On May 7, 2020 Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) reported financial results for the first quarter ended March 31, 2020 (Press release, Arena Pharmaceuticals, MAY 7, 2020, View Source [SID1234557397]).

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"We are pleased to announce that our ongoing clinical programs are currently on track and our liquidity position remains strong with approximately one billion dollars in cash and investments. While maintaining momentum has not been easy, and we – along with the rest of the industry – have experienced a slowing in clinical trial operations, including site activations, our teams have been actively monitoring our ongoing trials day-by-day to ensure patient safety, study momentum and conduct, and drug supply. Additionally, prior to the COVID-19 outbreak, our programs were well ahead of schedule, giving us an important buffer to weather the storm. Finally, given the broad clinical site base across our programs, we are also monitoring certain countries and regions as they begin to lift restrictions. We continue to evaluate the situation in real-time and we will provide further updates frequently as circumstances evolve," said Amit D. Munshi, President and CEO of Arena.

Mr. Munshi added, "In the meantime, as we navigate the difficult and uncertain global conditions, we are taking measures to slow down hiring and spend in non-clinical areas, ensuring that we are highly focused on our key clinical objectives. We continue to judiciously manage cash and explore ways to reduce burn without impacting the long-term value of Arena or the delivery of critical milestones."

Financial Update

First Quarter 2020 Financial Results

Revenues for the first quarter totaled $0.3 million compared to $801.1 million in the first quarter of 2019. This decrease was driven by the $800.0 million upfront payment from the United Therapeutics transaction in the first quarter of 2019
Research and development (R&D) expenses for the first quarter totaled $78.5 million compared to $45.4 million in the same period 2019. This increase was primarily driven by our advancing clinical studies, including the etrasimod Phase 3 program, as well as an increase in personnel expenses as we staff to support our clinical programs. The R&D non-cash share-based compensation was $6.6 million in the first quarter as compared to $6.7 million in the same period 2019
General and administrative (G&A) expenses for the first quarter totaled $26.4 million, compared to $16.6 million in the first quarter of 2019. This increase is primarily attributed to personnel expenses including share-based compensation. The G&A non-cash share-based compensation was $8.6 million in the first quarter as compared to $6.3 million in the same period 2019
Net loss for the first quarter was $100.2 million compared to net income of $620.1 million for the same period in 2019. In connection with the United Therapeutics transaction we incurred transaction fees of approximately $17.0 million, of which $14.6 million was incurred in the first quarter of 2019, and was presented as transaction costs in the condensed consolidated statement of operations
Basic and diluted net loss per share for the first quarter 2020 was $2.00 compared to basic net income per share of $12.53 and diluted net income per share of $12.11 for the same period in 2019
Cash, cash equivalents and marketable securities were $1.0 billion at March 31, 2020, as compared to $1.1 billion at December 31, 2019
Financial Outlook for 2020
Arena updated its 2020 financial guidance ranges:

Cash used in operating activities for the full-year 2020 is expected to be $400 million to $430 million, down compared to our previous guidance of $95 million in the first quarter, with a subsequent quarter over quarter increase in the high single-digits to low double-digits
Conference Call & Webcast Information
Arena will host a live and webcast question and answer session via conference call and live webcast with the investment community today, Thursday, May 7, 2020, at 4:30 PM ET to discuss the financial results and provide a corporate update.

When: Thursday, May 7, 2020, at 4:30 PM ET
Dial-in: (877) 643-7155 (United States) or (914) 495-8552 (International)
Conference ID: 4171767

Please join the conference call at least 15 minutes early to register. You can access the live webcast under the investor relations section of Arena’s website at: www.arenapharm.com. A replay of the event will be archived under the investor relations section of Arena’s website for 30 days shortly after the call.

On May 7, 2020 Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, reported financial results for the first quarter ended March 31, 2020 and provided updates on its programs (Press release, Kindred Healthcare, MAY 7, 2020, View Source [SID1234557396]). For the first quarter 2020, KindredBio reported net product revenues of $0.6 million and a net loss of $22.8 million, or $0.58 per share, which includes non-recurring charges of $5.1 million.

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"We are very pleased with the recent close of the $43 million Mirataz transaction. We look forward to continuing to build value in our promising pipeline," said KindredBio’s Chief Executive Officer, Richard Chin, M.D. "With the positive results from the IL-4/13 SINK pilot study we now have eight positive pilot studies in a row, which is a remarkable achievement, and speaks to the quality of our development capabilities."

Development and Corporate Updates

Biologics Candidates

The scale up process for KIND-016, a fully caninized, high-affinity monoclonal antibody targeting interleukin (IL)-31 for the treatment of atopic dermatitis in dogs, is proceeding as planned and the pivotal study remains on track to start in the second half of 2020.

On March 24, 2020 KindredBio announced positive results from the pilot field efficacy study of its canine IL-4/13 SINK molecule, a canine fusion protein targeting IL-4 and IL-13 for the treatment of atopic dermatitis in dogs. A higher treatment success rate was observed in the KIND-025 group over the placebo group from week 1 through week 4. Positive efficacy signals were also detected with other endpoints including 20mm or higher reduction from baseline in PVAS score.

On December 16, 2019, KindredBio unveiled positive results from its randomized, placebo-controlled laboratory pilot study of KIND-032, a fully caninized monoclonal antibody targeting IL-4R for the treatment of atopic dermatitis in dogs. A second pilot study to further assess efficacy and dosing is planned for mid-2020. The IL-4 pathway is a key driver of the inflammation that underlies atopic dermatitis. KIND-032 binds to the IL-4 receptor on the surface of immune cells. The KIND-032 program is advancing ahead of schedule and is being prioritized ahead of IL-4/13 SINK.

Pivotal studies for KIND-030, a monoclonal antibody targeting canine parvovirus, are expected to be completed in 2020 and the approval timeline is on track.

The pivotal efficacy study for KindredBio’s feline recombinant erythropoietin was initiated in the fourth quarter. Due to COVID-19, a number of veterinary clinics are not conducting clinical trials currently. KindredBio is actively implementing practices consistent with guidance provided by the U.S. Food and Drug Administration on studies conducted during the COVID-19 pandemic to minimize the impact on timelines. An update will be provided with the second quarter results.

The pilot field effectiveness study for KindredBio’s anti-TNF antibody for canine inflammatory bowel disease is underway. Due to COVID-19, a number of veterinary clinics are not conducting clinical trials currently, and completion is now expected to extend beyond the first half of 2020. KindredBio is actively implementing practices consistent with guidance provided by the U.S. Food and Drug Administration on studies conducted during the COVID-19 pandemic to minimize the impact on timelines. An update will be provided with the second quarter results.
Mirataz

KindredBio recorded Mirataz (mirtazapine transdermal ointment) net product revenues of $0.6 million in the first quarter, reflecting limited distributor stocking during the Mirataz sale negotiation. Sales of Mirataz from distributors to veterinary clinics reached a record $1.6 million in the quarter, underscoring continued growth in customer adoption. On April 15, 2020 KindredBio completed the sale of Mirataz to Dechra Pharmaceuticals PLC for an upfront payment of $43 million, and royalties on worldwide sales. Dechra plans to launch Mirataz in the UK and the European Union, and intends to conduct the necessary regulatory activities to achieve approvals in other key international markets. Royalties on future global sales of Mirataz by Dechra will be recorded by KindredBio as revenue.
KindredBio Equine

Pending the strategic evaluation of the future direction of the equine franchise, development of all candidates has been put on hold.

On November 25, 2019, KindredBio announced that the U.S. Food and Drug Administration approved Zimeta for the control of pyrexia in horses. KindredBio recorded net product revenues of $7,000 in the first three months of the year, reflecting expected limited activity during the winter months and a downturn in equine transportation as a result of COVID-19. An application for Zimeta was made in Canada in November, with anticipated approval in the second quarter of 2020.
First Quarter 2020 Financial Results

For the quarter ended March 31, 2020, KindredBio reported a net loss of $22.8 million or $0.58 per share, as compared to a net loss of $16.1 million or $0.42 per share, for the same period in 2019.

The Company recorded $0.6 million in net product revenues for Mirataz for the quarter ended March 31, 2020, compared to $0.5 million for the same period in 2019. Net product revenues for Zimeta IV were $7,000 in the first quarter. Zimeta IV became commercially available in December 2019.

The cost of product sales totaled $82,000 in the first quarter of 2020, compared to $92,000 in the same period in 2019, resulting in a gross margin of 86% and 82%, respectively. The Company recorded a $3.5 million inventory write-off on Mirataz, due to the transition to Dechra brand labelling.

Research and development expenses for the quarter ended March 31, 2020 were $8.9 million, compared to $7.2 million for the same period in 2019. The $1.7 million increase was primarily due to the inclusion of expenses from the Kansas facility as it began to manufacture clinical trial material. Prior to the first quarter, construction and commissioning expenditures associated with the Kansas facility had been categorized as general and administrative expenses. Stock based compensation expense for the first quarter of 2020 was $0.6 million, as compared to $0.4 million for the same period in 2019.

Selling, general and administrative expenses for the 2020 and 2019 first quarters were $8.9 million and $9.9 million, respectively. The $1.0 million year-over-year decrease was mainly due to the recategorization of Kansas plant expenditures as research and development expenses, offset by higher legal fees. Stock based compensation expense was $1.5 million for the 2020 first quarter, versus $1.4 million in the year-ago period.

The Company recorded a restructuring charge of $1.7 million in the first quarter of 2020 as a result of the strategic realignment and associated workforce reduction communicated in the fourth quarter 2019 results.

As of March 31, 2020, KindredBio had $54.6 million in cash, cash equivalents and investments, compared with $73.5 million as of December 31, 2019. Net cash used in operating activities for the first quarter of 2020 was approximately $17.1 million, reflecting a full organizational structure. The Company also invested approximately $1.4 million in capital expenditures for the purchase of associated lab and manufacturing equipment for the Kansas facility.

On April 15, 2020, KindredBio completed the sale of Mirataz to Dechra Pharmaceuticals for an upfront payment of $43 million, of which 10% shall be held in escrow for up to 18 months post closing.

With respect to spending in 2020, the Company remains focused on advancing its core biologics pipeline and programs, including the commencement of multiple pivotal studies. KindredBio anticipates operating expenses of between $57 million and $59 million, excluding the impact of stock-based compensation expense and the impact of acquisitions, if any. The 2020 operating expense includes the beforementioned one-time restructuring charge and first quarter expenditures that reflect a full organizational structure. KindredBio also plans to invest $3.0 million to $4.0 million in capital expenditures on lab and manufacturing equipment for its biologics programs in 2020. KindredBio believes its existing cash, cash equivalents, investments, proceeds from the Mirataz sale, revenues from anticipated partnerships, and additional drawdown of $30 million from its debt facility, which is contingent on the achievement of certain milestones, will be sufficient to fund the current operating plan through 2022.

Webcast and Conference Call

KindredBio will host a conference call and webcast today at 4:30 p.m. Eastern time/1:30 p.m. Pacific time. Interested parties may access the call by dialing toll-free (855) 433-0927 from the US, or (484) 756-4262 internationally, and using conference ID 4476025. The call will be webcast live here, with a replay available at that link for 30 days.

Important Safety Information

Zimeta (dipyrone injection) should not be used more frequently than every 12 hours. For use in horses only. Do not use in horses with a hypersensitivity to dipyrone, horses intended for human consumption or any food producing animals, including lactating dairy animals. Not for use in humans, avoid contact with skin and keep out of reach of children. Take care to avoid accidental self-injection and use routine precautions when handling and using loaded syringes. Prior to use, horses should undergo a thorough history and physical examination by a veterinarian. Monitor for signs of abnormal bleeding and use caution in horses at risk for hemorrhage. Concurrent use with other NSAIDs, corticosteroids and drugs associated with kidney toxicity, should be avoided. As a class, NSAIDs may be associated with gastrointestinal, kidney, and liver toxicity. The most common adverse reactions observed during clinical trials were elevated glucose conversion enzymes, decreased blood protein, and gastric ulcers. Please see the full Prescribing Information.

On May 7, 2020 Ardelyx, Inc. (Nasdaq: ARDX), a specialized biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases, reported business highlights and financial results for the first quarter ended March 31, 2020 (Press release, Ardelyx, MAY 7, 2020, View Source [SID1234557395]).

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"During these unprecedented times, our priorities are focused on the well-being and safety of our employees, patients, and communities, while continuing on our mission to provide patients with first-in-class, disruptive medicines based on our breakthrough science," said Mike Raab, president and chief executive officer of Ardelyx. "We are fortunate that much of our clinical work has been completed, with minimal impact of the pandemic on our business, and we are on track to submit our NDA for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis by mid-year. In preparation for potential approval in mid-2021, we are laying the foundation for launch with important pre-commercial activities underway."

Recent Business and Pipeline Updates

Initial data from NORMALIZE released in December 2019 demonstrated that of the 73 patients, treated for more than one month, 42% achieved normal phosphorus levels of less than 4.6 mg/dL and of those, 58% accomplished this with either tenapanor alone or with tenapanor in combination with only one to three sevelamer tablets per day. These early and exciting data represent a 45% improvement over current phosphate binder data from the 2019 Dialysis Outcomes and Practice Patterns Study (DOPPS), an ongoing, national prospective study of hemodialysis practice.
Appointed industry veteran, Onaiza Cadoret-Manier to the company’s board of directors.
Our collaboration partner in Canada, Knight Therapeutics, received approval from Health Canada for IBSRELA for the treatment of IBS-C in adults.
Planned initiation of the OPTIMIZE clinical trial in 2020, a study to inform physicians on the integration of tenapanor into clinical practice.
Expected 2020 Milestones

Preparing NDA Submission for Tenapanor for the Control of Serum Phosphorus in mid-2020: With strong data from its clinical program for tenapanor, Ardelyx is preparing a New Drug Application for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis, which the company currently intends to submit to the U.S. Food and Drug Administration in mid-2020.
Reporting AMPLIFY and PHREEDOM Phase 3 results and NORMALIZE Phase 4 results at upcoming medical conferences.
First Quarter 2020 Financial Results

Cash Position: As of March 31, 2020, Ardelyx had total cash, cash equivalents and short-term investments of $223.2 million, as compared to total cash, cash equivalents and short-term investments of $247.5 million as of December 31, 2019.
Revenue: The company generated $1.2 million in revenue, which primarily represents collaborative development revenue, for the quarter ended March 31, 2020.
R&D Expenses: Research and development expenses were $15.8 million for the three months ended March 31, 2020, a decrease of $4.6 million, or 22.3 percent, compared to $20.4 million for the three months ended March 31, 2019. The decrease was due primarily to a decrease in external R&D expenses, with a $5.1 million decrease in tenapanor-related expenses, as well as a $0.8 million decrease in RDX013 program-related expenses, partially offset by $0.8 million of higher expenses attributable to research conducted under the Research Collaboration and Option Agreement entered into with Kyowa Kirin Co., Ltd., in November 2019 and general R&D expenses. Of the overall tenapanor-related decrease, approximately $4.1 million relates to lower clinical study costs and approximately $1.4 million relates to lower manufacturing expenses.
G&A Expenses: General and administrative expenses were $7.1 million for the three months ended March 31, 2020, an increase of $2.0 million, or 39.5 percent, compared to $5.1 million for the three months ended March 31, 2019. The increase in general and administrative expenses was primarily due to an increase in headcount and related personnel costs, including stock-based compensation costs related to option vesting and performance-based restricted stock units, severance expenses related to the departure of the company’s former chief financial officer in March 2020, and an increase in professional services.
Net Loss: Net loss for the quarter ended March 31, 2020 was $22.4 million, as compared to $26.1 million for the quarter ended March 31, 2019.

On May 7, 2020 Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, reported financial results for the first quarter ended March 31, 2020 (Press release, Penumbra, MAY 7, 2020, View Source [SID1234557394]).

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Revenue of $137.3 million in the first quarter of 2020, an increase of 6.9%, or 7.6% in constant currency1, over the first quarter of 2019. Excluding Japan, total revenue in the first quarter of 2020 increased 13.6%, or 14.3% in constant currency1, over the first quarter of 2019.
First Quarter 2020 Financial Results

Total revenue grew to $137.3 million for the first quarter of 2020 compared to $128.4 million for the first quarter of 2019, an increase of 6.9%, or 7.6% on a constant currency basis. The United States represented 70% of total revenue and international represented 30% of total revenue for the first quarter of 2020. Revenue from sales of vascular products grew to $59.3 million for the first quarter of 2020, an increase of 26.2%, or 26.5% on a constant currency basis. Revenue from sales of neuro products declined to $78.1 million for the first quarter of 2020, a decrease of 4.2%, or 3.3% on a constant currency basis.

Gross profit was $88.0 million, or 64.1% of total revenue, for the first quarter of 2020, compared to $83.9 million, or 65.3% of total revenue, for the first quarter of 2019.

Total operating expenses for the first quarter of 2020 were $87.4 million, or 63.6% of total revenue. This compares to total operating expenses of $72.8 million, or 56.6% of total revenue, for the first quarter of 2019. R&D expenses were $12.9 million for the first quarter of 2020, compared to $11.7 million for the first quarter of 2019. SG&A expenses were $74.5 million for the first quarter of 2020, compared to $61.1 million for the first quarter of 2019.

Operating income for the first quarter of 2020 was $0.6 million, compared to an operating income of $11.2 million for the first quarter of 2019.

As of March 31, 2020, cash, cash equivalents and marketable investments totaled $168.2 million. In addition, on April 24, 2020, the Company entered into a secured credit agreement with JPMorgan Chase Bank, N.A., Bank of America, N.A. and Citibank, N.A., that provides for up to $100 million in available revolving borrowing capacity.

Impact of COVID-19 Pandemic

As noted in the Company’s April 6, 2020 press release, the Company began to observe more notable negative impact on business trends in March due to COVID-19. The Company has experienced and believes that the impact of the COVID-19 pandemic on the Company’s business differs by geography and procedure type. Due to the uncertain scope and duration of the pandemic, and uncertain timing of global recovery and economic normalization, we cannot, at this time, reliably estimate the future impact on our operations and financial results.

Webcast and Conference Call Information

Penumbra, Inc. will host a conference call to discuss the first quarter 2020 financial results after market close on Thursday, May 7, 2020 at 5:00 PM Eastern Time. The conference call can be accessed live over the phone by dialing (833) 227-5837 for domestic callers or (647) 689-4064 for international callers (conference id: 3899277), or the webcast can be accessed on the "Events" section under the "Investors" tab of the Company’s website at: www.penumbrainc.com. The webcast will be available on the Company’s website for at least two weeks following the completion of the call.

On May 7, 2020 Eiger BioPharmaceuticals, Inc. (NASDAQ: EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, reported financial results for first quarter 2020 and provided a business update (Press release, Eiger Biopharmaceuticals, MAY 7, 2020, View Source [SID1234557393]).

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"We achieved key milestones this quarter across programs, including Eiger’s first NDA and MAA submissions. Lonafarnib would be the first approved treatment for patients with Progeria and Progeroid Laminopathies," said David Cory, President and CEO of Eiger. "As previously announced, due to the impact of COVID-19, we anticipate full enrollment of our global Phase 3 HDV D-LIVR study in 2021, and we continue to enroll and dose patients. Peginterferon lambda in HDV is now Phase 3-ready, after harmonizing a single pivotal study with FDA and EMA. In addition, we look forward to future results from ongoing investigator sponsored studies of peginterferon lambda in COVID-19 patients."

Recent Highlights and Upcoming Milestones

Lonafarnib in Progeria and Progeroid Laminopathies

Marketing Authorization Application (MAA) validated by EMA
Accelerated Assessment for MAA granted by EMA
New Drug Application (NDA) submitted to FDA in March 2020
Lonafarnib in Hepatitis Delta Virus (HDV)

Phase 3 D-LIVR study (N=400) continues to enroll and dose patients
Full enrollment expected in 2021 due to previously announced impact of COVID-19
Prioritizing the safety of D-LIVR patients, study continuity, and study integrity
Peginterferon Lambda in HDV

Single pivotal Phase 3 study harmonized with FDA and EMA
Phase 2 LIFT (combo with lonafarnib) end-of-treatment data planned for EASL 2020
Peginterferon Lambda in COVID-19

First patients dosed at Stanford University
Six International Investigator Sponsored Studies initiating and enrolling
First Quarter 2020 Financial Results

Cash, cash equivalents, and short-term investments as of March 31, 2020 totaled $77.6 million compared to $95.0 million at December 31, 2019, a decrease of $17 million.

The Company reported net loss of $15.2 million, or $0.62 per share, for first quarter 2020, as compared to $17.2 million, or $0.90 per share, for first quarter 2019.

Research and Development expenses were $9.5 million for first quarter 2020, as compared to $12.9 million for first quarter 2019. The decrease was primarily due to lower clinical trial related expenses, including clinical material costs.

General and Administrative expenses were $5.2 million for first quarter 2020, as compared to $4.1 million for first quarter 2019. The increase was primarily due to increases in employee-related costs, including stock-based compensation, from increased headcount.

Total operating expenses include total non-cash expenses of $2.0 million for first quarter 2020, as compared to $1.4 million for the same period in 2019. As of March 31, 2020 the Company had 24.6 million of common shares outstanding.