On May 10, 2022 Myovant Sciences (NYSE: MYOV), a biopharmaceutical company that aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy, reported financial results for the fourth fiscal quarter and fiscal year ended March 31, 2022 and provided other corporate updates (Press release, Myovant Sciences, MAY 10, 2022, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-announces-corporate-updates-and-financial-3 [SID1234614021]).

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"Fiscal year 2021 was a transformative year for Myovant as we expanded ORGOVYX utilization in the U.S. and successfully launched MYFEMBREE, finishing the year with another quarter of strong demand growth. Our recent approval of ORGOVYX in Europe and partnership with Accord, coupled with our prior approval of RYEQO, will enable more patients than ever to have access to these meaningful and differentiated medicines," said David Marek, Chief Executive Officer of Myovant Sciences, Inc. Mr. Marek added, "Our strong commercial momentum, advancement of our lifecycle and business development strategies, and our financial strength position Myovant for another exciting year in fiscal year 2022."

Fourth Fiscal Quarter 2021 and Recent Corporate Updates

ORGOVYX (relugolix 120 mg)

Fourth fiscal quarter 2021 net product revenues for ORGOVYX in the U.S. were $29.4 million, reflecting 21% sequential net product revenue growth compared to third fiscal quarter 2021. ORGOVYX commercial demand volume grew 18% quarter-over-quarter despite seasonality in patient refill patterns due to annual reset of Medicare Part D plans and payer deductibles typically seen in the beginning of the calendar year.
Approximately 3,500 new patients started treatment on ORGOVYX in the fourth fiscal quarter of 2021, reaching approximately 14,500 cumulative patients since launch.
ORGOVYX prescriber satisfaction continues to increase and reached 73% in April 2022, reflecting the desirability of its differentiated clinical profile.
In April 2022, the European Commission (EC) approved ORGOVYX as the first and only oral androgen deprivation therapy for advanced hormone-sensitive prostate cancer in Europe.
In May 2022, Myovant entered into an exclusive license agreement with Accord Healthcare, Ltd. (Accord) to commercialize ORGOVYX for the treatment of advanced hormone-sensitive prostate cancer in Europe, with the right of first negotiation if Myovant decides to enter into licensing arrangements in countries in the Middle East, Africa, and India. Myovant expects an upfront payment of $50.0 million in the first fiscal quarter 2022. Myovant is also eligible to receive up to $90.5 million in commercial launch, sales-based, and other milestones. In addition, Myovant is eligible to receive tiered royalties from the high-teens to mid-twenties on net sales of ORGOVYX. Accord is expected to launch ORGOVYX in Europe in the second half of calendar year 2022.
MYFEMBREE (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg)

MYFEMBREE net product revenues in the fourth fiscal quarter 2021 were $2.2 million in the U.S. MYFEMBREE commercial demand nearly doubled quarter-over-quarter. This growth was offset by a lower net price due to the January reset of commercial payer deductibles, increasing copay card benefits.
MYFEMBREE established market leadership in new-to-brand prescription (NBRx) share among GnRH antagonist therapies FDA-approved for the treatment of uterine fibroids within 8 months of launch and exited fourth fiscal quarter 2021 with 59% market share.
MYFEMBREE is driving total prescription growth of the GnRH antagonist for uterine fibroids class, which has grown 137% since launch of MYFEMBREE in June 2021, with 60% of MYFEMBREE prescribers being first time prescribers of a GnRH antagonist FDA-approved for the treatment of uterine fibroids.
On May 6, 2022, Myovant and Pfizer announced that the FDA extended the PDUFA goal date to August 6, 2022 for the supplemental New Drug Application (sNDA) for MYFEMBREE for the management of moderate to severe pain associated with endometriosis to allow time to review additional analyses related to bone mineral density submitted in response to the FDA’s information request. No new clinical data was requested by the FDA. The submission of the additional analyses has been determined by the FDA to constitute a Major Amendment to the sNDA, resulting in an extension of the PDUFA goal date.
Data from the SPIRIT long-term extension study demonstrated clinically meaningful improvements in dysmenorrhea (84.8% of patients) and non-menstrual pain (75.8% of patients) over two years in women with endometriosis-associated pain. The safety profile during the second year of treatment, including bone mineral density, was consistent with that observed during the first year with no new safety signals identified.
Expected Upcoming Milestones

Myovant expects the FDA decision for the MYFEMBREE sNDA seeking approval for the management of moderate to severe pain associated with endometriosis by its extended PDUFA goal date of August 6, 2022. FDA approval would trigger a $100.0 million milestone payment from Pfizer. If approved by the PDUFA goal date, Myovant and Pfizer expect to launch MYFEMBREE in the U.S. in endometriosis in August 2022. This indication would utilize the same dosage, formulation, administration, and branding as MYFEMBREE that was previously approved by the FDA in May 2021 for the management of heavy menstrual bleeding associated with uterine fibroids.
European Medicines Agency regulatory submission for RYEQO for the treatment of women with endometriosis-associated pain is expected in calendar year 2022. Gedeon Richter Plc. (Richter) will be the sponsor.
Myovant expects to submit New Drug Submissions to Health Canada seeking marketing approval for ORGOVYX for advanced prostate cancer, MYFEMBREE for heavy menstrual bleeding associated with uterine fibroids, and MYFEMBREE for the treatment of endometriosis-associated pain in Canada in calendar year 2022.
Myovant expects to present additional details around two-year data from the SPIRIT long-term extension study at a scientific conference in mid-calendar year 2022.
Accord is expected to launch ORGOVYX for the treatment of advanced hormone-sensitive prostate cancer in Europe in the second half of calendar year 2022.
Fourth Fiscal Quarter and Fiscal Year Ended March 31, 2022 Financial Summary

Total revenues for the three months ended March 31, 2022, and 2021 were $57.6 million and $24.6 million, respectively. Total revenues for the year ended March 31, 2022, and 2021 were $231.0 million and $59.3 million, respectively.

Product revenue, net for the three months and year ended March 31, 2022, were $32.4 million and $94.3 million, respectively, compared to $3.6 million for both the three months and year ended March 31, 2021. Product revenue, net consisted of the following:
Product revenue, net from sales of ORGOVYX in the U.S. for the three months and year ended March 31, 2022, were $29.4 million and $83.0 million, respectively, compared to $3.6 million for both the three months and year ended March 31, 2021. ORGOVYX was launched in the U.S. in January 2021.
Product revenue, net from sales of MYFEMBREE in the U.S. for the three months and year ended March 31, 2022, were $2.2 million and $6.4 million, respectively. There was no such revenue in the year ago periods. MYFEMBREE was launched in the U.S in June 2021.
Product revenue, net related to product supply to Richter for the three months and year ended March 31, 2022, were $0.7 million and $4.7 million, respectively. Product revenue, net related to royalties on net sales of RYEQO in Richter’s Territory for the three months and year ended March 31, 2022, were $0.1 million and $0.3 million, respectively. There was no such revenue in the year ago periods.
Pfizer collaboration revenue for the three months and year ended March 31, 2022 was $25.1 million and $105.0 million, respectively, reflecting the partial recognition of the upfront payment Myovant received from Pfizer upon entering into the Pfizer Collaboration and License Agreement in December 2020 and of the regulatory milestone payment from Pfizer that was triggered upon the FDA approval of MYFEMBREE for the management of heavy menstrual bleeding associated with uterine fibroids in May 2021. Pfizer collaboration revenue for the three months and year ended March 31, 2021, was $21.0 million and $22.4 million, respectively, reflecting the partial recognition of the upfront payment received from Pfizer.
Richter license and milestone revenue for the year ended March 31, 2022, was $31.7 million, reflecting the recognition of the remaining $16.7 million of previously deferred revenue as a result of Myovant’s delivery of the remaining substantive relugolix combination tablet data packages to Richter pursuant to the Richter Development and Commercialization Agreement, and the $15.0 million regulatory milestone payment triggered by the EC approval of RYEQO for the uterine fibroids indication. Richter license and milestone revenue for the year ended March 31, 2021, was $33.3 million, reflecting the partial recognition of revenue associated with the $40.0 million upfront payment and a $10.0 million regulatory milestone payment received from Richter under the Richter Development and Commercialization Agreement. There was no Richter license and milestone revenue for the three months ended March 31, 2022, and 2021.
Cost of product revenue for the three months and year ended March 31, 2022, was $3.6 million and $11.5 million, respectively, compared to $0.3 million for both the three months and year ended March 31, 2021, related to the cost of goods sold and royalty expense payable to Takeda pursuant to the Takeda License Agreement. The increase in cost of product revenue in the fiscal year 2021 periods was due to an increase in cost of goods sold and royalty expense to Takeda as a result of higher sales of ORGOVYX in the U.S. during the fiscal 2021 periods, as well as sales of MYFEMBREE in the U.S., which began in June 2021, and sales of product supply to Richter, which began in the three months ended September 30, 2021.

Collaboration expense to Pfizer for the three months and year ended March 31, 2022, was $14.1 million and $40.0 million, respectively, compared to $1.7 million for both the three months and year ended March 31, 2021, reflecting Pfizer’s 50% share of net profits from sales of ORGOVYX and MYFEMBREE in the U.S., pursuant to the Pfizer Collaboration and License Agreement. The increase in collaboration expense to Pfizer in the fiscal 2021 periods was due to an increase in net profits generated from sales of ORGOVYX in the U.S., as well as net profits generated from sales of MYFEMBREE in the U.S., for which there were no such MYFEMBREE net profits in the year ago periods.

Selling, general and administrative (SG&A) expenses for the three months ended March 31, 2022, and 2021 were $67.2 million and $78.0 million, respectively. The decrease in SG&A expenses primarily reflects lower share-based compensation as the three months ended March 31, 2021 included incremental expense of $25.7 million related to the acceleration, modification, and remeasurement of Myovant’s former Principal Executive Officer’s equity awards, which did not recur in the three months ended March 31, 2022, partially offset by higher expenses to support the ORGOVYX and MYFEMBREE U.S. launches, including higher personnel-related costs due to the hiring of Myovant’s commercial operations, marketing, and market access teams, as well as the oncology and women’s health sales forces. SG&A expenses for the year ended March 31, 2022, and 2021 were $259.4 million and $181.4 million, respectively. The increase in SG&A expenses was primarily due to higher expenses to support the ORGOVYX and MYFEMBREE U.S. launches, including higher personnel-related costs. These costs were partially offset by lower share-based compensation.

Research and development (R&D) expenses for the three months ended March 31, 2022, and 2021 were $24.5 million and $21.6 million, respectively. The increase in R&D expenses primarily reflects an increase in personnel expenses due to an increase in medical affairs and other personnel to support the U.S. launches of ORGOVYX and MYFEMBREE, partially offset by a reduction in clinical study costs due to the completion and wind down of Myovant’s Phase 3 LIBERTY, HERO, and SPIRIT studies. R&D expenses for the year ended March 31, 2022, and 2021 were $107.4 million and $136.7 million, respectively. The decrease in R&D expenses primarily reflects a reduction in clinical study costs as a result of the completion and wind down of Myovant’s Phase 3 LIBERTY, HERO, and SPIRIT studies, as well as higher cost sharing with Pfizer for certain R&D expenses in the year ended March 31, 2022. In addition, the year ended March 31, 2021, included regulatory submission fees for Myovant’s initial NDA filings for ORGOVYX and MYFEMBREE, which did not recur during the year ended March 31, 2022.

Interest expense for both the three months ended March 31, 2022, and 2021 was $3.5 million, and was primarily related to the Sumitomo Pharma Loan Agreement. Interest expense for the year ended March 31, 2022, and 2021 was $14.0 million and $10.4 million, respectively. The increase in interest expense was primarily driven by a higher outstanding balance under the Sumitomo Pharma Loan Agreement during the year ended March 31, 2022, as well as higher accretion of the financing component of the cost share advance from Pfizer, which began in the fourth quarter of the year ended March 31, 2021.

Foreign exchange loss (gain) for the three months ended March 31, 2021, was a loss of less than $0.1 million, and for the year ended March 31, 2021, was a gain of $16.2 million, primarily as a result of the impact of fluctuations in the foreign currency exchange rate between the Swiss franc and the U.S. dollar on Myovant’s outstanding balance under the Sumitomo Pharma Loan Agreement. As a result of a change in the functional currency of Myovant’s wholly-owned subsidiary in Switzerland, Myovant Sciences GmbH, from the Swiss franc to the U.S. dollar in December 2020, Myovant is no longer exposed to significant foreign currency gains or losses.

Net loss for the three months ended March 31, 2022, was $59.3 million compared to $81.4 million for the year ago period. Net loss for the year ended March 31, 2022, was $206.0 million compared to $255.1 million for the year ago period. On a per common share basis, net loss was $0.63 and $0.89 for the three months ended March 31, 2022, and 2021, respectively, and $2.22 and $2.83, for the years ended March 31, 2022, and 2021, respectively.

Capital resources: Cash, cash equivalents, marketable securities, and amounts available under the Sumitomo Pharma Loan Agreement totaled $475.5 million as of March 31, 2022, and consisted of $434.2 million of cash, cash equivalents, and marketable securities and $41.3 million of available borrowing capacity under the Sumitomo Pharma Loan Agreement.

Conference Call
As previously announced, Myovant will hold a webcast and conference call at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) today, May 10, 2022, to discuss financial results for its fourth fiscal quarter and fiscal year ended March 31, 2022 and corporate updates. Investors and the general public may access a live webcast of the call by visiting the investor relations page of Myovant’s website at investors.myovant.com. Institutional investors and analysts may also participate in the conference call by dialing 1-800-891-3840 in the U.S. or +1-785-424-1677 from outside the U.S. and reference password MYOVQ421. A replay of the webcast, along with the earnings press release and presentation materials, can be found on Myovant’s investor relations website for a period of one year.

About Relugolix
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces testicular testosterone, a hormone known to stimulate the growth of prostate cancer, and ovarian estradiol, a hormone known to stimulate the growth of uterine fibroids and endometriosis. ORGOVYX (relugolix, 120 mg) was approved in the U.S. by the FDA in December 2020 as the first and only oral GnRH receptor antagonist for the treatment of adult patients with advanced prostate cancer. In April 2022, the European Commission approved ORGOVYX (relugolix, 120 mg) as the first and only oral GnRH receptor antagonist for the treatment of adult patients with advanced hormone-sensitive prostate cancer in Europe. MYFEMBREE (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) was approved in the U.S. by the FDA in May 2021 as the first and only once-daily oral treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months. In July 2021, the European Commission, and in August 2021, the United Kingdom (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA), approved RYEQO (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age, with no limitation for duration of use. In September 2021, the FDA accepted to review Myovant’s supplemental New Drug Application (sNDA) for MYFEMBREE for the management of moderate to severe pain associated with endometriosis. On May 6, 2022, Myovant and Pfizer announced that the FDA extended the Prescription Drug User Fee Act (PDUFA) goal date for this sNDA to August 6, 2022. MYFEMBREE is also being assessed for contraceptive efficacy in women with endometriosis or uterine fibroids who are 18 to 50 years of age and at risk for pregnancy.

On May 10, 2022 The Bayer Group reported a very successful start to 2022 (Press release, Bayer, MAY 10, 2022, View Source [SID1234614020]). "We achieved outstanding sales and earnings growth, with particularly substantial gains for our agriculture business," said Werner Baumann, Chairman of the Board of Management, on Tuesday as he presented the quarterly statement for the first quarter of 2022. "Our forecast going forward this year remains confident despite the great uncertainties, including the stability of supply chains and energy supplies, and we confirm the currency-adjusted outlook for the full year published in March."

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Group sales in the first quarter increased by 14.3 percent on a currency- and portfolio-adjusted basis (Fx & portfolio adj.) to 14.639 billion euros. EBITDA before special items increased by 27.5 percent to 5.251 billion euros. Positive currency effects benefited sales by 529 million euros (Q1 2021: minus 938 million euros) and EBITDA before special items by 67 million euros (Q1 2021: minus 337 million euros). EBIT increased by 36.6 percent to 4.212 billion euros. This figure included net special gains of 40 million euros (Q1 2021: 15 million euros). These primarily related to provisions in connection with the glyphosate litigations. Net income rose by 57.5 percent to 3.291 billion euros. Core earnings per share from continuing operations advanced by 36.3 percent to 3.53 euros.

Group sales and earnings were not negatively impacted by Russia’s invasion of Ukraine in the first quarter. In business terms, Russia and Ukraine do not rank among the company’s top ten key countries; in total, the two countries account for around 3 percent of sales.

Free cash flow improved by 63.2 percent to minus 1.187 billion euros. Net financial debt as of March 31, 2022, at 34.527 billion euros, was 4.2 percent higher than at year-end 2021, mainly as a result of cash outflows from operating activities and negative currency effects.

Crop Science increases earnings by around 50 percent

In the agricultural business (Crop Science), sales rose by 21.6 percent (Fx & portfolio adj.) to 8.447 billion euros thanks to substantial price and volume growth. Bayer’s sales grew by double-digit percentages in all regions and achieved particularly strong growth at Herbicides (Fx & portfolio adj. 59.8 percent) and Fungicides (Fx & portfolio adj. 18.6 percent). While there was particularly strong growth for Herbicides in North America, Fungicides generated double-digit percentage sales growth in all regions. Corn Seed & Traits posted sales gains, primarily due to price increases in all regions. Here, Bayer also benefited from volume gains in the Europe/Middle East/Africa, Latin America, and Asia/Pacific regions. Sales at Soybean Seed & Traits were level with the prior-year period (Fx & portfolio adj. up 0.8 percent), and were higher in North America due to price increases but lower in Latin America due to lower volumes.

EBITDA before special items at Crop Science advanced by 49.9 percent to 3.669 billion euros, driven mainly by higher prices. Bayer also benefited from higher volumes and ongoing efficiency programs. By contrast, earnings were diminished by an increase in costs, particularly in the cost of goods sold, that was mainly due to high inflation. There was a positive currency effect of 98 million euros (Q1 2021: minus 252 million euros). The EBITDA margin before special items increased significantly by 6.6 percentage points to an all-time high of 43.4 percent; currency effects had a dilutive effect of 0.8 percentage points.

Pharmaceuticals: sales up thanks to Eylea, Nubeqa and radiology business

Sales of prescription medicines (Pharmaceuticals) rose by 2.6 percent (Fx & portfolio adj.) to 4.624 billion euros, climbing substantially in the Europe/Middle East/Africa region. The division was more than able to offset price-related declines in sales due to tender procedures in China, especially for the oral anticoagulant Xarelto (Fx & portfolio adj. minus 5.0 percent) and the cancer drug Nexavar (Fx & portfolio adj. minus 34.7 percent) through higher volumes for other products. This was possible in part by continuing to expand business with the ophthalmology drug Eylea (Fx & portfolio adj. 13.9 percent), which boosted market share in a growing market, particularly in Europe and China. Moreover, Bayer achieved gains in the Radiology category, particularly with Ultravist (Fx & portfolio adj. 26.4 percent), against a weaker prior-year quarter driven by the pandemic. Due to encouraging growth in volumes in the United States, Europe and Japan, the cancer drug Nubeqa recorded a sales gain of 61.5 percent (Fx & portfolio adj.). In addition, the market launch of Kerendia for the treatment of patients with chronic kidney disease and type 2 diabetes in the third quarter of 2021 had a positive impact.

EBITDA before special items at Pharmaceuticals declined by 7.3 percent to 1.389 billion euros. The main factors for this development were increased investments in future growth, primarily in the marketing and distribution of new products such as Kerendia, Nubeqa and Verquvo. The division also incurred higher research and development expenses compared to the prior-year quarter which had benefited from the proportionate recognition of 52 million euros in proceeds from the sale of a priority review voucher in the United States. Negative currency effects of 34 million euros (Q1 2021: 57 million euros) were an additional burden. The EBITDA margin before special items was 30.0 percent; currency effects had a dilutive effect of 1.6 percentage points.

Consumer Health posts strong sales increase and even better earnings growth

Bayer’s sales of self-care products (Consumer Health) advanced significantly by 17.2 percent (Fx & portfolio adj.) to 1.512 billion euros. This strong development followed a weaker prior-year quarter driven by the pandemic. Growth was once again broad-based, with all regions and categories contributing. Allergy & Cold had the highest growth contribution with sales up 38.7 percent (Fx & portfolio adj.), despite Bayer’s comparatively smaller presence in Cough & Cold. The Nutritionals category delivered another outstanding quarter of growth at 15.4 percent (Fx & portfolio adj.) with strong brands outperforming the market.

EBITDA before special items at Consumer Health advanced by 32.9 percent to 388 million euros. This was mainly due to exceptional sales growth, active price management and cost control. Bayer also recorded one-time gains through the sale of a minor, nonstrategic brand. Investments associated with the launch of innovation behind Bayer brands and inflation-related increases in costs weighed on earnings. There were positive currency effects of 6 million euros (Q1 2021: minus 26 million euros). The EBITDA margin before special items improved significantly by 2.4 percentage points to 25.7 percent; currency effects had a dilutive effect of 0.3 percentage points.

Recognition of Bayer’s progress in the area of sustainability

Bayer has made good progress with its sustainability targets, as was confirmed by the investor-led CA100+ initiative’s Net-Zero Company Benchmark, in which Bayer was one of the top-rated companies. Bayer received seven (out of a total of ten) green indicators in the 2021 Benchmark published in late March (compared with only two in 2020), which was more than any other of the 166 evaluated companies. ISS ESG, one of the world’s leading rating agencies in the Environmental, Social and Governance sustainable investment segment, likewise honored Bayer as a "climate outperformer" in its Climate Awareness Scorecard. ESG ratings are primarily used by investors as an indicator of a company’s sustainability performance.

Furthermore, the Board of Management has decided to switch Bayer’s vehicle fleet worldwide to electromobility, to take place as soon as possible. The specific time frame will be mainly influenced by market conditions and the pace of expansion of the EV charging infrastructure.

On May 10, 2022 Kyowa Kirin Co., Ltd. reported that Consolidated Financial Summary (IFRS) Fiscal 2022 First Quarter(Press release, Kyowa Hakko Kirin, MAY 10, 2022, View Source [SID1234614019])

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1. Consolidated Financial Results for the Three Months Ended March 31, 2022
(1) Consolidated operating results
(2) Consolidated financial position

2. Dividends

3. Consolidated Earnings Forecasts for the Fiscal Year Ending December 31, 2022 (from January 1, 2022 to December 31, 2022)

* Quarterly financial results reports are exempt from quarterly review conducted by certified public accountants or an audit corporation.
* Notice regarding the appropriate use of the earnings forecasts and other special comments

The forward-looking statements, including earnings forecasts, contained in these materials are based on the information currently available to the Company and on certain assumptions deemed to be reasonable by management. As such, they do not constitute guarantees by the Company of future performance. Actual results may differ materially from these projections for a wide variety of reasons

1. Operating Results and Financial Statements
(1) Summary of Consolidated Financial Position  Assets as of March 31, 2022, were ¥907.8 billion, a decrease of ¥14.1 billion compared to the end of the previous fiscal year.  Non-current assets increased by ¥5.8 billion compared to the end of the previous fiscal year, to ¥409.4 billion, due mainly to an increase in deferred tax assets.  Current assets were ¥498.4 billion, a decrease of ¥19.9 billion compared to the end of the previous fiscal year, mainly reflecting a decrease in trade and other receivables as well as a decrease in cash and cash equivalents due to the payment of dividends and income taxes.

 Liabilities as of March 31, 2022, were ¥163.4 billion, a decrease of ¥21.3 billion compared to the end of the previous fiscal year, due mainly to decreases in income taxes payable and trade and other payables.  Equity as of March 31, 2022, was ¥744.5 billion, an increase of ¥7.3 billion compared to the end of the previous fiscal year, due mainly to an increase due to the recording of profit attributable to owners of parent as well as an increase in exchange differences on translation of foreign operations resulting from the impact of exchange rates, despite a decrease due to the payment of dividends, etc.

As a result, the ratio of equity attributable to owners of parent to total assets as of the end of the first quarter was 82.0%, an increase of 2.0 percentage points compared to the end of the previous fiscal year.

(2) Summary of Consolidated Business Performance
1) Overview of results The Group now applies the International Financial Reporting Standards ("IFRS") in line with its policy of expanding business globally, and adopts "core operating profit" as a level of profit that shows the recurring profitability from operating activities. Core operating profit is calculated by deducting "selling, general and administrative expenses" and "research and development expenses" from "gross profit," and adding "share of profit (loss) of investments accounted for using equity method" to the amountFor the three months ended March 31, 2022 (January 1, 2022 to March 31, 2022), revenue was ¥87.8 billion (up 8.2% compared to the same period of the previous fiscal year), and core operating profit was ¥17.3 billion (up 11.8%). Profit attributable to owners of parent was ¥16.0 billion (up 24.1%).

 The increase in revenue was the result of growth of global strategic products in North America and EMEA and a rise in revenue from technology out-licensing, despite lower revenue in Japan. The positive effect on revenue from foreign exchange was ¥3.6 billion.
 Core operating profit rose, despite increases in selling, general and administrative expenses and research and development expenses, due to higher gross profit resulting from an increase in overseas revenue and a rise in revenue from technology out-licensing. The positive effect on core operating profit from foreign exchange was ¥1.2 billion.  Profit attributable to owners of parent increased as a result of an increase in finance income and a decrease in income tax expense in addition to an increase in core operating profit.

On May 10, 2022 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported financial results for the first quarter ended March 31, 2022, and provided an overview of recent developments (Press release, UroGen Pharma, MAY 10, 2022, View Source [SID1234614018]).

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"The first quarter of 2022 saw further commercial, clinical and operational progress as we continued to grow patient access to Jelmyto, advance our clinical-stage candidates and significantly strengthened our financial position in support of our business," said Liz Barrett, President, and Chief Executive Officer of UroGen. "Thus far in 2022, we have begun enrolling patients in the Phase 3 ENVISION pivotal trial of UGN-102 in low-grade, intermediate-risk NMIBC and initiated a first-in-human, multi-arm Phase 1 clinical study of UGN-301 in high-grade NMIBC. Our accomplishments throughout 2021 and early 2022, coupled with our strengthened balance sheet, position us well to continue to execute on our strategic initiatives as we look to accelerate growth and advance our mission of transforming the treatment paradigm for patients with urothelial cancers."

Business Highlights:

Jelmyto (mitomycin) for pyelocalyceal solution in low-grade Upper Tract Urothelial Cancer (LG-UTUC):

Generated net product revenue of $13.6 million for the first quarter of 2022, representing 81% growth over the first quarter of 2021.
Continued phased launch of uTRACT patient registry intended to evaluate real-world outcomes of LG-UTUC patients treated with Jelmyto, provide insight into long-term treatment benefits, and evaluate its use in clinical practice in the U.S.
UGN-102 (mitomycin) for intravesical solution:

UroGen began dosing patients in the single-arm Phase 3 ENVISION pivotal trial of UGN-102 for the treatment of low-grade, intermediate-risk NMIBC. The study will enroll approximately 220 patients across 90 sites. Enrollment is expected to be completed by the end of 2022.
ENVISION is similar in design to the previously completed Phase 2b OPTIMA II study which demonstrated a complete response (CR) rate of 65% and probability of remaining in CR 12 months after therapy of 72.5% by Kaplan Meier analysis. Assuming positive findings, UroGen anticipates submitting a New Drug Application (NDA) for UGN-102 in 2024.
UGN-301 (zalifrelimab) for intravesical solution:

UroGen initiated a first-in-human, novel, multi-arm Phase 1 clinical trial of UGN-301, the Company’s anti-CTLA4- antibody, in high-grade NMIBC.
This Phase 1 clinical trial will utilize a Master Protocol to evaluate the safety and tolerability of UGN-301 as monotherapy and in combination with other immunomodulators, including UGN-201, the Company’s proprietary toll-like receptor 7 (TLR7) agonist, as well as other potential chemo and/or immune therapies in patients with NMIBC.
UGN-301 is in development through a strategic collaboration with The University of Texas MD Anderson Cancer Center and represents the Company’s expansion into immunotherapy. The Phase 1 program intends to build upon encouraging nonclinical data showing that intravesical administration of anti-CTLA4 and a TLR agonist leveraging RTGel has the potential to improve mortality in the setting of high-grade NMIBC.
First Quarter 2022 Financial Results:

Jelmyto Revenue: UroGen reported net product revenue of Jelmyto for the first quarter 2022 of $13.6 million, compared to $7.5 million in the first quarter of 2021.

R&D Expense: Research and development expenses for the first quarter 2022 were $12.7 million, including non-cash share-based compensation expense of $0.7 million as compared to $10.5 million, including non-cash share-based compensation expense of $1.1 million, for the same period in 2021.

SG&A Expense: Selling, general and administrative expenses for the first quarter 2022 were $21.3 million, including non-cash share-based compensation expense of $2.2 million. This compares to $22.2 million, including non-cash share-based compensation expense of $5.1 million, for the same period in 2021.

Financing on Prepaid Forward Obligation: UroGen reported non-cash financing expense related to the prepaid forward obligation to RTW Investments of $5.8 million for the first quarter 2022. The rate applied to cash payments incurred in 2022 is 13% based on $48 million of global net product sales of Jelmyto in 2021.

Net Loss: UroGen reported a net loss of $28.4 million, or basic and diluted net loss per ordinary share of $1.25, for the first quarter 2022 as compared to $25.9 million, or basic and diluted net loss per ordinary share of $1.17, for the same period in 2021.

Cash & Cash Equivalents: As of March 31, 2022, cash, cash equivalents and marketable securities totaled $137.1 million. This includes the first $75 million tranche of the up to $100 million term loan facility with funds managed by Pharmakon Advisors, which closed in March 2022.

2022 Revenue, Operating Expense and RTW Expense Guidance: The Company reiterates anticipated full year 2022 net product revenues from Jelmyto to be in the range of $70 to $80 million. The Company reiterates anticipated full year 2022 operating expenses in the range of $140 to $160 million, including non-cash share-based compensation expense of $10 to $16 million, subject to market conditions. The Company reiterates anticipated full year 2022 non-cash financing expense related to the prepaid obligation to RTW Investments in the range of $22 to $26 million, of which approximately $9.1 to $10.4 million will be paid in cash.

Conference Call & Webcast Information: Members of UroGen’s management team will host a live conference call and webcast today at 10:00 AM Eastern Time to review the Company’s financial results and provide a general business update.

The live webcast can be accessed by visiting the Investors section of the Company’s website at View Source Please connect at least 15 minutes prior to the commencement of the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (855) 765-5685 (U.S.) or (615) 247-5916 (International) to listen to the live conference call. The conference ID number for the live call will be 6687048. An archive of the webcast will be available for two weeks on the Company’s website.

About Jelmyto

Jelmyto (mitomycin) for pyelocalyceal solution, is a drug formulation of mitomycin indicated for the treatment of adult patients with low-grade upper tract urothelial cancer (LG-UTUC). Utilizing the RTGel technology platform, UroGen’s proprietary sustained release, hydrogel-based formulation, Jelmyto is designed to enable longer exposure of urinary tract tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. Jelmyto is delivered to patients using standard ureteral catheters or nephrostomy tube. The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC. On April 15, 2020, the FDA approved Jelmyto, making it the first drug approved for the treatment of LG-UTUC in adult patients.

APPROVED USE FOR JELMYTO

JELMYTO is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).

IMPORTANT SAFETY INFORMATION

You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.

Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you:

are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.
Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose.
Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose.
are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO and for 1 week after the last dose.
Tell your healthcare provider if you take water pills (diuretic).
How will I receive JELMYTO?

Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment.
You will receive your JELMYTO dose from your healthcare provider 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider’s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. Your healthcare provider may recommend up to an additional 11 monthly doses.
JELMYTO is given to your kidney through a tube called a catheter.
During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.
After receiving JELMYTO:

JELMYTO may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 6 hours.
To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.
Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.
JELMYTO may cause serious side effects, including:

Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell your healthcare provider right away if you develop side pain or fever during treatment with JELMYTO.
Bone marrow problems. JELMYTO can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO.
The most common side effects of JELMYTO include: urinary tract infection, blood in your urine, side pain, nausea, trouble with urination, kidney problems, vomiting, tiredness, stomach (abdomen) pain.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.

Please see JELMYTO Full Prescribing Information, including the Patient Information, for additional information.

About Upper Tract Urothelial Cancer (UTUC)

Urothelial cancer is the ninth most common cancer globally and the eighth most lethal neoplasm in men in the U.S. Between five percent and ten percent of primary urothelial cancers originate in the ureter or renal pelvis and are collectively referred to as upper tract urothelial cancers (UTUC). In the U.S., there are approximately 6,000 – 7,000 new or recurrent low-grade UTUC patients annually. Most cases are diagnosed in patients over 70 years old, and these older patients often face comorbidities. There are limited treatment options for UTUC, with the most common being endoscopic surgery or nephroureterectomy (removal of the entire kidney and ureter). These treatments can lead to a high rate of recurrence and relapse.

About UGN-102

UGN-102 (mitomycin) for intravesical solution is an investigational drug formulation of mitomycin in Phase 3 development for the treatment of low-grade intermediate risk NMIBC. Utilizing the RTGelTM Technology Platform, UroGen’s proprietary sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter. The Company presented results from the Phase 2b OPTIMA II trial in September 2021.

About the Phase 3 ENVISION Trial

The Phase 3 ENVISION trial is a single-arm, multinational, multicenter study evaluating the efficacy and safety of UGN-102 (mitomycin) as primary chemoablative therapy in patients with low-grade, intermediate-risk NMIBC. The Phase 3 ENVISION trial is expected to enroll approximately 220 patients across 90 sites and study participants will receive six once-weekly intravesical instillations of UGN-102. The planned primary endpoint will evaluate the complete response rate at three months after the first installation, and the key secondary endpoint will evaluate durability over time in patients who achieve complete response at the three-month assessment. Based on discussions with the FDA, and enrollment expected by the end of 2022, assuming positive findings, UroGen anticipates submitting an NDA for UGN-102 in 2024.

On May 10, 2022 Targovax ASA (OSE: TRVX), a clinical-stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that it has entered into a clinical trial collaboration agreement with Oslo University Hospital (OUS) to run a phase 1/2 study testing polyvalent mutant RAS vaccine TG01 in multiple myeloma (MM) following standard of care (SoC) therapy (Press release, Targovax, MAY 10, 2022, View Source [SID1234614005]).

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Oncogenic mutations in the RAS family of genes drive up to 30% of all cancers and remain a major unmet medical need with few good treatment alternatives. Targovax was recently awarded two prestigious research grants from Innovation Norway and the Norwegian Research Council, totaling NOK 18m, to advance its TG mutant RAS cancer vaccine program. These grants include funding towards several clinical studies, of which the first to open will be a TG01 phase 1/2 trial in MM patients with relevant KRAS and NRAS mutations (approx. 15-20% of MM patients) to be run in Oslo, Norway.

The trial is a collaboration between OUS and Targovax and will test TG01 vaccination as a monotherapy in 20 KRAS or NRAS mutated MM patients who continue to have measurable disease after completion of SoC treatment. The aim is to assess whether anti-RAS T-cell priming induced by TG01 can enhance the clinical response. OUS will sponsor and be responsible for running and funding the trial, with Dr. Schjesvold as the principal investigator. Targovax will provide TG01 drug supply, scientific support and financial contribution.

Dr. Fredrik Schjesvold, Founder and Leader Oslo Myeloma Center, at Oslo University Hospital, and President of the Nordic Myeloma Study Group, said: "RAS-mutant multiple myeloma has poor prognosis and there are currently no available targeted treatment options for this patient population. Prior data clearly demonstrates the capability of TG01 to induce robust anti-RAS T-cell responses and eliminate residual disease in cancer patients, and suggest that TG vaccination could be a valuable tool to deepen and prolong responses in multiple myeloma. Being a Norwegian product makes it particularly interesting, and we very much look forward to collaborating with Targovax to test this concept in practice at our center."

Earlier in 2022, Targovax announced a collaboration with Agenus to utilize their proprietary vaccine adjuvant QS-21 STIMULON as an immune-stimulatory component of the TG vaccines for future development and commercialization. QS-21 has consistently demonstrated powerful antibody and cell-mediated immune responses both in cancer trials and commercially as a component of the Shingrix and Mosquirix vaccines. QS-21 should further potentiate the TG vaccines by driving stronger anti-RAS T-cell responses. The OUS trial will be the first study in patients of TG01 adjuvanted by QS-21.

Dr. Erik Digman Wiklund, Chief Executive Officer of Targovax ASA, added: "Following promising data from the first generation TG01 vaccine in pancreatic cancer, we have focused on enhancing our mutant RAS platform and establishing a cost-efficient, collaborative development plan to bring the program forward. We are now ready to bring TG01 back into the clinic in a new and improved format and are excited to work with Dr. Schjesvold and his team to assess the potential of TG01 in multiple myeloma. This trial will be the first step in a broader exploratory program with multiple collaboration partners aimed at testing TG01 vaccination in various RAS mutant cancer types and treatment combinations."