Amryt Pharma Plc - Q1 2020 RESULTS
May 11, 2020 AIM: AMYT Euronext Growth: AYP |
AMRYT PHARMA PLC
(“Amryt” or the “Company”)
Q1 2020 RESULTS
- $44.6M unaudited Q1 revenues representing a 30% increase on unaudited combined revenues of $34.3M in Q1 20191
- 10% quarter on quarter unaudited revenue growth in Q1 2020 versus Q4 2019 ($40.5M)
- $4.6M EBITDA2 delivered in Q1. Including non-cash items and share based compensation expenses, this results in an operating loss before finance expense for Q1 of $17.0M
- Cash generated from Operating Activities of $6.2M during Q1 2020
- Aegerion integration successfully completed ahead of schedule, delivering positive EBITDA a quarter ahead of plan
- Robust financial position with $67.0M in cash compared to $65.2M at December 31, 2019
- Enrolment in EASE global Phase 3 study concluded with top-line data expected in late Q3 / early Q4 2020
- FILSUVEZ® confirmed as the global brand name for AP101
- Confidentially submitted a draft registration statement on Form F-1 to the U.S. Securities and Exchange Commission ("SEC") on February 18, 2020 relating to the proposed listing of American Depositary Shares ("ADSs") representing Amryt ordinary shares on the Nasdaq stock market ("Nasdaq")
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 unaudited financial results for the first quarter ended March 31, 2020.
Joe Wiley, CEO of Amryt Pharma, commented: “The positive momentum we experienced during 2019 has continued into Q1 2020. Our performance so far is exceeding expectations this year as our business performs and grows across a host of metrics. Most importantly, we have experienced strong revenue growth and the business is significantly EBITDA positive a quarter ahead of schedule.
We believe 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 unmet needs. We look forward to the top-line data readout from our EASE study in late Q3 or early Q4 which will represent a significant milestone for Amryt.
During the COVID-19 pandemic, our primary focus remains the health and well-being of our team, patients, carers, partners and their families. Given that our business lends itself to remote working and the majority of our revenues are inherently recurring in nature, I am pleased to report that our business is proving resilient and performing well”.
Q1 Financial Highlights:
Revenues
·$44.6M unaudited Q1 revenues representing a 30% increase on unaudited combined revenues of $34.3M in Q1 20191
·10% quarter on quarter unaudited revenue growth in Q1 2020 versus Q4 2019 ($40.5M)
·Myalept® / Myalepta® (metreleptin) generated revenues of $26.9M in the quarter (Q1 2019: unaudited combined revenues1 $18.0M)
·Juxtapid®/Lojuxta® (lomitapide) generated revenues of $17.4M in the quarter (Q1 2019: unaudited combined revenues1 $16.2M)
·Strong US revenues in Q1 accounted for 55% of total global revenues
·EMEA revenues accounted for 32% of global revenues, driven by the continued rollout of metreleptin post EMA approval in 2018
·ROW revenue was bolstered by a $3.0M metreleptin order in LATAM during Q1 2020. Unlike in other regions, ordering patterns in LATAM can be sporadic in nature and therefore we do not expect this revenue to recur each quarter
1 Unaudited combined revenues for 2019 represent the combined unaudited revenues of the Company assuming the acquisition by Amryt of Aegerion happened on 1 January 2019. It also (i) excludes revenues from sales to end-users in Japan following the out-licencing of Juxtapid to Recordati in February 2019, (ii) excludes up-front payments from Recordati in 2019, and (iii) includes a 22.5% royalty on Japanese sales of Juxtapid from 1 January 2019 as if the Recordati agreement was in place from that date.
Statutory and adjusted Q1 results
US$M | Q1 2019 (unaudited) | Q1 2020 (unaudited) | Q1 2020 Non-cash Items3 | Q1 2020 Non-GAAP Adjusted |
Revenue | 4.5 | 44.6 | - | 44.6 |
Gross profit | 2.7 | 12.0 | 20.7 | 32.7 |
R&D | (1.5) | (8.9) | - | (8.9) |
SG&A | (3.9) | (18.4) | 0.1 | (18.3) |
Acquisition & severance related costs | - | (0.9) | - | (0.9) |
Share based compensation expenses | (0.1) | (0.8) | 0.8 | - |
Operating (loss) / profit before finance expense | (2.8) | (17.0) | 21.6 | 4.6 |
Unrestricted Cash & cash equiv. | 11.4 | 67.0 | - | 67.0 |
2 EBITDA is earnings before interest, tax, depreciation, amorstisation and share based compensation expenses.
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 share based compensation expenses.
The Q1 operating loss of $17.0M includes the impact of non-cash items including amortisation, depreciation and the impact of share-based compensation expenses, plus acquisition & severance related costs associated with the Aegerion acquisition. Adjusting for these non-cash items, the Company delivered $4.6M of EBITDA2 for the quarter (or $5.5m if also adjusted for acquisition & severance related costs).
Financial Position:
Cash generated from operating activities in Q1 was $6.2M. During the quarter, the Company paid $1.4M in net finance payments and $0.1M in capital expenditure. At March 31, 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).
Business Highlights:
- Aegerion integration completed successfully and ahead of schedule
- In February 2020, we announced that we had confidentially submitted a draft registration statement on Form F-1 to the SEC relating to the proposed listing of ADSs representing Amryt ordinary shares on the Nasdaq
- Enrolment concluded in EASE, a global pivotal Phase 3 trial in patients with dystrophic and junctional EB. Top-line data from this study is expected in late Q3 / early Q4 2020
- In May 2020, FILSUVEZ® was confirmed as the global brand name for AP101. Establishing the brand name for AP101 is another important step forward in ensuring readiness for the global launch of FILSUVEZ®
COVID-19 Update
The primary concern of all the Amryt team is to ensure the safety of our colleagues, their families and our patients and partners at this time. Global healthcare systems are operating at or close to full capacity and the focus within systems now is to treat those patients in need of acute care. Amryt’s business lends itself to remote working and in recent weeks, we have successfully transitioned appropriate functions to remote platforms exclusively without incident. The impact of COVID-19 to date on Amryt’s business has been minimized and this is a result of deploying contingency plans already in place for a variety of scenarios and challenges which may occur.
Amryt provides therapeutic products to Homozygous Familial Hypercholesterolaemia (“HoFH”) and lipodystrophy patients globally on a recurring basis. Once lomitapide (for the treatment of HoFH) or metreleptin (for the treatment of lipodystrophy) are prescribed by physicians, patients are typically on treatment over a long period of time with repeat prescriptions for each patient. As such, the majority of our revenues are recurring in nature. During the pandemic our sales teams’ deployment in the field is restricted and we continue to evaluate remote and virtual physician access as a means to identify new patients that may be suitable for treatment with our products.
Amryt has in excess of 12 months of labelled and unlabelled finished products on hand for both lomitapide and metreleptin. Our supply chain is robust and we are confident that we can continue to supply patients for the foreseeable future. We are taking additional steps to further strengthen our inventory levels of both metreleptin and lomitapide. To date, we have not experienced any significant logistical difficulties in delivering product to patients. In major markets such as the USA, the UK and Germany, product has historically been delivered direct to patients’ homes. In other markets, product has typically been delivered to local hospitals/distributors and we are continuing to explore opportunities to expand direct to home delivery in these markets.
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 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.
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 Condensed Consolidated Statement of Financial Position | ||||||
As at, | ||||||
March 31, 2020 (unaudited) | December 31, 2019 (audited) | |||||
Note | US$’000 | |||||
Assets........................................................................................................................................... | ||||||
Non-current assets............................................................................................................................................ | ||||||
Goodwill | 7 | $ 30,813 | $ 30,813 | |||
Intangible assets............................................................................................................................................ | 7 | 339,094 | 350,953 | |||
Property, plant and equipment................................................................................................................................... | 2,862 | 3,036 | ||||
Other non-current assets............................................................................................................................................ | 2,310 | 2,306 | ||||
Total non-current assets............................................................................................................................................ | 375,079 | 387,108 | ||||
Current assets............................................................................................................................................ | ||||||
Trade and other receivables.................................................................................................................................. | 8 | 41,179 | 36,387 | |||
Inventories.................................................................................................................................. | 33,904 | 43,623 | ||||
Cash and cash equivalents, including restricted cash............................................................................................................................................... | 9 | 68,067 | 67,229 | |||
Total current assets............................................................................................................................................ | 143,150 | 147,239 | ||||
Total assets............................................................................................................................................ | 518,229 | 534,347 | ||||
Equity and liabilities..................................................................................................................................... | ||||||
Equity attributable to owners of the parent.......................................................................................................................................... | ||||||
Share capital.......................................................................................................................................... | 10 | 11,918 | 11,918 | |||
Share premium....................................................................................................................................... | 10 | 2,422 | 2,422 | |||
Other reserves........................................................................................................................................ | 249,386 | 248,656 | ||||
Accumulated deficit........................................................................................................................................... | (162,569 | ) | (133,674 | ) | ||
Total equity........................................................................................................................................... | 101,157 | 129,322 | ||||
Non-current liabilities..................................................................................................................................... | ||||||
Contingent consideration.............................................................................................................................. | 5 | 106,145 | 102,461 | |||
Deferred tax liability........................................................................................................................................ | 17,345 | 18,921 1 | ||||
Long term loan............................................................................................................................................... | 11 | 82,989 | 81,610 | |||
Convertible notes............................................................................................................................................. | 12 | 97,872 | 96,856 | |||
Provisions and other liabilities..................................................................................................................................... | 13 | 1,014 | 4,963 | |||
Total non-current liabilities..................................................................................................................................... | 305,365 | 304,811 | ||||
Current liabilities..................................................................................................................................... | ||||||
Trade and other payables....................................................................................................................................... | 87,575 | 76,596 | ||||
Provisions and other liabilities..................................................................................................................................... | 13 | 24,132 | 23,618 | |||
Total current liabilities..................................................................................................................................... | 111,707 | 100,214 | ||||
Total liabilities..................................................................................................................................... | 417,072 | 405,025 | ||||
Total equity and liabilities..................................................................................................................................... | $ 518,229 | $ 534,347 |
Amryt Pharma plc Condensed Consolidated Statement of Comprehensive Loss | ||||||||||
Three months ended March 31, | ||||||||||
2020 (unaudited) | 2019 (unaudited) | |||||||||
Note | US$’000 | |||||||||
Revenue.......................................................................................................................... | 3 | $ 44,574 | $ 4,542 | |||||||
Cost of sales................................................................................................................................. | (32,620 | ) | (1,830 | ) | ||||||
Gross profit............................................................................................................................... | 11,954 | 2,712 | ||||||||
Research and development expenses.......................................................................................................................... | (8,934 | ) | (1,505 | ) | ||||||
Selling, general and administrative expenses.......................................................................................................................... | (18,406 | ) | (3,896 | ) | ||||||
Acquisition and severance related costs................................................................................................................................. | (853 | ) | — | |||||||
Share based payment expenses.......................................................................................................................... | 4 | (745 | ) | (91 | ) | |||||
Operating loss before finance expense........................................................................................................................... | (16,984 | ) | (2,780 | ) | ||||||
Non-cash change in fair value of contingent consideration................................................................................................................. | 5 | (4,354 | ) | (1,938 | ) | |||||
Net finance expense........................................................................................................................... | (9,416 | ) | (661 | ) | ||||||
Loss on ordinary activities before taxation.......................................................................................................................... | (30,754 | ) | (5,379 | ) | ||||||
Tax credit/(charge) on loss on ordinary activities......................................................................................................................... | 1,857 | (6 | ) | |||||||
Loss for the year attributable to the equity holders of the Company........................................................................................................................ | (28,897 | ) | (5,385 | ) | ||||||
Exchange translation differences which may be reclassified through profit or loss | (13 | ) | 80 | |||||||
Total other comprehensive (loss)/income.................................................................................................................. | (13 | ) | 80 | |||||||
Total comprehensive loss for the year attributable to the equity holders of the Company........................................................................................................................ | $ (28,910 | ) | $ (5,305 | ) | ||||||
Loss per share | ||||||||||
Loss per share - basic and diluted, attributable to ordinary equity holders of the parent (US$)................................................................................................................................ | 6 | $ | (0.19 | ) | $ | (0.12 | ) |
Amryt Pharma plc Condensed Consolidated Statement of Cash Flows | ||||||
Three months ended March 31, | ||||||
2020 (unaudited) | 2019 (unaudited) | |||||
Note | US$’000 | |||||
Cash flows from operating activities | ||||||
Loss on ordinary activities after taxation | $ (28,897 | ) | $ (5,385 | ) | ||
Net finance expense | 9,416 | 661 | ||||
Depreciation and amortization | 11,241 | 91 | ||||
Amortization of inventory fair value step-up | 9,503 | — | ||||
Share based payment expenses | 4 | 745 | 91 | |||
Non-cash change in fair value of contingent consideration | 4,354 | 1,938 | ||||
Deferred taxation credit | (1,576 | ) | — | |||
Movements in working capital and other adjustments: | ||||||
Change in trade and other receivables |