Arena Pharmaceuticals to Present at the Bank of America Securities Healthcare Conference on May 13

On May 6, 2020 Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) reported that Preston Klassen, MD, MHS, the Company’s Executive Vice President, Head of Research & Development, is scheduled to participate in a virtual fireside chat at the Bank of America Securities 2020 Healthcare Conference on Wednesday, May 13, at 10:20 AM ET (7:20 AM PT) (Press release, Arena Pharmaceuticals, MAY 6, 2020, View Source [SID1234557177]).

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A live webcast of the presentation will be posted under the investor relations section of Arena’s website at www.arenapharm.com. A replay of the presentation will be available for 30 days following the event.

Vanda Pharmaceuticals Reports First Quarter 2020 Financial Results

On May 6, 2020 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) reported financial and operational results for the first quarter ended March 31, 2020 (Press release, Vanda Pharmaceuticals, MAY 6, 2020, View Source [SID1234557176]).

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"Our strong financial performance in the first quarter well positions Vanda to continue to innovate and serve our patients, even during this deadly pandemic," said Mihael H. Polymeropoulos, M.D., Vanda’s President and CEO.

Key Financial and Corporate Highlights

Total revenues from HETLIOZ and Fanapt were $58.0 million in the first quarter of 2020, a 22% increase compared to $47.7 million in the first quarter of 2019.
HETLIOZ net product sales were $35.3 million in the first quarter of 2020, a 22% increase compared to $29.0 million in the first quarter of 2019.
Fanapt net product sales were $22.7 million in the first quarter of 2020, a 21% increase compared to $18.8 million in the first quarter of 2019.
Cash, cash equivalents and marketable securities (Cash) were $312.3 million as of March 31, 2020, representing an increase to Cash of $44.5 million compared to March 31, 2019.
Net income was $0.5 million for the first quarter of 2020, compared to a net loss of $0.6 million for the first quarter of 2019.
Key Product and Pipeline Highlights

Vanda is working proactively across its business and research units to protect employees and customers, and to maintain business continuity as a result of the COVID-19 pandemic.

Products

Vanda is encouraged by the strong performance of its commercial products during the first quarter of 2020, driving 22% year-over-year growth. Vanda is implementing marketing and sales strategies aimed at overcoming the disruptions caused by the pandemic. Vanda remains committed to continue innovating and bringing value to patients and prescribers, while advancing and strengthening the awareness and use of its products.

Pipeline

The COVID-19 pandemic has impacted clinical research globally, including Vanda’s previously reported clinical trials. New recruitment for the tradipitant atopic dermatitis, gastroparesis and motion sickness programs, as well as the HETLIOZ delayed sleep phase disorder study and Fanapt bipolar disorder and long acting injectable studies, is currently on hold.

Tradipitant

The ongoing atopic dermatitis and gastroparesis studies have been adapted in accordance with U.S. Food and Drug Administration (FDA) guidance to protect the health and safety of currently enrolled patients and healthcare providers.
The results of the recent atopic dermatitis (EPIONE), gastroparesis (VLY686-2301) and motion sickness (Motion Sifnos) studies have all been submitted to peer-review publications.
See below for details on Vanda’s clinical study, ODYSSEY VLY-686-3501, for the treatment of patients with COVID-19 Acute Respiratory Distress Syndrome (ARDS).
HETLIOZ (tasimelteon)

Discussions with the FDA are ongoing regarding the supplemental New Drug Applications for HETLIOZ in the treatments of jet lag disorder and Smith-Magenis Syndrome.
COVID-19 Therapeutic Program

Vanda initiated the following activities aimed at combating COVID-19:

Vanda announced the initiation of ODYSSEY VLY-686-3501, a Phase III double-blind placebo-controlled trial investigating the efficacy and safety of tradipitant for the treatment of patients with COVID-19 ARDS. Results of this study are expected in the third quarter of 2020.
Vanda also announced the initiation of the CALYPSO genetics study to evaluate the role of human and viral genetic variations in COVID-19 infection and disease severity.
Vanda and the University of Illinois at Chicago (UIC) announced a research partnership to identify small molecule inhibitors of cathepsin-L, a host enzyme required for viral processing.
GAAP Financial Results

Net income was $0.5 million for the first quarter of 2020, compared to a net loss of $0.6 million for the first quarter of 2019. Diluted net income per share was $0.01 in the first quarter of 2020, compared to a diluted net loss per share of $0.01 in the first quarter of 2019.

2020 Financial Guidance

Vanda will continue to assess the impact of the rapidly evolving COVID-19 pandemic on its business and operations and will provide future updates to its financial guidance as necessary. The financial guidance communicated by Vanda as of February 25, 2020 is shown below.

Conference Call

Vanda has scheduled a conference call for today, Wednesday, May 6, 2020, at 4:30 PM ET. During the call, Vanda’s management will discuss the first quarter 2020 financial results and other corporate activities. Investors can call 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode 2583625. A replay of the call will be available on Wednesday, May 6, 2020, beginning at 7:30 PM ET and will be accessible until Wednesday, May 13, 2020 at 7:30 PM ET. The replay call-in number is 1-855-859-2056 for domestic callers and 1-404-537-3406 for international callers. The passcode number is 2583625.

The conference call will be broadcast simultaneously on Vanda’s website, www.vandapharma.com. Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda’s website for a period of 30 days.

NuVasive Announces First Quarter 2020 Financial Results

On May 6, 2020 NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, reported financial results for the quarter ended March 31, 2020 (Press release, NuVasive, MAY 6, 2020, View Source [SID1234557175]).

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First Quarter 2020 Highlights

Revenue decreased -5.4% to $259.9 million, or -5.1% on a constant currency basis;
GAAP operating margin of 10.9%; Non-GAAP operating margin of 16.9%; and
GAAP diluted earnings per share of $0.10; Non-GAAP diluted earnings per share of $0.48.
"First and foremost, I want to recognize the healthcare professionals who are battling COVID-19 on the front lines and whose work is truly heroic during this global healthcare crisis," said J. Christopher Barry, chief executive officer of NuVasive. "Additionally, I am proud of the resiliency demonstrated by NuVasive employees, as the Company remains committed to supporting our surgeon partners and their patients during this time.

"NuVasive’s first quarter performance was consistent with the preliminary revenue results provided in the business update shared last month," Barry continued. "The Company began the quarter positioned to build upon the financial momentum delivered last year, but faced a decline in elective procedure volumes due to the COVID-19 pandemic. However, with a strong cash position, dedicated team and innovative technology in our pipeline, we are confident in the long-term trajectory of the business and our purpose to transform surgery, advance care and change lives."

A full reconciliation of GAAP to non-GAAP financial measures can be found in the tables of this news release.

First Quarter 2020 Results
NuVasive reported first quarter 2020 total revenue of $259.9 million, a -5.4% decrease compared to $274.8 million for the first quarter 2019. On a constant currency basis, first quarter 2020 total revenue decreased -5.1% compared to the same period last year.

For the first quarter 2020, both GAAP and non-GAAP gross profit was $188.0 million and GAAP and non-GAAP gross margin was 72.3%. These results compared to GAAP and non-GAAP gross profit of $200.3 million and GAAP and non-GAAP gross margin of 72.9%, for the first quarter 2019.

The Company reported GAAP net income of $5.3 million, or diluted earnings per share of $0.10, for the first quarter 2020 compared to GAAP net income of $9.4 million, or diluted earnings per share of $0.18, for the first quarter 2019. On a non-GAAP basis, the Company reported net income of $25.4 million, or diluted earnings per share of $0.48, for the first quarter 2020 compared to non-GAAP net income of $27.6 million, or diluted earnings per share of $0.53, for the first quarter 2019.

Expense Control Measures and 2020 Financial Guidance
On April 14, 2020, NuVasive provided a business update related to COVID-19, including the following temporary actions to reduce operating expenses:

Implementing compensation reductions for its board of directors and executive officers;
Controlling discretionary spend across the organization; and
Adjusting manufacturing capacity based on certain government directives and demand, while ensuring sufficient inventory levels to support current procedure volumes.
Additionally, on April 14, 2020, NuVasive withdrew its annual financial guidance for 2020. The COVID-19 pandemic has had a significant negative impact on elective procedure volumes. As visibility for spine surgery volumes for the remainder of the year is limited, and the Company is not able to predict when or how quickly elective surgery volumes will recover, the Company is not providing further financial guidance for 2020 at this time.

Supplementary Financial Information
For additional financial detail, please visit the Investor Relations section of the Company’s website at www.nuvasive.com to access Supplementary Financial Information.

Reconciliation of GAAP to Non-GAAP Information
Management uses certain non-GAAP financial measures such as non-GAAP diluted earnings per share, non-GAAP net income, non-GAAP operating expenses and non-GAAP operating margin, which exclude amortization of intangible assets, business transition costs, purchased in-process research and development, one-time restructuring and related items in connection with acquisitions, investments and divestitures, non-recurring consulting fees, certain litigation expenses and settlements, certain European medical device regulation costs, gains and losses from strategic investments, and non-cash interest expense (excluding debt issuance cost). Management also uses certain non-GAAP measures which are intended to exclude the impact of foreign exchange currency fluctuations. The measure constant currency utilizes an exchange rate that eliminates fluctuations when calculating financial performance numbers. The Company also uses measures such as free cash flow, which represents cash flow from operations less cash used in the acquisition and disposition of capital. Additionally, the Company uses an adjusted EBITDA measure which represents earnings before interest, taxes, depreciation and amortization and excludes the impact of stock-based compensation, business transition costs, purchased in-process research and development, one-time restructuring and related items in connection with acquisitions, investments and divestitures, non-recurring consulting fees, certain litigation expenses and settlements, certain European medical device regulation costs, gains and losses on strategic investments, and other significant one-time items.

Management calculates the non-GAAP financial measures provided in this earnings release excluding these costs and uses these non-GAAP financial measures to enable it to further and more consistently analyze the period-to-period financial performance of its core business operations. Management believes that providing investors with these non-GAAP measures gives them additional information to enable them to assess, in the same way management assesses, the Company’s current and future continuing operations. These non-GAAP measures are not in accordance with, or an alternative for, GAAP, and may be different from non-GAAP measures used by other companies. Set forth below are reconciliations of the non-GAAP financial measures to the comparable GAAP financial measure.

Investor Conference Call
NuVasive will hold a conference call today at 4:30 p.m. ET / 1:30 p.m. PT to discuss the results of its financial performance for the first quarter 2020. The dial-in numbers are 1-877-407-9039 for domestic callers and 1-201-689-8470 for international callers. A live webcast of the conference call will be available online from the Investor Relations page of the Company’s website at www.nuvasive.com. After the live webcast, the call will remain available on NuVasive’s website through June 6, 2020. In addition, a telephone replay of the call will be available until May 13, 2020. The replay dial-in numbers are 1-844-512-2921 for domestic callers and 1-412-317-6671 for international callers. Please use pin number: 13702256.

Jazz Pharmaceuticals Announces Participation at Upcoming Virtual Investor Conferences

On May 6, 2020 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the company will webcast its corporate presentations at the following virtual investor conferences (Press release, Jazz Pharmaceuticals, MAY 6, 2020, View Source [SID1234557174]):

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BofA Securities Virtual Healthcare Conference on Tuesday, May 12, 2020 at 3:00 p.m. EDT / 8:00 p.m. IST. Bruce Cozadd, chairman and chief executive officer, will provide an overview of the company and a business and financial update.
RBC Virtual Healthcare Conference on Tuesday, May 19, 2020 at 1:20 p.m. EDT / 6:20 p.m. IST. Daniel Swisher, president and chief operating officer, will provide an overview of the company and a business and financial update.
A live audio webcast of each presentation may be accessed from the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of each presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast.

Natera Reports First Quarter 2020 Financial Results

On May 6, 2020 Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, reported financial results for the first quarter ended March 31, 2020 and provided an update on recent business progress (Press release, Natera, MAY 6, 2020, View Source [SID1234557173]).

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Recent Accomplishments & Highlights

Generated total revenues of $94.0 million in the first quarter of 2020 compared to $66.8 million in the first quarter of 2019, an increase of 41%.
Processed approximately 235,500 tests in the first quarter of 2020, compared to approximately 200,200 tests processed in the first quarter of 2019 and 209,400 tests processed in the fourth quarter of 2019.
Achieved cost of goods sold of $202 per test accessioned in Natera’s laboratory; approaching the company’s long-term target of $200 cost of goods sold per unit.
Successfully enrolled the first 145 patients in the ProActive registry trial for ProsperaTM in kidney transplant rejection.
Responded to COVID-19 by implementing safety protocols in the laboratory, scaling remote ordering capabilities for patients and physicians.
Saw coverage for Panorama expanded during COVID-19 by greater than 20 million lives.
Successfully issued convertible senior notes due 2027 for net proceeds of $278.9 million in April 2020.
Repaid the obligations under its 2017 term loan with OrbiMed Advisors in April 2020.
"We were very pleased with our performance in the first quarter," said Steve Chapman, Natera’s Chief Executive Officer. "We had a record quarter for both volumes and revenues, and drove cost of goods sold per unit to very near the long-term target we had set out previously. We responded aggressively to the COVID-19 outbreak to ensure no disruptions to our lab operations, demonstrated our ability to rapidly scale our mobile ordering platforms for patients and providers, and further strengthened our balance sheet with the financing."

First Quarter Ended March 31, 2020 Financial Results

Total revenues were $94.0 million in the first quarter of 2020 compared to $66.8 million for the first quarter of 2019, an increase of 41%. The increase in total revenues was driven primarily by sales of Natera’s Panorama and Horizon tests. Natera processed 235,500 tests in the first quarter of 2020, including approximately 222,400 tests accessioned in its laboratory, compared to 200,200 tests processed in the first quarter of 2019, including approximately 186,500 tests accessioned in its laboratory.

In the three months ended March 31, 2020, Natera recognized revenue on approximately 221,500 tests for which results were reported to customers in the period (tests reported), including approximately 209,200 tests accessioned in its laboratory, compared to approximately 184,700 tests reported, including approximately 173,400 tests accessioned in its laboratory, in the first quarter of 2019, an overall increase of 20% for the quarter.

Gross profit for the three months ended March 31, 2020 and 2019 was $49.0 million and $23.5 million, respectively, representing a 52% and 35% gross margin, respectively. The company was able to achieve higher margins in Q1 2020 as a result of increases in both volume and average selling price as well as improved cost of goods sold per test.

Total operating expenses, representing research and development expenses and selling, general and administrative expenses, for the first quarter of 2020 were $83.9 million, compared to $55.3 million in the same period of the prior year. The increases were primarily driven by headcount growth to support new product offerings.

Loss from operations for the first quarter of 2020 was $34.9 million compared to $31.7 million for the same period of the prior year.

Net loss for the first quarter of 2020 was $35.4 million, or ($0.45) per diluted share, compared to net loss of $34.1 million, or ($0.54) per diluted share, for the same period in 2019. Weighted average shares outstanding were 78.3 million in the first quarter of 2020.

At March 31, 2020, Natera held $405.9 million in cash, cash equivalents, short-term investments and restricted cash, compared to $441.0 million as of December 31, 2019. As of March 31, 2020, Natera had a total outstanding debt balance of $123.0 million, comprised of $50.1 million with accrued interest under its $50.0 million line of credit with UBS at a variable interest rate of 30-day LIBOR plus 110 bps and a net carrying amount of $72.9 million under its debt agreement with OrbiMed Advisors.

Subsequent to March 31, 2020, Natera successfully issued seven-year convertible senior notes for net proceeds of $278.9 million, of which a portion was used to repay the obligations under the company’s 2017 term loan with OrbiMed Advisors. As of March 31, 2020, pro forma for the notes issuance and repayment of the term loan, the company’s cash, cash equivalents, short-term investments and restricted cash balance would have been $605.6 million.

2020 Financial Outlook

As previously disclosed, because of the highly dynamic situation and ongoing disruptions from COVID-19, the company has withdrawn its financial guidance for the 2020 fiscal year. At the present time, the company cannot predict the extent or duration of the impact of the COVID-19 outbreak on its financial and operating results.