Vaxart, Inc.: Form 10-Q for the period ended Mar 31, 2016
Filed with the SEC on May 10, 2016 and accepted by EDGAR at May 10, 2016, 14:02 ET.
Management's discussion and analysis
As filed, 34,673 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.
FORWARD LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In most cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “would,” “expect,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “project,” “predict,” “forecast,” “potential,” “likely” or “possible”, as well as the negative of such expressions, and similar expressions intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements relating to:
- the time frames in which we plan to report top line data from our Phase 2b SPIRITUS clinical trial for vapendavir;
- the anticipated timing of reporting top-line data from the Phase 2a challenge efficacy clinical trial for BTA585;
- the anticipated timing of reporting top-line data form the Phase2 clinical trial for BTA074;
- our anticipation that royalty revenue from net sales of Relenza® may decrease in the future due to the expiration of patents for Relenza® in multiple countries and royalty revenues from net sales of Inavir® may decrease in future due to the sale of a portion of the royalty rights of Inavir®;
- our anticipation that we will generally incur net losses from operations in the future due to our intention to continue to support the clinical development of our product candidates;
- our future financing requirements, the factors that may influence the timing and amount of those requirements and our ability to fund them;
- the number of months that our current cash, cash equivalents, investments and anticipated future proceeds from existing royalty-bearing license agreements will allow us to operate; and
- our plan to continue to finance our operations with our existing cash, cash equivalents, investments and proceeds from existing or potential future royalty-bearing licenses, collaborative research and development arrangements, or through future equity and/or asset or debt financings or other financing vehicles.
Various important factors could cause actual results, performance, events or achievements to materially differ from those expressed or implied by forward-looking statements, including the U.S. Food and Drug Administration (“FDA”) or a similar regulatory body in another country, a data safety monitoring board, or an institutional review board delaying, limiting, suspending or terminating any of the Company’s clinical development programs at any time for a lack of safety, tolerability, anti-viral activity, commercial viability, regulatory or manufacturing issues, or any other reason whatsoever; the Company's ability to secure, manage and retain qualified third-party clinical research, preclinical research, data management and contract manufacturing organizations upon which it relies to assist in the design, development, implementation and execution of the clinical and preclinical development of all its product candidates; and these third-party organizations fulfilling their contractual obligations on a timely and satisfactory basis; the safety or efficacy data from planned or ongoing future preclinical and clinical studies of any of its product candidates not supporting the clinical development of that product candidate; the successful enrollment of the requisite number of study participants on a timely basis; the Company’s ability to comply with applicable government regulations in various countries and regions in which we are conducting, or expect to conduct, clinical trials; the Company’s ability to retain and recruit sufficient staff, including key execute management and employees, to manage our business; the Company’s ability to maintain, protect or defend its proprietary rights from unauthorized use by others, or not infringe on the intellectual property rights of others; our ability to successfully manage our expenses, operating results and financial position in line with our plans and expectations; the condition of the financial equity and debt markets and our ability to raise sufficient funding in such markets; changes in the general economic business or competitive conditions in the industry or with respect to our product candidates; and other cautionary statements contained elsewhere in this Quarterly Report on Form10-Q and in the Company’s Annual Report on Form 10-K for the year ended June 30, 2015, as filed with the U.S. Securities and Exchange Commission on September 11, 2015.
There may be events in the future that we are unable to predict accurately, or over which we have no control. You should completely read this Form 10-Q and the documents that we reference herein that have been filed or incorporated by reference as exhibits and with the understanding that our actual future results may be materially different from what we expect. Our business, financial condition, results of operations, and prospects may change. We may not update these forward-looking statements, even though our situation may change in the future, unless we have an obligation under the federal securities laws to update and disclose material developments related to previously disclosed information. We qualify all of the information presented in this Form 10-Q, and particularly our forward-looking statements, by these cautionary statements.
Aviragen is a registered trademark of Aviragen Therapeutics Inc., Relenza ® is a registered trademark of GlaxoSmithKline plc, and Inavir ® is a registered trademark of Daiichi Sankyo Company, Ltd.
References to “we,” “us,” and “our” refer to Aviragen Therapeutics, Inc. and its subsidiaries.
The following is a discussion and analysis of the major factors contributing to our results of operations for the three and nine months ended March 31, 2016, and our financial condition at that date, and should be read in conjunction with the financial statements and the notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q.
Company Overview
We are focused on the discovery and development of direct-acting antivirals to treat infections that have limited therapeutic options and affect a significant number of patients globally. We have three product candidates in active clinical development: These include vapendavir, an oral treatment for human rhinovirus (“HRV”) upper respiratory infections in moderate-to-severe asthmatics currently being evaluated in the Phase 2b SPIRITUS trial; BTA585, an oral fusion protein inhibitor that has received Fast Track designation by the FDA, in Phase 2 development for the treatment and prevention of respiratory syncytial virus (“RSV”) infections; and BTA074, a topical antiviral treatment in Phase 2 development for condyloma caused by human papillomavirus types 6 & 11.
Although several of our influenza product candidates have been successfully developed and commercialized to-date by other larger pharmaceutical companies under license, collaboration or commercialization agreements with us, we have not independently developed or received regulatory approval for any product candidate, and we do not currently have any sales, marketing or commercial capabilities. Therefore, it is possible that we may not derive any significant product revenues from any product candidates that we are developing now, or may develop in the future. We expect to incur losses for the foreseeable future as we intend to support the clinical and preclinical development of our product candidates.
We would expect our royalty revenues to decrease in the future due to the expiration of the Relenza® patents and the sale of a portion of our royalty rights of Inavir®, which occurred in April of 2016. Further, we anticipate that our net losses will increase in the future based on the ongoing clinical development of vapendavir, BTA585 and BTA074.
We plan to continue to finance our operations with (i) our existing cash, cash equivalents, and investments (ii) proceeds from existing or potential future royalty-bearing licenses, collaborative research and development arrangements, (iii) future equity and/or forms of asset and debt financing or (iv) other financing arrangements. Our ability to continue to support our operations is dependent, in the near-term, upon our successful management of our cash resources, our continuing to receive royalty revenue under our existing licenses, our ability to enter into future collaboration, license or commercialization agreements, the successful development of our product candidates, our ability to execute future financings, if needed, and ultimately, upon the approval of our products for sale and achievement of positive cash flows from operations on a consistent basis. There can be no assurance that additional capital or funds will be available on terms acceptable to us, if at all, or that we will be able to enter into collaboration, license or commercialization agreements in the future, or that we will ever generate significant product revenue and become operationally profitable on a consistent basis.
On May 5, 2016, we reported the following:
Recent Corporate Highlights
Completed Royalty Deal with Healthcare Royalty Partners for Proceeds of $20 Million.
In April 2016, received gross proceeds of $20 million from HealthCare Royalty Partners from the sale of an undisclosed portion of the Company’s royalty rights related to Inavir®, an inhaled neuraminidase inhibitor that is approved in Japan for the treatment and prevention of influenza.
Transitioned Company Name to Aviragen Therapeutics, Inc. (NASDAQ:AVIR) from Biota Pharmaceuticals, Inc. The name change reflects the strategic shift in the organization’s prior focus on drug discovery and early-stage licensing to clinical development of next generation direct-acting antivirals to treat infections that have limited therapeutic options.
Announced Sale of Antibiotic Assets to Spero Therapeutics. Completed the sale of assets related to the Company’s broad spectrum antibiotic program to a newly formed subsidiary of Spero Therapeutics, LLC, a Cambridge-based biopharmaceutical company founded to develop novel therapies for the treatment of bacterial infections.
Recent Clinical Highlights
Initiated Phase 2a Efficacy Study of BTA585 for the Treatment of RSV Infections. Reported the initiation of a double-blind, placebo-controlled, Phase 2a trial that is designed to evaluate the safety, pharmacokinetics, and antiviral activity of orally-dosed BTA585 in healthy volunteers challenged intranasally with RSV. The primary endpoint of the study is reduction in viral load among subjects who test positive for RSV prior to dosing.
Reported Positive Results from Phase 1 Trial for RSV Antiviral BTA585. Reported top-line safety and pharmacokinetic data from a Phase 1 multiple ascending dose (“MAD”) trial of BTA585. Results from the MAD trial indicated BTA585 was generally well tolerated at all dose levels; there were no serious adverse events, and no drug-related clinically-significant adverse changes were observed in either ECGs or clinical laboratory values.
Received Fast Track Designation for RSV Antiviral BTA585. Granted Fast Track designation by the FDA for BTA585, an oral fusion inhibitor, for the treatment of RSV infections in infants, young children and adults. The FDA Fast Track process is designed to expedite the development and review of drugs for the treatment of serious or life-threatening conditions and which demonstrate potential to address unmet medical needs.
Commenced Dosing in Phase 2 Trial of BTA074 for Topical Treatment of Condyloma. Dosed first subject in a Phase 2 double-blind, randomized, placebo-controlled trial to evaluate the safety, tolerability and efficacy of BTA074 5% gel in male and female patients with condyloma, or anogenital warts, caused by human papillomavirus (“HPV”) types 6 & 11. A delay in the availability of clinical trial material required to resupply the initial clinical sites is expected to result in a delay in the availability of top-line data of the trial until the second half of 2017. To minimize the delay, we are in the process of identifying new clinical sites for participation in the Phase 2 trial.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
Management’s Discussion and Analysis of Results of Operations discusses our financial results, which (except to the extent described in the Notes thereto) have been presented in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The preparation of financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.
We base our estimates and judgments on historical experience, current economic and industry conditions, and various other factors that we believe to be reasonable under the circumstances. This forms the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We believe there have been no changes to our critical accounting policies that require significant judgment and estimates as discussed in detail in our 2015 annual 10-K filing:
- Use of estimates
- Revenue recognition
- Accrued expenses
- Share-based compensation
Recent Accounting Standards
In November 2015, the Financial Accounting Standards Board (“FASB”) issued guidance on the balance sheet classification of deferred taxes which eliminates the current requirement to present deferred tax assets and liabilities as current and noncurrent in a classified balance sheet and now requires entities to classify all deferred tax assets and liabilities as noncurrent. This guidance is effective for the Company’s fiscal year ended September 2018. Early adoption is permitted. We prospectively adopted the guidance immediately which resulted in the offset of $0.5 million of deferred tax assets and liabilities from the condensed consolidated balance sheet at December 31, 2015. We did not make any changes to prior periods.
In August 2014, the FASB issued authoritative accounting guidance related to management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and to provide related footnote disclosures. Management’s evaluation should be based on relevant conditions and events that are known and reasonably knowable at the date that the financial statements are issued. In doing so, the amendments should reduce diversity in the timing and content of footnote disclosures. This guidance is effective for public and non-public entities for annual periods ending after December 15, 2016, and interim periods thereafter. Early adoption is permitted. We are currently assessing the expected impact that this Accounting Standards update will have on the consolidated financial statements.
In May 2014, the FASB issued authoritative accounting guidance related to revenue from contracts with customers. This guidance is a comprehensive new revenue recognition model that requires a company to recognize revenue to depict the transfer of goods or services to a customer at an amount that reflects the consideration it expects to receive in exchange for those goods or services. This guidance is effective for annual reporting periods beginning after December 15, 2016 and early adoption is not permitted. We will adopt this guidance on July 1, 2017. Companies may use either a full retrospective or a modified retrospective approach to adopt this guidance. We are evaluating which transition approach to use and its impact, if any, on the consolidated financial statements.
In January 2016, the FASB issued guidance related to financial instruments - overall recognition and measurement of financial assets and financial liabilities. The guidance enhances the reporting model for financial instruments, which includes amendments to address aspects of recognition, measurement, presentation and disclosure. The update to the standard is effective for public companies for interim and annual periods beginning after December 15, 2017. We are currently evaluating the impact that the standard will have on the consolidated financial statements and will adopt this standard as of January 1, 2018.
In February 2016, the FASB issued new guidance on leases. This guidance replaces the prior lease accounting guidance in its entirety. The underlying principle of the new standard is the recognition of lease assets and lease liabilities by lessees for substantially all leases, with an exception for leases with terms of less than twelve months. The standard also requires additional quantitative and qualitative disclosures. The guidance is effective for interim and annual reporting periods beginning after December 15, 2018, and early adoption is permitted. The standard requires a modified retrospective approach, which includes several optional practical expedients. We are currently evaluating the impact that this guidance will have on the consolidated financial statements.
In March 2016, the FASB issued guidance on compensation - stock compensation: improvements to employee share- based payment accounting as part of the FASB simplification initiative. The new standard provides for changes to accounting for stock compensation including 1) excess tax benefits and tax deficiencies related to share based payment awards will be recognized as income tax expense in the reporting period in which they occur; 2) excess tax benefits will be classified as an operating activity in the statement of cash flow; 3) the option to elect to estimate forfeitures or account for them when they occur; and 4) increase tax withholding requirements threshold to qualify for equity classification. The guidance is effective for public companies for annual periods, and interim periods within those annual periods, beginning after December 15, 2016, and early adoption is permitted. We are currently evaluating the impact that the guidance will have on the consolidated financial statements.
Results of Operations for the Three months ended March 31, 2016 and March 31, 2015
Summary. For the three months ended March 31, 2016, we reported a net loss of $5.2 million, as compared to a net income of $1.2 million in the same period of the prior fiscal year. Basic and diluted net loss per share was $0.14 for the three month period ended March 31, 2016, as compared to a basic and diluted net income per share of $0.03 in the same period of 2015. The following commentary provides details underlying changes from last year in the major line items of our statement of operations:
Revenue. Revenue decreased to $5.3 million for the three months ended March 31, 2016 from $5.9 million for the same period in 2015. The following table summarizes the key components of our revenue for the three months ended March 31, 2016 and 2015:
(in millions)
| Three Months Ended March 31, 2016 | 2015 | |
|---|---|---|
| Royalty revenue – Relenza® | $1.7 | $3.0 |
| – Inavir® | 3.6 | 2.5 |
| Revenue from services | - | 0.4 |
| Total revenue | $5.3 | $5.9 |
18
Royalty revenues decreased primarily due to a reduction in Relenza® government stockpiling orders, which were largely offset by higher royalties from Inavir® sales in Japan. Revenue from services decreased due to a reduction in contract service revenue related to the cancellation of our contract with BARDA in May 2014.
Cost of Revenue. Cost of revenue decreased to zero for the three months ended March 31, 2016 from $0.3 million for the same period in 2015. Direct preclinical, clinical and product development expense in 2015 were incurred for the development of LANI under the BARDA contract, which has since been terminated.
Research and Development Expense. Research and development expense increased to $8.5 million for the three months ended March 31, 2016 from $4.8 million for the same period in 2015. The following table summarizes the components of our research and development expense for the three months ended March 31, 2016 and 2015.
(in millions)
| Three Months Ended March 31, 2016 | 2015 | |
|---|---|---|
| Direct preclinical, clinical and product development expenses | $7.1 | $2.7 |
| Salaries, benefits and share-based compensation expenses | 1.1 | 1.2 |
| Other expenses | 0.2 | 0.1 |
| Depreciation and facility related expenses | 0.1 | 0.8 |
| Total research and development expense | $8.5 | $4.8 |
Direct preclinical, clinical and product development expense increased largely due to ongoing clinical costs associated with the Phase 2b SPIRITUS clinical trial for vapendavir, the introduction of BTA585 into clinical trials this year, including the Phase 1 SAD and MAD and startup expenses for Phase 2a challenge trial that was initiated in April 2016, and expenses for the Phase 2 clinical trial for BTA074 that was initiated in February 2016. Salaries, benefits and share-based compensation decreased due to lower staff-related benefit expenses. Depreciation and facility related expenses decreased primarily due to the closure of our early-stage research facility in March 2015.
General and Administrative Expense. General and administrative expense decreased to $2.3 million for the three months ended March 31, 2016 from $3.2 million for the same period in 2015. The following table summarizes the components of our general and administrative expense for the three months ended March 31, 2016 and 2015.
(in millions)
| Three Months Ended March 31, 2016 | 2015 | |
|---|---|---|
| Salaries, benefits and share-based compensation expenses | $1.2 | $1.6 |
| Professional and legal fees expenses | 0.3 | 0.8 |
| Other expenses | 0.8 | 0.8 |
| Total general and administrative expense | $2.3 | $3.2 |
Salaries, benefits and share-based compensation decreased primarily due to lower staff-related benefit expenses. Professional and legal expense decreased primarily due to the absence of fees incurred as result of the acquisition of BTA074 in 2015.
Foreign Exchange Loss (Gain), net. Foreign exchange changed from a gain of $3.7 million in March 31, 2015 to a gain of $0.3 million for three months ended March 31, 2016. The positive impact on foreign exchange on our statement of operations in both periods was due to fluctuations in foreign currency exchange rates versus the U.S. dollar, largely related to the Australian dollar. We re-measure all of our foreign assets and liabilities at the period-end exchange rate and the net effect of these re-measurements is shown as a foreign currency loss or gain.
Results of Operations for the Nine months ended March 31, 2016 and March 31, 2015
Summary. For the nine months ended March 31, 2016, we reported a net loss of $18.4 million, as compared to a net income of $0.8 million in the same period of the prior fiscal year. Basic and diluted net loss per share was $0.48 for the nine month period ended March 31, 2016, as compared to a basic and diluted net income per share of $0.02 in the same period of 2015. The following commentary provides details underlying changes from last year in the major line items of our statement of operations:
Revenue. Revenue decreased to $8.8 million for the nine months ended March 31, 2016 from $20.5 million for the same period in 2015. The following table summarizes the key components of our revenue for the nine months ended March 31, 2016 and 2015:
(in millions)
| Nine Months Ended March 31, 2016 | 2015 | |
|---|---|---|
| Royalty revenue – Relenza® | $4.5 | $7.3 |
| – Inavir® | 4.3 | 4.7 |
| Revenue from services | - | 8.5 |
| Total revenue | $8.8 | $20.5 |
Royalty revenue decreased primarily due to a larger Relenza® government stock pile order received last year in 2015 and lower seasonal sales of Relenza® and Inavir® in 2016 due to a mild flu season as compared to last year. Revenue from services decreased due to a reduction in contract service revenue related to the cancellation of our contract with BARDA in May 2014.
Cost of Revenue. Cost of revenue decreased to zero for the nine months ended March 31, 2016 from $3.6 million for the same period in 2015. Cost of revenue in 2015 was incurred for the development of LANI under the BARDA contract, which has since been terminated.
Research and Development Expense. Research and development expense increased to $20.4 million for the nine months ended March 31, 2016 from $14.5 million for the same period in 2015. The following table summarizes the components of our research and development expense for the nine months ended March 31, 2016 and 2015.
(in millions)
| Nine Months Ended March 31, 2016 | 2015 | |
|---|---|---|
| Direct preclinical, clinical and product development expenses | $16.5 | $7.2 |
| Salaries, benefits and share-based compensation expenses | 3.1 | 4.7 |
| Other expenses | 0.6 | 0.6 |
| Depreciation and facility related expenses | 0.2 | 2.0 |
| Total research and development expense | $20.4 | $14.5 |
Direct preclinical, clinical and product development expense increased largely due to the ongoing costs of the Phase 2b SPIRITUS clinical trial for vapendavir, the introduction of BTA585 into clinical trials this year, including the Phase 1 SAD and MAD and startup expenses for Phase 2a challenge trial that was initiated in April 2016, and expenses for the Phase 2 clinical trial for BTA074 that was initiated in February 2016. Salaries, benefits and share-based compensation, as well as depreciation and facility related expenses decreased primarily due to the closure of our early-stage research facility in March 2015.
General and Administrative Expense. General and administrative expense decreased to $6.7 million for the nine months ended March 31, 2016 from $8.2 million for the same period in 2015. The following table summarizes the components of our general and administrative expense for the nine months ended March 31, 2016 and 2015.
(in millions)
| Nine Months Ended March 31, 2016 | 2015 | |
|---|---|---|
| Salaries, benefits and share-based compensation expenses | $3.7 | $4.4 |
| Professional and legal fees expenses | 0.9 | 1.6 |
| Other expenses | 2.1 | 2.2 |
| Total general and administrative expense | $6.7 | $8.2 |
Salaries, benefits and share-based compensation decreased primarily due to a reduction in administrative personnel related to our early-stage research facility closure in March 2015. Professional and legal expense primarily decreased to the absence of fees incurred as result of the acquisition of BTA074 in 2015.
Foreign Exchange Loss (Gain), net. The impact of foreign exchange changed from a gain of $6.5 million in 2015 to a loss of $0.2 million in 2016 due to fluctuations in foreign currency exchange rates versus the U.S. dollar, largely related to the Australian dollar. The vast majority of our cash holdings are held in the U.S. dollar. We re-measure all of our foreign assets and liabilities at the period-end exchange rate and the net effect of these re-measurements is shown as a foreign currency loss or gain.
LIQUIDITY AND CAPITAL RESOURCES
For the nine months ended March 31, 2016, cash and cash equivalents decreased by $14.8 million. This decrease was primarily the result of our operating activities, offset in part by the receipt of accounts receivable during the period and cash provided by our investing activities.
Net cash used by operating activities was $15.2 million for the nine months ended March 31, 2016, which reflected our net loss during the period of $18.4 million, partially offset by a net decrease in operating assets of $1.6 million and non-cash charges for share-based compensation of $1.6 million.
Our net loss resulted largely from our funding of research and development activities including conducting clinical and preclinical studies, manufacturing and formulation of our product candidates, as well as ongoing general and administrative expenses offset in part by our royalty revenues. The net changes in operating assets and liabilities reflects a $2.5 million decrease in accounts receivable, offset in part by a $0.8 million increase in prepaid expenses and a $0.1 million decrease in accounts payable and accrued expenses.
Net cash provided by investing activities during the nine months ended March 31, 2016 consisted of the maturity of $14.9 million of investments, offset in part by the purchase of $13.5 investments and capital expenditures of $0.1 million.
Net cash used in financing activities during the nine months ended March 31, 2016 consisted of $0.2 million for payment on a note payable.
At March 31, 2016, our cash and cash equivalents totaled $30.6 million, not including our short and long-term investments of $19.4 million. Our cash and cash equivalents are currently held in the form of short-term deposits with large U.S. banks. Our short-term and long-term investments consist primarily of U.S. treasury securities, U.S. government agency securities, certificates of deposit and corporate securities.
Our future funding requirements are difficult to determine and will depend on a number of factors, including:
- the variability of future royalty revenue we may receive from existing royalty-bearing license agreements, including the partial monetization of Inavir royalties in April 2016;
- the development timelines and plans for our product candidates, including any changes to those timelines, plans or our strategy;
- the variability, timing and costs associated with conducting clinical trials for our product candidates, the rate of enrollment in such clinical trials, and the results of these clinical trials:
- the variability, timing and costs associated with conducting preclinical studies, and the results of those studies;
- the cost of scaling up, formulating and manufacturing preclinical and clinical trial materials to evaluate our product candidates;
- whether we receive regulatory approval to advance or begin the clinical development of our product candidates in a timely manner, if at all;
- the cost and time to obtain regulatory approvals required to advance the development of our product candidates;
- the scope and size of our research and development efforts;
- the size and cost of our general and administrative function we need to manage our operations, including the infrastructure to support being a publicly-traded company; and
- the cost of filing, prosecuting, and enforcing patent and other intellectual property claims.
Based on our current strategy and operating plan, and considering the potential costs associated with advancing the clinical and preclinical development of our product candidates, we believe that our existing cash and cash equivalents of $30.6 million, plus our liquid investments of $19.4 million as of March 31, 2016, along with the $20.0 million proceeds from the sale of a portion of our royalty interest in Inavir® and anticipated proceeds from existing royalty-bearing licenses will enable us to operate for a period of at least 12 months from March 31, 2016. As part of the sale of a portion of our royalty interest in Inavir®, we will retain all of the $3.6 million third quarter royalty payment anticipated to be paid in May 2016, except for $1.25 million, which will be paid to HealthCare Royalty Partners.
We currently do not have any commitments for future funding, nor do we anticipate that we will generate significant revenue, aside from existing revenue from royalty-bearing arrangements. Therefore, in order to meet our anticipated liquidity needs beyond 12 months to support the development of our product candidates and operations, or possibly sooner in the event we enter into other transactions or revise our strategy or development plans, we may need to raise or secure additional capital. We would expect to do so primarily through the sale of additional common stock or other equity securities, as well as through proceeds from future licensing agreements, strategic collaborations, forms of asset and debt financing, or any other financing vehicle. On October 2, 2015, the Company entered into a sale agreement with MLV & Co. LLC and FBR Capital Markets & Co, (the “Sales Agents”) to offer shares of the Company’s common stock from time to time through the Sales Agents, as the Company’s Sales Agents for the offer and sale of the shares, in an “at the market” offering. The Company may offer and sells shares of common stock for an aggregate offering price of up to $25,000,000. Funds from these sources may not be available to us on acceptable terms, if at all, and our failure to raise such funds could have a material adverse impact on our future business strategy and plans, financial condition and results of operations. If adequate funds are not available to us on acceptable terms in the future, we may be required to delay, reduce the scope of, or eliminate one or more of our research and development programs, or delay or curtail our preclinical studies and clinical trials, or reduce our internal cost structure. If additional capital is not available to us on acceptable terms, we may need to obtain funds through license agreements, or collaborative or partner arrangements pursuant to which we will likely relinquish rights to certain product candidates that we might otherwise choose to develop or commercialize independently, or be forced to enter into such arrangements earlier than we would prefer, which would likely result in less favorable transaction terms. Additional equity financings may be dilutive to holders of our common stock, and debt financing, if available, may involve significant payment obligations and covenants that restrict how we operate our business.
Contractual and Commercial Commitments
There have been no material changes from the information included in our Annual Report on Form 10-K for the fiscal year ended June 30, 2015.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements, as defined in Item 303(a)(4) (ii) of Regulation S-K under the Securities Exchange Act of 1934, as amended.
Market risk
As filed, 265 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.
There has been no material change in our assessment of sensitivity to market risk since our presentation set forth in Item 7A “Quantitative and Qualitative Disclosures about Market Risk” in the our Annual Report on Form 10-K for the fiscal year ended June 30, 2015.
Controls and procedures
As filed, 854 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.
Evaluation of Disclosure Controls and Procedures
Our management, including our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of the end of the period covered by this report. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of the end of the period covered by this report.
Changes in Internal Controls over Financial Reporting
There has been no change in our internal control over financial reporting during the quarter ended March 31, 2016 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Risk factors
As filed, 172 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.
There have been no material changes from the risk factors disclosed in the “Risk Factors” section of our Annual Report on Form 10-K for the fiscal year ended June 30, 2015.
Figures reported in this filing
Standardized line items from the XBRL in this filing, for the period ended 2016-03-31. Comparative periods it repeats are left out.
| Line item | Period | Value | XBRL concept |
|---|---|---|---|
| Revenue | 3 months2016-01-01 to 2016-03-31 | $5.3m | us-gaap:Revenues |
| Revenue | 9 months2015-07-01 to 2016-03-31 | $8.8m | us-gaap:Revenues |
| Research and development | 3 months2016-01-01 to 2016-03-31 | $8.5m | us-gaap:ResearchAndDevelopmentExpense |
| Research and development | 9 months2015-07-01 to 2016-03-31 | $20.4m | us-gaap:ResearchAndDevelopmentExpense |
| Operating income | 3 months2016-01-01 to 2016-03-31 | −$5.2m | us-gaap:OperatingIncomeLoss |
| Operating income | 9 months2015-07-01 to 2016-03-31 | −$18.5m | us-gaap:OperatingIncomeLoss |
| Net income | 3 months2016-01-01 to 2016-03-31 | −$5.2m | us-gaap:NetIncomeLoss |
| Net income | 9 months2015-07-01 to 2016-03-31 | −$18.4m | us-gaap:NetIncomeLoss |
| Diluted EPS | 3 months2016-01-01 to 2016-03-31 | −$0.14 | us-gaap:EarningsPerShareDiluted |
| Diluted EPS | 9 months2015-07-01 to 2016-03-31 | −$0.48 | us-gaap:EarningsPerShareDiluted |
| Basic EPS | 3 months2016-01-01 to 2016-03-31 | −$0.14 | us-gaap:EarningsPerShareBasic |
| Basic EPS | 9 months2015-07-01 to 2016-03-31 | −$0.48 | us-gaap:EarningsPerShareBasic |
| Diluted shares (weighted) | 3 months2016-01-01 to 2016-03-31 | 38,640,254 shares | us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding |
| Diluted shares (weighted) | 9 months2015-07-01 to 2016-03-31 | 38,633,786 shares | us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding |
| Operating cash flow | 9 months2015-07-01 to 2016-03-31 | −$15.2m | us-gaap:NetCashProvidedByUsedInOperatingActivities |
| Capital expenditure | 9 months2015-07-01 to 2016-03-31 | $100.0k | us-gaap:PaymentsToAcquirePropertyPlantAndEquipment |
| Cash and equivalents | At period end2016-03-31 | $30.6m | us-gaap:CashAndCashEquivalentsAtCarryingValue |
| Current assets | At period end2016-03-31 | $60.5m | us-gaap:AssetsCurrent |
| Total assets | At period end2016-03-31 | $61.9m | us-gaap:Assets |
| Current liabilities | At period end2016-03-31 | $8.7m | us-gaap:LiabilitiesCurrent |
| Total liabilities | At period end2016-03-31 | $9.2m | us-gaap:Liabilities |
| Shareholders' equity | At period end2016-03-31 | $52.7m | us-gaap:StockholdersEquity |
Source: SEC EDGAR, the filing index for accession 0001437749-16-031390. Last ingested by Listed: Nov 5, 2026, 18:48 ET. Listed shows no prices and gives no investment advice.