Full Press Release Details
Flamel Technologies Announces Second
Quarter of Fiscal Year 2014 Results
Company received FDA Approval of Vazculep
Conference call with management to
take place at 10:00 am ET on July 29, 2014
Lyon, France - July 29, 2014
- Flamel Technologies (NASDAQ: FLML) today announced its financial results for the second quarter of fiscal year 2014. Highlights
from the quarter include:
"We are pleased that the FDA listed
clat Pharmaceuticals as the only supplier of neostigmine methylsulfate as of June 19th. We have been in frequent
communication with the FDA with regard to Bloxiverz, and look forward to learning more about any specific actions in the near future,"
said Mike Anderson, Chief Executive Officer of Flamel.
"Additionally, we continue to execute
on our strategy with FDA's recent approval of Vazculep," added Mr. Anderson. "Our prompt resubmission of our
NDA for Vazculep and the FDA's subsequent approval ahead of the scheduled PDUFA date is an example of the Company's
ability to work effectively and positively with the FDA and other third parties in order to execute our business plan."
We continue to make progress on our proprietary
pipeline, including the clinical testing of sodium oxybate and other compounds using our Micropump , LiquiTime , Trigger
Lock , and Medusa drug delivery platforms. Continued prioritization of these programs and investments in our internal
infrastructure will facilitate high quality and timely execution on our major proprietary pipeline products throughout 2014 and
Flamel's Second Quarter Results
Flamel reported total revenues during the
second quarter of 2014 of $8.1 million, an increase of $2.5 million in revenues compared to the prior year period. Product sales
and services revenues in the second quarter of 2014 of were $4.1 million, compared to $2.2 million in the prior year quarter, principally
due to sales of Bloxiverz, which was not launched in the second quarter of 2013. On a sequential basis, second quarter 2014 revenues
of $8.1 million were down from $9.2 million in the first quarter of 2014, due to a leveling off of Bloxiverz sales after a spike
in sales in the first quarter when two suppliers of unapproved neostigmine methylsulfate were off the market for a portion of the
Costs of goods and services sold for the
second quarter of 2014 were $1.6 million compared to $1.3 million in the second quarter of 2013, principally due to cost of sales
of Bloxiverz. Research and development costs in the second quarter of 2014 totaled $6.7 million versus $7.3 million in the prior
year period. Selling, general and administrative costs were $4.3 million in the second quarter of 2014 versus $2.7 million in the
second quarter of 2013. This increase resulted from the cost of post-marketing studies requested by the FDA and increased legal
costs. Amortization of R&D assets associated with the development of Bloxiverz was $2.9 million in the second quarter of 2014.
Total net interest income was $94,000 in
the second quarter of 2014 compared to interest expense of $640,000 in the second quarter of 2013. Interest expense was largely
eliminated with the Company's repayment of nearly all of its debt and lines of credit with a portion of the net proceeds
from its offering of 12.4 million ADSs in mid-March 2014.
Net loss for the second quarter of 2014
was $21.1 million versus net loss of $32.8 million in the year-ago period. Earnings per share (both basic and diluted) was $(0.55)
in the second quarter of 2014 versus $(1.29) in the second quarter of 2013.
Adjusted net loss for the second quarter
of 2014 was $4.9 million versus an adjusted net loss of $4.5 million in the second quarter of 2013. Adjusted loss per share (both
basic and diluted) was $(0.13) in the second quarter of 2014 compared to an adjusted loss per share of $(0.18) in the prior year
The Company's cash position as of
June 30, 2014 was $77.9 million.
Flamel is disclosing non-GAAP financial
measures when providing financial results, including adjusted net loss. Flamel believes that an evaluation of its ongoing operations
(and comparison of current operations with historical and future operations) would be difficult if the disclosure of its financial
results were limited to financial measures prepared only in accordance with generally accepted accounting principles (GAAP) in
the U.S. In addition to disclosing its financial results in accordance with GAAP, Flamel is disclosing certain non-GAAP results
that exclude fair value remeasurements, impairment of intangible assets, amortization expense of intangible assets and effects
of accelerated reimbursement of certain debt instruments and include operating cash flows associated with the acquisition liabilities
and Royalty Agreements, in order to supplement investors' and other readers' understanding and assessment of the Company's financial
performance. The Company's management uses these non-GAAP measures internally for forecasting, budgeting and measuring its operating
performance. Investors and other readers are encouraged to review the related GAAP financial measures and the reconciliation of
non-GAAP measures to their most closely applicable GAAP measure set forth below and should consider non-GAAP measures only as a
supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with
Below is a reconciliation of GAAP net losses
attributable to Flamel and diluted GAAP losses per share to adjusted net losses attributable to Flamel and adjusted diluted losses
per share for the three months and six months ended June 30, 2014 and 2013 (in thousands except per share amounts).
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||||||||||||||||||
| 2013 | 2014 | 2013 | 2014 | |||||||||||||||||||||||||||||
| GAAP Net income (loss) and diluted earnings (loss) per share | $ | (32,854 | ) | $ | (1.29 | ) | $ | (21,073 | ) | $ | (0.55 | ) | $ | (41,683 | ) | $ | (1.64 | ) | $ | (47,711 | ) | $ | (1.43 | ) | ||||||||
| Fair value remeasurement of acquisition liabilities | 28,623 | 12,607 | 31,599 | 27,233 | ||||||||||||||||||||||||||||
| Fair value remeasurement of royalty agreements | 2,015 | 1,079 | 2,015 | 1,235 | ||||||||||||||||||||||||||||
| Amortization of Intangible R&D Assets | - | 2,938 | - | 5,875 | ||||||||||||||||||||||||||||
| Accelerated reimbursement of acquisition note | - | - | - | 3,013 | ||||||||||||||||||||||||||||
| Accelerated reimbursement of facility agreements | - | - | - | 4,741 | ||||||||||||||||||||||||||||
| Tax effects of the above items | (2,238 | ) | - | (2,253 | ) | - | ||||||||||||||||||||||||||
| Earn-out acquisition payment payable | - | (383 | ) | (108 | ) | (994 | ) | |||||||||||||||||||||||||
| Royalty payable | - | (54 | ) | - | (141 | ) | ||||||||||||||||||||||||||
| Adjusted Net Income (Loss) and adjusted diluted earnings (loss) per share | $ | (4,454 | ) | $ | (0.18 | ) | $ | (4,886 | ) | $ | (0.13 | ) | $ | (10,430 | ) | $ | (0.41 | ) | $ | (6,750 | ) | $ | (0.20 | ) |
A conference call to discuss these results
and other updates is scheduled for 10:00 AM ET on Tuesday, July 29, 2014. A question and answer period will follow management's
prepared remarks. To participate in the conference call, investors are invited to dial 888-428-9490 (U.S.) or 1+719-325-2376
(international). The conference ID number is 1681810. The conference call webcast may be accessed at www.flamel.com. A replay
of the webcast will be archived on Flamel's website for 90 days following the call.
About Flamel Technologies. Flamel
Technologies SA's (NASDAQ: FLML) business model is to blend high-value internally developed products with its leading drug delivery
capabilities. The company markets Bloxiverz (neostigmine methylsulfate) in the USA and manufactures Micropump-based microparticles
under FDA-audited GMP guidelines for Coreg CR (carvedilol phosphate), marketed in the USA by GlaxoSmithKline. The Company
has a proprietary pipeline of niche specialty pharmaceutical products, while its drug delivery platforms are focused on the goal
of developing safer, more efficacious formulations of drugs to address unmet medical needs. Its pipeline includes chemical and
biological drugs formulated with its Micropump (and its applications to the development of liquid formulations LiquiTime
and of abuse-deterrent formulations Trigger Lock ) and Medusa proprietary drug delivery platforms. Several Medusa-based
products have been successfully tested in clinical trials. The Company is headquartered in Lyon, France and has operations in
St. Louis, Missouri, USA, and manufacturing facilities in Pessac, France. Additional information may be found at www.flamel.com.
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 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," "may," 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 launch of Bloxiverz will not be as successful as anticipated; our ability to bring other R&D projects
of the former clat Pharmaceuticals to market may be unsuccessful; FDA may not take action on the status of unapproved versions
of neostigmine still on the market; clinical trial results may not be positive or 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;
products in development may not achieve market acceptance; competitive products and pricing may hinder our commercial opportunities;
we may not be successful in identifying and pursuing opportunities to develop our own product portfolio using Flamel's technology;
and the risks associated with our reliance on outside parties and key strategic alliances. These and other risks are described
more fully in Flamel's Annual Report on Form 20-F for the year ended December 31, 2013 that has been filed with the Securities
and Exchange Commission (SEC). 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.
| Contact: | Michael S. Anderson |
| Chief Executive Officer | |
| Phone: 33 (0)4 72 78 34 34 | |
| E-mail: anderson@flamel.com | |
| Investor Relations | |
| Bob Yedid | |
| ICR Inc . | |
| Phone: 646-277-1250 | |
| Email: bob.yedid@icrinc.com |
Condensed Consolidated Statements of
(Amounts in thousands, except per share
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2013 | 2014 | 2013 | 2014 | |||||||||||||
| Revenue: | ||||||||||||||||
| License and research revenue | $ | 1,650 | $ | 2,270 | $ | 2,923 | $ | 3,703 | ||||||||
| Product sales and services | 2,195 | 4,128 | 4,302 | 10,068 | ||||||||||||
| Other revenues | 1,696 | 1,683 | 3,456 | 3,485 | ||||||||||||
| Total revenue | 5,541 | 8,081 | 10,681 | 17,256 | ||||||||||||
| Costs and expenses: | ||||||||||||||||
| Cost of goods and services sold | (1,283 | ) | (1,636 | ) | (2,278 | ) | (3,588 | ) | ||||||||
| Research and development | (7,304 | ) | (6,742 | ) | (15,833 | ) | (13,836 | ) | ||||||||
| Amortisation of intangible R&D assets | - | (2,938 | ) | - | (5,875 | ) | ||||||||||
| Selling, general and administrative | (2,706 | ) | (4,295 | ) | (5,197 | ) | (7,850 | ) | ||||||||
| Fair value remeasurement of acquisition liabilities, incl. related parties | (28,623 | ) | (12,607 | ) | (31,599 | ) | (27,233 | ) | ||||||||
| Acquisition note expenses, incl. related parties | - | - | - | (3,013 | ) | |||||||||||
| Total | (39,916 | ) | (28,218 | ) | (54,907 | ) | (61,395 | ) | ||||||||
| Profit (loss) from operations | (34,375 | ) | (20,137 | ) | (44,226 | ) | (44,139 | ) | ||||||||
| Interest income (Expense) net | (640 | ) | 94 | (1,069 | ) | (5,414 | ) | |||||||||
| Interest expense on debt related to the royalty agreement with related parties | (2,015 | ) | (1,079 | ) | (2,015 | ) | (1,235 | ) | ||||||||
| Foreign exchange gain (loss) | (33 | ) | 292 | (9 | ) | 471 | ||||||||||
| Other income (loss) | 501 | 30 | 466 | 82 | ||||||||||||
| Income (loss) before income taxes | (36,562 | ) | (20,800 | ) | (46,853 | ) | (50,235 | ) | ||||||||
| Income tax benefit (expense) | 3,708 | (273 | ) | 5,170 | 2,524 | |||||||||||
| Net income (loss) | $ | (32,854 | ) | $ | (21,073 | ) | $ | (41,683 | ) | $ | (47,711 | ) | ||||
| Earnings (loss) per share | ||||||||||||||||
| Basic earnings (loss) per ordinary share | $ | (1.29 | ) | $ | (0.55 | ) | $ | (1.64 | ) | $ | (1.43 | ) | ||||
| Diluted earnings (loss) per share | $ | (1.29 | ) | $ | (0.55 | ) | $ | (1.64 | ) | $ | (1.43 | ) | ||||
| Weighted average number of shares outstanding (in thousands) : | ||||||||||||||||
| Basic | 25,421 | 38,438 | 25,418 | 33,403 | ||||||||||||
| Diluted | 25,421 | 38,438 | 25,418 | 33,403 |