Flamel Technologies Reports Third Quarter 2016 Results
Total Revenues Were $32.1 Million; 2016 Revenue Guidance Increased to $133 to $143 Million; REST-ON Phase III Trial of Micropump Sodium Oxybate Initiated
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LYON, FRANCE -- (Marketwired) -- 11/07/16 -- Flamel Technologies (NASDAQ: FLML) today announced its financial results for the third quarter 2016.
Third Quarter Highlights Include:
- Total revenues for third quarter 2016 were $32.1 million, compared to $47.3 million during the same period last year.
- GAAP net loss for the third quarter was $22.3 million, or $(0.54) per diluted share, compared to GAAP net loss of $28.1 million, or $(0.69) per diluted share, during the same period last year.
- Adjusted operating income was $2.5 million, compared to $24.4 million in the prior year.*
- Adjusted net loss for the third quarter was $3.5 million, or $(0.11) per diluted share, compared to an adjusted net loss of $13.1 million, or $0.32 per diluted share, during the same period last year. *
- Cash and marketable securities at September 30, 2016 were $149.7 million, compared to $154.9 million at June 30, 2016 and $144.8 million at December 31, 2015.
- Protocol for REST-ON Phase III trial of once-nightly Micropump sodium oxybate approved by the U.S. Food & Drug Administration (FDA) through a Special Protocol Assessment (SPA) and trial initiated in Europe and Canada.
* Non-GAAP financial measure. Descriptions of Flamel's non-GAAP financial measures are included under the caption "Non-GAAP Disclosures and Adjustments" included within this document and reconciliations of such non-GAAP financial measures to their most closely applicable GAAP financial measures are found in the "Supplemental Information" section within this document.
Michael Anderson, Flamel's Chief Executive Officer, commented, "Our base business, consisting of Bloxiverz® (neostigmine methylsulfate), Vazculep® (phenylephrine hydrochloride) and Akovaz" (ephedrine sulfate), remained strong during the third quarter with revenues coming in just above top line consensus. Although we were able to maintain strong share in the neostigmine market at about forty percent (40%) during the third quarter, the overall market volume slightly declined. This, in addition to a small loss in price, resulted in lower quarter over quarter sales of Bloxiverz, at $15.6 million for the quarter. The phenylephrine business remained stable with third quarter 2016 sales of $9.3 million, relatively in line with the previous quarter after adjusting for our change in revenue recognition. As expected in the third quarter, we launched Akovaz, the first FDA-approved ephedrine sulfate injection. Akovaz added $5.6 million in revenues, partially offsetting some weakness in the neostigmine market which, as we outlined at the beginning of the year, was expected with increased competition. I am very pleased with the on-time and successful launch of Akovaz as it once again demonstrates our ability to identify, develop and launch commercially viable pharmaceutical products. Given that we launched later in the quarter, we are off to a good start."
Mr. Anderson continued, "In addition to our solid base business, we were pleased to host our first investor and analyst day in September, at which we announced the initiation of our Phase III trial of once nightly sodium oxybate in Canada. We have since initiated sites in Europe and received SPA approval from the FDA, which has given us further confidence as we proceed with our trial. We look forward to providing more updates on trial progress as we begin to dose patients."
Third Quarter 2016 Results
The Company generated revenues during the third quarter 2016 of $32.1 million, compared to $47.3 million during the same period last year. On a GAAP basis, the Company recorded a net loss of $22.3 million during the third quarter 2016, or $(0.54) per diluted share, compared to a net loss of $28.1 million, or $(0.69) per diluted share, for the same period last year. Included in the net loss for the third quarter 2016 were $22.7 million of charges related to changes in the fair value of related party contingent consideration and related party payables. The Company recognized a foreign currency exchange loss of $1.1 million in the third quarter 2016, compared to a foreign currency exchange gain of $0.2 million the prior year quarter. Adjusted net loss for the third quarter was $3.5 million, or $(0.08) per diluted share, compared to an adjusted net income of $13.1 million, or $0.32 per diluted share, during the same period last year. The decline in adjusted net income and adjusted diluted EPS from the previous year was due to lower product sales resulting from increased competition for neostigmine and higher SG&A from increased headcount. Please see the Supplemental Information section within this document for a reconciliation of adjusted net income and adjusted diluted EPS to the respective GAAP amounts.
For the nine months ended September 30, 2016, cash flow from operations was $11.2 million, compared to $58.0 million in the same period last year. Cash and marketable securities at September 30, 2016 were $149.7 million, compared to $154.9 million at June 30, 2016.
2016 Guidance
As a result of the stable market to date for both Bloxiverz and Vazculep, in addition to a strong market for Akovaz, the Company is increasing its full year 2016 revenue guidance to the range of $133 to $143 million from its previous guidance range of $125 to $140 million. The Company expects to allocate a substantial amount of its R&D expenses to its REST-ON trial and is reiterating its full year 2016 guidance in the range of $30 to $40 million.
Conference Call
A conference call to discuss these results and other updates is scheduled for 10:00 a.m. ET on Monday, November 7, 2016. A question and answer period will follow management's prepared remarks. To participate in the conference call, investors are invited to dial 800-765-0709 (U.S. and Canada) or 913-312-0726 (international). The conference ID number is 9865797. A live audio webcast and accompanying slides can be accessed by visiting the Events & Presentations page of the Company's Investor website at http://www.flamel.com/investors. A replay of the webcast will be archived on Flamel's website for 90 days following the event.
About Flamel Technologies
Flamel Technologies SA (NASDAQ: FLML) is a specialty pharmaceutical company utilizing its core competencies in formulation development and drug delivery to develop safer and more efficacious pharmaceutical products, addressing unmet medical needs and/or reducing overall healthcare costs. Flamel currently markets three branded, sterile injectable products in the United States, Bloxiverz® (neostigmine methylsulfate injection), Vazculep® (phenylephrine hydrochloride injection), and Akovaz" (ephedrine sulfate injection). The Company also develops products utilizing its proprietary drug delivery platforms, Micropump® (oral sustained release microparticles platform), along with its tangent technologies, LiquiTime® (a Micropump-derivative platform for liquid oral products) and Trigger Lock" (a Micropump-derivative platform for abuse-resistant opioids). Additionally, the Company has developed a long acting injectable platform, Medusa", a hydrogel depot technology, particularly suited to the development of subcutaneously administered formulations. Applications of Flamel's drug delivery products include sodium oxybate (Micropump®), currently being studied in a Phase III trial to assess the safety and efficacy of a once nightly dose for treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy, and extended-release of liquid medicines (LiquiTime®) through a license arrangement with Elan Pharma International Limited for the U.S. Over-the-Counter market. Additionally, the Company's Trigger Lock" technology is currently being studied with hydromorphone, and several proof of concept studies of exenatide utilizing the Medusa" technology were completed in 2016. In February 2016, Flamel acquired FSC Pediatrics, a company that markets three pediatric pharmaceutical products - Cefaclor for oral suspension, Karbinal" ER, and AcipHex® Sprinkle" (rabeprazole sodium). FSC also received 510(k) clearance from the FDA in October 2014 for Flexichamber", a collapsible holding chamber used in the administration of aerosolized medication using pressurized Metered Dose Inhalers (pMDIs) for the treatment of asthma. The Company is headquartered in Lyon, France and has operations in Dublin, Ireland and in St. Louis, Missouri. Additional information may be found at www.flamel.com.
Safe Harbor
This release may include "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements herein that are not clearly historical in nature are forward-looking, and the words "anticipate," "assume," "believe," "expect," "estimate," "plan," "will," "may," and the negative of these and similar expressions generally identify forward-looking statements. All forward-looking statements involve risks, uncertainties and contingencies, many of which are beyond Flamel's control and could cause actual results to differ materially from the results contemplated in such forward-looking statements. These risks, uncertainties and contingencies include the risks relating to: our dependence on a small number of products and customers for the majority of our revenues; the possibility that our Bloxiverz®, Vazculep® and Akovaz" products, which are not patent protected, could face substantial competition resulting in a loss of market share or forcing us to reduce the prices we charge for those products; the possibility that we could fail to successfully complete the research and development for the pipeline product we are evaluating for potential application to the FDA pursuant to our "unapproved-to-approved" strategy, or that competitors could complete the development of such product and apply for FDA approval of such product before us; our dependence on the performance of third parties in partnerships or strategic alliances for the commercialization of some of our products; the possibility that our products may not reach the commercial market or gain market acceptance; our need to invest substantial sums in research and development in order to remain competitive; our dependence on certain single providers for development of several of our drug delivery platforms and products; our dependence on a limited number of suppliers to manufacture our products and to deliver certain raw materials used in our products; the possibility that our competitors may develop and market technologies or products that are more effective or safer than ours, or obtain regulatory approval and market such technologies or products before we do; the challenges in protecting the intellectual property underlying our drug delivery platforms and other products; our dependence on key personnel to execute our business plan; the amount of additional costs we will incur to comply with U.S. securities laws as a result of our ceasing to qualify as a foreign private issuer; and the other risks, uncertainties and contingencies described in the Company's filings with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K for the year ended December 31, 2015, all of which filings are also available on the Company's website. Flamel undertakes no obligation to update its forward-looking statements as a result of new information, future events or otherwise, except as required by law.
Non GAAP Disclosures and Adjustments
Flamel discloses certain non-GAAP financial measures, including adjusted net income and loss and adjusted net income and loss per diluted share and earnings before interest, taxes, depreciation and amortization (EBITDA) as management believes that a comparison of its current and historical results would be difficult if the disclosures were limited to financial measures prepared only in accordance with generally accepted accounting principles (GAAP) in the U.S. In addition to reporting its financial results in accordance with GAAP, Flamel reports certain non-GAAP results that exclude, if any, fair value remeasurements of its contingent consideration, impairment of intangible assets, amortization of intangible assets, effects of accelerated reimbursement of certain debt instruments, foreign exchange gains and losses on assets and liabilities denominated in foreign currency, the net income (loss) from discontinued operations and related tax effects, but includes the operating cash flows plus any unpaid accrued amounts associated with the contingent consideration, 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 GAAP. The table provided within the following "Supplemental Information" section reconciles GAAP net income and loss and diluted earnings or loss per share to the corresponding adjusted amounts. *******
FLAMEL TECHNOLOGIES S.A.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF LOSS
(In thousands, except per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
--------------------- -------------------
2016 2015 2016 2015
---------- ---------- --------- ---------
Revenues:
Product sales and services $ 31,340 $ 47,313 $104,858 $128,441
License and research revenue 747 -- 2,303 --
---------- ---------- --------- ---------
Total 32,087 47,313 107,161 128,441
Operating expenses:
Cost of products and services
sold 2,844 2,087 10,657 8,473
Research and development expenses 8,143 7,221 21,135 20,447
Selling, general and
administrative expenses 12,740 4,568 33,491 14,904
Intangible asset amortization 3,702 3,141 10,918 9,423
Changes in fair value of related
party contingent consideration 20,848 44,782 52,989 82,036
---------- ---------- --------- ---------
Total 48,277 61,799 129,190 135,283
---------- ---------- --------- ---------
Operating loss (16,190) (14,486) (22,029) (6,842)
Investment income, net 490 197 1,080 1,171
Interest expense, net (264) -- (702) --
Other expense - changes in fair
value of related party payable (1,828) (6,644) (6,135) (9,629)
Foreign exchange gain (loss) (1,054) 160 (2,315) 8,096
---------- ---------- --------- ---------
Loss before income taxes (18,846) (20,773) (30,101) (7,204)
Income tax provision 3,451 7,302 18,212 24,516
---------- ---------- --------- ---------
Net loss $ (22,297) $ (28,075) $(48,313) $(31,720)
========== ========== ========= =========
Net loss per share - basic $ (0.54) $ (0.69) $ (1.17) $ (0.79)
========== ========== ========= =========
Net loss per share - diluted $ (0.54) $ (0.69) $ (1.17) $ (0.79)
========== ========== ========= =========
Weighted average number of shares
outstanding - basic 41,241 40,625 41,241 40,397
Weighted average number of shares
outstanding - diluted 41,241 40,625 41,241 40,397
FLAMEL TECHNOLOGIES S.A.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share data)
September 30, December 31,
2016 2015
-------------- -------------
ASSETS
Current assets:
Cash and cash equivalents $ 18,780 $ 65,064
Marketable securities 130,887 79,738
Accounts receivable 15,395 7,487
Inventories 3,909 3,666
Research and development tax credit
receivable -- 2,382
Prepaid expenses and other current assets 8,883 8,064
-------------- -------------
Total current assets 177,854 166,401
-------------- -------------
Property and equipment, net 3,186 2,616
Goodwill 19,134 18,491
Intangible assets, net 25,508 15,825
Research and development tax credit receivable 4,240 --
Income tax deferred charge 11,243 11,581
Other 6,820 167
-------------- -------------
Total assets $ 247,985 $ 215,081
============== =============
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Current portion of long-term debt $ 286 $ 434
Current portion of long-term related party
payable 33,359 25,204
Accounts payable 8,966 5,048
Deferred revenue 3,115 5,121
Accrued expenses 13,032 9,308
Other 427 133
-------------- -------------
Total current liabilities 59,185 45,248
-------------- -------------
Long-term debt, less current portion 734 684
Long-term related party payable, less current
portion 146,926 97,489
Other 4,307 2,526
-------------- -------------
Total liabilities 211,152 145,947
-------------- -------------
Shareholders' equity:
Ordinary shares, nominal value of 0.122 euro
per share; 53,178 shares authorized; 41,241
issued and outstanding at September 30, 2016
and December 31, 2015 6,331 6,331
Additional paid-in capital 374,724 363,984
Accumulated deficit (326,837) (278,524)
Accumulated other comprehensive loss (17,385) (22,657)
-------------- -------------
Total shareholders' equity 36,833 69,134
-------------- -------------
Total liabilities and shareholders' equity $ 247,985 $ 215,081
============== =============
FLAMEL TECHNOLOGIES S.A.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
Nine Months Ended September 30,
--------------------------------
2016 2015
---------------- ---------------
Cash flows from operating activities:
Net loss $ (48,313) $ (31,718)
Adjustments to reconcile net loss to net
cash provided by operating activities:
Depreciation and amortization 11,555 9,800
Loss on disposal of property and
equipment 110 --
Loss on sale of marketable securities 666 635
Unrealized exchange loss (gain) 2,315 (7,248)
Grants recognized in research and
development expenses (70) (1,086)
Remeasurement of related party
acquisition-related contingent
consideration 52,989 82,036
Remeasurement of related party financing-
related contingent consideration 6,135 9,628
Change in deferred tax and income tax
deferred charge (5,680) (714)
Stock-based compensation expense 10,541 5,485
Increase (decrease) in cash from:
Accounts receivable (7,594) (1,553)
Inventories 2,080 1,543
Prepaid expenses and other current assets 671 (4,293)
Research and development tax credit
receivable (1,794) 2,481
Accounts payable & other current
liabilities 1,291 (4,231)
Deferred revenue (2,198) (1,317)
Accrued expenses 2,700 (1,094)
Accrued income taxes -- (490)
Earn-out payments for related party
contingent consideration in excess of
acquisition-date fair value (14,488) --
Royalty payments for related party
payable in excess of original fair value (1,790) --
Other long-term assets and liabilities 2,033 131
---------------- ---------------
Net cash provided by operating activities 11,159 57,995
---------------- ---------------
Cash flows from investing activities:
Purchases of property and equipment (1,000) (1,065)
Acquisitions of businesses 628 --
Proceeds from sales of marketable
securities 46,483 23,995
Purchase of marketable securities (96,199) (36,210)
---------------- ---------------
Net cash used in investing activities (50,088) (13,280)
---------------- ---------------
Cash flows from financing activities:
Earn-out payments for related party
contingent consideration (6,834) (15,497)
Royalty payments for related party payable (1,117) (2,099)
Repayment of debt -- (4,965)
Reimbursement of conditional grants (61) (681)
Cash proceeds from issuance of ordinary
shares and warrants -- 6,990
---------------- ---------------
Net cash used in financing activities (8,012) (16,252)
---------------- ---------------
Effect of exchange rate changes on cash and
cash equivalents 657 (2,358)
Net increase (decrease) in cash and cash
equivalents (46,284) 26,105
Cash and cash equivalents at January 1 65,064 39,760
---------------- ---------------
Cash and cash equivalents at September 30 $ 18,780 $ 65,865
================ ===============
FLAMEL TECHNOLOGIES S.A.
UNAUDITED SUPPLEMENTAL INFORMATION
(In thousands, except per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
--------------------- -------------------
Revenues 2016 2015 2016 2015
---------------------------------- ---------- ---------- --------- ---------
Bloxiverz $ 15,591 $ 41,243 $ 65,958 $ 114,074
Vazculep 9,340 5,605 29,167 12,757
Akovaz 5,568 -- 5,568 --
Other 841 465 4,165 1,610
---------- ---------- --------- ---------
Total product sales and services 31,340 47,313 104,858 128,441
License and research revenue 747 -- 2,303 --
---------- ---------- --------- ---------
Total revenues $ 32,087 $ 47,313 $ 107,161 $ 128,441
========== ========== ========= =========
----------------------------
Adjustments for the three
months ended, September 30,
2016
----------------------------
Exclude
----------------------------
Intangible Foreign
asset exchange
GAAP amortization (gain)/loss
---------- -------------- -------------
Revenues:
Product sales and services $ 31,340 $ -- $ --
License and research
revenue 747 -- --
---------- -------------- -------------
Total 32,087 -- --
Operating expenses:
Cost of products and
services sold 2,844 -- --
Research and development
expenses 8,143 -- --
Selling, general and
administrative expenses 12,740 -- --
Intangible asset
amortization 3,702 (3,702) --
Changes in fair value of
related party contingent
consideration 20,848 -- --
---------- -------------- -------------
Total 48,277 (3,702) --
---------- -------------- -------------
Operating (loss) income (16,190) 3,702 --
Investment income, net 490 -- --
Interest expense, net (264) -- --
Other expense - changes in
fair value of related
party payable (1,828) -- --
Foreign exchange gain
(loss) (1,054) -- 1,054
---------- -------------- -------------
(Loss) income before income
taxes (18,846) 3,702 1,054
Income tax provision
(benefit) 3,451 1,329 --
---------- -------------- -------------
Net (loss) income $ (22,297) $ 2,373 $ 1,054
========== ============== =============
Net (loss) income per share
- diluted $ (0.54) 0.06 0.03
Weighted average number of
shares outstanding -
diluted 41,241 41,241 41,241
----------------------------
Adjustments for the three
months ended, September 30,
2016
----------------------------
Exclude Include
--------------- ------------
Contingent Contingent
related party related
payable fair party
value payable Total Adjusted
remeasurements paid/accrued adjustments GAAP
-------------- ------------ ----------- --------
Revenues:
Product sales and services $ -- $ -- $ -- $31,340
License and research
revenue -- -- -- 747
-------------- ------------ ----------- --------
Total -- -- -- 32,087
Operating expenses:
Cost of products and
services sold -- -- -- 2,844
Research and development
expenses -- -- -- 8,143
Selling, general and
administrative expenses -- -- -- 12,740
Intangible asset
amortization -- -- (3,702) --
Changes in fair value of
related party contingent
consideration (20,848) 5,884 (14,964) 5,884
-------------- ------------ ----------- --------
Total (20,848) 5,884 (18,666) 29,611
-------------- ------------ ----------- --------
Operating (loss) income 20,848 (5,884) 18,666 2,476
Investment income, net -- -- -- 490
Interest expense, net -- -- -- (264)
Other expense - changes in
fair value of related
party payable 1,828 (785) 1,043 (785)
Foreign exchange gain
(loss) -- -- 1,054 --
-------------- ------------ ----------- --------
(Loss) income before income
taxes 22,676 (6,669) 20,763 1,917
Income tax provision
(benefit) 1,021 (385) 1,965 5,416
-------------- ------------ ----------- --------
Net (loss) income $ 21,655 $ (6,284) $ 18,798 $(3,499)
============== ============ =========== ========
Net (loss) income per share
- diluted 0.53 (0.15) 0.46 (0.08)
Weighted average number of
shares outstanding -
diluted 41,241 41,241 41,241 41,241
----------------------------
Adjustments for the three
months ended, September 30,
2015
----------------------------
Exclude
----------------------------
Intangible Foreign
asset exchange
GAAP amortization (gain)/loss
---------- -------------- -------------
Revenues:
Product sales and services $ 47,313 $ -- $ --
License and research
revenue -- -- --
---------- -------------- -------------
Total 47,313 -- --
Operating expenses:
Cost of products and
services sold 2,087 -- --
Research and development
expenses 7,221 -- --
Selling, general and
administrative expenses 4,568 -- --
Intangible asset
amortization 3,141 (3,141) --
Changes in fair value of
related party contingent
consideration 44,782 -- --
---------- -------------- -------------
Total 61,799 (3,141) --
---------- -------------- -------------
Operating (loss) income (14,486) 3,141 --
Investment income, net 197 -- --
Interest expense, net -- -- --
Other expense - changes in
fair value of related
party payable (6,644) -- --
Foreign exchange gain
(loss) 160 -- (160)
---------- -------------- -------------
(Loss) income before income
taxes (20,773) 3,141 (160)
Income tax provision
(benefit) 7,302 1,099 (48)
---------- -------------- -------------
Net (loss) income $ (28,075) $ 2,042 $ (112)
========== ============== =============
Net (loss) income per share
- diluted $ (0.69) $ 0.05 $ --
Weighted average number of
shares outstanding -
diluted 40,625 40,625 40,625
----------------------------
Adjustments for the three
months ended, September 30,
2015
----------------------------
Exclude Include
--------------- ------------
Contingent Contingent
related party related
payable fair party
value payable Total Adjusted
remeasurements paid/accrued adjustments GAAP
-------------- ------------ ----------- --------
Revenues:
Product sales and services $ -- $ -- $ -- $47,313
License and research
revenue -- -- -- --
-------------- ------------ ----------- --------
Total -- -- -- 47,313
Operating expenses:
Cost of products and
services sold -- -- -- 2,087
Research and development
expenses -- -- -- 7,221
Selling, general and
administrative expenses -- -- -- 4,568
Intangible asset
amortization -- -- (3,141) --
Changes in fair value of
related party contingent
consideration (44,782) 9,027 (35,755) 9,027
-------------- ------------ ----------- --------
Total (44,782) 9,027 (38,896) 22,903
-------------- ------------ ----------- --------
Operating (loss) income 44,782 (9,027) 38,896 24,410
Investment income, net -- -- -- 197
Interest expense, net -- -- -- --
Other expense - changes in
fair value of related
party payable 6,644 (1,211) 5,433 (1,211)
Foreign exchange gain
(loss) -- -- (160) --
-------------- ------------ ----------- --------
(Loss) income before income
taxes 51,426 (10,238) 44,169 23,396
Income tax provision
(benefit) 2,325 (424) 2,952 10,254
-------------- ------------ ----------- --------
Net (loss) income $ 49,101 $ (9,814) $ 41,217 $13,142
============== ============ =========== ========
Net (loss) income per share
- diluted $ 1.21 $ (0.24) $ 1.01 $ 0.32
Weighted average number of
shares outstanding -
diluted 40,625 40,625 40,625 40,625
-------------------------------------
Adjustments for the nine months
ended, September 30, 2016
-------------------------------------
Exclude
-------------------------------------
Purchase
Intangible Foreign accounting
asset exchange adjustments
GAAP amortization (gain)/loss - FSC
--------- ------------ ----------- ------------
Revenues:
Product sales and services $104,858 $ -- $ -- $ --
License and research
revenue 2,303 -- -- --
--------- ------------ ----------- ------------
Total 107,161 -- -- --
Operating expenses:
Cost of products and
services sold 10,657 -- -- (1,525)
Research and development
expenses 21,135 -- -- --
Selling, general and
administrative expenses 33,491 -- -- --
Intangible asset
amortization 10,918 (10,918) -- --
Changes in fair value of
related party contingent
consideration 52,989 -- -- --
--------- ------------ ----------- ------------
Total 129,190 (10,918) -- (1,525)
--------- ------------ ----------- ------------
Operating (loss) income (22,029) 10,918 -- 1,525
Investment income, net 1,080 -- -- --
Interest expense, net (702) -- -- --
Other expense - changes in
fair value of related
party payable (6,135) -- -- --
Foreign exchange gain
(loss) (2,315) -- 2,315 --
--------- ------------ ----------- ------------
(Loss) income before income
taxes (30,101) 10,918 2,315 1,525
Income tax provision
(benefit) 18,212 3,920 -- 533
--------- ------------ ----------- ------------
Net (loss) income $(48,313) $ 6,998 $ 2,315 $ 992
========= ============ =========== ============
Net (loss) income per share
- diluted $ (1.17) $ 0.17 $ 0.06 $ 0.02
Weighted average number of
shares outstanding -
diluted 41,241 41,241 41,241 41,241
----------------------------
Adjustments for the nine
months ended, September 30,
2016
----------------------------
Exclude Include
--------------- ------------
Contingent Contingent
related party related
payable fair party
value payable Total Adjusted
remeasurements paid/accrued adjustments GAAP
-------------- ------------ ----------- --------
Revenues:
Product sales and services 104,85
$ -- $ -- $ -- $ 8
License and research
revenue -- -- -- 2,303
-------------- ------------ ----------- --------
Total 107,16
-- -- -- 1
Operating expenses:
Cost of products and
services sold -- -- (1,525) 9,132
Research and development
expenses -- -- -- 21,135
Selling, general and
administrative expenses -- -- -- 33,491
Intangible asset
amortization -- -- (10,918) --
Changes in fair value of
related party contingent
consideration (52,989) 19,321 (33,668) 19,321
-------------- ------------ ----------- --------
Total (52,989) 19,321 (46,111) 83,079
-------------- ------------ ----------- --------
Operating (loss) income 52,989 (19,321) 46,111 24,082
Investment income, net -- -- -- 1,080
Interest expense, net -- -- -- (702)
Other expense - changes in
fair value of related
party payable 6,135 (2,618) 3,517 (2,618)
Foreign exchange gain
(loss) -- -- 2,315 --
-------------- ------------ ----------- --------
(Loss) income before income
taxes 59,124 (21,939) 51,943 21,842
Income tax provision
(benefit) 2,986 (1,165) 6,274 24,486
-------------- ------------ ----------- --------
Net (loss) income $ 56,138 $ (20,774) $ 45,669 $(2,644)
============== ============ =========== ========
Net (loss) income per share
- diluted $ 1.36 $ (0.50) $ 1.11 $ (0.06)
Weighted average number of
shares outstanding -
diluted 41,241 41,241 41,241 41,241
----------------------------
Adjustments for the nine
months ended, September 30,
2015
----------------------------
Exclude
----------------------------
Intangible Foreign
asset exchange
GAAP amortization (gain)/loss
---------- -------------- -------------
Revenues:
Product sales and services $ 128,441 $ -- $ --
License and research
revenue -- -- --
---------- -------------- -------------
Total 128,441 -- --
Operating expenses:
Cost of products and
services sold 8,473 -- --
Research and development
expenses 20,447 -- --
Selling, general and
administrative expenses 14,904 -- --
Intangible asset
amortization 9,423 (9,423) --
Changes in fair value of
related party contingent
consideration 82,036 -- --
---------- -------------- -------------
Total 135,283 (9,423) --
---------- -------------- -------------
Operating (loss) income (6,842) 9,423 --
Investment income, net 1,171 -- --
Interest expense, net -- -- --
Other expense - changes in
fair value of related
party payable (9,629) -- --
Foreign exchange gain
(loss) 8,096 -- (8,096)
---------- -------------- -------------
(Loss) income before income
taxes (7,204) 9,423 (8,096)
Income tax provision
(benefit) 24,516 3,298 (2,429)
---------- -------------- -------------
Net (loss) income $ (31,720) $ 6,125 $ (5,667)
========== ============== =============
Net (loss) income per share
- diluted $ (0.79) $ 0.15 $ (0.14)
Weighted average number of
shares outstanding -
diluted 40,397 40,397 40,397
----------------------------
Adjustments for the nine
months ended, September 30,
2015
----------------------------
Exclude Include
--------------- ------------
Contingent Contingent
related party related
payable fair party
value payable Total Adjusted
remeasurements paid/accrued adjustments GAAP
-------------- ------------ ----------- --------
Revenues:
Product sales and services 128,44
$ -- $ -- $ -- $ 1
License and research
revenue -- -- -- --
-------------- ------------ ----------- --------
Total 128,44
-- -- -- 1
Operating expenses:
Cost of products and
services sold -- -- -- 8,473
Research and development
expenses -- -- -- 20,447
Selling, general and
administrative expenses -- -- -- 14,904
Intangible asset
amortization -- -- (9,423) --
Changes in fair value of
related party contingent
consideration (82,036) 23,923 (58,113) 23,923
-------------- ------------ ----------- --------
Total (82,036) 23,923 (67,536) 67,747
-------------- ------------ ----------- --------
Operating (loss) income 82,036 (23,923) 67,536 60,694
Investment income, net -- -- -- 1,171
Interest expense, net -- -- -- --
Other expense - changes in
fair value of related
party payable 9,629 (3,291) 6,338 (3,291)
Foreign exchange gain
(loss) -- -- (8,096) --
-------------- ------------ ----------- --------
(Loss) income before income
taxes 91,665 (27,214) 65,778 58,574
Income tax provision
(benefit) 3,370 (1,152) 3,087 27,603
-------------- ------------ ----------- --------
Net (loss) income $ 88,295 $ (26,062) $ 62,691 $30,971
============== ============ =========== ========
Net (loss) income per share
- diluted $ 2.19 $ (0.65) $ 1.55 $ 0.77
Weighted average number of
shares outstanding -
diluted 40,397 40,397 40,397 40,397
Source: Flamel Technologies
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