Amryt Pharma Plc - Full Year 2019 RESULTS
May 11, 2020 AIM: AMYT Euronext Growth: AYP |
AMRYT PHARMA PLC
(“Amryt” or the “Company”)
FY 2019 RESULTS
- Transformational year of performance and growth for Amryt
- Aegerion integration completed successfully and ahead of schedule
- Business performing ahead of expectations
- Strong year end cash balances of $65.2M
- Unaudited combined revenues of $154.1M in 2019, an increase of 13.1% on 2018 unaudited combined revenues of $136.3M1
- The Company has also today separately issued Q1 results for 2020
Amryt, 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 audited results for the year ended December 31, 2019. These audited results include the full year results for Amryt which include contributions from the legacy Aegerion Pharmaceuticals, Inc. ("Aegerion") business beginning on the date of acquisition on September 24, 2019.
Dr Joe Wiley, CEO of Amryt, commented: “2019 was a truly transformational year for Amryt. Post the Aegerion acquisition, we now have two substantial revenue-generating products which generated 2019 combined revenues of $154.1M representing a 13.1% increase on the 2018 combined revenues, an international commercial business in the US, Europe, the Middle East and Latin America, a strong pipeline of development and life-cycle opportunities in areas of significant high unmet medical need, and the financial flexibility to execute on our growth plans. Amryt is now very well positioned to execute on our strategy of becoming a global leader in rare and orphan diseases and most importantly, delivering therapies to patients with high unmet needs.
I would like to take this opportunity to thank all our stakeholders for their commitment and support during 2019 and beyond.”
2019 Financial Highlights:
The 2019 audited financial results reflect the acquisition of Aegerion from September 24, 2019 and are not reflective of the performance of the combined businesses for a full year. Total reported revenues of $58.1M reflect sales of the legacy Amryt business for the full financial year, plus sales of the acquired Aegerion business with effect from September 24, 2019.
To aid comparison, we also report unaudited combined revenues1 that reflect the combined businesses, had they been integrated for a full financial year. On this basis, the unaudited combined revenues for 2019 would have been $154.1M representing a growth rate of 13.1% on 2018 unaudited combined revenues of $136.3M.
·Myalept® / Myalepta® (metreleptin) generated revenues of $85.4M (2018: $71.4M) representing an increase of 19.6%
·Juxtapid®/Lojuxta® (lomitapide) generated revenues of $68.0M (2018: $64.0M), representing a growth rate of 6.3%
·The significant growth in metreleptin revenues was driven by the ongoing rollout of Myalepta® in Europe following the approval of the product by the European Medicines Agency in Q3 2018
1 Unaudited combined revenues for 2018 and 2019 represent the combined unaudited revenues of the Company assuming the acquisition by Amryt of Aegerion occurred on 1 January 2018. It also (i) excludes revenues from sales to end-users in Japan following the out-licencing of Juxtapid to Recordati in February 2019, (ii) excludes up-front payments from Recordati in 2019, and (iii) includes a 22.5% royalty on Japanese sales of Juxtapid from 1 January 2018 as if the Recordati agreement was in place from that date.
Statutory and adjusted 2019 results
US$M | 2018 | 2019 | Restructuring / Deal Costs Adjs2 | Non-cash Items3 | 2019 Non-GAAP Adjusted |
Revenue | 17.1 | 58.1 | - | - | 58.1 |
Gross profit | 10.8 | 16.1 | 2.5 | 22.2 | 40.8 |
R&D | (10.7) | (15.8) | - | - | (15.8) |
SG&A | (17.3) | (35.5) | - | 0.8 | (34.7) |
Restructuring & acquisition costs | - | (13.1) | 13.1 | - | - |
Share based compensation expenses | (0.8) | (0.8) | - | 0.8 | - |
Impairment charge | - | (4.7) | - | 4.7 | - |
Operating loss before finance expense | (18.0) | (53.8) | 15.6 | 28.5 | (9.7) |
Unrestricted cash & cash equiv. | 9.9 | 65.2 | - | - | 65.2 |
2 Restructuring / deal cost adjustments includes the Amryt acquisition and deal related costs associated with the Aegerion acquisition, the subsequent restructuring costs during the period post the completion of the acquisition associated with the relocation of a number of functions from Boston and EMEA to Dublin, Ireland, and the removal of royalties paid by Amryt to Aegerion in the period prior to completion of the acquisition which become an intercompany payment post completion of the acquisition.
3 Non-cash items include amortisation of the acquired metreleptin and lomitapide intangible assets, amortisation of the inventory fair value step-up that was acquired at the acquisition date, depreciation and other amortisation, share based compensation expenses and the impairment of our AP102 asset.
As outlined in the table above, the operating loss for 2019 of $53.8M (2018 : $18.0M) includes the significant impact of restructuring and deal costs associated with the Aegerion acquisition and non-cash items including amortisation, impairment, depreciation and the impact of share based compensation expenses. Operating losses before non-cash items and restructuring & deal costs in 2019 were $9.7M (operating loss for 2018: $16.8M).
Financial Position:
In August 2019, Amryt raised gross proceeds of $8.0M by way of an interim equity placing. These proceeds were used to meet the Amryt legal, financial and other costs associated with the Aegerion acquisition which were payable at deal close. On completion of the acquisition in September 2019, Amryt raised an additional $57.0M net of fees by way of an equity placing. This compares to the year-end unrestricted cash balance of $65.2M which was significantly ahead of expectations and reflects the strong performance of the business in the period since the acquisition of Aegerion.
In conjunction with the acquisition, Amryt re-structured the existing Amryt and Aegerion debt facilities. This resulted in Amryt repaying the EIB debt facility and putting in place a new five-year term loan of $81M and a new five and a half year convertible facility of $125.0M. Amryt's debt maturity profile offers significant flexibility. No principal repayments are due on the term loan until September 2024 and on the convertible facility until April 2025.
2019 Business Highlights:
- Amryt acquired Aegerion on September 24, 2019 creating a global commercial rare disease business with two approved products, which delivered $154.1M in unaudited combined revenues1 in 2019
- The Company’s lead development candidate, FILSUVEZ® (AP101), is currently completing a pivotal Phase 3 prospective double-blind randomised placebo controlled study (“EASE”) in patients with dystrophic and junctional EB. EASE is the largest ever global Phase 3 study conducted in patients with EB, operating across 55 sites in 27 countries globally. In January 2019, Amryt reported the outcome of an unblinded interim efficacy analysis, at which point an Independent Data Monitoring Committee recommended that the trial should continue with an increase of 48 patients in the study to a total of 230 evaluable patients in order to achieve 80% statistical power. On April 23, 2020, since the study was close to full enrolment and following expert statistical advice, the company announced the decision to close the EASE study to further recruitment and anticipates top-line data read out in late Q3 / early Q4 2020
- FILSUVEZ® received Fast-Track Designation from the U.S. Food and Drug Administration (“FDA”) in September 2019 having previously received a Rare Pediatric Disease Designation. These designations from the FDA are designed to accelerate the development and review of products such as FILSUVEZ® and Amryt will be eligible to receive a Priority Review Voucher (“PRV”) that can be used, sold or transferred if FILSUVEZ® is ultimately approved by the FDA. The most recent confirmed sale of a PRV was in March 2020 for $108.1M
- AP103, is currently in preclinical development for the treatment of patients with Recessive Dystrophic EB, a subset of EB. AP103 is Amryt’s first gene therapy product candidate based on our novel polymer-based topical gene therapy delivery platform, which also has potential use for the treatment of other rare genetic diseases. On January 7, 2019 Amryt announced that two pre-clinical studies showed that topical application of AP103 restored production of collagen VII in pre-clinical models of EB to levels exceeding those produced by healthy human keratinocytes and to levels similar to those observed following delivery with a viral vector. In addition, AP103 exhibited no evidence of cellular toxicity after repeated administration
- Board Renewal - In September 2019 post completion of the Aegerion acquisition, Harry Stratford, Rory Nealon, James Culverwell and Markus Zeiner stood down from the Board. George Hampton, Dr Alain Munoz, Donald Stern, Dr Patrick Vink and Stephen Wills all joined the Board as Non-executive Directors with Ray Stafford becoming Non-executive Chairman
Post-Period End Highlights
Amryt has also today separately issued Q1 2020 results incorporating information on post-period end events.
Management will host a conference call for analysts and investors today at 14.30 BST. Dial in details for the call are as follows - Conference ID: 3725306 | Ireland: (01) 431 9615 | UK/International: + 44 (0) 2071 928000 | US: + 1 631 510 7495.
A playback facility will be available approximately 4 hours after the call ends through May 25, 2020. Playback details as follows: Conference ID: 3725306 | UK/International: +44 (0) 3333 00 9785 | US: + 1 917 677 7532.
Enquiries:
Amryt Pharma plc | +353 (1) 518 0200 |
Joe Wiley, CEO Rory Nealon, CFO/COO | |
Shore Capital | +44 (0) 20 7408 4090 |
NOMAD and Joint Broker | |
Edward Mansfield, Daniel Bush, John More | |
Stifel | +44 (0) 20 7710 7600 |
Joint Broker | |
Jonathan Senior, Ben Maddison | |
Davy | +353 (1) 679 6363 |
ESM Adviser and Joint Broker | |
John Frain, Daragh O’Reilly | |
Consilium Strategic Communications | +44 (0) 20 3709 5700 |
Amber Fennell, Matthew Neal, Carina Jurs | |
LifeSci Advisors, LLC | +1 (212) 915 2564 |
Tim McCarthy |
About Amryt
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 FDA. 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.
Forward-Looking Statements
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 Consolidated Statement of Financial Position | ||||||
Year ended December 31, | ||||||
2019 | 2018 | |||||
Note | US$’000 | |||||
Assets........................................................................................................................................... | ||||||
Non-current assets............................................................................................................................................ | ||||||
Goodwill | 12 | $ 30,813 | $ — | |||
Intangible assets............................................................................................................................................ | 12 | 350,953 | 60,297 | |||
Property, plant and equipment................................................................................................................................... | 13 | 3,036 | 1,098 | |||
Other non-current assets............................................................................................................................................ | 2,306 | 149 | ||||
Total non-current assets............................................................................................................................................ | 387,108 | 61,544 | ||||
Current assets............................................................................................................................................ | ||||||
Trade and other receivables.................................................................................................................................. | 14 | 36,387 | 5,927 | |||
Inventories.................................................................................................................................. | 15 | 43,623 | 2,137 | |||
Cash and cash equivalents, including restricted cash............................................................................................................................................... | 16 | 67,229 | 11,226 | |||
Total current assets............................................................................................................................................ | 147,239 | 19,290 | ||||
Total assets............................................................................................................................................ | 534,347 | 80,834 | ||||
Equity and liabilities..................................................................................................................................... | ||||||
Equity attributable to owners of the parent.......................................................................................................................................... | ||||||
Share capital.......................................................................................................................................... | 17 | 11,918 | 25,198 | |||
Share premium....................................................................................................................................... | 17 | 2,422 | 68,233 | |||
Other reserves........................................................................................................................................ | 248,656 | (24,865 | ) | |||
Accumulated deficit........................................................................................................................................... | (133,674 | ) | (72,263 | ) | ||
Total equity........................................................................................................................................... | 129,322 | (3,697 | ) | |||
Non-current liabilities..................................................................................................................................... | ||||||
Contingent consideration.............................................................................................................................. | 6 | 102,461 | 47,316 | |||
Deferred tax liability........................................................................................................................................ | 18 | 18,921 | 6,161 | |||
Long term loan............................................................................................................................................... | 19 | 81,610 | 19,011 | |||
Convertible notes............................................................................................................................................. | 20 | 96,856 | — | |||
Provisions and other liabilities..................................................................................................................................... | 22 | 4,963 | — | |||
Total non-current liabilities..................................................................................................................................... | 304,811 | 72,488 | ||||
Current liabilities..................................................................................................................................... | ||||||
Trade and other payables....................................................................................................................................... | 21 | 76,596 | 12,043 | |||
Provisions and other liabilities..................................................................................................................................... | 22 | 23,618 | — | |||
Total current liabilities..................................................................................................................................... | 100,214 | 12,043 | ||||
Total liabilities..................................................................................................................................... | 405,025 | 84,531 | ||||
Total equity and liabilities..................................................................................................................................... | $ 534,347 | $ 80,834 |
Amryt Pharma plc Consolidated Statement of Comprehensive Loss | ||||||||||
Year ended December 31, | ||||||||||
2019 | 2018 | |||||||||
Note | US$’000 | |||||||||
Revenue............................................................................................................................. | 3 | $ 58,124 | $ 17,095 | |||||||
Cost of sales..................................................................................................................................... | 4 | (42,001 | ) | (6,266 | ) | |||||
Gross profit................................................................................................................................... | 16,123 | 10,829 | ||||||||
Research and development expenses............................................................................................................................. | (15,827 | ) | (10,703 | ) | ||||||
Selling, general and administrative expenses............................................................................................................................. | (35,498 | ) | (17,342 | ) | ||||||
Restructuring and acquisition costs.................................................................................................................................... | 6 | (13,038 | ) | — | ||||||
Share based payment expenses............................................................................................................................. | 5 | (841 | ) | (821 | ) | |||||
Impairment charge................................................................................................................................. | 12 | (4,670 | ) | — | ||||||
Operating loss before finance expense............................................................................................................................... | 7 | (53,751 | ) | (18,037 | ) | |||||
Non-cash change in fair value of contingent consideration..................................................................................................................... | 6 | (8,251 | ) | (10,566 | ) | |||||
Net finance expense............................................................................................................................... | 9 | (4,759 | ) | (1,841 | ) | |||||
Loss on ordinary activities before taxation.............................................................................................................................. | (66,761 | ) | (30,444 | ) | ||||||
Tax credit/(charge) on loss on ordinary activities............................................................................................................................. | 10 | 1,226 | (43 | ) | ||||||
Loss for the year attributable to the equity holders of the Company........................................................................................................................... | (65,535 | ) | (30,487 | ) | ||||||
Exchange translation differences which may be reclassified through profit or loss...................................................................................................................................... | 781 | (77 | ) | |||||||
Total other comprehensive profit/(loss)........................................................................................................................ | 781 | (77 | ) | |||||||
Total comprehensive loss for the year attributable to the equity holders of the Company........................................................................................................................... | $ (64,754 | ) | $ (30,564 | ) | ||||||
Loss per share | ||||||||||
Loss per share - basic and diluted, attributable to ordinary equity holders of the parent (US$)................................................................................................................................... | 11 | $ | (0.86 | ) | $ | (0.67 | ) |
Amryt Pharma plc Consolidated Statement of Cash Flows | ||||||
Year ended December 31, | ||||||
2019 | 2018 | |||||
Note | US$’000 | |||||
Cash flows from operating activities | ||||||
Loss on ordinary activities after taxation | $ (65,535 | ) | $ (30,487 | ) | ||
Net finance expense | 9 | 4,759 | 1,841 | |||
Depreciation and amortization | 12, 13 |
By: GlobeNewswire
- 11 May 2020
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