PARMA, ITALY--(Marketwired - March 30, 2016) -

• Chiesi Farmaceutici generated just under EUR1.5bn in revenue in 2015, a year-on-year increase of almost 10%.
• The international footprint of the Group continues to grow: 80% of turnover is now from the non-Italian market.
• The expansion of Chiesi's US affiliate is extremely promising, as is the Group's solid market position in Europe.
• Investment in Research and Development hit EUR300 million, or 20% of turnover, in 2015.
• Chiesi continues to focus on innovation in key therapeutic areas such as Respiratory, Neonatology and Rare Diseases, strengthening the Group's portfolio and securing long-term revenue streams.
• Over 40 research and development projects are currently underway in the Group.
• 4,500 people are now employed by Chiesi: passion, entrepreneurship and diversity are central to its success, and are the values which will continue to drive the company's development in the coming years.

Chiesi Farmaceutici closed 2015 on a high note by reporting annual turnover of EUR1.467 million, an increase of more than 9.4% over the previous year, and EBITDA equal to EUR407 million (a year-on-year increase of over 9%). The robust health of the company is mirrored in its investment in innovation and development, with R&D expenditure rising by over 28% in the 2014-2015 period, from EUR236m to EUR300m, or 20% of total sales. The Group currently has 41 active research and development projects.

Chiesi remains committed to the domestic market, and 2015 saw significant investment in Italy with EUR35m spent on expanding the state-of-the-art production plant forCurosurf^® (poractant alfa) Intratracheal Suspension in Parma to meet demand for one of the group's most successful products.

"In the latest chapter of a story that just turned 80 years old, we have once again demonstrated our commitment to excellence and our ability to achieve outstanding results, thanks to our agility and ability to both adapt to the dynamic circumstances which characterize our industry, and to be at the cutting-edge of development.

Chiesi's expertise in the areas of Respiratory, Neonatology and Rare Diseases underpins our success, with our constantly expanding knowledge-base generating a wealth of fresh ideas that in turn lead to the development of innovative -- and in many cases unique -- medical solutions. Our aim is to continue to give hope to those patients who until now have no, or limited, therapeutic alternatives.

2016 will continue to see Chiesi adhering to its core aim of drug development through its own internal pre-clinical and clinical research programs, but also seeking opportunities to acquire products which are an organic fit with our range of respiratory and special care solutions."

Alberto Chiesi, President of Chiesi Farmaceutici S.p.A.

PRODUCTS
The respiratory drug market is one in which Chiesi is a key global player, and a number of brands in its portfolio are continuing to generate significant growth, and revenue. Chiesi's asthma products achieved sales exceeding EUR668 million in 2015, a significant year-on-year increase. Sales of Curosurf^® (poractant alfa), a lung surfactant used to treat Respiratory Distress Syndrome (RDS) in premature infants, exceeded EUR200m globally. Curosurf grew 14.4% over 2014, and increased its share of not only the European market, but also that of the U.S. and Far East. 

MARKETS AND COMMERCIAL OPERATIONS
Chiesi's global presence is reflected by 80% of turnover in 2015 being generated by non-Italian sales. The Group's excellent results were also in part attributable to Chiesi's swift and smooth integration of the U.S. specialty pharmaceutical business Cornerstone Therapeutics, acquired little more than a year ago. Strong sales of two products developed by Chiesi's own research division were complemented by drugs from Cornerstone's portfolio, boosting turnover in 2015 by 16.9%, in US$.

In Europe, Chiesi affiliates showed solid growth, with an average increase in turnover of 5.2%. Similarly, despite the volatility in emerging markets and continuing economic uncertainties, the Group still achieved remarkable results in Brazil, Turkey, China, Pakistan and Mexico. Overall, sales grew by 11.7%, in local currencies.

PROSPECTS FOR 2016
2016 will see the submission of two new innovative products to the European Medicine Agency, both relating to Chiesi's core Respiratory and Rare Disease therapeutic areas.

In the words of Ugo Di Francesco, CEO of Chiesi Farmaceutici:

"Chiesi Group's presence in the global pharmaceutical landscape is well-established. The main objective of the company in the coming years is to continue to sustain our current virtuous cycle of expansion and reinvestment in research and development. Constant innovation is integral to who we are; it was the basis for our past and present successes, and is the key to our future.

Chiesi's people are at the heart of this vision, embodying our values and driving innovation through the contribution of bold new ideas to our development programs.

In the coming year we will continue our pioneering work with cell and gene therapies, as well as on other molecular entity drugs which we have in the pipeline. These drugs hold enormous promise for addressing many hitherto challenging or untreatable conditions, and we are committed to realizing their potential."

UNITED STATES -- INDICATION
Curosurf^® (poractant alfa) Intratracheal Suspension is indicated for the rescue treatment of Respiratory Distress Syndrome (RDS) in premature infants. Curosurf reduces mortality and pneumothoraces associated with RDS.

UNITED STATES -- IMPORTANT SAFETY INFORMATION
Curosurf^® (poractant alfa) Intratracheal Suspension is intended for intratracheal use only. The administration of exogenous surfactants, including Curosurf, can rapidly affect oxygenation and lung compliance. Therefore, infants receiving Curosurf should receive frequent clinical and laboratory assessments so that oxygen and ventilatory support can be modified to respond to respiratory changes.

Curosurf should only be administered by those trained and experienced in the care, resuscitation, and stabilization of preterm infants.

Transient adverse effects seen with the administration of Curosurf include bradycardia, hypotension, endotracheal tube blockage, and oxygen desaturation. These events require stopping Curosurf administration and taking appropriate measures to alleviate the condition. After the patient is stable, dosing may proceed with appropriate monitoring.

Pulmonary hemorrhage is a known complication of premature birth and very low birth-weight and has been reported with Curosurf. The rates of common complications of prematurity observed in a multicenter single-dose study that enrolled infants 700-2000 g birth weight with RDS requiring mechanical ventilation and FiO2 ≥ 0.60 are as follows for Curosurf 2.5 mL/kg (200 mg/kg) (n=78) and control (n=66; no surfactant) respectively: acquired pneumonia (17% vs. 21%), acquired septicemia (14% vs. 18%), bronchopulmonary dysplasia (18% vs. 22%), intracranial hemorrhage (51% vs. 64%), patent ductus arteriosus (60% vs. 48%), pneumothorax (21% vs. 36%), and pulmonary interstitial emphysema (21% vs. 38%).

Please see Full Prescribing Information available at www.Curosurf.com.

About Chiesi Farmaceutici
Headquartered in Parma, Italy Chiesi Farmaceutici is an international research-focused Healthcare group, with over 80 years of experience in the pharmaceutical industry. Chiesi researches, develops and markets innovative drugs in the respiratory therapeutics, specialist medicine and rare diseases areas.

Its R&D centers in Parma (Italy), Paris (France), Cary (USA), Chippenham (UK) and the R&D team of the acquired Danish company Zymenex, integrate their efforts to advance Chiesi's pre-clinical, clinical and registration programs. Chiesi employs over 4,500 people, 560 of whom are solely dedicated to Research and Development activities.

For more information, please visit the website www.chiesi.com.

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