Pharming Reports Financial Results First Quarter 2012
Leiden, The Netherlands, April 26, 2012. Biotech company Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) today published its financial report for the first quarter ended March 31, 2012.
FINANCIAL HIGHLIGHTS
Revenues and other income increased to €1.0 million (Q1 2011: €0.7 million)
Operating costs from continuing operations increased to €5.2 million (Q1 2011: €4.9 million). Total net loss from continuing operations increased to €6.5 million (Q1 2011: €4.2 million), mainly as a result of the costs associated with the December 2011 €8.4 million convertible bond
Cash outflows from operations decreased to €3.5 million (Q1 2011: €4.5 million)
Cash increased to €8.8 million (2011 year end: €5.1 million) The negati ve equity position of €1.2 million at year end 2011 increased by €2.4 million to €3.6 million
OPERATIONAL HIGHLIGHTS
The ongoing pivotal clinical trial Study 1310 remains on track and is expected to readout by the third quarter of 2012
New agreements signed for the commercialization of Ruconest® with Transmedic Pte Ltd. (for the territories of Brunei, Indonesia, Malaysia, Philippines, Singapore, and Thailand) and Hyupjin Corporation for the Republic of Korea
Commenced an open-label Phase II clinical study evaluating Ruconest® for the treatment of acute attacks of angioedema in pediatric patients with HAE
Positive study results published in peer-reviewed journal Biodrugs demonstrated that recombinant human C1 inhibitor was not observed to have a prothombotic effect when used to treat acute HAE attacks
Sijmen de Vries, CEO, commented: "The first three months of 2012 has seen us de livering on extending the geographical coverage for Pharming’s C1 inhibitor franchise, and this remains a key goal. We are also pleased to report that recruitment into our ongoing pivotal clinical trial Study 1310 remains on track and we look forward to updating on further progress."
FINANCIAL RESULTS
In the three months to March 31, 2012 the Company generated revenue and other income from continuing operations of €1.0 million (Q1 2011: €0.7 million). This increase comes, in part, from Ruconest® sales of €0.4 million (up from €0.15 million in Q1 2011) and increased income from grants of €0.1 million. Costs associated with the revenues and other income amounted to €0.4 million (Q1 2011: €0.1 million).
Total operating costs from continuing operations increased by €0.3 million from €4.9 million in the first quarter of 2011 to €5.2 million in the same quarter of 2012. Th e increase reflects the Company’s activities in relation to Study 1310 required for US regulatory approval for Rhucin®. Successful completion of this study, which is anticipated to readout by the third quarter of 2012, will trigger a US$10.0 million milestone payment by Santarus. In addition, the Company anticipates submitting a BLA filing approximately three months thereafter with another US$5.0 million due from Santarus as and when the U.S. Food and Drug Administration accepts the BLA filing for review.
Early in 2012 the Company finalized a transaction announced in December 2011 under which it issued €8.4 million convertible bonds plus 38,717,484 warrants. The bonds have to be repaid in six monthly instalments and can be settled in cash and/or in shares. To date four of the six payments have been made. If the Company elects to pay in shares the instalment amount plus interest is converted to a number of shares based on the share price (average of volume weighted average price over the period and to which a discount is applied). With regards to these pay- backs in shares, the Company issued a total of 67,437,000 shares until the end of the first quarter of 2012. These items largely accounted for a net loss in financial income and expense of €1.9 million as compared to a €0.1 million net profit on financial income and expenses in the comparative quarter of 2011.
As a result of the above items, net loss from continuing operations increased by €2.3 million to €6.5 million in Q1 2012 (Q1 2011: €4.2 million). Due to a one-time €0.6 million profit on discontinued operations in the first quarter of 2011, which followed liquidation and deconsolidation of the DNage business early in 2011, total net loss increased from €3.6 million to €6.5 million. The net loss per share for the first quarter of both 2011 and 2012 amounted to €0.01.
FINANCIAL POSITION
Total cash and cash equivalents (including restricted cash) increased by €3.7 million from €5.1 million at year end 2011 to €8.8 million at the end of the first quarter 2012.
As explained in the financial results section, the Company anticipates receiving US$10.0 million from Santarus upon the successful completion of Ruconest®’s Study 1310 in Q3 2012 and another US$5.0 million as and when the U.S. Food and Drug Administration accepts the BLA filing for review. Receipts of these milestones are expected to significantly improve the Company’s cash and equity position.
NEGATIVE EQUITY
In December 2011 the Company announced that it had entered negative equity. This negative equity position of €1.2 million at year end 2011, as expected, increased by €2.4 million to €3.6 million and reflects the €6.5 million net loss for the first quarter, net of €4.1 millio n posted for shares issued as a repayment of convertible bonds (€3.8 million) and other share-based payments (€0.3 million).
The negative equity position has in itself no immediate impact on the execution of Pharming’s business plan, nor does it imply that the Company is legally required to issue new share capital. However, the Company is considering various options in order to reduce the negative equity and return to a positive equity position.
Pharming is continuously reviewing its financial and liquidity position and has various options to improve its equity standing under International Financial Reporting Standards (IFRS). Notably, the Company reports that the negative equity position was mainly caused by the inability to recognize the €19.7 million upfront payments and milestones received from Sobi and Santarus as equity (at March 31, 2012 the deferred license fees income amounted to €16.9 million; if release to the stat ement of income would have been permitted under IFRS, the Company would have reported a positive equity position of €13.3 million). Anticipated receipt of the two development milestones associated with the successful readout of Study 1310 (US$10.0 million) and acceptance of the BLA filing by the FDA (US$5.0 million) will, under IFRS, be recognized immediately and thus augment the equity position.
As a result of the negative equity position announced in December 2011, the Company committed to comply with Euronext Amsterdam Notice 2011-001 paragraph 3 requirements, which include the publication of quarterly financial statements within two months after the end of the quarter in compliance with International Accounting Standard 34 (Interim Financial Reporting). Therefore, the condensed consolidated interim financial statements for the quarter ended March 31, 2012 can be found on Pharming’s website as of today.
RHUCIN Phase III Study
Pharming is conducting a Phase III clinical study with RHUCIN under a Special Protocol Assessment (SPA) that is intended to support the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). RHUCIN is being evaluated for the treatment of acute attacks of angioedema in patients with HAE in an international, multicenter, randomized, placebo-controlled Phase III study at a dosage strength of 50 U/kg with a primary endpoint of time to beginning of relief of symptoms. Santarus has licensed certain exclusive rights from Pharming to commercialize RHUCIN in North America for the treatment of acute attacks of HAE and other future indications. Under the terms of the license agreement, a $10 million milestone is payable to Pharming upon successful achievement of the primary endpoint of the Phase III clinical study. The study is expected to be completed by the third quarter of 2012.
About RUCONEST® (RHUCIN&re g; in non-European territories) and Hereditary Angioedema
RUCONEST® (INN conestat alfa) is a recombinant version of the human protein C1 inhibitor (C1INH). RUCONEST is produced through Pharming’s proprietary technology in milk of transgenic rabbits and in Europe is approved under the name RUCONEST for treatment of acute angioedema attacks in patients with HAE. RHUCIN® is an investigational drug in the U.S. and has been granted orphan drug designation 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 A ssociation, epidemiological estimates for HAE range from one in 10,000 to one in 50,000 individuals
