 

 

11



 

AMAG Pharmaceuticals, Inc.

Reconciliation of 2016 Financial Guidance of Non-GAAP Adjusted EBITDA and Non-GAAP Net Income

(unaudited, amounts in millions)

 

 

 

2016

 

 

 

Financial

 

 

 

Guidance

 

GAAP Net Income

 

$0 - $30

 

Adjustments:

 

 

 

Interest expense

 

73

 

Provision for income tax

 

20

 

Operating income

 

$93 - $123

 

Purchase accounting adjustments related to CBR deferred revenue

 

17

 

Depreciation and intangible asset amortization

 

91

 

Non-cash inventory step-up adjustments

 

5

 

Stock-based compensation

 

26

 

Adjustments to contingent consideration

 

6

 

Impairment charges of intangible assets

 

16

 

Restructuring costs

 

1

 

Non-GAAP adjusted EBITDA

 

$255 - $285

 

Cash interest

 

(60

)

Non-GAAP Net Income

 

$195 - $225

 

 

AMAG Pharmaceuticals, Inc.

Share Count Reconciliation

(unaudited, amounts in millions)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30, 2016

 

June 30, 2015

 

June 30, 2016

 

June 30, 2015

 

Weighted average basic shares outstanding

 

34.2

 

30.6

 

34.5

 

28.9

 

Employee equity incentive awards

 

(15)

1.8

 

(15)

1.6

 

Convertible notes

 

(15)

7.4

 

(15)

7.4

 

Warrants

 

(15)

3.4

 

(15)

2.9

 

GAAP diluted shares outstanding

 

34.2

 

43.2

 

34.5

 

40.8

 

Employee equity incentive awards

 

0.4

(16)

 

0.3

(16)

 

Effect of bond hedge and warrants

 

 

(3.2

)(17)

 

(3.6

)(17)

Non-GAAP diluted shares outstanding

 

34.6

 

40.0

 

34.8

 

37.2

 

 


(15) 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.

(16) Reflects the Non-GAAP dilutive impact of the employee equity incentive awards.

(17) Reflects the impact of the non-GAAP benefit of the bond hedge and warrants.

 

 

CONTACT:

AMAG Pharmaceuticals, Inc.

Linda Lennox

Vice President, Investor Relations

617-498-2846

 

12