On May 11, 2020 Protagonist Therapeutics, Inc. (Nasdaq: PTGX), a clinical stage biopharmaceutical company, reported that it has commenced an underwritten public offering of 5,000,000 shares of its common stock (Press release, Protagonist, MAY 11, 2020, View Source [SID1234557542]). All of the shares of common stock are being offered by Protagonist. In connection with this offering, Protagonist expects to grant the underwriters a 30-day option to purchase up to 750,000 additional shares of common stock.

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Jefferies LLC and BMO Capital Markets Corp. are acting as joint book-running managers for the offering. H.C. Wainwright & Co., LLC and Nomura Securities International, Inc. are acting as co-lead managers for the offering. The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed or the actual size or terms of the offering.

A shelf registration statement relating to the offered shares of common stock was filed with the Securities and Exchange Commission (SEC) on October 31, 2019, and was declared effective on November 22, 2019. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website, located at www.sec.gov. Prospective investors should read the preliminary prospectus supplement, when available, and the accompanying prospectus and other documents we have filed with the SEC for more complete information about us and the offering. Copies of the prospectus supplement and the accompanying prospectus related to the offering may be obtained, when available, from Jefferies LLC Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at 877-547-6340 or by email at [email protected] or from BMO Capital Markets Corp., Attention: Equity Syndicate Department, 3 Times Square, 25th Floor, New York, NY 10036, by telephone at 800-414-3627 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities nor shall 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.

On May 11, 2020 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported financial results for the first quarter of 2020 (Press release, CASI Pharmaceuticals, MAY 11, 2020, View Source [SID1234557541]).

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Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "Despite the unprecedented macro conditions impacting our global economy, I am pleased to report that we have made very encouraging progress this past quarter. Importantly, EVOMELA revenues were $3.4 million in Q1, driven in large part by the high unmet need in this patient population. EVOMELA has proven to be an essential drug for multiple myeloma patients and is the only form of melphalan commercially available in China."

Dr. He continued, "I am also pleased to report that, together with our partner Juventas Cell Therapy Ltd., our CNCT19 CAR-T development program targeting B-cell driven hematological malignancies are well underway, which was an incredible accomplishment during this period of uncertainty. We continue expecting to file an IMPD/CTA for CID-103, our novel anti-CD38 monoclonal antibody program, in the first half of 2020 and will provide additional guidance on initial enrollment expectations after we get a better sense for COVID-related impacts throughout our trial sites."

First Quarter 2020 Financial Results

Revenues consisted primarily of product sales of EVOMELA that launched in August of 2019. Revenue was $3.4 million for the three months ended March 31, 2020, compared with $0 for the three months ended March 31, 2019.
Costs of revenues were $3.2 million for the quarter ended March 31, 2020, compared with $0 for the quarter ended March 31, 2019. The increase is due to the launch of EVOMELA that occurred during August of 2019. Costs of revenues have been impacted by a previous transitional supply agreement. A new supply agreement has been implemented with an alternate manufacturer; therefore, the Company expects unit cost of inventories of EVOMELA to be considerably reduced in the future.
Research and development expenses for the first quarter ended March 31, 2020 were $3.0 million, compared with $2.6 million for the same period in 2019. The increase in R&D expenses primarily reflects costs incurred related to the development of CID-103 and costs associated with the EVOMELA post marketing study, partially offset by reduced regulatory costs associated with our ANDAs and lower costs associated with preclinical development activities related to a 2019 terminated immune-oncology program.
General and administrative expenses for the first quarter of 2020 were $4.1 million, compared with $5.7 million for the same period in 2019. The decrease in G&A expenses was primarily because the 2019 period included costs related to sales and marketing efforts to prepare for the August 2019 launch of EVOMELA, as well as lower professional fees and travel costs incurred during the 2020 period.
Selling and marketing expenses for the first quarter 2020 were $1.3 million, compared with $0 for the same period in 2019. The increase is due to selling costs related to commercial sales of EVOMELA that began in August of 2019.
Gain on disposal of intangible assets was $0.5 million for the three months ended March 31, 2020 and related to the sale of seven ANDAs during the 2020 period.
Acquired in-process R&D expenses for the three months ended March 31, 2020 were $1.1 million, relating to milestone fees payable as a result of the approval of Octreotide in the UK.
Net loss for the first quarter of 2020 was $8.2 million compared to $8.2 million for the same period in 2019.
As of March 31, 2020, the Company had cash and cash equivalents of $53.9 million compared to $53.6 million as of December 31, 2019.
Further information regarding the Company, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, can be found at www.casipharmaceuticals.com.

Conference Call

The Company will host a conference call reviewing the first quarter highlights at 4:30 p.m. ET on Monday, May 11, 2020. On the call, CASI’s Chairman & CEO will provide an update on the Company’s business and upcoming milestones. The conference call can be accessed by dialing (833) 647-4459 (U.S.), 8008700181 (China), 58086567 (Hong Kong) to listen to the live conference call. The conference ID number for the live call is 8716619.

On May 11, 2020 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") reported that it has launched an offering of $1,250,000,000 aggregate principal amount of new senior notes due 2029 (the "Notes") (Press release, Bausch Health, MAY 11, 2020, View Source [SID1234557540]). Bausch Health intends to use the proceeds from the offering of the Notes, along with cash on hand, to fund the conditional redemption (the "Redemption") of its existing 6.50% Senior Secured Notes due 2022 (the "Existing Notes") and to pay related fees, premiums and expenses.

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The Notes will be guaranteed by each of the Company’s subsidiaries that are guarantors under the Company’s credit agreement and existing senior notes.

The Notes will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state securities law and may not be offered or sold in the United States absent registration or an applicable exemption from registration under the Securities Act and applicable state securities laws. The Notes will be offered in the United States only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act and outside the United States to non-U.S. persons pursuant to Regulation S under the Securities Act. The Notes have not been and will not be qualified for sale to the public by prospectus under applicable Canadian securities laws and, accordingly, any offer and sale of the Notes in Canada will be made on a basis, which is exempt from the prospectus requirements of such securities laws.

The Company also announced that it issued today a conditional notice of redemption to redeem the full $1.25 billion aggregate principal amount of outstanding Existing Notes. The Redemption is conditioned upon the completion by the Company or its subsidiaries of one or more debt financings in an aggregate principal amount of at least $1.25 billion (the "Condition").

A copy of the conditional notice of redemption with respect to the Existing Notes was issued to the record holders of the Existing Notes. Payment of the redemption price and surrender of the Existing Notes for redemption will be made through the facilities of the Depository Trust Company in accordance with the applicable procedures of the Depository Trust Company on June 10, 2020, unless the Condition is not satisfied, in which case the redemption date will be delayed until the Condition is satisfied. The name and address of the paying agent are as follows: The Bank of New York Mellon Trust Company, N.A., c/o The Bank of New York Mellon; 111 Sanders Creek Parkway, East Syracuse, N.Y. 13057; Attn: Redemption Unit; Tel: (800) 254- 2826.

The foregoing transactions are subject to market and other conditions and are anticipated to close in the second quarter of 2020. However, there can be no assurance that the Company will be able to successfully complete the transactions, on the terms described above, or at all.

This news release is being issued pursuant to Rule 135c under the Securities Act and shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

On May 11, 2020 BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) reported that it intends to offer, subject to market conditions and other factors, $500.0 million aggregate principal amount of senior subordinated convertible notes due 2027 in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (Press release, BioMarin, MAY 11, 2020, View Source [SID1234557538]). BioMarin also intends to grant the initial purchasers of the notes a 13-day option to purchase up to an additional $50.0 million aggregate principal amount of notes.

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The notes will be general senior subordinated, unsecured obligations of BioMarin and will accrue interest payable semi-annually in arrears. The notes will be convertible into shares of BioMarin’s common stock. The interest rate, initial conversion rate and other terms of the notes will be determined at the time of pricing of the offering.

BioMarin intends to use up to $50.0 million of the net proceeds from the offering to repurchase shares of its common stock either concurrently with the offering in privately negotiated transactions with purchasers of the notes effected through one of the initial purchasers or its affiliate, as BioMarin’s agent, or following the offering in privately negotiated or other repurchase transactions. BioMarin intends to use a majority of the net proceeds from the offering to repay, repurchase or settle in cash some or all of its 1.50% senior subordinated convertible notes due in 2020, although it does not intend to effect any such repayment, repurchase or settlement concurrently with the offering. BioMarin intends to use the remainder of the net proceeds for general corporate purposes.

The offer and sale of the notes and the shares of BioMarin common stock issuable upon conversion of the notes have not been registered under the Securities Act or any state securities laws, and unless so registered, the notes and such shares may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.

This press release is neither an offer to sell nor a solicitation of an offer to buy any securities, nor shall it constitute an offer, solicitation or sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On May 11, 2020 Nuvo Pharmaceuticals Inc. (Nuvo or the Company) (TSX:NRI;OTCQX:NRIFF), a Canadian focused, healthcare company with global reach and a diversified portfolio of commercial products, reported its financial and operational results for the three months ended March 31, 2020 (Press release, Nuvo Pharmaceuticals, MAY 11, 2020, View Source [SID1234557537]). For further details on the results, please refer to Nuvo’s Management, Discussion and Analysis (MD&A) and Condensed Consolidated Interim Financial Statements for the three months ended March 31, 2020 which are available on the Company’s website (www.nuvopharmaceuticals.com). All figures are in Canadian dollars, unless otherwise noted.

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Q1 2020 Financial Highlights

For the three months ended March 31, 2020, adjusted total revenue(1) was $18.9 million, an increase of 11% compared to $17.1 million for the three months ended March 31, 2019.

The Company’s Commercial Business segment includes the promoted products – Blexten and Cambia . Revenue related to these products was $6.0 million, an increase of 94% compared to revenue of $3.1 million for the three months ended March 31, 2019. Canadian prescriptions of Blexten and Cambia increased by 54% and 30% respectively compared to the three months ended March 31, 2019.

For the three months ended March 31, 2020, adjusted EBITDA(1) was $8.0 million, an increase of 53% compared to $5.2 million for the three months ended March 31, 2019.

Principal loan repayments of $11.5 million (US$8.7 million) were made in the three months ended March 31, 2020.
(1)

Non-International Financial Reporting Standards (IFRS) financial measure defined by the Company below.

Business Update

In March 2020, Nuvo Pharmaceuticals (Ireland) DAC (Nuvo Ireland) received notice from Takeda Pharmaceutical Co., Ltd. (Takeda), that Japan’s Ministry of Health, Labor and Welfare (the MHLW) approved Cabpirin tablets, a combination of vonoprazan fumarate and aspirin. Takeda holds a non-exclusive license to Nuvo Ireland’s Japanese patent no. 4756823 which covers the Cabpirin formulation. The MHLW approval triggered two milestone payments due to Nuvo Ireland of $2.8 million (US$2.0 million) each. Nuvo Ireland is contractually entitled to receive the first $2.8 million (US$2.0 million) milestone payment no later than May 29, 2020 and the second milestone payment is to be received no later than May 31, 2022, provided the licensed intellectual property remains valid and enforceable. Nuvo Ireland is entitled to retain 50% of all royalty and milestone revenues generated from the Yosprala intellectual property with the remaining 50% to be paid to the estate of POZEN, Inc.

In March 2020, Dr. Reddy’s Laboratories Inc. (DRL) launched its generic version of Vimovo in the United States. As a result of an entry of a generic version of Vimovo in the U.S., Nuvo Ireland’s US$7.5 million annual minimum royalty from its partner has ceased. The royalty rate for 2020 will be calculated as 10% of net U.S. sales of Vimovo, subject to certain step-down provisions upon achievement of generic market share thresholds.

In February 2020, Aralez Pharmaceuticals Canada, Inc. (Aralez Canada) received a Notice of Compliance from Health Canada for Suvexx indicated for the acute treatment of migraine with or without aura in adults. Suvexx is a patent protected, fixed dose combination of naproxen sodium and sumatriptan. Aralez Canada anticipates launching Suvexx into the approximately $130 million Canadian prescription acute migraine market in Q3 2020.

In January 2020, the Company was informed by its licensee in Switzerland and Lichtenstein, Gebro Pharma AG (Gebro Pharma) that the marketing authorization for Pennsaid 2% was issued by Swissmedic, the overseeing regulatory authority. Gebro Pharma is currently preparing for the commercial launch of Pennsaid 2% in Switzerland anticipated in Q4 2020.

In January 2020, the Company repaid the outstanding balance of $4.5 million (US$3.5 million) of the original US$6.0 million Bridge Loan (coupon interest rate of 12.5% per annum) to Deerfield Management Company, L.P. (Deerfield), ahead of its June 2020 maturity date. The Company also made a $7.0 million (US$5.2 million) principal payment applied to the Company’s debt owed to Deerfield. Since January 1, 2020, the Company has repaid $11.5 million (US$8.7 million) of debt. The Company’s remaining loans, aggregating a cash principal value of $152.2 million (US$107.3 million), carry coupon interest rates of 3.5% per annum.
"The COVID-19 pandemic has been the overriding focus of the world over the last couple of months. During this time, Nuvo continues to operate as an essential business. We have made necessary changes so we can continue to operate and supply our healthcare products to global partners, wholesalers, pharmacies, and ultimately patients, while ensuring our employees remain safe and healthy," said Jesse Ledger, Nuvo’s President & CEO. "Despite the challenges presented by the COVID-19 pandemic, we are making progress in achieving a number of anticipated milestones in the second quarter, including the launch of Resultz in Germany and the submission of the Blexten pediatric dossier to Health Canada, and we continue to prepare for the Canadian commercial launches of Suvexx and Neovisc Plus and Neovisc One later this year. Furthermore, Blexten and Cambia continued their strong performance in the first quarter."

First Quarter 2020 Financial Results
Total revenue is comprised of product sales, license revenue and contract revenue. Total revenue was $24.4 million for the three months ended March 31, 2020 compared to $14.6 million for the three months ended March 31, 2019. The significant increase in total revenue for the current quarter was the result of an increase in the Company’s license revenue and product sales, partially offset by a decrease in contract revenue.

Adjusted total revenue increased to $18.9 million for the three months ended March 31, 2020 compared to $17.1 million for the three months ended March 31, 2019. The $1.8 million increase in adjusted total revenue in the current quarter was primarily attributable to an increase of $3.8 million of revenue contributed from the Commercial Business segment and an increase of $0.4 from the Licensing and Royalty Business segment, partially offset by a $2.5 million decrease in the Production and Service Business segment.

For the three months ended March 31, 2020, the increase in the Commercial Business segment revenue was a result of continued organic growth of its key promoted products, Blexten and Cambia, as well as an increase in sales through the latter part of the quarter as the COVID-19 pandemic progressed and wholesaler and pharmacy demand increased beyond traditional ordering patterns. The Company believes this increase in wholesaler and pharmacy demand has now ended and there will be a decline in demand before a return to more traditional buying patterns in subsequent quarters. The COVID-19 pandemic will impact the timing of revenue in future quarters and the Company will continue to monitor market dynamics accordingly. Also, adjusted total revenue increased due to a back order of a competing generic product of Fiorinal, which the Company does not anticipate continuing beyond the first quarter. These increases were partially offset by a decrease in the product sales included in the Production and Service Business segment, as a result of a decrease in the Company’s Pennsaid product sales and the absence of contract revenue relating to transition services that were included in the three months ended March 31, 2019.

Adjusted EBITDA increased to $8.0 million for the three months ended March 31, 2020 compared to $5.2 million for the three months ended March 31, 2019. The increase in the current quarter was primarily attributable to the decrease of $1.8 million in general and administrative (G&A) expenses and sales and marketing expenses (net of amortization), largely as a result of the June 2019 restructuring. Also contributing to the increase in adjusted EBITDA was the increase in gross profit of $1.0 million (net of revenue recognized upon recognition of contract assets, amounts billed to customers for existing contract assets and inventory-step up expenses). This improvement in gross profit was due to an increase in gross margin on product sales and an increase in license revenue.

Gross profit on total revenue was $18.9 million or 77% for the three months ended March 31, 2020 compared to a gross profit of $9.0 million or 62% for the three months ended March 31, 2019. The increase in gross profit for the current quarter was primarily attributable to an increase in license revenue and gross margin on product sales.

Non-IFRS Financial Measures
The Company discloses non-IFRS measures (such as adjusted total revenue, adjusted EBITDA and adjusted EBITDA per share) that do not have standardized meanings prescribed by IFRS. The Company believes that shareholders, investment analysts and other readers find such measures helpful in understanding the Company’s financial performance and in interpreting the effect of the Aralez Transaction and the Deerfield Financing on the Company. Non-IFRS financial measures do not have any standardized meaning prescribed by IFRS and may not have been calculated in the same way as similarly named financial measures presented by other companies.

Adjusted Total Revenue
The Company defines adjusted total revenue as total revenue, plus amounts billed to customers for existing contract assets, less revenue recognized upon recognition of a contract asset. Management believes adjusted total revenue is a useful supplemental measure to determine the Company’s ability to generate cash from its customer contracts used to fund its operations.

Adjusted EBITDA
EBITDA refers to net income (loss) determined in accordance with IFRS, before depreciation and amortization, net interest expense (income) and income tax expense (recovery). The Company defines adjusted EBITDA as net income before net interest expense (income), depreciation and amortization and income tax expense (recovery) (EBITDA), plus amounts billed to customers for existing contract assets, inventory step-up expenses, stock-based compensation expense, Other Expenses (Income), less revenue recognized upon recognition of a contract asset and other income. Management believes adjusted EBITDA is a useful supplemental measure to determine the Company’s ability to generate cash available for working capital, capital expenditures, debt repayments, interest expense and income taxes.

Virtual Annual and Special Meeting of Shareholders
Due to the coronavirus pandemic, Nuvo’s 2020 Annual and Special Meeting of Shareholders (Meeting) will be held as an online meeting only. The Meeting will take place on Monday, May 11, 2020 (today) at 9:00 a.m. Registered shareholders can attend the Meeting online, vote shares electronically and submit questions during the Meeting. You will need to have your 16-digit Control Number (the Control Number) to participate in the Meeting. If you are a shareholder and do not have a Control Number or if you are not a Nuvo shareholder, you can attend the Meeting as a guest, but you will not be able to vote at the Meeting. Shareholders can vote by proxy in advance of the Meeting as in prior years or online during the Meeting.

The link to participate in the Meeting is: View Source If a participant experiences any technical difficulties during the Meeting, they may call 1-800-586-1548 (Canada and US) or 1-303-562-9288 (International) for assistance.