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Adamis Pharmaceuticals Announces First Quarter 2020 Financial Results and Business Update

On May 18, 2020 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported financial results for the first quarter ended March 31, 2020 and provided a business update (Press release, Adamis Pharmaceuticals, MAY 18, 2020, View Source [SID1234558236]).

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Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated,

"We are pleased to have resubmitted our ZIMHI New Drug Application to the FDA to get us back on track for regulatory review. We are also very excited to be partnering with US WorldMeds to commercialize both our SYMJEPI and ZIMHI products here in the U.S. Certainly, Adamis has been negatively affected by the COVID-19 outbreak and the various degrees of lockdowns, and it remains to be seen how quickly everyone can get back to a new normal. However, we continue to operate and progress on a number of objectives. We will continue these efforts to mitigate the financial impact of the pandemic."

Product Updates

SYMJEPI (epinephrine) Injection

Earlier this month, the company announced that it had entered into an agreement with Sandoz Inc. providing for the mutually agreed return to Adamis of the marketing, promotion, and distribution rights to the company’s SYMJEPI (epinephrine) Injection 0.3mg, SYMJEPI (epinephrine) Injection 0.15mg products currently marketed and available in the United States, and the termination of the commercialization agreement between Adamis and Sandoz, following a transition period, supported by a transition services agreement that is currently being negotiated. Adamis also simultaneously entered into an exclusive distribution and commercialization agreement with USWM, LLC (USWM) for the United States commercial rights for the SYMJEPI products as well as the Company’s ZIMHI (naloxone HCI Injection, USP) 5mg/0.5mL product candidate.

In addition to the U.S., Adamis continues to seek opportunities to market SYMJEPI into other territories and in October 2019, the company announced it had entered into an exclusive distribution and commercialization agreement with Emerge Health to seek registration and commercialize SYMJEPI in both Australia and New Zealand.

ZIMHI (naloxone) Injection

Adamis has entered into an exclusive distribution and commercialization agreement with USWM for the U.S. commercial rights for ZIMHI (naloxone HCI Injection, USP) 5mg/0.5mL product candidate. Under the terms of the Adamis/USWM agreement, US WorldMeds obtained U.S. rights to commercialize and distribute the SYMJEPI products, upon the termination of Sandoz’s commercial rights, and ZIMHI, if approved by the U.S. Food and Drug Administration, in exchange for an upfront payment and potential regulatory and commercial milestones totaling up to $26 million. Additionally, after deducting the supply price and certain other deductions, including an allocation for US WorldMeds sales and distribution expenses from net sales of the products, Adamis and US WorldMeds will share equally in the net profits, as defined in the agreement.

Earlier today, the company announced the resubmission of the company’s New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for its ZIMHI product candidate. The resubmission follows the company’s meeting with the agency in February and is intended to address the issues raised by the FDA in the agency’s November 2019 Complete Response Letter ("CRL").

Drug Outsourcing Facility

During the first quarter of 2020, sterile and non-sterile revenues from the company’s wholly owned drug outsourcing facility, US Compounding (USC), decreased by approximately 6% in the first quarter compared to the same quarter in the prior year. Revenues from the sale of pharmaceutical formulations by USC were adversely affected by slowing demand due to the novel coronavirus outbreak. The company is seeking to mitigate the impact with the development and launch of products for which there has been a recent increase in demand.

First Quarter Financial Results

Revenues were approximately $4.7 million and $4.9 million for the three months ended March 31, 2020 and 2019, respectively. The decrease of approximately 5.0% in the first quarter of 2020 compared to the comparable period of 2019 was impacted by the effect of the pandemic on demand for USC’s products.

Selling, general and administrative expenses ("SG&A") for the three months ended March 31, 2020 and 2019 were approximately $6.1 million and $8.0 million, respectively. The decrease was primarily attributable to decreases in wages, benefits and other compensation expenses, and to a lesser extent by decreases in operational expenses relating to the ceasing of sales of certain USC products, and decreases in patent, consulting, outside services, professional fees, PDUFA fees, depreciation and other related expenses.

Research and development expenses were approximately $2.0 million and $2.2 million for the three months ended March 31, 2020 and 2019, respectively, a decrease of approximately 7.3%. The decrease was primarily due to a decrease in development costs of our product candidates.

Cash and equivalents at the end of the first quarter was approximately $10.5 million. In February 2020, the company completed a registered direct offering of common stock, and a concurrent private placement of warrants, resulting in estimated net proceeds of approximately $6.2 million.

Targeted Milestones

•Transition SYMJEPI commercial responsibility from Sandoz to US WorldMeds;
•FDA approval and U.S. commercial launch of ZIMHI;
•Develop and launch new USC products to help offset the impact of pandemic; and
•Complete a Phase III ulcer study in horses.

Conference Call

Adamis will host a conference call and live webcast on Monday, May 18, 2020 at 2:00 pm Pacific Time to discuss its financial and operating results for the first quarter of 2020 as well as provide an update on business developments and activities.

US Dial-in (Toll Free): 1-877-423-9813

TOLL/International Dial-in: 1-201-689-8573

Conference ID: 13703885

Webcast: View Source

In addition, a telephone playback of the call will be available after approximately 5:00 pm PT on May 18, 2020. To listen to the replay, call toll free 1-844-512-2921 within the United States or 1-412-317-6671 when calling internationally (toll). Please use the replay PIN number 13703885.

Quest Diagnostics Declares Quarterly Cash Dividend

On May 18, 2020 Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that its Board of Directors declared a quarterly cash dividend of $0.56 per share, payable on July 22, 2020 to shareholders of record of Quest Diagnostics common stock on July 8, 2020 (Press release, Quest Diagnostics, MAY 18, 2020, View Source [SID1234558235]).

Myovant Sciences Provides Recent Corporate Updates and Reports Financial Results for Fourth Fiscal Quarter and Full Fiscal Year Ended March 31, 2020

On May 18, 2020 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, reported financial results for the fourth fiscal quarter and full fiscal year ended March 31, 2020 (Press release, Myovant Sciences, MAY 18, 2020, View Source [SID1234558234]).

"I am tremendously proud of the many accomplishments of the Myovant team over the last year, with four positive Phase 3 studies, multiple regulatory submissions, and a strategic partnership with Gedeon Richter to accelerate the potential commercialization of relugolix combination tablet," said Lynn Seely, M.D., chief executive officer of Myovant Sciences. "We look forward to submitting our NDA in uterine fibroids this month and sharing the SPIRIT 1 results later this quarter, as we continue to realize our vision of redefining care for the millions of women and men with uterine fibroids, endometriosis, and prostate cancer."
Fourth Fiscal Quarter 2019 and Recent Business Highlights
Relugolix Clinical Programs

In March 2020, Myovant announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for once-daily, oral relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for the treatment of women with moderate to severe symptoms associated with uterine fibroids. The MAA submission has completed validation and is now under evaluation by the EMA. The MAA submission was supported by efficacy and safety data from the Phase 3 LIBERTY program which consisted of two multinational, replicate pivotal clinical studies, LIBERTY 1 and 2, as well as data from a long-term extension study of relugolix combination therapy. Myovant expects to submit an NDA for relugolix combination tablet in uterine fibroids in May 2020.

In April 2020, Myovant announced that the Phase 3 SPIRIT 2 study evaluating the safety and efficacy of relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) over 24 weeks in 623 women with endometriosis met its co-primary efficacy endpoints with a 75.2% response rate for dysmenorrhea (menstrual pain) and a 66.0% response rate for non-menstrual pelvic pain, while achieving six key secondary endpoints and demonstrating minimal bone mineral density loss. Myovant expects to report top-line results from a replicate Phase 3 study, SPIRIT 1, in the second quarter of calendar year 2020.

In April 2020, Myovant also announced that in an ovulation inhibition study relugolix combination therapy achieved 100% ovulation inhibition in 67 healthy women with no women ovulating during the 84-day treatment period, as evaluated by the Hoogland-Skouby assessment scale (score < 5). Furthermore, 100% of women resumed ovulation or menses upon discontinuation of treatment with an average time to ovulation of 23.5 days.

In April 2020, Myovant announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for once-daily, oral relugolix monotherapy tablet (120 mg) for the treatment of men with advanced prostate cancer. The NDA submission was supported by efficacy and safety data from the Phase 3 HERO study, a randomized pivotal study comparing relugolix monotherapy tablet versus leuprolide acetate. Myovant will present new efficacy and cardiovascular safety data from the HERO study in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program on May 29, 2020. Myovant expects to report additional data from the HERO study measuring castration resistance-free survival in approximately 430 men in the third quarter of calendar year 2020.
Corporate

In March 2020, Myovant and Gedeon Richter Plc. (Richter), a major pharmaceutical company in Central Eastern Europe focused on women’s health, entered into an exclusive license agreement for Richter to commercialize relugolix combination tablet for uterine fibroids and endometriosis in Europe, the Commonwealth of Independent States including Russia, Latin America, Australia, and New Zealand. Under the agreement, Myovant received an upfront payment of $40 million and is eligible to receive up to $40 million in regulatory milestones (of which $10 million was received in April 2020) and $107.5 million in sales-related milestones, and tiered royalties on net sales following regulatory approval. Myovant retains all rights to relugolix combination tablet in the U.S. and Canada, as well as rights to relugolix in other therapeutic areas outside of women’s health.
COVID-19 Pandemic Environment

To date the impact of the COVID-19 pandemic on Myovant’s ability to advance its clinical studies, regulatory activities, and preparation for the potential commercialization of its product candidates has been limited and all of Myovant’s publicly announced milestones remain on track. However, if the COVID-19 pandemic persists, and depending on the further evolution of the pandemic and its effects on Myovant’s activities, Myovant may experience more significant impacts on its business operations.

Fourth Fiscal Quarter and Full Fiscal Year 2019 Financial Summary
Research and development (R&D) expenses for the quarter ended March 31, 2020, were $41.7 million compared to $59.0 million for the comparable prior year period. R&D expenses for the fiscal year ended March 31, 2020, were $192.6 million, compared to $222.6 million for the prior fiscal year. R&D expenses for the periods presented primarily include expenses related to Myovant’s Phase 3 clinical programs, manufacturing expenses, as well as personnel-related expenses for employees engaged in R&D activities. R&D expenses related to Myovant’s clinical programs have continued to decline, driven primarily by the wind down of Myovant’s Phase 3 studies. The decrease in relugolix Phase 3 study costs were partially offset by increases in other R&D expenses related predominantly to regulatory activities in connection with regulatory submissions for relugolix combination tablet and relugolix monotherapy tablet in multiple indications and jurisdictions and the build out of Myovant’s medical affairs organization in connection with preparations for Myovant’s anticipated commercial launches, as well as increases in personnel expenses, share-based compensation, and other R&D expenses. For the year ended March 31, 2020, R&D expenses include $1.8 million of share-based compensation related to the accelerated vesting of certain equity awards as a result of a change in control in Myovant in connection with the closing of a transaction between Roivant and Sumitomo Dainippon Pharma.
General and administrative (G&A) expenses for the quarter ended March 31, 2020, were $22.4 million compared to $12.5 million for the comparable prior year period. G&A expenses for the fiscal year ended March 31, 2020, were $82.3 million, compared to $42.2 million for the prior fiscal year. The increase in G&A expenses for the quarter and the fiscal year ended March 31, 2020 were primarily due to increases in expenses related to commercial operations activities in advance of potential future regulatory approvals of relugolix combination tablet and relugolix monotherapy tablet, personnel-related expenses, and share-based compensation expenses, as well as professional services fees, and other general overhead, administrative and information technology expenses to support Myovant’s headcount growth and expanding operations. For the year ended March 31, 2020, G&A expenses include certain one-off increases as a result of the change in control in Myovant, namely $10.2 million in share-based compensation expense related to the accelerated vesting of certain equity awards as well as a $3.6 million capital tax accrual.
Interest expense for the quarters ended March 31, 2020 and 2019, was $0 and $3.9 million, respectively. On December 31, 2019, Myovant repaid all of its outstanding debt obligations to NovaQuest and Hercules and as a result there was no interest expense during the quarter ended March 31, 2020. For the year ended March 31, 2020, interest expense was $11.2 million, compared to $8.8 million for the comparable prior year period, reflecting higher outstanding debt balances with NovaQuest and Hercules until the debt repayment on December 31, 2019.
Loss on extinguishment of debt for the year ended March 31, 2020, was $4.9 million, which resulted from the early retirement of Myovant’s outstanding obligations to NovaQuest and Hercules. There were no such amounts in the other periods presented.

Interest expense (related party) for the quarter and year ended March 31, 2020, was $1.4 million in relation to Myovant’s outstanding debt of $113.7 million to Sumitomo Dainippon Pharma, which did not exist in the year ended March 31, 2019.

Interest income for the quarter and year ended March 31, 2020, was $0.2 million and $2.6 million, respectively. There was interest income of $0.8 million and $0.9 million for the quarter and year ended March 31, 2019, respectively.

Net loss for the quarter ended March 31, 2020, was $64.9 million, compared to $75.0 million for the comparable prior year period. Net loss for the fiscal year ended March 31, 2020, was $289.0 million, compared to $273.6 million for the prior fiscal year. On a per common share basis, net loss was $0.73 and $1.07 for the quarters ended March 31, 2020 and 2019, respectively, and $3.37 and $4.09 for the years ended March 31, 2020 and 2019, respectively.
Capital resources: Cash, cash equivalents, marketable securities, and committed funding totaled $365.9 million as of March 31, 2020, and consisted of $79.6 million of cash, cash equivalents, and marketable securities and $286.3 million of available borrowing capacity under the Sumitomo Dainippon Pharma Loan Agreement. Additional funds may be drawn down by Myovant once per calendar quarter, subject to certain terms and conditions, including consent of Myovant’s Board of Directors. In April 2020, Myovant borrowed an additional $80.0 million under the Sumitomo Dainippon Pharma Loan Agreement. In April 2020, Myovant received a $10.0 million regulatory milestone payment from Richter.

About Relugolix
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces ovarian estradiol production, a hormone known to stimulate the growth of uterine fibroids and endometriosis, and testicular testosterone production, a hormone known to stimulate the growth of prostate cancer. Myovant is developing a relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for women with uterine fibroids and for women with endometriosis. Myovant is also developing a relugolix monotherapy tablet (120 mg once daily) for men with advanced prostate cancer.

About MVT-602
MVT-602 is an oligopeptide kisspeptin-1 receptor agonist. Kisspeptin, the ligand, is a naturally-occurring peptide that stimulates GnRH release and is required for puberty and maintenance of normal reproductive function, including production of sperm, follicular maturation and ovulation, and production of estrogen and progesterone in women and testosterone in men. A Phase 2a clinical study in healthy female volunteers to characterize the dose-response curve in a minimal controlled ovarian stimulation setting has been completed.

PDL BioPharma Declares Distribution Ratio for Dividend of Evofem Biosciences Common Stock to PDL Stockholders

On May 18, 2020 PDL BioPharma, Inc. ("PDL" or the "Company") (Nasdaq: PDLI) reported the final distribution ratio for the previously announced distribution of all of the Company’s 13,333,334 shares of common stock of Evofem Biosciences, Inc. ("Evofem") (Nasdaq: EVFM) to be made on May 21, 2020 (the "distribution date") (Press release, PDL BioPharma, MAY 18, 2020, View Source [SID1234558233]). Based on the shares of PDL common stock outstanding as of the close of business on May 15, 2020 (the "record date"), PDL stockholders of record as of the record date will be entitled to receive 0.11591985 shares of Evofem common stock for each share of PDL common stock held as of the close of business on the record date.

Subject to certain conditions, the distribution by PDL will be made on the distribution date in the form of a pro rata common stock dividend to PDL stockholders of record as of the close of business on the record date. No fractional shares of Evofem common stock will be distributed. Instead, PDL stockholders will receive cash in lieu of any fraction of a share of Evofem common stock that they otherwise would have received. PDL stockholders should consult their tax advisors with respect to U.S. federal, state, local and non-U.S. tax consequences of the distribution. The distribution of Evofem common stock will be made in book entry form and no physical share certificates will be issued.

An information statement describing the distribution will be included as an exhibit to a Current Report on Form 8-K filed by PDL with the U.S. Securities and Exchange Commission (the "SEC"). PDL stockholders will not be required to pay cash or other consideration for the shares of Evofem common stock to be distributed to them or to surrender or exchange their shares of PDL common stock to receive Evofem common stock in the distribution.

Additional information on the distribution, including a copy of the information statement, will be posted to PDL’s website at View Source

Clovis Oncology Announces Proposed Offering of Common Stock

On May 18, 2020 Clovis Oncology, Inc. (NASDAQ:CLVS) reported that it has commenced an underwritten public offering of common stock (Press release, Clovis Oncology, MAY 18, 2020, View Source [SID1234558232]).

Clovis Oncology intends to offer, subject to market and other conditions, $85 million of shares of its common stock in an underwritten registered public offering. In connection with this offering, Clovis Oncology intends to grant to the underwriters a 30-day option to purchase up to an additional $12.75 million of shares of its common stock on the same terms and conditions. All shares of the common stock to be sold in the offering will be offered by Clovis Oncology.

Clovis Oncology intends to use the net proceeds of this offering for general corporate purposes, including repayment, repurchase or refinance of its debt obligations, sales and marketing expenses associated with Rubraca (rucaparib), funding of its development programs, payment of milestones pursuant to its license agreements, general and administrative expenses, acquisition or licensing of additional product candidates or businesses and working capital.

J. P. Morgan Securities LLC and BofA Securities are acting as joint book-running managers for the offering.

The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The common stock is being offered pursuant to an effective shelf registration statement that Clovis Oncology has filed with the Securities and Exchange Commission ("SEC"). Before you invest, you should read the prospectus in that registration statement and other documents Clovis Oncology has filed with the SEC for more complete information about Clovis Oncology and this offering. The offering is being made only by means of a prospectus supplement and the related prospectus. Copies of the prospectus supplement and related prospectus may be obtained from J. P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email to [email protected], or from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte NC 28255-0001, Attn: Prospectus Department, or by calling 1-800-294-1322 or by email to [email protected]. You may also obtain these documents free of charge when they are available by visiting EDGAR on the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.