UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
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☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended December 31, 2020
OR
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☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number: 001-38667
Urovant Sciences Ltd.
(Exact Name of Registrant as Specified in its Charter)
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Bermuda |
98-1463899 |
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(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
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Suite 1, 3rd Floor 11-12 St. James’s Square London SW1Y 4LB, United Kingdom |
Not Applicable |
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(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: +44 (0)207 400-3347
Securities registered pursuant to Section 12(b) of the Act:
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(Title of each class) |
(Trading Symbol) |
(Name of each exchange on which registered) |
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Common Shares, $0.000037453 par value |
UROV |
Nasdaq Global Select Market |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whetfher the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer |
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Accelerated filer |
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☐ |
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Non-accelerated filer |
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☒ |
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Smaller reporting company |
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☒ |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of February 11, 2021, the registrant had 32,743,396 common shares, $0.000037453 par value per share, outstanding.
REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements are often identified by the use of words such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “to be,” “will,” “would,” or the negative or plural of these words, or similar expressions or variations, although not all forward-looking statements contain these words. Examples of forward-looking statements included in this Quarterly Report on Form 10-Q include statements concerning future matters such as our expected liquidity, the commercialization of our lead product GEMTESA (vibegron), the development of our product candidate, URO-902, our expense levels, expectations regarding the outcome of legal proceedings and other statements regarding matters that are not historical are forward-looking statements. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results could differ materially from those expressed or implied by these forward-looking statements.
Factors that could cause or contribute to such differences include, but are not limited to, those listed below in the section entitled “Summary Risk Factors,” and those discussed in the section titled “Risk Factors” set forth in Part II. Item 1A. of this Quarterly Report on Form 10-Q, elsewhere in this Quarterly Report on Form 10-Q and in our other filings with the U.S. Securities and Exchange Commission (the “SEC”). These risks are not exhaustive. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements.
SUMMARY RISK FACTORS
Our business, financial condition and results of operations may be affected by a number of risks and uncertainties. The following is a summary of the principal risks and uncertainties that may impact us, all of which are more fully described in the section entitled “Risk Factors” set forth in Part II, Item 1A of this Quarterly Report on Form 10-Q. The summary below should not be relied upon as an exhaustive summary of the material risks facing our business, and should be read in conjunction with the “Risk Factors” section in Part II, Item 1A of this Quarterly Report on Form 10-Q. In addition, other risks not presently known to us or that we currently deem immaterial may also impact our business.
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The conditions to the Merger (as such term is defined below) may not be satisfied or waived in a timely manner or at all, and the Merger Agreement (as such term is defined below) may be terminated in accordance with its terms, which could negatively impact our business, financial condition, results of operations, and the price of our common shares. |
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The announcement of the Merger could negatively impact our business, financial condition, or results of operations. |
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Attending to matters related to the Merger could divert our management’s focus from our ongoing business operations. |
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Business interruptions resulting from effects of pandemics or epidemics such as the novel strain of the coronavirus known as COVID-19, may materially and adversely affect our business and financial condition. |
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We believe our current cash and current borrowing capacity under the Sumitomo Loan Agreement (as such term is defined below) will not be sufficient for us to fund our anticipated level of operations until we become cash flow positive. If we fail to obtain additional capital, we will not be able to commercialize GEMTESA or complete the development of, seek regulatory approval for, and commercialize GEMTESA for OAB in men with BPH or our gene therapy product candidate, URO-902. |
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The Sumitomo Loan Agreement (as such term is defined below) contains certain covenants that could adversely affect our operations and, if an event of default were to occur, we could be forced to repay our outstanding indebtedness sooner than planned, including at a time when we do not have sufficient capital to satisfy such obligation. In addition, servicing our existing debt requires a significant amount of cash, and we may not have sufficient cash flow from our business to pay our substantial debt. The occurrence of any of these events could cause a significant adverse impact on our business, prospects and share price. |
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We expect to incur significant operating losses and negative operating cash flows for the foreseeable future, and we may never achieve or maintain profitability. |
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The success of our business depends significantly on the commercial success of GEMTESA., and it may fail to achieve market acceptance by physicians, patients, third-party payors and others in the medical community, which is necessary for GEMTESA’ commercial success. If GEMTESA is not successfully commercialized, our business will be harmed. |
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We currently rely on a single supplier for the enzyme used to manufacture GEMTESA, and if such supplier fails to provide us with sufficient supplies of enzyme to manufacture the quantity of GEMTESA we will need for commercialization, it may slow or halt our commercialization efforts for GEMTESA and harm our business. |
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We currently rely on Sunovion Pharmaceuticals, Inc. (“Sunovion”), an affiliate of Sumitovant Biopharma Ltd. (“Sumitovant”), the holder of a majority of our common shares to provide us certain market access and co-promotion services. If we are unable to establish sales, market access, marketing, and distribution capabilities, either on our own or with third-party collaboration partners, we may not be successful in commercializing GEMTESA. |
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If Sunovion does not provide us the services and the commercial and operational support contemplated in the terms of the Market Access Services Agreement and Co-Promotion Agreement (as each item is defined below), our business could be adversely impacted. |
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Coverage and reimbursement may not be available for GEMTESA, which could make it difficult for us to sell it profitably. |
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We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively. |
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Clinical studies are very expensive, time-consuming, difficult to design and implement, and involve uncertain outcomes. Clinical study failures can occur at any stage of clinical studies, and we could encounter problems that cause us to suspend, abandon or repeat clinical studies. We cannot predict with any certainty the timing for commencement or completion of current or future clinical studies. |
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The results of our clinical studies may not support our proposed claims for our future product candidates. The results of previous clinical studies may not be predictive of future results, and interim or top-line data may be subject to change or qualification based on the complete analysis of data. |
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Our gene therapy product candidate, URO-902, is based on a novel technology, and the regulatory landscape that governs gene therapy products is uncertain and may change, which makes it difficult to predict the amount of time, money and other resources the Company will need to expend to develop URO-902 and obtain regulatory approval. |
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Our product and/or our gene therapy product candidate may cause adverse effects or have other properties that could limit their market acceptance and could delay or prevent the regulatory approval of or limit the scope of any approved label for, our gene therapy product candidate. |
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Regulatory requirements may make it difficult for us to obtain the materials and supplies necessary to conduct clinical studies regarding or to manufacture and sell GEMTESA or our gene therapy product candidate, if approved. |
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We are reliant on third parties to conduct, manage, and monitor our clinical studies, and if those third parties perform in an unsatisfactory manner, it may harm our business. |
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If we are unable to obtain and maintain patent protection for our technology and products, or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets. |
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If we fail to comply with our obligations under any license, collaboration or other agreements, we may be required to pay damages and could lose intellectual property rights that are necessary for developing and protecting our product and/or gene therapy product candidate. |
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We have agreements with Sumitovant, our majority shareholder, and with Sumitomo Dainippon Pharma Co., Ltd., the parent company of Sumitovant (“Sumitomo Dainippon Pharma”), that may be perceived to create conflicts of interest. To the extent other investors perceive that Sumitovant or Sumitomo Dainippon Pharma will not act in the best interests of all of our shareholders, such perception may negatively affect the price of our common shares. |
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We are a “controlled company” within the meaning of the applicable Nasdaq listing rules and, as a result, qualify for exemptions from certain corporate governance requirements. If we rely on these exemptions, our shareholders will not have the same protections afforded to shareholders of companies that are subject to such requirements. |
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We are a Bermuda company, and it may be difficult for shareholders to enforce judgments against us or our directors and executive officers. Bermuda law differs from the laws in effect in the United States and may afford less protection to our shareholders. |
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U.S. holders of our common shares may suffer adverse tax consequences if we are characterized as a passive foreign investment company. |
Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q to “Urovant,” the “Company,” “we,” “us,” and “our” refer to Urovant Sciences Ltd. and its wholly-owned subsidiaries, and references to “USL” refer to Urovant Sciences Ltd. on an unconsolidated basis and excluding its subsidiaries.
ii
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Page |
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PART I. |
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Item 1. |
4 |
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Condensed Consolidated Balance Sheets as of December 31, 2020 and March 31, 2020 |
4 |
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5 |
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6 |
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7 |
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Condensed Consolidated Statements of Cash Flows for the Nine Months Ended December 31, 2020 and 2019 |
9 |
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10 |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
26 |
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Item 3. |
41 |
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Item 4. |
41 |
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PART II. |
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Item 1. |
43 |
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Item 1A. |
43 |
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Item 2. |
90 |
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Item 3. |
90 |
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Item 4. |
90 |
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Item 5. |
90 |
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Item 6. |
91 |
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92 |
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iii
Item 1.Financial Statements (Unaudited)
UROVANT SCIENCES LTD.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
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December 31, 2020 |
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March 31, 2020 |
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Assets |
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(Note 2) |
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Current assets: |
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Cash |
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$ |
71,295 |
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$ |
51,414 |
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Restricted cash |
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250 |
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243 |
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Prepaid expenses and other current assets |
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14,509 |
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6,489 |
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Due from Sumitovant Biopharma Ltd. |
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— |
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172 |
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Total current assets |
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86,054 |
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58,318 |
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Property and equipment, net |
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2,020 |
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1,210 |
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Operating lease right-of-use assets |
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3,705 |
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3,135 |
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Intangible asset, net |
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14,000 |
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— |
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Restricted cash, net of current portion |
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2,198 |
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623 |
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Other assets |
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910 |
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9 |
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Total assets |
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$ |
108,887 |
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$ |
63,295 |
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Liabilities and Shareholders' Deficit |
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Current liabilities: |
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Accounts payable |
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$ |
3,509 |
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$ |
1,589 |
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Accrued expenses |
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35,113 |
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21,756 |
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Due to Roivant Sciences Ltd. |
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— |
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31 |
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Due to Sunovion Pharmaceuticals, Inc. |
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182 |
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— |
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Current portion of share-based compensation liabilities |
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1,112 |
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7,204 |
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Current portion of operating lease liabilities |
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520 |
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351 |
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Total current liabilities |
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40,436 |
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30,931 |
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Share-based compensation liabilities, net of current portion |
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1,195 |
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32 |
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Related-party long-term debt |
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209,285 |
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87,252 |
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Operating lease liabilities, net of current portion |
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3,588 |
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3,086 |
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Total liabilities |
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254,504 |
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|
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121,301 |
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Commitments and contingencies (Note 11) |
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Shareholders' deficit |
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Common shares, par value $0.000037453 per share, 267,001,308 shares authorized, 32,533,959 and 30,635,258 issued and outstanding at December 31, 2020 and March 31, 2020, respectively |
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1 |
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1 |
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Common shares subscribed |
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(1 |
) |
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(1 |
) |
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Accumulated other comprehensive (loss) income |
|
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(24 |
) |
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452 |
|
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Additional paid-in capital |
|
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289,130 |
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263,818 |
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Accumulated deficit |
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(434,723 |
) |
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(322,276 |
) |
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Total shareholders' deficit |
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(145,617 |
) |
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(58,006 |
) |
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Total liabilities and shareholders' deficit |
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$ |
108,887 |
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$ |
63,295 |
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
|
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Three Months Ended December 31, |
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Nine Months Ended December 31, |
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2020 |
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2019 |
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2020 |
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2019 |
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Operating expenses: |
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Research and development |
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$ |
15,616 |
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$ |
23,099 |
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$ |
46,506 |
|
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$ |
62,909 |
|
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General and administrative(1) |
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29,965 |
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16,687 |
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61,387 |
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29,587 |
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Total operating expenses |
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45,581 |
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|
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39,786 |
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107,893 |
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92,496 |
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Other (expense) income: |
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Interest expense, net(2) |
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(1,615 |
) |
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(1,401 |
) |
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(4,522 |
) |
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(2,495 |
) |
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Loss on disposal of property and equipment |
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— |
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— |
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|
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— |
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|
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(236 |
) |
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Other income (expense), net |
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271 |
|
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(34 |
) |
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(155 |
) |
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(145 |
) |
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Loss before (benefit from) provision for income taxes |
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(46,925 |
) |
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(41,221 |
) |
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(112,570 |
) |
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(95,372 |
) |
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(Benefit from) provision for income taxes |
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(128 |
) |
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38 |
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|
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(123 |
) |
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|
113 |
|
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Net loss |
|
$ |
(46,797 |
) |
|
$ |
(41,259 |
) |
|
$ |
(112,447 |
) |
|
$ |
(95,485 |
) |
|
Net loss per common share—basic and diluted |
|
$ |
(1.46 |
) |
|
$ |
(1.36 |
) |
|
$ |
(3.59 |
) |
|
$ |
(3.14 |
) |
|
Weighted average common shares outstanding—basic and diluted |
|
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32,101,832 |
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|
30,413,946 |
|
|
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31,355,190 |
|
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30,365,142 |
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(1) |
Includes $556 and $1,143 of costs from Sunovion Pharmaceuticals, Inc. during the three and nine months ended December 31, 2020, respectively (see Note 6[F]). Also, includes $80 and $213 of costs allocated from Roivant Sciences Ltd. during the three and nine months ended December 31, 2019, respectively. |
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(2) |
Includes $1,627 and $4,562 of interest expense from related-party long-term debt with Sumitomo Dainippon Pharma Co., Ltd. during the three and nine months ended December 31, 2020, respectively (see Note 5). |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
Condensed Consolidated Statements of Comprehensive Loss
(in thousands)
|
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Three Months Ended December 31, |
|
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Nine Months Ended December 31, |
|
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2020 |
|
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2019 |
|
|
2020 |
|
|
2019 |
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||||
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Net loss |
|
$ |
(46,797 |
) |
|
$ |
(41,259 |
) |
|
$ |
(112,447 |
) |
|
$ |
(95,485 |
) |
|
Other comprehensive (loss) income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustment |
|
|
(577 |
) |
|
|
29 |
|
|
|
(476 |
) |
|
|
125 |
|
|
Total other comprehensive (loss) income |
|
|
(577 |
) |
|
|
29 |
|
|
|
(476 |
) |
|
|
125 |
|
|
Comprehensive loss |
|
$ |
(47,374 |
) |
|
$ |
(41,230 |
) |
|
$ |
(112,923 |
) |
|
$ |
(95,360 |
) |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
6
Condensed Consolidated Statements of Shareholders’ (Deficit) Equity
(in thousands, except share data)
|
|
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Common Shares |
|
|
Common Shares |
|
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Additional |
|
|
Accumulated |
|
|
Accumulated Other Comprehensive |
|
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Total Shareholders' |
|
||||||||||
|
|
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Shares |
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Amount |
|
|
Subscribed |
|
|
Paid-in Capital |
|
|
Deficit |
|
|
(Loss) Income |
|
|
Deficit |
|
|||||||
|
Balance at March 31, 2020 |
|
|
30,635,258 |
|
|
$ |
1 |
|
|
$ |
(1 |
) |
|
$ |
263,818 |
|
|
$ |
(322,276 |
) |
|
$ |
452 |
|
|
$ |
(58,006 |
) |
|
Share-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,032 |
|
|
|
— |
|
|
|
— |
|
|
|
1,032 |
|
|
Exercise of stock options |
|
|
231,799 |
|
|
|
— |
|
|
|
— |
|
|
|
1,205 |
|
|
|
— |
|
|
|
— |
|
|
|
1,205 |
|
|
Share-based compensation liabilities reclassified to equity upon exercise of stock options |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
988 |
|
|
|
— |
|
|
|
— |
|
|
|
988 |
|
|
Change in fair value of share-based compensation liabilities recorded to liabilities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(35 |
) |
|
|
— |
|
|
|
— |
|
|
|
(35 |
) |
|
Issuance of common shares pursuant to 2019 ESPP |
|
|
39,541 |
|
|
|
— |
|
|
|
— |
|
|
|
331 |
|
|
|
— |
|
|
|
— |
|
|
|
331 |
|
|
Foreign currency translation adjustment |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
43 |
|
|
|
43 |
|
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(30,494 |
) |
|
|
— |
|
|
|
(30,494 |
) |
|
Balance at June 30, 2020 |
|
|
30,906,598 |
|
|
|
1 |
|
|
|
(1 |
) |
|
|
267,339 |
|
|
|
(352,770 |
) |
|
|
495 |
|
|
|
(84,936 |
) |
|
Share-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,824 |
|
|
|
— |
|
|
|
— |
|
|
|
1,824 |
|
|
Exercise of stock options |
|
|
670,318 |
|
|
|
— |
|
|
|
— |
|
|
|
2,921 |
|
|
|
— |
|
|
|
— |
|
|
|
2,921 |
|
|
Share-based compensation liabilities reclassified to equity upon exercise of stock options |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2,045 |
|
|
|
— |
|
|
|
— |
|
|
|
2,045 |
|
|
Change in fair value of share-based compensation liabilities recorded to additional paid-in capital |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
194 |
|
|
|
— |
|
|
|
— |
|
|
|
194 |
|
|
Foreign currency translation adjustment |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
58 |
|
|
|
58 |
|
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(35,156 |
) |
|
|
— |
|
|
|
(35,156 |
) |
|
Balance at September 30, 2020 |
|
|
31,576,916 |
|
|
|
1 |
|
|
|
(1 |
) |
|
|
274,323 |
|
|
|
(387,926 |
) |
|
|
553 |
|
|
|
(113,050 |
) |
|
Share-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,895 |
|
|
|
— |
|
|
|
— |
|
|
|
1,895 |
|
|
Exercise of stock options |
|
|
908,221 |
|
|
|
— |
|
|
|
— |
|
|
|
6,375 |
|
|
|
— |
|
|
|
— |
|
|
|
6,375 |
|
|
Share-based compensation liabilities reclassified to equity upon exercise of stock options |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
6,310 |
|
|
|
— |
|
|
|
— |
|
|
|
6,310 |
|
|
Vesting of restricted stock units, net of tax withholding |
|
|
21,145 |
|
|
|
— |
|
|
|
— |
|
|
|
(20 |
) |
|
|
— |
|
|
|
— |
|
|
|
(20 |
) |
|
Issuance of common shares pursuant to 2019 ESPP |
|
|
27,677 |
|
|
|
— |
|
|
|
— |
|
|
|
247 |
|
|
|
— |
|
|
|
— |
|
|
|
247 |
|
|
Foreign currency translation adjustment |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(577 |
) |
|
|
(577 |
) |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(46,797 |
) |
|
|
— |
|
|
|
(46,797 |
) |
|
Balance at December 31, 2020 |
|
|
32,533,959 |
|
|
$ |
1 |
|
|
$ |
(1 |
) |
|
$ |
289,130 |
|
|
$ |
(434,723 |
) |
|
$ |
(24 |
) |
|
$ |
(145,617 |
) |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
7
Condensed Consolidated Statements of Shareholders’ (Deficit) Equity — Continued
(in thousands, except share data)
|
|
|
Common Shares |
|
|
Common Shares |
|
|
Additional |
|
|
Accumulated |
|
|
Accumulated Other Comprehensive |
|
|
Total Shareholders' |
|
||||||||||
|
|
|
Shares |
|
|
Amount |
|
|
Subscribed |
|
|
Paid-in Capital |
|
|
Deficit |
|
|
Income |
|
|
(Deficit) Equity |
|
|||||||
|
Balance at March 31, 2019 |
|
|
30,322,911 |
|
|
$ |
1 |
|
|
$ |
(1 |
) |
|
$ |
250,032 |
|
|
$ |
(175,531 |
) |
|
$ |
269 |
|
|
$ |
74,770 |
|
|
Capital contributions from RSI and RSG |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
130 |
|
|
|
— |
|
|
|
— |
|
|
|
130 |
|
|
Share-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,047 |
|
|
|
— |
|
|
|
— |
|
|
|
1,047 |
|
|
Exercise of stock options |
|
|
17,521 |
|
|
|
— |
|
|
|
— |
|
|
|
70 |
|
|
|
— |
|
|
|
— |
|
|
|
70 |
|
|
Foreign currency translation adjustment |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
188 |
|
|
|
188 |
|
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(28,485 |
) |
|
|
— |
|
|
|
(28,485 |
) |
|
Balance at June 30, 2019 |
|
|
30,340,432 |
|
|
|
1 |
|
|
|
(1 |
) |
|
|
251,279 |
|
|
|
(204,016 |
) |
|
|
457 |
|
|
|
47,720 |
|
|
Capital contributions from RSI and RSG |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
60 |
|
|
|
— |
|
|
|
— |
|
|
|
60 |
|
|
Share-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,221 |
|
|
|
— |
|
|
|
— |
|
|
|
1,221 |
|
|
Exercise of stock options |
|
|
41,001 |
|
|
|
— |
|
|
|
— |
|
|
|
150 |
|
|
|
— |
|
|
|
— |
|
|
|
150 |
|
|
Warrants issued with long-term debt |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
438 |
|
|
|
— |
|
|
|
— |
|
|
|
438 |
|
|
Foreign currency translation adjustment |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(92 |
) |
|
|
(92 |
) |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(25,741 |
) |
|
|
— |
|
|
|
(25,741 |
) |
|
Balance at September 30, 2019 |
|
|
30,381,433 |
|
|
|
1 |
|
|
|
(1 |
) |
|
|
253,148 |
|
|
|
(229,757 |
) |
|
|
365 |
|
|
|
23,756 |
|
|
Capital contributions from RSI and RSG |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
61 |
|
|
|
— |
|
|
|
— |
|
|
|
61 |
|
|
Share-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
12,529 |
|
|
|
— |
|
|
|
— |
|
|
|
12,529 |
|
|
Exercise of stock options |
|
|
128,434 |
|
|
|
— |
|
|
|
— |
|
|
|
498 |
|
|
|
— |
|
|
|
— |
|
|
|
498 |
|
|
Vesting of restricted stock units, net of tax withholding |
|
|
9,821 |
|
|
|
— |
|
|
|
— |
|
|
|
(63 |
) |
|
|
— |
|
|
|
— |
|
|
|
(63 |
) |
|
Foreign currency translation adjustment |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
29 |
|
|
|
29 |
|
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(41,259 |
) |
|
|
— |
|
|
|
(41,259 |
) |
|
Balance at December 31, 2019 |
|
|
30,519,688 |
|
|
$ |
1 |
|
|
$ |
(1 |
) |
|
$ |
266,173 |
|
|
$ |
(271,016 |
) |
|
$ |
394 |
|
|
$ |
(4,449 |
) |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
8
Condensed Consolidated Statements of Cash Flows
(in thousands)
|
|
|
Nine Months Ended December 31, |
|
|||||
|
|
|
2020 |
|
|
2019 |
|
||
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(112,447 |
) |
|
$ |
(95,485 |
) |
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
272 |
|
|
|
178 |
|
|
Share-based compensation expense |
|
|
9,324 |
|
|
|
14,797 |
|
|
Amortization of debt discount and issuance costs |
|
|
33 |
|
|
|
664 |
|
|
Non-cash operating lease cost |
|
|
722 |
|
|
|
448 |
|
|
Loss on disposal of property and equipment |
|
|
— |
|
|
|
236 |
|
|
Unrealized foreign currency translation adjustment |
|
|
(476 |
) |
|
|
125 |
|
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets |
|
|
(8,020 |
) |
|
|
2,897 |
|
|
Other assets |
|
|
(576 |
) |
|
|
77 |
|
|
Due from Sumitovant Biopharma Ltd. |
|
|
172 |
|
|
|
(111 |
) |
|
Due to Roivant Sciences Ltd. |
|
|
(31 |
) |
|
|
(8 |
) |
|
Due to Sunovion Pharmaceuticals, Inc. |
|
|
182 |
|
|
|
— |
|
|
Accounts payable |
|
|
1,920 |
|
|
|
463 |
|
|
Accrued expenses |
|
|
(723 |
) |
|
|
4,998 |
|
|
Operating lease liabilities |
|
|
(621 |
) |
|
|
(153 |
) |
|
Interest payable |
|
|
— |
|
|
|
343 |
|
|
Net cash used in operating activities |
|
|
(110,269 |
) |
|
|
(70,531 |
) |
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(1,082 |
) |
|
|
(732 |
) |
|
Capitalized website development costs |
|
|
(245 |
) |
|
|
— |
|
|
Cash used in investing activities |
|
|
(1,327 |
) |
|
|
(732 |
) |
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
Proceeds from capital contributions from Roivant Sciences Ltd. |
|
|
— |
|
|
|
251 |
|
|
Proceeds from exercise of stock options |
|
|
10,501 |
|
|
|
718 |
|
|
Debt financing costs paid |
|
|
— |
|
||||