On August 6, 2015 Oncothyreon Inc. (NASDAQ:ONTY) reported financial results for the second quarter ended June 30, 2015 (Press release, Oncothyreon, AUG 6, 2015, View Source [SID:1234507100]).

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Net loss for the three months ended June 30, 2015 was $10.9 million, or $0.11 per basic and diluted share, compared with a net loss of $6.0 million, or $0.09 per basic and diluted share, for the comparable period in 2014. The $4.9 million increase in net loss was primarily attributable to the difference in the change in the fair value of warrant liability of $4.3 million. The increase in net loss was also due to increases in research and development expenses of $0.3 million and increases in general and administrative expenses of $0.2 million.

Net loss for the six months ended June 30, 2015 was $18.8 million, or $0.19 per basic and diluted share, compared with a net loss of $15.6 million, or $0.22 per basic and diluted share, for the comparable period in 2014. The $3.2 million increase in net loss was attributable to the difference in the change in the fair value of warrant liability of $1.7 million, increases in research and development expenses of $1.3 million and increases in general and administrative expenses of $0.2 million.

As of June 30, 2015, Oncothyreon’s cash, cash equivalents and investments were $70.0 million, compared to $63.7 million at December 31, 2014, an increase of $6.3 million, or 9.9 percent. The increase was primarily attributable to net proceeds of $22.4 million from the closing of concurrent but separate underwritten offerings of common stock and Series B convertible preferred stock in February 2015, partially offset by $15.6 million of cash used in operations during the six months ended June 30, 2015.

Financial Guidance

Oncothyreon believes the following financial guidance to be correct as of the date provided. Oncothyreon is providing this guidance as a convenience to investors and assumes no obligation to update it.

Oncothyreon currently expects operating expenses in 2015 to be lower than in 2014, which included the upfront payment to Array BioPharma Inc. for the exclusive license to ONT-380. Oncothyreon currently expects cash used in operations in 2015 to be approximately $32.0 – $34.0 million.

(Filing, 10-Q, Synta Pharmaceuticals, AUG 6, 2015, View Source [SID:1234507078])

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On August 5, 2015 PDL BioPharma, Inc. (PDL) (NASDAQ: PDLI) reported financial results for the second quarter and six months ended June 30, 2015 (Press release, PDL BioPharma, AUG 5, 2015, View Source [SID:1234507040]).

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Total revenues were $138.1 million for the three months ended June 30, 2015, compared to $162.8 million for the same period of 2014, and $287.8 million for the six months ended June 30, 2015, compared to $299.6 million for the six months ended June 30, 2014. During the three and six months ended June 30, 2015 and 2014, our Queen et al. royalty revenues consisted of royalties and maintenance fees earned on sales of products under license agreements associated with our Queen et al. patents. During the three and six months ended June 30, 2015 and 2014, royalty rights – change in fair value consisted of revenues associated with the change in fair value of our royalty right assets, primarily Depomed, Inc., The Regents of the University of Michigan , and Viscogliosi Brothers, LLC. Revenues for the quarter ended June 30, 2015 included $116.9 million in royalty and license payments from PDL’s licensees to the Queen et al. patents, $12.2 million in net royalty payments from acquired royalty rights and a change in fair value of the royalty rights assets, which included approximately $1.2 million in net cash royalty rights payments, and $9.0 million in interest revenue from notes receivable debt financings to late-stage healthcare companies. Revenues for the six months ended June 30, 2015 included $244.7 million in royalty and license payments from PDL’s licensees to the Queen et al. patents, $23.6 million in net royalty payments from acquired royalty rights and a change in fair value of the royalty rights assets, which included approximately $2.1 million in net cash royalty rights payments, and $19.5 million in interest revenue from notes receivable debt financings to late-state healthcare companies.

Total revenues decreased by 15% and 4%, respectively, for the three and six months ended June 30, 2015, when compared to the same periods in 2014. The decrease is primarily driven by the decrease in the Depomed royalty rights cash proceeds related to the Salix Pharmaceuticals, Ltd (recently acquired by Valeant Pharmaceuticals International, Inc.) excess supply of Glumetza at the wholesaler inventory levels, decreased interest revenues due to the early payoff of the AxoGen and Durata notes receivables, and decreased Actemra royalties as a result of the conclusion of the Actemra license agreement, partially offset by increased royalties from sales of Perjeta, Xolair, Kadcyla, Herceptin, and Tysabri.

Operating expenses in the second quarter of 2015 were $7.4 million, compared with $6.9 million in the second quarter of 2014. The increase in operating expenses for the three months ended June 30, 2015, as compared to the same period in 2014, was a result of an increase in general and administrative expenses of $1.0 million for professional service expenses mostly related to the asset management of Wellstat Diagnostics, partially offset by a decrease of $0.3 million for share-based compensation and a decrease of $0.2 million for legal services.

Operating expenses for the six months ended June 30, 2015 were $15.1 million, compared with $11.5 million in the first six months of 2014. The increase in operating expenses for the six months ended June 30, 2015, as compared to the same period in 2014, was a result of an increase in general and administrative expenses of $2.8 million for professional service expenses primarily related to the asset management of Wellstat Diagnostics and an increase of $0.9 million in share-based compensation.

Net income in the second quarter of 2015 was $78.3 million, or $0.47 per diluted share as compared with net income in the second quarter of 2014 of $92.1 million, or $0.52 per diluted share. Net income in the six months ended June 30, 2015 was $162.8 million, or $0.97 per diluted share as compared with net income in the first six months of 2014 of $164.9 million, or $0.94 per diluted share. The decrease in net income for the six months ended June 30, 2015, compared to the same period in 2014, is primarily driven by the decrease in the Depomed royalty rights cash proceeds.

Net cash provided by operating activities in the first six months of 2015 was $155.9 million, compared with $146.2 million in the same period in 2014. At June 30, 2015, PDL had cash, cash equivalents and short-term investments of $294.1 million, compared with $293.7 million at December 31, 2014. The change and slight increase in the cash balance at June 30, 2015 was primarily attributable to net cash provided by the proceeds from the March 2015 Term Loan of $100.0 million, proceeds from royalty rights of $2.1 million, and cash provided by operating activities of $155.9 million, offset in part by retirement of the Series 2012 Notes and May 2015 Notes for $177.4 million, payment of dividends of $49.1 million, repayment of a portion of the March 2015 Term Loan for $25.0 million, additional note receivable purchases of $5.2 million, and the payment of $0.6 million for debt issuance costs related to the March 2015 Term Loan.

Recent Developments

ARIAD Revenue Interest Assignment
On July 28, 2015, the Company entered into a revenue interest assignment agreement (the "Agreement") in which it agreed to provide ARIAD Pharmaceuticals, Inc. ("ARIAD") with up to $200 million in cash in exchange for royalties on the net revenues of Iclusig (ponatinib). Funding of the first $100 million will be made in two tranches of $50 million each, with the initial amount having already been funded on the closing date of the Agreement and an additional $50 million to be funded on the 12-month anniversary of the closing date. In addition, ARIAD has an option to draw up to an additional $100 million at any time between the six and twelve month anniversaries of the closing date.

PDL will initially receive 2.5% of the worldwide net revenues of Iclusig until the 12-month anniversary of the closing date, at which time the royalty increases to 5.0% of the worldwide net revenues of Iclusig and remains until December 31, 2018. Beginning January 1, 2019 and thereafter, the royalty rate will increase to 6.5%, subject to an additional increase to 7.5% if PDL’s funding exceeds $150 million. If PDL does not receive payments equal to or greater than the total amount funded on or before the fifth anniversary of each of the respective fundings, ARIAD will pay PDL make-whole payments calculated as the difference between the amounts funded by PDL and the amounts paid to PDL to such date.

PDL has a put option based upon certain events and ARIAD has a call option to repurchase the revenue interest at any time. Both the put and call prices have been pre-determined.

(Filing, 10-Q, Delcath Systems, AUG 5, 2015, View Source [SID:1234507032])

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On August 5, 2015 OPKO Health, Inc. (NYSE:OPK), a multi-national biopharmaceutical and diagnostics company, reported operating and financial results for its second quarter ended June 30, 2015 (Filing, 8-K, Opko Health, AUG 5, 2015, View Source [SID:1234507042]).

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Business Highlights

• OPKO to Acquire Bio-Reference Laboratories: OPKO and Bio-Reference Laboratories signed a definitive merger agreement on June 3, 2015 under which OPKO will acquire Bio-Reference Laboratories. Bio-Reference Laboratories is the third largest full service clinical laboratory in the United States and is known for its innovative technological solutions and pioneering leadership in the areas of genomics and genetic sequencing. Through GeneDx, Bio-Reference Laboratories’ genetic sequencing laboratory, and GenPath Diagnostics, its Oncology and Women’s Health business units, Bio-Reference Laboratories has accumulated a vast array of genetic and genomics data that OPKO will make available to industry and academic scientists to enhance their drug discovery and clinical trial programs. Under the terms of the agreement, holders of Bio-Reference Laboratories common stock will receive 2.75 shares of OPKO common stock for each share of Bio-Reference Laboratories common stock. Closing of the transaction is subject to approval of Bio-Reference Laboratories’ shareholders, and other customary conditions. OPKO intends to leverage the national marketing, sales, and distribution resources of Bio-Reference Laboratories to enhance sales of OPKO’s 4Kscore test, a blood test that provides a man’s specific personalized risk score for aggressive prostate cancer, and other OPKO diagnostic products under development.

• Acquired EirGen Pharma; A Growing, Profitable Specialty Pharmaceutical Developer and Manufacturer: OPKO acquired EirGen Pharma, Ltd., a growing, profitable, cash flow positive specialty pharmaceutical company focused on the development, manufacturing, and commercial supply of high potency, high barrier to entry pharmaceutical products for sale in the U.S., Canada, Japan, Australia, Europe, and in other countries around the world. The company, situated in a state of the art, high containment research and development and manufacturing facility, is approved by the FDA, EMEA (European Health Authorities) and the PMDA (Japanese Health Authorities). To date, EirGen and its commercial partners have filed 10 product applications with the FDA and 5 each in Europe and Japan. EirGen has a strong research and development portfolio of over 20 niche, high barrier to entry drugs. EirGen will rapidly expand its drug portfolio with access to additional capital from OPKO, together with the generous benefits of Irish government programs encouraging research and development in Ireland. Eirgen also offers significant synergies and benefits to OPKO through is ability to manufacture OPKO’s current and future products which will contribute to a more favorable tax rate in the future.

• Rayaldee NDA Submission Accepted by FDA; Expected PDUFA date of March 29, 2016: OPKO previously announced successful top-line results from both of its pivotal Phase 3 trials with Rayaldee in late 2014. These trials were identical randomized, double-blind, placebo-controlled, multi-site studies intended to establish the safety and efficacy of Rayaldee as a new treatment for secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.

• Completed the Enrollment in its ongoing Phase 3 Trial in Growth Hormone Deficient Adults: The trial is designed to evaluate the safety and efficacy of hGH-CTP with a primary endpoint of superiority compared to placebo in decreasing fat mass in adults with GHD. The trial is a randomized, double-blind, placebo-controlled, multi-center, global study in adults with GHD. The study is divided into two treatment periods: a 26-week, double-blind, placebo-controlled part, followed by a 26-week, open-label extension. The study is expected to end toward the second half of 2016; regulatory submission will follow study completion.

• IND for Long Acting Factor VIIa-CTP for Hemophilia Filed and Accepted: In March 2015, the FDA accepted OPKO’s IND application to Initiate a Phase 2a Trial for its Long-Acting Coagulation Factor VIIa-CTP to Treat Hemophilia. Clinical Trials are expected to commence during Q3 2015.

• Clinical Studies for Long Acting Oxyntomodulin for Obesity and Diabetes Expected to Begin During 2015: OPKO expects to commence studies for its long acting Oxyntomodulin for diabetes and obesity in the second half of 2015.

• OPKO’s 4Kscore Recommended in National Comprehensive Cancer Network Guidelines for Prostate Cancer Early Detection: The National Comprehensive Cancer Network (NCCN) included 4Kscore as a recommended test in the 2015 NCCN Guidelines for Prostate Cancer Early Detection. The panel concluded that the 4Kscore, as a blood test with greater specificity over the PSA test, is indicated for use prior to a first prostate biopsy or after a negative biopsy to assist patients and physicians in further defining the probability of high-grade cancer.

•
Rolapitant PDUFA Date is September 5, 2015: OPKO’s partner, TESARO, submitted a NDA to the FDA for approval of oral rolapitant, an investigational neurokinin-1 (NK-1) receptor antagonist in development for the prevention of chemotherapy-induced nausea and vomiting (CINV). The NDA is supported by data from four controlled studies covering a spectrum of patients receiving chemotherapy that commonly causes nausea and vomiting. The top-line results of three of the Phase 3 studies were previously announced by TESARO. Upon approval and following commercialization, OPKO will receive up to $110 Million in additional milestones and tiered, double digit royalties.

"The first half of 2015 was transformational for OPKO," said Phillip Frost, M.D., Chairman and CEO. "We believe that the closing of the Pfizer transaction, the acquisition of EirGen and our pending transaction with Bio-Reference will result in OPKO having significant revenue opportunities and an expanded commercial presence to broadly sell and market our products and services. The submission and acceptance of our NDA filing for Rayaldee were also important parts of bringing to market a new therapeutic option for patients with stage 3 or 4 chronic kidney disease and vitamin D insufficiency. We expect the initiation of our important clinical development programs for Factor VIIa-CTP and oxyntomodulin, products with great commercial potential, during the second half of the year," continued Dr. Frost. "The 4Kscore Test’s addition to the NCCN guideline represents a major step towards its becoming the standard of care for early detection of aggressive prostate cancer as well as obtaining reimbursement from the healthcare providers."

Financial Highlights

• Cash, cash equivalents and marketable securities were $221.2 million as of June 30, 2015.

¡ Reflects receipt of Pfizer upfront payments of $295.0 million, partially offset by a $94.7 million cash payment for the acquisition of EirGen (net of cash on hand of EirGen) and a one-time $25.9 million payment to the Office of the Chief Scientist in Israel related to the Pfizer transaction.

• Consolidated revenues increased to $42.4 and $72.5 million during the three and six months ended June 30, 2015 from $23.5 and $45.8 million in the comparable periods of 2014. Revenue for the three and six months ended June 30, 2015 included $17.7 and $30.2 million of revenue resulting from OPKO’s collaboration agreement with Pfizer. OPKO is recording revenue in connection with the Pfizer transaction on a straight-line basis over the expected development period.

• Net loss for the three and six months ended June 30, 2015 was $42.8 million and $159.9 million and included increased operating expenses including increased research and development expense of $13.3 million and $17.8 million, respectively, in comparison to the 2014 periods. Further, the three and six month periods included significant non-recurring and or non-cash charges, such as:

¡ $25.9 million of non-recurring operating expense related to the repayment of a grant to the Office of the Chief Scientist in Israel related to the Pfizer transaction; and

¡ $16.6 million and $66.3 million in non-cash charges related to the change in value of embedded derivatives during the three and six months of 2015, which are part of our January 2013 convertible senior notes due in 2033 (the "2033 Senior Notes"). This non-cash charge is principally a result of the increased market price of our common stock since December 31, 2014.