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AMAG Pharmaceuticals Announces Third Quarter 2019 Financial Results and Provides Corporate Update

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Commercial products achieve strong revenue and market share performance

Vyleesi™ (bremelanotide injection) launched nationally in September

Committed to work with the FDA to keep Makena available for at-risk pregnant women

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

WALTHAM, Mass., Nov. 01, 2019 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today reported unaudited consolidated financial results for the third quarter ended September 30, 2019 and provided a business update.

"We're pleased with the strong performance of Feraheme which posted a record quarter of more than $44 million in revenue, and the Makena subcutaneous auto-injector which held market share and generated revenue of more than $41 million despite continued generic competition. As we look toward the remainder of 2019 and beyond, AMAG continues to focus on strong commercial execution and progressing our new drug candidates through clinical development, and we remain on track for adjusted EBITDA neutrality in 2020," said William Heiden, AMAG president and chief executive officer. "While we are disappointed with the mixed vote of the U.S. Food and Drug Administration's (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC), we are committed to working with the FDA on a path forward that could allow at-risk pregnant women to continue to have access to Makena."

KEY UPDATES

  • Vyleesi launched nationally in September
    ○ Through four weeks post launch, more than 3,000 Vyleesi prescriptions have been written across more than 1,300 prescribing healthcare providers.
  • Continued strong revenue and market share performance across promoted products
    ○ Makena® (hydroxyprogesterone caproate injection) subcutaneous (SC) auto-injector maintained 63% market share of all FDA-approved hydroxyprogesterone caproate prescription volume in the quarter.
    ○ Feraheme® (ferumoxytol injection) grew market share to 17.5% in the third quarter.
    ○ Intrarosa® (prasterone) average market share of total prescriptions grew to 4.8%.

($M) Three Months Ended September 30,
    2019       2018     % Change
Total product revenues, net $ 84.1     $ 122.2     (31 )%
Feraheme   44.2       37.0     20 %
Makena subcutaneous auto-injector   41.3       39.2     5 %
Makena intramuscular - branded and generic   (7.0 )     41.0     N/A  
Intrarosa   5.6       4.9     14 %
Other         0.1      
Operating loss $ (18.0 )   $ (19.3 )   N/A  
Non-GAAP adjusted EBITDA1 $ (8.2 )   $ 30.0     N/A  

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


MAKENA FDA ADVISORY COMMITTEE UPDATE

On October 29, 2019, the FDA held an advisory committee meeting to better understand and interpret the PROLONG (Progestin's Role in Optimizing Neonatal Gestation) confirmatory trial for Makena. While the committee discussed multiple questions, on the key question, seven committee members voted to leave the product on the market under accelerated approval and require a new confirmatory trial and nine advisory committee members voted to recommend that the FDA pursue withdrawal of approval for Makena. The approval of Makena was based on the Meis trial, conducted by the National Institute of Child Health and Human Development and the Maternal-Fetal Medicine Units Network and published in the New England Journal of Medicine in 2003. The PROLONG trial was conducted post approval under the FDA's Subpart H accelerated approval process.

Makena's active ingredient, 17α hydroxyprogesterone caproate (often referred to as 17P), is the only FDA-approved treatment for pregnant women who have had a prior spontaneous preterm birth (which is a substantial risk factor for recurrent preterm birth). 17P has been recognized as the standard of care and used for more than a decade by healthcare providers to treat patients with a history of spontaneous preterm birth, which represents approximately 130,000 births a year in the U.S. The American College of Obstetricians and Gynecologists (ACOG) and Society for Maternal-Fetal Medicine (SMFM) recently (October 25, 2019) reiterated their continued support of the use of Makena for at-risk pregnant women.

The withdrawal of all FDA-approved formulations of hydroxyprogesterone caproate would take away an important, and safe, treatment option for high-risk pregnant women. AMAG firmly believes in the safety and efficacy of Makena and remains committed to working collaboratively with the FDA on a path forward to ensure eligible pregnant women continue to have access to 17P, the only FDA-approved therapy for this orphan condition.

VYLEESI LAUNCH UPDATE
AMAG launched Vyleesi nationally in September with its established women's health sales force of approximately 125 sales representatives who also support Makena and Intrarosa. In the four weeks since the national launch, more than 1,300 healthcare providers have prescribed Vyleesi, which has resulted in more than 3,000 prescriptions received by our specialty pharmacy partners to date.

The company is working with payers and healthcare professionals to help ensure that women with hypoactive sexual desire disorder (HSDD) have access to Vyleesi. To help women access treatment, AMAG offers a copay assistance program so that eligible patients can obtain their first four-pack of Vyleesi auto-injectors at no cost. Under the current copay program, women who choose to refill their prescriptions can receive a four-pack of Vyleesi for no more than $99.

CIRAPARANTAG UPDATE
The company is planning to conduct a clinical study in healthy volunteers to confirm the lowest effective dose of ciraparantag after reaching peak steady state blood concentrations of certain novel oral anticoagulant (NOAC) drugs. This proposed study will utilize an automated coagulometer developed by Perosphere Technologies, an independent company, to measure whole blood clotting time. The coagulometer requires FDA clearance for use in clinical studies through an investigational device exemption (IDE), which Perosphere Technologies will submit once the healthy subject study design is finalized. Over the past several months, Perosphere Technologies has completed additional analytic studies and AMAG continues to work with the FDA on the design of the next clinical study. Following the completion of this study (estimated second half 2020), the company plans to schedule an End of Phase 2 meeting with the FDA to discuss the design of the Phase 3 program evaluating the safety and efficacy of ciraparantag in the target patient population.

2019 FINANCIAL GUIDANCE UPDATE
"We're tightening our guidance range for the full year of 2019. On a revenue basis, we are lowering the mid-point from $340 million to $325 million; however, we are lowering our expected adjusted EBITDA loss from a mid-point of $80 million to $70 million by continuing to carefully manage expenses and aggressively reprioritizing our spend to optimize the value in our portfolio," said Ted Myles, AMAG's chief financial officer. "This is evident in our adjusted EBITDA loss trend, which was approximately $50 million in the first half of 2019 and we expect to be less than $20 million in the second half of 2019."

Mr. Myles continued, "We firmly believe in Makena and are committed to working with the FDA. While these conversations continue, we recognize that the advisory committee vote heightens uncertainty around the durability of Makena revenue. We are prepared for a variety of potential scenarios and continue to look for ways to optimize the value of our portfolio to maximize shareholder value. As we gain more clarity on the path forward with the FDA regarding Makena, we'll be in a better position to provide formal revenue and earnings guidance for 2020."

2019 Financial Guidance        
($M)   Updated   Previous
Total revenue   $320 - $330   $325 - $355
Operating loss   ($278) - ($268)   ($286) - ($276)
Adjusted EBITDA2   ($75) - ($65)   ($85) - ($75)

2 See reconciliations of 2019 GAAP to non-GAAP financial guidance at conclusion of this press release.


THIRD QUARTER ENDED SEPTEMBER 30

Revenue
The company's commercial organization drove strong market share and revenue performance across all key marketed products.

  • Makena SC auto-injector revenue totaled $41.3 million, compared with $39.2 million in the same period last year, which is in-line with the company's quarterly expectation for this product.
  • The company did not ship any Makena IM product during the third quarter of 2019, therefore the full impact of the change in estimated commercial rebate liabilities from prior period sales appears as negative revenue during the quarter.
  • Feraheme achieved record quarterly revenue of $44.2 million, an increase of 20% over the same period last year. Feraheme's average quarterly market share increased to 17.5%, compared with 15.7% in the third quarter last year, and 17.2% in the second quarter of 2019.
  • Intrarosa revenue in the third quarter of 2019 totaled $5.6 million, compared with $4.9 million in the same period last year. The average quarterly share of total prescriptions grew to 4.8%, compared with 3.8% in the third quarter last year, and 4.3% in the second quarter of 2019.

($M) Three Months Ended September 30,
    2019     2018  
Total product revenues, net $ 84.1   $ 122.2  
Feraheme   44.2     37.0  
Makena subcutaneous auto-injector   41.3     39.2  
Makena intramuscular - branded and generic   (7.0 )   41.0  
Intrarosa   5.6     4.9  
Other       0.1  


Operating Expenses

  • Cost of products sales (CoPS) in the third quarter of 2019 decreased by $25.4 million, driven by a $26.7 million decrease in amortization expense associated with the Makena IM intangible asset. Non-amortization CoPS as a percent of net revenue increased due to a lower net price for Makena and a shift to products with higher CoPS and royalty burdens.
  • Research and development (R&D) expenses totaled $15.3 million, compared with $10.1 million in the third quarter of last year. This increase included additional clinical site initiations in Europe for the AMAG-423 development program.
  • In the third quarter of 2018, the company recorded $12.5 million of acquired in-process R&D (IPR&D) expense in connection with the acquisition of AMAG-423, with no comparable expense in the third quarter of 2019.
  • Selling, general and administrative (SG&A) expenses totaled $65.7 million in the third quarter of 2019, compared with $72.5 million in the third quarter of 2018. This decrease was primarily related to combining the company's maternal health and women's health sales forces in February 2019, partially offset by increased investment in the launch of Vyleesi.

($M) Three Months Ended September 30,
    2019     2018  
Amortization of intangible assets $ 4.2   $ 30.9  
Direct cost of product sales
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