On September 12, 2019 PDL BioPharma, Inc. ("PDL" or the "Company") (Nasdaq: PDLI) reported that it has entered into separate privately negotiated transactions to exchange approximately $86.1 million in aggregate principal amount of its 2.75% Convertible Senior Notes due 2021 (the "Existing Notes") for approximately $86.1 million in aggregate original principal amount of new 2.75% Convertible Senior Notes due 2024 (the "Exchange Notes" and such transaction, the "Exchange") together with an aggregate of approximately $6.0 million of cash (Press release, PDL BioPharma, SEP 12, 2019, View Source;300917650.html [SID1234539473]). Following the closing of the Exchange, approximately $63.9 million aggregate principal amount of Existing Notes will remain outstanding with terms unchanged. The Existing Notes and Exchange Notes hereafter referred to herein as the "Notes."

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"We are capitalizing on the strength of the convertible notes market to extend the maturity of our debt under favorable terms," said Dominique Monnet, president and CEO of PDL. "This transaction will further strengthen our balance sheet as we execute on our strategy to build a focused portfolio of actively managed operating companies with significant revenue potential."

Each $1,000 principal amount of Existing Notes will be exchanged for $1,000 original principal amount of Exchange Notes and a cash payment of $70.

The Exchange Notes will be senior, unsecured obligations of PDL and will bear interest at a rate of 2.75% per year. Interest will be payable semi-annually in arrears on June 1 and December 1 of each year, beginning on December 1, 2019. The Exchange Notes will mature on December 1, 2024, unless earlier converted, redeemed or repurchased in accordance with the terms of the Exchange Notes.

The original principal amount of the Exchange Notes will accrete at a rate of 2.375% per year commencing September 17, 2019 through the maturity date of the Exchange Notes. The accreted principal amount of the Exchange Notes is payable in cash upon maturity. However, regular cash interest payments on the Exchange Notes, and the composition of the consideration due upon their conversion, will be determined based on their original principal amount and not their accreted principal amount.

The initial conversion rate of the Exchange Notes is 262.2951 share of PDL’s common stock per $1,000 original principal amount, which is equivalent to an initial conversion price of approximately $3.81 per share of PDL’s common stock. The initial conversion price of the Exchange Notes represents a premium of approximately 61% over the last reported sale price of PDL’s common stock on the Nasdaq Global Select Market on September 12, 2019. The Exchange Notes will be convertible at the option of the holders in certain circumstances and during certain periods prior to the close of business on the business day immediately preceding June 1, 2024 or at any time beginning on June 1, 2024, until the close of business on the second scheduled trading day immediately preceding the stated maturity. Upon conversion of the Exchange Notes, holders will receive cash, shares of PDL’s common stock or a combination of cash and shares of PDL’s common stock, at PDL’s election.

Holders of the Exchange Notes will have the right, at their option, to require PDL to purchase their notes for cash if PDL undergoes a fundamental change (as defined in the indenture for the Exchange Notes), at a repurchase price equal to 100% of the accreted principal amount of the Exchange Notes on the fundamental change repurchase date, plus accrued and unpaid interest, if any, to, but excluding, such repurchase date. If a "make-whole fundamental change" (as defined in the indenture for the Exchange Notes) occurs, then, under certain circumstances, PDL will increase the conversion rate applicable to Exchange Notes converted in connection with that make-whole fundamental change.

On or after December 1, 2021 and on or before the 60th trading day before the stated maturity, PDL may redeem all or any portion of the Exchange Notes for cash, but only if the last reported sale price per share of PDL’s common stock exceeds 128% of the conversion price of the Exchange Notes for a specified period of time. The redemption price for any Exchange Notes to be redeemed will equal 100% of the accreted principal amount of such Exchange Notes on the redemption date, plus accrued and unpaid interest, if any, to, but excluding, the redemption date.

PDL will not receive any cash proceeds from the Exchange. In return for issuing the Exchange Notes pursuant to the Exchange, PDL will receive and cancel the exchanged Existing Notes.

Piper Jaffray & Co. acted as financial advisor to PDL in connection with the Exchange.

In connection with the Exchange, PDL entered into a capped call transaction with Royal Bank of Canada (the "Counterparty" or "RBC") on similar terms and conditions as the capped call transaction entered into by PDL and Counterparty in connection with the Existing Notes (the "Existing Capped Call"). The capped call transaction is expected generally to offset potential dilution to PDL’s common stock and/or any cash payments PDL will be required to make in excess of the original principal amount upon any conversion of the Exchange Notes, with such offset subject to a cap initially equal to $4.88 per share (which represents a premium of approximately 106% over the last reported sale price of PDL’s common stock on the Nasdaq Global Select Market on September 12, 2019), subject to certain adjustments under the terms of the capped call transaction. In addition, PDL and the Counterparty entered into an agreement to terminate a portion of the Existing Capped Call, in a notional amount corresponding to the amount of Existing Notes exchanged.

PDL has been advised that, in connection with the entry into the capped call transaction, the termination of the Existing Capped Call, the partial unwinding of its hedge position with respect to the Existing Capped Call and establishing its initial hedge position with respect to the capped call transaction for the Exchange Notes, the Counterparty (and or its affiliates) expects to purchase and/or sell shares of PDL’s common stock and/or enter into various derivative transactions with respect to PDL’s common stock concurrently with or shortly after the entry into the Exchange and during any valuation period related thereto, which PDL expects to commence on the trading day immediately following the entry into the Exchange. This activity could cause or avoid an increase or decrease in the market price of PDL’s common stock or the Notes at that time. In connection with the unwinding of the Existing Capped Call, the Company expects to receive separately a payment from Counterparty in an amount that depends on the market price of the Company’s common shares over a valuation period as agreed with Counterparty.

In addition, the Counterparty may modify its hedge positions by entering into or unwinding derivatives with respect to PDL’s common stock and/or by purchasing or selling PDL’s common stock in secondary market transactions following the entry into the Exchange and any valuation period related to the establishment of its initial hedge position with respect to the capped call transaction or partial unwinding of its hedge position with respect to the Existing Capped Call (and is likely to do so during any observation period related to a conversion of Notes). This activity could also cause or avoid an increase or a decrease in the market price of PDL’s common stock or the Notes, which could affect a holder’s ability to convert the Notes and, to the extent the activity occurs during any observation period related to a conversion of Notes, could affect the amount and value of the consideration that a holder will receive upon conversion of the Notes.

On September 12, 2019 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, reported the pricing of a global offering of 2,000,000 ordinary shares, comprised of 1,717,391 ordinary shares in the form of American Depositary Shares ("ADSs") offered in the United States, Canada and certain countries outside of Europe at a price per ADS of $10.00 (the "U.S. offering"), and 282,609 ordinary shares in Europe and certain countries outside of the United States and Canada in a concurrent private placement at a price per share of €9.08 (together with the U.S. offering, the "global offering") (Press release, Celyad, SEP 12, 2019, View Source [SID1234539471]). Each ADS represents the right to receive one ordinary share. The price per ADS was determined based on an exchange rate of $1.1008 per €1. The gross proceeds to Celyad from the global offering are expected to be approximately $20.0 million (approximately €18.2 million), before deducting underwriting discounts and commissions and estimated offering expenses.

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In connection with the global offering, Celyad has granted the underwriters a 30-day option to purchase up to an additional 300,000 ordinary shares (which may be in the form of ADSs) on the same terms and conditions. The closing of the global offering is expected to occur on September 16, 2019, and is subject to customary closing conditions. Our ADSs and our ordinary shares are listed under the symbol "CYAD" on the Nasdaq Global Market and on the Euronext Brussels and Euronext Paris, respectively.

Wells Fargo Securities, LLC, William Blair & Company, L.L.C. and Bryan, Garnier & Co. Limited are acting as joint book-running managers for the offering. Kempen & Co U.S.A., Inc. is acting as co-manager for the offering. LifeSci Capital, LLC is Celyad’s advisor in connection with the offering.

The securities are being offered pursuant to an effective shelf registration statement that was previously filed with, and declared effective by, the U.S. Securities and Exchange Commission (SEC). A preliminary prospectus supplement dated September 10, 2019 and accompanying prospectus relating to and describing the terms of the offering was filed with the SEC on September 10, 2019. The final prospectus supplement relating to the offering will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement, the accompanying prospectus and the final prospectus supplement, when available, can also be obtained for free from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York, 10152, or by telephone at (800) 326-5897 or by email at [email protected]; William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, Illinois 60606, or by telephone at (800) 621-0687, or by email at [email protected]; or from Bryan, Garnier & Co. Limited, Beaufort House, 15 Saint Botolph Street, London EC3A 7BB, United Kingdom, or by telephone at +44 20 7332 2500, or by email at [email protected].

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

On September 12, 2019 Palatin Technologies, Inc. (NYSE American: PTN), a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, whose product candidates are targeted, receptor-specific therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, reported results for its fourth quarter and fiscal year ended June 30, 2019 (Press release, Palatin Technologies, SEP 12, 2019, View Source [SID1234539467]).

"The last year was a landmark one for Palatin. We are proud of the recent FDA approval of Vyleesi and the continued advancement of our pipeline programs," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "The FDA approval is an incredible achievement and milestone, and we are excited that premenopausal women now have a safe and effective, as-needed option available to them for the treatment of acquired, generalized HSDD. Our cash and accounts receivable balances at June 30, 2019 of $102 million is sufficient to cover planned operations through at least calendar year 2021. We remain focused on advancing discussions on Vyleesi collaborations for territories outside the currently licensed territories of North America, China, and Korea, and initiating multiple clinical trials for our pipeline programs over the next several quarters for the treatment of dry eye disease, non-infectious uveitis and ulcerative colitis."

2019 Fiscal Year Highlights and Recent Events

Hypoactive Sexual Desire Disorder / Vyleesi (bremelanotide injection)
The U.S. Food and Drug Administration (FDA) granted marketing approval of AMAG Pharmaceuticals, Inc.’s New Drug Application (NDA) for Vyleesi (bremelanotide injection), a melanocortin receptor agonist developed by Palatin, indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). The FDA’s approval of the NDA on June 21, 2019 triggered a $60 million milestone payment to Palatin under its North American license agreement with AMAG that was received in July. Additionally, Palatin is entitled to receive tiered royalties on net sales ranging from high single-digit to low double-digit percentages, and sales milestones based on escalating annual net sales thresholds, the first of which is $25 million, triggered at annual net sales of $250 million.

Vyleesi is the first as needed treatment for premenopausal women with acquired, generalized HSDD. Vyleesi is currently available through specialty pharmacies, Avella and BioPlus, and AMAG will launch Vyleesi nationally with its full sales force in mid-September.

Anti-Inflammatory / Autoimmune Programs
Melanocortin agonist products are under development for the treatment of inflammatory and autoimmune diseases such as dry eye, uveitis, diabetic retinopathy and inflammatory bowel diseases (ulcerative colitis).

We announced positive results of a micro-dose study of radiolabeled PL8177, a selective melanocortin receptor 1 ("MC1r") peptide agonist, using an oral, delayed-release, polymer formulation. The study met all primary and secondary endpoints. PL8177 has potential application in treatment of ulcerative colitis and other inflammatory bowel diseases. The FDA has granted orphan drug designation for PL8177 for the treatment of non-infectious intermediate, posterior, pan and chronic anterior uveitis. Non-infectious uveitis (NIU) is a group of inflammatory diseases that produces swelling and destroys eye tissue and can result in vision loss. A Phase 2 proof-of-concept clinical study with a systemic formulation in NIU patients is anticipated to commence in the fourth quarter of calendar year 2019. A Phase 2 proof-of-concept clinical study with an oral formulation in ulcerative colitis patients is anticipated to commence in the first quarter of calendar year 2020.

An IND application for PL9643, a melanocortin peptide agonist, and commencement of a Phase 2 clinical study in dry eye disease, are currently anticipated in the first quarter of calendar year 2020.

Natriuretic Peptide Receptor ("NPR") System Program
The Company has designed and is developing potential drug candidates that are selective agonist for one or more different natriuretic peptide receptors, including natriuretic peptide receptor-A ("NPR-A"), natriuretic peptide receptor B ("NPR-B"), and natriuretic peptide receptor C ("NPR-C"). Active collaborations with several institutions are ongoing for PL3994, an NPR-A agonist that has potential utility in the treatment of a number of cardiovascular diseases, including genetic and orphan diseases resulting from a deficiency of endogenous active NPR-A, and PL5028, a dual NPR-A and NPR-C agonist in development for cardiovascular diseases, including reducing cardiac hypertrophy and fibrosis. A Phase 2A clinical trial evaluating PL3994 in heart failure patients with preserved left ventricular ejection fraction will begin enrollment in the latter half of calendar year 2019. This trial is supported by a grant from the American Heart Association.

Genetic Obesity Program
The Company’s melanocortin receptor 4 ("MC4r") peptide PL8905 and orally-active small molecule PL9610 are currently under investigation for the treatment of rare genetic metabolic and obesity disorders. These programs are under internal evaluation for orphan designation and potential development.

Corporate
Cash and accounts receivable balances at June 30, 2019 of $102 million is sufficient to cover planned operations through at least calendar year 2021. Included in the accounts receivable balance is a $60 million milestone payment due from AMAG for the Vyleesi FDA approval, which was received in July 2019.

Debt and related liabilities decreased from $7.2 million at June 30, 2018 to $0.8 million at June 30, 2019, with a final payment remitted in July 2019.

Fourth Quarter and Fiscal 2019 Financial Results
Palatin reported net income of $52.2 million, or $0.25 per basic and $0.23 per diluted share, for the fourth quarter ended June 30, 2019, compared to net income of $11.8 million, or $0.06 per basic and diluted share, for the same period in 2018.

The difference between the three months ended June 30, 2019 and 2018 was attributable to the recognition of license and contract revenue pursuant to our license agreement with AMAG of $60.3 million for the quarter ended June 30, 2019 compared to $20.6 million in 2018.

For the year ended June 30, 2019, Palatin reported net income of $35.8 million, or $0.17 per basic and $0.16 per diluted share, compared to net income of $24.7 million, or $0.12 per basic and diluted share for the year ended June 30, 2018.

The difference in net income for the years ended June 30, 2019 and 2018, was primarily the result of a $16.6 million decrease in operating expenses to $24.6 million for the year ended June 30, 2019, compared to $41.2 million for the year ended June 30, 2018, partially offset by the recognition of license and contract revenue of $60.3 million for the year ended June 30, 2019, compared to $67.1 million of license and contract revenue for the year ended June 30, 2018.

Revenue
For the quarter and year ended June 30, 2019, Palatin recognized $60.3 million in license and contract revenue related to our license agreement with AMAG.

For the quarter and year ended June 30, 2018, Palatin recognized $20.6 million and $62.1 million, respectively, in license and contract revenue related to our license agreement with AMAG and an additional $5 million in license revenue for the year ended June 30, 2018 related to our license agreement with Fosun.

Operating Expenses
Total operating expenses for the quarter ended June 30, 2019 were $8.1 million, compared to $8.3 million for the comparable quarter of 2018. For the year ended June 30, 2019, Palatin incurred $24.6 million of operating expenses, compared to $41.2 million for the year ended June 30, 2018.

The decrease in operating expenses reflects the completion of the Vyleesi Phase 3 clinical trial program and ancillary studies necessary to file the NDA with the FDA in March 2018.

Other Income/Expense
Total other income, net, for the quarter and year ended June 30, 2019 was approximately $38,000 and $29,000, respectively.

Total other expense, net, for the quarter and year ended June 30, 2018 was $0.2 million and $1.1 million, respectively.

Total other income (expense), net consisted of investment income offset by interest expense related to venture debt.

Income Tax
Palatin recorded no income tax expense for the quarter and year ended June 30, 2019 as a result of the utilization of net operating losses.

Income tax expense was $0.3 and $0.1 million, respectively, for the quarter and year ended June 30, 2018. Income tax expense for the year ended June 30, 2018 related to $0.6 million in tax withholding requirements related to our Fosun and Kwangdong license agreements that was recorded as an expense during the fiscal year ended June 30, 2018 offset by a tax benefit of $0.5 million related to the release of a valuation allowance against Palatin’s federal alternative minimum tax credit as a result of the Tax Cuts and Jobs Act.

Cash Position
Palatin’s cash and cash equivalents were $43.5 million with accounts receivable of $60.3 million at June 30, 2019, compared to cash and cash equivalents and no accounts receivable of $38.0 million at June 30, 2018. Included in the accounts receivable balance at June 30, 2019 is a $60 million milestone payment due from AMAG for the Vyleesi FDA approval, which was received in July 2019. Current liabilities were $4.2 million as of June 30, 2019, compared to $10.8 million at June 30, 2018.
Palatin Drug Discovery Programs
During the conference call and webcast, management will update and discuss next steps in Palatin’s portfolio of drug development programs. These include Palatin’s melanocortin MC1r agonist peptides for treatment of inflammatory indications and natriuretic peptide receptor agonist compounds for treatment of cardiovascular and fibrotic diseases.

Conference Call / Webcast
Palatin will host a conference call and audio webcast on September 12, 2019 at 11:00 a.m. Eastern Time to discuss the results of operations in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-888-254-3590 (U.S./Canada) or 1-323-994-2093 (international), conference ID 1394071. The audio webcast and replay can be accessed by logging on to the "Investor/Webcasts" section of Palatin’s website at View Source A telephone and webcast replay will be available approximately one hour after the completion of the call. To access the telephone replay, dial 1-888-203-1112 (U.S./Canada) or 1-719-457-0820 (international), passcode 1394071. The webcast and telephone replay will be available through September 19, 2019.

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On September 12, 2019 Crescendo Biologics Ltd (Crescendo), the drug developer of novel, targeted T cell enhancing therapeutics, reported that it has signed collaborations with worldrenowned oncology research groups at the University of Oxford and the University of Surrey (Press release, Crescendo Biologics, SEP 12, 2019, View Source [SID1234539465]). These collaborations will accelerate the development of CB307, Crescendo’s lead programme for PSMA positive tumours, and its follow-on pipeline of CD137-directed T cell enhancing programmes.

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The Department of Oncology at the University of Oxford is one of the world’s leading cancer research centres. Dr Kerry Fisher’s group within this department, focuses on deepening our understanding of the tumour microenvironment to develop innovative new therapies for cancer patients.

Professor Hardev Pandha is a clinician scientist and a medical oncologist at the University of Surrey. He is head of the University’s Targeted Cancer Therapy research group, Director of the Surrey Cancer Research Institute and an expert in the management of patients with urological cancers. Professor Pandha leads a highly respected team with key interests in early phase clinical trials with targeted agents and novel therapies in translational settings.

Theodora Harold, CEO of Crescendo Biologics, commented:

Professor Pandha and Dr Fisher each head up world-leading groups-it is a credit to the quality of our science to be able to collaborate with them. Their multidisciplinary and collaborative approaches to oncology research will allow Crescendo to gain a greater understanding of these difficult to treat cancers and support us to deliver first in class, targeted T cell therapies."

Dr Kerry Fisher, Department of Oncology, University of Oxford, commented: "We look forward to working with Crescendo to further explore and understand the mechanisms driving the development of cancers and applying our group’s translational expertise to advance Crescendo’s novel Humabody programmes."

Professor Hardev Pandha, University of Surrey, added:

"We are delighted to be exploring the potential of Crescendo’s novel, targeted, T cell co-stimulatory molecules to deliver therapeutic benefit to patients with high unmet medical need."

On September 12, 2019 Bristol-Myers Squibb Company (NYSE:BMY) reported that it will announce results for the third quarter of 2019 on Thursday, October 31, 2019 (Press release, Bristol-Myers Squibb, SEP 12, 2019, View Source [SID1234539464]). During a conference call at 8:30 a.m. ET on October 31, company executives will review financial information and will address inquiries from investors and analysts.

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Investors and the general public are invited to listen to a live webcast of the call at View Source or by dialing in the U.S. toll free 800-458-4212 or international 786-789-4772, confirmation code: 532230. Materials related to the call will be available at the same website prior to the conference call. A replay of the call will be available beginning at 11:45 a.m. ET on October 31 through 11:45 a.m. ET on November 4, 2019. The replay will also be available through View Source or by dialing in the U.S. toll free 888-203-1112 or international 719-457-0820, confirmation code: 532230.