On November 3, 2016 AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) reported unaudited consolidated financial results for the third quarter ended September 30, 2016. Total revenue for the third quarter of 2016 increased approximately 50% to $143.8 million (Filing, Q3, AMAG Pharmaceuticals, 2016, NOV 3, 2016, View Source [SID1234516181]). This increase was driven by record sales of Makena and the recognition of a full quarter of revenue from Cord Blood Registry (CBR), which was acquired by AMAG on August 17, 2015. The company reported third quarter 2016 operating income of $38.8 million and net income of $16.2 million. Non-GAAP adjusted EBITDA for the third quarter of 2016 increased to $76.2 million1, or 44%, versus the same period in 2015. Non-GAAP net income for the third quarter of 2016 increased to $61.8 million1, or 46%, versus the same period in 2015.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We executed well against our key priorities in the third quarter, delivering strong financial results and hitting key milestones in our next-generation development programs," stated William Heiden, AMAG’s chief executive officer. "Our Makena subcutaneous auto-injector program is on-track for an sNDA filing in the second quarter of next year and the Feraheme sNDA submission seeking approval of a broader label has been accelerated to mid-year 2017."

"We have updated the company’s financial guidance based on our fourth quarter expectations of continued strong top and bottom line performance, building on our successes achieved in the third quarter," Mr. Heiden continued.

Third Quarter 2016 and Recent Business Highlights
• Delivered total revenue of $143.8 million in the third quarter of 2016, compared with $96.2 million in the same period last year. This increase of approximately 50% was driven by record sales of Makena and the recognition of a full quarter of revenue from CBR.
• Achieved Makena sales of $93.4 million in the third quarter of 2016, compared with $65.2 million in the same period last year. Makena’s robust sales growth of 43% was driven exclusively by an increase in volume. This growth resulted in Makena market share of 41%, four percentage points over the second quarter of 2016 and an 11 percentage point gain year-to-date.
• Generated 1.8% growth to $29.9 million1 in non-GAAP revenue from CBR over the second quarter of 2016 due to improved net revenue per new customer. In addition, enrollments were higher versus the second quarter of 2016.
• Reported $22.3 million in Feraheme sales, maintaining market share in the intravenous iron market, which experienced a slight decline in the third quarter of 2016.

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

• Achieved key milestones in the Makena subcutaneous auto-injector development program. The company dosed first subjects in both the definitive pharmacokinetic study and comparative pain study. Data from each of these studies is intended to support the supplemental new drug application (sNDA) that the company plans to file with the Food and Drug Administration (FDA) in the second quarter of 2017.
• Continued to enroll patients more rapidly than expected in the company’s head-to-head, Phase 3 clinical trial evaluating Feraheme in adults with iron deficiency anemia (IDA). The company is seeking to broaden Feraheme’s current label beyond its chronic kidney disease (CKD) indication to include all adult IDA patients who have failed or cannot tolerate oral iron treatment. The timeline to anticipated approval has been shortened by approximately six months as a result of the trial’s rapid enrollment, which has accelerated the company’s expected sNDA submission date to mid-2017.
• Generated an increase of $147.7 million in cash and investments in the first nine months of 2016 to $614.1 million, net of $20.0 million utilized to repurchase the company’s common stock and $13.1 million to repay debt.

Third Quarter Ended September 30, 2016 (unaudited)
Financial Results (GAAP Basis)
Total revenues for the third quarter of 2016 were $143.8 million, compared with $96.2 million in the third quarter of 2015. This increase is related to record sales of Makena and the recognition of a full quarter of revenue from CBR, which was acquired by AMAG on August 17, 2015. Net product sales of Makena increased to $93.4 million in the third quarter of 2016, compared with $65.2 million in the same period last year. This 43% growth in Makena sales was primarily driven by the successful launch of the single-dose, preservative-free formulation and strong growth in the company’s Makena @Home program. Sales of Feraheme and MuGard totaled $22.4 million in the third quarter of 2016, compared with $23.8 million in the third quarter of 2015. Service revenue from CBR totaled $28.0 million in the third quarter of 2016, as compared to $7.2 million in the third quarter of 2015.

Total costs and expenses, including costs of product sales and services, totaled $105.0 million for the third quarter of 2016, compared with $97.5 million for the same period in 2015. The increase in operating expenses in 2016 was related to: (i) higher research and development expenses for the company’s next generation development programs, (ii) higher selling, general and administrative expenses due to the recognition of a full quarter of CBR-related expenses, and (iii) higher non-cash amortization of the Makena intangible asset. These increases were partially offset by expenses in the third quarter of 2015 that did not recur in 2016 related to an upfront payment for AMAG’s exclusive option to acquire rights to a development stage asset to treat severe preeclampsia (Velo) and CBR-related acquisition costs.

Third quarter 2016 operating income totaled $38.8 million, compared with a $1.4 million loss in the third quarter of last year. The company reported net income of $16.2 million, or $0.47 per basic share and $0.43 per diluted share, for the third quarter of 2016, compared with a net loss of $20.6 million, or $0.62 per basic and diluted share, for the same period in 2015.

Balance Sheet Highlights
The company’s cash, cash equivalents and investments increased by $147.7 million in the first nine months of 2016 to approximately $614.1 million, net of $20.0 million utilized to repurchase the company’s common stock and $13.1 million to repay debt. Total debt (principal amount outstanding), including $200 million of convertible debt, was approximately $1.03 billion as of September 30, 2016. For the 12 months ended September 30, 2016, sales of Makena exceeded $300 million, triggering a $100 million milestone that will be paid to former Lumara Health shareholders in the fourth quarter of 2016.

"In the third quarter, we once again generated strong cash flow as a result of our solid commercial execution and operating discipline," stated Ted Myles, chief financial officer of AMAG. "We are now in an even better position to capitalize on acquisition or licensing opportunities that would diversify and expand our product portfolio."
Financial Results (Non-GAAP Basis)1,2
Non-GAAP revenues totaled $145.8 million in the third quarter of 2016, up from $103.5 million in the third quarter of 2015. Non-GAAP CBR revenue totaled $29.9 million in the third quarter of 2016, compared with $14.5 million in the same period in 2015. CBR’s financial results for the third quarter of 2015 include only a portion of the quarter, as AMAG purchased CBR on August 17, 2015. The difference between GAAP and non-GAAP revenue for the quarter represents purchase accounting adjustments related to CBR deferred revenue.

Total non-GAAP costs and expenses, including costs of product sales and services, totaled $69.6 million in the third quarter of 2016, compared with total non-GAAP costs and expenses of $50.6 million in the same period in 2015. Non-GAAP adjusted EBITDA for the third quarter of 2016 was $76.2 million, compared with $52.8 million for the same period in 2015.

The company generated third quarter 2016 non-GAAP net income of $61.8 million, or $1.81 per non-GAAP basic share and $1.78 per non-GAAP diluted share. In the third quarter of 2015, non-GAAP net income totaled $42.3 million, or $1.27 per non-GAAP basic share and $1.02 per non-GAAP diluted share. Non-GAAP diluted shares for the third quarter of 2016 do not include 7.4 million of potentially dilutive shares from the convertible notes, as the stock price was below the convertible notes’ exercise price.

Updated 2016 Financial Guidance Range3

2016 GAAP Guidance

2016 Non-GAAP Guidance
$ in millions

Previous
Updated

Previous
Updated
Makena sales

$310 – $340
$330 – $340

$310 – $340
$330 – $340
Feraheme and MuGard sales

$95 – $105
$95 – $105

$95 – $105
$95 – $105
CBR revenue

$98 – $108
$98 – $108

$115 – $125
$115 – $125
Total revenue

$503 – $553
$523 – $553

$520 – $570
$540 – $570

Net income

$0 – $30
$3 – $23

$195 – $225
$200 – $220
Operating income

$93 – $123
$98 – $118

N/A
N/A
Adjusted EBITDA

N/A
N/A

$255 – $285
$260 – $280