Mylan Reports Strong Second Quarter and First Half 2020 Results and Updates 2020 Guidance

On August 6, 2020 Mylan N.V. (NASDAQ: MYL) reported its financial results for the three and six months ended June 30, 2020 (Press release, Mylan, AUG 6, 2020, View Source [SID1234563222]).

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Second Quarter 2020 Financial Highlights

Total revenues of $2.73 billion, down 4%, down 2% on a constant currency basis, compared to the prior year period.
Revenue Highlights:
North America segment net sales of $1.04 billion, up 2% on an actual and constant currency basis.
Europe segment net sales of $935.0 million, down 6%, down 3% on a constant currency basis.
Rest of World segment net sales of $721.9 million, down 10%, down 5% on a constant currency basis.
U.S. GAAP net earnings of $39.4 million, compared to U.S. GAAP net loss of $(168.5) million in the prior year period.
Adjusted net earnings of $574.3 million, compared to adjusted net earnings of $532.8 million in the prior year period.
Adjusted EBITDA of $878.6 million, compared to adjusted EBITDA of $847.4 million in the prior year period.
Six Months Ended June 30, 2020 Financial Highlights

Total revenues of $5.35 billion, essentially flat, up 3% on a constant currency basis, compared to the prior year period.
Revenue Highlights:
North America segment net sales of $1.99 billion, up 2%, up 3% on a constant currency basis.
Europe segment net sales of $1.96 billion, up 4%, up 7% on a constant currency basis.
Rest of World segment net sales of $1.33 billion, down 8%, down 3% on a constant currency basis.
U.S. GAAP net earnings of $60.2 million, compared to U.S. GAAP net loss of $(193.5) million in the prior year period.
Adjusted net earnings of $1.04 billion, compared to adjusted net earnings of $954.7 million in the prior year period.
Adjusted EBITDA of $1.63 billion, compared to adjusted EBITDA of $1.56 billion in the prior year period.
U.S. GAAP net cash provided by operating activities for the six months ended June 30, 2020 of $670.6 million, compared to net cash provided by operating activities of $629.2 million in the prior year period, and adjusted free cash flow for the six months ended June 30, 2020 of $878.6 million, compared to $750.8 million in the prior year period.
Updated Full Year 2020 Financial Guidance

Mylan is not providing forward-looking guidance for U.S. GAAP reported financial measures or a quantitative reconciliation of forward-looking non-GAAP financial measures. Please see "Non-GAAP Financial Measures" for additional information.

Mylan is tightening its full year guidance within the ranges of the original expectations for both adjusted EBITDA and total revenues. We now expect the overall COVID-19 recovery efforts will occur slower than anticipated and may continue throughout the rest of the year. As a result, we expect total revenues, which absorbed a 2% net decline related to COVID-19 in the first half of the year, to have an overall similar negative impact for the second half of the year. As a result we are tightening our total revenue range to between $11.5 to $12.0 billion. In addition, we are also tightening our adjusted EBITDA guidance range to between $3.30 to $3.70 billion.

(in millions)

2020 Updated
Guidance Range

2020 Updated
Midpoint

Total Revenues

$11,500 – $12,000

$11,750

Adjusted EBITDA

$3,300 – $3,700

$3,500

Mylan CEO Heather Bresch commented: "Since the onset of the COVID-19 pandemic, Mylan has remained steadfast in its focus on continuing to protect the health and safety of its workforce while also serving patients and partnering with the global healthcare community in the fight against the disease. Mylan’s strong results from the first half of the year demonstrate the resilience of our underlying business, even amidst the current environment, with total revenues of $5.35 billion, an increase of 3% year-over-year on a constant currency basis, and adjusted EBITDA of $1.63 billion, representing an increase of 5%. Looking forward to the remainder of the year, we’re tightening our full year guidance within the ranges of our original expectations for both adjusted EBITDA and revenues. On adjusted EBITDA, we expect to be able to substantially maintain our original target for the full year while tightening the range to between $3.3 and $3.7 billion. At the midpoint, this implies slightly less than $1.9 billion of second half adjusted EBITDA, which we expect to be weighted more to the fourth quarter. And on revenue, we’re also tightening our full year range to between $11.5 and $12 billion, taking into consideration COVID-19 topline impacts to date and our anticipation that recovery efforts will continue until at least the end of the year. Mylan also continues to progress toward a successful deal close with Pfizer’s Upjohn business in the fourth quarter of this year, and I’m proud of all that we continue to achieve as Mylan in order to set up the new company for success in 2021 and beyond."

Mylan President Rajiv Malik added: "The commitment of our employees, especially our front-line workers, has enabled us to maintain supply continuity and strong customer service levels without any meaningful disruption during the first half of 2020. Through leveraging new technologies and virtual tools, our sales force has provided continual support to meet the needs of healthcare professionals and the patients they serve. As we navigate the current environment, we also remain focused on our long-term strategy. Our sustained momentum in achieving key pipeline and biosimilar development program milestones reflects our continued concentration in moving up the science spectrum and bringing to market difficult-to-develop and complex products. We are especially proud of the global biosimilars franchise we have built, as we are approaching $1 billion in expected cumulative biosimilar sales with 90% of this value coming from the last two years."

Mylan CFO Ken Parks added: "In the second quarter, Mylan once again generated strong cash flow taking first half 2020 adjusted free cash flow to $879 million, up 17% from the prior year. This strong cash flow allowed us to repay €500M of maturing debt during the quarter and to reduce leverage to 3.4 times, and marked significant progress toward our target of approximately $1 billion of 2020 debt repayments. Despite overall prevailing market uncertainty, we continue to expect full year adjusted free cash flow generation to be consistent with 2019 levels and remain fully committed to our investment grade credit rating."

RECENT DEVELOPMENTS

LEADERSHIP UPDATE

As previously shared as part of Mylan and Pfizer’s Upjohn business combination agreement on July 29, 2019, it was announced that Mylan CFO Ken Parks would depart Mylan upon closing of the pending transaction. Following his completion of the work required under his transition and succession agreement, and his acceptance of a CFO role at another publicly traded company, today Mylan announced that Ken Parks will depart effective September 1, 2020. As also announced in February 2020, Sanjeev Narula, current CFO of Pfizer’s Upjohn business will become CFO of Viatris once the new company launches, which is expected to occur in the fourth quarter of this year. Upon Mr. Parks’ transition, Paul Campbell, Controller and Chief Accounting Officer of Mylan, will lead Mylan’s global finance functions on an interim basis as he has done during previous transitions and pending the anticipated formation of Viatris.

Mylan Executive Chairman Robert J. Coury commented, "On behalf of Mylan’s Board of Directors, we would like to thank Ken for all his contributions and accomplishments during his tenure at Mylan. Ken has been a consummate professional and has completed all that was required as part of his transition agreement. We are delighted to wish him well in this next chapter of his career."

Mr. Parks said, "I am proud of what we have accomplished at Mylan, including further enhancing the strength and resiliency of our global platform – all while ensuring a robust financial profile that has enabled a foundation for future success. I wish the best for my Mylan colleagues and look forward to watching Mylan continue to build on this momentum as it works toward the formation of Viatris and beyond. I thank the leadership team and the Mylan Board of Directors for their support over the past four years."

MERIDIAN SUPPLY AGREEMENT

In connection with the Separation and Distribution Agreement, dated as of July 29, 2019, by and between Pfizer Inc. ("Pfizer") and Upjohn Inc. ("Upjohn") (as amended, the "Separation Agreement"), and the Business Combination Agreement, dated as of July 29, 2019, by and among Mylan, Pfizer, Upjohn and certain of their affiliates (as amended, the "Business Combination Agreement"), Pfizer, Upjohn and Mylan previously agreed to review and negotiate a potential transfer of Pfizer’s Meridian Medical Technologies business (the "Meridian Business") to Upjohn. The Meridian Business is Mylan’s supplier of EpiPen Auto-Injectors pursuant to an agreement that had an expiration date of December 31, 2020 (the "EpiPen Supply Agreement"). Instead of proceeding with the transfer of the Meridian Business, Pfizer and Mylan agreed subsequent to June 30, 2020 to extend the EpiPen Supply Agreement for an additional four-year period through December 31, 2024, with an option for Mylan (or Upjohn) to further extend the term for an additional one-year period thereafter.

Aethlon Medical Announces Collaboration with University of Pittsburgh on NIH Grant for Head and Neck Cancer

On August 6, 2020 Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic medical device and technology company focused on unmet needs in oncology and viral diseases reported that the National Institute for Dental and Craniofacial Research (NIDCR), a unit of the National Institutes for Health (NIH), has awarded a grant for studies in head and neck cancer that will be a collaborative project between Aethlon and the UPMC Hillman Cancer Center at the University of Pittsburgh (Press release, Aethlon Medical, AUG 6, 2020, View Source [SID1234563211]).

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The grant, entitled "Depleting exosomes to improve responses to immune therapy in head and neck squamous cell carcinoma" will profile the biomarkers of exosomes in patients with recurrent and metastatic head and neck cancer and will explore the impact of clinical depletion of exosomes using Aethlon’s proprietary Hemopurifier device. Exosomes are nanosized particles that are released in large quantities from cancer cells and carry the complement of a tumor’s genetic and protein cargo, which endows them with the capacity to fuel cancer growth and immune suppression. The Hemopurifier is being advanced as a potential therapeutic device for oncology by virtue of its capacity to capture and remove exosomes from plasma.

The total value of the award is $3.5 million over five years for multi-institution studies that will be led by Drs. Theresa Whiteside at UPMC and Annette Marleau at Aethlon as Principal Investigators. The funds will be primarily allocated to UPMC and two other participating academic institutions that will apply their expertise in immuno-oncology to programs that could accelerate the clinical advancement of the Hemopurifier.

"We are delighted to have the opportunity to work with Dr. Whiteside, a leading researcher in the area of tumor-derived exosomes, and the multidisciplinary team that has been assembled to evaluate the effects of exosomes in head and neck cancer," stated Timothy C. Rodell, M.D., CEO of Aethlon Medical. "Head and neck cancer continues to have a poor prognosis due to disease recurrence and the development of metastatic disease. We believe that the real value of this grant for Aethlon is that this work will provide insights into the potential clinical benefits of depleting circulating exosomes using the Hemopurifier for improving the responses of patients to the standard immunotherapy treatments."

"We are appreciative of the funding from NIDCR for this investigation of the roles of exosomes in head and neck cancer," stated Theresa Whiteside, Ph.D., Principal Investigator and Professor of Pathology, Immunology and Otolaryngology at UPMC. "Exosomes have emerged as major contributors to tumor-associated immune suppression and as significant barriers to cancer therapies. The overarching objective of this work will be to advance therapeutic capabilities and novel exosome-based predictive tools for head and neck cancer

I-Mab to Report Financial Results for the Six Months Ended June 30, 2020 and Provide Corporate Update on August 31, 2020

On August 6, 2020 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that it will report financial results for the six months ended June 30, 2020 before the market opens on Monday, August 31, 2020, and host a conference call to discuss the results and provide a corporate update at 8:00 a.m. ET (Press release, I-Mab Biopharma, AUG 6, 2020, View Source [SID1234563210]).

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Conference Call and Webcast Information

I-Mab will host a live conference call and webcast on August 31, 2020 at 8:00 a.m. ET. Participants must register in advance of the conference call. Details are as follows:

Registration Link:

View Source

Conference ID:

8959387

Upon registering, each participant will receive a dial-in number, Direct Event passcode, and a unique access PIN, which can be used to join the conference call.

A webcast replay will be archived on the Company’s website for one year after the conclusion of the call at View Source

A telephone replay will be available approximately two hours after the conclusion of the call. To access the replay, please call +1-855-452-5696 (U.S.), +61-2-8199-0299 (International), 400-632-2162 (Mainland China), or 800-963-117 (Hong Kong). The conference ID number for the replay is 8959387.

Protalix BioTherapeutics to Present at the BTIG Virtual Biotechnology Conference 2020

On August 6, 2020 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported that Dror Bashan, the Company’s President and Chief Executive Officer, and Eyal Rubin, the Company’s Sr. Vice President and Chief Financial Officer, will participate in the BTIG Virtual Biotechnology Conference (Press release, Protalix, AUG 6, 2020, View Source [SID1234563209]). The conference is taking place virtually on Monday, August 10 through Tuesday, August 11.

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Mr. Bashan will provide a corporate presentation in a fireside chat format on Monday, August 10 at 2:00 pm ET. A live webcast of the fireside chat will be available at www.protalix.com, on the event calendar page under the Investors tab and at the following link: View Source A replay of the webcast will be available for at least 15 days following the presentation.

BioLife Solutions Announces Second Quarter 2020 Financial Results

On August 6, 2020 BioLife Solutions, Inc. (NASDAQ: BLFS) ("BioLife" or the "Company"), a leading developer and supplier of a portfolio of class-defining bioproduction tools for cell and gene therapies, reported financial results for the three and six months ended June 30, 2020 (Press release, BioLife Solutions, AUG 6, 2020, View Source [SID1234563207]).

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Total revenue for the second quarter of 2020 was $9.9 million, a 48% increase over the second quarter of 2019. Revenue growth was driven by acquisitions completed in the second half of 2019. Revenue from biopreservation media accounted for approximately 67% of total revenue in the second quarter of 2020. Sales of BioLife’s ThawSTAR, evo and Custom Biogenic Systems (CBS) freezer products accounted for the balance of revenue and were in line with management’s reduced expectations given the effects of COVID-19.

Mike Rice, BioLife President & CEO, commented, "We continued to advance the business during the second quarter, achieving record revenue and further adoption of our media, thaw, evo cold chain and freezer platforms. In the first half of 2020, we gained 88 new customers across the product portfolio. Significant institutional investor interest resulted in our completion of an oversubscribed public stock offering just after the close of the quarter. BioLife is very well positioned for both organic and additional acquisition driven growth."

Key Accomplishments in the Second Quarter of 2020

Biopreservation media revenue of $6.7 million, representing 67% of total revenue. Media revenue decreased 23% from Q1 2020, during which several cell and gene therapy companies placed COVID-19-related safety stock orders. However, for the first half of 2020, media revenue increased 27% compared to the same period in 2019.
Gained 48 new customers including 14 using biopreservation media, 5 using ThawSTAR products, 6 using evo cold chain management solutions and 23 that placed initial orders for CBS freezers and related accessories.
Processed 14 new U.S. FDA Drug Master File cross-reference requests, indicating the planned use of CryoStor or HypoThermosol in human clinical trials of new cell or gene therapies. This brings the total U.S. FDA Drug Master File cross-reference requests to more than 400, including several requests that apply to potential therapies to treat COVID-19.
Confirmed that the evo cold chain management platform is now supporting more than 100 early stage cell and gene therapy clinical trials.
Closed a strategic capital investment by Casdin Capital for the purchase of $20 million of common stock.
Subsequent to the close of the quarter, raised gross proceeds of $86 million through an oversubscribed public offering of common stock.
Financial Highlights for the Second Quarter and Six Months Ended June 30, 2020

BioLife Solutions is presenting various financial metrics under U.S. Generally Accepted Accounting Principles (GAAP) and as adjusted (non-GAAP) to reflect acquisition-related activity. A reconciliation of GAAP to non-GAAP metrics appears at the end of this news release.

REVENUE

Total revenue for the second quarter of 2020 increased 48% to $9.9 million compared with $6.7 million for the second quarter of 2019.
Biopreservation media revenue of $6.7 million increased of 5% over the second quarter of 2019
Automated thawing product revenue of $376,000
evo cold chain management rental revenue of $439,000
CBS freezer and related accessories revenue of $2.4 million
Total revenue for the six months ended June 30, 2020 increased 77% to $22.1 million compared with $12.5 million for the first six months of 2019.
Biopreservation media revenue of $15.3 million increased 27% over the six months ended June 30, 2019
Automated thawing product revenue of $770,000
evo cold chain management rental revenue of $877,000
CBS freezer and related accessories revenue of $5.1 million
GROSS MARGIN

Gross margin (GAAP) for the second quarter of 2020 decreased to 48.7% from 69.4% in the second quarter of 2019. Adjusted gross margin (non-GAAP) for the second quarter of 2020 decreased to 56.6% from 72.2% in the second quarter of 2019.
Gross margin (GAAP) for the six months ended June 30, 2020 decreased to 53.7% from 70.4% for the same period in 2019. Adjusted gross margin (non-GAAP) for the six months ended June 30, 2020 decreased to 60.7% from 71.8% in the six months ended June 30, 2019.
The decline in 2020 second quarter and first half gross margin is due to product mix subsequent to acquisitions completed in the second half of 2019 having lower margins than the biopreservation media products and increases in manufacturing overhead.
OPERATING EXPENSE

Operating expenses (GAAP) for the second quarter of 2020 were $9.9 million compared with $6.0 million for the second quarter of 2019. Adjusted operating expenses (non-GAAP) for the second quarter of 2020 were $6.1 million compared with $3.8 million in the second quarter 2019.
Operating expenses (GAAP) for the six months ended June 30, 2020 were $21.7 million compared with $11.2 million for the same period in 2019. Adjusted operating expenses (non-GAAP) for the six months ended June 30, 2020 were $12.5 million compared with $7.2 million in the six months ended June 30, 2019.
The increase in 2020 second quarter and first half operating expenses is primarily due to acquisitions completed in the second half of 2019.
OPERATING INCOME/(LOSS)

Operating income (GAAP) for the second quarter of 2020 was $44,000 compared with $747,000 for the second quarter of 2019. Adjusted operating loss (non-GAAP) for the second quarter of 2020 was $510,000 compared with adjusted operating income of $993,000 in the second quarter of 2019.
Operating income (GAAP) for the six months ended June 30, 2020 was $414,000 compared with $1.3 million for the same period in 2019. Adjusted operating income (non-GAAP) for the six months ended June 30, 2020 was $906,000 compared with $1.8 million in the six months ended June 30, 2019.
NET INCOME/(LOSS)

Net loss (GAAP) for the second quarter of 2020 was $16.4 million compared with net income of $4.3 million for the second quarter of 2019. Net loss (GAAP) for the second quarter of 2020 included other expense of $16.4 million related to the change in fair value of warrants, and net income for the second quarter of 2019 included other income of $3.6 million related to the change in fair value of warrants. Adjusted net loss (non-GAAP) for the second quarter of 2020 was $492,000 compared with adjusted net income of $1.1 million in the second quarter of 2019.
Net income (GAAP) for the six months ended June 30, 2020 was $5.9 million compared with a net loss of $14.9 million for the same period in 2019. Net income (GAAP) for the six months ended June 30, 2020 included other income of $5.5 million related to the change in fair value of warrants, and net loss for the six months ended June 30, 2019 included other expense of $16.1 million related to the change in fair value of outstanding warrants. Adjusted net income (non-GAAP) for the six months ended June 30, 2020 was $952,000 compared with $2.1 million in the six months ended June 30, 2019.
EARNINGS/(LOSS) PER SHARE

Loss per share (GAAP) for the second quarter of 2020 was $0.70 compared with earnings per diluted share of $0.02 for the second quarter of 2019. Adjusted loss per share (non-GAAP) for the second quarter of 2020 was $0.01 compared with adjusted earnings per diluted share of $0.04 in the second quarter of 2019.
Earnings per diluted share (GAAP) for the six months ended June 30, 2020 was $0.01 compared with loss per share of $0.80 for the same period in 2019. Adjusted earnings per diluted share (non-GAAP) for the six months ended June 30, 2020 was $0.02 compared with $0.11 in the six months ended June 30, 2019.
EBITDA

EBITDA, a non-GAAP measure, for the second quarter of 2020 was negative $15.1 million compared with positive $4.3 million for the second quarter of 2019. Adjusted EBITDA for the second quarter of 2020 was positive $1.2 million compared with positive $1.9 million in the second quarter of 2019.
EBITDA, a non-GAAP measure, for the six months ended June 30, 2020 was positive $8.3 million compared with negative $14.9 million for the same period in 2019. Adjusted EBITDA for the six months ended June 30, 2020 was positive $4.1 million compared with positive $3.3 million in six months ended June 30, 2019.
CASH

Cash and cash equivalents as of June 30, 2020 were $29.9 million compared with $6.5 million as of December 31, 2019. The increase reflects a $20 million common share purchase agreement with Casdin Capital LLC during the second quarter.
Roderick de Greef, BioLife Chief Financial Officer and Chief Operating Officer, remarked, "With the $20 million raised from Casdin Capital and an additional $86 million raised in the July follow-on offering, we are well positioned to pursue additional strategic acquisitions to strengthen our portfolio of class-defining bioproduction tools for cell and gene therapies."

2020 Financial Guidance

Due to uncertainty regarding the impact of COVID-19 on BioLife and its customers, on May 1, 2020 the Company withdrew its financial guidance for 2020.

Conference Call & Webcast

Management will discuss the Company’s financial results and provide a general business update on a conference call and live webcast today at 4:30 p.m. ET (1:30 p.m. PT).

To access the webcast, log onto the Investor Relations page of the BioLife Solutions website at View Sourceearnings." target="_blank" title="View Sourceearnings." rel="nofollow">View Source Alternatively, you can access the live conference call by dialing 888-517-2485 with Conference ID 9675894. A webcast replay will be available approximately two hours after the call and will be archived on View Source for 90 days.