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PAIN THERAPEUTICS REPORTS THIRD QUARTER 2018 FINANCIAL RESULTS

On October 30, 2018 Pain Therapeutics, Inc. (Nasdaq: PTIE), a biopharmaceutical company, reported financial results for the third quarter ended September 30, 2018. Net loss was $1.3 million, or $0.11 per share (Press release, Pain Therapeutics, OCT 30, 2018, View Source [SID1234530363]). This compared to a net loss of $2.6 million, or $0.40 per share, for the same period in the prior year. Cash and cash equivalents were $20.4 million as of September 30, 2018, including net proceeds of approximately $12.3 million from common stock offerings during the quarter. The Company has no debt.

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"We are quite excited to advance our drug candidate for Alzheimer’s disease into a Phase IIa study," said Remi Barbier, President and CEO of Pain Therapeutics. "It helps that the science program stands up to rigorous, peer-reviewed evaluation, as evidenced by recently announced NIH grants, representing up to $6.7 million of non-dilutive financing."

Financial Highlights for Third Quarter 2018

Net loss was $1.3 million compared to $2.6 million for the same period in the prior year, representing a 51% decrease. Net loss per share was $0.11 compared to $0.40 for the same period in the prior year.
Cash and cash equivalents were $20.4 million as of September 30, 2018, compared to $9.6 million as of June 30, 2018. Cash and cash equivalents at September 30, 2018 included $10.3 million of net proceeds raised through a sale of common stock and issuance of warrants and $2.0 million of net proceeds raised through our At-The-Market common stock offerings. We have no debt outstanding.
We received research grant funding reimbursements of $1.1 million from the National Institutes of Health ("NIH") and recorded this as a reduction in research and development expenses ("R&D"). This compared to $0.8 million of NIH grant receipts received for the same period in the prior year.
R&D expenses were $0.4 million. This compared to $1.6 million for the same period in the prior year, representing a 73% decrease. R&D expenses included non-cash stock related compensation costs of $0.2 million, compared to $0.3 million for same period in the prior year.
General and administrative ("G&A") expenses were $0.8 million. This compared to $1.0 million for the same period in the prior year, representing a 13% decrease. G&A expenses included non-cash stock-related compensation costs of $0.3 million, compared to $0.4 million for the same period in the prior year.
On August 17, 2018, we announced the closing of a registered direct offering of 8,860,778 shares of our common stock and issuance of warrants. Total net proceeds from the offering were approximately $10.3 million.
In August and in October 2018, we announced that the NIH had awarded us research grants to support a Phase II program with PTI-125, our drug candidate to treat Alzheimer’s disease. Collectively, these two NIH grants represent up to $6.7 million of non-dilutive financing.
Third Quarter Developments

Our lead drug candidate has historically been REMOXY, a proprietary abuse-deterrent, extended-release form of oxycodone to treat severe chronic pain. On August 3, 2018, we received a Complete Response Letter ("CRL") from the Food and Drug Administration ("FDA") for our New Drug Application ("NDA") for REMOXY, stating that the data submitted in the NDA does not support the conclusion that the benefits of REMOXY outweigh the risks.

Based on data, we disagree with the FDA’s actions around REMOXY. Consequently, a formal dispute may arise between ourselves and the FDA. The FDA has in-place an administrative process to resolve complex scientific/medical disputes, which is called a Formal Dispute Resolution ("FDR"). Pending further discussions with the FDA, we may or may not chose to appeal the REMOXY CRL through an FDR or take other measures. If we appeal there can be no assurance that such appeal will satisfactorily resolve any scientific/medical disputes between ourselves and the FDA.

If we do not prevail in an FDR, or if we chose not to pursue an FDR, we may immediately cease development of REMOXY.

On October 2, 2018, we announced a strategic reorganization to align Company resources on advancing our drug and diagnostic pipeline in Alzheimer’s disease. On October 4, 2018, we provided details of our neuroprotection program during a conference call and presentation.

On October 11, 2018, we announced the appointment of Mr. Eric Schoen as Chief Financial Officer, effective on or before November 7, 2018.
About the Neuroprotection Program
Our lead drug candidate, PTI-125, is a small molecule with a unique mechanism of action for treating Alzheimer’s disease ("AD"). We expect to initiate a Phase IIa study with PTI-125 in AD in Q4 2018.

The underlying science for PTI-125 is published in prestigious peer-reviewed journals, including Journal of Neuroscience, Neurobiology of Aging, and Neuroimmunology and Neuroinflammation, and benefits from several peer-reviewed research grant awards from the NIH.

We are also developing a blood-based test, called PTI-125Dx, to detect whether a person has Alzheimer’s disease, possibly years before any symptoms appear. An early diagnosis of AD could optimize treatment options and empower physicians and patients to slow or halt the disease.

About Alzheimer’s Disease
Alzheimer’s Disease (AD) is a progressive brain disorder that destroys memory and thinking skills. Eventually, a person with AD may be unable to carry out even the simplest tasks. There is a profound and timely need to develop new drugs for Alzheimer’s. Currently, there are no drug therapies to halt Alzheimer’s, much less reverse its course

Blueprint Medicines Reports Third Quarter 2018 Financial Results

On October 30, 2018 Blueprint Medicines Corporation (NASDAQ: BPMC), a leader in discovering and developing targeted kinase medicines for patients with genomically defined diseases, reported financial results and provided a business update for the third quarter ended September 30, 2018 (Press release, Blueprint Medicines, OCT 30, 2018, View Source;q=View Source;source=gmail&ust=1541070221980000&usg=AFQjCNEV72tiQ5N9U9Dom5ERVILd_aDycQ [SID1234530361]).

"Our third quarter and recent accomplishments represent tremendous progress across our portfolio, marked by the receipt of positive regulatory feedback from the FDA for avapritinib and BLU-667 and the presentation of new data across our clinical- and research-stage pipeline," said Jeff Albers, Chief Executive Officer of Blueprint Medicines. "As we prepare to enter a critical year, we are now accelerating our efforts with a focus on executing five registration-enabling studies across seven patient populations, building a global commercial enterprise to deliver medicines to patients and investing in the next generation of precision therapies."

Clinical Programs:

Avapritinib: Systemic Mastocytosis (SM)

Blueprint Medicines announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to avapritinib for the treatment of patients with advanced SM, including the subtypes of aggressive SM, SM with an associated hematologic neoplasm and mast cell leukemia.
Blueprint Medicines announced that it has screened the first patient in PATHFINDER, its registration-enabling, open-label, single-arm Phase 2 clinical trial in patients with advanced SM. Blueprint Medicines expects to initiate PIONEER, its registration-enabling, randomized, placebo-controlled Phase 2 clinical trial in patients with indolent and smoldering SM, by the end of 2018.
Blueprint Medicines announced that the European Medicines Agency has granted orphan drug designation to avapritinib for the treatment of mastocytosis.
Enrollment in the expansion portion of the Phase 1 EXPLORER clinical trial for advanced SM is ongoing. Blueprint Medicines plans to present data from this trial at the 60thAmerican Society for Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2018.
Avapritinib: Gastrointestinal Stromal Tumors (GIST)

Blueprint Medicines continues to evaluate avapritinib in its Phase 1 NAVIGATOR clinical trial and will present updated data across multiple patient populations, including PDGFRA-driven GIST, third-line or later GIST, and second-line GIST, at the 2018 Connective Tissue Oncology Society (CTOS) Annual Meeting on November 15, 2018. Based on data from this trial, Blueprint Medicines plans to submit a new drug application (NDA) to the FDA for avapritinib for the treatment of patients with PDGFRα Exon 18 mutant GIST and fourth-line GIST in the first half of 2019.
BLU-667: RET-Altered Solid Tumors

Blueprint Medicines recently received written feedback from the FDA supporting expedited development of BLU-667 and plans to submit an NDA for BLU-667 in the first half of 2020 based on additional data from the ongoing Phase 1 ARROW trial. Based on the feedback from the FDA, Blueprint Medicines currently expects the NDA submission will be for separate potential indications: (1) patients with RET-fusion positive NSCLC and papillary thyroid cancer (PTC) who have progressed following prior systemic therapy and (2) patients with RET-mutant medullary thyroid cancer (MTC) who have progressed following treatment with a tyrosine kinase inhibitor.
In October 2018, Blueprint Medicines presented updated data from its ongoing Phase 1 ARROW clinical trial of BLU-667 in patients with MTC and PTC at the 88th Annual Meeting of the American Thyroid Association. The data showed that BLU-667 is highly active and well-tolerated in these patient populations, with increased activity observed at higher dose levels and longer treatment durations. Ninety percent of evaluable patients with MTC and PTC experienced radiographic tumor reductions, regardless of RET alteration or prior multi-kinase inhibitor therapy. The response rate was 62 percent in patients with MTC in the 300 and 400 milligram once daily dose groups who were treated for at least 24 weeks. The data also showed that BLU-667 was well-tolerated, and most adverse events reported by investigators were Grade 1. Read the full data here.
In September 2018, Blueprint Medicines presented two clinical case studies demonstrating proof-of-concept for BLU-667 in combination with Tagrisso (osimertinib) in patients with treatment-resistant, EGFR-mutant NSCLC harboring an acquired RET fusion. The data showed that the combination of BLU-667 and osimertinib overcame resistance to standard therapy, and both patients achieved a partial response with a 78 percent reduction in target tumors per RECIST version 1.1. In these two patients, the combination was well-tolerated, and all reported adverse events were Grade 1 or 2. Read the full data here.
BLU-554: Hepatocellular Carcinoma (HCC)

In September 2018, Blueprint Medicines and its partner, CStone Pharmaceuticals, submitted an investigational new drug (IND) application for BLU-554 to Chinese health authorities. Subject to approval of the IND application, the companies plan to expand Blueprint Medicines’ ongoing Phase 1 clinical trial of BLU-554 as a monotherapy for the treatment of advanced HCC to include clinical sites in Mainland China. Additionally, the companies plan to initiate a proof-of-concept clinical trial evaluating BLU-554 in combination with CS1001, a clinical-stage anti-PD-L1 immunotherapy, in 2019.
Research Programs:

BLU-782: Fibrodysplasia Ossificans Progressiva (FOP)

In September 2018, Blueprint Medicines presented preclinical proof-of-concept data for BLU-782, an investigational precision therapy specifically designed to target the underlying cause of FOP, at the 2018 American Society for Bone and Mineral Research Annual Meeting. The data showed that BLU-782 prevented injury- and surgery-induced heterotrophic ossification, reduced edema and restored healthy tissue response to muscle injury in a well-characterized FOP mouse model. Read the full data here.
Blueprint Medicines expects to submit an IND application to the FDA for BLU-782 by the end of 2018, and subject to review of the IND application, plans to initiate a Phase 1 clinical trial in healthy volunteers in the first quarter of 2019. Upon completion of the Phase 1 clinical trial, Blueprint Medicines plans to advance BLU-782 into a registration-enabling Phase 2 clinical trial in patients with FOP.
Corporate:

In October 2018, Blueprint Medicines announced the expansion of its leadership team with the appointment of Christina Rossi as Chief Commercial Officer. Blueprint Medicines also announced the appointment of Paul Beresford as General Manager, International.
Third Quarter Financial Results:

Cash Position: As of September 30, 2018, cash, cash equivalents and investments were $559.6 million, as compared to $673.4 million as of December 31, 2017. This decrease was primarily related to cash used in operating activities, partially offset by the $40.0 million upfront payment received in connection with entering into the collaboration with CStone Pharmaceuticals and the $10.0 million milestone payment achieved under the Roche collaboration in June 2018.
Collaboration Revenues: Collaboration revenues were $1.1 million for the third quarter of 2018, as compared to $8.1 million for the third quarter of 2017. This decrease was primarily due to the termination of the Alexion agreement in 2017.
R&D Expenses: Research and development expenses were $64.6 million for the third quarter of 2018, as compared to $39.3 million for the third quarter of 2017. This increase was primarily attributable to increased clinical and manufacturing expenses associated with advancing avapritinib and BLU-667 further through clinical trials and increased personnel-related expenses. Research and development expenses included $4.8 million in stock-based compensation expenses for the third quarter of 2018.
G&A Expenses: General and administrative expenses were $12.0 million for the third quarter of 2018, as compared to $7.4 million for the third quarter of 2017. This increase was primarily due to increased personnel-related expenses and increased professional fees, including pre-commercial planning activities. General and administrative expenses included $3.6 million in stock-based compensation expenses for the third quarter of 2018.
Net Loss: Net loss was $72.7 million for the third quarter of 2018, or a net loss per share of $1.66, as compared to a net loss of $37.7 million for the third quarter of 2017, or a net loss per share of $0.96.
Financial Guidance:

Based on its current plans, Blueprint Medicines expects that its existing cash, cash equivalents and investments, excluding any potential option fees and milestone payments under its existing collaborations with Roche and CStone Pharmaceuticals, will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the second half of 2020.

Earnings Conference Call Information:

Blueprint Medicines will host a live conference call and webcast at 8:30 a.m. ET today to discuss third quarter 2018 financial results and recent business activities. The conference call may be accessed by dialing (855) 626-8618 (domestic) or (531) 289-2784 (international) and referring to conference ID 7598866. A webcast of the conference call will be available in the Investors section of the Blueprint Medicines’ website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.

CTOS Conference Call Information:

Blueprint Medicines will host a live conference call and webcast to discuss data being presented at the 2018 CTOS Annual Meeting on November 15th at 7:30 a.m. ET. The conference call may be accessed by dialing (855) 728-4793 (domestic) or (503) 343-6666 (international) and referring to conference ID 3479587. A webcast of the conference call will be available in the Investors section of the Blueprint Medicines’ website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.

Incyte Reports 2018 Third Quarter and Nine Month Financial Results and Provides Updates on Key Clinical Programs

On October 30, 2018 Incyte Corporation (Nasdaq:INCY) reported 2018 third quarter and nine month financial results and provides a status update on the Company’s development portfolio (Press release, Incyte, OCT 30, 2018, View Source [SID1234530360]).

"The total number of patients taking Jakafi continues to increase in both approved indications, and we have raised the lower end of our full year revenue guidance," stated Hervé Hoppenot, Chief Executive Officer, Incyte. "We see a remarkable set of opportunities in the coming months from our late-stage development portfolio, including both ruxolitinib and itacitinib as potential treatments for certain patients with GVHD. Recent data from pemigatinib and capmatinib, which are both Incyte-invented molecules, as well as from ruxolitinib cream, all serve to highlight the quality of Incyte’s drug discovery capabilities, and the value created by our R&D efforts."

Portfolio Update

Oncology – key highlights

The sNDA seeking approval of ruxolitinib for the treatment of steroid-refractory acute GVHD has been accepted for Priority Review by the U.S. Food and Drug Administration (FDA), and was given a Prescription Drug User Fee Act (PDUFA) date of February 24, 2019. The application for approval was based on the successful REACH1 trial, additional results from which are expected to be presented in the fourth quarter of 2018. Planning is already underway for the U.S. launch should ruxolitinib be approved in this new indication.

The global Phase 3 GRAVITAS-301 trial of itacitinib as a treatment for patients with newly-diagnosed acute GVHD is enrolling well, and results are expected next year. If the GRAVITAS-301 trial is successful, Incyte expects to submit applications seeking marketing approval for itacitinib in major markets globally.

Data from the ongoing trials evaluating pemigatinib in cholangiocarcinoma and bladder cancer were recently presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. Incyte expects to submit an NDA for pemigatinib as a treatment for patients with advanced cholangiocarcinoma during 2019, and to start a Phase 3 trial for the first-line treatment of patients with cholangiocarcinoma in the coming months. Enrollment in the continuous dosing cohort of the Phase 2 trial of pemigatinib in patients with bladder cancer is now underway.

Positive data from the randomized Phase 2 trial of ruxolitinib cream in adult patients with atopic dermatitis were presented as an oral presentation at the European Academy of Dermatology and Venerology (EADV) Congress on September 13th. Incyte is planning to initiate a global, pivotal Phase 3 program in this indication.

Data from the randomized Phase 2 trial of ruxolitinib cream in patients with vitiligo are expected in 2019.

Incyte has initiated a Phase 2 trial of INCB54707, a selective JAK1 inhibitor, for the treatment of patients with hidradenitis suppurativa, an inflammatory follicular skin disease.

Lilly recently initiated a Phase 3 trial of baricitinib in patients with systemic lupus erythematosus and a Phase 2/3 adaptive design trial of baricitinib in patients with severe alopecia areata.

Novartis recently presented data from the ongoing trial of capmatinib in patients with MET exon-14 skipping mutated non-small cell lung cancer, and expects to submit an NDA for capmatinib in 2019.

The financial measures presented in this press release for the three and nine months ended September 30, 2018 and 2017 have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"), unless otherwise identified as a Non-GAAP financial measure. Management believes that Non-GAAP information is useful for investors, when considered in conjunction with Incyte’s GAAP disclosures. Management uses such information internally and externally for establishing budgets, operating goals and financial planning purposes. These metrics are also used to manage the Company’s business and monitor performance. The Company adjusts, where appropriate, for both revenues and expenses in order to reflect the Company’s core operations. The Company believes these adjustments are useful to investors by providing an enhanced understanding of the financial performance of the Company’s core operations. The metrics have been adopted to align the Company with disclosures provided by industry peers. Reconciliations of GAAP net income (loss) to Non-GAAP net income for the three and nine months ended September 30, 2018 and 2017 have been included at the end of this press release.

Guidance related to research and development and selling, general and administrative expenses does not include estimates associated with any potential future strategic transactions.

Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used in conjunction with and to supplement Incyte’s operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in our industry.

Revenues For the quarter ended September 30, 2018, GAAP net product revenues of Jakafi were $348 million as compared to $304 million for the same period in 2017, representing 14 percent growth. For the nine months ended September 30, 2018, GAAP net product revenues of Jakafi were $1.0 billion as compared to $831 million for the same period in 2017, representing 21 percent growth. For the three months ended September 30, 2018, GAAP net product revenues of Iclusig (ponatinib) were $20 million as compared to $18 million for the same period in 2017. For the nine months ended September 30, 2018, GAAP net product revenues of Iclusig were $61 million as compared to $47 million for the same period in 2017.

For the quarter and nine months ended September 30, 2018, GAAP product royalties from sales of Jakavi (ruxolitinib), which has been out-licensed to Novartis outside of the United States, were $51 million and $139 million, respectively, as compared to $41 million and $104 million, respectively, for the same periods in 2017. For the quarter and nine months ended September 30, 2018, GAAP product royalties from sales of Olumiant, which has been out-licensed to Lilly globally, were $11 million and $26 million, respectively, as compared to $3 million and $5 million, respectively, for the same periods in 2017.

For the quarter and nine months ended September 30, 2018, GAAP milestone revenues were $20 million and $120 million, as compared to $15 million and $105 million, respectively, for the same periods in 2017. GAAP milestone revenues in 2018 and 2017 related to milestones earned from our collaborative partners. Non-GAAP revenues exclude milestone revenues.

For the quarter and nine months ended September 30, 2018, total GAAP revenues were $450 million and $1.4 billion, respectively, as compared to $382 million and $1.1 billion, respectively, for the same periods in 2017. Total Non-GAAP revenues for the quarter and nine months ended September 30, 2018 were $430 million and $1.2 billion, respectively, as compared to $367 million and $987 million, respectively, for the same periods in 2017.

Cost of product revenues GAAP cost of product revenues for the quarter and nine months ended September 30, 2018 was $25 million and $68 million, respectively, as compared to $22 million and $57 million, respectively, for the same periods in 2017. Non-GAAP cost of product revenues for the quarter and nine months ended September 30, 2018 was $19 million and $52 million, respectively, as compared to $17 million and $41 million, respectively, for the same periods in 2017. Non-GAAP cost of product revenues excludes the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc.

Research and development expenses GAAP research and development expenses for the quarter and nine months ended September 30, 2018 were $293 million and $894 million, respectively, as compared to $270 million and $879 million, respectively, for the same periods in 2017. The increase in GAAP research and development expenses over the prior year quarter was driven primarily by $15 million in milestone expenses related to our collaboration agreements. The increase in GAAP research and development expenses from the prior year nine month period was driven primarily by an overall increase in development costs to advance our clinical pipeline.

Non-GAAP research and development expenses for the quarter and nine months ended September 30, 2018 were $251 million and $771 million, respectively, as compared to $234 million and $590 million, respectively, for the same periods in 2017. Non-GAAP research and development expenses for the quarter and nine months ended September 30, 2018 exclude the cost of stock-based compensation of $26 million and $75 million, respectively, and upfront consideration and milestones to our collaborative partners of $15 million and $47 million, respectively. Non-GAAP research and development expenses for the quarter and nine months ended September 30, 2017 exclude the cost of stock-based compensation of $23 million and $68 million, respectively, upfront consideration and milestones paid to our collaborative partners of $0 million and $209 million, respectively, and an asset impairment charge of $12 million.

Selling, general and administrative expenses GAAP selling, general and administrative expenses for the quarter and nine months ended September 30, 2018 were $97 million and $326 million, respectively, as compared to $91 million and $269 million, respectively, for the same periods in 2017. The increase in GAAP selling, general and administrative expenses from the prior year nine month period were driven by an increase in donations to independent non-profit patient assistance organizations in the United States and additional costs related to the commercialization of Jakafi.

Non-GAAP selling, general and administrative expenses for the quarter and nine months ended September 30, 2018 were $85 million and $291 million, respectively, as compared to $80 million and $237 million, respectively, for the same periods in 2017. Non-GAAP selling, general and administrative expenses exclude the cost of stock-based compensation.

Change in fair value of acquisition-related contingent consideration GAAP change in fair value of acquisition-related contingent consideration for the quarter and nine months ended September 30, 2018 was expense of $5 million and $19 million, respectively, as compared to a benefit of $16 million and $2 million respectively, for the same periods in 2017.

Unrealized gain (loss) on long term investments GAAP unrealized loss on long term investments for the quarter and nine months ended September 30, 2018 was $10 million and $22 million, respectively, as compared to a gain of $23 million and a loss of $2 million, respectively, for the same periods in 2017. The unrealized gain (loss) on long term investments for the quarter and nine months ended September 30, 2018 represents the fair market value adjustments of the Company’s investments in Agenus, Calithera, Merus, and Syros.

Expense related to senior note conversions GAAP expense related to senior note conversions for the nine months ended September 30, 2017 was $55 million related to the conversions of certain of our 2018 and 2020 convertible senior notes.

Net income (loss) GAAP net income for the quarter ended September 30, 2018 was $29 million, or $0.14 per basic and diluted share, as compared to a net income of $36 million, or $0.17 per basic and diluted share for the same period in 2017. GAAP net income for the nine months ended September 30, 2018 was $40 million, or $0.19 per basic and diluted share, as compared to a net loss of $164 million, or $0.81 per basic and diluted share for the same period in 2017.

Non-GAAP net income for the quarter ended September 30, 2018 was $83 million, or $0.39 per basic and $0.38 per diluted share, as compared to Non-GAAP net income of $41 million, or $0.20 per basic and $0.19 per diluted share for the same period in 2017. Non-GAAP net income for the nine months ended September 30, 2018 was $137 million, or $0.64 per basic and $0.63 per diluted share, as compared to Non-GAAP net income of $127 million, or $0.63 per basic and $0.61 per diluted share for the same period in 2017.

Cash, cash equivalents and marketable securities position As of September 30, 2018, cash, cash equivalents and marketable securities totaled $1.4 billion as compared to $1.2 billion as of December 31, 2017.

(1)Adjusted to exclude the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc.
(2)Adjusted to exclude the estimated cost of stock-based compensation, upfront consideration of approximately $12 million related to the Syros collaboration, upfront consideration of $15 million related to the BMS license agreement, milestone payments of $10 million related to the Agenus collaboration and milestone payments of $10 million related to the MacroGenics collaboration.
(3)Adjusted to exclude the estimated cost of stock-based compensation.
(4)Adjusted to exclude the change in fair value of estimated future royalties relating to sales of Iclusig in the licensed territory relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc.

Future Non-GAAP financial measures may also exclude upfront and ongoing milestones relating to third-party collaboration partners, impairment of goodwill or other assets, changes in the fair value of equity investments in our collaboration partners, non-cash interest expense related to the amortization of the initial discount on our 2018 and 2020 Senior Notes and the impact on our tax provision of discrete changes in our valuation allowance position on deferred tax assets.

Conference Call and Webcast Information

Incyte will hold a conference call and webcast this morning at 8:00 a.m. EDT. To access the conference call, please dial 877-407-3042 for domestic callers or 201-389-0864 for international callers. When prompted, provide the conference identification number, 13683637.

If you are unable to participate, a replay of the conference call will be available for 30 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference identification number, 13683637.

The conference call will also be webcast live and can be accessed at www.incyte.com in the Investors section under "Events and Presentations

Halozyme Licenses New ENHANZE® Targets For $25 Million Upfront Payment, Future Milestones And Royalties

On October 30, 2018 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that it has licensed its ENHANZE drug-delivery technology to Roche for exclusive development of a new undisclosed clinical stage therapeutic target, with an option to select two additional targets within four years (Press release, Halozyme, OCT 30, 2018, View Source [SID1234530358]).

Under terms of the agreement, Halozyme will receive an upfront fee of $25 million with the potential to earn additional payments of up to $160 million to $165 million per target subject to achievement of specified development, regulatory and sales-based milestones. Additionally, Halozyme will receive a nomination fee for each of the two additional new target nominations. Halozyme will also receive mid-single digit royalties on sales of commercialized products. The company expects to recognize the initial $25 million payment in the fourth quarter of 2018.

"I am delighted to announce another further expansion of our long-term relationship with Roche, covering the selection of these three new targets," said Dr. Helen Torley, president and CEO. This agreement is a strong illustration of our strategy to unlock and grow ENHANZE value through supporting partners in advancing more promising targets into the clinic through the expansion of existing agreements and the addition of new ones."

The Halozyme/Roche relationship dates back to the original global collaboration and licensing agreement for the ENHANZE technology signed in 2006. Under this agreement, Roche developed Rituxan SC ex-U.S., Rituxan Hycela in the U.S., Herceptin SC ex-U.S., is awaiting an FDA action date in 2019 for Herceptin SC in the U.S., and is conducting a Phase 3 study for the fixed dose combination of Perjeta/Herceptin SC. In addition, Roche is in Phase 1 testing with an undisclosed target. More recently, in 2017, the relationship expanded to include the right to evaluate an additional target with ENHANZE.

The Halozyme ENHANZE technology is based on a proprietary recombinant human hyaluronidase enzyme (rHuPH20) that temporarily degrades hyaluronan — a glycosaminoglycan or chain of natural sugars in the body — to aid in the dispersion and absorption of other injected therapeutic drugs. For Halozyme partners, this technology may allow for more rapid delivery of injectable medications through subcutaneous delivery.

About ENHANZE Technology
Halozyme’s proprietary ENHANZE drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

Audentes Therapeutics to Release Third Quarter 2018 Financial Results and Provide Corporate Update on Tuesday, November 6, 2018

On October 30, 2018 Audentes Therapeutics, Inc. (Nasdaq: BOLD), a biotechnology company focused on developing and commercializing innovative gene therapy products for patients living with serious, life-threatening rare diseases, reported that it will host a conference call and webcast to report its third quarter 2018 financial results and provide a corporate update on Tuesday, November 6, 2018 (Press release, Audentes Therapeutics, OCT 30, 2018, View Source [SID1234530357]).

The conference call will be held at 4:30 pm EST, after the market closes. To access a live webcast of the conference call, please visit the Events & Presentations page within the Investor + Media section of the Audentes website at www.audentestx.com. Alternatively, please call (833) 659-8620 (U.S.) or (409) 767-9247 (international) and dial the conference ID# 1473209 to access the call.

A replay of the live webcast will be available on the Audentes website for approximately 30 days