On August 5, 2020 MannKind Corporation (NASDAQ:MNKD) reported financial results for the quarter and six months ended June 30, 2020 (Press release, Mannkind, AUG 5, 2020, View Source [SID1234562907]).

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"I am proud of how our employees pulled together during these uncertain times and innovated as a team to minimize the impact of the COVID-19 pandemic on our business during the second quarter," said Michael Castagna, Chief Executive Officer. "A small 3% reduction in Afrezza TRx compared to the first quarter, when there was a bolus of prescriptions due to patient stockpiling, reflects the successful execution of our commercial plan in a new virtual environment. We faced many challenges during this quarter, but whether it was production personnel ensuring Afrezza supply through the end of the year, the research team producing clinical supplies for our collaboration partner, United Therapeutics, the field force executing new sales tactics or home office staff adapting to a totally virtual environment, our team exceeded all expectations."

Second Quarter 2020 Results

Total revenues were $15.1 million for the second quarter of 2020, reflecting Afrezza net revenue of $7.0 million and collaboration and services revenue of $8.1 million. Afrezza net revenue increased 15% compared to $6.1 million in the second quarter of 2019, primarily driven by price, a favorable mix of cartridges and higher product demand. Collaboration and services revenue for the second quarter of 2020 decreased $0.8 million compared to the second quarter of 2019, primarily due to the substantial completion of the research agreement with United Therapeutics in the second quarter of 2019.

Afrezza gross profit for the second quarter of 2020 was $3.3 million vs. $1.7 million in the same period of 2019, a 90% increase that was driven primarily by higher Afrezza revenue combined with a reduction in cost of goods sold. Cost of goods sold decreased by $0.7 million, primarily due to $0.6 million in reduced spending. Gross margin in the second quarter of 2020 increased to 47% from 29% for the same quarter in 2019.

Selling, general and administrative expenses for the second quarter of 2020 were $13.7 million compared to $16.6 million for the second quarter of 2019. This 18% decrease was primarily due to a $1.9 million reduction in promotional and marketing activities, a $0.5 million decrease in personnel related costs as well as a $0.2 million decrease in professional costs.

Interest expense for the second quarter of 2020 was $2.4 million compared to $1.7 million for the second quarter of 2019. This $0.7 million increase was primarily attributable to a higher balance of outstanding principal.

The net loss for the second quarter of 2020 was $10.3 million, or $0.05 per share, compared to a $12.4 million net loss in the second quarter of 2019, or $0.07 per share. The lower net loss is mainly attributable to a decrease in operating expenses of $2.9 million. The reduction in the net loss per share was impacted by both lower operating expenses and a greater number of outstanding shares.

Six Months Ended June 30, 2020

Total revenues were $31.3 million for the six months ended June 30, 2020, reflecting Afrezza net revenue of $15.0 million and collaboration and services revenue of $16.4 million. Afrezza net revenue increased 35% compared to $11.1 million for the six months ended June 30, 2019, primarily driven by higher product demand, a more favorable mix of Afrezza cartridges, price and a reduction in wholesaler channel inventory in the six months ended June 30, 2019. Collaboration and services revenue for the six months ended June 30, 2020 decreased $4.9 million compared to the six months ended June 30, 2019, primarily due to a $5.5 million decrease in revenue recognized from the UT Research Agreement, which was substantially completed in the second quarter of 2019, partially offset by a $0.6 million increase in revenue from the UT License Agreement.

Afrezza gross profit for the six months ended June 30, 2020 was $7.1 million vs. $2.8 million in the same period of 2019, a 156% increase that was driven primarily by higher Afrezza revenue. Cost of goods sold decreased by $0.5 million, primarily attributable to $1.2 million of increased manufacturing activities, which resulted in a greater amount of costs capitalized to inventory and $0.6 million in reduced spending, partially offset by $0.9 million in costs associated with higher commercial product sales and $0.5 million of inventory write-offs. Gross margin for the six months ended June 30, 2020 increased to 48% from 25% for the same period in 2019, primarily due to higher Afrezza revenue.

Selling, general and administrative expenses for the six months ended June 30, 2020 were $28.0 million compared to $42.3 million for the same period in 2019. This 34% decrease was primarily due to $9.3 million spent on direct-to-consumer television advertising in 2019 (which was not repeated in 2020), a $3.1 million decrease in promotional and marketing activities, a $1.2 million decrease in personnel and employee related costs and a $0.5 million decrease in consulting costs.

Interest expense for the six months ended June 30, 2020 was $4.7 million compared to $3.3 million for the same period in 2019. This $1.4 million increase was primarily due to the borrowings under the MidCap Credit Facility in August 2019.

The net loss for the six months ended June 30, 2020 was $19.6 million, or $0.09 per share, compared to a $27.3 million net loss for the same period in 2019, or $0.15 per share. The lower net loss is mainly attributable to a decrease in operating expenses of $10.5 million. The reduction in the net loss per share was impacted by both lower operating expenses and a greater number of outstanding shares.

Cash, cash equivalents and restricted cash at June 30, 2020 was $63.5 million compared to $50.2 million at December 31, 2019, which also included short-term investments of $20.0 million. The increase was primarily due to the receipt of a $12.5 million United Therapeutics milestone payment, $12.2 million of net proceeds received from the at-the-market offering, $11.6 million received from warrant exercises and the origination of a Paycheck Protection Program loan for $4.9 million, offset by non-GAAP net cash used in operating activities of $27.4 million.

Chief Commercial Officer

As previously announced, Alejandro Galindo, M.B.A, M.S., joined the Company on August 4, 2020 as Chief Commercial Officer. Mr. Galindo has an accomplished track-record of over 25 years in the healthcare, energy, and consumer industries. He spent the past six years at Medtronic as Vice President and President of the Advanced Insulin Management Business Unit, where he led a fast-paced, double-digit growth global business within their diabetes division. Prior to Medtronic, Mr. Galindo spent nine years at General Electric (GE) Healthcare in a variety of leadership roles, leading emerging markets, strategic corporate development and global supply chain operations. Prior to joining GE’s Healthcare division, he spent eleven years in various global leadership positions for the company’s energy and appliance sectors, overseeing advanced manufacturing engineering and product development. Mr. Galindo received a B.Sc. in Industrial & Systems Engineering from Monterrey Institute of Technology, Mexico and M.B.A. and M.S. degrees from Indiana University.

Non-GAAP Measures

Certain financial information contained in this press release is presented on both a reported basis (GAAP) and a non-GAAP basis. Reported results were prepared in accordance with GAAP whereas non-GAAP measures exclude items described in the reconciliation tables below. Non-GAAP financial information is intended to portray the results of our baseline performance, supplement or enhance management, analysts and investors overall understanding of our underlying financial performance and facilitate comparisons among current and past periods. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.

On August 5, 2020 Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI) ("Spectrum" or the "Company"), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that the underwriters of its previously announced public offering of common stock have fully exercised and closed on their option to purchase an additional 3,250,000 shares of the Company’s common stock at the public offering price of $3.00 per share, less underwriting discounts and commissions, for additional anticipated net proceeds to the Company of approximately $9.2 million (Press release, Spectrum Pharmaceuticals, AUG 5, 2020, View Source [SID1234562906]). The option was granted in connection with the public offering of 21,666,667 shares of common stock at a public offering price of $3.00 per share, which closed on August 3, 2020.

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After giving effect to the exercise in full of the underwriters’ option, the total number of shares sold by Spectrum in the public offering was 24,916,667 shares and net proceeds to Spectrum were approximately $70.3 million, after deducting underwriting discounts and commissions, but before deducting the expenses of the offering.

Jefferies and Cantor Fitzgerald & Co. acted as joint book-running managers for the offering. JMP Securities acted as the lead manager for the offering. B. Riley FBR and H.C. Wainwright & Co. acted as co-managers for the offering.

The securities were offered pursuant to a shelf registration statement on Form S-3 (333-237319), which was declared effective by the Securities and Exchange Commission (the "SEC") on May 8, 2020. The offering was made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement relating to the offering was filed by Spectrum with the SEC on July 29, 2020 and is available on the SEC’s website at www.sec.gov. A final prospectus supplement and the accompanying prospectus was filed with the SEC on July 30, 2020 and is available at the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained for free by contacting: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at 1-877-547-6340 or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, NY 10022, or by email at [email protected].

On August 5, 2020 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that Jeff Goater, its chief executive officer, will present at the upcoming Wedbush PacGrow Healthcare Virtual Conference on Surface’s lead programs, SRF617 (targeting CD39) and SRF388 (targeting IL-27), as well as Surface’s emerging preclinical pipeline, including SRF813 (targeting CD112R, also known as PVRIG) (Press release, Surface Oncology, AUG 5, 2020, View Source [SID1234562904]).

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The presentation will take place virtually on Tuesday, August 11, 2020 at 10:55 a.m. EDT. The live audio and subsequent archived webcasts of the Company’s presentations will be accessible from the Company’s investor relations website: investors.surfaceoncology.com.

On August 5, 2020 Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) reported its financial results for the second quarter of 2020 and recent business highlights (Press release, Ionis Pharmaceuticals, AUG 5, 2020, View Source [SID1234562896]).

"The first half of this year was marked by numerous important achievements. Our Phase 3 programs progressed, we advanced our cardio-renal, metabolic and neurological disease franchises and added new medicines to our Ionis-owned pipeline. Together, these catalysts moved us closer to delivering 10 or more marketing applications through 2025, which we expect to result in a number of new commercial medicines. In the second half of this year, we are expanding the reach of our technology in neurological and pulmonary diseases, as studies in sporadic ALS and COPD get underway. We also look forward to proof-of-concept data from additional mid-stage programs," said Brett P. Monia, Ph.D., chief executive officer at Ionis. "Our achievements, together with our significant financial resources, position us to realize my vision for Ionis – to lead in the delivery of transformational medicines for patients around the world."

Second Quarter 2020 Financial Results and Highlights

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•
On track to achieve financial guidance of being meaningfully profitable this year

o
Net income of $8 million on a non-GAAP basis and a net loss of $32 million on a GAAP basis

•
Achieved quarter over quarter growth in commercial and R&D revenues

o
Commercial revenue from SPINRAZA (nusinersen) royalties increased to $72 million

o
Product sales from TEGSEDI (inotersen) and WAYLIVRA (volanesorsen) increased to $16 million

o
R&D revenue increased to more than $55 million, including $26 million from Ionis’ neurological disease franchise, $13 million from the oncology franchise and more than $10 million from the cardio-renal franchise

•
Cash position of more than $2.3 billion provides substantial financial resources to continue executing on strategic goals

"We ended the second quarter with net income on a non-GAAP basis, an increase compared to our first quarter results. Looking ahead, we are maintaining our 2020 financial guidance and expect revenue and earnings growth in the second half of this year. With our substantial resources, we are well positioned to continue executing on our ambitious agenda and to deliver increasing value near-term and into the future," said Elizabeth L. Hougen, chief financial officer of Ionis.

All non-GAAP amounts referred to in this press release exclude non-cash compensation expense related to equity awards. Please refer to the reconciliation of non-GAAP and GAAP measures, which is provided later in this release.

Commercial Medicine Highlights

•
SPINRAZA: a global foundation-of-care for the treatment of spinal muscular atrophy (SMA) patients of all ages

o
$495 million in worldwide sales in the second quarter of this year

o
More than 11,000 patients were on SPINRAZA treatment worldwide at the end of the second quarter, including patients across commercial, expanded access and clinical trial settings

1

o
The Phase 4 RESPOND study to evaluate SPINRAZA benefit in patients with a suboptimal clinical response to Zolgensma (onasemnogene abeparvovec) is expected to begin early next year

o
The DEVOTE study evaluating a higher dose of SPINRAZA with the potential to deliver even greater efficacy in SMA patients of all ages is progressing

o
New clinical data from the NURTURE and SHINE studies, as well as new real-world data, further support SPINRAZA’s durable efficacy and established safety profile across SMA patients of all ages

•
TEGSEDI: the only approved at-home subcutaneous therapy for the treatment of hereditary transthyretin amyloidosis (hATTR) with polyneuropathy in adult patients

o
Commercially available in 15 countries

o
Reimbursement approved in Portugal, Spain, Italy and Austria

o
Expanding commercial availability in additional EU countries and in Latin America this year

•
WAYLIVRA: the only approved treatment in the EU for adults with genetically confirmed familial chylomicronemia syndrome (FCS) at high risk for pancreatitis

o
Launch progressing in Germany, Austria, Greece and through the ATU in France; launching in additional EU countries this year

Filed for marketing approval in Brazil; refiling new drug application for U.S. marketing authorization

Second Quarter 2020 and Recent Pipeline Highlights

Completed enrollment in the global GENERATION HD1 Phase 3 study of tominersen in patients with Huntington’s disease

Progressed multiple neurological disease medicines under Ionis’ broad Biogen collaboration

Published data from the Phase 1/2 study of tofersen in the New England Journal of Medicine

Progressed the IONIS-MAPTRx long-term extension study in patients with Alzheimer’s disease and achieved a $12 million milestone payment

Advanced ION464 into a Phase 1/2 study in patients with multiple system atrophy and achieved an $18 million milestone payment

Advanced medicines for the treatment of cancer and immune-mediated GI disease

Licensed ION736 to AstraZeneca for the treatment of cancer and achieved a $13 million license fee

Initiated a Phase 1 study of ION253 for the treatment of immune-mediated GI disease and achieved a $5 million milestone payment from Janssen
Expanded the Ionis-owned pipeline with the addition of ION363 for the treatment of FUS-ALS

Upcoming Catalysts

Report clinical proof-of-concept results for four or more programs

Present positive Phase 2 results from vupanorsen and AKCEA-APOCIII-LRx

Initiate a Phase 3 study of AKCEA-APOCIII-LRx in patients with FCS

Initiate a registration study of ION363 in patients with FUS-ALS

Initiate a Phase 1/2 study of ION541 in patients with sporadic ALS

Initiate a Phase 2 study of IONIS-ENaC-2.5Rx in patients with chronic obstructive pulmonary disease (COPD)

Initiate a Phase 2 study of IONIS-FXI-LRx in patients with clotting disorders

Initiate a Phase 2 study of IONIS-HBVRx in patients with hepatitis B virus infection

Advance additional new medicines into development

Operating Expenses

Ionis’ operating expenses for the second quarter of 2020 increased compared to the same period in 2019 driven by its investments in advancing its strategic priorities, including advancing the Phase 3 program for AKCEA-TTR-LRx and other medicines in its Ionis-owned pipeline.

Net Loss Attributable to Noncontrolling Interest in Akcea

At June 30, 2020, Ionis owned approximately 76 percent of Akcea. The Company’s net loss attributable to noncontrolling interest in Akcea for the second quarter of 2020 was consistent with the same period last year. The line titled "Net loss attributable to noncontrolling interest in Akcea" on Ionis’ statement of operations reflects the portion of Akcea’s net income or loss attributable to the other owners of Akcea’s common stock.

Net Income (Loss) Attributable to Ionis Common Stockholders

Ionis’ net loss attributable to Ionis’ common stockholders for the second quarter of 2020 was larger compared to the same period in 2019 primarily due to higher revenue and lower operating expenses in the same period last year.

Balance Sheet

Ionis ended June 2020 with cash, cash equivalents and short-term investments of more than $2.3 billion, compared to $2.5 billion at December 31, 2019.

Webcast

Today, at 11:30 a.m. Eastern Time, Ionis will conduct a live webcast to discuss this earnings release and related activities. Interested parties may access the webcast here. A webcast replay will be available for a limited time at the same address.

On August 5, 2020 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that its Chief Financial Officer, Joseph J. Ferra, will present a corporate overview at the 2020 Wedbush PacGrow Healthcare Virtual Conference. Details are as follows (Press release, Syros Pharmaceuticals, AUG 5, 2020, View Source [SID1234562894]):

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2020 Wedbush PacGrow Healthcare Virtual Conference:
Date: Wednesday, August 12
Time: 8:00 a.m. ET

A live webcast of the presentation will be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.