F-1 1 v414851_f1.htm F-1

 

As filed with the Securities and Exchange Commission on July 6, 2015

 

Registration No. 333-

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM F-1

 

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

 

 

 

OASMIA PHARMACEUTICAL AB

 

(Exact name of Registrant as specified in its charter)

 

Not Applicable

 

(Translation of Registrant’s name into English)

 

Sweden 2834 Not Applicable

(State or other jurisdiction of

incorporation or organization)

(Primary Standard Industrial

Classification Code Number)

(I.R.S. Employer

Identification No.)

 

Vallongatan 1

752 28 Uppsala, Sweden

+46 18 50 54 40

 

(Address, including zip code, and telephone number, including area code, of Registrant’s principal executive offices)

 

CT Corporation System

111 Eighth Avenue

New York, NY 10011

(212) 590-9330

 

(Name, address, including zip code, and telephone number, including area code, of agent for service)

 

Copies to:

 

Gregory Sichenzia, Esq.

Henry Nisser, Esq.

Sichenzia Ross Friedman Ference LLP

61 Broadway

New York, NY 10036

Telephone: (212) 930-9700

Facsimile: (212) 930-9725

Julian Aleksov

Executive Chairman

Oasmia Pharmaceutical AB

Vallongatan 1

752 28 Uppsala, Sweden

Telephone: +46 18 50 54 40

Facsimile: +46 18 51 08 73

Stephen E. Older, Esq.

Rakesh Gopalan, Esq.

McGuireWoods LLP

1345 Avenue of the Americas, 7th Floor

New York, NY 10105

Tel: (212) 548-2100

Fax: (212) 548-2150

 

Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this registration statement.

 

If any of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box.

¨

 

If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.

¨

 

If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.

¨

 

If this form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.

¨

 

 

CALCULATION OF REGISTRATION FEE

 

Title of each
class of securities
to be registered
 

Proposed maximum

aggregate offering

price(1)(2)

  Amount of
registration fee
Ordinary Shares, par value SEK 0.10 per share (3)  $23,000,000   $2,672.60 

 

(1)Estimated solely for the purpose of computing the registration fee pursuant to Rule 457(o) under the Securities Act of 1933, as amended.

(2)Includes securities that the underwriters have the option to purchase to cover over-allotments, if any.

(3)

American Depositary Shares issuable on deposit of the ordinary shares registered hereby have been registered under a separate registration statement on Form F-6 (File No.: 333- ). Each American Depositary Share will represent two (2) ordinary shares.

 

 

 

The Registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Commission, acting pursuant to such Section 8(a), may determine.

 

 
 

 

The information in this preliminary prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any state or other jurisdiction where the offer or sale is not permitted.

 

SUBJECT TO COMPLETION, DATED JULY 6, 2015

 

PRELIMINARY PROSPECTUS

 

OASMIA PHARMACEUTICAL AB

(Incorporated in Sweden)

 

 

American Depositary Shares

Representing Ordinary Shares

$ per American Depositary Share

 

This is the initial public offering of Oasmia Pharmaceutical AB in the United States. We are offering American Depositary Shares (each, an “ADS” and, collectively the “ADSs”), each representing two (2) of our ordinary shares (the “Ordinary Shares”). Prior to this offering, there has been no public market for the ADSs representing the Ordinary Shares. We estimate that the initial public offering price will be between $ and $ per ADS.

 

The Ordinary Shares are listed on Nasdaq Stockholm under the symbol “OASM” and on the Frankfurt Stock Exchange under the symbol “OMAX.” On June 26, 2015, the last reported sale price of the Ordinary Shares on Nasdaq Stockholm and the Frankfurt Stock Exchange was $2.11 and $2.12, respectively, based on the certified foreign exchange rates published by the Federal Reserve Bank of New York on June 26, 2015.

 

We have applied to list the ADSs on the NASDAQ Capital Market under the symbol “OASM.”

 

We are an “emerging growth company” as defined by the Jumpstart Our Business Startups Act of 2012 and as such, we have elected to comply with certain reduced public company reporting requirements for this prospectus and future filings.

 

Investing in the ADSs involves a high degree of risk. See “Risk Factors” beginning on page 8 of this prospectus for certain factors you should consider before investing in the ADSs.

 

    Per Share     Total  
Initial public offering price $   $  
Underwriting discounts and commissions(1) $   $  
Proceeds, before expenses to us $   $  

 

(1)See “Underwriting” for a description of the compensation payable to the underwriters.

 

We have granted the underwriters a 45-day option to purchase a total of up to     additional ADSs.

 

The underwriters expect to deliver the ADSs to purchasers on    , 2015.

 

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

 

Sole Book-Running Manager

 

Ladenburg Thalmann

 

The date of this prospectus is July    , 2015.

 

 
 

 

TABLE OF CONTENTS

 

  Page
Prospectus Summary 1
   
The Offering 5
   
Summary of Selected Consolidated Financial Data 7
   
Risk Factors 9
   
Cautionary Note Regarding Forward-Looking Statements 37
   
Exchange Rate Information 39
   
Price Range of the Ordinary Shares 40
   
Use of Proceeds 43
   
Dividend Policy 44
   
Capitalization 45
   
Dilution 46
   
Selected Consolidated Financial Data 48
   
Management’s Discussion and Analysis of Financial Condition and Results of Operations 50
   
Industry Data 65
   
Business 66
   
Management 103
   
Related Party Transactions 112
   
Principal Shareholders 113
   
Description of the Ordinary Shares 114
   
Description of the American Depositary Shares 119
   
Ordinary Shares and ADSs Eligible for Future Sale 126
   
Taxation 127
   
Underwriting 133
   
Expenses Relating to the Offering 142
   
Legal Matters 142
   
Experts 142
   
Enforceability of Civil Liabilities 142
   
Where You Can Find Additional Information 143
   
Index to Consolidated Financial Statements F-1

 

Until , 2015 (25 days after the commencement of this offering), all dealers that buy, sell or trade the Ordinary Shares or the ADSs, whether or not participating in this offering, may be required to deliver a prospectus. This delivery requirement is in addition to the obligation of dealers to deliver a prospectus when acting as underwriters and with respect to their unsold allotments or subscriptions.

 

i
 

 

We have not, and the underwriters have not, authorized anyone to provide any information or to make any representations other than those contained in this prospectus or in any free writing prospectus prepared by or on behalf of us or to which we have referred you. We take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. This prospectus is an offer to sell only the shares offered hereby, and only under the circumstances and in the jurisdictions where it is lawful to do so. The information contained in this prospectus or in any applicable free writing prospectus is current only as of its date, regardless of its time of delivery or any sale of the ADSs. Our business, financial condition, results of operations and prospects may have changed since that date.

 

For investors outside the United States: We have not, and the underwriters have not, done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the case of the U.S. Persons outside the U.S. who come into possession of this prospectus, who must inform themselves of, and observe any restrictions relating to, the offering of the ADSs and the distribution of this prospectus outside the U.S.

 

Oasmia, the Oasmia logo and other trademarks or service marks of Oasmia Pharmaceutical AB appearing in this prospectus are the property of Oasmia Pharmaceutical AB. This prospectus also includes trademarks, trade names and service marks that are the property of other organizations. Solely for convenience, trademarks and trade names referred to in this prospectus appear without the ® and TM symbols, but those references are not intended to indicate that we will not assert, to the fullest extent under applicable law, our rights or that the applicable owner will not assert its rights, to these trademarks and trade names.

 

All references in this prospectus to “$” are to U.S. dollars, all references to “SEK” are to Swedish kronor and all references to “TSEK” are to Swedish kronor in thousands. Solely for the convenience of the reader some, but not all, Swedish krona and Euro amounts have been translated into U.S. dollars at the relevant exchange rate posted by the Federal Reserve Bank. These translations should not be considered representations that any such amounts have been, could have been or could be converted into U.S. dollars at that or any other exchange rate as of that or any other date.

 

ii
 

 

PROSPECTUS SUMMARY

 

This summary highlights information contained elsewhere in this prospectus. This summary does not contain all of the information you should consider before investing in the ADSs. You should read this entire prospectus carefully, especially the section in this prospectus entitled “Risk Factors” beginning on page 8 and our financial statements and the related notes thereto appearing at the end of this prospectus, before making an investment decision. As used in this prospectus, references to “Oasmia,” the “company,” “we,” “us” and “our” refer to Oasmia Pharmaceutical AB and its consolidated subsidiaries, except where the context otherwise requires.

 

Overview

 

We are a pharmaceutical company focused on innovative treatments within human and animal oncology. Our product and product candidates utilize a proprietary, nanoparticle formulation technology that is designed to facilitate the administration of intravenously-delivered active pharmaceutical ingredients, without the addition of toxic solvents. We believe our formulation may result in improved safety, efficacy and ease of administration over existing drugs. Our initial development and commercialization efforts are focused on creating novel formulations of well-established chemotherapeutic drugs that can be used for the treatment of cancer in both humans and companion animals. We have four human oncology product candidates in pre-clinical and/or clinical development, and two veterinary oncology product candidates. We disclosed top-line Phase III data for our lead human oncology product candidate in the fourth quarter of 2014. In February 2014, we received conditional approval by the United States Food and Drug Administration (“FDA”) for our initial veterinary oncology product.

 

Our lead products utilize paclitaxel, the active ingredient of Taxol and Abraxane, two widely used cancer drugs marketed by Bristol-Myers Squibb and Celgene, respectively. Based on the potential benefits of our proprietary formulation technology, we are pursuing a strategy to replace the use of existing paclitaxel-based products in multiple cancers with our novel formulations. Our formulation is currently called Paclical for human indications, and is marketed under the name Paccal Vet-CA1 (“Paccal Vet”) for veterinary indications. We own the global commercial rights to Paclical, excluding Israel, Turkey, Russia, the Commonwealth of Independent States (“CIS”), Ukraine, Georgia and Turkmenistan. We have licensed the global commercial rights to Paccal Vet for sale in Japan, Russia and the CIS.

 

Since we do not yet have sales and marketing operations, we have entered into various licensing and distribution agreements with established pharmaceutical companies to sell Paclical, Paccal Vet, and our other product candidates. We have entered into an agreement with Pharmasyntez for the commercialization of Paclical in Russia and the CIS, as well as Ukraine, Georgia and Turkmenistan, and a separate agreement with Medison Pharma for the commercialization of Paclical in Israel and Turkey. Furthermore, we have entered into an agreement with Nippon Zenyaku Kogyo for the commercialization of Paccal Vet in Japan.

 

Paccal Vet is the first injectable chemotherapeutic agent authorized for marketing for the treatment of squamous cell carcinoma (a cancer occurring in certain cells in the skin and the lining of other organs) and mammary carcinoma (a cancer occurring in the lining of the milk ducts of the mammary glands) in dogs. We received conditional approval by the FDA for Paccal Vet for the treatment of mammary carcinoma and squamous cell carcinoma under the Minor Use and Minor Species (“MUMS”) designation in the U.S. MUMS designation is a status similar to orphan designation for human drugs, making the sponsor eligible for incentives to support the approval or conditional approval of the designated drug, including seven years of market exclusivity in the U.S. For a description of the qualifications for Paccal Vet to receive the MUMS designation, conditional approval and full approval for dogs, see “Business—Overview.” We believe Paccal Vet can be on the market for up to five years, through annual renewals, while we collect remaining required effectiveness data for full approval. We are currently planning additional efficacy studies in dogs to collect all the necessary efficacy data for full U.S. approval of Paccal Vet for mammary carcinoma and squamous cell carcinoma.

 

From our inception through October 31, 2014, such agreements have yielded net cash of SEK 87.83 million in upfront fees and milestone payments and SEK 1.5 million in royalties and sales revenue. In addition to these partnerships, we may eventually directly commercialize Paclical ourselves using a targeted sales strategy similar to the approach used by Abraxis during the launch of Abraxane in 2005. To that end, we generally expect to retain some rights to commercialize Paclical in the U.S. and the EU.

 

1
 

 

We are a newly-commercial stage company with one product conditionally approved for marketing and sale, and given our recent change from development stage to commercial stage, we have not generated any significant revenue other than milestone payments from our commercial partners. We have incurred significant net losses since our inception on April 15, 1988. We incurred net losses of SEK 59.70 million, SEK 105.11 million and SEK 72.38 million for the six months ended October 31, 2014, and the fiscal years ended April 30, 2014 and April 30, 2013, respectively. These losses have resulted principally from costs incurred in connection with research and development activities and general and administrative costs associated with our operations. As of April 30, 2014, we had a deficit accumulated during development stage of SEK 404.26 million and cash, cash equivalents and short-term investments of SEK 48.24 million. We expect to continue to incur operating losses in the near future as we continue our clinical and preclinical development programs, apply for marketing approval for our product candidates and, subject to obtaining regulatory approval of our product candidates, establish sales and marketing partnerships in preparation for the potential commercialization of our product candidates. We believe that the net proceeds of this offering, together with our existing cash and cash equivalents, will enable us to fund our operating expenses and capital expenditure requirements for at least the next twelve months.

 

Risk Factors

 

        Our business is subject to numerous risks that could prevent us from successfully implementing our business strategy. These and other risks are discussed more fully in “Risk Factors” immediately following this prospectus summary and include the following:

 

·We are substantially dependent on the success of our product and product candidates, of which none may receive full regulatory approval or be successfully commercialized.
·Our product and product candidates may not achieve market acceptance, which would curtail or vitiate our ability to generate revenue from new products.
·Problems in our manufacturing process, failure to comply with manufacturing regulations or unexpected increases in our manufacturing costs could harm our business, results of operations and financial condition.
·We expect to face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
·We may not be successful in our efforts to expand our pipeline of product candidates.
·The veterinary market we are seeking to enter with Paccal Vet and our other animal health products is untested.
·Our independent registered public accounting firm has advised us that it has identified a material weakness in our internal control over financial reporting relating to inadequate financial statement preparation and review procedures.
·Our concentration of ownership could be disadvantageous to shareholders.
·There are relationships among our directors and our largest shareholders that could pose a conflict of interest.
·We have incurred significant losses since our inception. We expect to incur losses over the next several years and may never achieve or maintain profitability.
·There is a high rate of failure for drug candidates proceeding through clinical trials.
·Clinical trials for our product candidates are expensive, time consuming, uncertain and susceptible to change, delay or termination.
·The regulatory approval process is uncertain, requires us to utilize significant resources, and may prevent us or our commercial partners from obtaining approvals for the commercialization of some or all of our drug candidates.
·If our efforts to protect the proprietary nature of the intellectual property related to our product or any of our current or future product candidates are not adequate, we may not be able to compete effectively in our market.

 

Recent developments

 

Conditional Approval of Paccal Vet

 

On February 27, 2014, we received FDA conditional approval for Paccal Vet, which made us eligible for royalties and potential milestone payments from our commercial partner Abbott Animal Health, the animal health division of Abbott Laboratories.

 

2
 

 

New Financing

 

As at March 31, 2015, Oasmia has a loan from Nexttobe, its presently second largest shareholder, of SEK 87 million. This loan, which replaces the earlier loan from Nexttobe of SEK 105 million, has a maturity date of December 30, 2015and carries an interest rate of 8.5%.

 

Oasmia has also a bank loan of SEK 20 million from Nordea Bank AB, which replaces the earlier loan from the same bank of SEK 40 million. This loan is due on December 30, 2015, and the interest rate is tied to the Stockholm interbank rate (STIBOR).

 

New Ordinary Share Issuance

 

During the business year 2014/2015 two new share issues were performed:

 

In July, 2014, 2,500,000 Ordinary Shares were issued, providing approximately SEK 50 million before transaction costs and in December, 2014, 9,785,814 Ordinary Shares were issued in a preferential rights issue, which provided approximately SEK 176 million before transaction costs.

 

Termination of Zoetis Agreement

 

In connection with Zoetis’ purchase of Abbott Animal Health, Zoetis provided the Company with notice that Zoetis will terminate the distribution arrangement effective September 30, 2015. The parties are currently formulating a plan to transition the distribution activities back to Oasmia. Oasmia views this as a positive development, and is implementing alternative sales and distribution channels that aligns with its business plans and growth strategy, including by use of its newly formed subsidiary, Oasmia Pharmaceutical, Inc.

Corporate Information

 

Our registered and principal executive offices are located at Vallongatan 1, 752 28 Uppsala, Sweden, our general telephone number is (46) 18 50 54 40 and our website is http://www.oasmia.com. Our website and information contained on or accessible through our website are not part of this prospectus. Our agent for service of process in the U.S. is CT Corporation System. Our Ordinary Shares have been listed on NASDAQ Stockholm since June 24, 2010 and on the Frankfurt Stock Exchange since January 24, 2011.

 

Implications of Being an Emerging Growth Company

 

As a company with less than $1.0 billion in revenue for our fiscal year ending April 30, 2014, we qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). An emerging growth company may take advantage of specified reduced reporting and other requirements that are otherwise applicable to public companies in the U.S. These reduced requirements include not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act of 2002, as amended (the “Sarbanes-Oxley Act”), in the assessment of the emerging growth company’s internal control over financial reporting. The JOBS Act also provides that an emerging growth company does not need to comply with any new or revised financial accounting standards until such date that a private company is otherwise required to comply with such new or revised accounting standards.

 

We may take advantage of these reduced reporting obligations until the last day of our fiscal year following the fifth anniversary of the date of the first sale of the Ordinary Shares pursuant to an effective registration statement under the Securities Act of 1933, as amended (the “Securities Act”), and as a result of, such reduced reporting obligations will cease 2021. However, if certain events occur prior to the end of such five-year period, including if we become a “large accelerated filer,” our annual gross revenue exceeds $1.0 billion or we issue more than $1.0 billion of non-convertible debt in any three-year period, we will cease to be an emerging growth company.

 

3
 

 

We have elected to take advantage of certain of the reduced disclosure obligations in this prospectus and may elect to take advantage of other reduced reporting requirements in future filings with the Securities and Exchange Commission (the “SEC”). As a result, the information that we provide to our shareholders and holders of the Ordinary Shares may be different than the information you might receive from other public reporting companies in which you hold equity interests.

 

The JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. We have irrevocably elected not to avail ourselves of this exemption and, therefore, we will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.

 

4
 

 

THE OFFERING

 

Securities offered by us ADSs (or   ADSs if the underwriters exercise their option to purchase additional ADSs in full).
   
ADSs to be outstanding after this offering (or   ADSs if the underwriters exercise their option to purchase additional ADSs in full).
   
   
Option to purchase additional ADSs We have granted the underwriters a 45-day option to purchase up to   additional ADSs to cover over-allotments, if any.
   
Use of Proceeds We intend to use the net proceeds of this offering to fund (1) new clinical trials and other regulatory requirements of multiple product candidates; (2) production development, including validation batches; (3) capital expenditures; and (4) other general corporate purposes, including employees, rent, and costs and expenses of being a U.S. public company.  See “Use of Proceeds” for a description of the intended use of proceeds from this offering.
   
Offering price On June 26, 2015, the last reported sale price of the Ordinary Shares on the Nasdaq Stockholm was SEK 17.50 per Ordinary Share, equivalent to $4.22 per ADS based on an assumed exchange rate of SEK 8.3113 to $1.00 and a ratio of two (2) Ordinary Shares for each ADS.  See “Underwriting” for a discussion of factors considered in determining the price to the public of the ADSs.
   
The ADSs Each ADS represents two (2) Ordinary Shares.  The depositary will hold the Ordinary Shares underlying your ADSs.  You will have rights as provided in the deposit agreement.  You may cancel your ADSs and withdraw the underlying Ordinary Shares.  The depositary will charge you fees for, among other acts, any cancellation.  Except in certain limited instances described in the deposit agreement, we may amend or terminate the deposit agreement without your consent.  If you continue to hold your ADSs, you agree to be bound by the terms of the deposit agreement then in effect.
   
  To better understand the terms of the ADSs, you should carefully read “Description of American Depositary Shares” in this prospectus.  You should also read the deposit agreement, which is an exhibit to the registration statement that includes this prospectus.
   
Expected NASDAQ Capital Market Symbol OASM

 

5
 

 

Lock-up Agreements We expect to enter into an agreement with the underwriters, subject to certain exceptions, not to sell or dispose of any of the Ordinary Shares, the ADSs or securities convertible into or exchangeable or exercisable for any of these securities until 180 days after the date of this prospectus.  Our directors, officers, and large institutional investors have agreed to similar lock-up restrictions for a period of 180 days.  See “Underwriting.”
   
Risk Factors See “Risk Factors” beginning on page 8 and other information included in this prospectus for a discussion of factors that you should consider carefully before deciding to invest in the ADSs.

 

6
 

 

SUMMARY OF SELECTED CONSOLIDATED FINANCIAL DATA

 

You should read the following selected financial data in conjunction with our financial statements and the related notes thereto appearing elsewhere in this prospectus and in the section of this prospectus entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

 

The following table summarizes our consolidated financial data as of the dates and for the periods indicated. The selected consolidated financial data for the six month periods ended October 31, 2014 and October 31, 2013 and for the fiscal years ended April 30, 2014 and April 30, 2013 have been derived from our consolidated financial statements, which have been prepared in accordance with International Financial Reporting Standards (“IFRS”) issued by the International Accounting Standards Board (“IASB”) and interpretations issued by the International Financial Reporting Interpretations Committee. Furthermore, the recommendation RFR 1, Supplementary accounting regulations for Groups, issued by the Swedish Financial Reporting Board, has been applied. We have restated our consolidated financial statements for the interim period ended October 31, 2013 and the fiscal year ended April 30, 2013 as a result of the reasons disclosed in Note 32 to our consolidated financial statements, included elsewhere in this prospectus. We have prepared the unaudited consolidated financial information set forth below on the same basis as our audited consolidated financial statements. The results for any interim period are not necessarily indicative of the results that may be expected for a full year.

 

Our consolidated financial statements are prepared and presented in Swedish krona, which is our presentation currency. All tables, if not expressly otherwise stated, in this prospectus are therefore in Swedish krona.

 

Our historical results are not necessarily indicative of the results that may be expected in the future. The following summary consolidated financial data should be read in conjunction with the section “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements included elsewhere in this prospectus, including our discussion therein regarding the material weakness in our internal control over financial reporting identified by our auditors.

 

Key figures are translated into USD as additional information as a service to readers of this prospectus in the US. The US Dollar is not the functional currency of Oasmia, which is SEK. The conversion of currency has been made by use of a convenience rate for all figures including those from previous periods. This rate is the closing rate as per June 26, 2015 which was 8.3113 SEK per one USD.

 

Consolidated Income Statement Data:  Six Months Ended   Year Ended 
   October 31,   April 30, 
           (Restated(1))               (Restated(1))     
   2014   2014   2013   2013   2014   2014   2013   2013 
   (TSEK)   (USD, in
thousands)
   (TSEK)   (USD, in
thousands)
   (TSEK)   (USD, in
thousands)
   (TSEK)   (USD, in
thousands)
 
Net sales   1,552    187    24    3    60    7    -    - 
Capitalized development cost   9,928    1,195    15,484    1,863    29,464    3,545    46,229    5,562 
Other operating income   153    18    4,353    524    4,454    536    2,524    304 
Raw materials, consumables and goods for resale   (5,567)   (670)   (2,286)   (275)   (6,835)   (822)   (6,137)   (738)
Other external expenses   (34,767)   (4,183)   (2,627)   (3,324)   (75,189)   (9,047)   (62,616    (7,534)
Employee benefit expenses   (23,335)   (2,808)   (21,827)   (2,626)   (45,101)   (5,426)   (42,408)   (5,102)
Depreciation, amortization and impairment   (2,461)   (296)   (2,479)   (298)   (4,941)   (594)   (5,089)   (612)
Other operating expenses                       (3)   (0,4)   (86)   (10)
Operating income   (54,496)   (6,557)   (34,359)   (4,134)   (98,091)   (11,802)   (67,583)   (8,131)
Financial income   16    2    140    17    192    23    587    71 
Financial expenses   (5,224)   (629)   (2,666)   (321)   (7,213)   (868)   (5,384)   (648)
Financial items, net   (5,208)   (627)   (2,526)   (304)   (7,021)   (845)   (4,798)   (577)
Income before taxes   (59,704)   (7,183)   (36,885)   (4,438)   (105,112)   (12,647)   (72,381)   (8,709)
Taxes                                        
Income for the period   (59,704)   (7,183)   (36,885)   (4,438)   (105,112)   (12,647)   (72,381)   (8,709)
                                         
Earnings per share, before and after dilution, SEK(2)   (0.68)   (0.08)   (0.45)   (0.05)   (1.27)   (0.15)   (1.05)   (0.13)
Weighted average number of shares, in thousands before and after dilution(2)   87,745    87,745    82,345    82,345    82,848    82,848    69,082    69,082 

 

 

7
 

 

 

(1) Restatement of figures has been performed in order to correct the accrual of development costs that have been capitalized at the end of each reporting period. See “Management’s Discussion and Analysis of Financial Condition and Results of OperationsInternal control over financial reporting.”

 

(2) Recalculation of historical figures has been performed with regards to capitalization issue components in the preferential rights share issue carried out in the fiscal quarter ended January 31, 2013 and January 31, 2015.

 

Consolidated Balance Sheet Data:      Six Months Ended           Year Ended     
   October 31,   April 30, 
           (Restated(1))               (Restated(1))     
   2014   2014   2013   2013   2014   2014   2013   2013 
   (TSEK)   (USD, in
thousands)
   (TSEK)   (USD, in
thousands)
   (TSEK)   (USD, in
thousands)
   (TSEK)   (USD, in
thousands)
 
Non-current assets   422,689    50,857    398,838    47,987    414,106    49,824    383,368    46,126 
Liquid assets   27,135    3,265    10,851    1,306    48,241    5,804    62,956    7,575 
Total current assets   35,735    4,300    18,252    2,196    54,276    6,530    69,895    8,410 
Total assets   458,424    55,157    417,090    50,183    468,383    56,355    453,263    54,536 
Total equity   269,035    32,370    282,268    33,962    281,907    33,919    319,153    38,400 
Total non-current liabilities   891    107    891    107    891    107    891    107 
Total current liabilities   188,498    22,680    133,931    16,114    185,584    22,329    133,219    16,029 
Total liabilities   189,389    22,787    134,822    16,222    186,476    22,436    134,110    16,136 

 

Consolidated Cash Flow Data:  Six Months Ended   Year Ended 
   October 31,   April, 30 
           (Restated(1))               (Restated(1))     
   2014   2014   2013   2013   2014   2014   2013   2013 
   (TSEK)   (USD, in
thousands)
   (TSEK)   (USD, in
thousands)
   (TSEK)   (USD, in
thousands)
   (TSEK)   (USD, in
thousands)
 
Cash flow from operating activities   (55,695)   (6,701)   (34,157)   (4,110)   (86,899)   (10,456)   (71,946)   (8,656)
Cash flow from investing activities   (12,243)   (1,473)   (17,949)   (2,160)   (35,682)   (4,293)   (57,388)   (6,905)
Cash flow from financing activities   46,832    5,635    -    -    107,865    12,978    190,263    22,892 

 

 

(1) Restatement of figures has been performed in order to correct the accrual of development costs that have been capitalized at the end of each reporting period. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Internal control over financial reporting.”

 

8
 

 

RISK FACTORS

 

Investing in the ADSs involves a high degree of risk. You should carefully consider the following risk factors and all other information contained in this prospectus, including our consolidated financial statements, before making an investment decision regarding our securities. The risks and uncertainties described below are those significant risk factors, currently known and specific to us, which we believe are relevant to an investment in our securities. The risk factors are not placed in order of priority and should not be construed as comprehensive. Additional risks and uncertainties not currently known to us or those we now deem immaterial may also harm us and adversely affect your investment in the ADSs. If any of these risks materialize, our business, results of operations, financial condition and future prospects could suffer and the price of the ADSs could decline and you could lose part or all of your investment. In addition to the information disclosed in this prospectus, investors should make their own assessment of each risk factor and its potential impact on our future development as well as an assessment of the impact of general conditions, including market conditions and world events.

 

Risks Related to Our Product and Product Candidates

 

We are substantially dependent on the success of our product and product candidates, none of which may receive full regulatory approval or be successfully commercialized.

 

None of our product candidates has been approved for full commercial distribution, and only one of our product candidates has been approved for commercial distribution at all. To date, we have invested nearly all of our resources in the research and development of our product candidates, which consist of Paccal Vet-CA1 (“Paccal Vet”) for cancer in dogs, Paclical for ovarian cancer and other cancers in humans, Docecal for breast cancer in humans, Doxophos Vet for lymphoma in dogs, Doxophos for breast cancer and other cancers in humans, and OAS-19 for various cancers in humans. Our near-term prospects, including our ability to finance our company and to enter into strategic collaborations and generate revenue, are directly dependent upon the successful development and commercialization of our product and product candidates, particularly Paccal Vet and Paclical.

 

The development and commercial success of our product and product candidates will depend on a number of factors, including, without limitation, the following:

 

timely initiation and successful completion of preclinical studies and clinical trials for our product candidates;
demonstration to the satisfaction of the United States Food and Drug Administration (“FDA”), the European Medicines Agency (“EMA”) and other applicable regulatory authorities the safety and efficacy of our product and product candidates as well as to obtain regulatory and marketing approval for our product and product candidates in the U.S., Europe and elsewhere;
continued compliance with all clinical and regulatory requirements applicable to our product and product candidates;
maintenance of an acceptable safety profile of our products following regulatory approval;
competition with other treatments;
creation, maintenance and protection of our intellectual property portfolio, including patents and trade secrets, and regulatory exclusivity for our product and product candidates;
effectiveness of our and our partners’ marketing, sales and distribution strategy and operations;
ability of our third-party manufacturers to manufacture supplies of our product and product candidates and to develop, validate and maintain commercially viable manufacturing processes;
ability to launch commercial sales of our product and product candidates following regulatory approval, whether alone or in collaboration with others;
acceptance of our animal health product and product candidates by veterinarians, pet owners and the animal health community; and
acceptance of our human health product candidates from physicians, health care payers, patients and the medical community.

 

9
 

 

Many of these factors are beyond our control, and we cannot assure you that we will ever be able to generate sufficient revenue or any revenue from the sale of our product and product candidates. Our failure in any of the above factors or in successfully commercializing one or more of our product and product candidates, or any significant delay in doing so, could have a material adverse effect on our business, results of operations and financial condition, and the value of your investment could substantially decline.

 

Our product and product candidates may not achieve market acceptance, which could limit our ability to generate revenue from new products.

 

Even if we develop our product and product candidates and gain regulatory approvals for our products, unless veterinarians, physicians, and patients accept our products, we may not be able to sell our products and generate significant revenue. We cannot assure you that our current product and product candidates or any other planned products will achieve market acceptance and revenue if and when they obtain the requisite regulatory approvals. Market acceptance of any product depends on a number of factors, including but not limited to:

 

·the indication and warnings approved by regulatory authorities in the product label;
·continued demonstration of efficacy and safety in commercial use;
·physicians’ or veterinarians’ willingness to prescribe the product;
·reimbursement from third-party payors such as government health care systems and insurance companies;
·the price of the product, including pet owners’ willingness to pay for treatment;
·the nature of any post-approval risk management plans mandated by regulatory authorities;
·competition; and
·the effectiveness of marketing and distribution support.

 

Any failure by our product and product candidates to achieve market acceptance or commercial success could have a material adverse effect on our business, results of operations and financial condition.

 

Problems in our manufacturing process, failure to comply with manufacturing regulations or unexpected increases in our manufacturing costs could harm our business, results of operations and financial condition.

 

We are responsible for the manufacture and supply of Paccal Vet, Paclical, and our other product candidates for our commercial partners and for use in clinical trials. The manufacturing of our product and product candidates necessitates compliance with US FDA, EU EMA and international current Good Manufacturing Practice (“cGMP”) and other international regulatory requirements. Although we contract with third parties such as Baxter Oncology GmbH for a certain amount of the manufacturing of Paccal Vet, Paclical and our other product candidates, the market authorization for Paccal Vet and Paclical remains with us. As such, even if we could potentially have a claim against one or more third parties, we are legally liable for any noncompliance related to Paccal Vet and Paclical and we expect to retain legal responsibility for future product candidates as well.

 

If we are unable to manufacture, or contract to manufacture, our product and product candidates in accordance with regulatory specifications, or if there are disruptions in the manufacturing process due to damage, loss or failure to pass regulatory inspections of manufacturing facilities, we may not be able to meet the demand for our products or supply sufficient product for use in clinical trials, and this may harm our ability to commercialize Paccal Vet, Paclical and our other product candidates on a timely or cost-competitive basis, or preclude us from doing so at all. In addition, we are in the process of expanding and changing parts of our manufacturing facilities in order to meet future demand and FDA requirements, a program which requires significant time and resources. We also expect to expand and upgrade other parts of our manufacturing facilities in the future. These activities may lead to delays, interruptions in supply, or may prove to be more costly than we currently anticipate. Any problems in our manufacturing process could have a material adverse effect on our business, results of operations and financial condition.

 

In addition, under our license agreements, we expect to generate revenue from the supply of commercial products to our partners at a fixed percentage of our cost of goods sold, and thus any increases in our manufacturing costs could materially and adversely affect our margins and our financial condition.

 

10
 

 

Before we can begin commercial manufacture of Paccal Vet, Paclical or our other product candidates for sale in the U.S., we must obtain FDA regulatory approval for the product, which requires a successful FDA inspection of our manufacturing facilities, processes and quality systems in addition to other product-related approvals. Although we successfully passed an FDA Pre-Approval Inspection of our manufacturing facility in Uppsala, Sweden, our pharmaceutical facilities are continuously subject to inspection by the FDA and foreign regulatory authorities, even after product approval. Due to the complexity of the processes used to manufacture our product and product candidates, we may be unable to pass federal, state or international regulatory inspections in a cost effective manner, whether initially on at any time thereafter. If we are unable to comply with manufacturing regulations, we may be subject to fines, unanticipated compliance expenses, recall or seizure of any approved products, or legal actions such as injunctions or criminal or civil prosecution. These possible sanctions could materially and adversely affect our business, results of operations and financial condition. See also “– Risks Related to Development and Regulatory Approval of Our Product and Product Candidates – The regulatory approval process is uncertain, requires us to utilize significant resources, and may prevent us or our commercial partners from obtaining approvals for the commercialization of some or all of our drug candidates.”

 

We expect to face substantial competition, which may result in others discovering, developing or commercializing products before, or more successfully than, we do.

 

The development and commercialization of new drug products is highly competitive. We face competition with respect to our current product and product candidates, and will face competition with respect to any product candidates that we may seek to develop or commercialize in the future, from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide. In addition to existing therapeutic treatments for the indications we are targeting with our product and product candidates, we also face potential competition from other drug candidates in development by other companies. Our potential competitors include large health care companies, such as Celgene, Merck & Co., Inc., Sanofi S.A., Eli Lilly and Company, Bayer AG, Novartis AG and Boehringer Ingelheim GmbH. Each of these companies also has a presence in animal health. We also know of several smaller early stage companies that are developing products for use in the animal or human health products market. We expect that Paccal Vet and Doxophos Vet will face competition from Palladia, made by Zoetis, Inc., Masivet, made by AB Science S.A., and AT-004 and AT-005, made by Aratana Therapeutics, Inc. We may also face competition from generic medicines and products approved for use in humans that are used off-label for pets. Some of the potential competitive compounds referred to above are being developed by large, well-financed and experienced pharmaceutical and biotechnology companies or have been partnered with such companies, which may give them development, regulatory and marketing advantages over our products.

 

Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop. Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market. In addition, our ability to compete may be affected in many cases by insurers or other third-party payers seeking to encourage the use of generic products. Generic products are currently on the market for the indications that we are pursuing. If our product candidates achieve marketing approval, we expect that they will be priced at a significant premium over competing generic products.

 

Some of the companies against which we are competing or against which we may compete in the future have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller and other early stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These third parties compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.

 

If we are unable to compete successfully, we may be unable to grow and sustain our revenue, which could materially and adversely affect our business, results of operations and financial condition.

 

11
 

 

Generic products may be more cost-effective than our products.

 

In addition to the competition that we may face from products produced by other companies in general, we may also face competition from generic alternatives to our products. For example, Paclical is expected to compete with the generic form of Taxol. Generic alternatives are generally less expensive, and competitors who market generic drugs are becoming more aggressive in terms of pricing. Consequently, generic products constitute an increasing percentage of both overall human and animal health sales in certain regions. If human and animal health care customers increase their use of new or existing generic products, or if we are unable to compete with existing generic products, our business, results of operations and financial condition could be materially and adversely affected.

 

Serious adverse events or other safety risks could require us to abandon development and preclude, delay or limit approval of our product and product candidates, or limit the scope of any approved label or market acceptance.

 

If any of Paccal Vet, Paclical, or any of our other product candidates, prior to or after any approval for commercial sale, causes serious or unexpected side effects, or become associated with other safety risks such as misuse, abuse or diversion, a number of potentially significant negative consequences could result, including, without limitation:

 

regulatory authorities may interrupt, delay or halt clinical trials;
regulatory authorities may deny regulatory approval of our product candidates;
regulatory authorities may require certain labeling statements, such as warnings or contraindications or limitations on the indications for use, or impose restrictions on distribution in the form of a Risk Evaluation and Mitigation Strategy (“REMS”), in connection with approval, if any;
regulatory authorities may withdraw their approval, require more onerous labeling statements or impose a more restrictive REMS of any product that is approved;
we may be required to change the way the product is administered or conduct additional clinical trials;
our relationships with our commercial partners may suffer;
we could be sued and held liable for harm caused to patients; and
our reputation may suffer.

 

We may voluntarily suspend or terminate our clinical trials if at any time we believe that they present an unacceptable risk to participants or if preliminary data demonstrate that our product and product candidates are unlikely to receive regulatory approval or are unlikely to be successfully commercialized. In addition, regulatory agencies, an Institutional Review Board (“IRB”), or data safety monitoring boards may at any time recommend the temporary or permanent discontinuation of our clinical trials or request that we cease using investigators in the clinical trials if they believe that the clinical trials are not being conducted in accordance with applicable regulatory requirements, or that they present an unacceptable safety risk to participants. Although we have never been asked by a regulatory agency, IRB or data safety monitoring board to temporarily or permanently discontinue a clinical trial, if we elect or are forced to suspend or terminate a clinical trial of Paccal Vet, Paclical or any of our other product candidates, the commercial prospects for that product will be harmed and our ability to generate product revenue from that product may be delayed or eliminated. Furthermore, any of these events could prevent us or our partners from achieving or maintaining market acceptance of the affected product and could substantially increase the costs of commercializing our product and product candidates and materially impair our ability to generate revenue from the commercialization of these products either by us or by our commercial partners and could have a material adverse effect on our reputation, business, results of operations and financial condition.

 

If we fail to obtain and sustain an adequate level of reimbursement for our products by third-party payers, sales and profitability will be adversely affected.

 

The course of medical treatment for human patients is, and will continue to be, expensive. We expect that most patients and their families will not be capable of paying for our products themselves. Accordingly, it is unlikely that there will be a commercially viable market for Paclical or our other human health care product candidates without reimbursement from third-party payors. Additionally, even if there is a commercially viable market, if the level of third-party reimbursement is insufficient from the patient’s perspective, our revenue and gross margins will be materially and adversely affected.

 

12
 

 

A current trend in the U.S. health care industry, as well as in other countries around the world, is toward cost containment. Large public and private payers, managed care organizations, group purchasing organizations and similar organizations are exerting increasing influence on decisions regarding the use of, and reimbursement levels for, particular treatments. Third-party payers, such as government programs, including Medicare in the U.S. and private health care insurers, carefully review and have increasingly been challenging the coverage of, and prices charged for, medical products and services. Many third-party payers limit coverage of or reimbursement for newly-approved health care products. Reimbursement rates from private health insurance companies vary depending on the company, the insurance plan and other factors. Cost-control initiatives could decrease the price we or our partners establish for products, which could result in lower product revenue and profitability.

 

Reimbursement systems in international markets vary significantly by country and by region, and reimbursement approvals must be obtained on a country-by-country basis. Our partners may elect to reduce the price of our products in order to increase the likelihood of obtaining reimbursement approvals. In many countries, products cannot be commercially launched until reimbursement is approved and the negotiation process in some countries can exceed 12 months. In addition, pricing and reimbursement decisions in certain countries can be affected by decisions taken in other countries, which can lead to mandatory price reductions and/or additional reimbursement restrictions across a number of other countries, which may thereby adversely affect our sales and profitability. If countries set prices that are not sufficient to allow us or our partners to generate a profit, our partners may refuse to launch the product in such countries or withdraw the product from the market, which would adversely affect our sales and profitability and could materially and adversely affect our business, results of operations and financial condition.

 

We may not be successful in our efforts to expand our pipeline of product candidates.

 

One element of our strategy is to expand our pipeline of pharmaceuticals based on our XR-17 technology and advance these product candidates through clinical development for the treatment of a variety of indications. Although our research and development efforts to date have resulted in a number of development programs based on XR-17 technology, we may not ultimately be able to develop product candidates that are safe and effective. Even if we are successful in continuing to expand our pipeline, the potential product candidates that we identify may not be suitable for clinical development, including as a result of being shown to have harmful side effects or other characteristics that indicate that they are unlikely to receive marketing approval and achieve market acceptance. In addition, if we attempt to apply XR-17 technology to develop product candidates for indications outside of cancer, we will need to conduct genotoxicity, carcinogenicity and immunotoxicity trials, in which the results may be uncertain. If we do not successfully develop and commercialize product candidates based upon our technological approach, we will not be able to obtain product revenue in future periods, which would make it unlikely that we would ever achieve profitability.

 

The veterinary market we are seeking to enter with Paccal Vet and our other animal health products is untested.

 

The market for cancer drugs for dogs is nascent and changing. Consequently, it is difficult to assess to what extent cancer drugs might be accepted by veterinarians, which complicates both the estimate of the market size as well as our share thereof, if any. If a market does not develop, or our share thereof is not meaningful, it could have a material adverse effect on our business, results of operations and financial condition.

 

For our animal health products, changes in distribution channels could negatively impact our market share and distribution of our animal health products.

 

Since our animal health product and product candidates are designed to be given intravenously by veterinarians, pet owners will not be able to obtain our products over-the-counter or via the internet. Increasingly, pet owners purchase animal health products from sources other than veterinarians, such as internet-based retailers, “big-box” retail stores or other over-the-counter distribution channels. This trend has been demonstrated by the significant shift away from the veterinarian distribution channel in the sale of parasiticides and vaccines in recent years. Pet owners also could decrease their reliance on, and visits to, veterinarians as they rely more on internet-based animal health information. Since we market our animal health products through the veterinarian distribution channel, any decrease in visits to veterinarians by pet owners could reduce our market share for such products and materially and adversely affect our operating results and financial condition.

 

13
 

 

Business interruptions could delay us in the process of developing our product and product candidates and could disrupt our product sales.

 

Loss of our manufacturing facilities, stored inventory or laboratory facilities through accidents, fire or other causes could have an adverse effect on our ability to meet demand for our products, to continue product development activities and to conduct our business. Failure to supply our partners with commercial products may lead to adverse consequences, including the right of certain partners to take over responsibility for product supply. We have insurance coverage to compensate us for such business interruptions, but should such coverage prove insufficient to fully compensate us for damage to our business resulting from any significant property or casualty loss to our inventory or facilities, it could have a material adverse effect on our business, results of operations and financial condition.

 

Product recalls or inventory losses caused by unforeseen events, cold chain interruption and testing difficulties may adversely affect our operating results and financial condition.

 

Paccal Vet, Paclical and our other product candidates are manufactured and distributed using technically complex processes requiring specialized facilities, highly specific raw materials and other production constraints. The complexity of these processes, as well as the strict company and government standards for the manufacture of our products, subjects us to production risks. While product batches released for use in clinical trials or for commercialization undergo sample testing, some defects may only be identified following product release. In addition, process deviations or unanticipated effects of approved process changes may result in these intermediate products not complying with stability requirements or specifications. Most of our products must be stored and transported at temperatures within a certain range, which is known as “strict cold chain” storage and transportation. If these environmental conditions deviate, our products’ remaining shelf lives could be impaired or their efficacy and safety could become adversely affected, making them no longer suitable for use. The occurrence or suspected occurrence of production and distribution difficulties can lead to lost inventories, and in some cases product recalls, with consequential reputational damage and the risk of product liability. The investigation and remediation of any identified problems can cause production delays, substantial expense, lost sales and delays of new product launches, any of which could have a material adverse effect on our business, results of operations and financial condition.

 

Risks Related to Our Financial Position and Capital Needs

 

Our independent registered public accounting firm has advised us that it has identified a material weakness in our internal control over financial reporting relating to inadequate financial statement preparation and review procedures.

 

In connection with the audit of our financial statements as of and for the fiscal years ended April 30, 2013 and April 30, 2012 our independent registered public accounting firm reported to our audit committee that it had identified a material weakness in our internal control over financial reporting related to inadequate financial statement preparation and review procedures. Under standards established by the Public Company Accounting Oversight Board (United States), a material weakness is a deficiency or combination of deficiencies in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected and corrected on a timely basis. Specifically, our independent registered public accounting firm determined that we did not have adequate procedures and controls to ensure that accurate financial statements could be prepared and reviewed on a timely basis, including:

 

insufficient resources in place in the finance and accounting department to properly perform the financial statement close process, causing period-end accruals for invoices relating to capitalized research and development expenses to not be accounted for properly in 2013 and 2012; and
lack of sufficient or timely review procedures in place regarding critical accounting areas, including a timely process whereby management identifies and resolves complex accounting matters that require judgment and estimates.

 

As a result of this material weakness, we plan to:

 

supplement the existing finance and accounting department by hiring additional resources with experience in SEC reporting;

 

14
 

 

implement and formalize written policies and procedures for the timely accrual of capitalized research and development expenses;
implement enhanced oversight procedures to ensure that the accrual process has been performed prior to finalization of the financial statements at each reporting period; and
formalize accounting evaluation of non-routine judgments and estimations.

 

We concurred with the findings of our independent registered public accounting firm. We are working to remediate the material weakness. The actions that we are taking are subject to ongoing senior management review and audit committee oversight. Although we plan to complete this remediation process as quickly as possible, we cannot at this time estimate how long it will take, and our initiatives may not prove to be successful in remediating this material weakness. If we are unable to successfully remediate this material weakness and if we are unable to produce accurate and timely financial statements, our share price may be adversely affected and we may be unable to maintain compliance with applicable stock exchange listing requirements.

 

We will be required to disclose changes made in our internal control over financial reporting and procedures on a semi-annual basis and our management will be required to assess the effectiveness of these controls annually.  However, for as long as we are an “emerging growth company” under the JOBS Act, our independent registered public accounting firm will not be required to attest to the effectiveness of our internal control over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act.  We could be an “emerging growth company” for up to five years.  An independent assessment of the effectiveness of our internal control over financial reporting could detect problems that our management’s assessment might not.  Additional undetected material weaknesses in our internal control over financial reporting could lead to financial statement restatements and require us to incur additional expenses of remediation, and adversely affect our reputation, financial condition and operating results.

 

We face litigation risks as a result of the material weakness in our internal control over financial reporting identified by our independent registered public accounting firm.

 

In connection with the audit of our financial statements as of and for the fiscal years ended April 30, 2013 and April 30, 2012 our independent registered public accounting firm reported to our audit committee that it had identified a material weakness in internal control over financial reporting related to inadequate financial statement preparation and review procedures.  See “–Our independent registered public accounting firm has advised us that it has identified a material weakness in our internal control over financial reporting relating to inadequate financial statement reparation and review procedures.”

 

As a result of such material weakness and our disclosure thereof, we face the potential for litigation by current or former shareholders based on their purported inability to accurately evaluate our financial performance from reviewing our audited financial statements, based on an alleged material statement or omission contained in our audited financial statements or based on other claims arising from our inadequate financial statement preparation and review procedures.  As of the date of this prospectus, we have no knowledge of any such shareholder litigation.  However, we can provide no assurance that such shareholder litigation will not arise in the future.  Any such shareholder litigation, whether successful or not, could have a material adverse effect on our business, results of operations and financial condition.

 

Our concentration of ownership could be disadvantageous to shareholders.

 

Alceco International S.A. (“Alceco”), as of the date of this prospectus, owned approximately 36.02 percent of our shares. Nexttobe AB (“Nexttobe”), as of as of the date of this prospectus, owned approximately 20.03 percent of our shares, and also holds a significant amount of our debt. Alceco and Nexttobe can thus, both before and after the offering, exercise significant influence over all matters requiring shareholder approval, and may be able to prevent a change in control or take other measures that may benefit Alceco or Nexttobe but could be disadvantageous to other shareholders. Moreover, the sale of a substantial number of our shares by Alceco and/or Nexttobe within a short period of time could cause our share price to decrease, make it more difficult for us to raise funds through future offerings of Ordinary Shares or acquire other businesses using Ordinary Shares as consideration. Additionally, Alceco and Nexttobe may have conflicting interests with us. See “–There are relationships among our directors and our largest shareholders that could pose a conflict of interest.”

 

15
 

 

There are relationships among our directors and our largest shareholders that could pose a conflict of interest.

 

There are relationships among some of the members of our board of directors with each other and with our largest shareholders that could pose a conflict of interest. Two of our directors, our Executive Chairman Julian Aleksov and Bo Cederstrand are co-owners of Alceco, a holding company based in Luxembourg that conducts no business and exists only for financial management. Alceco owns 35,243,908 of the Ordinary Shares as of the date of this prospectus and is our largest shareholder. In addition to being partners in Alceco, Messrs. Aleksov and Cederstrand also have a familial relationship. Mr. Aleksov is the partner of Mr. Cederstrand’s daughter and the father of his two grandchildren. Alceco has also extended a credit facility of SEK 40 million to us, which as of April 15, 2015 has not been drawn upon.

 

Another director, Alexander Kotsinas, is a partner at Nexttobe, which owned 19,602,173 of our Ordinary Shares as of March 31, 2015 and is our second-largest shareholder. Nexttobe is also our largest creditor, from whom we have a loan of SEK 87 million.

 

These directors may have actual or apparent conflicts of interest with respect to matters involving or affecting us and Alceco and/or Nexttobe. Examples of possible conflicts include:

 

·the board of directors could have to decide whether to use funds for operating expenses or the repayment of a loan to Nexttobe;
·issues or disputes could arise under the commercial agreements that exist between us and Alceco and Nexttobe;
·under the terms of Alceco’s loan agreements, one or more Alceco creditors could become shareholders and could exercise their voting rights in a manner that could conflict with your interests;
·Nexttobe, a venture capital company, could own or come to own interests in companies that compete with us; and
·given the close relationship between Messrs. Cederstrand and Aleksov, Mr. Cederstrand could be conflicted as to any board decision on the compensation and employment status of Mr. Aleksov.

 

See also “Related Party Transactions.”

 

Apart from the conflicts of interest policy contained in our Code of Ethics and Business Conduct, we and Alceco and Nexttobe have not established any formal procedures for us and Alceco and Nexttobe to resolve potential or actual conflicts of interest between us. There can be no assurance that any of the foregoing conflicts will be resolved in a manner that does not adversely affect our business, financial condition or results of operations.

 

U.S. investors may have difficulty enforcing civil liabilities against us, our directors or members of senior management and the experts named in this prospectus.

 

All of our directors and officers named in this prospectus are non-residents of the U.S., and all or a substantial portion of the assets of such persons are located outside the U.S. As a result, it may not be possible to serve process on such persons or our company in the U.S. or to enforce judgments obtained in U.S. courts against them or us based on civil liability provisions of the securities laws of the U.S. There is doubt as to whether Swedish courts would enforce certain civil liabilities under U.S. securities laws in original actions or judgments of U.S. courts based upon these civil liability provisions. In addition, awards of punitive damages in actions brought in the U.S. or elsewhere may be unenforceable in Sweden. An award for monetary damages under the U.S. securities laws would be considered punitive if it does not seek to compensate the claimant for loss or damage suffered and is intended to punish the defendant. The enforceability of any judgment in Sweden will depend on the particular facts of the case as well as the laws and treaties in effect at the time. The U.S. and Sweden do not currently have a treaty providing for recognition and enforcement of judgments (other than arbitration awards) in civil and commercial matters.

 

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We have incurred significant losses since our inception. We expect to incur losses over the next several years and may never achieve or maintain profitability.

 

Since our inception on April 15, 1988, we have incurred significant operating losses. We incurred net losses of SEK 59.70 million for the six months ended October 31, 2014 and SEK 105.11 million and SEK 72.38 million for the fiscal years ended April 30, 2014 and April 30, 2013, respectively. To date, we have financed our operations primarily through private placements of shares in our company and through one-time milestone payments from our commercial partners. We have devoted substantially all of our financial resources and efforts to research and development, including preclinical studies and clinical trials. We expect to continue to incur significant expenses and operating losses over the next few years. Our net losses may fluctuate significantly from quarter to quarter and year to year. We anticipate that our expenses will increase substantially as we:

 

initiate and conduct a Phase II program for Paclical for the treatment of metastatic breast cancer;
conduct additional efficacy studies in dogs to collect all the necessary efficacy data for full FDA approval of Paccal Vet;
continue research and development for and commence pre-clinical and clinical trials of Docecal, Doxophos, Doxophos Vet and OAS-19;
seek to discover and develop additional product candidates;
seek regulatory approvals for any product candidates that successfully complete clinical trials;
ultimately establish a sales, marketing and distribution infrastructure and scale up external manufacturing capabilities to commercialize any products that we choose not to license to a third party and for which we may obtain regulatory approval;
maintain, expand and protect our intellectual property portfolio;
hire additional clinical and scientific personnel; and
add operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts.

 

To become and remain profitable, we must succeed in developing and eventually commercializing products that generate significant revenue. This will require us to be successful in a range of challenging activities, including completing preclinical testing and clinical trials of our product candidates, discovering additional product candidates, potentially entering into collaboration and license agreements, obtaining regulatory approval for product candidates and manufacturing, marketing and selling any products for which we may obtain regulatory approval. We are only in the preliminary stages of most of these activities. We may never succeed in these activities and, even if we do, may never achieve profitability.

 

Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability. If we are required by the FDA or by other regulatory authorities outside of the U.S. to perform studies in addition to those currently expected, or if there are any delays in completing our clinical trials or the development of any of our product candidates, our expenses could increase.

 

Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would depress the value of our company and could impair our ability to raise capital, expand our business, maintain our research and development efforts, diversify our product offerings or even continue our operations. A decline in the value of our company could also cause you to lose all or part of your investment.

 

We may need substantial additional funding, which may not be available to us on acceptable terms, or at all. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or our commercialization efforts.

 

Our operations have consumed substantial cash since inception. Excluding receipts from milestone fees, our cash flow used for operating activities for the six months ended October 31, 2014 and the fiscal years ended April 30, 2014 and April 30, 2013 was approximately SEK 55.70 million, SEK 86.90 million and SEK 71.95 million, respectively, with development costs, which are capitalized, for the six months ended October 31, 2014 and those years totaling approximately SEK 9.93 million, SEK 29.46 million and SEK 46.23 million, respectively. We expect our operating and management and administrative expenses and cash used for operations to continue to be significant and to increase substantially in connection with our planned research, development and continued product commercialization efforts and as we transition to a U.S. public company. We may need to raise additional capital following this offering to fund our operations and continue to conduct clinical trials to support potential regulatory approval of marketing applications. If we are unable to raise capital when needed or on attractive terms, we could be forced to:

 

delay, reduce or eliminate our research and development programs or any future commercialization efforts;

 

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relinquish or license on unfavorable terms our rights to technologies, our product, or product candidates that we otherwise would seek to develop or commercialize ourselves;
seek collaborators for our product or one or more of our product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available; or
cease operations altogether.

 

We believe that future capital requirements from cash flow from operations, including milestone and other payments from our partners and the net proceeds from this offering, will enable us to fund our operating expenses and capital expenditure requirements for at least the next twelve months. We have based this estimate on assumptions that may prove to be wrong, and we could use up our capital resources sooner than we currently expect. We do not expect our existing capital resources, including the net proceeds from this offering, to enable us to complete Phase III development of Paclical for the treatment of epithelial ovarian cancer, conduct Phase II development of Paclical for the treatment of metastatic breast cancer, conduct additional efficacy studies in dogs for full FDA approval of Paccal Vet or continue research and development for and commence clinical trials of Docecal, Doxophos Vet, Doxophos and OAS-19. Accordingly, we expect that we will need to raise substantial additional funds in the future. Our future capital requirements will depend on many factors, including:

 

the revenue, if any, related to commercial sales of our product and product candidates for which we receive marketing approval, including royalties and milestones received from Abbott Animal Health (the animal health division of Abbott Laboratories);
the Phase II clinical program for Paclical for the treatment metastatic breast cancer;
the scope, progress, results and costs of preclinical development, laboratory testing and clinical trials for our other product candidates, including those of Docecal, Doxophos Vet, Doxophos and OAS-19;
our ability to enter into collaborative agreements for the development and commercialization of our product candidates;
the number and development requirements of other product candidates that we pursue;
the costs, timing and outcome of regulatory review of our product candidates or any future product candidates, both in the U.S. and outside the U.S.;
the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for our product or any of our product candidates for which we receive marketing approval;
any product liability or other lawsuits related to our products;
the expenses needed to attract and retain skilled personnel; and
the costs involved in preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims, both in the U.S. and outside the U.S.

 

Identifying potential product candidates and conducting preclinical testing and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain regulatory approval and achieve product sales. In addition, our product and our product candidates, if approved, may not achieve commercial success. Our commercial revenue, if any, will be derived from sales of products that we do not expect to be commercially available for several months, if at all. Accordingly, we will need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all. In addition, we may seek additional capital due to favorable market conditions or strategic considerations, even if we believe we have sufficient funds for our current or future operating plans.

 

We do not currently intend to pay dividends on the Ordinary Shares or make any other distribution of earnings to holders of the Ordinary Shares.

 

Since our inception, we have not declared or paid any dividends on the Ordinary Shares. We intend to retain any earnings for use in our business and do not currently intend to pay dividends on the Ordinary Shares. The declaration and payment of any future dividends will be at the discretion of our board of directors and will depend upon our results of operations, cash requirements, financial condition, contractual restrictions, restrictions imposed by our indebtedness, any future debt agreements or applicable laws and other factors that our board of directors may deem relevant. This policy may have a material adverse effect on the value of your Ordinary Shares. See “Dividend Policy.”

 

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The milestone payments we receive are not reliable sources of income and in some cases may be required to be returned at a later date.

 

Much of our income has consisted of, and may in the future take the form of, milestone payments, which are contractual one-time payments from our partners as we reach certain targets. There have been cases in which we have not reached the targets and there is no guarantee that we will be able to reach such targets in the future. We may also be required to repay already obtained milestone payments if the agreed upon schedules are not kept or if the required marketing approvals are not obtained. Further, milestone payments often occur irregularly over time, causing fluctuations in our sales and earnings. Milestone payments are not sustainable earnings and any dependence on milestone payments could have a material adverse effect on our business, results of operations and financial condition. See also “Business—Strategic Alliances and Collaborations.”

 

Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.

 

We commenced active operations in 1999, and our operations thus far have been limited to organizing and staffing our company, business planning, raising capital, identifying potential product candidates, undertaking preclinical studies and conducting clinical trials. To date we have had no commercial operations. All but three of our product candidates are still in preclinical development. We have not yet demonstrated our ability to successfully complete later stage clinical trials, obtain full regulatory approvals, manufacture a commercial scale product, or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization. Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if we had a longer operating history.

 

In addition, as a business with a limited operating history, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors. We will need to expand our capabilities to support commercial activities. We may not be successful in adding such capabilities.

 

We expect our financial condition and operating results to continue to fluctuate significantly from quarter to quarter and year to year due to a variety of factors, many of which are beyond our control. Accordingly, you should not rely upon the results of any past annual or interim periods as indications of future operating performance.

 

Risks Related to Development and Regulatory Approval of Our Product and Product Candidates

 

There is a high rate of failure for drug candidates proceeding through clinical trials.

 

Generally, there is a high rate of failure for drug candidates proceeding through clinical trials. We may suffer significant setbacks in our clinical trials similar to the experience of a number of other companies in the pharmaceutical and biotechnology industries, even after receiving promising results in earlier trials. Further, even if we view the results of a clinical trial to be positive, the FDA or other regulatory authorities may disagree with our interpretation of the data. For instance, because a large percentage of subjects in our pivotal trials for Paccal Vet, Paclical and our other product candidates in cancer treatment, are being enrolled at sites outside the U.S. (25% of canine subjects and 100% of human patients), differences in efficacy results between U.S. and non-U.S. sites could cause the FDA to require additional trials. In the event that:

 

·we obtain negative results from the Paccal Vet or Paclical Phase III trials,
·we receive poor clinical results for our other product candidates,
·the FDA places a clinical hold on our Phase III trials due to potential chemistry, manufacturing and controls issues or other hurdles, or
·the FDA does not approve our New Animal Drug Application (“NADA”) for Paccal Vet or our New Drug Application (“NDA”) for Paclical or for our other product candidates,

then:

·we may not be able to generate sufficient revenue or obtain financing to continue our operations,
·our ability to execute our current business plan will be materially impaired,

 

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·our reputation in the industry and in the investment community would likely be significantly damaged, and
·the price of the Ordinary Shares would likely decrease significantly.

 

Any of these results could materially and adversely affect our business, results of operations or financial condition.

 

Clinical trials for our product candidates are expensive, time consuming, uncertain and susceptible to change, delay or termination.

 

Clinical trials are expensive, time consuming and difficult to design and implement. The result of a clinical trial may be undesirable and can result in a clinical trial cancellation or the need for re-evaluation and supplementation. Even if the results of our clinical trials are favorable, the clinical trials for a number of our product candidates are expected to continue for several years and may even take significantly longer to complete. In addition, we, the FDA, an IRB, or other regulatory authorities, including in the U.S., EU and elsewhere, may suspend, delay or terminate our clinical trials at any time, for various reasons, including:

 

lack of effectiveness of any product candidate during clinical trials;
discovery of serious or unexpected toxicities or side effects experienced by trial participants or other safety issues;
slower than expected rates of subject recruitment and enrollment rates in clinical trials;
difficulty in retaining subjects who have initiated a clinical trial but may have withdrawn due to adverse side effects from the therapy, insufficient efficacy, fatigue with the clinical trial process or for any other reason;
delays or inability in manufacturing or obtaining sufficient quantities of materials for use in clinical trials due to manufacturing or regulatory constraints;
inadequacy of or changes in our manufacturing process or product formulation;
delays in obtaining regulatory authorization to commence a trial, including experiencing “clinical holds” or delays requiring suspension or termination of a trial by a regulatory agency, such as the FDA, before or after a trial is commenced;
changes in applicable regulatory policies and regulations;
delays or failure in reaching agreement on acceptable terms in clinical trial contracts or protocols with prospective clinical trial sites;
delay or failure to supply product for use in clinical trials which conforms to regulatory specification;
unfavorable results from ongoing pre-clinical studies and clinical trials;
failure of our contract research organizations (“CROs”), or other third-party contractors to comply with all contractual requirements or to perform their services in a timely or acceptable manner;
failure by us, our employees, our CROs or their employees to comply with all applicable FDA or other regulatory requirements relating to the conduct of clinical trials;
scheduling conflicts with participating clinicians and clinical institutions;
failure to design appropriate clinical trial protocols; or
regulatory concerns with pharmaceutical products generally and the potential for abuse.

 

Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition.

 

The regulatory approval process is uncertain, requires us to utilize significant resources, and may prevent us or our commercial partners from obtaining approvals for the commercialization of some or all of our drug candidates.

 

The research, testing, manufacturing, labeling, approval, sale, marketing and testing of our product and product candidates are subject to extensive regulation by regulatory authorities in the U.S. and Europe, and regulatory requirements applicable to our product and product candidates differ from country to country. Neither we nor any commercial partner is permitted to market any of our current or future product candidates in the U.S. until we receive approval from the FDA of an NADA for our animal health products or an NDA for our human health products. We received conditional approval for Paccal Vet from the FDA in February 2014, which will require additional follow-up efficacy studies for full approval, but have yet to receive any type of approval for any of our other current product candidates. Obtaining approval of either an NADA or an NDA can be an uncertain process that requires us to utilize significant resources. Furthermore, regulatory authorities possess broad discretion regarding processing time and usually request additional information and raise questions which have to be answered. There is considerable uncertainty regarding the times at which products may be approved. In addition, failure to comply with FDA and other applicable U.S. and foreign regulatory requirements may subject us to administrative or judicially imposed sanctions, including: warning letters, civil and criminal penalties, injunctions, withdrawal of approved products from the market, product seizure or detention, product recalls, total or partial suspension of production, and refusal to approve pending applications or supplements to approved applications.

 

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The process required by the FDA and most foreign regulatory authorities before human health care pharmaceuticals may be marketed generally involves nonclinical laboratory and animal tests; submission of an Investigational New Drug (“IND”) application, which must become effective before clinical trials may begin; adequate and well-controlled human clinical trials to establish the safety and efficacy of the proposed drug for its intended use or uses; pre-approval inspection of manufacturing facilities and clinical trial sites; and FDA approval of an NDA, which must occur before a drug can be marketed or sold.

 

In order to gain approval to market a pet therapeutic for a particular species of pet, we must provide the FDA and foreign regulatory authorities with data from animal safety and effectiveness studies that adequately demonstrate the safety and efficacy of that product in the target animal for the intended indication applied for in the NADA or other regulatory filing. Conditional approval is available under the FDA Minor Use and Minor Species (“MUMS”) designation, which gives the sponsor the right to promote a product before all of the efficacy data necessary for full approval are available. If approved, this provides the sponsor with seven years of market exclusivity. Even for conditional approval, the development of animal health products is a lengthy, expensive and uncertain process, and delay or failure can occur at any stage of any of our development efforts. Success in prior target animal studies or even in the treatment of human beings with a product candidate does not ensure that our studies will be successful and the results of development efforts by other parties may not be indicative of the results of our studies and other development efforts.

 

Regulatory approval of a NADA or an NDA, or any supplements of either, is not guaranteed, and the approval process requires us to utilize significant resources, could take several years, and is subject to the substantial discretion of the FDA. Despite the time and expense exerted, failure can occur at any stage, and we could encounter problems that cause us to abandon or have to repeat or perform additional studies. If our product or any of our current or future product candidates fails to demonstrate safety and efficacy in our studies, or for any other reason does not gain regulatory approval, our business and results of operations will be materially and adversely harmed.

 

In addition, separate regulatory approvals are required in order to market any product in many jurisdictions, including the U.S., the European Economic Area, which consists of the 28 Member States of the European Union plus Norway, Iceland and Liechtenstein, and many others. Approval procedures vary among countries and can involve additional studies and testing, and the time required to obtain approval may differ from that required to obtain FDA approval. Studies conducted in one country may not be accepted by regulatory authorities in other countries. Approval by the FDA does not ensure approval by regulatory authorities in other countries, and approval by one or more foreign regulatory authorities does not ensure approval by regulatory authorities in other foreign countries or by the FDA. However, a failure or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory process in others. The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval. We may be unable to file for regulatory approvals or to do so on a timely basis and, even if we are able to, we may not receive necessary approvals to commercialize our products in any market. Any of these results could have a material adverse effect on our business, results of operations and financial condition.

 

Even if we receive regulatory approval for any of our current or future product candidates, we will be subject to ongoing FDA and other regulatory body obligations and continued regulatory review, which may result in significant additional expense. Additionally, our product and any product candidates, if approved, will be subject to labeling and manufacturing requirements and could be subject to other restrictions. Failure to comply with these regulatory requirements or the occurrence of unanticipated problems with our products could result in significant penalties.

 

Any regulatory approvals that we or any of our collaborators receive for any of our current or future product candidates may be subject to conditions of approval or limitations on the approved indicated uses for which the product may be marketed, or may contain requirements for potentially costly surveillance to monitor the safety and efficacy of the product candidate. In addition, our product and any of our current or future product candidates, if approved by the FDA or other regulatory bodies, will be subject to extensive and ongoing regulatory requirements regarding the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion and recordkeeping. These requirements will include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMP, Good Laboratory Practice and Good Clinical Practice for any studies that we conduct post-approval. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:

 

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restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market, or voluntary or mandatory product recalls;
fines, warning letters or holds on target studies;
refusal by the FDA or other applicable regulatory body to approve pending applications or supplements to approved applications filed by us or our strategic collaborators, or suspension or revocation of product license approvals;
product seizure or detention, or refusal to permit the import or export of products; and
injunctions or the imposition of civil or criminal penalties

 

The policies of the FDA and other regulatory bodies may change, and additional government regulations may be promulgated that could prevent, limit or delay regulatory approval of our product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the U.S. or elsewhere. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability, which would materially and adversely affect our business, results of operations and financial condition.

 

Our product and any of our current or future product candidates, if approved, may cause or contribute to adverse medical events that we are required to report to the FDA and regulatory authorities in other countries and, if we fail to do so, we could be subject to sanctions that would materially harm our business.

 

If we are successful in commercializing our product and any of our current or future product candidates, regulations of the FDA and of the regulatory authorities in other countries require that we report certain information about adverse medical events if those products may have caused or contributed to those adverse events. The timing of our obligation to report would be triggered by the date we become aware of the adverse event as well as the nature of the event. We may fail to report adverse events we become aware of within the prescribed timeframe. We may also fail to appreciate that we have become aware of a reportable adverse event, especially if it is not reported to us as an adverse event or if it is an adverse event that is unexpected or removed in time from the use of our products. If we fail to comply with our reporting obligations, the FDA and regulatory authorities in other countries could take action including criminal prosecution, the imposition of civil monetary penalties, seizure of our products, or delay in approval or clearance of future products, which could have a material adverse effect on our business, results of operations and financial condition.

 

Legislative or regulatory reforms with respect to human or animal health products may make it more difficult and costly for us to obtain regulatory clearance or approval of any of our current or future product candidates and to produce, market, and distribute our products after clearance or approval is obtained.

 

From time to time, legislation is drafted and introduced in the U.S. Congress and lawmaking bodies in other countries that could significantly change the statutory provisions governing the testing, regulatory clearance or approval, manufacture, and marketing of regulated products. In addition, FDA regulations and guidance are often revised or reinterpreted by the FDA in ways that may significantly affect our business and our products. Similar changes in laws or regulations can occur in other countries. Any new regulations or revisions or reinterpretations of existing regulations in the U.S. or in other countries may impose additional costs or lengthen review times of our product and any of our current or future product candidates. We cannot determine what effect changes in regulations, statutes, legal interpretation or policies, when and if promulgated, enacted or adopted may have on our business in the future. Such changes could, among other things, require:

 

requests for additional endpoints or studies;
changes to manufacturing methods;
recall, replacement, or discontinuance of certain products; and
additional record keeping.

 

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Each of these would likely entail substantial time and cost and could have a material adverse effect on our financial results. In addition, delays in receipt of or failure to receive regulatory clearances or approvals for any future products could materially and adversely affect our business, results of operations and financial condition.

 

Our ability to market our product and product candidates in the U.S., if approved, will be limited to use for the treatment of the indications for which they are approved, and if we want to expand the indications for which we may market our product and product candidates, we will need to obtain additional FDA approvals, which may not be granted.

 

We plan to seek full FDA approval in the U.S. for Paccal Vet for mammary carcinoma and squamous-cell carcinoma in dogs, Paclical for ovarian cancer in humans, Docecal for breast cancer in humans, Doxophos Vet for lymphoma in dogs, Doxophos for breast cancer in humans, and OAS-19 for various cancers in humans. If our product candidates are approved, the FDA will restrict our ability to market or advertise them for the treatment of indications other than the indications for which they are approved, which could limit their use. If we decide to attempt to develop, promote and commercialize new treatment indications and protocols for our product and product candidates in the future, we could not predict when, or if, we would ever receive the approvals required to do so. We would be required to conduct additional studies to support such applications for additional use, which would consume additional resources and may produce results that do not result in FDA approvals. If we do not obtain additional FDA approvals, our ability to expand our business in the U.S. would be adversely affected, which could materially and adversely affect our business, results of operations and financial condition.

 

The anticipated development of a REMS for Paclical and our other human health product candidates could cause delays in the approval process and would add additional layers of regulatory requirements that could impact our ability to commercialize our human health product candidates in the U.S. and reduce their market potential.

 

As a condition of approval of an NDA, the FDA may require a REMS to ensure that the benefits of the drug outweigh the potential risks. REMS elements can include medication guides, communication plans for health care professionals, and elements to assure safe use (“ETASU”). ETASU can include, but are not limited to, special training or certification for prescribing or dispensing, dispensing only under certain circumstances, special monitoring, and the use of patient registries. Moreover, product approval may require substantial post-approval testing and surveillance to monitor the drug’s safety or efficacy. We may be required to adopt a REMS for Paclical and our other human health product candidates to ensure that the benefits outweigh the risks of abuse, misuse, diversion and other potential safety concerns. Even if the risk of abuse, misuse or diversion are not as high as for some other products, there can be no assurance that the FDA will approve a manageable REMS for Paclical and our other human health product candidates, which could create material and significant limits on our ability to successfully commercialize our human health product candidates in the U.S. Delays in the REMS approval process could result in delays in the NDA approval process. In addition, as part of the REMS, the FDA could require significant restrictions, such as restrictions on the prescription, distribution and patient use of the product, which could significantly impact our ability to effectively commercialize Paclical and our other human health candidates, and dramatically reduce their market potential thereby adversely impacting our business, financial condition and results of operations. Even if initial REMS are not highly restrictive, if, after launch, Paclical or our other human health product candidates were to be subject to significant abuse/non-medical use or diversion from licit channels, this could lead to negative regulatory consequences, including a more restrictive REMS, which could materially and adversely affect our business, results of operations and financial condition.

 

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If we are found in violation of “fraud and abuse” laws, we may be required to pay a penalty and/or be suspended from participation in government-run health care programs, which may adversely affect our business, financial condition and results of operations.

 

If we are successful in obtaining marketing approval for our products in the U.S. and elsewhere, we will be subject to various health care “fraud and abuse” laws, including anti-kickback laws, false claims laws and other laws intended to reduce fraud and abuse in government-run health care programs, which could affect us, particularly upon successful commercialization of our products in the U.S. For example, the Medicare and Medicaid Patient Protection Act of 1987 (otherwise known as the federal “Anti-Kickback Statute”) makes it illegal for any person, including a prescription drug manufacturer (or a party acting on its behalf), to knowingly and willfully solicit, receive, offer or pay any remuneration that is intended to induce the referral of business, including the purchase, order or prescription of a particular drug for which payment may be made under a U.S. health care program such as Medicare or Medicaid. Under U.S. federal government regulations, some arrangements, known as safe harbors, are deemed not to violate the Anti-Kickback Statute. Although we seek to structure our business arrangements in compliance with all applicable requirements, these laws are broadly written, and it is often difficult to determine precisely how the law will be applied in specific circumstances. Accordingly, it is possible that our practices may be challenged under the Anti-Kickback Statute and similar laws in other jurisdictions. False claims laws prohibit anyone from knowingly and willfully presenting or causing to be presented for payment to third-party payers, including government payers, reimbursement claims for drugs or services that are false or fraudulent, claims for items or services that were not provided as claimed, or claims for medically unnecessary items or services. Cases have been brought under false claims laws alleging that off-label promotion of pharmaceutical products or the payment of kickbacks to pharmaceutical providers has resulted in the submission of false claims to governmental health care programs. Under laws such as the Health Insurance Portability and Accountability Act of 1996 in the U.S., we are prohibited from knowingly and willfully executing a scheme to defraud any health care benefit program, including private payers, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for health care benefits, items or services. Violations of fraud and abuse laws may be punishable by criminal and/or civil sanctions, including fines and/or exclusion or suspension from government-run health care programs such as Medicare and Medicaid and debarment from contracting with the U.S. and other governments. In addition, in the U.S. individuals have the ability to bring actions on behalf of the government under the federal False Claims Act as well as under state false claims laws.

 

Many states in the U.S. have adopted laws similar to the Anti-Kickback Statute, some of which apply to the referral of patients for health care services reimbursed by any source, not just governmental payers. In addition, California and a few other states in the U.S. have passed laws that require pharmaceutical companies to comply with the April 2003 Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers and/or the Pharmaceutical Research and Manufacturers of America Code on Interactions with Health Care Professionals. In addition, several states impose other marketing restrictions or require pharmaceutical companies to make marketing or price disclosures to the state. There are ambiguities as to what is required to comply with these state requirements and if we fail to comply with an applicable state law requirement we could be subject to penalties.

 

We have yet to receive definitive guidance on the application of fraud and abuse laws to our business. Law enforcement authorities are increasingly focused on enforcing these laws, and it is possible that some of our practices may be challenged under these laws. While we believe we have structured our business arrangements to comply with these laws, it is possible that the government could allege violations of, or convict us of violating, these laws. If we are found in violation of one of these laws, we could be required to pay a penalty and could be suspended or excluded from participation in certain government-run health care programs, and our business, results of operations and financial condition may be materially and adversely affected.

 

Risks Related to Our Business and Industry

 

If we fail to attract and keep senior management and key scientific personnel, we may be unable to successfully develop our product or our current or future product candidates, conduct our in-licensing and development efforts or commercialize our product or any of our current or future product candidates.

 

Our future growth and success depends in part on our continued ability to attract, retain and motivate highly qualified management and scientific personnel. We are highly dependent upon our senior management, particularly Julian Aleksov, our Executive Chairman, as well as our senior scientists and other members of our senior management team. The loss of services of any of these individuals could delay or prevent the successful development of our current or future product pipeline, completion of our planned development efforts or the commercialization of our product and product candidates. Although we have entered into an employment agreement with Julian Aleksov, the agreement does not provide for a fixed term of service, and does not contain any competition or non-solicitation clauses after the termination of employment. It is possible that current or former employees of Oasmia could put forward claims for an alleged right to our patents and demand compensation therefor. However, all our employees have signed an agreement where they assign all their inventions and intellectual property rights generated by them in their work to us. In addition, there is a law in Sweden that regulates the right to patentable inventions made by employees which gives the employer the rights to the inventions if they are invented in the course of the employees work. If one or more of the key personnel were to leave us and engage in competing operations, our business, results of operations and financial condition could be materially and adversely affected. To date, none of our key personnel has left us or, to our knowledge, engaged in competing operations, nor has any departure of key personnel had any material effect on Oasmia.

 

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We may have trouble hiring additional qualified personnel.

 

As we expand our development and commercial activities, we will need to hire additional personnel and could experience difficulties attracting and retaining qualified employees. Competition for qualified personnel in the biopharmaceutical field is intense due to the limited number of individuals who possess the skills and experience required by that industry. We may not be able to attract and retain quality personnel on favorable terms, or at all. In addition, to the extent we hire personnel from competitors, we may be subject to allegations that such personnel have been improperly solicited or that they have divulged proprietary or other confidential information, or that their former employers own their research output. Any of these difficulties could have a material adverse effect on our business, results of operations and financial condition.

 

We are subject to risks relating to legal proceedings.

 

We are subject to various claims and legal actions arising in the ordinary course of its business. Any such litigation could be very costly and could distract our management from focusing on operating our business. The existence of any such litigation could harm our business, results of operations and financial condition. Results of actual and potential litigation are inherently uncertain. Additionally, in the past we have been subject to fines by a foreign exchange relating to our disclosures. See “Business—Foreign Exchanges.” An unfavorable result in a legal proceeding could adversely affect our reputation, financial condition and operating results.

 

If product liability lawsuits are successfully brought against us, we will incur substantial liabilities and may be required to limit the commercialization of Paccal Vet, Paclical and our other product candidates.

 

We and our partners face potential product liability exposure related to the testing of our product and product candidates in human and animal clinical trials. We will face exposure to claims by an even greater number of persons if we begin to market and distribute our products commercially in the U.S. and elsewhere, including those relating to misuse of Paccal Vet, Paclical and our other product candidates. Now, and in the future, an individual may bring a liability claim against us alleging that our product or one of our product candidates caused an injury. While we continue to take, what we believe to be appropriate precautions (including SEK 20 million, approximately $3 million, in product liability insurance coverage as of the date of this prospectus), we may be unable to avoid significant liability if any product liability lawsuit is brought against us. It should be noted that the amount of the product liability insurance is revised continuously of the insurance broker. If we cannot successfully defend ourselves against product liability claims, we will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

 

decreased demand for Paccal Vet, Paclical and our other product candidates, if such product candidates are approved;
injury to our reputation;
withdrawal of clinical trial participants;
costs of related litigation;
substantial monetary awards to patients, pet owners and others;
increased cost of liability insurance;
loss of revenue; and
our inability to successfully commercialize our products.

 

Furthermore, in the future there may be a need to expand the scope of our insurance coverage, which could result in significantly increased costs or the inability to obtain sufficient insurance coverage. Any of these occurrences could have a material adverse effect on our business, results of operations and financial condition.

 

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Failure of our information technology systems could significantly disrupt the operation of our business.

 

Our ability to execute our business plan and to comply with regulatory requirements with respect to data control and data integrity depends, in part, on the continued and uninterrupted performance of our information technology systems (“IT systems”). These systems are vulnerable to damage from a variety of sources, including telecommunications or network failures, malicious human acts and natural disasters. Moreover, despite network security and back-up measures, some of our servers are potentially vulnerable to physical or electronic break-ins, computer viruses and similar disruptive problems. Despite the precautionary measures we have taken to prevent unanticipated problems that could affect our IT systems, there are no assurances that electronic break-ins, computer viruses and similar disruptive problems, and/or sustained or repeated system failures or problems arising during the upgrade of any of our IT systems that interrupt our ability to generate and maintain data will not occur. The occurrence of any of the foregoing with respect to our IT systems could have a material adverse effect on our business, results of operations or financial condition.

 

We are subject to the U.S. Foreign Corrupt Practices Act and other anti-corruption laws, as well as export control laws, customs laws, sanctions laws and other laws governing our operations. If we fail to comply with these laws, we could be subject to civil or criminal penalties, other remedial measures, and legal expenses, which could adversely affect our business, results of operations and financial condition.

 

Our operations are subject to certain anti-corruption laws, including the U.S. Foreign Corrupt Practices Act (“FCPA”), and other anti-corruption laws that apply in countries where we do business. The FCPA and other anti-corruption laws generally prohibit us and our employees and intermediaries from bribing, being bribed or making other prohibited payments to government officials or other persons to obtain or retain business or gain some other business advantage. We and our commercial partners operate in a number of jurisdictions that pose a high risk of potential FCPA violations and we participate in collaborations and relationships with third parties whose actions could potentially subject us to liability under the FCPA or local anti-corruption laws. In addition, we cannot predict the nature, scope or effect of future regulatory requirements to which our international operations might be subject or the manner in which existing laws might be administered or interpreted.

 

We are also subject to other laws and regulations governing our international operations, including regulations administered in the U.S. and in the EU, including applicable export control regulations, economic sanctions on countries and persons, customs requirements and currency exchange regulations (collectively, “Trade Control Laws”).

 

There can be no assurance that we will be completely effective in ensuring our compliance with all applicable anticorruption laws, including the FCPA or other legal requirements, such as Trade Control Laws. Any investigation of potential violations of the FCPA, other anti-corruption laws or Trade Control Laws by U.S., EU or other authorities could have an adverse impact on our reputation, our business, results of operations and financial condition. Furthermore, should we be found not to be in compliance with the FCPA, other anti-corruption laws or Trade Control Laws, we may be subject to criminal and civil penalties, disgorgement and other sanctions and remedial measures, as well as the accompanying legal expenses, any of which could have a material adverse effect on our reputation and liquidity, as well as on our business, results of operations and financial condition.

 

We are exposed to risks related to currency exchange rates.

 

Currency risks arise when future commercial transactions or reported assets or liabilities are denominated in a currency other than our functional currency, the Swedish krona. Our primary contract manufacturer and all of our clinical trials are located outside of Sweden. Because our financial statements are presented in kronor, changes in currency exchange rates have had and could continue to have a significant effect on our operating results. Exchange rate fluctuations between local currencies and the krona create risk in several ways, including the following:

 

·weakening of the krona may increase the krona cost of overseas research and development expenses and the cost of sourced product components outside Sweden;
·strengthening of the krona may decrease the value of our revenues denominated in other currencies;
·the exchange rates on non-kronor transactions and cash deposits can distort our financial results; and
·the pricing and profit margins of Paccal Vet, Paclical and our other product candidates may be affected by currency fluctuations.

 

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In addition, to the extent our need for contract manufacturing increases once our products reach the commercial market, our exposure to currency risks will increase proportionally. We do not engage in regular hedging transactions, since to date our currency exposure has been mostly related to purchased services for product development, which has been irregular and difficult to anticipate. It is possible that fluctuations in currency exchange rates could have a material adverse effect on our business, results of operations and financial condition.

 

If we are unable to use our net operating loss and tax credit carryforwards and certain built-in losses to reduce future tax payments or benefit from favorable tax legislation, our business, results of operations and financial condition may be adversely affected.

 

As a Swedish resident trading entity, we are subject to Swedish corporate taxation. As of April 30, 2014, we had cumulative carry forward tax losses of SEK 404.26 million, and as of April 30, 2013, we had cumulative carry forward tax losses of SEK 300.55 million. As of October 31, 2014, the cumulative loss carry forward amounted to SEK 463.86 million. These losses are available to carry forward and offset against future operating profits, unlimited in time. If, however, there are unexpected adverse changes to the Swedish tax law, our business, results of operations and financial condition may be adversely affected.

 

Risks Related to Our Reliance upon Third Parties

 

We depend substantially on the commercial expertise of our commercial partners.

 

We do not have a sales and marketing operation and expect to rely, in certain geographical areas such as Japan and the CIS, on the expertise and commercial skills of our commercial partners to sell Paccal Vet, Paclical, Doxophos Vet, and our other product candidates in selected territories. We have entered into agreements for the commercialization of Paccal Vet in Japan, where Paccal Vet is licensed to Nippon Zenyaku Kogyo, and Russia and the CIS, where we retain commercialization rights. We have entered into agreements for the commercialization of Paclical with Medison Pharma in Israel and Turkey and with Pharmasyntez in Russia and the CIS, as well as Ukraine, Georgia and Turkmenistan. The commercial success of Paclical and many of our other product candidates in each of these markets will depend entirely on the expertise and commercial skills of our commercial partners, whereas we will be responsible for the distribution and sales of Paccal Vet and Doxophos Vet. In addition, it is customary that in these types of commercial agreements our partners are entitled to price our products, which means that much of our financial performance will be dependent on our partners. Our partners also have the right, under certain circumstances, to terminate their agreements with us. See “Business – Strategic Alliances and Collaborations” for descriptions of the agreements with our commercial partners. A failure by our partners to successfully market Paccal Vet, Paclical, Doxophos Vet and our other product candidates, or the termination of agreements with our partners, would have a material adverse effect on our business, results of operations and financial condition.

 

As referred to elsewhere herein, we have entered into various licensing and distribution agreements with established pharmaceutical companies to sell Paccal Vet. Specifically, we had entered into an agreement for the global commercialization of Paccal Vet with Abbott Animal Health, the assets of which were acquired by Zoetis on February 10, 2015. In connection with Zoetis’ purchase of Abbott Animal Health, Zoetis provided the Company with notice that Zoetis will terminate the distribution arrangement effective September 30, 2015.

 

We currently have no sales and marketing organization for the distribution of Paccal Vet or Doxophos Vet as a result of the pending termination of the Distribution Agreement with Zoetis. If we are unable to establish a direct sales force in the U.S. to promote our products, the commercial opportunity for our products may be diminished.

 

We currently have no sales and marketing organization for the distribution of Paccal Vet or Doxophos Vet as a result of the pending termination of the Distribution Agreement with Zoetis, which covered the entire world except for Japan and the CIS. While we have established an entity through which Oasmia intends to distribute these products in the United States, the Company currently has no sales and marketing organization for these products. The Company will incur significant additional expenses and commit significant additional management resources to establish our sales force. The Company may not be able to establish these capabilities despite these additional expenditures. The Company will also have to compete with other pharmaceutical and biotechnology companies to recruit, hire and train sales and marketing personnel. While the Company has no present intention of doing so, if the Company elects to rely on third parties to sell these products in the U.S., it may receive less revenue than the Company we sold our products directly. In addition, while the Company anticipates using due diligence in monitoring their activities, it may have little or no control over the sales efforts of those third parties. In the event the Company is unable to develop its own sales force or collaborate with a third party to sell these products, the Company may not be able to commercialize these products which would negatively impact its ability to generate revenue.

 

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We rely on contract manufacturers for the production of our products, which can create production uncertainties.

 

Our own production facility has the technical capacity for production of our finished products up to a limited commercial scale. We produced the launch supply of Paccal Vet, but we do not have adequate capacity to supply the product in the long term. As such, full-scale production of our products for commercial use will be carried out by contract manufacturers. Production at our primary contract manufacturer is expected to commence shortly. If it proves difficult for contract manufacturers to scale-up production, full-scale production may be delayed, which could then delay the product launch schedule.

 

We will also be required to validate full-scale production and submit documentation to the relevant health authorities in connection with the scaling-up of the production to full-scale production. These agencies must approve the production at the manufacturers we select. We will be relying upon the contract manufacturers to provide us with the appropriate information for the regulators, and if the documentation is incomplete or incorrect there is a risk that the product launch will be delayed, which may have a material adverse effect on our financial position and performance.

 

We depend on a limited number of suppliers for materials and components required to manufacture Paccal Vet, Paclical and our other product candidates. The loss of these suppliers, or their failure to supply us on a timely basis, could cause delays in our current and future capacity and adversely affect our business.

 

The majority of the raw materials used in the production of our pharmaceuticals are purchased from a limited number of suppliers. As a result, we may not be able to obtain sufficient quantities of critical materials and components in the future. A delay or interruption by our suppliers may harm our business, results of operations and financial condition. In addition, the lead time needed to establish a relationship with a new supplier can be lengthy, and we may experience delays in meeting demand in the event we must switch to a new supplier. The time and effort to qualify for and, in some cases, obtain regulatory approval for a new supplier could result in additional costs, diversion of resources or reduced manufacturing yields, any of which would negatively impact our operating results. Our dependence on a limited number of suppliers exposes us to numerous risks, including:

 

·our suppliers could cease or reduce production or deliveries, raise prices or renegotiate terms;
·we may be unable to locate a suitable replacement suppliers on acceptable terms or on a timely basis, or at all; and
·delays caused by supply issues may harm our reputation, frustrate our customers and cause them to turn to our competitors for future needs.

 

Any one of these occurrences could have a material adverse effect on our business, results of operations and financial condition.

 

Risks Related to Our Intellectual Property

 

We may be forced to litigate to enforce or defend our intellectual property rights, or the intellectual property rights of our licensors.

 

We may be forced to litigate to enforce or defend our intellectual property rights against infringement and unauthorized use by competitors. In so doing, we may place our intellectual property at risk of being invalidated, held unenforceable, or narrowed in scope. Further, an adverse result in any litigation or defense proceedings may place pending applications at risk of non-issuance. In addition, if any licensor fails to enforce or defend its intellectual property rights, this may adversely affect our ability to develop and commercialize our product and product candidates as well as our ability to prevent competitors from making, using, and selling competing products. Any such litigation could be very costly and could distract our management from focusing on operating our business. The existence or outcome of any such litigation could harm our business, results of operations and financial condition.

 

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Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential and proprietary information could be compromised by disclosure during this type of litigation. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of the Ordinary Shares.

 

We may be unable to adequately prevent disclosure of trade secrets and other proprietary information.

 

We rely on trade secrets to protect our proprietary know-how and technological advances, especially where we do not believe patent protection is appropriate or obtainable. However, trade secrets are difficult to protect. We rely in part on confidentiality agreements with our employees, consultants, outside scientific collaborators, sponsored researchers and other advisors to protect our trade secrets and other proprietary information. These agreements may not effectively prevent disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. In addition, others may independently discover our trade secrets and proprietary information. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary rights. Failure to obtain or maintain trade secret protection or failure to adequately protect our intellectual property could enable competitors to develop generic products or use our proprietary information to develop other products that compete with our products or cause additional, material adverse effects upon our business, results of operations and financial condition.

 

The transfer of technology and knowledge to contract manufacturers pursuant to the production of our products also creates a risk of uncontrolled distribution and copying of concepts, methods and processes relating to our products. Such uncontrolled distribution and copying could have a material adverse effect on the value of our products if used for the production of competing drugs or otherwise used commercially without our obtaining financial compensation.

 

We may become subject to third parties’ claims alleging infringement of patents and proprietary rights or seeking to invalidate our patents or proprietary rights, which would be costly, time-consuming and, if successfully asserted against us, delay or prevent the development and commercialization of our product and our current or future product candidates.

 

There has been substantial litigation and other proceedings regarding patent and other intellectual property rights in the pharmaceutical industry, as well as patent challenge proceedings, including interference and administrative law proceedings before the U.S. Patent and Trademark Office (“U.S. PTO”) and the European Patent Office (“EPO”), and oppositions and other comparable proceedings in other jurisdictions. Recently, under U.S. patent reform laws, new procedures including inter partes review and post grant review have been implemented. As stated below, the novel implementation of such reform laws presents uncertainty regarding the outcome of challenges to our patents in the future.

 

We cannot assure you that our product or any of our current or future product candidates will not infringe existing or future patents. We may be unaware of patents that have already issued that a third party might assert are infringed by our product or one of our current or future product candidates. Because patent applications can take many years to issue and may be confidential for eighteen months or more after filing, there may be applications now pending of which we are unaware and which may later result in issued patents that we may infringe by commercializing our product or any of our current or future product candidates. In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon these patents. Moreover, we may face claims from non-practicing entities (commonly referred to as “patent trolls”), which have no relevant product revenue and against whom our own patent portfolio may thus have no deterrent effect.

 

We may be subject to third-party claims in the future against us or our collaborators that would cause us to incur substantial expenses and, if successful against us, could cause us to pay substantial damages, including treble damages and attorney’s fees if we are found to be willfully infringing a third party’s patents. If a patent infringement suit were brought against us or our collaborators, we or our collaborators could be forced to stop or delay research, development, manufacturing or sales of the product candidate that is the subject of the suit. As a result of patent infringement claims, or in order to avoid potential claims, we or our collaborators may choose to seek, or be required to seek, a license from the third party and would most likely be required to pay license fees or royalties or both. These licenses may not be available on acceptable terms, or at all. Even if we or our collaborators were able to obtain a license, the rights may be nonexclusive, which would give our competitors access to the same intellectual property. Ultimately, we could be prevented from commercializing a product, or forced to redesign it, or to cease some aspect of our business operations if, as a result of actual or threatened patent infringement claims, we or our collaborators are unable to enter into licenses on acceptable terms. Even if we are successful in defending such claims, infringement and other intellectual property litigation can be expensive and time-consuming to litigate and divert management’s attention from our core business. Any of these events could harm our business significantly.

 

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In addition to infringement claims against us, if third parties have prepared and filed patent applications in the U.S. that also claim technology to which we have rights, we may have to participate in interference proceedings in the U.S. PTO to determine the priority of invention. Third parties may also attempt to initiate reexamination, post grant review or inter partes review of our patents in the U.S. PTO. We may also become involved in similar opposition proceedings in the EPO or comparable offices in other jurisdictions regarding our intellectual property rights with respect to our products and technology. Any of these claims could have a material adverse effect on our business, results of operations and financial condition.

 

If our efforts to protect the proprietary nature of the intellectual property related to our product or any of our current or future product candidates are not adequate, we may not be able to compete effectively in our market.

 

We rely upon a combination of patents, trade secret protection as well as confidentiality and license agreements to protect the intellectual property related to our product and our current product candidates and our development programs.

 

Composition-of-matter patents on an active pharmaceutical ingredient are generally considered to be the strongest form of intellectual property protection for pharmaceutical products, as such patents provide protection without regard to any particular method of use or manufacture. We cannot be certain that the claims in our patent application covering composition-of-matter of our product and our product candidates will be considered patentable by the U.S. PTO and courts in the U.S., or by the patent offices and courts in foreign countries. Method-of-use patents protect the use of a product for the specified method. This type of patent does not prevent a competitor from making and marketing a product that is identical to our product for an indication that is outside the scope of the patented method. Moreover, for our animal health products particularly, even if competitors do not actively promote their products for our targeted indications, veterinarians may recommend that pet owners use these products off label, or pet owners may do so themselves. Although off-label use may infringe or contribute to the infringement of method-of-use patents, we believe the practice is common and such infringement is difficult to prevent or prosecute.

 

The strength of patents in the field of human and animal health products involves complex legal and scientific questions and can be uncertain. The patent applications that we own or license may fail to result in issued patents in the U.S. or in other foreign countries. Even if the patents do successfully issue, third parties may challenge the validity, enforceability or scope thereof, which may result in such patents being narrowed, invalidated or held unenforceable. Furthermore, even if they are unchallenged, our patents and patent applications may not adequately protect our intellectual property or prevent others from designing around our claims. If the breadth or strength of protection provided by the patent applications we own, in-license or pursue with respect to our product or any of our current or future product candidates is threatened, it could threaten our ability to commercialize our product or any of our current or future product candidates. Further, if we encounter delays in our development efforts, the period of time during which we could market our product or any of our current or future product candidates under patent protection would be reduced. Since patent applications in the U.S. and most other countries are confidential for a period of time after filing, we cannot be certain that we were the first to file any patent application related to our product and product candidates. Furthermore, for patent applications in which claims are entitled to a priority date before March 16, 2013, an interference proceeding can be initiated by a third party or instituted by the U.S. PTO to determine who was the first to invent any of the subject matter covered by the patent claims of our applications. For patent applications containing a claim not entitled to a priority date before March 16, 2013, there is a greater level of uncertainty in the patent law with the passage of the America Invents Act, some provisions of which went into effect on that date whereas the America Invents Act itself first went into effect on September 16, 2011 and brought about significant changes to the U.S. patent laws that have yet to be well defined, and which introduces new procedures for challenging pending patent applications and issued patents. A primary change under this reform is creating a “first to file” system in the U.S., which requires us to minimize the time from invention to filing of a patent application.

 

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Even where laws provide protection, costly and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary rights, and the outcome of such litigation would be uncertain. Moreover, any actions we may bring to enforce our intellectual property against our competitors could provoke them to bring counterclaims against us, and some of our competitors have substantially greater intellectual property portfolios than we have.

 

We also rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable, processes for which patents are difficult to enforce and any other elements of our product development processes that involve proprietary know-how, information or technology that is not covered by patents. Although we endeavor to execute confidentiality agreements with all of our employees, consultants, advisors and any third parties who have access to our proprietary know-how, information or technology, we cannot be certain that we have executed such agreements with all parties who may have helped to develop our intellectual property or had access to our proprietary information, nor that our agreements will not be breached. We cannot guarantee that our trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques. Further, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the EU or the U.S. As a result, we may encounter significant problems in protecting and defending our intellectual property both in the U.S. and elsewhere. If we are unable to prevent material disclosure of the intellectual property related to our technologies to third parties, we will not be able to establish or maintain a competitive advantage in our market, which could materially and adversely affect our business, results of operations and financial condition.

 

Any disclosure to or misappropriation by third parties of our confidential proprietary information could enable competitors to quickly duplicate or surpass our technological achievements, thus eroding our competitive position in our market.

 

Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.

 

As is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceutical industry involves both technological and legal complexity. Therefore, obtaining and enforcing biopharmaceutical patents is costly, time-consuming and inherently uncertain. In addition, the U.S. has recently enacted and is currently implementing wide-ranging patent reform legislation. The U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in other situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by the U.S. Congress, the federal courts, and the U.S. PTO, the laws and regulations governing patents could change in ways that would weaken our ability to obtain new patents or to enforce our existing licensed patents and patents that we might obtain in the future. Similarly, changes in EU patent law and elsewhere could negatively affect the value of our patents registered outside of the U.S.

 

Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with any of these requirements.

 

The U.S. PTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process. There are situations in which noncompliance can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, competitors might be able to enter the market earlier than would otherwise have been the case, which could have a material adverse effect on our business, results of operations and financial condition.

 

We may not be able to protect our intellectual property rights throughout the world.

 

Filing, prosecuting and defending patents on product and product candidates throughout the world is prohibitively expensive. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection, but where enforcement is not as strong as that in the U.S. These products may compete with our products in jurisdictions where we do not have any issued or licensed patents and our patent claims or other intellectual property rights may not be effective or sufficient to prevent them from so competing.

 

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Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to biopharmaceuticals, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial cost and divert our efforts and attention from other aspects of our business.

 

Risks related to the ADSs and this offering

 

As a new investor, you will experience substantial dilution as a result of this offering.

 

The public offering price per Ordinary Share will be substantially higher than the net tangible book value per Ordinary Share prior to the offering. Consequently, if you purchase ADSs in this offering at a public offering price of $ per Ordinary Share, you will incur immediate dilution of $ per Ordinary Share. See “Dilution” for further information regarding the dilution resulting from this offering. In addition, you may experience further dilution to the extent that additional ADSs are issued upon exercise of outstanding options and warrants. This dilution is due in large part to the fact that our earlier investors paid substantially less than the initial public offering price when they purchased their ADSs. In addition, if the underwriters exercise their overallotment option, you will experience additional dilution.

 

There is no established trading market for the ADSs.

 

This offering constitutes our initial public offering of ADSs, and no public market for the ADSs currently exists. We have applied to list the ADSs on the NASDAQ Capital Market (“Nasdaq”), and if approved we expect the ADSs to be quoted on Nasdaq, subject to completion of customary procedures in the U.S. Any delay in the commencement of trading of the ADSs on Nasdaq would impair the liquidity of the market for the ADSs and make it more difficult for holders to sell the ADSs.

 

Even if the ADSs are listed on Nasdaq, there can be no assurance that an active trading market for the ADSs will develop or be sustained after this offering is completed. The initial offering price has been determined by negotiations among the lead underwriters and us. Among the factors considered in determining the initial offering price were our future prospects and the prospects of our industry in general, our revenue, net income and certain other financial and operating information in recent periods, and the financial ratios, market prices of securities and certain financial and operating information of companies engaged in activities similar to ours. However, there can be no assurance that following this offering the ADSs will trade at a price equal to or greater than the offering price.

 

In addition, the market price of the ADSs may be volatile. Many factors may have a material adverse effect on the market price of the ADSs, including, but not limited to:

 

announcements of the failure to obtain regulatory approvals or receipt of a “complete response letter” from the FDA;
announcements of restricted label indications or patient populations, or changes or delays in regulatory review processes;
announcements of therapeutic innovations or new products by us or our competitors;
adverse actions taken by regulatory agencies with respect to our clinical trials, manufacturing supply chain or sales and marketing activities;
changes or developments in laws or regulations applicable to Paccal Vet, Paclical, or our other product candidates;
the failure of our testing and clinical trials;
product liability claims, other litigation or public concern about the safety of our product, product candidates or future products;
any adverse changes to our relationship with licensors, manufacturers or suppliers;

 

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the loss of any of our key scientific or management personnel;
any major changes in our board of directors or management;
the failure to retain our existing, or obtain new, commercial partners;
announcements concerning our competitors or the pharmaceutical industry in general;
the achievement of expected product sales and profitability;
the failure to obtain reimbursements for our products or price reductions;
manufacture, supply or distribution shortages;
actual or anticipated fluctuations in our cash position or operating results;
manufacturing and supply issues related to our product or our current or future product candidates for our development programs and commercialization;
changes in financial estimates or recommendations by securities analysts;
the termination of any of our existing license agreements;
announcements relating to future licensing or development agreements;
potential acquisitions;
the trading volume of ADSs on Nasdaq and of the Ordinary Shares on NASDAQ Stockholm and the Frankfurt Stock Exchange;
sales of the ADSs or Ordinary Shares by us, our executive officers or directors or our shareholders;
fluctuations in the U.S. equity markets;
changes in accounting principles;
market conditions in the human and animal health sectors; and
general economic conditions in the U.S. and elsewhere.

 

In addition, the stock market in general, and Nasdaq in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of the Ordinary Shares, regardless of our actual operating performance.

 

The multiple listing of the Ordinary Shares and the ADSs following this offering may adversely affect the liquidity and value of the ADSs.

 

Following this offering and after the ADSs are traded on Nasdaq, the Ordinary Shares will continue to be listed on NASDAQ Stockholm and the Frankfurt Stock Exchange. We cannot predict the effect of this multiple listing on the value of the Ordinary Shares and the ADSs. However, it is possible the multiple listing of the Ordinary Shares and ADSs may dilute the liquidity of these securities in one or all three markets and may adversely affect the development of an active trading market for the ADSs in the U.S. The price of the ADSs could also be adversely affected by trading in the Ordinary Shares on NASDAQ Stockholm and the Frankfurt Stock Exchange. Although currently we have no plans to do so, we may decide to delist the Ordinary Shares from either exchange in the future. We cannot predict the effect such delisting of the Ordinary Shares would have on the market price of the ADSs on Nasdaq.

 

If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding the ADSs or the Ordinary Shares, the price of these securities and their trading volume could decline.

 

The trading market for the ADSs and the Ordinary Shares will be influenced by the research and reports that industry or securities analysts publish about us or our business. We do not currently have and may never obtain research coverage by securities and industry analysts. If we do not obtain adequate securities or industry analyst coverage, the trading price for the ADSs and the Ordinary Shares may be negatively impacted. In the event we obtain securities or industry analyst coverage, if any of the analysts who cover us issue an adverse or misleading opinion regarding us, our business model, our products, our intellectual property or the ADSs or our ordinary share performance, or if our target studies and operating results fail to meet the expectations of analysts, the prices of the ADSs and the Ordinary Shares may decline. If one or more of these analysts cease coverage of us or fail to publish reports on us regularly, we could lose visibility in the financial markets, which in turn could cause the prices of the ADSs and the Ordinary Shares, as well as their respective trading volume to decline.

 

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Substantial future sales of the Ordinary Shares or the ADSs in the public market, or the perception that these sales could occur, could cause the price of the ADSs to decline.

 

Additional sales of the Ordinary Shares in the public market after this offering, or the perception that such sales could occur, could cause the market price of the Ordinary Shares to decline. Upon completion of this offering, we will have ___________ Ordinary Shares issued and outstanding. All ADSs sold in this offering will be freely transferable without restriction or additional registration under the Securities Act. The Ordinary Shares held by our directors, officers, and large institutional shareholders will be available for sale upon the expiration of a lock-up period, which we expect will expire 180 days after the date of this prospectus. The remaining Ordinary Shares will be available for sale after this offering since they are not subject to contractual and legal restrictions on resale. Any or all of these shares may be released prior to expiration of the lock-up period at the discretion of the lead underwriters for this offering. To the extent shares are released before the expiration of the lock-up period and these shares are sold into the market, the market price of the ADSs could decline.

You may not have the same voting rights as the holders of the Ordinary Shares and may not receive voting materials in time to be able to exercise your right to vote.

 

Holders of ADSs are not shareholders of our company and therefore do not have direct voting rights or the right to attend shareholders’ meetings. ADS holders do have the right to instruct the depositary how to vote the Ordinary Shares underlying their ADSs, but the depositary will only send voting materials to ADS holders if we ask it to. Therefore, you may not receive voting materials or you may not receive voting materials in time to instruct the depositary to vote, and it is possible that you, or persons who hold their ADSs through brokers or other securities intermediaries, will not have the opportunity to exercise a right to vote.

 

You may not receive distributions on the Ordinary Shares represented by the ADSs or any value for them if it is illegal or impractical to make them available to holders of ADSs.

 

The depositary for the ADSs has agreed to pay to you the cash dividends or other distributions it or the custodian receives on the Ordinary Shares or other deposited securities after deducting its fees and expenses. You will receive these distributions in proportion to the number of the Ordinary Shares your ADSs represent. However, in accordance with the limitations set forth in the deposit agreement, it may be unlawful or impractical to make a distribution available to holders of ADSs. We have no obligation to take any other action to permit the distribution of the ADSs, Ordinary Shares, rights or anything else to holders of the ADSs. This means that you may not receive the distributions we make on the Ordinary Shares or any value from them if it is unlawful or impractical to make them available to you. These restrictions may have a material adverse effect on the value of your ADSs.

 

As a foreign private issuer, we are exempt from a number of U.S. securities laws and rules promulgated thereunder and are permitted to file less information with the SEC than U.S. companies must. This will limit the information available to holders of the ADSs.

 

We currently qualify as a “foreign private issuer,” as defined in the SEC’s rules and regulations and, consequently, we are not subject to all of the disclosure requirements applicable to companies organized within the U.S. For example, we are exempt from certain rules under the U.S. Securities Exchange Act of 1934, as amended (the “Exchange Act”), that regulate disclosure obligations and procedural requirements related to the solicitation of proxies, consents or authorizations applicable to a security registered under the Exchange Act. In addition, our officers and directors are exempt from the reporting and “short-swing” profit recovery provisions of Section 16 of the Exchange Act and related rules with respect to their purchases and sales of our securities. Moreover, we are not required to file periodic reports and financial statements with the SEC as frequently or as promptly as U.S. public companies. We are also not subject to Regulation FD under the Exchange Act, which would prohibit us from selectively disclosing material nonpublic information to certain persons without concurrently making a widespread public disclosure of such information. Accordingly, there may be less publicly available information concerning our company than there is for U.S. public companies.

 

As a foreign private issuer, we will file an annual report on Form 20-F within four months of the close of each fiscal year ended April 30 and reports on Form 6-K relating to certain material events promptly after we publicly announce these events. However, because of the above exemptions for foreign private issuers, our shareholders will not be afforded the same protections or information generally available to investors holding shares in public companies organized in the U.S.

 

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As a foreign private issuer, we are not subject to certain Nasdaq corporate governance rules applicable to U.S. listed companies.

 

We rely on a provision in Nasdaq’s Listed Company Manual that allows us to follow Swedish corporate law and the Swedish Companies Act (SFS 2005:551) (the “Swedish Companies Act”) with regard to certain aspects of corporate governance. This allows us to follow certain corporate governance practices that differ in significant respects from the corporate governance requirements applicable to U.S. companies listed on Nasdaq.

 

For example, we are exempt from Nasdaq regulations that require a listed U.S. company to:

 

have a majority of the board of directors consist of independent directors;
require non-executive directors to meet on a regular basis without management present;
promptly disclose any waivers of the code of ethics for directors or executive officers that should address certain specified items;
have an independent nominating committee;
solicit proxies and provide proxy statements for all shareholder meetings; and
seek shareholder approval for the implementation of certain equity compensation plans and issuances of ordinary shares.

 

As a foreign private issuer, we are permitted to, and we will, follow home country practice in lieu of the above requirements. The determination of foreign private issuer is made annually on the last business day of an issuer’s most recently completed second fiscal quarter, and, accordingly, the next determination will be made with respect to us as of the end of our second quarter of the current fiscal year. If we do not meet the SEC’s requirements for foreign private issuer, we will be subject to a number of additional rules and regulations, including those identified above, and as a result we may incur significant regulatory compliance costs.

 

In accordance with our Nasdaq listing, our audit committee is required to comply with the provisions of Section 301 of the Sarbanes-Oxley Act, and Rule 10A-3 of the Exchange Act, both of which are also applicable to Nasdaq-listed U.S. companies. Because we are a foreign private issuer, however, our audit committee is not subject to additional Nasdaq requirements applicable to listed U.S. companies, including an affirmative determination that all members of the audit committee are “independent,” using more stringent criteria than those applicable to us as a foreign private issuer.

 

We are an “emerging growth company,” as defined in the JOBS Act, and as a result of the reduced disclosure and governance requirements applicable to emerging growth companies, the ADS and Ordinary Shares may be less attractive to investors.

 

We are an “emerging growth company,” as defined in the JOBS Act, and we intend to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act. We cannot predict if investors will find the ADSs or the Ordinary Shares less attractive because we will rely on these exemptions. If some investors find the ADSs or the Ordinary Shares less attractive as a result, there may be a less active trading market for the ADSs or the Ordinary Shares and the price of the ADSs may be more volatile. We may take advantage of these reporting exemptions until we are no longer an emerging growth company. We will remain an emerging growth company until the earlier of (1) the last day of the fiscal year: (a) following the fifth anniversary of the completion of this offering, (b) in which we have total annual gross revenue of at least USD$1.0 billion, or (c) in which we are deemed to be a large accelerated filer, which means the market value of the Ordinary Shares that is held by non-affiliates exceeds USD$700 million as of the prior June 30; and (2) the date on which we have issued more than USD$1.0 billion in non-convertible debt during the prior three-year period.

 

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If we fail to establish and maintain proper internal controls, our ability to produce accurate financial statements or comply with applicable regulations could be impaired.

 

Section 404(a) of the Sarbanes-Oxley Act requires that beginning with our annual report for the year ending April 30, 2016, management shall assess and report annually on the effectiveness of our internal control over financial reporting and identify any material weaknesses in our internal controls over financial reporting. Although Section 404(b) of the Sarbanes-Oxley Act requires our independent registered public accounting firm to issue an annual report that addresses the effectiveness of our internal control over financial reporting, we have opted to rely on the exemptions provided in the JOBS Act, and consequently will not be required to comply with SEC rules that implement Section 404(b) of the Sarbanes-Oxley Act until such time as we are no longer an emerging growth company.

 

Our first Section 404(a) assessment will take place beginning with our annual report for the year ending April 30, 2016. The presence of a material weakness could result in financial statement errors which, in turn, could lead to errors in our financial reports or delays in our financial reporting, and could require us to restate our operating results or require our auditors to issue a qualified audit report. For the fiscal years ended April 30, 2013 and April 30, 2012, our independent registered public accounting firm reported to our audit committee that it had identified a material weakness in internal control over financial reporting related to inadequate financial statement preparation and review procedures. See “Our independent registered public accounting firm has advised us that it has identified a material weakness in our internal control over financial reporting relating to inadequate financial statement preparation and review procedures.” In order to maintain and improve the effectiveness of our disclosure controls and procedures and our internal controls over financial reporting, we will need to expend significant resources and provide significant management oversight. Implementing any appropriate changes to our internal controls may require specific compliance training of our directors and employees, entail substantial costs in order to modify our existing accounting systems, take a significant period of time to complete and divert management’s attention from other business concerns. These changes may not, however, be effective in maintaining the adequacy of our internal controls.

 

If we are unable to conclude that we have effective internal control over financial reporting or, at the appropriate time, our independent auditors are unwilling or unable to provide us with an unqualified report on the effectiveness of our internal control over financial reporting as required by Section 404(b) of the Sarbanes-Oxley Act, investors may lose confidence in our operating results, the price of the Ordinary Shares could decline and we may be subject to litigation or regulatory enforcement actions. In addition, if we are unable to meet the requirements of Section 404 of the Sarbanes-Oxley Act, we may not be able to remain listed on Nasdaq.

 

We will incur significant increased costs as a result of operating as a company whose ADSs are publicly traded in the U.S., and our management will be required to devote substantial time to new compliance initiatives.

 

As a company with publicly traded ADSs in the U.S., we will incur significant legal, accounting, insurance and other expenses that we have not previously incurred. In addition, the Sarbanes-Oxley Act, Dodd-Frank Wall Street Reform Act, Consumer Protection Act and related rules implemented by the SEC and Nasdaq have imposed various requirements on public companies, including requiring establishment and maintenance of effective disclosure and financial controls. Our management and other personnel will need to devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly. We estimate that our annual compliance expenses following the completion of this offering will be approximately SEK 3 million in each of the next two fiscal years. Among other matters, we expect these rules and regulations to make it more difficult and more expensive for us to obtain director and officer liability insurance, and we may be required to incur substantial costs to maintain the same or similar coverage. These laws and regulations could also make it more difficult and expensive for us to attract and retain qualified persons to serve on our board of directors, our board committees or as our executive officers. Furthermore, if we are unable to satisfy our obligations as a public company, we could be subject to delisting of the ADSs, fines, sanctions and other regulatory action and potentially civil litigation.

 

We have broad discretion to determine how to use the funds raised in this offering, and may use them in ways that may not enhance our operating results or the price of the ADSs or the Ordinary Shares.

 

Though we intend to use the proceeds from this offering as indicated in “Use of Proceeds,” our management will have broad discretion over how to use proceeds from this offering, and we could spend the proceeds from this offering in ways our investors and shareholders may not agree with or that do not yield a favorable return, if at all. We intend to use the net proceeds of this offering to fund (1) new clinical trials and other regulatory requirements of multiple product candidates; (2) production development, including validation batches; (3) discovery and development of new product candidates; (4) working capital; (5) capital expenditures; and (6) other general corporate purposes, including employees, rent, and costs and expenses of being a U.S. public company. However, our ultimate use of these proceeds may differ substantially from our current plans. If we do not invest or apply the proceeds of this offering in ways that improve our operating results, we may fail to achieve expected financial results, which could cause the price of the ADSs to decline.

 

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The rights of our shareholders may differ from the rights typically offered to shareholders of a U.S. corporation.

 

We are incorporated under Swedish law. The rights of holders of Ordinary Shares and, therefore, certain of the rights of holders of ADSs, are governed by Swedish law, including the provisions of the Swedish Companies Act, and by our Articles of Association. These rights differ in certain respects from the rights of shareholders in typical U.S. corporations. See “Description of the Ordinary SharesDifferences in Corporate Law” for a description of the principal differences between the provisions of the Swedish Companies Act applicable to us and, for example, the Delaware General Corporation Law relating to shareholders’ rights and protections.

 

We may be or may become a passive foreign investment company (“PFIC”) for U.S. federal income tax purposes.

 

Whether we are or may be a PFIC is a complex determination based on the classification of various assets and income under the PFIC rules. Further, a determination as to whether or not we are a PFIC must be made annually and our circumstances may change in any given year. We do not intend to make decisions regarding our business operations with the specific purpose of reducing the likelihood of our becoming a PFIC. Accordingly, our business plan may result in our engaging in activities that could cause us to become a PFIC. If we are or become a PFIC, U.S. Holders may be subject to increased U.S. federal income taxes on a sale or other disposition of our ADSs and on the receipt of certain distributions and will be subject to increased U.S. federal income tax reporting requirements. Moreover, we may not decide to provide the information that would enable U.S. Holders to make an election to treat us as a “qualified electing fund” (a “QEF”), which election could mitigate the adverse U.S. federal income tax consequences of us being classified as a PFIC if we were so classified. See “Taxation—Passive Foreign Investment Company Status” for a more detailed discussion of the consequences if we are treated as a PFIC.

 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This prospectus contains estimates and forward-looking statements, principally in “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business.” Some of the matters discussed concerning our operations and financial performance include estimates and forward-looking statements within the meaning of the Securities Act and the Exchange Act.

 

These forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that could cause our actual results of operations, financial condition, liquidity, performance, prospects, opportunities, achievements or industry results, as well as those of the markets we serve or intend to serve, to differ materially from those expressed in, or suggested by, these forward-looking statements. These forward-looking statements are based on assumptions regarding our present and future business strategies and the environment in which we expect to operate in the future. Important factors that could cause those differences include, but are not limited to:

 

increasing expenses related to clinical studies and development of our product candidates;
our ability to obtain funding on acceptable terms or at all;
the inherent uncertainty of product development/commercialization of our products;
manufacturing and commercialization;
patents, including, but not limited to, legal challenges;
government regulation and approval, including, but not limited to, the expected regulatory approval dates for Paccal Vet, Paclical, and our other product candidates;
current revenue being insufficient to fund operating expenses;
future revenue being lower than expected;
the level of pricing and reimbursement for our products;
increasing competitive pressures in the industry;

 

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general economic conditions or conditions affecting demand for the services offered by us in the markets in which it operates, both domestically and internationally, being less favorable than expected;
fluctuations in the price of raw materials and utilities;
currency fluctuations and hedging risks;
worldwide economic and business conditions and conditions in the industries in which we operate;
our relationships with our customers and suppliers;
increased competition from other companies in the industries in which we operate;
changing technology;
serious adverse events or other safety risks related to our products;
claims for personal injury or death arising from the use of products produced by us;
the occurrence of accidents or other interruptions to our production processes;
changes in our business strategy or development plans, and our expected level of capital expenses;
our ability to attract and retain qualified personnel;
regulatory, environmental, legislative and judicial developments;
our ability to expand our pipeline of product candidates;
our intention to pay dividends; and
factors that are not known to us at this time.

 

Additional factors that could cause actual results, financial condition, liquidity, performance, prospects, opportunities, achievements or industry results to differ materially include, but are not limited to, those discussed under “Risk Factors” in this prospectus. Additional risks that we may currently deem immaterial or that are not presently known to us could also cause the forward-looking events discussed in this prospectus not to occur. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect” and similar words are intended to identify estimates and forward-looking statements. Estimates and forward-looking statements speak only at the date they were made, and we undertake no obligation to update or to review any estimate and/or forward-looking statement because of new information, future events or other factors. Estimates and forward-looking statements involve risks and uncertainties and are not guarantees of future performance. Our future results may differ materially from those expressed in these estimates and forward-looking statements. In light of the risks and uncertainties described above, the estimates and forward-looking statements discussed in this prospectus might not occur and our future results and our performance may differ materially from those expressed in these forward-looking statements due to, inclusive of, but not limited to, the factors mentioned above. Because of these uncertainties, you should not make any investment decision based solely on these estimates and forward-looking statements.

 

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EXCHANGE RATE INFORMATION

 

Fluctuations in the exchange rate between the Swedish krona and the U.S. dollar will affect the U.S. dollar amounts received by owners of the ADSs on conversion of dividends, if any, paid in kronor on the Ordinary Shares and will affect the U.S. dollar price of the ADSs on Nasdaq. The table below shows the period end, average, high and low exchange rates of kronor per U.S. dollar for the periods shown. Average rates are computed by using the noon buying rate of the Federal Reserve Bank of New York for the U.S. dollar on the last business day of each month during the relevant year indicated or each business day during the relevant month indicated. The rates set forth below are provided solely for your convenience and may differ from the actual rates used in the preparation of our consolidated financial statements included in this prospectus and other financial data appearing in this prospectus.

 

   Period
End
   Average   High   Low 
                 
Year Ended April 30:                    
                     
2010   7.2359    7.2694    8.0405    6.7908 
2011   6.0258    6.9437    8.0593    6.0258 
2012   6.7274    6.5990    7.0137    5.9968 
2013   6.4817    6.6747    7.2655    6.2880 
2014   6.5049    6.5244    6.8171    6.3237 
                     
Month Ended:                    
                     
April 2014   6.5049    6.5488    6.6229    6.4524 
May 2014   6.6855    6.5719    6.6855    6.4864 
June 2014   6,6874    6.6859    6.7398    6.6238 
July 2014   6.8958    6.8189    6.8958    6.6937 
August 2014   6,9753    6.8983    6.9753    6.8341 
September 2014   7.2151    7.1302    7.2600    7.0127 
October 2014   7.3971    7.2456    7.3971    7.1632 
November 2014   7.4544    7.4155    7.4754    7.3605 
December 2014   7.8245    7.6289    7.8245    7.4119 
January 2015   8.2732    8.1131    8.2732    7.8847 
February 2015   8.3555    8.3537    8.4193    8.2265 
March 2015   8.6268    8.5448    8.7505    8.2612 

 

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PRICE RANGE OF THE ORDINARY SHARES

 

The Ordinary Shares have been trading on NASDAQ Stockholm under the symbol “OASM” since June 24, 2010 and on the Frankfurt Stock Exchange under the symbol “OMAX” since January 24, 2011.

 

The following table sets forth, for the periods indicated, the reported high and low closing sale prices of the Ordinary Shares on NASDAQ Stockholm and the Frankfurt Stock Exchange, in kronor and U.S. dollars and in Euros and U.S. dollars, respectively. U.S. dollar per ordinary share amounts have been translated into U.S. dollars at $1.00 = SEK 8.6268 and $1.00 = €0.9310 based on the certified foreign exchange rates published by the Federal Reserve Bank of New York on March 31, 2015.

 

NASDAQ Stockholm

 

   Krona   Dollar 
   Price Per Ordinary Share   Price Per Ordinary Share 
   High   Low   High   Low 
                 
Annual (Year Ended April 30):                    
                     
2011 (beginning June 24, 2010)   26.00    11.60    3.01    1.34 
2012   14.60    6.60    1.69    0.77 
2013   13.55    4.70    1.57    0.54 
2014   29.80    10.00    3.45    1.16 
                     
Quarterly (Fourth Quarter Ended January 31):                    
                     
First Quarter 2013   8.00    6.30    0.93    0.73 
Second Quarter 2013   8.45    5.10    0.98    0.59 
Third Quarter 2013   10.50    4.70    1.22    0.54 
Fourth Quarter 2013   13.55    10.20    1.57    1.18 
First Quarter 2014   12.45    10.00    1.44    1.16 
Second Quarter 2014   18.20    11.90    2.11    1.38 
Third Quarter 2014   23.90    16.80    2.77    1.95 
Fourth Quarter 2014   29.80    18.60    3.45    2.16 
First Quarter 2015   23.00    18.80    2.67    2.18 
Second Quarter 2015   22.10    18.30    2.56    2.12 
Third Quarter 2015   20.80    18.30    2.41    2.12 
                     
Most Recent Six Months:                    
                     
October 2014   20.00    18.30    2.32    2.12 
November 2014   20.70    18.30    2.40    2.12 
December 2014   20.80    18.70    2.41    2.17 
January 2015   20.80    19.30    2.41    2.24 
February 2015   22.50    19.50    2.61    2.26 
March 2015   22.20    19.90    2.57    2.31 

 

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Frankfurt Stock Exchange

 

   Euro   Dollar 
   Price Per Ordinary Share   Price Per Ordinary Share 
   High   Low   High   Low 
                 
Annual (Year Ended April 30):                    
                     
2011 (beginning January 24, 2011)   1.95    1.29    2.09    1.38 
2012   1.60    0.71    1.72    0.76 
2013   1.63    0.53    1.75    0.57 
2014   3.31    1.13    3.56    1.21 
                     
                     
Quarterly (Fourth Quarter Ended January 31):                    
                     
First Quarter 2013   0.88    0.67    0.95    0.72 
Second Quarter 2013   0.97    0.58    1.04    0.63 
Third Quarter 2013   1.16    0.53    1.24    0.57 
Fourth Quarter 2013   1.63    1.13    1.75    1.21 
First Quarter 2014   1.41    1.13    1.52    1.21 
Second Quarter 2014   2.10    1.34    2.26    1.43 
Third Quarter 2014   2.74    1.86    2.94    2.00 
Fourth Quarter 2014   3.31    2.00    3.56    2.15 
First Quarter 2015   2.48    1.99    2.66    2.14 
Second Quarter 2015   2.41    1.93    2.59    2.08 
Third Quarter 2015   2.21    1.87    2.37    2.01 

 

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Most Recent Six Months:                    
                     
October 2014   2.13    1.93    2.29    2.08 
November 2014   2.21    1.99    2.37    2.14 
December 2014   2.16    1.87    2.32    2.01 
January 2015   2.19    2.02    2.35    2.17 
February 2015   2.32    2.04    2.49    2.20 
March 2015   2.36    2.10    2.53    2.26 

 

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USE OF PROCEEDS

 

We estimate that we will receive total estimated net proceeds from this offering of approximately ($18.4 million based on an offering price of $ per ADS, or $ million if the underwriters exercise the overallotment option in full, in each case after deducting underwriting discounts and commissions and estimated expenses of the offering payable by us).

 

We intend to use the net proceeds we receive from this offering as follows:

 

approximately $ 7.3 million to fund new clinical trials and other regulatory requirements of our product and product candidates;

 

approximately $ 3 million to fund production development, including validation batches;

 

approximately $ 0.5 million to fund capital expenditures; and

 

approximately $ 7.6 million for other general corporate purposes, including employees, rent, and costs and expenses of being a U.S. public company.

 

Of the total use of proceed, USD 7.3 million, is planned for clinical trials. The Company plans to allocate approximately USD 2.2 million to animal health studies, approximately USD 4.5 million to human health studies and approximately USD 0.6 million to a XR-17 pharmacokinetic study.

 

For the animal health, Oasmia has been granted conditional approval in the US by the FDA of Paccal Vet-CA1 for the treatment of mammary carcinoma and squamous cell carcinoma in dogs. In order to apply for a full approval for these indications, Oasmia is planning a Phase III study for each indication. With the allocated funds of approximately USD 1.5 million, we estimate being able to reach approximately 20-25% of completion. The Company also plans to allocate USD 0.7 million to continue a Phase II study with Doxophos Vet the primary goal of which is to assess response rate in the treated dogs. The study will continue throughout 2016 and with the allocated funds the study is estimated to reach completion. The Phase II study will form the basis for a conditional approval application in the US for the treatment of lymphoma in dogs.

 

For human health, the Company plans to allocate approximately USD 4.5 million in total whereof USD 3.0 million to Docecal, approximately USD 0.5 million to Doxophos and USD 1.0 million to Paclical. For Docecal, the plan is to start a clinical Phase I study and a safety and tolerance study. With the allocated funds Oasmia estimates being able to reach 75% and 30% completion, respectively. The Company plans to initiate a Paclical study for the breast cancer indication and intends to allocate USD 1.0 million for this purpose. The estimated completion rate for the Paclical study will be less than 10%.

 

The Company plans to spend approximately USD 3.0 million on product development, mainly scale up of production at our contract manufacturing partner, Baxter Oncology GmbH in Germany. The proceeds will include cost for validation batches and be equally allocated among Paclical, Docecal and Doxophos.

 

The expected use of the net proceeds we receive from this offering represent our intentions based upon our current plans and business conditions. The amounts and timing of our actual expenses may vary significantly depending on numerous factors. Accordingly, we will have broad discretion over the uses of the net proceeds in this offering and investors will be relying on the judgment of our management regarding the application of the net proceeds. In addition, it is possible that the amount set forth above will not be sufficient for the purposes described above.

 

Pending these uses, we intend to invest the net proceeds from this offering in short or medium term investments.

 

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DIVIDEND POLICY

 

Since our inception, we have not declared or paid any dividends on the Ordinary Shares. We intend to retain any earnings for use in our business and do not currently intend to pay dividends on the Ordinary Shares. The declaration and payment of any future dividends will be at the discretion of our board of directors and will depend upon our results of operations, cash requirements, financial condition, contractual restrictions, restrictions imposed by our indebtedness, any future debt agreements or applicable laws and other factors that our board of directors may deem relevant.

 

See “Description of American Depositary Shares—Dividends and Other Distributions” for more information on the procedure for awarding dividends to nonresidents of Sweden.

 

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CAPITALIZATION

 

The following table sets forth our total capitalization and cash and cash equivalents as of April 30, 2015.

 

on an actual basis; and

 

on an as adjusted basis to give effect to the sale by us of ADSs in this offering at an offering price of $ per ADS (after deduction of the underwriting discounts and commissions and estimated offering expenses payable by us in connection with this offering and assuming no exercise of the overallotment option by the underwriters and the application of proceeds therefrom).

 

You should read this table together with our consolidated financial statements and the related notes, which we include elsewhere in this prospectus, and with the information under “Selected Consolidated Financial Data” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

 

  

As of April 30, 2015

 
  

Actual

  

As adjusted(1)

 
   (in TSEK) 
         
Liquid Assets   76,990   $

 
           
Liabilities:          
Total current liabilities   107,000   $ 
Total non-current liabilities   -    - 
Total long-term debt, including current portion   107,000   $

 
           
Shareholders’ equity:          
Share capital, SEK 0.10 par value; 97,858,144 shares outstanding; shares issued   9,786   $ 
Other capital provided   850,996      
Retained earnings   (484,613)  $

 
Total stockholders’ equity   376,169   $

 
           
Total capitalization   406,179   $

 

 

(1)Assuming the number of ADSs sold by us in this offering remains the same, a $1.00 increase or decrease in the assumed initial public offering price of $ per ADS, the midpoint of the price range set forth on the cover page of this prospectus, would increase or decrease our total capitalization by $ million.

 

45
 

  

DILUTION

 

If you invest in the ADSs in this offering, your ownership interest will be immediately diluted to the extent of the difference between the initial public offering price per ADS and the as adjusted net tangible book value per ADS after giving effect to this offering.

 

As of October 31, 2014, we had a historical net tangible book value (deficit) of $ million, or $ per Ordinary Share and $ per ADS. Our historical net tangible book value (deficit) per share represents total tangible assets less total liabilities divided by the number of Ordinary Shares outstanding at October 31, 2014.

 

After giving effect to the sale of ADSs at an assumed initial public offering price of $ per ADS, the midpoint of the range set forth on the cover page of this prospectus, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, our as adjusted net tangible book value as of October 31, 2014, would have been approximately $ million, or approximately $ per outstanding Ordinary Share, including Ordinary Shares underlying the outstanding ADSs, or $ per ADS. This amount represents an immediate increase in historical net tangible book value of $ per Ordinary Share, or $ per ADS, to existing shareholders and an immediate dilution in historical net tangible book value of approximately $ per Ordinary Share, or $ per ADS to new investors purchasing ADSs in this offering.

 

Dilution per ADS to new investors is determined by subtracting historical as adjusted net tangible book value per Ordinary Share after this offering from the initial public offering price per ADS paid by new investors. The following table illustrates this dilution:

 

Assumed initial public offering price per ADS  
Historical net tangible book value (deficit) as of October 31, 2014  
Increase in as adjusted net tangible book value per ADS attributable to this offering  
As adjusted net tangible book value per ADS after this offering  
Dilution per ADS to new investors  

 

Each $1.00 increase (decrease) in the assumed initial public offering price of $ per ADS, the midpoint of the range set forth on the cover page of this prospectus, would increase (decrease) the as adjusted net tangible book value after this offering by approximately $ per Ordinary Share and $ per ADS, and dilution in historical net tangible book value per share to new investors by approximately $ per Ordinary Share and $ per ADS, assuming that the number of ADSs offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and the estimated offering expenses payable by us.

 

The following table summarizes on the as adjusted basis described above, as of October 31, 2014, the differences between the shareholders as of October 31, 2014 and the new investors with respect to the number of ADSs purchased from us, the total consideration paid to us in cash and the average price per ADS paid at an assumed initial public offering price of $ per ADS. The calculation below is based on the assumed initial public offering price of $ per ADS, the midpoint of the range set forth on the cover page of this prospectus, before deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

 

    Ordinary Shares
Purchased
    Total Consideration     Average Price Per
Ordinary Share
    Average Price Per
ADS
 
    Number    

%

   

Amount

   

%

             
Existing shareholders               %   $         %   $       $    
New investors                                                
Total           100 %           $ 100 %   $       $    

 

46
 

 

Each $1.00 increase (decrease) in the assumed public offering price of $ per ADS would increase (decrease) total consideration paid by new investors, average price per Ordinary Share and per ADS paid by all shareholders by $ million, respectively, assuming sale of ADSs by us at an assumed initial public offering price of $ per ADS before deducting estimated underwriting discounts and commissions and offering expenses payable by us.

 

If the underwriters exercise their option to purchase additional ADSs in full:

 

·the percentage of the Ordinary Shares held by existing shareholders will decrease to approximately % of the total number of Ordinary Shares outstanding after this offering; and
·the number of ADSs held by new investors will increase to , or approximately % of the total number of Ordinary Shares outstanding after this offering.

 

47
 

  

SELECTED CONSOLIDATED FINANCIAL DATA

 

You should read the following selected financial data in conjunction with our financial statements and the related notes thereto appearing elsewhere in this prospectus and in the section of this prospectus entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

 

The following table summarizes our consolidated financial data as of the dates and for the periods indicated. The selected consolidated financial data for the six months ended October 31, 2014 and October 31, 2013 and the fiscal years ended April 30, 2014 and April 30, 2013 have been derived from our consolidated financial statements, which have been prepared in accordance with International Financial Reporting Standards (“IFRS”) issued by the International Accounting Standards Board (“IASB”) and interpretations issued by the International Financial Reporting Interpretations Committee as adopted by the EU (“IFRIC-EU”). Furthermore, the recommendation RFR 1, Supplementary accounting regulations for Groups, issued by the Swedish Financial Reporting Board, has been applied. We have restated our consolidated financial statements for the six months ended October 31, 2013 and the fiscal years ended April 30, 2013 and April 30, 2012 as a result of the reasons disclosed in Note 32 to our consolidated financial statements, included elsewhere in this prospectus. We have prepared the unaudited consolidated financial information set forth below on the same basis as our audited consolidated financial statements. The results for any interim period are not necessarily indicative of the results that may be expected for a full year.

 

Our consolidated financial statements are prepared and presented in Swedish krona, which is our presentation currency.

 

Our historical results are not necessarily indicative of the results that may be expected in the future. The following summary consolidated financial data should be read in conjunction with the section “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements included elsewhere in this prospectus.

 

Key figures are translated into USD as additional information as a service to readers of this prospectus in the US. The US Dollar is not the functional currency of Oasmia, which is SEK. The conversion of currency has been made by use of a convenience rate for all figures including those from previous periods. This rate is the closing rate as per June 26, 2015 which was 8.3113 SEK per one USD.

 

Consolidated Income Statement Data:  Six Months Ended   Year Ended 
   October 31,   April 30, 
           (Restated(1))               (Restated(1))     
   2014   2014   2013   2013   2014   2014   2013   2013 
   (TSEK)   (USD, in
thousands)
   (TSEK)   (USD, in
thousands)
   (TSEK)   (USD, in
thousands)
   (TSEK)   (USD, in
thousands)
 
Net sales   1,552    187    24    3    60    7    -    - 
Capitalized development cost   9,928    1,195    15,484    1,863    29,464    3,545    46,229    5,562 
Other operating income   153    18    4,353    524    4,454    536    2,524    304 
Raw materials, consumables and goods for resale   (5,567)   (670)   (2,286)   (275)   (6,835)   (822)   (6,137)   (738)
Other external expenses   (34,767)   (4,183)   (2,627)   (3,324)   (75,189)   (9,047)   (62,616    (7,534)
Employee benefit expenses   (23,335)   (2,808)   (21,827)   (2,626)   (45,101)   (5,426)   (42,408)   (5,102)
Depreciation, amortization and impairment   (2,461)   (296)   (2,479)   (298)   (4,941)   (594)   (5,089)   (612)
Other operating expenses                       (3)   (0,4)   (86)   (10)
Operating income   (54,496)   (6,557)   (34,359)   (4,134)   (98,091)   (11,802)   (67,583)   (8,131)
Financial income   16    2    140    17    192    23    587    71 
Financial expenses   (5,224)   (629)   (2,666)   (321)   (7,213)   (868)   (5,384)   (648)
Financial items, net   (5,208)   (627)   (2,526)   (304)   (7,021)   (845)   (4,798)   (577)
Income before taxes   (59,704)   (7,183)   (36,885)   (4,438)   (105,112)   (12,647)   (72,381)   (8,709)
Taxes                                        
Income for the period   (59,704)   (7,183)   (36,885)   (4,438)   (105,112)   (12,647)   (72,381)   (8,709)
                                         
Earnings per share, before and after dilution, SEK(2)   (0.68)   (0.08)   (0.45)   (0.05)   (1.27)   (0.15)   (1.05)   (0.13)
Weighted average number of shares, in thousands before and after dilution(2)   87,745    87,745    82,345    82,345    82,848    82,848    69,082    69,082 

 

 

(1) Restatement of figures has been performed in order to correct the accrual of development costs that have been capitalized at the end of each reporting period. See “Management’s Discussion and Analysis of Financial Condition and Results of OperationsInternal control over financial reporting.”

 

(2) Recalculation of historical figures has been performed with regards to capitalization issue components in the preferential rights share issue carried out in the fiscal quarter ended January 31, 2013 and January 31, 2015.

 

48
 

 

Consolidated Balance Sheet Data:      Six Months Ended           Year Ended     
   October 31,   April 30, 
           (Restated(1))               (Restated(1))     
   2014   2014   2013   2013   2014   2014   2013   2013 
   (TSEK)   (USD, in
thousands)
   (TSEK)   (USD, in
thousands)
   (TSEK)   (USD, in
thousands)
   (TSEK)   (USD, in
thousands)
 
Non-current assets   422,689    50,857    398,838    47,987    414,106    49,824    383,368    46,126 
Liquid assets   27,135    3,265    10,851    1,306    48,241    5,804    62,956    7,575 
Total current assets   35,735    4,300    18,252    2,196    54,276    6,530    69,895    8,410 
Total assets   458,424    55,157    417,090    50,183    468,383    56,355    453,263    54,536 
Total equity   269,035    32,370    282,268    33,962    281,907    33,919    319,153    38,400 
Total non-current liabilities   891    107    891    107    891    107    891    107 
Total current liabilities   188,498    22,680    133,931    16,114    185,584    22,329    133,219    16,029 
Total liabilities   189,389    22,787    134,822    16,222    186,476    22,436    134,110    16,136 

 

Consolidated Cash Flow Data:  Six Months Ended   Year Ended 
   October 31,   April, 30 
           (Restated(1))               (Restated(1))     
   2014   2014   2013   2013   2014   2014   2013   2013 
   (TSEK)   (USD, in
thousands)
   (TSEK)   (USD, in
thousands)
   (TSEK)   (USD, in
thousands)
   (TSEK)   (USD, in
thousands)
 
Cash flow from operating activities   (55,695)   (6,701)   (34,157)   (4,110)   (86,899)   (10,456)   (71,946)   (8,656)
Cash flow from investing activities   (12,243)   (1,473)   (17,949)   (2,160)   (35,682)   (4,293)   (57,388)   (6,905)
Cash flow from financing activities   46,832    5,635    -    -    107,865    12,978    190,263    22,892 

 

 

 

(1) Restatement of figures has been performed in order to correct the accrual of development costs that have been capitalized at the end of each reporting period. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Internal control over financial reporting.”

 

 

49
 

  

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes and other financial information included elsewhere in this prospectus. Some of the information contained in this discussion and analysis or set forth elsewhere in this prospectus, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. You should review the “Risk Factors” section of this prospectus for a discussion of important factors that could cause our actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

 

Overview

 

We are a pharmaceutical company focused on innovative treatments within human and animal oncology. Our product and product candidates utilize a proprietary, nanoparticle formulation technology that is designed to facilitate the administration of intravenously-delivered active pharmaceutical ingredients, without the addition of toxic solvents. We believe our formulation may result in improved safety, efficacy and ease of administration over existing drugs. Our initial development and commercialization efforts are focused on creating novel formulations of well-established chemotherapeutic drugs that can be used for the treatment of cancer in both humans and companion animals. We have four human oncology product candidates in pre-clinical and/or clinical development, and two veterinary oncology product candidates. We disclosed top-line Phase III data for our lead human oncology product candidate in the fourth quarter of 2014. In February 2014, we received conditional approval by the United States Food and Drug Administration (“FDA”) for our initial veterinary oncology product.

 

Our lead products utilize paclitaxel, the active ingredient of Taxol and Abraxane, two widely used cancer drugs marketed by Bristol-Myers Squibb and Celgene, respectively. Based on the potential benefits of our proprietary formulation technology, we are pursuing a strategy to replace the use of existing paclitaxel-based products in multiple cancers with our novel formulations. Our formulation is currently called Paclical for human indications, and is marketed under the name Paccal Vet-CA1 (“Paccal Vet”) for veterinary indications. We own the global commercial rights to Paclical, excluding Israel, Turkey, Russia, the Commonwealth of Independent States (“CIS”), Ukraine, Georgia and Turkmenistan. We have licensed the commercial rights to Paccal Vet for sale in Japan, Russia and the CIS.

 

Since we do not have sales and marketing operations, we have entered into various licensing and distribution agreements with established pharmaceutical companies to sell Paclical, Paccal Vet, and our other product candidates. We have entered into an agreement with Pharmasyntez for the commercialization of Paclical in Russia and the CIS, as well as Ukraine, Georgia and Turkmenistan, and a separate agreement with Medison Pharma for the commercialization of Paclical in Israel and Turkey. Furthermore, we have entered into an agreement with Nippon Zenyaku Kogyo for the commercialization of Paccal Vet in Japan.

 

Paccal Vet is the first injectable chemotherapeutic agent authorized for marketing for the treatment of squamous cell carcinoma (a cancer occurring in certain cells in the skin and the lining of other organs) and mammary carcinoma (a cancer occurring in the lining of the milk ducts of the mammary glands) in dogs. We received conditional approval by the FDA for Paccal Vet for the treatment of mammary carcinoma and squamous cell carcinoma under the Minor Use and Minor Species (“MUMS”) designation in the U.S. MUMS designation is a status similar to orphan designation for human drugs, making the sponsor eligible for incentives to support the approval or conditional approval of the designated drug, including seven years of market exclusivity in the U.S. For a description of the qualifications for Paccal Vet to receive the MUMS designation, conditional approval and full approval for dogs, see “Business—Overview.” We believe Paccal Vet can be on the market for up to five years, through annual renewals, while we collect remaining required effectiveness data for full approval. We are currently planning additional efficacy studies in dogs to collect all the necessary efficacy data for full U.S. approval of Paccal Vet for mammary carcinoma and squamous cell carcinoma.

 

From our inception through October 31, 2014, such agreements have yielded net cash of SEK 87.83 million in upfront fees and milestone payments and SEK 1.5 million in royalties and sales revenue. In addition to these partnerships, we may eventually directly commercialize Paclical ourselves using a targeted sales strategy similar to the approach used by Abraxis during the launch of Abraxane in 2005. To that end, we generally expect to retain some rights to commercialize Paclical in the U.S. and the EU.

 

50
 

  

We are a newly-commercial stage company with one product conditionally approved for marketing and sale, and given our recent change from development stage to commercial stage, we have not generated any significant revenue other than milestone payments from our commercial partners. We have incurred significant net losses since our inception on April 15, 1988. We incurred net losses of SEK 59.70 million, SEK 105.11 million and SEK 72.38 million for the six months ended October 31, 2014, and the fiscal years ended April 30, 2014 and April 30, 2013, respectively. These losses have resulted principally from costs incurred in connection with research and development activities and general and administrative costs associated with our operations. As of April 30, 2014, we had a deficit accumulated during development stage of SEK 404.26 million and cash, cash equivalents and short-term investments of SEK 48.24 million. We expect to continue to incur operating losses in the near future as we continue our clinical and preclinical development programs, apply for marketing approval for our product candidates and, subject to obtaining regulatory approval of our product candidates, establish sales and marketing partnerships in preparation for the potential commercialization of our product candidates. We believe that the net proceeds of this offering, together with our existing cash and cash equivalents, will enable us to fund our operating expenses and capital expenditure requirements for at least the next twelve months.

 

Other than what is disclosed in this prospectus, there are at present no significant trends known to us that are reasonably likely to have a material effect on our financial situation.

 

Events after balance sheet date of October 31, 2014

 

On December 12, 2014, the Company announced the results of a SEK 176 million rights issue that provided the Company with SEK 165 million after issue expenses. In total, 9,785,814 Ordinary Shares were issued to a price of SEK 18 per such share. The total number of Ordinary Shares amounted to 97,858,144 after completion of the offering. The increase in number of the Ordinary Shares was approximately 11%.

 

On December 14, 2014, Oasmia announced that its then Chairman of the Board, Joel Citron, acquired 100,000 shares in the Company through open market purchases.

 

On December 17, 2014 Oasmia announced that from January 2, 2015, the Company’s shares will be listed on the Mid Cap segment of Nasdaq Stockholm.

 

On December 30, 2014, Oasmia announced that the bank loan of SEK 40 million that expired on December 30, 2014 had been replaced by a new bank loan of SEK 20 million that expires on June 30, 2015. The maturity date of this loan was subsequently extended to December 30, 2015.

 

Oasmia announced that the investment company Nexttobe extended its loan to Oasmia. The new loan amounts to SEK 87 million and is due on December 30, 2015, and the interest rate for the period January 1, 2015 to December 30, 2015 is 8.5%. Nexttobe is Oasmia’s second largest owner after Alceco International S.A. with approximately 20% of the shares in the Company.

 

Financial Operations Overview

 

Net sales. We generate net sales pursuant to agreements with our commercial partners. These agreements generally include some of the following sources of revenue: an initial payment, additional milestone payments dependent upon the achievement of certain clinical, regulatory or commercial milestones, invoiced supply price for products delivered to commercial partners and royalties on product sales of licensed products when such product sales occur. Net sales also include amounts earned from the sale of miscellaneous supplies, such as sterile water. We recognize net sales when the amount earned can be measured in a reliable way and when we have determined it is likely that future economic benefits will accrue to us and certain criteria have been met, which will vary based on specific contractual arrangements. Revenue from licensing arrangements during the six months ended October 31, 2014 and fiscal years ended April 30, 2014 and April 30, 2013 amounted to zero. No net sales, other than sterile water amounting to TSEK 60, have been recognized during the fiscal years ended April 30, 2014. No royalties or product sales have been recognized during the applicable period.

 

51
 

  

Capitalized development cost. Capitalized development cost consists of expenditures for materials and services used in development of the intangible asset and employee benefit expenses for staff engaged in developing the intangible asset. Expenditures for research and development operations are generally expensed as they occur. Development costs which are attributable to clinical trials and registration are capitalized to the extent that they are expected to generate future economic benefits. We have determined that the beginning of Phase III trials is the earliest point for capitalization of development expense. This has been applied for Paccal Vet and Paclical, for which all conditions for capitalization are fulfilled. These conditions are generally met when it is probable that expected future economic benefits attributable to an asset will flow to us and the asset’s cost can be measured reliably. The disclosure of the development costs in Phase III is accounted for gross, i.e. the costs are included in various operating expenses whereas the capitalized part is disclosed on a specific line in the income statement.

 

Other operating income. Other operating income comprises revenues that are not generated in the ordinary course of business. For the periods disclosed, other operating income primarily consists of a capital gain in connection with the signing of the amendment of the distribution agreement with Abbott in January 2013 and an insurance compensation we received in June 2013 and November 2012 due to defective water equipment valves that lost small particles, resulting in product recall, destruction of clinical batches and lost time for the production of vials for clinical trials. All proceeds received from the insurance compensation were used towards paying for the extra costs associated with the resulting business interruption.

 

Operating expenses. Operating expenses includes four categories described below.

 

Raw materials, consumables and goods for resale. Raw materials, consumables and goods for resale consist of materials and consumables for manufacturing of pharmaceuticals for sales, clinical trials, cost of analysis for such pharmaceuticals and handling of waste.

 

Other external expenses. Other external expenses consist mainly of external fees paid for clinical trials, fees paid for regulatory, administration and other services such as rent of facility and cost for utilities.

 

Employee benefit expenses. Employee benefit expenses consist of salaries to employees, remuneration to board members, social security cost and other employee benefits and expenses.

 

Depreciation and amortization. Depreciation consists of depreciation for machinery, equipment and patents. The capitalized development expense is not yet subject to amortization.

 

Financial income. Financial income consists primarily of interest earned by investing our cash reserves in short-term interest-bearing deposit accounts.

 

Financial expenses. Financial expenses consist primarily of interest expense on interest-bearing loans.

 

Income taxes. As a Swedish resident trading equity, we are subject to Swedish corporate taxation. Since we have been loss-making since inception, no corporate taxes have been recorded.

 

52
 

  

Results of operations

 

Interim Six Months Results of Operations

 

Comparison of the six month periods ended October 31, 2014 and October 31, 2013

 

  

Six Months Ended October 31,

 
      

(Restated(1))

 
  

2014

  

2013

 
   (in TSEK) 
Net sales   1,552    24 
Capitalized development cost   9,928    15,484 
Other operating income   153    4,353 
Operating expenses   (66,129)   (54,219)
Financial income   16    140 
Financial expense   (5,224)   (2,666)
Income taxes   -    - 
Income for the period   (59,704)   (36,885)

 

(1)Restatement of figures has been performed in order to correct the accrual of development costs that have been capitalized at the end of the reporting period. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations―Internal control over financial reporting.”

 

Net sales

 

  

Six Months Ended October 31,

 
  

2014

  

2013

 
   (in TSEK) 
Net sales   1,552    24 

 

Net sales for the six months ended October 31, 2014, amounted to SEK 1.55 million, consisting mainly of Paccal Vet-CA1 sales of goods SEK 1.46 million, royalty SEK 0.06 million and sales of necessities SEK 0.03 million. Net sales in the same period prior year amounted to SEK 0.02 million, consisting of sales of necessities.

 

Capitalized development cost

 

  

Six Months Ended October 31,

 
      

(Restated(1))

 
  

2014

  

2013

 
   (in TSEK) 
Capitalized development cost   9,928    15,484 

 

(1)Restatement of figures has been performed in order to correct the accrual of development costs that have been capitalized at the end of each reporting period. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations―Internal control over financial reporting.”

 

Capitalized development cost decreased by SEK 5.56 million, or 36%, from SEK 15.48 million in the six month period ended October 31, 2013 to SEK 9.93 million in the same period ended October 31, 2014. In both periods there were two product candidates, Paclical and Paccal Vet, subject to capitalization. For Paclical, capitalization decreased by SEK 5.05 million, from SEK 10.41 million to SEK 5.36 million, as the Phase III study for this product candidate was nearing completion. For Paccal Vet, capitalization decreased by SEK 0.51 million, from SEK 5.07 million to SEK 4.57 million.

 

Other operating income

 

  

Six Months Ended October 31,

 
  

2014

  

2013

 
   (in TSEK) 
Other operating income   153    4,353 

 

53
 

 

 

In the six months ended October 31, 2014, other operating income decreased to SEK 0.15 million, compared to SEK 4.35 million during the same period prior year. During the prior year an insurance compensation payment of SEK 4.25 million was received.

 

Operating expenses

 

  

Six Months Ended October 31,

 
      

(Restated(1))

 
  

2014

  

2013

 
   (in TSEK) 
Raw materials, consumables and goods for resale   5,567    2,286 
Other external expenses   34,767    27,627 
Employee benefit expenses   23,335    21,827 
Depreciation, amortization and impairment   2,461    2,479 
Total operating expenses   66,129    54,219 

 

(1)Restatement of figures has been performed in order to correct the accrual of development costs that have been capitalized at the end of each reporting period. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations―Internal control over financial reporting.”

 

Operating expenses including depreciation and amortization increased by 22%, or SEK 11.91 million, from SEK 54.22 million to SEK 66.13 million, for the six months ended October 31, 2014, compared to the same period prior year. The increase in raw materials, consumables and goods resale of SEK 3.28 million was attributable to an increase in production volume and related analysis. Other external expenses increased by SEK 7.14 million. The increase relates to method development in production at Oasmia and its contract manufacturers SEK 5.65 million, preparation costs for US listing SEK 1.99 million, consumable equipment SEK 0.57 million, rent SEK 0.45 million and offset by decrease in preclinical and clinical trials by SEK 2.11 million. Employee expenses increased by SEK 1.51 million due to higher salary level and introduction of a pension plan.

 

Financial income

 

  

Six Months Ended October 31,

 
  

2014

  

2013

 
   (in TSEK) 
Financial income   16    140 

 

Financial income in the six months ended October 31, 2014 amounted to SEK 0.02 million, compared to SEK 0.14 million in the corresponding period in the prior fiscal year. This decrease was a result of lower amounts of invested cash reserves in short-term interest-bearing deposit accounts.

 

Financial expense

 

  

Six Months Ended October 31,

 
  

2014

  

2013

 
   (in TSEK) 
Financial expense   5,224    2,666 

 

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Financial expense in the six months ended October 31, 2014 amounted to SEK 5.22 million, compared to SEK 2.67 million in the corresponding period in the prior fiscal year. The increase in financial expenses is attributable to higher interest on loan from Nexttobe AB of SEK 1.80 million and interest costs related to new bank loan of SEK 0.70 million.

 

Comparison of Fiscal Years Ended April 30, 2014 and April 30, 2013

 

  

Year Ended April 30,

 
      

(Restated(1))

 
  

2014

  

2013

 
   (in TSEK) 
Net sales   60    - 
Capitalized development cost   29,464    46,229 
Other operating income   4,454    2,524 
Operating expenses   (132,069)   (116,336)
Financial income   192    587 
Financial expense   (7,213)   (5,384)
Income taxes   -    - 
Income for the period   (105,112)   (72,381)

 

(1)Restatement of figures has been performed in order to correct the accrual of development costs that have been capitalized at the end of the reporting period. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations―Internal control over financial reporting.”

 

Net sales

 

  

Year Ended April 30,

 
  

2014

  

2013

 
   (in TSEK) 
Net sales   60    - 

 

There were sales of sterile water in the year ended April 30, 2014. In the prior fiscal year, there were no net sales.

 

Capitalized development cost

 

  

Year Ended April 30,

 
      

(Restated(1))

 
  

2014

  

2013

 
   (in TSEK) 
Capitalized development cost   29,464    46,229 

 

(1)Restatement of figures has been performed in order to correct the accrual of development costs that have been capitalized at the end of the reporting period. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations―Internal control over financial reporting.”

 

Capitalized development cost decreased by SEK 16.76 million, or 36%, from SEK 46.23 million in the year ended April 30, 2013 to SEK 29.46 million in the year ended April 30, 2014. In both years there were two product candidates, Paccal Vet and Paclical, subject to capitalization. For Paclical, capitalization went down by SEK 21.93 million, from SEK 41.61 million to SEK 19.68 million as the Phase III study for this product candidate was nearing completion. For Paccal Vet, capitalization increased by SEK 5.17 million from SEK 4.62 million to SEK 9.79 million in the year ending April 30, 2014. This was a result of a new complementary Phase III study that was started in the second quarter of the fiscal year ending April 30, 2013.

 

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Other operating income

 

  

Year Ended April 30,

 
  

2014

  

2013

 
   (in TSEK) 
Other operating income   4,454    2,524 

 

In the year ended April 30, 2014, other operating income increased to SEK 4.45 million, compared to SEK 2.52 million in the prior year. This consisted mainly of an insurance compensation amounting to SEK 4.25 million.

 

Operating expenses

 

  

Year Ended April 30,

 
      

(Restated(1))

 
  

2014

  

2013

 
   (in TSEK) 
Raw materials, consumables and goods for resale   6,835    6,137 
Other external expenses   75,189    62,616 
Employee benefit expenses   45,101    42,408 
Depreciation, amortization and impairment   4,941    5,089 
Other operating expenses   3    86 
Total operating expenses   132,069    116,336 

 

(1)Restatement of figures has been performed in order to correct the accrual of development costs that have been capitalized at the end of the reporting period. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations―Internal control over financial reporting.”

 

Operating expenses including depreciation and amortization increased by SEK 15.73 million, or 14%, from SEK 116.34 million to SEK 132.07 million, in the year ended April 30, 2014 compared to the year before.

 

Raw materials, consumables and goods for resale increased by SEK 0.70 million which was due to higher demand of raw materials in research and development.

 

Other external expenses increased by SEK 12.57 million due to a number of factors. Method development of production methods increased by SEK 9.40 million compared to prior year. Financial activities, mainly related to external services in connection with an activity of potential stock listing in the U.S increased by SEK 8.03 million. External expenses in clinical trials increased by SEK 4.84 million in animal health but decreased by SEK 7.06 million in human health. Freight and transport decreased by SEK 2.84 million due to lower volume and also more cost-efficient freight activity.

 

Employees benefit expenses increased by SEK 2.69 million. This was due to the number of employees increasing to 78 by April 30, 2014 compared to 75 the year before and also annual wages adjustments.

 

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Financial income

 

  

Year Ended April 30,

 
  

2014

  

2013

 
   (in TSEK) 
Financial income   192    587 

 

Financial income in the year ended April 30, 2014 amounted to SEK 0.19 million, compared to SEK 0.59 million for the year before. This 67% decrease was a result of lower amounts of invested cash reserves in short-term interest-bearing deposit accounts.

 

Financial expense

 

  

Year Ended April 30,

 
  

2014

  

2013

 
   (in TSEK) 
Financial expense   7,213    5,384 

 

Financial expense is primarily attributable to interest on loans from Nexttobe. Interest expense was higher in the year ended April 30, 2014 than in the previous year due to the maturity of the loan and an increased interest rate. The loan was provided to the Company in three portions. The first portion, for SEK 25 million, was provided in February 2012. The second portion, for SEK 65 million, was in May 2012. The third portion of SEK 15 million was provided in September 2012, amounting to a total loan of SEK 105 million. The interest rate was fixed at 5% for all portions of the loan until December 31, 2013. From January 1, 2014, the interest was set to 8.5%. This component amounted to an additional interest expense of SEK 1.23 million.

 

Furthermore, Oasmia was granted a bank loan from Nordea amounting to SEK 40 million, with a term from December 1, 2013. Interest expense for this loan was SEK 0.65 million in the fiscal year ending April 30, 2014.

 

Liquidity and Capital Resources

 

Sources of funds

 

Our primary uses of cash are to fund research and development expenses and capital expenditures. In recent years, we have largely funded our operations and growth from loans, share issuances and milestone payments from our partners and licensees. Our cash flows may fluctuate, are difficult to forecast and will depend on many factors including:

 

the realization of revenue from our product and product candidates, which will rely upon the timing of regulatory approvals, the marketing efforts of our commercial partners, and the price levels achieved by our partners;
the extent of success in our pre-clinical and clinical stage research programs which will determine the amount of funding required to further the development of our product candidates;
the outcome, timing and cost of regulatory approvals of Paccal Vet, Paclical, Doxophos Vet and our other product candidates;
the timing of achievement of the milestones receivable if Paccal Vet, Paclical, Doxophos Vet and our other product candidates are approved and launched in the U.S. and elsewhere;
the extent to which we seek to retain development rights to our pipeline of new product candidates or whether we seek to license such candidates to a partner who will fund future research and development expenditure in return for a right to share in future commercial revenue;
the terms and timing of new strategic collaborations;
the number and characteristics of the product candidates that we seek to develop;
the costs involved in filing and prosecuting patent applications and enforcing and defending potential patent claims; and
the costs of hiring additional skilled employees to support our continued growth.

 

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On March 31, 2015 we had the following loans and credit lines: (i) one loan from Nexttobe amounting to SEK 87 million, due December 30, 2015 with an interest rate of 8.5%, (ii) one loan from Nordea Bank AB (“Nordea”) amounting to SEK 20 million with an interest rate pegged to the Stockholm Interbank Offered Rate (“STIBOR”) one week plus 2%, (iii) one unutilized SEK 5 million credit facility with Nordea with a variable interest rate upon utilization, and (iii) one unutilized credit facility of SEK 40 million with Alceco, with a fixed interest rate of 5% upon utilization.

 

Assuming gross proceeds of $20 million are raised, we believe that, together with our cash and cash equivalents and unutilized credit facilities, we expect to have sufficient resources to fund our operations, including currently anticipated research and development activities and planned capital spending, for the foreseeable future, including for at least the next twelve months. Our expectation is based, in part, on our ability to either extend the maturity date of the Nexttobe loan (as we have done in the past) beyond December 30, 2015 or secure new credit overdraft facility. We cannot assure you that we will be able to extend the maturity date or obtain this new credit facility.

 

Summary of cash flows

 

  

Six Months Ended October 31,

  

Year Ended April 30,

 
      

(Restated(1))

      

(Restated(1))

 
  

2014

  

2013

  

2014

  

2013

 
   (in TSEK)   (in TSEK) 
Cash flow from operating activities   (55,695)   (34,157)   (86,899)   (71,946)
Cash flow from investing activities   (12,243)   (17,949)   (35,682)   (57,388)
Cash flow from financing activities   46,832    -    107,865    190,263 

 

(1)Restatement of figures has been performed in order to correct the accrual of development costs that have been capitalized at the end of each reporting period.

 

Cash flow from operating activities

 

The negative cash flow from operating activities for the six month period ended October 31, 2014, SEK 55.70 million, consists of the operating income loss, SEK 54.50 million, adjusted for depreciation and amortization, SEK 2.46 million, and negative changes in working capital, SEK 3.06 million, plus interest received, SEK 0.02 million, less interest paid, SEK 0.61 million. The significant items in the changes in working capital included a decrease in accounts payable of SEK 1.14 million, an increase in inventories of SEK 1.11 million and a decrease in other current liabilities of SEK 0.56 million.

 

The significant items in the changes in working capital included an increase in other current receivables of SEK 2.14 million, a decrease in accounts payable of SEK 3.2 million and a decrease in other current liabilities of SEK 2.00 million, all normal changes between periods in our operations.

 

Cash flow from investing activities

 

For the six month period ending October 31, 2014, cash used in investing activities amounted to SEK 12.24 million. This amount included intangible assets of SEK 10.23 million, which consisted of capitalized development costs of SEK 9.93 million and patents of SEK 0.30 million. Investments in tangible assets amounted to SEK 2.01 million, which primarily related to the purchase of production equipment.

 

Cash flow from financing activities

 

During the period ending October 31, 2014, cash flow provided by financing activities amounted to SEK 46.83 million. This amount consisted of a new share issue of SEK 46.83 million net of issue expenses.

 

On July 3, 2014, the Company consummated a SEK 50 million directed share issue that provided the Company with SEK 46.83 million after issue expenses. It was directed at a number of international institutional investors and investors in Sweden. In the aggregate, 2,500,000 Ordinary Shares were issued at a price of SEK 20 per share. The total number of shares amounted to 88,072,330 afterwards. The increase in number of the Ordinary Shares was approximately 3%.

 

58
 

  

On December 12, 2014, Oasmia announced the final result in the right issue of a total approximately SEK 176 million (before transaction related costs), of which approximately SEK 35.3 million by means were set-off of debt to Nexttobe AB.

 

On December 30, 2014, Oasmia announced that Nexttobe extended its loan and Oasmia used some of the proceeds from the rights issue in November/December to pay accrued interest and a part of the original principal amount of the loan from Nexttobe. The new loan amounts to SEK 87 million and is due December 30, 2015.

 

On December 5, 2013, we reported that we were granted a new bank loan from Nordea amounting to SEK 40 million, with a term from December 1, 2013 to March 31, 2014.

 

On March 25, 2014, we reported that a new bank loan of SEK 40 million from Nordea had replaced the previous bank loan, with the new bank loan having a term of April 1, 2014 to August 31, 2014. We reported on September 5, 2014 that the maturity of this bank loan was extended to September 30, 2014 and then renegotiated to expire December 30, 2014. On December 30, 2014 we announced that Oasmia obtained a new SEK 20 million bank loan that replaces the previous SEK 40 million bank loan which was due on December 30, 2014. The new SEK 20 million bank loan has a maturity date of June 30, 2015. As of January 1, 2015, the Company has SEK 20 million placed in a blocked fixed income fund as a pledge for the SEK 20 million bank loan. We intend to renegotiate the terms of this loan with Nordea to convert it into a bank overdraft facility and to extend its maturity.

 

Contractual Obligations

 

The following table summarizes our contractual commitments and obligations as of March 31, 2015.

 

   Payments Due by Period 
   Total      Less than
1 year
   1-3 years    3-5 years      More than
5 years
 
   (in TSEK) 
Operating lease obligations(1)   10,791    5,288    5,503         - 
Purchase obligations(2)   75,004    36,097    37,967    1,003    - 
Interest Payments   7,497    7,497              - 
Long-term debt obligations(3)   87,000    87,000                
Total contractual cash obligations   180,292    135,882    43,470    1,003    - 

 

 

(1)Consists of the leasing of space at SEK 5.09 million and office equipment at SEK 200,000 per year. Each floor of our building is leased separately, with expiration dates of December 31, 2015, December 31, 2016 or March 31, 2017. Leases automatically extend for an additional three years if not terminated with nine months’ notice.

 

(2)Purchase obligations include signed orders for technical services and clinical studies which have been committed but not yet received at the balance sheet date totaling SEK 75.07 million.

 

(3)Long-term obligations include repayment of loan to Nexttobe AB of total SEK 87.00 million.

 

Pension obligations

 

The pension plan for the Executive Chairman obligates us to pay 20% of his annual pensionable salary to any company chosen by him. We also allocate to a pension plan 4.5% of the salary of all employees, excluding our Executive Chairman. In addition to the pension plan allocation of 4.5%, the CFO has a total pension plan allocation of 30% for the annual pensionable salary that exceed SEK 0.43 million. The threshold is valid for calendar year 2014 and is index calculated on an annual basis.

 

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Critical accounting policies and significant judgments and estimates

 

In the application of our accounting policies, we are required to make judgments, estimates and assumptions about the carrying amounts of assets and liabilities that are not readily apparent from other sources. Estimates and judgments are continually evaluated and are based on historical experience and other factors, including expectations of future events that are believed to be reasonable under the current circumstances. Actual results may differ from these estimates.

 

The following are critical judgments we have made in the process of applying our accounting policies, other than those judgments involving estimation uncertainty, which we believe have the most significant effect on the amounts recognized in our consolidated financial statements.

 

Initial Milestone Payment

 

In 2011, Medison Pharma LTD paid us EUR 0.20 million (SEK 1.81 million) in accordance with the license agreement we signed with Medison. Should we not receive marketing authorization for Paclical from the European Commission by 2015, EUR 0.10 million (SEK 0.91 million) of this amount will be refunded. This item is subject to assessment each quarter. In the fiscal years ended April 30, 2014 and 2013 this item was reported as other long-term liability.

 

Research and Development Expenses

 

Research and development expenses are incurred for the development of new products and processes and include conducting clinical trials, development materials, payroll, including scientists and professionals for product registration and approval, external advisors and the allotted cost of manufacturing facility for research and development purposes. Expenditures for research and development are expensed as they occur. Development costs attributable to clinical trials and registration are capitalized to the extent that they are expected to generate future economic benefits. We have determined the beginning of Phase III as the earliest point for capitalization of development expense. This has been applied for two pharmaceutical candidates, for which all conditions for capitalization are fulfilled. Research and development expenses as included in the Income statement lines, is disclosed below.

 

   Six months Ended
October 31,
  

Year Ended

April 30,

 
       (Restated(1))       (Restated(1)) 
   2014   2013   2014   2013 
   (in TSEK)   (in TSEK) 
Raw materials, consumables   3,169    2,284    6,771    5,945 
Other external expenses   26,231    22,200    56,810    54,831 
Employee benefit expenses   16,755    16,490    33,219    31,519 
Depreciation   1,906    1,935    3,826    4,150 
Total R & D expenses   48,061    42,909    100,626    96,444 

 

(1)Restatement of figures has been performed in order to correct the accrual of development costs that have been capitalized at the end of the reporting period.

 

The reason research and development expenses are not disclosed separately for each product candidate is that all costs cannot be allocated to each product candidate separately.

 

Intangible assets; Amortization and impairment tests

 

Amortization of the intangible assets is carried out on a straight-line basis over the period that the expected benefits are expected to generate earnings for the company, which is from the date that commercial sale to final customers is commenced. This point in time frequently occurs after receiving full approval for the indication (e.g., a cancer-type) of a product candidate in a specific market.

 

At the end of each fiscal year, we perform an assessment of whether there is a need for impairment of the capitalized development cost. The impairment test on intangible assets is based on a discounted cash flow model per cash generating unit (CGU). The CGUs are the two products candidates in Phase III. We have made the judgment that there is no need for impairment since of the two pharmaceutical candidates that are capitalized one has already received conditional approval, and approval for the other lies within the foreseeable future. We estimate that future profits motivate the value of the assets.

 

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The impairment tests requires us to use a number of assumptions, including market factors specific to the pharmaceutical business, potential pricing for our product and product candidates, the amount and timing of estimated future cash flows and the time value of money. In general, cost estimates (cash outflows) can normally be estimated with a higher degree of accuracy than revenues (cash inflows). Some specific areas of uncertainty are described below.

 

We have no history on which to base our forecasts. The cytostatic market for dogs is completely new so for this segment there is no product on which to study volumes and prices. The cytostatic market for human use is well known but there have been substantial changes in recent years as patents have expired and generic products have been introduced. One product whose patent has not expired is Abraxane, which is commercially available in many countries, with a higher price than that of generic products but with notable differences in price in those countries where it is on the market.

 

One further market uncertainty is that we do not yet have distributors or licensees for our human product candidates in the majority of countries and therefore have not received any parameters by which to estimate our net sales.

 

Another uncertainty is cost of goods sold. The only experience that we have with manufacturing is with small-scale production in our plant in Uppsala. We expect that large scale production in Uppsala and elsewhere will reduce the cost of goods sold per unit over time.

 

Our estimates have been calculated by the following procedures.

 

Animal Health

 

We have access to statistics for the number of dogs in the U.S. and the rates of cancer incidence among dogs. We cannot be certain how many dogs with cancer will be treated so we have estimated very small numbers of sales for the first few years. We also cannot be certain what revenue can be derived per patient. We have received estimates from our partner Abbott Animal Health for the amounts dog owners are willing to pay for treatment, not specifically for cytostatics but for other treatments (as there have been no cytostatics for dogs available on any market before we received conditional approval for Paccal Vet from the FDA). Cost of goods sold has been estimated by calculating all components at our plant and at the plants of our sub-contractor.

 

Human Health

 

We have access to figures on populations per country, cancer incidents per year, per cancer type and per country as well as net sales and prices for existing cytostatics. We also have access to the number of patients treated with taxanes. Of this figure we have estimated very small numbers for the first few years. Cost of goods sold has been estimated in the same way as in animal health above.

 

Since until just recently we had no product approved, we have not been able to verify any of our estimates. There have been no major changes to any of our assumptions, other than that we have had to move back our estimate of the first year of market approval per product due to the approval processes with the relevant authorities taking more time than we had originally anticipated.

 

If our products are not approved, or the probability of their approval is diminished, capitalized expenditures will be carried as expenses. We annually evaluate whether a need for impairment exists for all intangible assets.

 

61
 

  

Income taxes

 

As of October 31, 2014, the group had cumulative carried forward tax losses, related to previous years and the six month period, amounting to SEK 463.86 million and at April 30, 2014, we had cumulative carried forward tax losses of SEK 404.26 million, related to previous years and the fiscal year. These are available to carry forward and offset against future operating profits, unlimited in time. Future profits will depend on continued marketing approvals for our product and marketing approvals for our product candidates. It is expected that depreciation and amortization will appear on our income statement before the cumulative losses carried forward can be utilized. Furthermore, we intend to retain earnings for use in our business, such as for additional clinical trials. We do not believe that fiscal surpluses will exist in the future to defend a capitalization of the deficits.

 

Off-Balance Sheet Arrangements

 

As of October 31, 2014, we have no off-balance sheet arrangements that have or are reasonably likely to have current or future material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity or capital resources.

 

Segment reporting

 

Our management manages our operations on an integrated basis. There are no operating results produced for any part of our operations for the purpose of allocating resources. Accordingly, we have determined that we operate as a single reporting segment.

 

Quantitative and qualitative disclosures about market risk

 

Market risk arises from our exposure to fluctuations in interest rates, currency exchange rates, commodity prices, and the creditworthiness of our counterparties. We manage these risks by borrowing mainly at fixed rates, limiting the number of trading currencies, minimizing the net exposure in each currency, by engaging a variety of suppliers, and by diligent selection of counterparties.

 

Interest rate risk

 

Interest rate risk is connected to changes in market rates that have an influence on our net financials. There is an interest rate risk when utilizing credit facilities in which the utilized amount is exposed to variable interest rates. We address interest risks by limiting the amounts exposed to variable interest. If the variable interest rates had been 1.0 percent higher/lower with all other variables constant, net income as of April 30, 2014 would have been SEK 0.17 million lower/higher, as a result of recalculated interest on utilized credits.

 

The credit facility available to us from Alceco on SEK 40 million carries a fixed interest rate of 5% on utilization, and therefore does not entail any interest rate risk. A credit facility available to us from a Swedish bank for SEK 5 million will carry a variable interest rate, based upon STIBOR upon utilization. The loan from Nexttobe on SEK 87.00 million carries a fixed interest of 8.5% for 2015.

 

The loan from Nordea of SEK 20 million carries a variable interest rate which is STIBOR plus 2%. The current term of this loan is from January 1, 2015 to December 30, 2015. We believe any change in STIBOR will have a very limited effect on us.

 

The Company does not currently use any swap or hedge instruments.

 

Currency Risk

 

Currency risks arise when future business transactions or recognized assets or liabilities are expressed in a currency other than SEK, our functional currency. While we currently make payments in EUR and USD, few payments have been received in those currencies during the last two fiscal years. We address currency risks by limiting the number of trading currencies and seeking to minimize the net exposure in each currency as much as possible. Both of these situations can be affected by our choice of contract currency with business partners. There is no regular forward hedging at present as the currency exposure is dominated by the purchased product development services, which are irregular and difficult to predict.

 

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Commodity price risk

 

Commodity price risk is the risk of changes in purchase prices from suppliers of materials used in the production of our pharmaceuticals. The vast majority of raw materials are purchased in EUR and USD, where the underlying prices may change. We have several suppliers of raw materials to choose from and have been able to exploit the current competitive situation to exert price pressure on our suppliers.

 

Credit and counterparty risks

 

Credit and counterparty risks are connected to the risk of loss if counterparties do not fulfill their obligations. Our revenues are received from just a few partners. These counterparties have good credit ratings, and thus we currently assess our credit and counterparty risks as being very low.

 

Recent accounting pronouncements

 

We have considered recent accounting pronouncements and have determined that they are either not applicable to our business or that no material effect is expected on the consolidated financial statements as a result of future adoption.

 

Internal control over financial reporting

 

In connection with the audit of our financial statements as of and for the fiscal years ended April 30, 2013 and April 30, 2012 under the Public Company Accounting Oversight Board (United States) (“PCAOB”) standards in preparation for this offering, our independent registered public accounting firm reported to our audit committee that it had identified a material weakness in our internal control over financial reporting related to inadequate financial statement preparation and review procedures. Under standards established by the PCAOB, a material weakness is a deficiency or combination of deficiencies in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected and corrected on a timely basis. Specifically, our independent registered public accounting firm determined that:

 

period-end accruals relating to capitalized research and development expenses was not accounted for properly in the fiscal year 2012 and 2013;
the internal review processes of critical accounting areas whereby management identifies and resolves complex accounting matters that require judgment and estimates should be enhanced; and
that the finance department does not currently have the resources and experience of maintaining additional financial reporting under U.S. standards including regulatory requirements of SEC reporting.

 

As a result of this material weakness, we:

 

have implemented what we believe to be necessary procedures to capture all expenses for capitalized research and development expenses;
have enhanced the internal review processes of critical accounting areas by involving the management group deeper in such judgments and estimates;
have strengthened the finance department in the calendar year 2014 by recruitments and organizational change and further strengthened it during 2015 by hiring additional personnel;
have advanced in knowhow of IFRS standards, as adopted by the EU. There are plans for education in IFRS standards not adopted by the EU and also specific SEC reporting in the U.S.;
have implemented and formalized written policies and procedures for the timely accrual of capitalized research and development expenses;
implemented enhanced oversight procedures in an effort to ensure that the accrual process has been performed prior to finalization of the financial statements at each reporting period; and
plan to formalize accounting evaluation of non-routine judgments and estimations.

 

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The material weakness led to a restatement of our consolidated financial statements for the fiscal years ended April 30, 2013 and April 30, 2012. We concurred with the findings of our independent registered public accounting firm. We have been working and are still working to remediate the material weakness. The actions that we are taking are subject to ongoing senior management review and audit committee oversight. We plan to complete this remediation process as quickly as possible; however this will not be a one-time process, rather an on-going continuing improvement process.

 

We cannot assure you that our remediation process will be successful, that our auditors will not identify additional material weaknesses or significant deficiencies in the future, and that we will not be required to restate our financial statements or remediate additional material weaknesses or significant deficiencies in the future.

 

We will be required to disclose changes made in our internal control over financial reporting and procedures on a semi-annual basis and our management will be required to assess the effectiveness of these controls annually.  However, for as long as we are an “emerging growth company” under the JOBS Act, our independent registered public accounting firm will not be required to attest to the effectiveness of our internal control over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act.  We could be an “emerging growth company” for up to five years.  An independent assessment of the effectiveness of our internal control over financial reporting could detect problems that our management’s assessment might not.  Any future undetected material weaknesses or significant deficiencies in our internal control over financial reporting could lead to financial statement restatements and require us to incur the expense of remediation.

 

Jumpstart Our Business Startups Act

 

The JOBS Act permits an emerging growth company such as us to take advantage of relief from certain regulatory burdens that are otherwise generally applicable to public companies. Among the relief available is an exemption from the auditor attestation requirement under Section 404 of the Sarbanes-Oxley Act in the assessment of an emerging growth company’s internal control over financial reporting. We have elected to rely on this exemption and will not provide such an attestation from our auditors. In addition, we are in the process of evaluating the benefits of relying on other exemptions and reduced reporting requirements afforded by the JOBS Act, including the exemption from complying with any requirement that may be adopted by PCAOB regarding mandatory audit firm rotation or requiring any supplement to the auditor’s report provide additional information about the audit and the financial statements (auditor discussion and analysis).

 

We will remain an emerging growth company until the earliest of (a) the last day of our fiscal year during which we have total annual gross revenue of at least $1.0 billion; (b) the last day of our fiscal year following the fifth anniversary of the completion of this offering; (c) the date on which we have, during the previous three-year period, issued more than $1.0 billion in non-convertible debt; or (d) the date on which we are deemed to be a “large accelerated filer” under the Exchange Act, which would occur if the market value of our ADSs that are held by non-affiliates exceeds $700 million as of the last business day of our most recently completed second fiscal quarter. Once we cease to be an emerging growth company, we will not be entitled to the exemptions and other relief provided in the JOBS Act.

 

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INDUSTRY DATA

 

Unless otherwise indicated, information contained in this prospectus concerning our industry and the markets in which we operate, including our general expectations and market position, market opportunity and market share, is based on information from our own management estimates and research, as well as from industry and general publications and research, surveys and studies conducted by third parties. Management estimates are derived from publicly available information, our knowledge of our industry and assumptions based on such information and knowledge, which we believe to be reasonable. In addition, assumptions and estimates of our and our industry’s future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in “Risk Factors.” These and other factors could cause our future performance to differ materially from our assumptions and estimates. See “Special Note Regarding Forward-Looking Statements.”

 

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BUSINESS

 

Overview

 

We are a pharmaceutical company focused on innovative treatments within human and animal oncology. Our product and product candidates utilize a proprietary, nanoparticle formulation technology that is designed to facilitate the administration of intravenously-delivered active pharmaceutical ingredients, without the addition of toxic solvents. We believe our formulation may result in improved safety, efficacy and ease of administration over existing drugs. Our initial development and commercialization efforts are focused on creating novel formulations of well-established chemotherapeutic drugs that can be used for the treatment of cancer in both humans and companion animals. We have four human oncology product candidates in pre-clinical and/or clinical development, and two veterinary oncology product candidates. We disclosed top-line Phase III data for our lead human oncology product candidate in the fourth quarter of 2014. In February 2014, we received conditional approval by the United States Food and Drug Administration (“FDA”) for our initial veterinary oncology product in February 2014, which made us eligible for royalties and potential milestone payments from our commercial partner Abbott Animal Health, the animal health division of Abbott Laboratories. Our lead products utilize paclitaxel, the active ingredient of Taxol and Abraxane, two widely used cancer drugs marketed by Bristol-Myers Squibb and Celgene, respectively. Based on the potential benefits of our proprietary formulation technology, we are pursuing a strategy to replace the use of existing paclitaxel-based products in multiple cancers with our novel formulations. Our formulation is currently called Paclical for human indications, and is marketed under the name Paccal Vet-CA1 (“Paccal Vet”) for veterinary indications. We own the global commercial rights to Paclical, excluding Israel, Turkey, Russia, the Commonwealth of Independent States (“CIS”), Ukraine, Georgia and Turkmenistan. We have licensed the global commercial rights to Paccal Vet, excluding Japan, Russia and the CIS, to Abbott Animal Health., which was subsequently acquired by Zoetis in connection with the closing of its purchase of certain assets from Abbott on February 10, 2015.

 

A phase III study with our lead human oncology product candidate, Paclical, for the treatment of epithelial ovarian cancer has recently been completed. We have received orphan designation for Paclical in the EU and the U.S. Results regarding progression free survival are available, and we intend to file an MAA in the EU based upon these results. The results were disclosed in the fourth quarter of 2014. We previously submitted an application to market Paclical in Russia, and we received market authorization in April 2015. We are also conducting and planning additional clinical trials to evaluate Paclical in other cancer types, initially breast cancer.

 

Paccal Vet is the first injectable chemotherapeutic agent authorized for marketing for the treatment of squamous cell carcinoma and mammary carcinoma in dogs. We obtained conditional approval by the FDA for Paccal Vet for the treatment of mammary carcinoma and squamous cell carcinoma under the Minor Use and Minor Species (“MUMS”) designation in the U.S. MUMS designation is a status similar to orphan designation for human drugs, making the sponsor eligible for incentives to support the approval or conditional approval of the designated drug, including seven years of market exclusivity in the U.S, during which period a different drug company cannot pursue full or conditional approval of a generic version or another brand name version of the drug in the same form for the same intended use.

 

In order to receive the MUMS designation in the U.S. for Paccal Vet, we were required to show that squamous cell carcinoma and mammary carcinoma, the drug’s two indications, occur infrequently and in less than 70,000 dogs in the U.S. each year. To receive conditional approval pursuant to the MUMS designation, we were also required to show (i) that our manufacturing process for Paccal Vet satisfied certain criteria, including purity and stability (see “Government Regulation—Requirements for Approval of Veterinary Pharmaceuticals for Pets—Defined Manufacturing Process”); (ii) that the production and use of Paccal Vet satisfied certain human and environmental safety criteria (see “Government Regulation—Requirements for Approval of Veterinary Pharmaceuticals for Pets—Safe for Humans and the Environment”); and (iii) a reasonable expectation of effectiveness in treating mammary carcinoma and squamous cell carcinoma. To receive full approval, we will need to show that the manufacturing and safety criteria described above remain satisfied, and that Paccal Vet is completely effective in treating mammary carcinoma and squamous cell carcinoma. Accordingly, upon our receipt of conditional approval pursuant to the MUMS designation our commercial partner, sales of Paccal Vet could be made in the U.S. We believe Paccal Vet can be on the market for up to five years, through annual renewals, while we collect remaining required effectiveness data for full approval. We are currently conducting additional studies in dogs to collect all the necessary efficacy data for full U.S. approval of Paccal Vet for mammary carcinoma and squamous cell carcinoma.

 

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“[The] FDA’s Center for Veterinary Medicine determined that the drug’s two indications fit the ‘minor use in a major species’ category. Both mammary carcinoma and squamous cell carcinoma – within the limitations described on the label – occur infrequently and in a small number of dogs each year (fewer than 70,000 dogs in the U.S. in one year).” Reference: FDA http://www.fda.gov/animalveterinary/resourcesforyou/ucm402476.htm

 

“[The] FDA’s Center for Veterinary Medicine granted Oasmia Pharmaceutical AB’s request to declare the drug a “designated” animal drug for its two label indications. This designation status qualifies the company to receive financial incentives. First, it gives Oasmia Pharmaceutical AB seven years of exclusive marketing rights, beginning on February 27, 2014, the date that FDA conditionally approved PACCAL VET-CA1. During this 7-year period, a different drug company cannot pursue approval or conditional approval of a generic copy or another pioneer (brand name) version of the same drug in the same form for the same intended use.”

 

Reference to FDA (quotes): http://www.fda.gov/animalveterinary/resourcesforyou/ucm402476.htm

 

In Europe, we intend to submit a Marketing Authorization Application (“MAA”) to the European Medicines Agency (“EMA”) for Paccal Vet for the treatment of squamous cell carcinoma, mammary carcinoma and mast cell (mast cells develop in bone marrow and are found in connective tissue throughout the body. Mast cells are, among other items, involved in the defense against parasitic infestations and infections. They contain histamine and are associated with allergic reactions based on data from the ongoing phase III studies.

 

In addition to Paccal Vet and Paclical, we have four additional product candidates:

 

·Docecal is a proprietary, patented formulation of docetaxel. Docetaxel is the active ingredient in Taxotere, a product marketed by Sanofi. Taxotere, one of the most commercially-successful and widely used chemotherapeutic medications, generated annual worldwide sales of more than $2.8 billion in 2010, the year its patent expired. We have completed a number of pre-clinical studies and we currently plan on initiating human clinical trials with Docecal for the treatment of metastatic breast cancer during 2015. We retain global rights to Docecal.

 

·Doxophos Vet and Doxophos are a proprietary, patented formulation of doxorubicin, one of the most effective and commonly used substances for the treatment of cancer. Doxorubicin is the active ingredient in Doxil and Adriamycin. Our product candidate is called Doxophos Vet for veterinary indications and Doxophos for human indications. Doxophos Vet is being developed for the treatment of lymphoma, one of the most common cancers in dogs. A Phase I dose-finding clinical trial with Doxophos Vet was completed during the fourth quarter of 2014 and the study report was completed in June of 2015. We have completed a number of pre-clinical studies and we are currently planning to initiate a clinical trial of Doxophos in humans to explore its pharmacokinetics compared to generic Adriamycin and to Doxil.

 

·OAS-19 is a proprietary combination of two widely used chemotherapeutic agents in a single formulation that can be administered in a single dose. In the past, cancers were often treated with a single chemotherapeutic agent but combination therapies have become more prevalent in clinical practice, including the combined use of multiple traditional chemotherapeutic agents and the combined use of newer cancer therapies in conjunction with traditional chemotherapeutic agents, which often require multiple infusions that can be time consuming and costly. By combining two chemotherapeutic agents in a single formulation, we believe that OAS-19 could offer physicians the ability to dose chemotherapy in a single infusion instead of two sequential infusions, which we believe decreases infusion times, the number of clinical visits, and associated treatment costs. We are currently evaluating OAS-19 in preclinical studies. We retain global rights to OAS-19.

 

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We believe that our strategy of applying our formulation technology to existing chemotherapeutic drugs will allow us to use the 505(b)(2) regulatory pathway in the United States to obtain regulatory approval for our human product candidates. The 505(b)(2) regulatory pathway permits the filing of a New Drug Application (“NDA”) where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. We believe this pathway is attractive as it has the potential to prevent the need for costly and time consuming clinical trials. We believe we will first be able to apply this to Paclical in the United States referencing Taxol.

 

Glossary of terms used in this prospectus

 

API Active Pharmaceutical Ingredient
   
Clinical phase Tests of a drug candidate in humans (in a veterinary context, in animals).
   
Clinical phase I During clinical development of a drug the drug is tested in humans for the first time in phase I. The safety of the drug is studied in a limited group (25-100 people) of healthy volunteers. The compounds for treatment of cancer that Oasmia is working on constitute an important exception. These candidates are also tested on volunteers but on a patient group that has the disease concerned.
   
Clinical phase II A developed study in patients (50-300 people) with the disease against which the intended drug will be used. Study of efficacy and safety.
   
Clinical phase III The final phase comprises a larger patient group (300-3,000 people) and the aim is to verify the efficacy and safety and identify any previously observed side effects.
   
Clinical phase IV After the market launch the finished drug is monitored with respect mainly to rare side effect symptoms.
   
Cytostatics Cytotoxins, drugs against tumor disease.
   
EMA European Medical Agency.
   
Excipient Platform, carrier molecule.
   
Incidence Number of diagnosed cases of disease in one year.
   
Infusion A route of administering a drug in liquid form. Infusion is often intravenous, i.e. the drug is administered into a vein over a longer period.
   
Mammary carcinoma A type of cancer situated in the epithelium (the lining) of the milk ducts of the mammary glands
   
Mastocytoma A form of skin cancer.
   
Mast cell Cells derived from the bone marrow and found in connective tissue throughout the body. Mast cells are e.g. involved in the defense against parasitic infestations and infections. They contain histamine and are associated with allergic reactions  
   
Micelle Spherical structures with the ability to form aggregates.
   
MUMS Minor Uses / Minor species. FDA-designation that provides an incentive to develop drug candidates
intended to treat rare diseases or diseases in a limited number of species.
   
Nanoparticle A particle whose size is measured in nanometers, 10-9 m.
   
Neutropenia Low number of neutrophils (a kind of white blood cells)
   
Orphan Drug Pharmaceutical for treatment of a disease with a small patient group.

 

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Paclitaxel The first taxane to be isolated from a yew tree. One of the most common cytostatics used today.
   
Pharmacokinetics The study of the distribution and metabolism over time of a drug or other substance in the body.
   
Pre-clinical phase Selection of drug candidates. The selected candidate is tested with respect to specificity, efficacy and safety.
   
Retinoid Vitamin A like acid.
   
Squamous cell Flat, scale-like cells of the epithelium (e.g. the skin)
   
Taxane A group of chemicals originally derived from a yew tree. The group is one of the most commonly
used compounds against tumor diseases today.
   
XR-17  Oasmia’s patented, nanoparticle formulation technology

 

XR-17 Formulation Technology

 

Drug Solubility: An Ongoing Issue in Drug Development

 

Solubility is a major challenge in the development of drug formulations; drugs that are not water-soluble cannot be easily delivered through the bloodstream to targeted tissues. Historically, salts have been used to increase solubility, however, this approach often only provides marginal improvements, particularly with larger, more complex, or highly hydrophobic (water-repelling) molecules. Newer, more effective methods of providing solubility have been successfully applied to commercial products, including the use of lipids, proteins, nanoparticles and mixed-micelles.

 

Within oncology, emulsifying solvents have typically been used in recent years to improve the solubility of chemotherapeutics. However, while these solvents create water-soluble formulations, many cause toxic side effects that limit the amount of active drug that can be administered to patients, or may require patients to be pretreated with steroids and other medications.

 

XR-17 Overview

 

We have developed a patented, nanoparticle formulation technology, XR-17, which makes a single API or multiple APIs water soluble. XR-17 forms spherical structures called micelles, which consist of Vitamin A derivatives that encapsulate the active substance. A micelle containing a water insoluble substance consists of the active ingredient surrounded by XR-17 with the hydrophobic (water-repelling), non-polar chain pointing inwards towards the active ingredient and the hydrophilic (water-attracting), polar head pointing outwards (see below). The micelles are extremely small, 20 to 60 nm depending on the API, and are considered nanoparticles.

 

All of our XR-17 based therapeutics undergo lyophilization, or freeze-drying, to improve shelf life, facilitate storage, and create a sterile powder form of the product for reconstitution before intravenous use.

 

 

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XR-17 Advantages

 

XR-17 technology enables the encapsulation of individual APIs as well as combinations of multiple APIs with different solubility profiles. The beneficial properties of XR-17 technology have been affirmed in our toxicological and clinical studies. We believe the following are possible advantages of XR-17:

 

·Improves solubility, facilitating the safe administration of APIs to animals and humans;

·Shortens infusion time, providing convenience for patients;

·Reduces severe hypersensitivity, allowing for higher dosage of APIs, given its reduced toxicity; and

·Improves dosing profiles of combination therapy by enabling dual encapsulation of water-soluble and water-insoluble APIs in one nanoparticle.

 

Oasmia Strategy

 

Our goal is to establish Oasmia as a leading pharmaceutical company that develops and commercializes novel therapeutics based on our proprietary, nanoparticle formulation technology for a variety of indications. Major elements of our strategy include:

 

·Obtain approval of Paclical in ovarian cancer and continue to pursue development in additional indications to replace the use of paclitaxel-based products. We have been granted orphan designation for the use of Paclical for epithelial ovarian cancer in the U.S. and the EU. We have completed a Phase III clinical trial with Paclical for the treatment of epithelial ovarian cancer and we disclosed top-line data in the fourth quarter of 2014. The results will be used to seek marketing approval in the EU and other regions. We anticipate obtaining overall survival data from the Phase III clinical trial as well, in the second half of 2015. In addition, we intend to conduct additional studies to enable the extension of Paclical use, initially into metastatic breast cancer.

 

·Maximize the commercial potential of Paclical. Depending on the region and timing of a potential Paclical approval, we may seek to enter into regional or global license and commercialization agreements, as well as evaluate the possibility of directly commercializing Paclical ourselves using a targeted sales force to identify key cancer centers to support the launch of Paclical. This targeted sales strategy, which can be effected economically in terms of cost and personnel, was successfully utilized by Abraxis for the launch of Abraxane in 2005.

 

·Initiate the clinical development, regulatory strategy and commercialization of Paccal Vet. We are responsible for commercializing Paccal Vet in the U.S. We plan to produce launch supply in our FDA-approved facilities and transition to our manufacturing partner Baxter Oncology GmbH over time. We are also conducting and plan to conduct additional clinical trials to support the full approval of Paccal Vet in the U.S. and EU.

 

·Advance our additional development stage human and veterinary oncology programs. We have three additional human oncology product candidates, Docecal, Doxophos, and OAS-19, in preclinical development. We intend to initiate pharmacokinetic studies for Docecal and Doxophos in 2015. We have one veterinary oncology product candidate, Doxophos Vet, a dose-finding study in dogs that has recently been completed and the study results are available. Based on the results of the dose-finding study, we plan to evaluate Doxophos Vet in additional trials for cancer in dogs.

 

·Further capitalize on our technology platform. We believe our proprietary formulation technology is broadly applicable and we plan to pursue licensing opportunities for new indications, other compounds, whether new or already on the market, and compounds with other modes of administration. We intend to seek licensing agreements that may provide us with significant funding to advance our pipeline and to provide access to development, manufacturing and commercial expertise and capabilities, as well as potential milestone and royalty payments with respect to sales, of any related products that may be developed. We signed a research agreement with a multinational pharmaceutical company in June, 2014. Under the terms of the agreement, Oasmia shall perform initial experimental tests of XR-17 together with a substance specified by the partner.

 

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Market Overview

 

Our initial development efforts are focused on the fields of human and veterinary oncology. We believe that our XR-17 technology can be applied to address commercially attractive opportunities in these two markets based on the limitations of existing therapies.

 

Human Oncology Market Opportunity

 

Cancer is a serious, widespread and growing disease. According to the World Health Organization (“WHO”), approximately 8.2 million people died of cancer in 2012, and it is expected to rise by 70% over the next two decades.

 

Despite the development and introduction of new drugs to treat cancer, chemotherapeutic agents, used in combination with other treatments such as surgery or radiation, remain the primary treatment of cancer worldwide. Chemotherapeutic agents generally work by blocking cell division, thereby inhibiting the reproduction of cancer cells and suppressing tumor growth. Many new drugs that have obtained marketing approval for the treatment of cancer are used in combination with chemotherapeutic agents. In addition, many drug candidates in development across the industry, like most chemotherapeutics, are not water soluble and will require innovative formulations to enable intravenous use. We believe that the widespread use of chemotherapeutic agents worldwide and the potential use of our formulation technology with new drug candidates present a large commercial opportunity.

 

Animal Health Market Opportunity

 

 

Source: American Pet Products Association. (http://www.americanpetproducts.org/press_industrytrends.asp)

 

The U.S. is the single largest pet market, with 83 million pet dogs and 96 million pet cats, according to the American Pet Products Association (“APPA”) 2013-2014 National Pet Owners Survey. According to The European Pet Food Industry Federation 2012 Facts & Figures, there are approximately 60 million pet dogs and 64 million pet cats in the EU.

 

Dogs in particular are receiving increased amounts of veterinary care. According to APPA, approximately 78% of dog owners in the U.S. treated their dogs with medications in 2010, as compared to 50% in 1998. The increased spending is largely due to a changing attitude of owners toward their pets, as they increasingly view pets as family members. Accordingly, owners are willing to seek quality medical care for their pets. While the actual number of dogs in need of chemotherapy that actually received such treatment is unknown, one study estimated the number of dogs receiving cancer treatment in 2008 in the United States to be over one million, and that the average age of the dog when cancer is detected is eight years. Also, in Sweden pet insurance is becoming more widespread. It is estimated that eighty to ninety percent of dogs are covered by medical insurance, and approximately eighty percent of such insurance policies includes coverage for chemotherapy. The approximate life expectancy of dogs that do not receive treatment could be one to two months after the diagnosis, whereas for a dog that is treated with chemotherapy it could be one year from the diagnosis. It should be noted that this is an example since it is impossible to generalize the life expectancy since it depends on for instance the type of tumor and treatment.

 

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Due to the limited number of registered available oncology treatments for companion animals, we believe that there is a significant commercial opportunity to apply our formulation technology within veterinary oncology. According to the Center for Cancer Research and CanineCancer.com, approximately six million dogs in the U.S. are diagnosed with cancer each year, of which approximately one third have cutaneous, or skin, cancers. Current treatments consist largely of surgery, chemotherapy, and radiation therapy. For dogs in need of chemotherapy, the standard of care has largely been the off-label use of injectable human chemotherapeutic agents such as cisplatin, doxorubicin, carboplatin, and vincristine. Due to the fact that existing injectable chemotherapeutic agents have been formulated for humans and have not been optimized for animals, combined with broad acceptance of their anti-cancer effect, we believe that our intravenous chemotherapy labeled specifically for use in dogs will be viewed favorably by the veterinary community.

 

Based on the attributes of XR-17, we believe that there is a significant commercial opportunity to apply our proprietary formulation technology within veterinary oncology to enable the safe delivery of well-established chemotherapeutics, approved for the first time specifically for animal use.

 

Our Product and Product Candidates

 

The following table summarizes key information about our product and our most advanced product candidates:

 

Product Candidate Commercial Rights Stage of Development & Anticipated Milestones
Paclitaxel

Paclical

 

Oasmia: Global (excluding Israel, Turkey, Russia/CIS, Ukraine, Georgia and Turkmenistan)

Medison Pharma: Israel and Turkey

Pharmasyntez: Russia/CIS, Ukraine, Georgia and Turkmenistan

· Results from Phase III trial vs. Taxol was disclosed in the fourth quarter of 2014

· Apply for marketing authorization in EU by the end of 2015 or early 2016 and in the U.S. in 2017

· Applied for marketing authorization in Russia

· Initiate Phase III clinical trials for metastatic breast cancer in 2015

Paccal Vet

 

Oasmia: Global (excluding Japan, Russia/CIS)

Nippon Zenyaku Kogyo: Japan

Oasmia: Russia/CIS

· Conditional U.S. approval received in February 2014

· Conducting additional efficacy studies in dogs to support EMA approval, full U.S. approval and additional cancer indications

Apply for marketing authorization with the EMA

    ·
Docetaxel
Docecal Oasmia: Global

· Pre-clinical studies ongoing

· Initiate Phase I pharmacokinetic clinical trial in metastatic breast cancer in the second half of 2015

· Initiate clinical trials in the second half of 2015 in Russia and Latvia in metastatic breast cancer

Doxorubicin
Doxophos Vet

Oasmia: Global (excluding Russia/CIS)

Oasmia: Russia/CIS

· Dose-finding clinical trial completed

· Proof of Concept study has been initiated

Doxophos Oasmia: Global

· Pre-clinical studies ongoing

· Initiate Phase I pharmacokinetic clinical trial in metastatic breast cancer in 2015

Combination
OAS-19 Oasmia: Global

· Currently in pre-clinical development

· Initiate a Phase I dose-finding clinical trial

 

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Definitions

 

The following definitions are used throughout this document;

 

-Phase I: The first study initiated with a compound. This can be either a dose-finding study or a PK-study.
-Phase II: A study to assess safety and efficacy in a smaller study in the intended indication.
-Phase III: A study to show efficacy and safety and to be used as a basis for an application to obtain marketing authorization.

 

The label phase I is also used for veterinary studies although the nomenclature of the Center for Veterinary Medicine at the FDA (“CVM”) is “Dose characterization study” for phase I. Phase II is referred to herein as “Dose confirmation study” and phase III “field study”.

 

Paclical, Our Lead Human Oncology Candidate

 

Paclical Overview

 

Paclical is our XR-17 formulation of paclitaxel for human use. Our XR-17 technology increases the solubility of paclitaxel without the use of toxic solvents, which we believe facilitates the ease of administration and allows for higher doses than some of the other existing products on the market (250 mg/m2 compared to 175 mg/m2).

 

Based on the potential benefits of XR-17, we are pursuing a strategy to replace the use of existing paclitaxel-based products in treating multiple types of cancer. Our initial focus is to obtain regulatory approval for the treatment of ovarian cancer and expand use through additional regulatory approvals, starting with breast cancer. Since there are no human clinical studies in the U.S. we are not required to file an IND.

 

We have obtained orphan designation for epithelial ovarian cancer in the EU and in the U.S. based on the hypothesis that Paclical provides potential benefits to safety and tolerability compared to Taxol, which is currently used as a treatment for epithelial ovarian cancer. Both Paclical and Taxol are being administered in combination with carboplatin, a platinum-based chemotherapeutic that is the current standard of care for ovarian cancer. Carboplatin has historically been given as a monotherapy for the treatment of ovarian cancer, but some studies have demonstrated an incremental survival benefit by adding Taxol. On June 16, 2014, Oasmia announced that the primary endpoint for the Phase III study with Paclical for treatment of ovarian cancer had been met. The endpoint was to demonstrate that Paclical and Taxol, both in combination with carboplatin, have the same progression-free survival time. Further, we disclosed final results which showed a positive risk/benefit profile in the fourth quarter of 2014. This data will serve as the basis of an MAA to the EMA, which we intend to submit in 2016. We will continue to follow patients from the Phase III clinical trial to measure overall survival and expect to have results in the second half of 2016. We expect to be able to utilize the Section 505(b)(2) regulatory pathway for Paclical in the United States. We do not currently plan to conduct any other pivotal study of Paclical for epithelial ovarian cancer at this time since only one study is needed for submission to the FDA and EMA, although we may include other supportive studies in our Section 505(b)(2) application if time permits.

 

In addition to the development of Paclical in ovarian cancer, we intend to enhance the commercial potential of Paclical by demonstrating the potential safety, efficacy, and convenience advantages of Paclical over other paclitaxel-based therapies in additional clinical trials. For example, we are currently conducting a pharmacokinetic study to compare Paclical with Abraxane. In addition, this data can be used in our discussions with payor organizations and physicians to help drive market acceptance of Paclical.

 

In addition to our efforts in the EU and the U.S., we submitted an application for marketing authorization for Paclical in Russia in September 2012 and received approval in April of 2015.

 

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Paclical Market

 

The two leading paclitaxel-based products on the market are Taxol and Abraxane, two widely used cancer drugs. Taxol generated $1.6 billion in sales in 2000 alone, prior to losing its patent protection in 2001. In 2013, Taxol generated $92 million in post-patent sales. Abraxane, which received FDA approval in 2005 for metastatic breast cancer, followed by approvals for lung (in 2012) and pancreatic cancer (in 2013), generated $649 million in worldwide annual sales in 2013 and generated $848 million in 2014. In order to deliver paclitaxel, Taxol contains the solvent Cremophor EL. The toxicity of Cremophor EL limits the dose of Taxol that can be administered during a reasonable time, potentially limiting the efficacy of the drug. In addition, patients receiving Taxol require pre-medication with steroids and antihistamines to prevent the toxic side effects associated with the combination of paclitaxel and Cremophor EL. Abraxane was developed as a Cremophor-free product containing paclitaxel suspended in human albumin. Because Abraxane contains no Cremophor solvent, Abraxane’s recommended dosing enables the delivery of 50% more paclitaxel while maintaining a similar safety profile, and requires no routine pre-medication to prevent hypersensitivity reactions or the immediate allergic effects that often prevent or limit treatment. Like Abraxane, Paclical is free of Cremophor EL, but unlike Abraxane, Paclical does not contain human albumin.

 

Our initial indication for Paclical is epithelial ovarian cancer, which is the fifth leading cause of cancer death among American women, and an indication for which Abraxane has no approval. There are clinical studies and case reports that indicate that Abraxane is used off-label by oncologists to treat certain types of epithelial ovarian cancer, but we cannot estimate how frequently they do so or whether Abraxane is used off-label to treat second line epithelial ovarian cancer. It is easier to find publications on platinum resistant epithelial ovarian cancer and first line epithelial ovarian cancer than on second line epithelial ovarian cancer (Paclical’s intended indication), but it is not possible to say if that reflects the usage. Epithelial ovarian cancers account for about 85% to 90% of ovarian cancers, and are the most aggressive and dangerous sub-type. According to the National Cancer Institute, in 2011, the most recent year in which data are available, there were over 185,000 women living with ovarian cancer in the U.S. The five year survival rate for ovarian cancer from 2004 to 2010 was 44.6%, and it is estimated that 21,980 women will develop and 14,270 women will die from ovarian cancer in 2014. In the EU, the five year survival rate for ovarian cancer was 37.6% from 2000-2007 according to a study published in The Lancet. In 2012, there were 44,149 diagnosed cases of ovarian cancer in the EU, according to the European Cancer Observatory/International Agency for Research on Cancer, while 29,758 women died of ovarian cancer. In the U.S., 51% of women with ovarian cancer are diagnosed with stage III cancer, characterized by microscopically confirmed peritoneal metastasis outside the pelvis and/or regional lymph node metastasis. Common chemotherapy drugs used for the treatment for ovarian cancer include cisplatin or carboplatin, and paclitaxel or docetaxel, which are most often given in combination.

 

Our second indication, breast cancer, will be targeted with weekly administration of Paclical. Breast cancer is by far the most frequent cancer among women. The WHO estimates that 1.38 million women worldwide are diagnosed with breast cancer each year. Roughly 458,000 women worldwide die from the disease annually.

 

Although we may choose to license Paclical to a commercial partner, we also believe we could successfully market and sell the product ourselves. There have been numerous examples of successful oncology drugs, including Abraxane, launched by small companies.

 

Paclical Ongoing Phase III Clinical Trial

 

We have completed dosing in a Phase III open, randomized, multi-center trial in patients with recurrent epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer to compare the efficacy and safety of Paclical to Taxol, both in combination with carboplatin. Carboplatin was historically given as a monotherapy for the treatment of ovarian cancer but some studies have demonstrated an incremental survival benefit from adding Taxol, which has increased the use of the two drugs in combination. Top-line progression free survival results were disclosed in the second quarter of 2014. Since there are no human clinical studies in the U.S. we are not required to file an IND.

 

The study was designed to achieve the following primary objectives:

 

·For progression free survival, to show non-inferiority of Paclical (250 mg/m2) versus Taxol (175 mg/m2) using computed tomography (“CT”) scans according to RECIST, as assessed by central review.

 

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·For overall survival, to show non-inferiority of Paclical (250 mg/m2) versus Taxol (175 mg/m2).

 

Inclusion criteria included patients, in total 789 patients, who relapsed at least six months after ending the first line or second line treatment including platinum based therapy. Paclical was administered as a one-hour intravenous infusion at its recommended dose of 250 mg/m2 to 397 patients. Taxol was administered as a three-hour intravenous infusion at its recommended dose of 175 mg/m2 to 392 patients. Both drugs were dosed in six three-week cycles, which is consistent with clinical practice. After completing the treatment cycles, patients were managed by their respective physicians and tracked for certain measures, including progression free survival and overall survival.

 

Tumor response was evaluated with a biomarker, CA 125, and through CT scans. CA 125 is used in clinical practice to assess when to re-treat a patient, as it is generally accepted as a sign of disease progression. We received guidance from Russian regulators that CA 125 would be an acceptable endpoint for regulatory submission. In an interim analysis we assessed the response to Paclical and to Taxol with regard to concentration average of CA 125 during the treatment period. The objective to show non-inferiority of the two treatments was met. The results of the interim analysis were used in a submission for marketing authorization to Russian authorities. Beyond the Russian market, we believe the use of both CA 125 and CT scan data in one study will give us the opportunity to include a comparison of progression free survival based on CA 125 and based on CT evaluation in the final analysis.

 

On June 16, 2014, we announced the results of this trial. The primary end-point has been analyzed and it shows a progression free survival of 10.3 months in the Paclical + carboplatin group and 10.1 months in the control group (Taxol + carboplatin). The protocol objective to show non-inferiority (or similar efficacy) was thus met (p-value of 0.09).

 

A protocol amendment increased the frequency of CT scans to be performed every three months after end of treatment. An analysis of the Progression Free Survival rate (“PFS”) in this subset of patients showed a PFS for Paclical of 12.2 month and 10.2 months for Taxol. The non-inferiority criteria were met regarding the secondary efficacy variables. Even though the data on efficacy were not significantly different, PFS tended to be better in the Paclical group regardless of patient population; more frequent CTs showed the most pronounced differences.

 

The safety profile of Paclical active substance dose of 250 mg/m2, is rather similar to the safety profile of Taxol, active substance of 175 mg/m2. The number of patients with serious myelosuppression is substantial, but many of them were detected in the hematology analyses and were without clinical signs. Further, when needed, myelosuppression is easily managed in the clinic.

 

Considering both efficacy and safety of Paclical, including a comparatively short infusion time and less frequent use of pre-medications, we believe that the benefits of Paclical outweigh the potential risks of the treatment.

 

Paclical Phase I and Phase I/II Clinical Trials

 

Paclical Phase I/II Dose Escalation Trial

 

We evaluated Paclical in a dose escalating Phase I/II trial to define the maximum tolerated dose and desired dose to use in clinical trials of Paclical. Thirty-four patients with different kinds of cancers were included in the trial. Patients received escalating doses (90-275 mg/m2) of Paclical, until the dose-limiting toxicity was noted. Dose-limiting toxicity (“DLT”) is the emergence of side effects during treatment that are severe enough to prevent further increases in dosage of the treatment. Paclical was given as a one-hour intravenous infusion every 21 days for three cycles. No premedication was administered prior to Paclical administration.

 

Eight patients experienced at least one adverse event classified as DLT. The first occurred at 225 mg/m2 and consisted of fatigue, skin reaction, and stomatitis. The following 4 incidences of DLT occurred at 250 mg/m2 where one patient experienced myalgia, arthralgia and leukopenia classified as DLT during both first and second treatment cycle, and another three patients experienced mucositis, peripheral neuropathy and neuropathy, respectively. Three patients also experiences DLTs at the 275 mg/m2 dose level; all three experienced fatigue, one in combination with small intestinal obstruction and one in combination with peripheral sensory neuropathy.

 

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Stomatitis (at 250 mg/m2), myalgia, arthralgia (at 250 mg/m2), and small intestinal obstruction (at 250 mg/m2) fulfilled the criteria of serious adverse event. Other serious adverse events considered related to Paclical were pyrexia (2 patients) and hemoglobin decrease (2 patients).

 

The maximum tolerated dose was established at 250 mg/m2, which is 75mg/m2 greater than the recommended dose for Taxol of 175 mg/m2 and similar to the recommended dose for Abraxane of 260 mg/m2. No hypersensitivity reactions were reported despite the fact that no premedication was given before the administration of Paclical. In addition to the foregoing results, this trial indicated that Paclical was effective when administered with a one hour infusion period, while Taxol requires three hours.

 

The patient population consisted of terminally ill patients for whom no further treatment was available. Further, no patient received more than 3 cycles. Considering these circumstances, we consider the efficacy results, 10 patients with stable disease to be promising.

 

The most important result from these trials, in our view, was that Paclical can be given without pre-treatment, the maximum tolerated dose is 250 mg/m2 and the infusion period is one hour. This demonstrates that there are benefits associated with Paclical compared to Taxol since Taxol requires pre-treatment, the maximum tolerated dose is 175 mg/m2 and the infusion for Taxol is three hours.

 

Pharmacokinetic Comparison with Taxol

 

The pharmacokinetic properties of paclitaxel following an intravenous infusion of Paclical at a dose of 175 mg/m2 were evaluated in a Phase I crossover pharmacokinetic study comparing the pharmacokinetics of Paclical and Taxol in humans. The mean unbound plasma concentrations, which indicate the levels of paclitaxel in the bloodstream that are not bound to common blood proteins and therefore can readily cross cell membranes, were similar for the two formulations (see Figure 2). We believe that this supports the thesis that the paclitaxel-related effects for Paclical and Taxol when given at the same dose and during the same infusion time should be comparable and should have the same temporal course of action. We believe that this trial supports the pursuit of the 505(b)(2) regulatory path in the U.S.

 

Figure 2: Mean curves of unbound plasma concentration of paclitaxel after identical doses of Paclical and Taxol, 175 mg/m2 over 3 hours.

 

 

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Paccal Vet, Our Initial Animal Health Product

 

Paccal Vet Overview

 

Paccal Vet is a novel XR-17 based formulation of paclitaxel. Paclitaxel is a well-established, widely used chemotherapeutic that on its own is practically insoluble in water. Paccal Vet is our initial product in veterinary oncology. Our commercial partner, Abbott Animal Health, a leading animal health company, intends to launch the product in mid-2014, at which time we will be eligible to receive royalties that start at a minimum approximately one third of net sales. The Investigative New Animal Drug (“INAD”) number for Paccal Vet is 011609, which we requested on March 20, 2007.

 

In February 2014, we received conditional approval from the FDA for Paccal Vet for the treatment of nonresectable stage III, IV or V mammary carcinoma and resectable and nonresectable squamous-cell carcinoma, both for dogs that have not received previous chemotherapy or radiotherapy.

 

To receive conditional approval pursuant to the MUMS designation, we were also required to (i) show that our manufacturing process for Paccal Vet satisfied certain criteria, including purity and stability (see “Government Regulation—Requirements for Approval of Veterinary Pharmaceuticals for Pets—Defined Manufacturing Process”); (ii) show that the production and use of Paccal Vet satisfied certain human and environmental safety criteria (see “Government Regulation—Requirements for Approval of Veterinary Pharmaceuticals for Pets—Safe for Humans and the Environment”); and (iii) provide a reasonable expectation of effectiveness in treating mammary carcinoma and squamous cell carcinoma. To receive full approval, we will need to show that the manufacturing and safety criteria described above remain satisfied, and that Paccal Vet is completely effective in treating mammary carcinoma and squamous cell carcinoma.

 

Conditional approval allows veterinarians to treat dogs with Paccal Vet in the approved indications. Conditional approval grants Paccal Vet seven years of market exclusivity, and gives us the right to promote the product before all of the efficacy data necessary for a full approval are available. Conditional approval also allows us to keep the product on the market for up to five years, through annual renewals, while collecting the remaining required efficacy data.

 

“[The] FDA’s Center for Veterinary Medicine determined that the drug’s two indications fit the ‘minor use in a major species’ category. Both mammary carcinoma and squamous cell carcinoma – within the limitations described on the label occur infrequently and in a small number of dogs each year (fewer than 70,000 dogs in the U.S. in one year).”

 

“The company has shown that, when used according to the label, PACCAL VET-CA1 is safe and has a ‘reasonable expectation of effectiveness.’” Reference: FDA http://www.fda.gov/animalveterinary/resourcesforyou/ucm402476.htm

 

In order to obtain the remaining required efficacy data for full approval of Paccal Vet, we are planning a clinical trial evaluating Paccal Vet against placebo in 165 dogs with mammary carcinoma and 165 dogs with squamous-cell carcinoma. We initiated these studies in the fourth quarter of 2014. In early phase trials where one seeks to ascertain whether the dose or trial can assess a particular degree of safety there are usually no comparative treatments. That was the case for the study called Paccal Vet in Malignant High-Grade Solid Tumors in Dogs.

 

The study Paccal Vet Prospective Single-Arm Trial in Mast Cell Tumors in Dogs was a single-arm study. This was because the comparator used in clinical trials is the standard of care, the most commonly used treatment for the indication. When we started to develop Paccal Vet there were no chemotherapeutics approved for dogs. One can of course always compare to no treatment or the vehicle (“placebo”). With a disease such as cancer, it is not ethical not to treat, and that was the reason for the single arm study.

 

When it was possible for us to apply for conditional approval, discussions were held with CVM/FDA and it was concluded that data from a comparative study were not needed to obtain the conditional approval. Although, according to CVM/FDA, the number of dogs with the specific indications treated in the study Paccal Vet in Malignant High-Grade Solid Tumors in Dogs, was too low to meet requirements of reasonable expectation of effectiveness. Therefore it was decided, through discussions with CVM/FDA, to include dogs from a study not done by Oasmia (mammary carcinoma) and to conduct a small study (squamous cell carcinoma) in order to meet the requirements of a conditional approval.

 

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EMA CVMP Scientific Advice and FDA protocol concurrence were requested and received for the pivotal clinical study protocol(s) for full approval. The study protocol was submitted to EMA for scientific advice. An answer was obtained on July 12, 2012 (EMA/CVMP/SAWP/296308/2012). The questions asked by Oasmia referred to study design, primary objective/end-point, the use of placebo as comparator, sample size calculations, quality of life scale, the use of anti-emetics, and the possibility to use safety data from previous studies. The answers to some of the questions were ambiguous and clarifications were requested on Aug 10, 2012, and answered on Sep 13, 2012 (EMA/CVMP/SAWP/548291/2012). EMA’s comments were addressed in the final study protocol.

 

The Clinical Study Protocol(s) have received FDA “concurrence” which means FDA agrees with the design of the clinical protocol(s), and as such also agrees with the numbers of dogs to be in the study(s). FDA as a status quo requires a minimum of 150 dogs. EMA does not generally require a specific minimum number of dogs such as 150 dogs, but the numbers should be based on a hypothesis that is statistically valid. Oasmia asked in scientific advice to EMA CVMP Oct 2013 specifically, “Does the CVMP agree that this number of dogs is sufficient?” EMA CVMP Answer (excerpted) “As outlined in the CVMP GL on statistical principles for clinical trials for veterinary medicinal products (EMA/CVMP/EWP/81976/2010) ‘the number of animals in a clinical trial should always be large enough to provide reliable answers to the questions addressed. This number is usually determined by the primary objective of the trial’. Thus, a formal sample size calculation is considered necessary in the planned confirmatory clinical trial. Based on the treatment effects specified in the company’s position, the planned sample size initially appears reasonable.”

 

We are conducting a study in 50 dogs for the treatment of mast cell tumors, with the aim of assessing progression free survival (as opposed to a prior study conducted with the aim of assessing the response rate of dogs with mast cell tumors to Paccal Vet, see “—Paccal Vet in Mast Cell Tumors in Dogs”). We determined the final protocol for this study based on a request we made to the EMA for scientific advice as to study design, primary objective/end-point, use of placebo as comparator, sample size calculations, quality of life scale, the use of anti-emetics, and the possibility of using safety data from previous studies. Once the data are collected, we expect to submit an MAA to the EMA for Paccal Vet, which may include data collected from any, or all, of the other studies conducted by us described below.

 

Whether or not to submit a NADA for the treatment of mast cell tumors depends on the results of the study. The protocol is not designed according to the requirements of CVM/FDA, but the results might allow submission nonetheless.

 

Paccal Vet Market

 

According to the Animal Cancer Foundation, approximately six million dogs per year are diagnosed with cancer in the U.S., slightly less than 10% of the population. Based on a population of 60 million dogs in the EU, we estimate almost six million dogs per year are diagnosed with cancer in Europe. We estimate that between 36,000 and 41,250 dogs are treated annually for mammary carcinoma, while the number of diagnoses for squamous cell carcinoma in dogs is less than 10,000 annually. This is the reason Paccal Vet was eligible for conditional approval, the drug’s two indications fit the “minor use in a minor species” category. As mentioned earlier both mammary carcinoma and squamous cell carcinoma occur infrequently and in a small number of dogs each year (fewer than 70,000 dogs in the U.S. each year).

 

Based on the referenced sources for the U.S. and Europe, we believe that the incidence rates and overall prevalence of cancer in dogs is similar for cats. Solid tumors, with or without metastatic disease, are one of the most common forms of cancer in dogs and cats. Aside from Paccal Vet, there are currently no injectable chemotherapeutic drugs specifically approved for use in pets in the U.S., although, as an alternative, human drugs are often used off-label. Taxol and Abraxane, both of which deliver paclitaxel, cannot safely be used in dogs. Taxol has toxicity associated with Cremophor El (polyoxyethylated castor oil) (“Cremophor”), and dogs have a resistance to human albumin, which is found in Abraxane.

 

The first drug to be approved specifically for the treatment of cancer in dogs was Zoetis’ Palladia, a toceranib phosphate tablet, which is indicated for the treatment of mast cell tumors and launched in 2009. While Zoetis does not disclose sales of Palladia, we believe the product is well known to veterinarians.

 

Mammary carcinoma and squamous-cell carcinoma are two of the most common types of solid tumors in dogs. Skin cancers, which include squamous-cell carcinomas, comprise one third of all canine cancers. Mammary tumors are the most common type of cancer in female dogs, accounting for about half of all tumors and affecting up to 25% of female dogs that are not spayed.

 

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Paccal Vet in Malignant High-Grade Solid Tumors in Dogs

 

We evaluated Paccal Vet in an open-label, single arm, dose-escalating clinical field study to determine a clinically safe and effective dose and to evaluate single-dose pharmacokinetics in tumor-bearing dogs. This was our first clinical report of a Cremophor-free formulation of paclitaxel, suggesting successful administration without premedication in dogs. We ran this study as a single-arm study because the objective of this study, and other early phase studies, was to assess appropriate dosage and to assess certain particular safety aspects of Paccal Vet, for which a control group was not required.

 

The study included 27 dogs, with one-quarter of the dogs diagnosed with mast cell tumors, another quarter diagnosed with mammary tumors, and the others diagnosed with lymphoma, squamous cell carcinoma and other types of tumors. The dogs were treated with Paccal Vet for at least three cycles and up to five cycles, with each treatment cycle consisting of separate infusions approximately 21 days apart. The majority of dogs were treated with 150 mg/m2, which is the dose of Paccal Vet used in subsequent studies. We used data from this study to receive conditional approval in mammary carcinoma and squamous cell carcinoma from the FDA.

 

Efficacy was assessed as best overall response rate (“BORR”) during treatment. Response was determined using Response Evaluation Criteria in Solid Tumors (“RECIST”), the standard evaluation method for treatment of solid tumors in animals and humans, for which “complete response” is the disappearance of all target and non-target lesion(s) and no appearance of new lesion(s). “Partial response” is at least a 30% decrease (relative to baseline) of the sum of longest diameter of target lesion, non-progression of non-target lesion, and no appearances of new lesions. Twenty of the 27 dogs (74%) experienced either a complete response (9 dogs) or partial response (11 dogs) at some time during treatment. With regard to safety, Paccal Vet was well tolerated at levels at or below 150 mg/m2. The most common adverse events noted were a reduction in white blood cells, vomiting, diarrhea, fatigue and anorexia, all of which are commonly seen during chemotherapy treatment.

 

Paccal Vet in Mast Cell Tumors in Dogs

 

The safety and efficacy of Paclical for the treatment of grade II or III mast cell tumors in dogs that cannot be safely removed surgically were evaluated in a randomized, masked, controlled, multinational 14-week clinical field study. The objective was to demonstrate clinical superiority of Paccal Vet compared to active control lomustine, an oral chemotherapeutic commonly used for dogs. Efficacy was evaluated by the portion of dogs with a confirmed overall response, defined as complete response or partial response, 14 weeks after four consecutive three-week treatment cycles. This study began in October 2008.

 

In total, 249 dogs were randomly assigned to treatment with either 150 mg/m2 Paccal Vet (168 dogs) administered as a slow intravenous infusion or 70 mg/m2 lomustine (81 dogs) administered orally, every three weeks for four consecutive treatment cycles.

 

The majority of adverse events observed in dogs treated with Paccal Vet involved transient neutropenia (a low number of neutrophils, a form of white blood cell) that was often subclinical. Dogs treated with lomustine experienced elevated levels of liver enzymes as the most common adverse event.

 

The efficacy analysis found a statistically significant difference in favor of Paccal Vet, with a “p value” (the estimated probability of rejecting the hypothesis that there is no difference between the two treatment groups) of less than 0.05, which is the maximum p-value required to conclude a statistically significant result. However, the response rate in both treatment groups was surprisingly low, 1% response in the lomustine group, where there are published results of 42% response, and 7% response in the Paccal Vet group. We have developed several hypotheses to explain these low results, including the fact that dogs with grade III mast cell tumors may already be too ill to undergo further treatment. Additionally, some of the dogs included in the study had several small tumors, which are difficult to measure. It is also possible that the response of mast cell tumors to treatment may have resulted in dogs being taken off treatment too soon. When dogs in which the disease was kept stable were included in a supplementary analysis, BORR was significantly greater (23% versus 10%; p-value = .012) for Paccal Vet compared with lomustine. Paccal Vet-treated dogs were also 3.1 times more likely, compared with lomustine-treated dogs, to have a confirmed BORR at 14 weeks. This study differs from the study described below under the heading “—Paccal Vet Single-Arm Trial in Mast Cell Tumors in Dogs” because in that study, the BORR was assessed at certain pre-selected times during the treatment period, while in this study, the BORR was assessed after four treatment cycles. Because of these suboptimal results, we do not intend to rely on the results from this study for any submission.

 

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Paccal Vet in Mammary Carcinoma

 

We received conditional approval for mammary carcinoma indication from the FDA in February 2014. This approval was based on safety data for Paccal Vet and the limited efficacy data for the indication.

 

Efficacy data relating to mammary carcinoma were obtained from the study with Paccal Vet on malignant high-grade solid tumors. In that study, seven dogs with mammary carcinoma were treated, four of which responded to treatment (one complete response and three partial responses). Furthermore, two of the seven dogs survived over a year after the treatment was completed. In addition to the dogs from the previous study, literature data on three dogs previously treated at University of Wisconsin was added, for a total of 10 cases of mammary carcinoma, of which six responded. We included these data from the University of Wisconsin in accordance with discussions we had with the CVM in order to satisfy the reasonable expectation of effectiveness requirement to obtain conditional approval for Paccal Vet for the mammary carcinoma indication.

 

Paccal Vet in Squamous Cell Carcinoma

 

We also received conditional approval for squamous cell carcinoma indication for Paccal Vet from the FDA in February 2014. This approval was likewise based on safety data for Paccal Vet and limited efficacy data for the indication.

 

The study of Paccal Vet in malignant high-grade solid tumors included only three cases of squamous cell carcinoma, and as this was not enough to show reasonable expectation of efficacy, we conducted a small, exploratory study in dogs with this indication. In this study, 14 dogs with various types of squamous cell carcinoma were treated with Paccal Vet for four cycles. Two of the dogs responded to treatment and another two dogs had prolonged stable disease, which, according to the protocol, was considered a response to treatment. A dog with squamous cell carcinoma had also been treated in a compassionate use program in the U.S., and this dog was also included in the efficacy analysis, which consisted of a total of 18 dogs, with six dogs showing BORR and two dogs having prolonged periods of stable disease.

 

Paccal Vet Single-Arm Trial in Mast Cell Tumors in Dogs

 

We conducted a single-arm, open-label, multi-center, clinical trial to determine the efficacy and safety of Paccal Vet in client-owned dogs with grade II or III mast cell tumors. Mast cell tumors are graded histologically from I to III: grade I tumors are benign and local, curable with surgery alone; grade II tumors are intermediate and approximately 25% of these metastasize; and grade III tumors are advanced with high metastatic potential and short overall survival despite aggressive treatment. We ran this trial as a single-arm trial for ethical purposes – because there was no other approved chemotherapeutic for dogs at the time, there was no most commonly used treatment for the indication. It would have been unethical to administer no treatment or a placebo to a dog diagnosed with cancer for the purpose of establishing comparative results for this study. This study was completed in December 2008.

 

Dogs that received at least one dose of treatment (29 dogs) were included in the analysis of safety, and 28 of those dogs had tumor measurements and were included in an efficacy analysis. The dogs were administered an intravenous dose of 150 mg/m2 of Paccal Vet once every 21 days for three cycles. Clinical safety was assessed by clinicopathological analyses and recording of adverse events. Following the end of the study, the owners were contacted to provide information used to assess progression free survival.

 

BORR at any time during treatment was seen in 54% of dogs whereas complete or partial response was observed in 31% of dogs at the end of the study. It took an average of 247 days from the start of the treatment until the cancer reappeared in the dog. Adverse events were reductions in the number of two types of white blood cells, neutrophils and leucophils. These events, which are common with chemotherapy, were short lasting and seen only sub-clinically (i.e. the dogs did not display any evidence of fever or other symptoms, other than in the blood sample analyses).

 

The difference between this study and the one including 249 dogs called Paccal Vet in Mast Cell Tumors in Dogs is the response rate, BORR. In this study including 29 dogs the BORR is assessed at any time during the treatment period. In the study including 249 dogs the BORR was assessed after 4 treatment cycles.

 

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Paccal Vet Planned Clinical Studies

 

In order to be granted full approval in the United States for mammary carcinoma and squamous cell carcinoma in dogs, we are required to perform field studies to show efficacy of treatment. We plan to conduct randomized, placebo-controlled trials in dogs with mammary carcinoma and squamous cell carcinoma (one trial for each indication), to compare progression free survival in dogs treated with Paccal Vet compared to placebo. The study will enroll approximately 165 dogs. Dogs will be randomized to receive either a 150mg/kg dose of Paccal Vet or placebo in a two-to-one ratio. The treatment period will consist of four cycles of therapy at three week intervals after which the dogs will be monitored until tumor progression. In the meantime, we expect Paccal Vet to remain available for the treatment of mammary carcinoma and squamous cell carcinoma pursuant to the conditional approval we received in February 2014. We initiated the study in the fourth quarter of 2014. We requested and received scientific advice from the EMA and protocol concurrence from the FDA for the protocol of this study and number of dogs studied. The FDA requires that at least 100 dogs be tested, and since we use 2:1 randomization the number of dogs needed was 150. To compensate for dogs that could not be used in the analysis another 10 % was added. EMA does not require a specific minimum number of dogs to be tested, but the number should be based on a hypothesis that is statistically valid. A sample size calculation showed that we would need fewer than 165 dogs.

 

After consultations with the EMA, we have initiated a study of Paccal Vet in no fewer than 50 dogs for the treatment of mast cell tumors. The ongoing trial is also placebo-controlled study designed to evaluate progression free survival in dogs treated with Paccal Vet compared to placebo. Results are expected during the second half of 2015. We are currently planning to use the data from this trial to obtain regulatory approval in Europe in dogs.

 

  

Paclical & Paccal Vet Preclinical Data

 

We conducted a comprehensive program of preclinical testing of Paclical, including several in vitro and in vivo studies. Key findings from our preclinical program include:

 

·In vitro studies showed that the chemotherapeutic activity of Paclical was equal to or more potent than that of Taxol in ten different rat tumor cell lines.

 

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·The pharmacokinetic pattern of paclitaxel was investigated in rats receiving either Taxol or Paclical. Higher concentrations of total paclitaxel were observed after administration of Taxol compared to Paclical, but when studying the unbound concentrations, no obvious difference between the two formulations could be seen.

 

·In a plasma concentration study of 21 dogs receiving 100-150 mg/m2 of paclitaxel as a 30 minute intravenous infusion, the distribution of paclitaxel into the tissue was rapid, and the distribution phase ended within one hour after the start of infusion.

 

·Hematological toxicity of Paclical was studied in rats and found to be similar to Taxol in terms of extent and duration of effect. A strong rebound in the white blood cell count followed the initial decrease, and at days 16 to 17 following a single dose, the white blood cell counts were stabilized at the baseline level.

 

·Repeat dose toxicity studies were performed in rats. The mortality rate at 10 mg/kg Taxol was high and the dose in the 10 mg/kg group was reduced to 5 mg/kg. All animals that received 10 mg/kg of Paclical survived.

 

·The safety of Paclical in dogs has been shown to be consistent with expectations for a chemotherapeutic with bone marrow suppression as the most apparent toxicity. Gastrointestinal disorders such as diarrhea and vomiting have also been commonly observed. None of the severe hypersensitivity reactions, such as anaphylactic shock, reported to occur in humans treated with other formulations of paclitaxel have been observed in dogs.

 

·Toxicity investigations conducted with the excipient XR-17 showed increases in liver enzymes, bile acids and total bilirubin as well as the presence of pigmented Kupffer cells at high doses (4.6-fold and 8.3-fold clinical levels for humans on a mg/m2 and mg/kg basis, respectively). No histological findings of significance were observed in low dose animals. Toxic reactions were not seen until doses reached almost five times higher than the doses given to Paclical patients.

 

Docecal

 

Overview

 

Docecal is our patented formulation of docetaxel, the active ingredient in Taxotere, a widely used chemotherapeutic medication that generated annual worldwide sales of more than $2.8 billion in 2010, when its patent expired. Taxotere contains the solvent polysorbate 80, which is potentially linked to adverse side effects such as acute hypersensitivity and edema. To minimize these effects, patients typically undergo premedication with steroids. Like Paclical, Docecal is free of toxic solvents. We believe Docecal may be able to deliver equal, or potentially greater, amounts of docetaxel as Taxotere without the effects of polysorbate 80 and, if approved, compete with Taxotere and generic versions thereof. Since there are no human clinical studies in the U.S. we are not required to file an IND.

 

Docecal Preclinical Studies

 

The anti-proliferative effects of Docecal were investigated in a panel of six human cancer cell lines and compared with the effects of commercially available Taxotere using a standard cell proliferation assay. For all of the tested cell-lines, Docecal was as effective as Taxotere in inhibiting cell growth.

 

Rats were injected with Docecal once weekly for 28 days with doses of 4.2 mg/kg or 6.0 mg/kg or with Taxotere 4.2 mg/kg. The Docecal group showed Docecal-related signs such as erythema, paleness, wounds on the tails, limpness and local skin reactions seen as dry skin with scale formations in both sexes following both treatments. The effects were most pronounced in the 6 mg/kg group. Changes in hematology, clinical chemistry, organ mass, macroscopic and microscopic findings were seen in both sexes. In the absence of any histological examination in the Docecal 4.2 mg/kg group, the significance of these differences cannot be assessed.

 

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A no-observed-adverse-effect level, or the highest exposure of docetaxel having no adverse effect, was not established in this study with Docecal. However, we believe that the failure to establish a no-observed-adverse-effect level has not hindered the approval process for other APIs used in the treatment of cancer and will not hinder the Docecal approval process.

 

Docecal Planned Studies

 

We plan to apply for permission to initiate a pharmacokinetic study, comparing Docecal with Taxotere, in June of 2015. If successful, we plan to discuss the results and a proposed clinical development plan with both the EMA and the FDA.

 

We will also initiate a study in September or October of 2015 to assess the need for pre-medication and possibly to fulfill the requirements of the Russian authorities in order to obtain market authorization in Russia and the CIS.

 

Doxophos Vet

 

Doxophos Vet Overview

 

Doxophos Vet is a patented formulation of doxorubicin, one of the most effective and commonly used chemotherapeutic agents for the treatment of cancer, which we are developing for the treatment of lymphoma in dogs. Lymphoma is the most common cancer in dogs, and the FDA granted MUMS designation for Doxophos Vet for the indication. Treatment with Doxophos Vet has shown reduced cardiovascular side effects compared to standard treatments with doxorubicin. We completed a dose-finding study in the fourth quarter of 2014 and the results were obtained in June of 2015. The INAD number for Doxophos Vet is 011910, which we requested on March 10, 2010.

 

Doxophos Vet Planned Clinical Trials

 

Upon determining the dose in the dose ranging study, we initiated a proof of concept study in dogs with lymphoma during the first quarter of 2015, which as a result of the MUMS designation, may enable us to apply for a conditional approval, as we did for Paccal Vet. The aim of the study will be to assess the response rate in dogs with lymphoma, but will also monitor progression to estimate progression free survival.

 

A large field study with Doxophos Vet is needed to obtain full approval, and this study is planned to start following completion of the proof of concept study and discussions with FDA and EMA.

 

Doxophos

 

Doxophos Overview

 

Doxophos is a proprietary formulation of doxorubicin. Despite the efficacy of doxorubicin, significant cardiovascular toxicity, including irreversible cardiomyopathy, has been observed and the cumulative dose should not exceed 550 mg/m². We are planning to seek permission in September of 2015 to initiate a pharmacokinetic study in humans in December of 2015 or early 2016 to evaluate whether doxorubicin in our proprietary formulation could have potential benefits over existing therapies. Since there are no human clinical studies in the U.S. we are not required to file an IND.

 

Doxophos Market

 

The two leading doxorubicin-based products are Adriamycin and Doxil, or Caelyx when marketed outside of the U.S. Doxil is a lipid, or fat, encapsulation of doxorubicin introduced as a replacement for Adriamycin. Treatment with Doxophos Vet has shown reduced cardiovascular side effects as compared to standard treatments with doxorubicin.

 

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Doxophos Preclinical Trials

 

We conducted a preclinical trial in which rats injected with six human cancer cell lines were administered Doxophos as compared to standard doxorubicin. Doxophos was as effective in inhibiting cell growth as standard doxorubicin in all of the tested cell lines and had a comparable pharmacokinetic profile in rats.

 

Repeat dose toxicity in rats showed that the incidence and severity of the clinical effects were similar in the Doxophos and doxorubicin exposed rats and less frequent or less severe in rats receiving the lower dose of Doxophos. Expected changes were observed in most hematology parameters and were similar for Doxophos and standard doxorubicin treated rats.

 

Rats treated with standard doxorubicin had a higher incidence of fluid-filled abdomens (ascites), which could be a sign of (right sided) heart failure. However, histopathological examination failed to show any differences between the two treatments and a lower cardiotoxicity potential of Doxophos compared to standard doxorubicin was thus not seen in this study.

 

Doxophos Planned Clinical Trials

 

As stated above, we are planning to seek permission in September of 2015 to initiate a pharmacokinetic study in humans in December of 2015 or early 2016, comparing Doxophos with generic Adriamycin and Doxil. The results will be discussed with both the EMA and the FDA, and clinical development will be based on these discussions.

 

OAS-19

 

OAS-19 Overview

 

Historically, chemotherapeutic agents were used as single agents. However, combination therapies have become standard treatment for a number of cancers, such as ovarian cancer, first line breast cancer, prostate cancer and lung cancer. OAS-19 is an XR-17 based combination of two widely-used chemotherapy drugs in a single micelle. OAS-19 applies a dual chemotherapeutic agent encapsulation and release mechanism in one infusion and may provide us with a new platform for further product candidate development. Since there are no human clinical studies in the U.S. we are not required to file an IND.

 

OAS-19 Preclinical Studies

 

Male and female rats received four intravenous administrations of OAS-19, one week apart, at the doses of 0 (micelle excipient only), 4.2, 6 and 8.5 mg/kg/week. Mortality was noted in highly-dosed males only, while effects on food consumption and body weight gain were observed at all doses and in both genders, with a dose-dependent relationship. Treatment-related changes were noted almost at all doses, albeit without a clear dose-dependent relationship, in organs/tissues of the hemolymphoietic, gastrointestinal, urinary, genital, musculoskeletal, nervous and integumentary systems. The toxic effects observed in target organs were those expected to occur after administration of the underlying agents included in OAS-19.

 

Under the applied conditions, 6 mg/kg was considered the maximum tolerated dose, while the lowest observed adverse effect level (LOAEL) was the lowest tested dose of 4.2 mg/kg/week.

 

The dose to be used in humans will be established in the first clinical trial, but it is estimated that 6 mg/kg corresponds to six to eight times the human dose.

 

OAS-19 Planned Studies

 

We plan to develop a clinical program for this product candidate.

  

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Competition

 

Our industry is highly competitive and subject to rapid and significant technological change. While we have significant development experience and scientific knowledge, we may face competition from both large and small pharmaceutical and biotechnology companies, including specialty pharmaceutical and veterinary pharmaceutical companies and generic drug companies, as well as academic institutions, government agencies and research institutions, among others.

 

Our competition will be determined in part by the potential indications for which our products are developed and ultimately approved by regulatory authorities. It is likely that the timing of market introductions of some of our potential products or our competitors’ products will be an important competitive factor. Accordingly, the speed with which we can develop our compounds, conduct preclinical studies and clinical trials to obtain approval and manufacture or obtain supplies of commercial quantities of any approved products should also be important competitive factors. We expect that competition among products approved for sale will be based on additional factors, such as product efficacy, safety, reliability, availability, price and patent position.

 

Human Health

 

We believe that Paclical will compete, directly or indirectly, with Bristol-Myers Squibb’s Taxol and its generic equivalents, Celgene’s Abraxane and other cancer therapies, including alternative formulations of paclitaxel, or other chemotherapeutic agents, that have been or are being developed by other pharmaceutical and biotechnology companies.

 

Animal Health

 

We expect that Paccal Vet will face competition from Palladia, made by Zoetis, Inc., and Masivet, made by AB Science S.A. We expect that Doxophos Vet will face competition from AT-004 and AT-005, made by Aratana Therapeutics, Inc., and that both Paccal Vet and Doxophos Vet will compete with the off-label use of chemotherapeutic drugs for humans.

 

Since the development and commercialization of new veterinary medicines is highly competitive, we expect considerable competition from major pharmaceutical, biotechnology and specialty animal health companies. We are also aware of several smaller early stage companies that are developing products for use in the pet therapeutics market.

 

Strategic Alliances and Collaborations

 

We have entered into three separate agreements with established pharmaceutical companies for our products. Each agreement provides the pharmaceutical company with an exclusive right in a defined geographic territory to market one or more products in all indications. In return, we receive royalty payments or a profit participation, as well as milestone payments, and we retain the exclusive right with respect to the manufacture and supply of the product during the commercial life of the product. The various agreements generally are terminable upon a material breach or insolvency of either of the parties. Under all of the agreements, we supply the products at an agreed upon formula related to our production cost (subject to annual adjustment) and the pharmaceutical company establishes the price at which the products are sold in the territory.

 

Nippon Zenyaku Kogyo, Japan

 

We entered into a development, supply and exclusive license agreement with Nippon Zenyaku Kogyo, Co. Ltd. (“Nippon”) in April 2010 (the “Nippon Agreement”). The Nippon Agreement grants Nippon the exclusive right to market Paccal Vet in Japan. The initial term of the Nippon Agreement is the later to occur of (i) 10 years from the date of the Nippon Agreement, or (ii) upon the expiration of the patent rights granted under the Nippon Agreement. Nippon is solely responsible for all sales and marketing costs as well as the requisite clinical trials in order to obtain marketing approval for Paccal Vet in Japan.

 

We receive royalties of (i) 27% of Nippon’s gross profits for net sales up to $7.5 million and (ii) 36% of Nippon’s gross profits for net sales above $7.5 million. The Nippon Agreement also includes various milestone payments, the first of which, €0.55 million, we received upon entering into the Nippon Agreement. The remaining milestone payments are payable upon our achieving certain marketing approvals and net sales thresholds, including €0.7 million upon marketing authorization, €1.0 million when annual net sales reach $7.5 million and €1.0 million when annual net sales reach $12.5 million. We may be required to repay the first milestone payment if marketing approval cannot be obtained or if we are guilty of a breach of contract that results in the termination of the Nippon Agreement or the withdrawal of the product from the market. We may also be liable to compensate Nippon for costs incurred in relation to obtaining marketing approval.

 

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We are responsible to Nippon for maintaining the quality of the product, but Nippon is solely responsible for pharmacovigilance. The Nippon Agreement may be terminated by either party if the other party commits a material breach or becomes insolvent. In the event that the Nippon Agreement is terminated, regardless of which party terminates the agreement and the grounds for termination, the marketing approval, if received in Japan, will be transferred to us.

 

Medison Pharma, Israel

 

We entered into a supply and exclusive license agreement with Medison Pharma, Ltd. (“Medison”) in May 2011 (the “Medison Agreement”). The Medison Agreement grants Medison exclusive license and distribution rights for Paclical in Israel and Turkey. The initial term of the Medison Agreement is (i) ten years from the first commercial sale of Paclical in Israel or Turkey, or (ii) the expiration of our patent rights granted under the Medison Agreement, whichever occurs later. The Medison Agreement provides that Medison will use its commercially reasonable best efforts to launch Paclical in Israel and Turkey within six months of Paclical obtaining marketing authorization, and will assume sole responsibility for sales and marketing costs. We are responsible under the Medison Agreement for obtaining marketing approval for Paclical in Israel and Turkey, while Medison is responsible for obtaining reimbursement approval.

Medison has agreed to purchase specified, minimum quantities of Paclical once all approvals have been obtained. Should the minimum purchase requirements not be met, we have the right to terminate exclusivity. We receive royalties of (i) 25% of Medison’s net sales for net sales up to €7.5 million and (ii) 30% of Medison’s net sales for net sales above €7.5 million. The Medison Agreement also includes milestone payments, the first of which, €0.2 million, we received upon entering into the Medison Agreement, and the second of which, €0.2 million, we are entitled to receive upon the grant of marketing authorization by the European Commission. We are required to repay 50% of the initial milestone payment if marketing authorization is not received by 2015.

 

We are responsible under the Medison Agreement to maintain the quality of the product, but Medison is solely responsible for pharmacovigilance. The Medison Agreement may be terminated by us if Medison fails to launch Paclical in Israel and Turkey within six months of Paclical obtaining marketing authorization. The Medison Agreement may also be terminated by either party if the other party fails to remedy a material breach or becomes insolvent.

 

Pharmasyntez, Russia

 

We entered into a supply and exclusive marketing, sales and distribution agreement with the Russian pharmaceutical company Pharmasyntez in February 2013 (the “Pharmasyntez Agreement”). The Pharmasyntez Agreement grants Pharmasyntez exclusive license and distribution rights for Paclical in Russia and the CIS, as well as Ukraine, Georgia and Turkmenistan. The initial term of the Pharmasyntez Agreement expires five (5) years from the date Paclical receives marketing authorization in Russia. Pharmasyntez will have sole responsibility under the Pharmasyntez Agreement for sales and marketing costs in Russia and the CIS. We are responsible for obtaining registration approval in Russia, including performing any clinical research required to market Paclical. Pharmasyntez pays all costs relating to marketing authorization approval in the CIS, including any necessary clinical trials.

 

Pharmasyntez has agreed to purchase specified minimum quantities of the product, and should the minimum purchase requirements not be met, we have the right to terminate exclusivity. The Pharmasyntez Agreement provides that all profits from the sale of Paclical in Russia and the CIS be split evenly between us and Pharmasyntez. The Pharmasyntez Agreement defines profits as gross sales minus (i) our supply price (which are our production costs, subject to annual adjustment) and (ii) Pharmasyntez’s distribution costs. We are liable to Pharmasyntez for maintaining the quality of the product and for pharmacovigilance.

 

The Pharmasyntez Agreement may be terminated by either party if the other party commits a material breach or becomes insolvent. In the event the Pharmasyntez Agreement is terminated, regardless of which party terminates the agreement and the grounds for termination, the marketing approval, if received in any of the territories, will be transferred to us.

 

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Intellectual Property

 

Our success depends in significant part on our ability to protect the proprietary nature of XR-17, our product and product candidates, technology and know-how, to operate without infringing on the proprietary rights of others, and to prevent others from infringing on our proprietary rights. We have sought, and plan to continue to seek, patent protection in the U.S., the EU and other countries for our proprietary technologies. Our intellectual property portfolio consists of our trademark-protected product Paccal Vet and our product candidates Paclical, Docecal, Doxophos Vet, and Doxophos. All of these drugs are based on our excipient model developed with nanotechnology and are protected by patents in all countries which we consider to be important. As of March 31, 2015, we own 91 granted patents and have 22 pending patent applications worldwide. Within the U.S., we already have 11 issued patents with one further pending patent application under active prosecution. All of our patents are part of one or more of nine different patent families. A patent family is a collection of patents and patent applications, regional and national, which cover an invention or a group of related inventions.

 

See below for information regarding the patent families currently used in our product and product candidates.

 

Patent families  Products patent
family applies to
  Status
(US)
  Status
(EU)
   Status
(Japan)
    Status
(Israel)
    Status
(Eurasia)
    Expiration
date
 
Taxol containing compositions  Paccal Vet, Paclical, Docecal  Granted  Granted   Granted    -    -    2022 
Anticancer compositions  Paccal Vet, Paclical, Docecal  Granted  Granted   -    -    -    2022 
Water insoluble  Paccal Vet, Paclical, Docecal  Granted  Pending