Illumina Reports Financial Results for Second Quarter of Fiscal Year 2020

On August 6, 2020 Illumina, Inc. (NASDAQ: ILMN) reported its financial results for the second quarter of fiscal year 2020 (Press release, Illumina, AUG 6, 2020, View Source [SID1234563084]).

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Second quarter 2020 results reflect the impact of the global COVID-19 pandemic:

•Revenue of $633 million, a 25% decrease compared to $838 million in the second quarter of 2019
•GAAP net income attributable to Illumina stockholders for the quarter of $47 million, or $0.32 per diluted share, compared to $296 million, or $1.99 per diluted share, for the second quarter of 2019
•Non-GAAP net income attributable to Illumina stockholders for the quarter of $92 million, or $0.62 per diluted share, compared to $200 million, or $1.35 per diluted share, for the second quarter of 2019. Non-GAAP net income excludes discrete tax expenses and net gains from mark-to-market adjustments on our strategic investments, primarily from our marketable equity securities (see the "Reconciliation Between GAAP and Non-GAAP Net Income Attributable to Illumina Stockholders" table for a reconciliation of these GAAP and non-GAAP financial measures)
•Cash flow from operations of $240 million compared to $143 million in the second quarter of 2019. Cash flow from operations for the second quarter of 2019 included an $84 million payment of the accreted debt discount related to the conversion of our 2019 Notes
•Free cash flow (cash flow from operations less capital expenditures) of $202 million for the quarter compared to $96 million in the second quarter of 2019. Free cash flow for the second quarter of 2019 included the convertible notes payment, referenced above

Gross margin in the second quarter of 2020 was 67.7% compared to 68.4% in the prior year period. Excluding amortization of acquired intangible assets and the net impact from payroll credits and expenses related to COVID-19, non-GAAP gross margin was 68.6% for the second quarter of 2020 compared to 69.5% in the prior year period.

Research and development (R&D) expenses for the second quarter of 2020 were $155 million compared to $166 million in the prior year period. Excluding payroll credits related to COVID-19, non-GAAP R&D expenses as a percentage of revenue were 24.7% compared to 19.8% in the prior year period.

Selling, general and administrative (SG&A) expenses for the second quarter of 2020 were $177 million compared to $202 million in the prior year period. Excluding acquisition-related expenses, restructuring charges, and the net impact from payroll credits and expenses related to COVID-19, non-GAAP SG&A expenses as a percentage of revenue were 28.1% compared to 23.1% in the prior year period.

Depreciation and amortization expenses were $46 million and capital expenditures for free cash flow purposes were $38 million during the second quarter of 2020. At the close of the quarter, the company held $3.3 billion in cash, cash equivalents and short-term investments, compared to $3.4 billion as of December 29, 2019.

"As expected, the second quarter was significantly impacted by pandemic-related disruption in our customers’ operations and was particularly challenging for many of our research customers who remain closed or operating at limited scale," said Francis deSouza, President and CEO. "It is clear that the role of genomics in infectious disease will continue to grow through and beyond this pandemic."

Updates since our last earnings release:

•Launched TruSight software to accelerate the identification of rare genetic diseases through whole genome sequencing
•Received an Emergency Use Authorization from the US FDA for COVIDSeq, the first sequencing-based COVID-19 diagnostic test
•Acquired BlueBee and Enancio to lower data storage costs and accelerate data interpretation
•Accepted seven genomic startups to Illumina Accelerator’s first global cohort, with 3 in Cambridge, UK and 4 in San Francisco, to build breakthrough genomic technologies
•Repurchased approximately $143 million of common stock in the second quarter and $420 million remains available for repurchase under our current plan
•Welcomed Dr. Alex Aravanis to lead research and development efforts as CTO and appointed Mostafa Ronaghi to lead entrepreneurial development

Financial outlook and guidance

As previously announced, Illumina has withdrawn its fiscal 2020 full year revenue and earnings per share guidance due to the uncertainties around the severity and duration of the COVID-19 pandemic.

Quarterly conference call information

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Thursday, August 6, 2020. Interested parties may access the live teleconference through the Investor Info section of Illumina’s website under the "Company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 1 (866) 211-4597 or 1 (647) 689-6853 outside North America, both with conference ID 4194447.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

Statement regarding use of non-GAAP financial measures

The company reports non-GAAP results for diluted net income per share, net income, gross margins, operating expenses, operating margins, other income, and free cash flow in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The company’s financial measures under GAAP include substantial charges such as amortization of acquired intangible assets, non-cash interest expense associated with the company’s convertible debt instruments that may be settled in cash, and others that are listed in the itemized reconciliations between GAAP and non-GAAP financial measures included in this press release. Management has excluded the effects of these items in non-GAAP measures to assist investors in analyzing and assessing past and future operating performance. Additionally, non-GAAP net income attributable to Illumina stockholders and diluted earnings per share attributable to Illumina stockholders are key components of the financial metrics utilized by the company’s board of directors to measure, in part, management’s performance and determine significant elements of management’s compensation.

The company encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. Reconciliations between GAAP and non-GAAP results are presented in the tables of this release.

Guardant Health Reports Second Quarter 2020 Financial Results

On August 6, 2020 ardant 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 quarter ended June 30, 2020 (Press release, Guardant Health, AUG 6, 2020, View Source [SID1234563083]).
Recent Highlights
•Revenue of $66.3 million for the second quarter of 2020, an increase of 23% over the corresponding period of 2019
◦Precision oncology revenue of $51.0 million, an increase of 21% over the corresponding period of 2019
◦Development services revenue of $15.3 million, an increase of 29% over the corresponding period of 2019
•Reported 13,694 tests to clinical customers and 2,805 tests to biopharmaceutical customers in the second quarter of 2020, representing an increase of 15% and a decrease of 47%, respectively, over the second quarter of 2019
•Presented data from a new patient cohort that demonstrated that its LUNAR-2 liquid assay achieved 90% sensitivity and 94% specificity in detecting early-stage colorectal cancer
•Launched GuardantINFORM, a real-world clinical-genomic platform to accelerate precision oncology drug development
•Announced two strategic collaborations to develop the Guardant360 assay as a companion diagnostic for Janssen Biotech’s amivantamab in non-small-cell lung carcinoma, and expanding to a new indication, for Radius Health’s elacestrant in breast cancer
•Strengthened financial position with an underwritten public offering raising $354.6 million in net proceeds, ending the second quarter with $1.1 billion cash, cash equivalents and marketable securities
"During this challenging time, our team at Guardant Health successfully executed across our business and has never wavered from our commitment to serve patients," said Helmy Eltoukhy, PhD, co-founder and CEO. "As we look to the second half of this year, despite the ongoing pandemic, I am more confident than ever in the strength and resilience of our team, the promise of the Guardant platform and the significant opportunity ahead to transform patient care."
Second Quarter 2020 Financial Results
Revenue was $66.3 million for the three months ended June 30, 2020, a 23% increase from $54.0 million for the three months ended June 30, 2019. Precision oncology revenue grew 21% driven predominantly by an increase in average selling price. There were 13,694 clinical tests and 2,805 biopharmaceutical tests performed during the second quarter of 2020. Development services revenue increased 29% primarily related to the timing of project related milestones for companion diagnostic development programs.
Gross profit, or total revenue less cost of precision oncology testing and cost of development services, was $43.9 million for the second quarter of 2020, an increase of $6.8 million from $37.1 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 66%, as compared to 69% for the corresponding prior year period.
Operating expenses were $98.5 million for the second quarter of 2020, as compared to $52.4 million for the corresponding prior year period, an increase of 88%.
Net loss attributable to Guardant Health, Inc. common stockholders was $54.6 million for the second quarter of 2020, as compared to $11.6 million for the corresponding prior year period. Net loss per share attributable to Guardant Health, Inc. common stockholders was $0.57 for the second quarter of 2020, as compared to $0.13 for the corresponding prior year period.
Cash, cash equivalents and marketable securities were $1.1 billion as of June 30, 2020. This includes approximately $354.6 million of net proceeds from Guardant Health’s follow-on public offering which closed in early June.
2020 Guidance
Guardant Health is not providing 2020 financial guidance due to the continued uncertainties from the impact of COVID-19.
Webcast and Conference Call Information
Guardant Health will host a conference call to discuss the second quarter 2020 financial results after market close on Thursday, August 6, 2020 at 1:30 PM Pacific Time / 4:30 PM Eastern Time. A webcast of the conference call can be accessed at View Source The webcast will be archived and available for replay for at least 90 days after the event.

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Non-GAAP Measure
We believe that the exclusion of certain income and expenses in calculating non-GAAP Adjusted EBITDA can provide a useful measure for investors when comparing our period-to-period core operating results, and when comparing those same results to that published by our peers. To derive Adjusted EBITDA, we remove from GAAP results the impact of income (expenses) attributable to material non-cash items, specifically stock-based compensation and fair value remeasurements due to the subjectivity, management judgment, and market fluctuations involved around these amounts. We exclude certain other items because we believe that these income (expenses) do not reflect expected future operating expenses. Additionally, certain items are inconsistent in amounts and frequency, making it difficult to perform a meaningful evaluation of our current or past operating performance.
This non-GAAP financial measure is not intended to be considered in isolation from, as substitute for, or as superior to, the corresponding financial measure prepared in accordance with GAAP. There are limitations inherent in non-GAAP financial measures because they exclude charges and credits that are required to be included in a GAAP presentation, and do not present the full measure of our recorded costs against its revenue. In addition, our definition of the non-GAAP financial measures may differ from non-GAAP measures used by other companies.
Definition of Non-GAAP Adjusted EBITDA
"Adjusted EBITDA" is defined as net loss attributable to Guardant Health, Inc. common stockholders before: (i) interest income,(ii) interest expense (iii) provision for (benefit from) income taxes, (iv) depreciation and amortization expense, (v) other (income) expense, net, (vi) stock-based compensation expense, (vii) adjustments relating to non-controlling interest and contingent consideration and, if applicable in a reporting period, and (viii) acquisition-related expenses, and other non-recurring items.

Kura Oncology Reports Second Quarter 2020
Financial Results

On August 6, 2020 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported second quarter 2020 financial results and provided a corporate update (Press release, Kura Oncology, AUG 6, 2020, View Source [SID1234563082]).

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"Last quarter we implemented a number of strategic measures to focus on our two major development pillars: tipifarnib in HRAS-dependent head and neck squamous cell carcinoma (HNSCC) and KO-539 in acute myeloid leukemia (AML)," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "We believe tipifarnib and KO-539 provide opportunities to address large proportions of head and neck cancers and acute leukemias, respectively. Now, following a successful public offering this past quarter, we are well-positioned to advance each of these programs toward important upcoming catalysts."

Corporate Update

Encouraging progress in Phase 1/2A trial of menin inhibitor, KO-539 – KO-539 is a potent and small molecule inhibitor of the menin-KMT2A(MLL) protein-protein interaction, with the potential to target at least 35% of patients with AML. A Phase 1/2A clinical trial of KO-539 in patients with relapsed/refractory AML (KOMET-001) continues in dose escalation. Kura remains focused on its goal of reaching a recommended Phase 2 dose and schedule, after which it intends to open expansion cohorts in NPM1-mutant and KMT2A(MLL)-rearranged AML – selected patient populations where KO‑539 has the potential to demonstrate increased clinical benefit. The Company intends to submit an abstract for preliminary data presentation of the KO-539 program at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in

December 2020, and continues to add clinical sites to the trial in anticipation of moving into the expansion cohorts.

Updated data from Phase 2 trial of tipifarnib in HRAS mutant HNSCC – Kura reported updated clinical outcome data from a Phase 2 clinical trial of tipifarnib in patients with recurrent or metastatic HRAS mutant HNSCC (RUN-HN) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program in May 2020. The data showed a median overall survival of 15.4 months, median progression-free survival of 5.9 months and an overall response rate of 50% among the 18 evaluable patients. Outcomes for three FDA-approved therapies for HNSCC are poor, with reported median OS of 5-8 months, PFS of 2-3 months and ORR of 13-16% in the second line. These data further support the Company’s efforts in HRAS mutant HNSCC, a disease of high unmet need.

Expanded enrollment in registration-directed trial of tipifarnib – Kura has amended its ongoing registration-directed trial of tipifarnib (AIM-HN) to enroll all recurrent or metastatic HNSCC patients with HRAS mutations, regardless of variant allele frequency, expanding the proportion of patients who are being treated in the trial. The primary outcome measure for AIM-HN remains overall response rate in patients with high HRAS mutant variant allele frequency. The amendment enables the Company to assess the potential clinical benefit of tipifarnib in the overall HRAS mutant HNSCC population as well.

Expansion opportunity for tipifarnib in HRAS and PI3K dependent tumors – Based upon the unmet need and encouraging preclinical data, Kura is prioritizing the clinical development of tipifarnib in combination with a PI3K alpha inhibitor as a strategy to treat HNSCC patients whose tumors overexpress the HRAS protein, as well as those with PI3K dependent tumors. These patients may represent significant subsets of HNSCC patients with distinct biology that may be targeted by tipifarnib, which is supported by observed activity in multiple models and in each of these subsets in preclinical studies. The Company believes that the total addressable population for tipifarnib may be as high as 50% of HNSCC.

Financial Results

Research and development expenses for the second quarter of 2020 were $13.7 million, compared to $11.4 million for the second quarter of 2019.

General and administrative expenses for the second quarter of 2020 were $7.5 million, compared to $4.5 million for the second quarter of 2019.

Net loss for the second quarter of 2020 was $20.5 million, compared to a net loss of $14.9 million for the second quarter of 2019.

Cash, cash equivalents and short-term investments totaled $338.9 million as of June 30, 2020, including net proceeds of approximately $134.9 million from a public

offering completed in May 2020, compared with $236.9 million as of December 31, 2019.

Management expects that current cash, cash equivalents and short-term investments will be sufficient to fund current operations into 2023.

Conference Call and Webcast

Kura’s management will host a webcast and conference call today at 4:30 p.m. ET / 1:30 p.m. PT today, August 6, 2020, to discuss the financial results for the second quarter 2020 and provide a corporate update. The live call may be accessed by dialing (866) 278-7953 for domestic callers and +1 (323) 347-3281 for international callers and entering the conference code: 1697775. A live webcast of the call will be available from the Investors and Media section of the Company’s website at www.kuraoncology.com, and will be archived there for 30 days.

PDL BioPharma Reports 2020 Second Quarter Financial Results

On August 6, 2020 PDL BioPharma, Inc. ("PDL" or "the Company") (Nasdaq: PDLI) reported financial results for the three and six months ended June 30, 2020 and provides an update on important milestones achieved in the execution of its monetization plan (Press release, PDL BioPharma, AUG 6, 2020, View Source [SID1234563081]):

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"I am pleased with the significant progress we have made over the past couple of months in the execution of our monetization strategy," commented PDL’s President and CEO Dominique Monnet. "We continue to focus on maximizing the net proceeds from the monetization of our assets for our stockholders, and I believe the actions we have taken so far have served them well. I would like to thank the PDL Board and team, our advisors and our LENSAR and Noden colleagues for their continued engagement, dedication and support."

•On May 21, 2020, the Company distributed 100% of its shares of Evofem Biosciences, Inc. ("Evofem") common stock to the PDL stockholders.
•On July 17, 2020, the Company announced that its majority owned subsidiary, LENSAR, Inc. ("LENSAR"), confidentially submitted a registration statement on Form 10 to the Securities and Exchange Commission relating to a potential spin-off of LENSAR as a stand-alone publicly traded company. The Company continues to pursue various strategic alternatives for LENSAR in addition to a spin-off.
•On July 30, 2020, the Company announced the signing of a definitive agreement for the sale of 100% of the outstanding stock in its wholly owned subsidiaries Noden Pharma DAC and Noden Pharma USA (collectively "Noden"). The total value of the transaction will result in payments to PDL of up to $48.25 million in cash. Upon closing, which we expect to occur by mid-August, PDL will be released of its guarantee to Novartis under Noden’s supply agreement.

In February 2020, the Board of Directors of PDL BioPharma (the "Board") approved a Plan of Complete Liquidation ("Plan of Liquidation"). The Company is seeking stockholder approval at its 2020 Annual Meeting of Stockholders on August 19, 2020 to dissolve the Company under Delaware state law. If stockholders approve the dissolution proposal, the Board would have the authority to cause the Company to file a Certificate of Dissolution to begin the process of winding down and dissolving the Company if and when the Board decides that it would serve best the interest of PDL stockholders.

As announced previously, the Company has engaged financial advisors and initiated processes either to sell its remaining assets separately or to sell the Company as a whole. The Company intends to pursue its monetization strategy in a disciplined and cost-effective manner seeking to maximize net proceeds to stockholders. While the Company cannot provide a definitive

timeline for the liquidation process, it is targeting to complete the monetization or distribution of its key assets over the next 12 months.

Discontinued Operations Classified as Assets Held for Sale

As a result of the Company’s plans to monetize its assets and the actions put in place in the first quarter of 2020, as of March 31, 2020 the assets held for sale and discontinued operations criteria were met for the Company’s royalty assets and for its Pharmaceutical segment, which consisted of Noden. The royalty assets are a component of the Income Generating Assets segment. In the second quarter of 2020, upon the distribution of the Evofem common stock to the Company’s stockholders, the discontinued operations criteria were met for the Strategic Positions segment. The Strategic Positions segment was comprised solely of the Company’s investment in Evofem.

During the period in which a component meets the assets held for sale and discontinued operations criteria, an entity must present the assets and liabilities of the discontinued operation separately in the asset and liability sections of the balance sheet for the current and comparative reporting periods. The prior period balance sheet is reclassified for the held for sale items. For statements of operations, the current and prior periods report the results of operations of the component in discontinued operations.

Second Quarter Financial Highlights

•Total revenues were $5.2 million, consisting primarily of LENSAR product, lease and service revenues.
•LENSAR revenues were $5.1 million, a decrease of 31% over the prior-year period, with procedure volume also declining 31%.
•Net cash from all royalty rights was $11.5 million, down 43% from $20.1 million for the prior-year period.
•Revenue from our Pharmaceutical segment was $8.2 million, compared with $10.4 million for the prior-year period.
•GAAP net loss was $50.0 million. Non-GAAP net loss was $23.0 million. A reconciliation of GAAP to non-GAAP financial results can be found in Table 4 at the end of this news release.

Revenue Highlights

•Total revenues for the second quarter of 2020 were $5.2 million and consisted primarily of LENSAR product, lease and service revenues.
•Product revenue from LENSAR was $5.1 million, a 31% decrease from the second quarter of 2019. LENSAR procedure volume for the second quarter of 2020 also declined 31% from the prior-year period, primarily due to lower system sales and procedures driven by the negative impact of the COVID-19 pandemic and the associated decline in elective surgical procedures. LENSAR operating results are expected to improve as elective surgical procedures progressively ramp to pre-COVID-19 levels as the pandemic subsides.
•Total revenues for the first half of 2020 were $11.2 million, compared with $14.2 million for the first half of 2019.
◦Revenues from LENSAR for the six months ended June 30, 2020 decreased by $3.0 million, or 21%, to $11.1 million from $14.1 million for the six months ended June 30, 2019. LENSAR procedure volume for the six months ended June 30, 2020 declined by 18% from the prior-year period.

Operating Expense Highlights

•Operating expenses from continuing operations of the Company include general and administrative expenses for corporate overhead. A significant amount of these costs had historically not been allocated to individual segments.
•Operating expenses for the three months ended June 30, 2020 were $19.0 million, a $2.3 million increase from $16.7 million for the three months ended June 30, 2019. The increase was primarily a result of:
◦higher general and administrative expenses, primarily due to increased professional fees associated with the ongoing monetization efforts,
◦higher research & development expenses in our Medical Devices segment as LENSAR pursues its next-generation workstation, ALLY, which integrates an enhanced femtosecond laser with a phacoemulsification system in a compact, mobile workstation, partially offset by
◦lower cost of product revenue, due to decreased sales in our Medical Devices segment, and
◦lower sales and marketing expenses in our Medical Devices segment.

•Operating expenses for the six months ended June 30, 2020 were $56.7 million, a $25.1 million increase from $31.6 million for the six months ended June 30, 2019. The increase was primarily a result of:
◦provisions under our Wind-Down Retention Plan, which, as a result of the adoption of the Plan of Liquidation, accelerated the vesting of outstanding stock awards for employees in the first quarter of 2020,
◦higher general and administrative expenses of $5.5 million, or 32% from the prior period, primarily due to increased professional fees, and
◦higher research & development expenses in our Medical Devices segment, partially offset by
◦lower cost of product revenue, due to decreased sales in our Medical Devices segment.

Discontinued Operations Highlights

•Loss from discontinued operations for the three months ended June 30, 2020 was $37.4 million, a $40.9 million decrease from the $3.5 million of income recognized for the three months ended June 30, 2019. The change was primarily a result of:
◦A $58.4 million change in the fair value of our equity affiliate from an unrecognized gain of $45.5 million in the three months ended June 30, 2019, compared with a $12.9 million loss in the three months ended June 30, 2020.
◦A $16.8 million loss recorded in the three months ended June 30, 2020 associated with reducing the estimated fair value of Noden as informed by negotiations and terms for the disposition of the entity.
◦A $2.2 million, or 22%, decline in revenue from our Pharmaceutical segment for the three months ended June 30, 2020, compared with the same period in the prior year. The decrease in revenue from our Pharmaceutical segment is primarily due to lower net revenues in the United States.
▪The decrease in revenue from our Pharmaceutical segment in the U.S. for the three months ended June 30, 2020 is due to the increased sales of our authorized generic and lower sales of our branded Tekturna, compared with the second quarter of 2019.
▪U.S. market share for branded Tekturna and the authorized generic of Tekturna of approximately 65% at June 30, 2020 declined from 68% as of March 31, 2020.

These amounts were partially offset by:
◦Revenue from our royalty right assets of negative $16.3 million in the three months ended June 30, 2020, compared with a negative $40.4 million for the three months ended June 30, 2019. The difference was primarily due to a larger decrease in fair value in the second quarter of 2019 primarily resulting from the $60.0 million AcelRx write-down, compared with a $22.9 million write down in the three months ended June 30, 2020 for certain royalty assets, as informed by bids received during our monetization process.
▪The royalty right assets in our Income Generating Assets segment generated cash flows of $11.5 million and a loss from the net change in fair value of $27.8 million in the three months ended June 30, 2020, compared with cash flows of $20.1 million and a loss in the net change in fair value of $60.5 million in the three month period ended June 30, 2019.
▪See Table 3 for a rollforward of royalty assets for the second quarter of 2020, compared with the comparable period in 2019.

•Loss from discontinued operations for the six months ended June 30, 2020 was $50.2 million, a $68.7 million decrease from the $18.6 million of income recognized for the six months ended June 30, 2019. The unfavorable change was primarily a result of:
◦A $72.2 million change in the fair value of our equity affiliate from an unrecognized gain of $45.5 million in the six months ended June 30, 2019, compared with a $26.7 million loss in the six months ended June 30, 2020.
◦A $23.5 million write down of our Pharmaceutical segment in the current year due to a decrease in the estimated fair value of the entity.
◦A $7.2 million, or 24%, decline in revenue from our Pharmaceutical segment for the six months ended June 30, 2020, compared with the same period in the prior year.

3

These amounts were partially offset by:
◦Revenue from our royalty right assets in our Income Generating Assets segment of negative $6.9 million for the six months ended June 30, 2020, compared with negative $28.1 million for the corresponding period of the prior year. The difference was primarily due to a larger decrease in fair value in the second quarter of 2019 resulting from the $60 million AcelRx write-down, compared with the six months ended June 30, 2020, which includes the fair value adjustments for certain royalty assets as informed by the bids received during our monetization process.
▪The royalty right assets generated cash flows of $25.0 million in the current period, compared with $32.7 million in the prior-year period.

Other Financial Highlights

•On a GAAP basis, the net loss attributable to PDL’s shareholders for the second quarter of 2020 was $50.0 million, or $0.43 per share, compared with a GAAP net loss attributable to PDL’s shareholders of $4.4 million, or $0.04 per share, for the prior-year period. Non-GAAP net loss attributable to PDL’s shareholders was $23.0 million for the second quarter of 2020, compared with non-GAAP net income for PDL’s shareholders of $12.7 million for the second quarter of 2019.
•On a GAAP basis, the net loss attributable to PDL’s shareholders for the first half of 2020 was $81.7 million, or $0.68 per share, compared with GAAP net income attributable to PDL’s shareholders of $2.3 million, or $0.02 per share, for the prior-year period. Non-GAAP net loss attributable to PDL’s shareholders was $29.7 million for the first half of 2020, compared with non-GAAP net income for PDL’s shareholders of $24.5 million for the first half of 2019.
•PDL had cash and cash equivalents from continuing operations of $105.4 million as of June 30, 2020, compared with $169.0 million as of December 31, 2019.
◦The $63.6 million reduction was primarily the result of common stock repurchases of $39.4 million, the net cash used for the repurchase of convertible debt of $18.0 million and net cash used in operations of $33.8 million. This reduction was partially offset by the proceeds from royalty rights of $25.0 million.

Stock and Convertible Note Repurchase Program

•In January 2020, PDL began repurchasing shares of its common stock in the open market pursuant to the 10b5-1 program entered into in December 2019 following a $275 million repurchase plan approved by the Board. In the first half of 2020, the Company acquired 12.3 million shares of its common stock for $39.4 million, at an average cost of $3.20 per share, including commissions.
•Under this same program, in the first half of 2020, the Company also repurchased $15.9 million par value of convertible notes.
•In consideration of the impact and uncertainty introduced by the COVID-19 pandemic on the Company’s monetization process, the Company discontinued its 10b5-1 program on May 31, 2020.
•Through June 30, 2020, the total amount spent of the $275 million Board authorized repurchase program, including the value of the Company’s stock issued in connection with the December 2019 convertible debt exchange, was $213.0 million.
•As of July 31, 2020, the Company had approximately 114.0 million shares of common stock outstanding.

Conference Call and Webcast

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 View Source." target="_blank" title="View Source." rel="nofollow">View Source

To access the live conference call via phone, please dial (866) 777-2509 from the United States or (412) 312-5413 internationally. The conference ID is 10146007. A telephone replay will be available for one week beginning approximately one hour after the completion of the call and can be accessed by dialing (877) 344-7529 from the U.S., (855) 669-9658 from Canada or (412) 317-0088 internationally. The replay passcode is 10146007.

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

Monopar Therapeutics Reports Second Quarter 2020 Financial Results and Business Updates

On August 6, 2020 Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported second quarter 2020 financial results and business updates (Press release, Monopar Therapeutics, AUG 6, 2020, View Source [SID1234563064]).

Second Quarter and Recent Highlights

Collaboration with NorthStar Medical Radioisotopes to Develop Potential Therapeutic for Severe COVID-19 and Other Respiratory Diseases

oMonopar and NorthStar entered into a 50/50 collaboration to develop potential Radio-Immuno-Therapeutics (RITs) to treat severe COVID-19.

oMonopar will provide its pre-IND stage humanized uPAR targeted monoclonal antibody, known as MNPR-101, and NorthStar will supply a cytotoxic radioisotope. The aim is to create a highly selective agent that has the potential to kill aberrantly activated cytokine-producing immune cells thought to be largely responsible for the severe lung injury that contributes to poor outcomes and death in patients with severe COVID-19.

oProvisional patent has been filed that covers novel compositions and uses of cytotoxic radioisotopes attached to antibodies that bind to uPAR, thereby creating precision targeted radio-immuno-therapeutics (uPRITs) for the treatment of severe COVID-19 and other respiratory diseases.

Validive Phase 2b/3 Clinical Trial and Camsirubicin Phase 2 Clinical Trial Continue on Schedule

oMonopar’s two clinical-stage programs both continue to be on schedule for first patient dosing in the second half of 2020.

Second Quarter Summary Financial Results

Results for the Quarter Ended June 30, 2020 Compared to the Quarter Ended June 30, 2019

Cash and cash equivalents as of June 30, 2020 were $12.5 million. Net loss for the three months ended June 30, 2020 was $1.4 million or $0.14 per share compared to net loss of $0.9 million or $0.10 per share for the three months ended June 30, 2019.
R&D expenses for the three months ended June 30, 2020 were $0.8 million, compared to $0.3 million, for the three months ended June 30, 2019. This represents an increase of $0.5 million primarily attributed to increases in camsirubicin and Validive clinical trial planning and materials manufacturing costs and increases in personnel expenses for three new R&D employees and higher salary and stock-based (non-cash) compensation for 2020.

General and Administrative (G&A) Expenses

G&A expenses for the three months ended June 30, 2020 were $0.6 million, compared to $0.6 million, for the three months ended June 30, 2019.

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