AMAG Pharmaceutical’s (AMAG) presentation highlighted that compared to guidance issued a
year ago, preliminary 2018 financial results exceeded their earlier expectations by $64M on the
top-line and $50M on the bottom line, with total revenue expected to be $471-476m and
adjusted EBITDA at $115-125m. They had announced earlier in the week, though, that there had
been a negative impact from temporary supply constraints for Makena, which has also been
hampered by the entry of generics in 2018, though the supply constraints have been resolved.
The company stressed the successful performance of intravenous iron therapy, Ferraheme, which
experienced 30% in growth in 2018, bringing in $135m in net revenue. Initially approved for
anemia due to chronic kidney disease, Ferraheme received FDA label expansion in Feb 2018 for
patients with iron-deficiency anemia who cannot tolerate oral iron formulations, further
increasing its market potential.
Whilst generic versions of the first-generation, intramuscular formulation of Makenna have been
on the market for around six months, AMAG have held approximately 50% of the entire Makena
product volume with the second-generation branded SC auto-injector. Furthermore, AMAG’s
authorised generic partner maintained a significant share of the generic Makena market,
approximately 50% in Q4 2018. So while the franchise had preliminary Q4-2018 net revenues of
$46-48m, down from $80.2m in Q3 2018 (partly due to a supply constraint, as noted above), the
company felt the SC auto-injector has stabilized the franchise and going forward, despite the
introduction of more generics, they expected continued Makena revenues for 2019 of around
$40-50m/quarter. The resolution of the supply constraint would give some boost in January and
there may be share gains for the SC autoinjector, but these would be offset by price pressures.
In women’s health, the company highlighted Intrarossa as a key future cash driver. Following its
launch in July 2017 in moderate to severe dyspareunia due to menopause, the company
announced 2018 annual revenues of $15-16m, with strong and growing physician and patient
support for the therapy driven by the direct-to-consumer campaign. Looking forward, AMAG also
anticipate a commercial launch for Vyleesi in 2H 2019, their investigational product for low sexual
desire/libido associated with distress, following positive results from two large Phase III trials.
With the condition affecting approximately 12 million women in the US, AMAG predicts an annual
peak revenue opportunity of more than $700m for the therapy. In pre-eclampsia, the company
also highlighted the future potential of orphan therapy, AMAG-423, which demonstrated positive
results in a small Phase II trial and is currently enrolling patients in a larger Phase III study. Topline data for the trial is expected in 1H 2020, with an FDA approval and commercial launch
anticipated in 1H 2021.
The company also reported on the recent acquisition of Phase II pipeline agent, Ciraparantag, a
next-generation broad spectrum reversal agent for the novel oral anticoagulants (NOACs). With
200,000 patients per year estimated to require urgent reversal of NOAC treatment, AMAG
approximates an annual US peak revenue opportunity of more than $500m for the therapy.
AMAG plans to initiate a Phase IIIa trial for Ciraparantag in H2 2019.
With $400m of cash and securities as of December 2018, the company continues to explore
licensing/acquiring long-lived, durable products.
year ago, preliminary 2018 financial results exceeded their earlier expectations by $64M on the
top-line and $50M on the bottom line, with total revenue expected to be $471-476m and
adjusted EBITDA at $115-125m. They had announced earlier in the week, though, that there had
been a negative impact from temporary supply constraints for Makena, which has also been
hampered by the entry of generics in 2018, though the supply constraints have been resolved.
The company stressed the successful performance of intravenous iron therapy, Ferraheme, which
experienced 30% in growth in 2018, bringing in $135m in net revenue. Initially approved for
anemia due to chronic kidney disease, Ferraheme received FDA label expansion in Feb 2018 for
patients with iron-deficiency anemia who cannot tolerate oral iron formulations, further
increasing its market potential.
Whilst generic versions of the first-generation, intramuscular formulation of Makenna have been
on the market for around six months, AMAG have held approximately 50% of the entire Makena
product volume with the second-generation branded SC auto-injector. Furthermore, AMAG’s
authorised generic partner maintained a significant share of the generic Makena market,
approximately 50% in Q4 2018. So while the franchise had preliminary Q4-2018 net revenues of
$46-48m, down from $80.2m in Q3 2018 (partly due to a supply constraint, as noted above), the
company felt the SC auto-injector has stabilized the franchise and going forward, despite the
introduction of more generics, they expected continued Makena revenues for 2019 of around
$40-50m/quarter. The resolution of the supply constraint would give some boost in January and
there may be share gains for the SC autoinjector, but these would be offset by price pressures.
In women’s health, the company highlighted Intrarossa as a key future cash driver. Following its
launch in July 2017 in moderate to severe dyspareunia due to menopause, the company
announced 2018 annual revenues of $15-16m, with strong and growing physician and patient
support for the therapy driven by the direct-to-consumer campaign. Looking forward, AMAG also
anticipate a commercial launch for Vyleesi in 2H 2019, their investigational product for low sexual
desire/libido associated with distress, following positive results from two large Phase III trials.
With the condition affecting approximately 12 million women in the US, AMAG predicts an annual
peak revenue opportunity of more than $700m for the therapy. In pre-eclampsia, the company
also highlighted the future potential of orphan therapy, AMAG-423, which demonstrated positive
results in a small Phase II trial and is currently enrolling patients in a larger Phase III study. Topline data for the trial is expected in 1H 2020, with an FDA approval and commercial launch
anticipated in 1H 2021.
The company also reported on the recent acquisition of Phase II pipeline agent, Ciraparantag, a
next-generation broad spectrum reversal agent for the novel oral anticoagulants (NOACs). With
200,000 patients per year estimated to require urgent reversal of NOAC treatment, AMAG
approximates an annual US peak revenue opportunity of more than $500m for the therapy.
AMAG plans to initiate a Phase IIIa trial for Ciraparantag in H2 2019.
With $400m of cash and securities as of December 2018, the company continues to explore
licensing/acquiring long-lived, durable products.
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