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Alligator Bioscience AB (publ): Interim report January-September 2020

On October 22, 2020 Alligator Bioscience reported that (Press release, Alligator Bioscience, OCT 22, 2020, View Source [SID1234568887])

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Encouraging clinical safety data for ATOR-1017

The Phase I study with ATOR-1017 has progressed exceptionally well and in August we presented interim data that showed a good safety profile at clinically relevant dose levels. The dose evaluation will continue with yet higher doses and we expect to present safety and potentially efficacy data from the entire study in the spring of 2021. At the same time, we have shown strong Proof of Mechanism data for mitazalimab, while the ATOR-1015 program reported side effects at high dose levels.The nature of the reactions have lead to a need to re-design the planned clinical trial in malignant melanoma and to perform additional preclinical investigations. We will now focus our clinical investments to ATOR-1017 and mitazalimab. Both programs have first-in-class potential, and will move into clinical Phase II during 2021", commented CEO Per Norlén.

SIGNIFICANT EVENTS JULY – SEPTEMBER

Mitazalimab:

Positive biomarker data demonstrating Proof of Mechanism in clinical Phase I study performed by Janssen.
Clinical development program defined. The CTA for the upcoming Phase II study in pancreatic cancer is scheduled to be submitted in December 2020.
ATOR-1015:

Revised plan due to further evaluation of doses and adverse reactions, leading to delay of Phase Ib.
US composition of matter patent granted.
ATOR-1017:

Encouraging emerging safety data at clinically relevant dose levels in the ongoing Phase I study.
Preclinical:

Neo-X-Prime: New unique drug concept for tumorspecific treatment launched at 11th World Bispecific Summit.
Other:

Gayle Mills appointed Chief Business Officer.
SIGNIFICANT EVENTS AFTER THE END OF THE PERIOD

Clinical focus on ATOR-1017 and mitazalimab:

Preparations to bring ATOR-1017 and mitazalimab to Phase II efficacy studies in 2021.
ATOR-1015: A partner will be sought for further clinical studies.
FINANCIAL SUMMARY

July-September 2020

Net sales, SEK 0.0 million (4.3).
Operating result, SEK -30.6 million (-58.5).
Result for the period, SEK -30.8 million (-56.6).
Earnings per share before and after dilution, SEK -0.43 (-0.79).
Cash flow for the period, SEK -32.7 million (-47.3).
Cash and cash equivalents, incl. interest-bearing securities, SEK 137.0 million (302.2)
January-September 2020

Net sales, SEK 4.4 million (4.4).
Operating result, SEK -110.2 million (-155.2).
Result for the period, SEK -108.8 million (-150.3).
Earnings per share before and after dilution, SEK-1.52 (-2.11).
Cash flow for the period, SEK 42.6 million (-27.8).
During the first quarter, the holdings in corporate bonds and interest funds were divested, which had a positive effect on cash flow.

Read the complete report in the pdf below.

Alligator will host a conference call today at 2:00 p.m. CEST for investors, analysts and media, where CEO Per Norlén will present and comment on the Q3 interim report and the focus of the clinical operations. The conference will be held in English. All necessary information to listen-in and ask questions are available on the following link: View Source

West Announces Third-Quarter 2020 Results

On October 22, 2020 West Pharmaceutical Services, Inc. (NYSE: WST) reported its financial results for the third-quarter 2020 and updated full-year 2020 financial guidance (Press release, West Pharmaceutical Services, OCT 22, 2020, View Source [SID1234568886]).

Third-Quarter 2020 Summary (comparisons to prior-year period)

Net sales of $548.0 million grew 20.1%; organic sales growth was 18.2%.
Reported-diluted EPS of $1.09 increased 45%.
Adjusted-diluted EPS of $1.15 increased 46%.
Company is raising full-year 2020 net sales guidance to a new range of $2.10 billion and $2.11 billion.
Company is raising full-year 2020 adjusted-diluted EPS guidance to a new range of $4.50 and $4.55.
"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.

"Third-quarter results were robust across the entire business, led by High-Value Products (HVP) and Biologics. Additionally, we benefited from incremental sales related to the COVID-19 pandemic including components used with treatments and supporting therapies as well as potential vaccines currently in clinical trials," said Eric M. Green, President and Chief Executive Officer. "I am proud of our team members for their relentless passion and sense of urgency to help our customers and the patients we jointly serve. Continued excellence in executing our market-led strategy and our global operations position us well for the remainder of the year and into 2021."

Proprietary Products Segment
Net sales grew by 22.1% to $421.5 million. Organic sales growth was 20.3%, with currency translation increasing sales growth by 180 basis points. HVP components 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, Daikyo and NovaPure film-coated components, as well as Westar and Envision components. Our Generics market unit posted high single-digit organic sales growth, and our Pharma market unit grew organic sales by mid-single digits. Both Generics and Pharma market units were led by sales of film-coated and Westar components.

Contract-Manufactured Products Segment
Net sales grew by 14.0% to $126.6 million. Organic sales growth was 11.7% with currency translation increasing sales growth by 230 basis points. Segment performance was led by strong sales of healthcare-related injection and diagnostic devices.

Financial Highlights (first nine months of 2020)
Operating cash flow was $323.8 million, an increase of 24.2%. Capital expenditures were $116.7 million. Free cash flow (operating cash flow minus capital expenditures) was $207.1 million, an increase of 20.4%.

Full-Year 2020 Financial Guidance
Full-year 2020 net sales guidance is expected to be in a range of $2.10 billion and $2.11 billion, compared to a prior range of $2.035 billion and $2.055 billion.

Organic sales growth is expected to be approximately 14% to 15%, compared to a prior guidance of 12%.
Net sales guidance includes an estimated full-year headwind of $4 million for the full-year 2020 based on current foreign exchange rates, compared to prior guidance of a headwind of $26 million.
Full-year 2020 adjusted-diluted EPS is expected to be in a range of $4.50 and $4.55, compared to a prior range of $4.15 and $4.25.
Full-year adjusted-diluted EPS guidance includes an estimated headwind of approximately $0.02 based on current foreign currency exchange rates, compared to prior guidance of a headwind of $0.07.
The revised guidance includes an $0.18 EPS impact from tax benefits from stock-based compensation in the first nine months of 2020.
For the remainder of the year, our EPS guidance range assumes a tax rate of 24% and does not include potential tax benefits from stock-based compensation. Any tax benefits associated with stock-based compensation beyond those recorded in the first nine months of 2020 would provide a positive adjustment to our full-year EPS guidance.
Third-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 7564183.

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, October 29, 2020, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International) and entering conference ID 7564183.

Danaher Reports Third Quarter 2020 Results

On October 22, 2020 Danaher Corporation (NYSE: DHR) (the "Company") reported results for the quarter ended October 2, 2020 (Press release, Danaher, OCT 22, 2020, View Source [SID1234568885]). All results in this release reflect only continuing operations unless otherwise noted.

For the third quarter 2020, net earnings were $883.5 million, or $1.16 per diluted common share which represents a 38.0% year-over-year increase from the comparable 2019 period.

Non-GAAP adjusted diluted net earnings per common share were $1.72 which represents a 62.0% increase over the comparable 2019 period. Revenues increased 34.5% year-over-year to $5.9 billion, with 14.0% non-GAAP core revenue growth including Cytiva.

Operating cash flow for the third quarter 2020 was $1.7 billion, representing a 93.0% increase year-over-year, and non-GAAP free cash flow was $1.5 billion, representing a 110.0% increase year-over-year.

For the fourth quarter 2020 the Company anticipates that non-GAAP core revenue growth including Cytiva will be in the low-double digit range.

Rainer M. Blair, President and Chief Executive Officer, stated, "We delivered outstanding third quarter results, achieving double-digit revenue growth, over 60% adjusted EPS growth, and we more than doubled our free cash flow year-over-year. Since the onset of the COVID-19 pandemic, our team has turned unprecedented challenges into impactful opportunities to support our customers and the global community, and we’re proud to play a pivotal role in tackling COVID-19 head-on."

Blair continued, "Our performance is a testament to our associates’ dedication, as they stay focused on executing for our customers during the pandemic. With the Danaher Business System as our driving force and the powerful combination of our innovative team, strong portfolio of businesses, and solid balance sheet, we believe Danaher will continue to outperform well into the future."

Danaher will discuss its results during its quarterly investor conference call on October 22, 2020 starting at 8:00 a.m. ET. The call and an accompanying slide presentation will be webcast on the "Investors" section of Danaher’s website, www.danaher.com, under the subheading "Events & Presentations." A replay of the webcast will be available in the same section of Danaher’s website shortly after the conclusion of the presentation and will remain available until the next quarterly earnings call.

The conference call can be accessed by dialing 866-503-8675 within the U.S. or by dialing +1 786-815-8792 outside the U.S. a few minutes before the 8:00 a.m. ET start and telling the operator that you are dialing in for Danaher’s earnings conference call (access code 6799891). A replay of the conference call will be available shortly after the conclusion of the call and until November 5, 2020. You can access the replay dial-in information on the "Investors" section of Danaher’s website under the subheading "Events & Presentations." In addition, presentation materials relating to Danaher’s results have been posted to the "Investors" section of Danaher’s website under the subheading "Quarterly Earnings."

Theravance Biopharma to Report Third Quarter 2020 Financial Results on November 5, 2020

On October 22, 2020 Theravance Biopharma, Inc. (NASDAQ: TBPH), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, reported that it will report its third quarter 2020 financial results and provide a business update after market close on Thursday, November 5, 2020 (Press release, Theravance, OCT 22, 2020, View Source [SID1234568884]). An accompanying conference call and simultaneous webcast will be hosted at 5:00 p.m. ET (2:00 p.m. PT/10:00 p.m. GMT) that day.

Conference Call Information

To participate in the live call by telephone, please dial (855) 296-9648 from the US or (920) 663-6266 for international callers, using the confirmation code 1269525. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma’s website at www.theravance.com, under the Investor Relations section, Presentations and Events.

A replay of the conference call will be available on Theravance Biopharma’s website for 30 days through December 5, 2020. An audio replay will also be available through 8:00 p.m. ET on November 12, 2020 by dialing (855) 859-2056 from the US, or (404) 537-3406 for international callers, and then entering confirmation code 1269525.

Protalix BioTherapeutics to Hold Third Quarter 2020 Financial Results and Business Update Conference Call on October 29, 2020

On October 22, 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 it will release its financial results for the third quarter 2020 and business update on Thursday, October 29, 2020 (Press release, Protalix, OCT 22, 2020, View Source [SID1234568883]). The Company’s management will host a conference call to discuss the financial results and provide a general business update at 8:30 a.m. Eastern Daylight Time (EDT).

Conference Call Details:

Thursday, October 29, 2020, 8:30 a.m. Eastern Daylight Time (EDT)
Domestic: 877-423-9813
International: 201-689-8573
Conference ID: 13711708

The conference call will be webcast live from the Company’s website and will be available via the following links:

Webcast Details:

Company Link: View Source
Webcast Link: View Source
Conference ID: 13711708

Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

The conference call will be available for replay for two weeks on the Events Calendar of the Investors section of the Company’s website, at the above link.