Earnings Release • Mar 3, 2011
Earnings Release
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Leiden, The Netherlands, March 3, 2011. Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today published its preliminary (unaudited) financial results for the year ended December 31, 2010.
Sijmen de Vries, CEO, commented "This has been a breakthrough year for Pharming. We are now at the beginning of a transformational period in the evolution of the company as we move from a development led organisation towards a commercially focussed one. Throughout 2010 we consistently delivered upon our stated targets. We have gained our first major product approval, for Ruconest in Europe, appointed strong commercialization partners in key markets and substantially improved our capital structure and bolstered our balance sheet. We look forward to advancing the European roll out of Ruconest and, despite the recent setback with the FDA, to continuing progress with bringing Rhucin to the US market as expeditiously as possible with our partner Santarus. I remain very excited about Pharming's prospects in 2011 and beyond."
2010 revenues of €0.6 million include the portion of upfront and milestone payments received from new partnerships with Santarus and SOBI as well as first product sales following market launch of Ruconest. In Q2 2010, the Company entered into a distribution agreement with SOBI under which a €3.0 million upfront payment was received. The Company received a further €5.0 million Market Approval milestone payment in Q4 2010 on receipt of the marketing authorisation approval for Ruconest in Europe. These cash receipts are not recognised as revenues immediately but deferred and released to the statement of revenue over the 10 year lifetime of the agreement.
Pharming also received an upfront payment of US\$15.0 million (€11.7 million) from Santarus with respect to a license agreement for recombinant human C1 inhibitor in the US, Canada and Mexico. A similar accounting treatment applies to this upfront payment as of the start of the agreement.
Operational costs decreased in 2010 compared to 2009 with 2010 R&D costs reduced significantly by 22% to €19.1 million (2009: € 24.5 million); the decrease stems mainly from various costs savings as 2009 costs included significant DNage costs (€4.4 million) and costs associated with the EMA filing for Ruconest. Our general and administrative costs were €3.3 million, slightly below last year (2009: €3.6 million).
The most significant item in the consolidated statement of income for 2010 is the high level of impairment charges. These relate overwhelmingly to the impairment of goodwill and intangible assets of DNage. In the second half of 2010, the Company financed the operations of DNage through the (maximum) bridge funding facility of €1.2 million.
In January 2011, a significant majority of DNage shareholders voted to put DNage into voluntary liquidation and accordingly the remaining carry value of the goodwill (€1.8 million) as well as the intangible assets representing the minimum future discounted cash flows from DNage product lines (€16.8 million) were fully impaired. These Q4 2010 charges were partially offset with a similar release of a deferred tax liability, which
has been linked to the value of the intangible assets, in the amount of €4.3 million. Additional impairment charges of €2.1 million in Q4 2010 relate to inventories.
The financial income and expenses in 2009 and 2010 are mainly non-cash and are primarily driven by transactions with bondholders and Yorkville Associates, anti-dilution share rights triggered by timing of securities issues as well as the interest on earn-out obligations in relation to DNage.
In December 2010, Pharming entered into an equity agreement with Socius Capital to raise €16.1 million. As part of the agreement Pharming issued debt notes with a nominal value of €12,000,000 carrying nominal interest of 10% per annum over a four year period. Socius exercised its right to subscribe for shares up to €16,080,000. Payment of these shares by Socius is part settled in cash (€3,033,962 for the nominal value, received early 2011) and partly through issuance of debt notes Socius to Pharming which carry 0.65% interest per annum over a four year period.
After four years, the nominal values of the debt notes issued by Pharming and Socius (including accrued nominal interest) are equal; and the mutual debts are off-settable.
The structure of the agreement is, in substance, an all equity agreement (including the warrants as the number and exercise price are both fixed) so that the overall accounting treatment in 2010 is as follows:
Overall, the net increase of equity amounts to €13,733,000. No (financial) assets or liabilities nor effective interest income or expenses are recognised throughout the lifetime of the mutual notes.
2010 marked the beginning of a transformational period in Pharming's evolution as the company accomplished the most significant steps yet in its transition from a late-stage development company to an emerging pharmaceutical business. This commercial phase is led by our lead product Ruconest™/Rhucin® (recombinant human C1 inhibitor).
We believe that the prevalence of HAE is approximately 1/30,000 which implies a target population of 11,000- 12,000 potential patients. Our commercialisation partner SOBI estimates the market to be worth approximately €100 million and this is expected to grow as both physician and patient awareness increase, driving additional needs for effective therapies against acute attacks. In Q4 Ruconest was launched and in December the first sales were made in Norway and Denmark. The European region requires a step wise approach to launching a drug as each country has its own reimbursement guidelines. We anticipate that the European roll out will be completed by Q4 2011.
In February 2011, a "refusal to file" letter for the Rhucin BLA was received from the FDA. The FDA required that the results of the ongoing Phase IIIb study, which has been initiated based on previous discussions with the FDA, to be included in a future BLA filing. The FDA also indicated that they would provide additional feedback on the ongoing study. Santarus and Pharming intend to jointly meet with the FDA to discuss the issues raised.
We also aim to complete additional partnering deals on our lead asset (Ruconest/Rhucin) outside of Europe and the US to increase its geographic and regional coverage.
We aim to evaluate the utility of our recombinant C1 inhibitor asset in other indications such as reperfusion injury. With the EMA approval, preparations for development of Rhucin in other larger indications have started to gain momentum. As a result, the first Phase II study for development of a C1 inhibitor product for applications in the field of transplant indications, such as the treatment of antibody-mediated rejection in kidney transplantation, was initiated at the end of 2010.
As of March 21, 2011, Pharming's shares will be included in the Amsterdam Midcap Index (AMX-index).
Today, Chief Executive Officer Sijmen de Vries and Chief Financial Officer, Karl Keegan will present the preliminary full year 2010 results in a conference call for analysts at 9:30 am CET. To participate, please call one of the following numbers 10 minutes prior to the call:
| Participant Telephone Numbers: | +31 (0)20 713 3420 | Netherlands Toll |
|---|---|---|
| +44 (0)20 7138 0823 | UK Toll |
Following a brief presentation of the results, the lines will be opened for a question and answer session.
RHUCIN (INN conestat alfa) is a recombinant version of the human protein C1 inhibitor (C1INH). RHUCIN is produced through Pharming's proprietary technology in the milk of transgenic rabbits and in Europe is approved under the name RUCONEST for treatment of acute angioedema attacks in patients with HAE. The FDA has granted Orphan Drug Status to RHUCIN for the treatment of acute attacks of HAE, a genetic disorder in which the patient is deficient in or lacks a functional plasma protein C1 inhibitor, resulting in unpredictable and debilitating episodes of intense swelling of the extremities, face, trunk, genitals, abdomen and upper airway. The frequency and severity of HAE attacks vary and are most serious when they involve laryngeal edema, which can close the upper airway and cause death by asphyxiation. According to the U.S. Hereditary Angioedema Association, epidemiological estimates for HAE range from one in 10,000 to one in 50,000 individuals. Additional information is available on the international patient association's website, www.haei.org.
Pharming Group NV is developing innovative products for the treatment of unmet medical needs. Ruconest™ (Rhucin® in non-European territories) is a recombinant human C1 inhibitor approved for the treatment of angioedema attacks in patients with HAE in all 27 EU countries plus Norway, Iceland and Liechtenstein. The product is also under development for follow-on indications, i.e. antibody-mediated rejection (AMR) and delayed graft function (DGF) following kidney transplantation. The advanced technologies of the Company include innovative platforms for the production of protein therapeutics, technology and processes for the purification and formulation of these products. Additional information is available on the Pharming website, www.pharming.com.
Karl Keegan, CFO, Pharming Group NV, T: +31 (0)71 52 47 181 or +31 (0)6 3168 0465
At December 31, 2010
(amounts in €'000) (unaudited)
| December 31, 2010 |
December 31, 2009 |
|
|---|---|---|
| Goodwill | - | 4,312 |
| Intangible assets | 1,163 | 17,585 |
| Property, plant and equipment | 6,702 | 5,240 |
| Restricted cash | 176 | 176 |
| Non-current assets | 8,041 | 27,313 |
| Inventories | 9,013 | 11,255 |
| Other current assets | 9,932 | 1,392 |
| Cash and cash equivalents | 10,302 | 15,923 |
| Current assets | 29,247 | 28,570 |
| Total assets | 37,288 | 55,883 |
| Share capital | 17,450 | 77,251 |
| Share premium | 219,220 | 187,708 |
| Other reserves | (225,806) | (251,646) |
| Shareholders' equity | 10,864 | 13,313 |
| Non-controlling interest | (764) | - |
| Equity | 10,100 | 13,313 |
| Deferred license fees income | 17,342 | - |
| Deferred tax liability | - | 4,276 |
| Earn-out obligations | - | 1,788 |
| Other | 162 | 236 |
| Non-current liabilities | 17,504 | 6,300 |
| Bank overdrafts | - | 13,761 |
| Convertible bonds | - | 9,461 |
| Earn-out obligations | - | 4,208 |
| Derivative financial liability | 573 | - |
| Trade and other payables | 7,175 | 8,840 |
| Deferred license fees income | 1,936 | - |
| Current liabilities | 9,684 | 36,270 |
| Total equity and liabilities |
37,288 | 55,883 |
For the year ended December 31, 2010
(amounts in €'000, except per share data) (unaudited)
| 2010 | 2009 | |
|---|---|---|
| License fees |
465 | 335 |
| Product sales | 108 | - |
| Revenues | 573 | 335 |
| Grants | 1,191 | 761 |
| Other income | 1,191 | 761 |
| Costs of product sales | 91 | - |
| Research and development | 19,082 | 24,525 |
| General and administrative | 3,313 | 3,570 |
| Impairment charges | 22,773 | 202 |
| Share-based compensation | 636 | 647 |
| Costs | 45,895 | 28,944 |
| Loss from operating activities | (44,131) | (27,848) |
| Financial income | - | 4,408 |
| Financial expenses | (16,512) | (8,284) |
| Financial income and expenses | (16,512) | (3,876) |
| Income taxes | 4,276 | (336) |
| Net loss | (56,367) | (32,060) |
| Attributable to: | ||
| Equity owners of the parent |
(50,215) | (32,060) |
| Minority interest | (6,152) | - |
| Share information: | ||
| Basic and diluted net loss per share (€) | (0.19) | (0.28) |
| Weighted average shares outstanding | 266,313,183 | 116,177,686 |
For the year ended December 31, 2010
(amounts in €'000) (unaudited)
| 2010 | 2009 | |
|---|---|---|
| Payments of third party fees and expenses, including Value Added Tax | (18,583) | (20,052) |
| Net compensation paid to board members and employees | (3,817) | (3,885) |
| Payments of pension premiums, payroll taxes and social securities, net of grants settled |
(3,002) | (3,043) |
| Interest paid | (100) | - |
| Other payments | (389) | (885) |
| Receipts from license partners | 20,355 | 100 |
| Receipt of Value Added Tax | 1,519 | 2,098 |
| Interest received | 78 | 584 |
| Receipt of grants | 367 | 302 |
| Other receipts | 414 | 497 |
| Net cash flows used in operating activities | (3,158) | (24,284) |
| Purchase of property, plant and equipment | (909) | (304) |
| Divestment of available-for-sale financial asssets | - | 4,506 |
| Net cash flows from/(used in) investing activities |
(909) | 4,202 |
| Net proceeds of equity issued | 18,240 | 9,230 |
| Proceeds convertible bonds issued | 7,500 | - |
| Payments of transaction fees and expenses | (1,146) | - |
| Payments of convertible bonds at nominal value | (10,900) | (4,745) |
| Interest payments convertible bonds | (750) | (1,928) |
| Payments of other financial liabilities | (49) | (85) |
| Net cash flows from financing activities | 12,895 | 2,472 |
| Net increase/(decrease) cash and cash equivalents | 8,828 | (17,610) |
| Net cash and cash equivalents at January 1 | 2,338 | 19,786 |
| Exchange rate effect | (688) | 162 |
| Net increase/(decrease) cash and cash equivalents | 8,828 | (17,610) |
| Net cash and cash equivalents at December 31 | 10,478 | 2,338 |
| Liquidity information | ||
| Restricted cash | 176 | 176 |
| Cash and cash equivalents | 10,302 | 15,923 |
| Bank overdrafts | - | (13,761) |
| Net cash and cash equivalents at December 31 | 10,478 | 2,338 |
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