On February 13, 2020 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, reported its financial results for the quarter and full year ended December 31, 2019 and reaffirmed its financial guidance for 2020 (Press release, Ultragenyx Pharmaceutical, FEB 13, 2020, View Source [SID1234554297]).

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"In 2019 we created a substantial foundation based on the strong launch of Crysvita and the validation of our gene therapy platform across multiple clinical programs," said Emil D. Kakkis, M.D., Ph.D., Chief Executive Officer and President of Ultragenyx. "In 2020, we anticipate building on this momentum as we look to the potential approvals of UX007 for LC-FAOD and Crysvita for TIO. We also expect to advance our gene therapy programs into pivotal studies and bring two new programs into the clinic while continuing to exercise financial discipline."

Fourth Quarter and Full Year 2019 Financial Results

Net Revenues
For the fourth quarter of 2019, Ultragenyx reported $35.6 million in total revenue. Ultragenyx recognized $29.9 million in total Crysvita revenue. This includes $26.1 million in collaboration revenue in the North American1 profit share territory and $2.2 million in royalty revenue in the European territory from the collaboration and license agreement with Kyowa Kirin Co., Ltd (KKC). Net product sales for Crysvita in other regions were $1.6 million. Mepsevii (vestronidase alfa) product revenue for the fourth quarter of 2019 was $4.4 million, and UX007 named patient revenue was $1.2 million. Ultragenyx recognized $0.1 million in revenue from its research agreement with Bayer.

Net revenue for the year ended December 31, 2019 totaled $103.7 million. In 2019, Ultragenyx recognized $87.3 million in total Crysvita revenue. This includes $74.9 million in collaboration revenue in the North American1 profit share territory and $8.1 million in royalty revenue in the European territory from the collaboration and license agreement with KKC. Net product sales for Crysvita in other regions totaled $4.3 million. Mepsevii product revenue for the year ended December 31, 2019 was $12.6 million, and UX007 named patient revenue was $3.3 million. Ultragenyx recognized $0.5 million in revenue from its research agreement with Bayer in the year ended December 31, 2019.

Operating Expenses
Total operating expenses for the fourth quarter of 2019 were $130.0 million compared with $106.6 million for the same period in 2018, including non-cash stock-based compensation of $19.7 million and $21.1 million in the fourth quarter of 2019 and 2018, respectively. Total operating expenses for the year ended December 31, 2019, were $527.9 million, which includes $15.6 million in expenditures for Arcturus collaboration and license amendment and $20 million for the upfront payment on the GeneTx agreement, compared with operating expenses of $422.9 million for the same period in 2018. The operating expenses include non-cash stock-based compensation of $82.0 million and $80.1 million in the full year of 2019 and 2018, respectively. The increase in total operating expenses is due to the increase in commercial, development, and general and administrative costs as the company commercializes, grows, and advances its pipeline.

For the fourth quarter of 2019, Ultragenyx reported a net loss of $93.8 million, or $1.62 per share, basic and diluted, compared with a net loss for the fourth quarter of 2018 of $87.8 million, or $1.73 per share, basic and diluted. For the year ended December 31, 2019, the net loss was $402.7 million, or $7.12 per share, basic and diluted, compared with a net loss for the same period in 2018 of $197.6 million, or $3.97 per share, basic and diluted. The loss for the fourth quarter of 2019 and for the year ended December 31, 2019 includes unrealized gains of $1.4 million and $13.4 million, respectively, from the fair value adjustments on the investment in Arcturus equity securities. The loss from the full year 2018 was reduced by the gain on the sale of the Mepsevii priority review voucher (PRV) in January 2018 for net proceeds of $130.0 million and a $40.3 million gain from Ultragenyx’s portion of the sales of the PRV received with the Crysvita approval. The net loss for the full year 2019 reflected cash used in operations of $345.4 million compared to $290.6 million for the same period in 2018.

Cash, Cash Equivalents and Investments
Cash, cash equivalents, and investments were $760.4 million as of December 31, 2019, including proceeds of $320.0 million received from the sale of the company’s royalty interest in Crysvita in the European territory.

2020 Guidance

Crysvita Guidance in Ultragenyx Territories
In 2020, the company continues to expect Crysvita revenue in the Ultragenyx territories to be between $125 million and $140 million, which excludes the European territory revenue. Ultragenyx territories include the collaboration revenue from the North American profit share territory (US and Canada) and other regions where revenue from product sales are recognized by Ultragenyx (Latin America, Turkey). In December 2019, the European territory royalty revenue rights were sold to Royalty Pharma. As a result, the company will no longer receive cash payments from the EU territory royalty revenue rights beginning January 1, 2020, until the respective threshold amount is met; however, the company will continue to record the royalty as "non-cash" revenue.

2020 Expected Net Cash Burn Rate
The company also expects a more than 20 percent reduction in net cash burn (net cash used in operations plus capital expenditures) in 2020 compared to 2019 due to a combination of financial discipline in spending with flattening operating expense growth, combined with the significantly larger growth in revenue.

Recent Updates and Upcoming Milestones

Crysvita for X-linked Hypophosphatemia: Non-dilutive $320 million sale of future European royalties

In December 2019, Ultragenyx sold to Royalty Pharma for $320 million its royalty interest in Crysvita in the European territory, where it is being commercialized by Kyowa Kirin Co., Ltd.
Crysvita for Tumor-Induced Osteomalacia (TIO): Supplemental Biologics License Application (sBLA) submitted

Ultragenyx submitted the sBLA to the U.S. FDA on December 18, 2019 and expects to hear back from FDA on submission acceptance and review designation in February 2020.
UX007 for Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD): NDA under review by U.S. FDA

The U.S. FDA accepted for review the New Drug Application (NDA) and has set a Prescription Drug User Fee Act (PDUFA) date of July 31, 2020. The FDA has indicated that it is not currently planning to hold an advisory committee meeting to discuss the application. The review process is on track for a decision by the PDUFA date.
DTX301 for Ornithine Transcarbamylase (OTC) Deficiency: Positive data from higher dose cohort of Phase 1/2 study; data from prophylactic steroid cohort in second half 2020

Recent positive data from Cohort 3 indicated two confirmed responders and a potential third responder out of three total patients, as well as a new responder in Cohort 2. There are currently up to six responders of the nine dosed to date with a more consistent response at higher doses.
Ultragenyx is initiating a fourth cohort (n=3) using prophylactic steroids at the same dose as Cohort 3. Data from the prophylactic steroid cohort are expected in the second half of 2020.
DTX401 for Glycogen Storage Disease Type Ia (GSDIa): Positive data from Phase 1/2 study; enrollment complete in confirmatory cohort and data expected in first half 2020

Enrollment is complete in the confirmatory cohort of three patients at the second dose cohort, with data expected in the first half of 2020. Following the results of the confirmatory cohort, a Phase 3 study could begin in the second half of 2020.
GTX-102 for Angelman Syndrome (AS): Partnered program with GeneTx; IND active and enrollment of first patient expected in first half 2020

An investigational new drug (IND) application is now active and GeneTx has received Institutional Review Board (IRB) approval from the first study site. Enrollment in the Phase 1/2 study of GTX-102 is expected to begin in the first half of 2020.
In February 2020, Ultragenyx paid $25 million after the acceptance of the IND to maintain its option to acquire GeneTx until the earlier of 30 months from the first dosing of a patient in the Phase 1/2 study (subject to extensions) or 90 days after results are available from that study.
UX701 for Wilson Disease: IND expected by the end of the year

An IND application is expected by the end of 2020 for a new gene therapy for Wilson disease, a larger rare metabolic disease. UX701 will be the company’s second clinical program to utilize its HeLa manufacturing system.
DTX201 / BAY 2599023 for Hemophilia A: Partnered with Bayer; Cohort 2 data presented at European Association for Haemophilia and Allied Disorders (EAHAD)

Three cohorts with two patients each, six patients in total, have been dosed with AAVhu37 (DTX201 / BAY 2599023), using material from Ultragenyx’s proprietary HeLa manufacturing platform. Longer term dose cohort 1 and new dose cohort 2 data presented at EAHAD showed three of four patients have achieved clinically meaningful FVIII levels. One patient in Cohort 1 has achieved clinically meaningful FVIII levels and has experienced four bleeds since receiving treatment down from 99 bleeds the prior year. Both patients in dose cohort 2 achieved clinically meaningful FVIII levels out to 24 and 30 weeks. Patient 4 has been off treatment and bleed free for seven months as of the data cut-off date. The second patient in dose cohort 2 had mild ALT/AST elevations that was managed with a short tapering course of corticosteroids.
Conference Call and Webcast Information

Ultragenyx will host a conference call today, Thursday, February 13, 2020, at 2 p.m. PT/ 5 p.m. ET to discuss fourth quarter and full year 2019 financial results and provide a corporate update. The live and replayed webcast of the call will be available through the company’s website at View Source To participate in the live call by phone, dial (855) 797-6910 (USA) or (262) 912-6260 (international) and enter the passcode 5068548. The replay of the call will be available for one year.

On February 13, 2020 Dendreon Pharmaceuticals, a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy, reported results of a first-of-its-kind study examining survival outcomes in men with metastatic castrate-resistant prostate cancer (mCRPC) who were treated with PROVENGE (sipuleucel-T) and oral agents in a real-world treatment setting (Press release, Dendreon, FEB 13, 2020, View Source [SID1234554313]).

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According to a retrospective analysis of medical and pharmacy claims data from more than 6,000 Medicare Fee for Service beneficiaries, the addition of PROVENGE to either Zytiga (abiraterone acetate) or Xtandi (enzalutamide), at any point in a patient’s mCRPC treatment regimen, reduced the risk of death by 45% and extended median overall survival (OS) by 14.5 months.1 These findings were presented in a poster session at the 2020 ASCO (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium in San Francisco (abstract #42, Poster Session A, 11:30 a.m. PST).

"Based on our analysis of these real-world data, men with mCRPC who had immunotherapy added to their treatment regimen had a significant reduction in the risk of death at three years, regardless of the sequencing," said Rana R. McKay, M.D., lead study author, and medical oncologist and assistant professor of medicine at Moores Cancer Center, University of California, San Diego. "This magnitude of risk reduction is a compelling finding, and additional analyses are underway looking at other variables that could impact outcomes."

Based upon the real-world use and survival outcomes associated with the utilization of PROVENGE and oral agents Zytiga or Xtandi in men receiving treatment for mCRPC, the study authors found that:

In mCRPC patients treated with Zytiga or Xtandi, the median OS was significantly higher among men who also were treated with PROVENGE (35.2 months vs. 20.7 months; p<0.0001).
Three-year survival rates were significantly higher in men who received PROVENGE in any line of treatment compared to men who never received treatment with PROVENGE (48% vs. 28%; p<0.0001).
More than 150 variations of mCRPC treatment sequences were identified in the analysis, underscoring the importance of developing a structured approach to managing mCRPC patients.
Further statistical analysis of these treatment cohorts is underway.
"These findings underscore the importance of using complementary MOAs to maximize patient survival outcomes, and highlights the critical role immunotherapy plays in the mCRPC treatment regimen," said Bruce A. Brown, M.D., chief medical officer at Dendreon. "These real-world data contribute to a growing body of evidence that PROVENGE continues to deliver on its promise of helping men with advanced prostate cancer live longer."

Additional findings on the use of immunotherapy in earlier stage prostate cancer and the potential impact of the treatment on cell death were presented today in poster sessions at the 2020 ASCO (Free ASCO Whitepaper) GU Cancers Symposium:

A comparison of sipuleucel-T (sip-T) product parameters from two phase III studies: ProVent in active surveillance prostate cancer and IMPACT in metastatic castrate-resistant prostate cancer (mCRPC) (abstract #321, Poster Session A, 11:30 a.m. PST)
This study compared the final product parameters (CD54 upregulation, CD54+ cell count and total nucleated cell [TNC] count) in 313 men on active surveillance (AS) enrolled in the ongoing Phase 3 ProVent clinical trial and 341 men with mCRPC treated with sip-T in the randomized, pivotal Phase 3 IMPACT trial. Results showed that men enrolled in ProVent yielded higher apheresis TNC and CD54+ cell counts than men in IMPACT, possibly a reflection of a healthier immune system in patients in the ProVent trial. Additionally, final product CD54+ cell counts, CD54 upregulation and TNC cell counts were statistically higher in men enrolled in ProVent than in men enrolled in IMPACT.

The association of humoral antigen spread (AgS) with cytotoxic T lymphocyte (CTL) activity after sipuleucel-T (sip-T) treatment in two phase II clinical studies: STAMP and STRIDE (abstract #112, Poster Session A, 11:30 a.m. PST)
One mechanism of action of cancer immunotherapy is to induce an immune response to specific antigen-bearing tumor cells. The resultant destruction of the tumor cells by the immune system’s T cells leads to the release of additional tumor-associated antigens. These secondary antigens prime subsequent immune responses – a process called antigen spread. This immunological phenomena was previously shown to correlate with survival benefit in the IMPACT study. Sip-T has been shown in clinical trials to induce lytic T cell responses against the immunizing antigen (PA2024) and/or the target antigen (prostatic acid phosphatase or PAP), with responses correlating with overall survival. In this analysis, researchers demonstrated that antigen spread observed after sipuleucel-T treatment correlated with observed lytic T cell responses, concluding that treatment with sip-T in men with mCRPC appears to invoke the tumor immunity cycle, in which tumor cell death releases secondary antigens resulting in antigen spread.

About PROVENGE (sipuleucel-T)

PROVENGE is the only FDA-approved immunotherapy made from a patient’s own immune cells for the treatment of prostate cancer. More than 30,000 men have been prescribed PROVENGE, and it has been clinically proven to extend life for certain men in advanced stages of the disease.

INDICATION

PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

IMPORTANT SAFETY INFORMATION

Acute Infusion Reactions: Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events (dyspnea, hypoxia, and bronchospasm), syncope, hypotension, hypertension, and tachycardia.

Thromboembolic Events: Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events. PROVENGE should be used with caution in patients with risk factors for thromboembolic events.

Vascular Disorders: Cerebrovascular events (hemorrhagic/ischemic strokes and transient ischemic attacks) and cardiovascular disorders (myocardial infarctions) have been reported following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events.

Handling Precautions: PROVENGE is not tested for transmissible infectious diseases.

Concomitant Chemotherapy or Immunosuppressive Therapy: Chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. Concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE.

Adverse Reactions: The most common adverse reactions reported in clinical trials (≥ 15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache, and headache.

On February 13, 2020 Sosei Group Corporation ("the Company") (TSE: 4565) reported an update on operational activities and reports its consolidated results for the twelve months ended 31 December 2019 (Press release, Sosei Heptares, FEB 13, 2020, View Source [SID1234554329]). The full report can be accessed by clicking here.

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Operational Highlights for Q4 2019

US$3 million payment received from Genentech – triggered by the nomination of a new GPCR disease target under the multi-target research collaboration and license agreement, signed in July 2019
Positive results announced from Phase III IRIDIUM study of QVM149 in patients with uncontrolled asthma announced by Novartis – QVM149 is an investigational, once-daily, inhaled combination treatment for asthma submitted for registration in Europe (Q2 2019) and Japan (Q3 2019) in which Sosei Heptares has an economic interest
US$5 million clinical milestone from Pfizer – triggered by Pfizer dosing the first subject in a clinical trial with a new drug candidate nominated from the multi-target drug discovery collaboration between the two companies
US$3 million pre-clinical milestone from Pfizer – payment resulted from the nomination of a third clinical candidate from the multi-target drug discovery collaboration between the two companies
Creation of Scientific Advisory Board (SAB) – new SAB includes experts from academia and the pharmaceutical industry in the US and Europe. The SAB will provide valuable insight and perspective relevant to strategic areas of focus for Sosei Heptares
Operational Highlights for the Full Year 2019

Two new multi-target collaborations initiated with major global partners – Genentech and Takeda – together, these collaborations are expected to generate up to US$52 million in the form of upfront and early progress payments over the next two to three years, with potential for significant future milestone payments plus royalties
Excellent progress with other partnered programs – AstraZeneca (AZD4635), Pfizer (two candidate nominations), Novartis (QVM149), all triggering progress-related milestones
Creation of two spin-out companies – Spin out of discovered assets (orexin agonists targeting neurological diseases) into Orexia Ltd and Inexia Ltd with funding of up to €40 million from Medicxi, an international investment firm focused on the life sciences sector. Significant progress, triggering release of funding, reported in January 2020
R&D Day for investors (September 2019) – successful event held in Japan showcasing the Company’s state-of-the-art UK R&D center, the potential of StaR technology and artificial intelligence in drug discovery and how this positions Sosei Heptares to continue delivering high-quality drug candidates, strategic partnerships and significant shareholder value
Financial Highlights for the 12-month Period ended 31 December 2019

Revenue totalled JPY 9,726 million (US$89.2 million) (an increase of JPY 6,176 million (US$57.0 million) vs. the prior corresponding period), and related primarily to strong growth in milestones, upfront fees from new partnerships plus royalty payments received.
Total cash operating expenses[1] were down to JPY 6,101 million (US$55.9 million) (an improvement of JPY 2,865 million (US$25.4 million) vs. the prior corresponding period), primarily due to a decrease in R&D costs.
Cash profit[2] totalled JPY 2,802 million (US$25.7 million) vs. a cash loss of JPY 5,704 million (US$51.7 million) in the prior corresponding period, as a result of strong revenue growth and tight cost management.
Net profit totalled JPY 1,432 million (US$13.1 million) vs. a net loss of JPY 6,919 million (US$62.7 million) in the prior corresponding period, on the back of strong business plan execution.
Term loan facilities were fully repaid in FY2019. New ¥5bn ($45m) commitment line (undrawn) established with Mizuho Bank provides financial flexibility for the future
The Company remains well capitalized, with Cash at Hand of JPY 15,375 million (US$140.3 million) as at 31 December 2019.
* Convenience conversion to US$ at the following rates: 2019: 1US$ =109.035 JPY; 2018: 1US$ =110.291 JPY

On February 13, 2020 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported that they have executed agreements with two existing investors, including John K. Scott, Jr. (collectively, the "Investors"), to purchase approximately 4.0 million shares of the Company’s common stock, par value $0.001 per share, for aggregate gross proceeds to Navidea of approximately $3.4 million (Press release, Navidea Biopharmaceuticals, FEB 13, 2020, View Source [SID1234554362]). The securities to be issued to the Investors will represent approximately 16.5% of the Company’s outstanding common stock after such issuance.

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In addition, the Company executed a binding term sheet to sell the judgment entered by the Ohio Court of Common Pleas in favor of Navidea in the amount of $4.3 million plus interest (the "Judgment"), for $4.2 million of proceeds to Navidea. The Company has the option, within 45 days of the sale, to repurchase the Judgment for a 10% premium. Such repurchase option may be in the form of the Company’s common stock at a 10% discount to the then-current market price.

Navidea intends to use the net proceeds from these transactions to fund its research and development programs, including continued advancement its two Phase 2b and Phase 3 clinical trials of Tc99m tilmanocept in patients with rheumatoid arthritis, and for general working capital purposes and other operating expenses.

John K. Scott commented, "I continue to support management and the Board of Directors. They have made great strides over the past 18 months to move Navidea into its next chapter of success. My family and I look forward to the continued development of Navidea’s rheumatoid arthritis and pipeline assets."

"This financing allows Navidea to advance through several key milestones and maintain our NYSE listing," commented Jed Latkin, Chief Executive Officer of Navidea. "We’re pleased to continue to receive support from current shareholders and look forward to providing updates as the company moves ahead. Navidea is encouraged with the clinical study results announced in the fourth quarter, and we will provide further update on the third cohort as the data is finalized. We are moving ahead as planned and thank our shareholders for their support during this time."

The securities offered and to be sold by Navidea in the private placement to Mr. Scott have not been registered under the Securities Act of 1933 (the "Securities Act"), as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (the "SEC") or an applicable exemption from registration requirements. Navidea has agreed to file a registration statement with the SEC covering the resale of the shares of common stock to be issued to Mr. Scott.

The shares of common stock being offered and sold to the other existing investor are being issued pursuant to a shelf registration statement previously filed with and declared effective by the SEC. A prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of Navidea’s securities. No offer, solicitation or sale will be made in any state or other jurisdiction in which such offering, solicitation or sale would be unlawful.

On February 13, 2020 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 [SID1234554258]).

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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.