On May 9, 2019 PDL BioPharma, Inc. ("PDL" or "the Company") (NASDAQ: PDLI) reported financial results for the three months ended March 31, 2019 (Press release, PDL BioPharma, MAY 9, 2019, View Source [SID1234536071]):

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First Quarter and Recent Financial Highlights

Total revenues of $38.9 million.

GAAP net income of $6.7 million or $0.05 per diluted share.

Non-GAAP net income attributable to PDL’s shareholders of $11.9 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 $366.3 million as of March 31, 2019.

Repurchased 13.1 million shares of common stock in the open market during the first quarter of 2019 for $44.4 million, or an average price of $3.38 per share.

Invested $30.0 million in Evofem Biosciences, Inc. in April 2019.

"This is a very exciting time at PDL as we report strong first quarter financial results while we consider expanding our strategic transaction with Evofem Biosciences, as announced on April 11," said Dominique Monnet, president and CEO of PDL. "The elements of this transaction fit with our commitment to creating shareholder value by entering into strategic collaborations with pharmaceutical companies with innovative products and technologies. Evofem Biosciences provides us with an attractive opportunity to make a contribution to women’s healthcare, which presents many unmet medical needs that have been largely underserved by large pharmaceutical companies. Evofem’s lead investigational drug product, Amphora, offers a novel non-hormonal approach to contraception for women. Additionally, we are confident that Evofem’s team has the talent, expertise and dedication to execute successfully its commercial plan for Amphora.

"Should we make the second $30 million tranche of our proposed investment in Evofem, our team at PDL would bring significant value to the Amphora launch by contributing our capital and expertise in commercializing products in the U.S. and internationally," he added.

First Quarter Revenue Highlights

Total revenues of $38.9 million included:

Product revenue of $26.7 million, which consisted of $20.0 million from the sales of our branded prescription medicine products Tekturna and Tekturna HCT in the U.S. and Rasilez and Rasilez HCT in the rest of the world and revenue generated from the sale of an authorized generic form of Tekturna in the United States (collectively, the Noden Products), and $6.7 million of product revenue from the LENSAR Laser System.

Product revenue from the Noden Products was $12.2 million in the U.S. and $7.8 million in the rest of the world.

Net royalty payments from acquired royalty rights and a change in fair value of the royalty rights assets of $12.3 million, primarily related to the Assertio royalty asset.

Total revenues of $38.9 million, compared with $38.5 million for the first quarter of 2018.

Product revenue of $26.7 million, increased 14.4%, compared with $23.3 million for the prior-year period. The increase is primarily due to the initial inventory stocking related to the launch of an authorized generic form of Tekturna in the United States in March 2019.

PDL recognized $12.3 million in revenue from royalty rights – change in fair value, compared with $11.1 million in the prior-year period. The increase is related to higher royalties from the Assertio royalty asset.

PDL received $12.6 million in net cash royalties from its royalty rights in the first quarter of 2019.

Royalties from PDL’s licensees to the Queen et al. patents were less than $0.1 million in the first quarter of 2019, compared with $2.8 million for the first quarter of 2018 as royalties on the sales of Tysabri are nearing completion.

Interest revenue decreased by $0.7 million from the prior-year period due to CareView Communications not making its interest payment in the first quarter of 2019.

First Quarter Operating Expense Highlights

Operating expenses were $28.4 million, a $5.8 million decrease from $34.2 million for the first quarter of 2018. The variance was primarily a result of:

a $4.7 million decline in amortization expense for the Noden intangible assets as a result of the impairment recorded for these intangible assets in the second quarter of 2018,

a $1.2 million, or 10%, decline in general and administrative expenses primarily due to lower professional fees,

a $2.8 million, or 50%, decline in sales and marketing expenses, reflecting the cost savings from the change in our marketing strategy for the Noden Products,

offset by a $2.2 million increase in Noden Products and LENSAR cost of product revenue, due to higher sales in both segments,

a $0.6 million favorable adjustment to the fair value of the contingent consideration recorded in the first quarter of 2018 with no corresponding adjustment in the first quarter of 2019, and

higher research and development expenses in our Medical Devices segment.

Stock Repurchase Programs

In November 2018, PDL began repurchasing shares of its common stock pursuant to the $100.0 million share repurchase program. During the first quarter of 2019, the Company repurchased 13.1 million shares for an aggregate purchase price of $44.4 million, or an average cost of $3.38 per share, including trading commission.

Subsequent to the close of the first quarter of 2019, the Company repurchased 2.8 million shares at an average price of $3.77 per share, for a total of $10.4 million.

To date, the Company has repurchased 24.5 million shares for a total of $80.3 million in the $100.0 million program leaving $19.7 million available to be repurchased.

Since initiating its first stock repurchase program in March 2017, the Company has used $135.3 million to repurchase a total of 46.6 million shares of its common stock.

Other Financial Highlights

PDL had cash and cash equivalents of $366.3 million as of March 31, 2019, compared with cash and cash equivalents of $394.6 million as of December 31, 2018.

The reduction in cash and cash equivalents was primarily the result of common stock repurchases of $44.4 million, partially offset by the proceeds from operations and royalty rights.

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. Slides to accompany the conference call will be 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 1099595. 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 1099595.

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

On May 9, 2019 Array BioPharma Inc. (Nasdaq: ARRY) reported that its Chief Executive Officer, Ron Squarer, will speak at the Bank of America Merrill Lynch 2019 Health Care Conference in Las Vegas (Press release, Array BioPharma, MAY 9, 2019, View Source [SID1234536070]). The public is welcome to participate in the conference through a webcast on the Array BioPharma website.

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Event:

Bank of America Merrill Lynch 2019 Health Care Conference

Presenter:

Ron Squarer, Chief Executive Officer, Array BioPharma

Date:

Thursday, May 16, 2019

Time:

10:00 a.m. Pacific Time / 1:00 p.m. Eastern Time

Webcast:

http://www.veracast.com/webcasts/baml/healthcare2019/id83306305205.cfm

On May 9, 2019 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for patients with kidney disease, reported financial results for the first quarter ended March 31, 2019 (Press release, Akebia, MAY 9, 2019, View Source [SID1234536069]). The company also announced full enrollment of its global Phase 3 INNO2VATE studies for vadadustat, that it has bolstered its commercial capabilities with the addition of Dell Faulkingham as Senior Vice President, Chief Commercial Officer, and appointed Steven K. Burke, M.D., as Senior Vice President, Chief Medical Officer.

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"The first quarter marked the achievement of another important milestone for Akebia with the announcement of positive top-line results from two Phase 3, active-controlled, pivotal studies evaluating vadadustat in Japanese patients with anemia due to chronic kidney disease (CKD)," stated John P. Butler, President and Chief Executive Officer of Akebia Therapeutics. "We are excited by these results as they increase our level of confidence in the hypoxia inducible factor (HIF) pathway and more specifically, the direction of our clinical program for vadadustat. These results are expected to serve as the basis for a New Drug Application in Japan (JNDA) by our collaboration partner, Mitsubishi Tanabe Pharma Corporation (MTPC), in 2019."

Butler continued, "We are also pleased to announce the completion of enrollment in our global Phase 3 INNO2VATE studies evaluating vadadustat for the treatment of anemia due to CKD in dialysis-dependent CKD subjects. With the addition of Dell Faulkingham to our executive team, we have strengthened our commercial capabilities and believe we are well positioned to execute on our revenue growth strategies for Auryxia. Lastly, we look forward to welcoming Dr. Steven Burke as our new Chief Medical Officer as we continue to execute on the multiple catalysts expected with vadadustat’s Phase 3 program over the next 12 to 18 months."

Auryxia Highlights

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Auryxia net product revenue for the first quarter of 2019 was $23.1 million, representing 12.1 percent growth over the first quarter of 2018.

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Total Auryxia prescriptions were 40,080, representing 22.5 percent growth over the first quarter of 2018.

Vadadustat Highlights

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Announced positive top-line results from two Phase 3, active-controlled, pivotal studies evaluating vadadustat in Japanese subjects with anemia due to CKD in March 2019. Data from these two pivotal studies as well as from two additional single-arm studies in peritoneal dialysis and hemodialysis subjects, also recently announced, are expected to serve as the basis for a JNDA submission by MTPC in 2019.

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Expanded license agreement with Vifor Pharma announced in April 2019 creates opportunity for accelerated introduction of vadadustat, if approved by the U.S. Food and Drug Administration (FDA), in up to 60 percent of U.S. dialysis patients.

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Enrollment in the global Phase 3 INNO2VATE studies evaluating the safety and efficacy of vadadustat in dialysis-dependent CKD subjects with anemia due to CKD, has been completed. Enrollment in the smaller of the two INNO2VATE studies (the "Correction Study"), was completed in April 2019, with a total of 369 subjects enrolled. Enrollment in the larger INNO2VATE study (the "Conversion Study") was completed in February 2019, with a total of 3,554 subjects enrolled. The company continues to expect to report top-line data from both INNO2VATE studies in the second quarter of 2020, subject to the accrual of major adverse cardiovascular events (MACE).

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The company expects enrollment in the global Phase 3 PRO2TECT studies evaluating the safety and efficacy of vadadustat in non-dialysis dependent CKD subjects with anemia due to CKD, to be completed in 2019, with up to approximately 3,700 subjects expected to be enrolled. The company continues to expect to report top-line results in mid-2020, subject to the accrual of MACE.

Financial Results

Total revenue for the first quarter of 2019 was $72.7 million, compared to $45.9 million in the first quarter of 2018.

Auryxia net product revenue for the first quarter of 2019 was $23.1 million, compared to $20.6 million, as reported by Keryx Biopharmaceuticals, Inc. ("Keryx") prior to its merger with the company, during the same period in 2018. This represents a 12.1 percent increase in net product revenue from the first quarter of 2018. Auryxia is the company’s FDA approved oral iron tablet to treat non-dialysis dependent adult CKD patients for iron deficiency anemia (IDA) and dialysis-dependent adult CKD patients for hyperphosphatemia.

"As we previously discussed, the Centers for Medicare & Medicaid Services’ (CMS) new prior authorization requirement for Auryxia caused delays in approvals of prescriptions and negatively impacted Auryxia product revenue for the first quarter. We believe our efforts to help patients and prescribers navigate this process are working and we’re encouraged with the growth in weekly prescriptions that we are now seeing. In fact, the prescription demand we’ve seen in the first four weeks of the second quarter exceeded the first four weeks of any quarter since Auryxia was launched," stated Butler. "Looking ahead, we believe continued execution on our growth strategy and underlying market demand, will drive increased revenue for Auryxia in the second quarter and across the year."

Collaboration revenue for the first quarter of 2019 was $49.6 million, compared with $45.9 million in the first quarter of 2018. The increase was primarily due to increased collaboration revenue in the first quarter of 2019 from the company’s cost sharing arrangement under its Otsuka collaboration agreements. The company expects Otsuka to begin funding 80 percent of its development costs for vadadustat in the second quarter of 2019.

Cost of goods sold was $31.3 million for the first quarter of 2019, consisting of $7.6 million of costs associated with the manufacture of Auryxia and $23.7 million related to the application of purchase accounting as a result of the merger with Keryx, including $14.6 million of inventory step-up and $9.1 million of amortization of intangibles.

Research and development expenses were $82.4 million for the first quarter of 2019 compared to $61.4 million for the first quarter of 2018. The increase was primarily attributable to an increase in external costs related to the continued advancement of the PRO2TECT and INNO2VATE Phase 3 studies.

Selling, general and administrative expenses were $34.3 million for the first quarter of 2019 compared to $9.0 million for the first quarter of 2018. The increase in selling, general and administrative expenses was primarily attributable to commercialization costs associated with Auryxia, as there were no comparable commercialization costs in the first quarter of 2018.

The company reported a net loss for the first quarter of 2019 of $72.4 million, or ($0.62) per share, as compared to a net loss of $23.4 million, or ($0.48) per share, for the first quarter of 2018. The company’s net loss for the first quarter of 2019 includes the impact of merger-related accounting charges totaling $23.7 million, offset by a $2.8 million deferred tax benefit.

The company ended the quarter with cash, cash equivalents and available-for-sale securities of $168.0 million. The decrease from the fourth quarter of 2018 was primarily related to the timing of cash flows between quarters, including reimbursement amounts from the company’s collaboration partners and payments related to its Phase 3 program for vadadustat, including $13.0 million of advanced purchases of comparator drug inventory in anticipation of Brexit. Additionally, cash was impacted by one-time payments of certain previously accrued, merger-related liabilities totaling $30.0 million. The company continues to expect its cash resources, including the prepaid quarterly committed cost-share funding from its collaboration partners, to fund its current operating plan into the third quarter of 2020.

Leadership Team Additions

Steven K. Burke, M.D. will succeed Rita Jain, M.D., who informed the company of her plans to step down from her position as Senior Vice President, Chief Medical Officer effective June 17, 2019 to pursue other opportunities. Dr. Jain has been a valued member of the company’s leadership team, and during her tenure made important contributions to the vadadustat development program and enhanced the development organization. She has advised the company that she is committed to supporting the company during a transitional period and ensuring a seamless and successful transition to her successor, Dr. Burke.

Dr. Burke will join the company from Proteon Therapeutics, Inc., where he has been Senior Vice President and Chief Medical Officer since 2006. Prior to joining Proteon, Dr. Burke served as Senior Vice President of Medical and Regulatory Affairs at Genzyme Corporation, where he worked from 2001 to 2006. From 1994 to 2001, Dr. Burke held roles at GelTex Pharmaceuticals, Inc. including Vice President of Clinical Research and Medical Director, and before that he held positions at Glaxo, Inc.. Dr. Burke received an A.B. from Harvard College and an M.D. from Cornell University Medical College. He completed a medical residency and fellowship at Brigham and Women’s Hospital and is certified by the American Board of Internal Medicine.

Dell Faulkingham joins the company with more than 20 years of commercial experience across a broad range of specialty pharmaceutical categories. His experience includes commercial leadership roles with Biogen Inc., where he held multiple positions of increasing responsibility, most recently serving as Senior Vice President and Head, U.S. Multiple Sclerosis (MS) Franchise. Mr. Faulkingham also recently served as Vice President, Head of U.S. MS Marketing and Field Operations at Biogen. Prior to joining Biogen, Mr. Faulkingham held several roles with Takeda Pharmaceuticals. Mr. Faulkingham began his career in sales at Forest Pharmaceuticals, Inc. and received a B.S. in biology from the University of Georgia.

Conference Call:

Akebia will host a conference call today, Thursday, May 9, 2019, at 9:00 a.m. Eastern Time to discuss its first quarter financial results. To listen to the conference call, please dial (877) 458-0977 (domestic) or (484) 653-6724 (international) using conference ID number 4271217. The call will also be webcast LIVE and can be accessed via the Investors section of the company’s website at View Source

A replay of the conference call will be available two hours after the completion of the call through May 15, 2019. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference conference ID number 4271217. An online archive of the conference call can be accessed via the Investors section of the company’s website at View Source

On May 9, 2019 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage biopharmaceutical company pioneering the discovery and development of targeted therapies that disrupt cellular metabolic pathways, reported its financial results for the first quarter ended March 31, 2019. As of March 31, 2019, cash equivalents and investments totaled $117.0 million (Press release, Calithera Biosciences, MAY 9, 2019, View Source [SID1234536068]).

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"This year we expect to achieve multiple, key milestones in our clinical development program and several data readouts, including top-line results of the ENTRATA trial mid-year, and with our partner Incyte, data from the INCB001158 program in the second half of the year," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "In the first quarter, we’ve also made great strides in our earlier stage programs, moving our cystic fibrosis program into the clinic and presenting preclinical data on our CD73 inhibitor, which is poised to enter the clinic by year end."

First Quarter 2019 and Recent Highlights

Completed enrollment of the Phase 2 renal cell carcinoma ENTRATA trial. The ENTRATA trial (NCT03163667) is a Phase 2 randomized, double blind trial designed to evaluate the safety and efficacy of telaglenastat in combination with everolimus versus placebo with everolimus in patients with advanced clear cell RCC who have been treated with at least two prior lines of systemic therapy, including at least one prior VEGFR-targeted tyrosine kinase inhibitor. The trial enrolled 69 patients at multiple centers in the United States. The primary endpoint of ENTRATA is progression-free survival (PFS). Calithera plans to report top-line results including key efficacy and safety data in mid-2019.

Initiated Phase 1/2 clinical trial of telaglenastat (CB-839) in combination with talazoparib for solid tumors. The Phase 1/2 clinical trial is evaluating telaglenastat in combination with Pfizer’s PARP inhibitor talazoparib in patients with solid tumors. Calithera expects to initiate an additional trial of the combination of telaglenastat plus the CDK4/6 inhibitor palbociclib in patients with KRAS-mutated colorectal cancer and KRAS-mutated non-small cell lung cancer in the second quarter of 2019.

Initiated Phase 1 trial of arginase inhibitor CB-280 for the treatment of cystic fibrosis. Arginase is believed to be critical in the pathology of cystic fibrosis. It impairs production of nitric oxide and generates metabolites of arginine that may impair lung function. CB-280 is an orally administered small molecule inhibitor of arginase. The first-in-human Phase 1 trial initiated in February 2019 will evaluate the safety, tolerability and pharmacokinetic profile of oral CB-280 in healthy volunteers.

Presented preclinical data for CB-708 at AACR (Free AACR Whitepaper) Annual Meeting 2019. The preclinical data presented at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting demonstrate that CB-708 is a potent and selective inhibitor of CD73 that has immune-mediated, single-agent activity in syngeneic mouse tumor models. In the pre-clinical studies presented, CB-708 was well-tolerated and shows enhanced anti-tumor activity in combination with checkpoint inhibitors as well as chemotherapy. Calithera anticipates that CB-708 will enter clinical trials in 2019.

Selected First Quarter 2019 Financial Results

Cash, cash equivalents and investments totaled $117.0 million at March 31, 2019.

Research and development expenses were $20.2 million for the three months ended March 31, 2019, compared with $15.5 million for the same period in the prior year. The increase of $4.7 million was primarily due to a $2.3 million increase in the telaglenastat program, including our Phase 2 CANTATA trial, an increase of $1.1 million in the INCB001158 program, an increase of $1.0 million in the CB-280 program, as well as investment in early stage research.

General and administrative expenses were $4.2 million for the three months ended March 31, 2019, compared with $3.5 million for the same period in the prior year. The increase of $0.7 million was related to higher personnel-related costs and professional services costs.

Net loss for the three months ended March 31, 2019 was $23.7 million, or $0.61 per share.

Conference Call Information

Calithera will host an update conference call today, Thursday, May 9 at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time. The call may be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 and referring to conference ID 1182244. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. The webcast will be recorded and available for replay on Calithera’s website for 30 days.

On May 9, 2019 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics, reported financial results for the first quarter ended March 31, 2019 (Press release, Guardant Health, MAY 9, 2019, View Source [SID1234536067]).
Recent Highlights

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Total revenue for the first quarter of 2019 was $36.7 million, a 120% increase over the first quarter of 2018. Revenue was recognized in accordance with a new revenue recognition standard ("ASC 606"), which the company adopted effective January 1, 2019. Without the adoption of ASC 606, total revenue for the first quarter of 2019 would have been $37.6 million, a 126% increase over the first quarter of 2018

Reported 9,521 tests to clinical customers and 3,762 tests to biopharmaceutical customers in the first quarter, representing increases of 31% and 61% respectively, over the first quarter 2018

Draft local coverage determination proposed by Palmetto GBA that will potentially expand Medicare coverage of the Guardant360 assay to over a dozen advanced solid tumor cancer types with guideline-recommended genomic targets, pending final publication

NILE study results published in Clinical Cancer Research demonstrated Guardant360’s concordance to tissue testing in advanced NSCLC

Acquired Bellwether Bio, Inc., a privately held company focused on improving oncology patient care through its pioneering research into the epigenomic content of cell free DNA

Planning to initiate a prospective colorectal screening study of over 10,000 patients in the second half of 2019
"During the first quarter of 2019, we made important headway on several key initiatives," said Helmy Eltoukhy, PhD, Chief Executive Officer. "We are encouraged by the momentum we are seeing with continued adoption of Guardant360 and GuardantOMNI in the advanced cancer setting and the progress we are making with our LUNAR program in proving out the feasibility of our liquid biopsy platform for early cancer management and early detection."
First Quarter 2019 Financial Results
ASC 606 primarily impacted the company’s recognition of revenue related to patient claims paid by third-party commercial and governmental payors. The company adopted ASC 606 using the modified retrospective method, which means that the total amount of revenue reported for first quarter 2018 has not been restated in the current financial statements. Instead, the accumulated difference resulting from applying the new revenue standard to all contracts that were not completed as of adoption was recorded to accumulated deficit as of January 1, 2019.
Total revenue was $36.7 million for the three months ended March 31, 2019, a 120% increase from $16.7 million for the three months ended March 31, 2018. Without the adoption of ASC 606, total revenue for the three months ended March 31, 2019 would have been $37.6 million, a 126% increase over the first quarter of 2018. Precision oncology revenue increased 103% driven by higher testing volume and increased revenue per test. There were 9,521 clinical tests and 3,762 biopharmaceutical tests performed during the first quarter of 2019.
Gross profit, or total revenue less cost of precision oncology testing and cost of development services, was $23.1 million for the first quarter of 2019, an increase of $15.7 million from $7.4 million in the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 63.1% as compared to 44.6% in the corresponding prior year period.
Total operating expenses were $46.8 million for the first quarter of 2019, as compared to $26.1 million in the corresponding prior year period, an increase of 79%.
Net loss attributable to Guardant Health, Inc. common stockholders was $26.1 million in the first quarter of 2019, which included a charge of $4.7 million for an increase in the fair value of the redeemable noncontrolling interest in our joint venture with SoftBank, as compared to $13.8 million in the corresponding prior year period. Net loss per share attributable to Guardant Health, Inc. common stockholders was $0.30 in the first quarter of 2019, as compared to $1.16 in the corresponding prior year period.
Cash, cash equivalents and marketable securities were $492.8 million as of March 31, 2019.
2019 Financial Guidance

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Guardant Health now expects full year 2019 total revenue to be in the range of $145 million to $150 million, representing 60% to 65% growth over full year 2018. This compares to the company’s previous full year 2019 total revenue guidance of $130 to $135 million.
Webcast and Conference Call Information
Guardant Health will host a conference call to discuss the first quarter 2019 financial results after market close on Thursday, May 9, 2019 at 4:30 PM Eastern Time. The conference call can be accessed live over the phone (866) 417-5537 for U.S. callers or (409) 217-8233 for international callers (Conference ID: 4891017). The webcast can be accessed at View Source