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Recordati Industria Chimica e Farmaceutica

Earnings Release Jul 27, 2017

4056_ir_2017-07-27_92886cc5-4be0-4af8-bc18-74d16e21d8c8.pdf

Earnings Release

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RECORDATI: VERY GOOD RESULTS IN THE FIRST HALF 2017. CONTINUED GROWTH IN SALES +10.7%, OPERATING INCOME +19.4%, NET INCOME +19.8%.

  • Consolidated revenues € 650.9 million, +10.7%.
  • EBITDA(1) € 224.0 million, +19.1%
  • Operating income € 203.2 million, +19.4%.
  • Net income € 147.0 million, +19.8%.
  • Net financial position(2): net debt of € 356.3 million.
  • Shareholders' equity € 991.1 million.
  • Full year 2017 targets increased: sales between € 1,290 and € 1,300 million, EBITDA(1) between € 450 and € 460 million, operating income between € 400 and € 410 million and net income between € 290 and € 295 million.

Milan, 27 July 2017 – The Board of Directors of Recordati S.p.A. approved the Group's consolidated results for the first half 2017 prepared in accordance with International Accounting Standards and International Financial Reporting Standards (IAS/IFRS) and in particular as per IAS 34 requirements for interim reporting. These financial statements will be available today at the company's offices and on the company's website (www.recordati.com) and can also be viewed on the authorized storage system (). The independent auditors' report on the consolidated condensed half-year financial statements will be available within the legal deadline at the company's offices and on the company's website (www.recordati.com) and can also be viewed on the authorized storage system ().

Financial highlights

  • Consolidated revenuesin the first half 2017 are € 650.9 million, up by 10.7% compared to the same period of the preceding year. International sales grow by 9.2%.
  • EBITDA(1), at 34.4% of sales, is € 224.0 million, an increase of 19.1% over the same period of the preceding year.
  • Operating income, at 31.2% of sales, is € 203.2 million, an increase of 19.4%.
  • Net income, at 22.6% of sales, is € 147.0 million, an increase of 19.8% over the first half of 2016.
  • Net financial position(2) at 30 June 2017 records a net debt of € 356.3 million compared to net debt of € 198.8 million at 31 December 2016. During the period dividends were distributed and the acquisition of the marketing rights to the metoprolol based products from AstraZeneca was concluded for an overall disbursement of € 324.9 million. Shareholders' equity increasesto € 991.1 million.

(1) Operating income before depreciation, amortization and write down of both tangible and intangible assets. (2) Cash and short-term financial investments less bank overdrafts and medium/long-term loans which include the measurement at fair value of hedging derivatives.

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.p.A.

VIA M. CIVITALI, 1 CAPITALE SOCIALE € 26.140.644,50 I.V. 20148 MILANO, ITALIA REG. IMP. MILANO N. 00748210150 TEL. (39) 0248787.1 CODICE FISCALE/P.IVA 007482210150

Corporate development news

In January the European Union Commission granted the European marketing authorization for its orphan medicinal product Cystadrops® 3.8mg/mL. Cystadrops® is the first eye-drop solution containing cysteamine hydrochloride approved in the European Union for "the treatment of corneal cystine crystal deposits in adults and children from 2 years of age with cystinosis". The European Commission had granted Cystadrops® orphan drug designation in November 2008. Cystadrops® eye-drop solution was developed specifically for cystinosis patients by Orphan Europe (Recordati Group). Cystinosis is a rare congenital lysosomal storage disorder recognized as a severe life threatening condition. It is characterized by an accumulation of cystine crystals which negatively affects all organs in the body, especially the kidneys and eyes. Cystinosis benefits from systemic treatment with cysteamine orally administered. However, oral cysteamine does not adequately address ocular cystinosis because of the non-vascularization of cornea. Without a proper, continued, local eye treatment, cystine crystals accumulate in the cornea, leading to severe consequences and possibly to blindness in the long term.

In February an exclusive worldwide licensing agreement covering the know-how developed by the Meyer Hospital in Florence (Italy) for the development of a treatment for pre-term babies affected by retinopathy of prematurity (ROP) was signed. The treatment is currently being investigated in a phase II clinical trial by the Meyer Hospital, while Recordati will complete the clinical development and the regulatory steps necessary to obtain the marketing approval for the drug. Retinopathy of prematurity (ROP) is a potentially blinding eye disorder that primarily affects premature infants weighing about 1.25 kg or less that are born before 31 weeks of gestation This disorder, which usually develops in both eyes, is a rare condition, however presenting as one of the most common causes of visual loss in childhood that can lead to lifelong vision impairment and blindness. Furthermore, within the deal, Recordati shall support other Meyer projects in the rare disease area over a period of three years based on a mutually agreed plan. This collaboration between public and private institutions recognizes the important results obtained by the internal research conducted by the pediatric hospital in Florence.

In May Recordati signed an agreement with AstraZeneca for the acquisition of the rights to Seloken®/Seloken® ZOK (metoprolol succinate) and associated Logimax® fixed dose combination (metoprolol succinate and felodipine) treatments in Europe. The transaction was successfully concluded on 30 June (on 10 July for part of the transaction related to Romania). The consideration for the acquisition of the assets is of \$ 300 million (€ 267 million). In addition, royalties for the use of the existing product brands will be due to AstraZeneca for an agreed period. Overall net sales in Europe in 2016 of the brands object of the transaction are of around € 100 million. Metoprolol succinate is a beta-blocker mainly indicated for the control of a range of conditions including hypertension, angina pectoris, disturbances of cardiac rhythm, maintenance treatment after myocardial infarction, and functional heart disorders with palpitations. It is a widely used drug in all European countries which will enable us to reinforce our product portfolios in a number of our European subsidiaries, in particular in Poland, France and Germany. Furthermore, existing sales of the metoprolol brands will provide the base to enter new markets and thus complete our European geographical footprint. Recordati has significant experience in the marketing of treatments for cardiovascular disease with an existing portfolio of medicines for hypertension and related conditions as well as an established salesforce across European markets.

On May 31, 2017, Recordati S.p.A. issued and privately placed a bond for a total of € 125.0 million with Pricoa Capital Group. The main terms and conditions provide for a 2.07% fixed interest rate and a duration of 15 years with repayment in annual instalments starting on 31 May 2025. The transaction, the object of which is to provide the necessary liquidity to support the growth of the group, was able to take advantage of the favourable market conditions.

In June Recordati signed an exclusive license agreement with MimeTech, an Italian development stage company founded by scientists from the University in Florence, for the development and subsequent commercialization on a global basis of a low molecular weight peptidomimetic of human nerve growth factor (NGF) for the treatment of neurotrophic keratitis, which already received an Orphan Drug Designation in the EU. Additional indications linked to NGF defects are also contemplated in the scope of the partnership. Under the terms of the agreement Recordati made an upfront payment upon signature of the contract and further milestone payments shall be linked to the development process and commercial performance. Neurotrophic keratitis is a rare degenerative corneal disease which in its more severe forms affects less than one person out of 10,000 worldwide, and is initiated by an impairment of trigeminal nerve. Impairment or loss of corneal sensory innervation is responsible for corneal epithelial defects, ulcer, and perforation. The most common causes of loss of corneal innervation are: viral infection (herpes simplex and herpes zoster keratoconjunctivitis), chemical burns, physical injuries, and corneal surgery. Neuroma, meningioma, and aneurysms may also determine a compression of the trigeminal nerve or ganglion and produce an impairment of corneal sensitivity. Furthermore, systemic diseases such as diabetes, multiple sclerosis, and leprosy may decrease sensory nerve function or damage sensory fibres compromising corneal sensitivity. The corneal epithelium is the first cell layer of the disease showing changes and defects, with poor predisposition to self-healing. The progression of the disease may lead to corneal ulcers, melting, and perforation leading to dramatic impairment to patients' sight.

Subsequent events

During July Gedeon Richter Plc. was granted marketing authorization from the European Commission for Reagila® (cariprazine), a novel antipsychotic for the treatment of schizophrenia in adult patients, valid for all European Union Member States. In August 2016 Richter and Recordati signed an exclusive license agreement to commercialize cariprazine in Western Europe, Algeria, Tunisia and Turkey.

Management Comments

"The financial results obtained in the first half of the year confirmed the continued growth of the group, with revenues and profitability increasing strongly", declared Andrea Recordati, Vice Chairman and CEO. "Furthermore, important development initiatives for further growth were undertaken. In addition to the marketing approval for Cystadrops® and the agreement with the Meyer Hospital in Florence, an agreement was signed with AstraZeneca for the acquisition of the European marketing rights to their metoprolol based products which will contribute to significantly reinforce our presence in Europe. More recently, an exclusive license agreement was signed with MimeTech for the development and subsequent marketing on a global basis of a new compound for the treatment of neurotrophic keratitis and, in July the European Commission approved the marketing of Reagila®, a novel antipsychotic for the treatment of schizophrenia in adults," continued Andrea Recordati. "The group's business continued to perform very well during July and for the full year 2017, including the consolidation as from this month of the sales of the metoprolol based products acquired from AstraZeneca, our expectation is to achieve sales of between € 1,290 and 1,300 million, EBITDA of between € 450 and 460 million, EBIT of between € 400 and 410 million and net income of between € 290 and 295 million."

Conference call

Recordati will be hosting a conference call today 4 May 2017 at 4.00 pm Italian time (3.00 pm London time, 10.00 am New York time). The dial-in numbers are:

Italy +39 02 8058811, toll free 800 213 858
UK +44 1 212818003, toll free 800 0156384
USA +1 718 7058794, toll free 855 2656959
France +33 170918703
Germany +49 69 255114451

Callers are invited to dial-in 10 minutes before conference time. If conference operator assistance is required during the connection, please digit * followed by 0 or call +39 02 8061371. A recording of the conference call will be placed on the website www.recordati.com.

A set of slides which will be referred to during the call will be available on our website www.recordati.com under Investors/Company Presentations.

Recordati, established in 1926, is an international pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT 0003828271), with a total staff of more than 4,100, dedicated to the research, development, manufacturing and marketing of pharmaceuticals. Headquartered in Milan, Italy, Recordati has operations in the main European countries, in Russia, other Central and Eastern European countries, Turkey, North Africa, the United States of America, Canada, Mexico and in some South American countries. An efficient field force of medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in a number of therapeutic areas including a specialized business dedicated to treatments for rare diseases. Recordati is a partner of choice for new product licenses for its territories. Recordati is committed to the research and development of new specialties with a focus on treatments for rare diseases. Consolidated revenue for 2016 was € 1,153.9 million, operating income was € 327.4 million and net income was € 237.4 million.

For further information:

Recordati website: www.recordati.com

Investor Relations Media Relations Marianne Tatschke Studio Noris Morano (39)0248787393 (39)0276004736, (39)0276004745

e-mail: [email protected] e-mail: [email protected]

Statements contained in this release, other than historical facts, are "forward-looking statements" (as such term is defined in the Private Securities Litigation Reform Act of 1995). These statements are based on currently available information, on current best estimates, and on assumptions believed to be reasonable. This information, these estimates and assumptions may prove to be incomplete or erroneous, and involve numerous risks and uncertainties, beyond the Company's control. Hence, actual results may differ materially from those expressed or implied by such forward-looking statements. All mentions and descriptions of Recordati products are intended solely as information on the general nature of the company's activities and are not intended to indicate the advisability of administering any product in any particular instance.

RECORDATI GROUP

Summary of consolidated results prepared in accordance with the International Accounting Standards and International Financial Reporting Standards (IAS/IFRS)

(thousands of €)

INCOME STATEMENT First half 2017 First half 2016 Change %
REVENUE 650,868 587,864 10.7
Cost of sales (196,742) (180,472) 9.0
GROSS PROFIT 454,126 407,392 11.5
Selling expenses (168,521) (155,215) 8.6
Research and development expenses (47,152) (41,626) 13.3
General & administrative expenses (33,841) (31,798) 6.4
Other income (expenses), net (1,414) (8,537) (83.4)
OPERATING INCOME 203,198 170,216 19.4
Financial income (expenses), net (6,991) (5,978) 16.9
PRE-TAX INCOME 196,207 164,238 19.5
Provision for income taxes (49,220) (41,520) 18.5
NET INCOME 146,987 122,718 19.8
Attributable to:
Equity holders of the parent 146,967 122,704 19.8
Minority interests 20 14 42.9
EARNINGS PER SHARE First half 2017 First half 2016 Change %
Basic € 0.713 € 0.598 19.2
Diluted € 0.703 € 0.587 19.8

Earnings per share (EPS) are based on average shares outstanding during each year, 205,984,391 in 2017 and 205,297,564 in 2016, net of average treasury stock which amounted to 3,140,765 shares in 2017 and to 3,827,592 shares in 2016. Diluted earnings per share is calculated taking into account stock options granted to employees.

COMPOSITION OF REVENUE First half 2017 First half 2016 Change %
Total revenue 650,868 587,864 10.7
Italy 142,415 122,267 16.5
International 508,453 465,597 9.2

Pending the completion of independent audit.

RECORDATI GROUP

Summary of consolidated results prepared in accordance with the International Accounting Standards and International Financial Reporting Standards (IAS/IFRS)

(thousands of €)

INCOME STATEMENT Second
Quarter
2017
Second
Quarter
2016
Change %
REVENUE 308,928 285,617 8.2
Cost of sales (90,933) (86,771) 4.8
GROSS PROFIT 217,995 198,846 9.6
Selling expenses (79,900) (75,650) 5.6
Research and development expenses (23,985) (19,350) 24.0
General & administrative expenses (16,708) (15,758) 6.0
Other income (expenses), net (1,475) (8,027) (81.6)
OPERATING INCOME 95,927 80,061 19.8
Financial income (expenses), net (5,207) (3,454) 50.8
PRE-TAX INCOME 90,720 76,607 18.4
Provision for income taxes (22,248) (19,367) 14.9
NET INCOME 68,472 57,240 19.6
Attributable to:
Equity holders of the parent 68,462 57,233 19.6
Minority interests 10 7 42.9
COMPOSITION OF REVENUE Second
Quarter
Second
Quarter
Change %
2017 2016
Total revenue 308,928 285,617 8.2
Italy 65,692 58,507 12.3
International 243,236 227,110 7.1

Pending the completion of independent audit.

RECORDATI GROUP

Summary of consolidated results prepared in accordance with the International Accounting Standards and International Financial Reporting Standards (IAS/IFRS)

(thousands of €)

ASSETS 30.6.2017 31.12.2016
Property, plant and equipment 104,922 110,202
Intangible assets 521,527 279,884
Goodwill 548,905 556,566
Equity investments 25,226 19,199
Non-current receivables 6,236 5,428
Deferred tax assets 31,433 37,231
TOTAL NON-CURRENT ASSETS 1,238,249 1,008,510
Inventories 166,971 158,800
Trade receivables 232,195 205,988
Other receivables 29,900 30,974
Other current assets 8,698 5,481
Fair value of hedging derivatives (cash flow hedge) 8,129 12,497
Short-term financial investments, cash and cash equivalents 85,759 138,493
TOTAL CURRENT ASSETS 531,652 552,233
TOTAL ASSETS 1,769,901 1,560,743
EQUITY AND LIABILITIES 30.6.2017 31.12.2016
Share capital 26,141 26,141
Capital in excess of par value 83,719 83,719
Treasury stock (25,048) (76,761)
Hedging reserve (4,330) (7,420)
Translation reserve (101,595) (78,309)
Other reserves 38,971 35,295
Retained earnings 826,169 756,004
Net income for the period 146,967 237,406
Interim dividend 0 (72,245)
GROUP SHAREHOLDERS' EQUITY 990,994 903,830
Minority interest 130 110
SHAREHOLDERS' EQUITY 991,124 903,940
Loans due after one year 385,691 293,644
Employees' termination pay 22,334 21,675
Deferred tax liabilities 26,825 27,659
Other non-current liabilities 2,515 2,515
TOTAL NON-CURRENT LIABILITIES 437,365 345,493
Trade payables 132,833 124,644
Other payables 78,911 77,957
Tax liabilities 35,232 20,432
Other current liabilities 847 562
Provisions 26,398 27,977
Fair value of hedging derivatives (cash flow hedge) 5,687 3,621
Loans due within one year 41,579 40,428
Bank overdrafts 19,925 15,689
TOTAL CURRENT LIABILITIES 341,412 311,310
TOTAL EQUITY AND LIABILITIES 1,769,901 1,560,743

Pending the completion of independent audit.

DECLARATION BY THE MANAGER RESPONSIBLE FOR PREPARING THE COMPANY'S FINANCIAL REPORTS

The manager responsible for preparing the company's financial reports Fritz Squindo declares, pursuant to paragraph 2 of Article 154-bis of the Consolidated Law on Finance, that the accounting information contained in this press release corresponds to the document results, books and accounting records.

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