On August 1, 2019 Ziopharm Oncology, Inc. ("Ziopharm") (Nasdaq: ZIOP), reported that it has entered into an agreement with existing investors for the exercise of previously issued warrants to purchase common stock in a private placement that is expected to result in gross proceeds to Ziopharm of approximately $45 million, before deducting placement agent and other offering expenses (Press release, Ziopharm, AUG 1, 2019, View Source [SID1234538072]). The private placement, which strengthens Ziopharm’s balance sheet and provides capital to fund operations into 2021, is being led by existing stockholder, MSD Partners, L.P.

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Pursuant to the terms of the securities issuance agreement, at the closing of the private placement, the investors have agreed to exercise their warrants for an aggregate of 15,015,152 shares of common stock, at an exercise price of $3.01 per share. The warrants being exercised were originally issued by Ziopharm in a private placement Ziopharm closed in November 2018

Concurrently, in this private placement, Ziopharm will issue new warrants to purchase up to 15,015,152 additional shares of common stock. The warrants will become exercisable six months following the date of issuance, will expire on the fifth anniversary of the initial exercise date and have an exercise price of $7.00.

The private placement is expected to close on or about July 30, 2019, subject to the satisfaction of customary closing conditions. Additional details regarding the private placement will be included in a Form 8-K to be filed by Ziopharm with the Securities and Exchange Commission (the "SEC").

The warrants to be issued in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"). Accordingly, these securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. As part of the private placement, Ziopharm has agreed to file a registration statement with the SEC for the purpose of registering the resale of the shares of Ziopharm common stock to be issued in the private placement as well as the shares of Ziopharm common stock issuable upon exercise of the warrants.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

On August 1, 2019 IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) ("IntelGenx"), a leader in pharmaceutical films, reported that it will release its second quarter 2019 financial results after market close on August 8, 2019 (Press release, IntelGenx, AUG 1, 2019, View Source;Conference-Call-to-Follow/default.aspx [SID1234538071]).

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An accompanying conference call will be hosted by Dr. Horst G. Zerbe, Chief Executive Officer, and Mr. Andre Godin, President and Chief Financial Officer, to discuss the results and provide a business update. Details of the conference call and webcast are below:

Date: Thursday, August 8, 2019

Time: 4:30 p.m. ET

Conference dial-in: (833) 231-8269

International dial-in: (647) 689-4114

Conference ID: 5684153

Live Webcast Registration: Click here

Following the live call, an archived replay of the webcast will be available for 90 days on IntelGenx’s website at www.intelgenx.com under "Presentations" in the Investors section.

On August 1, 2019 Emergent BioSolutions Inc. (NYSE: EBS) reported financial results for the second quarter and six months ended June 30, 2019 (Press release, Emergent BioSolutions, AUG 1, 2019, View Source [SID1234538070]).

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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

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Q2 2019 AND RECENT BUSINESS ACCOMPLISHMENTS

Procurement

Announced the exercise by the Biomedical Advanced Research and Development Authority (BARDA) of the first contract option, valued at $261 million, to procure doses of the next generation anthrax vaccine candidate AV7909 (anthrax vaccine adsorbed with adjuvant) for delivery into the U.S. Strategic National Stockpile (SNS) over 12 months.

Awarded a 10-year procurement contract from the U.S. Department of Health and Human Services (HHS), valued at approximately $535 million, to deliver VIGIV (vaccinia immune globulin intravenous) into the SNS in support of smallpox preparedness.

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Product Development

Initiated a Phase III trial to evaluate the lot consistency, immunogenicity and safety of the next generation anthrax vaccine candidate AV7909, with funding from BARDA, pursuant to a development and procurement contract signed in September 2016; the Company also continued manufacturing of AV7909, first begun in Q1 2019, and is preparing to initiate in the third quarter the first delivery of doses of AV7909 into the SNS pursuant to the same September 2016 contract. More recently, enrollment for this Phase III trial has now been completed, ahead of schedule.

Provided interim analysis of the Phase II clinical study evaluating the safety and immunogenicity of the Company’s chikungunya virus virus-like-particle (VLP) vaccine candidate, CHIKV-VLP, showing with a single dose administered up to 98% of study participants produced neutralizing antibodies against the chikungunya virus by day 7, with persistent effect out to the six-month visit, including in the single-dose regimen.

Granted marketing authorization in five EU countries for the Company’s oral typhoid vaccine, expanding the availability of this vaccine across Europe.

Granted approval by the U.S. Food and Drug Administration (FDA) of a change in the storage conditions of the Company’s oral cholera vaccine, Vaxchora (Cholera Vaccine, Live, Oral) from frozen to 2-8 degrees Celsius as well as the transfer of bulk drug substance manufacturing from the Company’s facilities in San Diego to its manufacturing site in Bern, Switzerland.

2019 FINANCIAL PERFORMANCE (unaudited)

(I) Quarter Ended June 30, 2019 (Q2)

Revenues

Total Revenues
For Q2 2019, total revenues were $243.2 million, an increase of 10% over 2018. Total revenues reflect the contribution of recently acquired products as well as increased contracts and grants revenue.

Product Sales
For Q2 2019, product sales were $183.5 million, an increase of $3.4 million or 2% as compared to 2018. The increase primarily reflects sales of both NARCAN (naloxone HCl) Nasal Spray, which was acquired in October 2018, and other products, offset by decreased sales of ACAM2000 (Smallpox (Vaccinia) Vaccine, Live) and BioThrax (Anthrax Vaccine Adsorbed).

Contract Manufacturing
For Q2 2019, revenue from the Company’s contract manufacturing operations was $18.7 million, a decrease of $4.9 million or 21% as compared to 2018. The decrease primarily reflects contracted service work for a single customer in Q2 2018 that did not recur in Q2 2019.

Contracts and Grants
For Q2 2019, revenue from the Company’s development-based contracts and grants was $41.0 million, an increase of $24.5 million as compared to 2018. The increase primarily reflects increased R&D activities related to certain ongoing funded development programs, most notably AV7909.

Operating Expenses

Cost of Product Sales and Contract Manufacturing
For Q2 2019, cost of product sales and contract manufacturing was $100.8 million, an increase of $15.5 million or 18% as compared to 2018. The increase primarily reflects the impact of an increase in product sales due to the contribution of recently acquired products NARCAN Nasal Spray, Vivotif (Typhoid Vaccine Live Oral Ty21a), and Vaxchora, as well as an increase in facilities expenses.

Research and Development (Gross and Net)

For Q2 2019, gross R&D expenses were $63.9 million, an increase of $39.2 million or 159% as compared to 2018. The increase primarily reflects costs associated with incremental development programs from the recent acquisitions of PaxVax and Adapt Pharma in October 2018, as well as timing of manufacturing development activities related to the AV7909 program.

For Q2 2019, net R&D expense, which reflects investments made in development programs that are not currently funded in whole or in part by third-party partners and is calculated as gross research and development expenses minus contracts and grants revenue, was $22.9 million, an increase of $14.7 million or 179% as compared to 2018. The increase primarily reflects investments in the development of the CHIKV-VLP vaccine, FLU-IGIV hyperimmune and various programs related to opioid overdose response. The Q2 2019 net R&D expense was 11% of adjusted revenue (total revenue less contracts & grants) compared to 4% of adjusted revenue in Q2 2018.

Selling, General and Administrative

For Q2 2019, selling, general and administrative expenses were $70.8 million, an increase of $31.3 million or 79% as compared to 2018. The increase primarily reflects the addition of the operations and integration costs associated with the PaxVax and Adapt Pharma acquisitions.

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Amortization of Intangible Assets

For Q2 2019, amortization of intangible assets was $14.7 million versus $3.9 million as compared to 2018. The increase entirely reflects higher non-cash intangible asset amortization costs associated with the PaxVax and Adapt Pharma acquisitions.

Income Taxes

For Q2 2019, the benefit from income taxes in the amount of $5.6 million includes the impact of non-deductible acquisition transaction costs and other permanent items. The effective tax rate for Q2 2019 is not meaningful given the lack of any pre-tax income for the quarter.

Net (Loss) Income & Adjusted Net (Loss) Income

For Q2 2019, the Company recorded a net loss of $9.5 million, or $0.18 per diluted share, versus a net income of $50.1 million, or $0.98 per diluted share, in 2018.

For Q2 2019, the Company recorded an adjusted net loss of $6.3 million, or $0.12 per diluted share, versus an adjusted net income of $54.7 million, or $1.07 per diluted share, in 2018. (1)

EBITDA & Adjusted EBITDA

For Q2 2019, the Company recorded EBITDA of $21.6 million versus $79.0 million in 2018. (1)

For Q2 2019, the Company recorded adjusted EBITDA of $26.2 million versus $80.4 million in 2018. (1)

(II) Six months ended June 30, 2019 (unaudited)

Revenues

Total Revenues
For the six months ended June 30, 2019, total revenues were $433.9 million, an increase of 28% over 2018. Total revenues reflect a significant increase in product sales due to the contribution of recently acquired products.

Product Sales
For the six months ended June 30, 2019, product sales were $336.5 million, an increase of $80.7 million or 32% as compared to 2018. The increase primarily reflects sales of NARCAN Nasal Spray, which was acquired in October 2018, and other products, offset by decreased sales of ACAM2000 and BioThrax.

Contract Manufacturing
For the six months ended June 30, 2019, revenue from the Company’s contract manufacturing operations was $34.6 million, a decrease of $15.2 million or 31% as compared to 2018. The decrease primarily reflects contracted service work in the six months of 2018 that did not recur in the six months of 2019.

Contracts and Grants
For the six months ended June 30, 2019, revenue from the Company’s development-based contracts and grants was $62.8 million, an increase of $30.4 million or 94% as compared to 2018. The increase primarily reflects increased R&D activities related to certain ongoing funded development programs, most notably AV7909.

Operating Expenses

Cost of Product Sales and Contract Manufacturing
For the six months ended June 30, 2019, cost of product sales and contract manufacturing was $192.7 million, an increase of $53.3 million or 38% as compared to 2018. The increase primarily reflects the impact of an increase in product sales due to the contribution of recently acquired products NARCAN Nasal Spray, Vivotif, and Vaxchora, which were all acquired in October 2018, as well as an increase in facilities related expenses.

Research and Development (Gross and Net)
For the six months ended June 30, 2019, gross R&D expenses were $110.0 million, an increase of $56.2 million compared to 2018. The increase primarily reflects costs associated with incremental development programs from the recent acquisitions of PaxVax and Adapt Pharma in October 2018, as well as timing of manufacturing development activities related to the AV7909 program.

For the six months ended June 30, 2019, net R&D expense, which reflects investments made in development programs that are not currently funded in whole or in part by third-party partners and is calculated as gross research and development expenses minus contracts and grants revenue, was $47.2 million, an increase of $25.8 million or 121% as compared to 2018. The increase primarily reflects investments in the development of the CHIKV-VLP vaccine, FLU-IGIV hyperimmune and various programs related to opioid overdose response. The six months of 2019 net R&D expense was 13% of adjusted revenue (total revenue less contracts & grants) compared to 7% of adjusted revenue in the six months of 2018.

Selling, General and Administrative
For the six months ended June 30, 2019, selling, general and administrative expenses were $136.4 million, an increase of $56.7 million or 71% as compared to 2018. The increase primarily reflects the addition of the operations and integration costs associated with the PaxVax and Adapt Pharma acquisitions.

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Amortization of Intangible Assets
For the six months ended June 30, 2019, amortization of intangible assets was $29.2 million versus $7.8 million as compared to 2018. The increase entirely reflects higher non-cash intangible asset amortization costs associated with the PaxVax and Adapt Pharma acquisitions.

Income Taxes
For the six months ended June 30, 2019, the benefit from income taxes in the amount of $17.4 million includes the impact of non-deductible acquisition transaction costs and other permanent items. The effective tax rate for the six months of 2019 is not meaningful given the lack of any pre-tax income for the six month period.

Net (Loss) Income & Adjusted Net (Loss) Income
For the six months ended June 30, 2019, the Company recorded a net loss of $35.6 million, or $0.69 per diluted share, versus a net income of $45.2 million, or $0.89 per diluted share, in 2018.

For the six months ended June 30, 2019, the Company recorded an adjusted net loss of $0.7 million, or $0.01 per diluted share, versus an adjusted net income of $53.1 million, or $1.04 per diluted share, in 2018. (1)

EBITDA & Adjusted EBITDA
For the six months ended June 30, 2019, the Company recorded EBITDA of $19.8 million versus $82.1 million in 2018. (1)

For the six months ended June 30, 2019, the Company recorded adjusted EBITDA of $33.3 million versus $83.7 million in 2018. (1)

2019 FINANCIAL FORECAST (Reaffirmed)

For full year 2019, the company reaffirms its expectation of the following forecasted financial metrics:

The Company’s financial forecast for 2019 includes the anticipated impact of full year product sales, continued contract manufacturing and contracts & grants revenue as well as continued investment in internally funded development projects. The outlook for 2019 does not include estimates for potential new corporate development or other M&A transactions.

Q3 2019 REVENUE FORECAST

For Q3 2019, the Company forecast for total revenues is $245 million to $275 million.

FOOTNOTES

(1) See "Reconciliation of Net (Loss) Income to Adjusted Net (Loss) Income, EBITDA and Adjusted EBITDA" for a definition of terms and a reconciliation table.

CONFERENCE CALL AND WEBCAST INFORMATION
Company management will host a conference call at 5:00 pm (Eastern Time) today, August 1, 2019, to discuss these financial results. This conference call can be accessed live by telephone or through Emergent’s website:

Live Teleconference Information:
Dial in: [US] (855) 766-6521; [International] (262) 912-6157
Conference ID: 8166567

Live Webcast Information:
Visit View Source for the live webcast feed.

A replay of the call can be accessed at www.emergentbiosolutions.com under "Investors."

On August 1, 2019 Cerus Corporation (Nasdaq: CERS) reported financial results for the second quarter ended June 30, 2019 (Press release, Cerus, AUG 1, 2019, View Source [SID1234538069]).

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Recent developments and highlights include:

Total second quarter revenue of $22.5 million
Record quarterly product revenue of $18.2 million, an 18% increase compared to the prior year quarter
Government contract revenue of $4.3 million
Worldwide disposable kit demand increased 23% in the quarter compared to the prior year quarter
Raising 2019 full year product revenue guidance to a range of $72 million to $75 million from $71 million to $74 million given the strong demand for INTERCEPT
Cash, cash equivalents, and short-term investments of $96.2 million at June 30, 2019
Received European CE Mark approval for INTERCEPT plasma with DEHP-free plastic disposable kits
"We are pleased to report another strong quarter of commercial execution and record product revenues. Increasing customer adoption of INTERCEPT Blood Systems continues to be driven by the clinical, operational, and economic benefits conferred by our pathogen inactivation technology," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "Robust demand for INTERCEPT kits was reported across multiple geographies with the greatest volume increase in the U.S. as blood centers and hospitals implement pathogen reduction in advance of the expected FDA final guidance document on bacterial risk control strategies for platelet collection and transfusion. In the face of increasing demand for our products from blood centers, we are continuing to invest in working capital, particularly in inventory."

"Pathogen-reduced cryoprecipitate continues to be an exciting pipeline opportunity and a product which could have a meaningful impact on improving patient outcomes. We now believe that we will be able to optimize the availability of plasma in order to realize manufacturing efficiencies for cryoprecipitate production with our blood center partners, potentially affording us with improved economics," continued Greenman.

Revenue

Product revenue during the second quarter of 2019 was $18.2 million, compared to $15.4 million during the same period in 2018. Revenue growth in the quarter benefited from the higher INTERCEPT kit demand in the U.S. and select international markets, partially offset by product mix in France and the strengthening of the U.S. dollar relative to the Euro compared to prior year exchange rates. Year-to-date product revenue totaled $35.7 million, an increase of 23% compared to the same period in 2018.

Government contract revenue from the Company’s Biomedical Advanced Research and Development Authority (BARDA) agreement was $4.3 million during the second quarter of 2019, compared to $4.0 million during the same period in 2018, as a result of increasing INTERCEPT red blood cell clinical and development activities. Year-to-date government contract revenue totaled $8.7 million compared to $7.5 million in the first half of 2018. The total potential value of the current BARDA agreement is $201 million with $34 million recognized as revenue to date.

BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. The development of the INTERCEPT red blood cell program has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600009C.

Gross Margins

Gross margins on product revenue during the second quarter of 2019 were 55%, compared to 50% for the second quarter of 2018. The increase in gross margin was tied to economies of scale realized for our cost of goods sold and additional manufacturing efficiencies. Gross margins during the first half of 2019 were 54% compared to 48% reported in the first half of 2018.

Operating Expenses

Total operating expenses for the second quarter of 2019 were $31.2 million compared to $24.3 million for the same period the prior year. Year-to-date, operating expenses totaled $60.8 million compared to $47.4 million for the first half of 2018.

Selling, general, and administrative (SG&A) expenses for the second quarter of 2019 totaled $16.7 million, compared to $14.4 million for the second quarter of 2018. The year-over-year increase in SG&A expenses was tied to higher investments in our manufacturing and supply chain capabilities. Year-to-date SG&A expenses totaled $32.9 million compared to $28.0 million for the first half of 2018.

Research and development (R&D) expenses for the second quarter of 2019 were $14.4 million, compared to $9.9 million for the second quarter of 2018. The increase in year-over-year R&D expenses was largely due to additional activities tied to the development of our INTERCEPT red blood cell system, including BARDA activities and initiatives aimed at ensuring supply and compatibility for our platelet and plasma products. Year-to-date R&D expenses totaled $27.9 million compared to $19.3 million for the first half of 2018.

Net Loss

Net loss for the second quarter of 2019 was $17.6 million, or $0.13 per diluted share, compared to a net loss of $13.3 million, or $0.10 per diluted share, for the second quarter of 2018. Year-to-date net loss was $36.4 million or $0.26 per diluted share compared to $27.2 million, or $0.21 per diluted share in the first half of 2018.

Cash, Cash Equivalents and Investments

At June 30, 2019, the Company had cash, cash equivalents and short-term investments of $96.2 million, compared to $117.6 million at December 31, 2018.

At June 30, 2019, the Company had approximately $39.3 million in outstanding term loan debt and $4.5 million of borrowings under its revolving loan credit agreement, compared to $29.9 million in outstanding term loan debt at December 31, 2018.

Revised 2019 Product Revenue Guidance

The Company now expects 2019 product revenue to be in the range of $72 million to $75 million compared to our previous guidance range of $71 million to $74 million. The new guidance range represents 18% to 23% growth compared to 2018 reported product revenue.

QUARTERLY CONFERENCE CALL

The Company will host a conference call and webcast at 4:30 P.M. EDT this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To access the live webcast, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on the Company’s website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 2898719. The replay will be available approximately three hours after the call through August 15, 2019.

On August 1, 2019 Acorda Therapeutics, Inc. (NASDAQ: ACOR) reported a financial and pipeline update for the quarter ended June 30, 2019 (Press release, Acorda Therapeutics, AUG 1, 2019, View Source [SID1234538068]).

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"We made significant progress on the launch of Inbrija during the second quarter. Effective May 24, 2019, Inbrija became preferred on the Express Scripts National Preferred, Basic, and High Performance commercial national formularies, and we expect to reach agreements with other key payers in the near future," said Ron Cohen, M.D., Acorda’s President and CEO. "We have also been receiving encouraging feedback on Inbrija from both people with Parkinson’s and health care professionals. This is consistent with our market research and supports our expectation that Inbrija will become a standard of care."

Second Quarter 2019 Financial Results

For the quarter ended June 30, 2019, the Company reported INBRIJA net revenue of $3.0 million. INBRIJA became commercially available on February 28, 2019.

For the quarter ended June 30, 2019, the Company reported AMPYRA net revenue of $44.2 million compared to $150.3 million for the same quarter in 2018. In September 2018, AMPYRA lost its exclusivity and generics entered the market. Consequently, the Company expects AMPYRA revenue to continue to decline.

Research and development (R&D) expenses for the quarter ended June 30, 2019 were $19.0 million, including $0.8 million of share-based compensation compared to $25.9 million, including $1.5 million of share-based compensation for the same quarter in 2018.

Sales, general and administrative (SG&A) expenses for the quarter ended June 30, 2019 were $50.2 million, including $3.5 million of share-based compensation compared to $44.3 million, including $3.7 million of share-based compensation for the same quarter in 2018.

Provision for income taxes for the quarter ended June 30, 2019 was $0.2 million compared to a provision for income taxes of $8.4 million for the same quarter in 2018.

The Company reported a GAAP net loss of $27.5 million for the quarter ended June 30, 2019, or $0.58 per diluted share. GAAP net income in the same quarter of 2018 was $46.2 million, or $0.98 per diluted share.

Non-GAAP net loss for the quarter ended June 30, 2019 was $26.3 million, or $0.55 per diluted share. Non-GAAP net income in the same quarter of 2018 was $65.9 million, or $1.40 per diluted share. This quarterly non-GAAP net (loss) income measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, changes in the fair value of acquired contingent consideration, and restructuring costs. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

At June 30, 2019, the Company had cash, cash equivalents and short-term investments of $296.9 million. The Company has $345 million of convertible senior notes due in 2021 with a conversion price of $42.56.

2019 Financial Guidance

During INBRIJA’s launch year, the Company does not expect to provide INBRIJA revenue guidance.
The Company expects AMPYRA net revenue for the full year 2019 to be greater than $140 million.
R&D expenses for the full year 2019 are expected to be $70-$80 million and SG&A expenses for the full year 2019 are expected to be $200-$210 million. This guidance is a non-GAAP projection that excludes share-based compensation as more fully described below under "Non-GAAP Financial Measures."
Second Quarter 2019 Highlights

INBRIJA launch metrics through July 2019
– ~4,500 prescription request forms (PRFs)
– > 1,900 patients received a first dispense
– > 6,200 total cartons dispensed
– > 1,250 unique prescribers; ~50% repeat prescribers

Effective May 24, 2019, INBRIJA was made preferred on the Express Scripts National Preferred, Basic, and High Performance commercial national formularies.
In July, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending INBRIJA’s approval by the European Commission (EC). The final EC decision is expected before the end of the year. Acorda is in discussions with potential partners to market INBRIJA in Europe.
Webcast and Conference Call

The Company will host a conference call today at 4:30 p.m. ET. To participate in the conference call, please dial (866) 393-4306 (domestic) or (734) 385-2616 (international) and reference the access code 2287274. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 7:30 p.m. ET on August 1, 2019 until 11:59 p.m. ET on August 31, 2019. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international); reference code 2287274. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

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 (loss) income, adjusted to exclude the items below, and has provided 2019 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 (loss) 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, and acquired Biotie debt, and (iii) changes in the fair value of acquired contingent consideration which do not correlate to our actual cash payment obligations in the relevant periods, and (iv) expenses that pertain to non-routine restructuring events. The Company believes its non-GAAP net (loss) 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 (loss) income, we have provided 2019 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.