Joe Wiley of Amryt Pharma discusses their strong operational and financial results in Q3

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Joe Wiley of Amryt Pharma discusses their strong operational and financial results in Q3

Joe Wiley CEO of Amryt Pharma #AMYT discusses their strong Q3, which saw 14.6% YoY revenue growth to $56.5M & the 7th consecutive quarter of positive EBITDA generation.

Q3 2021 Highlights
- Chiasma, Inc. acquisition completed on August 5, 2021 and integration proceeding well
- Oleogel-S101 target PDUFA date set by the FDA for November 30, 2021
- Oleogel-S10 MAA accepted by EMA and CHMP opinion expected in Q4 2021
- Commercial launch plans well advanced for Oleogel-S10 launch, if approved
- FY 2021 revenue guidance increased in September to $220M - $225M, representing 20-23% growth over 2020
- 14.6% YoY revenue growth in Q3 2021 to $56.5M (Q3 2020: $49.3M)
- Excluding the impact of sporadic LATAM ordering and Mycapssa®, revenues grew 26.3% YoY and 5.7% QoQ
- 21.5% increase in metreleptin revenues YoY to $36.3M in Q3 2021 (Q3 2020: $29.9M). Excluding the impact of sporadic LATAM ordering, metreleptin revenue growth was 51.6% YoY.
- US accounted for 51.7% of global metreleptin revenues and EMEA accounted for 43.0% in Q3 2021
- EMEA metreleptin revenues grew 143.2% YoY in Q3
- Mycapssa® delivered $1.45M in Q3 (from August 5 when Chiasma was acquired)
- Mycapssa® revenues in Q3 were impacted by pre-ordering in Q2; normalised ordering patterns have returned in September with Mycapssa® delivering $1.14M in the month
- The integration of Chiasma is significantly advanced and we continue to extract cost synergies
- $21.4M operating loss before finance expense for Q3 2021 (Q3 2020: $3.6M operating loss). Excluding non-cash items, share based compensation expenses and Chiasma restructuring and acquisition costs, this resulted in EBITDA3 - Cash of $123.2M at September 30, 2021 (June 30, 2021: $142.9M) post repayment of outstanding Chiasma revenue interest financing debt and transaction related costs in the period.

About Amryt
Amryt is a global commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing innovative treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets.

Amryt’s commercial business comprises three orphan disease products – metreleptin (Myalept®/ Myalepta®); oral octreotide (Mycapssa®); and lomitapide (Juxtapid®/ Lojuxta®).

Myalept®/Myalepta® (metreleptin) is approved in the US (under the trade name Myalept®) as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in the EU (under the trade name Myalepta®) as an adjunct to diet for the treatment of leptin deficiency in patients with congenital or acquired GL in adults and children two years of age and above and familial or acquired partial lipodystrophy (PL) in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control. For additional information, please follow this link.

Mycapssa® (oral octreotide) is approved in the US for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. Mycapssa® is the first and only oral somatostatin analogapproved by the FDA. Mycapssa® has also been submitted to the EMA for regulatory approval. For additional information, please follow this link.

Juxtapid®/Lojuxta® (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia ("HoFH") in the US, Canada, Colombia, Argentina and Japan (under the trade name Juxtapid®) and in the EU, Israel and Brazil (under the trade name Lojuxta®). For additional information, please follow this link.

Amryt's lead development candidate, Oleogel-S10 (Filsuvez®) is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa (“EB”), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. Filsuvez® has been selected as the brand name for Oleogel-S10. The product does not currently have regulatory approval to treat EB but has been submitted to the FDA for approval and in June 2021, Amryt received confirmation from the FDA that its NDA for Oleogel-S10 had been accepted and granted priority review. The FDA also set a target PDUFA date of November 30, 2021. In Europe, a MAA for Oleogel-S10 was accepted for assessment by the EMA in March 2021.
Amryt’s pre-clinical gene therapy candidate, AP103, offers a potential treatment for patients with Dystrophic EB, and the polymer-based delivery platform has the potential to be developed for the treatment of other genetic disorders.

Amryt also intends to develop oral medications that are currently only available as injectable therapies through its Transient Permeability Enhancer (TPE®) technology platform. For more information on Amryt, including products, please visit www.amrytpharma.com.