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BioLife Solutions Announces Third Quarter 2020 Financial Results

On November 5, 2020 BioLife Solutions, Inc. (NASDAQ: BLFS) ("BioLife" or the "Company"), a leading developer and supplier of a portfolio of class-defining bioproduction products and services for cell and gene therapies, reported financial results for the three and nine months ended September 30, 2020 (Press release, BioLife Solutions, NOV 5, 2020, View Source [SID1234570217]).

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Total revenue for the third quarter of 2020 was $11.3 million, a 71% increase over the third quarter of 2019. Revenue growth was driven by increased sales of the Company’s biopreservation media products and by acquisitions completed in the second half of 2019. Revenue from biopreservation media accounted for 66% of total revenue in the third quarter of 2020. Sales of the Company’s ThawSTAR, evo and Custom Biogenic Systems (CBS) freezer products accounted for the balance of revenue and were in line with management’s revised expectations based on the effects of COVID-19.

Mike Rice, BioLife President & CEO, commented, "The team delivered another solid quarter of execution and growth. We gained 56 new customers across the business. We also brought SciSafe into the Company via the acquisition that closed on October 1st. This addition strengthens our value proposition to cell and gene therapy developers. BioLife is configured for continued success as the cell and gene therapy market matures over the next several years."

Third Quarter 2020 and Recent Accomplishments

Entered into a purchase agreement with SciSafe Holdings, Inc., which became a wholly owned subsidiary of the Company on October 1, 2020. Management estimates that SciSafe will contribute revenue of at least $9 million in 2021.
Raised $86 million in gross proceeds through an oversubscribed follow-on public offering of 5,951,250 shares of common stock.
Booked biopreservation media revenue of $7.4 million, representing 66% of total revenue. Media revenue increased 22% compared with the same period in 2019.
Gained 56 new customers including 21 using biopreservation media, 7 using ThawSTAR products, 5 using evo cold chain management solutions and 23 placing initial orders for CBS freezers and related accessories.
Processed 22 new U.S. FDA Drug Master File cross-reference requests, indicating the planned use of CryoStor or HypoThermosol in pending cell and gene therapy clinical trials. To date, the Company’s biopreservation media products have been incorporated into more than 450 customer clinical applications, including several COVID-19 treatments or vaccines.
Financial Highlights for the Third Quarter and Nine Months Ended September 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 third quarter of 2020 increased 71% to $11.3 million compared with $6.6 million for the third quarter of 2019.
Biopreservation media revenue was $7.4 million, up 22% over the third quarter of 2019
Automated thawing product revenue was $277,000
evo cold chain management rental revenue was $494,000
CBS freezer and related accessories revenue was $3.1 million
Total revenue for the nine months ended September 30, 2020 increased 75% to $33.4 million compared with $19.1 million for the first nine months of 2019.
Biopreservation media revenue was $22.8 million, up 25% over the nine months ended September 30, 2019
Automated thawing product revenue was $1.0 million
evo cold chain management rental revenue was $1.4 million
CBS freezer and related accessories revenue was $8.2 million
GROSS MARGIN

Gross margin (GAAP) for the third quarter of 2020 was 52% compared with 64% for the third quarter of 2019, while adjusted gross margin (non-GAAP) for the third quarter of 2020 was 57% compared with 69% for the third quarter of 2019.
Gross margin (GAAP) for the nine months ended September 30, 2020 was decreased to 53% compared with 68% for the same period in 2019, while adjusted gross margin (non-GAAP) for the nine months ended September 30, 2020 was 60% compared with 71% for the nine months ended September 30, 2019.
The decline in 2020 third quarter and nine month gross margin was due to products acquired in the second half of 2019 having lower margins than biopreservation media products and to higher manufacturing overhead.
OPERATING EXPENSE

Operating expense (GAAP) for the third quarter of 2020 was $12.5 million compared with $7.4 million for the third quarter of 2019, while adjusted operating expense (non-GAAP) for the third quarter of 2020 was $6.8 million compared with $4.6 million for the third quarter 2019.
Operating expense (GAAP) for the nine months ended September 30, 2020 was $34.2 million compared with $18.5 million for the same period in 2019, while adjusted operating expense (non-GAAP) for the nine months ended September 30, 2020 was $19.3 million compared with $11.8 million for the nine months ended September 30, 2019.
The increase in 2020 third quarter and nine month operating expense was primarily due to acquisitions completed in the second half of 2019.
OPERATING INCOME/(LOSS)

Operating loss (GAAP) for the third quarter of 2020 was $1.2 million compared with $772,000 for the third quarter of 2019, while adjusted operating loss (non-GAAP) for the third quarter of 2020 was $359,000 compared with $68,000 for the third quarter of 2019.
Operating loss (GAAP) for the nine months ended September 30, 2020 was $832,000 compared with operating income of $541,000 for the same period in 2019, while adjusted operating income (non-GAAP) for the nine months ended September 30, 2020 was $547,000 compared with $1.7 million for the nine months ended September 30, 2019.
NET INCOME/(LOSS)

Net loss (GAAP) for the third quarter of 2020 was $1.1 million compared with net income of $10.3 million for the third quarter of 2019. Net loss (GAAP) for the third quarter of 2020 included other expense of $1.0 million related to the change in fair value of warrants and other income of $1.1 million related to change in fair value of investments. Net income for the third quarter of 2019 included other income of $1.1 million related to the change in fair value of warrants and other income of $10.1 million related to the gain on acquisition of SAVSU. Adjusted net loss (non-GAAP) for the third quarter of 2020 was $346,000 compared with adjusted net income of $41,000 for the third quarter of 2019.
Net income (GAAP) for the nine months ended September 30, 2020 was $4.8 million compared with a net loss of $4.6 million for the same period in 2019. Net income (GAAP) for the nine months ended September 30, 2020 included other income of $4.5 million related to the change in fair value of warrants, other income of $1.5 million related to the change in fair value of contingent consideration and other income of $1.1 million related to the change in fair value of investments. Net loss for the nine months ended September 30, 2019 included other expense of $15.0 million related to the change in fair value of outstanding warrants and other income of $10.1 million related to the gain on acquisition of SAVSU. Adjusted net income (non-GAAP) for the nine months ended September 30, 2020 was $606,000 compared with adjusted net income of $2.1 million for the nine months ended September 30, 2019.
EARNINGS/(LOSS) PER SHARE

Loss per diluted share (GAAP) for the third quarter of 2020 was $0.04 compared with earnings per diluted share of $0.35 for the third quarter of 2019. Adjusted loss per diluted share (non-GAAP) for the third quarter of 2020 was $0.02 compared with adjusted loss per diluted share of $0.02 for the third quarter of 2019.
Earnings per diluted share (GAAP) for the nine months ended September 30, 2020 was $0.01 compared with loss per diluted share of $0.24 for the same period in 2019. Adjusted earnings per diluted share (non-GAAP) for the nine months ended September 30, 2020 was $0.03 compared with adjusted earnings per diluted share of $0.11 for the nine months ended September 30, 2019.
EBITDA

EBITDA, a non-GAAP measure, for the third quarter of 2020 was $41,000 compared with $10.7 million for the third quarter of 2019, while adjusted EBITDA for the third quarter of 2020 was $1.7 million compared with $926,000 for the third quarter of 2019.
EBITDA, a non-GAAP measure, for the nine months ended September 30, 2020 was $8.3 million compared with negative $4.2 million for the same period in 2019, while adjusted EBITDA for the nine months ended September 30, 2020 was $5.8 million compared with $4.3 million for the nine months ended September 30, 2019.
CASH

Cash, cash equivalents and restricted cash as of September 30, 2020 were $109.0 million compared with $6.4 million as of December 31, 2019. The increase reflects a $20 million common share purchase agreement with Casdin Capital LLC during the second quarter of 2020 and an $86 million capital raise in the third quarter of 2020.
Roderick de Greef, BioLife Chief Financial Officer and Chief Operating Officer, remarked, "We continue to execute well on our acquisition and integration strategy. Although we have seen a slightly negative impact on capital equipment product revenue due to COVID-19 restrictions on in-person sales meetings, our media business has consistently grown throughout 2020, increasing 25% for the first nine months of 2020 compared to the same period in 2019. We now have an even more robust offering with our acquisition of SciSafe, which closed on October 1, 2020."

2020 Financial Guidance

Due to uncertainty regarding the impact of the COVID-19 pandemic 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 (844) 825-0512 with Conference ID 1296883. A webcast replay will be available approximately two hours after the call ends and will be archived on View Source for 90 days.

Inhibrx Announces Participation in Upcoming Investor and Scientific Conferences

On November 5, 2020 Inhibrx, Inc. (Nasdaq: INBX), a clinical-stage biotechnology company focused on developing a broad pipeline of novel biologic therapeutic candidates, reported that the Company will be presenting at the following upcoming virtual investor and scientific conferences (Press release, Inhibrx, NOV 5, 2020, View Source [SID1234570216]):

The 29th Annual Credit Suisse Virtual Healthcare Conference; Thursday, November 12th at 3:30 p.m. Eastern Time;

Jefferies Virtual London Healthcare Conference; Tuesday, November 17th at 2:10 p.m. Eastern Time;
CTOS 2020 Virtual Annual Meeting; Friday, November 20th at 9:00 a.m. Eastern Time; and

Evercore’s Annual Conference; Thursday, December 3rd at 3:30 p.m. Eastern Time
Each investor conference presentation will be webcast live and may be accessed through a link on the investors section of Inhibrx’s website at View Source The webcasts will be available for 60 days following the events.

Avidity Biosciences to Present at the Credit Suisse 29th Annual Virtual Healthcare Conference 2020

On November 5, 2020 Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company pioneering a new class of oligonucleotide-based therapies called Antibody Oligonucleotide Conjugates (AOCs), reported that Sarah Boyce, President and Chief Executive Officer, will be presenting at the Credit Suisse 29th Annual Virtual Healthcare Conference 2020 on Thursday, November 12th, 2020 at 8:45am PST (Press release, Avidity Biosciences, NOV 5, 2020, View Source [SID1234570215]). The conference is being held in a virtual format.

A live webcast of the virtual fireside chat will be available on the Company’s website at www.aviditybiosciences.com in the Investor Resources section. A replay of the fireside presentation will be archived on the site for one year.

Mettler-Toledo International Inc. Reports Third Quarter 2020 Results

On November 5, 2020 Mettler-Toledo International Inc. (NYSE: MTD) reported third quarter results for 2020 (Press release, Mettler-Toledo, NOV 5, 2020, View Source [SID1234570214]). Provided below are the highlights:

Reported sales increased 7% compared with the prior year. In local currency, sales increased 6% in the quarter as currency benefited reported sales growth by 1%.
Net earnings per diluted share as reported (EPS) were $6.68, compared with $5.20 in the prior-year period. Adjusted EPS was $7.02, an increase of 22% over the prior-year amount of $5.77. Adjusted EPS is a non-GAAP measure, and a reconciliation to EPS is included on the last page of the attached schedules.
Quarterly Results

Olivier Filliol, President and Chief Executive Officer, stated, "Outstanding growth in China and strong growth in our Laboratory business resulted in excellent performance in the quarter despite negative impacts on our business from COVID-19. Our strong product portfolio combined with innovative sales and marketing strategies are yielding very good results despite the overall challenging environment. With the benefit of our temporary cost initiatives as well as ongoing margin and productivity initiatives, we had a strong increase in Adjusted Operating Profit margins and excellent growth in Adjusted EPS. Finally, cash flow generation was also very robust."

GAAP Results

EPS in the quarter was $6.68, compared with the prior-year amount of $5.20.

Compared with the prior year, total reported sales increased 7% to $807.4 million. By region, reported sales increased 2% in the Americas, 9% in Europe and 11% in Asia/Rest of World. Earnings before taxes amounted to $205.8 million, compared with $169.4 million in the prior year.

Non-GAAP Results

Adjusted EPS was $7.02, an increase of 22% over the prior-year amount of $5.77.

Compared with the prior year, total sales in local currency increased 6% as currency benefited sales growth by 1%. By region, local currency sales increased 3% in the Americas, 4% in Europe and 10% in Asia/Rest of World. Adjusted Operating Profit amounted to $230.0 million, a 17% increase from the prior-year amount of $196.2 million.

Adjusted EPS and Adjusted Operating Profit are non-GAAP measures. Reconciliations to the most comparable GAAP measures are provided in the attached schedules.

Year-to-Date Results

GAAP Results

EPS was $15.92, compared with the prior-year amount of $14.67.

Compared with the prior year, total reported sales decreased 1% to $2.147 billion. By region, reported sales decreased 1% in the Americas and 1% in Europe and was constant in Asia/Rest of World. Earnings before taxes amounted to $479.6 million, compared with $450.3 million in the prior year.

Non-GAAP Results

Adjusted EPS was $16.30, compared with the prior-year amount of $15.02.

Compared with the prior year, total sales in local currency was constant as currency reduced reported sales by 1%. By region, local currency sales decreased 1% in the Americas and 2% in Europe and increased 1% in Asia/Rest of World. Adjusted Operating Profit amounted to $547.9 million, a 5% increase from the prior-year amount of $521.8 million.

Adjusted EPS and Adjusted Operating Profit are non-GAAP measures. Reconciliations to the most comparable GAAP measures are provided in the attached schedules.

Share Repurchase Authorization

The Company has $0.9 billion remaining under the current authorization for the share repurchase program. The Company announced that the Board of Directors authorized an additional $2.5 billion to the share repurchase program. Any amount remaining under the existing program will be incorporated into the new authorization. Filliol commented, "The additional authorization allows us to continue the share repurchase program, which has provided strong returns for our shareholders over many years. We are confident in our future growth prospects, and our balance sheet and cash flow generation remain very strong." The Company expects the additional authorization will be utilized over the next several years. The Company added that the repurchases will be made through open market transactions, and the amount and timing will depend on business and market conditions, stock price, trading restrictions, the level of acquisition activity and other factors.

Outlook

The Company stated that forecasting continues to be challenging given the significant uncertainty surrounding COVID-19 and ensuing impact to the global economic environment. While the Company is providing an estimate for sales growth and Adjusted EPS for 2020 and 2021, management cautions that market dynamics and impacts related to COVID-19 are fluid and changes to the business environment can happen quickly. The estimates include significant uncertainty and management acknowledges that market conditions are subject to change.

Based on today’s assessment of market conditions, management anticipates the local currency sales growth in the fourth quarter 2020 will be in the range of 4% to 5%, and Adjusted EPS is forecasted to be in the range of $8.60 to $8.70, an increase of 11% to 12%.

For the full year 2020, local currency sales growth is expected to be approximately 1% and Adjusted EPS is forecasted to be $24.87 to $24.97, a growth rate of 9% to 10%. This compares with previous guidance for Adjusted EPS of $22.70 to $23.20.

The Company said that based on its assessment of market conditions today, management anticipates local currency sales growth in 2021 to be in the range of 4% to 6%. This sales growth is expected to result in Adjusted EPS in the range of $27.50 to $28.30. Using the mid-point of 2020 guidance, this would result in Adjusted EPS growth of 10% to 14%.

While the Company has provided an outlook for local currency sales growth and Adjusted EPS, it has not provided an outlook for reported sales growth or EPS as it would require an estimate of currency exchange fluctuations and non-recurring items, which are not yet known.

Conclusion

Filliol concluded, "The regional dynamics surrounding COVID-19 continue to change rapidly and the outlook for the global economy remains uncertain. We remain focused on factors we can control, namely ensuring the safety of our employees while serving our customers, the majority of which are in essential end markets including life sciences and food manufacturing. We continue to launch leading-edge instruments and services and have adapted our innovative digital sales and marketing approaches to ensure our go-to-market approach is highly effective given current market conditions. As we look to the remainder of 2020 and to 2021, we believe we will continue to gain share and deliver solid results. We will remain agile and adapt as necessary to changes in market conditions."

Other Matters

The Company will host a conference call to discuss its quarterly results today (Thursday, Nov 5) at 5:00 p.m. Eastern Time. To hear a live webcast or replay of the call, visit the investor relations page on the Company’s website at www.mt.com/investors. The presentation referenced in the conference call will be located on the website prior to the call.

New Drug for Gastrointestinal Stromal Tumours (GIST) to be Launched in Australia, New Zealand and South East Asia Following Distribution Agreement

On November 5, 2020 Specialised Therapeutics Asia reported A NEW therapy to treat advanced gastrointestinal stromal tumours (GIST) will be available to patients in Australia, New Zealand and in some parts of South East Asia, following an exclusive distribution agreement (Press release, Specialised Therapeutics Asia, NOV 5, 2020, View Source [SID1234570212]).

Independent pharmaceutical company Specialised Therapeutics Asia (STA) has signed an agreement with US-based Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH) to commercialise the switch-control tyrosine kinase inhibitor QINLOCK (ripretinib) in key regions, including Australia, New Zealand, Singapore, Malaysia and Brunei.

The therapy was one of the first approved by Australia’s Therapeutic Goods Administration (TGA) earlier this year under Project Orbis, which enables concurrent review of oncology products by international regulators, including the TGA, FDA and Health Canada.

It is indicated "for the treatment of adult patients with advanced gastrointestinal stromal tumours (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib".

QINLOCK has also been approved by the US Food and Drug Administration (FDA) and Health Canada (HC) for the fourth-line treatment of GIST.

The TGA approval was based on efficacy results from the pivotal global Phase 3 INVICTUS study in patients with advanced GIST as well as combined safety results from INVICTUS and the Phase 1 study of QINLOCK. In INVICTUS, QINLOCK demonstrated a median progression-free survival of 6.3 months compared to 1.0 month in the placebo arm and significantly reduced the risk of disease progression or death by 85% (hazard ratio of 0.15; 95% CI 0.09-0.25; p<0.0001). In addition, QINLOCK demonstrated a median overall survival of 15.1 months compared to 6.6 months in the placebo arm and reduced the risk of death by 64% (hazard ratio of 0.36; 95% CI 0.21-0.62).[1]

One of the INVICTUS study authors, Professor John Zalcberg who holds the Tony Charlton Chair of Oncology and is Head of the Cancer Research Program in the School of Public Health at Monash University as well as a consultant medical oncologist at Alfred Health, described QINLOCK as an important new agent in the GIST treatment armamentarium, noting it was the first TGA approved fourth-line therapy to treat the disease.

"QINLOCK represents another step forward to improve outcomes for patients who are affected by this rare cancer," Professor Zalcberg said.

"This is an area of high unmet need because of the poor prognosis of patients whose tumours continue to grow on prior treatment.

"We are further encouraged by data demonstrating that QINLOCK is well-tolerated, with patient-reported outcomes (PROs) suggesting that patients who received QINLOCK therapy in the INVICTUS study were able to maintain their quality of life in contrast to the fact that quality of life deteriorated in patients not receiving QINLOCK."

STA Chief Executive Officer Carlo Montagner said QINLOCK would bolster the company’s already-robust oncology portfolio, and was synergistic with its mission to address areas of unmet clinical need.

"We are thrilled to introduce this valuable therapy to patients with GIST in our region, working in collaboration with our new international partner, Deciphera Pharmaceuticals," Mr Montagner said.

"STA will expedite access to this important medicine, with a Patient Access Program to open in Q1 2021. This will provide subsidised access for appropriate patients at the earliest opportunity, as we file for additional regulatory approvals in other key markets, including New Zealand, Singapore and Malaysia."

Deciphera President and Chief Executive Officer Mr Steve Hoerter commented: "We are committed to ensuring QINLOCK’s global commercial availability and are proud to be executing on our plan to deliver this important medicine to patients with advanced GIST worldwide.

"We look forward to collaborating with STA as we bring a much-needed therapeutic option to patients living in locations where we do not anticipate setting up our own commercial activities near term."

A submission to have QINLOCK reimbursed for eligible Australian patients has been lodged with the Pharmaceutical Benefits Advisory Committee in November for consideration at the March 2021 meeting. If successful, QINLOCK could be reimbursed for Australian patients in the latter half of 2021.