Bermuda | | | 98-1173944 |
(State or Other Jurisdiction of Incorporation or Organization) | | | (I.R.S. Employer Identification Number) |
Large accelerated filer ☐ | | | Accelerated filer ☐ |
Non-accelerated filer ☒ | | | Smaller reporting company ☒ |
| | Emerging growth company ☒ |
• | a base prospectus which covers (i) the offering, issuance and sale by us of an indeterminate number of common shares, $0.0000000341740141 par value per share (the “Common Shares”), and preference shares, an indeterminate principal amount of our debt securities, an indeterminate number of warrants to purchase Common Shares, preference shares or debt securities, and an indeterminate number of units consisting of two or more types of the foregoing securities, of up to a maximum aggregate offering price of $1.0 billion and (ii) the issuance by us of up to (x) 20,535,896 Common Shares that are issuable by us upon the exercise of outstanding public warrants (the “Public Warrants”), the issuance of which was previously registered, and (y) 10,214,365 Common Shares that are issuable by us upon the exercise of outstanding private warrants (the “Private Placement Warrants” and, together with the Public Warrants, the “Warrants”) originally issued in a private placement to Patient Square Capital LLC; |
• | a prospectus covering the offering, issuance and sale by us of Common Shares up to a maximum aggregate offering price of $400.0 million pursuant to a Sales Agreement, dated September 19, 2022 with Cowen and Company, LLC (the “Sales Agreement”); and |
• | a secondary offering prospectus which covers the offer and sale by the securityholders named therein (the “Holders”) of up to 566,982,174 issued and outstanding Common Shares (including Common Shares underlying vested restricted share awards) from time to time in one or more offerings (which includes Common Shares the resale of which was previously registered on a resale registration statement on Form S-1). |
PRELIMINARY PROSPECTUS (Subject to Completion) | | | Dated September 19, 2022 |
• | commercially launched VTAMA® (tapinarof) cream 1% for the treatment of plaque psoriasis in adults; |
• | conducted nine international Phase 3 trials, the last eight of which have been successful; |
• | consummated a $3 billion upfront partnership with Sumitomo Pharma Co., Ltd. (“Sumitomo”); |
• | received six FDA approvals for drugs developed by Vants launched by Roivant, including VTAMA and four drugs that received FDA approval after their transfer to Sumitomo; |
• | built a broad and differentiated pipeline of drugs and drug candidates ranging from early discovery to commercial stage; and |
• | launched Roivant Discovery, our small molecule discovery engine, consisting of a collection of advanced computational physics capabilities, integrated with an in-house wet lab facility. |
• | our limited operating history and risks involved in biopharmaceutical product development; |
• | our limited experience as a commercial-stage company and ability to successfully commercialize VTAMA® (tapinarof); |
• | our ability to raise additional capital to fund our business on acceptable terms or at all; |
• | the fact that we will likely incur significant operating losses for the foreseeable future; |
• | the impact of public health outbreaks, epidemics or pandemics (such as the COVID-19 pandemic) on our business (including our clinical trials and preclinical studies), operations and financial condition and results; |
• | our ability to acquire, in-license or discover new product candidates; |
• | our Vant structure and the potential that we may fail to capitalize on certain development opportunities; |
• | clinical trials and preclinical studies, which are very expensive, time-consuming, difficult to design and implement and involve uncertain outcomes; |
• | the unproven nature of our approach to the discovery and development of product candidates from our small molecule discovery engine; |
• | the novelty, complexity and difficulty of manufacturing certain of our products and product candidates, including any manufacturing problems that result in delays in development or commercialization of our products and product candidates; |
• | difficulties we may face in enrolling and retaining patients in clinical trials and/or clinical development activities; |
• | the results of our clinical trials not supporting our proposed claims for a product candidate; |
• | changes in interim, top-line and/or preliminary data from our clinical trials changing as more data becoming available or being delayed due to audit and verification process; |
• | changes in product manufacturing or formulation that could lead to the incurrence of costs or delays; |
• | the failure of any third-party we contract with to conduct, supervise and monitor our clinical trials to perform in a satisfactory manner or to comply with applicable requirements; |
• | the fact that obtaining approvals for new drugs is a lengthy, extensive, expensive and unpredictable process that may end with our inability to obtain regulatory approval by the FDA or other regulatory agencies in other jurisdictions; |
• | the failure of our clinical trials to demonstrate substantial evidence of the safety and efficacy of our products and product candidates, including, but not limited to, scenarios in which our products and product candidates may cause adverse effects that could delay regulatory approval, discontinue clinical trials, limit the scope of approval or generally result in negative media coverage of us; |
• | our inability to obtain regulatory approval for a product or product candidate in certain jurisdictions, even if we are able to obtain approval in certain other jurisdictions; |
• | our ability to effectively manage growth and to attract and retain key personnel; |
• | any business, legal, regulatory, political, operational, financial and economic risks associated with conducting business globally; |
• | our ability to obtain and maintain patent and other intellectual property protection for our technology, products and product candidates; |
• | the inadequacy of patent terms and their scope to protect our competitive position; |
• | the failure to issue (or the threatening of their breadth or strength of protection) or provide meaningful exclusivity for our current and future products and product candidates of our patent applications that we hold or have in-licensed; |
• | the fact that we do not currently and may not in the future own or license any issued composition of matter patents covering certain of our products and product candidates and our inability to be certain that any of our other issued patents will provide adequate protection for such products and product candidates; |
• | the fact that our largest shareholders (and certain members of our management team) own a significant percentage of our shares and will be able to exert significant control over matters subject to shareholder approval; |
• | the outcome of any pending or potential litigation, including but not limited to our expectations regarding the outcome of any such litigation and costs and expenses associated with such litigation; |
• | changes in applicable laws or regulations; |
• | the possibility that we may be adversely affected by other economic, business and/or competitive factors; and |
• | other risks and uncertainties indicated from time to time in filings made with the SEC. |
• | prior to the date of the transaction that resulted in the shareholder becoming an interested shareholder, our board of directors approved either the business combination or the transaction that resulted in the shareholder becoming an interested shareholder; |
• | upon consummation of the transaction that resulted in the shareholder becoming an interested shareholder, the interested shareholder owned at least 85% of our issued and voting shares outstanding at the time the transaction commenced; or |
• | after the date of the transaction that resulted in the shareholder becoming an interested shareholder, the business combination is approved by our board of directors and authorized at an annual or special meeting of shareholders by the affirmative vote of at least 662∕3% of our issued and outstanding voting shares that are not owned by the interested shareholder. |
• | classification as senior or subordinated debt securities; |
• | ranking of the specific series of debt securities relative to other outstanding indebtedness, including subsidiaries’ debt; |
• | if the debt securities are subordinated, the aggregate amount of outstanding indebtedness, as of a recent date, that is senior to the subordinated securities, and any limitation on the issuance of additional senior indebtedness; |
• | the designation, aggregate principal amount and authorized denominations; |
• | the maturity date; |
• | the interest rate, if any, and the method for calculating the interest rate; |
• | the interest payment dates and the record dates for the interest payments; |
• | any mandatory or optional redemption terms or prepayment, conversion, sinking fund or exchangeability or convertibility provisions; |
• | the place where we will pay principal and interest; |
• | if other than denominations of $1,000 or multiples of $1,000, the denominations the debt securities will be issued in; |
• | whether the debt securities will be issued in the form of global securities or certificates; |
• | additional provisions, if any, relating to the defeasance of the debt securities; |
• | the currency or currencies, if other than the currency of the United States, in which principal and interest will be paid; |
• | any United States federal income tax consequences; |
• | the dates on which premium, if any, will be paid; |
• | our right, if any, to defer payment interest and the maximum length of this deferral period; |
• | any listing on a securities exchange; |
• | the initial public offering price; and |
• | other specific terms, including any additional events of default or covenants. |
• | any insolvency or bankruptcy proceedings, or any receivership, liquidation, reorganization or other similar proceedings which concern us or a substantial part of our property; |
• | a default having occurred for the payment of principal, premium, if any, or interest on or other monetary amounts due and payable on any senior indebtedness or any other default having occurred concerning any senior indebtedness, which permits the holder or holders of any senior indebtedness to accelerate the maturity of any senior indebtedness with notice or lapse of time, or both. Such an event of default must have continued beyond the period of grace, if any, provided for such event of default, and such an event of default shall not have been cured or waived or shall not have ceased to exist; or |
• | the principal of, and accrued interest on, any series of the subordinated debt securities having been declared due and payable upon an event of default pursuant to the subordinated debt indenture. This declaration must not have been rescinded and annulled as provided in the subordinated debt indenture. |
(i) | we default in the payment of principal of such debt securities when it becomes due and payable at maturity, upon acceleration, redemption or mandatory repurchase, including as a sinking fund installment or otherwise; |
(ii) | we default in the payment of interest on such debt securities when it becomes due and payable and such default continues for a period of 30 days or more; |
(iii) | we default in the performance of, or breach, any other covenant or agreement in the indenture with respect to such debt securities or in such debt securities (other than defaults specified in clause (i) or (ii) above) and such default or breach continues for a period of 30 days or more after written notice to |
(iv) | certain events of bankruptcy, insolvency, reorganization, administration or similar proceedings with respect to us or any material subsidiary has occurred; or |
(v) | any other Events of Default set forth in the prospectus supplement. |
• | cure any ambiguity, defect or inconsistency; provided that such amendments or supplements do not materially and adversely affect the interests of the holders; |
• | provide for the assumption of our obligations in the case of a merger or consolidation; |
• | comply with any requirements of the SEC in connection with qualification of the indenture under the Trust Indenture Act; |
• | evidence and provide for the acceptance of appointment by a successor trustee and add to or change any of the provisions of the indenture; |
• | establish the form or forms or terms of debt securities of any series or of the coupons appertaining to such debt securities; |
• | provide for uncertificated or unregistered debt securities and make all appropriate changes for such purpose; and |
• | make any change that does not materially and adversely affect the rights of any holder. |
• | change the stated maturity of the principal of, or any sinking fund obligation or any installment of interest on, such holder’s debt security; |
• | reduce the principal amount of such holder’s debt security or the rate of interest thereon (including any amount in respect of original issue discount); |
• | reduce the percentage of outstanding debt securities the consent of whose holders is necessary to modify or amend the indenture with respect to the debt securities; and |
• | reduce the percentage in principal amount of outstanding debt securities the consent of whose holders is required for any supplemental indenture or for any waiver of compliance with certain provisions of the indenture or certain defaults and their consequences provided for in the indenture. |
• | we have paid or caused to be paid the principal of and interest on such series of debt securities as and when such debt securities become due and payable; |
• | we have delivered to the trustee for cancellation all debt securities of such series that have been authenticated; or |
• | all debt securities of such series not delivered to the trustee for cancellation have become due and payable, or by their terms to become due and payable within one year or are to be called for redemption within one year under arrangements satisfactory to the trustee for the giving of notice of redemption, and we have irrevocably deposited or caused to be deposited with the trustee the entire amount in cash or |
• | rights of registration of transfer and exchange, and our right of optional redemption; |
• | substitution of apparently mutilated, defaced, destroyed, lost or stolen debt securities; |
• | rights of holders to receive payments of principal of the debt securities and interest thereon, upon the original stated due dates (but not upon acceleration); |
• | the rights, obligations and immunities of the trustee; and |
• | the rights of the holders of debt securities of such series as beneficiaries with respect to the property deposited with the trustee payable to all or any of them. |
• | we have deposited or caused to be irrevocably deposited with the trustee as trust funds in trust, specifically pledged as security for, and dedicated solely to, the benefit of the holders of the debt securities of such series, (i) money in an amount, or (ii) U.S. government obligations which through the payment of interest and principal in respect thereof in accordance with their terms will provide not later than one day before the due date of any payment money in an amount, or (iii) a combination thereof, sufficient to pay and discharge without consideration of the reinvestment of such interest and after payment of all federal, state and local taxes or other charges and assessments in respect thereof payable by the trustee (x) the principal of, premium, if any, and each installment of interest on the outstanding debt securities of such series on the due dates thereof and (y) any mandatory sinking fund payments or analogous payments applicable to the debt securities of such series on the day on which such payments are due and payable in accordance with the terms of debt securities of such series and the indenture; |
• | we have delivered to the trustee (i) an opinion of counsel to the effect that holders of debt securities of such series will not recognize income, gain or loss for U.S. federal income tax purposes as a result of our exercise of legal defeasance or covenant defeasance and will be subject to U.S. federal income tax on the same amount and in the same manner and at the same times as would have been the case if such deposit, defeasance and discharge had not occurred, or a ruling directed to the trustee received from the U.S. Internal Revenue Service to the same effect as such opinion of counsel and (ii) an opinion of counsel to the effect that the creation of the defeasance trust does not violate the Investment Company Act of 1940 and after the passage of 123 days following the deposit, the trust fund will not be subject to the effect of Section 547 of the U.S. Bankruptcy Code or Section 15 of the New York Debtor and Creditor Law; |
• | immediately after giving effect to such deposit on a pro forma basis, no event of default, or event that after the giving of notice or lapse of time or both would become an event of default, shall have occurred and be continuing on the date of such deposit or during the period ending on the 123rd day after the date of such deposit, and such deposit shall not result in a breach or violation of, or constitute a default under, any other agreement or instrument to which we are a party or by which we are bound; |
• | if at such time the debt securities of such series are listed on a national securities exchange, we have delivered to the trustee an opinion of counsel to the effect that the debt securities of such series will not be delisted as a result of such deposit, defeasance and discharge; |
• | we have delivered to the trustee an officers’ certificate and an opinion of counsel, each stating that all conditions precedent to the defeasance and discharge have been complied with; and |
• | in the case of covenant defeasance, if the debt securities of such series are to be redeemed prior to the final maturity thereof (other than from mandatory sinking fund payments or analogous payments), notice of such redemption has been duly given pursuant to the indenture. |
• | in whole and not in part; |
• | at a price of $0.01 per warrant; |
• | upon not less than 30 days’ prior written notice of redemption to each Warrant holder; and |
• | if, and only if, the last reported sale price of the Common Shares for any 20 trading days within a 30-trading day period ending three business days before Roivant sends to the notice of redemption to the Warrant holders (which Roivant refers to as the “Reference Value”) equals or exceeds $18.00 per share (as adjusted for share subdivisions, share capitalizations, dividends, reorganizations, recapitalizations and the like). |
• | in whole and not in part; |
• | at $0.10 per Warrant upon a minimum of 30 days’ prior written notice of redemption; provided that holders will be able to exercise their Warrants on a cashless basis prior to redemption and receive that number of shares determined by reference to the table below, based on the redemption date and the “fair market value” of Common Shares (as defined below); |
• | if, and only if, the Reference Value (as defined above under-”Redemption of Warrants When the Price per Common Share Equals or Exceeds $18.00”) equals or exceeds $10.00 per share (as adjusted for share subdivisions, share capitalizations, reorganizations, recapitalizations and the like); and |
• | if the Reference Value is less than $18.00 per share (as adjusted for share subdivisions, share capitalizations, reorganizations, recapitalizations and the like) the private placement Warrants must also be concurrently called for redemption on the same terms (except as described above with respect to a holder’s ability to cashless exercise its Warrants) as the outstanding Public Warrants, as described above. |
| | Fair Market Value of Common Shares | |||||||||||||||||||||||||
Redemption Date (period to expiration of Warrants) | | | ≤$10.00 | | | $11.00 | | | $12.00 | | | $13.00 | | | $14.00 | | | $15.00 | | | $16.00 | | | $17.00 | | | ≥$18.00 |
60 months | | | 0.261 | | | 0.281 | | | 0.297 | | | 0.311 | | | 0.324 | | | 0.337 | | | 0.348 | | | 0.358 | | | 0.361 |
57 months | | | 0.257 | | | 0.277 | | | 0.294 | | | 0.310 | | | 0.324 | | | 0.337 | | | 0.348 | | | 0.358 | | | 0.361 |
54 months | | | 0.252 | | | 0.272 | | | 0.291 | | | 0.307 | | | 0.322 | | | 0.335 | | | 0.347 | | | 0.357 | | | 0.361 |
51 months | | | 0.246 | | | 0.268 | | | 0.287 | | | 0.304 | | | 0.320 | | | 0.333 | | | 0.346 | | | 0.357 | | | 0.361 |
48 months | | | 0.241 | | | 0.263 | | | 0.283 | | | 0.301 | | | 0.317 | | | 0.332 | | | 0.344 | | | 0.356 | | | 0.361 |
45 months | | | 0.235 | | | 0.258 | | | 0.279 | | | 0.298 | | | 0.315 | | | 0.330 | | | 0.343 | | | 0.356 | | | 0.361 |
42 months | | | 0.228 | | | 0.252 | | | 0.274 | | | 0.294 | | | 0.312 | | | 0.328 | | | 0.342 | | | 0.355 | | | 0.361 |
39 months | | | 0.221 | | | 0.246 | | | 0.269 | | | 0.290 | | | 0.309 | | | 0.325 | | | 0.340 | | | 0.354 | | | 0.361 |
36 months | | | 0.213 | | | 0.239 | | | 0.263 | | | 0.285 | | | 0.305 | | | 0.323 | | | 0.339 | | | 0.353 | | | 0.361 |
33 months | | | 0.205 | | | 0.232 | | | 0.257 | | | 0.280 | | | 0.301 | | | 0.320 | | | 0.337 | | | 0.352 | | | 0.361 |
30 months | | | 0.196 | | | 0.224 | | | 0.250 | | | 0.274 | | | 0.297 | | | 0.316 | | | 0.335 | | | 0.351 | | | 0.361 |
27 months | | | 0.185 | | | 0.214 | | | 0.242 | | | 0.268 | | | 0.291 | | | 0.313 | | | 0.332 | | | 0.350 | | | 0.361 |
24 months | | | 0.173 | | | 0.204 | | | 0.233 | | | 0.260 | | | 0.285 | | | 0.308 | | | 0.329 | | | 0.348 | | | 0.361 |
21 months | | | 0.161 | | | 0.193 | | | 0.223 | | | 0.252 | | | 0.279 | | | 0.304 | | | 0.326 | | | 0.347 | | | 0.361 |
18 months | | | 0.146 | | | 0.179 | | | 0.211 | | | 0.242 | | | 0.271 | | | 0.298 | | | 0.322 | | | 0.345 | | | 0.361 |
15 months | | | 0.130 | | | 0.164 | | | 0.197 | | | 0.230 | | | 0.262 | | | 0.291 | | | 0.317 | | | 0.342 | | | 0.361 |
12 months | | | 0.111 | | | 0.146 | | | 0.181 | | | 0.216 | | | 0.250 | | | 0.282 | | | 0.312 | | | 0.339 | | | 0.361 |
9 months | | | 0.090 | | | 0.125 | | | 0.162 | | | 0.199 | | | 0.237 | | | 0.272 | | | 0.305 | | | 0.336 | | | 0.361 |
6 months | | | 0.065 | | | 0.099 | | | 0.137 | | | 0.178 | | | 0.219 | | | 0.259 | | | 0.296 | | | 0.331 | | | 0.361 |
3 months | | | 0.034 | | | 0.065 | | | 0.104 | | | 0.150 | | | 0.197 | | | 0.243 | | | 0.286 | | | 0.326 | | | 0.361 |
0 months | | | — | | | — | | | 0.042 | | | 0.115 | | | 0.179 | | | 0.233 | | | 0.281 | | | 0.323 | | | 0.361 |
• | the title of such warrants; |
• | the aggregate number of such warrants; |
• | the price or prices at which such warrants will be issued; |
• | the currency or currencies in which the price of such warrants will be payable; |
• | the securities or other rights, including rights to receive payment in cash or securities based on the value, rate or price of one or more specified commodities, currencies, securities or indices, or any combination of the foregoing, purchasable upon exercise of such warrants; |
• | the price at which and the currency or currencies in which the securities or other rights purchasable upon exercise of such warrants may be purchased; |
• | the date on which the right to exercise such warrants shall commence and the date on which such right shall expire; |
• | if applicable, the minimum or maximum amount of such warrants which may be exercised at any one time; |
• | if applicable, the designation and terms of the securities with which such warrants are issued and the number of such warrants issued with each such security; |
• | if applicable, the date on and after which such warrants and the related securities will be separately transferable; |
• | information with respect to book-entry procedures, if any; |
• | if applicable, a discussion of any material United States Federal income tax considerations; and |
• | any other terms of such warrants, including terms, procedures and limitations relating to the exchange and exercise of such warrants. |
• | the terms of the units and of the warrants, debt securities, preference shares and Common Shares comprising the units, including whether and under what circumstances the securities comprising the units may be traded separately; |
• | a description of the terms of any unit agreement governing the units; and |
• | a description of the provisions for the payment, settlement, transfer or exchange of the units. |
• | at a fixed price or prices, which may be changed; |
• | at market prices prevailing at the time of sale; |
• | at prices related to such prevailing market prices; or |
• | at negotiated prices. |
• | the name or names of any underwriters, dealers, agents or other purchasers; |
• | the purchase price of the securities or other consideration therefor, and the proceeds, if any, we will receive from the sale; |
• | any options to purchase additional shares or other options under which underwriters, dealers, agents or other purchasers may purchase additional securities from us; |
• | any agency fees or underwriting discounts and other items constituting agents’ or underwriters’ compensation; |
• | any public offering price; |
• | any discounts or concessions allowed or reallowed or paid to dealers; and |
• | any securities exchange or market on which the securities may be listed. |
• | our Annual Report on Form 10-K for the year ended March 31, 2022, filed with the SEC on June 28, 2022; |
• | our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, filed with the SEC on August 15, 2022; |
• | the information specifically incorporated by reference in our Annual Report on Form 10-K for the year ended March 31, 2022 from our Definitive Proxy Statement on Schedule 14A relating to our 2022 annual meeting of stockholders, filed with the SEC on July 26, 2022; |
• | our Current Report on Form 8-K filed with the SEC on June 28, 2022 (solely with respect to Item 5.02); and |
• | the description of our Common Shares in our registration statement on Form 8-A/A filed with the SEC on September 30, 2021, including any amendments thereto or reports filed for the purpose of updating such description. |
PRELIMINARY PROSPECTUS (Subject to Completion) | | | Dated September 19, 2022 |
• | commercially launched VTAMA® (tapinarof) cream 1% for the treatment of plaque psoriasis in adults; |
• | conducted nine international Phase 3 trials, the last eight of which have been successful; |
• | consummated a $3 billion upfront partnership with Sumitomo Pharma Co., Ltd. (“Sumitomo”); |
• | received six FDA approvals for drugs developed by Vants launched by Roivant, including VTAMA and four drugs that received FDA approval after their transfer to Sumitomo; |
• | built a broad and differentiated pipeline of drugs and drug candidates ranging from early discovery to commercial stage; and |
• | launched Roivant Discovery, our small molecule discovery engine, consisting of a collection of advanced computational physics capabilities, integrated with an in-house wet lab facility. |
• | 157,844,194 Common Shares issuable upon the exercise of options outstanding as of June 30, 2022, having a weighted average exercise price of $7.82 per share; |
• | 30,690,240 Common Shares issuable upon exercise of outstanding warrants as of June 30, 2022, having a weighted average exercise price of $11.50 per share; and |
• | 64,391,867 Common Shares issuable upon settlement of outstanding restricted stock units and capped value appreciation rights as of June 30, 2022. |
• | our limited operating history and risks involved in biopharmaceutical product development; |
• | our limited experience as a commercial-stage company and ability to successfully commercialize VTAMA® (tapinarof); |
• | our ability to raise additional capital to fund our business on acceptable terms or at all; |
• | the fact that we will likely incur significant operating losses for the foreseeable future; |
• | the impact of public health outbreaks, epidemics or pandemics (such as the COVID-19 pandemic) on our business (including our clinical trials and preclinical studies), operations and financial condition and results; |
• | our ability to acquire, in-license or discover new product candidates; |
• | our Vant structure and the potential that we may fail to capitalize on certain development opportunities; |
• | clinical trials and preclinical studies, which are very expensive, time-consuming, difficult to design and implement and involve uncertain outcomes; |
• | the unproven nature of our approach to the discovery and development of product candidates from our small molecule discovery engine; |
• | the novelty, complexity and difficulty of manufacturing certain of our products and product candidates, including any manufacturing problems that result in delays in development or commercialization of our products and product candidates; |
• | difficulties we may face in enrolling and retaining patients in clinical trials and/or clinical development activities; |
• | the results of our clinical trials not supporting our proposed claims for a product candidate; |
• | changes in interim, top-line and/or preliminary data from our clinical trials changing as more data becoming available or being delayed due to audit and verification process; |
• | changes in product manufacturing or formulation that could lead to the incurrence of costs or delays; |
• | the failure of any third-party we contract with to conduct, supervise and monitor our clinical trials to perform in a satisfactory manner or to comply with applicable requirements; |
• | the fact that obtaining approvals for new drugs is a lengthy, extensive, expensive and unpredictable process that may end with our inability to obtain regulatory approval by the FDA or other regulatory agencies in other jurisdictions; |
• | the failure of our clinical trials to demonstrate substantial evidence of the safety and efficacy of our products and product candidates, including, but not limited to, scenarios in which our products and product candidates may cause adverse effects that could delay regulatory approval, discontinue clinical trials, limit the scope of approval or generally result in negative media coverage of us; |
• | our inability to obtain regulatory approval for a product or product candidate in certain jurisdictions, even if we are able to obtain approval in certain other jurisdictions; |
• | our ability to effectively manage growth and to attract and retain key personnel; |
• | any business, legal, regulatory, political, operational, financial and economic risks associated with conducting business globally; |
• | our ability to obtain and maintain patent and other intellectual property protection for our technology, products and product candidates; |
• | the inadequacy of patent terms and their scope to protect our competitive position; |
• | the failure to issue (or the threatening of their breadth or strength of protection) or provide meaningful exclusivity for our current and future products and product candidates of our patent applications that we hold or have in-licensed; |
• | the fact that we do not currently and may not in the future own or license any issued composition of matter patents covering certain of our products and product candidates and our inability to be certain that any of our other issued patents will provide adequate protection for such products and product candidates; |
• | the fact that our largest shareholders (and certain members of our management team) own a significant percentage of our shares and will be able to exert significant control over matters subject to shareholder approval; |
• | the outcome of any pending or potential litigation, including but not limited to our expectations regarding the outcome of any such litigation and costs and expenses associated with such litigation; |
• | changes in applicable laws or regulations; |
• | the possibility that we may be adversely affected by other economic, business and/or competitive factors; and |
• | other risks and uncertainties indicated from time to time in filings made with the SEC. |
• | our Annual Report on Form 10-K for the year ended March 31, 2022, filed with the SEC on June 28, 2022; |
• | our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, filed with the SEC on August 15, 2022; |
• | the information specifically incorporated by reference in our Annual Report on Form 10-K for the year ended March 31, 2022 from our Definitive Proxy Statement on Schedule 14A relating to our 2022 annual meeting of stockholders, filed with the SEC on July 26, 2022; |
• | our Current Report on Form 8-K filed with the SEC on June 28, 2022 (solely with respect to Item 5.02); and |
• | the description of our Common Shares in our registration statement on Form 8-A/A filed with the SEC on September 30, 2021, including any amendments thereto or reports filed for the purpose of updating such description. |
PRELIMINARY PROSPECTUS (Subject to Completion) | | | Dated September 19, 2022 |
• | commercially launched VTAMA® (tapinarof) cream 1% for the treatment of plaque psoriasis in adults; |
• | conducted nine international Phase 3 trials, the last eight of which have been successful; |
• | consummated a $3 billion upfront partnership with Sumitomo Pharma Co., Ltd. (“Sumitomo”); |
• | received six FDA approvals for drugs developed by Vants launched by Roivant, including VTAMA and four drugs that received FDA approval after their transfer to Sumitomo; |
• | built a broad and differentiated pipeline of drugs and drug candidates ranging from early discovery to commercial stage; and |
• | launched Roivant Discovery, our small molecule discovery engine, consisting of a collection of advanced computational physics capabilities, integrated with an in-house wet lab facility. |
• | our limited operating history and risks involved in biopharmaceutical product development; |
• | our limited experience as a commercial-stage company and ability to successfully commercialize VTAMA® (tapinarof); |
• | our ability to raise additional capital to fund our business on acceptable terms or at all; |
• | the fact that we will likely incur significant operating losses for the foreseeable future; |
• | the impact of public health outbreaks, epidemics or pandemics (such as the COVID-19 pandemic) on our business (including our clinical trials and preclinical studies), operations and financial condition and results; |
• | our ability to acquire, in-license or discover new product candidates; |
• | our Vant structure and the potential that we may fail to capitalize on certain development opportunities; |
• | clinical trials and preclinical studies, which are very expensive, time-consuming, difficult to design and implement and involve uncertain outcomes; |
• | the unproven nature of our approach to the discovery and development of product candidates from our small molecule discovery engine; |
• | the novelty, complexity and difficulty of manufacturing certain of our products and product candidates, including any manufacturing problems that result in delays in development or commercialization of our products and product candidates; |
• | difficulties we may face in enrolling and retaining patients in clinical trials and/or clinical development activities; |
• | the results of our clinical trials not supporting our proposed claims for a product candidate; |
• | changes in interim, top-line and/or preliminary data from our clinical trials changing as more data becoming available or being delayed due to audit and verification process; |
• | changes in product manufacturing or formulation that could lead to the incurrence of costs or delays; |
• | the failure of any third-party we contract with to conduct, supervise and monitor our clinical trials to perform in a satisfactory manner or to comply with applicable requirements; |
• | the fact that obtaining approvals for new drugs is a lengthy, extensive, expensive and unpredictable process that may end with our inability to obtain regulatory approval by the FDA or other regulatory agencies in other jurisdictions; |
• | the failure of our clinical trials to demonstrate substantial evidence of the safety and efficacy of our products and product candidates, including, but not limited to, scenarios in which our products and product candidates may cause adverse effects that could delay regulatory approval, discontinue clinical trials, limit the scope of approval or generally result in negative media coverage of us; |
• | our inability to obtain regulatory approval for a product or product candidate in certain jurisdictions, even if we are able to obtain approval in certain other jurisdictions; |
• | our ability to effectively manage growth and to attract and retain key personnel; |
• | any business, legal, regulatory, political, operational, financial and economic risks associated with conducting business globally; |
• | our ability to obtain and maintain patent and other intellectual property protection for our technology, products and product candidates; |
• | the inadequacy of patent terms and their scope to protect our competitive position; |
• | the failure to issue (or the threatening of their breadth or strength of protection) or provide meaningful exclusivity for our current and future products and product candidates of our patent applications that we hold or have in-licensed; |
• | the fact that we do not currently and may not in the future own or license any issued composition of matter patents covering certain of our products and product candidates and our inability to be certain that any of our other issued patents will provide adequate protection for such products and product candidates; |
• | the fact that our largest shareholders (and certain members of our management team) own a significant percentage of our shares and will be able to exert significant control over matters subject to shareholder approval; |
• | the outcome of any pending or potential litigation, including but not limited to our expectations regarding the outcome of any such litigation and costs and expenses associated with such litigation; |
• | changes in applicable laws or regulations; |
• | the possibility that we may be adversely affected by other economic, business and/or competitive factors; and |
• | other risks and uncertainties indicated from time to time in filings made with the SEC. |
| | Common Shares | ||||||||||
Name | | | Number Beneficially Owned Prior to Offering | | | Number Registered for Sale Hereby | | | Number Beneficially Owned After Offering | | | Percent Owned After Offering |
SVF Investments(1) | | | 99,375,586 | | | 99,375,586 | | | — | | | — |
QVT Entities(2) | | | 129,393,817 | | | 129,393,817 | | | — | | | — |
Dexxon Holdings(3)(**) | | | 98,849,443 | | | 98,849,443 | | | — | | | — |
Viking Global Entities(4) | | | 88,238,700 | | | 88,238,700 | | | — | | | — |
Sumitomo Pharma(5) | | | 86,367,360 | | | 86,367,360 | | | — | | | — |
Vivek Ramaswamy(**) | | | 79,322,818 | | | 58,409,211 | | | 20,913,607 | | | 2.9% |
Parkway Limited(6) | | | 595,400 | | | 197,036 | | | 398,364 | | | * |
Chengwei Capital HK Limited(7) | | | 11,575,980 | | | 3,830,829 | | | 7,745,151 | | | 1.1% |
Sequoia Capital China(8) | | | 5,205,418 | | | 1,639,419 | | | 3,565,999 | | | * |
Junson Development International Limited(9) | | | 2,161,562 | | | 680,773 | | | 1,480,789 | | | * |
* | Less than 1%. |
** | Each of these holders continues to be subject to an extended lock-up covering their equity securities, including those registered hereby, as follows: (i) 25% of holdings are subject to a one year lock-up, measured from the closing of our business combination with Montes Archimedes Acquisition Corp. (the “Business Combination”) (which will expire on September 30, 2022) and (ii) 50% of holdings are subject to a three year lock-up, measured from the closing of the Business Combination. 25% of the holdings were subject to a six-month lock-up, measured from the closing of the Business Combination and the lock-up of such shares expired on March 30, 2022. |
(1) | Securities held of record by SVF Investments (UK) Limited (“SVF Investments”). SVF GP (Jersey) Limited is the general partner of Softbank Vision Fund LP, which is the managing member of SVF Holdings (UK) LLP (“SVF Holdings”), which is the sole owner of |
(2) | Consists of Common Shares held by QVT Financial Investment Cayman Ltd., QVT Roiv Hldgs Offshore Ltd., QVT Roiv Hldgs Onshore Ltd., QVT Deferred Compensation Holdings Ltd., QVT P&E Roiv Hldgs Ltd. and Fourth Avenue Capital Partners LP (together, the “QVT Entities”). Fourth Avenue Capital Partners GP LLC may be deemed to share beneficial ownership of the Common Shares held by Fourth Avenue Capital Partners LP. Each of QVT Financial LP and QVT Financial GP LLC may be deemed to share beneficial ownership of the Common Shares held by the QVT Entities. The Managing Members of QVT Financial GP LLC and Fourth Avenue Capital Partners GP LLC are Daniel Gold, Nicholas Brumm, Arthur Chu and Tracy Fu, each of whom disclaims beneficial ownership of the securities held by the QVT Entities. The principal business address for the QVT Entities, QVT Financial LP, QVT Financial GP LLC, Fourth Avenue Capital Partners GP LLC and the Managing Members is 888 Seventh Avenue, 43rd Floor, New York, NY 10106. |
(3) | Consists of Common Shares held by Dexxon Holdings Ltd. (“Dexxon Holdings”) and Dexcel Pharma Technologies Ltd. (“Dexcel Pharma”). Dan Oren is the sole shareholder and sole director of Dexxon Holdings and the ultimate (indirect) sole shareholder and the Executive Chairman of Dexcel Pharma. As such, each of Dexxon Holdings, Dexcel Pharma and Dan Oren may be deemed to share beneficial ownership of the Common Shares. The principal business address of Dexxon Holdings and Dan Oren is 1 Dexcel Street, Or Akiva, 3060000, Israel. The principal business address of Dexcel Pharma is 21 Nahum Haftzadi Street, Jerusalem, 9548402, Israel. |
(4) | Consists of Common Shares held by Viking Global Equities Master Ltd. (“VGEM”), Viking Global Equities II LP (“VGEII”), Viking Long Fund Master Ltd. (“VLFM”) and Viking Global Opportunities Illiquid Investments Sub-Master LP (“Opportunities Fund,” and together with all of the preceding entities, the “Viking Global Entities”). VGEM has the power to dispose of and vote the shares directly owned by it, which power may be exercised by its investment manager, Viking Global Performance LLC (“VGP”), and by Viking Global Investors LP (“VGI”), which provides managerial services to VGEM. VGEII has the authority to dispose of and vote the shares directly owned by it, which power may be exercised by its general partner, VGP, and by VGI, which provides managerial services to VGEII. VLFM has the authority to dispose of and vote the shares directly owned by it, which power may be exercised by its investment manager, Viking Long Fund GP LLC (“VLFGP”), and by VGI, which provides managerial services to VLFM. Opportunities Fund has the authority to dispose of and vote the shares directly owned by it, which power may be exercised by its general partner, Viking Global Opportunities Portfolio GP LLC (“Opportunities GP”), and by VGI, which provides managerial services to Opportunities Fund. O. Andreas Halvorsen, David C. Ott and Rose Shabet, as Executive Committee members of Viking Global Partners LLC (the general partner of VGI), VGP, VLFGP and Viking Global Opportunities Parent GP LLC (the sole member of Viking Global Opportunities GP LLC, which is the sole member of Opportunities GP) have shared authority to direct the voting and disposition of investments beneficially owned by VGI, VGP, VLFGP and Opportunities GP. The business address of each of the Viking Global Entities is 55 Railroad Avenue, Greenwich, Connecticut 06830. |
(5) | Consists of Common Shares held by Sumitomo Pharma Co., Ltd. (“Sumitomo”). The principal business address of Sumitomo is 6-8 Doshomachi 2-chome, Chuo-ku, Osaka 541-0045 Japan. |
(6) | Xie Yi Jing is a director of Parkway Limited and has voting and dispositive power over the Common Shares. The address of each of Mr. Jing and Parkway Limited is 25F East Tower, Raffles City, the Bund, No. 1089 East Daming Road, Shanghai, China. |
(7) | Chengwei Capital HK Limited is wholly owned by Chengwei Evergreen Capital, LP. Chengwei Evergreen Management, LLC is the general partner and wholly controls Chengwei Evergreen Capital, LP. Chengwei Evergreen Management, LLC in return is controlled by EXL Holdings, LLC, which is controlled by Eric X. Li. Eric X. Li is a Director of Chengwei Capital HK Limited and has voting and dispositive power over the Common Shares. The address of each of Eric X. Li and Chengwei Capital HK Limited is Room 3303A The Centrium, 60 Wyndham Street Central, Hong Kong. |
(8) | SCC Venture VII Holdco H, Ltd. is an exempted company with limited liability incorporated under the law of the Cayman Islands, and is wholly owned by Sequoia Capital China Venture Fund VII, L.P. The general partner of Sequoia Capital China Venture Fund VII, L.P. is SC China Venture VII Management, L.P., whose general partner is SC China Holding Limited. SC China Holding Limited is wholly owned by SNP China Enterprises Limited, which in turn is wholly owned by Mr. Neil Nanpeng Shen. The registered address of SCC Venture VII Holdco H, Ltd. is Maples Corporate Services Limited, PO Box 309, Ugland House, Grand Cayman, KY1-1104, Cayman Islands. |
(9) | Mr. Kui CAI is a director of Junson Development International Limited and has voting and dispositive power over the Common Shares. The address of each of Mr. Kui CAI and Junson Development International Limited is Units 4607-11, 46/F, The Center, 99 Queen’s Road Central, Hong Kong. |
• | purchases by a broker-dealer as principal and resale by such broker-dealer for its own account pursuant to this prospectus; |
• | ordinary brokerage transactions and transactions in which the broker solicits purchasers; |
• | block trades in which the broker-dealer so engaged will attempt to sell the shares as agent but may position and resell a portion of the block as principal to facilitate the transaction; |
• | an over-the-counter distribution in accordance with the rules of Nasdaq; |
• | through trading plans entered into by a Holder pursuant to Rule 10b5-1 under the Exchange Act, that are in place at the time of an offering pursuant to this prospectus and any applicable prospectus supplement hereto that provide for periodic sales of their securities on the basis of parameters described in such trading plans; |
• | to or through underwriters or broker-dealers; |
• | in “at the market” offerings, as defined in Rule 415 under the Securities Act, at negotiated prices, at prices prevailing at the time of sale or at prices related to such prevailing market prices, including sales made directly on a national securities exchange or sales made through a market maker other than on an exchange or other similar offerings through sales agents; |
• | in privately negotiated transactions; |
• | in options transactions; |
• | through a combination of any of the above methods of sale; or |
• | any other method permitted by applicable law. |
• | our Annual Report on Form 10-K for the year ended March 31, 2022, filed with the SEC on June 28, 2022; |
• | our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, filed with the SEC on August 15, 2022; |
• | the information specifically incorporated by reference in our Annual Report on Form 10-K for the year ended March 31, 2022 from our Definitive Proxy Statement on Schedule 14A relating to our 2022 annual meeting of stockholders, filed with the SEC on July 26, 2022; |
• | our Current Report on Form 8-K filed with the SEC on June 28, 2022 (solely with respect to Item 5.02); and |
• | the description of our Common Shares in our registration statement on Form 8-A/A filed with the SEC on September 30, 2021, including any amendments thereto or reports filed for the purpose of updating such description. |
Item 14. | Other Expenses of Issuance and Distribution |
| | Amount | |
SEC registration fee | | | $92,712.29 |
Nasdaq Global Market fee | | | (1) |
FINRA filing fee | | | (1) |
Accounting fees and expenses | | | (1) |
Legal fees and expenses | | | (1) |
Transfer agent and registrar fees and expenses | | | (1) |
Printing and miscellaneous fees and expenses | | | (1) |
Total | | | (1) |
(1) | The amount of securities and number of offerings are indeterminable and the expenses cannot be estimated at this time. An estimate of the aggregate expenses in connection with the sale and distribution of securities being offered will be included in the applicable prospectus supplement. |
Item 15. | Indemnification of Directors and Officers |
Item 16. | Exhibits |
| | | | Incorporation By Reference | ||||||||||||||
Exhibit Number | | | Exhibit Description | | | Form | | | SEC File No. | | | Exhibit | | | Filing Date | | | Filed Herewith |
1.1* | | | Form of Underwriting Agreement. | | | | | | | | | | | |||||
| | Sales Agreement, by and between the Registrant and Cowen and Company, LLC, dated September 19, 2022. | | | | | | | | | | | X | |||||
| | Memorandum of Association of Roivant Sciences Ltd. | | | S-4/A | | | 333-256165 | | | 3.1 | | | 07/01/2021 | | | ||
| | Amended and Restated Bye-laws of Roivant Sciences Ltd. | | | 8-K | | | 001-40782 | | | 3.1 | | | 10/01/2021 | | | ||
4.1* | | | Specimen Preference Shares Certificate and Form of Certificate of Designation of Preference Shares. | | | | | | | | | | | |||||
| | Form of Senior Debt Indenture. | | | | | | | | | | | X | |||||
| | Form of Subordinated Debt Indenture. | | | | | | | | | | | X | |||||
4.4* | | | Form of Senior Note. | | | | | | | | | | | |||||
4.4* | | | Form of Subordinated Note. | | | | | | | | | | | |||||
4.5* | | | Form of Warrant Agreement and Warrant Certificate. | | | | | | | | | | | |||||
4.6* | | | Form of Unit Agreement. | | | | | | | | | | | |||||
| | Opinion of Conyers Dill & Pearlman Limited. | | | | | | | | | | | X | |||||
| | Consent of Ernst & Young LLP, Independent Registered Public Accounting Firm of Roivant Sciences Ltd. | | | | | | | | | | | X | |||||
| | Consent of Conyers Dill & Pearlman Limited (included in Exhibit 5.1). | | | | | | | | | | | X | |||||
| | Power of Attorney. Reference is made to the signature pages of this Form S-3. | | | | | | | | | | | ||||||
25.1** | | | Statement of Eligibility of Trustee under the Indenture. | | | | | | | | | | | |||||
| | Calculation of Filing Fee Tables | | | | | | | | | | | X |
* | To be filed by amendment or as an exhibit to a Current Report on Form 8-K and incorporated herein by reference, if applicable. |
** | To be filed in accordance with the requirements of Section 305(b)(2) of the Trust Indenture Act of 1939, as amended, and the applicable rules thereunder. |
Item 17. | Undertakings |
(1) | To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement: |
(i) | to include any prospectus required by Section 10(a)(3) of the Securities Act of 1933; |
(ii) | to reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the |
(iii) | to include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement; |
(2) | That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
(3) | To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering. |
(4) | That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser: |
(i) | Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and |
(ii) | Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information required by Section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date. |
(5) | That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution of the securities, the undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser: |
(i) | Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424; |
(ii) | Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant; |
(iii) | The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and |
(iv) | Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser. |
(6) | That, for the purpose of determining liability of the registrant under the Securities Act of 1933, each filing of the registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
| | ROIVANT SCIENCES LTD. | |||||||
| | | | | | ||||
| | By: | | | /s/ Matt Maisak | ||||
| | | | Name: | | | Matt Maisak | ||
| | | | Title: | | | Authorized Signatory |
Name | | | Title | | | Date |
| | | | |||
/s/ Matthew Gline | | | Chief Executive Officer and Director (principal executive officer) | | | September 19, 2022 |
Matthew Gline | | |||||
| | | | |||
/s/ Richard Pulik | | | Chief Financial Officer (principal financial officer) | | | September 19, 2022 |
Richard Pulik | | |||||
| | | | |||
/s/ Rakhi Kumar | | | Chief Accounting Officer (principal accounting officer) | | | September 19, 2022 |
Rakhi Kumar | | |||||
| | | | |||
/s/ Vivek Ramaswamy | | | Director | | | September 19, 2022 |
Vivek Ramaswamy | | |||||
| | | | |||
/s/ Andrew Lo | | | Director | | | September 19, 2022 |
Andrew Lo | | |||||
| | | | |||
/s/ Melissa Epperly | | | Director | | | September 19, 2022 |
Melissa Epperly | | |||||
| | | | |||
/s/ Keith Manchester | | | Director | | | September 19, 2022 |
Keith Manchester | | |||||
| | | | |||
/s/ Ilan Oren | | | Director | | | September 19, 2022 |
Ilan Oren | | |||||
| | | | |||
/s/ Daniel Gold | | | Director | | | September 19, 2022 |
Daniel Gold | | |||||
| | | | |||
| | Director | | | ||
Hiroshi Nomura | | |||||
| | | | |||
/s/ James C. Momtazee | | | Director | | | September 19, 2022 |
James C. Momtazee | |