Quarterly Report • Apr 18, 2008
Quarterly Report
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Leiden, The Netherlands, April 18, 2008. Biotech company Pharming Group NV ("Pharming" or "the Company") (Euronext: PHARM) announced today its financial first quarter (Q1) results for the period ended March 31, 2008.
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Products
"In the first quarter of 2008, Pharming encountered a disappointment in the form of a negative opinion regarding its marketing authorization application of Rhucin® for the treatment of acute attacks of Hereditary Angioedema in Europe," said Dr. Bruno Giannetti, COO of Pharming. "However, we remain determined to bring Rhucin® to the market and provide the relevant patient community with a safe and effective product to relive their medical needs. Pharming is fortunate to have a strong financial position which will allow us to take the necessary next steps in our Rhucin® program as well as invest in other portfolio programs. "
Pharming's cash position (including marketable securities, excluding restricted cash) at March 31, 2008 was € 49.2 million in comparison to € 54.9 million at the end of 2007. The equity position of the Company was € 28.2 million compared to € 34.7 million at the end of 2007. Current liabilities were € 13.3 million compared to € 23.5 million at December 31, 2007. This decrease is large caused by the planned payment of € 10.2 million to Paul Capital as part of the final settlement in the restructuring of the original agreement with Paul Capital. Total non-current assets were € 35.4 million, almost identical to December 31, 2007. Total cash used for operating activities in the first quarter amounted to € 5.5 million compared to € 4.8 million in Q1 2007.
The operational costs and expenses in Q1 2008 were € 5.3 million compared to € 4.8 million in Q1 2007. The net loss after tax in Q1 2008 was € 6.4 million compared to a net loss of € 5.0 million in Q1 2007. Costs for Research and Development increased due to due to costs associated with the EMEA re-examination process as well preparations for the first clinical study of Prodarsan®, a DNage-product being developed for the treatment of premature ageing. Revenues decreased to € 0.,1 million compared to March 31, 2007 due to the one-time effect of an FDA grant recognized in 2007.
On March 20, 2008 Pharming received a negative opinion regarding its Marketing Authorization Application for Rhucin® in the European Union. the Committee for Medicinal Products for Human Use (CHMP), after reexamination of its initial opinion, was not reassured that there is sufficient evidence to confirm the clinical benefits of Rhucin® in repeat use. In particular, the CHMP was not reassured about the potential for undesirable immune responses following repeated administration. The re-examination procedure by EMEA included a review by an independent scientific advisory group composed of European recognized experts in the field of HAE. There was consensus among the experts, recognizing that the available clinical data were limited, that there was no evidence to indicate the development of neutralising antibodies to C1-inhibitor with repeat administration of Rhucin®. The Company now intends to re-submit the registration dossier with the inclusion of additional clinical data including those from the recently completed North American clinical study when these results become available in the second quarter of 2008. As part of the re-submission, Pharming will request an expedited review, which is an assessment period of 150 days. In the meantime the Company will pursue registration in markets outside the European Union.
In March 2008 Pharming signed an exclusive licensing and distribution agreement with EİP Eczacıbaşı İlaç Pazarlama A.Ş., (EIP), a leading Turkish pharmaceutical company for the marketing and sales of Rhucin® in Turkey. The agreement covers the use of Rhucin® to treat acute attacks of HAE with a right of first refusal to EIP for other indications. EIP will be responsible for registration of the product in Turkey and has already taken the first steps in this process. Rhucin® may be eligible for an accelerated review procedure given the high medical need for new therapies in the HAE-patient community as a life threatening disease. Data submitted to the EMEA as well as additional data generated after the EMEA-submission will be used in the registration procedure, although the decision on registration in Turkey will be independent of decisions made in the EU or the USA. Under the terms of the agreement, EIP will purchase the product from Pharming and market, sell and distribute it in Turkey. EIP will also pay a license fee to Pharming for the product.
In February, a license agreement with Advanced Cell Technology Inc was concluded to obtain exclusive rights on patents in the field of transgenic technology. Pharming already had non-exclusive rights to this Intellectual Property. The patents were previously owned by Infigen Inc and cover a wide range of technologies including for Pharming relevant elements of nuclear transfer, which is an essential step in generating transgenic cattle. The agreement provides Pharming strict control over the generation of its transgenic cattle, while, at the same time, increasing the barriers of entry for others.
Using an International Innovation Subsidy of € 0.9 million for a period of three years, Pharming's subsidiary DNage has initiated a project with the Eberhard Karls University in Tubingen Germany, and Pyxis Discovery BV, to design new drug development tools aimed at discovery of new therapeutics to treat (premature) ageing diseases. In addition, DNage has announced that it will collaborate with the Leiden University Medical Center to identify unique biomarkers of such diseases that will facilitate the clinical development of new therapies.
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 (MAA under review by EMEA) and human lactoferrin for use in food products (GRAS notification under review by US FDA). The advanced technologies of the Company include innovative platforms for the production of protein therapeutics and 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 its acquisition of 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.
Rein Strijker Pharming Group NV T: +31 (0)71 52 47 400
At March 31, 2008 (amounts in €'000) (unaudited)
| March 31, 2008 |
December 31, 2007 |
|
|---|---|---|
| Goodwill | 9,190 | 9,190 |
| Intangible assets | 19,040 | 18,981 |
| Property, plant and equipment | 6,813 | 7,098 |
| Financial assets | 200 | 200 |
| Restricted cash | 176 | 176 |
| Non-current assets | 35,419 | 35,645 |
| Inventories | 11,640 | 11,720 |
| Other current assets | 2,073 | 1,893 |
| Marketable securities | 3,998 | 3,956 |
| Restricted cash | - | 10,180 |
| Cash and cash equivalents | 45,180 | 50,954 |
| Current assets | 62,891 | 78,703 |
| Total assets | 98,310 | 114,348 |
| Share capital | 45,618 | 45,618 |
| Share premium | 182,243 | 182,243 |
| Other reserves | 22,070 | 22,110 |
| Accumulated deficit | (221,701) | (215,280) |
| Total equity | 28,230 | 34,691 |
| Convertible bonds | 50,500 | 49,768 |
| Earn-out obligations | 2,423 | 2,315 |
| Deferred tax liability | 3,513 | 3,613 |
| Other | 382 | 412 |
| Non-current liabilities | 56,818 | 56,108 |
| Paul Royalty Fund | - | 10,180 |
| Trade and other payables | 6,592 | 7,830 |
| Earn-out obligations | 4,564 | 4,634 |
| Nominal interest convertible bonds | 2,005 | 801 |
| Current portion of other non-current liabilities | 101 | 104 |
| Current liabilities | 13,262 | 23,549 |
| Total equity and liabilities | 98,310 | 114,348 |
For the period ended March 31, 2008 (amounts in €'000, except per share data) (unaudited)
| March 31, 2008 |
March 31, 2007 |
|
|---|---|---|
| Revenues | 87 | 180 |
| Research and development | 4,125 | 3,566 |
| General and administrative | 660 | 561 |
| Depreciation and amortization charges | 333 | 358 |
| Share-based compensation | 169 | 265 |
| Costs | 5,287 | 4,750 |
| Loss from operating activities | (5,200) | (4,570) |
| Effective interest convertible bonds | (1,935) | - |
| Interest on liability Paul Royalty Fund | - | (656) |
| Interest on earn-out obligations | (38) | (270) |
| Other interest income, net | 634 | 303 |
| Finance revenue and costs | (1,339) | (623) |
| Foreign currency effect on liability Paul Royalty Fund | - | 121 |
| Other foreign currency results | 18 | (16) |
| Other income and expenses | 18 | 105 |
| Loss before tax | (6,521) | (5,088) |
| Income tax benefit | 100 | 39 |
| Net loss after tax | (6,421) | (5,049) |
| Attributable to Equity holders of the parent | (6,421) | (5,049) |
| Share information: | ||
| Basic and diluted net loss per share (€) | (0.07) | (0.06) |
| Weighted average shares outstanding | 91,235,178 | 90,311,468 |
Number of shares outstanding at March 31, 2008 was 91,235,178
For the period ended March 31, 2008 (amounts in €'000) (unaudited)
| March 31, 2008 |
March 31, 2007 |
|
|---|---|---|
| Payments of third party fees and expenses, including Value Added Tax | (4,383) | (4,987) |
| Net compensation paid to board members and employees | (1,023) | (693) |
| Payments of pension premiums, payroll taxes and social securities, net of grants settled | (1,052) | (537) |
| Other payments | (202) | - |
| Receipt of Value Added Tax | 293 | 632 |
| Interest received from cash and marketable securities | 675 | 414 |
| Receipt of grants | 79 | 187 |
| Other receipts | 133 | 184 |
| Net cash flows used in operating activities | (5,480) | (4,800) |
| Purchase of property, plant and equipment | (89) | (352) |
| Purchase of intangible assets | (175) | - |
| Net cash flows used in investing activities | (264) | (352) |
| Net proceeds of increase of share capital | - | 905 |
| Repayment to Paul Royalty Fund | (10,075) | - |
| Repayment of other financial liabilities | (23) | (10) |
| Net cash flows from/(used in) financing activities | (10,098) | 895 |
| Net decrease cash and cash equivalents | (15,842) | (4,257) |
| Cash and cash equivalents at January 1 (including restricted cash) | 61,310 | 26,258 |
| Exchange rate effect | (112) | (3) |
| Net decrease cash and cash equivalents | (15,842) | (4,257) |
| Cash and cash equivalents at March 31 (including restricted cash) | 45,356 | 21,998 |
| Liquidity information | ||
| Cash and cash equivalents at March 31 (including restricted cash) | 45,356 | 21,998 |
| Marketable securities at March 31 | 3,998 | 4,337 |
| Total liquidities at March 31 | 49,354 | 26,335 |
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