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RANCHO CUCAMONGA, Calif., May 10, 2017 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced today that Jason Shandell, President will be presenting at the 20th Annual Bank of America Merrill Lynch Healthcare Conference on Tuesday, May 16, 2017 at 5:00 p.m. Pacific Time in Las Vegas, NV. This presentation will be made available with a live webcast and may be accessed by visiting Amphastar’s Pharmaceuticals website at http://ir.amphastar.com/events.cfm. This webcast will be available for 90 days following the presentation. Amphastar is a specialty pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation, and intranasal products. Additionally, the Company sells insulin active pharmaceutical ingredient products. Most of the Company’s finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. More information is available at the Company’s website at www.amphastar.com. The Amphastar Pharmaceuticals’ logo and other trademarks or service marks of Amphastar Pharmaceuticals, Inc., including, but not limited to Primatene®, Amphadase® and Cortrosyn®, are the property of Amphastar Pharmaceuticals, Inc. All statements in this press release and in the conference call referenced above that are not historical are forward-looking statements, including, among other things, statements relating to the Company’s expectations regarding future financial performance, backlog, sales and marketing of its products, market size and growth, the timing of FDA filings or approvals, acquisitions and other matters related to its pipeline of product candidates, the timing for completion of construction at the Company’s IMS facility, its share buyback program and other future events. These statements are not historical facts but rather are based on Amphastar’s historical performance and its current expectations, estimates, and projections regarding Amphastar’s business, operations and other similar or related factors. Words such as “may,” “might,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expect,” “intend,” “plan,” “project,” “believe,” “estimate,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Amphastar’s control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Amphastar’s filings with the Securities and Exchange Commission. You can locate these reports through the Company’s website at http://ir.amphastar.com and on the SEC’s website at www.sec.gov. Amphastar undertakes no obligation to revise or update information in this press release or the conference call referenced above to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause the Company’s expectations to change.


News Article | May 9, 2017
Site: www.eurekalert.org

Dan Kallen, a detective in southern New Jersey, was searching a home with fellow officers in August 2015, when they found a bag of white powder. Kallen removed a scoop of powder for testing. When he was done, he closed the bag, and a bit of air escaped, carrying a puff of powder with it. It was enough to send Kallen and a fellow officer to the emergency room. The drugs in the bag had been spiked with fentanyl, a synthetic drug that, like heroin, is an opioid. But it is 50 times more potent than heroin--even a tiny amount inhaled or absorbed through the skin can be extremely dangerous or deadly. Kallen described his experience in a Drug Enforcement Agency video that warns first responders of the dangers of handling unknown powders. Scientists from the National Institute of Standards and Technology (NIST) are working to address this hazard. In a paper published in Forensic Chemistry, they report that two technologies, Ion Mobility Spectrometry (IMS) and Direct Analysis in Real Time Mass Spectrometry (DART-MS), can detect trace amounts of fentanyl even when mixed with heroin and other substances. This research is the first to identify the lowest concentrations at which fentanyl mixtures can be detected using these techniques, and it suggests new ways to protect law enforcement officers, evidence examiners, and drug-sniffing dogs. IMS instruments are commonly used at airports. In that setting, a security officer might swab a piece of luggage or a passenger's hands, then insert the swab into the instrument to check for traces of explosive residue. Similarly, a police officer might test a bag of powder for fentanyl before opening it. "Currently, police officers have to handle drugs to test them," said Ed Sisco, a research chemist at NIST and the lead author of the study. "But with these technologies, they can just swab the outside of a bag to test for fentanyl." If the test comes back positive, they can take extra precautions. Amber Burns, chief of the Controlled and Dangerous Substances Unit at the Maryland State Police Crime lab, agreed that screening with IMS or DART-MS would be useful. "Several law enforcement agencies have reached out to us about how to better handle suspected drugs," Burns said. "Because IMS is portable, it would be pretty user friendly for them to bring to a scene and screen a sample quickly." IMS instruments cost around $35,000 and are the size of a microwave oven. Burns said the DART-MS instruments, which are more sensitive but larger and more expensive, might be ideal for screening incoming material at a forensic lab before it's handled by evidence examiners. In addition, these technologies might be used to screen packages at the border or at postal service inspection facilities. The authors have also reached out to medical researchers about investigating whether fentanyl screening might be useful when treating overdose victims. Because fentanyl is so potent, reviving an individual after a fentanyl-related overdose often requires multiple doses of the opioid antidote naloxone. Swabbing the victim's hands might reveal if fentanyl is involved, and that information might be useful in determining a course of treatment. According to a recent report from the Centers for Disease Control and Prevention, more than 52,000 people died of drug overdoses in the United States in 2015, more than triple the number from 1999. That rapid increase is being driven by heroin and synthetic opioids, mainly fentanyl. In just a single year, from 2014 to 2015, the death rate from synthetic opioids (excluding methadone) increased by 72 percent. Pharmaceutical fentanyl is used as a painkiller. But according to the Drug Enforcement Agency, most illicit fentanyl is smuggled into the United States. The manufacturers constantly create new forms of fentanyl, each with a slightly different chemical structure. They do this to stay one step ahead of the authorities, who must individually ban each new fentanyl analog as it emerges. Drug dealers often lace their supply with fentanyl or an analog to boost its potency. Users may not know the strength of the drugs they're buying, or how the different substances in it interact. A particularly dangerous fentanyl analog, carfentanil, is increasingly turning up in the U.S. drug supply. Carfentanil is used as a large animal tranquilizer, and it is 100 times more potent than fentanyl--5,000 times more potent than heroin. "A small amount, just the size of a poppy seed, can kill you," Burns said. For their research, Sisco and colleagues used IMS and DART-MS instruments to detect 16 different fentanyl analogs, including carfentanil. Both technologies work by ionizing the molecules in question, which gives them an electric charge. An electrical field then draws the ions toward a detector, and you can measure how long it takes for them to arrive. That time delay is like a signature that identifies the molecule. Detecting the synthetic drugs in their pure form is easy. In this case, the researchers mixed small amounts of fentanyl and fentanyl analogs with heroin and with common cutting agents such as caffeine. "We wanted to mimic what first responders and evidence examiners are likely to see in the field," said Sisco. "Would the large amounts of cutting agents mask the fentanyl signatures? That's what we wanted to find out." They found that, using IMS, they could detect fentanyl in mixtures that contain as little as 0.2 percent fentanyl. With DART-MS, they could easily detect mixtures down to 0.1 percent. Both types of instruments were able to detect traces of the compounds that inevitably land on the outside of plastic bags through handling. In addition, both techniques distinguished between most of the different analogs of fentanyl. This is important because some analogs are far more potent than others. In addition, identifying specific analogs will help law enforcement and public health officials keep track of new analogs as they emerge. This research paper is the first to publish the IMS and DART-MS signatures for the 16 fentanyl analogs tested. Sisco and his co-authors are speaking with IMS manufacturers about adding the newly identified signatures to their product software. That way, agencies that already own the instruments would be able to identify the fentanyl analogs after their next software update. NIST publishes a widely used DART-MS library, and the authors are working on getting the signatures added to that library as well. "We hope this makes a real difference to the safety of people who come into contact with synthetic opioids," Sisco said. "The opioid epidemic is a huge problem. This might be one small way to try to get a handle on it." Paper:  E. Sisco, J. Verkouteren, J. Staymates, J. Lawrence, Rapid Detection of Fentanyl, Fentanyl Analogues, and Opioids for on-Site or Laboratory Based Drug Seizure Screening using Thermal Desorption DART-MS and Ion Mobility Spectrometry.  Published online 27 April 2017. Forensic Chemistry. DOI: 10.1016/j.forc.2017.04.001


News Article | May 9, 2017
Site: globenewswire.com

ROCKVILLE, Md., May 09, 2017 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today reported financial results for first quarter 2017 and associated company developments. First quarter 2017 product prescriptions for Trokendi XR® and Oxtellar XR®, as reported by IMS, totaled 134,855, a 17.1% increase over the first quarter of 2016. Net product sales for the first quarter of 2017 were $56.4 million, a 31.2% increase over $43.0 million in the same period the prior year. Consistent with historical patterns, product prescriptions and net product sales for the first quarter of 2017 for Trokendi XR and Oxtellar XR were impacted by the continued shift of patients to high deductible and high co-pay plans. Lower wholesaler and pharmacy inventory levels during the first quarter of 2017, compared to the fourth quarter of 2016, had the effect of reducing net product sales by approximately $5 million in the first quarter of 2017. After receiving final approval from the Food and Drug Administration (FDA) in April 2017, the Company launched Trokendi XR as a new treatment for prophylaxis of migraine headache in adults and adolescents 12 years and older. While it is still early in the launch, for the first three weeks post launch, IMS prescription data for Trokendi XR show a strong upward trend in total and new prescriptions. During the three week period post launch, total prescriptions were 26,472 compared to 24,109 in the three weeks prior to launch, representing a 10% increase. Similarly, for the same three week period post launch, new prescriptions were 12,978 compared to 10,898 in the three weeks prior to launch, representing a 19% increase. Consistent with these early data, feedback from our sales force indicates that physicians are very receptive to the new indication and appreciate the unique benefits that Trokendi XR brings to migraine patients. “We are excited about the launch of Trokendi XR in migraine, and are very encouraged by the early IMS prescription data. We continue to believe that the migraine indication should allow us to realize the full potential of Trokendi XR,” said Jack Khattar, President and CEO of Supernus Pharmaceuticals. "Trokendi XR, with its novel formulation, provides full 24 hour coverage for patients with smooth pharmacokinetics compared to immediate-release topiramate products, making it an important new prophylactic treatment option for adult and adolescent patients suffering from migraine headache.” Enrollment continues in both Phase III trials for SPN-810, currently in development for Impulsive Aggression in patients aged 6 to 12 years who have ADHD. Protocol revisions to improve patient retention during the screening period and programs to drive patient enrollment for the Phase III trials are having a positive impact. We expect enrollment to continue through 2017. Regarding SPN-812, currently in development for patients aged 6 to 12 years with ADHD, the Company continues to plan to initiate Phase III clinical testing during the second half of 2017. The Company is on track to meet with the FDA in the second quarter of 2017 for an end-of-Phase II meeting. “We look forward to discussing further with the FDA our Phase IIb clinical trial results and the design of our Phase III program for SPN-812,” said Jack Khattar. “We remain focused on advancing SPN-812 as a novel highly effective and well tolerated non-stimulant for the treatment of ADHD.” Research and development expenses in the first quarter of 2017 were $9.6 million, as compared to $10.6 million in the same quarter last year. This decrease is primarily due to the completion of enrollment in the Phase IIb trial for SPN-812, which occurred in the third quarter of 2016. Selling, general and administrative expenses in the first quarter of 2017 were $28.2 million, as compared to $25.2 million in the same quarter last year. The increase is due to marketing program development, sample production, and other activities related to preparing for the launch of the migraine headache indication for Trokendi XR, which occurred in April 2017. Operating income in the first quarter of 2017 was $16.8 million, a 160.8% increase over $6.4 million in the same period the prior year. This improvement in operating income is primarily due to increased net product sales. Diluted earnings per share for the first quarter of 2017 were $0.19 compared to $0.08 in the same period last year, an increase of 138% over the prior year. Diluted earnings per share for the first quarter of 2017 includes an effective tax rate of 36.5%, as compared to an effective tax rate of 4.0% during the first quarter of 2016. Weighted-average diluted common shares outstanding were approximately 52.8 million in the first quarter of 2017, as compared to approximately 51.2 million in the same period the prior year. As of March 31, 2017, the Company had $176.3 million in cash, cash equivalents, marketable securities, and long term marketable securities, as compared to $165.5 million at December 31, 2016.  As of May 8, 2017, approximately $1.6 million of the Company’s six year, $90 million notes remain outstanding. During the second quarter of 2017, the Company initiated the process of calling the remaining outstanding principal balance of its six year notes and expects that process to be completed in the quarter. For full year 2017, the Company reiterates its expectation for net product sales, R&D expenses and operating income as set forth below: The Company will hold a conference call hosted by Jack Khattar, President and Chief Executive Officer, and Greg Patrick, Vice President and Chief Financial Officer, to discuss these results at 9:00 a.m. ET, on Wednesday, May 10, 2017. An accompanying webcast also will be provided. Please refer to the information below for conference call dial-in information and webcast registration. Callers should dial in approximately 10 minutes prior to the start of the call. Following the live call, a replay will be available on the Company's website, www.supernus.com, under ‘Investors’. Supernus Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases. The Company currently markets Trokendi XR® (extended-release topiramate) for treatment of migraine and epilepsy and Oxtellar XR® (extended-release oxcarbazepine) for treatment of epilepsy. The Company is also developing several product candidates to address large market opportunities in psychiatry, including SPN-810 for the treatment of Impulsive Aggression in ADHD patients and SPN-812 for the treatment of ADHD. This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information, but relate to predicted or potential future events that are based upon management's current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Company’s ability to sustain and increase its profitability; the Company’s ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company’s corporate strategy; the Company’s future financial performance and projected expenditures; the Company’s ability to increase the number of prescriptions written for each of its products; the Company’s ability to increase its net revenue; the Company’s ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company’s product research and development activities, including the timing and progress of the Company’s clinical trials, and projected expenditures; the Company’s ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company’s product candidates; the Company’s ability to protect its intellectual property and operate its business without infringing upon the intellectual property rights of others; the Company’s expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company’s product candidates; the accuracy of the Company’s estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Company’s ability to increase its manufacturing capabilities for its products and product candidates; the Company’s projected markets and growth in markets; the Company’s product formulations and patient needs and potential funding sources; the Company’s staffing needs; and other risk factors set forth from time to time in the Company’s SEC filings made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events.


RANCHO CUCAMONGA, Calif., May 08, 2017 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) (“Amphastar” or the “Company”) today reported results for the three months ended March 31, 2017. Dr. Jack Zhang, Amphastar’s CEO, commented:  “We continue to execute on our pipeline, having filed four ANDAs in the past two quarters. We will use our extensive research and development capabilities to further expand our pipeline.” For the three months ended March 31, 2017, the Company reported net revenues of $56.7 million, a decrease of 5% compared to $59.4 million for the three months ended March 31, 2016. For the three months ended March 31, 2017, net revenues of enoxaparin were $10.4 million, a decrease of 43% compared to $18.4 million for the three months ended March 31, 2016. $5.6 million of the decrease was due to lower unit volumes, while the remainder was due to lower pricing. Other finished pharmaceutical product revenues were $45.5 million for the three months ended March 31, 2017, representing an increase of 13% compared to $40.2 million for the three months ended March 31, 2016. This was primarily due to an increase in sales of epinephrine to $9.6 million from $4.4 million resulting from increases in both average selling price and unit volumes. The FDA recently requested that the Company discontinue the manufacturing and distribution of its epinephrine injection, USP vial product, which has been marketed under the “grandfather” exception to the FDA’s “Prescription Drug Wrap-Up” program. Unless the FDA grants our request for an extension of the time to sell epinephrine vials, we will discontinue selling this product in the second quarter of 2017. Net revenues from this product were $8.0 million for the three months ended March 31, 2017. Additionally, sales of naloxone increased to $10.9 million from $10.3 million, primarily as a result of an increase in unit volumes that was partially offset by a decrease in average selling price, which resulted from an increase in rebates. Sale of lidocaine decreased to $8.3 million from $9.9 million, primarily as a result of a decrease in unit volumes. Sales of the Company’s insulin active pharmaceutical ingredient, or API, products were $0.7 million for the three months ended March 31, 2017, compared to $0.8 million for the three months ended March 31, 2016. A decrease in production at our IMS facility resulting from a partial plant shutdown and an increase in demand, which was primarily due to a market shortage for three of our pre-filled syringe products, resulted in a sales order backlog of approximately $8.0 million as of March 31, 2017. Specifically, the sterile filling area of the IMS facility was shut down for the month of December 2016 and for part of the month of January 2017 for construction and installation of equipment in a new sterile suite. The backlog created by this shutdown is expected to be fulfilled in the second quarter of 2017. There were no significant backlogs as of March 31, 2016 and December 31, 2016. Cost of revenues were $33.8 million, or 60% of revenues, and $34.5 million, or 58% of revenues, for the three months ended March 31, 2017 and 2016, respectively, representing a decrease of $0.7 million.  Cost of revenues of enoxaparin decreased by $5.6 million, primarily due to a reduction in the number of units shipped. Additional factors affecting gross profit in the first quarter of 2017 included an increase in the unabsorbed manufacturing expense related to decreased production at our IMS facility due to the partial shutdown noted above. Selling, distribution, and marketing expenses were $1.5 million and $1.4 million for the three months ended March 31, 2017 and 2016, respectively. For the three months ended March 31, 2017, general and administrative expenses increased to $11.3 million from $10.9 million for the three months ended March 31, 2016, primarily due to an increase in legal fees. For the three months ended March 31, 2017, research and development expenses increased by 31% to $11.3 million from $8.6 million for the three months ended March 31, 2016, primarily due to expenses related to the production of APIs for our pipeline at the Company’s ANP facility. In February 2017, the Company sold the ANDAs that it acquired in March 2016 and recognized a gain of $2.6 million. The Company recorded an income tax expense of $0.6 million for the three months ended March 31, 2017, compared to an income tax expense of $1.3 million for the three months ended March 31, 2016. The Company recognized net income of $0.9 million, or $0.02 per diluted share, for the three months ended March 31, 2017, compared to a net income of $2.5 million, or $0.05 per fully diluted share, for the three months ended March 31, 2016. The Company’s adjusted non-GAAP quarterly net income was $4.5 million, or $0.09 per fully diluted share, for the three months ended March 31, 2017, compared to an adjusted non-GAAP net income of $5.5 million, or $0.12 per fully diluted share, for the three months ended March 31, 2016. Please see the discussion in the section entitled “Non-GAAP Financial Measures” and the reconciliation of GAAP to non-GAAP measures in Table II of this press release. The Company’s cash and cash equivalents, short-term investments, and unrestricted short-term investments were $79.0 million as of March 31, 2017. Cash flow provided by operating activities for the three months ended March 31, 2017, was $22.4 million. The Company currently has six abbreviated new drug applications, or ANDAs filed with the FDA, targeting products with a market size of over $1.1 billion, three biosimilar products in development targeting products with a market size of $15.0 billion, and 11 generic products in development targeting products with a market size of over $12.0 billion. This market information is based on IMS Health data for the 12 months ended March 31, 2017. The Company’s proprietary pipeline includes NDAs for Primatene® Mist and intranasal naloxone. The Company is currently developing four other proprietary products, which include injectable, inhalation and intranasal dosage forms. Amphastar is a specialty pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation, and intranasal products. Additionally, the Company sells insulin active pharmaceutical ingredient products. Most of the Company’s finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. More information is available at the Company’s website at www.amphastar.com. The Amphastar Pharmaceuticals’ logo and other trademarks or service marks of Amphastar Pharmaceuticals, Inc., including, but not limited to Primatene®, Amphadase® and Cortrosyn®, are the property of Amphastar Pharmaceuticals, Inc. To supplement its consolidated financial statements, which are prepared and presented in accordance with U.S. generally accepted accounting principles, or GAAP, the Company is disclosing non-GAAP financial measures when providing financial results. The Company believes that an evaluation of its ongoing operations (and comparisons of its current operations with historical and future operations) would be difficult if the disclosure of its financial results were limited to financial measures prepared only in accordance with GAAP. As a result, the Company is disclosing certain non-GAAP results, including (i) Adjusted non-GAAP net income (loss) and (ii) Adjusted non-GAAP diluted EPS, that exclude amortization expense, share-based compensation and impairment charges in order to supplement investors’ and other readers’ understanding and assessment of the Company’s financial performance, because the Company’s management uses these measures internally for forecasting, budgeting, and measuring its operating performance. Whenever the Company uses such non-GAAP measures, it will provide a reconciliation of non-GAAP financial measures to their most directly comparable GAAP financial measure. Investors and other readers are encouraged to review the related GAAP financial measures and the reconciliation of non-GAAP measures to their most directly comparable GAAP measure set forth below and should consider non-GAAP measures only as a supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with GAAP. The Company will hold a conference call to discuss its financial results today, May 8, 2017, at 2:00 p.m. Pacific Time. To access the conference call, dial toll-free (877) 881-2595 or (315) 625-3083 for international callers, five minutes before the conference. The passcode for the conference call is 1824897. The call can also be accessed on the Investors page on the Company’s website www.amphastar.com. All statements in this press release and in the conference call referenced above that are not historical are forward-looking statements, including, among other things, statements relating to the Company’s expectations regarding future financial performance, backlog, sales and marketing of its products, market size and growth, the timing of FDA filings or approvals, acquisitions and other matters related to its pipeline of product candidates, the timing for completion of construction at the Company’s IMS facility, its share buyback program and other future events. These statements are not historical facts but rather are based on Amphastar’s historical performance and its current expectations, estimates, and projections regarding Amphastar’s business, operations and other similar or related factors. Words such as “may,” “might,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expect,” “intend,” “plan,” “project,” “believe,” “estimate,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Amphastar’s control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Amphastar’s filings with the Securities and Exchange Commission. You can locate these reports through the Company’s website at http://ir.amphastar.com and on the SEC’s website at www.sec.gov. Amphastar undertakes no obligation to revise or update information in this press release or the conference call referenced above to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause the Company’s expectations to change.


"There's no better place in the world to make significant investments in the biopharmaceutical industry, and in just over a year, Lupin has doubled down on its economic investment in the Somerset community and the global pharmaceutical landscape," said Rep. Watson Coleman. "By expanding their facilities, this organization is not only putting more residents of New Jersey's twelfth congressional district to work, but also, focusing on making affordable medicine for patients worldwide." Since 2016, Lupin has invested over $1 billion in R&D and Manufacturing in the United States. Lupin employs 635 highly skilled and specialized employees in the U.S., with that number expected to grow as Lupin expands. In March 2016, Lupin acquired the Somerset facility for $880 million. Since acquisition, over 80 jobs have been created to support the site bringing the total number of employees in Somerset up to 380.  50 more jobs are expected to be added over the next 12 to 18 months.  In addition, Lupin has invested around $35 million in R&D and infrastructure. "The opening of this facility in Somerset enhances our scale in the U.S. generic market, and is a complement to Lupin's Coral Springs, Florida, inhalation R&D center," stated Lupin President Kurt Nielsen. "We have set ambitious targets for ourselves in the U.S. market.  This 10-fold expansion of our manufacturing site will enable us to meet and exceed our targets.  We are confident that we will continue to grow, and look forward to creating additional opportunities which benefit our community." Headquartered in Mumbai, Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds a global leadership position in the Anti-TB segment. Lupin is the 5th and the 6th largest generics pharmaceutical company by market capitalization (December 31st, 2016, Bloomberg) and sales globally (September 30th, 2016, Bloomberg). The Company is the 4th largest generics pharmaceutical player in the U.S. by prescriptions (5.2% market share – IMS MAT March 2017). It employs more than 635 highly skilled and specialized people at its various facilities across the U.S., including the commercial headquarters in Baltimore, Maryland, and its R&D centers in Somerset, New Jersey and Coral Springs, Florida. The CEO's office is located in Naples, Florida. For the financial year ended 31st March 2016, Lupin's Consolidated sales and Net profit stood at $2.09 billion USD and $345 million USD respectively. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/lupin-announces-opening-of-its-new-100000-square-foot-expansion-at-its-somerset-nj-manufacturing-site-300454680.html


RANCHO CUCAMONGA, Calif., May 08, 2017 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) (“Amphastar” or the “Company”) today reported results for the three months ended March 31, 2017. Dr. Jack Zhang, Amphastar’s CEO, commented:  “We continue to execute on our pipeline, having filed four ANDAs in the past two quarters. We will use our extensive research and development capabilities to further expand our pipeline.” For the three months ended March 31, 2017, the Company reported net revenues of $56.7 million, a decrease of 5% compared to $59.4 million for the three months ended March 31, 2016. For the three months ended March 31, 2017, net revenues of enoxaparin were $10.4 million, a decrease of 43% compared to $18.4 million for the three months ended March 31, 2016. $5.6 million of the decrease was due to lower unit volumes, while the remainder was due to lower pricing. Other finished pharmaceutical product revenues were $45.5 million for the three months ended March 31, 2017, representing an increase of 13% compared to $40.2 million for the three months ended March 31, 2016. This was primarily due to an increase in sales of epinephrine to $9.6 million from $4.4 million resulting from increases in both average selling price and unit volumes. The FDA recently requested that the Company discontinue the manufacturing and distribution of its epinephrine injection, USP vial product, which has been marketed under the “grandfather” exception to the FDA’s “Prescription Drug Wrap-Up” program. Unless the FDA grants our request for an extension of the time to sell epinephrine vials, we will discontinue selling this product in the second quarter of 2017. Net revenues from this product were $8.0 million for the three months ended March 31, 2017. Additionally, sales of naloxone increased to $10.9 million from $10.3 million, primarily as a result of an increase in unit volumes that was partially offset by a decrease in average selling price, which resulted from an increase in rebates. Sale of lidocaine decreased to $8.3 million from $9.9 million, primarily as a result of a decrease in unit volumes. Sales of the Company’s insulin active pharmaceutical ingredient, or API, products were $0.7 million for the three months ended March 31, 2017, compared to $0.8 million for the three months ended March 31, 2016. A decrease in production at our IMS facility resulting from a partial plant shutdown and an increase in demand, which was primarily due to a market shortage for three of our pre-filled syringe products, resulted in a sales order backlog of approximately $8.0 million as of March 31, 2017. Specifically, the sterile filling area of the IMS facility was shut down for the month of December 2016 and for part of the month of January 2017 for construction and installation of equipment in a new sterile suite. The backlog created by this shutdown is expected to be fulfilled in the second quarter of 2017. There were no significant backlogs as of March 31, 2016 and December 31, 2016. Cost of revenues were $33.8 million, or 60% of revenues, and $34.5 million, or 58% of revenues, for the three months ended March 31, 2017 and 2016, respectively, representing a decrease of $0.7 million.  Cost of revenues of enoxaparin decreased by $5.6 million, primarily due to a reduction in the number of units shipped. Additional factors affecting gross profit in the first quarter of 2017 included an increase in the unabsorbed manufacturing expense related to decreased production at our IMS facility due to the partial shutdown noted above. Selling, distribution, and marketing expenses were $1.5 million and $1.4 million for the three months ended March 31, 2017 and 2016, respectively. For the three months ended March 31, 2017, general and administrative expenses increased to $11.3 million from $10.9 million for the three months ended March 31, 2016, primarily due to an increase in legal fees. For the three months ended March 31, 2017, research and development expenses increased by 31% to $11.3 million from $8.6 million for the three months ended March 31, 2016, primarily due to expenses related to the production of APIs for our pipeline at the Company’s ANP facility. In February 2017, the Company sold the ANDAs that it acquired in March 2016 and recognized a gain of $2.6 million. The Company recorded an income tax expense of $0.6 million for the three months ended March 31, 2017, compared to an income tax expense of $1.3 million for the three months ended March 31, 2016. The Company recognized net income of $0.9 million, or $0.02 per diluted share, for the three months ended March 31, 2017, compared to a net income of $2.5 million, or $0.05 per fully diluted share, for the three months ended March 31, 2016. The Company’s adjusted non-GAAP quarterly net income was $4.5 million, or $0.09 per fully diluted share, for the three months ended March 31, 2017, compared to an adjusted non-GAAP net income of $5.5 million, or $0.12 per fully diluted share, for the three months ended March 31, 2016. Please see the discussion in the section entitled “Non-GAAP Financial Measures” and the reconciliation of GAAP to non-GAAP measures in Table II of this press release. The Company’s cash and cash equivalents, short-term investments, and unrestricted short-term investments were $79.0 million as of March 31, 2017. Cash flow provided by operating activities for the three months ended March 31, 2017, was $22.4 million. The Company currently has six abbreviated new drug applications, or ANDAs filed with the FDA, targeting products with a market size of over $1.1 billion, three biosimilar products in development targeting products with a market size of $15.0 billion, and 11 generic products in development targeting products with a market size of over $12.0 billion. This market information is based on IMS Health data for the 12 months ended March 31, 2017. The Company’s proprietary pipeline includes NDAs for Primatene® Mist and intranasal naloxone. The Company is currently developing four other proprietary products, which include injectable, inhalation and intranasal dosage forms. Amphastar is a specialty pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation, and intranasal products. Additionally, the Company sells insulin active pharmaceutical ingredient products. Most of the Company’s finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. More information is available at the Company’s website at www.amphastar.com. The Amphastar Pharmaceuticals’ logo and other trademarks or service marks of Amphastar Pharmaceuticals, Inc., including, but not limited to Primatene®, Amphadase® and Cortrosyn®, are the property of Amphastar Pharmaceuticals, Inc. To supplement its consolidated financial statements, which are prepared and presented in accordance with U.S. generally accepted accounting principles, or GAAP, the Company is disclosing non-GAAP financial measures when providing financial results. The Company believes that an evaluation of its ongoing operations (and comparisons of its current operations with historical and future operations) would be difficult if the disclosure of its financial results were limited to financial measures prepared only in accordance with GAAP. As a result, the Company is disclosing certain non-GAAP results, including (i) Adjusted non-GAAP net income (loss) and (ii) Adjusted non-GAAP diluted EPS, that exclude amortization expense, share-based compensation and impairment charges in order to supplement investors’ and other readers’ understanding and assessment of the Company’s financial performance, because the Company’s management uses these measures internally for forecasting, budgeting, and measuring its operating performance. Whenever the Company uses such non-GAAP measures, it will provide a reconciliation of non-GAAP financial measures to their most directly comparable GAAP financial measure. Investors and other readers are encouraged to review the related GAAP financial measures and the reconciliation of non-GAAP measures to their most directly comparable GAAP measure set forth below and should consider non-GAAP measures only as a supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with GAAP. The Company will hold a conference call to discuss its financial results today, May 8, 2017, at 2:00 p.m. Pacific Time. To access the conference call, dial toll-free (877) 881-2595 or (315) 625-3083 for international callers, five minutes before the conference. The passcode for the conference call is 1824897. The call can also be accessed on the Investors page on the Company’s website www.amphastar.com. All statements in this press release and in the conference call referenced above that are not historical are forward-looking statements, including, among other things, statements relating to the Company’s expectations regarding future financial performance, backlog, sales and marketing of its products, market size and growth, the timing of FDA filings or approvals, acquisitions and other matters related to its pipeline of product candidates, the timing for completion of construction at the Company’s IMS facility, its share buyback program and other future events. These statements are not historical facts but rather are based on Amphastar’s historical performance and its current expectations, estimates, and projections regarding Amphastar’s business, operations and other similar or related factors. Words such as “may,” “might,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expect,” “intend,” “plan,” “project,” “believe,” “estimate,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Amphastar’s control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Amphastar’s filings with the Securities and Exchange Commission. You can locate these reports through the Company’s website at http://ir.amphastar.com and on the SEC’s website at www.sec.gov. Amphastar undertakes no obligation to revise or update information in this press release or the conference call referenced above to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause the Company’s expectations to change.


News Article | May 9, 2017
Site: globenewswire.com

ROCKVILLE, Md., May 09, 2017 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today reported financial results for first quarter 2017 and associated company developments. First quarter 2017 product prescriptions for Trokendi XR® and Oxtellar XR®, as reported by IMS, totaled 134,855, a 17.1% increase over the first quarter of 2016. Net product sales for the first quarter of 2017 were $56.4 million, a 31.2% increase over $43.0 million in the same period the prior year. Consistent with historical patterns, product prescriptions and net product sales for the first quarter of 2017 for Trokendi XR and Oxtellar XR were impacted by the continued shift of patients to high deductible and high co-pay plans. Lower wholesaler and pharmacy inventory levels during the first quarter of 2017, compared to the fourth quarter of 2016, had the effect of reducing net product sales by approximately $5 million in the first quarter of 2017. After receiving final approval from the Food and Drug Administration (FDA) in April 2017, the Company launched Trokendi XR as a new treatment for prophylaxis of migraine headache in adults and adolescents 12 years and older. While it is still early in the launch, for the first three weeks post launch, IMS prescription data for Trokendi XR show a strong upward trend in total and new prescriptions. During the three week period post launch, total prescriptions were 26,472 compared to 24,109 in the three weeks prior to launch, representing a 10% increase. Similarly, for the same three week period post launch, new prescriptions were 12,978 compared to 10,898 in the three weeks prior to launch, representing a 19% increase. Consistent with these early data, feedback from our sales force indicates that physicians are very receptive to the new indication and appreciate the unique benefits that Trokendi XR brings to migraine patients. “We are excited about the launch of Trokendi XR in migraine, and are very encouraged by the early IMS prescription data. We continue to believe that the migraine indication should allow us to realize the full potential of Trokendi XR,” said Jack Khattar, President and CEO of Supernus Pharmaceuticals. "Trokendi XR, with its novel formulation, provides full 24 hour coverage for patients with smooth pharmacokinetics compared to immediate-release topiramate products, making it an important new prophylactic treatment option for adult and adolescent patients suffering from migraine headache.” Enrollment continues in both Phase III trials for SPN-810, currently in development for Impulsive Aggression in patients aged 6 to 12 years who have ADHD. Protocol revisions to improve patient retention during the screening period and programs to drive patient enrollment for the Phase III trials are having a positive impact. We expect enrollment to continue through 2017. Regarding SPN-812, currently in development for patients aged 6 to 12 years with ADHD, the Company continues to plan to initiate Phase III clinical testing during the second half of 2017. The Company is on track to meet with the FDA in the second quarter of 2017 for an end-of-Phase II meeting. “We look forward to discussing further with the FDA our Phase IIb clinical trial results and the design of our Phase III program for SPN-812,” said Jack Khattar. “We remain focused on advancing SPN-812 as a novel highly effective and well tolerated non-stimulant for the treatment of ADHD.” Research and development expenses in the first quarter of 2017 were $9.6 million, as compared to $10.6 million in the same quarter last year. This decrease is primarily due to the completion of enrollment in the Phase IIb trial for SPN-812, which occurred in the third quarter of 2016. Selling, general and administrative expenses in the first quarter of 2017 were $28.2 million, as compared to $25.2 million in the same quarter last year. The increase is due to marketing program development, sample production, and other activities related to preparing for the launch of the migraine headache indication for Trokendi XR, which occurred in April 2017. Operating income in the first quarter of 2017 was $16.8 million, a 160.8% increase over $6.4 million in the same period the prior year. This improvement in operating income is primarily due to increased net product sales. Diluted earnings per share for the first quarter of 2017 were $0.19 compared to $0.08 in the same period last year, an increase of 138% over the prior year. Diluted earnings per share for the first quarter of 2017 includes an effective tax rate of 36.5%, as compared to an effective tax rate of 4.0% during the first quarter of 2016. Weighted-average diluted common shares outstanding were approximately 52.8 million in the first quarter of 2017, as compared to approximately 51.2 million in the same period the prior year. As of March 31, 2017, the Company had $176.3 million in cash, cash equivalents, marketable securities, and long term marketable securities, as compared to $165.5 million at December 31, 2016.  As of May 8, 2017, approximately $1.6 million of the Company’s six year, $90 million notes remain outstanding. During the second quarter of 2017, the Company initiated the process of calling the remaining outstanding principal balance of its six year notes and expects that process to be completed in the quarter. For full year 2017, the Company reiterates its expectation for net product sales, R&D expenses and operating income as set forth below: The Company will hold a conference call hosted by Jack Khattar, President and Chief Executive Officer, and Greg Patrick, Vice President and Chief Financial Officer, to discuss these results at 9:00 a.m. ET, on Wednesday, May 10, 2017. An accompanying webcast also will be provided. Please refer to the information below for conference call dial-in information and webcast registration. Callers should dial in approximately 10 minutes prior to the start of the call. Following the live call, a replay will be available on the Company's website, www.supernus.com, under ‘Investors’. Supernus Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases. The Company currently markets Trokendi XR® (extended-release topiramate) for treatment of migraine and epilepsy and Oxtellar XR® (extended-release oxcarbazepine) for treatment of epilepsy. The Company is also developing several product candidates to address large market opportunities in psychiatry, including SPN-810 for the treatment of Impulsive Aggression in ADHD patients and SPN-812 for the treatment of ADHD. This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information, but relate to predicted or potential future events that are based upon management's current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Company’s ability to sustain and increase its profitability; the Company’s ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company’s corporate strategy; the Company’s future financial performance and projected expenditures; the Company’s ability to increase the number of prescriptions written for each of its products; the Company’s ability to increase its net revenue; the Company’s ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company’s product research and development activities, including the timing and progress of the Company’s clinical trials, and projected expenditures; the Company’s ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company’s product candidates; the Company’s ability to protect its intellectual property and operate its business without infringing upon the intellectual property rights of others; the Company’s expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company’s product candidates; the accuracy of the Company’s estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Company’s ability to increase its manufacturing capabilities for its products and product candidates; the Company’s projected markets and growth in markets; the Company’s product formulations and patient needs and potential funding sources; the Company’s staffing needs; and other risk factors set forth from time to time in the Company’s SEC filings made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events.


RANCHO CUCAMONGA, Calif., May 08, 2017 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) (“Amphastar” or the “Company”) today reported results for the three months ended March 31, 2017. Dr. Jack Zhang, Amphastar’s CEO, commented:  “We continue to execute on our pipeline, having filed four ANDAs in the past two quarters. We will use our extensive research and development capabilities to further expand our pipeline.” For the three months ended March 31, 2017, the Company reported net revenues of $56.7 million, a decrease of 5% compared to $59.4 million for the three months ended March 31, 2016. For the three months ended March 31, 2017, net revenues of enoxaparin were $10.4 million, a decrease of 43% compared to $18.4 million for the three months ended March 31, 2016. $5.6 million of the decrease was due to lower unit volumes, while the remainder was due to lower pricing. Other finished pharmaceutical product revenues were $45.5 million for the three months ended March 31, 2017, representing an increase of 13% compared to $40.2 million for the three months ended March 31, 2016. This was primarily due to an increase in sales of epinephrine to $9.6 million from $4.4 million resulting from increases in both average selling price and unit volumes. The FDA recently requested that the Company discontinue the manufacturing and distribution of its epinephrine injection, USP vial product, which has been marketed under the “grandfather” exception to the FDA’s “Prescription Drug Wrap-Up” program. Unless the FDA grants our request for an extension of the time to sell epinephrine vials, we will discontinue selling this product in the second quarter of 2017. Net revenues from this product were $8.0 million for the three months ended March 31, 2017. Additionally, sales of naloxone increased to $10.9 million from $10.3 million, primarily as a result of an increase in unit volumes that was partially offset by a decrease in average selling price, which resulted from an increase in rebates. Sale of lidocaine decreased to $8.3 million from $9.9 million, primarily as a result of a decrease in unit volumes. Sales of the Company’s insulin active pharmaceutical ingredient, or API, products were $0.7 million for the three months ended March 31, 2017, compared to $0.8 million for the three months ended March 31, 2016. A decrease in production at our IMS facility resulting from a partial plant shutdown and an increase in demand, which was primarily due to a market shortage for three of our pre-filled syringe products, resulted in a sales order backlog of approximately $8.0 million as of March 31, 2017. Specifically, the sterile filling area of the IMS facility was shut down for the month of December 2016 and for part of the month of January 2017 for construction and installation of equipment in a new sterile suite. The backlog created by this shutdown is expected to be fulfilled in the second quarter of 2017. There were no significant backlogs as of March 31, 2016 and December 31, 2016. Cost of revenues were $33.8 million, or 60% of revenues, and $34.5 million, or 58% of revenues, for the three months ended March 31, 2017 and 2016, respectively, representing a decrease of $0.7 million.  Cost of revenues of enoxaparin decreased by $5.6 million, primarily due to a reduction in the number of units shipped. Additional factors affecting gross profit in the first quarter of 2017 included an increase in the unabsorbed manufacturing expense related to decreased production at our IMS facility due to the partial shutdown noted above. Selling, distribution, and marketing expenses were $1.5 million and $1.4 million for the three months ended March 31, 2017 and 2016, respectively. For the three months ended March 31, 2017, general and administrative expenses increased to $11.3 million from $10.9 million for the three months ended March 31, 2016, primarily due to an increase in legal fees. For the three months ended March 31, 2017, research and development expenses increased by 31% to $11.3 million from $8.6 million for the three months ended March 31, 2016, primarily due to expenses related to the production of APIs for our pipeline at the Company’s ANP facility. In February 2017, the Company sold the ANDAs that it acquired in March 2016 and recognized a gain of $2.6 million. The Company recorded an income tax expense of $0.6 million for the three months ended March 31, 2017, compared to an income tax expense of $1.3 million for the three months ended March 31, 2016. The Company recognized net income of $0.9 million, or $0.02 per diluted share, for the three months ended March 31, 2017, compared to a net income of $2.5 million, or $0.05 per fully diluted share, for the three months ended March 31, 2016. The Company’s adjusted non-GAAP quarterly net income was $4.5 million, or $0.09 per fully diluted share, for the three months ended March 31, 2017, compared to an adjusted non-GAAP net income of $5.5 million, or $0.12 per fully diluted share, for the three months ended March 31, 2016. Please see the discussion in the section entitled “Non-GAAP Financial Measures” and the reconciliation of GAAP to non-GAAP measures in Table II of this press release. The Company’s cash and cash equivalents, short-term investments, and unrestricted short-term investments were $79.0 million as of March 31, 2017. Cash flow provided by operating activities for the three months ended March 31, 2017, was $22.4 million. The Company currently has six abbreviated new drug applications, or ANDAs filed with the FDA, targeting products with a market size of over $1.1 billion, three biosimilar products in development targeting products with a market size of $15.0 billion, and 11 generic products in development targeting products with a market size of over $12.0 billion. This market information is based on IMS Health data for the 12 months ended March 31, 2017. The Company’s proprietary pipeline includes NDAs for Primatene® Mist and intranasal naloxone. The Company is currently developing four other proprietary products, which include injectable, inhalation and intranasal dosage forms. Amphastar is a specialty pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation, and intranasal products. Additionally, the Company sells insulin active pharmaceutical ingredient products. Most of the Company’s finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. More information is available at the Company’s website at www.amphastar.com. The Amphastar Pharmaceuticals’ logo and other trademarks or service marks of Amphastar Pharmaceuticals, Inc., including, but not limited to Primatene®, Amphadase® and Cortrosyn®, are the property of Amphastar Pharmaceuticals, Inc. To supplement its consolidated financial statements, which are prepared and presented in accordance with U.S. generally accepted accounting principles, or GAAP, the Company is disclosing non-GAAP financial measures when providing financial results. The Company believes that an evaluation of its ongoing operations (and comparisons of its current operations with historical and future operations) would be difficult if the disclosure of its financial results were limited to financial measures prepared only in accordance with GAAP. As a result, the Company is disclosing certain non-GAAP results, including (i) Adjusted non-GAAP net income (loss) and (ii) Adjusted non-GAAP diluted EPS, that exclude amortization expense, share-based compensation and impairment charges in order to supplement investors’ and other readers’ understanding and assessment of the Company’s financial performance, because the Company’s management uses these measures internally for forecasting, budgeting, and measuring its operating performance. Whenever the Company uses such non-GAAP measures, it will provide a reconciliation of non-GAAP financial measures to their most directly comparable GAAP financial measure. Investors and other readers are encouraged to review the related GAAP financial measures and the reconciliation of non-GAAP measures to their most directly comparable GAAP measure set forth below and should consider non-GAAP measures only as a supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with GAAP. The Company will hold a conference call to discuss its financial results today, May 8, 2017, at 2:00 p.m. Pacific Time. To access the conference call, dial toll-free (877) 881-2595 or (315) 625-3083 for international callers, five minutes before the conference. The passcode for the conference call is 1824897. The call can also be accessed on the Investors page on the Company’s website www.amphastar.com. All statements in this press release and in the conference call referenced above that are not historical are forward-looking statements, including, among other things, statements relating to the Company’s expectations regarding future financial performance, backlog, sales and marketing of its products, market size and growth, the timing of FDA filings or approvals, acquisitions and other matters related to its pipeline of product candidates, the timing for completion of construction at the Company’s IMS facility, its share buyback program and other future events. These statements are not historical facts but rather are based on Amphastar’s historical performance and its current expectations, estimates, and projections regarding Amphastar’s business, operations and other similar or related factors. Words such as “may,” “might,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expect,” “intend,” “plan,” “project,” “believe,” “estimate,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Amphastar’s control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Amphastar’s filings with the Securities and Exchange Commission. You can locate these reports through the Company’s website at http://ir.amphastar.com and on the SEC’s website at www.sec.gov. Amphastar undertakes no obligation to revise or update information in this press release or the conference call referenced above to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause the Company’s expectations to change.


LOWELL, Mass.--(BUSINESS WIRE)--MACOM Technology Solutions Inc. (“MACOM”), will showcase its industry leading GaN on Silicon portfolio and other high-performance MMIC and Diode products at IEEE’s International Microwave Symposium (IMS) 2017 in Honolulu, Hawaii, June 6 - 8. MACOM’s booth will feature new product solutions optimized for commercial, industrial, scientific and medical RF applications. Visit Booth #1312 to meet with MACOM experts and learn more about: Members of MACOM’s product management, engineering and applications teams will be available at Booth #1312 to answer any inquiries or questions. MACOM experts will also be participating in various sessions throughout IMS, including: For more information about IMS 2017 visit www.ims2017.org. ABOUT MACOM: MACOM is a new breed of analog semiconductor company — one that delivers a unique combination of high growth, diversification and high profitability. We are enabling a better-connected and safer world by delivering breakthrough semiconductor technologies for optical, wireless and satellite networks that satisfy society’s insatiable demand for information. Today, MACOM powers the infrastructure that millions of lives and livelihoods depend on every minute to communicate, transact business, travel, stay informed and be entertained. Our technology increases the speed and coverage of the mobile Internet and enables fiber optic networks to carry previously unimaginable volumes of traffic to businesses, homes and data centers. Keeping us all safe, MACOM technology enables next-generation radars for air traffic control and weather forecasting, as well as mission success on the modern networked battlefield. MACOM is the partner of choice to the world’s leading communications infrastructure and aerospace and defense companies, helping solve their most complex challenges in areas including network capacity, signal coverage, energy efficiency, and field reliability, through its best-in-class team and broad portfolio of RF, microwave, millimeterwave and lightwave semiconductor products. MACOM is a pillar of the semiconductor industry, thriving for more than 60 years of daring to change the world for the better through bold technological strokes that deliver true competitive advantage to customers and superior value to investors. Headquartered in Lowell, Massachusetts, MACOM is certified to the ISO9001 international quality standard and ISO14001 environmental management standard. MACOM has design centers and sales offices throughout North America, Europe, Asia and Australia. MACOM, M/A-COM, M/A-COM Technology Solutions, M/A-COM Tech, Partners in RF & Microwave, The First Name in Microwave and related logos are trademarks of MACOM. All other trademarks are the property of their respective owners. For more information about MACOM, please visit www.macom.com follow @MACOMtweets on Twitter, join MACOM on LinkedIn, or visit the MACOM YouTube Channel. DISCLAIMER FOR NEW PRODUCTS: Any express or implied statements in MACOM product announcements are not meant as warranties or warrantable specifications of any kind. The only warranty MACOM may offer with respect to any product sale is one contained in a written purchase agreement between MACOM and the purchaser concerning such sale and signed by a duly authorized MACOM employee, or, to the extent MACOM's purchase order acknowledgment so indicates, the limited warranty contained in MACOM's standard Terms and Conditions for Quotation or Sale, a copy of which may be found at: http://www.macom.com/purchases.


SHANGHAI, May 12, 2017 /PRNewswire/ -- Budweiser STORM Music Festival's 2017 press conference was held in Shanghai on May 11. Eric Zho, founder and CEO of A2LiVE, the producer and promoter of Budweiser STORM, announced the 2017 touring plans and cities at the event. Having made a spectacular impact in 2016 on five major Chinese cities and received accolades from media and fans, Budweiser STORM announced its 2017 return to key markets plus expansionary plans into new cities within China, including Beijing, Shanghai, Chengdu, Guangzhou, Shenzhen, Nanjing, Hangzhou, Changsha, and Xiamen. More lovers of electronic dance music will be able to revel in Budweiser STORM's signature music and lifestyle experience at the festivals, or via live stream broadcast from their living rooms. Additionally, Budweiser STORM Music Festival is delighted to announce its unprecedented spread to cities outside mainland China, touching down in Taipei and announcing STORM Australia as part of the 2017 tour. This marks a milestone for the development of the Asian electronic music industry, and for A2LiVE, the pioneering company that is leading the charge. Historically, the electronic dance music scene in China has drawn heavily from Western influences. With increasing numbers of international festivals taking aim at the enormous consumer market in China, the genre is getting more influences from outside its borders. When China-born titan STORM goes abroad for the first time, pushing its blend of international electronic music stars outside its home country, China will finally become more cemented in the world view as a real pillar of the electronic music community. Due to STORM's rapid expansion, more music lovers worldwide will experience the magical energy that STORM produces and propagates. China will no longer only take cues from abroad but will also play a crucial role in innovating, setting the trends and shaping the global dance music scene. A2LiVE is also proud to unveil its latest project in the world of electronic dance music - Storm Records! This new record label has been formed in proud partnership with Spinnin' Records, the biggest and baddest independent dance music label in the world today. A2LiVE will collaborate with the iconic Amsterdam-based Spinnin' imprint in order to truly blend East and West - fusing together their vast networks of talented music producers around the world. This will generate interesting new artistic collaborations and a stream of releases that merits the backing of such highly respected industry leaders. Electronic dance music has been trending hard with Chinese youth - rave to the world's best DJs at the 2017 Budweiser STORM Festivals! Elaine Liu, Connections Director of AB-InBev APAC North, has deemed the past three years partnership with A2LiVe as a huge success. "Electronic dance music always inspires and encourages people to unleash themselves, which coincides with the spirit that Budweiser holds dear. It's great to witness the rapid popularization of electronic music within the Chinese youth market; more and more young people have started to unleash their true selves via the power of this musical genre and lifestyle. In some markets, tickets for the 2016 editions of the Budweiser STORM Festival sold out in minutes, and the limited-edition aluminum Budweiser STORM bottle became a fashionable and iconic image amongst electronic dance music fans. In 2017, together with A2LiVE, we will bring all Budweiser STORM Festivals to a whole new level of production, music programming, and surprises. Meanwhile, there are plans for a series of branded and themed events surrounding Budweiser STORM Festivals to bring these phenomenal experiences to even more consumers." On the heels of Budweiser STORM Festival in Shanghai, International Music Summit (IMS) Asia Pacific is the three-day inspirational and educational dance music conference platform, where professionals in the international electronic music industry participate in a series of talks, interactive workshops and intimate networking opportunities. Last year, A2LiVE brought IMS Asia Pacific to Shanghai, and gathered a broad range of industry giants to discuss the developments and challenges of the explosive electronic dance music industry in the Asia Pacific region. Two of the world's biggest electronic artists, Alesso and Skrillex, respectively shared how they built their profiles in Asia. Alesso announced his collaboration with Asia's Pop Mandarin Queen and vocalist Jolin Tsai-"I Wanna Know". In tandem with IMS Asia-Pacific and OWSLA, Boiler room returned to Shanghai with a special debut from IMS speaker Skrillex and was one of the most viewed and highest streamed Boiler Rooms ever. This year IMS Asia Pacific will return on September21-22, 2017. Early bird badges will be on sale on May 24 at imsasiapacific.cn. More information on IMS Asia Pacific, please visit the official website at imsasiapacific.cn, or follow " IMS_China" on Wechat. A2LiVE is a live entertainment company based in Shanghai, and is the premier guiding force of the live electronic music industry in China today. Its mission is to become the leading vertically integrated electronic music platform in Asia, bringing the biggest and best destination electronic music experiences, music, video, news, and culture. Since inception, A2LiVE has showcased many well-known international and homegrown artists in China including Axwell & Ingrosso, Skrillex, Hardwell, Afrojack, Dash Berlin, Avicii, David Guetta, Wang Lee Hom, Benny Benassi, Afrojack, Cazzette, Icona Pop, Oliver Heldens, Far East Movement, Pitbull, Kanye West, Incubus, etc. A2LiVE's "Budweiser STORM" electronic music festival toured 5 markets in 2016 and energized 250,000 festival goers, with multiple new cities coming online in 2017. This year also marks the launch of DianYinTai (streaming electronic music service), growth of A2LiVE's artist management holdings (A2ARTIST and Strobe Light Talent), unveiling of its new DJ/production academy and record label divisions, and other related businesses. Find out more at www.a2live.cn Budweiser, an American-style lager, was introduced in 1876 when company founder Adolphus Busch set out to create the United States' first truly national beer brand - brewed to be universally popular and transcend regional tastes. Each batch of Budweiser stays true to the same family recipe used by five generations of Busch family brewmasters. Budweiser is a medium-bodied, flavorful, crisp and pure beer with blended layers of premium American and European hop aromas, brewed for the perfect balance of flavor and refreshment. Budweiser is made using time-honored methods including "kraeusening" for natural carbonation and Beechwood aging, which results in unparalleled balance and character. More information on Budweiser, please visit their official website at budweiser.com.

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