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Oxurion NV — Earnings Release 2012
Mar 20, 2013
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Earnings Release
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ThromboGenics Announces Business Update and 2012 Full-Year Results
Transformational 2012 Delivers Euro 30 Million in Net Profit
REGULATED INFORMATION
Leuven, Belgium – 14 March, 2013 - ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, today issued a business update and its financial results for the full year ending December 31, 2012.
The past 12 months have been a defining period for ThromboGenics, resulting in the approval and launch of its lead drug JETREA® (ocriplasmin) in the US. US patients and physicians now have access to the first pharmacological treatment for the sight-threatening condition symptomatic vitreomacular adhesion (VMA). The launch of JETREA ® has completed ThromboGenics' transformation into an integrated company with operations in R&D through to full-scale commercialization.
ThromboGenics expects 2013 to be another crucial year as JETREA® gains more traction in the US and Europe, if approved.
2012 Highlights (including post-period events):
JETREA® (ocriplasmin)
Commercializing JETREA® in the US
- JETREA® was launched in the US on 14 January 2013 after the US Food and Drug Administration (FDA) approved it as the first pharmacological treatment of symptomatic vitreomacular adhesion (VMA)
- o Highly focused commercial team, including specialist salesforce, is now working to drive the US sales of JETREA®
- o Structure in place to help US physicians process reimbursement claims for JETREA®
Major strategic partnership alliance with Alcon in Europe and ROW
- ThromboGenics entered into a €375 million strategic commercialization agreement with Alcon (Novartis) for the commercialization of ocriplasmin outside the US.
- o ThromboGenics received €75 million in an upfront payment.
- o It is eligible for a further €90 million in potential near-term milestone payments, potential further milestones of €210 million, plus additional significant royalties on Alcon's sales of JETREA® outside the US.
- o ThromboGenics and Alcon are to share the costs equally of the further development of JETREA® , including new formulations and new indications.
- In January 2013, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency granted a positive opinion for JETREA® for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns, paving the way for the product's potential EU approval.
Financial
- ThromboGenics raises €77.9 million through a private placement via the issue of 3,244,675 new shares in April 2012.
- Positive Belgian tax authority ruling in June 2012 has enabled ThromboGenics to benefit from a "patent income deduction regime" and, therefore, from a reduced tax rate for all patent-related JETREA® income.
- €148.2 million in cash and cash investments as of 31 December 2012, compared with €80.4 million at the end of December 2011.
- €75.1 million in total revenue in 2012, compared with €2.5 million in 2011.
- Net profit of €30.4 million in 2012, equivalent to diluted earnings per share of €0.84. In 2011, the Company reported a net loss of €21.6 million, equivalent to a diluted loss per share of €0.67.
Dr Patrik De Haes, CEO of ThromboGenics, said: "The past 12 months have been the most important period in ThromboGenics' history. The recent launch of JETREA® has completed our transformation into a profitable fully integrated company focused on developing and commercializing innovative ophthalmic medicines. We are delighted that US patients and physicians now have access to JETREA® which is the first pharmacological treatment for symptomatic VMA, an important sight-threatening condition. Initial reactions from retinal physicians and patients to this novel treatment option have been positive and our commercial organization is now focused on building sales of JETREA® ."
"Our partnership agreement with Alcon is progressing well and we anticipate gaining EU approval for JETREA® shortly. We are working with Alcon to finalize our reimbursement strategies in the five largest markets in Europe so we are well positioned for the JETREA® launch, which is expected in the first half of 2013. Over the next 12 months we expect to generate further shareholder value as the US sales of JETREA® continue to build and we receive further milestones and the first royalties from Alcon as this novel pharmacological treatment option for symptomatic VMA is commercialized in Europe."
JETREA® Highlights
JETREA® in the US
ThromboGenics launches the first pharmacological treatment for symptomatic VMA
ThromboGenics made history when it launched JETREA® for the treatment of symptomatic VMA in the US on 14 January 2013. The FDA approved JETREA® for this indication in October 2012.
Symptomatic VMA is a progressive condition that, if left untreated, frequently leads to retinal distortion, further deterioration in vision and has the potential to cause irreversible damage and complications. It is estimated that initially around 250,000 people in the US could benefit from treatment with JETREA® .
The FDA approval was based on the data from ThromboGenics' phase III program where JETREA® was shown to be superior to placebo for the treatment of symptomatic VMA.
Treatment with JETREA® was associated with some, mainly transient, ocular adverse events.
The FDA approval followed an endorsement from an FDA Advisory Committee, which unanimously voted (10 to 0) in favour of recommending the drug in July 2012.
Highly focused commercial organization in place
ThromboGenics' launch of JETREA® in the US through its own highly focused commercial organization was a key strategic milestone for the Company.
The commercial team which ThromboGenics has been building over the past 18 months is now fully operational and includes a specialist salesforce that is focused on driving the high awareness of JETREA® into product revenues. The team is targeting over 2,000 retinal physicians in the US who treat most of the patients presenting with symptomatic VMA.
The US team also includes reimbursement managers who are implementing a comprehensive reimbursement support program to help US physicians process claims so that they can be reimbursed for JETREA® as quickly as possible.
The Centers for Medicare and Medicaid Services (CMS) has recently granted JETREA® a unique billing code for use in the Hospital outpatient setting, C9298, that will become effective on April 1, 2013. ThromboGenics has applied for a permanent J-code which it expects to receive and take effect on January 1, 2014. A permanent J-code would lead to the reimbursement process for JETREA® being automated.
NEJM publishes paper on ocriplasmin
In August 2012, the New England Journal of Medicine (NEJM) published a paper entitled "Enzymatic Vitreolysis with Ocriplasmin for Vitreomacular Traction and Macular Holes."
The paper in this prestigious journal highlighted that a single intravitreal injection of ocriplasmin resolved vitreomacular adhesion (VMA), releasing traction and closing macular holes in significantly more patients than placebo.
JETREA® in Europe and ROW
Major strategic commercialization deal with Alcon for JETREA® outside the US
In March 2012, ThromboGenics signed a €375 million strategic deal with Alcon, the global leader in eye care to commercialize JETREA® outside the US.
ThromboGenics received an upfront payment of €75 million. The Company is entitled to a further €90 million in potential near-term milestone payments, a further €210 million in potential milestones and in addition significant royalties on Alcon's sales of JETREA® outside the US.
As part of the agreement, ThromboGenics is working in partnership with Alcon to launch and commercialize JETREA® in the five largest European markets plus Belgium. In the Rest of the World (ROW) Alcon will be solely responsible for commercializing JETREA® .
ThromboGenics and Alcon will work together on the further development of JETREA® . The two companies will share the costs equally to explore new formulations and clinical applications of the product that the companies could introduce in their respective territories. In November 2012, ThromboGenics won the Licensing Deal of the Year at the Scrip Awards
2012 for its partnership agreement with Alcon (Novartis) to commercialize JETREA® outside the US.
The Scrip Awards are one of the most prestigious awards recognizing excellence in the global biopharmaceutical and clinical research industries. The awards are judged by an independent panel of senior executives from these sectors against strict criteria.
CHMP positive opinion for JETREA®
On 18 January 2013, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion for JETREA® , recommending it for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.
VMT, which in the US is referred to as symptomatic VMA, is an age-related progressive, sight-threatening condition that may lead to visual distortion, decreased visual acuity and central blindness.
The positive opinion from the CHMP clears the way for the potential EMA approval of JETREA® as the first pharmacological option for this indication. A decision by the European Commission will apply to all 27 European Union Member states plus Iceland and Norway.
If approved, the launch of JETREA® in Europe by partner Alcon is anticipated in the first half of 2013, starting with the UK and Germany. It is estimated that around 250,000 to 300,000 people in Europe suffer from VMT.
ThromboGenics and Alcon are working with the national health authorities in the main markets of Europe to ensure that JETREA® is reimbursed at an appropriate price when it becomes available. In November 2012 JETREA® was selected to receive a Single Technology Appraisal (STA) from the UK's National Institute for Health and Clinical Excellence (NICE). NICE guidance on the use of JETREA® within the National Health Service (NHS) is expected later in 2013, following the launch of the drug in the UK.
Further development of JETREA®
ThromboGenics is evaluating the use of JETREA® in treating adhesion associated with agerelated macular degeneration (AMD). It is estimated that a third of AMD patients have VMA and that this adhesion occurs in the same location as the AMD.1
JETREA® is currently being studied in a phase II trial to determine the resolution of VMA associated with AMD. The primary endpoint is the proportion of patients in whom there is release of vitreomacular traction by day 28 following treatment with JETREA® . ThromboGenics has completed the recruitment of 100 patients and results are expected in the second quarter of 2013.
This phase II trial is expected to provide some preliminary data to help inform ThromboGenics and Alcon on their future plans to develop JETREA® for further indications such as AMD.
1 Robison CD et al, 2009; Mojana J et al, 2008; Krebs I et al; 2007
Other Pipeline Products
ThromboGenics to study TB-403 (anti-PlGF) for ophthalmic indications
ThromboGenics is now investigating the potential of TB-403 to treat ophthalmic indications such as AMD and diabetic retinopathy (DR).
TB-403 is a monoclonal antibody against placental growth factor (PlGF). PIGF is a naturally occurring protein that belongs to the family of vascular endothelial growth factors (VEGF) that promote the formation of blood vessels. TB-403's ability to block selectively the growth of new blood vessels and modulate inflammation means it could potentially be used in a broad range of ophthalmic indications.
ThromboGenics and BioInvent regained the global rights to TB-403 from Roche in June 2012. TB-403 was licensed to Roche in 2008.
Corporate highlights
International Capital Market Days
ThromboGenics hosted Capital Market Days (CMD) in New York and Brussels during 2012 to update investors about development and commercialization plans for JETREA® as well as proving further background information on symptomatic VMA and its treatment.
At the New York CMD, held on 7 June 2012, vitreoretinal specialist Dr Jeffrey Heier presented phase III clinical data with ocriplasmin and discussed his own experience of using this innovative drug.
In Brussels, retinal experts Dr Peter Kaiser, based in the US, and Dr Tim Jackson, based in the UK, provided their clinical experiences of using JETREA® in the different regions. Management also provided an update on marketing and reimbursement plans for JETREA® .
US office opening
ThromboGenics officially opened its new US office in Iselin, New Jersey, in March 2012.
As a result of its decision to locate its US offices in Iselin, ThromboGenics will benefit from a Business Employment Incentive grant from the New Jersey Economic Development Authority.
Financial Review
ThromboGenics raises €78 million
In April 2012, ThromboGenics raised €77.9 million in an over-subscribed private placement at a price of €24 per share shortly after signing the strategic deal with Alcon for the commercialization of JETREA® outside the US. The new funds came from a range of domestic and international investors as well as qualified institutional buyers in the United States.
ThromboGenics has invested part of these funds in the launch and commercialization of JETREA® in the US and for the further clinical development for additional indications with
Alcon. The Company also intends to use the funds to strengthen its core ophthalmic franchise by in-licensing development-stage product candidates.
Positive patent income deduction ruling
In June 2012, ThromboGenics announced that the Belgian tax authorities had granted the Company a positive ruling enabling it to benefit from the "patent income deduction regime" and, therefore, from a reduced tax rate for all patent-related JETREA® income.
The patent income deduction will apply to ThromboGenics' anticipated sales of JETREA® in the US through its own commercial organization, to the extent that the revenues relate to the JETREA® patents.
It will also apply to all upfront and milestone payments and royalties that ThromboGenics has or could receive from Alcon.
Revenue and Results
In 2012, ThromboGenics' total revenue was €75.1 million compared with €2.5 million in 2011. The main source of revenue in 2012 was the €75 million upfront payment received from Alcon as part of the strategic agreement to commercialize JETREA® outside the US.
Gross profit in 2012 was €72.0 million. In 2011, ThromboGenics reported a gross profit of €2.3 million.
R&D expenses in 2012 were €20.1 million compared with €19.7 million in 2011. This level of expenditure in 2012 was due to the costs associated with additional studies with ocriplasmin, the phase IIb trial with TB-402 and our investment in preclinical research. €35.3 million of the costs related to the ocriplasmin development program were capitalized in 2012. This compares with €11.2 million in 2011.
In 2012, ThromboGenics' selling expenses rose significantly to €17.1 million (€5.6 million in 2011) as a result of the Company's investment in the organization needed to launch JETREA® which took place in January 2013.
In 2012, ThromboGenics made an operating profit of €29.1 million, as a result of the upfront payment from Alcon. In 2011, the Company's operating loss was €24.8 million.
ThromboGenics had net financial income of €1.3 million in 2012. In 2011, the Company reported net financial income of €3.1 million.
In 2012, ThromboGenics made a pre-tax profit of €30.4 million. This compares with a pre-tax loss of €21.6 million in 2011.
The reported net profit in 2012 was €30.4 million or €0.84 diluted earnings per share. In 2011, the Company made a net loss of €21.6 million, equivalent to diluted loss per share of €0.67.
Financial Position and Cash Flow
As of 31 December 2012, ThromboGenics had €148.2 million in cash and cash investments. This compares with €80.4 million in cash and cash investments as of 31 December 2011.
The increase in cash resources is due to a combination of the private placement that took place in April 2012 and the upfront milestone payment from Alcon. These funds have allowed the Company to invest in the commercial organization needed to successfully launch JETREA® .
At the end of 2012, ThromboGenics had total shareholder equity of €228.0 million, up from €118.0 million at the end of 2011.
For further information please contact:
Wouter Piepers, Global Head of Corporate Communications +32 16 75 13 10 / +32 478 33 56 32 [email protected]
Dr. Patrik De Haes, CEO +32 16 75 13 10 [email protected]
Chris Buyse, CFO +32 16 75 13 10 [email protected]
| Citigate Dewe Rogerson | The Trout Group (US investor relations) |
|---|---|
| David Dible/ Nina Enegren/ Sita Shah Tel: +44 20 7638 9571 [email protected] |
Todd James/ Simon Harnest Tel: +1 646 378 2926 [email protected] |
About JETREA® (ocriplasmin)
JETREA® (ocriplasmin) is a truncated form of human plasmin. In the US, JETREA® is indicated for the treatment of symptomatic VMA. In Europe, the CHMP granted a positive opinion for JETREA® for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter ≤ 400 microns.
JETREA® is a selective proteolytic enzyme that cleaves fibronectin, laminin and collagen, three major components of the vitreoretinal interface that play an important role in vitreomacular adhesion.
JETREA® has been evaluated in two multi-center, randomized, double-masked phase III trials conducted in the US and Europe involving 652 patients with vitreomacular adhesion. Both studies met the primary endpoint of resolution of VMA at day 28.
JETREA® 's phase III program found that 26.5% of patients treated with ocriplasmin saw resolution of VMA, compared with 10.1% of patients receiving placebo (p<0.01).
The phase III program also showed that JETREA® was generally well tolerated. Any adverse reactions were ocular. The most commonly reported were vitreous floaters, eye pain and photopsia, as well as conjunctival haemorrhage resulting from the injection procedure. Most
of the adverse reactions occurred within the first week after the injection. The majority of these reactions were non-serious, mild in intensity and resolved within 2 to 3 weeks. 2
About ThromboGenics
ThromboGenics is an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines. The Company's lead product, JETREA® (ocriplasmin), has been approved by the US FDA for the treatment of symptomatic VMA and was launched in January 2013.
In March 2012, ThromboGenics signed a strategic partnership with Alcon (Novartis) for the commercialization of JETREA® outside the United States. Under this agreement, ThromboGenics could receive up to a total of €375 million in upfront and milestone payments. It will receive significant royalties from Alcon's net sales of JETREA® . ThromboGenics and Alcon intend to share the costs equally of developing JETREA® for a number of new vitreoretinal indications.
The JETREA® European Marketing Authorisation Application is currently under review by the European Medicines Agency. Following the positive CHMP recommendation, a final decision by the European Commission on European approval is expected in the first half of 2013.
ThromboGenics is also further exploring anti-PIGF (Placental Growth Factor), also referred to as TB-403, for the treatment of ophthalmic and oncology indications.
ThromboGenics is headquartered in Leuven, Belgium, and has offices in Iselin, NJ (US) and Dublin, Ireland. The Company is listed on the NYSE Euronext Brussels exchange under the symbol THR. More information is available at www.thrombogenics.com.
Important information about forward-looking statements
Certain statements in this press release may be considered "forward-looking". Such forwardlooking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report.
This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of ThromboGenics in any jurisdiction. No securities of ThromboGenics may be offered or sold within the United States without registration under the US Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable US state securities laws.
2 Stalmans P, Benz MS, Gandorfer A et al. Enzymatic vitreolysis with ocriplasmin for vitreomacular traction and macular holes. N Engl J Med 2012;367:606–615
Consolidated statement of comprehensive income
| In '000 euro (for the year ended on 31 December) |
2012 | 2011 |
|---|---|---|
| Income | 75,105 | 2,476 |
| License income | 75,036 | 2,400 |
| Income from royalties | 47 | 45 |
| Other income | 22 | 31 |
| Cost of sales | -3,145 | -216 |
| Gross profit | 71,960 | 2,260 |
| Research and development expenses | -20,053 | -19,676 |
| General and administrative expenses | -9,685 | -5,881 |
| Selling expenses | -17,102 | -5,555 |
| Other operating income | 3,983 | 4,080 |
| Operating result | 29,103 | -24,772 |
| Finance income | 2,432 | 3,350 |
| Finance expense | -1,086 | -214 |
| Result before income tax | 30,449 | -21,636 |
| Income tax expense | -34 | -1 |
| Net result for the period | 30,415 | -21,637 |
| Attributable to: | ||
| Equity holders of the company | 30,415 | -21,637 |
| Result per Share | ||
| Basic earnings per share (euro) | 0.87 | -0.67 |
| Diluted earnings per share (euro) | 0.84 | -0.67 |
| In '000 euro (for the year ended on 31 December) | 2012 | 2011 |
|---|---|---|
| Result of the period | 30,415 | -21,637 |
| Net change in fair value of available-for-sale financial assets | 19 | 13 |
| Exchange differences on translation of foreign operations | 305 | -653 |
| Other comprehensive income, net of income tax 324 |
-640 | |
| Total comprehensive income for the period | 30,739 | -22,277 |
| Attributable to: | ||
| Equity holders of the company | 30,739 | -22,277 |
Consolidated statement of financial position
| In '000 euro (for the year ended on 31 December) | 2012 | 2011 |
|---|---|---|
| ASSETS | ||
| Property, plant and equipment | 2,699 | 1,492 |
| Intangible assets | 72,338 | 37,021 |
| Goodwill | 2,586 | 2,586 |
| Other financial assets | 1,724 | 133 |
| Employee benefits | 73 | 73 |
| Non-current assets | 79,420 | 41,305 |
| Trade and other receivables | 11,520 | 7,405 |
| Investments | 8,833 | 22,831 |
| Cash and cash equivalents | 139,398 | 57,548 |
| Current assets | 159,751 | 87,784 |
| Total assets | 239,171 | 129,089 |
| EQUITY AND LIABILITIES | ||
| Share capital | 150,938 | 138,351 |
| Share premium | 155,754 | 91,165 |
| Accumulated translation differences | -328 | -633 |
| Other reserves | -15,205 | -17,246 |
| Retained earnings | -63,193 | -93,608 |
| Equity attributable to equity holders of the | 227,966 | 118,029 |
| company | ||
| Minority interests | ||
| Total equity | 227,966 | 118,029 |
| Trade payables | 9,303 | 9,336 |
| Other short-term liabilities | 1,902 | 1,724 |
| Current liabilities | 11,205 | 11,060 |
| Total equity and liabilities | 239,171 | 129,089 |
Consolidated statement of cash flows
| In '000 euro (for the year ended on 31 December) | 2012 | 2011 |
|---|---|---|
| Cash flows from operating activities | ||
| (Loss) profit for the period | 30,415 | -21,637 |
| Finance expense | 1,086 | 214 |
| Finance income | -2,432 | -3,350 |
| Depreciation on property, plant and equipment | 653 | 382 |
| Amortization of intangible assets | 15 | 0 |
| Gain on sale of property, plant and equipment | 0 | 0 |
| Equity settled share-based payment transactions | 2,022 | 1,597 |
| Change in trade and other receivables including tax receivables | -4,115 | -3,083 |
| Change in short-term liabilities | 145 | 6,313 |
| Net cash (used) from operating activities | 27,789 | -19,564 |
| Cash flows from investing activities | ||
| Disposal of property, plant and equipment | 9 | 3 |
| Change in investments | 14,017 | 458 |
| Interest received and similar income | 2,016 | 1,427 |
| Acquisition of intangible assets | -35,332 | -11,189 |
| Acquisition of property, plant and equipment | -1,868 | -983 |
| Acquisition of other financial assets | -1,591 | -58 |
| Net cash (used in) generated by investing activities | -22,749 | -10,342 |
| Cash flows from financing activities | ||
| Proceeds from issue of share capital | 77,176 | 519 |
| Paid interests | -9 | -9 |
| Net cash (used in) generated by financing activities | 77,167 | 510 |
| Net change in cash and cash equivalents | 82,207 | -29,396 |
| Cash and cash equivalents at the start of the period | 57,548 | 85,866 |
| Effect of exchange rate fluctuations | -357 | 1,078 |
| Cash and cash equivalents at the end of the period | 139,398 | 57,548 |
Consolidated statement of changes in equity
| Share capital | Share premium | Cumulative translation differences |
Other reserves |
Retained earnings |
Attributable to equity holders of the company |
Minority interests |
Total | |
|---|---|---|---|---|---|---|---|---|
| Balance sheet as at 1 | ||||||||
| January 2011 Net result 2011 |
138,095 | 90,902 | 20 | -18,856 | -71,971 | 138,190 | 0 | 138,190 |
| Change to foreign currency | -21,637 | -21,637 | -21,637 | |||||
| translation differences | -653 | -653 | -653 | |||||
| Net change in fair value of investments |
13 | 13 | 13 | |||||
| Conversion of warrants by ThromboGenics NV |
256 | 263 | 519 | 519 | ||||
| Share-based payment transactions |
1,597 | 1,597 | 1,597 | |||||
| Balance sheet as at 31 | ||||||||
| December 2011 | 138,351 | 91,165 | -633 | -17,246 | -93,608 | 118,029 | 0 | 118,029 |
| Net result 2012 | 30,415 | 30,415 | 30,415 | |||||
| Change to foreign currency translation differences |
305 | 305 | 305 | |||||
| Net change in fair value of investments |
19 | 19 | 19 | |||||
| Issue of ordinary shares | 11,827 | 63,273 | 75,100 | 75,100 | ||||
| Conversion of warrants by ThromboGenics NV |
760 | 1,316 | 2,076 | 2,076 | ||||
| Share-based payment transactions |
2,022 | 2,022 | 2,022 | |||||
| Balance sheet as at 31 December 2012 |
150,938 | 155,754 | -328 | -15,205 | -63,193 | 227,966 | 0 | 227,966 |