Flamel Technologies announced on 14th March 2012 its financial results for the fourth quarter and year ended 31st December 2011.
Flamel's fourth quarter 2011 and recent highlights
Flamel's fourth quarter 2011 and recent highlights include:
- inclusion in the Orange Book of Flamel's US Pat. No. 8,101,209 related to their Micropump technology;
- a €1.3 MM payment resulting from a multi-year supply agreement signed with GSK for the production of Coreg CR® microparticles;
- completion of the Phase I Clinical study of long acting beta interferon 1 a by Merck Serono, which results they are analyzing and discussing with their partners;
- interferon alpha results are largely complete and Flamel has applied to present them at a major scientific congress. Licensing discussions are currently ongoing with multiple parties;
- partnership with Pfizer discontinued;
- signed two new feasibility agreements:
- one for LiquiTime and
- one for Trigger Lock.
Statements of Mr Willard, Flamel's chief executive officer
Mr Willard stated, "The issuance of our new Micropump patent and its inclusion in the FDA Orange Book is, I believe, a very significant event, in that it is a major expansion of our Micropump technology intellectual property. The new patent covers the delivery of microparticles with varying release profiles, such that we can better match or improve the delivery of oral molecules. Because it is used in Coreg CR, the grant of this patent may strengthen the ability to defend Coreg CR in the future. It also will be helpful in our efforts to expand significantly into partnerships or other transactions for our Micropump platform, including our patented long-acting stable liquid formulations (i.e., LiquiTime)."
Mr Willard continued, "We are approaching completion of our Phase 2 clinical trial on Interferon alpha. We have a number of other partnered projects in various clinical trials and we continue working to execute on the initiatives we have discussed on our recent public conference calls."
Flamel's fourth quarter 2011 results
Revenues
Flamel reported total revenues for the fourth quarter 2011 of $8.6 million versus total revenues of $13.5 million in the year-ago period; total revenues in the fourth quarter of 2010 included
- a milestone payment of €3 million from Merck Serono that resulted from the commencement of a Phase 1 clinical trial on an improved formulation of beta-interferon 1-a, as well as
- a separate €1 million milestone that was triggered by certain technical achievements.
License and research revenues were $2.2 million during the fourth quarter of 2011, versus $8.8 million in the fourth quarter of 2010. Product sales and services during the fourth quarter of 2011, related primarily to production of Coreg CR microparticles, were $4.2 million versus $2.2 million during the year-ago quarter. Other revenues, consisting primarily of royalty income from GSK on the sales of Coreg CR, were $2.2 million as compared to $2.4 million in the fourth quarter of 2010.
Costs and expenses
Total costs and expenses during the fourth quarter of 2011 declined to $10.9 million versus $11.4 million in the year-ago period.
Costs of goods and services sold for the fourth quarter 2011 were comparable with the prior year at $1.9 million. Research and development costs in the fourth quarter of 2011 totaled $5.9 million versus $6.9 million in the year-ago period. Selling, general, and administrative costs were $3.2 million in the fourth quarter 2011 versus $2.7 million in the fourth quarter of 2010.
Net loss
Net loss for the fourth quarter of 2011 was ($2.1 million) versus net income of $2.7 million in the year-ago period. Net loss per share (basic and diluted) was ($0.08) versus net income per share (basic and diluted) of $0.11 in the fourth quarter of 2010.
Flamel's 2011 annual results
Revenues
For the calendar year 2011, Flamel reported total revenues of $32.6 million, compared to $37.1 million in 2010.
License and research revenue during 2011 was $10.6 million versus $19.7 million in 2010. Product sales and services for the year 2011 increased to $13.4 million, from $8.2 million in the year-ago period. Other revenues, consisting primarily of royalty income from sales of Coreg CR by GSK, totaled $8.6 million in 2011 versus $9.2 million in 2010.
Costs and expenses
Total costs and expenses declined in 2011 to $42.2 million from $46.9 million in 2010.
Costs of goods and services sold declined as well, to $6.3 million in 2011 versus $6.9 million in 2010. Research & development expenses were $25.1 million versus $28.7 million in 2010. SG&A in 2011 totaled $10.8 million versus $11.3 million in 2010.
Net loss
The Company reported a net loss for the year 2011 of ($8.8 million) or ($0.36) per share versus a net loss in 2010 of ($9.0 million), or ($0.37) per share. Flamel finished 2011 with $24.5 million in cash and marketable securities.
The Company is also updating its legal proceeding disclosure, noting that on March 6, 2012, the US District Court for the Southern District of New York issued its opinion granting the lead plaintiff's motion for class certification in the pending Billhofer v. Flamel Technologies, et al. securities litigation. The Company intends to continue to defend itself vigorously in this matter.