Leerink - AMRN: Takeaways from Investor Conference: Day 2
• Bottom Line: In this note, we highlight key takeaways from Day 2
at a competitor conference. We include takeaways for the following companies in our coverage universe: AMRN, ENDP, JAZZ, MYOV, and XERS.
• AMRN (OP): Management highlights strong Vascepa US and
EU commercial outlook, significant unmet need in other ROW markets, and its intention to pursue pipeline diversification.
(1) On January 7, AMRN released its preliminary results for 2020, issued its 2021 OpEx guidance, and provided an outlook for 2021, highlighting record FY revenues and the elimination of all debt in 4Q20. Entering 1Q21 with a cash balance of ~ $550M, management is committed to resuming growth of its US Vascepa franchise as the impact of COVID-19 subsides.
(2) With managed
care coverage expected to improve further in 2021, management sees significant growth potential ahead as prescription volumes grow, and patients resume physician visits. Despite Vascepa's value proposition
as an effective option for CV risk reduction, awareness levels remain
low (32% among HCPs and <1% among at-risk patients). As such, management highlighted strategic initiatives to increase awareness of
CV risk reduction beyond statins, serving to further differentiate Vascepa from alternatives. Further, management noted that switching patients
to Vascepa from unproven products represents a >$10B opportunity
at the asset's current NSP.
(3) AMRN expects to parry the threat of generic competition in what management described as an atypical market for generics. Generic supply continues to be limited and potentially variable as a result of manufacturing complexities, costs, and lead times. Additionally, skinny-labeling employed by launched generics is exclusively indicated for very high TGs (with TG ≥500 mg/dL), representing a mere ~7% of Vascepa Rx count. To substantiate its outlook, management highlighted the case of Epadel in Japan, where ~60% branded share
was maintained despite the >10 year overhang of Gx competition.
AMRN continues to pursue its infringement lawsuit against Hikma's Gx Vascepa (launched in 4Q20).
(4) On Vascepa's potential multi-billion- dollar opportunity in the EU, a CHMP decision is expected in the near- term (Jan/Feb 2021), with an expected approval to follow ~2 months after. Net pricing for the asset is expected to be at least as good as in the US and Canada, substantiated by CVOT results unavailable at the time of US pricing. On commercial status, management expects country-by-country launches to commence in 2021, with an expected launch in Germany following AMRN's initial awareness campaign. Management highlighted the expansion of its EU team to ~50 professionals, and expects it to grow to ~200 by YE. Upon approval, regulatory exclusivity is expected for 10 years, with filed patent applications potentially extending protection into 2039.
(5) On Vascepa's potential billion-dollar opportunity across ROW markets, AMRN continues to pursue CV risk reduction indications in the Middle East, while a regulatory submission in China is expected in early 2021. Further, large ROW markets remain untapped and management highlighted its intention to pursue them after securing EU approval and
S&P 500 Health Care Index: market access.
(6) On the infectious disease development and pipeline diversification front, AMRN is evaluating the efficacy of Vascepa in preventing COVID-19, highlighting the asset's potential in reducing the severity of infection. Management shed light on supporting studies, underlining the positive results yielded from CardioLink-9. Given its small size, additional trials in larger patient subsets are ongoing in Argentina (PREPARE-IT) and the US (MITIGATE), with potential results from each expected in mid-2021 and YE2021, respectively.
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