EX-99 3 exhibit_2.htm EXHIBIT 2


Exhibit 2

REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION
(UNAUDITED)
March 31, 2021
 

 
REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION
(UNAUDITED)
March 31, 2021

TABLE OF CONTENTS

UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS AS OF MARCH 31, 2021 IN U.S. DOLLARS:
    Page
   
3
   
4
   
5
   
6
   
7-11

2


REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited)

   
Three Months Ended
 
   
March 31,
 
   
2021
   
2020
 
   
U.S. dollars in thousands
 
NET REVENUES
   
20,575
     
1,056
 
COST OF REVENUES
   
10,253
     
1,715
 
GROSS PROFIT
   
10,322
     
(659
)
RESEARCH AND DEVELOPMENT EXPENSES
   
7,484
     
2,765
 
SELLING AND MARKETING EXPENSES
   
13,895
     
9,006
 
GENERAL AND ADMINISTRATIVE EXPENSES
   
7,095
     
4,586
 
OPERATING LOSS
   
18,152
     
17,016
 
FINANCIAL INCOME
   
(42
)
   
(214
)
FINANCIAL EXPENSES
   
4,753
     
355
 
FINANCIAL EXPENSES, net
   
4,711
     
141
 
LOSS AND COMPREHENSIVE LOSS FOR THE PERIOD
   
22,863
     
17,157
 
                 
LOSS PER ORDINARY SHARE, basic and diluted (U.S. dollars):
   
0.05
     
0.05
 
WEIGHTED AVERAGE OF ORDINARY SHARE (in thousands)
   
429,603
     
352,696
 

The accompanying notes are an integral part of these condensed consolidated financial statements.

3


REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
(Unaudited)

   
March 31,
   
December 31,
 
   
2021
   
2020
 
   
U.S. dollars in thousands
 
CURRENT ASSETS:
           
Cash and cash equivalents
   
75,972
     
29,295
 
Bank deposits
   
16
     
17
 
Financial assets at fair value through profit or loss
   
     
481
 
Trade receivables
   
23,306
     
28,655
 
Prepaid expenses and other receivables
   
4,094
     
5,521
 
Inventory
   
9,270
     
6,526
 
     
112,658
     
70,495
 
NON-CURRENT ASSETS:
               
Restricted cash
   
16,158
     
16,164
 
Fixed assets
   
553
     
511
 
Right-of-use assets
   
4,702
     
5,192
 
Intangible assets
   
86,052
     
87,879
 
     
107,465
     
109,746
 
TOTAL ASSETS
   
220,123
     
180,241
 
                 
CURRENT LIABILITIES:
               
Accounts payable
   
6,536
     
11,553
 
Lease liabilities
   
1,636
     
1,710
 
Allowance for deductions from revenue
   
22,677
     
18,343
 
Accrued expenses and other current liabilities
   
25,446
     
24,082
 
Payable in respect of intangible assets purchase
   
10,334
     
17,547
 
     
66,629
     
73,235
 
                 
NON-CURRENT LIABILITIES:
               
Borrowing
   
82,524
     
81,386
 
Payable in respect of intangible assets purchase
   
13,788
     
7,199
 
Lease liabilities
   
3,391
     
3,807
 
Royalty obligation
   
750
     
750
 
     
100,453
     
93,142
 
TOTAL LIABILITIES
   
167,082
     
166,377
 
                 
EQUITY:
               
Ordinary shares
   
1,309
     
1,054
 
Additional paid-in capital
   
354,057
     
293,144
 
Accumulated deficit
   
(302,325
)
   
(280,334
)
TOTAL EQUITY
   
53,041
     
13,864
 
TOTAL LIABILITIES AND EQUITY
   
220,123
     
180,241
 

The accompanying notes are an integral part of these condensed consolidated financial statements.

4


REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY
(Unaudited)

   
Ordinary
   
Additional
   
Accumulated
   
Total
 
   
shares
   
paid-in capital
   
deficit
   
equity
 
   
U.S. dollars in thousands
 
BALANCE AT JANUARY 1, 2021
   
1,054
     
293,144
     
(280,334
)
   
13,864
 
                                 
CHANGES IN THE THREE-MONTHS PERIOD ENDED MARCH 31, 2021:
                               
Share-based compensation to employees and service providers
   
     
     
872
     
872
 
Issuance of ordinary shares, net of expenses
   
242
     
57,699
     
     
57,941
 
Exercise of options into ordinary shares
   
13
     
3,214
     
     
3,227
 
Comprehensive loss
   
     
     
(22,863
)
   
(22,863
)
BALANCE AT MARCH 31, 2021
   
1,309
     
354,057
     
(302,325
)
   
53,041
 
                                 
BALANCE AT JANUARY 1, 2020
   
962
     
267,403
     
(208,363
)
   
60,002
 
CHANGES IN THE THREE-MONTHS PERIOD ENDED MARCH 31, 2020:
                               
Share-based compensation to employees and service providers
   
     
     
802
     
802
 
Comprehensive loss
   
     
     
(17,157
)
   
(17,157
)
BALANCE AT MARCH 31, 2020
   
962
     
267,403
     
(224,718
)
   
43,647
 

The accompanying notes are an integral part of these condensed consolidated financial statements.

5


REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
(Unaudited)

   
Three Months Ended
 
   
March 31,
 
   
2021
   
2020
 
   
U.S. dollars in thousands
 
OPERATING ACTIVITIES:
           
Comprehensive loss
   
(22,863
)
   
(17,157
)
Adjustments in respect of income and expenses not involving cash flow:
               
Share-based compensation to employees and service providers
   
872
     
802
 
Depreciation
   
492
     
350
 
Amortization and impairment of intangible assets
   
1,827
     
1,076
 
Non-cash interest expenses related to borrowing and payable in respect of intangible assets purchase
   
2,639
     
104
 
Fair value losses (gains) on financial assets at fair value through profit or loss
   
6
     
75
 
Exchange differences and revaluation of bank deposits
   
46
     
(159
)
     
5,882
     
2,248
 
Changes in assets and liability items:
               
Decrease (increase) in trade receivables
   
5,349
     
(501
)
Decrease in prepaid expenses and other receivables
   
1,428
     
971
 
Increase in inventories
   
(2,744
)
   
(885
)
Decrease in accounts payable
   
(5,017
)
   
(999
)
Increase in accrued expenses and other liabilities
   
1,364
     
6,030
 
Increase (decrease) in allowance for deductions from revenue
   
4,334
     
(331
)
     
4,714
     
4,285
 
Net cash used in operating activities
   
(12,267
)
   
(10,624
)
INVESTING ACTIVITIES:
               
Purchase of fixed assets
   
(88
)
   
(242
)
Change in investment in current bank deposits
   
     
3,200
 
Transactions costs related to purchase of intangible assets
   
     
(1,183
)
Proceeds from sale of financial assets at fair value through profit or loss
   
475
     
2,225
 
Net cash provided by (used in) investing activities
   
387
     
4,000
 
FINANCING ACTIVITIES:
               
Proceeds from long-term borrowings, net of transaction costs
   
     
79,345
 
Proceeds from issuance of ordinary shares, net of issuance costs
   
57,941
     
 
Exercise of options into ordinary shares
   
3,227
     
 
Repayment of payable in respect of intangible asset purchase
   
(2,125
)
   
 
Increase in restricted cash
   
     
(20,000
)
Payment of principal with respect to lease liabilities
   
(383
)
   
(261
)
Net cash provided by financing activities
   
58,660
     
59,084
 
INCREASE IN CASH AND CASH EQUIVALENTS
   
46,780
     
52,460
 
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
   
(103
)
   
131
 
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
   
29,295
     
29,023
 
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD
   
75,972
     
81,614
 
SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH
   
19
     
178
 
SUPPLEMENTARY INFORMATION ON INTEREST PAID IN CASH
   
1,990
     
231
 
SUPPLEMENTARY INFORMATION ON NON-CASH INVESTING AND FINANCING ACTIVITIES:
               
Acquisition of right-of-use assets by means of lease liabilities
   
     
1,575
 
Long-term borrowings transaction costs
   
     
1,284
 

The accompanying notes are an integral part of these condensed consolidated financial statements.

6

REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)

NOTE 1 - GENERAL:


a.
General


1)
RedHill Biopharma Ltd. (the “Company”), incorporated on August 3, 2009, together with its wholly-owned subsidiary, RedHill Biopharma Inc. (“RedHill Inc.”), incorporated in Delaware, U.S. on January 19, 2017, is a specialty biopharmaceutical company primarily focused on gastrointestinal (“GI”) diseases and infectious diseases.

The Company’s ordinary shares were traded on the Tel-Aviv Stock Exchange (“TASE”) from February 2011 to February 2020, after which the Company voluntarily delisted from trading on the TASE, effective February 13, 2020. The Company’s American Depositary Shares (“ADSs”) were traded on the Nasdaq Capital Market from December 27, 2012 and have been listed on the Nasdaq Global Market (“Nasdaq”) since July 20, 2018.

The Company’s registered address is 21 Ha’arba’a St, Tel-Aviv, Israel.


2)
Since the Company established its commercial presence in the U.S. in 2017, it has promoted or commercialized various GI-related products that were either developed internally or acquired through in-licensing agreements. As of the date of approval of these condensed consolidated interim financial statements, the Company commercializes in the U.S., Talicia®, for the treatment of Helicobacter pylori infection in adults, the first product approved by the U.S. Food and Drug Administration (“FDA”) being developed primarily internally by the Company, Movantik®, for the treatment of opioid-induced constipation, and Aemcolo® (rifamycin), for traveler’s diarrhea.

Effective April 1, 2020, RedHill Inc. entered into an exclusive license agreement (the “License Agreement”) with AstraZeneca AB (“AstraZeneca”), granting RedHill Inc. exclusive, worldwide (excluding Europe, Canada) commercialization and development rights to Movantik® (naloxegol). In addition, RedHill Inc. entered into certain related agreements, pursuant to which AstraZeneca provides RedHill Inc. transitional services for an agreed period. See also notes 1a(2) and 16a(5) to the annual financial statements as of December 31, 2020.


3)
Through March 31, 2021, the Company has an accumulated deficit and its activities have been funded primarily through public and private offerings of the Company’s securities and borrowing. There is no assurance that the Company’s business will generate sustainable positive cash flows.

The Company plans to further fund its future operations through commercialization and out-licensing of its therapeutic candidates, commercialization of in-licensed or acquired products and raising additional capital through equity or debt financing or through non-dilutive financing. The Company’s current cash resources are not sufficient to complete the research and development of all of its therapeutic candidates and to fully support its commercial operations until generation of sustainable positive cash flows. Management expects that the Company will incur additional losses as it continues to focus its resources on advancing the development of its therapeutic candidates, as well as advancing its commercial operations, based on a prioritized plan that will result in negative cash flows from operating activities. The Company believes its existing capital resources should be sufficient to fund its current and planned operations for at least the next 12 months.

If the Company is unable to out-license, sell or commercialize its therapeutic candidates, generate sufficient and sustainable revenues from its commercial operations, or obtain future financing, the Company may be forced to delay, reduce the scope of, or eliminate one or more of its research and development or commercialization programs, any of which may have a material adverse effect on the Company’s business, financial condition or results of operations.

7

REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)

The current COVID-19 pandemic has presented substantial public health and economic challenges around the world and specifically in the Company’s target markets in the U.S., affecting employees, patients, medical clinics, medical diagnosis, communities and business operations. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted at this stage. The Company took actions designed to mitigate the potential impact of the COVID-19 pandemic on its business operations and to date, the COVID-19 pandemic has not caused significant disruptions to the supply chain and the Company has sufficient supply on hand to meet U.S. commercial demand.

A number of the Company’s commercial activities have been impacted by the COVID-19 pandemic, including some launch sales and marketing activities for Talicia® for H. pylori infection and significant impact on sales of Aemcolo® for travelers’ diarrhea.

Although no major disruptions, other than manageable impact on its development and commercial activities, the Company continues to assess the potential impact of the COVID-19 pandemic on its business and operations, including on its sales, expenses, supply chain, financial resources, and clinical trials.

 
b.
Approval of the condensed consolidated interim financial statements:

These condensed consolidated interim financial statements were approved by the Board of Directors (the "BoD") on May 26, 2021.

NOTE 2 - BASIS OF PREPARATION OF THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS:

The Company’s condensed consolidated interim financial statements for the three months ended March 31, 2021 (the "Condensed Consolidated Interim Financial Statements"), have been prepared in accordance with International Accounting Standard IAS 34, “Interim Financial Reporting”. These Condensed Consolidated Interim Financial Statements, that are unaudited, do not include all the information and disclosures that would otherwise be required in a complete set of annual financial statements and should be read in conjunction with the annual financial statements as of December 31, 2020, and their accompanying notes, which have been prepared in accordance with International Financial Reporting Standards (“IFRS”) as published by the International Accounting Standards Board (“IASB”). The results of operations for the three months ended March 31, 2021, are not necessarily indicative of the results that may be expected for the entire fiscal year or for any other interim period.

The accounting policies applied in the preparation of the Condensed Consolidated Interim Financial Statements are consistent with those applied in the preparation of the annual financial statements as of December 31, 2020.

8

REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)

NOTE 3 - SIGNIFICANT EVENTS DURING THE CURRENT REPORTING PERIOD:


a.
Movantik® License Agreement amendment

In connection with the agreements mentioned in note 1a(2) above, in April 2020, RedHill Inc. made an upfront payment of $52.5 million to AstraZeneca. Under the terms of the License Agreement, as amended on July 14, 2020, RedHill Inc. agreed to pay a further noncontingent payment of $15.5 million in December 2021. On March 11, 2021, RedHill Inc and AstraZeneca signed an amendment to the License Agreement. Pursuant to which, the $15.5 million payment due in December 2021 will be adjusted to gradual payments starting in March 2021 and ending in December 2022, totaling $16 million. The amendment is not considered a substantial modification of the terms and resulted in an adjustment of approximately $0.5 million in the carrying amount of the Payable in respect of intangible assets purchase, and a corresponding charge in the statements of comprehensive loss, under financial expenses.
 

b.
During the three months ended March 31, 2021, the Company issued 7,836,209 and 428,421 ADSs for net proceeds of approximately $58 million from underwritten offerings and $3 million from options exercises, respectively.
 

c.
On February 22, 2021, Aether Therapeutics Inc., filed a complaint against the Company in the United States District Court for the District of Delaware ("Aether Litigation"). The complaint asserts that the Company's marketing of the Movantik® product infringes U.S. Patent No’s. 6,713,488, 8,748,448, 8,883,817 and 9,061,024 held by Aether Therapeutics Inc., or the Aether Patents. Aether has asserted the Aether Patents against other entities previously involved in the marketing of the Movantik® product. The complaint requests customary remedies for patent infringement, including (i) a judgment that the Company has infringed, contributed to and induced infringement of the Aether patents, (ii) damages, (iii) attorneys’ fees and (iv) costs and expenses. the Company intends to vigorously defend itself against these claims. Given the early stage of the Aether Litigation, the Company is unable to predict the likelihood of success of the claims of Aether Therapeutics Inc. or to quantify any risk of loss.

NOTE 4 – ALLOWANCE FOR DEDUCTIONS FROM REVENUE:

The following table shows the movement of the allowance for deductions from revenue:

   
Rebates and patient discount programs
   
Product returns
   
Total
 
   
U.S. dollars in thousands
 
As of January 1, 2021
   
16,380
     
1,963
     
18,343
 
Increases
   
17,804
     
460
     
18,264
 
Decreases (utilized)
   
(13,028
)
   
(243
)
   
(13,271
)
Adjustments
   
(659
)
   
-
     
(659
)
As of March 31, 2021
   
20,497
     
2,180
     
22,677
 
                         
   
Rebates and patient discount programs
   
Product returns
   
Total
 
   
U.S. dollars in thousands
 
As of January 1, 2020
   
1,001
     
266
     
1,267
 
Increases
   
252
     
392
     
644
 
Decreases (utilized)
   
(223
)
   
(8
)
   
(231
)
Adjustments
   
(82
)
   
-
     
(82
)
As of March 31, 2020
   
948
     
650
     
1,598
 

9

REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)

NOTE 5 - SHARE-BASED PAYMENTS:

 The following is information on options granted during the three months ended March 31, 2021:


 
Number of options granted
 

 
According to the Award Plan
   

   
Fair value of
 
   
of the Company
   

   
options on date of
 
   
Other
than to
               
Exercise
price for 1
   
grant in
U.S. dollars
in thousands
 
Date of grant
 
directors (1)
   
To directors (1)(2)
   
Total
   
ADS ($)
   
(1)(2)
 
March 2021
   
40,500
     
     
40,500
     
9.44
     
151
 


1)
The options will vest as follows: for directors, employees and consultants of the Company and the Company's subsidiary who had provided services exceeding one year as of the grant date, options will vest in 16 equal quarterly installments over a four-year period. For directors, employees and consultants of the Company and the Company's subsidiary who had not provided services exceeding one year as of the grant date, the options will vest as follows: 1/4 of the options will vest one year following the grant date and the rest over 12 equal quarterly installments. During the contractual term, the options will be exercisable, either in full or in part, from the vesting date until the end of 10 years from the date of grant. 


2)
The fair value of the options was computed using the binomial model and the underlying data used was mainly the following: exercise price of the Company's ADS: $9.44, expected volatility: 64.05%, risk-free interest rate: 1.73% and the expected term was derived based on the contractual term of the options, the expected exercise behavior and expected post-vesting forfeiture rates.

NOTE 6 - NET REVENUES:

   
Three Months Ended March 31,
 
   
2021
   
2020
 
   
U.S dollars in thousands
 
Movantik® revenues
   
18,898
     
 
Other products
   
1,677
     
1,056
 
     
20,575
     
1,056
 

NOTE 7 - FINANCIAL INSTRUMENTS:


a.
Fair value hierarchy

The Company's financial assets as of December 31, 2020, measured at fair value, are at level 1. The Company has no liabilities measured at fair value in the reported periods.

During the reported periods, there were no transfers of financial assets between Levels 1, 2, or 3 fair value measurements.

 
b.
The carrying amount of cash equivalents, bank deposits, restricted cash, receivables, account payables and accrued expenses approximate their fair value due to their short-term characteristics.

The fair value of the borrowing and Payable in respect of intangible assets purchase is approximately $103 million and $27 million as of March 31, 2021, respectively.

10

REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)
NOTE 8 - SEGMENT INFORMATION:

The Company has two segments, Commercial Operations and Research and Development. The following table presents net revenues and operating loss for the Company's segments for the three months ended March 31, 2021 and 2020:

   
Three Months Ended March 31,
 
   
2021
 

 
Commercial
Operations
   
Research and Development
   
Consolidated
 
   
U.S. dollars in thousands
 
Net revenues
   
20,575
     
     
20,575
 
Operating loss
   
8,515
     
9,637
     
18,152
 
       
   
Three Months Ended March 31,
 
   
2020
 
   
Commercial
Operations
   
Research and Development
   
Consolidated
 
   
U.S. dollars in thousands
 
Net revenues
   
1,056
     
     
1,056
 
Operating loss
   
12,076
     
4,940
     
17,016
 

NOTE 9 - EVENT SUBSEQUENT TO MARCH 31, 2021:
 

a.
On April 26, 2021, the Company has filed with the SEC a schedule tender offer to exchange 2,805,281 of its options for the Company’s ADSs with new 2,805,281 options for the Company’s ADSs (the “New Options”). The New Options will have lower exercise prices than in the original options, as stipulated in the terms and conditions filed in the exchange offer.
 
The incremental compensation expense to be recognized by the Company will be measured as the excess of the fair value of each award of New Option granted, measured as of the date the New Options are granted, over the fair value of the options cancelled in exchange for the New Options, measured immediately prior to the cancellation. The Company will recognize any such incremental compensation expense related to the vested options immediately.
 

b.
On April 28, 2021, the BoD approved a grant of options to purchase 2,121,296 ADSs to employees, consultants and advisory board members of the Company and RedHill Inc. The estimated fair value of the options on the grant date was approximately $8.5 million.
 
On the same date, the BoD also approved, subject to the approval of a general meeting of the Company’s shareholders, a grant of options to purchase 110,000 and 115,485 ADSs to the Company’s CEO and members of the BoD, respectively.
 
11