0001113481-13-000038.txt : 20131009 0001113481-13-000038.hdr.sgml : 20131009 20131009165059 ACCESSION NUMBER: 0001113481-13-000038 CONFORMED SUBMISSION TYPE: 8-K/A PUBLIC DOCUMENT COUNT: 7 CONFORMED PERIOD OF REPORT: 20130805 ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20131009 DATE AS OF CHANGE: 20131009 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MEDICINES CO /DE CENTRAL INDEX KEY: 0001113481 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 043324394 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K/A SEC ACT: 1934 Act SEC FILE NUMBER: 000-31191 FILM NUMBER: 131143729 BUSINESS ADDRESS: STREET 1: 8 SYLVAN WAY CITY: PARSIPPANY STATE: NJ ZIP: 07054 BUSINESS PHONE: 973-290-6000 MAIL ADDRESS: STREET 1: 8 SYLVAN WAY CITY: PARSIPPANY STATE: NJ ZIP: 07054 FORMER COMPANY: FORMER CONFORMED NAME: MEDICINES CO/ MA DATE OF NAME CHANGE: 20000504 8-K/A 1 form8-kaprofibrix.htm 8-K/A Form 8-K/A (ProFibrix)


    


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON D.C. 20549
____________
FORM 8‑K/A
(Amendment No. 1)

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported): August 5, 2013


The Medicines Company
(Exact Name of Registrant as Specified in Charter)


Delaware
 
000-31191
 
04-3324394
(State or Other Jurisdiction
of Incorporation)
 
(Commission
File Number)
 
(IRS Employer
Identification No.)
                       

8 Sylvan Way
Parsippany, New Jersey
 
07054
(Address of Principal Executive Offices)
 
(Zip Code)

Registrant's telephone number, including area code: (973) 290-6000

 
(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))






Explanatory Note
On August 7, 2013, The Medicines Company (“MDCO”) filed a Current Report on Form 8-K (the “Initial Form 8-K”) reporting the completion of its acquisition of ProFibrix B.V., a company registered in The Netherlands (“ProFibrix”). In accordance with and as permitted by Section 9.01(a)(4) of Form 8-K, MDCO is filing this amendment to the Initial Form 8-K to provide the required financial statements and pro forma financial information that were not filed with the Initial Form 8-K.
Item 9.01. Financial Statements and Exhibits
(a) Financial Statements of Businesses Acquired
The audited consolidated financial statements of ProFibrix as of and for the year ended December 31, 2012 and the period from January 29, 2004 (inception) through December 31, 2012 and accompanying notes and the report of Deloitte Accountants B.V. with respect to such financial statements, as required by this Item 9.01(a), are attached as Exhibit 99.2 hereto and incorporated herein by reference.
The unaudited financial statements of ProFibrix as of June 30, 2013 and for the six months ended June 30, 2013 and 2012 and for the period from January 29, 2004 (inception) through June 30, 2013 are also included in Exhibit 99.3 and are incorporated herein by reference .
(b) Pro Forma Financial Information
The following unaudited pro forma combined financial statements, together with related explanatory notes, showing the pro forma effect on MDCO's financial statements of MDCO's acquisition of ProFibrix and other related pro forma events are attached hereto as Exhibit 99.3 and are incorporated herein by reference: (i) balance sheet as of June 30, 2013 and (ii) statements of operations for the six months ended June 30, 2013 and 2012.
(d) Exhibits
2.1*† Share Purchase Agreement, dated June 4, 2013, by and among the Company, ProFibrix, the equityholders of ProFibrix, certain members of the management team of ProFibrix in their capacities as warrantors of certain information in the Purchase Agreement, the holders of options to acquire equity interests in ProFibrix and the Representative.
23.1
Consent of Deloitte Accountants B.V. Independent Auditors for ProFibrix
99.1
Press Release dated August 5, 2013, announcing completion of the acquisition of ProFibrix (filed as exhibit 99.1 to MDCO’s current report on Form 8-K, filed on August 7, 2013, and incorporated herein by reference)
99.2
Audited financial statements of ProFibrix as of and for the year ended December 31, 2012 and the period from January 29, 2004 (inception) through December 31, 2012.
99.3 Unaudited interim financial statements of ProFibrix as of June 30, 2013 and for the six months ended June 30, 2013 and 2012 and for the period from January 29, 2004 (date of inception) through June 30, 2013.
99.4
Unaudited pro forma combined financial statements of MDCO as of and for the six months ended June 30, 2013 and year ended December 31, 2012.

* Schedules (and similar attachments) have been omitted pursuant to Item 601(b)(2) of Regulation S-K. The Company agrees to furnish supplementally copies of any of the omitted schedules (or similar attachments) to the Securities and Exchange Commission upon request.
† Confidential treatment requested as to portions of the exhibit. Confidential materials omitted and filed separately with the Securities and Exchange Commission.


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 hereunto duly authorized.

THE MEDICINES COMPANY
Date:  October 9, 2013        
By:    /s/ Paul M. Antinori
Paul M. Antinori
Senior Vice President and General Counsel







Exhibit Index
 

Exhibit No.
Description
2.1*†
Share Purchase Agreement, dated June 4, 2013, by and among the Company, ProFibrix, the equityholders of ProFibrix, certain members of the management team of ProFibrix in their capacities as warrantors of certain information in the Purchase Agreement, the holders of options to acquire equity interests in ProFibrix and the Representative.
23.1
Consent of Deloitte Accountants B.V. Independent Auditors for ProFibrix
99.1
Press Release dated August 5, 2013, announcing completion of the acquisition of ProFibrix (filed as exhibit 99.1 to MDCO’s current report on Form 8-K, filed on August 7, 2013, and incorporated herein by reference)
99.2
Audited financial statements of ProFibrix B.V. as of and for the year ended December 31, 2012 and the period from January 29, 2004 (inception) through December 31, 2012.
99.3
Unaudited interim financial statements of ProFibrix as of June 30, 2013 and for the six months ended June 30, 2013 and 2012 and for the period from January 29, 2004 (date of inception) through June 30, 2013.
99.4
Unaudited pro forma combined financial statements of MDCO as of and for the six months ended June 30, 2013 and year ended December 31, 2012

* Schedules (and similar attachments) have been omitted pursuant to Item 601(b)(2) of Regulation S-K. The Company agrees to furnish supplementally copies of any of the omitted schedules (or similar attachments) to the Securities and Exchange Commission upon request.
† Confidential treatment requested as to portions of the exhibit. Confidential materials omitted and filed separately with the Securities and Exchange Commission.








EX-23.1 2 exhibit231profibrixconsent.htm EXHIBIT Exhibit 23.1 (ProFibrix Consent)


Exhibit 23.1


CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

We consent to the incorporation by reference in Registration Statements (Forms S-8 No. 333-44884, 333-74612, 333-98191, 333-116295, 333-135460, 333-135461, 333-148602, 333-152105, 333-157499, 333-161672, 333-167895, 333-167896, 333-189710) pertaining to the 1998 Stock Incentive Plan, the 2000 Outside Director Stock Option Plan, the 2000 Employee Stock Purchase Plan, the 2001 Non-Officer, Non Director Employee Stock Incentive Plan, the 2004 Stock Incentive Plan, the 2007 Equity Inducement Plan, the 2009 Equity Inducement Plan, the Amended and Restated 2004 Stock Incentive Plan, the 2010 Employee Stock Purchase Plan and the 2013 Stock Incentive Plan of The Medicines Company and Registration Statement (Form S-3 Nos. 333-139987 and 333-190568) on Form 8-K/A of our report dated August 5, 2013 relating to the financial statements of Profibrix B.V. and its subsidiary, a development stage company, as of and for the year ended December 31, 2012 and for the period from January 29, 2004 (inception) through December 31, 2012, appearing in this Form 8-K/A of The Medicines Company.

                                    
/s/ Deloitte Accountants B.V.

October 9, 2013






EX-99.2 3 exhibit992profibrix.htm EXHIBIT Exhibit 99.2 (Profibrix)
Exhibit 99.2






ProFibrix B.V.
(A Development Stage Company)
US GAAP Financial Statements 2012
 
BioScience Park Leiden, the Netherlands
August 5, 2013








Table of Contents



2
 



Consolidated financial statements
 
   Consolidated Balance Sheet
   Consolidated Statements of Operations
    Consolidated Statements of Comprehensive Income
   Consolidated Statements of Stockholders’ Deficit
   Consolidated Statements of Cash Flows
   Notes to the Consolidated Financial Statements




3
 



Consolidated Balance Sheet
 
Notes
 
31.12.2012
 
 
 
 
 
EUR
 
 
Assets
 
 
 
 
 
Current assets
 
 
 
 
 
Cash and cash equivalents
 
 
2,465,843
 
 
Restricted cash
3.19
 
250,000
 
 
Other receivables
12
 
422,277
 
 
Total current assets
 
 
3,138,120
 
 
 
 
 
 
 
 
Non-current assets
Property and equipment, net
9
 
111,448
 
 
Intangible assets
10
 
30,519
 
 
Restricted cash
3.19
 
500,000
 
 
Total non-current assets
 
 
641,967
 
 
 
 
 
 
 
 
Total assets
 
 
3,780,087
 
 
 
 
 
 
 
 
Liabilities
 
 
 
 
 
Current liabilities
15
 
 
 
 
Accounts payable
 
 
1,322,887
 
 
Convertible notes payable
 
 
15,427,364
 
 
Short-term part of borrowings
 
 
1,616,773
 
 
Social securities and other taxes
 
 
83,260
 
 
Deferred grant income
 
 
45,727
 
 
Other current liabilities
 
 
1,493,441
 
 
Total current liabilities
 
 
19,989,452
 
 

Non-current liabilities
 
 
 
 
 
Long-term liabilities
14
 
7,588,986
 
 
Total liabilities
 
 
27,578,438
 
 
 
 
 
 
 
 
Commitments and contingencies
16, 17
 
-
 
 
 
 
 
 
 
 

4
 





Stockholders’ deficit
13
 
 
 
 
 
 
 
 
 
 
Preferred A stock; € 0.01 nominal value;
29,629,200 authorized and 12,434,523 issued and outstanding at December 31, 2012
 
 
124,345
 
 
 
 
 
 
 
 
Preferred B stock ; € 0.01 nominal value;
29,629,200 authorized and 16,414,459 issued and outstanding at December 31, 2012
 
 
164,145
 
 
 
 
 
 
 
 
Common stock; € 0.01 nominal value;
29,629,200 authorized and 5,643,925 issued and outstanding at December 31, 2012
 
 
56,439
 
 
Additional Paid-in Capital
 
 
28,958,013
 
 
Deficit accumulated during development stage
 
 
(53,109,319)
 
 
Accumulated other comprehensive income
 
 
8,026
 
 
Total stockholders’ deficit
 
 
(23,798,351)
 
 
 
 
 
 
 
 
Total liabilities and stockholders’ deficit
 
 
3,780,087
 
 


5
 



Consolidated Statements of Operations

 
Note
 
Year ended 31.12.2012
 
Period from January 29, 2004 (Inception) through December 31, 2012
 
 
 
EUR
 
EUR
 
 
 
 
 
 
 
 
 
 
 
 
Product sales
 
 
-
 
494,395
License revenues
 
 
-
 
161,421
Total revenues
 
 
-
 
655,816
Cost of product sales
 
 
-
 
120,000
Gross profit
 
 
-
 
535,816
 
 
 
 
 
 
Income from grants
 
 
77,792
 
314,761
Total other operating income

 
 
77,792
 
314,761
Operating expenses:
Research and development
5
 
16,346,959
 
46,918,497
General and administrative
 
 
1,503,741
 
5,169,010
Total operating expenses
 
 
17,850,700
 
52,087,507
 
 
 
 
 
 
Loss from operations
 
 
(17,772,908)
 
(51,236,930)
 
 
 
 
 
 
Financial expense (net)
7
 
(1,244,145)
 
(1,925,748)
Total financial expense
 
 
(1,244,145)
 
(1,925,748)

Net loss before income tax
 
 
(19,017,053)
 
(53,162,678)
 
 
 
 
 
 
Corporate income taxes
8
 
(47,081)
 
53,359
 
 
 
 
 
 
Net loss
 
 
(19,064,134)
 
(53,109,319)


6
 



Consolidated Statements of Comprehensive Income


 
Note
 
Year ended 31.12.2012
 
Period from January 29, 2004 (Inception) through December 31, 2012
 
 
 
EUR
 
EUR
 
 
 
 
 
 
 
 
 
 
 
 
Net loss
 
 
(19,064,134)
 
(53,109,319)
 
 
 
 
 
 
Foreign currency translation
 
 
 
 
 
Gain (loss) on foreign currency translation
 
 
(11,072)
 
8,026
Comprehensive income
 
 
(19,075,206)
 
(53,101,293)
 
 
 
 
 
 



7
 



Consolidated Statements of Stockholders’ Deficit
 
 
 
Preferred stock
 
Common stock
 
Additional Paid-in Capital
 
Accumulated Other Comprehensive Income
 
Deficit accumulated in development stage
 
Total stockholders’ deficit
 
Note
 
Shares
Amount
 
Shares
Amount
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Balance at January 29, 2004 (Inception)
 
 
-
-
 
-
-
 
-
 
-
 
-
 
-
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Proceeds from issuance of common stock in January 2004
 
 
-
-
 
4,000,000
40,000
 
-
 
-
 
-
 
40,000
Proceeds from issuance of common stock in 2005
 
 
-
-
 
973,000
9,730
 
483,348
 
-
 
-
 
493,078
Proceeds from issuance of common stock for Fibrocaps patents based on market value
 
 
-
-
 
290,000
2,900
 
144,060
 
-
 
-
 
146,960
Proceeds from issuance of Preferred A-stock in 2007
 
 
5,802,778
58,028
 
-
-
 
4,119,972
 
-
 
-
 
4,178,000
Proceeds from issuance of Preferred A-stock in 2008
 
 
6,631,745
66,317
 
-
-
 
4,708,540
 
-
 
-
 
4,774,857
Proceeds from issuance of common stock in 2009
 
 
-
-
 
80,000
800
 
43,200
 
-
 
-
 
44,000
Proceeds from issuance of Preferred B-stock in 2009
 
 
7,407,407
74,074
 
-
-
 
7,891,449
 
-
 
-
 
7,965,523
Fair value equity option convertible notes payable
 
 
-
-
 
-
-
 
12,750
 
 
 
-
 
12,750
Proceeds from issuance of common stock in 2011
 
 
-
-
 
300,925
3,009
 
-
 
-
 
-
 
3,009
Proceeds from issuance of Preferred B-stock in 2011
 
 
9,007,052
90,071
 
-
-
 
10,833,622
 
-
 
-
 
10,923,693
Other comprehensive income
 
 
-
-
 
-
-
 
-
 
19,098
 
-
 
19,098
Stock-based compensation
13
 
-
-
 
-
-
 
555,108
 
-
 
-
 
555,108
Net loss
13
 
-
-
 
-
-
 
-
 
-
 
(34,045,185)
 
(34,045,185)
Balance at December 31, 2011
 
 
28,848,982
288,490
 
5,643,925
56,439
 
28,792,049
 
19,098
 
(34,045,185)
 
(4,889,109)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Net loss
 
 
-
-
 
-
-
 
-
 
-
 
(19,064,134)
 
(19,064,134)
Other comprehensive income for the year
 
 
-
-
 
-
-
 
-
 
(11,072)
 
-
 
(11,072)
Total comprehensive income for 2012
 
 
-
-
 
-
-
 
-
 
(11,072)
 
(19,064,134)
 
(19,075,206)
Warrants issued with convertible notes payable
 
 
-
-
 
-
-
 
52,034
 
-
 
-
 
52,034
Stock-based compensation
13
 
-
-
 
-
-
 
113,930
 
-
 
-
 
113,930
Balance at December 31, 2012
 
 
28,848,982
288,490
 
5,643,925
56,439
 
28,958,013
 
8,026
 
(53,109,319)
 
(23,798,351)


8
 



Consolidated Statements of Cash Flows
 
Note
 
 Year ended 31.12.2012
 
Period from January 29, 2004 (Inception) through December 31, 2012
 
 
 
EUR
 
EUR
Cash flows from operating activities
 
 
 
 
 
Net loss
 
 
(19,064,134)
 
(53,109,319)
Adjustments to reconcile net loss to net cash used in operating activities:
 
 
 
 
 
- Depreciation and amortization
9,10
 
75,328
 
329,646
- Stock-based compensation
6
 
113,930
 
683,437
- Interest income and expenses
7
 
1,123,868
 
1,929,759
- Impairment loss on Haemostatix
 
 
-
 
1,465
Changes in operating assets and liabilities:
 
 
 
 
 
- Other receivables
 
 
432,768
 
(422,277)
- Accounts payable
 
 
190,228
 
2,899,588
Net cash used in operations
 
 
(17,128,012)
 
(47,687,701)
 
 
 
 
 
 
Cash flows from investing activities
 
 
 
 
 
Purchase of property and equipment
 
 
(25,355)
 
(322,092)
Purchase of financial assets
9
 
-
 
(1,465)
Net cash used in investing activities
 
 
(25,355)
 
(323,557)
 
 
 
 
 
 
Cash flows from financing activities
Proceeds from issuance of common and preferred stock
13
 
-
 
26,128,923
Proceeds from convertible notes payable
15
 
15,000,000
 
17,250,000
Proceeds from long-term loans
 
 
-
 
7,535,000
Repayment of long-term loans
 
 
(300,000)
 
(442,291)
Net cash provided by financing activities
 
 
14,700,000
 
50,471,632
 
 
 
 
 
 
Exchange rate effects and translation differences on cash
 
 
(10,803)
 
5,469
Net (decrease)/increase in cash and cash equivalents
 
(2,464,170)
 
2,465,843
 
 
 
 
 
 
Cash and cash equivalents - beginning of period
 
 
4,930,013
 
-
Cash and cash equivalents – end of period
 
 
2,465,843
 
2,465,843
 
 
 
 
 
 
Supplemental disclosures of Cash Flow Information
Corporate income tax received (paid)
 
 
(49,196)
 
56,188
Interest received (paid)
 
 
(94,787)
 
60,196


9
 



Notes to the consolidated financial statements
1. Description of business
ProFibrix B.V. and its 100% subsidiary (“ProFibrix” or the “Company”) is a biopharmaceutical Company which leverages its expertise in fibrinogen technology to develop and market innovative products for the haemostasis and regenerative medicine markets. The Company’s products are aimed at treatments that stop acute and severe bleeding during surgery or after trauma injury and support tissue repair. At the heart of all ProFibrix products is human fibrinogen a matrix protein with unique functional properties that plays a pivotal role in blood clotting and tissue healing.
ProFibrix B.V. is a limited liability company incorporated in the Netherlands, with its statutory seat in Leiderdorp. The address of its headquarters and registered office is Zernikedreef 9, 2333 CK Leiden, the Netherlands.
The Company is in its development stage as defined by the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 915, Development Stage Entities. The Company’s activities since inception have consisted principally of acquiring product and technology rights, raising capital and performing research and development activities. Since inception, the Company has incurred significant losses from operations and expects losses to continue for the foreseeable future. The Company’s success depends primarily on the successful development and regulatory approval of its product candidates and its ability to obtain adequate financing as discussed below.
Liquidity Matters

The Company strengthened its financial position in February 2012 through the successful closing of a EUR 12.0 million convertible notes payable Agreement with its existing investors, followed in November 2012 with an additional convertible notes payable Agreement amounting to EUR 6.0 million also sponsored by all four existing investors (of which EUR 3.0 million had been drawn before year-end). On April 20, 2013 the Company agreed to increase the additional convertible notes payable with EUR 3.0 million to a total amount of EUR 9.0 million.
On November 28, 2012 Agentschap NL granted the Company a second loan under its Innovation Credit scheme of EUR 4.7 million to finance the further Phase III clinical development of FibrocapsTM. The first payment amounting to EUR 2.0 million has been received in January 2013 and the second payment amounting to EUR 2.7 million has been received in April 2013.
On June 4, 2013 the Company and The Medicines Company announced an agreement for The Medicines Company to purchase all of the outstanding capital stock of ProFibrix B.V. subject to satisfactory review of the pending Phase 3 clinical trial results of our lead product FibrocapsTM. Under the terms of the agreement we received a USD 10 million upfront option payment.

10
 



If the Medicines Company is satisfied with the trial results it will purchase all of the outstanding capital stock at closing after conversion of the € 12.0 million convertible notes payable received in 2012. The additional convertible notes payable amounting to € 9.0 million (of which currently € 7.0 million is drawn) and the loans from Agentschap NL and ABNAMRO-bank will be repaid at closing (including accumulated interest). We received positive data from our phase 3 clinical trials and after review by the Medicines Company, the purchase options for all the outstanding capital stock of the Company was executed by them. Closing of the acquisition took place on August 5, 2013.

The Medicines Company confirmed to provide the resources that are necessary for the Company to meet its financial obligations. As a consequence the Company has sufficient funds for a period of at least 12 months after balance sheet date. These financial statements have therefore been prepared based on going concern.

2. New U.S. GAAP Accounting Pronouncements
The 2012 consolidated financial statements of ProFibrix B.V. have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). New Standards and Interpretations, which became effective as of January 1, 2012, did not have a material impact on our consolidated financial statements.
In June 2011, the FASB issued ASU No. 2011-05, “Comprehensive Income (Topic 220)”. Under the ASU, an entity has the option to present comprehensive income in either one continuous statement or two consecutive financial statements. Under both options, an entity is required to present each component of net income along with total net income, each component of other comprehensive income (“OCI”) along with a total for OCI and a total amount for comprehensive income. The option under current guidance which permits the presentation of components of OCI as part of the statement of changes in shareholders’ equity has been eliminated. In December 2011, the FASB issued ASU 2011-12 which indefinitely defers certain provisions of ASU 2011-05, the main deferred provision relating to a requirement for entities to present reclassification adjustments out of accumulated OCI by component in both the statements in which net income is presented and the statement in which OCI in any period is presented. The ASU is effective for annual and interim periods beginning after December 15, 2011. We have adopted this standard; adoption had no impact on our consolidated financial statements.
In December 2011, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2011-11 “Disclosures about Offsetting Assets and Liabilities”. Under the new guidance, the entities must disclose both gross information and net information about both instruments and transactions eligible for offset on the balance sheet in accordance with the offsetting guidance in ASC 210-20-45 or ASC 815-10-45, and instruments and transactions subject to an agreement similar to a master netting arrangement. The new guidance will be effective for us beginning January 1, 2013. Other than requiring some additional disclosures, we do not anticipate material impacts on our consolidated financial statements upon adoption.

11
 



In July 2012, the FASB issued ASU No. 2012-02 “Testing Indefinite-Lived Intangible Assets for Impairment”. This ASU amends the guidance in ASC 350-30 on testing indefinite-lived intangible assets, other than goodwill, for impairment. The FASB issued the ASU in response to feedback on ASU 2011-08, which amended the goodwill impairment testing requirements by allowing an entity to perform a qualitative impairment assessment before proceeding to the two-step impairment test. The new guidance will be effective for annual and interim impairment tests performed for fiscal years beginning after September 15, 2012. Early adoption is permitted. The ASU 2012-02 will not have any effect on our consolidated financial statements.
In October 2012 the FASB issued ASU No. 2014-04 “Technical Corrections and Improvements”. This ASU makes certain technical corrections (i.e., relatively minor corrections and clarifications) and “conforming fair value amendments” to the FASB Accounting Standards Codification (the “Codification”). The new guidance will be effective for fiscal years beginning after December15, 2012. We do not anticipate material impacts on our consolidated financial statements upon adoption.
In February 2013, FASB issued guidance establishing new requirements for disclosing reclassifications of items out of accumulated other comprehensive income. Specifically, (1) disclosure is required of the changes in components of accumulated OCI, (2) disclosure is required of the effects on individual line items in net income for each item of accumulated OCI that is reclassified in its entirety to net income, and (3) cross references are required to other disclosures that provide additional details for OCI items that are not reclassified in their entirety to net income. The guidance will be effective for interim and annual periods beginning after December 15, 2012. We are in the process of evaluating this guidance and currently do not believe that it will have a material effect on our consolidated financial statements.
3.     Summary of Significant Accounting Policies
3.1    Statement of compliance
The consolidated financial statements of ProFibrix B.V. and its subsidiary have been prepared in accordance with U.S. generally accepted accounting principles (GAAP).
3.2    Basis of preparation and use of estimates
The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make judgments, estimates and assumptions that affect the amounts reported in the Company’s financial statements and accompanying notes. The accounting estimates that require the Company to make significant judgments include, but are not limited to, the valuation of its preferred stock, common stock, and stock options for purposes of determining stock-based compensation. Actual results could differ materially from those estimates and such differences could affect the result of operations in future periods.
3.3    Basis of consolidation
The consolidated financial statements incorporate the financial statements of the ProFibrix B.V. and its 100% subsidiary ProFibrix Inc.

12
 



All intercompany transactions, balances, income and expenses are eliminated in full on consolidation.
3.4    Revenue recognition
Revenue comprises the fair value of the sale of goods and services, and is shown net of value added tax, rebates and discounts and after eliminated sales within the Company.
Revenues from goods are recognized upon delivery. The cost price of these goods is allocated to the same period.
License and royalty revenues include amounts earned from third parties with licenses and/or options to the Company’s intellectual property. License and royalty revenues are recognized when earned in accordance with the substance and under the terms of the related agreements and when it is probable that the economic benefits associated with the transaction will flow to the entity and the amount of the revenue can be measured reliably.
3.5    Government grants
Government grants are not recognized until there is reasonable assurance that the Company will comply with the conditions attached to them and that grants will be received.
The benefit of a government loan at a below-market rate of interest is treated as a government grant, measured as the difference between proceeds received and the fair value of the loan based on prevailing market interest rates.
Other government grants are recognized as other operating income over the period necessary to match them with the costs for which they are intended to compensate, on a systematic basis. Government grants that are receivable as compensation for expenses or losses already incurred or for the purpose of giving immediate financial support to the Company with no future related costs are recognized in profit or loss in the period in which they become receivable.
The WBSO (“law for stimulation of research and development”) is a fiscal facility that provides grants to companies, knowledge centers and self-employed people who perform research and development activities (as defined in the WBSO Act). Under this Act, a contribution is paid towards the labor costs of employees directly involved in research and development. The contribution is in the form of a reduction of payroll taxes and social security contributions. Grants relating to labor costs (WBSO) are deferred and recognized in the income statement as negative labor costs over the period necessary to match them with the labor costs that they are intended to compensate.

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3.6    Operating leases
Leases in which a significant portion of the risks and rewards of ownership are retained by the lessor are classified as operating leases. Payments made under operating leases (net of any incentives received from the lessor) are charged to the income statement on a straight-line basis over the period of the lease.
3.7     Foreign currencies
Items included in the financial statements of each of the Company’s entities are measured using the currency of the primary economic environment in which the entity operates (“the functional currency”). The consolidated financial statements are presented in Euros, which is the Company’s functional and presentation currency.
Foreign currency transactions are translated into the functional currency using the exchange rates prevailing at the dates of the transactions. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at year-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognized in the income statement.
3.8    Classes of financial instruments
Classes of financial instruments
Financial instruments can be both primary financial instruments, such as receivables and payables, and financial derivatives. For the accounting principles of primary financial instruments, reference is made to the accounting principles per individual class of financials instruments.
Financial derivatives are valued at fair value. Upon first recognition, financial derivatives are recognized at fair value and then revalued at fair value as at balance sheet date.

Fair Value Measurement
Fair value is defined as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining the fair value measurements for assets and liabilities required to be recorded at fair value, the Company considers the principal or most advantageous market in which it would transact and considers assumptions that market participants would use when pricing the asset or liability, such as inherent risk, transfer restrictions and risk of nonperformance.

A fair value hierarchy was established which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. A financial instrument’s categorization within the fair value hierarchy is based upon the lowest level of input that is significant to the fair value measurement. The three levels of inputs that may be used to measure fair value are as follows:

Level I – Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date;

14
 



Level II – Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and
Level III – Unobservable inputs that are significant to the measurement of the fair value of the assets or liabilities that are supported by little or no market data.

As of December 31, 2012 the Company’s derivatives consisted of one interest rate swap. The valuation of this interest rate swap is based on level II inputs. The valuation technique used to determine the fair value of the interest rate swap is the Net Present Value technique, which is the estimated amount that a bank would receive or pay to terminate the swap agreements at the reporting date, taking into account current interest rates.
3.9    Pension obligations
The Company operates a defined contribution pension plan for all employees funded through payments to an insurance company. The Company has no legal or constructive obligation to pay further contributions once the contributions have been paid. The contributions are recognized as employee benefit expense when they are due. Prepaid contributions are recognized as an asset to the extent that a cash refund or a reduction in the future payments is available.
3.10        Stock-based payments

The Company operates an equity-settled stock-based compensation plan. The Company accounts for stock-based compensation following the provisions of FASB ASC Topic 718, Stock Compensation. The Company measures compensation cost for share-based payment awards granted to employees and non-employee directors at fair value using the Black-Scholes option pricing model.
The fair value determined at the grant date of the equity-settled stock-based payments is expensed over the requisite service period based on the estimated grant-date fair value of the awards and forfeiture rates. At the end of each reporting period, the Company revises its estimate of the number of equity instruments expected to vest. The impact of the revision of the original estimates, if any, is recognized in profit or loss such that the cumulative expense reflects the revised estimate, with a corresponding adjustment to additional paid-in capital (common stock) within shareholders’ deficit.
Equity-settled stock-based payment transactions with parties other than employees are measured based on the fair value of the goods or services or the fair value of the equity instruments issued, depending on which is more reliably measurable..
3.11    Bonus plans
The Company recognizes a liability and an expense for bonuses if contractually obliged or if there is a past practice that has created a constructive obligation.

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3.12    Taxation

The Company accounts for uncertain tax positions in accordance with Accounting Standards Codification Topic 740, Income Taxes (ASC 740). ASC 740 provides for the recognition of deferred tax assets if realization of such assets is more likely than not. The Company uses the liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax basis of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company must then assess the likelihood that the resulting deferred tax assets will be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. Due to the Company’s lack of earnings history, its net deferred tax assets have been fully offset by a valuation allowance.
3.13    Property and equipment
Property and equipment comprise mainly laboratory equipment, furniture and computer hardware and software. All property and equipment are stated at historical cost less depreciation. Historical cost includes expenditure that is directly attributable to the acquisition of the items.
Subsequent costs are included in the asset’s carrying amount or recognized as a separate asset, as appropriate, only when it is probable that the future economic benefits associated with the item will flow to the Company and the cost of the item can be measured reliably. All other repairs and maintenance charges are expensed in the financial period in which these are incurred.
Depreciation is calculated using the straight-line method to allocate the cost of the assets to their residual values over their estimated useful lives. Property and equipment are depreciated as follows:
Laboratory equipment                5 years
-    Furniture                                5 years
-    Computer hardware/software        3-5 years
The assets’ residual values and useful lives are reviewed, and adjusted if appropriate, at each balance sheet date.
An asset’s carrying amount is written down immediately to its recoverable amount if the asset’s carrying amount is greater than its estimated recoverable amount (also refer to 3.15).
Gains and losses on disposals are determined by comparing proceeds with carrying amounts. These are included in the income statement.

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3.14    Intangible assets
Licenses
Acquired patents have a definite useful life and are carried at cost less accumulated amortization and impairment losses. Amortization is calculated using the straight-line method to allocate the cost of patents over their estimated useful lives (generally 10 years unless a patent expires prior to that date). Amortization begins when an asset is available for its intended use.
3.15    Impairment of tangible and intangible assets
The Company reviews long-lived assets, including property and equipment, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends, and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset to its carrying value. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of an asset are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset over its fair value, determined based on discounted cash flows. To date, the Company has not recorded any impairment losses on long-lived assets.
3.16    Financial assets
All financial assets are recognized and derecognized on trade date where the purchase or sale of a financial asset is under a contract whose terms require delivery of the financial asset within the timeframe established by the market concerned, and are initially measured at fair value, plus transaction costs, except for those financial assets classified as at fair value through profit or loss, which are initially measured at fair value.
(a)    Other financial assets
Other financial assets are carried at cost and assessed for indicators of impairment at the end of each reporting period. Other financial assets are investments in unquoted equity instruments that are not carried at fair value because their fair value cannot be reliably measured. They are included in non-current assets unless Management intends to dispose the investment within 12 months of the balance sheet date.


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3.17    Derivative financial instruments

Derivatives financial instruments are initially recognized at fair value at the date a derivative contract is entered into and are subsequently remeasured to their fair value at the end of each reporting period. The fair value is based on the market prices of the instruments. Derivatives are carried as assets when the fair value is positive and as liabilities when the fair value is negative. To the extent that no formal hedge accounting is applied, any gains and losses arising from changes in the fair value of the instruments are recognized in the statement of income during the period in which they arise.
3.18    Cash and cash equivalents

Cash and cash equivalents include cash in hand and all highly liquid investments with maturities of three months or less that are convertible to a known amount of cash and bear an insignificant risk of change in value.
3.19 Restricted cash
In connection with a loan agreement with ABNAMRO-bank amounting to EUR 2,250,000, an amount of EUR 750,000 is not at our free disposal (locked up as part of the securisation of the loan). The restricted amount is reduced EUR 62,500 per quarter in connection with the quarterly repayments of the loan starting April 1, 2013. The amount is presented as restricted cash on the balance sheet.

3.20    Financial liabilities and equity instruments
Debt and equity instruments are classified as either financial liabilities or as equity in accordance with the substance of the contractual arrangement.

(a) Equity instruments
An equity instrument is any contract that evidences a residual interest in the assets of an entity after deducting all of its liabilities. Equity instruments issued by the Company are recognized at the proceeds received, net of direct issue costs.

(b) Compound instruments
The component parts of compound instruments (convertible bonds) issued by the Company are classified separately as financial liabilities and equity in accordance with the substance of the contractual arrangement. At the date of issue, the fair value of the liability component is estimated using the prevailing market interest rate for a similar non-convertible instrument. This amount is recorded as a liability on an amortized cost basis using the effective interest method until extinguished upon conversion or at the instrument’s maturity date. The equity component is determined by deducting the amount of the liability component from the fair value of the compound instrument as a whole. This is recognized and included in equity, net of income tax effects, and is not subsequently remeasured.


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(c) Other financial liabilities
Other financial liabilities, including borrowings, are initially measured at fair value, net of transaction costs incurred, and are subsequently measured at amortized cost using the effective interest method, with interest expense recognized on an effective yield basis.
The effective interest method is a method of calculating the amortized cost of a financial liability and of allocating interest expense over the relevant period. The effective interest rate is the rate that exactly discounts estimated future cash payments through the expected life of the financial liability, or, where appropriate, a shorter period.

Borrowings and other financial liabilities are classified as ‘non-current liabilities’ unless the Company has liabilities with maturities up to one year, which are classified as “current liabilities”.
 
The Company derecognizes financial liabilities when the liability is discharged, cancelled or expired.
3.21 Research and development costs and credits
Costs relating to research and development (R&D) are charged to operating expenses as incurred. ProFibrix B.V. receives grants and other credits from several Dutch institutes (see 3.5 above). For as far as such government grants and other credits cover R&D costs, these are recorded as R&D credits in the R&D line in the consolidated statements of operations in the period in which such costs occur.
3.22 Clinical trial accruals
Clinical trial costs are a component of research and development expenses. The Company accrues and expenses clinical trial activities performed by third parties based upon actual work completed in accordance with agreements established with clinical research organizations and clinical sites. The Company determines the actual costs through review of documentation, discussions with internal personnel and external service providers, data as to the progress or stage of completion of trials or services, and the agreed-upon fee to be paid for such services.
Nonrefundable advance payments for goods and services that will be used or rendered in future research and development activities, are deferred and recognized as expense in the period that the related goods are delivered or services are performed.

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4.     Financial risk management
4.1    Risk management policies
The Company’s activities expose it to a variety of financial risks: market risk (including currency risk, interest rate risk and price risk), credit risk and liquidity risk. The Company’s overall financial risk management seeks to minimize potential adverse effects resulting from unpredictability of financial markets on the Company’s financial performance.
Risk management is carried out by the finance department. The finance department identifies and evaluates financial risks and hedges these risks if deemed appropriate.
(a)Market risk
Foreign exchange risk arises from future commercial transactions and recognized assets and liabilities in foreign currencies. In the years presented, the Company had no significant outstanding receivables, but had significant expenditures in various currencies, predominately in US-Dollars and British-Pounds. The Company has an exposure associated with the time delay between entering into a contract, budget or forecast and the realization thereof. It is the Company’s policy to manage these exposures by hedging foreign currency risks on a selective basis by Management’s decision. As of December 31, 2012 no hedge instruments related to foreign currency risks were outstanding. The impact of fair value measurements on the financial statements is limited. We included the disclosure requirements of ASC 820 (Fair Value Measurement) in the notes of the applicable account balance (where relevant).
(b) Interest rate risk
The Company is exposed to interest rate risks as a result of changes in the market interest rates compared to loans with fixed rates. The Company has three loans with fixed interest rates, which total € 20.6 million at 31 December 2012. The Company has one loan amounting to € 2.25 million which bears a floating interest rate. By use of interest rate swaps the floating interest rate has been swapped into a fixed interest rate. Details on the interest rates and maturity of these loans are provided in note 17 “Long-term liabilities”.
(c) Credit risk
Credit risk represents the risk of financial loss caused by default of the counterparty. The Company has no large receivables balances with external parties. The Company’s principal financial assets are cash and cash equivalents which are placed at Rabobank and ABN AMRO-bank.
(d) Liquidity risk
Liquidity risk represents the risk that an entity will encounter difficulty in meeting obligations associated with its financial liabilities. Prudent liquidity risk management implies ensuring sufficient availability of cash resources for funding of the operations and planning to raise cash as if and when needed, either through issue of shares or through credit facilities. Management monitors rolling forecasts of the Company’s liquidity reserve on the basis of expected cash flow.


20
 



The Company strengthened its financial position in February 2012 through the successful closing of a EUR 12.0 million convertible notes payable Agreement with its existing investors, followed in November 2012 with an additional convertible notes payable Agreement amounting to EUR 6.0 million also sponsored by all four existing investors.
On November 28, 2012 Agentschap NL granted the Company a second loan under its Innovation Credit scheme of EUR 4.7 million to finance the further Phase III clinical development of FibrocapsTM. The first payment amounting to EUR 2.0 million have been received in January 2013.
Our liquidity analysis consist of the following cash outflow from financial liabilities:
(in thousands)
 
 
 
 
 

Total 
 

< 1 year
 

1-3 years
 
 
 
 
 
 
 
EUR
 
EUR
 
EUR
 
 
 
 
 
 
 
 
 
 
 
 
 
Cash outflow from loans
 
 
 
 
 
24,003
 
17,173
 
6.830
 
Under the cash outflow from loans with a maturity < 1 year, an amount of EUR 12,467 is included regarding a convertible notes payable which is expected to convert into Preference B-shares in 2013 and therefore will likely not lead to cash outflows.

In November 2012 the Company strengthened its financial position with an additional convertible notes payable Agreement amounting to EUR 6.0 million also sponsored by all four existing investors (of which EUR 3.0 million had been drawn before year-end). On April 20, 2013 the Company agreed to increase the additional convertible notes payable with EUR 3.0 million to a total amount of EUR 9.0 million.
On November 28, 2012 Agentschap NL granted the Company a second loan under its Innovation Credit scheme of EUR 4.7 million to finance the further Phase III clinical development of FibrocapsTM. The first payment amounting to EUR 2.0 million has been received in January 2013 and the second payment amounting to EUR 2.7 million has been received in April 2013.
On June 4, 2013 the Company and The Medicines Company announced an agreement for The Medicines Company to purchase all of the outstanding capital stock of ProFibrix B.V. subject to satisfactory review of the pending Phase 3 clinical trial results of our lead product FibrocapsTM. Under the terms of the agreement we received a USD 10 million upfront option payment. If the Medicines Company is satisfied with the trial results it will purchase all of the outstanding capital stock at closing after conversion of the € 12.0 million convertible notes payable received in 2012. The additional convertible notes payable amounting to € 9.0 million (of which currently € 7.0 million is drawn) and the loans from Agentschap NL and ABNAMRO-bank will be repaid at closing (including accumulated interest). We received positive data from our phase 3 clinical trials and after review by the Medicines Company, the purchase options for all the outstanding capital stock of the Company was executed by them. Closing of the acquisition took place on August 5, 2013.
The Medicines Company confirmed to provide the resources that are necessary for the Company to meet its financial obligations.

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5.     Research and development costs
The research and development costs amounted to € 16,346,959 in 2012 and comprise allocated employee costs, clinical development costs, the costs of materials and laboratory consumables, license- and IP-costs, allocated depreciation costs and allocated other costs.
6.      Employee benefits

 
2012
 
 
 
EUR
 
 
 
 
 
 
Wages and salaries
3,079,081
 
 
Social security costs
182,656
 
 
Stock-based compensation (Note 16.3)
113,930
 
 
Pension costs – defined contribution plans
139,075
 
 
Other personnel costs
178,710
 
 
 
3,693,452
 
 
 
 
 
 
Average number of R&D employees
19.2
 
 
Average number of General and Administrative employees
4.5
 
 
Average number of employees for the period
23.7
 
 
 
 
 
 
Number of employees at December 31 (converted to FTE)
24.8
 
 
At December 31, 2012 7.0 FTE were employed in foreign countries.
Included in the wages and salaries for 2012 is an amount of EUR 195,249 with respect to WBSO grants.


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7.      Financial income and expense

 
 
2012
 
 
 
 
EUR
 
 
Financial income:
 
 
 
 
-    Current accounts
 
38,033
 
 
-    Exchange rate differences
 
138,774
 
 
 
 
176,807
 
 
 
 
 
 
 
Financial expense:
 
 
 
 
-    Interest loan-Innovatiekrediet
 
643,314
 
 
-    Interest loan-Uitdagerskrediet
 
77,792
 
 
-    Interest and costs loan ABNAMRO-bank
 
138,292
 
 
-    Fair value interest rate swap
 
1,156
 
 
-    Interest convertible notes payable
 
479,398
 
 
-    Interest/fair value equity options convertible notes payable
 
-
 
 
-    Costs new financing
 
81,000
 
 
 
 
1,420,952
 
 
 
 
 
 
 
Financial expense (net)
 
(1,244,145)
 
 

8.     Income taxes

The calculation of the tax charge is as follows:
 
 
2012
 
 
 
 
 
 
EUR
 
 
 
 
 
 
 
 
 
 
 
Income tax provision based on domestic rate (25%)
 
4,766,034
 
 
 
 
Effects of tax rates in foreign jurisdictions
 
(21,510)
 
 
 
 
Adjustments in respect of tax incentives
 
720,000
 
 
 
 
 
 
5,464,524
 
 
 
 
Less: Valuation allowance
 
(5,511,605)
 
 
 
 
Income tax charge
 
(47,081)
 
-0,2%
 
 
The Company’s only US subsidiary recharges its costs incurred to its parent company with an at arm’s length mark-up. As a result the US subsidiary is profitable and pays a small amount of income taxes in the US. A current tax payable is recognized in other current liabilities for EUR 12,678 related to the tax expense of this subsidiary.

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Due to the operating losses incurred since inception the Company has no tax provisions at ProFibrix B.V. level. Deferred tax assets reflect the net tax effects of net operating loss and tax credit carryforwards and temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. The significant components of the deferred tax assets are as follows:

Deferred tax assets
 
2012
 
 
 
 
 
 
 
Net operating loss carryforwards
 
13,868,450
 
 
Other
 
13,655
 
 
Total gross deferred tax assets
 
13,882,105
 
 
 
 
 
 
 
Valuation allowance
 
(13,868,450)
 
 
Net deferred tax asset
 
13,655
 
 
Realization of deferred tax assets is dependent on future earnings, if any, the timing and amount of which are uncertain. Accordingly, the Company’s net deferred tax assets related to operating loss and tax credit carryforwards have been fully offset by a valuation allowance. According to current tax regulations the first amount of the tax loss carryforwards will expire in 2013 and the last will expire in 2021. The other deferred tax assets relate to temporary differences between commercial and fiscal books for the Company’s US operations.

It is the Company’s policy to recognize interest and penalties related to income tax matters in income tax expense. As of December 31, 2012, the Company had no uncertain tax position and consequentially no accrued interest and penalties related to uncertain tax positions.

9.    Property and equipment
 
Lab
Equipment
 
Office
      furniture
 
Total
 
 
EUR
 
EUR
 
EUR
 
Cost
 
 
 
 
 
 
Balance at December 31, 2011
203,620
 
97,041
 
300,661
 
Additions
15,032
 
10,323
 
25,355
 
Effect of changes in exchange rates
-
 
(1,149)
 
(1,149)
 
Balance at December 31, 2012
218,652
 
106,215
 
324,867
 
 
 
 
 
 
 
 
Accumulated depreciation
 
 
 
 
 
 
Balance at December 31, 2011
102,706
 
50,961
 
153,667
 
Depreciation
39,363
 
20,886
 
60,249
 
Effect of changes in exchange rates
-
 
(497)
 
(497)
 
Balance at December 31, 2012
142,069
 
71,350
 
213,419
 
 
 
 
 
 
 
 
Carrying amount
 
 
 
 
 
 
December 31, 2012
76,583
 
34,865
 
111,448
 


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10.        Intangible assets
 
Patents
 
EUR
Cost
 
Balance at December 31, 2011
146,960
Additions
-
Balance at December 31, 2012
146,960

Accumulated amortization and impairment
 
Balance at December 31, 2011
101,745
Amortization expense
14,696
Balance at December 31, 2012
116,441
 
 
Carrying amount December 31, 2012
30,519
11. Investments
Other financial assets relate to the cost value less impairments of the non-consolidated interest in Haemostatix Ltd., Nottingham United Kingdom. As part of an option agreement dated November 4, 2005, ProFibrix received in 2006 EUR 60,000 in cash and 90,427 in shares of Haemostatix Ltd. being the equivalent of EUR 40,000. In 2010 ProFibrix invested € 1,465 in a Series E-round. Our interest in Haemostatix Ltd. amounts to 0.7% as per 31 March 2012. Haemostatix shares are not traded on an active market and, as a result, a quoted market price is not available. The shares are valued at EUR 0, being management’s best estimate. In total
€ 41,466 impairment losses have been recognized in prior years.

12.    Other receivables
 
31.12.2012
 
 
 
EUR
 
 
 
 
 
 
Value added tax
83,410
 
 
Deferred taxation
13,655
 
 
Prepayments
247,106
 
 
Other
78,106
 
 
 
422,277
 
 
All other receivables are considered short-term and due within one year. Refer to note 9 for further disclosures on the deferred tax asset.


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13.    Stockholders’ deficit
13.1    Issued stock

 
Common
 
Preferred
 
Preferred
 
Share
 
stock
 
A stock
 
B stock
 
capital
Share capital
EUR
 
EUR
 
EUR
 
EUR
 
 
 
 
 
 
 
 
Balance at December 31, 2011
56,439
 
124,345
 
164,145
 
344,929
New shares issued
-
 
-
 
-
 
-
Balance at December 31, 2012
56,439
 
124,345
 
164,145
 
344,929

 
Common
 
Preferred
 
Preferred
 
Number of
 
stock
 
A stock
 
B stock
 
Issued shares
Number of issued shares
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Balance at December 31, 2011
5,643,925
 
12,434,523
 
16,414,459
 
34,492,907
New stock issued
-
 
-
 
-
 
-
Balance at December 31, 2012
5,643,925
 
12,434,523
 
16,414,459
 
34,492,907

 
Common
 
Preferred
 
Preferred
 
Share
 
stock
 
A stock
 
B stock
 
premium
Additional Paid-in Capital
EUR
 
EUR
 
EUR
 
EUR
 
 
 
 
 
 
 
 
Balance at December 31, 2011
1,225,716
 
8,828,512
 
18,737,821
 
28,792,049
Issue of new shares
-
 
-
 
-
 
-
Warrants issued with convertible notes payable
52,034
 
-
 
-
 
52,034
Stock-based compensation
113,930
 
-
 
-
 
113,930
Balance at December 31, 2012
1,391,680
 
8,828,512
 
18,737,821
 
28,958,013
The authorized share capital of the Company amounting to EUR 888,876 consists of 29,629,200 common stock, 29,629,200 preferred A stock and 29,629,200 preferred B stock, each with a par value of EUR 0.01 per share. All issued shares have been fully paid in cash.
The preferred stock include a liquidation and anti-dilution preference. Preferred A and B stock can be converted into common stock at any time. Certain decisions of the Management Board are subject to approval of the meeting of holders of preferred A and B stock.

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13.2    Stock options
The Company operates an equity-settled stock-based compensation plan. The Remuneration Committee of the Supervisory Board may grant options to employees, directors and members of the Supervisory Board and consultants. The compensation expenses included in operating costs for those plans were € 113,930 in 2012. Options granted under the stock option plan are exercisable once vested. Granted options vest over a period of four years (25% after one year, there after straightline per quarter). Under certain conditions and with prior approval of the Supervisory Board options can be exercised upon the grant date. The options expire ten years after date of grant. Options granted under the stock option plan are granted at exercise prices which equal the fair value of the ordinary shares of the Company at the date of the grant.
The Company accounts for its employee stock options under the fair value method. The fair value of the options is estimated at the date of grant using the Black-Scholes option-pricing model, with the following assumptions:
 
Options granted in 2012

 
 
 
 
 
 
Dividends
-

 
 
Expected life
2.5 years

 
 
Risk-free interest rate
0.5
%
 
 
Volatility
66.7
%
 
 
Movements in the number of options outstanding and their related weighted average exercise prices are as follows:
 
Number of options
 
Average exercise price
 
 
 
EUR
 
 
 
 
Balance at December 31, 2011
3,621,843
 
0.40
Granted
437,912
 
0.44
Forfeited
-
 
-
Exercised
-
 
-
Lapsed
-
 
-
Balance at December 31, 2012
4,059,755
 
0.40
Other details with respect to stock options are set out in the table below:
 
2012
Average remaining contractual term of currently vested awards (years)
6.26
Total amount of compensation cost to be recognized in future years for unvested awards
75,936
Weighted-average future period over which compensation cost is expected to be recognized for unvested awards (years)
1.4
14.    Long-term liabilities

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31.12.2012
 
 
 
EUR
 
 
 
 
 
 
Loans from Agentschap NL:
 
 
 
-    Uitdagerskrediet
-
 
 
-    Innovatiekrediet
4,500,000
 
 
- Accrued interest Innovatiekrediet
1,286,418
 
 
ABNAMRO-bank
1,687,500
 
 
Derivative financial instruments
115,068
 
 
 
7,588,986
 
 
(a)        Uitdagerskrediet
ProFibrix started a development project in the year 2008 of which the expected costs approximated EUR 3,476,859. For this project Agentschap NL, the department of the
Ministry of Economic Affairs responsible for grants, has granted a loan facility of 35%
of the costs incurred until December 31, 2009, with a maximum of EUR 1,000,000. As at December 31, 2009 the maximum amount under this loan facility was received from
Agentschap NL. The amount due in 2013 has been presented under current liabilities.
The loan bears interest at 0%. The securities for amounts due to Agentschap NL are a pledge on all intangible and tangible fixed assets which are co-financed with the awarded grant. As per October 1, 2012 40% of the loan facility has been repaid. As per October 1, 2013 60% has to be repaid. Using prevailing market interest rates for an equivalent loan of 11%, the fair value of the loan is estimated at EUR 554,273 at December 31, 2012. The difference between the nominal value and the fair value of the loan, is the fair value of the benefit derived from the interest-free loan which is recognized as deferred grant income.
(b)        Innovatiekrediet
Agentschap NL has granted the Company a second loan under its new Innovation Credit scheme of up to EUR 5 million to finance the further clinical development of FibrocapsTM. In 2010
the first payments amounting to EUR 2,320,150 have been received. In 2011 the last payments amounting to EUR 2,679,850 have been received. The loan bears interest at 11.4%, to be paid
in arrears. As per November 1, 2013 10% of the loan facility has to be repaid, as per
November 1, 2014 20% and as per November 1, 2015 the additional 70% plus the total amount of accrued interest. The securities for amounts due to Agentschap NL are a pledge on all intangible and tangible fixed assets which are co-financed with the awarded grant.
(c)        ABNAMRO-bank
In March 2011 the Company entered into a loan agreement (“MKB Borgstellingskrediet”) with ABNAMRO-bank amounting to EUR 2,250,000 of which EUR 750,000 is not at our free disposal (locked up as part of the securisation of the loan). We have granted a right of pledge on inventory, stock, receivables to ABN AMRO Bank to secure the repayment of the loan. The loan bears a floating interest rate. As per April 1, 2013 the loan has to be repaid in 12 equal quarterly installments amounting to EUR 187,500 each.


28
 



As part of the loan agreement the Company entered into derivative instruments (interest rate swaps) for the management of interest rate risks. Under interest rate swap contracts the Company agrees to exchange the difference between fixed and floating interest rate amounts calculated on the principal loan amount. Such contracts enable the Company to mitigate the risk of changing interest rates and the cashflow exposures on the issued variable rate debt. The fair value of interest rate swaps at the end of the reporting period is determined by discounting the future cash flows using the curves at the end of the reporting period and the credit risk inherent in the contract. The changes in fair value are recognized in the profit and loss account. The fair value of the interest rate swaps as per December 31, 2012 amounts to EUR 115,068.
15.    Current liabilities

 
31.12.2012
 
 
 
EUR
 
 
 
 
 
 
Accounts payable
1,322,887
 
 
Convertible notes payable
14,947,966
 
 
Interest convertible notes payable
479,398
 
 
Short-term part of borrowings
1,616,773
 
 
Social securities and other taxes
83,260
 
 
Deferred grant income
45,727
 
 
Employee bonuses
506,832
 
 
Invoices to be received
590,248
 
 
Other
396,361
 
 
 
19,989,452
 
 
The majority of our current liabilities are denominated in Euro.
Convertible notes payable
On February 27, 2012 the Company entered into a convertible notes payable agreement with its existing shareholders amounting to EUR 12,000,000. The loan bears interest at 8.0%, to be paid in arrears. The loan, including accrued interest, matures post Phase III, but no later than July 1, 2013. The total loan amount will be converted into preference B-shares. The conditions of the loan have been evaluated and no equity component was recognized.
On November 22, 2012 the Company entered into a second convertible notes payable agreement with its existing shareholders amounting to EUR 6,000,000 of which EUR 3,000,000 has been received in 2012. The loan bears interest at 8.0%, to be paid in arrears. The loan, including accrued interest, matures on July 1, 2013. The total loan amount including accrued interest will either be paid out in cash (see below) or converted into preference B-shares. The lending shareholders have a right to a commitment fee of 10% of the commitment for the period from signing until utilization. The commitment fee per December 31, 2012 amounts to EUR 37,500 and is recorded under accrued expenses.

29
 



As part of the agreement the Company granted 121,000 warrants to the lending shareholders in connection with the receipt of the first tranche of EUR 3,000,000. Another 121,000 warrants will be granted to the lending shareholders when the second tranche of EUR 3,000,000 will be drawn by the Company. Each warrant entitles the lending shareholder to acquire one ordinary share upon payment of the nominal value per share of EUR 0,01. The warrants may be exercised during the term of the loan. In case a liquidation event (other than an IPO) occurs prior to the maturity date, the total loan amount of the second loan, including accrued interest at a rate of 30% per annum, will be repaid in cash at the time of the closing of the liquidation event. In case an IPO occurs prior to the maturity date, the loan amount, including accrued interest at a rate of 8% per annum, will convert into preference B-shares.
The conditions of the loan have been evaluated. The proceeds from the convertible notes payable have been allocated to the notes payable and the detachable warrants based on their relative fair value. The portion of the proceeds so allocated to the warrants (EUR 52,034) has been accounted for as Paid-in Capital.
Deferred grant income
The deferred grant income arises as a result of the benefit received from an interest-free government loan received in February 2008 and April 2009 (see note 17(a)). The grant income will be recorded in ‘Financial income and expense’ in 2013 (EUR 45,727).
16.    Contingencies

(a) Milestone payments and royalties
In the course of its business the Company enters as licensee into contracts with other parties to obtain freedom to operate with regard to the development and marketing of its pipeline products. The Company will need to pay milestone payments whenever defined milestones will be met (under one major license agreement GBP 100,000 per year) and Royalty payments to the licensors based on future sales levels. As future sales levels are uncertain, as well as if and when the milestones will be met, the financial effect of these agreements cannot be estimated reliably.
(b) Claims
There are no claims known at all to Management related to the activities of the Company.

17.    Commitments
Operating lease commitments
Annual lease obligations entered into with third parties in respect of property are EUR 235,000. The remaining term of the lease contracts is 1.0 year or less. An amount of EUR 242,327 was recorded as operating lease expenses in the consolidated profit and loss account.
The obligations for other leases entered into with third parties are EUR 8,600. Of this amount EUR 4,000 is due after one year.

30
 



18.    Related-party transactions
Balances and transactions between the Company and its subsidiary, which is a related party of the Company, have been eliminated on consolidation and are not disclosed in this note. Details of transactions between the Company and other related parties are disclosed below.
(a) Other related party transactions
The Company has a subcontracting agreement with Bioceros B.V. which is a related party,
since a member of the Company’s Supervisory Board (till February 2011) and shareholder,
M. de Boer, is also member of the Supervisory Board of Bioceros B.V.
During 2012, the Company received services from Bioceros B.V. totaling EUR 18,588
excluding VAT. At December 31, 2012 no amounts were owed to
Bioceros B.V. All amounts due to Bioceros B.V. have been settled in cash at arm’s length
terms as stipulated in the various agreements between the two parties.

19.    Subsequent events
In November 2012 the Company strengthened its financial position with an additional convertible notes payable Agreement amounting to EUR 6.0 million sponsored by all four existing investors (of which EUR 3.0 million had been drawn before year-end). On April 20, 2013 the Company agreed to increase the additional convertible notes payable with EUR 3.0 million to a total amount of EUR 9.0 million.
On November 28, 2012 Agentschap NL granted the Company a second loan under its Innovation Credit scheme of EUR 4.7 million to finance the further Phase III clinical development of FibrocapsTM. The first payment amounting to EUR 2.0 million has been received in January 2013 and the second payment amounting to EUR 2.7 million has been received in April 2013.
On June 4, 2013 the Company and The Medicines Company announced an agreement for The Medicines Company to purchase all of the outstanding capital stock of ProFibrix B.V. subject to satisfactory review of the pending Phase 3 clinical trial results of our lead product FibrocapsTM. Under the terms of the agreement we received a USD 10 million upfront option payment. If the Medicines Company is satisfied with the trial results it will purchase all of the outstanding capital stock at closing after conversion of the € 12.0 million convertible notes payable received in 2012. The additional convertible notes payable amounting to € 9.0 million (of which currently € 7.0 million is drawn) and the loans from Agentschap NL and ABNAMRO-bank will be repaid at closing (including accumulated interest). We received positive data from our phase 3 clinical trials and after review by the Medicines Company, the purchase options for all the outstanding capital stock of the Company was executed by them. Closing of the acquisition took place on August 5, 2013.
The Medicines Company confirmed to provide the resources that are necessary for the Company to meet its financial obligations.


31
 



Independent auditor's report
To: The Supervisory Board of Profibrix BV
Report on the financial statements
We have audited the accompanying consolidated financial statements of Profibrix BV and subsidiary, a development stage company, which comprise the Consolidated Balance Sheet as of December 31, 2012, and the related Statement of Operations, Comprehensive Income, Stockholders’ Deficit and Cash Flows for the year then ended, and for the period from January 29, 2004 (inception) through December 31, 2012, and the related notes to the financial statements.
Management's responsibility
Management is responsible for the preparation and fair presentation of these financial statements in accordance with accounting principles generally accepted in the United States of America; this includes the design, implementation, and maintenance of internal control relevant to the preparation and fair presentation of financial statements that are free from material misstatement, whether due to fraud or error.
Auditor's responsibility
Our responsibility is to express an opinion on these financial statements based on our audit. We conducted our audit in accordance with auditing standards generally accepted in the United States of America. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free from material misstatement.
An audit involves performing procedures to obtain audit evidence about the amounts and disclosures in the financial statements. The procedures selected depend on the auditor’s judgment, including the assessment of the risks of material misstatement of the financial statements, whether due to fraud or error.
In making those risk assessments, the auditor considers internal control relevant to the entity’s preparation and fair presentation of the financial statements in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the entity’s internal control. Accordingly, we express no such opinion. An audit also includes evaluating the appropriateness of accounting policies used and the reasonableness of significant accounting estimates made by management, as well as evaluating the overall presentation of the financial statements.
We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinion.

32
 



Opinion with respect to the financial statements
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Profibrix BV and subsidiary as of December 31, 2012 and the results of their operations and their cash flows for the year then ended, and for the period from January 29, 2004 (inception) through December 31, 2012, in conformity with accounting principles generally accepted in the United States of America.

/s/ Deloitte Accountants BV
Eindhoven, The Netherlands
August 5, 2013


33
 

EX-99.3 4 exhibit993profibrix.htm EXHIBIT Exhibit 99.3 (ProFibrix)
Exhibit 99.3







ProFibrix B.V.
(A Development Stage Company)
US GAAP Interim Condensed Financial Statements 2013
 
BioScience Park Leiden, the Netherlands
August 5, 2013






US GAAP Interim Condensed Financial Statements 2013 of ProFibrix B.V.
(A Development Stage Company)



Table of Contents





2
 


US GAAP Interim Condensed Financial Statements 2013 of ProFibrix B.V.
(A Development Stage Company)


    Interim condensed consolidated financial statements (Unaudited)
 
Interim condensed Consolidated Balance Sheets (Unaudited)
 Interim condensed Consolidated Statements of Operations (Unaudited)
Interim condensed Consolidated Statements of Comprehensive Income (Unaudited)
Interim condensed Consolidated Statements of Cash Flows (Unaudited)
Notes to the Interim Condensed Consolidated Financial Statements (Unaudited)
 




3
 


US GAAP Interim Condensed Financial Statements 2013 of ProFibrix B.V.
(A Development Stage Company)


Interim Condensed Consolidated Balance Sheets (Unaudited)

 
Notes
 
30.06.2013
31.12.2012
 
 
 
 
 
EUR
EUR
 
 
 
 
 
 
(Note 1)
 
 
Assets
 
 
 
 
 
 
Current assets
 
 
 
 
 
 
Cash and cash equivalents
 
 
8,780,453
2,465,843
 
 
Restricted cash
3.14
 
250,000
250,000
 
 
Other receivables
6
 
333,901
422,277
 
 
Total current assets
 
 
9,364,354
3,138,120
 
 
 
 
 
 
 
 
 
Non-current assets
Property and equipment, net
 
 
99,330
111,448
 
 
Intangible assets
 
 
23,171
30,519
 
 
Restricted cash
3.14
 
437,500
500,000
 
 
Total non-current assets
 
 
560,001
641,967
 
 
 
 
 
 
 
 
 
Total assets
 
 
9,924,355
3,780,087
 
 
 
 
 
 
 
 
 
Liabilities
 
 
 
 
 
 
Current liabilities
9
 
 
 
 
 
Accounts payable
 
 
2,412,725
1,322,887
 
 
Convertible notes payable
 
 
20,685,758
15,427,364
 
 
Short-term part of borrowings
 
 
1,833,942
1,616,773
 
 
Social securities and other taxes
 
 
60,389
83,260
 
 
Deferred grant income
 
 
16,058
45,727
 
 
Other current liabilities
 
 
1,935,971
1,493,441
 
 
Total current liabilities
 
 
26,944,843
19,989,452
 
 

Non-current liabilities
 
 
 
 
 
 
Long-term liabilities
8
 
12,376,642
7,588,986
 
 
Total liabilities
 
 
39,321,485
27,578,438
 
 
 
 
 
 
 
 
 
Commitments and contingencies
11, 12
 
-
-
 
 


 
 


 
 
 

4
 


US GAAP Interim Condensed Financial Statements 2013 of ProFibrix B.V.
(A Development Stage Company)



Stockholders’ deficit
7
 
 
 
 
 
 
 
 
 
 
 
 
Preferred A stock; € 0.01 nominal value;
29,629,200 authorized and 12,434,523 issued and outstanding at June 30, 2013 and December 31, 2012
 
 
124,345
124,345
 
 
 
 
 
 
 
 
 
Preferred B stock ; € 0.01 nominal value;
29,629,200 authorized and 16,414,459 issued and outstanding at June 30, 2013 and December 31, 2012
 
 
164,145
164,145
 
 
 
 
 
 
 
 
 
Common stock; € 0.01 nominal value;
29,629,200 authorized and 5,643,925 issued and outstanding at June 30, 2013 and December 31, 2012
 
 
56,439
56,439
 
 
Additional Paid-in Capital
 
 
36,758,215
28,958,013
 
 
Deficit accumulated during development stage
 
 
(66,516,887)
(53,109,319)
 
 
Accumulated other comprehensive income
 
 
16,613
8,026
 
 
Total stockholders’ deficit
 
 
(29,397,130)
(23,798,351)
 
 
 
 
 
 
 
 
 
Total liabilities and stockholders’ deficit
 
 
9,924,355
3,780,087
 
 


5
 


US GAAP Interim Condensed Financial Statements 2013 of ProFibrix B.V.
(A Development Stage Company)


Interim Condensed Consolidated Statements of Operations (Unaudited)

 
Note
 
Period ended 30.06.2013
Period ended 30.06.2012
 
Period from January 29, 2004 (Inception) to
June 30, 2013
 
 
 
EUR
EUR
 
EUR
 
 
 
 
 
 
 
Product sales
 
 
-
-
 
494,395
License revenues
 
 
-
-
 
161,421
Total revenues
 
 
-
-
 
655,816
Cost of product sales
 
 
-
-
 
120,000
Gross profit

 
 
-
-
 
535,816
Income from grants
 
 
29,669
40,867
 
344,430
Total other operating income

 
 
29,669
40,867
 
344,430
Operating expenses:
Research and development
5
 
9,325,422
6,919,492
 
56,243,919
General and administrative
 
 
1,946,000
712,500
 
7,115,010
Total operating expenses
 
 
11,271,422
7,631,992
 
63,358,929
 
 
 
 
 
 
 
Loss from operations
 
 
(11,241,753)
(7,591,125)
 
(62,478,683)
 
 
 
 
 
 
 
Financial expense (net)
 
 
(2,147,280)
(338,009)
 
(4,073,028)
Total financial expense
 
 
(2,147,280)
(338,009)
 
(4,073,028)

Net loss before income tax
 
 
(13,389,033)
(7,929,134)
 
(66,551,711)
 
 
 
 
 
 
 
Corporate income taxes
10
 
(18,535)
(14,573)
 
34,824
 
 
 
 
 
 
 
Net loss
 
 
(13,407,568)
(7,943,707)
 
(66,516,887)
 
 
 
 
 
 
 


6
 


US GAAP Interim Condensed Financial Statements 2013 of ProFibrix B.V.
(A Development Stage Company)


Interim Condensed Consolidated Statements of Comprehensive Income (Unaudited)


 
Note
 
Period ended 30.06.2013
Period ended 30.06.2012
 
Period from January 29, 2004 (Inception) to
June 30, 2013
 
 
 
EUR
EUR
 
EUR
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Net loss
 
 
(13,407,568)
(7,943,707)
 
(66,516,887)
 
 
 
 
 
 
 
Foreign currency translation
 
 
 
 
 
 
Gain (loss) on foreign currency translation
 
 
8,587
11,154
 
16,613
Comprehensive income
 
 
(13,398,981)
(7,932,553)
 
(66,500,274)
 
 
 
 
 
 
 


7
 


US GAAP Interim Condensed Financial Statements 2013 of ProFibrix B.V.
(A Development Stage Company)


Interim Condensed Consolidated Statements of Cash Flows (Unaudited)

 
Note
 
Period ended June 30, 2013
Period ended June 30, 2012
 
Period from January 29, 2004 (Inception) to
June 30, 2013
 
 
 
EUR
EUR
 
EUR
Cash flows from operating activities
 
 
 
 
 
 
Net loss
 
 
(13,407,568)
(7,943,707)
 
(66,516,887)
Adjustments to reconcile net loss to net cash used in operating activities:
 
 
 
 
 
 
- Depreciation and amortization
 
 
39,339
38,811
 
368,985
- Stock-based compensation
 
 
60,000
90,000
 
743,437
- Interest income and expenses
 
 
1,755,454
396,119
 
3,685,213
- Impairment loss on Haemostatix
 
 
-
-
 
1,465
Changes in operating assets and liabilities:
 
 
 
 
 
 
- Other receivables
 
 
88,376
457,215
 
(333,901)
- Accounts payable
 
 
1,509,497
(1,277,951)
 
4,409,085
Net cash used in operations
 
 
(9,954,902)
(8,239,513)
 
(57,642,603)
 
 
 
 
 
 
 
Cash flows from investing activities
Purchase of property and equipment
 
 
(19,480)
(5,317)
 
(341,572)
Changes in restricted cash
 
 
62,500
 
 
62,500
Purchase of financial assets
 
 
-
-
 
(1,465)
Net cash used in investing activities
 
 
43,020
(5,317)
 
(280,537)
 
 
 
 
 
 
 
Cash flows from financing activities
 
 
 
 
 
 
Proceeds from issuance of common and preferred stock
 
 
-
-
 
26,128,923
Option payment received
9
 
7,688,168
-
 
7,688,168
Proceeds from long-term loans
8
 
4,717,630
-
 
12,252,630
Proceeds from convertible notes payable
9
 
4,000,000
7,200,000
 
21,250,000
Repayment of long-term loans
8
 
(187,500)
-
 
(629,791)
Net cash provided by financing activities
 
 
16,218,298
7,200,000
 
66,689,930
 
 
 
 
 
 
 
Exchange rate effects and translation differences on cash
 
 
8,194
10,201
 
13,663
Net (decrease)/increase in cash and cash equivalents
 
 
6,314,610
(1,034,629)
 
8,780,453
 
 
 
 
 
 
 

8
 


US GAAP Interim Condensed Financial Statements 2013 of ProFibrix B.V.
(A Development Stage Company)


Cash and cash equivalents - beginning of period
 
 
2,465,843
4,930,013
 
-
Cash and cash equivalents – end of period
 
 
8,780,453
3,895,384
 
8,780,453
 
 
 
 
 
 
 
Supplemental disclosures of Cash Flow Information
 
 
 
Corporate income tax paid
 
 
(26,140)
(24,598)
 
(30,048)
Interest received (paid)
 
 
(48,178)
(47,394)
 
(12,018)


9
 


US GAAP Interim Condensed Financial Statements 2013 of ProFibrix B.V.
(A Development Stage Company)


Notes to Interim Condensed Consolidated Financial Statements (Unaudited)
1. Description of business
ProFibrix B.V. and its 100% subsidiary, (“ProFibrix” or the “Company”) are engaged in leveraging their expertise in fibrinogen technology to develop and market innovative products for the haemostasis and regenerative medicine markets. The Company’s products are aimed at treatments that stop acute and severe bleeding during surgery or after trauma injury and support tissue repair. At the heart of all ProFibrix products is human fibrinogen a matrix protein with unique functional properties that plays a pivotal role in blood clotting and tissue healing.
ProFibrix B.V. is a limited liability company incorporated in the Netherlands, with its statutory seat in Leiderdorp. The address of its headquarters and registered office is Zernikedreef 9, 2333 CK Leiden, the Netherlands.
The Company is in its development stage as defined by the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 915, Development Stage Entities. The Company’s activities since inception have consisted principally of acquiring product and technology rights, raising capital and performing research and development activities. Since inception, the Company has incurred significant losses from operations and expects losses to continue for the foreseeable future. The Company’s success depends primarily on the successful development and regulatory approval of its product candidates and its ability to obtain adequate financing as discussed below.
On June 4, 2013 the Company and The Medicines Company announced an agreement for The Medicines Company to purchase all of the outstanding capital stock of ProFibrix B.V. subject to satisfactory review of the pending Phase 3 clinical trial results of our lead product FibrocapsTM. On August 5, The Medicines Company completed the acquisition of the Company pursuant to this agreement, with the Company becoming a wholly-owned subsidiary of The Medicines Company.
2. Basis for preparation and use of estimates
The accompanying unaudited interim condensed consolidated financial statements of ProFibrix B.V. have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim information. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. These interim condensed financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments (consisting only of normal recurring adjustments) that are necessary for a fair presentation of the Company’s financial position as of June 30, 2013 and its results of operations and comprehensive loss and cash flows for the six months ended June 30, 2013 and 2012, and for the period from January 29, 2004 (inception) through June 30, 2013. The results of operations for the six months ended June 30, 2013 are not necessarily indicative of the results to be expected for the year ending December 31, 2013 or for any other interim period or for any other future year.
The preparation of these interim condensed financial statements requires the Company to make estimates and judgments that affect the reported amounts of assets, liabilities, expenses, and related disclosures. Those estimates and assumptions include, but are not limited to, the valuation of equity

10
 


US GAAP Interim Condensed Financial Statements 2013 of ProFibrix B.V.
(A Development Stage Company)


instruments, stock-based compensation, the estimated useful lives of property and equipment, clinical trial accruals, and certain other accrued liabilities. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could materially differ from those estimates and assumptions.
The interim condensed consolidated balance sheet as of December 31, 2012 was derived from the Company’s audited consolidated financial statements included elsewhere in this Report on Form 8-K. These interim financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the related notes thereto for the year ended December 31, 2012.
Recently issued and adopted accounting pronouncements
The interim condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). New Standards and Interpretations, which became effective as of June 30, 2013, did not have a material impact on our interim condensed consolidated financial statements.
In December 2011, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2011-11 “Disclosures about Offsetting Assets and Liabilities”. Under the new guidance, the entities must disclose both gross information and net information about both instruments and transactions eligible for offset on the balance sheet in accordance with the offsetting guidance in ASC 210-20-45 or ASC 815-10-45, and instruments and transactions subject to an agreement similar to a master netting arrangement. This guidance became effective for us beginning January 1, 2013. This guidance had no effect on the interim condensed consolidated financial statements.
In July 2012, the FASB issued ASU No. 2012-02 “Testing Indefinite-Lived Intangible Assets for Impairment”. This ASU amends the guidance in ASC 350-30 on testing indefinite-lived intangible assets, other than goodwill, for impairment. The FASB issued the ASU in response to feedback on ASU 2011-08, which amended the goodwill impairment testing requirements by allowing an entity to perform a qualitative impairment assessment before proceeding to the two-step impairment test. The new guidance will be effective for annual and interim impairment tests performed for fiscal years beginning after September 15, 2012. Early adoption is permitted. The ASU 2012-02 had no effect on our interim condensed consolidated financial statements.
In October 2012. the FASB issued ASU No. 2014-04 “Technical Corrections and Improvements”. This ASU makes certain technical corrections (i.e., relatively minor corrections and clarifications) and “conforming fair value amendments” to the FASB Accounting Standards Codification (the “Codification”). The new guidance became effective for fiscal years beginning after December15, 2012. The implementation of this guidance had no effect on our interim condensed consolidated financial statements.
In February 2013, FASB issued guidance establishing new requirements for disclosing reclassifications of items out of accumulated other comprehensive income. Specifically, (1) disclosure is required of the changes in components of accumulated OCI, (2) disclosure is required of the effects on individual line items in net income for each item of accumulated OCI that is reclassified in its entirety to net income, and (3) cross references are required to other disclosures that provide additional details for OCI items that are not reclassified in their entirety

11
 


US GAAP Interim Condensed Financial Statements 2013 of ProFibrix B.V.
(A Development Stage Company)


to net income. The guidance became effective for interim and annual periods beginning after December 15, 2012. The implementation of this guidance did not have a material effect on our interim condensed consolidated financial statements.
3.     Summary of Significant Accounting Policies
3.1    Basis of consolidation
The consolidated financial statements incorporate the financial statements of ProFibrix B.V. and its 100% subsidiary ProFibrix Inc.
All intercompany transactions, balances, income and expenses are eliminated in full on consolidation.
3.2     Foreign currencies
Items included in the financial statements of each of the Company’s entities are measured using the currency of the primary economic environment in which the entity operates (“the functional currency”). The consolidated financial statements are presented in Euros, which is the Company’s functional and presentation currency.
Foreign currency transactions are translated into the functional currency using the exchange rates prevailing at the dates of the transactions. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at year-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognized in the income statement.
3.3    Classes of financial instruments
Classes of financial instruments
Financial instruments can be both primary financial instruments, such as receivables and payables, and financial derivatives. For the accounting principles of primary financial instruments, reference is made to the accounting principles per individual class of financials instruments.
Financial derivatives are valued at fair value. Upon first recognition, financial derivatives are recognized at fair value and then revalued at fair value as at balance sheet date.


12
 


US GAAP Interim Condensed Financial Statements 2013 of ProFibrix B.V.
(A Development Stage Company)


Fair Value Measurement
Fair value is defined as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining the fair value measurements for assets and liabilities required to be recorded at fair value, the Company considers the principal or most advantageous market in which it would transact and considers assumptions that market participants would use when pricing the asset or liability, such as inherent risk, transfer restrictions and risk of nonperformance.

A fair value hierarchy was established which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. A financial instrument’s categorization within the fair value hierarchy is based upon the lowest level of input that is significant to the fair value measurement. The three levels of inputs that may be used to measure fair value are as follows:

Level I – Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date;
Level II – Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and
Level III – Unobservable inputs that are significant to the measurement of the fair value of the assets or liabilities that are supported by little or no market data.

As of June 30, 2013 and June 30, 2012 the Company’s derivatives consisted of one interest rate swap. The valuation of this interest rate swap is based on level II inputs. The valuation technique used to determine the fair value of the interest rate swap is the Net Present Value technique, which is the estimated amount that a bank would receive or pay to terminate the swap agreements at the reporting date, taking into account current interest rates.
3.4    Pension obligations
The Company operates a defined contribution pension plan for all employees funded through payments to an insurance company. The Company has no legal or constructive obligation to pay further contributions once the contributions have been paid. The contributions are recognized as employee benefit expense when they are due. Prepaid contributions are recognized as an asset to the extent that a cash refund or a reduction in the future payments is available.
3.5        Stock-based payments

The Company operates an equity-settled stock-based compensation plan. The Company accounts for stock-based compensation following the provisions of FASB ASC Topic 718, Stock Compensation. The Company measures compensation cost for share-based payment awards granted to employees and non-employee directors at fair value using the Black-Scholes option pricing model.
The fair value determined at the grant date of the equity-settled stock-based payments is expensed over the requisite service period based on the estimated grant-date fair value of the awards and forfeiture rates. At the end of each reporting period, the Company revises its estimate

13
 


US GAAP Interim Condensed Financial Statements 2013 of ProFibrix B.V.
(A Development Stage Company)


of the number of equity instruments expected to vest. The impact of the revision of the original estimates, if any, is recognized in profit or loss such that the cumulative expense reflects the revised estimate, with a corresponding adjustment to additional paid-in capital (common stock) within shareholders’ deficit.
Equity-settled stock-based payment transactions with parties other than employees are measured based on the fair value of the goods or services or the fair value of the equity instruments issued, depending on which is more reliably measurable.
3.6    Bonus plans
The Company recognizes a liability and an expense for bonuses if contractually obliged or if there is a past practice that has created a constructive obligation.
3.7    Taxation
The Company accounts for uncertain tax positions in accordance with Accounting Standards Codification Topic 740, Income Taxes (ASC 740). ASC 740 provides for the recognition of deferred tax assets if realization of such assets is more likely than not. The Company uses the liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax basis of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company must then assess the likelihood that the resulting deferred tax assets will be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. Due to the Company’s lack of earnings history, its net deferred tax assets have been fully offset by a valuation allowance.
3.8    Property and equipment
Property and equipment comprise mainly laboratory equipment, furniture and computer hardware and software. All property and equipment are stated at historical cost less depreciation. Historical cost includes expenditure that is directly attributable to the acquisition of the items.
Subsequent costs are included in the asset’s carrying amount or recognized as a separate asset, as appropriate, only when it is probable that the future economic benefits associated with the item will flow to the Company and the cost of the item can be measured reliably. All other repairs and maintenance charges are expensed in the financial period in which these are incurred.

14
 


US GAAP Interim Condensed Financial Statements 2013 of ProFibrix B.V.
(A Development Stage Company)


Depreciation is calculated using the straight-line method to allocate the cost of the assets to their residual values over their estimated useful lives. Property and equipment are depreciated as follows:
-    Laboratory equipment            5 years
-    Furniture                5 years
-    Computer hardware/software        3-5 years
The assets’ residual values and useful lives are reviewed, and adjusted if appropriate, at each balance sheet date.
An asset’s carrying amount is written down immediately to its recoverable amount if the asset’s carrying amount is greater than its estimated recoverable amount (also refer to 3.15).
Gains and losses on disposals are determined by comparing proceeds with carrying amounts. These are included in the income statement.
3.9    Intangible assets
Licenses
Acquired patents have a definite useful life and are carried at cost less accumulated amortization and impairment losses. Amortization is calculated using the straight-line method to allocate the cost of patents over their estimated useful lives (generally 10 years unless a patent expires prior to that date). Amortization begins when an asset is available for its intended use.
3.10    Impairment of tangible and intangible assets
The Company reviews long-lived assets, including property and equipment, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends, and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset to its carrying value. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of an asset are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset over its fair value, determined based on discounted cash flows. To date, the Company has not recorded any impairment losses on long-lived assets.

15
 


US GAAP Interim Condensed Financial Statements 2013 of ProFibrix B.V.
(A Development Stage Company)


3.11    Financial assets
All financial assets are recognized and derecognized on trade date where the purchase or sale of a financial asset is under a contract whose terms require delivery of the financial asset within the timeframe established by the market concerned, and are initially measured at fair value, plus transaction costs, except for those financial assets classified as at fair value through profit or loss, which are initially measured at fair value.
(a)    Other financial assets
Other financial assets are carried at cost and assessed for indicators of impairment at the end of each reporting period. Other financial assets are investments in unquoted equity instruments that are not carried at fair value because their fair value cannot be reliably measured. They are included in non-current assets unless Management intends to dispose the investment within 12 months of the balance sheet date.
3.12    Derivative financial instruments
Derivatives financial instruments are initially recognized at fair value at the date a derivative contract is entered into and are subsequently remeasured to their fair value at the end of each reporting period. The fair value is based on the market prices of the instruments. Derivatives are carried as assets when the fair value is positive and as liabilities when the fair value is negative. To the extent that no formal hedge accounting is applied, any gains and losses arising from changes in the fair value of the instruments are recognized in the statement of income during the period in which they arise.
3.13    Cash and cash equivalents

Cash and cash equivalents include cash in hand and all highly liquid investments with maturities of three months or less that are convertible to a known amount of cash and bear an insignificant risk of change in value.
3.14 Restricted cash
In connection with a loan agreement with ABNAMRO-bank amounting to EUR 2,250,000, an amount of EUR 750,000 was not at our free disposal (locked up as part of the securisation of the loan). The restricted amount is reduced EUR 62,500 per quarter in connection with the quarterly repayments of the loan starting April 1, 2013. The amount is presented as restricted cash on the face balance sheet. The total restricted amount is EUR 687,500 as at June 30, 2013 (2012: EUR 750,000).


16
 


US GAAP Interim Condensed Financial Statements 2013 of ProFibrix B.V.
(A Development Stage Company)


3.15    Financial liabilities and equity instruments
Debt and equity instruments are classified as either financial liabilities or as equity in accordance with the substance of the contractual arrangement.

(a) Equity instruments
An equity instrument is any contract that evidences a residual interest in the assets of an entity after deducting all of its liabilities. Equity instruments issued by the Company are recognized at the proceeds received, net of direct issue costs.

(b) Compound instruments
The component parts of compound instruments (convertible bonds) issued by the Company are classified separately as financial liabilities and equity in accordance with the substance of the contractual arrangement. At the date of issue, the fair value of the liability component is estimated using the prevailing market interest rate for a similar non-convertible instrument. This amount is recorded as a liability on an amortized cost basis using the effective interest method until extinguished upon conversion or at the instrument’s maturity date. The equity component is determined by deducting the amount of the liability component from the fair value of the compound instrument as a whole. This is recognized and included in equity, net of income tax effects, and is not subsequently remeasured.

(c) Other financial liabilities
Other financial liabilities, including borrowings, are initially measured at fair value, net of transaction costs incurred, and are subsequently measured at amortized cost using the effective interest method, with interest expense recognized on an effective yield basis.
The effective interest method is a method of calculating the amortized cost of a financial liability and of allocating interest expense over the relevant period. The effective interest rate is the rate that exactly discounts estimated future cash payments through the expected life of the financial liability, or, where appropriate, a shorter period.

Borrowings and other financial liabilities are classified as ‘non-current liabilities’ unless the Company has liabilities with maturities up to one year, which are classified as “current liabilities”.
 
The Company derecognizes financial liabilities when the liability is discharged, cancelled or expired.
3.16 Research and development costs and credits
Costs relating to research and development (R&D) are charged to operating expenses as incurred. ProFibrix B.V. receives grants and other credits from several Dutch institutes (see 3.5 above). For as far as such government grants and other credits cover R&D costs , these are recorded as R&D credits in the R&D line in the consolidated statements of operations in the period in which such costs occur.

17
 


US GAAP Interim Condensed Financial Statements 2013 of ProFibrix B.V.
(A Development Stage Company)


3.17 Clinical trial accruals
Clinical trial costs are a component of research and development expenses. The Company accrues and expenses clinical trial activities performed by third parties based upon actual work completed in accordance with agreements established with clinical research organizations and clinical sites. The Company determines the actual costs through review of documentation, discussions with internal personnel and external service providers, data as to the progress or stage of completion of trials or services, and the agreed-upon fee to be paid for such services.
Nonrefundable advance payments for goods and services that will be used or rendered in future research and development activities, are deferred and recognized as expense in the period that the related goods are delivered or services are performed.
3.18    Revenue recognition
Revenue comprises the fair value of the sale of goods and services, and is shown net of value added tax, rebates and discounts and after eliminated sales within the Group.
Revenues from goods are recognized upon delivery. The cost price of these goods is allocated to the same period.
License and royalty revenues include amounts earned from third parties with licenses and/or options to the Group’s intellectual property. License and royalty revenues are recognized when earned in accordance with the substance and under the terms of the related agreements and when it is probable that the economic benefits associated with the transaction will flow to the entity and the amount of the revenue can be measured reliably.
4.     Financial risk management
4.1    Risk management policies
The Company’s activities expose it to a variety of financial risks: market risk (including currency risk, interest rate risk and price risk), credit risk and liquidity risk. The Company’s overall financial risk management seeks to minimize potential adverse effects resulting from unpredictability of financial markets on the Company’s financial performance.

18
 


US GAAP Interim Condensed Financial Statements 2013 of ProFibrix B.V.
(A Development Stage Company)


Risk management is carried out by the finance department. The finance department identifies and evaluates financial risks and hedges these risks if deemed appropriate.
(a)Market risk
Foreign exchange risk arises from future commercial transactions and recognized assets and liabilities in foreign currencies. In the years presented, the Company had no significant outstanding receivables, but had significant expenditures in various currencies, predominately in US-Dollars and British-Pounds. The Company has an exposure associated with the time delay between entering into a contract, budget or forecast and the realization thereof. It is the Company’s policy to manage these exposures by hedging foreign currency risks on a selective basis by Management’s decision. As of June 30, 2013 no hedge instruments related to foreign currency risks were outstanding. The impact of fair value measurements on the financial statements is limited. We included the disclosure requirements of ASC 820 (Fair Value Measurement) in the notes of the applicable account balance (where relevant).
(b) Interest rate risk
The Company is exposed to interest rate risks as a result of changes in the market interest rates compared to loans with fixed rates. The Company has three loans with fixed interest rates, with a total of € 28.7 million principal value at 30 June 2013 (December 2012: € 20.6 million). The Company has one loan with principal value of € 1.9 million per June 30, 2013 which bears a floating interest rate (December 2012: € 2.25 million). By use of interest rate swaps the floating interest rate has been swapped into a fixed interest rate. Details on the interest rates and maturity of these loans are provided in “Long-term liabilities” note.
(c) Credit risk
Credit risk represents the risk of financial loss caused by default of the counterparty. The Company has no large receivables balances with external parties. The Company’s principal financial assets are cash and cash equivalents which are placed at Rabobank and ABN AMRO-bank.
(d) Liquidity risk
Liquidity risk represents the risk that an entity will encounter difficulty in meeting obligations associated with its financial liabilities. Prudent liquidity risk management implies ensuring sufficient availability of cash resources for funding of the operations and planning to raise cash as if and when needed, either through issue of shares or through credit facilities. Management monitors rolling forecasts of the Company’s liquidity reserve on the basis of expected cash flow.

5.     Research and development costs
The research and development costs comprise allocated employee costs, clinical development costs, the costs of materials and laboratory consumables, license- and IP-costs, allocated depreciation costs and allocated other costs.


19
 


US GAAP Interim Condensed Financial Statements 2013 of ProFibrix B.V.
(A Development Stage Company)


6.    Other receivables
 
30.06.2013
 
31.12.2012
 
 
 
EUR
 
EUR
 
 
 
 
 
 
 
 
Value added tax
121,139
 
83,410
 
 
Other deferred tax
21,674
 
13,655
 
 
Other
191,088
 
325,212
 
 
 
333,901
 
422,277
 
 
All other receivables are considered short-term and due within one year. Refer to note 10 for further disclosures on deferred tax.

7.    Stockholders’ deficit
During the six-month period ended June 30, 2013 and June 30, 2012, no new shares of common or preferred stock have been issued.
During 2012 the Company granted 437,912 options to purchase common share of the Company to employees of the Company. No new options were granted in 2013.
Option payment
On June 4, 2013, the Company entered into an option agreement with The Medicines Company. Under the terms of the agreement, the Medicines Company paid to the Company an upfront, non-refundable payment of $10.0 million for granting The Medicines Company an exclusive, irrevocable option to purchase all of the Company’s outstanding preferred and common shares from its shareholders. This $10.0 million payment is recognized as part of Shareholders’ deficit as this option fee was effectively a transaction between shareholders and is contributed by the current shareholders of ProFibrix to the company. When the acquisition closes (part of) the option fee will be settled through the working capital adjustment.
The amount of EUR 7.7 million recognized on the June 30, 2013 balance sheet reflects the $10.0 million converted in EUR against the exchange rate prevailing at transaction date.
8.    Long-term liabilities
 
30.06.2013
 
31.12.2012
 
 
 
EUR
 
EUR
 
 
Loans from Agentschap NL:
 
 
 
 
 
-    Uitdagerskrediet
-
 
-
 
 
-    Innovatiekrediet
4,500,000
 
4,500,000
 
 
-    Accrued interest Innovatiekrediet
1,644,744
 
1,286,418
 
 
-    Innovatiekrediet II
4,717,630
 
-
 
 
-    Accrued interest Innovatiekrediet II
121,934
 
-
 
 
ABNAMRO-bank
1,312,500
 
1,687,500
 
 
Derivative financial instruments
79,835
 
115,068
 
 
 
12,376,643
 
7,588,986
 
 
(a)        Uitdagerskrediet
The remaining principal amount of EUR 600k of this no interest bearing loan is payable per

20
 


US GAAP Interim Condensed Financial Statements 2013 of ProFibrix B.V.
(A Development Stage Company)


October 1, 2013, and therefore fully presented in the current liabilities. The securities for amounts due to Agentschap NL are a pledge on all intangible and tangible fixed assets which are co-financed with the awarded grant. Using prevailing market interest rates for an equivalent loan of 11%, the fair value of the remaining amount of the loan is estimated at EUR 583,942 at June 30, 2013. The difference between the nominal value and the fair value of the loan, is the fair value of the benefit derived from the interest-free loan which is recognized as deferred grant income.
(b)        Innovatiekrediet
Agentschap NL has granted the company a loan under the Innovation Credit scheme of EUR 5 million in the past to finance the further clinical development of FibrocapsTM. The loan bears interest at 11.4%, to be paid in arrears. As per November 1, 2013 10% of the loan facility has to be repaid, as per November 1, 2014 20% and as per November 1, 2015 the additional 70% plus the total amount of accrued interest. The securities for amounts due to Agentschap NL are a pledge on all intangible and tangible fixed assets which are co-financed with the awarded grant.
The second loan agreement for the Innovation Credit (Innovatiekrediet II) was entered into in late 2012. The cash receipts related to this loan were fully received in the first half of 2013, leading to a total loan amount of EUR 4.7 million. The loan bears an interest rate of 10% to be paid in arrears. As per June 30, 2014 10% of the loan facility has to be repaid, as per June 30, 2015 40% and as per June 30, 2016 the remaining 50% plus the total amount of accrued interest. The securities for amounts due to Agentschap NL are a pledge on all intangible and tangible fixed assets which are co-financed with the awarded grant

(c)        ABNAMRO-bank
In March 2011 the Company entered into a loan agreement (“MKB Borgstellingskrediet”) with ABNAMRO-bank amounting to EUR 2,250,000 of which EUR 750,000 is not at our free disposal (locked up as part of the securisation of the loan). We have granted a right of pledge on inventory, stock, receivables to ABN AMRO Bank to secure the repayment of the loan. The loan bears a floating interest rate. Starting April 1, 2013 the loan has to be repaid in 12 equal quarterly installments amounting to EUR 187,500 each.

As part of the loan agreement the Company entered into derivative instruments (interest rate swaps) for the management of interest rate risks. Under interest rate swap contracts the Company agrees to exchange the difference between fixed and floating interest rate amounts calculated on the principal loan amount. Such contracts enable the Company to mitigate the risk of changing interest rates and the cashflow exposures on the issued variable rate debt. The fair value of interest rate swaps at the end of the reporting period is determined by discounting the future cash flows using the curves at the end of the reporting period and the credit risk inherent in the contract. The changes in fair value are recognized in the profit and loss account. The fair value of the interest rate swaps as per June 30, 2013 amounts to EUR 79,835 (December 2012: EUR 115,068).

21
 


US GAAP Interim Condensed Financial Statements 2013 of ProFibrix B.V.
(A Development Stage Company)


9.    Current liabilities
Convertible notes payable
On February 27, 2012 the Company entered into a convertible notes payable agreement with its existing shareholders amounting to EUR 12,000,000. The loan bears interest at 8.0%, to be paid in arrears. The loan, including accrued interest, matures post Phase III, but no later than August 1, 2013. The total loan amount will be converted into preference B-shares. The conditions of the loan have been evaluated and no equity component was recognized.
On November 22, 2012 the Company entered into a second convertible notes payable agreement with its existing shareholders amounting to EUR 6,000,000 with an extension of this loan under the same conditions amount to another EUR 3,000,000 agreed in April, 2013. As of June 30, 2013, EUR 7,000,000 of this total of EUR 9,000,000 was drawn. The loan bears interest at 8.0%, to be paid in arrears. The loan, including accrued interest, matures on August 1, 2013. The total loan amount including accrued interest will either be paid out in cash (see below) or converted into preference B-shares. The lending shareholders have a right to a commitment fee of 10% of the commitment for the period from signing until utilization. The commitment fee per June 30, 2013 amounts to EUR 125,000 and is recorded under accrued expenses.
As part of the agreement the Company granted 121,000 warrants to the lending shareholders in connection with the receipt of the first tranche of EUR 3,000,000, which was drawn in December 2012. Another 121,000 warrants were granted to the lending shareholders when the second tranche of EUR 3,000,000 was drawn by the Company in March, 2013. Each warrant entitles the lending shareholder to acquire one ordinary share upon payment of the nominal value per share of EUR 0,01. The warrants may be exercised during the term of the loan. In case a liquidation event (other than an IPO) occurs prior to the maturity date, the total loan amount of the second loan, including accrued interest at a rate of 30% per annum, will be repaid in cash at the time of the closing of the liquidation event. In case an IPO occurs prior to the maturity date, the loan amount, including accrued interest at a rate of 8% per annum, will convert into preference B-shares. Considering the high probability of a liquidation event (other than an IPO) at June 30, 2013, the Company accrued interest for this loan at a rate of 30% per annum as per June 30, 2013.
The conditions of the loan have been evaluated. The proceeds from the convertible notes payable have been allocated to the Notes Payable and the detachable warrants based on their relative fair value. The portion of the proceeds so allocated to the warrants (EUR 104,068) has been accounted for as Paid-in Capital.
Other current liabilities
Other current liabilities consist of the following:
 
30.06.2013
 
31.12.2012
 
EUR
 
EUR
 
 
 
 
Employee bonuses
305,417
 
506,832
Accrual clinical trials
1,075,500
 
481,335
Other
555,054
 
505,274
 
1,935,971
 
1,493,441




22
 


US GAAP Interim Condensed Financial Statements 2013 of ProFibrix B.V.
(A Development Stage Company)


10.    Income tax
The income tax charge relates to the tax expense of ProFibrix B.V.’s only US subsidiary, ProFibrix Inc. The US subsidiary recharges its costs incurred to its parent company with an at arm’s length mark-up. As a result the US subsidiary is profitable and pays a small amount of income taxes in the US. Due to the operating losses incurred since inception the Company has no tax provisions at ProFibrix B.V. level.
We have calculated the tax charge for the six-month period ended June 30, 2013 based on our best estimate of the effective tax rate expected to be applicable for the full fiscal year.
Deferred tax assets reflect the net tax effects of net operating loss and tax credit carryforwards (against which a full valuation allowance has been recorded) and temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes (related to the income taxes of ProFibrix Inc.).
Realization of deferred tax assets is dependent on future earnings, if any, the timing and amount of which are uncertain. Accordingly, the Company’s net deferred tax assets related to operating loss and tax credit carryforwards have been fully offset by a valuation allowance.
11.    Contingencies

(a) Milestone payments and royalties
In the course of its business the Company enters as licensee into contracts with other parties to obtain freedom to operate with regard to the development and marketing of its pipeline products. The company will need to pay milestone payments whenever defined milestones will be met (under one major license agreement GBP 100,000 per year) and Royalty payments to the licensors based on future sales levels. As future sales levels are uncertain, as well as if and when the milestones will be met, the financial effect of these agreements cannot be estimated reliably.
(b) Claims
There are no claims known at all to Management related to the activities of the Company.

12.    Commitments
Operating lease commitments
Annual lease obligations entered into with third parties in respect of property are EUR 151,000. The remaining term of the lease contracts is 1.0 year or less. An amount of EUR 160,000 was recorded as operating lease expenses in the 2013 interim condensed consolidated financial statements.

23
 


US GAAP Interim Condensed Financial Statements 2013 of ProFibrix B.V.
(A Development Stage Company)


13.    Related-party transactions
Balances and transactions between the Company and its subsidiary, which is a related party of the Company, have been eliminated on consolidation and are not disclosed in this note. We note no other significant transactions took place during the six-months ended June 30, 2013 and June 30, 2012 with related parties.
14.    Subsequent events
On June 4, 2013 the Company and The Medicines Company announced an agreement for The Medicines Company to purchase all of the outstanding capital stock of ProFibrix B.V. subject to satisfactory review of the pending Phase 3 clinical trial results of our lead product FibrocapsTM. Under the terms of the agreement we received a USD 10 million upfront option payment. If the Medicines Company is satisfied with the trial results it will purchase all of the outstanding capital stock at closing after conversion of the € 12.0 million convertible notes payable received in 2012. The additional convertible notes payable amounting to € 9.0 million (of which currently € 7.0 million is drawn) and the loans from Agentschap NL and ABNAMRO-bank will be repaid at closing (including accumulated interest). We received positive data from our phase 3 clinical trials and after review by the Medicines Company, the purchase options for all the outstanding capital stock of the Company was executed by them. Closing of the acquisition took place on August 5, 2013.
The Medicines Company confirmed to provide the resources that are necessary for the Company to meet its financial obligations.

24
 

EX-99.4 5 exhibit994profibrix.htm EXHIBIT Exhibit 99.4 (ProFibrix)


Exhibit 99.4

UNAUDITED PRO FORMA COMBINED FINANCIAL STATEMENTS
On August 5, 2013, The Medicines Company (the “Company”) completed its acquisition of all of the outstanding equity of ProFibrix B.V., a company registered in The Netherlands (“ProFibrix”), pursuant to a Share Purchase Agreement dated June 4, 2013 (the “Purchase Agreement”) with ProFibrix, the equityholders of ProFibrix, certain members of the management team of ProFibrix in their capacities as warrantors of certain information in the Purchase Agreement (the “Warrantors”), the holders of options to acquire equity interests in ProFibrix and Stichting ProFibrix Sellers Representative, solely in its capacity as Representative (the “Representative”). Upon the completion of the acquisition, ProFibrix became a wholly owned subsidiary of the Company.
The following unaudited pro forma combined financial statements of MDCO as of and for the six months ended June 30, 2013 and year ended December 31, 2012 (“pro forma financial statements”) have been derived from (1) the unaudited consolidated financial statements of MDCO for the six months ended June 30, 2013 contained in MDCO’s Quarterly Report on Form 10-Q for the six months ended June 30, 2013, including the notes thereto, filed with the SEC on August 9, 2013; (2) the audited consolidated financial statements of MDCO for the year ended December 31, 2012, including the notes thereto, contained in MDCO's Annual Report on Form 10-K for the year ended December 31, 2012 filed with the SEC on March 1, 2013 (3) the unaudited condensed consolidated financial statements of ProFibrix for the six months ended June 30, 2013, including the notes thereto and (4) the audited consolidated financial statements of ProFibrix for the year ended December 31, 2012, including the notes thereto, included as Exhibit 99.2 to this Amended No. 1 filed on October 9, 2013 to MDCO's Current Report on Form 8-K filed on August 7, 2013.
The unaudited pro forma combined statements of operations of MDCO for the six months ended June 30, 2013 and year ended December 31, 2012 give effect to the acquisition of ProFibrix and other related pro forma events as if they had occurred on January 1, 2012. The unaudited pro forma combined balance sheet of MDCO as of June 30, 2013 gives effect to the acquisition of ProFibrix and other pro forma events as if they had occurred on June 30, 2013.
The acquisition of ProFibrix is accounted for in accordance with the revised Statement of Financial Accounting Standards ASC 805-10, “Business Combinations,” (ASC 805-10) under which, among other things, transactions costs are expensed as incurred, the value of acquired in-process research and development is capitalized and contingent payments are recorded at their estimated fair value. The total estimated purchase price, calculated as described in Note 2 to these pro forma financial statements, is allocated to the net tangible and intangible assets of ProFibrix based on their estimated fair values for purposes of these pro forma financial statements. Management has made a preliminary allocation of the estimated purchase price to the tangible and intangible assets acquired and liabilities assumed based on a preliminary valuation and other preliminary estimates for purposes of these pro forma financial statements. A final determination of these estimated fair values will be based on the actual net tangible and intangible assets of ProFibrix that exist as of the date of completion of the transaction, and upon the final purchase price.
The pro forma financial statements are based on the estimates and assumptions which are preliminary and have been made solely for purposes of developing such pro forma information. The pro forma financial statements do not include liabilities that may result from integration activities after completion of the acquisition of ProFibrix which are not presently estimable. The management of MDCO is in the process of making these estimates. Any such liabilities will be recorded as expense in subsequent periods. In addition, the pro forma financial statements do not include any potential operating efficiencies or cost savings from expected synergies. The timing and effect of actions associated with integration are as yet uncertain.
The pro forma financial statements should be relied on only for the limited purpose of presenting what the results of operations and financial position of the combined businesses of MDCO and ProFibrix might have looked like had the acquisition of ProFibrix and other pro forma events taken place at an earlier date. The pro forma financial statements are not necessarily an indication of the results that would have been achieved had the acquisition of ProFibrix been completed and other pro forma events occurred of the dates indicated or that may be achieved in the future.
The following pro forma financial statements should be read in conjunction with:
the accompanying notes to the pro forma financial statements;

Page 1 of 9



the audited consolidated financial statements of MDCO for the year ended December 31, 2012 contained in MDCO’s Annual Report on Form 10-K for the fiscal year ended December 31, 2012 filed with the SEC on March 1, 2013; and
the audited financial statements of ProFibrix for the year ended December 31, 2012 and the unaudited financial statements for the six months ended June 30, 2013 and 2012 attached as Exhibit 99.2 and Exhibit 99.3, respectively, to this Amendment No. 1 filed on October 9, 2013 to MDCO's Current Report on Form 8-K filed on August 7, 2013

Page 2 of 9




Unaudited Pro Forma Combined Consolidated Balance Sheet
As of June 30, 2013
(in thousands)
 
 
 
 
 
 
 
 
 
 
 
The Medicines Company
 
ProFibrix B.V.1
 
Pro Forma Adjustments
 
Pro Forma Combined
 
 
 
 
 
 
 
 
 
ASSETS
 
 
 
 
 
 
 
 
Current assets:
 
 
 
 
 
 
 
 
 Cash and cash equivalents
 
$
292,891

 
$
11,425

 
$
(103,979
)
(a)
$
200,337

 Restricted cash
 
 
 
325

 
 
 
325

 Available for sale securities
 
8,112

 

 

 
8,112

 Accrued interest receivable
 
75

 

 

 
75

 Accounts receivable, net
 
90,333

 

 

 
90,333

 Inventory
 
86,750

 

 

 
86,750

 Deferred tax assets
 
13,881

 

 
 
 
13,881

 Prepaid expenses and other current assets
 
10,598

 
435

 

 
11,033

    Total current assets
 
502,640

 
12,185

 
(103,979
)
 
410,846

 
 
 
 
 
 
 
 

Fixed assets, net
 
30,053

 
129

 

 
30,182

Intangible assets, net
 
462,486

 
30

 
176,000

(b)
638,516

Restricted cash
 
1,558

 
570

 

 
2,128

Goodwill
 
135,627

 

 
44,729

(b)
180,356

Other assets
 
17,559

 
 
 

 
17,559

    Total assets
 
$
1,149,923

 
$
12,914

 
$
116,750

 
$
1,279,587

 
 
 
 
 
 
 
 
 
LIABILITIES AND STOCKHOLDERS' EQUITY
 
 
 
 
 
 
 
 
Current liabilities:
 
 
 
 
 
 
 
 
 Accounts payable
 
$
5,067

 
$
3,140

 
$

 
$
8,207

 Accrued expenses
 
113,235

 
2,618

 

 
115,853

 Convertible notes payable
 
 
 
26,919

 
(26,919
)
(c)

 Short-term borrowings
 
 
 
2,387

 
(2,387
)
(c)

 Deferred revenue
 
2,319

 
 
 

 
2,319

    Total current liabilities
 
120,621

 
35,064

 
(29,306
)
 
126,379

Contingent purchase price
 
100,524

 

 
83,000

(d)
183,524

Convertible senior notes (due 2017)
 
231,025

 

 

 
231,025

Deferred tax liabilities
 
34,504

 

 
44,006

(e)
78,510

Other long term liabilities
 
5,815

 
16,106

 
(16,106
)
(c)
5,815

    Total liabilities
 
492,489

 
51,170

 
81,594

 
625,253

Commitments and contingencies:
 
 
 
 
 
 
 
 
 Redeemable convertible preferred stock
 

 
375

 
(375
)
(f)

Stockholders' equity:
 
 
 
 
 
 
 
 
 Preferred stock
 

 

 

 

 Common stock
 
58

 
73

 
(73
)
(f)
58

 Additional paid-in capital
 
763,127

 
47,833

 
(47,833
)
(f)
763,127

 Treasury stock
 
(50,000
)
 

 

 
(50,000
)
 Accumulated deficit
 
(53,890
)
 
(86,559
)
 
83,459

(f) (g)
(56,990
)

Page 3 of 9



 Accumulated other comprehensive loss
 
(1,684
)
 
22

 
(22
)
 
(1,684
)
    Total The Medicines Company stockholders' equity
 
657,611

 
(38,256
)
 
35,156

 
654,511

 Non-controlling interest in joint venture
 
(177
)
 

 

 
(177
)
    Total stockholders' equity
 
657,434

 
(38,256
)
 
35,156

 
654,334

    Total liabilities, convertible preferred stock and stockholders' equity
 
$
1,149,923

 
$
12,914

 
$
116,750

 
$
1,279,587


1 Amounts translated to U.S. Dollars on a basis consistent with MDCO's policy.


Page 4 of 9





Unaudited Pro Forma Combined Consolidated Statement of Operations
six months ended June 30, 2013
(in thousands, except per share data)
 
 
 
 
 
 
 
 
 
The Medicines Company
 
ProFibrix B.V.1
 
Pro Forma Adjustments
 
Pro Forma Combined
 
 
 
 
 
 
 
 
 
Net revenue
 
$
328,579

 
$

*
$

 
$
328,579

Operating expenses:
 
 
 
 
 
 
 
 
 Cost of revenue
 
120,653

 

 

 
120,653

 Research and development
 
85,221

 
12,212

*

 
97,433

 Selling, general and administrative
 
116,426

 
2,556

 
 
 
118,982

 Total operating expenses
 
322,300

 
14,768

 

 
337,068

 
 
 
 
 
 
 
 
 
Income (loss) from operations
 
6,279

 
(14,768
)
 

 
(8,489
)
 Co-promotion income
 
7,818

 

 

 
7,818

 Interest expense
 
(7,377
)
 
(2,821
)
 
2,821

(h)
(7,377
)
 Other income
 
803

 
12

 

 
815

Income (loss) before income taxes
 
7,523

 
(17,577
)
 
2,821

 
(7,233
)
Provision for income taxes
 
(1,095
)
 
(25
)
 

 
(1,120
)
 
 
 
 
 
 
 
 
 
Net income (loss)
 
6,428

 
(17,602
)
 
2,821

 
(8,353
)
Net loss attributable to non-controlling interest
 
93

 

 

 
93

Net income (loss) attributable to The Medicines Company
 
$
6,521

 
$
(17,602
)
 
$
2,821

 
$
(8,260
)
 
 
 
 
 
 
 
 
 
Basic earnings (loss) per common share attributable to The Medicines Company
 
$
0.12

 


 


 
$
(0.15
)
Shares used in computing basic earnings per common share
 
54,804

 
 
 
 
 
54,804

 
 
 
 
 
 
 
 
 
Diluted earnings (loss) per common share attributable to The Medicines Company
 
$
0.11

 


 


 
$
(0.15
)
Shares used in computing diluted earnings per common share
 
59,154

 
 
 
 
 
54,804


1 Amounts translated to U.S. Dollars on a basis consistent with MDCO's policy.
* Research and development expenses are net of grant revenue.


Page 5 of 9





Unaudited Pro Forma Combined Consolidated Statement of Operations
Year Ended December 31, 2012
(in thousands, except per share data)
 
 
 
 
 
 
 
 
 
The Medicines Company
 
ProFibrix B.V.1
 
Pro Forma Adjustments
 
Pro Forma Combined
 
 
 
 
 
 
 
 
 
Net revenue
 
$
558,588

 
$

*
$

 
$
558,588

Operating expenses:
 
 
 
 
 
 
 
 
 Cost of revenue
 
177,339

 

 

 
177,339

 Research and development
 
126,423

 
20,926

*

 
147,349

 Selling, general and administrative
 
171,753

 
1,935

 
 
 
173,688

 Total operating expenses
 
475,515

 
22,861

 

 
498,376

 
 
 
 
 
 
 
 
 
Income (loss) from operations
 
83,073

 
(22,861
)
 

 
60,212

 Co-promotion income
 
10,000

 

 

 
10,000

 Interest expense
 
(8,005
)
 
(1,600
)
 
1,600

(h)
(8,005
)
 Other income (loss)
 
1,140

 
(14
)
 

 
1,126

Income (loss) before income taxes
 
86,208

 
(24,475
)
 
1,600

 
63,333

(Provision) benefit for income taxes
 
(35,038
)
 
(60
)
 

 
(35,098
)
 
 
 
 
 
 
 
 
 
Net income (loss)
 
51,170

 
(24,535
)
 
1,600

 
28,235

Net loss attributable to non-controlling interest
 
84

 

 

 
84

Net income (loss) attributable to The Medicines Company
 
$
51,254

 
$
(24,535
)
 
$
1,600

 
$
28,319

 
 
 
 
 
 
 
 
 
Basic earnings per common share attributable to The Medicines Company
 
$
0.96

 
 
 
 
 
$
0.53

Shares used in computing basic earnings per common share
 
53,545

 
 
 
 
 
53,545

 
 
 
 
 
 
 
 
 
Diluted earnings per common share attributable to The Medicines Company
 
$
0.93

 
 
 
 
 
$
0.51

Shares used in computing diluted earnings per common share
 
55,346

 
 
 
 
 
55,346


1 Amounts translated to U.S. Dollars on a basis consistent with MDCO's policy.
* Research and development expenses are net of grant revenue.



Page 6 of 9




Notes to Unaudited Pro Forma Combined Consolidated Financial Statements

(1) Description of Transaction
On August 5, 2013, The Medicines Company (the “Company”) completed its acquisition of all of the outstanding equity of ProFibrix B.V., a company registered in The Netherlands (“ProFibrix”), pursuant to a Share Purchase Agreement dated June 4, 2013 (the “Purchase Agreement”) with ProFibrix, the equityholders of ProFibrix, certain members of the management team of ProFibrix in their capacities as warrantors of certain information in the Purchase Agreement (the “Warrantors”), the holders of options to acquire equity interests in ProFibrix and Stichting ProFibrix Sellers Representative, solely in its capacity as Representative (the “Representative”). Upon the completion of the acquisition, ProFibrix became a wholly owned subsidiary of the Company.
In connection with the signing of the Purchase Agreement, the Company paid ProFibrix a $10,000,000 option payment for the right to acquire ProFibrix in the event that the Company was satisfied with the results of the then pending FINISH-3 Phase 3 clinical trial of ProFibrix’s lead biologic, Fibrocaps™. On July 20, 2013, ProFibrix delivered to the Company the results of the Phase 3 trial. Following the Company’s review of the Phase 3 trial results, on August 2, 2013 the Company notified ProFibrix that it wished to proceed with the closing of its acquisition of ProFibrix.
On August 5, 2013, upon the closing of the transactions contemplated by the Purchase Agreement (the “Closing”), the Company paid an aggregate purchase price of $90.9 million in cash in connection with its acquisition of all the outstanding equity of ProFibrix. This purchase price is subject to agreed upon post-closing adjustments. The Company deposited $9,000,000 of the purchase price into an escrow fund for the purpose of (i) securing the indemnification obligations of the ProFibrix equityholders and optionholders to the Company for any and all losses for which the Company is entitled to indemnification under the Purchase Agreement, and (ii) providing the source of recovery for any amounts payable to the Company as a result of the post-Closing purchase price adjustment process (the “Escrow Amount”).
Under the terms of the Purchase Agreement, the Company is also obligated to pay up to an aggregate of $140,000,000 in cash to the ProFibrix equityholders and optionholders upon the achievement of certain U.S. and European regulatory approvals prior to January 1, 2016 and certain U.S. and European sales milestones during the twenty-four (24) month period that follows the initial commercial sale of Fibrocaps™.
At the Closing, the Company entered into an escrow agreement with the Representative and JP Morgan Chase, N.A., as the escrow agent, with respect to the Escrow Amount. To the extent that any portion of the Escrow Amount remains in the escrow fund and is not subject to any claims by the Company, such amounts will be released to the ProFibrix equityholders and optionholders, subject to certain conditions set forth in the Purchase Agreement (i) on August 4, 2014, with respect to fifty percent (50%) of the Escrow Amount, and (ii) on December 4, 2015, with respect to all of the then remaining portion of the Escrow Amount.
Pursuant to the terms of the Purchase Agreement, certain of the ProFibrix equityholders and the Warrantors have agreed on behalf of themselves and their respective affiliates, to refrain, for a period of two years from the date of the Closing, from (i) soliciting certain employees and consultants of ProFibrix, subject to specified limitations and (ii) engaging in any business or other activity involving the research, development, production or commercialization of products to treat (a) bleeding related to surgery, percutaneous vascular access or physical trauma or (b) genetic or acquired fibrinogen deficiencies.







Page 7 of 9



(2) Purchase Price
Total estimated purchase price is summarized as follows:


 
 
(in thousands)
Estimated upfront cash consideration
 
$
100,879

Estimated fair value of contingent cash payment
 
83,000

Total preliminary estimated purchase price
 
$
183,879

 
 
 


For purposes of this pro forma analysis, the above estimated purchase price has been allocated based on a preliminary estimate of the fair value of assets acquired and liabilities assumed:



 
 
 
Assets Acquired:
 
(in thousands)
Cash and cash equivalents
 
$
11,425

Restricted cash
 
895

Prepaid expenses and other current assets
 
435

Fixed assets, net
 
129

In-process research and development
 
176,000

Goodwill
 
44,729

Other assets
 
30

Total Assets
 
233,643

Liabilities Assumed:
 
 
Accounts payable
 
3,140

Accrued expenses
 
2,618

Deferred tax liabilities
 
44,006

Total Liabilities
 
49,764

 
 
 
Total preliminary estimated purchase price
 
$
183,879

 
 
 

The value of the acquired in-process research and development is based upon a preliminary valuation. Differences between the preliminary and final valuation could have a material impact on the accompanying unaudited pro forma condensed combined financial statement information and MDCO’s future results of operations and financial position.

(3) Pro Forma Adjustments
Adjustments included in the column under the heading “Pro Forma Adjustments” are related to the following:
(a) Cash and cash equivalents adjustments consist of the following (in thousands):

Page 8 of 9



 
 
(in thousands)
Estimated MDCO transaction fees
 
$
3,100

Estimated upfront cash consideration paid to shareholders
 
100,879

Total
 
$
103,979

 
 
 

(b) To record the estimated fair value of in-process research and development and goodwill. No amortizable intangible assets have been identified in the preliminary analysis. The value of in-process research and development is based upon a preliminary valuation. The Company expects to complete the allocation of the purchase price within one year from the date of the acquisition. Differences between the preliminary and final valuation could have a material impact on the accompanying unaudited pro forma combined financial statement information and MDCO’s future results of operations and financial position.
(c) To eliminate the debt obligations settled in conjunction with the acquisition of ProFibrix.
(d) To record the fair value of contingent purchase consideration at the date of acquisition in accordance with ASC 805-10.
(e) To record the estimated tax impact of identifiable intangible assets recorded in connection with the acquisition of ProFibrix. Under MDCO’s current tax strategy, deferred tax liabilities are recorded on certain of the non-amortizing intangible assets at an assumed tax rate of 25%, the actual deferred tax liabilities recorded as a result of the acquisition could be significantly different.
(f) To eliminate the historical convertible preferred stock, equity and stockholder’s deficit accounts of ProFibrix.
(g) To record transaction costs incurred by the Company after the interim June 30, 2013 balance sheets presented herein.
(h) To eliminate the historical interest expense incurred by ProFibrix for debt obligations settled in conjunction with the acquisition of ProFibrix.







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