Supernus’ (SUPN) CEO Jack Khattar began by giving an update on the company’s financials with
2018 net sales guidance around $388-395M based mainly on strong prescription growth of
Trokendi XR and Oxtellar XR, and a total 2018 projected operating income of $120-125M. Annual
Trokendi XR and Oxtellar XR prescriptions grew by 36% and 12%, respectively, from 2017 owing
to their positive differentiating factors as compared to other products within the neurology
market.
Management further highlighted the Company’s lead pipeline candidates SPN-812 for the
treatment of ADHD and SPN-810 for impulsive aggression, both of which are in Phase III
development. For both drugs, the company is currently developing strong IP with expected
patient expirations in 2029-2033. While SPN-812 is already used in the EU as a successful
antidepressant, Supernus has completed three positive Phase III trials in children/adolescents
demonstrating that the norepinephrine reuptake inhibitor is a clinically efficacious in the
treatment of ADHD. One Phase III trial (P304 Study) is ongoing and top-line data is expected in Q1
2019. Management emphasized that the primary endpoints were met in all three Phase III trials
supported by positive and strong P-values. Significantly, the non-stimulating drug consistently
demonstrates a fast onset of action and works from Week 1, which will be a key differentiating
factor. SPN-812 is also well-tolerated and is efficacious in reducing both hyperactivity and
inattention, something which management believes will further differentiate it from potential
competitors. Company guidance predicts a peak market share of 5-10% with 4.5-10M potential
prescriptions of SPN-812.
With no approved therapies for impulsive aggression, Supernus presented a positive outlook for
its dopamine-2 receptor targeted pipeline candidate, SPN-810. Impulsive aggression occurs
across ADHD, autism, bipolar disorder, and PTSD, representing a $6.3B market opportunity. SPN810 has Fast Track Designation and is currently in three ongoing Phase III trials. Supernus stated
that data from the P301 and P302 trials in pediatric patients are expected in the second half of
2019, and data from the P503 trial in adolescents will be released in 2020.
2018 net sales guidance around $388-395M based mainly on strong prescription growth of
Trokendi XR and Oxtellar XR, and a total 2018 projected operating income of $120-125M. Annual
Trokendi XR and Oxtellar XR prescriptions grew by 36% and 12%, respectively, from 2017 owing
to their positive differentiating factors as compared to other products within the neurology
market.
Management further highlighted the Company’s lead pipeline candidates SPN-812 for the
treatment of ADHD and SPN-810 for impulsive aggression, both of which are in Phase III
development. For both drugs, the company is currently developing strong IP with expected
patient expirations in 2029-2033. While SPN-812 is already used in the EU as a successful
antidepressant, Supernus has completed three positive Phase III trials in children/adolescents
demonstrating that the norepinephrine reuptake inhibitor is a clinically efficacious in the
treatment of ADHD. One Phase III trial (P304 Study) is ongoing and top-line data is expected in Q1
2019. Management emphasized that the primary endpoints were met in all three Phase III trials
supported by positive and strong P-values. Significantly, the non-stimulating drug consistently
demonstrates a fast onset of action and works from Week 1, which will be a key differentiating
factor. SPN-812 is also well-tolerated and is efficacious in reducing both hyperactivity and
inattention, something which management believes will further differentiate it from potential
competitors. Company guidance predicts a peak market share of 5-10% with 4.5-10M potential
prescriptions of SPN-812.
With no approved therapies for impulsive aggression, Supernus presented a positive outlook for
its dopamine-2 receptor targeted pipeline candidate, SPN-810. Impulsive aggression occurs
across ADHD, autism, bipolar disorder, and PTSD, representing a $6.3B market opportunity. SPN810 has Fast Track Designation and is currently in three ongoing Phase III trials. Supernus stated
that data from the P301 and P302 trials in pediatric patients are expected in the second half of
2019, and data from the P503 trial in adolescents will be released in 2020.
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