On August 9, 2018 Protalix BioTherapeutics, Inc. (NYSE American:PLX, TASE:PLX), a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx, reported its financial results for the six-month period ended June 30, 2018 and provided a corporate update (Press release, Protalix, AUG 9, 2018, View Source;p=RssLanding&cat=news&id=2363036 [SID1234528668]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This has been a fantastic quarter for the company highlighted by the expansion of our partnership with Chiesi that resulted from the strong relationship developed over the past months," commented Moshe Manor, Protalix’s President and Chief Executive Officer. "Additionally, we believe that the recent draft guidelines from the U.S. Food and Drug Administration, or the FDA, released in July regarding enzyme replacement therapies could significantly benefit the regulatory path forward for PRX-102."

2018 Second Quarter and Recent Clinical Highlights

Expanded partnership with Chiesi Farmaceutici S.p.A., or Chiesi, to include exclusive U.S. rights for the development and commercialization of PRX-102. Terms of the agreement include an up-front payment of $25 million, up to $20 million in development costs, up to $760 million, in the aggregate, in regulatory and commercial milestone payments and tiered royalties ranging from 15 to 40%.
In July, the FDA issued a draft guideline "Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition that Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies". The draft guideline recognizes the challenges in achieving clinical evidence in rare, slow progressing diseases and provides additional preclinical and clinical results that may be acceptable to the FDA in its consideration for accelerated approval. The Company is reviewing the draft guidelines to determine how they might apply to the Company’s Fabry clinical development program.
With the additional cash from Chiesi, the Company is funded through read-outs of all clinical trials of PRX-102.
Presented data at the Digestive Disease Week (DDW) 2018 Annual Meeting on OPRX-106, which showed mucosal improvement in 61% of patients, mucosal healing in 33% of patients and clinical responses in 67% of patients.
Exchanged 4.50% convertible notes for a combination of shares and cash, and effectively discharged the remainder of the 4.50% notes.
Financial Results for the Six Months ended June 30, 2018

The Company reported a net loss of $20.7 million, or $0.14 per share, basic and diluted for the six-month period ended June 30, 2018 compared to a net loss of $20.6 million, or $0.16 per share, basic and diluted, excluding a one-time, non-cash net charge of $38.1 million in connection with the remeasurement of a derivative, for the same period of 2017.
The Company recorded total revenues of $6.6 million for the six-month period ended June 30, 2018, compared to $9.2 million for the same period of 2017. The decrease is attributed mainly to lower sales of drug substance to Pfizer Inc. and of alfataliglicerase in Brazil.
Research and development expenses were $14.8 million for the six-month period ended June 30, 2018, compared to $15.3 million for the same period of 2017. Chiesi’s participation in the clinical trials of PRX-102 for the treatment of Fabry disease in the amount of $5.0 million was recorded as deferred revenues and not as a deduction from the research and development expenses.
Selling, general and administrative expenses were $4.7 million for the six-month period ended June 30, 2018 compared to $5.4 million for the same period of 2017.
As of June 30, 2018, the Company had $28.3 million of cash and cash equivalents.
Pro forma cash balance for June 30, 2018 to include the upfront from the exclusive license signed with Chiesi for the rights to PRX-102 in the United States is $53.3 million.
Conference Call and Webcast Information

The Company will host a conference call on Thursday, August 9, 2018, at 8:30 am ET to review the clinical, corporate and financial highlights.

To participate in the conference call, please dial the following numbers prior to the start of the call: United States: +1-844-358-6760; International: +1-478-219-0004. Conference ID number 9488046.

The conference call will also be broadcast live and available for replay for two weeks on the Company’s website, www.protalix.com, in the Events Calendar of the Investors section. Please access the Company’s website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software.

On August 9, 2018 AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, reported financial results for the second quarter ended June 30, 2018 (Press release, AmpliPhi Biosciences, AUG 9, 2018, View Source [SID1234528749]). AmpliPhi Biosciences will not be conducting a conference call in conjunction with this financial release.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"I’m delighted to report that we have made substantial progress with our expanded access program for AB-SA01 and AB-PA01," said Paul C. Grint, M.D., CEO of AmpliPhi Biosciences. "As of today, we have treated a total of nineteen patients at seven different hospitals and we are encouraged by the results. We are analyzing the data and plan to share a more detailed update in the near future. We look forward to our two meetings with the FDA over the next two months, the goal of which is to obtain important clinical development feedback for Phase 2 and potentially pivotal trials in one or more indications."

Recent Business Highlights

Two meetings are scheduled with the FDA for August and September to discuss Phase 2 trial plans and the path forward to regulatory approval for investigational drug candidates AB-SA01, targeting Staphylococcus aureus (S. aureus), and AB-PA01, targeting Pseudomonas aeruginosa (P. aeruginosa).
North America’s first Center for Innovative Phage Applications and Therapeutics (IPATH) was launched by UC San Diego (UCSD) in June 2018 with AmpliPhi as an industry partner. As part of the IPATH launch, UCSD announced the successful case of a patient treated with AmpliPhi’s AB-SA01. Prior to phage therapy, the patient had a persistent S. aureus ventricular assist device infection that was not eradicated for three years despite antibiotic treatment.
Presented four case studies of critically ill patients suffering from severe S. aureus bloodstream infections, who received treatment with AB-SA01, at the American Society for Microbiology (ASM) Microbe 2018 annual meeting in Atlanta in June 2018. In all cases, standard medical and surgical therapy was considered inadequate before starting bacteriophage therapy. AB-SA01 was well-tolerated and bacterial elimination was demonstrated in three out of four patients.
Presented a successful case study of a patient with cystic fibrosis (CF), suffering from recurrent multi-drug resistant (MDR) P. aeruginosa pneumonia and multiple CF exacerbations, who received treatment with AB-PA01, at the 41st European Cystic Fibrosis Conference in Belgrade, Serbia, in June 2018. Prior to treatment with AB-PA01, the patient received multiple courses of antibiotics, including colistin, but due to renal failure, colistin administration was discontinued. Treatment with AB-PA01 was well tolerated and the patient’s infection resolved. No recurrence of pneumonia or CF exacerbation was reported during the two-month follow-up period after the completion of treatment with AB-PA01. The patient’s renal failure resolved.
Presented a successful case study of a lung transplant recipient suffering from recurrent episodes of MDR P. aeruginosa pneumonia who received treatment with bacteriophage therapeutics, including AB-PA01, at the International Society of Heart and Lung Transplant Annual Meeting in Nice, France, in April 2018. The patient clinically responded to bacteriophage and antibiotic therapy with resolution of pneumonia and improved respiratory status.
Utilized the Therapeutic Development Services funded by the National Institute of Allergy and Infectious Disease (NIAID), part of the National Institutes of Health (NIH), to conduct further preclinical studies of AB-SA01. The Therapeutic Development Services program funds the provision of preclinical services for selected companies and researchers in order to advance development of promising interventional agents.
Second Quarter and Six Months Ended June 30, 2018 Financial Results

Research and development (R&D) expenses for the second quarter of 2018 were $1.7 million compared to $1.1 million for the second quarter of 2017, primarily attributable to a $0.2 million increase in professional and consulting fees and a $0.2 million increase in clinical costs.
R&D expenses for the six months ended June 30, 2018 increased by $0.6 million to $3.2 million from $2.6 million for the six months ended June 30, 2017, primarily due to an increase in clinical costs.
General and administrative (G&A) expenses were $1.4 million for the second quarter of 2018 compared to $2.8 million for the second quarter of 2017. The decrease was primarily due to lower payroll-related costs, lower legal and professional fees, as well as a $0.6 million decrease in non-cash stock-based compensation and other non-cash charges.
G&A expenses for the first six months of 2018 decreased by $1.7 million to $3.0 million from $4.7 million for the first six months of 2017. The decrease was primarily attributable to a decrease in the items described above for the second quarter comparison.
Net cash used in operating activities for the six months ended June 30, 2018 was $5.7 million compared to $6.2 million for the six months ended June 30, 2017.
Cash and cash equivalents as of June 30, 2018 totaled $5.8 million.
In July 2018, the Company received $1.2 million of tax rebate incentive payments in cash from the Australian tax authority. The incentive payments are based on R&D activities in Australia in 2017.
As of August 6, 2018, there were 16.5 million shares of common stock outstanding.

On August 9, 2018 Intrexon Corporation (NYSE: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet,reported that it will host a call today to provide a general update and highlight recent business developments, as well as provide select preliminary and unaudited second quarter results (Press release, Intrexon, AUG 9, 2018, View Source [SID1234528585]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company is not announcing final financial results for the quarter ended June 30, 2018 and is delaying the filing of its quarterly report on Form 10-Q. The delay in filing the second quarter report is related to the Company’s application of certain aspects of ASC 606 in the Company’s first quarter Form 10-Q. The Company will be filing an amended Form 10-Q for the first quarter of 2018. The Company expects to file the second quarter report and amended first quarter report within the next few days.

Business Highlights:

Precigen, Inc., a wholly owned subsidiary of Intrexon and a pharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients, announced the treatment of the first patient in Phase 1 first-in-human clinical trials of its investigational therapy, INXN‑4001, the first multigene cardiac approach to express proteins encoded by three effector genes to treat heart failure;
Intrexon and Epimeron, Inc., a world-class provider of gene discovery and biosynthetic pathway optimization, announced the isolation and recombinant expression of a novel gene from the opium poppy (Papaver somniferum) encoding the enzyme thebaine synthase. The existence of this enzyme, which was not previously verified, is essential to increase the rate of the final step in thebaine synthesis, which the Company believes is a major breakthrough and allows biosynthesis of several important active agents and intermediates including thebaine, codeine and morphine;
Oxitec, Ltd., a wholly owned subsidiary of Intrexon, entered into a cooperative agreement with the Bill & Melinda Gates Foundation to develop a new strain of Oxitec’s self-limiting Friendly Mosquitoes to combat the Anopheles mosquito species that spreads malaria in the Western Hemisphere;
Collaborator Ziopharm Oncology, Inc. (Nasdaq: ZIOP) presented clinical data showing the company’s controlled IL-12 platform as monotherapy achieved anti-tumor responses in patients with metastatic breast cancer and recurrent glioblastoma at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting;
Collaborator Ziopharm Oncology, Inc. (Nasdaq: ZIOP) announced that the first patient has been dosed in a new Phase 1 trial evaluating combination therapy of controlled IL-12 and OPDIVO (nivolumab) for the treatment of recurrent glioblastoma;
Collaborator Fibrocell Science, Inc. (Nasdaq: FCSC) reported interim results on the Phase 1/2 trial of FCX‑007 trial, a gene therapy for the treatment of recessive dystrophic epidermolysis bullosa. The results highlighted that FCX-007 was well tolerated at 52 weeks post-administration and showed continued positive trends in wound healing and pharmacological signals, including type VII collagen expression and evidence of anchoring fibrils; and
In July 2018, Intrexon completed its registered underwritten public offering of $200 million aggregate principal amount of 3.50% convertible senior notes due 2023. Concurrently with the notes offering, the Company entered into a share lending agreement with J.P. Morgan Securities LLC and JPMorgan Chase Bank, National Association, New York branch, as share borrower, pursuant to which the Company agreed to lend 7,479,431 shares of common stock of the Company, no par value per share to the share borrower. Randal J. Kirk, the Chairman, Chief Executive Officer and principal shareholder of the Company, and an entity with which he is affiliated, agreed with the share borrower to purchase all of the shares of Common Stock offered in the borrowed shares offering.
Recent Developments:

2,3, BDO yields are up 22% since last reported and continue to support the Company’s stated plan to break ground on a 40,000 ton/year plant by year end;
Intrexon scientists continue to engineer the methanotrophic organism to improve the utilization of natural gas as a carbon source;
Intrexon remains engaged in advanced discussions with multiple strategic partners for the methane bioconversion platform;
Xogenex, LLC, a majority owned subsidiary of Precigen, has dosed multiple patients in its Phase 1 trial of the gene therapy INXN-4001;
Helen Sabzevari, PhD, President of Precigen, will host an analyst day in Germantown, Maryland in the fourth quarter. At this meeting, Dr. Sabzevari will provide an in depth review and update of Precigen’s cell and gene based therapeutic programs; and
To date, Okanagan Specialty Fruits has completed the planting of over 900,000 Arctic apple trees on 592 total acres and is targeting planting 1,000,000 more trees in the spring of 2019.
Select Preliminary Unaudited Second Quarter 2018 Financial Results:

Revenues will be approximately $45.3 million;
Net loss attributable to Intrexon will be approximately $65.4 million (including noncash charges of $43.9 million); and
Earnings per share will be a loss of approximately $0.51 per basic share.
"The businesses of intrexon continue to advance, leaving their roots as historic achievements of numerous world first instances in the field of engineered biology to become strong economic engines that should produce revenues and profits for years to come," commented Randal J. Kirk, Chairman and Chief Executive Officer of Intrexon. "From the creation of the world’s first organisms that turn the cheapest source of carbon into valuable petrochemicals, fuels and lubricants, we are moving forward to capture the economic and social advantages of our achievements. From our demonstration of multigeneic and controllable gene and cell systems we are advancing into the clinic with therapies against many of the most important unmet health needs. From the development of the first engineered fish, insects, fruits and pigs, we are moving forward adroitly to see each of these become real businesses that contribute significant value to the world."

Mr. Kirk concluded, "I feel that we are on the cusp of showing with business what we have long demonstrated in the science and technology of engineered biology and believe that our shareholders will be pleased by the result."

Restatement of First Quarter Financial Results:

Effective January 1, 2018, the Company adopted ASC 606 using the modified retrospective method. The Company has reassessed its application of certain aspects of ASC 606, including gross versus net presentation for payments pursuant to one of the Company’s contracts and the guidance for contract modifications to a contract that had been modified prior to the adoption of ASC 606. The Company estimates that these errors have resulted in an overstatement of deferred revenue and accumulated deficit by approximately $67 million as of the adoption date, and an overstatement of revenues by approximately $4 million for the three months ended March 31, 2018. These estimates are based on the Company’s current expectations and are subject to finalization, including completion of quarterly procedures and completion of the Company’s technical accounting analysis for ASC 606.

Conference Call and Webcast

The Company will host a conference call today Thursday, August 9th, at 5:30 PM ET to provide a general business update. The conference call may be accessed by dialing 1‑888-317-6003 (Domestic US), 1-866-284-3684 (Canada), and 1-412-317-6061 (International) and providing the number 6027271 to join the Intrexon Corporation Call. Participants may also access the live webcast through Intrexon’s website in the Investors section at View Source

On August 9, 2018 GlycoMimetics, Inc. (Nasdaq: GLYC) reported its financial results for the second quarter ended June 30, 2018 and highlighted recent company achievements (Press release, GlycoMimetics, AUG 9, 2018, View Source [SID1234528603]). Quarter-end cash at June 30, 2018 was $229.4 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our second-quarter 2018 accomplishments reflect significant progress as we finalized our plans to conduct a comprehensive Phase 3 development program for uproleselan across the spectrum of AML. With our announcement in May of an NCI CRADA, in addition to the previously announced trial in Europe sponsored by the prestigious HOVON consortium and our own sponsored registration trial, we are now planning three separate randomized, controlled trials, which we believe should provide clear efficacy and safety outcome measures in each of settings being evaluated," said Rachel King, GlycoMimetics Chief Executive Officer. "The unique mechanism of action of uproleselan allows for the potential treatment of not only relapsed/refractory AML patients, but also older, newly diagnosed AML patients who are considered to be either fit or unfit for intensive chemotherapy. If successful, we believe that the combination of these trials could position us to offer a new standard treatment across the continuum of care in AML."

Key Operational Highlights for the Second Quarter of 2018:

The company’s agreement with the NCI, part of the National Institutes of Health (NIH), provides for GlycoMimetics to collaborate with both the NCI and the Alliance for Clinical Trials in Oncology to conduct a randomized, controlled clinical trial testing the addition of uproleselan to a standard cytarabine/daunorubicin regimen (7&3) in older adults with previously untreated AML who are eligible for intensive chemotherapy. The trial will be funded by the NCI. GlycoMimetics will provide uproleselan as well as financial support to augment data analysis and monitoring. Geoffrey Uy, M.D., Associate Professor of Medicine, Bone Marrow Transplantation and Leukemia, Washington University School of Medicine in St. Louis, will lead this Phase 3 trial. The primary endpoint will be overall survival, with a planned interim analysis based on event-free survival (EFS) after the first 250 patients have been enrolled in the study.
At the AACR (Free AACR Whitepaper) annual meeting, the company highlighted data from preclinical models of selected cancers in which uproleselan and GMI-1359, a dual antagonist of E-selectin and CXCR4, exhibited anti-cancer activity. Key findings from the preclinical research include:
Uproleselan could potentially be used with a hypomethylating agent, such as 5-azacitidine, to treat AML patients not healthy enough for intensive chemotherapy.
GMI-1359 mobilized tumor-reactive T-cells from bone marrow, which could enhance effectiveness of treatments despite tumor resistance.
Both tumor growth and metastasis of osteosarcoma to lung tissue were reduced with GMI-1359 treatment.
The company’s strategic partner Pfizer continues to enroll individuals with sickle cell disease (SCD) in its Phase 3 clinical study of rivipansel for the treatment of vaso-occlusive crisis (VOC). Pfizer has advised GlycoMimetics that enrollment is approximately 75% complete and is estimated to be completed in early 2019, with top-line data expected to be available in the second quarter of 2019.
Second Quarter 2018 Financial Results:

Cash position: As of June 30, 2018, GlycoMimetics had cash and cash equivalents of $229.4 million as compared to $123.9 million as of December 31, 2017. In March 2018, GlycoMimetics completed a public offering of 8,050,000 shares of common stock, yielding net proceeds of $128.4 million.
R&D Expenses: The Company’s research and development expenses increased to $9.3 million for the quarter ended June 30, 2018 as compared to $5.7 million for the prior year quarter. The increase was primarily due to higher manufacturing costs for uproleselan clinical supplies as the Company prepares for our planned Phase 3 clinical trial and to meet our supply obligations for clinical trials of uproleselan conducted by or in collaboration with third parties. This increase was offset in part by a decrease in clinical trial expenses as patient enrollment for our Phase 1/2 clinical trial of uproleselan was completed in May 2017.
G&A Expenses: The Company’s general and administrative expenses increased to $2.8 million for the quarter ended June 30, 2018 as compared to $2.5 million for the prior year quarter. The increase was primarily due to higher patent and other legal expenses.
Shares Outstanding: Shares outstanding as of June 30, 2018 were 43,055,424.
The company will host a conference call and webcast tomorrow, Friday, August 10, 2018, at 8:30 a.m. ET. The dial-in number for the conference call is (844) 413-7154 (U.S. and Canada) or (216) 562-0466 (international) with passcode 3876308. To access the live audio webcast, or the subsequent archived recording, visit the "Investors – Events & Presentations" section of the GlycoMimetics website at www.glycomimetics.com. The webcast will be recorded and available for replay on the GlycoMimetics website for 30 days following the call.

About Uproleselan (GMI-1271)

Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed/refractory patients with AML. In both populations, patients treated with uproleselan together with standard chemotherapy achieved better than expected remission rates and overall survival compared to historical controls, which have been derived from results from third party clinical trials evaluating standard chemotherapy, as well as lower than expected induction-related mortality rates. Treatment in these patient populations was generally well tolerated, with fewer than expected adverse effects. The FDA has granted uproleselan Breakthrough Therapy designation for the treatment of adult AML patients with relapsed/refractory (R/R) disease. GlycoMimetics plans to implement a comprehensive development program across the clinical spectrum of AML. This will include a company sponsored Phase 3 trial in R/R AML and two consortia-sponsored trials in newly diagnosed patients. One consortium trial will be sponsored by the NCI and will enroll newly diagnosed patients fit for intensive chemotherapy. The other trial will be sponsored by the HOVON group in Europe and will enroll newly diagnosed patients unfit for intensive chemotherapy.

About Rivipansel

Rivipansel, the most advanced drug candidate in the GlycoMimetics pipeline, is a glycomimetic drug candidate that acts as a pan-selectin antagonist, meaning it binds to all three members of the selectin family – E-, P- and L-selectin. The first potential indication for rivipansel is VOC of SCD, one of the most severe complications of SCD which can result in acute ischemic organ injury at one or more sites. By reducing cell adhesion, activation and inflammation that are believed to contribute to reduced blood flow through the microvasculature during VOC, GlycoMimetics believes that rivipansel could be the first drug to interrupt the underlying cause of VOC, thereby potentially enabling patients to leave the hospital more quickly. Pfizer is conducting a Phase 3 clinical trial for rivipansel in SCD.

About GMI-1359

GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both adhesion molecules that keep cancer cells in the bone marrow. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow such as AML and multiple myeloma (MM) or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer. GMI-1359 is currently in Phase 1 testing in healthy volunteers.

On August 8, 2018 PDL BioPharma, Inc. ("PDL" or the "Company") (NASDAQ: PDLI) reported its financial results for the three and six months ended June 30, 2018 including (Press release, PDL BioPharma, AUG 8, 2018, View Source [SID1234528766]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Second Quarter Financial Highlights

Total revenues of $46.6 million.

GAAP net loss attributable to PDL’s shareholders of $112.3 million or $(0.76) per share.

GAAP net loss includes a one-time $133.3 million, net of tax, non-cash accounting charge related to the impairment of an intangible asset from Noden Pharma DAC, due to the increased probability of a generic version of aliskiren being launched in the United States by Anchen, offset by a $19.7 million, net of tax, non-cash decrease in the fair value of the contingent liability related to a reduced estimate of the probability in paying milestones to Novartis for Tekturna.

Non-GAAP net income attributable to PDL’s shareholders of $14.7 million. A reconciliation of GAAP to non-GAAP financial results can be found in Table 3 at the end of this news release.

Cash, cash equivalents, short-term investments and other investments of $395.7 million as of June 30, 2018.

Repurchased 6.8 million shares of common stock in the open market during the quarter for $19.4 million.

"Our financial results for the second quarter reflect higher product sales resulting from our change in strategy to equity and product investments, and we continue to have a strong cash balance to pursue acquisitions. While we are disappointed with the write down of the Noden asset, the impairment is not an indication of the performance of the business this quarter, but rather is based upon uncertainty in the future generic aliskiren competition in the United States," said John P. McLaughlin, CEO of PDL.

"Last week we announced an amended agreement with Depomed to purchase Depomed’s remaining interests in future royalties for $20 million in a transaction we view as highly attractive to our shareholders," he added. "While we are shifting our strategy away from royalty agreements, our familiarity with the Depomed assets and our past success with them supported this investment decision. We expect to begin realizing a return on this investment by late 2020 with meaningful cash returns expected through 2026."

Revenue Highlights

Total revenues of $46.6 million for the three months ended June 30, 2018 included:
◦
Product revenues of $31.8 million, which consisted of $25.9 million from sales of Tekturna and Tekturna HCT in the United States and Rasilez and Rasilez HCT in the rest of the world (collectively, the Noden Products), and $5.9 million for product sales of the LENSAR Laser System;
◦
Net royalty payments from acquired royalty rights and a change in fair value of the royalty rights assets of $12.8 million, which consisted of the change in estimated fair value of our royalty right assets, primarily related to the Depomed royalty asset;

Royalties from PDL’s licensees to the Queen et al. patents of $1.2 million, which consisted of royalties earned on sales of Tysabri; and
◦
Interest revenue from note receivable investment to CareView Communications of $0.8 million.

Total revenues for the second quarter of 2018 were $46.6 million, compared with $143.8 million for the second quarter of 2017, reflecting PDL’s strategic shift to a pharmaceutical business model and the decline in royalty income from the expired Queen et al. patents.
◦
Product revenues were $31.8 million, a 69% increase from $18.8 million for the prior year 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 68% of total revenues compared with 13% in the second quarter of 2017;
◦
Product revenues from Noden Products were $10.4 million in the U.S. and $15.5 million in the rest of the world.
◦
PDL recognized $12.8 million in revenue from royalty rights – change in fair value, compared with $83.7 million in the prior-year period. The decrease was primarily due to a higher prior year royalty rights – change in fair value as a result of the increase in fair value of the Depomed, Inc. royalty asset in the second quarter of 2017 based upon revised future cash flows;
◦
PDL received $19.4 million in net cash royalties from its royalty rights for the second quarter of 2018, compared with $34.6 million for the prior-year period. The decrease is mainly due to the launch of the authorized generic for Glumetza in February 2017 sold by a subsidiary of Bausch Health Companies Inc. (formerly Valeant Pharmaceuticals International, Inc.) and included a retroactive payment in the second quarter of 2017;
◦
Royalties from PDL’s licensees to the Queen et al. patents of $1.2 million, compared with $16.3 million for the second 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 revenues decreased primarily due to the sale of the kaléo, Inc. note receivable in September 2017.

Total revenues for the six months ended June 30, 2018, were $85.1 million, compared with $189.3 million for the prior-year period:
◦
Product revenues were $55.1 million, a 75% increase from $31.4 million for the prior-year period. Product revenues for 2018 consisted of $44.2 million from sales of the Noden Products and $10.9 million for product sales of the LENSAR Laser System;
◦
PDL recognized $23.9 million in net royalty payments from acquired royalty rights and a change in fair value of the royalty rights assets, compared with $96.9 million for the prior-year period;
◦
PDL received $38.0 million in net cash royalties from its royalty rights year-to-date 2018, compared with $48.1 million for the prior-year period;
◦
Royalties from PDL’s licensees to the Queen et al. patents of $4.0 million, compared with $30.4 million for the prior-year period; and
◦
Interest revenue from note receivable investment to CareView Communications of $1.5 million.

Operating Expense Highlights

Operating expenses for the three months ended June 30, 2018 of $171.7 million increased $140.6 million from $31.1 million for the three months ended June 30, 2017. The increase was a result of the impairment of the Noden intangible asset of $152.3 million due to the increased probability of a generic version of aliskiren being launched in the United States, partially offset by the $22.5 million decrease in fair value of the contingent liability related to reduced estimate in the probabilities in paying milestones to Novartis for Tekturna.

Cost of product revenue for the three months ended June 30, 2018 increased as a result of the Noden Products and LENSAR contributing additional cost of product revenue of $8.4 million and $1.6 million, respectively, due to increased revenue from Noden Products and recognition of costs of goods for ex-U.S. revenue and increased revenue from LENSAR, which PDL did not begin to recognize until May 2017. General and administrative expenses of $14.5 million, increased compared with $11.3 million a year ago, with the increase due to a full quarter of expenses from LENSAR in 2018 versus a partial quarter as a result of its acquisition in May 2017, operation growth for Noden and expenses related to business development activities. Sales and marketing expenses were $5.4 million, compared with $3.6 million in the prior-year period, with the increase due to an increase in marketing efforts for Noden and LENSAR, and research and development costs decreased based upon the completion of a pediatric trial for Tekturna.

Operating expenses for the six months ended June 30, 2018 were $205.9 million, a $147.9 million increase from $58.0 million for the prior-year period, with the increase primarily a result of the impairment of the Noden intangible asset of $152.3 million, as well as a result of Noden and LENSAR contributing additional cost of product revenue of $14.0 million and $4.0 million, respectively, which was due to increased revenue in Noden and recognition of costs of goods for ex-U.S. revenue and increased revenue from LENSAR, which PDL did not begin to recognized until May 2017, partially offset by the decrease in fair value of the contingent liability.

Stock Repurchase Programs

PDL repurchased 8.2 million shares of its common stock under the $25.0 million share repurchase program during the six months ended June 30, 2018, for an aggregate purchase price of $23.6 million, or an average cost of $2.89 per share, including trading commission. All shares repurchased were retired.

From July 1, 2018 to July 5, 2018, the Company completed this 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.

Since initiating its first stock repurchase program in March 2017, the Company has used $55.0 million to repurchase a total of 22.0 million shares of its common stock.

Other Financial Highlights

PDL had cash, cash equivalents, short-term investments and other investments of $395.7 million as of June 30, 2018, compared with $532.1 million as of December 31, 2017.

The reduction in cash balance for the six months ended June 30, 2018 was primarily a result of the retiring of the remaining $126.4 million of principal from PDL’s 4.0% Convertible Senior Notes due 2018, plus $2.6 million of accrued interest, and common stock repurchases of $23.6 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, August 8, 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 United States and Canada or (706) 679-2458 internationally. The conference ID is 7356309. Please dial in approximately 10 minutes prior to the start of the call. 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 United States and Canada or (404) 537-3406 internationally. The replay passcode is 7356309.

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