On February 15, 2018 Acorda Therapeutics, Inc. (Nasdaq:ACOR) reported a financial and pipeline update for the fourth quarter and full year ended December 31, 2017 (Press release, Acorda Therapeutics, FEB 15, 2018, View Source [SID1234523984]).

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!

"We continue to prepare for the potential approval and launch of INBRIJA, our investigational inhaled levodopa treatment for symptoms of OFF periods in people with Parkinson’s disease. We look forward to working with the FDA during the NDA review process, and to bringing this new treatment option to the Parkinson’s community to help address an important unmet need," said Ron Cohen, M.D., Acorda’s President and CEO. "Based on our continued market research, as well as the strength of our Phase 3 data, we believe INBRIJA’s US market opportunity to be greater than $800 million."

Fourth Quarter 2017 Financial Results

AMPYRA (dalfampridine) Extended Release Tablets, 10 mg – For the quarter ended December 31, 2017, the Company reported AMPYRA net revenue of $167.2 million compared to $132.3 million for the same quarter in 2016.

Royalty Revenue – For the quarter ended December 31, 2017, the Company reported royalty revenue of $16.1 million as compared to $4.4 million for the same quarter in 2016. The Company reported FAMPYRA royalties from sales outside of the U.S. of $3.1 million compared to $2.7 million for the same quarter in 2016. Additionally, the Company completed a transaction that provides a fully paid-up, royalty-free license for Selincro in exchange for $13.0 million which was recorded as royalty revenue in the quarter ended December 31, 2017. During the quarter ended December 31, 2017, the Company completed a royalty purchase transaction for its Fampyra royalty revenue in exchange for an upfront payment of $40 million. The transaction was recorded as a liability in accordance with US GAAP which will be reduced over time as royalty revenue is recognized.

Research and development (R&D) expenses for the quarter ended December 31, 2017 were $35.1 million, including $2.2 million of share-based compensation compared to $53.8 million, including $3.0 million of share-based compensation for the same quarter in 2016.

Sales, general and administrative (SG&A) expenses for the quarter ended December 31, 2017 were $39.5 million, including $5.4 million of share-based compensation compared to $59.0 million, including $6.0 million of share-based compensation for the same quarter in 2016.

The Company recorded non-cash asset impairment charges of $233.5 million for tozadenant as a result of the termination of this program, and $23.8 million for SYN120 as a result of the trial not meeting key primary and secondary endpoints. The Company assessed the valuation assumptions for both programs and determined the assets were fully impaired. Both of these charges were recorded in the quarter ended December 31, 2017.

Benefit from income taxes for the quarter ended December 31, 2017 was $51.9 million, including $2.7 million of cash taxes, compared to a provision for income taxes of $1.0 million, including $0.7 million of cash taxes for the same quarter in 2016.

The Company reported a GAAP net loss attributable to Acorda of $(171.1) million for the quarter ended December 31, 2017, or $(3.70) per diluted share. GAAP net loss in the same quarter of 2016 was $(3.1) million, or $(0.07) per diluted share.

Non-GAAP net income for the quarter ended December 31, 2017 was $28.5 million, or $0.61 per diluted share. Non-GAAP net income in the same quarter of 2016 was $2.5 million, or $0.05 per diluted share. This quarterly non-GAAP net income measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, restructuring expenses, changes in the fair value of acquired contingent consideration, asset impairment charges, gain on sale of assets and acquisition-related expenses. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

Financial Results – Full Year Ended December 31, 2017

AMPYRA (dalfampridine) Extended Release Tablets, 10 mg – For the full year ended December 31, 2017 net revenue was $543.3 million compared to $492.8 million for full year 2016. Full year 2017 net revenue increased 10.2% over 2016.

Royalty Revenue – For the full year ended December 31, 2017, the Company reported royalty revenue of $29.5 million compared to $17.2 million for the full year 2016. The Company reported FAMPYRA royalties from sales outside of the U.S. of $11.6 million compared to $10.6 million for the full year 2016. Royalty revenue related to the authorized generic version of Zanaflex was $2.6 million compared to $3.9 million for the full year 2016. Additionally, the Company reported $15.3 million in royalties for Selincro for the full year 2017, which includes $13.0 million of royalty revenue related to the Selincro royalty transaction.

Research and development (R&D) expenses for the full year ended December 31, 2017 were $166.1 million, including $9.7 million of share-based compensation, compared to $203.4 million, including $10.6 million of share-based compensation for the full year 2016

Sales, general and administrative (SG&A) expenses for the full year ended December 31, 2017 were $181.6 million, including $23.1 million of share-based compensation, compared to $235.4 million, including $25.8 million of share-based compensation for the full year 2016.

Asset impairment charges for the full year ended December 31, 2017 include $233.5 million for tozadenant, $23.8 million for SYN120, and $39.4 million for Selincro.

Benefit from income taxes for the full year ended December 31, 2017 was $28.5 million, including $14.1 million of cash taxes compared to a benefit from income taxes of $6.7 million, including $4.3 million of cash taxes for the full year 2016.

For the full year ended December 31, 2017, the Company reported a GAAP net loss of $(223.4) million, or $(4.86) per diluted share. GAAP net loss for the full year 2016 was $(34.6) million, or $(0.76) per diluted share.

Non-GAAP net income for the full year ended December 31, 2017 was $80.7 million, or $1.75 per diluted share. Non-GAAP net income for the full year ended December 31, 2016 was $11.5 million, or $0.25 per diluted share. This full year non-GAAP net income measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, restructuring expenses, changes in the fair value of acquired contingent consideration, asset impairment charges, gain on sale of assets, realized foreign currency loss (gain) and acquisition related expenses. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

At December 31, 2017, the Company had cash and cash equivalents of $307.1 million.

2018 Financial Guidance

AMPYRA net revenue is expected to be $330-$350 million. The Company expects to maintain exclusivity of AMPYRA at least through July 30, 2018; this guidance is subject to change based on the appellate court’s decision.
R&D expenses for the full year 2018 are expected to be $100-$110 million and include manufacturing expenses associated with INBRIJA. This guidance is a non-GAAP projection that excludes share-based compensation as more fully described below under "Non-GAAP Financial Measures."
SG&A expenses for the full year 2018 are expected to be $170-$180 million. This guidance is a non-GAAP projection that excludes share-based compensation as more fully described below under "Non-GAAP Financial Measures."
Year-end cash balance for 2018 is projected to be over $300 million
Fourth Quarter 2017 Pipeline and Corporate Updates

INBRIJA (levodopa inhalation powder) Next Steps
The Company resubmitted the NDA for INBRIJA in December 2017. The FDA is expected to inform the Company if the submission has been deemed complete and permits a full review in February 2018.
The Company expects to file a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in Q1 2018.
AMPYRA (dalfampridine) Patent Appeal
In November, 2017, the Company and the defendants filed reply briefs for the appeal to the U.S. Court of Appeals for the Federal Circuit of the District Court’s decision in the AMPYRA patent litigation. The date for oral argument is expected in the first half of 2018.
Both BIO and PhRMA filed amicus briefs in support of the Company’s appeal, raising important issues in conjunction with biopharmaceutical innovation.
Royalty Monetization Transactions/ZANAFLEX (tizanidine hydrochloride) Franchise Sale
In November, 2017, the Company announced royalty monetization transactions of $53 million for FAMPYRA and SELINCRO.
The Company also announced the sale of ZANAFLEX and ZANAFLEX CAPSULES for $4 million.
SYN120 Phase 2 Data in Parkinson’s disease
Data from the Phase 2 proof-of-concept study for SYN120 showed that several of the outcome measures trended in favor of drug versus placebo; neither the primary nor key secondary endpoints achieved statistical significance.
The Company continues to review the data, which will be presented at an upcoming medical meeting.
Tozadenant Program Discontinued
In November, 2017, the Company discontinued its clinical development program for tozadenant, an investigational treatment for Parkinson’s disease. The Company made this decision based on the emergence of serious adverse events in its Phase 3 program.
Webcast and Conference Call

The Company will host a conference call today at 8:30 a.m. ET. To participate, dial (866) 393-4306 (domestic) or (734) 385-2616 (international); access code 8789908. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 11:30 a.m. ET on February 15, 2018 until 11:59 p.m. ET on March 15, 2018. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international); reference code 8789908. The archived webcast will be available in the Investor Relations section of the Acorda website.

Non-GAAP Financial Measures

This press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP), and also certain historical and forward-looking non-GAAP financial measures. In particular, Acorda has provided non-GAAP net income, adjusted to exclude the items below, and has provided 2018 guidance for R&D and SG&A expenses on a non-GAAP basis. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, the Company believes the presentation of non-GAAP net income, when viewed in conjunction with our GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because this measure excludes (i) non-cash compensation charges and benefits that are substantially dependent on changes in the market price of our common stock, (ii) non-cash interest charges related to the accounting for our outstanding convertible debt which are in excess of the actual interest expense owing on such convertible debt as well as non-cash interest related to the Fampyra monetization, non-cash interest charges related to our asset based loan which was terminated in 2017 and acquired Biotie debt, (iii) changes in the fair value of acquired contingent consideration which do not correlate to our actual cash payment obligations in the relevant periods, (iv) acquisition related expenses and related foreign currency losses and gains that pertain to a non-recurring event, (v) corporate restructuring expenses that pertain to a non-recurring event, (vi) asset impairments which are non-cash charges that relate to program terminations that are not routine to the operation of the business, and (vii) gain on sale of assets that pertains to a non-recurring event. The Company believes its non-GAAP net income measure helps indicate underlying trends in the Company’s business and is important in comparing current results with prior period results and understanding projected operating performance. Also, management uses this non-GAAP financial measure to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance.

In addition to non-GAAP net income, we have provided 2018 guidance for R&D and SG&A expenses on a non-GAAP basis. Due to the forward looking nature of this information, the amount of compensation charges and benefits needed to reconcile these measures to the most directly comparable GAAP financial measures is dependent on future changes in the market price of our common stock and is not available at this time. The Company believes that these non-GAAP measures, when viewed in conjunction with our GAAP results, provide investors with a more meaningful understanding of our ongoing and projected R&D and SG&A expenses. Also, management uses these non-GAAP financial measures to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance..

On February 15, 2018 West Pharmaceutical Services, Inc. (NYSE: WST) reported its financial results for the fourth-quarter and full-year 2017 and provided financial guidance for full-year 2018 (Press release, West Pharmaceutical Services, FEB 15, 2018, View Source;p=RssLanding&cat=news&id=2332657 [SID1234524017]).

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!

(PRNewsfoto/West Pharmaceutical Services, I)

Executive Summary

Fourth-quarter 2017 reported net sales of $415.6 million grew 8.7% over the prior-year quarter. At constant currency, organic sales growth was 4.5%. Excluding impacts from the deconsolidation of operations in Venezuela and hurricane-related shutdowns, organic sales growth would have been 6.0%.
Full-year 2017 reported net sales of $1.599 billion grew 6.0% over the prior year. At constant currency, organic sales growth was 5.2%.
Fourth-quarter 2017 reported-diluted EPS was $0.00, reflecting a charge related to U.S. tax reform that reduced EPS by $0.64. Excluding this impact, fourth-quarter 2017 adjusted-diluted EPS was $0.64, as compared to $0.54 in the prior-year quarter.
Full-year 2017 reported-diluted EPS was $1.99, including the aforementioned tax charge. Full-year 2017 adjusted-diluted EPS was $2.78, as compared to $2.18 in the prior year, representing 28% growth.
For full-year 2018, net sales at constant-currency growth is expected to be within our long-term projected 6-8% range. Excluding 2017 net sales that will not recur in 2018, constant-currency sales growth is expected to be at the high end of that 6-8% range.
Full-year 2018 adjusted-diluted EPS is expected to be in a range of $2.80 and $2.90, an increase of 1% to 4%, respectively, compared to $2.78 in 2017.
The Company announced that its Board of Directors has approved a second-quarter 2018 dividend of $0.14 per share. The dividend will be paid on May 2, 2018, to shareholders of record as of April 18, 2018. The Board of Directors also authorized a share repurchase program for calendar-year 2018 of up to 800,000 shares.
In conjunction with the ongoing Global Operations strategy, our Board of Directors has approved a restructuring program that will help streamline our manufacturing plant network. These changes are expected to be implemented over the next twelve to twenty-four months. The plan will require restructuring expense in the range of $8.0 million to $13.0 million.
"Adjusted-diluted EPS," "net sales at constant currency" and "organic sales" are Non-GAAP measurements. See discussion under the heading "Non-GAAP Financial Measures" in this release.

Executive Commentary

"We had a solid finish to the year with fourth-quarter 2017 organic sales growth in line with our expectations," said Eric M. Green, President and Chief Executive Officer. "We were pleased to see a return to double-digit growth in our Biologics market unit and high-single digit growth in our Generics market unit."

Mr. Green concluded, "We expect 2018 will be another year of above-market sales growth and operating profit margin expansion. We have been growing in excess of the 2-3% underlying unit growth of the injectable drug market we serve, as we continue to leverage the demand for our high-value products. Our teams continue to work closely with our global customer base to deliver the highest-quality critical components and solutions in a demanding regulatory backdrop for the packaging and delivery of injectable medicines."

Fourth-Quarter and Full-Year 2017 Financial Results (comparisons to prior-year periods)

Fourth-quarter 2017 reported net sales of $415.6 million grew 8.7% over the prior-year quarter. At constant currency, organic sales growth was 4.5%. Excluding impacts from the deconsolidation of operations in Venezuela and hurricane-related shutdowns, we estimate that organic sales growth would have been 6.0%. Proprietary Products segment organic sales growth was 1.4%. By market unit, fourth-quarter 2017 Proprietary Products segment sales growth was led by double-digit growth in Biologics and high-single digit growth in Generics, offset by a low-single digit decline in Pharma. Contract-Manufactured Products segment organic sales growth was 14.2%.

Full-year reported net sales of $1.599 billion grew 6.0% over the prior year. At constant currency, organic sales growth was 5.2%. Proprietary Products segment organic sales growth was 3.2%. By market unit, 2017 Proprietary Products segment sales growth was led by high-single digit growth in Biologics and mid-single digit growth in Pharma with flat performance in Generics. Contract-Manufactured Products segment organic sales growth was 12.0%.

Gross profit margin in fourth-quarter 2017 was 30.9%, a decline of 140 basis points from the same period last year, mainly due to higher unabsorbed overhead from new capacity at our Waterford and Dublin, Ireland and Kinston, North Carolina sites and due to Contract-Manufactured Products constituting a higher percentage of total sales. Fourth-quarter 2017 operating profit margin was 14.7%, a 30-basis point increase from the same quarter last year (excluding prior-year restructuring and related charges and a pension curtailment gain). SG&A as a percent of sales dropped from 15.9% in Q4 2016 to 14.2% in Q4 2017, due to lower stock-based compensation and U.S. pension expense, slightly offset by higher compensation and benefits and incremental costs associated with foreign currency rate translation.

Gross profit margin in full-year 2017 declined by 110 basis points, mainly due to higher sales of lower-margin Contract-Manufactured Products and unabsorbed overhead from newly-commissioned facilities.

Full-year 2017 reported operating profit margin was 14.3%. Adjusted operating profit margin was 15.0%, an increase of 20 basis points over the prior year (please see reconciliation data at the end of this press release). The decrease in gross profit margin was more than offset by lower SG&A expense as a percentage of sales and other income of $9.1 million for reimbursed costs associated with a technology license.

For the full-year 2017, income tax expense was $80.9 million, which represented an effective tax rate of 36.4%. Excluding a $48.8 million charge from U.S. tax reform in the fourth quarter of 2017 and a $33.1 million benefit from changes associated with accounting for share-based payment transactions, the effective tax rate in 2017 would have been 29.3%. We believe, as a result of U.S. tax reform, our effective 2018 tax rate (excluding any tax benefits from stock-based compensation expense) will be reduced by approximately three percentage points from the 2017 effective tax rate of 29.3%.

During the fourth-quarter 2017, the Company repurchased 475,000 shares of common stock at a cost of $47.4 million. For the full-year 2017, the Company repurchased 800,000 shares of common stock at a cost of $74.4 million.

Full-Year 2018 Financial Guidance

The Company expects 2018 organic sales growth is expected to be within our long-term projected 6-8% range. Excluding sales that will not recur in 2018 ($32.6 million of 2017 sales will not recur in 2018 due to the cessation of a single customer contract, who opted to bring in-house its consumer plastics contract manufacturing operations, and deconsolidation of our Venezuelan operations), the Company expects 2018 sales growth to be at the higher end of that range. Full-year 2018 sales are expected to be in the range of $1.720 billion to $1.730 billion, using an assumed translation exchange rate of $1.20 per Euro.

The Company expects to expand both gross and operating profit margins in 2018. Excluding items from 2017 that will not recur in 2018 (e.g., the Company does not expect any 2018 income from the sale of a technology license that occurred in 2017), operating profit margin is expected to increase in excess of 100 basis points, which includes investments we are making for future growth such as required validation testing at our Waterford facility in advance of commercial production later this year.

In conjunction with the ongoing Global Operations strategy, our Board of Directors has approved a restructuring program that will help streamline our manufacturing plant network and enable us to make investments to drive our high-value proprietary products and healthcare-related contract manufacturing business, and drive margin expansion.

These changes are expected to be implemented over the next twelve to twenty-four months. The plan will require restructuring expense in the range of $8.0 million to $13.0 million and capital expenditures in the range of $9.0 million to $14.0 million. Once fully completed, we expect that the plan will provide the Company with annualized savings in the range of $17.0 million to $22.0 million.

Full-year 2018 adjusted-diluted EPS is expected to be in a range of $2.80 to $2.90, an increase of 1% to 4%, respectively, compared to $2.78 in 2017. This estimate excludes any expense or benefits from the Global Operations restructuring plan. Excluding tax-benefits from stock-based compensation expense ($0.44 of diluted EPS benefits in 2017, an estimated $0.14 of diluted-EPS benefits in 2018), the Company expects full-year 2018 adjusted-diluted EPS to increase by 14% to 18%.

The Company estimates its 2018 capital spending will be approximately $150 million.

Fourth-Quarter 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 9393569.

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 22, 2018, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International) and entering conference ID 9393569.

Forward-Looking Statements

Certain forward-looking statements are included in this release. They use such words as "expected," "continue," "are," "increase," "will," "estimated," "believe," "expect," "include," "estimate," and other similar terminology. These statements reflect management’s current expectations regarding future events and operating performance and speak only as of the date of this release. There is no certainty that actual results will be achieved in-line with current expectations. These forward-looking statements involve a number of risks and uncertainties. The following are some of the factors that could cause our actual results to differ materially from those expressed in or underlying our forward-looking statements: customers’ changing inventory requirements and manufacturing plans; customer decisions to move forward with our new products and product categories; average profitability, or mix, of the products we sell; dependence on third-party suppliers and partners; interruptions or weaknesses in our supply chain; increased raw material costs; fluctuations in currency exchange; and the ability to meet development milestones with key customers. This list of important factors is not all inclusive. For a description of certain additional factors that could cause the Company’s future results to differ from those expressed in any such forward-looking statements, see Item 1A, entitled "Risk Factors," in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016.

Except as required by law or regulation, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.

Non-GAAP Financial Measures

This press release and the preceding discussion of the Company’s results, financial guidance, and the accompanying financial tables use the following financial measures that have not been calculated in accordance with U.S. generally accepted accounting principles (GAAP), and therefore are referred to as Non-GAAP financial measures:

Net sales at constant currency (organic sales growth)
Adjusted operating profit
Adjusted operating profit margin
Adjusted income tax expense
Adjusted net income
Adjusted diluted EPS
Net debt
Total invested capital
Net debt-to-total invested capital
The Company believes that these Non-GAAP measures of financial results provide useful information to management and investors regarding business trends, results of operations, and the Company’s overall performance and financial position. The Company’s executive management team uses these financial measures to evaluate the performance of the Company in terms of profitability and efficiency, to compare operating results to prior periods, to evaluate changes in the operating results of each segment, and to measure and allocate financial resources to its segments. The Company believes that the use of these Non-GAAP financial measures provides an additional tool for investors to use in evaluating ongoing operating results and trends in comparing its financial measures with other companies.

The Company’s executive management does not consider such Non-GAAP measures in isolation or as an alternative to such measures determined in accordance with GAAP. The principal limitation of these financial measures is that they exclude significant expenses and income that are required by GAAP to be recorded. In addition, they are subject to inherent limitations as they reflect the exercise of judgment by management about which items are excluded. In order to compensate for these limitations, Non-GAAP financial measures are presented in connection with GAAP results. The Company urges investors and potential investors to review the reconciliations of its Non-GAAP financial measures to the comparable GAAP financial measures, and not to rely on any single financial measure to evaluate the Company’s business.

Net sales at constant currency translates the current-period reported sales of subsidiaries whose functional currency is other than the U.S. Dollar at the applicable foreign exchange rates in effect during the comparable prior-year period. In calculating adjusted operating profit, adjusted operating profit margin, adjusted income tax expense, adjusted net income and adjusted diluted EPS, the Company excludes the impact of items that are not considered representative of ongoing operations. Such items may include restructuring and related costs, certain asset impairments, other specifically-identified gains or losses, and discrete income tax items. A reconciliation of these adjusted Non-GAAP measures to the comparable GAAP financial measures is included in the accompanying tables.

The following is a description of the items excluded from adjusted operating profit, adjusted income tax expense, adjusted net income, and adjusted diluted EPS for the three and twelve months presented in the accompanying tables:

Tax law changes – During the three and twelve months ended December 31, 2017, the Company recorded a net tax charge of $48.8 million due to the estimated impact of U.S. tax reform, including the repatriation tax on accumulated foreign earnings and the remeasurement of deferred tax assets and other tax liabilities, as well as the impact of changes in enacted international tax rates on previously-recorded deferred tax asset and liability balances. During the three and twelve months ended December 31, 2016, the Company recorded a discrete tax charge of $0.7 million and $1.0 million, respectively, resulting from the impact of changes in enacted tax rates on its previously-recorded deferred tax asset and liability balances.

Venezuela deconsolidation – During the twelve months ended December 31, 2017, as a result of the continued deterioration of conditions in Venezuela, as well as its continued reduced access to U.S. Dollar settlement controlled by the Venezuelan government, the Company recorded a charge of $11.1 million related to the deconsolidation of its Venezuelan subsidiary, following its determination that it no longer met the GAAP criteria for control of that subsidiary. As of April 1, 2017, the Company’s consolidated financial statements exclude the results of its Venezuelan subsidiary.

Restructuring and related charges – During the three months ended December 31, 2016, the Company recorded $2.7 million in restructuring and related charges, consisting of $1.1 million for severance charges, $1.4 million for non-cash asset write-downs associated with the discontinued use of certain equipment, and $0.2 million for other charges. During the twelve months ended December 31, 2016, the Company incurred $26.4 million in restructuring and related charges, including $8.9 million for severance charges, $17.3 million for non-cash asset write-downs associated with the discontinued use of certain trademarks and certain equipment, and $0.2 million for other charges.

Pension curtailment gain – During the three and twelve months ended December 31, 2016, the Company recorded a pension curtailment gain of $2.1 million in connection with its decision to freeze both its U.S. qualified and non-qualified defined benefit pension plans as of January 1, 2019.

Venezuela currency devaluation – During the twelve months ended December 31, 2016, the Company recorded a charge of $2.7 million related to the devaluation of the Venezuelan Bolivar from the previously-prevailing official exchange rate of 6.3 Bolivars to U.S. Dollars to 10.0 Bolivars to U.S. Dollars.

WEST PHARMACEUTICAL SERVICES, INC.

CONSOLIDATED STATEMENTS OF INCOME

(UNAUDITED)

(in millions, except per share data)

Three Months Ended

December 31,

Twelve Months Ended

December 31,

2017

2016

2017

2016

Net sales

$415.6

100%

$382.3

100%

$1,599.1

100%

$1,509.1

100%

Cost of goods and services sold

287.1

69

258.9

68

1,086.5

68

1,008.0

67

Gross profit

128.5

31

123.4

32

512.6

32

501.1

33

Research and development

9.7

2

9.6

2

39.1

3

36.8

2

Selling, general and administrative expenses

58.9

14

60.9

16

242.6

15

239.8

16

Other (income) expense, net

(1.1)

–

(1.4)

–

2.0

–

27.7

2

Operating profit

61.0

15

54.3

14

228.9

14

196.8

13

Interest expense, net

1.7

1

1.1

–

6.5

–

7.0

–

Income before income taxes

59.3

14

53.2

14

222.4

14

189.8

13

Income tax expense

61.8

15

16.1

4

80.9

5

54.4

4

Equity in net income of affiliated companies

2.5

1

2.0

–

9.2

–

8.2

1

Net income

$ –

-%

$39.1

10%

$150.7

9%

$143.6

10%

Net income per share:

Basic

$ –

$0.53

$2.04

$1.96

Diluted

$ –

$0.52

$1.99

$1.91

Average common shares outstanding

74.2

73.2

73.9

73.3

Average shares assuming dilution

75.9

74.9

75.8

75.0

WEST PHARMACEUTICAL SERVICES

REPORTING SEGMENT INFORMATION

(UNAUDITED)

(in millions)

Three Months Ended

Twelve Months Ended

December 31,

December 31,

Net Sales:

2017

2016

2017

2016

Proprietary Products

$306.4

$290.0

$1,236.9

$1,189.9

Contract-Manufactured Products

109.2

92.4

362.5

320.2

Eliminations

–

(0.1)

(0.3)

(1.0)

Consolidated Total

$415.6

$382.3

$1,599.1

$1,509.1

Operating Profit (Loss):

Proprietary Products

$54.0

$56.3

$242.2

$241.9

Contract-Manufactured Products

18.2

12.6

48.3

38.2

U.S. pension expense

(1.1)

(2.2)

(4.3)

(8.8)

Stock-based compensation expense

(2.5)

(5.4)

(16.1)

(19.5)

General corporate costs

(7.6)

(6.4)

(30.1)

(28.0)

Adjusted Operating Profit

$61.0

$54.9

$240.0

$223.8

Adjusted Operating Profit Margin

14.7%

14.4%

15.0%

14.8%

Venezuela deconsolidation

–

–

(11.1)

–

Venezuela currency devaluation

–

–

–

(2.7)

Restructuring and related charges

–

(2.7)

–

(26.4)

Pension curtailment gain

–

2.1

–

2.1

Reported Operating Profit

$61.0

$54.3

$228.9

$196.8

Reported Operating Profit Margin

14.7%

14.2%

14.3%

13.0%

WEST PHARMACEUTICAL SERVICES

RECONCILIATION OF NON-GAAP MEASURES (UNAUDITED)

Please refer to "Non-GAAP Financial Measures" for more information

(in millions, except per share data)

Reconciliation of Reported and Adjusted Operating Profit, Net Income and Diluted EPS

Three months ended December 31, 2017

Operating
profit

Income
tax
expense

Net
income

Diluted
EPS

Reported (GAAP)

$61.0

$61.8

$ –

$ –

Tax law changes

–

(48.8)

48.8

0.64

Adjusted (Non-GAAP)

$61.0

$13.0

$48.8

$0.64

Twelve months ended December 31, 2017

Operating
profit

Income
tax
expense

Net
income

Diluted
EPS

Reported (GAAP)

$228.9

$80.9

$150.7

$1.99

Tax law changes

–

(48.8)

48.8

0.64

Venezuela deconsolidation

11.1

–

11.1

0.15

Adjusted (Non-GAAP)

$240.0

$32.1

$210.6

$2.78

Three months ended December 31, 2016

Operating
profit

Income
tax
expense

Net
income

Diluted
EPS

Reported (GAAP)

$54.3

$16.1

$39.1

$0.52

Restructuring and related charges

2.7

0.9

1.8

0.02

Pension curtailment gain

(2.1)

(0.8)

(1.3)

(0.01)

Tax law changes

–

(0.7)

0.7

0.01

Adjusted (Non-GAAP)

$54.9

$15.5

$40.3

$0.54

Twelve months ended December 31, 2016

Operating
profit

Income
tax
expense

Net
income

Diluted
EPS

Reported (GAAP)

$196.8

$54.4

$143.6

$1.91

Restructuring and related charges

26.4

9.0

17.4

0.23

Venezuela currency devaluation

2.7

–

2.7

0.04

Pension curtailment gain

(2.1)

(0.8)

(1.3)

(0.01)

Tax law changes

–

(1.0)

1.0

0.01

Adjusted (Non-GAAP)

$223.8

$61.6

$163.4

$2.18

WEST PHARMACEUTICAL SERVICES

RECONCILIATION OF NON-GAAP MEASURES (UNAUDITED)

Please refer to "Non-GAAP Financial Measures" for more information

(in millions, except per share data)

Reconciliation of Net Sales to Net Sales at Constant Currency (1)

Three months ended December 31, 2017

Proprietary

CM

Eliminations

Total

Reported net sales (GAAP)

$306.4

$109.2

$ –

$415.6

Effect of changes in currency translation rates

(12.3)

(3.6)

–

(15.9)

Net sales at constant currency (Non-GAAP) (1)

$294.1

$105.6

$ –

$399.7

Twelve months ended December 31, 2017

Proprietary

CM

Eliminations

Total

Reported net sales (GAAP)

$1,236.9

$362.5

$(0.3)

$1,599.1

Effect of changes in currency translation rates

(8.4)

(3.8)

–

(12.2)

Net sales at constant currency (Non-GAAP) (1)

$1,228.5

$358.7

$(0.3)

$1,586.9

(1)

Net sales at constant currency translates the current-period reported sales of subsidiaries whose functional currency is other than the U.S. Dollar at the applicable foreign exchange rates in effect during the comparable prior-year period.

WEST PHARMACEUTICAL SERVICES

RECONCILIATION OF NON-GAAP MEASURES (UNAUDITED)

Please refer to "Non-GAAP Financial Measures" for more information

(in millions, except per share data)

Reconciliation of Reported Diluted EPS Guidance to Adjusted Diluted EPS Guidance

2017 Actual

2018 Guidance

% Change

Reported diluted EPS

$1.99

$2.80 to $2.90

40.7% to 45.7%

Venezuela deconsolidation

0.15

–

Tax law changes impact

0.64

–

Adjusted diluted EPS

$2.78

$2.80 to $2.90

0.7% to 4.3%

Stock comp tax benefit

(0.44)

(0.14)

Adjusted diluted EPS

excl. stock comp tax benefit

$2.34

$2.66 to $2.76

13.7% to 17.9%

Notes:

See "Full-Year 2018 Financial Guidance" and "Non-GAAP Financial Measures" in today’s press release for additional information regarding adjusted diluted EPS.

Guidance includes various currency exchange rate assumptions, most significantly the Euro at $1.20 for 2018. 2017 results were translated at an average rate of $1.13. Each $0.01 change in the Euro exchange rate results in approximately a $0.01 change in EPS.

Guidance excludes possible cost and benefits from the announced Global Operations restructuring plan.

WEST PHARMACEUTICAL SERVICES

CASH FLOW ITEMS

(UNAUDITED)

(in millions)

Twelve Months Ended December 31,

2017

2016

Depreciation and amortization

$96.7

$90.7

Operating cash flow

$263.3

$219.4

Capital expenditures

$130.8

$170.2

WEST PHARMACEUTICAL SERVICES

FINANCIAL CONDITION

(UNAUDITED)

(in millions)

As of
December 31, 2017

As of
December 31, 2016

Cash and cash equivalents

$235.9

$203.0

Debt

$197.0

$228.6

Equity

$1,279.9

$1,117.5

Net debt-to-total invested capital (2)

N/A

2.2%

Working capital

$464.0

$400.9

(2)

Net debt and total invested capital are Non-GAAP measures. Net debt is determined by reducing total debt by the amount of cash and cash equivalents, and for purpose of measuring net debt to invested capital, total invested capital is the sum of net debt and shareholders’ equity. Please refer to "Non-GAAP Financial Measures" in this release for additional information regarding those measures.

On February 14, 2018 Alkermes plc (Nasdaq: ALKS) today reported financial results for the twelve months ended Dec. 31, 2017 and provided financial expectations for 2018 (Press release, Alkermes, FEB 14, 2018, View Source [SID1234523962]).

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!

Quarter Ended Dec. 31, 2017 Financial Highlights

•Total revenues for the quarter were $275.4 million. This compared to $213.5 million for the same period in the prior year, representing an increase of 29%.

•Net loss according to generally accepted accounting principles in the U.S. (GAAP) was $9.8 million, or a basic and diluted GAAP loss per share of $0.06. This compared to GAAP net loss of $21.1 million, or a basic and diluted GAAP loss per share of $0.14 for the same period in the prior year.

•Non-GAAP net income was $50.3 million, or a non-GAAP basic earnings per share of $0.33 and non-GAAP diluted earnings per share of $0.31, for the quarter. This compared to non-GAAP net income of $23.3 million, or a non-GAAP basic and diluted earnings per share of $0.15, for the same period in the prior year.

Quarter Ended Dec. 31, 2017 Financial Results

Revenues

•Net sales of VIVITROL were $75.6 million, compared to $62.1 million for the same period in the prior year, representing an increase of 22%.

•Net sales of ARISTADA were $28.3 million, compared to $17.3 million for the same period in the prior year, representing an increase of 64%.

•Manufacturing and royalty revenues from RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA were $78.2 million, compared to $74.0 million for the same period in the prior year.

•Manufacturing and royalty revenues from AMPYRA/FAMPYRA1 were $38.1 million, compared to $32.3 million for the same period in the prior year.

•Revenues from the collaboration with Biogen for BIIB098 (formerly ALKS 8700) included $28.0 million of license revenue and $2.3 million of R&D reimbursement.

Costs and Expenses

•Operating expenses were $269.5 million, compared to $237.1 million for the same period in the prior year.

•Income tax provision of $20.6 million included a $21.5 million tax charge related to the reduction in the value of our deferred tax assets due to the enactment of the Tax Cuts and Jobs Act of 2017. This compared to an income tax benefit of $3.2 million for the same period in the prior year.

Calendar Year 2017 Financial Highlights

•Total revenues increased 21% to $903.4 million in 2017, which included VIVITROL net sales of $269.3 million and ARISTADA net sales of $93.5 million. This compared to total revenues of $745.7 million for 2016, which included VIVITROL net sales of $209.0 million and ARISTADA net sales of $47.2 million. Please see the tables at the end of this press release for a detailed breakdown of the revenues from our key commercial products.

•GAAP net loss was $157.9 million, or a basic and diluted GAAP loss per share of $1.03, for 2017. This compared to a GAAP net loss of $208.4 million, or a basic and diluted GAAP loss per share of $1.38, for 2016.

•Non-GAAP net income was $27.8 million, or a non-GAAP basic earnings per share of $0.18 and non-GAAP diluted earnings per share of $0.17, for 2017. This compared to non-GAAP net loss of $10.3 million, or a non-GAAP basic and diluted loss per share of $0.07, for 2016.

•At Dec. 31, 2017, Alkermes recorded cash, cash equivalents and total investments of $590.7 million, compared to $619.2 million at Dec. 31, 2016. At Dec. 31, 2017, the company’s total debt outstanding was $281.4 million, compared to $283.7 million at Dec. 31, 2016.

"Our financial results in 2017 were driven by the strong year-over-year growth of our proprietary products, VIVITROL and ARISTADA, our base royalty and manufacturing business and our strategic alliance with Biogen for BIIB098. We exited the year well positioned to execute on our key strategic initiatives in 2018," commented James Frates, Chief Financial Officer of Alkermes. "Looking ahead, 2018 will be a transformative year for Alkermes. Our financial expectations for 2018 reflect important investments that will drive future value as we advance our late-stage pipeline and prepare for the anticipated launch of ALKS 5461, with the planned expansion of our commercial organization midyear. We also expect solid growth for VIVITROL and ARISTADA, and remain committed to driving awareness and advancing the treatment paradigm for these important medicines."

Recent Events:

•ALKS 5461: In January 2018, Alkermes submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD). ALKS 5461 was granted Fast Track status by the FDA in October 2013 for the adjunctive treatment of MDD in patients with an inadequate response to standard antidepressant therapies.

•BIIB098: Biogen and Alkermes announced a license and collaboration agreement for the development and commercialization of BIIB098 for the treatment of relapsing forms of Multiple Sclerosis (MS). Under the terms of the agreement, Alkermes granted Biogen an exclusive, worldwide license to develop and commercialize BIIB098 and Biogen will pay Alkermes a mid-teens royalty on worldwide net sales of BIIB098. Biogen is responsible for all development and commercialization expenses, effective Jan. 1, 2018. Alkermes may also receive milestone payments for BIIB098 with a maximum aggregate value of $200 million upon certain clinical and regulatory achievements.

•ARISTADA: A NDA was filed with the FDA for Aripiprazole Lauroxil NanoCrystal Dispersion (ALNCD), a novel, investigational product designed for initiation onto ARISTADA. A target action date of June 30, 2018 was assigned to the ALNCD NDA under the Prescription Drug User Fee Act (PDUFA).

•VIVITROL: Results from the National Institute on Drug Abuse (NIDA)-funded X:BOT study, comparing extended-release naltrexone (VIVITROL) and buprenorphine-naloxone, were published in The Lancet. Data from the study demonstrated that, once treatment was initiated, both medications were equally safe and effective in preventing relapse to opioid dependence.

•ALKS 4230: Preclinical data on ALKS 4230 was presented at the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. The data showed that treatment with ALKS 4230 significantly delayed tumor growth and led to accumulation of tumor-killing T cells in the tumor microenvironment in individualized and humanized melanoma xenograft models of tumor immunology.

2

"We are making significant progress in advancing our pipeline of late-stage CNS development candidates, highlighted by the recent submission of the ALKS 5461 NDA, the recently announced license and collaboration agreement with Biogen to develop and commercialize BIIB098, and as we near completion of enrollment in the six-month pivotal weight study for ALKS 3831," said Richard Pops, Chief Executive Officer of Alkermes. "Alkermes has worked for many years toward this moment. With a diversified CNS business and significant news flow expected across our pipeline of development candidates in 2018, we are focused on executing on our business strategy to bring these important potential new medicines to patients and creating value for our shareholders."

2018 Expected Milestones

The following outlines the company’s expected milestones for 2018. The following statements are forward-looking, and actual results may differ materially. Please see "Note Regarding Forward-Looking Statements" at the end of this press release for risks that could cause results to differ materially from these forward-looking statements.

•VIVITROL

oPublication and presentation of detoxification protocols for induction onto VIVITROL from recent clinical trials (H1)

•ARISTADA

oALNCD for initiation onto ARISTADA PDUFA target action date (June 30, 2018)

•ALKS 5461

oAssignment of PDUFA target action date, following NDA acceptance (Q2)

oPotential Advisory Committee meeting and FDA action (H2)

•ALKS 3831

oENLIGHTEN-2 six-month weight study enrollment completion (Q1)

oPhase 1 human metabolic study data presentation (H1)

oENLIGHTEN-2 topline results (Fall)

•BIIB098 (formerly ALKS 8700)

oPotential receipt of $50 million payment following initial data from EVOLVE-MS-2 gastrointestinal head-to-head study (mid-2018)

oPlanned NDA submission for treatment of MS (H2)

•ALKS 4230

oDose escalation data and dose expansion initiation (H2)

oPlanned submission of Investigational New Drug (IND) application for subcutaneous dosing phase 1 study (H2)

Financial Expectations for 2018

The following outlines the company’s financial expectations for 2018, which include investments in commercial infrastructure in preparation for the expected launch of ALKS 5461 and in the company’s pipeline of late-stage development candidates. The following statements are forward-looking, and actual results may differ materially. Please see "Note Regarding Forward-Looking Statements" at the end of this press release for risks that could cause results to differ materially from these forward-looking statements.

•Revenues: The company expects total revenues to range from $975 million to $1.025 billion, driven by continuing growth of VIVITROL and ARISTADA. Included in this total revenue expectation, Alkermes expects VIVITROL net sales to range from $300 million to $330 million, and ARISTADA net sales to range from $140 million to $160 million.

•Cost of Goods Manufactured and Sold: The company expects cost of goods manufactured and sold to range from $180 million to $190 million.

•Research and Development (R&D) Expenses: The company expects R&D expenses to range from $415 million to $445 million.

•Selling, General and Administrative (SG&A) Expenses: The company expects SG&A expenses to range from $555 million to $585 million. This increase reflects important planned investment in the

3

expansion of our commercial organization in preparation for the anticipated launch of ALKS 5461.

•Amortization of Intangible Assets: The company expects amortization of intangibles to be approximately $65 million.

•Net Interest Expense: The company expects net interest expense to be approximately $10 million.

•Income Tax Expense: The company expects income tax expense of up to $10 million.

•GAAP Net Loss: The company expects GAAP net loss to range from $250 million to $280 million, or a basic and diluted loss per share of $1.61 to $1.81, based on a weighted average basic and diluted share count of approximately 155 million shares outstanding.

•Non-GAAP Net Loss: The company expects non-GAAP net loss to range from $5 million to $35 million, or a non-GAAP basic and diluted loss per share of $0.03 to $0.23, based on a weighted average basic and diluted share count of approximately 155 million shares outstanding.

•Capital Expenditures: The company expects capital expenditures to range from $80 million to $90 million.

Conference Call

Alkermes will host a conference call at 8:30 a.m. ET (1:30 p.m. GMT) on Wednesday, Feb. 14, 2018, to discuss these financial results and provide an update on the company. The conference call may be accessed by visiting Alkermes’ website or by dialing +1 888 424 8151 for U.S. callers and +1 847 585 4422 for international callers. The conference call ID number is 6037988. In addition, a replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. GMT) on Wednesday, Feb. 14, 2018, through 5:00 p.m. ET (10:00 p.m. GMT) on Wednesday, Feb. 21, 2018, and may be accessed by visiting Alkermes’ website or by dialing +1 888 843 7419 for U.S. callers and +1 630 652 3042 for international callers. The replay access code is 6037988.

On February 14, 2018 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new cancer therapies, reported its financial results for the second quarter ended December 31, 2017 (Press release, DelMar Pharmaceuticals, FEB 14, 2018, View Source [SID1234523988]). DelMar executive management will host a business update conference call for investors, analysts and other interested parties on Tuesday, February 20, 2018 at 4:30 p.m. Eastern Standard Time.

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!

"This quarter has been an exciting period for DelMar. Our priority is to leverage VAL-083’s unique mechanism of action to efficiently advance it into the most promising indications, including MGMT-unmethylated glioblastoma and platinum-resistant ovarian cancer. We now have a revised VAL-083 development strategy that is focused on MGMT methylation status in glioblastoma, which has become routine in clinical practice as a biomarker which correlates with resistance to the standard-of-care chemotherapy with temozolomide (Temodar "TMZ"), and patient outcomes. We believe using this biomarker will allow us to optimize patient selection for treatment with our lead drug candidate, VAL-083, thereby streamlining development and enhancing opportunities for success in our clinical development programs," commented Saiid Zarrabian, Interim President and Chief Executive Officer.

KEY DEVELOPMENTS AND UPDATED STRATEGIC PLAN

● Evaluation of MGMT promoter methylation status has increasingly become common practice in the diagnostic assessment of glioblastoma multiforme (GBM). DelMar believes that this provides it with an enhanced ability to leverage MGMT methylation as a biomarker to optimize patient selection for DelMar’s novel DNA-targeting agent in the treatment of GBM.

● The National Comprehensive Cancer Network (NCCN), provided updated guidelines for the standard treatment of GBM based on MGMT methylation status. DelMar believes these recently published guidelines may allow the Company to capitalize on VAL-083’s unique mechanism of action and activity in the estimated 60 percent of GBM patients whose tumors are MGMT-unmethylated.

● The U.S. Food and Drug Administration (FDA) allowed a second Investigational New Drug Application (IND) to enable DelMar to study its lead drug candidate, VAL-083, as a potential treatment for ovarian cancer.

● In November 2017, at the annual meeting of the Society for NeuroOncology (SNO), DelMar presented a positive interim update from its ongoing open label Phase 2 clinical trial in patients with MGMT-unmethylated recurrent GBM (rGBM) whose tumors have recurred following treatment with temozolomide (Avastin naïve). This study, which was initiated in February 2017, is being conducted at the University of Texas MD Anderson Cancer Center.

● In December 2017, the FDA fully approved Avastin (bevacizumab) which may impact our ability to recruit suitable patients for our STAR-3 Phase 3 clinical trial.

● In December 2017, the FDA granted Fast Track designation for VAL-083, in recurrent glioblastoma.

● Based on the above developments, and other factors as stated in DelMar’s Quarterly Report on Form 10-Q for the quarter ended December 31, 2017 (10-Q) filed with the Securities and Exchange Commission (SEC) on February 14, 2018, DelMar has decided to put the STAR-3 program on hold for up to 12 months and will suspend further site or patient enrollment. This will allow DelMar to fully evaluate the possible impact of Avastin’s recent approval by the FDA on patient enrollment for this study, and possible protocol amendments, non-dilutive financing sources, as well as to increase focus on the MGMT-unmethylated clinical studies currently underway as further described in the SEC filings. During this interim evaluation period, DelMar will continue to provide treatment to patients already enrolled in the STAR-3 trial, and consider, on a case-by-case basis, and subject to required institutional and regulatory approvals, providing VAL-083 to patients in accordance with our expanded access policy

● Based on this updated strategy, DelMar believes it has cash available into the second quarter of calendar 2019.

For further details on the Company’s operating and financial results, as well as more detail about its updated strategy, refer to DelMar’s 10-Q filed with the SEC on February 14, 2018, View Source

CONFERENCE CALL DETAILS

DelMar plans to host a conference call to discuss its financial results for the quarter ended December 31, 2017 and provide a corporate update on Tuesday, February 20, 2018, at 4:30 p.m. Eastern Time. For both "listen-only" participants and those who wish to take part in the question and answer portion of the call, the telephone Dial-in Number is 1 888 632 3384 (toll free) with Conference ID DELMAR.

A replay of the conference call will be available on the IR Calendar of the Investors section of the Company’s website at www.delmarpharma.com and will be archived for 30 days.

SUMMARY OF FINANCIAL RESULTS FOR THE PERIOD ENDED DECEMBER 31, 2017

At December 31, 2017, the Company had cash and clinical trial deposits on hand of approximately $12.0 million (unaudited).

For the three months ended December 31, 2017, the Company reported a net loss of $3,161,598 or $0.14 per share, compared to a net loss of $1,321,973, or $0.13 per share, for the three months ended December 31, 2016. For the six months ended December 31, 2017, the Company reported a net loss of $5,828,004 or $0.31 per share, compared to a net loss of $3,612,312, or $0.36 per share, for the six months ended December 31, 2016.

-2-

The following represents selected financial information as of December 31, 2017. The Company’s financial information has been prepared in accordance with U.S. GAAP and this selected information should be read in conjunction with DelMar’s consolidated financial statements and management’s discussion and analysis ("MD&A"), as filed.

DelMar’s financial statements as filed with the U.S. Securities Exchange Commission can be viewed on the company’s website at: View Source

Selected Balance Sheet Data

December 31,
2017
$

June 30,
2017
$

Cash 11,021,568 6,586,014
Working capital 9,959,948 6,566,371
Total assets 12,216,116 7,911,021
Derivative liability 5,549 61,228
Total stockholders’ equity 9,983,574 6,578,524

Selected Statement of Operations Data

For the three months ended:

December 31, December 31,
2017 2016
$ $

Research and development 2,141,945 1,120,910
General and administrative 1,011,879 571,286
Change in fair value of stock option and derivative liabilities 889 (361,668 )
Foreign exchange loss (gain) 7,120 (8,495 )
Interest income (235 ) (60 )
Net and comprehensive loss for the period 3,161,598 1,321,973
Series B Preferred stock dividend 54,066 159,756
Net and comprehensive loss available to common stockholders 3,215,664 1,481,729
Basic weighted average number of shares outstanding 22,559,234 11,424,485
Basic and fully diluted loss per share 0.14 0.13

Excluding the impact of non-cash expense, research and development expenses increased to $2,015,570 during the current quarter compared to $1,186,637 for the same period in the prior year. The increase was largely attributable to an increase in clinical development costs related to the three clinical studies ongoing for VAL-083, as well as personnel, and preclinical research costs. Excluding the impact of non-cash expenses, general and administrative expenses increased in the quarter ended December 31, 2017 to $909,747 from $580,761 for the quarter ended December 31, 2016.

-3-

For the six months ended:

December 31, December 31,
2017 2016
$ $

Research and development 4,076,588 1,853,639
General and administrative 1,756,500 1,887,925
Change in fair value of stock option and derivative liabilities (55,679 ) (135,980 )
Foreign exchange loss 50,986 6,829
Interest income (391 ) (101 )
Net and comprehensive loss for the period 5,828,004 3,612,312
Series B Preferred stock dividend 95,732 467,054
Net and comprehensive loss available to common stockholders 5,923,736 4,079,366
Basic weighted average number of shares outstanding 18,882,259 11,363,237
Basic and fully diluted loss per share 0.31 0.36

Excluding the impact of non-cash expense, research and development expenses increased to $3,955,187 during the six months ended December 31, 2017 compared to $1,863,529 for the same period in the prior year. The increase was largely attributable to VAL-083 clinical development and manufacturing costs related to the Company’s STAR-3 refractory-GBM clinical trial and two Phase 2 clinical trials in MGMT-unmethylated GBM.

Excluding the impact of non-cash expenses, general and administrative expenses increased in the current six months to $1,586,005 compared to $1,307,175 for the six months ended December 31, 2016.

We believe, based on our current estimates, that we will be able to fund our operations into the second quarter of calendar year 2019.

On February 14, 2018 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, reported that its abstract highlighting interim results of its Phase 2 study on HS-110 (viagenpumatucel-L) and nivolumab (Opdivo) combination therapy in the treatment of advanced non-small cell lung cancer (NSCLC), has been accepted as a scientific poster presentation during the 2018 Keystone Symposia Conference XI: Immunological Memory: Innate, Adaptive and Beyond, February 25 – March 1, 2018 in Austin (Press release, Heat Biologics, FEB 14, 2018, View Source [SID1234523971]).

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!

The poster presentation details are as follows:

Title: "Correlation of Adaptive Immune Response with Clinical Response after Treatment with Viagenpumatucel-L and Nivolumab in Previously Treated Non-Small Cell Lung Cancer (NSCLC) Patients"
Session Date/Time: February 27, 2018, 7:30 p.m. – 10 p.m. CT
Authors: Lori McDermott, MSc; Vamsidhar Velcheti, MD; Roger B. Cohen, MD; Jeff Hutchins, PhD; Daniel Morgensztern, MD
In addition, Heat will be hosting an analyst and investor event in New York City on February 28, 2018, at 8 a.m. ET, to discuss these results. Event details and webcast information to be provided prior to the event.