AMRYT ANNOUNCES Q2 2020 RESULTS AND ISSUES POSITIVE REVENUE GUIDANCE FOR FY 2020
AMRYT ANNOUNCES Q2 2020 RESULTS AND ISSUES POSITIVE REVENUE GUIDANCE FOR FY 2020
New revenue guidance of $170M - $175M in 2020
Conference call and webcast today 0830 ET / 1330 BST
DUBLIN, Ireland, and Boston MA, August 6, 2020, Amryt (Nasdaq: AMYT, AIM: AMYT, Euronext Growth: AYP), a global, commercial-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from serious and life-threatening rare diseases, today announces unaudited financial results and provides a business update for the second quarter ended June 30, 2020.
- 22% YoY growth in unaudited Q2 revenues to $46.2M (Q2 20191 unaudited combined revenues: $37.9M)
- 26% YoY increase in unaudited H1 revenues to $90.8M (H1 20191 unaudited combined revenues: $72.3M)
- 4% QoQ unaudited revenue growth in Q2 versus Q1 ($44.6M). 9% growth QoQ excluding the impact of irregular orders in Q1 and Q2
- $12.0M operating loss before finance expense in Q2. Excluding non-cash items and share based compensation expenses, this resulted in EBITDA2 of $6.9M in Q2 representing 50% QoQ growth and delivering $11.5M EBITDA2 for H1
- Strong cash generation during H1 with $9.7M of cash generated from operating activities
- Robust financial position with $67.0M in unrestricted cash at June 30, 2020
- Issuing FY 2020 revenue guidance of between $170M and $175M (20191: $154.1m)
- On July 8, 2020, Amryt listed on the Nasdaq Global Select Market (“Nasdaq”)
Joe Wiley, CEO of Amryt Pharma, commented:
“The very positive momentum we experienced during 2019 and Q1 this year has been maintained through Q2 and I am pleased to report that our business continues to perform and grow beyond our expectations, notwithstanding the obvious challenges we have faced in working through the very different environment presented by the COVID-19 pandemic. Our primary focus remains the health and well-being of our team, patients, carers, partners and their families.
Our two commercial products, metreleptin and lomitapide continue to deliver growth across a host of metrics including revenue and EBITDA growth, cash generation and market expansion. We have had in place for some time, the management team, systems and infrastructure to support and scale the growth of our global business.
Our exciting development pipeline of new therapeutic drug candidates for diseases where there is a high unmet medical need continues to progress in line with our expectations. In particular, we look forward to announcing top-line data from our EASE Phase 3 global clinical trial in late Q3 / early Q4.
Despite the uncertainties brought about by COVID-19, we believe we have good visibility on our commercial business in the second half of the year. Our confidence in the stability and prospects for our business is illustrated today as we are issuing formal and positive guidance to the market for FY 2020 revenues.”
Q2 and Recent Business Highlights:
- In June 2020, Amryt publicly filed a Registration statement on Form F-1 with the U.S. Securities and Exchange Commission ("SEC") relating to the listing of American Depositary Shares ("ADSs") on Nasdaq. Amryt’s ADSs began trading on Nasdaq on July 8, 2020 under the symbol AMYT
- Amryt signed a distribution agreement for Myalepta® with Swixx BioPharma AG (“Swixx”) across 17 jurisdictions in Central and Eastern Europe in June 2020
- EASE, Amryt’s global pivotal Phase 3 trial in patients with dystrophic and junctional Epidermolysis Bullosa (“EB”), closed enrolment in April and is on track for top-line data readout in late Q3 / early Q4 2020
Q2 Financial Highlights:
- $46.2M unaudited Q2 revenues representing a 22% increase on unaudited combined revenues of $37.9M in Q2 20191
- 4% quarter on quarter unaudited revenue growth in Q2 2020 versus Q1 2020 ($44.6M). 9% growth quarter on quarter excluding the impact of irregular orders in Q1 and Q2
- 33% growth in Myalept® / Myalepta® (metreleptin) revenues to $27.9M in the quarter (Q2 2019: unaudited combined revenues1 $20.9M). Metreleptin revenues were bolstered by a $1.1M order which typically occurs once annually
- 8% increase in Juxtapid®/Lojuxta® (lomitapide) revenues to $18.1M in the quarter (Q2 2019: unaudited combined revenues1 $16.8M)
- US revenues accounted for 52% of total global revenues in Q2
- EMEA revenues accounted for 38% of global revenues, driven by the continued rollout of metreleptin post European Medicines Agency (“EMA”) approval in 2018. Q2 revenues for EMEA were favourably impacted by seasonal patterns and by forward ordering in certain jurisdictions driven by the COVID-19 pandemic
1 Unaudited combined revenues for 2019 represent the combined unaudited revenues of the Company assuming the acquisition by Amryt of Aegerion happened on 1 January 2019. It also (i) excludes revenues from sales to end-users in Japan following the out-licencing of Juxtapid to Recordati in February 2019, (ii) excludes up-front payments from Recordati in 2019, and (iii) includes a 22.5% royalty on Japanese sales of Juxtapid from 1 January 2019 as if the Recordati agreement was in place from that date.
Statutory and adjusted Q2 results:
|Q2 2020 Non-cash Items3||Q2 2020 Non-GAAP Adjusted|
|Acquisition & severance related costs||(2.6)||(0.1)||-||(0.1)|
|Share based compensation expenses||(0.1)||(0.8)||0.8||-|
|Operating (loss) / profit before finance expense||(9.7)||(12.0)||18.9||6.9 2|
|Unrestricted cash & cash equiv.||5.3||67.0||-||67.0|
2 EBITDA is earnings before interest, tax, depreciation, amorstisation and share based compensation expenses. To supplement Amryt's financial results presented in accordance with IFRS generally accepted accounting principles, the Company uses EBITDA as a key measure of company performance as the Company believes that this measure is most reflective of the operational profitability or loss of the Company and provides management and investors with useful supplementary information which can enhance their ability to evaluate the operating performance of the business. EBITDA, as measured by the Company, is not meant to be considered in isolation or as a substitute to operating profit / loss attributable to Amryt and should be read in conjunction with the Company's condensed consolidated financial statements prepared in accordance with IFRS.
3 Non-cash items include amortisation of the acquired metreleptin and lomitapide intangible assets ($11.1M), amortisation of the inventory fair value step-up that was acquired at the acquisition date ($6.5M), depreciation ($0.5M) and share based compensation expenses ($0.8M).
The Q2 operating loss of $12.0M includes the impact of non-cash items including amortisation, depreciation and the impact of share-based compensation expenses. Adjusting for these non-cash items, the Company delivered $6.9M of EBITDA2 for the quarter. R&D expenses decreased to $6.2M in Q2 (Q1: $8.9M). SG&A expenses increased in Q2 to $21.6M (Q1: $18.4M).
Cash generated from operating activities in Q2 was $3.5M. During the quarter, the Company paid $4.0M in net finance payments, $4.2M in residual payments related to legacy fines levied on Aegerion and $0.1M in capital expenditure. The legacy fines will be fully discharged by the end of Q1 2021. At June 30, 2020, the Company had unrestricted cash and cash equivalents of $67.0M (unaudited), compared to unrestricted cash and cash equivalents at December 31, 2019 of $65.2M (audited).
Financial Guidance and Outlook:
Revenues for the FY 2020 are expected to be in the range $170M - $175M. This forecast takes into account the seasonality and forward-ordering patterns already identified in Q2 and the impact of variable orders in H1.
Webcast and Conference Call:
Management will host a webcast for analysts and investors today at 0830 ET / 1330 BST.
Webcast Player URL: https://edge.media-server.com/mmc/p/7ujspsgk
Telephone Dial in details:
|Standard International Number||+44 (0) 203 009 5709|
|United States||+1 646 787 1226|
|United Kingdom (Local)||+44 (0) 844 493 6766|
|Ireland||+ 353 (1) 506 0626|
A playback facility will be available from August 6, 2020 at 1330 ET / 1830 BST – August 13, 2020 at 1330 ET / 1830 BST. Access details as follows: Confirmation Code: 7674874 | US: + 1 917 677 7532 | UK/International: +44 (0) 3333 00 9785 | Ireland: +353 (1) 553 8777.
|Amryt Pharma plc||+353 (1) 518 0200|
|Joe Wiley, CEO|
Rory Nealon, CFO/COO
LifeSci Advisors, LLC
|+1 (212) 915 2564|
Consilium Strategic Communications
|+44 (0) 20 3709 5700|
|Amber Fennell, Matthew Neal, Ashley Tapp|
Amryt is a biopharmaceutical company focused on developing and delivering innovative new 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 two orphan disease products.
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, Columbia, Argentina and Japan (under the trade name Juxtapid®) and in the EU (under the trade name Lojuxta®). HoFH is a rare genetic disorder which impairs the body's ability to remove low density lipoprotein ("LDL") cholesterol ("bad" cholesterol) from the blood, typically leading to abnormally high blood LDL cholesterol levels in the body from before birth - often ten times more than people without HoFH - and subsequent aggressive and premature cardiovascular disease.
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®) 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. Metreleptin is also approved for lipodystrophy in Japan. Generalised and partial lipodystrophy are rare disorders characterised by loss or lack of adipose tissue resulting in the deficiency of the hormone leptin, produced by fat cells and are associated with severe metabolic abnormalities including severe insulin resistance, diabetes, hypertriglyceridemia and fatty liver disease.
Amryt's lead development candidate, FILSUVEZ® is a potential treatment for the cutaneous manifestations of 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 granted Rare Pediatric Disease Designation and has also received a Fast Track Designation from the U.S. Food and Drug Administration. The European and US market opportunity for EB is estimated by the Company to be in excess of $1.0 billion.
In March 2018, Amryt in-licenced a pre-clinical gene-therapy platform technology, AP103, which offers a potential treatment for patients with Recessive Dystrophic Epidermolysis Bullosa, a subset of EB, and is also potentially relevant to other genetic disorders.
For more information on Amryt, including products, please visit www.amrytpharma.com.
This announcement contains inside information for the purposes of article 7 of the Market Abuse Regulation (EU) 596/2014.
The person making this notification on behalf of Amryt is Rory Nealon, CFO/COO and Company Secretary.
Shore Capital (Edward Mansfield, Daniel Bush, John More) are NOMAD and Joint Broker to Amryt in the UK. Stifel (Ben Maddison, Nicholas Moore) are Joint Broker to the company in the UK. Davy (John Frain, Daragh O’Reilly) act as Euronext Growth advisor and Joint Broker to the company in Dublin.
Statements in this announcement with respect to Amryt's business, strategies, timing for completion of and announcing results from the EASE study, the potential impact of closing enrollment in the EASE study, as well as other statements that are not historical facts are forward-looking statements involving risks and uncertainties which could cause the actual results to differ materially from such statements. Statements containing the words "expect", "anticipate", "intends", "plan", "estimate", "aim", "forecast", "project" and similar expressions (or their negative) identify certain of these forward-looking statements. The forward-looking statements in this announcement are based on numerous assumptions and Amryt's present and future business strategies and the environment in which Amryt expects to operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. These statements are not guarantees of future performance or the ability to identify and consummate investments. Many of these risks and uncertainties relate to factors that are beyond each of Amryt's ability to control or estimate precisely, such as future market conditions, the course of the COVID-19 pandemic, currency fluctuations, the behaviour of other market participants, the outcome of clinical trials, the actions of regulators and other factors such as Amryt's ability to obtain financing, changes in the political, social and regulatory framework in which Amryt operates or in economic, technological or consumer trends or conditions. Past performance should not be taken as an indication or guarantee of future results, and no representation or warranty, express or implied, is made regarding future performance. No person is under any obligation to update or keep current the information contained in this announcement or to provide the recipient of it with access to any additional relevant information that may arise in connection with it. Such forward-looking statements reflect the Company’s current beliefs and assumptions and are based on information currently available to management.
|Amryt Pharma plc|
Condensed Consolidated Statement of Comprehensive Loss
|Three Months Ended |
|Six Months Ended |
|2020 (unaudited)||2019 (unaudited)||2020 (unaudited)||2019 (unaudited)|
|Cost of sales||(29,471||)||(1,874||)||(62,091||)||(3,704||)|
|Research and development expenses||(6,197||)||(3,713||)||(15,131||)||(5,218||)|
|Selling, general and administrative expenses||(21,588||)||(6,051||)||(39,994||)||(9,947||)|
|Acquisition and severance related costs||(47||)||(2,619||)||(900||)||(2,619||)|
|Share based payment expenses||4||(858||)||(131||)||(1,603||)||(222||)|
|Operating loss before finance expense||(11,976||)||(9,739||)||(28,960||)||(12,519||)|
|Non-cash change in fair value of contingent consideration||5||(3,118||)||(1,913||)||(6,024||)||(3,851||)|
|Non-cash contingent value rights finance expense||5||(1,493||)||—||(2,941||)||—|
|Net finance expense - other||(4,717||)||(671||)||(14,133||)||(1,332||)|
|Loss on ordinary activities before taxation||(21,304||)||(12,323||)||(52,058||)||(17,702||)|
|Tax credit/(charge) on loss on ordinary activities||3,135||(10||)||4,992||(16||)|
|Loss for the period attributable to the equity holders of the Company||(18,169||)||(12,333||)||(47,066||)||(17,718||)|
|Exchange translation differences which may be reclassified through profit or loss||(926||)||(80||)||(939||)||—|
|Total other comprehensive loss||(926||)||(80||)||(939||)||—|
|Total comprehensive loss for the period attributable to the equity holders of the Company||(19,095||)||(12,413||)||(48,005||)||(17,718||)|
|Loss per share|
|Loss per share - basic and diluted, attributable to ordinary equity holders of the parent (US$)||6||(0.12||)||(0.27||)||(0.30||)||(0.39||)|
|Amryt Pharma plc|
Condensed Consolidated Statement of Financial Position
|June 30, |
|Property, plant and equipment||6,989||3,036|
|Other non-current assets||1,754||2,306|
|Total non-current assets||368,705||387,108|
|Trade and other receivables||8||46,259||36,387|
|Cash and cash equivalents, including restricted cash||9||67,126||67,229|
|Total current assets||136,984||147,239|
|Equity and liabilities|
|Equity attributable to owners of the parent|
|Contingent consideration and contingent value rights||5||111,707||102,461|
|Deferred tax liability||14,275||18,921|
|Long term loan||11||84,392||81,610|
|Provisions and other liabilities||13||4,734||4,963|
|Total non-current liabilities||314,023||304,811|
|Trade and other payables||89,424||76,596|
|Provisions and other liabilities||13||19,322||23,618|
|Total current liabilities||108,746||100,214|
|Total equity and liabilities||505,689||534,347|
|Amryt Pharma plc|
Condensed Consolidated Statement of Cash Flows
|Six Months Ended June 30,|
By: GlobenewsWire - 23 Jan 2021Return to news
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