UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
______________________
FORM 6-K
Report of Foreign
Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
For the month of March 2012
Commission File Number: 000-28508
Flamel Technologies
(Translation of registrant's name into English)
Parc Club du Moulin à Vent
33 avenue du Dr. Georges Levy
69693 Vénissieux Cedex France
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
| Form 20-F S | Form 40-F £ |
Indicate by check mark whether registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
| Yes £ | No S |
If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-____________
INFORMATION FILED WITH THIS REPORT
Document Index
99.1 Press release regarding 2011 fourth quarter and annual results, dated March 14, 2011.
99.2 Press release regarding acquisition of Éclat Pharmaceuticals, LLC and appointment of Michael S. Anderson as Chief Executive Officer, dated March 14, 2011.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Flamel Technologies, S.A. | ||
| Dated: March 15, 2012 | By: | /s/ Michael S. Anderson |
| Name: Michael S. Anderson | ||
| Title: Chief Executive Officer | ||
EXHIBIT INDEX
| Exhibit Number | Description |
| 99.1 | Press release regarding 2011 fourth quarter and annual results, dated March 14, 2011. |
| 99.2 | Press release regarding acquisition of Éclat Pharmaceuticals, LLC and appointment of Michael S. Anderson as Chief Executive Officer, dated March 14, 2011. |
Flamel Technologies Announces Fourth Quarter
And Year-End 2011 Results
Flamel to Acquire Éclat Pharmaceuticals; Mike Anderson named Flamel CEO
Lyon, France – March 14, 2012 - Flamel Technologies (NASDAQ: FLML) today announced its financial results for the fourth quarter and year ended December 31, 2011.
Separately, the Company also announced today that it has agreed to acquire Éclat Pharmaceuticals, a St. Louis, Missouri-based special pharmaceutical company focused on developing and commercializing niche brands and generic products. Éclat Pharmaceuticals is a wholly owned subsidiary of an affiliate of Deerfield Capital L.P., which together with its other affiliates is our largest shareholder. Steve Willard, Flamel’s current chief executive officer, has resigned as CEO, and Mike Anderson, Éclat’s chief executive officer, has become chief executive officer of Flamel Technologies. Mr. Willard will remain a director of Flamel and an employee of a US subsidiary of Flamel. A press release announcing these changes is available at www.flamel.com
*******
Fourth Quarter and Recent Highlights:
| - | Inclusion in the Orange Book of Flamel’s US Pat. No. 8,101,209 related to our 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 1a by Merck Serono, which results we are analyzing and discussing with our partner |
| - | 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. |
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).”
| Page 1 of 5 |
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 Results
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.
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 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
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.
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.
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.
*******
| Page 2 of 5 |
A conference call to discuss these results as well as the acquisition of Éclat Pharmaceuticals is scheduled for 8:30 AM Eastern Daylight Time Thursday, March 15, 2012. A question and answer period is scheduled to follow management’s prepared remarks. The dial in number is 1-888-256-9132. The conference ID number is 4062934. The conference call webcast may be accessed at www.flamel.com.
*******
About Flamel Technologies. Flamel Technologies SA (NASDAQ: FLML) is a leading drug delivery company focused on the goal of developing safer, more efficacious formulations of drugs that address unmet medical needs. Its product development pipeline includes biological and chemical drugs formulated with the Medusa® and Micropump® proprietary platforms. Several Medusa-based products are at various clinical stages of development; Medusa’s lead internal product candidate IFN-alpha XL (long-acting interferon alpha-2b) is being evaluated a Phase 2a trial in HCV patients. The Company has developed approved products and manufactures Micropump-based microparticles under FDA-audited GMP guidelines. Flamel Technologies has collaborations with a number of leading pharmaceutical and biotechnology companies, including GlaxoSmithKline (Coreg CR®, carvedilol phosphate) and Merck Serono (long acting interferon beta 1a). Additional information can be found at www.flamel.com.
About Medusa®. The Medusa® drug delivery platform consists of proprietary hydrogels for the formulation and/or the extended release of a broad range of biologics (including proteins, antibodies, peptides and vaccines) and of small molecules (injectable drugs). The hydrogel, which are easy and cost effective to produce under EMA/FDA cGMP guidance, has been proven to be safe and biodegradable: Flamel Technologies filed a DMF for Medusa with the FDA on February 12, 2011 (assigned number 024634). Medusa enables the controlled delivery from 1 day up to 14 days of non-denatured or non-modified drugs that remain fully active (as distinguished to protein engineering or chemical modification approaches). It is used to develop biobetters with potentially improved efficacy and reduced toxicity, as well as greater patient convenience. Additional information can be found at www.flamel.com/technology-platforms/medusa/.
About Micropump®. The Micropump® micro-encapsulation drug delivery platform (oral drugs) is designed to increase the absorption time of drugs, particularly for drugs only absorbed in the small intestine. Micropump enables the achievement of precise pharmacokinetics Micropump can be presented in various dosage forms such as capsules, tablets, sachets or oral suspensions (LiquiTime®) without modifying the release rate. Flamel develops also another drug delivery technology for oral drugs, i.e. Trigger Lock™ for the controlled release of narcotic and opioid analgesics while deterring tampering (particles cannot be crushed to extract the active). Additional information can be found at www.flamel.com/technology-platforms/micropump/.
*******
| Page 3 of 5 |
| Contacts: | Stephen H. Willard | |
| Phone: | + 33 (0)4 7278 3434 | |
| Fax: | + 33 (0)4 7278 3435 | |
| E-mail: | willard@flamel.com | |
*******
This document contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including certain plans, expectations, goals and projections regarding financial results, product developments and technology platforms. All statements that are not clearly historical in nature are forward-looking, and the words “anticipate,” “assume,” “believe,” “expect,” “estimate,” “plan,” will,” and similar expressions are generally intended to identify forward-looking statements. All forward-looking statements involve risks, uncertainties and contingencies, many of which are beyond our control, that could cause actual results to differ materially from those contemplated in such forward-looking statements. These risks include risks that the acquisition of Éclat Pharmaceuticals will not be successful, clinical trial results will not be positive or that our partners may decide not to move forward, management transition to a new chief executive officer may be disruptive or not succeed as planned, products in the development stage may not achieve scientific objectives or milestones or meet stringent regulatory requirements, products in development may not achieve market acceptance, competitive products and pricing may hinder our commercial opportunities, and the risks associated with Flamel's reliance on outside parties and key strategic alliances. These and other risks are described more fully in Flamel's Annual Report on the Securities and Exchange Commission Form 20-F for the year ended December 31, 2010. All forward-looking statements included in this release are based on information available at the time of the release. We undertake no obligation to update or alter our forward-looking statements as a result of new information, future events or otherwise.
| Page 4 of 5 |
Condensed Consolidated Statements of Operations
(amounts in thousands, except per share data)
| Three months ended December 31, | Twelve months ended December 31, | |||||||||||||||
| 2010 | 2011 | 2010 | 2011 | |||||||||||||
| Revenue: | ||||||||||||||||
| License and research revenue | $ | 8,839 | $ | 2,170 | $ | 19,704 | $ | 10,566 | ||||||||
| Product sales and services | 2,210 | 4,242 | 8,180 | 13,395 | ||||||||||||
| Other revenues | 2,402 | 2,237 | 9,210 | 8,639 | ||||||||||||
| Total revenue | 13,451 | 8,649 | 37,094 | 32,600 | ||||||||||||
| Costs and expenses: | ||||||||||||||||
| Cost of goods and services sold | (1,869 | ) | (1,850 | ) | (6,914 | ) | (6,284 | ) | ||||||||
| Research and development | (6,863 | ) | (5,910 | ) | (28,687 | ) | (25,089 | ) | ||||||||
| Selling, general and administrative | (2,674 | ) | (3,166 | ) | (11,333 | ) | (10,810 | ) | ||||||||
| Total | (11,406 | ) | (10,926 | ) | (46,934 | ) | (42,183 | ) | ||||||||
| Profit (loss) from operations | 2,045 | (2,277 | ) | (9,840 | ) | (9,583 | ) | |||||||||
| Interest income net | 114 | 122 | 440 | 594 | ||||||||||||
| Foreign exchange gain (loss) | 196 | 118 | 109 | 273 | ||||||||||||
| Other income (loss) | 432 | 5 | 525 | 134 | ||||||||||||
| Income (loss) before income taxes | 2,787 | (2,032 | ) | (8,766 | ) | (8,582 | ) | |||||||||
| Income tax expense | (109 | ) | (59 | ) | (209 | ) | (192 | ) | ||||||||
| Net Income (loss) | $ | 2,678 | ($ | 2,091 | ) | ($ | 8,975 | ) | ($ | 8,774 | ) | |||||
| Earnings (loss) per share | ||||||||||||||||
| Basic earnings (loss) per ordinary share | $ | 0.11 | ($ | 0.08 | ) | ($ | 0.37 | ) | ($ | 0.36 | ) | |||||
| Diluted earnings (loss) per share | $ | 0.11 | ($ | 0.08 | ) | ($ | 0.37 | ) | ($ | 0.36 | ) | |||||
| Weighted average number of shares outstanding (in thousands) : | ||||||||||||||||
| Basic | 24,472 | 24,737 | 24,411 | 24,669 | ||||||||||||
| Diluted | 24,941 | 24,737 | 24,411 | 24,669 | ||||||||||||
| Page 5 of 5 |
Flamel Technologies Announces
Acquisition of Éclat Pharmaceuticals
Mike Anderson appointed Flamel’s Chief Executive Officer;
Steve Willard resigns as CEO but will remain on Board of Directors
Lyon, France – March 14, 2012 - Flamel Technologies (NASDAQ: FLML) today announced the acquisition of Éclat Pharmaceuticals, a specialty pharmaceutical company that is focused on the development, approval, and commercialization of niche brands and generic products. Prior to the acquisition, Éclat Pharmaceuticals was an affiliate of Deerfield Capital L.P., which together with its other affiliates is Flamel’s largest shareholder. Éclat has one approved product on the market, Hycet® (hydrocodone acetaminophen oral solution), as well as a suite of products in various stages of development. Éclat’s founder and chief executive officer is Mike Anderson. Mr. Anderson has over forty years of experience in the pharmaceutical industry at companies including AH Robins, Schein Pharmaceutical, and KV Pharmaceutical Co. Steve Willard has resigned as Flamel’s chief executive officer, and Mike Anderson, Éclat’s chief executive officer, has become chief executive officer of Flamel. Mr. Willard will remain a director of Flamel and an employee of a US subsidiary of Flamel.
Under the terms of the acquisition, a newly formed US subsidiary of Flamel has issued a $12 million senior note to Éclat Holdings, LLC, the former owner of Éclat, that is guaranteed by Flamel and its subsidiaries and secured by the equity interests and assets of Éclat. The note is payable over six years only if certain contingencies tied to the approval and net sales of certain Éclat products are satisfied. The note accrues interest at an annual rate of 7.5%, payable in kind, until satisfaction of certain of the foregoing contingencies. Flamel also will pay Éclat Holdings an earnout payment of 20% of the gross profit generated by the Éclat launch products.
In addition to the note, Flamel has issued two warrants that are subject to shareholder approval. One warrant is exercisable for up to 2,200,000 American Depositary Shares (ADSs), each representing one Ordinary Share, of Flamel at an exercise price of $7.44 per share, and the second warrant is exercisable for up to 1,100,000 ADSs at an exercise price of $11.00 per share. The warrants are exercisable for a six year term, and Flamel also has committed to registering the ADSs underlying the warrants with the SEC if shareholder approval is obtained. If shareholder approval is not obtained, the warrants will be cash settled, and the term will be extended to seven years. The warrants also contain a limitation generally preventing them from being exercised during any time that would result in the holder beneficially owning greater than 19.985% of our ordinary shares.
Stephen H. Willard stated, “We are glad to have arrived at such a mutually beneficial agreement with Éclat, a company that complements Flamel in key areas, such as U.S. product development and market analysis. We believe we have structured this acquisition in the best interest of both parties by limiting risk to Flamel shareholders through an earn-out structure for the Éclat shareholders.”
| Page 1 of 4 |
Mr. Willard continued, “In addition to pipeline assets, the acquisition brings Mike Anderson and his strong industry experience and knowledge to Flamel. I am pleased that Mike has agreed to become Flamel’s new chief executive officer, as I believe he is the ideal person to implement our planned transition to a more vertically integrated drug development model with an increased commercial capability.”
Mike Anderson, Flamel’s chief executive officer, commented, “I am excited at the potential to develop new products using the Medusa®, Micropump®, Trigger Lock™, and LiquiTime® platforms. I have been greatly impressed by the expertise, dedication, and passion that the scientists at Flamel bring to their work every day in creating solutions for Flamel’s partners and believe that Flamel’s best-in-class drug delivery platforms can serve as the foundation to create multiple new products with the potential to address important areas of unmet medical need.”
Mr. Willard concluded, “We expect that the combination of Mike’s drug development and regulatory expertise with Flamel’s best-in-class drug delivery platforms will create dramatic opportunities for the growth of Flamel Technologies. I am very much looking forward to working with Mike in my continuing role as a member of the Board of Directors.”
Elie Vannier, the Chairman of Flamel’s Board of Directors, commented, “The Éclat acquisition offers Flamel shareholders an important strategic complement to our leading drug-delivery technology platforms. We are excited at the new initiatives that Mike will be undertaking to leverage our leading drug delivery technologies. I would like to take this opportunity to express the Board’s gratitude to Steve Willard for his service to the Company over the past twelve years. We are pleased that Steve has agreed to continue serving as a member of the Board of Directors and understand his wish to be able to be closer to his family in the U.S.”
Flamel expects to furnish a report on Form 6-K with the U.S. Securities and Exchange Commission that will contain more detailed disclosure regarding this acquisition.
*******
Separately, Flamel Technologies today announced its results for the fourth quarter and fiscal year 2011. The press release is available at www.flamel.com. A conference call to discuss these results as well as the acquisition of Éclat Pharmaceuticals is scheduled for 8:30 AM Eastern Daylight Time Thursday, March 15, 2012. A question and answer period is scheduled to follow management’s prepared remarks. The dial in number is 1-888-256-9132. The conference ID number is 4062934. The conference call webcast may be accessed at www.flamel.com.
*******
| Page 2 of 4 |
About Flamel Technologies. Flamel Technologies SA (NASDAQ: FLML) is a leading drug delivery company focused on the goal of developing safer, more efficacious formulations of drugs that address unmet medical needs. Its product development pipeline includes biological and chemical drugs formulated with the Medusa® and Micropump® proprietary platforms. Several Medusa-based products are at various clinical stages of development; Medusa’s lead internal product candidate IFN-alpha XL (long-acting interferon alpha-2b) is being evaluated in a Phase 2a trial in HCV patients. The Company has developed approved products and manufactures Micropump-based microparticles under FDA-audited GMP guidelines. Flamel Technologies has collaborations with a number of leading pharmaceutical and biotechnology companies, including GlaxoSmithKline plc (Coreg CR®, carvedilol phosphate) and Merck Serono S.A. (long acting interferon beta-1a). Additional information can be found at www.flamel.com.
About Éclat Pharmaceuticals. Éclat Pharmaceuticals, L.L.C., a St. Louis, Missouri-based specialty pharmaceutical company, is focused on the development, approval and commercialization of niche brands and generic products. Éclat’s mission is simple: Improve today’s medicine for better patient outcomes tomorrow. Éclat is of French origin and typically is used to describe success. True to its name, Éclat Pharmaceuticals was established to successfully develop creative and cost-effective ways to deliver pharmaceutical therapy to patients. Whether improving the convenience of drug delivery or improving upon difficult side effect profiles, Éclat’s approach is to find solutions to problems with existing therapies. Éclat has singled out several promising product opportunities and initiated the development of a number of them. The company has identified expertise in the regulatory process, the development process and the manufacturing and distribution arenas that it can leverage to bring products to the market.
*******
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including certain plans, expectations, goals and projections regarding Flamel and Éclat. All statements that are not clearly historical in nature are forward-looking, and the words “anticipate,” “assume,” “believe,” “expect,” “estimate,” “plan,” will,” and similar expressions are generally intended to identify forward-looking statements. All forward-looking statements involve risks, uncertainties and contingencies, many of which are beyond our control, that could cause actual results to differ materially from those contemplated in such forward-looking statements. These risks include risks that the acquisition of Éclat Pharmaceuticals will not be successful, the Éclat launch products will not be approved by the FDA or become commercially viable, the planned transition to a more vertically integrated drug development model may not be achieved, shareholder approval of the warrants is not obtained, the management transition to a new chief executive officer may be disruptive or unsuccessful, clinical trial results will not be positive or that our partners may decide not to move forward, products in the development stage may not achieve scientific objectives or milestones or meet stringent regulatory requirements, and the risks associated with Flamel's reliance on outside parties and key strategic alliances. These and other risks are described more fully in Flamel's Annual Report on the Securities and Exchange Commission Form 20-F for the year ended December 31, 2010. All forward-looking statements included in this release are based on information available at the time of the release. We undertake no obligation to update or alter our forward-looking statements as a result of new information, future events or otherwise.
| Page 3 of 4 |
| Contact: | |
| Stephen H. Willard | |
| Phone: | + 33 (0)4 7278 3434 |
| Fax: | + 33 (0)4 7278 3435 |
| E-mail: | willard@flamel.com |
*******
| Page 4 of 4 |