Earnings Release • Feb 15, 2008
Earnings Release
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Leiden, The Netherlands, February 15, 2008. Biotech company Pharming Group NV ("Pharming" or "the Company") (Euronext: PHARM) announced today its financial results (unaudited) for the year ending 31 December, 2007. The Company has strengthened its cash position and has made significant progress in the development of Rhucin® (recombinant human C1 inhibitor or rhC1INH for treatment of acute attacks of Hereditary Angioedema or HAE).
Financial
"In 2007, the Company made good progress on the development of several products and developed new research initiatives," said Dr. Francis J. Pinto, CEO of Pharming. "Based on these developments, we were able to significantly strengthen our cash position despite difficult market conditions. Although the initial negative opinion of the CHMP causes a delay in getting Rhucin® to HAE-patients in Europe, it does not change our plans or strategy. We remain focused on bringing this product to the market as soon as possible based on strong scientific and medical data. The Company is well financed and we will continue to further build on our product portfolio and our technology platforms. Pharming is now close to getting its first products approved which should generate an enormous boost for the validation of our technology platform and should open the door for one or more licensing agreements."
Pharming's cash position including marketable securities and restricted cash was € 65.3 million at December 31, 2007 in comparison to € 31.3 million at the end of 2006. In 2007, the Company raised € 70 million through the issuance of convertible bonds to institutional investors, which was managed by UBS Investment Bank. Approximately € 19.3 million (of which € 10.2 million in Q1 2008) of these proceeds were used to restructure the existing agreement with Paul Royalty Fund while approximately € 3.0 million were used for transaction fees. As per the relevant IFRS rules, the convertible bonds have a liability component as well as an equity component. Applying these regulations yields an equity component of € 18.5 million and a liability component of € 51.5 million. These have been charged to the balance sheet accordingly. The equity position of the Company as of the end of 2007 was € 34.7 million compared to € 49.8 million at the end of 2006. Current liabilities were € 23.5 million compared to € 9.2 million at December 31, 2006. These changes are largely associated with the convertible bonds issued to institutional investors and the restructuring of the financing agreement with Paul Royalty Fund.
The total costs and expenses in 2007 (including € 3.4 million non-cash costs) were € 25.3 million compared to € 18.2 million in 2006 (including € 2.2 million non-cash costs). The net loss in 2007 was € 35.6 million compared to a net loss of € 18.5 million in 2006. This difference is largely caused by one-time-events, in particular the settlement with Paul Royalty Fund, and costs directly associated with the regulatory filings of Rhucin®. In addition, the effect of share-based compensation was significantly higher than in 2006. Finally, costs were higher in line with increased costs in general, a modest increase in headcount and the first full year consolidation of DNage. In line with earlier guidance, the net cash used for operating activities in 2007 was slightly higher than in 2006 (€ 21.9 million in 2007 compared to € 19.6 million in 2006). Inventories further increased to € 11.7 million from € 9.2 million at December 31, 2006, which is needed in preparation for the first commercial launch of Rhucin® later in 2008 as well as for use in the new clinical programs with Rhucin® in the field of organ transplantation.
In the European placebo-controlled randomized clinical study on Rhucin® for treatment of acute attacks of HAE both the primary endpoint, time to beginning of symptom relief, and the secondary endpoint, time to minimal symptoms, were achieved with statistical significance. Based on these positive results the trial was discontinued for methodological and ethical reasons. In addition, Pharming received confirmation from the EMEA that its production facilities and processes conform with Good Manufacturing Practice and are thus licensed for manufacturing of pharmaceutical products. However, the Committee for Medicinal Products for Human Use decided to not grant a European marketing authorisation for Rhucin®. With this initial refusal, the registration process in the European Union has been delayed. However, Pharming remains confident that the available scientific and clinical data form the basis for a positive risk benefit ratio for Rhucin®. Therefore, the Company has requested re-examination of the negative opinion and has submitted detailed grounds for its reexamination request in February 2008. A final decision on the Market Authorization of Rhucin® within the EU is expected in the first half of 2008.
The North American double-blind randomized placebo-controlled clinical trial was completed in the fourth quarter of 2007 and the data are currently being analyzed. The US open-label study is still ongoing.
Meanwhile, Pharming has made good progress on the development of several other products. The Company expects to start several new clinical programs in 2008, including clinical studies with rhC1INH in the field of organ transplantation, a clinical program with Prodarsan® for treatment of premature ageing diseases and a development program for recombinant human fibrinogen as a replacement therapy for genetic and acquired deficiencies of fibrinogen.
In interactions with the FDA throughout 2007, no questions appeared to be outstanding with regard to the use of human lactoferrin in nutritional products. The GRAS-notification has been reviewed by an independent scientific expert panel who agreed that hLF is safe for its intended uses. Although Pharming had expected to receive a decision from the FDA in 2007, it is still hopeful that the agency will accept Pharming's notification in the near future.
During 2007, Pharming initiated and continued several research programs, exemplifying the Company's strategy to expand its research engine and to strengthen its product pipeline. In the second half of 2007, the Company announced its participation in a Biomedical Materials Program, a public-private partnership in the Netherlands that focuses on research and development in the field of biomedical materials. Throughout the year Pharming received commitments for several grants to support its activities in research related to socalled ageing diseases. With support from Top Institute Pharma, Pharming's wholly owned subsidiary DNage BV also started a collaboration with Solvay and academic groups on Parkinson's and Alzheimer's diseases.
Through the issuance of convertible bonds to institutional investors, the Company solidified its cash position by raising € 70 million. The proceeds of the convertible offering have partly been used to restructure the agreement with Paul Capital Healthcare. The remainder will be used for general corporate purposes including investments in research and development and in clinical programs.
Today, Chief Commercial Officer Rein Strijker will present the 2007 results and the outlook for 2008 in a conference call for analysts (in English) and press (in Dutch) at 9:00 am and 10:30 am CET respectively. An audiocast of the conference calls will be available on Pharming's website after the calls.
Pharming Group NV is developing innovative products for the treatment of genetic disorders, ageing diseases, specialty products for surgical indications, intermediates for various applications and nutritional products. Pharming has two products in late stage development - Rhucin® (recombinant human C1 inhibitor) for Hereditary Angioedema and human lactoferrin for use in food products. 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, as well as technologies in the field of tissue repair (via its collaboration with Novathera) and DNA repair (via DNage). Additional information is available on the Pharming website, http://www.pharming.com and on http://www.dnage.nl.
This press release contains forward looking statements that involve known and unknown risks, uncertainties and other factors, which may cause the actual results, performance or achievements of the Company to be materially different from the results, performance or achievements expressed or implied by these forward looking statements. The press release also appears in Dutch. In the event of any inconsistency, the English version will prevail over the Dutch version.
Carina Hamaker, Investor Voice T: +31 (0)6 537 499 59 or T: +31 (0)71 52 47 400 Julia Philips (UK), Financial Dynamics, T: +44 (0)20 7269 7187 or T: +44 (0)7770 827 263 Samir Singh (US), Pharming Healthcare Inc, T: +1 908 720 6224 Rein Strijker, Pharming Group NV, T: +31 (0)71 52 47 400
At December 31, 2007 (amounts in €'000) (unaudited)
| December 31, | December 31, | ||
|---|---|---|---|
| 2007 | 2006 | ||
| Goodwill | 9,190 | 9,190 | |
| Intangible assets | 18,981 | 19,783 | |
| Property, plant and equipment | 7,098 | 7,325 | |
| Financial assets | 200 | 200 | |
| Restricted cash | 176 | 176 | |
| Non-current assets | 35,645 | 36,674 | |
| Inventories | 11,720 | 9,169 | |
| Other current assets | 1,893 | 2,159 | |
| Marketable securities | 3,956 | 4,995 | |
| Restricted cash | 10,180 | - | |
| Cash and cash equivalents | 50,954 | 26,082 | |
| Current assets | 78,703 | 42,405 | |
| Total assets | 114,348 | 79,079 | |
| Share capital | 45,618 | 44,377 | |
| Share premium | 182,243 | 175,339 | |
| Other reserves | 22,110 | 9,795 | |
| Accumulated deficit | (215,280) | (179,668) | |
| Total equity | 34,691 | 49,843 | |
| Convertible bonds | 49,768 | - | |
| Paul Royalty Fund | - | 10,108 | |
| Earn-out obligations | 2,315 | 5,791 | |
| Deferred tax liability | 3,613 | 3,889 | |
| Other | 412 | 255 | |
| Non-current liabilities | 56,108 | 20,043 | |
| Trade and other payables | 7,830 | 7,614 | |
| Earn-out obligations | 4,634 | - | |
| Paul Royalty Fund | 10,180 | 1,518 | |
| Nominal interest convertible bonds | 802 | - | |
| Current portion of other non-current liabilities | 103 | 61 | |
| Current liabilities | 23,549 | 9,193 | |
| Total equity and liabilities | 114,348 | 79,079 |
For the year ended December 31, 2007 (amounts in €'000, except per share data) (unaudited)
| 2007 | 2006 | |
|---|---|---|
| Revenues | 690 | 147 |
| Research and development | 14,821 | 8,410 |
| Operations | 4,267 | 4,762 |
| Selling, general and administrative | 2,824 | 2,808 |
| Depreciation and amortization charges | 1,408 | 1,208 |
| Impairment charges | 302 | 357 |
| Share-based compensation | 1,689 | 635 |
| Costs and expenses | 25,311 | 18,180 |
| Loss from operating activities | (24,621) | (18,033) |
| Effective interest convertible bonds | (1,250) | - |
| Interest on liability to Paul Royalty Fund | (2,151) | (2,205) |
| Interest on earn-out obligations | (1,158) | (216) |
| Other interest income, net | 1,328 | 1,295 |
| Finance revenues and costs | (3,231) | (1,126) |
| Settlement Paul Royalty Fund | (9,125) | - |
| Foreign currency effect on liability to Paul Royalty Fund | 1,069 | 976 |
| Other foreign currency results | 20 | (364) |
| Other results | (8,036) | 612 |
| Loss before tax | (35,888) | (18,547) |
| Income tax benefit | 276 | 51 |
| Net loss after tax | (35,612) | (18,496) |
| Share information | ||
| Basic and diluted net loss per share (€) | (0.39) | (0.21) |
| Weighted average shares outstanding | 90,912,531 | 86,155,453 |
| Number of shares outstanding at year-end | 91,235,178 | 88,753,511 |
For the year ended December 31, 2007 (amounts in €'000) (unaudited)
| 2007 | 2006 | |
|---|---|---|
| Net loss after tax | (35,612) | (18,496) |
| Adjustments to reconcile net loss after tax to cash flows used in operating activities: | ||
| Change in operating assets and liabilities | ||
| Increase inventories | (2,551) | (5,314) |
| Decrease/(increase) other current assets, net of accrued interest | 304 | (865) |
| Increase trade and other payables | 469 | 1,538 |
| Accrued interest | (1,339) | (1,303) |
| Received interest | 1,301 | 1,181 |
| Non-cash items | ||
| Depreciation and amortization charges | 1,408 | 1,208 |
| Impairment charges | 302 | 357 |
| Share-based compensation | 1,689 | 635 |
| Settlement Paul Royalty Fund | 9,125 | - |
| Interest on liability to Paul Royalty Fund | 2,151 | 2,205 |
| Foreign currency effect on liability to Paul Royalty Fund | (1,069) | (976) |
| Effective interest convertible bonds | 1,250 | - |
| Interest on earn-out obligations | 1,158 | 216 |
| Income tax benefit | (276) | (51) |
| Other | (227) | 45 |
| Net cash flows used in operating activities | (21,917) | (19,620) |
| Purchase of property, plant and equipment | (671) | (3,151) |
| Acquisition of subsidiary, net of cash acquired | - | (46) |
| Net cash flows used in investing activities | (671) | (3,197) |
| Net proceeds of increase of share capital | 1,157 | 22,746 |
| Proceeds convertible bonds, net of transaction fees paid | 67,012 | - |
| Upfront payment Paul Royalty Fund, net of transaction fees paid | - | 11,686 |
| Repayments to Paul Royalty Fund | (10,469) | - |
| Repayments of other financial liabilities | (60) | (46) |
| Net cash flows from financing activities | 57,640 | 34,386 |
| Net increase cash and cash equivalents | 35,052 | 11,569 |
| Cash and cash equivalents at January 1 (including restricted cash) | 26,258 | 14,689 |
| Net increase cash and cash equivalents | 35,052 | 11,569 |
| Cash and cash equivalents at December 31 (including restricted cash) | 61,310 | 26,258 |
| Liquidity information | ||
| Cash and cash equivalents at December 31 (including restricted cash) | 61,310 | 26,258 |
| Marketable securities at December 31 | 3,956 | 4,995 |
| Total liquidities at December 31 | 65,266 | 31,253 |
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