RedHill Biopharma to Host Third Quarter 2018 Financial Results Conference Call on November 13, 2018

On November 6, 2018 RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on proprietary drugs for gastrointestinal diseases, reported that it will report its third quarter 2018 financial results on Tuesday, November 13, 2018 (Press release, RedHill Biopharma, NOV 6, 2018, View Source [SID1234530864]).

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The Company will host a conference call on Tuesday, November 13, 2018 at 8:30 a.m. EST to review the financial results and business highlights.

To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-866-575-6539; International: +1-929-477-0402; and Israel: +972-3-376-1315. The access code for the call is: 2166581.

The conference call will be broadcast live and will be available for replay for 30 days on the Company’s website, View Source Please access the Company’s website at least 15 minutes ahead of the conference call to register.

Jounce Therapeutics to Announce Third Quarter 2018 Financial Results and Host Conference Call on Tuesday, November 13, 2018

On November 6, 2018 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that it will report third quarter 2018 financial results and provide a corporate update before market open on Tuesday, November 13, 2018 (Press release, Jounce Therapeutics, NOV 6, 2018, View Source;p=RssLanding&cat=news&id=2375531 [SID1234530885]). Jounce Therapeutics’ management team will host a live conference call and webcast at 8:00 a.m. ET.

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Conference Call and Webcast
To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 4689666. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days thereafter.

Nordic Nanovector ASA: Results for the Third Quarter 2018

On November 6, 2018 Nordic Nanovector ASA (OSE: NANO) reported its third quarter 2018 results (Press release, Nordic Nanovector, NOV 6, 2018, View Source [SID1234553487]). A presentation by the company’s senior management team will take place today in Oslo at 08:30 CET, see details below.

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Eduardo Bravo, CEO, commented: "The latest updated clinical results from a once-only administration of Betalutin, to be presented at ASH (Free ASH Whitepaper) in December, highlight the very promising clinical profiles of the two dosing regimens that are being evaluated in patients with relapsed/refractory indolent NHL. We are working hard to advance the PARADIGME study to confirm these results in a trial with 130 patients and to enable the selection of the best dosing regimen for our regulatory submissions. We are also pleased that Betalutin has received PIM designation in the UK reflecting the high unmet medical need of the FL patient population as well as the potential of Betalutin to offer therapeutic benefits to these patients. Both the PIM and Fast Track designations (granted by the FDA in June) provide opportunities for enhanced dialogue with health authorities and a route to bring Betalutin to patients quicker. We have a clear focus on delivering results from PARADIGME in 1H 2020 and in building further value in Nordic Nanovector from our CD37-targeting approach to treating patients with NHL."

Operational Highlights
• Abstract reporting promising clinical results from LYMRIT 37-01 trial with Betalutin published ahead of poster presentation at ASH (Free ASH Whitepaper)
o Overall response rates of 69% in Arm 4 (100 mg/m2 lilotomab followed by 20 MBq/kg Betalutin) and 64% in Arm 1 (40 mg lilotomab followed by 15 MBq/kg Betalutin) in relapsed/refractory follicular lymphoma patients
o Median duration of response of 13.3 months for all patients (20.5 months for those with a complete response)
o Well tolerated with predictable and manageable safety profile

• Site activations and patient recruitment progressing for pivotal Phase 2b PARADIGME trial
o As of 5 November, 51 (of 80-85) sites in 16 (of 20) countries are open for enrolment
o First US site in Long Beach, CA open for enrolment

Betalutin granted Promising Innovative Medicine (PIM) Designation in the UK for the treatment of advanced relapsed/refractory FL

• First patient dosed in Phase 1b Archer-1 trial of Betalutin in combination with rituximab in second-line (2L) FL patients

• Promising results from a collaborative R&D project to develop a CD37-targeted alpha therapy published in abstract ahead of ASH (Free ASH Whitepaper) presentation
o Next-generation targeted alpha therapy comprises Nordic Nanovector’s chimeric anti-CD37 antibody (NNV003) linked to lead-212 for treating B-cell malignancies

Financial Highlights Third Quarter 2018

(Figures in brackets = same period 2017 unless otherwise stated)

• Revenues for the third quarter amounted to NOK 0 (NOK 0.1 million).

• Total operating expenses for the third quarter were NOK 76.9 million (NOK 72.7 million). Total operating expenses for the first nine months of 2018 amounted to NOK 243.7 million (NOK 214.9 million)
o Research and development (preclinical, clinical, medical affairs, regulatory and CMC activities) expenses accounted for 73.0 % of total operating expenses (71.0 %) for the first nine months of 2018.

• Comprehensive loss for the third quarter amounted to NOK 75.4 million (loss of NOK 85.9 million). Comprehensive loss for the first nine months of 2018 was NOK 249.1 million (loss of NOK 207.9 million)

• Cash and cash equivalents amounted to NOK 499.7 million at the end of September 2018 (NOK 570.1 million at 30 June 2018 and NOK 756.6 million at 31 December 2017)

Outlook

Nordic Nanovector aspires to become a leader in the field of targeted therapies for haematological cancers by developing, manufacturing and commercialising innovative therapies to address major unmet medical needs and advance cancer care.
Betalutin, the company’s most advanced product candidate, has a highly differentiated, competitive, clinical profile for R/R FL, based on the promising results from the LYMRIT 37-01 Phase 1/2 clinical study. The company’s pivotal Phase 2b PARADIGME trial with Betalutin in 3L R/R FL is underway with the initial clinical data read-out targeted for 1H 2020 and subsequent filing in 2020 for marketing approval.
Betalutin has been granted Fast Track and PIM designations in the US and UK, respectively, for the treatment of patients with R/R FL.
Nordic Nanovector intends to maximize the value of Betalutin and other CD37-targeting opportunities across other stages of FL, NHL and other haematological cancer indications.
The company is confident that Betalutin could become an attractive and convenient therapeutic option, which, based on detailed market research, has the potential to be commercially successful.
Current cash resources are expected to be sufficient to reach data read-out from PARADIGME in 1H 2020.

Third Quarter 2018 Results Presentation and Webcast

A presentation by Nordic Nanovector’s senior management team will take place today at 8:30 am CET at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo
Meeting Room: HOLMENKOLLEN

The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media
The results report and the presentation are available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentations/Interim Reports/2018.

UroGen Pharma to Present at November 2018 Investor Conferences

On November 6, 2018 UroGen Pharma Ltd. (Nasdaq:URGN), reported that management will present at two investor conferences in November 2018 (Press release, UroGen Pharma, NOV 6, 2018, View Source;p=RssLanding&cat=news&id=2375526 [SID1234530784]):

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Stifel 2018 Healthcare Conference
Tuesday, November 13
9:30AM Eastern Time
New York, NY
Jefferies 2018 London Healthcare Conference
Thursday, November 15
9:20AM Greenwich Mean Time
London, UK
A live audio webcast of each event will be available on the Investors section of UroGen’s website, www.urogen.com. A replay of each webcast will be available on the website for approximately two weeks.

PDL BioPharma Reports Third Quarter 2018 Financial Results

On November 6, 2018 PDL BioPharma, Inc. ("PDL" or "the Company") (NASDAQ: PDLI) reported financial results for the three and nine months ended September 30, 2018 including (Press release, PDL BioPharma, NOV 6, 2018, View Source [SID1234530825]):

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Third Quarter Financial Highlights

Total revenues of $67.9 million.

GAAP net income attributable to PDL’s shareholders of $25.6 million or $0.18 per share.

Non-GAAP net income attributable to PDL’s shareholders of $12.3 million. A reconciliation of GAAP to non-GAAP financial results can be found in Table 3 at the end of this news release.

Cash and cash equivalents of $401.0 million as of September 30, 2018.

Completed a $25.0 million share repurchase program authorized in September 2017 by repurchasing 0.6 million shares of common stock in the open market during the quarter for $1.4 million.

Announced new share repurchase program of up to $100.0 million.

"Our third quarter revenues increased 8% from the prior year to $68 million, reflecting higher product sales and $42 million in royalty rights revenue that included an increase in fair value of the royalty rights from Assertio Therapeutics, formerly known as Depomed, as a result of our purchase of the remaining interest in royalty payments of this asset," said John P. McLaughlin, CEO of PDL. "We benefitted from a particularly strong showing during the quarter from the type 2 diabetes drug Glumetza, and I’m pleased to report that overall the Assertio asset has performed substantially better than we expected. With Tekturna, we are cautiously optimistic about the transition to a non-personal promotion campaign from a direct sales model, which we completed mid-way through the third quarter. Tekturna sales remained stable throughout the quarter, with the new sales strategy reducing costs and increasing profitability."

"We announced a new $100 million share repurchase program in late September after completing the previous program early in the third quarter," he added. "While to date we have been unable to execute any share buybacks under the new program due to blackout periods, we plan to begin aggressively repurchasing shares once the blackout is lifted."

"After serving as CEO for more than 10 years, I have informed the board of directors of my intention to retire as CEO at year-end 2018 while continuing to serve on the board," said McLaughlin. "It has been a pleasure to serve PDL and its shareholders. I’m gratified to announce our plan for PDL President, Dominique Monnet, to succeed me as CEO effective December 31, 2018 and to simultaneously join the PDL board. Dominique is a seasoned industry veteran with a track record of commercial success in biopharmaceutical development and has been an integral part of our management team for more than a year. I’m confident in Dominique’s leadership abilities and am delighted to be transferring the CEO responsibilities to his very capable hands."

Mr. Monnet joined PDL as President in September 2017, bringing more than 30 years of leadership experience in the biotech and pharmaceutical industries. He was instrumental in overseeing global commercialization operations, including successful new product launches, while serving in senior management positions at Alexion Pharmaceuticals, Amgen and Schering-Plough.

"It is a privilege to succeed John as we continue to execute our strategy to accelerate PDL’s growth and deliver value to our shareholders," said Monnet. "Under John’s leadership, PDL built a very strong balance sheet and an impressive track-record of investments. As a result, we are exceptionally well positioned to pursue exciting acquisition and partnership opportunities and invest and nurture companies and products that have the potential to grow, succeed and return superior shareholder value. I am delighted that John has agreed to remain on the Board, and I look forward to my continued partnership with the teams at PDL, Noden and Lensar."

Revenue Highlights


Total revenues of $67.9 million for the three months ended September 30, 2018 included:

Product revenues of $24.4 million, which consisted of $17.8 million from sales of Tekturna and Tekturna HCT in the U.S. and Rasilez and Rasilez HCT in the rest of the world (collectively, the Noden Products), and $6.6 million for product revenue from the LENSAR Laser System;

Net royalty payments from acquired royalty rights and a change in fair value of the royalty rights assets of $42.2 million, primarily related to the Assertio royalty asset;

Royalties from PDL’s licensees to the Queen et al. patents of $0.5 million, which consisted of royalties earned on sales of Tysabri; and

Interest revenue from note receivable investment to CareView Communications ("CareView") of $0.8 million.


Total revenues for the third quarter of 2018 were $67.9 million, compared with $62.7 million for the third quarter of 2017, reflecting PDL’s strategic shift to a pharmaceutical business model.

Product revenue was $24.4 million, a 22% increase from $20.1 million for the comparable prior-year quarter due to sales of the Noden Products and the LENSAR Laser System, the latter of which PDL did not begin to recognize until May 2017. Product revenues accounted for 36% of total revenues compared with 32% in the third quarter of 2017;

Product revenue from the Noden Products was $9.7 million in the U.S. and $8.1 million in the rest of the world;

PDL recognized $42.2 million in revenue from royalty rights – change in fair value, compared with $35.4 million in the prior-year period. The increase was due to the increased fair value of the Assertio royalty rights as a result of the purchase of all of Assertio’s remaining interest in royalty and milestone payments payable on sales of type 2 diabetes products licensed by Assertio, offset by declines in fair value adjustments for certain other royalty right assets;

PDL received $19.1 million in net cash royalties from its royalty rights for the third quarter of 2018, compared with $26.3 million for the prior-year period. The decrease is mainly due to higher royalties in 2017 as a result of the launch of the authorized generic for Glumetza in February 2017 sold by a subsidiary of Bausch Health Companies Inc. (formerly known as Valeant Pharmaceuticals International, Inc.);

Royalties from PDL’s licensees to the Queen et al. patents were $0.5 million, compared with $1.4 million for the third quarter of 2017 as product supply of Tysabri manufactured prior to patent expiry in the U.S. have been extinguished and ex-U.S. product supplies are rapidly being depleted; and

Interest revenue from the note receivable investment to CareView was $0.8 million. Interest revenue decreased from $5.3 million in the prior-year due to the sale of the kaléo, Inc. note receivable in September 2017.


Total revenues for the nine months ended September 30, 2018 were $153.0 million, compared with $252.0 million for the nine months ended September 30, 2017:

Product revenue was $79.5 million, a 54% increase from $51.5 million for the prior-year period. Product revenue for 2018 consisted of $62.0 million from sales of the Noden Products and $17.5 million from sales of the LENSAR Laser System;

PDL recognized $66.1 million in revenue from royalty rights – change in fair value, compared with $132.2 million for the prior-year period;

PDL received $57.0 million in net cash royalties from its royalty rights year-to-date 2018, compared with $74.4 million for the prior-year period;


Royalties from PDL’s licensees to the Queen et al. patents were $4.5 million, compared with $31.9 million for the prior-year period; and

Interest revenue from note receivable investment to CareView was $2.3 million. Interest revenue decreased from $17.0 million in the comparable nine-month period of 2017 due to the above-noted sale of the kaléo, Inc. note receivable in September 2017.

License and other revenue decreased by $18.9 million primarily due to a $19.5 million payment received in 2017 from Merck as part of the previously announced settlement agreement to resolve the patent infringement lawsuits related to Keytruda.

Operating Expense Highlights


Operating expenses for the three months ended September 30, 2018 of $31.2 million increased $1.0 million from $30.1 million for the three months ended September 30, 2017. The increase was a result of the Noden Products and LENSAR contributing additional cost of product revenue of $6.0 million and $0.4 million, respectively, due to increased revenue from the Noden Products and recognition of costs of product revenue for ex-U.S. revenue and increased revenue from LENSAR, as well as general and administrative expenses increasing 10%, or $1.2 million, primarily due to stock-based compensation awards granted in the period, partially offset by lower asset management and asset purchase professional expenses. The increase in operating expenses was partially offset by lower intangible asset amortization expense due to the second quarter of 2018 impairment of the intangible assets related to the Noden Products, as well as by reduced sales and marketing expenses related to the change in marketing strategy of the Noden Products.

Operating expenses for the nine months ended September 30, 2018 were $237.1 million, a $149.0 million increase from $88.1 million for the prior-year period. The increase was primarily a result of the impairment of the Noden intangible asset of $152.3 million, as well as the Noden Products and LENSAR contributing additional cost of product revenue of $20.0 million and $4.4 million, respectively, which was due to increased revenue from the Noden Products and recognition of costs of product revenue for ex-U.S. revenue and increased revenue from LENSAR, which PDL did not begin to recognize until May 2017, partially offset by the decrease in fair value of the contingent liability.

Stock Repurchase Programs


From July 1, 2018 to July 5, 2018, the Company completed its $25.0 million stock repurchase program with the repurchase of 0.6 million shares of its common stock at a weighted average price of $2.44 per share, for a total of $1.4 million.

PDL repurchased 8.7 million shares of its common stock under the $25.0 million share repurchase program during the nine months ended September 30, 2018, for an aggregate purchase price of $25.0 million, or an average cost of $2.86 per share, including trading commission. All shares repurchased were retired.

Since initiating its first stock repurchase program in March 2017, the Company has used $55.0 million to repurchase a total of 22.1 million shares of its common stock.

On September 21, 2018, the Company’s board of directors authorized the repurchase of issued and outstanding shares of the Company’s common stock having an aggregate value of up to $100.0 million pursuant to a new share repurchase program.

Other Financial Highlights


PDL had cash and cash equivalents of $401.0 million as of September 30, 2018, compared with cash, cash equivalents and short-term investments of $532.1 million as of December 31, 2017.

The reduction in cash balance for the nine months ended September 30, 2018 was primarily a result of retiring the remaining $126.4 million of principal from PDL’s 4.0% Convertible Senior Notes due 2018, plus $2.6 million of accrued interest, common stock repurchases of $25.0 million and the $20.0 million purchase of Assertio’s remaining interest in royalty and milestone payments payable on sales of type 2 diabetes products licensed by Assertio, partially offset by the proceeds from royalty rights of $57.0 million.

Conference Call and Webcast Details

PDL will hold a conference call to discuss financial results and provide a business update at 4:30 p.m. Eastern time today, November 6, 2018. Slides to accompany the conference call are available in the Investor Relations section of www.pdl.com.

To access the live conference call via phone, please dial 844-535-4071 from the U.S. and Canada or 706-679-2458 internationally. The conference ID is 6461756. A telephone replay will be available beginning approximately one hour after the call through one week following the call and may be accessed by dialing 855-859-2056 from the U.S. and Canada or 404-537-3406 internationally. The replay passcode is 6461756.

To access the live and subsequently archived webcast of the conference call, go to the Company’s website at www.pdl.com and go to the Investor Relations section and select "Events & Presentations."