West Announces Fourth-Quarter and Full-Year 2020 Results

On February 18, 2021 West Pharmaceutical Services, Inc. (NYSE: WST) reported its financial results for the fourth-quarter, full-year 2020 and introduced full-year 2021 financial guidance (Press release, West Pharmaceutical Services, FEB 18, 2021, View Source [SID1234575253]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Fourth-Quarter and Full-Year 2020 Summary (comparisons to prior-year period)

Fourth-quarter 2020 net sales of $580.2 million grew 23.3%; organic sales growth was 19.8%. Full-year 2020 net sales of $2.147 billion grew 16.7%; organic sales growth was 16.3%.
Fourth-quarter 2020 reported-diluted EPS of $1.29 increased 53.6%. Full-year 2020 reported-diluted EPS of $4.57 increased 42.4%.
Fourth-quarter 2020 adjusted-diluted EPS of $1.34 increased 63.4%. Full-year 2020 adjusted-diluted EPS of $4.76 increased 46.9%.
Company is introducing full-year 2021 financial guidance of net sales in a range of $2.500 billion to $2.525 billion and reported-diluted EPS in a range of $6.00 to $6.15.
"Adjusted-diluted EPS" and "organic sales growth" are Non-U.S. GAAP measurements. See discussion under the heading "Non-U.S. GAAP Financial Measures" in this release.

"We had a successful 2020 with tremendous execution, dedication and resiliency of our team and, most importantly, the trust of our customers across the globe. I am proud that we finished the year with record full-year net sales, organic sales growth and operating profit margin. Fourth quarter results were robust, led by strong growth in our Biologics and Generics market units. In addition, we experienced an acceleration in COVID-19-associated sales of high-value product (HVP) components used for vaccines and therapeutics," said Eric M. Green, President and Chief Executive Officer.

Mr. Green concluded, "As we look ahead, we believe there is strong momentum in our base business and uptake of our HVP components and devices. We will continue to operate with excellence and a sense of urgency to maintain the supply of life-saving solutions that our customers, and ultimately patients, rely upon during these challenging times."

Proprietary Products Segment
In the fourth-quarter 2020, net sales grew by 28.7% to $454.1 million. Organic sales growth was 25.1%, with currency translation increasing sales growth by 360 basis points. HVP components and devices represented over 65% of segment sales and generated double-digit organic sales growth.

Our Biologics market unit had strong double-digit organic sales growth, led by Flurotec, Westar, Daikyo and NovaPure components. Our Generics market unit posted double-digit organic sales growth, led by Flurotec and Westar components. Our Pharma market unit had low single-digit organic sales growth, led by Westar and Flurotec components and Crystal Zenith containers.

In the full-year 2020, net sales grew 17.9% to $1.649 billion. Organic sales growth was 17.6%, with currency translation increasing sales growth by 20 basis points. HVP components and devices represented 66% of segment sales and generated double-digit organic sales growth.

Contract-Manufactured Products Segment
In the fourth-quarter 2020, net sales grew by 7.0% to $126.1 million. Organic sales growth was 4.1%, with currency translation increasing sales growth by 290 basis points. Segment performance was led by strong sales of healthcare-related injection and diagnostic devices.

In the full-year 2020, net sales grew by 12.9% to $498.6 million. Organic sales growth was 12.1%, with currency translation increasing sales growth by 80 basis points.

Full-Year 2020 Financial Highlights
Operating cash flow was $472.5 million, an increase of 28.7%. Capital expenditures were $174.4 million. Free cash flow (operating cash flow minus capital expenditures) was $298.1 million, an increase of 23.8%.

Full-Year 2021 Financial Guidance
Full-year 2021 net sales are expected to be in a range of $2.500 billion to $2.525 billion.

Organic sales growth is expected to be in a range of 13% to 14%.
Net sales guidance includes an estimated full-year 2021 benefit of $75 million based on current foreign exchange rates.
Full-year 2021 reported-diluted EPS is expected to be in a range of $6.00 to $6.15.
Full-year reported-diluted EPS guidance range includes an estimated benefit of approximately $0.23 based on current foreign currency exchange rates.
This reported-diluted EPS guidance range assumes a full-year 2021 tax rate of 23%, which does not include potential tax benefits from stock-based compensation. As in prior years, we are not including potential 2021 tax benefits from stock-based compensation, as they are out of the Company’s control. Any tax benefits associated with stock-based compensation that we receive in 2021 would provide a positive adjustment to our full-year EPS guidance.
Full-year 2021 capital spending is expected to be in a range of $230 million to $240 million. This includes incremental capital spending to support capacity expansions at existing HVP facilities to produce components to be used with treatments and vaccines related to COVID-19.
Fourth-Quarter 2020 Conference Call
The Company will host a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time today. To participate on the call please dial 877-930-8295 (U.S.) or 253-336-8738 (International). The conference ID is 4095168.

A live broadcast of the conference call will be available at the Company’s website, www.westpharma.com, in the "Investors" section. Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select "Presentations" in the "Investors" section of the Company’s website.

An online archive of the broadcast will be available at the website three hours after the live call and will be available through Thursday, February 25, 2021, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International) and entering conference ID 4095168.

Year-end Report 2020: Scandion Oncology is poised for the future

On February 18, 2021 Scandion Oncology A/S ("Scandion Oncology" or "the Company") reported the Year-end Report for the period 1 January – 31 December 2020 (Press release, Scandion Oncology, FEB 18, 2021, View Source;scandion-oncology-is-poised-for-the-future,c3288509 [SID1234575252]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Bo Rode Hansen, President & CEO, Scandion Oncology A/S comments:

"2020 was undoubtedly a historic year of change in the name of COVID-19 and we all had to accept and adapt to the situation. For Scandion Oncology’s part, we managed to navigate through the crisis in the best possible way, and I can ultimately summarize 2020 as coming out strong for the Company.

The Company had 4 major goals for 2020:

Initiation of two clinical trials with our lead compound, SCO-101
Strengthen and internationalize executive management in the Company
Secure financing for our two planned efficacy studies with SCO-101
Change listing from Spotlight to Nasdaq First North, Stockholm
I am pleased to say that we achieved all of them. We are thus better positioned in terms of organization, pipeline, finances, and our international footprint in our journey to become the cancer drug resistance company.

We are looking at 2021 and the upcoming important milestones with conviction and to ensure a dedicated focus to our clinical activities, we have used the first month of the year updating Scandion Oncology’s strategy and to prioritize our activities within oncology."

Reporting period October 2020 – December 2020

Net sales amounted to DKK 0 (0)

Operating profit was DKK -9.2 m (-1.2)
Cash position amounted to DKK 5.8* m (15.4)
Earnings per share was DKK -0.24 (-0.01)
* Cash position is increased in January 2021 by the net proceeds of the Rights Issue
in 2020 amounting to DKK 145.9 million.

Reporting period January 2020 – December 2020

Net sales amounted to DKK 0 (0)

Operating profit was DKK -22.9 m (-15.4)
Earnings per share was DKK -0.83 (-0.81)
Equity ratio was 84% (92%)
Highlights during Q4 2020

ON OCTOBER 7, Scandion Oncology announced modified timelines for the clinical Phase II colorectal cancer study (CORIST) and the Phase Ib study for pancreatic cancer (PANTAX). The updated timeline came as a result of the spread of COVID-19.

ON OCTOBER 28, Scandion Oncology announced that its second clinical study with SCO-101 had been initiated. The Phase Ib study (PANTAX) enrolls metastatic pancreatic cancer patients who will receive SCO-101 together with 1st line standard chemotherapy (Nab-paclitaxel plus gemcitabine) in cohorts of three. The endpoints of this study are safety and efficacy.
ON DECEMBER 15, Scandion Oncology announced the result of its Rights Issue, which provided the Company with proceeds amounting to approximately SEK 236 million before issue costs.
Highlights after the end of the period

ON JANUARY 19, Scandion Oncology announced that the Company had applied for and received approval for admission to trading on Nasdaq First North Growth Market Sweden. The first day of trading on Nasdaq First North was February 3, 2021.

ON JANUARY 23, Scandion Oncology announced that the Company had completed the first 12 patient cohort in the ongoing dose-range finding part of the clinical Phase II study (CORIST) with SCO-101 in combination with chemotherapy (FOLFIRI) in patients with drug resistant metastatic colorectal cancer. The Company received the green light from the Data Safety Monitoring Board to move forwardwith the next treatment cohorts.
ON JANUARY 28, Scandion Oncology announced that the Company had submitted an amendment to the Danish Medicines Agency regarding the PANTAX study. The amendment is based on the learnings obtained from treating the first 12 patients in the CORIST study and will contribute to an optimization of the PANTAX clinical trials. The processing time for the amendment is expected to be approximately four weeks, which on top of the current impact of the COVID-19 pandemic could delay the planned readout from the study into Q4 2021.

The Year-end Report is available on the Company’s website: www.scandiononcology.com.

Live webcast tomorrow, February 19 at 10:00 am CET

Scandion Oncology A/S will be hosting a live webcast on February 19 at 10:00 – 10:30 CET to present results for 2020 followed by a Q&A session. Participants will be President & CEO, Bo Rode Hansen and CFO, Carit Jacques Andersen. Link to the webcast is Scandion Oncology Year-end 2020 webcast.

This information is information that Scandion Oncology A/S is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on February 18, 2021 CET on 8:30.

Molecular Templates, Inc. Announces Pricing of $75.9 Million Public Equity Offering

On February 18, 2021 Molecular Templates, Inc. (Nasdaq: MTEM) (the "Company" or "Molecular"), a clinical-stage biopharmaceutical company focused on the discovery and development of the Company’s proprietary engineered toxin bodies (ETBs), which are differentiated, targeted, biologic therapeutics for cancer, reported the pricing of its underwritten public offering of 6,000,000 shares of its common stock at a public offering price of $12.65 per share (Press release, Molecular Templates, FEB 18, 2021, View Source [SID1234575251]). All of the shares of common stock to be sold in the offering are being sold by Molecular. In addition, Molecular has granted to the underwriters a 30-day option to purchase up to 900,000 additional shares of common stock. The offering is expected to close on or about February 22, 2021, subject to the satisfaction of customary closing conditions. The gross proceeds to Molecular from the offering, before deducting the underwriting discounts and commissions and estimated offering expenses payable by Molecular, are expected to be $75.9 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Molecular intends to use the net proceeds from the offering, together with its existing cash and cash equivalents, to fund: its Phase II clinical studies for MT-3724 and/or development of other CD20-targeted molecules; its ongoing Phase I clinical study of MT-5111; its share of development expenses in its CD38 collaboration with Takeda; its PD-L1 program (including its anticipated upcoming Phase I clinical study for MT-6402); further preclinical development and drug discovery activities in its other programs; and for working capital and general corporate purposes.

BofA Securities, Cowen, Evercore ISI and Barclays are acting as joint book-running managers for the offering.

The securities are being offered by Molecular pursuant to a shelf registration statement on Form S-3 that was previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC. A preliminary prospectus supplement relating to the offering was filed with the SEC and a final prospectus supplement relating to the offering will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus relating to these securities may be obtained from BofA Securities, Inc., c/o BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or via e-mail at [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or via telephone at (833) 297-2926; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, via telephone at (888) 474-0200, or via e-mail at [email protected]; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, via telephone at (888) 603-5847, or via e-mail at [email protected][email protected]. You may also obtain these documents free of charge by visiting the SEC’s website at www.sec.gov.

This press release does not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities, in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

Kura Oncology to Participate in Four Upcoming Investor Conferences

On February 18, 2021 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that Troy Wilson, Ph.D., J.D., President and Chief Executive officer is scheduled to participate in four upcoming virtual investor conferences (Press release, Kura Oncology, FEB 18, 2021, View Source [SID1234575250]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A fireside chat at the SVB Leerink 10th Annual Global Healthcare Conference at 2:20 p.m. ET / 11:20 a.m. PT on February 25, 2021;

A leukemias panel discussion at the Cowen 41st Annual Health Care Conference at 11:40 a.m. ET / 8:40 a.m. PT on March 3, 2021;

A pre-recorded fireside chat at the H.C Wainwright Global Life Sciences Conference available on-demand starting at 7:00 a.m. ET / 4:00 a.m. PT on March 9, 2021; and

A company presentation at the Barclays Virtual Global Healthcare Conference on March 10, 2021 at 4:10 p.m. ET / 1:10 p.m. PT.
Live audio webcasts of the SVB Leerink and Barclays events will be available in the Investors section of Kura’s website at www.kuraoncology.com, with archived replays available for 30 days following the events.

Aurinia Pharmaceuticals to Present at the SVB Leerink 10th Annual Global Healthcare Conference

On February 18, 2021 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the "Company") reported that members of the executive management team will participate in a fireside chat at the (virtual) SVB Leerink 10th Annual Global Healthcare Conference on Thursday, February 25, 2021 at 1:00 p.m. ET (Press release, Aurinia Pharmaceuticals, FEB 18, 2021, View Source [SID1234575248]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In order to participate in the audio webcast, interested parties can access the live webcast under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.