On May 7, 2020 Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, reported financial results for its fiscal 2020 second quarter (Press release, Anavex Life Sciences, MAY 7, 2020, View Source [SID1234561603]).

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"We are pleased to report that we are approaching the conclusion of the double-blind Phase 2 Parkinson’s disease dementia trial with ANAVEX2-73 (blarcamesine) and we expect to report top line results by mid-2020," said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. "Both the Alzheimer’s disease Phase 2b/3 trial and clinical Rett syndrome programs are also proceeding as planned. Our focus on Precision Medicine studies for neurological disorders remains persistent."

Program Updates:

Enrollment for the two randomized, double-blind, placebo-controlled Phase 2 ANAVEX2-73 (blarcamesine) U.S. Phase 2 Rett syndrome trial[1] and the AVATAR Rett syndrome trial[2] each have surpassed the 50% mark and continue to enroll.
Despite the outbreak of COVID-19, all clinical trial programs continue to proceed. While Rett syndrome protocols have always by default allowed at-home visits, Anavex implemented contingency plans as recommended by local regulatory authorities for the Phase 2b/3 ANAVEX2-73 (blarcamesine) Alzheimer’s disease (AD) study[3] and the Phase 2 study in Parkinson’s Disease Dementia (PDD) study[4] to ensure remote or virtual assessments for all active patients and all respective extension studies. Because ANAVEX2-73 (blarcamesine) is an oral formulation, study participants are able to receive shipments of their study medication in a controlled and compliant fashion, and direct-to-patient delivery is occurring in multiple countries.
In January 2020, Anavex announced achieving the enrollment target for the ANAVEX2-73 (blarcamesine) Phase 2 study in Parkinson’s disease dementia (PDD). Topline results from this randomized, double-blind, placebo-controlled study are expected by mid-2020.
In February 2020, Anavex announced a publication in the peer-reviewed Journal of Neuroimmunology titled "Sigma-1 Receptor Agonists as Potential Protective Therapies in Multiple Sclerosis" featuring preclinical data of ANAVEX2-73 (blarcamesine) relevant to multiple sclerosis.
In April 2020, Anavex announced a publication in the peer-reviewed journal Alzheimer’s & Dementia: Translational Research & Clinical Interventions,entitled, "A precision medicine framework using Artificial Intelligence for the identification and confirmation of genomic biomarkers of response to an Alzheimer’s disease therapy: Analysis of the Blarcamesine (ANAVEX2-73) Phase 2a clinical study" highlights the relevance of phenotypic and genotypic precision medicine analyses of Whole Exome Sequencing (WES) and gene expression (RNAseq) data in drug development and in particular the potential to identify patients’ genetic variants and gene expression changes that may predict increased chances of success of Alzheimer’s disease treatments.
Financial Highlights:

Cash and cash equivalents of $26.6 million at March 31, 2020, compared to $22.2 million at fiscal year ended September 30, 2019.
Research and development expenses of $6.1 million for both the current quarter as well as the comparable quarter in 2019.
General and administrative expenses of $1.7 million for the quarter as compared to $2.1 million for the comparable quarter in 2019.
Net loss of $7.2 million, or $0.12 per share for the quarter, compared to net loss of $7.2 million, or $0.15 per share in the comparable quarter of 2019.
The financial information for the fiscal quarter ended March 31, 2020 should be read in conjunction with the Company’s consolidated interim financial statements, which will appear on EDGAR, www.sec.gov and will be available on the Anavex website at www.anavex.com.

Conference Call / Webcast Information

Anavex will host a conference call and webcast today at 4:30 p.m. ET.

The live webcast of the conference call can be accessed online at View Source

To join the conference call, live via telephone, interested parties within the U.S. should dial, toll-free, 1 (866) 939-3921 and international callers should dial 1 (678) 302-3550. Please use confirmation number 49673201, followed by the pound sign (#).

A replay of the conference call will also be available on www.anavex.com.

On May 7, 2020 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported it will participate in the Bank of America Securities 2020 Healthcare Conference on Thursday, May 14, 2020, as well as the Jeffries Virtual Healthcare Conference 2020 on Tuesday, June 2, 2020 (Press release, West Pharmaceutical Services, MAY 7, 2020, View Source [SID1234557206]). Management will participate in virtual presentations at both events.

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A live audio webcast will be available in the "Investors" section of the Company’s website at www.westpharma.com. Replay of the webcasts will be available for approximately 90 days after the events.

On May 7, 2020 CTI BioPharma Corp. (Nasdaq: CTIC) reported its financial results for the first quarter ended March 31, 2020 (Press release, CTI BioPharma, MAY 7, 2020, View Source [SID1234557269]).

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"With a sufficient cash runway into Q4 2021, we have the resources to continue to advance pacritinib as quickly as possible as a potential treatment for severely thrombocytopenic myelofibrosis patients through the execution of the ongoing Phase 3 PACIFICA trial," said Adam R. Craig, M.D., Ph.D. "Additionally, in response to the global COVID-19 pandemic, as pacritinib has the potential to reduce the inflammatory response to the infection, which can lead to acute respiratory distress and mechanical ventilation, we recently announced the initiation of PRE-VENT, a Phase 3 double-blind, placebo-controlled, multicenter study of pacritinib for the treatment of hospitalized patients with severe COVID-19, including patients with and without cancer. We look forward to providing updates on the PRE-VENT trial in the coming months. With regards to the PACIFICA Phase 3 trial timeline, we anticipate at least a three-month delay to enrollment due to the COVID-19 pandemic."

First Quarter Financial Results
Operating loss was $11.9 million for the first quarter of 2020, compared to operating loss of $10.5 million for the same period in 2019. The increase in operating loss in the first quarter of 2020 as compared to operating loss in the same period in 2019 resulted primarily from expenses related to provisions for our Italian Value Added Tax receivables due to uncertainty regarding the collectability of such receivables as a result of the recent COVID-19 global pandemic, partially offset by decreases in research and development expenses and restructuring expenses.

License and contract revenues for the three months ended March 31, 2019 were $0.6 million while no revenues were recognized for the same period in 2020. The decrease is primarily due to royalty and other revenues recognized in 2019 from Les Laboratoires Servier and Institut de Recherches Internationales Servier ("Servier") related to transition period activities pursuant to the terms of the Termination and Transfer Agreement with Servier.
Net loss attributable to common stockholders for the first quarter of 2020 was $12.2 million, or $(0.20) for basic and diluted loss per share, compared to net loss attributable to common stockholders of $10.8 million, or $(0.19) for basic and diluted loss per share, for the same period in 2019.

As of March 31, 2020, cash, cash equivalents and short-term investments totaled $81.1 million, compared to $33.7 million as of December 31, 2019. We expect current cash, cash equivalents and short-term investments will enable us to fund our operations into the fourth quarter of 2021.

On May 7, 2020 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the first quarter ended March 31, 2020 (Press release, Puma Biotechnology, MAY 7, 2020, View Source [SID1234557285]). Unless otherwise stated, all comparisons are for the first quarter of 2020 compared to the first quarter of 2019.

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Product revenue, net consists entirely of sales revenue from NERLYNX, Puma’s first commercial product. Net product revenue in the first quarter of 2020 was $48.6 million, compared to net product revenue of $45.6 million in the first quarter of 2019.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss of $16.9 million, or $0.43 per share, for the first quarter of 2020, compared to a net loss of $10.1 million, or $0.26 per share, for the first quarter of 2019.

Non-GAAP adjusted net loss was $8.0 million, or $0.20 per share, for the first quarter of 2020, compared to non-GAAP adjusted net income of $8.1 million, or $0.21 per basic share and $0.20 per diluted share, for the first quarter of 2019. Non-GAAP adjusted net income (loss) excludes stock-based compensation expense. For a reconciliation of GAAP net loss to non-GAAP adjusted net income (loss) and GAAP net loss per share to non-GAAP adjusted net income (loss) per share, please see the financial tables at the end of this news release.

Net cash used in operating activities for the first quarter of 2020 was $11.5 million, compared to $16.1 million used in the first quarter of 2019. At March 31, 2020, Puma had cash, cash equivalents and marketable securities of $100.6 million, compared to cash, cash equivalents and marketable securities of $111.6 million at December 31, 2019.

"We remain focused on providing a significant impact to cancer patients in need. The earlier-than-expected approval of the sNDA of NERLYNX in combination with capecitabine to treat adult patients with HER2-positive metastatic breast cancer who have received two or more prior anti HER2-based regimens in the metastatic setting is an important step toward this goal," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "Our global partners also are working hard to bring the drug to market in their respective territories, thereby increasing global access to NERLYNX. Earlier today, we announced that our licensing partner CANbridge Pharmaceuticals received marketing approval of NERLYNX in mainland China. In addition, we are closely monitoring the changing COVID-19 situation. We are pleased to announce that we maintain a significant stock of NERLYNX and do not anticipate any disruption of supply to existing or new patients."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) conducting a pre-NDA meeting with the FDA to discuss accelerated approval of neratinib in HER2 mutated hormone receptor positive breast cancer and HER2 mutated cervical cancer in the first quarter of 2021; (ii) reporting Phase II data from the HER-positive breast and cervical cancer cohort from the SUMMIT trial of neratinib in patients with HER2 mutations in the fourth quarter of 2020; (iii) reporting additional data from the Phase II CONTROL trial in the fourth quarter of 2020; and (iv) receiving regulatory decisions for an extended adjuvant HER2-positive early stage breast cancer indication in additional countries."

Revenue

Total revenue consists of net product revenue from sales of NERLYNX, Puma’s first commercial product, license revenue and royalty revenue. For the first quarter of 2020, total revenue was $51.2 million, of which $48.6 million was net product revenue, $2.0 million was license revenue from a Puma sub-licensee and $0.6 million was royalty revenue. This compares to total revenue of $99.1 million in the first quarter of 2019, of which $45.6 million was net product revenue and $53.5 million was license revenue from Puma’s sub-licensees.

Operating Costs and Expenses

Total operating costs and expenses were $65.5 million for the first quarter of 2020, compared to $89.2 million for the first quarter of 2019.

Cost of Sales

Cost of sales was $9.1 million for the first quarter of 2020, compared to $8.0 million for the first quarter of 2019.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were $30.9 million for the first quarter of 2020, compared to selling, general and administrative expenses of $45.5 million for the first quarter of 2019. The $14.6 million decrease resulted primarily from decreases in professional fees and expenses of approximately $8.7 million, stock-based compensation expense of approximately $5.2 million, payroll and payroll-related expenses of approximately $0.6 million, and travel and meetings of approximately $0.3 million. These decreases were partially offset by an increase in training expenses and compliance fees of approximately $0.2 million.

Research and Development Expenses

Research and development expenses were $25.5 million for the first quarter of 2020, compared to $35.7 million for the first quarter of 2019. The $10.2 million decrease resulted primarily from decreases in clinical trial expense of approximately $4.9 million, stock-based compensation expense of approximately $4.0 million, and consultant and contractors expenses of approximately $1.4 million.

Total Other Income (Expenses)

Total other expenses were $2.6 million for the first quarter of 2020, compared to total other expenses of $20.0 million for the first quarter of 2019. The $17.4 million decrease resulted primarily from decreases in legal verdict expense of approximately $16.3 million and interest expense of approximately $1.5 million. These decreases were partially offset by a decrease in interest income of approximately $0.5 million.

Conference Call

Puma Biotechnology will host a conference call to report its first quarter 2020 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, May 7, 2020. The call may be accessed by dialing 1-866-548-4713 (domestic) or 1-323-794-2093 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available shortly after completion of the call and will be archived on Puma’s website for 90 days.

On May 7, 2020 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported financial results for the first quarter ending March 31, 2020 (Press release, Integra LifeSciences, MAY 7, 2020, View Source [SID1234557301]).

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First Quarter 2020 Financial Summary

Reported revenues were $354.3 million, representing a decrease of (1.5)% on a reported basis and (0.1)% on an organic basis, compared to the prior year. These results are in line with the preliminary results provided on April 7, 2020;

GAAP earnings per diluted share were $0.11, compared to GAAP earnings of $0.38 in the first quarter of 2019. Adjusted earnings per diluted share were $0.48, compared to $0.65 in the prior year. The decline in earnings was largely attributable to the negative impact of COVID-19;

For the first two and a half months of the first quarter of 2020, revenue was trending at the higher end of the Company’s expectations. The Company estimates the revenue impact from the decline in surgical procedures related to COVID-19 during the second half of March to be between $20 and $25 million;

Consistent with our previous communication on April 7, 2020, the Company’s full-year 2020 guidance, provided on February 19, 2020, remains withdrawn due to the uncertainty related to the decline and recovery in surgical procedures resulting from COVID-19.
"The COVID-19 pandemic has had such a profound impact on families, communities and the global healthcare system. Throughout this period, Integra has remained focused on safeguarding the health and well-being of our people, while continuing to deliver lifesaving products to our customers and patients," said Peter Arduini, Integra’s president and chief executive officer. "I remain extremely proud of our people’s spirit, resilience and professionalism, supporting each other, while navigating through these unprecedented times."

The Company reported GAAP gross margin of 62.3%, compared to 64.2% in the first quarter of 2019. Adjusted gross margin was 68.3% compared to 68.4% in the prior year.

Adjusted EBITDA for the first quarter of 2020 was $75.7 million, or 21.4% of revenue, compared to $87.4 million, or 24.3% of revenue, in the prior year.
The Company reported GAAP net income of $9.2 million, or $0.11 per diluted share, in the first quarter of 2020, compared to GAAP net income of $32.8 million, or $0.38 per diluted share, in the prior year.
Adjusted net income for the first quarter of 2020 was $41.3 million, compared to $56.4 million in the prior year.
The decreases in gross margin, EBITDA and net income are primarily attributable to COVID-19, which resulted in lower than expected revenues, as non-emergent surgical procedures were deferred, primarily in the U.S. This decline in U.S. revenue relative to growth in international revenue resulted in an unfavorable gross margin compared to original expectations. Additionally, lower revenue levels relative to our selling, general and administrative costs, research and development costs and a higher tax rate contributed to the declines in net income, and were similarly driven by COVID-19.
Integra’s financial position and liquidity remain strong. In early February, the Company renegotiated the terms of its $2.2 billion bank facility, extended the maturity of its credit agreement by two years to 2025, and issued a $575 million convertible note with a 0.5% fixed interest rate. The Company ended the quarter with $358 million in cash and cash equivalents, $1.15 billion in undrawn revolver capacity, and a net debt bank leverage ratio of 3.1x. The Company previously reported in February that it had entered into an accelerated share repurchase (ASR) agreement to repurchase, in aggregate, approximately $92.4 million of the Company’s common stock. Approximately 80% of the shares to be repurchased were received by the company in the first quarter, and the Company expects that all repurchases under the ASR will be completed by the end of the second quarter.

Impact of COVID-19
Integra’s primary focus during this global crisis remains on supporting patients, providing customers with life-saving products and protecting the well-being of its employees.
For the first two and a half months of the first quarter of 2020, revenue was trending at the higher end of our expectations. However, as noted in the Company’s April 7, 2020 press release, surgical procedures declined significantly in the second half of March as healthcare providers reallocated resources to address the increasing demands caused by COVID-19.

The Company has estimated the revenue impact from the decline in surgical procedures to be approximately $20 to $25 million in the first quarter. Based on April trends and the ongoing impact from restrictions on surgical procedures and shelter-in-place policies, the Company expects a more substantial negative impact on second quarter performance.
In February, the Company implemented contingency plans to address the operational impact of COVID-19, focusing primarily on the Asia Pacific region. During March, the rapid and evolving spread of the virus resulted in an unprecedented challenge to the global healthcare industry. In response to the challenge, the Company expanded its contingency plans to enable its manufacturing and distribution sites around the world to continue operating at levels required to meet demand and to provide for the safety of its employees. In addition, in April, the Company initiated significant cost-savings measures, which include the following:

Reduced executive management and board cash compensation

Reduced cash compensation for all other employees through reduced commissions, reduction in hours and/or furloughs

Hiring freeze, elimination of overtime, cessation of third-party services and temporary contractor relationships, and

Significant reduction in capital expenditures and discretionary spending including travel, events and marketing programs

These comprehensive spending cuts were necessary to protect our financial strength in the face of near-term challenges. Yet, despite those challenges, the Company remains focused on managing the business for the long-term, including preserving full time jobs needed to support the expected rebound in surgical procedure volumes. Our adaptability and resiliency in the face of this unprecedented crisis is made possible in part by prior investments in technology infrastructure and operations as well as our talented and committed global workforce. And despite the current cost-reduction measures, we continue to prioritize and invest in our critical R&D and clinical programs.

2020 Full-Year Outlook
Given the existing uncertainty related to COVID-19, the Company’s guidance for the full-year 2020, issued on February 19, 2020, remains withdrawn as announced on April 7, 2020.
Supplemental financial and operational information is included in a presentation that can be found in the "Investor" section of the Company’s website at investor.integralife.com under "Events & Presentations".
In the future, the company may record, or expects to record, gains or losses, expenses, or charges as described in the Discussion of Adjusted Financial Measures below, which will be excluded from the calculation of adjusted EBITDA, adjusted earnings per share for historical periods and in adjusted earnings per share guidance.

Conference Call and Presentation Available Online
Integra has scheduled a conference call for 8:30 AM ET today, Thursday, May 7, 2020, to discuss financial results for the first quarter. The conference call will be hosted by Integra’s senior management team and will be open to all listeners. Additional forward-looking information may be discussed in a question and answer session following the call.
Integra’s management team will reference a presentation during the conference call. The presentation can be found on investor.integralife.com.
Access to the live call is available by dialing (800) 263-0877 and using the passcode 5089204. The call can also be accessed via a webcast link provided on investor.integralife.com. A replay of the call will be available until May 15, 2020 by dialing (888) 203-1112 and using the passcode 5089204. The webcast will also be archived on the website.