On February 13, 2019 West Pharmaceutical Services, Inc. (NYSE: WST) reported its financial results for the fourth-quarter and full-year 2019 and introduced full-year 2020 financial guidance (Press release, West Pharmaceutical Services, FEB 13, 2020, View Source [SID1234554305]).

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Fourth-Quarter and Full-Year 2019 Summary (comparisons to prior-year period)

Fourth-quarter 2019 net sales of $470.6 million grew 11.4%; organic sales growth was 12.7%; sales from a recent acquisition contributed an additional 30 basis points of growth; currency translation reduced sales by 160 basis points.
Full-year 2019 net sales of $1.840 billion grew 7.1%; organic sales growth was 10.0%; sales from a recent acquisition contributed an additional 10 basis points of growth; currency translation reduced sales by 300 basis points.
Fourth-quarter 2019 reported-diluted EPS of $0.84 increased 22%. Full-year 2019 reported-diluted EPS of $3.21 increased 17%.
Fourth-quarter 2019 adjusted-diluted EPS of $0.82 increased 12%. Full-year 2019 adjusted-diluted EPS of $3.24 increased 15%.
Company is introducing full-year 2020 financial guidance of net sales in a range of $1.95 billion to $1.97 billion and reported-diluted EPS in a range of $3.45 to $3.55.
"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.

"I am pleased to report strong fourth-quarter 2019 sales and EPS growth, which continues a trend seen throughout the year," said Eric M. Green, President and Chief Executive Officer. "We had double-digit organic sales growth in all three market units of our Proprietary Products segment. High-value products (HVPs) once again fueled sales growth and gross margin expansion, led by Daikyo and Westar components."

Mr. Green continued, "We are introducing full-year 2020 financial guidance that is in line with our long-term financial construct of organic sales growth and operating margin expansion. Our end markets are stable and growing, and we are off to a good start to 2020 with a strong book of committed orders for our high value products, such as NovaPure and Envision components, as well as Daikyo Crystal Zenith containers and our portfolio of self-injection delivery platforms. Our teams across the globe have demonstrated their passion for customers throughout 2019, with new product and services offerings, and are poised to deliver another strong year of sales and profit growth for our business in 2020."

Proprietary Products Segment
In the fourth-quarter 2019, net sales grew 13.3% to $352.7 million. Organic sales growth was 14.7%, with incremental sales from a recent acquisition contributing 40 basis points of Proprietary Products growth and currency translation decreasing sales by 180 basis points. HVPs represented over 60% of segment sales and generated double-digit organic sales growth.

In the fourth-quarter 2019, the Biologics market unit had strong double-digit organic sales growth, led by customer purchases of Daikyo, Westar and Flurotec components. The Generics market unit posted double-digit organic sales growth, led by sales of Westar components and self-injection delivery platforms. The Pharma market unit had double-digit organic sales growth, led by HVPs and a favorable year-over-year comparison due to the fourth-quarter 2018 financial impact from the previously reported voluntary recall of the Vial2Bag product.

In the full-year 2019, net sales grew 6.9% to $1.399 billion. Organic sales growth was 9.9% with incremental sales from a 2019 acquisition contributing 30 basis points of growth and currency translation decreasing sales by 330 basis points. HVPs represented over 60% of segment sales and generated double-digit organic sales growth.

Contract-Manufactured Products Segment
In the fourth-quarter 2019, net sales grew 5.9% to $117.9 million. Organic sales growth was 7.2% with currency translation decreasing sales by 130 basis points. Segment performance was led by sales of healthcare-related injection and diagnostic devices.

For the full-year 2019, net sales grew 7.9% to $441.5 million. Organic sales growth was 10.2% with currency translation decreasing sales by 230 basis points.

Full-Year 2019 Financial Highlights
Operating cash flow was $367.2 million, an increase of 27%. Capital expenditures were $126.4 million, compared to $104.7 million over the same period last year, and represented 6.9% of full-year 2019 net sales. Free cash flow (operating cash flow minus capital expenditures) was $240.8 million, an increase of over 30%.

The Company recorded $4.9 million of restructuring and related charges in 2019 from previously announced actions that have streamlined its manufacturing network. This restructuring plan is now considered complete. Implemented in first-quarter 2018, cumulative expenses over the plan period were approximately $14.0 million. The Company anticipates that the plan will provide annualized savings of approximately $14.0 million.

Full-Year 2020 Financial Guidance

The Company expects full-year 2020 net sales guidance to be in a range of $1.95 billion to $1.97 billion.
Organic sales growth is expected to be in the range of 7% to 8%.
Net sales guidance includes an estimated headwind of $15 million for the full-year 2020 based on current foreign exchange rates.
The Company expects full-year 2020 reported-diluted EPS to be in the range of $3.45 to $3.55.
This includes an estimated headwind of approximately $0.04 based on current foreign currency exchange rates.
This reported-diluted EPS guidance range assumes a full-year 2020 tax rate of 24%, which does not include potential tax benefits from stock-based compensation. As in prior years, we are not including potential 2020 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 2020 would provide a positive adjustment to our full-year EPS guidance.
Full-year 2020 capital spending is expected to be approximately 7% of expected full-year 2020 net sales.
Fourth-Quarter and Full-Year 2019 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 5587337.

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 20, 2020, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International) and entering conference ID 5587337.

On February 13, 2020 CryoLife, Inc. (NYSE: CRY), a leading cardiac and vascular surgery company focused on aortic disease, reported its financial results for the fourth quarter and full year ended December 31, 2019 (Press release, CryoLife, FEB 13, 2020, View Source [SID1234554321]).

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"The fourth quarter was marked by significant progress on our key initiatives, highlighted by European approvals for two next generation JOTEC products, E-nside and E-nya, the approval to commence the PROACT Xa trial to study the use of Eliquis with the On-X Aortic Valve, the initial launch of NEXUS into select European markets, as well as our collaboration with Misonix," said Pat Mackin, Chairman, President, and Chief Executive Officer. "Additionally, we anticipate the approval for E-vita OPEN NEO in the first quarter of 2020, and we continue to increase JOTEC and vascular tissue supply. The full launch in 2020 of three next generation JOTEC products and NEXUS, as well as the commencement of the PROACT Xa trial, positions us well to deliver high single-digit revenue growth over the next several years."

Fourth Quarter 2019 Financial Results
Total revenues for the fourth quarter of 2019 were $69.7 million, reflecting growth of 3%, and 4% on a non-GAAP constant currency basis, both compared to the fourth quarter of 2018. The non-GAAP constant currency increase was driven by revenue growth from On-X, tissue processing, and JOTEC, excluding JOTEC OEM.

Net loss for the fourth quarter of 2019 was ($681,000), or ($0.02) per fully diluted common share, compared to a net loss of ($776,000), or ($0.02) per fully diluted common share for the fourth quarter of 2018. Non-GAAP net income for the fourth quarter of 2019 was $3.8 million, or $0.10 per fully diluted common share, compared to non-GAAP net income of $1.9 million, or $0.05 per fully diluted common share for the fourth quarter of 2018.

Full Year 2019 Financial Results
Total revenues for 2019 were $276.2 million, reflecting growth of 5% on a reported basis and 7% on a non-GAAP constant currency basis compared to 2018. The increase was driven by growth in the On-X, BioGlue and JOTEC product lines as well as the tissue processing business. For 2019, On-X and JOTEC non-GAAP constant currency revenues increased by 12% and 9%, respectively, versus 2018.

Net income for 2019 was $1.7 million or $0.05 per share compared to a net loss of ($2.8) million or ($0.08) per share for 2018. Non-GAAP net income for 2019 was $11.7 million, or $0.31 a share compared to non-GAAP net income of $9.6 million, or $0.26 per share in 2018.

The independent registered public accounting firm’s audit report with respect to the Company’s fiscal year-end financial statements will not be issued until the Company completes its annual report on Form 10-K, including its evaluation of the effectiveness of internal controls over financial reporting. Accordingly, the financial results reported in this earnings release are preliminary pending completion of the audit.

2020 Financial Outlook
CryoLife expects constant currency revenue growth of between 6.3% and 8.5% for the full year of 2020 compared to 2019. Assuming a Euro/USD exchange rate of 1.10, revenues are expected to be in the range of $292 million to $298 million. Our 2020 revenue guidance assumes no contribution during 2020 from BioGlue in China, PerClot in the U.S., or TMR handpieces.

Non-GAAP earnings per share for 2020 are expected to be between $0.15 and $0.17. Non-GAAP earnings per share reflect approximately $0.12 per share in planned incremental investment in the Company’s pipeline, an estimated $0.06 per share additional investment in our Asia Pacific and Latin American infrastructure, and approximately $0.05 per share in planned incremental spending related to new product launches.

All numbers are presented on a GAAP basis except where expressly referenced as non-GAAP. The Company does not provide GAAP income per common share on a forward-looking basis because the Company is unable to predict with reasonable certainty business development and acquisition-related expenses, purchase accounting fair value adjustments, and any unusual gains and losses without unreasonable effort. These items are uncertain, depend on various factors, and could be material to results computed in accordance with GAAP.

The Company’s financial guidance for 2020 is subject to the risks identified below.

Non-GAAP Financial Measures
This press release contains non-GAAP financial measures. Investors should consider this non-GAAP information in addition to, and not as a substitute for, financial measures prepared in accordance with U.S. GAAP. In addition, this non-GAAP financial information may not be the same as similar measures presented by other companies. The Company’s non-GAAP net income and non-GAAP EBITDA results exclude (as applicable) business development and integration expenses, rebranding expenses, amortization expense, inventory basis step-up expense, loss on foreign currency revaluation, and stock-based compensation expense. The Company believes that these non-GAAP presentations provide useful information to investors regarding unusual non-operating items; the operating expense structure of the Company’s existing and recently acquired operations, without regard to its on-going efforts to acquire additional complementary products and businesses and the transaction and integration expenses incurred in connection with recently acquired and divested product lines; and the operating expense structure excluding fluctuations resulting from foreign currency revaluation and stock-based compensation expense. The Company believes it is useful to exclude certain expenses because such amounts in any specific period may not directly correlate to the underlying performance of its business operations or can vary significantly between periods as a result of factors such as acquisitions, or non-cash expense related to amortization of previously acquired tangible and intangible assets. The Company has excluded the impact of changes in currency exchange from certain revenues to evaluate growth rates on a constant currency basis. The Company does, however, expect to incur similar types of expenses and currency exchange impacts in the future, and this non-GAAP financial information should not be viewed as a statement or indication that these types of expenses will not recur.

Webcast and Conference Call Information
The Company will hold a teleconference call and live webcast later today, February 13, 2020 at 4:30 p.m. ET to discuss the results followed by a question and answer session. To listen to the live teleconference, please dial 201-689-8261. A replay of the teleconference will be available through February 20, 2020 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415. The Conference ID for the replay is 13698400.

The live webcast and replay can be accessed by going to the Investor Relations section of the CryoLife website at www.cryolife.com and selecting the heading Webcasts & Presentations.

On February 13, 2020 FORMA Therapeutics, Inc., a clinical stage biopharmaceutical company focused on rare hematologic diseases and cancers, reported the online publication of the structure-based design and discovery of its most advanced clinical asset, olutasidenib, in the Journal of Medicinal Chemistry (Press release, Forma Therapeutics, FEB 13, 2020, View Source [SID1234554266]). The paper details structure-based approaches to design a potent mutant IDH1 inhibitor with pharmacokinetic properties that include blood-brain barrier permeability. The paper is also expected to be published in the Feb. 27 print edition of the journal.

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"This work highlights FORMA’s efforts to discover and develop highly selective, potent molecules to create breakthrough medicines for patients with rare hematologic diseases and cancers," said Patrick Kelly, M.D., chief medical officer of FORMA Therapeutics. "Olutasidenib is a viable oral clinical compound that potently and selectively inhibits 2-hydroxyglutarate production, and these results lead us to believe it will be able to restore normal cellular differentiation in IDH1-mutated cancers."

FORMA discovered olutasidenib through the company’s innovative drug discovery platform, which combines high throughput screening with DNA-encoded library screens for lead identification and then utilizes a highly technology-leveraged parallel optimization process to develop lead candidates. The program has since been moved into the clinic to allow further investigation of its demonstrated potential. Additional information about proof of mechanism and differentiating clinical data for FORMA’s program in glioma was presented at the 2019 Society for Neuro-Oncology Conference.

"We are extremely proud of the technical and scientific prowess our team has demonstrated by yielding a diverse pipeline of novel or next-generation oral medicines for FORMA’s own continued development and development by licensees of our molecules," Dr. Kelly added.

About Olutasidenib

FORMA Therapeutics’ most advanced clinical asset, olutasidenib, is designed to be a potent and selective next generation inhibitor of mutated isocitrate dehydrogenase 1 (IDH1m) to treat patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), as well as patients with glioma and other solid tumors with an IDH1 mutation. IDH1 is a natural enzyme that is part of the normal metabolism in all cells; when mutated, its activity can promote blood malignancies and solid tumors. IDH1 mutations are present in 7-14% of patients with AML, 3-4% of patients with MDS, and more than 70% of patients with gliomas. In AML, hypermethylation driven by IDH mutations inhibits normal differentiation of progenitor cells leading to accumulation of immature blasts. Quality of life declines for patients with each successive line of treatment for AML, and well-tolerated treatments in relapsed disease remain an unmet need. In MDS, often a precursor to AML, epigenetic changes from aberrant DNA methylation contribute to the formation of blast cells and the progression of MDS to AML.

FORMA is evaluating olutasidenib as a single agent and in combination with azacitidine in a pivotal study in patients with relapsed/refractory acute myeloid leukemia (R/R AML) with an IDH1 mutation. Additional patient populations with IDH1m hematological oncology disease or advanced solid tumors and gliomas are also being evaluated.

On February 13, 2020 Dana-Farber Cancer Institute reported Scientists report promising activity of a novel drug that targets a key molecular driver of clear cell renal cell carcinoma (ccRCC) in patients with metastatic disease (Press release, Dana-Farber Cancer Institute, FEB 13, 2020, View Source [SID1234554290]).

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Researchers from Dana-Farber Cancer Institute report a response rate of 24 percent across all risk categories of patients given an oral first-in-class agent that targets hypoxia-inducible factor (HIF) 2-a, which promotes new blood vessel growth that fuels kidney tumors.

Results of treatment with the drug, known as MK-6482, are being presented in an abstract of a phase I/II study at the ASCO (Free ASCO Whitepaper) 2020 Genitourinary Cancers Symposium. Based on these findings, a phase III trial has been launched.

"A new drug as a single agent showing an overall response rate of 24 percent across all risk categories – poor, intermediate, and good and in a heavily refractory population – is quite promising," said Toni Choueiri, MD, first author of the abstract. Choueiri is director of the Lank Center for Genitourinary Oncology and the Jerome and Nancy Kohlberg Professor of Medicine at Harvard Medical School.

The drug targets a component of the body’s mechanism for sensing oxygen levels and turning on genes that enable the body to adjust to hypoxia – a shortage of oxygen – by making more red blood cells and forming new blood vessels. Dana-Farber scientist and Choueiri’s mentor and collaborator William G. Kaelin Jr., MD shared the 2019 Nobel Prize in Medicine with two other researchers for unraveling this complex mechanism, which can be hijacked by cancer to help tumors survive and grow.

In the vast majority of patients with clear cell renal carcinoma, a tumor suppressor protein known as Von Hippel-Lindau (VHL) is not functional. As a result, hypoxia inducible factor (HIF) proteins accumulate inside the tumor cell, wrongly signaling there is a shortage of oxygen, and activating the formation of blood vessels, fueling tumor growth. Understanding this abnormal process has paved the way for new cancer drugs – MK-6482 being one of them and is distinct in that it targets HIF-2a directly leading to blocking cancer cell growth, proliferation, and abnormal blood vessel formation.

The study of MK-6482 included 55 patients with advanced clear cell kidney cancer who had an average of 3 prior lines of therapies.

After a median follow-up period of 13 months, the overall response rate was 24 percent. Forty-one patients had stable disease with a disease control rate (complete response plus partial response plus stable disease) of 80 percent. There were partial responses in two of five favorable-risk patients; 10 of 40 intermediate-risk patients; and one of 10 poor-risk patients.

The median duration of response had not been reached: 81 percent of patients had an estimated response of more than six months, and 16 patients continued treatment beyond 12 months. The median progression-free response rate was 11 months.

The authors concluded that MK-6482 "is well-tolerated with a favorable safety profile and demonstrated promising single-agent activity in heavily pre-treated patients" with clear-cell kidney cancer across the various risk groups.

The presentation (Abstract 611) is scheduled for Oral Abstract Session C: Renal Cell Cancer on Saturday, February 15, 2020, at 8:00 a.m. (PT) at the ASCO (Free ASCO Whitepaper) 2020 Genitourinary Cancers Symposium in the Moscone West Building, San Francisco, CA.

Funding for this research was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Choueiri has pending patents for biomarkers of immune checkpoint blockers. Choueiri’s disclosures include grants, personal fees or nonfinancial support from Agensys, Alexion, Alligent, Analysis Group, AstraZeneca, Bayer, Bristol-Myers Squibb, Calithera, Cerulean, Clinical Care Options, Corvus, Eli Lilly, Esai, Exelixis, Foundation Medicine Inc., Genentech, Roche, F. Hoffman-La Roche, GlaxoSmithKline, Heron Therapeutics, Harborside Press, American Society of Medical Oncology, Ipsen, NCCN, Kidney Cancer Journal, L-path, Merck, Michael J. Hennessy Associates, Research to Practice, Navinata Healthcare, NEJM, Novartis, Peloton, Pfizer, EMD Serono, Platform Q, Prometheus Labs, Sanofi/Aventis, Takeda, Tracon, Pionyr, Tempest, The Lancet Oncology and Up-to-Date.

On February 13, 2020 Calidi Biotherapeutics, Inc., a clinical‐stage immuno-oncology company at the forefront of cell-based oncolytic virus immunotherapies for cancer, reported pre-clinical data on their lead oncolytic virus candidate SNV1 (allogeneic adipose derived mesenchymal stem cells loaded with tumor selective CAL1 vaccinia virus) in a poster presentation at the 2020 ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium (Press release, Calidi Biotherapeutics, FEB 13, 2020, View Source [SID1234554306]).

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SNV1 demonstrated enhanced therapeutic effects when compared to naked vaccinia virus across multiple human cancer cell lines and animal tumor models. "The biggest hurdle in oncolytic virotherapy is the quick elimination of an oncolytic virus by the patient’s immune system," said Boris Minev, MD, President, Medical and Scientific Affairs, Calidi Biotherapeutics. "We presented data documenting potent anti-tumor and immunologic effects not only at the SNV1-injected site, but also at distant non-treated tumor sites. These abscopal effects on non-injected tumors support our premise that Calidi’s proprietary stem cell vehicle and vaccinia virus combination can modulate the tumor microenvironment and activate the immune system making it a powerful combination therapy partner in immuno-oncology. We look forward to exploring partnerships and licensing opportunities with other companies working in this space."

SNV1 was analyzed for its ability to kill cancer cell lines in vitro, and protect and potentiate the oncolytic virus even in the presence of active neutralizing antibodies and complement. SNV1 was also injected intratumorally in various xenograft and syngeneic animal models. Immune cell infiltration of the injected tumors was analyzed by flow cytometry of tumor-derived single cell suspensions. Intratumoral SNV1 treatment showed statistically significant tumor growth inhibition when compared to control (non-treated tumors) or to CAL1 naked virus treatment in all tested syngeneic tumor models (breast, melanoma, colon, and prostate cancers). Importantly, the local administration of SNV1 induced systemic therapeutic effects as well as modulation of local and distant tumor immune infiltration.

The therapeutic premise behind Calidi’s cell-based platform is to protect and potentiate the oncolytic vaccinia virus by circumventing humoral innate and adaptive immune barriers, resulting in enhanced oncolytic virotherapy. These findings provide a fundamental rationale for the development of cell-based platforms to maximize the therapeutic potential of various oncolytic viruses. A copy of the abstract and poster presentation materials can be found in the Publications section of the Calidi Biotherapeutics website.