ALLSCHWIL/BASEL, SWITZERLAND - 21 April 2016 - Actelion Ltd (SIX: ATLN) today announced its results for the first three months of 2016.
| in CHF millions |
(except for per share data)
|3M 2016||3M 2015||in CHF||at CER(1)|
|US GAAP results|
|Core operating income||249||218||14||8|
|Core net income||215||185||16||10|
|Core diluted EPS||1.98||1.61||23||17|
|Cash flow||3M 2016||3M 2015|
|Operating cash flow||172||94|
|Free cash flow||67||-57|
|Net cash position as of 31 March||472||913|
Jean-Paul Clozel, MD, Chief Executive Officer, commented: "Actelion has started the year very well. Opsumit continues on its exceptional launch trajectory and Uptravi is off to an excellent start - much better than anyone could have expected. Our other products are also performing well, our pipeline projects are advancing and our discovery efforts continue to deliver compounds into the clinic. With the business performing better than anticipated, even while launching new products and investing in future products, I am confident to upgrade our financial guidance."
Otto Schwarz, Chief Operating Officer, commented: "We are very pleased with the Uptravi launch in the United States. After almost three months, approximately 650 patients are on treatment with Uptravi. We assume the majority of patients are now benefitting from an all-oral triple combination therapy. The Opsumit launch momentum continues across all regions and markets. Our outcome-based PAH portfolio now accounts for 40% of our sales, with Tracleer for the first time contributing less than 50% of sales, thus demonstrating the progress in the transformation of our PAH business."
André C. Muller, Chief Financial Officer, commented: "The strong start to 2016, along with some more clarity on a number of factors - including the strong Opsumit and Uptravi launch dynamics and stable pricing in Japan for Opsumit and Tracleer - enables us to increase the outlook for the full year. Barring unforeseen events, we now expect high single-digit percentage core operating income growth, at constant exchange rates."
Actelion delivered an outstanding first quarter driven by the continued successful uptake of Opsumit, a very strong Uptravi launch, consistently strong recruitment of new PAH patients across markets, and ERA market expansion due to increased combination therapy with PDE-5 inhibitors.
In the US, sales increased by 25% at CER, driven by the strong Uptravi launch, continued Opsumit momentum and ERA market share gains. European sales were flat at CER with increased Opsumit uptake and Tracleer use in the digital ulcer indication offset by continued pricing pressure and market erosion from generics. Sales in Japan increased by 11% at CER and were driven by Opsumit (launched in June 2015), Veletri, and Zavesca (Japanese trade name Brazaves). Sales in the rest of the world decreased by 14%, at CER.
Comparing average exchange rates for the first three months of 2016 to the first three months of 2015, the Swiss franc weakened, mostly against the US dollar and the Euro, resulting in a positive currency variance of 17 million Swiss francs.
Sales by product - year-to-date
|in CHF millions||3M 2016||3M 2015||in CHF||at CER|
|Total product sales||589||515||14||11|
Sales by region - year-to-date
|in CHF millions||3M 2016||3M 2015||in CHF||at CER|
|Rest of the world||49||59||-18||-14|
|Total product sales||589||515||14||11|
*Europe = EU28 and Switzerland
Sales of Opsumit (macitentan) amounted to 178 million Swiss francs for the first three months of 2016, an increase of 82% at CER compared to the first three months of 2015. This increase is driven by the continued uptake trajectory with commercial availability in over 30 countries. The strong enrollment continues to be driven by treatment-naïve patients together with increased early combination with PDE-5 inhibitors.
Sales of Uptravi (selexipag) amounted to 35 million Swiss francs since the product was launched in the United States on 4 January 2016. Of this total amount, approximately 20 million Swiss francs can be attributed to the launch inventory as Uptravi is available in 10 different presentations across the various doses. At the end of March, approximately 650 patients were using this outcome-based, oral selective IP receptor agonist, originally discovered by Nippon Shinyaku.
Market authorization has so far been received from the US FDA (21 December 2015) and Health Canada (20 January 2016), New Zealand's Medsafe (17 March 2016) and Australia's TGA (18 March 2016). In Europe, the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Uptravi for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II-III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies. A CHMP positive opinion is one of the final steps before marketing authorization is granted by the European Commission. The European Commission is expected to issue a final decision in the coming months.
Submission of the registration dossier to other health authorities is ongoing, with regulatory reviews underway in Japan, South Korea, Switzerland, Taiwan and Turkey.
Sales of Tracleer (bosentan) amounted to 290 million Swiss francs for the first three months of 2016, a decrease of 18% at CER compared to the first three months of 2015. This decrease is mostly a consequence of lower volumes in countries where Opsumit is availabledue to lower enrollments of new patients as well as switches to Opsumit. Underlying units sold globally decreased by 14%. Tracleer sales were further impacted by continued pricing pressure in Europe and increased generic bosentan competition, notably in Spain. Positively, Tracleer sales were supported by the digital ulcer indication in Europe, the DU launch in Japan and continued solid demand in markets where Opsumit is not yet available. In March 2016, Actelion Japan was notified that the biannual Japanese pricing review would lead to no change.
Following the Pediatric Investigation Plan (PIP) compliance statement from the European Committee for Medicinal Products for Human Use (CHMP), applications for extension of the Supplementary Protection Certificate (SPC) were filed in 19 EU countries and have been granted in 15 of those.
Sales of Veletri (epoprostenol for injection) amounted to 24 million Swiss francs for the first three months of 2016, an increase of 20% at CER compared to the first three months of 2015. The increase was mostly driven by increased market penetration, successful launches in additional markets, notably in France - the biggest European i.v. epoprostenol market in terms of prostacyclin patients - and continued growth in Japan (where it is marketed as Epoprostenol "ACT"). In March 2016, Actelion Japan was notified of an average 12% price cut for Veletri, effective 1 March 2016. At the end of March 2016, Veletri was available in 15 countries globally.
Sales of Ventavis (iloprost) amounted to 27 million Swiss francs for the three months of 2016, a decrease of 18% at CER compared to the first three months of 2015. The underlying unit decrease of 24% is due to continued competitive pressure.
Sales of Valchlor (mechlorethamine) for the first three months of 2016 amounted to 9 million Swiss francs. In the US, the company is continuing its efforts to establish Valchlor as an option in the treatment algorithm for early-stage mycosis fungoides, a type of Cutaneous T-Cell Lymphoma (MF-CTCL). In France, patients benefited from the drug under a temporary authorization for use ("ATU") program initiated during the second half of 2014. The regulatory dossier is currently under review with the European Medicines Agency (under the trade name Ledaga®).
Sales of Zavesca (miglustat) amounted to 25 million Swiss francs for the first three months of 2016, an increase of 26% at CER compared to the first three months of 2015. Underlying units sold increased by 15%. Sales in the US were strong due to a very low prior year base as a consequence of last year's inventory adjustment. In Europe, sales were lower by 5% mainly due to launch of generic miglustat, which has become commercially available (approved for the type 1 Gaucher disease indication only) in Spain, Sweden and the Czech Republic. Sales in Japan (where it is marketed as Brazaves®) were 13% higher driven by increased patient demand in the Niemann-Pick type C indication.
RESULTS DAY CENTER
Investor community: To make your job easier, we provide links to all relevant documentation, such as a full financial review, reconciliation US-GAAP to Core results and geographical breakdown by product, from the Results Day Center on our corporate website: www.actelion.com/results-day-center.
In the first three months of 2016, the company significantly increased enrollment into both the cadazolid and ponesimod Phase III studies, raising confidence that full recruitment can be achieved by the end of the year.
During the first quarter a new chemical entity entered into man for neurological disorders. Other projects in the clinical development pipeline are progressing according to plan.
|Registration||Selexipag||PAH||GRIPHON||Regulatory reviews ongoing|
|Phase III||Cadazolid||Clostridium difficile-associated diarrhea||IMPACT||Ongoing|
|Phase II||Clazosentan||Reversal of vasospasm associated with aneurysmal subarachnoid hemorrhage||REVERSE||Ongoing|
|Endothelin Receptor Antagonist||Specialty cardiovascular disorders||-||Initiating|
|Macitentan||Chronic thromboembolic pulmonary hypertension||MERIT||Ongoing|
|Macitentan||Combined pre- and post-capillary pulmonary hypertension||MELODY||Complete|
|Cenerimod||Systemic lupus erythematosus||-||Ongoing|
|Phase Ib||Lucerastat||Fabry disease||-||Complete|
|Phase I||NCE||Neurological disorders||-||Complete|
NOTE TO SHAREHOLDERS:
The Annual General Meeting (AGM) of Shareholders to approve the Business Report of the year ending
31 December 2015 will be held on 4 May 2015. The invitation was published in the Swiss Official Gazette of Commerce (Schweizerisches Handelsamtsblatt) on 6 April 2016 and is available, together with the Company's Annual Report and Compensation Report, on www.actelion.com/agm.
In order to attend and vote at the Annual General Meeting of Shareholders, Shareholders must have been registered in the Company's shareholder register by 22 April 2016 at the latest.
NOTES TO THE EDITOR
ABOUT ACTELION LTD.
Actelion Ltd. is a leading biopharmaceutical company focused on the discovery, development and commercialization of innovative drugs for diseases with significant unmet medical needs.
Actelion is a leader in the field of pulmonary arterial hypertension (PAH). Our portfolio of PAH treatments covers the spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications. Although not available in all countries, Actelion has treatments approved by health authorities for a number of specialist diseases including Type 1 Gaucher disease, Niemann-Pick type C disease, Digital Ulcers in patients suffering from systemic sclerosis, and mycosis fungoides type cutaneous T-cell lymphoma.
Founded in late 1997, with now over 2,500 dedicated professionals covering all key markets around the world including Europe, the US, Japan, China, Russia and Mexico, Actelion has its corporate headquarters in Allschwil / Basel, Switzerland.
Actelion shares are traded on the SIX Swiss Exchange (ticker symbol: ATLN) as part of the Swiss blue-chip index SMI (Swiss Market Index SMI®). All trademarks are legally protected.
For further information please contact:
Senior Vice President, Head of Investor Relations & Corporate Communications
Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil
+41 61 565 62 62 - www.actelion.com