-Landmark Settlement with Sumitomo Dainippon Pharma to offer main monetary backing and safeguards for minority shareholders
-Myovant to report top-line information from Part three HERO research in superior prostate most cancers by the top of calendar yr 2019 and Part three SPIRIT research in endometriosis within the first and second quarters of calendar yr 2020
-Myovant secured dedication from Roivant Sciences and Sumitomo Dainippon Pharma for a precedence assessment voucher (PRV) anticipated to turn into accessible in early December 2019
-Submission of New Drug Utility (NDA) for uterine fibroids along with PRV now anticipated in April 2020 with a purpose to embody 12-month security information to reinforce prospects for labeled period of use
BASEL, Switzerland, Nov. 12, 2019 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV), a healthcare firm targeted on growing revolutionary remedies for ladies’s well being and prostate most cancers, immediately introduced latest company updates and reported monetary outcomes for the second fiscal quarter ended September 30, 2019.
“Myovant continues to make nice progress in the direction of our milestones and is poised for a robust business launch of relugolix if accepted, with two constructive Part three research evaluating relugolix mixture remedy in ladies with uterine fibroids and roughly $500 million in whole money and dedicated financing, together with the Sumitomo Dainippon Pharma time period mortgage facility,” stated Lynn Seely, M.D., President and CEO of Myovant Sciences. “Bringing a brand new remedy to the hundreds of thousands of ladies that suffer from uterine fibroids and endometriosis has been the important thing imaginative and prescient for the event of Myovant’s relugolix mixture pill. The usage of a precedence assessment voucher allows us to expedite the assessment of our NDA whereas strengthening the information package deal within the submission to assist this goal.”
Second Fiscal Quarter 2019 and Current Enterprise Highlights
Relugolix Part three Scientific Packages
- In July 2019, Myovant introduced constructive top-line information from LIBERTY 2, the second of two Part three research evaluating relugolix mixture remedy (relugolix 40 mg plus estradiol 1.zero mg and norethindrone acetate zero.5 mg) in ladies with uterine fibroids and heavy menstrual bleeding. Outcomes from a separate bioequivalence research assist submission to the FDA of a possible one pill, once-daily dosing routine of relugolix mixture remedy. As well as, the 12-month security information from the LIBERTY open-label extension research are anticipated within the first quarter of calendar yr 2020.
- Roivant Sciences and Sumitomo Dainippon Pharma have dedicated to Myovant a precedence assessment voucher (PRV) anticipated to turn into accessible in early December 2019. Myovant plans to make use of the PRV along side its NDA submission for a once-daily, relugolix mixture pill for the remedy of heavy menstrual bleeding and uterine fibroids, doubtlessly lowering the usual FDA assessment time. Myovant has determined to defer its NDA submission for a once-daily, relugolix mixture pill for the remedy of heavy menstrual bleeding and uterine fibroids till April 2020, which might enable inclusion of the entire 12-month security information from the LIBERTY open-label extension research, key information that will positively affect the labeled period of use of the mix pill. The phrases relating to how the PRV can be transferred to Myovant can be decided in reference to the closing of the Roivant-Sumitomo Dainippon Pharma transaction. The switch is predicted to be a related-party transaction and won’t contain the issuance of Myovant shares. Myovant nonetheless plans to submit a Advertising and marketing Authorisation Utility (MAA) to the European Medicines Company within the first quarter of calendar yr 2020.
- In July 2019, Myovant accomplished enrollment of a further cohort of 139 males with metastatic prostate most cancers within the Part three HERO research with a purpose to assess the secondary goal of demonstrating that relugolix can delay the time to development of the deadly state of the illness, castration-resistant prostate most cancers, as in comparison with leuprolide. Myovant expects the top-line information readout for the HERO research by the top of calendar yr 2019, with outcomes from this extra cohort, together with the castration resistance-free survival endpoint, anticipated within the third quarter of calendar yr 2020. Myovant additionally anticipates submitting its NDA for its once-daily, oral relugolix monotherapy pill for males with superior prostate most cancers within the second quarter of calendar yr 2020.
- In August and October 2019, Myovant accomplished affected person recruitment for the Part three SPIRIT 2 and SPIRIT 1 research, respectively, evaluating the security and efficacy of relugolix mixture remedy in ladies with ache related to endometriosis. Myovant expects to report top-line outcomes from SPIRIT 2 and SPIRIT 1 within the first and second quarters of calendar yr 2020, respectively.
- In October 2019, Myovant entered right into a landmark settlement with Sumitomo Dainippon Pharma to safe a $350 million low-interest, five-year time period mortgage facility, with no funds due till the top of the time period, and an Traders Rights Settlement, which is meant to offer safeguards to minority shareholders. The time period mortgage facility and Traders Rights Settlement are anticipated to turn into efficient in reference to the closing of Sumitomo Dainippon Pharma’s transaction with Roivant.
Second Fiscal Quarter 2019 Monetary Abstract
Analysis and improvement (R&D) bills for the quarter ended September 30, 2019, have been $50.eight million in comparison with $53.eight million for the comparable prior yr interval. R&D bills in each intervals primarily embody bills associated to Myovant’s Part three medical research, manufacturing bills in addition to personnel-related bills for workers engaged in R&D actions. R&D bills associated to Myovant’s medical research have continued to say no pushed primarily by the wind down of Myovant’s LIBERTY Part three research. The lower in research prices have been partially offset by will increase in different R&D bills associated predominantly to Myovant’s manufacturing actions in reference to preparations for Myovant’s anticipated business launches and regulatory submissions for relugolix in a number of indications and jurisdictions, in addition to will increase in personnel bills, share-based compensation expense, and different R&D bills.
Basic and administrative (G&A) bills for the quarter ended September 30, 2019, have been $16.6 million in comparison with $10.three million for the comparable prior yr interval. The rise primarily displays will increase in personnel-related bills, share-based compensation, skilled service charges, bills associated to business operations actions prematurely of potential regulatory approvals of relugolix, and different basic overhead and administrative bills to assist Myovant’s headcount development and increasing operations which was partially pushed by the belief of actions beforehand offered by Roivant.
Curiosity expense for the quarter ended September 30, 2019, was $three.eight million in comparison with $1.6 million within the comparable prior yr interval. The rise for the quarter was primarily the results of increased excellent debt balances beneath Myovant’s financing agreements as in comparison with the prior yr interval.
Curiosity earnings for the quarter ended September 30, 2019, was $zero.9 million. There was no curiosity earnings for the quarter ended September 30, 2018. In the course of the quarter ended September 30, 2019, a portion of Myovant’s money was invested in a mixture of cash market funds, business paper, and short-term company bonds. There have been no such investments throughout the comparable prior yr interval.
Web loss for the quarter ended September 30, 2019, was $70.6 million, in comparison with $65.eight million for the comparable prior yr interval. The rise within the web loss for the quarter was pushed primarily by the rise in prices outlined above. On a per widespread share foundation, web loss was $zero.79 and $zero.99 for the quarters ended September 30, 2019, and 2018, respectively. The lower within the web loss per widespread share for the quarter was on account of a rise within the weighted-average widespread shares excellent primarily on account of Myovant’s underwritten public fairness providing in June 2019.
Capital sources: Money, money equivalents, and marketable securities totaled $157.6 million as of September 30, 2019. Myovant’s time period mortgage facility to be entered into with Sumitomo Dainippon Pharma, which is predicted to turn into efficient in reference to the shut of the Sumitomo-Roivant transaction, is predicted to offer a further $350.zero million of capital to assist Myovant’s operations.
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces ovarian estradiol manufacturing, a hormone identified to stimulate the expansion of uterine fibroids and endometriosis, and testicular testosterone manufacturing, a hormone identified to stimulate the expansion of prostate most cancers. Myovant Sciences is growing a relugolix mixture pill (relugolix 40 mg plus estradiol 1.zero mg and norethindrone acetate zero.5 mg) for ladies with heavy menstrual bleeding related to uterine fibroids and for ladies with endometriosis-associated ache. Myovant can also be evaluating relugolix monotherapy (120 mg as soon as every day) in males with superior prostate most cancers.
MVT-602 is an oligopeptide kisspeptin-1 receptor agonist. Kisspeptin, the ligand, is a naturally-occurring peptide that stimulates GnRH launch and is required for puberty and upkeep of regular reproductive operate, together with manufacturing of sperm, follicular maturation and ovulation, and manufacturing of estrogen and progesterone in ladies and testosterone in males. A Part 2a medical research in wholesome feminine volunteers to characterize the dose-response curve in a minimal managed ovarian stimulation setting has been accomplished.
About Myovant Sciences
Myovant Sciences aspires to be the main healthcare firm targeted on revolutionary remedies for ladies’s well being and prostate most cancers. The corporate’s lead product candidate is relugolix, a once-daily, oral GnRH receptor antagonist. The corporate has three late-stage medical packages for relugolix in uterine fibroids, endometriosis, and prostate most cancers. The corporate can also be growing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, that has accomplished a Part 2a research for the remedy of feminine infertility as a part of assisted replica. Takeda Prescription drugs Worldwide AG, a subsidiary of Takeda Pharmaceutical Firm Restricted, granted the corporate an unique, worldwide license to develop and commercialize relugolix (excluding Japan and sure different Asian international locations) and an unique license to develop and commercialize MVT-602 in all international locations worldwide. For extra data, please go to the corporate’s web site at www.myovant.com. Observe @Myovant on Twitter and LinkedIn.
This press-release comprises forward-looking statements throughout the that means of the Personal Securities Litigation Reform Act of 1995. Ahead-looking statements embody all statements relating to Myovant Sciences’ intent, perception, or expectations relating to future occasions or outcomes and will be recognized by phrases resembling “anticipate,” “aspire,” “consider,” “can,” “proceed,” “may,” “estimate,” “count on,” “intend,” “seemingly,” “might,” “would possibly,” “goal,” “ongoing,” “plan,” “potential,” “predict,” “challenge,” “ought to,” “to be,” “will,” “would,” or the unfavourable or plural of those phrases or different related expressions or variations, though not all forward-looking statements include these figuring out phrases. On this press launch, forward-looking statements embody, however should not restricted to, statements relating to Myovant Sciences’ aspirations to turn into the main healthcare firm targeted on revolutionary remedies for ladies’s well being and prostate most cancers; the anticipated timing and phrases of agreements with Sumitomo Dainippon Pharma, together with an anticipated mortgage facility and Traders Rights Settlement; the anticipated timing of bulletins of knowledge from Myovant’s medical research, together with the Part three HERO and SPIRIT research; the anticipated timing of Myovant Sciences’ uterine fibroids NDA submission to the FDA and Advertising and marketing Authorisation Utility to the European Medicines Company; the potential for Myovant Sciences to acquire a precedence assessment voucher from Roivant Sciences and Sumitomo Dainippon Pharma and the probability and timing of when such precedence assessment voucher is predicted to be accessible and transferred to Myovant Sciences.
Myovant Sciences’ forward-looking statements are based mostly on administration’s present expectations and beliefs and are topic to quite a few dangers, uncertainties, assumptions and different components identified and unknown that might trigger precise outcomes and the timing of sure occasions to vary materially from future outcomes expressed or implied by the forward-looking statements. Myovant Sciences can not guarantee you that the occasions and circumstances mirrored within the forward-looking statements can be achieved or happen and precise outcomes may differ materially from these expressed or implied by these forward-looking statements. Elements that might materially have an effect on Myovant Sciences’ operations and future prospects or which may trigger precise outcomes to vary materially from expectations embody, however should not restricted to the dangers and uncertainties listed in Myovant Sciences’ filings with the USA Securities and Trade Fee (SEC), together with beneath the heading “Threat Elements” in Myovant Sciences’ Quarterly Report on Kind 10-Q filed with the SEC on August 6, 2019, and in Myovant Sciences’ future filings with the SEC together with with out limitation, Myovant Sciences’ Quarterly Report on Kind 10-Q anticipated to be filed with the SEC on or about November 12, 2019, as such threat components could also be amended, supplemented or outmoded every so often by different experiences Myovant Sciences information with the SEC. As well as, the phrases of the time period mortgage facility, the Traders Rights Settlement and the precedence assessment voucher switch with Sumitomo Dainippon Pharma, though agreed to be entered into, haven’t but been totally negotiated, and are anticipated to be negotiated, entered into and turn into efficient in reference to the closing of Sumitomo Dainippon Pharma’s transaction with Roivant Sciences. Because of this, sudden disagreements might come up within the negotiations of those agreements that will delay or forestall the coming into into of those agreements; additional, these agreements will solely turn into efficient upon closing of Sumitomo Dainippon Pharma’s transaction with Roivant Sciences, which if the closing doesn’t happen will trigger these agreements to not turn into efficient. These dangers should not exhaustive. New threat components emerge every so often and it’s not doable for Myovant Sciences’ administration to foretell all threat components, nor can Myovant Sciences assess the affect of all components on its enterprise or the extent to which any issue, or mixture of things, might trigger precise outcomes to vary materially from these contained in any forward-looking statements. You shouldn’t place undue reliance on the forward-looking statements on this press launch, which communicate solely as of the date hereof, and, besides as required by regulation, Myovant Sciences undertakes no obligation to replace these forward-looking statements to mirror occasions or circumstances after the date of such statements, besides as could also be required by regulation.
MYOVANT SCIENCES LTD.
Condensed Consolidated Statements of Operations
(Unaudited, in 1000’s, besides share and per share information)
|Three Months Ended September 30,||Six Months Ended September 30,|
|Analysis and improvement (1)||$||50,803||$||53,813||$||101,920||$||105,154|
|Basic and administrative (1)||16,603||10,310||30,755||19,052|
|Whole working bills||67,406||64,123||132,675||124,206|
|Different expense (earnings), web||121||(21||)||(584||)||268|
|Loss earlier than earnings taxes||(70,373||)||(65,682||)||(137,964||)||(127,671||)|
|Earnings tax expense||195||88||508||233|
|Web loss per widespread share — fundamental and diluted||$||(zero.79||)||$||(zero.99||)||$||(1.68||)||$||(1.97||)|
|Weighted common widespread shares excellent — fundamental and diluted||88,798,398||66,666,876||82,667,061||64,997,698|
(1) Contains the next share-based compensation bills:
|Analysis and improvement||$||three,618||$||1,846||$||6,166||$||three,407|
|Basic and administrative||$||four,313||$||2,879||$||eight,217||$||5,562|
MYOVANT SCIENCES LTD.
Condensed Consolidated Stability Sheet
(Unaudited, in 1000’s)
|September 30, 2019||March 31, 2019|
|Money and money equivalents||$||130,373||$||156,074|
|Pay as you go bills and different present property||9,969||10,194|
|Earnings tax receivable||17||524|
|Whole present property||167,579||166,792|
|Property and gear, web||2,288||2,071|
|Working lease right-of-use asset||eight,973||—|
|Liabilities and Shareholders’ Fairness|
|Working lease legal responsibility||853||—|
|Resulting from Roivant Sciences Ltd., Roivant Sciences, Inc., and Roivant Sciences GmbH||271||121|
|Present maturities of long-term debt||eight,402||6,142|
|Whole present liabilities||60,zero30||71,973|
|Deferred curiosity payable||5,323||2,273|
|Lengthy-term working lease legal responsibility||9,320||—|
|Lengthy-term debt, much less present maturities||92,075||93,240|
|Whole shareholders’ fairness||17,254||four,334|
|Whole liabilities and shareholders’ fairness||$||184,002||$||172,977|
Chief Monetary Officer
Myovant Sciences, Inc.
SOURCE: Myovant Sciences